[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)] [Proposed Rules] [Pages 21781-21804] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2010-8934] [[Page 21781]] ----------------------------------------------------------------------- Part VII Department of Health and Human Services ----------------------------------------------------------------------- ###Semiannual Regulatory Agenda### [[Page 21782]] DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) _______________________________________________________________________ DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 21 CFR Ch. I 42 CFR Chs. I-V 45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII Regulatory Agenda AGENCY: Office of the Secretary, HHS. ACTION: Semiannual regulatory agenda _______________________________________________________________________ SUMMARY: The following Agenda presents the results of the statutorily required semi-annual inventory of rulemaking actions currently under development within the U.S. Department of Health and Human Services (HHS). We hope that this information will enable interested members of the public to more effectively participate in the Department's regulatory activity. FOR FURTHER INFORMATION CONTACT: Dawn L. Smalls, Executive Secretary, Department of Health and Human Services, Washington, DC 20201. SUPPLEMENTARY INFORMATION: The information provided in the Agenda presents a forecast of the rulemaking activities that HHS expects to undertake in the foreseeable future. Rulemakings are grouped according to pre-rulemaking actions, proposed rules, final rules, long-term actions, and rulemaking actions completed since the most recent Agenda was published on December 7, 2009. Please note that the actions included in this issue of the Federal Register, as required by the Regulatory Flexibility Act of 1980, relate only to those prospective rulemakings that are likely to have a significant economic impact on a substantial number of small entities. The purpose of the Agenda is to encourage more effective public participation in the regulatory process. HHS invites all interested members of the public to comment on the rulemaking actions included in this issuance of the Agenda. The complete Agenda is accessible online at www.reginfo.gov in an interactive format that offers users enhanced capabilities to obtain information from the Agenda's database. Dated: March 10, 2010. Dawn L. Smalls, Executive Secretary, Department of Health and Human Services. Office of the Secretary--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 120 Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health 0991-AB57 Information Technology for Economic and Clinical Health Act........................... ---------------------------------------------------------------------------------------------------------------- Office of the Secretary--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 121 Health Information Technology: Initial Set of Standards, Implementation 0991-AB58 Specifications, and Certification Criteria for Electronic Health Record Technology (Rulemaking Resulting From a Section 610 Review)...................................... ---------------------------------------------------------------------------------------------------------------- Substance Abuse and Mental Health Services Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 122 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section 0930-AA14 610 Review)........................................................................... ---------------------------------------------------------------------------------------------------------------- Substance Abuse and Mental Health Services Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 123 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical 0930-AA10 Community-Based Facilities for Children and Youth..................................... ---------------------------------------------------------------------------------------------------------------- [[Page 21783]] Centers for Disease Control and Prevention--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 124 Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of 0920-AA14 HHS/CDC Animal Importation Regulations................................................ 125 Control of Communicable Diseases: Foreign Quarantine Regulations, Nonhuman Primate.... 0920-AA23 126 Total Inward Leakage Requirements for Respirators..................................... 0920-AA33 ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 127 Quality Assurance Requirements for Respirators........................................ 0920-AA04 128 Control of Communicable Diseases: Foreign Quarantine.................................. 0920-AA12 ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 129 Possession, Use, and Transfer of Select Agents and Toxins: Chapare Virus (Section 610 0920-AA32 Review)............................................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 130 Control of Communicable Diseases: Interstate Quarantine, Passenger Information........ 0920-AA27 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 131 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of 0910-AG06 Shell Eggs Held for Retail Distribution (Section 610 Review).......................... 132 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; 0910-AG14 Policies, Requirements, and Administrative Procedures (Section 610 Review)............ 133 Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Section 610 0910-AG25 Review)............................................................................... 134 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco 0910-AG33 To Protect Children and Adolescents................................................... 135 Over-the-Counter Human Drugs; Labeling Requirements (Section 610 Review).............. 0910-AG34 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 136 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics....... 0910-AC52 137 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31 138 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36 139 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38 140 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43 141 Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products............... 0910-AF69 142 Process Controls for Animal Feed Ingredients and Mixed Animal Feed.................... 0910-AG10 [[Page 21784]] 143 Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug 0910-AG12 Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph........ 144 Unique Device Identification.......................................................... 0910-AG31 145 Produce Safety Regulation............................................................. 0910-AG35 146 Modernization of the Current Food Good Manufacturing Practices Regulation............. 0910-AG36 147 Cigars Subject to the Family Smoking Prevention and Tobacco Control Act............... 0910-AG38 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 148 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products.... 0910-AA97 149 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53 150 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11 Requirements for Pregnancy and Lactation Labeling..................................... 151 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; 0910-AF27 Notification Requirements; Records and Reports; and Quality Factors................... 152 Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32 153 Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33 154 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35 155 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42 156 Use of Materials Derived From Cattle in Human Food and Cosmetics...................... 0910-AF47 157 Label Requirement for Food That Has Been Refused Admission Into the United States..... 0910-AF61 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 158 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding 0910-AB88 Operations for Dietary Supplements.................................................... 159 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34 160 Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37 161 Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39 162 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40 163 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44 164 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45 165 Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products......... 0910-AF51 166 Over-the-Counter (OTC) Drug Review--Antacid Products.................................. 0910-AF52 167 Over-the-Counter (OTC) Drug Review--Skin Bleaching Products........................... 0910-AF53 168 Over-the-Counter (OTC) Drug Review--Stimulant Drug Products........................... 0910-AF56 169 Over-the-Counter Antidiarrheal Drug Products.......................................... 0910-AF63 170 Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products................... 0910-AF70 171 Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients..... 