[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR5.10] [Page 45-52] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 5_DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents Subpart A_Delegations of Authority to the Commissioner of Food and Drugs Sec. 5.10 Delegations from the Secretary of Health and Human Services to the Commissioner of Food and Drugs. Subpart A_Delegations of Authority to the Commissioner of Food and Drugs Sec. 5.10 Delegations from the Secretary of Health and Human Services to the Commissioner of Food and Drugs. 5.11 Reservation of authority. Subpart B_General Redelegations of Authority 5.20 General redelegations of authority from the Commissioner to other officers of the Food and Drug Administration. 5.21 Emergency functions. 5.22 Certification of true copies and use of Department seal. 5.23 Disclosure of official records and authorization of testimony. 5.24 Authority relating to technology transfer. 5.25 Research, investigation, and testing programs and health information and promotion programs. 5.26 Service fellowships. 5.27 Patent term extensions for human drug products, medical devices, and food and color additives; and authority to perform [[Page 46]] due diligence determinations and informal hearings. 5.28 Hearings. 5.29 Petitions under part 10. 5.30 Authority to select temporary voting members for advisory committees and authority to sign conflict of interest waivers. 5.31 Enforcement activities. 5.32 Certification following inspections. 5.33 Issuance of reports of minor violations. 5.34 Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment. 5.35 Officials authorized to make certification under 5 U.S.C. 605(b) for any proposed and final rules. Subpart C_Human Drugs; Redelegations of Authority 5.100 Issuance of notices implementing the provisions of the Drug Amendments of 1962. 5.101 Termination of exemptions for new drugs for investigational use in human beings. 5.102 Authority to approve and to withdraw approval of a charge for investigational new drugs. 5.103 Approval of new drug applications and their supplements. 5.104 Responses to Drug Enforcement Administration temporary scheduling notices. 5.105 Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements. 5.106 Submission of and effective approval dates for abbreviated new drug applications and certain new drug applications. 5.107 Extensions or stays of effective dates for compliance with certain labeling requirements for human prescription drugs. 5.108 Authority relating to waivers or reductions of prescription drug user fees. 5.109 Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new drugs. Subpart D_Biologics; Redelegations of Authority 5.200 Functions pertaining to safer vaccines. 5.201 Redelegation of the Center for Biologics Evaluation and Research Director's program authorities. 5.202 Issuance of notices of opportunity for a hearing on proposals for denial of approval of applications for licenses, suspension of licenses, or revocation of licenses and certain notices of revocation of licenses. 5.203 Issuance and revocation of licenses for the propagation or manufacture and preparation of biological products. 5.204 Notification of release for distribution of biological products. Subpart E_Foods and Cosmetics; Redelegations of Authority 5.300 Food standards, food additives, generally recognized as safe (GRAS) substances, color additives, nutrient content claims, and health claims. 5.301 Issuance of initial emergency permit orders and notices of confirmation of effective date of final regulations on food for human and animal consumption. 5.302 Detention of meat, poultry, eggs, and related products. 5.303 Establishing standards and approving accrediting bodies under the National Laboratory Accreditation Program. 5.304 Approval of schools providing food-processing instruction. Subpart F_Medical Devices and Radiological Health; Redelegations of Authority 5.400 Issuance of Federal Register documents to recognize or to withdraw recognition of a standard to meet premarket submission requirements. 5.401 Issuance of Federal Register documents pertaining to exemptions from premarket notification. 5.402 Detention of adulterated or misbranded medical devices. 5.403 Authorization to use alternative evidence for determination of the effectiveness of medical devices. 5.404 Notification of petitioners of determinations made on petitions for reclassification of medical devices. 5.405 Determination of classification of devices. 5.406 Notification of sponsors of deficiencies in petitions for reclassification of medical devices. 