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 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.
§ 5.36 - 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, 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.
§ 5.73 - Certification of insulin.
§ 5.74 - Issuance, amendment, or repeal of regulations pertaining to drugs containing insulin.
§ 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 temporaryscheduling 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.