[May 11, 2009 (Volume 74, Number 89)] [Unified Agenda] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID: f:ua090506.wais] [Page 21920-21941] Department of Health and Human Services ----------------------------------------------------------------------- Part VI ----------------------------------------------------------------------- Semiannual Regulatory Agenda [[Page 21920]] 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, Chs. II, III, and XIII Unified Agenda of Federal Regulatory and Deregulatory Actions AGENCY: Office of the Secretary, HHS. ACTION: Semiannual regulations agenda. _______________________________________________________________________ SUMMARY: The Department's semiannual Agenda of Regulatory and Deregulatory Actions forecasts the rulemaking activities that we expect to undertake over the foreseeable future. We focus primarily on those areas of work anticipated to result in publication of Notices of Proposed Rulemaking or of Final Rules within the next 12 months. (Please note that the abstracts included below relate only to those prospective rulemakings that are likely to have a significant economic impact on a substantial number of small entities; the Regulatory Flexibility Act of 1980 requires dissemination of this information in the paper edition of the Federal Register. The complete HHS Agenda is accessible online at www.reginfo.gov.) FOR FURTHER INFORMATION CONTACT: by e-mail, John.Gallivan@hhs.gov; by fax, (202) 205-2135; by telephone, (202) 205-9165. SUPPLEMENTARY INFORMATION: The Regulatory Flexibility Act of 1980 and Executive Order 12866 require semi-annual publication of an inventory outlining all current and projected rulemakings. The purpose of this exercise is to inform the public about regulatory actions under development across the Department, and to provide an opportunity for all concerned with the impact of these actions to participate in their development at an early stage. The regulatory actions capsulized in this Agenda do not necessarily reflect the policy perspectives of the Obama Administration. The statutorily dictated timing of the Agenda caused the Department to initiate preparation of the requisite information before the Department's policy officials had the opportunity to conduct a full review. This Agenda thus reflects ongoing efforts by HHS to comply with existing statutory obligations, or to effect improvements at the program- implementation level based on experience in administering existing programs. By contrast, the timing of the October 2009 Agenda will, obviously, provide the Department with an opportunity to set out a regulatory agenda that does reflect current policy directions of the Obama Administration. Public commentary is invited. Comments may be directed to the agency officials cited at the conclusion of each entry. If early attention at the Secretary's level appears needed, comments should be sent to: Ashley Files Flory, Acting Executive Secretary to the Department, Suite 603H, 200 Independence Avenue SW., Washington, DC 20201. Dated: April 3, 2009. Ashley Files Flory, Acting Executive Secretary to the Department. Substance Abuse and Mental Health Services Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 147 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addition (Section 0930-AA14 610 Review)........................................................................... ---------------------------------------------------------------------------------------------------------------- Substance Abuse and Mental Health Services Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 148 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical 0930-AA10 Community-Based Facilities for Children and Youth..................................... ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 149 Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation 0920-AA14 Regulations........................................................................... 150 Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of 0920-AA23 HHS/CDC Nonhuman Primate Regulations.................................................. ---------------------------------------------------------------------------------------------------------------- [[Page 21921]] Centers for Disease Control and Prevention--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 151 Control of Communicable Diseases Foreign Quarantine................................... 0920-AA12 152 Control of Communicable Diseases: Interstate Quarantine, Passenger Information........ 0920-AA27 ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 153 Possession, Use and Transfer of Select Agents and Toxins (Section 610 Review)......... 0920-AA32 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 154 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of 0910-AG06 Shell Eggs Held for Retail Distribution (Section 610 Review).......................... 155 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; 0910-AG14 Policies, Requirements, and Administrative Procedures (Section 610 Review)............ ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 156 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics....... 0910-AC52 157 Over-The-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31 158 Over-The-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38 159 Over-The-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43 160 Over-The-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45 161 Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug 0910-AG12 Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph........ ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 162 Prevention of Salmonella Enteritidis in Shell Eggs.................................... 0910-AC14 163 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53 164 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55 165 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11 Requirements for Pregnancy and Lactation Labeling..................................... 166 Over-The-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32 167 Over-The-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33 168 Over-The-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35 169 Over-The-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36 170 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42 171 Substances Prohibited From Use in Animal Food or Feed To Prevent the Transmission of 0910-AF46 Bovine Spongiform Encephalopathy...................................................... 172 Use of Materials Derived From Cattle in Human Food and Cosmetics...................... 0910-AF47 173 Label Requirement for Food That Has Been Refused Admission Into the United States..... 