5.407 Approval, disapproval, or withdrawal of approval of product development protocols and applications for premarket approval for medical devices. 5.408 Determinations concerning the type of valid scientific evidence submitted in a premarket approval application. 5.409 Determinations that medical devices present unreasonable risk of substantial harm. 5.410 Orders to repair or replace, or make refunds for, medical devices. 5.411 Medical device recall authority. 5.412 Temporary suspension of a medical device application. [[Page 47]] 5.413 Approval, disapproval, or withdrawal of approval of applications and entering into agreements for investigational device exemptions. 5.414 Postmarket surveillance. 5.415 Authority relating to medical device reporting procedures. 5.416 Medical device tracking. 5.417 Authority pertaining to accreditation functions for medical devices. Subpart G_Animal Drugs; Redelegations of Authority 5.500 Issuance of Federal Register documents pertaining to the determination of safe levels, notice of need for development of an analytical method, notice of availability of a developed analytical method, and prohibition of certain extralabel drug use. 5.501 Approval of new animal drug applications, medicated feed mill license applications and their supplements. 5.502 Issuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications. 5.503 Submission of and effective approval dates for abbreviated new animal drug applications and certain new animal drug applications. 5.504 Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new animal drugs and feeds bearing or containing new animal drugs. 5.505 Termination of exemptions for new drugs for investigational use in animals. Subpart H_Radiation Control; Redelegations of Authority 5.600 Variances from performance standards for electronic products. 5.601 Exemption of electronic products from performance standards and prohibited acts. 5.602 Testing programs and methods of certification and identification for electronic products. 5.603 Notification of defects in, and repair or replacement of, electronic products. 5.604 Manufacturers requirement to provide date to ultimate purchasers of electronic products. 5.605 Dealer and distributor direction to provide data to manufacturers of electronic products. 5.606 Acceptance of assistance from State and local authorities for enforcement of radiation control legislation and regulations. Subpart I_Product Designation; Redelegations of Authority 5.700 Authority relating to determination of product primary jurisdiction. 5.701 Premarket approval of a product that is or contains a biologic, a device, or a drug. Subpart J_Imports and Exports; Redelegations of Authority 5.800 Imports and exports. 5.801 Export of unapproved drugs. 5.802 Manufacturer's resident import agents. Subpart K_Orphan Products; Redelegations of Authority 5.900 Orphan products. Subpart L_Mammography Facilities; Redelegations of Authority 5.1000 Authority to ensure that mammography facilities meet quality standards. Subpart M_Organization 5.1100 Headquarters. 5.1105 Chief Counsel, Food and Drug Administration. 5.1110 Food and Drug Administration Public Information Offices. 5.1115 Field Structure. Authority: 5 U.S.C. 504, 552, App. 2 605; 7 U.S.C. 138a, 2217; 15 U.S.C. 638, 1261-1282, 1451-1461, 3701-3711a; 21 U.S.C., 61-63, 141-149, 301-394, 467f, 679(b), 801-886, 1031-1309, 1401-1403; 35 U.S.C. 156; 42 U.S.C. 238, 241, 242, 242a, 242l, 242n, 242o, 243, 262, 263, 264, 265, 300u-300u-5, 300aa-1, 300ar-25-28, 300cc, 300ff, 1395y, 4332, 4831(a), 10007-10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131; E.O. 12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223. Source: 66 FR 30993, June 8, 2001, unless otherwise noted. (a) The Secretary of Health and Human Services (the Secretary) has redelegated to the Commissioner of Food and Drugs (Commissioner), with authority to redelegate (except when specifically prohibited), all authority as follows: [[Page 48]] (1) Functions vested in the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), as amended, the Filled Milk Act (21 U.S.C. 61-63), the Federal Import Milk Act (21 U.S.C. 141 et seq.), the Federal Caustic Poison Act (44 Stat. 1406; see also Public Law 86-613, section 19, formerly section 18) and The Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), under section 12 of Reorganization Plan No. IV and Reorganization Plan No. 1 of 1953, including authority to administer oaths vested in the Secretary of