Page images
PDF
EPUB

component identified in the intercenter agreement before submitting an application of premarket review or to confirm coverage and to discuss the application process.

(b) For a combination product not covered by a guidance document or for a product where the agency component with primary jurisdiction is unclear or in dispute, the sponsor of an application for premarket review should follow the procedures set forth in §3.7 to request a designation of the agency component with primary jurisdiction before submitting the application.

§3.6 Product jurisdiction officer.

FDA Ombudsman (HF-7), Food and Drug Administration, rm. 14-84, 5600 Fishers Lane, Rockville, MD 20857, 301443-1306, is the designated product jurisdiction officer.

§3.7 Request for designation.

(a) Who should file: the sponsor of: (1) Any combination product the sponsor believes is not covered by an intercenter agreement; or

(2) Any product where the agency component with primary jurisdiction is unclear or in dispute.

(b) When to file: a sponsor should file a request for designation before filing any application for premarket review, whether an application for marketing approval or a required investigational notice. Sponsors are encouraged to file a request for designation as soon as there is sufficient information for the agency to make a determination.

(c) What to file: an original and two copies of the request for designation must be filed. The request for designation must not exceed 15 pages, including attachments, and must set forth:

(1) The identity of the sponsor, including company name and address, establishment registration number, company contact person and telephone number.

(2) A description of the product, including:

(i) Classification, name of the product and all component products, if applicable;

(ii) Common, generic, or usual name of the product and all component products;

(iii) Proprietary name of the product;

(iv) Identification of any component of the product that already has received premarket approval, is marketed as not being subject to premarket approval, or has received an investigational exemption, the identity of the sponsors, and the status of any discussions or agreements between the sponsors regarding the use of this product as a component of a new combination product.

(v) Chemical, physical, or biological composition;

(vi) Status and brief reports of the results of developmental work, including animal testing;

(vii) Description of the manufacturing processes, including the sources of all components;

(viii) Proposed use or indications;

(ix) Description of all known modes of action, the sponsor's identification of the primary mode of action, and the basis for that determination;

(x) Schedule and duration of use; (xi) Dose and route of administration of drug or biologic;

(xii) Description of related products, including the regulatory status of those related products; and

(xiii) Any other relevant information.

(3) The sponsor's recommendation as to which agency component should have primary jurisdiction, with accompanying statement of reasons.

(d) Where to file: all communications pursuant to this subpart shall be addressed to the attention of the product jurisdiction officer. Such a request, in its mailing cover should be plainly marked “Request for Designation.”

§3.8 Letter of designation.

(a) Each request for designation will be reviewed for completeness within 5 working days of receipt. Any request for designation determined to be incomplete will be returned to the applicant with a request for the missing information. The sponsor of an accepted request for designation will be notified of the filing date.

(b) Within 60 days of the filing date of a request for designation, the product jurisdiction officer will issue a letter of designation to the sponsor, with copies to the centers, specifying the agency component designated to have primary

jurisdiction for the premarket review and regulation of the product at issue, and any consulting agency components. The product jurisdiction officer may request a meeting with the sponsor during the review period to discuss the request for designation. If the product jurisdiction officer has not issued a letter of designation within 60 days of the filing date of a request for designation, the sponsor's recommendation of the center with primary jurisdiction, in accordance with §3.7(c)(3), shall become the designated agency component.

(c) Request for reconsideration by sponsor: If the sponsor disagrees with the designation, it may request the product jurisdiction officer to reconsider the decision by filing, within 15 days of receipt of the letter of designation, a written request for reconsideration not exceeding 5 pages. No new information may be included in a request for reconsideration. The product jurisdiction officer shall review and act on the request in writing within 15 days of its receipt.

§3.9 Effect of letter of designation.

(a) The letter of designation constitutes an agency determination that is subject to change only as provided in paragraph (b) of this section.

(b) The product jurisdiction officer may change the designated agency component with the written consent of the sponsor, or without its consent to protect the public health or for other compelling reasons. A sponsor shall be given 30 days written notice of any proposed nonconsensual change in designated agency component. The sponsor may request an additional 30 days to submit written objections, not to exceed 15 pages, to the proposed change, and shall be granted, upon request, a timely meeting with the product jurisdiction officer and appropriate center officials. Within 30 days of receipt of the sponsor's written objections, the product jurisdiction officer shall issue to the sponsor, with copies to appropriate center officials, a written determination setting forth a statement of reasons for the proposed change in designated agency component. A nonconsensual change in the designated agency component requires the concur

[blocks in formation]

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 vac

cines.

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 foodprocessing 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 branded medical devices.

mis

[blocks in formation]
[blocks in formation]

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.

[blocks in formation]

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, 14511461, 3701-3711a; 21 U.S.C., 61-63, 141-149, 301394, 467f, 679(b), 801-886, 1031-1309, 1401-1403; 35 U.S.C. 156; 42 U.S.C. 238, 241, 242, 242a, 2421, 242n, 2420, 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.

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

§ 5.10 Delegations from the Secretary of Health and Human Services to the Commissioner of Food and Drugs.

(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:

(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 (FederalState Cooperation) of the Public Health Service Act (the PHS 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 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 effective

ness 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 §5.11. The reservation of authority contained in Chapter 2-000 of the Department Organization Manual shall not apply.

(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.

« PreviousContinue »