0910-AF61 174 Over-The-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide.... 0910-AG00 ---------------------------------------------------------------------------------------------------------------- [[Page 21922]] Food and Drug Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 175 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products.... 0910-AA97 176 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding 0910-AB88 Operations for Dietary Supplements.................................................... 177 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34 178 Over-The-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37 179 Over-The-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39 180 Over-The-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40 181 Over-The-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44 182 Over-The-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products......... 0910-AF51 183 Over-The-Counter (OTC) Drug Review--Antacid Products.................................. 0910-AF52 184 Over-The-Counter (OTC) Drug Review--Skin Bleaching Products........................... 0910-AF53 185 Over-the-Counter (OTC) Drug Review--Stimulant Drug Products........................... 0910-AF56 186 Over-The-Counter Antidiarrheal Drug Products.......................................... 0910-AF63 187 Over-The-Counter (OTC) Drug Review--Poison Treatment Drug Products.................... 0910-AF68 188 Over-The-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products............... 0910-AF69 189 Over-The-Counter (OTC) Drug Review--Urinary Analgesic Drug Products................... 0910-AF70 190 Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients..... 0910-AF95 191 Process Controls for Animal Feed Ingredients and Mixed Animal Feed.................... 0910-AG10 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 192 Requirements for Submission of In Vivo Bioequivalence Data............................ 0910-AC23 193 Cochineal Extract and Carmine Label Declaration....................................... 0910-AF12 194 Obstetrical and Gynecological Devices; Designation of Special Controls for Male 0910-AF21 Condoms Made of Natural Rubber Latex.................................................. 195 Food Labeling; Serving Sizes and Nutrition Labeling (Completion of a Section 610 0910-AF99 Review)............................................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 196 Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 0938-AP39 2010 (CMS-1406-P)..................................................................... 197 Revisions to Payment Policies Under the Physician Fee Schedule For CY 2010 (CMS-1413- 0938-AP40 P).................................................................................... 198 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP41 Center Payment System for CY 2010 (CMS-1414-P)........................................ 199 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- 0938-AP46 Update for FY 2010 (CMS-1410-P)....................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 200 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 0938-AG81 Review)............................................................................... 201 Electronic Claims Attachments Standards (CMS-0050-IFC)................................ 0938-AK62 202 Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610 0938-AO53 Review)............................................................................... 203 Medicaid Graduate Medical Education (CMS-2279-F)...................................... 0938-AO95 204 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610 0938-AP32 Review)............................................................................... ---------------------------------------------------------------------------------------------------------------- [[Page 21923]] Centers for Medicare & Medicaid Services--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 205 Updates to Electronic Transactions (Version 5010) (CMS-0009-F) (Completion of a 0938-AM50 Section 610 Review)................................................................... 206 Revisions to HIPAA Code Sets (CMS-0013-F) (Completion of a Section 610 Review)........ 0938-AN25 207 Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, 0938-AO84 Orthotics, and Supplies (DMEPOS) (CMS-6006-F) (Completion of a Section 610 Review).... 208 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP17 Center Payment System for CY 2009 (CMS-1404-F)........................................ 209 Revisions to Payment Policies Under the Physician Fee Schedule for CY 2009 (CMS-1403- 0938-AP18 FC)................................................................................... 210 Home Health Prospective Payment System Refinements and Rate Update for CY 2009 (CMS- 0938-AP20 1555-N)............................................................................... 211 Changes to Long-Term Care Prospective Payment System Based on Specific Provisions in 0938-AP33 the Medicare, Medicaid, and SCHIP Extension Act of 2007 (CMS-1493-F).................. ---------------------------------------------------------------------------------------------------------------- _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 147. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE ADDITION (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 proposed rule, when finalized will modify the regulatory dispensing restrictions under 42 CFR part 8 for the drug substance buprenorphine. This medication is used to treat kersin and other opioid addiction. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/09 Regulatory Flexibility Analysis Required: No Agency Contact: Nicholas Reuter, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, One Choke Cherry Rd, Suite 2-1063, 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) _______________________________________________________________________ 148. 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 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 149. FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC ANIMAL IMPORTATION REGULATIONS Legal Authority: Not Yet Determined 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 [[Page 21924]] 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 Unite States (42 CFR parts 71, Subpart F). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 07/31/07 72 FR 41676 Notice Extending ANPRM Comment Period 10/01/07 72 FR 55729 NPRM 12/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 16, Room 4324, MS E03, Atlanta, GA 30329 Phone: 404 498-1600 RIN: 0920-AA14 _______________________________________________________________________ 150. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC NONHUMAN PRIMATE REGULATIONS Legal Authority: 42 U.S.C. 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 two 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 12/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 16, Room 4324, MS E03, Atlanta, GA 30329 Phone: 404 498-1600 RIN: 0920-AA23 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 151. 