Agriculture by 7 U.S.C. 2217. (2) Functions vested in the Secretary under section 301 (Research and Investigations); section 307 (International Cooperation); and section 311 (Federal-State Cooperation) of the Public Health Service Act (the PHS Act) (42 U.S.C. 241, 242l, 243), as amended, which relate to the functions of the Food and Drug Administration. (3) Functions vested in the Secretary under section 361 of the PHS Act (42 U.S.C. 264), as amended, which relate to the law enforcement functions of the Food and Drug Administration concerning the following products and activities: Biologicals (including blood and blood products); interstate travel sanitation (except interstate transportation of etiologic agents under 42 CFR part 72); food (including milk and food service sanitation and shellfish sanitation); and drugs, devices, cosmetics, electronic products, and other items or products regulated by the Food and Drug Administration. (4) Functions vested in the Secretary under sections 351 and 352 of part F, subpart 1 of the PHS Act (42 U.S.C. 262 and 263), as amended (Biological Products), insofar as they relate to the functions assigned to the Food and Drug Administration. (5) Functions vested in the Secretary under section 302(a) of the PHS Act (42 U.S.C. 242(a)), as amended, which relate to the determination and reporting requirements with respect to the medicinal and scientific requirements of the United States for controlled substances. (6) Functions vested in the Secretary under section 303 of the PHS Act (42 U.S.C. 242a), as amended, which relate to the authorization of persons engaged in research on the use and effect of drugs to protect the identity of their research subjects with respect to drugs scheduled under Public Law 91-513 for which an investigational new drug application is filed with the Food and Drug Administration and with respect to all drugs not scheduled under Public Law 91-513. (7) Functions vested in the Secretary pertaining to section 4 of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (Public Law 91-513, 84 Stat. 1241) which relate to the determination of the safety and effectiveness of drugs or to approve new drugs to be used in the treatment of narcotic addicts. (8) Functions vested in the Secretary pertaining to section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)), which relate to the merits of the research protocol and to the determination of the qualifications and competency of practitioners wishing to conduct research with controlled substances listed in Schedule I of the Act. (9) Functions vested in the Secretary pertaining to provisions of the Controlled Substances Act (21 U.S.C. 801 et seq.), which relate to administration of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (10) Functions vested in the Secretary under section 409(b) of the Federal Meat Inspection Act (21 U.S.C. 679(b)), which relate to the detention of any carcass, part thereof, meat, or meat product of cattle, sheep, swine, goats, or equines. (11) Functions vested in the Secretary under section 24(b) of the Poultry Products Inspection Act (21 U.S.C. 467f(b)), which relate to the detention of any poultry carcass, part thereof, or poultry product. (12) Functions vested in the Secretary under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.). (13) Functions vested in the Secretary by amendments to the foregoing statutes subsequent to Reorganization Plan No. 1 of 1953. (14) Function of issuing all regulations of the Food and Drug Administration, except as provided in Sec. 5.11. The reservation of authority contained in Chapter 2-000 of the Department Organization Manual shall not apply. [[Page 49]] (15) Functions vested in the Secretary under section 1103 of Executive Order 11490, as amended by Executive Order 11921, which relate to emergency health functions as they pertain to the operations and functional responsibilities assigned to the agency. This authority shall be exercised in accordance with section 102 and pertinent sections of part 30 of Executive Order 11490 and guidelines issued by the Federal Preparedness Agency of the General Services Administration and the Office of the Secretary. (16) Function vested in the Secretary of authorizing and approving miscellaneous and emergency expenses of enforcement activities. (17) Functions vested in the Secretary under the Federal Advisory Committee Act, Public Law 92-463, to: (i) Renew, recharter, amend and terminate established Federal Advisory Committees; (ii) Authority to approve waivers to appoint