5.25 Research, investigation, and testing programs and health information and health promotion programs.

5.26 Service fellowships. 5.27 Patent term extensions for human drug products, medical devices, and food and color additives; and due diligence determinations.

5.28 Cardiac pacemaker devices and pacemaker leads.

5.29 Functions pertaining to safer vaccines. 5.30 Hearings.

5.31 Petitions under part 10.

5.32 Authority relating to determination of product classification and assignment of primary jurisdiction.

5.33 Premarket approval of a product that is or contains a biologic, a device, or a drug.

5.34 Authority to select temporary voting members for advisory committees and authority to sign conflict of interest waivers.

5.35 5.36 Certification following inspections. 5.37 Issuance of reports of minor violations. 5.38 Issuance of written notices concerning

Enforcement activities.

patent information, current good manufacturing practices and false or misleading labeling of new drugs, new animal drugs, and feeds bearing or containing new animal drugs.

5.39 Redelegation of the Center for Bio

logics Evaluation and Research Director's program authorities.

5.40 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.

5.44 Export of unapproved drugs.

5.45 Imports and exports.

5.46 Manufacturer's resident import agents. 5.47 Detention of adulterated or misbranded medical devices.

5.49 Authorization to use alternative evidence for determination of the effectiveness of medical devices.

5.50 Notification to petitioners of determinations made on petitions for reclassification of medical devices.

5.51 Determination of classification of de

vices.

5.52 Notification to sponsors of deficiencies in petitions for reclassification of medical devices.

5.53 Approval, disapproval, or withdrawal of approval of product development protocols and applications for premarket approval for medical devices.

5.54 Determinations that medical devices present unreasonable risk of substantial harm.

5.55 Orders to repair or replace, or make refunds for, medical devices.

5.56 Recall authority.

5.57 Temporary suspension of a medical device application.

5.58

5.59

Orphan products.

Approval, disapproval, or withdrawal of approval of applications for investigational device exemptions.

5.60 Required and discretionary postmarket surveillance.

5.61 Food standards, food additives, generally recognized as safe (GRAS) substances, color additives, nutrient content claims, and health claims.

5.62 Issuance of initial emergency permit orders and notices of confirmation of effective date of final regulations on food for human and animal consumption. 5.63 Detention of meat, poultry, eggs, and related products.

5.64 Establishing standards and approving accrediting bodies under the National Laboratory Accreditation Program. 5.66 Approval of schools providing foodprocessing instruction.

5.67 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.

5.68 Issuance and revocation of licenses for the propagation or manufacture and preparation of biological products.

5.69 Notification of release for distribution of biological products.

5.70 Issuance of notice implementing the provisions of the Drug Amendments of 1962.

5.71 Termination of exemptions for new drugs for investigational use in human beings and in animals.

5.72 Authority to approve and to withdraw approval of a charge for investigational new drugs.

5.80 Approval of new drug applications and their supplements.

5.81 Responses to Drug Enforcement Administration temporary scheduling notices. 5.82 Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements.

5.83 Approval of new animal drug applications, medicated feed mill license applications and their supplements. 5.84 Issuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications. 5.85 Authority to ensure that mammography facilities meet quality standards. 5.86 Variances from performance standards for electronic products.

5.87 Exemption of electronic products from performance standards and prohibited

acts.

5.88 Testing programs and methods of certification and identification for electronic products.

5.89 Notification of defects in, and repair or replacement of, electronic products. 5.90 Manufacturers requirement to provide data to ultimate purchasers of electronic products.

5.91 Dealer and distributor direction to provide data to manufacturers of electronic products.

5.92 Acceptance of assistance from State and local authorities for enforcement of radiation control legislation and regulations.

5.93 Submission of and effective approval dates for abbreviated new drug applications and certain new drug applications. 5.94 Extensions or stays of effective dates for compliance with certain labeling requirements for human prescription drugs.

5.95 Submission of and effective approval

dates for abbreviated new animal drug applications and certain new animal drug applications.

5.98 Authority relating to medical device

5.210 FDA Public Information Offices. 5.215 Field structure.

AUTHORITY: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15 U.S.C. 638, 1261-1282, 37013711a; 15 U.S.C. 1451-1461; 21 U.S.C. 41-50, 6163, 141-149, 321-394, 467f, 679(b), 801-886, 10311309; 35 U.S.C. 156; 42 U.S.C. 241, 242, 242a, 2421, 242n, 243, 262, 263, 264, 265, 300u-300u-5, 300aa-1; 1395y, 3246b, 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: 42 FR 15560, Mar. 22, 1977, unless otherwise noted.

Subpart A-Delegations of Authority to the Commissioner of Food and Drugs

$5.10 Delegations from the Secretary, the Assistant Secretary for Health,

and Public Health Service Officials. (a) The Assistant Secretary for Health has redelegated to the Commissioner of Food and Drugs, with authority to redelegate except when specifically prohibited, all authority delegated to the Assistant Secretary for Health by the Secretary of Health and Human Services, as follows:

(1) Functions vested in the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Filled Milk Act (21 U.S.C. 61-63), the Federal Import Milk Act (21 U.S.C. 141 et seq.), the Tea Importation Act (21 U.S.C. 41 et seq.), the Federal Caustic Poison Act (44 Stat. 1406), and The Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), pursuant to 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 (FederalState Cooperation) of the Public Health Service Act (42 U.S.C. 241, 2421, 243), as amended, which relate to the functions of the Food and Drug Administration.

(3) Functions vested in the Secretary under sections 354 through 360F of the Public Health Service Act (42 U.S.C. 263b through 263n), as amended, which relate to electronic product radiation control.