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 Final Action 09/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 16, Room 4324, MS E03, Atlanta, GA 30329 Phone: 404 498-1600 RIN: 0920-AA12 _______________________________________________________________________ 152. 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 [[Page 21925]] 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 Final Action 12/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 16, Room 4324, MS E03, Atlanta, GA 30329 Phone: 404 498-1600 RIN: 0920-AA27 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 153. POSSESSION, USE AND TRANSFER OF SELECT AGENTS AND TOXINS (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 reuslt 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 andy 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 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 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 154. 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) provides that part 16 does not apply to a hearing on an order for relabeling, diversion, or destruction if 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, [[Page 21926]] 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 12/00/09 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: geraldine.june@fda.hhs.gov RIN: 0910-AG06 _______________________________________________________________________ 155. 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: (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 Regulation12/00/09 Regulatory Flexibility Analysis Required: Yes 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, 10903 New Hampshire Avenue, Bldg. 51, Room 6234, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301 847-8440 Email: howard.mullerjr@fda.hhs.gov RIN: 0910-AG14 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 156. 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. The proposal would also require that FDA periodically issue guidance on the use of standardized data structure, terminology, and code sets (e.g., the Study Data Tabulation Model (SDTM) developed by the Clinical Data Interchange Standards Consortium) to allow for more efficient and comprehensive data review. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/09 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, 10903 New Hampshire Avenue, Bldg. 51, Room 6224, Silver Spring, MD 20993-0002 Phone: 301 796-3471 Fax: 301 847-8440 [[Page 21927]] Email: martha.nguyen@fda.hhs.gov RIN: 0910-AC52 _______________________________________________________________________ 157. 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 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 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) 04/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF31 _______________________________________________________________________ 158. 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 final action will address laxative drug products. 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Granular Psyllium)03/29/07 72 FR 14669 Final Action (Laxative Drug Products) To Be Determined NPRM (Professional Labeling-- Sodium Phosphate) 09/00/09 NPRM (Professional Labeling) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF38 _______________________________________________________________________ 159. 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 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 action addresses active ingredients reviewed under Time and Extent Applications. The second action is the final action that addresses sunscreen formulation, labeling, and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The third 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) 09/00/09 Final Action (UVA/UVB) 09/00/09 NPRM (Sunscreen and Insect Repellent) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF43 _______________________________________________________________________ 160. 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. One action addresses the ingredient phenylpropanolamine, and the other actions address the ingredient benzocaine. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Phenylpropanol amine) 12/22/05 70 FR 75988 NPRM (Benzocaine) 09/00/09 Final Action (Phenylpropanol amine) 05/00/10 Final Action (Benzocaine) To Be Determined [[Page 21928]] Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF45 _______________________________________________________________________ 161. 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 to 360(a); 21 USC 371 to 371(a) 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 09/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AG12 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 162. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 393; 42 USC 243; 42 USC 264; 42 USC 271; Abstract: Publication of this final rule was an action item in the Food Protection Plan announced by the Department of Health and Human Services (HHS) in November 2007. In July 1999, the Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) committed to developing an action plan to address the presence of Salmonella Enteritidis (SE) in shell eggs and egg products using a farm-to-table approach. FDA and FSIS held a public meeting on August 26, 1999, to obtain stakeholder input on the draft goals, as well as to further develop the objectives and action items for the action plan. The Egg Safety Action Plan was announced on December 11, 1999. The goal of the Action Plan is to reduce egg-related SE illnesses. The Egg Safety Action Plan consists of eight objectives covering all stages of the farm-to-table continuum as well as support functions. On March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July 31, 2000 (Washington, DC), joint public meetings were held by FDA and FSIS to solicit and discuss information related to the implementation of the objectives in the Egg Safety Action Plan. On September 22, 2004, FDA published a proposed rule that would require egg safety measures to prevent the contamination of shell eggs with SE during egg production. The proposal also solicited comment on whether recordkeeping requirements should include a written SE prevention plan and records for compliance with the SE prevention measures, and whether safe egg handling and preparation practices should be mandated for retail establishments that specifically serve a highly susceptible population (e.g., nursing homes, hospitals, day care centers). The proposed egg production SE prevention measures included: (1) Provisions for procurement of chicks and pullets; (2) a biosecurity program; (3) a rodent and pest control program; (4) cleaning and disinfection of poultry houses that have had