2004 CFR Title 21, Volume 1

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION
	5.10	Delegations from the Secretary of Health and Human Services to the Commissioner of Food and Drugs.
	5.11	Reservation 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 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.
	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.
	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.
	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.
	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 to petitioners of determinations made on petitions for reclassification of medical devices.
	5.405	Determination of classification of devices.
	5.406	Notification to 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.
	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.
	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.
	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 data 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.
	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.
	5.800	Imports and exports.
	5.801	Export of unapproved drugs.
	5.802	Manufacturer's resident import agents.
	5.900	Orphan products.
	5.1000	Authority to ensure that mammography facilities meet quality standards.
	5.1100	Headquarters.
	5.1105	Chief Counsel, Food and Drug Administration.
	5.1110	Food and Drug Administration Public Information Offices.
	5.1115	Field structure.