committee members to established Federal Advisory Committees; (iii) Authority to close review meetings following approval by the Office of the General Counsel based on a determination that the Advisory Committee meeting or a portion thereof may be closed to the public under the provisions of 5 U.S.C. 552b(c) and section 10(d) of the Federal Advisory Committee Act. These authorities are to be exercised in accordance with the requirements of 5 U.S.C. 552b; the Federal Advisory Committee Act (Public Law 92-463); Departmental regulations (45 CFR part 11, superseded by 41 CFR part 101-6); and any other applicable statutes and regulations. These authorities may be redelegated. (18) Functions vested in the Secretary under the second sentence of section 310(a) and under section 310(b) (Health Conferences and Health Education Information) of the PHS Act (42 U.S.C. 242o), as amended, to call for a conference and invite as many health authorities and officials of State or local public or private agencies or organizations as deemed necessary or proper on subjects related to the functions of the Food and Drug Administration, and to issue information related to health for the use of the public and other pertinent health information for the use of persons and institutions concerned with health services when such information is related to the functions of the Food and Drug Administration. (19) Functions vested in the Secretary under section 2701 of the PHS Act (42 U.S.C. 238), as amended, to accept offers of gifts, excluding the acceptance of gifts of real property. Only the authority to accept unconditional gifts of personal property valued at $5,000 or less may be redelegated. (20) Functions vested in the Secretary under section 362 of the PHS Act (42 U.S.C. 265), as amended, which relate to the prohibition of the introduction of foods, drugs, devices, cosmetics, electronic products, and other items or products regulated by the Food and Drug Administration into the United States when it is determined that it is required in the interest of public health when such functions relate to the law enforcement functions of the Food and Drug Administration. (21) Functions vested in the Secretary under section 401(a) of the Lead-Based Paint Poisoning Prevention Act, as amended by Public Law 94- 317 (42 U.S.C. 4831(a)), relating to the prohibition of the application of lead-based paint to cooking, drinking, or eating utensils. (22) Functions vested in the Secretary for the health information and health promotion program under title XVII of the PHS Act (42 U.S.C. 300u et seq.), as amended, insofar as the authorities pertain to functions assigned to the Food and Drug Administration. The delegation includes, but is not limited to, the authorities under: Section 1702(a)(1) and (3) and section 1704(1) and (2) (42 U.S.C. 300u-1(a) and (3) and 300u-3(1) and (2)). The delegation excludes the authority to select all Senior Executive Service, supergrade and equivalent, and Schedule C (GS-12 and above) positions; issue regulations; and submit reports to the President. (23) To administer a Small Business Innovation Research Program under section 9 of the Small Business Act (15 U.S.C. 638), as amended. The delegation excludes the authority to issue regulations, establish advisory councils and committees, appoint members to advisory councils and committees, and submit reports to Congress. [[Page 50]] (24) Functions vested in the Secretary under sections 982 and 983 of the Consumer-Patient Radiation Health and Safety Act of 1981 (the Act) (42 U.S.C. 10007 and 10008), as amended. The delegation excludes the authority to issue regulations and submit reports to Congress. The authority delegated under section 983 of the Act may only be exercised as it relates to functions assigned to the Food and Drug Administration. (25) Functions vested in the Secretary under section 156 of title 35 of the U.S. Code (35 U.S.C. 156), as amended, which allows for the extension of patent terms for human drug products, medical devices, food additives, and color additives subject to the Federal Food, Drug, and Cosmetic Act (the act). These authorities may be redelegated, except the authority to make due diligence determinations under section 156(d)(2)(B), which may not be redelegated to an Office below the Office of the Commissioner of Food and Drugs. (26) Functions vested in the Secretary under the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 3701 et seq.) (the Act), as amended, and under Executive Order 12591 of April 10, 