an environmental or egg test positive for SE; (5) egg testing when an environmental test is positive; and (6) refrigerated storage of eggs held at the farm. Additionally, to verify that the measures have been effective, the rule proposes that producers test the poultry house environment for SE. If the environmental test is positive, eggs from that environment must be tested for SE, and if the egg test is positive, the eggs must be diverted to egg products processing or a treatment process that achieves at least a five-log destruction of SE. The proposed rule was a step in a broader farm-to-table egg safety effort that includes FDA's requirements for safe handling statements on egg cartons, and refrigerated storage of shell eggs at retail, and egg safety education for consumers and retail establishments. The rule had a 90-day comment period, which ended December 21, 2004. To discuss the proposed rule and solicit comments from interested stakeholders, FDA held three public meetings: October 28, 2004, in College Park, MD; November 9, 2004, in Chicago, IL; and November 16, 2004, in Los Angeles, CA. The comment period was reopened until July 25, 2005, to solicit further comment and information on industry practices and programs that prevent SE-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into laying hen houses. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/22/04 69 FR 56824 NPRM Comment Period End 12/21/04 NPRM Reopened Comment Period End06/09/05 70 FR 24490 [[Page 21929]] NPRM Extension of Reopened Comment Period End 07/25/05 70 FR 33404 Final Action 07/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: John F. Sheehan, Director, Department of Health and Human Services, Food and Drug Administration, Division of Plant and Dairy Food Safety (HFS-315), Room 3B-012, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2367 Fax: 301 436-2632 Email: john.sheehan@fda.hhs.gov RIN: 0910-AC14 _______________________________________________________________________ 163. 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 mixups, 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 09/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Quynh H. Nguyen, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6370, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301 847-8440 Email: quynh.h.nguyen@fda.hhs.gov RIN: 0910-AC53 _______________________________________________________________________ 164. 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 would adopt 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 08/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Michael D. Bernstein, Supervisory Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Regulatory Policy, 10903 New Hampshire Ave., Bldg. 51, Room 6240, Silver Spring, MD 20993- 0002 Phone: 301 796-3478 Fax: 301 847-8440 Email: michael.bernstein@fda.hhs.gov RIN: 0910-AC55 _______________________________________________________________________ 165. 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). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/29/08 73 FR 30831 NPRM Comment Period End 08/27/08 Final Action 03/00/10 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, 10903 New Hampshire Ave., Bldg. 51, Room 6224, Silver Spring, MD 20993-0002 Phone: 301 796-4288 Fax: 301-847-8440 Email: rachel.bressler@fda.hhs.gov RIN: 0910-AF11 _______________________________________________________________________ 166. 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 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 addresses labeling for single ingredient bronchodilator products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment--Ephedrine Single Ingredient) 07/13/05 70 FR 40237 Final Action (Technical Amendment) 11/30/07 72 FR 63679 Final Action (Amendment-- Ephedrine Single Ingredient) 09/00/09 Regulatory Flexibility Analysis Required: Yes [[Page 21930]] Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF32 _______________________________________________________________________ 167. 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 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 technical amendment revises a paragraph designation in the CFR. The other action finalizes cough/cold combination products containing oral bronchodilators and expectorants. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 07/13/05 70 FR 40232 Final Action (Technical Amendment) 03/19/07 72 FR 12730 Final Action 09/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF33 _______________________________________________________________________ 168. 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) 12/00/09 NPRM (Amendment) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF35 _______________________________________________________________________ 169. 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 products marketed for children under 2 years old and weight- and age-based dosing for children's products. The third action addresses combination products containing the analgesic acetaminophen or aspirin and sodium bicarbonate used as an antacid ingredient. The fourth action addresses other miscellaneous issues relating to internal analgesics. The fifth document finalizes the document regarding the required warnings and other labeling. 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 (Amendment) (Overindulgence/ Hangover) 05/00/10 NPRM (Amendment) (Pediatric) To Be Determined NPRM (Amendment) (Combinations With Sodium Bicarbonate) 05/00/10 NPRM (Amendment) (Miscellaneous Issues) 05/00/10 Final Action (Required Warnings and Other Labeling) 05/00/09 Final Action (Internal Analgesics) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF36 _______________________________________________________________________ 170. 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 [[Page 21931]] skin protectant products used to treat fever blisters and cold sores. The second action addresses astringent active ingredients. The third action identifies safe and effective skin protectant active ingredients to treat and prevent diaper rash. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Technical Amendments) 02/01/08 73 FR 6014 Final Action (Fever Blisters/ Cold Sores) To Be Determined Final Action (Aluminum Acetate) (Technical Amendment) 03/06/09 74 FR 9759 Final Action (Diaper Rash) 12/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF42 _______________________________________________________________________ 171. