1999 CFR Title 24, Volume 4

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, the Assistant Secretary for Health, and Public Health Service Officials.
	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.
	5.24	Authority relating to technology transfer.
	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.
	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 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	Enforcement activities.
	5.36	Certification following inspections.
	5.37	Issuance of reports of minor violations.
	5.38	Issuance of written notices concerning 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 Biologics 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 devices.
	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	Orphan products.
	5.59	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 food-processing instruction.
	5.67	Issuance of notices of opportunity for a hearing on proposals for denial of approval of applications for 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.
	5.75	Designation of official master and working standards for antibiotic drugs.
	5.76	Certification of antibiotic drugs.
	5.78	Issuance, amendment, or repeal of regulations pertaining to antibiotic 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 reporting procedures.
	5.99	Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.
	5.100	Officials authorized to make certification under 5 U.S.C. 605(b) for any proposed and final rules.
	5.200	Headquarters.
	5.205	Chief Counsel, Food and Drug Administration.
	5.210	FDA Public Information Offices.
	5.215	Field structure.