1987, as they pertain to the functions of the Food and Drug Administration. The delegation excludes the authority to issue regulations and submit reports to Congress; under section 11(a)(2) of the Act (15 U.S.C. 3710a(a)(2)) to approve agreements and contracts with invention management organizations; and under section 11(c)(3)(B) of the Act (15 U.S.C. 3710a(c)(3)(B)) to propose necessary statutory changes regarding conflict of interest. (i) The authorities under section 11(c)(5)(A) and (B) of the act (15 U.S.C. 3710a(c)(5)(A) and (B)) to disapprove or require the modification of cooperative research and development agreements and licensing agreements after the agreement is presented to the Commissioner by the head of the laboratory concerned, and to transmit written explanation of such disapproval or modification to the head of the laboratory concerned, may be redelegated only to a senior official in the immediate Office of the Commissioner. (ii) The following authorities may not be redelegated: The authority under section 11(b)(3)(D) of the Act (15 U.S.C. 3710a(b)(3)(D)) to waive a right of ownership which the Federal Government may have to an invention made under a cooperative research and development agreement; the authority under section 11(b)(3)(C) of the Act (15 U.S.C. 3710a(b)(3)(C)) to permit employees or former employees to participate in efforts to commercialize inventions they made while in the service of the United States; the authority under section 11(c)(3)(A) of the Act (15 U.S.C. 3710a(c)(3)(A)) to review employee standards of conduct for resolving potential conflicts of interest; the authority under section 13(a)(1) of the Act (15 U.S.C. 3710c(a)(1)) to retain any royalties or other income, except as provided in section 13(a)(2) of the Act (15 U.S.C. 3710c(a)(2)); and the authority under section 13(a)(1)(A)(i) of the Act (15 U.S.C. 3710c(a)(1)(A)(i)) to pay royalties or other income the agency receives on account of an invention to the inventor if the inventor was an employee of the agency at the time the invention was made. (iii) Any authorities under paragraph (a)(26) of this section delegated by the Commissioner may not be further redelegated. (27) Functions vested in the Secretary under sections 4702, 4703, and 4704 of the Pesticide Monitoring Improvements Act of 1988 (21 U.S.C. 1401-1403) that relate to pesticide monitoring and enforcement information, foreign pesticide information, and pesticide analytical methods. The delegation excludes the authority to submit reports to Congress. (28) Functions vested in the Secretary under sections 2312(a)(1) and (2)(B), (b), and (c) (Use of Investigational New Drugs with Respect to Acquired Immunodeficiency Syndrome); 2314(c) (Scientific and Ethical Guidelines for Certain Treatments); and 2317(d) and (e) (Information Services) of title XXIII of the PHS Act (42 U.S.C. 300cc-12(a)(1) and (2)(B), (b) and (c), 300cc-14(c) and 300cc-17(d) and (e)), as amended, insofar as these authorities pertain to the functions assigned to the Food and Drug Administration. The delegation excludes the authority to [[Page 51]] issue regulations, submit reports to the Congress, establish advisory committees or national commissions, and appoint members to such committees or commissions. (29) Functions vested in the Secretary under section 2672(a)(1) (A) and (B) (Provisions Relating to Blood Banks) and section 2672(a)(2) (Information and Training Programs) of the PHS Act (42 U.S.C. 300ff- 72(a)(1)(A) and (B) and (a)(2) et seq.), as amended, insofar as these authorities pertain to the functions assigned to the Food and Drug Administration. The delegations exclude the authority to issue regulations, submit reports to the Congress, establish advisory committees or national commissioners, and appoint members to such committees or commissions. (30) Functions vested in the Secretary under sections 1322(b) and (c) of the Food, Agriculture, Conservation, and Trade Act of 1990 (the National Laboratory Accreditation Program) (7 U.S.C. 138a), as amended hereafter, which relate to setting standards for the National Laboratory Accreditation Program and approving State agencies or private, nonprofit entities as accrediting bodies to implement certification and quality assurance programs in accordance with the requirements of this section. The delegation excludes the authority to submit reports to Congress. (31) Functions vested in the Secretary under part C, subtitle 2 of title XXI of the PHS Act (42 U.S.C. 300aa-25 et seq.), as amended, and the