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED TO PREVENT THE TRANSMISSION OF BOVINE SPONGIFORM ENCEPHALOPATHY Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371 Abstract: On October 6, 2005, the Food and Drug Administration (FDA) proposed to amend its regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to help strengthen existing safeguards to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle. The discovery of a BSE-positive dairy cow in December 2003 has caused FDA to review its policies for prevention of BSE, which resulted in this rulemaking. FDA is correcting the final rule on BSE that appeared in the Federal Register of April 25, 2008 (73 FR 22719-22758). The final rule inadvertently published with incorrect dollar amounts in two separate areas: the summary of economic impacts and the paperwork burden table. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 07/14/04 69 FR 42288 ANPRM Comment Period End 08/13/04 NPRM 10/06/05 70 FR 58569 NPRM Comment Period End 12/20/05 Final Rule 04/25/08 73 FR 22720 Final Rule-Correction 10/23/08 73 FR 63072 Final Rule Effective 04/27/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Burt Pritchett, Biologist, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, HFV-222, 7519 Standish Place, MPN-4, Rockville, MD 20855 Phone: 240 453-6860 Fax: 240 453-6882 Email: burt.pritchett@fda.hhs.gov RIN: 0910-AF46 _______________________________________________________________________ 172. 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. On September 7, 2005, FDA amended the IFR to permit the use of small intestine in human food and cosmetics if it is effectively removed from the distal ileum. The amendment also clarified that milk and milk products, hides, and tallow derivatives are not prohibited for use in human food and cosmetics. On April 17, 2008, FDA amended the IFR so that FDA may designate a country as not subject to certain BSE-related restrictions relating to prohibited cattle materials applicable to human food and cosmetics. Comments submitted in response to the July 14, 2004 IFR that were not addressed in the September 7, 2005 and April 17, 2008 amendments will be addressed in the final rule. The final rule also will respond to comments submitted following the September 7, 2005 and April 17, 2008 amendments. 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 09/00/09 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, [[Page 21932]] (HFS-316), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2131 Fax: 301 436-2644 Email: amber.mccoig@fda.hhs.gov RIN: 0910-AF47 _______________________________________________________________________ 173. 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 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Kevin O. Kwon, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS-024), Room 1B-032, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2780 Fax: 301 436-2637 Email: kevin.kwon@fda.hhs.gov RIN: 0910-AF61 _______________________________________________________________________ 174. 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 10/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AG00 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Food and Drug Administration (FDA) _______________________________________________________________________ 175. 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: These regulations are one component of the Secretary's initiative to reduce medical errors. The final rule would amend the 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. 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 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Meredith S. Francis, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6238, Silver Spring, MD 20993-0002 Phone: 301 796-3476 Fax: 301-847-8440 RIN: 0910-AA97 _______________________________________________________________________ 176. 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. The final rule (the CGMP rule) was published to establish the minimum CGMPs necessary to ensure that, if firms engage in activities related to manufacturing, packaging, labeling, or [[Page 21933]] holding dietary supplements, they do so in a manner that will ensure the quality of the dietary supplements--i.e., to ensure that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act. FDA also published an interim final rule (IFR) in the June 25, 2007 Federal Register (72 FR 34959) that sets forth a procedure for requesting an exemption from the requirement in the final rule described above 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 Action 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: linda.kahl@fda.hhs.gov RIN: 0910-AB88 _______________________________________________________________________ 177. 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 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 addresses the ingredient phenylpropanolamine. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Sinusitis Claim) 08/02/04 69 FR 46119 NPRM (Phenylephrine Bitartrate) 11/02/04 69 FR 63482 NPRM (Phenylpropanol amine) 12/22/05 70 FR 75988 Final Action (Amendment) (Sinusitis Claim) 10/31/05 70 FR 58974 Final Action (Phenylephrine Bitartrate) 08/01/06 71 FR 83358 Final Action (Phenylpropanol amine) 05/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF34 _______________________________________________________________________ 178. 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 Final Action 05/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF37 _______________________________________________________________________ 179. 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 addresses emergency first aid eyewash products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Emergency First Aid Eyewashes) 02/19/03 68 FR 7917 NPRM (Amendment) (Emergency First Aid Eyewashes) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and [[Page 21934]] Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF39 _______________________________________________________________________ 180. 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. This 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, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF40 _______________________________________________________________________ 181. 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 to 360a; 21 USC 360gg to 360ss; 21 USC 371 to 371a; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 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) 05/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF44 _______________________________________________________________________ 182. 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 Final Action 05/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF51 _______________________________________________________________________ 183. 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) 05/00/10 Final Action (Overindulgence Labeling) 05/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF52 _______________________________________________________________________ 184. 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; [[Page 21935]] 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 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, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF53 _______________________________________________________________________ 185. 