(4) Functions vested in the Secretary under section 361 of the Public Health Service 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 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.

(5) Functions vested in the Secretary under sections 351 and 352 of part F, subpart 1 of the Public Health Service 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.

(6) Functions vested in the Secretary under section 302(a) of the Public Health Service 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.

(7) Functions vested in the Secretary under section 303 of the Public Health Service 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 Pub. L. 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 Pub. L. 91-513.

(8) Functions vested in the Secretary pertaining to section 4 of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (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.

(9) 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 determination of the qualifications and competency of practitioners wishing to conduct research with controlled substances list

ed in Schedule I of the Act, and the merits of the research protocol.

(10) 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.).

(11) 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.

(12) 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.

(13) Functions vested in the Secretary under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

(14) Functions vested in the Secretary by amendments to the foregoing statutes subsequent to Reorganization Plan No. 1 of 1953.

(15) Function of issuing all regulations of the Food and Drug Administration, except as provided in §5.11. The reservation of authority contained in Chapter 2-000 of the Department Organization Manual shall not apply.

(16) 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 promulgated by the Federal Preparedness Agency of the General Services Administration; Office of the Secretary, HHS; and Office of the Assistant Secretary for Health.

(17) Function vested in the Secretary of authorizing and approving miscellaneous and emergency expenses of enforcement activities.

(18) Functions vested in the Secretary under the Federal Advisory Committee Act, Public Law 92-463, to make determinations that advisory committee meetings are concerned with matters listed in 5 U.S.C. 552(b)

and therefore may be closed to the public for those committees under the administrative jurisdiction of the Commissioner of Food and Drugs. This authority may be redelegated to a single official who reports directly to the Commissioner of Food and Drugs. This authority is to be exercised in accordance with the requirements of the Federal Advisory Committee Act and only with respect to the following:

(i) Meetings, to the extent that they directly involve review, discussion or consideration of records of the Department which are exempt from disclosure under 5 U.S.C. 552(b) (4), (6), and (7), namely, (a) records containing trade secrets and commercial or financial information obtained from a person and privileged

or confidential; (b) personnel, medical and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy; and (c) investigatory files compiled for law enforcement purposes;

(ii) Meetings to the extent that they involve the review, discussion, and evaluation of specific drugs and devices regulated by FDA which are intended to result in recommendations for regulatory decisions under the Federal Food, Drug, and Cosmetic Act and which are concerned with matters listed in 5 U.S.C. 552(b) (4), (5), and (7);

(iii) Meetings held for the sole purpose of considering and formulating advice which the committee will give or any final report it will render, Provided:

(a) The meetings will involve solely the internal expression of views and judgments of the members and it is essential to close the meeting or portions thereof to protect the free exchange of such views and avoid undue interference with agency or committee operations, and such views if reduced to writing would be protected from mandatory disclosure under 5 U.S.C. 552(b);

(b) The meeting is closed for the shortest time necessary, summarizing the work of the committee during the closed session, and a report, prepared by the executive secretary will be made available promptly to the public. (c) When feasible, the public is given a timely opportunity to present rel

evant information and views to the committee; and

(d) Concurrence for closing the meetings for such purpose is obtained from the Office of the General Counsel and the Office of Public Affairs.

(19) 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 Public Health Service Act (42 U.S.C. 2420), 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.

(20) Functions vested in the Secretary under section 2101 of the Public Health Service Act (42 U.S.C. 219) 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.

(21) Functions vested in the Secretary under section 362 of the Public Health Service 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.

(22) Functions vested in the Secretary under section 1003(b)(3), title X, of the Public Works and Economic Development Act of 1965 (42 U.S.C. 3246b(b)(3)) to waive any matching requirements for programs or projects of State and local governments funded

under title X of that act where it is determined that State or local governments concerned cannot reasonably obtain any non-Federal contributions.

(23) Functions vested in the Secretary under section 401(a) of the LeadBased Paint Poisoning Prevention Act, as amended by Pub. L. 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.

(24) Functions vested in the Secretary for the health information and health promotion program under title XVII of the Public Health Service 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), (2), and (6). The delegation excludes the authority to select all Senior Executive Service, supergrade and equivalent, and Schedule C (GS-12 and above) positions; promulgate regulations; and submit reports to the President.

(25) 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 promulgate regulations, establish advisory councils and committees, appoint members to advisory councils and committees, and submit reports to Congress.

(26) Functions vested in the Secretary under sections 982 and 983 of the Consumer-Patient Radiation Health and Safety Act of 1981 (42 U.S.C. 10007 and 10008), as amended. The delegation excludes the authority to promulgate 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.

(27) 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. These authorities may be redelegated except the authority to make due diligence

under

section

determinations 156(d)(2)(B), which may not be redelegated to an Office below the Office of the Commissioner of Food and Drugs.

(28) Functions vested in the Secretary under section 1862(h) (1), (2)(A), and (3) of the Social Security Act (42 U.S.C. 1395y (h)(1), (2)(A), and (3)), as amended, which provides for a registry of all cardiac pacemaker devices and pacemaker leads for which payment was made under this title. The approval and issuance of regulations under that section are reserved to the Secretary, as provided in 21 CFR 5.11.

(29) 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 No. 12591 of April 10, 1987, as they pertain to the functions of the Food and Drug Administration. The delegation excludes the authority to promulgate 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 sections 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 of Food and Drugs 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) of the Act (15 U.S.C. 3710a(b)(3)) 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)(4) of the Act (15 U.S.C. 3710a(b)(4)) to permit employees or former employees to participate in