National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1 note), as amended hereafter, as follows: (i) Section 2125 of the PHS Act (42 U.S.C. 300aa-25)--Recording and reporting of information. (ii) Section 2127 of the PHS Act (42 U.S.C. 300aa-27)---Mandate for safer childhood vaccines. (iii) Section 2128 of the PHS Act (42 U.S.C. 300aa-28)--Manufacturer recordkeeping and reporting. (iv) Section 312 of the National Childhood Vaccine Injury Act of 1986--Related studies (42 U.S.C. 300aa-1 note). (v) Section 313 of the National Childhood Vaccine Injury Act of 1986--Study of other vaccine risks (42 U.S.C. 300aa-1 note). (vi) Section 314 of the National Childhood Vaccine Injury Act of 1986--Review of warnings, use instructions, and precautionary information (42 U.S.C. 300aa-1 note). (vii) The delegation excludes the authority to issue regulations and submit reports to Congress. (32) Functions vested in the Secretary under section 201(h)(4) of the Controlled Substances Act (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended) (21 U.S.C. 811(h)(4)) to provide responses to the Drug Enforcement Administration's temporary scheduling notices. The delegation excludes the authority to submit reports to Congress. (33) Functions vested in the Secretary under the Safe Medical Devices Act of 1990 (Pub. L. 101-629), as amended hereafter (e.g., 21 U.S.C. 360c note, 360i note, and 360j note). The delegation excludes the authority to submit reports to Congress. (34) Functions vested in the Secretary under section 601 of Effective Medication Guides of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 1997 (Public Law 104-180), as amended hereafter. The delegation excludes the authority to issue reports to Congress. (35) The Secretary has redelegated to the Commissioner of Food and Drugs, or his designee, the authority to take final action on matters pertaining to section 203 of the Equal Access to Justice Act (5 U.S.C. 504), and to develop procedures and regulations where necessary to supplement the Department's regulations, 45 CFR part 13. (36) The Secretary has delegated to the Commissioner, the authority to administer and make decisions regarding the invention and patent program as they pertain to the functions of the Food and Drug Administration and to make determinations of rights in inventions and patents in which the Department has an interest. This delegation excludes the authority to submit reports to Congress and further, it excludes those authorities under the Stevenson-Wydler Technology Innovation [[Page 52]] Act of 1980, as amended by the Federal Technology Transfer Act of 1986 and the National Technology Transfer and Advancement Act of 1995, which are governed by a separate delegation (under Sec. 5.10(a)(26)). All authorities other than the authority under 35 U.S.C. section 203 (March- In Rights) may be redelegated. (37) Functions vested in the Secretary under title III, Section 354, of the PHS Act (42 U.S.C. 262 et seq.), as amended. The authority pertains to the Food and Drug Administration's oversight of mammography facilities. (38) The Deputy Assistant Secretary for Health Management Operations, Public Health Service, has redelegated to the Commissioner of Food and Drugs, with authority to redelegate, the authority to certify true copies of any books, records, or other documents on file within the Food and Drug Administration, or extracts from such; to certify that true copies are true copies of the entire file of the Administration; to certify the complete original record or to certify the nonexistence of records on file within the Administration; and to cause the Seal of the Department to be affixed to such certifications and to agreements, awards, citations, diplomas, and similar documents. (39) The Secretary of Health and Human Services has redelegated to the Commissioner, of Food and Drugs, under 45 CFR 5b.8 regulations, appeal authority to take final action upon an individual's appeal of a refusal to correct or amend the individual's record when the appeal has been made by the individual under Privacy Act regulations (part 21 of this chapter and 45 CFR part 5b). The authority may not be redelegated. (b) The Chief Counsel of the Food and Drug Administration has been authorized to report apparent violations to the Department of Justice for the institution of criminal proceedings, under section 305 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335), section 4 of the Federal Import Milk Act (21 U.S.C. 144), and section 9(b) of the Federal Caustic Poison Act.