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 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 addresses the use of stimulant active ingredients to relieve symptoms associated with a hangover. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Hangover) 05/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF56 _______________________________________________________________________ 186. 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 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. These actions address new labeling for antidiarrheal drug products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Proposed 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, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF63 _______________________________________________________________________ 187. OVER-THE-COUNTER (OTC) DRUG REVIEW--POISON TREATMENT 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 ingredient ipecac syrup. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (IPECAC) 06/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF68 _______________________________________________________________________ 188. 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 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 action addresses food handler products. The second action addresses testing requirements. 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) To Be Determined NPRM (Consumer) To Be Determined Final Action (Healthcare) To Be Determined Final Action (Consumer) To Be Determined [[Page 21936]] Final Action (First Aid Antiseptic) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF69 _______________________________________________________________________ 189. 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 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 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, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF70 _______________________________________________________________________ 190. 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 to 360a; 21 USC 371 to 371a 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 is issuing 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 proposed rule is part of FDA's ongoing review of OTC drug products. 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, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF95 _______________________________________________________________________ 191. PROCESS CONTROLS FOR ANIMAL FEED INGREDIENTS AND MIXED ANIMAL FEED Legal Authority: 21 USC 342; 21 USC 371; 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 04/00/10 NPRM Comment Period End 07/00/10 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, MPN4, Room 106, HFV-230, 7519 Standish Place, Rockville, MD 20855 Phone: 240 276-9207 Email: kim.young@fda.hhs.gov RIN: 0910-AG10 [[Page 21937]] _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Food and Drug Administration (FDA) _______________________________________________________________________ 192. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 to 355a; 21 USC 356; 21 USC 356a to 356c; 21 USC 371; 21 USC 374; 21 USC 379 Abstract: The Food and Drug Administration (FDA) published a proposed regulation on October 29, 2003 (68 FR 61640), that would amend its regulations on submission of bioequivalence (BE) data to require an abbreviated new drug application (ANDA) applicant to submit data from all BE studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets BE criteria for FDA to approve the ANDA but have not typically submitted additional BE studies conducted on the same drug product formulation. If finalized, this rule would require ANDA applicants to submit information, in either a complete or summary report, from all additional passing and nonpassing BE studies conducted on the same drug product formulation submitted for approval. Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 01/16/09 74 FR 2849 Regulatory Flexibility Analysis Required: Yes Agency Contact: Jennifer L. Stevens Phone: 301 796-3601 Fax: 301 847-8440 Email: jennifer.stevens@fda.hhs.gov RIN: 0910-AC23 _______________________________________________________________________ 193. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION Legal Authority: 21 USC 379e(b) Abstract: The Agency published a final rule on January 5, 2009, to require the label declaration of all foods and cosmetics containing the color additives cochineal extract and carmine in order to protect consumers with allergies to these additives. This final rule was issued in response to adverse event reports received by FDA and to a citizen petition submitted to FDA. Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 01/05/09 74 FR 207 Final Rule--Objection Period End02/04/09 Final Rule-Confirmation of Effective Date 03/11/09 74 FR 10483 Regulatory Flexibility Analysis Required: Yes Agency Contact: Mical E. Honigfort Phone: 301 436-1278 Fax: 301 436-2972 Email: mical.honigfort@fda.hhs.gov RIN: 0910-AF12 _______________________________________________________________________ 194. OBSTETRICAL AND GYNECOLOGICAL DEVICES; DESIGNATION OF SPECIAL CONTROLS FOR MALE CONDOMS MADE OF NATURAL RUBBER LATEX Legal Authority: 21 USC 360c Abstract: The classification regulation for condoms would be amended to specify a labeling guidance document as a special control for condoms made from natural rubber latex. The new special control guidance document would identify issues presented by these devices, and would provide detailed recommendations for labeling to address these issues. FDA believes that addressing the issues identified in the guidance, either by following the recommendations in the guidance or by some other means that provide equivalent assurances of safety and effectiveness, together with the general controls, will provide a reasonable assurance of the safety and effectiveness of these devices. These labeling recommendations are also consistent with the labeling requirements of 21 CFR part 801. The rule will demonstrate how the Agency is addressing the congressional directive of Public Law 106-554 that FDA review condom labeling to assure that the information regarding the overall effectiveness or lack of effectiveness of condoms in preventing sexually transmitted diseases is medically accurate. Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 11/10/08 73 FR 66522 Regulatory Flexibility Analysis Required: Yes Agency Contact: Myrna Hanna Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF21 _______________________________________________________________________ 195. FOOD LABELING; SERVING SIZES AND NUTRITION LABELING (COMPLETION OF A 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 Abstract: Section 101.9 (21 CFR 101.9) describes the nutrition labeling requirements for foods. Section 101.12 (21 CFR 101.12) specifies the reference amount customarily consumed per eating occasion for each food category. The reference amount customarily consumed of a food is the basis for the serving size that is declared in the food's nutrition labeling. Under section 101.9, the serving size must be expressed in a common household measure that is appropriate to the food. The most recent change to sections 101.9 and 101.12 was in 1999, when FDA amended these regulations to reduce the reference amount customarily consumed for baking powder, baking soda, and pectin, and to include 1/8 teaspoon as an allowable unit of household measure for nutrition labeling purposes. FDA has completed a review of sections 101.9 and 101.12 under section 610 of the Regulatory Flexibility Act. The purpose of this review was to determine whether the regulations in sections 101.9 and 101.12 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 solicited comments on the following: (1) The continued need for the regulations in sections 101.9 and 101.12; (2) the nature of complaints or comments received concerning the regulations in sections 101.9 and 101.12; (3) the complexity of the regulations; (4) the extent to which the regulations in sections 101.9 and 101.12 overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in sections 101.9 and 101.12. FDA received no comments and concluded that there is a continuing [[Page 21938]] need for the nutrition labeling and serving size regulations in sections 101.9 and 101.12 and that these regulations should be retained without change. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 12/12/08 End Review 02/10/09 Regulatory Flexibility Analysis Required: No Agency Contact: Mary Brandt, Statistician, Department of Health and Human Services, Food and Drug Administration, Center for Food Safey and Applied Nutrition, 5100 Paint Branch Parkway, ONLDS (HFS-820), College Park, MD 20740 Phone: 301 436-1788 Fax: 301 436-1191 Email: mary.brandt@fda.hhs.gov RIN: 0910-AF99 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 196. CHANGES TO THE HOSPITAL INPATIENT AND LONG-TERM CARE PROSPECTIVE PAYMENT SYSTEM FOR FY 2010 (CMS-1406-P) Legal Authority: Sec 1886(d) of the Social Security Act Abstract: This major rule proposes to revise the Medicare hospital inpatient and Long Term Care prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Tiffany Swygert, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Div of Acute Care, Hosp and Ambulatory Policy Group, Mailstop C4-25-11, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786-4642 Email: tiffany.swygert@cms.hhs.gov RIN: 0938-AP39 _______________________________________________________________________ 197. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR CY 2010 (CMS-1413-P) Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871 Abstract: This major proposed rule would revise payment polices under the physician fee schedule, as well as other policy changes to payment under Part B. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/09 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 Blvd, Baltimore, MD 21244 Phone: 410 786-3355 Email: diane.milstead@cms.hhs.gov RIN: 0938-AP40 _______________________________________________________________________ 198. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2010 (CMS-1414-P) Legal Authority: BBA; PPRA; BIPA; MMA; MMSEA; MIPPA; DRA; TRHCA Abstract: This major 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 and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. 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 1 annually. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/09 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 Blvd, Baltimore, MD 21244 Phone: 410 786-0763 Email: alberta.dwivedi@cms.hhs.gov RIN: 0938-AP41 _______________________________________________________________________ 199. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED NURSING FACILITIES--UPDATE FOR FY 2010 (CMS-1410-P) Legal Authority: Social Security Act, sec 1888(e) Abstract: This major rule proposes updates to the payment rates used under the SNF PPS beginning October 1, 2009. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: William Ullman, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare Management, Mailstop C5-06-27, 7500 Security Boulvard, Baltimore, MD 21244 Phone: 410 786-5667 Fax: 410 786-0765 Email: bill.ullman@cms.hhs.gov RIN: 0938-AP46 [[Page 21939]] _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 200. 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) 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 To Be Determined 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 Group, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5716 Email: danielle.shearer@cms.hhs.gov RIN: 0938-AG81 _______________________________________________________________________ 201. 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 Interim Final Rule To Be Determined 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: elizabeth.holland@cms.hhs.gov, RIN: 0938-AK62 _______________________________________________________________________ 202. HOME AND COMMUNITY-BASED SERVICES (HCBS) STATE PLAN OPTION (CMS- 2249-F) (SECTION 610 REVIEW) Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6086 Abstract: This major rule amends the Medicaid regulations to define and describe the home- and community-based State plan services implementing the new section 1915(i) of the Social Security Act as added by section 6086 of the Deficit Reduction Act of 2005. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/04/08 73 FR 18676 NPRM Comment Period End 06/03/08 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Suzanne Bosstick, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1301 Email: suzanne.bosstick@cms.hhs.gov RIN: 0938-AO53 _______________________________________________________________________ 203. MEDICAID GRADUATE MEDICAL EDUCATION (CMS-2279-F) Legal Authority: title XIX; Social Security Act Abstract: As part of the President's 2008 Budget, this major rule establishes that States may not include GME as a reimbursable cost or program under their approved Medicaid State Plan. The rule enhances fiscal integrity and improves accountability with respect to payment for medical services in the Medicaid program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/23/07 72 FR 28930 NPRM Comment Period End 06/22/07 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Dianne Heffron, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid State Operations, Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21224 Phone: 410 786-3247 Fax: 410 786-1008 Email: dianne.heffron@cms.hhs.gov RIN: 0938-AO95 _______________________________________________________________________ 204. 