0910-AF95 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 172 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55 173 Over-the-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide.... 0910-AG00 ---------------------------------------------------------------------------------------------------------------- [[Page 21785]] Centers for Medicare & Medicaid Services--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 174 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 0938-AG81 Review)............................................................................... 175 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610 0938-AP32 Review)............................................................................... 176 Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care 0938-AP80 Hospitals and FY 2011 Rates and to the Long-Term Care Hospital PPS and RY 2011 Rates (CMS-1498-P).......................................................................... 177 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP82 Center Payment System for CY 2011 (CMS-1504-P)........................................ 178 Home Health Prospective Payment System Refinements and Rate Update for CY 2011 (CMS- 0938-AP88 1510-P)............................................................................... 179 Omnibus Influenza Immunization (CMS-3213-P)........................................... 0938-AP92 180 Proposed Changes to the Hospital Conditions of Participation: Requirements for 0938-AP97 Hospital Psychiatric and Rehabilitation Units Excluded From the Prospective Payment System (CMS-3177-P)................................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 181 Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs 0938-AP77 for Contract Year 2011 (CMS-4085-F)................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 182 Electronic Claims Attachments Standards (CMS-0050-IFC)................................ 0938-AK62 183 Revisions to Payment Policies Under the Physician Fee Schedule for CY 2010 (CMS-1413- 0938-AP40 FC)................................................................................... 184 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP41 Center Payment System for CY 2010 (CMS-1414-FC)....................................... ---------------------------------------------------------------------------------------------------------------- _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 120. MODIFICATIONS TO THE HIPAA PRIVACY, SECURITY, AND ENFORCEMENT RULES UNDER THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT Legal Authority: PL 111-5, secs 13400 to 13410 Abstract: The Department of Health and Human Services Office for Civil Rights will issue rules to modify the HIPAA Privacy, Security, and Enforcement Rules as necessary to implement the privacy, security, and certain enforcement provisions of subtitle D of the Health Information Technology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Andra Wicks, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201 Phone: 202 205-2292 Fax: 202 205-4786 Email: [email protected] RIN: 0991-AB57 [[Page 21786]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 121. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR ELECTRONIC HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION 610 REVIEW) Legal Authority: 42 USC 300jj-14 Abstract: The Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology, will issue an interim final rule with a request for comments to adopt an initial set of standards, implementation specifications, and certification criteria, as required by section 3004(b)(1) of the Public Health Service Act. The certification criteria adopted in this initial set establish the technical capabilities and related standards that certified electronic health record (EHR) technology will need to include in support of the Medicare and Medicaid EHR Incentive Programs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 01/13/10 75 FR 2014 Interim Final Rule Comment Period End 03/15/10 Interim Final Rule Effective 02/12/10 Final Action 05/00/10 Final Action Effective 06/00/10 Regulatory Flexibility Analysis Required: No Agency Contact: Steven Posnack, Policy Analyst, Department of Health and Human Services, Office of the Secretary, Office of the National Coordinator for Health Information Technology, 200 Independence Avenue SW., Washington, DC 20201 Phone: 202 690-7151 RIN: 0991-AB58 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 122. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE ADDICTION (SECTION 610 REVIEW) Legal Authority: 21 USC 823 (9); 42 USC 257a; 42 USC 290aa(d); 42 USC 290dd-2; 42 USC 300xx-23; 42 USC 300x-27(a); 42 USC 300y-11 Abstract: This rule will amend the Federal opioid treatment program regulations. It will modify the dispensing requirements for buprenorphine and buprenorphine combination products that are approved by the Food and Drug Administration (FDA) for opioid dependence and used in federally certified and registered opioid treatment programs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/19/09 74 FR 29153 NPRM Comment Period End 08/18/09 Final Action 09/00/10 Regulatory Flexibility Analysis Required: No Agency Contact: Nicholas Reuter, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Suite 2-1063, One Choke Cherry Road, Rockville, MD 20857 Phone: 240 276-2716 RIN: 0930-AA14 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 123. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH Legal Authority: PL 106-310, 42 USC 290jj to 290jj-2 Abstract: The Secretary is required by statute to publish regulations governing States that license nonmedical, community-based residential facilities for children and youth. The regulation requires States to develop licensing rules and monitoring requirements concerning behavior management practice that will ensure compliance; requires States to develop and implement such licensing rules and implementation requirements within one year; and ensures that States require such facilities to have adequate staff, and that the States provide training for professional staff. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Paolo Del Vecchio, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Room 13-103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-2619 RIN: 0930-AA10 [[Page 21787]] _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 124. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC ANIMAL IMPORTATION REGULATIONS Legal Authority: 42 USC 264 Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. The Secretary has designated the authority to prevent the introduction of diseases from foreign countries to the Director, Centers for Disease Control and Prevention (CDC). CDC also enforces entry requirements for certain animals, etiologic agents, and vectors deemed to be of public health significance. Currently the regulations restrict the importation of nonhuman primates, dogs, cats, small turtles, etiologic agents, hosts, and vectors, such as bats (42 CFR sections 71.53, 71.51, 71.52, 71.54). In addition, CDC has recently issued a series of emergency orders restricting the importation of African rodents (42 CFR section 71.56) and civets (67 FR 3364-01). CDC is issuing this Notice of Proposed Rulemaking (NPRM) to revise the regulations for importation of certain animals and vectors into the United States (42 CFR parts 71, subpart F). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 07/31/07 72 FR 41676 ANPRM Comment Period End 10/01/07 Notice Extending ANPRM Comment Period 10/01/07 72 FR 55729 ANPRM Extended Comment Period End 12/01/07 NPRM 11/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E03, CLFT Building 16, Room 4324, Atlanta, GA 30329 Phone: 404 498-1600 Email: [email protected] RIN: 0920-AA14 _______________________________________________________________________ 125. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS, NONHUMAN PRIMATE Legal Authority: 42 USC 264 Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. The Secretary has delegated the authority to prevent the introduction of diseases from foreign countries to the Director, CDC. CDC also enforces entry requirements for certain animals, etiologic agents, and vectors deemed to be of public health significance. CDC is proposing to amend its regulations related to the importation of live nonhuman primates (NHPs) by extending existing requirements for the importation of cynomolgus, African green, and rhesus monkeys to all NHPs. The agency also is proposing to reduce the frequency at which importers of the three species are required to renew their registrations (from every 180 days to every 2 years). CDC proposes to incorporate existing guidelines into the regulations and add new provisions to address NHPs imported as part of a circus or trained animal act, NHPs imported by zoological societies, the transfer of NHPs from approved laboratories, and non- live imported NHP products. CDC is also proposing that all NHPs be imported only through ports of entry where a CDC quarantine station is located. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E03, CLFT Building 16, Room 4324, Atlanta, GA 30329 Phone: 404 498-1600 Email: [email protected] RIN: 0920-AA23 _______________________________________________________________________ 126. TOTAL INWARD LEAKAGE REQUIREMENTS FOR RESPIRATORS Legal Authority: 29 USC 651 et seq; 29 USC 657(g); 30 USC 3; 30 USC 7; 30 USC 811; 30 USC 842(h) and 844 Abstract: The Centers for Disease Control and Prevention (CDC) proposes to establish total inward leakage (TIL) requirements under 42 CFR part 84 for half-mask air-purifying particulate respirators approved by the National Institute for Occupational Safety and Health (NIOSH) of CDC. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/30/09 74 FR 66935 NPRM Comment Period End 12/29/09 NPRM Comment Period Reopened 04/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: William E. Newcomb, Physical Scientist, Department of Health and Human Services, Centers for Disease Control and Prevention, 626 Cochran Mill Road, PO Box 18070, Pittsburgh, PA 15236 Phone: 412 386-5200 RIN: 0920-AA33 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 127. QUALITY ASSURANCE REQUIREMENTS FOR RESPIRATORS Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 USC 811; 30 USC 842(h); 30 USC 844 Abstract: NIOSH plans to modify the Administrative/Quality Assurance sections of 42 CFR part 84, Approval of Respiratory Protective Devices. Areas for potential modification in this module are: 1) Upgrade of quality assurance requirements; 2) ability to use private sector quality auditors and private sector testing laboratories in the approval program; and 3) revised approval label requirements. [[Page 21788]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/10/08 73 FR 75045 NPRM Comment Period End 02/09/09 NPRM Comment Period Reopened 03/04/09 74 FR 9381 NPRM Comment Period Reopened End04/10/09 NPRM Comment Period Reopening Extended 05/21/09 74 FR 23815 NPRM Comment Period End 10/09/09 Final Action 12/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: William E. Newcomb, Physical Scientist, Department of Health and Human Services, Centers for Disease Control and Prevention, 626 Cochran Mill Road, PO Box 18070, Pittsburgh, PA 15236 Phone: 412 386-5200 RIN: 0920-AA04 _______________________________________________________________________ 128. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE Legal Authority: 42 USC 243; 42 USC 248 and 249 Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. Quarantine regulations are divided into two parts: Part 71 dealing with foreign arrivals and part 70 dealing with interstate matters. This rule (42 CFR part 71) will update and improve CDC's response to both global and domestic disease threats by creating a multi-tiered illness detection and response process thus substantially enhancing the public health system's ability to slow the introduction, transmission, and spread of communicable disease. The rule will also modify current Federal regulations governing the apprehension, quarantine isolation, and conditional release of individuals suspected of carrying a quarantinable disease, while respecting individual autonomy. CDC maintains quarantine stations at 20 ports of entry staffed with medical and public health officers who respond to reports of diseases from carriers. According to the statutory scheme, the President determines through Executive Order which diseases may subject individuals to quarantine. The current disease list, which was last updated in April 2005, includes cholera, diphtheria, tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute respiratory syndrome (SARS), and influenza caused by novel or reemergent influenza viruses that are causing, or have the potential to cause a pandemic. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/30/05 70 FR 71892 NPRM Comment Period End 01/20/06 Final Action 11/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E03, CLFT Building 16, Room 4324, Atlanta, GA 30329 Phone: 404 498-1600 Email: [email protected] RIN: 0920-AA12 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 129. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS: CHAPARE VIRUS (SECTION 610 REVIEW) Legal Authority: PL 107-188 Abstract: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 authorizes the HHS Secretary to regulate the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety. These regulations are set forth at 42 CFR 73. Criteria used to determine whether a select agent or toxin should be included under the provisions of these regulations are based on: 1) The effect on human health as a result of exposure to the agent or toxin, 2) the degree of contagiousness of the agent or toxin, 3) the methods by which the agent or toxin is transferred to humans, 4) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent and illness resulting from infection by the agent or toxin, and 5) any other criteria, including the needs of children and other vulnerable populations that the HHS Secretary considers appropriate. Based on these criteria, we are proposing to amend the list of HHS select agents and toxins by adding Chapare virus to the list. After consulting with subject matter experts from CDC, the National Institutes of Health (NIH), the Food Drug Administration (FDA), the United States Department of Agriculture (USDA) /Animal and Plant Health Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), USDA/CVB (Center for Veterinary Biologics), and the Department of Defense (DOD)/United States Army Medical Research Institute for Infectious Diseases (USAMRIID) and review of relevant published studies, we believe the Chapare virus should be added to the list of HHS select agents and toxins based on our conclusion that the Chapare virus has been phylogenetically identified as a Clade B arenavirus and is closely related to other South American arenaviruses that cause haemorrhagic fever, particularly Sabia virus. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/19/09 74 FR 159 NPRM Comment Period End 10/19/09 Final Action To Be Determined Regulatory Flexibility Analysis Required: No Agency Contact: Robbin Weyant, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 20, Room 4202, 1600 Clifton Road NE., Atlanta, GA 30333 Phone: 404 718-2000 RIN: 0920-AA32 [[Page 21789]] _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 130. CONTROL OF COMMUNICABLE DISEASES: INTERSTATE QUARANTINE, PASSENGER INFORMATION Legal Authority: 25 USC 198.231; 25 USC 1661; 42 USC 243; 42 USC 248; 42 USC 249; 42 USC 264; 42 USC 266 to 268; 42 USC 270 to 272; 42 USC 2001 Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from one State or possession into another. Quarantine regulations are divided into two parts: Part 71 dealing with foreign arrivals and part 70 dealing with interstate matters. The CDC Director has been delegated the responsibility for carrying out these regulations. The Director's authority to investigate suspected cases and potential spread of communicable disease among interstate travelers is thus not limited to those known or suspected of having a quarantinable disease, but rather all communicable diseases that may necessitate a public health response. Among the fundamental components of the public health response to the report of a person with a communicable disease is the identification and evaluation of individuals who may have been exposed. This provision, which was proposed section 70.4, would require any airline operating in interstate traffic to solicit and electronically submit certain passenger information to CDC for use in contact tracing when necessary to protect the vital interests of an individual, or other persons, in regard to significant health risks. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/30/05 70 FR 71892 NPRM Comment Period End 01/30/06 Merged With 0920-AA22 02/12/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E03, CLFT Building 16, Room 4324, Atlanta, GA 30329 Phone: 404 498-1600 Email: [email protected] RIN: 0920-AA27 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 131. FOOD LABELING: SAFE HANDLING STATEMENTS, LABELING OF SHELL EGGS; REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION (SECTION 610 REVIEW) Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 331; 21 USC 342 and 343; 21 USC 348; 21 USC 371; 42 USC 243; 42 USC 264; 42 USC 271 Abstract: Section 101.17(h) (21 CFR 101.17(h)) describes requirements for the labeling of the cartons of shell eggs that have not been treated to destroy Salmonella microorganisms. Section 115. 50 (21 CFR 115.50) describes requirements for refrigeration of shell eggs held for retail distribution. Section 16.5(a)(4) (21 CFR 16.5(a)(4)) provides that part 16 does not apply to a hearing on an order for relabeling, diversion, or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264) and sections 101.17(h) and 115.50. FDA amended 21 CFR 101.17(h) on August 20, 2007 (72 FR 46375) to permit the safe handling statement to appear on the inside lid of egg cartons to provide the industry greater flexibility in the placement of the statement. FDA is undertaking a review of 21 CFR sections 101.17(h), 115.50, and 16.5(a)(4) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in sections 101.17(h), 115.50 and 16.5(a)(4) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 12/15/09 End Review 12/00/10 Regulatory Flexibility Analysis Required: Undetermined Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and Labeling Team, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS- 820), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1802 Fax: 301 436-2636 Email: [email protected] RIN: 0910-AG06 _______________________________________________________________________ 132. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE PROCEDURES (SECTION 610 REVIEW) Legal Authority: 21 USC 331; 21 USC 333; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 381 Abstract: FDA is undertaking a review of 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: [[Page 21790]] (1) The continued need for the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (2) the nature of complaints or comments received from the public concerning the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (4) the extent to which the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State and local governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 11/24/08 End Review of Current Regulation06/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Howard Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301 847-8440 Email: pdma610(c)[email protected] RIN: 0910-AG14 _______________________________________________________________________ 133. STERILITY REQUIREMENT FOR AQUEOUS-BASED DRUG PRODUCTS FOR ORAL INHALATION (SECTION 610 REVIEW) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360e; 21 USC 371; 21 USC 374; 21 USC 375 Abstract: FDA is undertaking a review of 21 CFR 200.51, under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether this regulation on aqueous-based drug products for oral inhalation should be continued without change, or whether it should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for 21 CFR 200.51; (2) the nature of complaints or comments received concerning 21 CFR 200.51; (3) the complexity of 21 CFR 200.51; (4) the extent to which the regulation overlaps, duplicates, or conflicts with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by 21 CFR 200.51. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 05/01/09 End Review 05/00/10 Regulatory Flexibility Analysis Required: No Agency Contact: Howard P. Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301 847-8440 Email: [email protected] RIN: 0910-AG25 _______________________________________________________________________ 134. REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES AND SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act; PL 111-31, Family Smoking Prevention and Tobacco Control Act Abstract: This rule establishes regulations restricting the sale and distribution of cigarettes and smokeless tobacco to children and adolescents, implementing section 102 of the Family Smoking Prevention and Tobacco Control Act (FSPTCA). FSPTCA sections 102 and 6(c)(1) require the Secretary to publish, within 270 days of enactment, a final rule regarding cigarettes and smokeless tobacco. This final rule must be identical, except for several changes identified in section 102(a)(2) of FSPTCA, to part 897 of the regulations promulgated by the Secretary of HHS in the August 28, 1996, issue of the Federal Register (61 FR 44396). This final rule prohibits the sale of cigarettes and smokeless tobacco to individuals under the age of 18 and requires manufacturers, distributors, and retailers to comply with certain conditions regarding access to, and promotion of, these products. Among other things, the final rule requires retailers to verify a purchaser's age by photographic identification. It also prohibits, with limited exception, free samples and prohibits the sale of these products through vending machines and self-service displays except in facilities where individuals under the age of 18 are not present or permitted at any time. The rule also limits the advertising and labeling to which children and adolescents are exposed. The rule accomplishes this by generally restricting advertising to which children and adolescents are exposed to a black-and-white, text-only format. The rule also prohibits the sale or distribution of brand-identified promotional, non-tobacco items such as hats and tee shirts. Furthermore, the rule prohibits sponsorship of sporting and other events, teams, and entries in a brand name of a tobacco product, but permits such sponsorship in a corporate name. FDA will also publish in the same issue of the Federal Register an advance notice of proposed rulemaking requesting comments, data, research, or other information on the regulation of outdoor advertising of cigarettes and smokeless tobacco. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 03/19/10 75 FR 13241 Final Rule 03/19/10 75 FR 13225 ANPRM Comment Period End 05/18/10 Final Rule Effective 06/22/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Annette L. Marthaler, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 9200 Corporate Boulevard, 100K, Rockville, MD 20850 Phone: 877 287-1373 Fax: 240 276-3904 Email: [email protected] RIN: 0910-AG33 [[Page 21791]] _______________________________________________________________________ 135. OVER-THE-COUNTER HUMAN DRUGS; LABELING REQUIREMENTS (SECTION 610 REVIEW) Legal Authority: 5 USC 610 Abstract: Part 201.66 (21 CFR section 201.66) established a standardized format for the labeling of OTC drug products that included: (1) Specific headings and subheadings presented in a standardized order, (2) standardized graphical features such as Helvetica type style and the use of ``bullet points'' to introduce key information, and (3) minimum standards for type size and spacing. FDA issued the final rule to improve labeling after considering comments submitted to the agency following the publication of the proposed regulation in 1997. In 1999, FDA published the final rule and stated that a standardized labeling format would significantly improve readability by familiarizing consumers with the types of information in OTC drug product labeling and the location of that information. In addition, a standardized appearance and standardized content, including various ``user-friendly'' visual cues, would help consumers locate and read important health and safety information and allow quick and effective product comparisons, thereby helping consumers to select the most appropriate product. FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulation in part 201.66. The purpose of this review is to determine whether the regulation in part 201.66 should be continued without change, or whether it should be further amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for the regulation in part 201.66; (2) the nature of the complaints or comments received concerning the regulation in part 201.66; (3) the complexity of the regulations in part 201.66; (4) the extent to which the regulations in part 201.66 overlap, duplicate, or conflict with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed for the products still subject to the labeling standard regulations in part 201. The section 610 review will be carried out along with a regulatory review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the agency's regulatory program more effective in achieving its goals, less burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive order. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 08/03/09 End Review of Current Regulation05/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AG34 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 136. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments, be provided in an electronic format that FDA can process, review, and archive. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Martha Nguyen, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6352, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone: 301 796-3471 Fax: 301 847-8440 Email: [email protected] RIN: 0910-AC52 _______________________________________________________________________ 137. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (ANTIHISTAMINE) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses antihistamine labeling claims for the common cold. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Reopening of Administrative Record 08/25/00 65 FR 51780 NPRM (Amendment) (Common Cold) 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug [[Page 21792]] Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF31 _______________________________________________________________________ 138. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses products labeled to relieve upset stomach associated with overindulgence in food and drink and to relieve symptoms associated with a hangover. The second action addresses acetaminophen safety. The third action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products. The fourth action addresses combination products containing the analgesic acetaminophen or aspirin and sodium bicarbonate used as an antacid ingredient. The last document finalizes the Internal Analgesic Products monograph. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Required Warnings and Other Labeling) 12/26/06 71 FR 77314 NPRM Comment Period End 05/25/07 NPRM (Over- indulgence/ Hangover) To Be Determined Final Action (Required Warnings and Other Labeling) 04/29/09 74 FR 19385 Final Action (Correction) 06/30/09 74 FR 31177 Final Action (Technical Amendment) 11/25/09 74 FR 61512 NPRM (Acetaminophen) 03/00/11 NPRM (Amendment) (Pediatric) To Be Determined NPRM (Amendment) (Sodium Bicarbonate) To Be Determined Final Action (Internal Analgesics) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF36 _______________________________________________________________________ 139. OVER-THE-COUNTER (OTC) DRUG REVIEW--LAXATIVE DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first NPRM listed will address the professional labeling for sodium phosphate drug products. The second NPRM listed will address all other professional labeling requirements for laxative drug products. The final action will address laxative drug products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Granular Psyllium)03/29/07 72 FR 14669 NPRM (Professional Labeling-- Sodium Phosphate) 10/00/10 NPRM (Professional Labeling) To Be Determined Final Action (Laxative Drug Products) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF38 _______________________________________________________________________ 140. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses active ingredients reviewed under Time and Extent Applications. The second action addresses other effectiveness issues for OTC sunscreen drug products. The third action finalizes sunscreen formulation, labeling, and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The last action addresses combination products containing sunscreen and insect repellent ingredients. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM (Sunscreen and Insect Repellent) 02/22/07 72 FR 7941 ANPRM Comment Period End 05/23/07 NPRM (UVA/UVB) 08/27/07 72 FR 49070 NPRM Comment Period End 12/26/07 NPRM (Time and Extent Applications) 07/00/10 NPRM (Effectiveness) 10/00/10 Final Action (UVA/UVB) 10/00/10 NPRM (Sunscreen and Insect Repellent) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human [[Page 21793]] Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF43 _______________________________________________________________________ 141. OVER-THE-COUNTER (OTC) DRUG REVIEW--TOPICAL ANTIMICROBIAL DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses food handler products. The second action addresses testing requirements for healthcare professional products. The third action addresses the safety and effectiveness of consumer products. The final actions listed will address the healthcare, consumer, and first aid antiseptic drug products respectively. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Healthcare) 06/17/94 59 FR 31402 NPRM (Food Handlers) To Be Determined NPRM (Testing -- Healthcare Professional Products) To Be Determined NPRM (Consumer) 03/00/11 Final Action (Healthcare) To Be Determined Final Action (Consumer) To Be Determined Final Action (First Aid Antiseptic) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF69 _______________________________________________________________________ 142. PROCESS CONTROLS FOR ANIMAL FEED INGREDIENTS AND MIXED ANIMAL FEED Legal Authority: 21 USC 342; 21 USC 350e; 21 USC 371; 21 USC 374; 42 USC 264; PL 110-85, sec 1002(a)(2) Abstract: The Food and Drug Administration (FDA) is proposing regulations for process controls for animal feed ingredients and mixed animal feed to provide greater assurance that marketed animal feed ingredients and mixed feeds intended for all animals, including pets, are safe. This action is being taken as part of the FDA's Animal Feed Safety System initiative. The proposed process controls will apply to animal feed ingredients and mixed animal feed, including pet food. This action is also being taken to carry out the requirements of the Food and Drug Administration Amendments Act of 2007. Section 1002(a) directs FDA to establish by regulation processing standards for pet food. This same provision of the law also directs that, in developing these new regulations, FDA obtain input from its stakeholders, including the Association of American Feed Control Officials, veterinary medical associations, animal health organizations, and pet food manufacturers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/11 NPRM Comment Period End 06/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 Standish Place, Rockville, MD 20855 Phone: 240 276-9207 Email: [email protected] RIN: 0910-AG10 _______________________________________________________________________ 143. PEDIATRIC DOSING FOR COUGH, COLD, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE; PROPOSED AMENDMENT OF FINAL MONOGRAPH Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a monograph is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AG12 _______________________________________________________________________ 144. UNIQUE DEVICE IDENTIFICATION Legal Authority: Not Yet Determined Abstract: The Food and Drug Administration Amendments Act of 2007, amended the Federal Food, Drug, and Cosmetic Act by adding section 519(f) (21 USC 360i(f)). This section requires FDA to promulgate regulations establishing a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless FDA specifies an alternative placement or provides for exceptions. The unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number. [[Page 21794]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: John J. Crowley, Senior Advisor for Patient Safety, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 980-1936 Email: [email protected] RIN: 0910-AG31 _______________________________________________________________________ 145. PRODUCE SAFETY REGULATION Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264 Abstract: The Food and Drug Administration (FDA) has determined that enforceable standards (as opposed to voluntary recommendations) for the production and packing of fresh produce are necessary to ensure best practices are commonly adopted. FDA is proposing to promulgate regulations setting enforceable standards for fresh produce safety at the farm and packing house. The purpose of the proposed rule is to reduce the risk of illness associated with contaminated fresh produce. The proposed rule will be based on prevention-oriented public health principles and incorporate what we have learned in the past decade since the agency issued general good agricultural practice guidelines entitled ``Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables'' (GAPs Guide). The proposed rule also will reflect comments received on the agency's 1998 update of its GAPs guide and its July 2009 draft commodity specific guidances for tomatoes, leafy greens, and melons. Although the proposed rule will be based on recommendations that are included in the GAPs guide, FDA does not intend to make the entire guidance mandatory. FDA's proposed rule would, however, set out clear standards for implementation of modern preventive controls. The proposed rule also would emphasize the importance of environmental assessments to identify hazards and possible pathways of contamination and provide examples of risk reduction practices recognizing that operators must tailor their preventive controls to particular hazards and conditions affecting their operations. The requirements of the proposed rule would be scale appropriate and commensurate with the relative risks and complexity of individual operations. FDA intends to issue guidance after the proposed rule is finalized to assist industry in complying with the requirements of the new regulation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Samir Assar, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1636 Email: [email protected] RIN: 0910-AG35 _______________________________________________________________________ 146. MODERNIZATION OF THE CURRENT FOOD GOOD MANUFACTURING PRACTICES REGULATION Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264 Abstract: The Food and Drug Administration (FDA) is proposing to amend its current good manufacturing practices (CGMP) regulations (21 CFR part 110) for manufacturing, packing, or holding human food. This proposed rule would require food facilities to address issues such as environmental pathogens, food allergens, mandatory employee training, and sanitation of food contact surfaces. The proposed rule also would require food facilities to develop and implement preventive control systems. FDA is taking this action to better address changes that have occurred in the food industry and protect public health. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Paul South, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-317), Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1640 Email: [email protected] RIN: 0910-AG36 _______________________________________________________________________ 147.CIGARS SUBJECT TO THE FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act; PL 111-31, The Family Smoking Prevention and Tobacco Control Act Abstract: The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Section 901 of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the Tobacco Control Act. This proposed rule would deem cigars to be subject to the Tobacco Control Act and include provisions to address public health concerns raised by cigars. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: May Nelson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 877 287-1373 Fax: 240 276-3904 Email: [email protected] RIN: 0910-AG38 [[Page 21795]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 148. POSTMARKETING SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262 and 263; 42 USC 263a to 263n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381 Abstract: The final rule would amend the postmarketing expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and to propose other revisions to these regulations to enhance the quality of safety reports received by FDA. These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. FDA plans to finalize the premarket and postmarket safety reporting requirements in separate final rules. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/14/03 68 FR 12406 NPRM Comment Period Extended 06/18/03 NPRM Comment Period End 07/14/03 NPRM Comment Period Extension End 10/14/03 Final Action 11/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6362, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone: 301 796-3469 Fax: 301 847-8440 Email: [email protected] RIN: 0910-AA97 _______________________________________________________________________ 149. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353 Abstract: The Food and Drug Administration is amending its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving high-pressure medical gas cylinders that have resulted in death and injuries to patients. These amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas accidents, do not occur in the future. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/10/06 71 FR 18039 NPRM Comment Period End 07/10/06 Final Action 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Patrick Raulerson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone: 301 796-3522 Fax: 301 847-8440 Email: [email protected] RIN: 0910-AC53 _______________________________________________________________________ 150. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 Abstract: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR parts 201.56, 201.57, and 201.80). Under FDA's current regulations, labeling concerning the use of prescription drugs in pregnancy uses letter categories (A, B, C, D, X) to characterize the risk to the fetus of using the drug in pregnancy. One of the deficiencies of the category system is that drugs may be assigned to the same category when the severity, incidence, and types of risk are quite different. Dissatisfaction with the category system has been expressed by health care providers, medical organizations, experts in the study of birth defects, women's health researchers, and women of childbearing age. Stakeholders consulted through a public hearing, several focus groups, and several advisory committees have recommended that FDA replace the category system with a concise narrative summarizing a product's risks to pregnant women and to women of childbearing age. Therefore, the revised format and the information provided in the labeling would make it easier for health care providers to understand the risks and benefits of drug use during pregnancy and lactation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/29/08 73 FR 30831 NPRM Comment Period End 08/27/08 Final Action 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Rachel S. Bressler, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation Research, WO 51, Room 6224, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone: 301 796-4288 [[Page 21796]] Fax: 301 847-8440 Email: [email protected] RIN: 0910-AF11 _______________________________________________________________________ 151. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND QUALITY FACTORS Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . . Abstract: The Food and Drug Administration (FDA) is revising its infant formula regulations in 21 CFR parts 106 and 107 to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/09/96 61 FR 36154 NPRM Comment Period End 12/06/96 NPRM Comment Period Reopened 04/28/03 68 FR 22341 NPRM Comment Period Extended 06/27/03 68 FR 38247 NPRM Comment Period End 08/26/03 NPRM Comment Period Reopened 08/01/06 71 FR 43392 NPRM Comment Period End 09/15/06 Final Action 10/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Benson Silverman, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-850), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1459 Email: [email protected] RIN: 0910-AF27 _______________________________________________________________________ 152. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (BRONCHODILATOR) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for single ingredient bronchodilator products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment--Ephedrine Single Ingredient) 07/13/05 70 FR 40237 NPRM Comment Period End 11/10/05 Final Action (Technical Amendment) 11/30/07 72 FR 67639 Final Action (Amendment--Single Ingredient Labeling) 09/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF32 _______________________________________________________________________ 153. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (COMBINATION) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant or any oral nasal decongestant. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 07/13/05 70 FR 40232 NPRM Comment Period End 11/10/05 Final Action (Technical Amendment) 03/19/07 72 FR 12730 Final Action 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF33 _______________________________________________________________________ 154. OVER-THE-COUNTER (OTC) DRUG REVIEW--EXTERNAL ANALGESIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final action addresses the 2003 proposed rule on patches, plasters, and poultices. The proposed rule will address issues not addressed in previous rulemakings. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (GRASE dosage forms) 12/00/10 NPRM (Amendment) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human [[Page 21797]] Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF35 _______________________________________________________________________ 155. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN PROTECTANT PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses skin protectant products used to treat fever blisters and cold sores. The second action identifies safe and effective skin protectant active ingredients to treat and prevent diaper rash. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Aluminum Acetate) (Technical Amendment) 03/06/09 74 FR 9759 Final Action (Diaper Rash) 03/00/11 Final Action (Technical Amendments) 02/01/08 73 FR 6014 Final Action (Fever Blisters/ Cold Sores) 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF42 _______________________________________________________________________ 156. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371 Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material and to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) beef. Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 07/14/04 69 FR 42256 Interim Final Rule Effective 07/14/04 Interim Final Rule Comment Period End 10/12/04 Interim Final Rule (Amendments) 09/07/05 70 FR 53063 Interim Final Rule (Amendments) Effective 10/07/05 Interim Final Rule (Amendments) Comment Period End 11/07/05 Interim Final Rule (Amendments) 04/17/08 73 FR 20785 Interim Final Rule (Amendments) Comment Period End 07/16/08 Interim Final Rule (Amendments) Effective 07/16/08 Final Action 10/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Amber McCoig, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS-316), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2131 Fax: 301 436-2644 Email: [email protected] RIN: 0910-AF47 _______________________________________________________________________ 157. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE UNITED STATES Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 342 and 343; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264 Abstract: The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the label's characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/18/08 73 FR 54106 NPRM Comment Period End 12/02/08 Final Action 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: John D. Reilly, Regulatory Counsel, Department of Health and Human Services, Food and [[Page 21798]] Drug Administration, Center for Food Safety and Applied Nutrition, CPK 1, Room 1C-015, (HFS-024), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1530 Fax: 301 436-2637 Email: [email protected] RIN: 0910-AF61 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Food and Drug Administration (FDA) _______________________________________________________________________ 158. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Legal Authority: 21 USC 321; 21 USC 342 and 343; 21 USC 348; 21 USC 371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264 Abstract: The Food and Drug Administration published a final rule in the Federal Register of June 25, 2007 (72 FR 34752), on current good manufacturing practice (CGMP) regulations for dietary supplements. FDA also published an Interim Final Rule in the same Federal Register (72 FR 34959) that provided a procedure for requesting an exemption from the final rule requirement that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met. This IFR also establishes a requirement for retention of records relating to the FDA's response to an exemption request. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 02/06/97 62 FR 5700 ANPRM Comment Period End 06/06/97 NPRM 03/13/03 68 FR 12157 NPRM Comment Period End 08/11/03 Final Rule 06/25/07 72 FR 34752 Interim Final Rule 06/25/07 72 FR 34959 Interim Final Rule Comment Period End 10/24/07 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Linda Kahl, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2784 Fax: 301 436-2657 Email: [email protected] RIN: 0910-AB88 _______________________________________________________________________ 159. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (NASAL DECONGESTANT) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the ingredient phenylpropanolamine. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Sinusitis Claim) 08/02/04 69 FR 46119 NPRM Comment Period End 11/01/04 NPRM (Phenylephrine Bitartrate) 11/02/04 69 FR 63482 NPRM Comment Period End 01/31/05 NPRM (Phenyl- propanolamine) 12/22/05 70 FR 75988 NPRM Comment Period End 03/22/06 Final Action (Amendment) (Sinusitis Claim) 10/31/05 70 FR 58974 Final Action (Phenylephrine Bitartrate) 08/01/06 71 FR 83358 Final Action (Phenyl- propanolamine) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF34 _______________________________________________________________________ 160. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR OTC HUMAN USE Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 UCS 374; 21 USC 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for convenience (small) size OTC drug packages. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Convenience Sizes) 12/12/06 71 FR 74474 NPRM Comment Period End 04/11/07 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF37 [[Page 21799]] _______________________________________________________________________ 161. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action finalizes the monograph for emergency first aid eyewash drug products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Emergency First Aid Eyewashes) 02/19/03 68 FR 7917 Final Action (Amendment) (Emergency First Aid Eyewashes) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF39 _______________________________________________________________________ 162. OVER-THE-COUNTER (OTC) DRUG REVIEW--ORAL HEALTH CARE PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM and final action will address oral health care products used to reduce or prevent dental plaque and gingivitis. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM (Plaque Gingivitis) 05/29/03 68 FR 32232 ANPRM Comment Period End 08/27/03 NPRM (Plaque Gingivitis) To Be Determined Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF40 _______________________________________________________________________ 163. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The proposed rule addresses vaginal contraceptive drug products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Warnings) 12/19/07 72 FR 71769 NPRM (Vaginal Contraceptive Drug Products) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF44 _______________________________________________________________________ 164. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT CONTROL PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM addresses the use of benzocaine for weight control. The first final action finalizes the 2005 proposed rule for weight control products containing phenylpropanolamine. The second final action will finalize the proposed rule for weight control products containing benzocaine. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Phenyl- propanolamine) 12/22/05 70 FR 75988 NPRM Comment Period End 03/22/06 NPRM (Benzocaine) To Be Determined Final Action (Phenyl- propanolamine) To Be Determined Final Action (Benzocaine) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF45 [[Page 21800]] _______________________________________________________________________ 165. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND DRINK PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses products containing bismuth subsalicylate for relief of symptoms of upset stomach due to overindulgence resulting from food and drink. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 01/05/05 70 FR 741 NPRM Comment Period End 04/05/05 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF51 _______________________________________________________________________ 166. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. One action addresses the labeling of products containing sodium bicarbonate as an active ingredient. The other action addresses the use of antacids to relieve upset stomach associated with overindulgence in food and drink. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Sodium Bicarbonate Labeling) To Be Determined Final Action (Overindulgence Labeling) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF52 _______________________________________________________________________ 167. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN BLEACHING PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses skin bleaching drug products containing hydroquinone. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/29/06 71 FR 51146 NPRM Comment Period End 12/27/06 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF53 _______________________________________________________________________ 168. OVER-THE-COUNTER (OTC) DRUG REVIEW--STIMULANT DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the use of stimulant active ingredients to relieve symptoms associated with a hangover. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Hangover) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF56 _______________________________________________________________________ 169. OVER-THE-COUNTER ANTIDIARRHEAL DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. These actions address new labeling for antidiarrheal drug products. [[Page 21801]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (New Labeling) To Be Determined Final Action (New Labeling) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF63 _______________________________________________________________________ 170. OVER-THE-COUNTER (OTC) DRUG REVIEW--URINARY ANALGESIC DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the products used for urinary pain relief. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Urinary Analgesic) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF70 _______________________________________________________________________ 171. STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG CATEGORY II ACTIVE INGREDIENTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The Food and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA issued this proposed rule because we did not receive any data and information on these ingredients in response to our request on December 31, 2003 (68 FR 75585). This rule will finalize the 2008 proposed rule. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/19/08 73 FR 34895 NPRM Comment Period End 09/17/08 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF95 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Food and Drug Administration (FDA) _______________________________________________________________________ 172. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING PRACTICES Legal Authority: PL 105-115, sec 121 Abstract: Section 121 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for current good manufacturing practices (CGMPs) for positron emission tomography (PET) drugs, a type of radiopharmaceutical. The final rule adopts CGMPs that reflect the unique characteristics of PET drugs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/20/05 70 FR 55038 NPRM Comment Period End 12/19/05 Final Action 12/10/09 74 FR 65409 Regulatory Flexibility Analysis Required: Yes Agency Contact: Reena Raman, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., WO 51, Room 6238, Silver Spring, MD 20993-0002 Phone: 301 796-7577 Fax: 301 847-8440 Email: [email protected] RIN: 0910-AC55 _______________________________________________________________________ 173. OVER-THE-COUNTER (OTC) DRUG REVIEW--ACNE DRUG PRODUCTS CONTAINING BENZOYL PEROXIDE Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will address acne drug products containing benzoyl peroxide. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 03/04/10 75 FR 9767 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO-22, [[Page 21802]] Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AG00 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 174. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS- 3819-P) (SECTION 610 REVIEW) Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 1395hh; 42 USC 1395bb Abstract: This proposed rule would revise the existing Conditions of Participation (CoPs), last set in 1999, that Home Health Agencies (HHAs) must meet to participate in the Medicare program. The requirements focus on the actual care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our efforts to achieve broad-based improvements and measurements of the quality of care furnished through Federal programs while at the same time reducing procedural burdens on providers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/10/97 62 FR 11005 NPRM Comment Period End 06/09/97 Second NPRM 09/00/10 Regulatory Flexibility Analysis Required: Undetermined Agency Contact: Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards & Quality, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6617 Email: [email protected] RIN: 0938-AG81 _______________________________________________________________________ 175. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS- 3140-P) (SECTION 610 REVIEW) Legal Authority: 42 USC 1302; 42 USC 1395hh Abstract: This proposed rule would establish that in order to participate in the Medicare and Medicaid programs, long-term care (LTC) facilities must have an agreement with hospice agencies when hospice care is provided in a long-term care facility. We are proposing new requirements to ensure that quality hospice care is provided to eligible residents. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Trish Brooks, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4561 Email: [email protected] RIN: 0938-AP32 _______________________________________________________________________ 176. PROPOSED CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2011 RATES AND TO THE LONG-TERM CARE HOSPITAL PPS AND RY 2011 RATES (CMS-1498-P) Legal Authority: Sec 1886(d) of the Social Security Act Abstract: This annual proposed rule would revise the Medicare hospital inpatient and long-term care prospective payment systems for operating and capital-related costs to implement changes arising from our continuing experience with these systems. These changes would be applicable to services furnished on or after October 1st. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Tiffany Swygert, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-25-11, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4642 Email: [email protected] RIN: 0938-AP80 _______________________________________________________________________ 177. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2011 (CMS-1504-P) Legal Authority: sec 1833 of the Social Security Act Abstract: This annual proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In addition, the proposed rule describes proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. The rule also proposes changes to the Ambulatory Surgical Center Payment System list of services and rates. These changes would be applicable to services furnished on or after January 1st. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Alberta Dwivedi, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C5-01-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0763 Email: [email protected] RIN: 0938-AP82 [[Page 21803]] _______________________________________________________________________ 178. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM REFINEMENTS AND RATE UPDATE FOR CY 2011 (CMS-1510-P) Legal Authority: Social Security Act, secs 1102 and 1871; 42 USC 1302 and 42 USC 1395(hh); Social Security Act, sec 1895 Abstract: This annual proposed rule would update the 60-day national episode rate (based on the applicable Home Health Market Basket Update and case-mix adjustment) and would also update the national per-visit rates (used to calculate low utilization payment adjustments (LUPAs) and outlier payments) amounts under the Medicare Prospective Payment System for home health agencies. These changes would be applicable to services furnished on or after January 1st. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Randy Throndeset, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare Management, Mailstop C5-07-28, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0131 Email: [email protected] RIN: 0938-AP88 _______________________________________________________________________ 179. OMNIBUS INFLUENZA IMMUNIZATION (CMS-3213-P) Legal Authority: Social Security Act sec 1881, 1861, 1920, 1102, 1871, 1965 Abstract: This proposed rule would require certain providers to offer all patients or residents an influenza immunization annually. The providers required to do so are hospitals, intermediate care facilities, critical access hospitals, rural health clinics, Federally qualified health centers, ESRD facilities, psychiatric residential treatment facilities, and inpatient rehabilitation facilities. This proposed rule is based on the most recent recommendations from the CDC's Advisory 3 Committee on Immunization Practices. The goal of this proposed rule is to improve influenza immunization rates for all patients and residents and to address the disparities in immunization rates Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Lauren Oviatt, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4683 Email: [email protected] RIN: 0938-AP92 _______________________________________________________________________ 180. PROPOSED CHANGES TO THE HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HOSPITAL PSYCHIATRIC AND REHABILITATION UNITS EXCLUDED FROM THE PROSPECTIVE PAYMENT SYSTEM (CMS-3177-P) Legal Authority: 42 USC 1385 X; 42 USC 1396 d; 42 USC 1395 hh Abstract: This proposed rule would transfer the existing process requirements for hospital psychiatric and rehabilitation units that are excluded from prospective payment systems to the hospital conditions of participation (CoPs) part of the Act. This would allow accrediting organizations to deem these units as part of their hospital accreditation process providing a timely and cost effective survey and certification process under the CoPs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Scott Cooper, Health Insurnce Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9465 Email: [email protected] RIN: 0938-AP97 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 181. REVISIONS TO THE MEDICARE ADVANTAGE AND MEDICARE PRESCRIPTION DRUG BENEFIT PROGRAMS FOR CONTRACT YEAR 2011 (CMS-4085-F) Legal Authority: MMA 2003; MIPPA (title XVIII of the Social Security Act) Abstract: This final rule makes revisions to the regulations governing the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D) based on our continued experience in the administration of the Part C and D programs. The revisions strengthen various program participation and exit requirements; strengthen beneficiary protections; ensure that plan offerings to beneficiaries include meaningful differences; improve plan payment rules and processes; improve data collection for oversight and quality assessment; implement new policy such as a Part D formulary policy; and clarify program policy. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/22/09 74 FR 54634 NPRM Comment Period End 12/07/09 Final Action 10/00/12 Regulatory Flexibility Analysis Required: Yes Agency Contact: Alissa Deboy, Director, Division of Drug Plan Policy and Quality, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C1-26-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6041 Email: [email protected] RIN: 0938-AP77 [[Page 21804]] _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 182. ELECTRONIC CLAIMS ATTACHMENTS STANDARDS (CMS-0050-IFC) Legal Authority: 42 USC 1320d-2(a)(2)(B) Abstract: This rule sets forth electronic standards for health care claims attachments. The standards are required by the Health Insurance Portability and Accountability Act of 1996. They will be used to transmit clinical or administrative data for claims adjudication purposes. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/23/05 70 FR 55989 NPRM Comment Period End 11/22/05 Withdrawn 01/25/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Elizabeth Holland, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of E-Health Standards and Services, Mailstop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1309 Email: [email protected], RIN: 0938-AK62 _______________________________________________________________________ 183. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR CY 2010 (CMS-1413-FC) Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871 Abstract: This annual rule revises payment polices under the physician fee schedule, as well as other policy changes to payment under Part B. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/13/09 74 FR 33520 NPRM Comment Period End 08/31/09 Final Action 11/25/09 74 FR 61738 Regulatory Flexibility Analysis Required: Yes Agency Contact: Diane Milstead, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid Mangement, Mailstop C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3355 Email: [email protected] RIN: 0938-AP40 _______________________________________________________________________ 184. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2010 (CMS-1414-FC) Legal Authority: BBA; BBA; BIPA; MMA; MMSEA; MIPPA; DRA; TRHCA Abstract: This annual rule revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain related provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). In addition, the rule describes changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. The rule also changes the Ambulatory Surgical Center Payment System list of services and rates. These changes are applicable to services furnished on or after January 1st. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/20/09 74 FR 35231 NPRM Comment Period End 08/31/09 Final Action 11/20/09 74 FR 60315 Regulatory Flexibility Analysis Required: Yes Agency Contact: Alberta Dwivedi, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare Management, Mailstop C5-01-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0763 Email: [email protected] RIN: 0938-AP41 [FR Doc. 2010-8934 Filed 04-23-10; 8:45 am] BILLING CODE 4150-24-S