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 requirements that long- term care (LTC) facilities must have an agreement with hospice agencies when hospice care is provided in a long-term care facility to participate in the Medicare and Medicaid programs. We are proposing these new requirements to ensure that quality hospice care is provided to eligible residents. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined 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: trish.brooks@cms.hhs.gov RIN: 0938-AP32 [[Page 21940]] _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 205. UPDATES TO ELECTRONIC TRANSACTIONS (VERSION 5010) (CMS-0009-F) (COMPLETION OF A SECTION 610 REVIEW) Legal Authority: sec 1171 to 1179 of the Social Security Act; Deficit Reduction Act of 2005, PL 109-171, sec 6035 Abstract: This rule adopts new versions of the X12 suite of HIPAA transactions and allows the industry to use the most up-to-date versions of the HIPAA transactions for claims and remittance advice. The rule will also adopt an updated pharmacy transactions standard for retail pharmacy claims. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/22/08 73 FR 49741 NPRM Comment Period End 10/21/08 Final Action 01/16/09 74 FR 3296 Regulatory Flexibility Analysis Required: Yes Agency Contact: Gladys C. Wheeler, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of E-Health Standards and Services, Mailstop S2-24-18, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0273 Email: gladys.wheeler@cms.hhs.gov RIN: 0938-AM50 _______________________________________________________________________ 206. REVISIONS TO HIPAA CODE SETS (CMS-0013-F) (COMPLETION OF A SECTION 610 REVIEW) Legal Authority: PL 104-191 Abstract: This rule revises some of the adopted transaction and code set standards detailed in regulations published by HHS on August 17, 2000, and February 20, 2003. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/22/08 73 FR 49795 NPRM Comment Period End 10/21/08 Final Action 01/16/09 74 FR 3328 Regulatory Flexibility Analysis Required: Yes Agency Contact: Denise Buenning, Health Insurance Specialist, Office of E-Health Standards and Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6711 Email: denise.buenning@cms.hhs.gov RIN: 0938-AN25 _______________________________________________________________________ 207. SURETY BOND REQUIREMENT FOR SUPPLIERS OF DURABLE MEDICAL EQUIPMENT, PROSTHETICS, ORTHOTICS, AND SUPPLIES (DMEPOS) (CMS-6006-F) (COMPLETION OF A SECTION 610 REVIEW) Legal Authority: sec 4312(a) of BBA of 1997 Abstract: This rule implements section 4312(a) of the Balanced Budget Act of 1997, which requires a Medicare supplier of durable medical equipment (DME) to furnish CMS with a surety bond. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/01/07 72 FR 42001 NPRM Comment Period End 10/01/07 Final Action 01/02/09 74 FR 166 Regulatory Flexibility Analysis Required: Yes Agency Contact: Frank Whelan, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, Mailstop C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1302 Email: frank.whelan@cms.hhs.gov RIN: 0938-AO84 _______________________________________________________________________ 208. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2009 (CMS-1404-F) Legal Authority: BBA; PPRA; BIPA; MMA; 42 USC 1302 et al Abstract: This rule revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from continuing experience with this system and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In addition, the 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 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 1 annually. Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 11/18/08 73 FR 68501 Regulatory Flexibility Analysis Required: Yes Agency Contact: Alberta Dwivedi Phone: 410 786-0763 Email: alberta.dwivedi@cms.hhs.gov RIN: 0938-AP17 _______________________________________________________________________ 209. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR CY 2009 (CMS-1403-FC) Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871 Abstract: This major rule makes changes affecting Medicare Part B payment to physicians and other Part B suppliers. Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 11/19/08 73 FR 69725 Regulatory Flexibility Analysis Required: Yes Agency Contact: Diane Milstead Phone: 410 786-3355 Email: diane.milstead@cms.hhs.gov RIN: 0938-AP18 _______________________________________________________________________ 210. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM REFINEMENTS AND RATE UPDATE FOR CY 2009 (CMS-1555-N) Legal Authority: Social Security Act, secs 1102 and 1871; (42 USC 1302 and 1395(hh)); Social Security Act, sec 1895 (42 USC 1395fff) Abstract: Section 1895 of the Act requires that the Home Health PPS be adjusted in a prospective manner specified by the Secretary by the home health increase percentage applicable to the year involved. [[Page 21941]] Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 11/03/08 73 FR 65351 Regulatory Flexibility Analysis Required: Yes Agency Contact: Randy Throndset Phone: 410 786-0131 Fax: 410 786-0765 Email: randy.throndset@cms.hhs.gov RIN: 0938-AP20 _______________________________________________________________________ 211. CHANGES TO LONG-TERM CARE PROSPECTIVE PAYMENT SYSTEM BASED ON SPECIFIC PROVISIONS IN THE MEDICARE, MEDICAID, AND SCHIP EXTENSION ACT OF 2007 (CMS-1493-F) Legal Authority: Provisions of sec 114 of PL 110-173 (MMSE Act of 2007); sec 1886(d) of the Social Security Act as amended by sec 114 of PL 110-173 (MMSE Act of 2007) Abstract: This rule implements provisions of the Medicare, Medicaid, and SCHIP Extension Act of 2007 relating to long-term care hospitals. In addition to amending section 1861 of the Act with a new definition of LTCHs, this rule includes provisions that are effective on the date of enactment (December 29, 2007). Specifically, the statute imposes a 3-year delay in implementation of certain payment policies that set percentage thresholds for LTCH patients admitted from certain referring hospitals and raises the percentage threshold for those LTCHs unaffected by the 3-year delay. The legislation imposes the same 3-year delay on the implementation of a particular payment adjustment for short-stay patients and also for the possible application of a one-time adjustment to the standard Federal rate. The statute also required a change in the Federal rate for RY 2008, (effective April 1, 2008). Additionally, the statute created a 3-year moratorium on the establishment of new LTCHs and LTCH satellites and on bed expansion in existing LTCHs, subject to significant exceptions. Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 01/29/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Tzvi Hefter Phone: 410 786-4487 Email: tzvi.hefter@cms.hhs.gov RIN: 0938-AP33 [FR Doc. E9-10274 Filed 05-08-09; 8:45 am] BILLING CODE 4150-24-S