CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR25]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

PART 25 ENVIRONMENTAL IMPACT CONSIDERATIONS

Subpart A - General Provisions

Sec. 25.1 Purpose.

The National Environmental Policy Act of 1969 (NEPA), as amended, directs that, to the fullest extent possible, the policies, regulations, and public laws of the United States shall be interpreted and administered in accordance with the policies set forth in NEPA. All agencies of the Federal Government shall comply with the procedures in section 102(2) of NEPA except where compliance would be inconsistent with other statutory requirements. The regulations in this part implement section 102(2) of NEPA in a manner that is consistent with FDA's authority under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. This part also supplements the regulations for implementing the procedural provisions of NEPA that were published by the Council on Environmental Quality (CEQ) in 40 CFR parts 1500 through 1508 and the procedures included in the "HHS General Administration Manual, part 30: Environmental Protection" (45 FR 76519 to 76534, November 19, 1980).

Sec. 25.5 Terminology.

(a) Definitions that apply to the terms used in this part are set forth in the CEQ regulations under 40 CFR part 1508. The terms and the sections of 40 CFR part 1508 in which they are defined follow:

(1) Categorical exclusion (40 CFR 1508.4).

(2) Cooperating agency (40 CFR 1508.5).

(3) Cumulative impact (40 CFR 1508.7).

(4) Effects (40 CFR 1508.8).

(5) Environmental assessment (EA) (40 CFR 1508.9).

(6) Environmental document (40 CFR 1508.10).

(7) Environmental impact statement (EIS) (40 CFR 1508.11).

(8) Federal agency (40 CFR 1508.12).

(9) Finding of no significant impact (40 CFR 1508.13).

(10) Human environment (40 CFR 1508.14).

(11) Lead agency (40 CFR 1508.16).

(12) Legislation (40 CFR 1508.17).

(13) Major Federal action (40 CFR 1508.18).

(14) Mitigation (40 CFR 1508.20).

(15) NEPA process (40 CFR 1508.21).

(16) Notice of intent (40 CFR 1508.22).

(17) Proposal (40 CFR 1508.23).

(18) Scope (40 CFR 1508.25).

(19) Significantly (40 CFR 1508.27).

(b) The following terms are defined solely for the purpose of implementing the supplemental procedures provided by this part and are not necessarily applicable to any other statutory or regulatory requirements:

(1) Abbreviated application applies to an abbreviated new drug application and an abbreviated new animal drug application.

(2) Active moiety means the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex chelate or clathrate) of the molecule responsible for the physiological or pharmacological action of the drug substance.

(3) Agency means the Food and Drug Administration (FDA).

(4) Increased use of a drug or biologic product may occur if the drug will be administered at higher dosage levels, for longer duration or for different indications than were previously in effect, or if the drug is a new molecular entity. The term "use" also encompasses disposal of FDA-regulated articles by consumers.

(5) Responsible agency official means the agency decisionmaker designated in the delegated authority for the underlying actions.

(c) The following acronyms are used in this part:

(1) CEQ - Council on Environmental Quality.

(2) CGMP - Current good manufacturing practice.

(3) EA - Environmental assessment.

(4) EIS - Environmental impact statement.

(5) The act - Federal Food, Drug, and Cosmetic Act.

(6) FIFRA - Federal Insecticide, Fungicide, and Rodenticide Act.

(7) FONSI - Finding of no significant impact.

(8) GLP - Good laboratory practice.

(9) GRAS - Generally recognized as safe.

(10) HACCP - Hazard analysis critical control point.

(11) IDE - Investigational device exemption.

(12) IND - Investigational new drug application.

(13) INAD - Investigational new animal drug application.

(14) NADA - New animal drug application.

(15) NDA - New drug application.

(16) NEPA - National Environmental Policy Act of 1969.

(17) OTC - Over-the-counter.

(18) PDP - Product development protocol.

(19) PMA - Premarket approval application.

[62 FR 40592, July 29, 1997, as amended at 64 FR 399, Jan. 5, 1999; 69 FR 17291, Apr. 2, 2004]

Sec. 25.10 Policies and NEPA planning.

(a) All FDA's policies and programs will be planned, developed, and implemented to achieve the policies declared by NEPA and required by CEQ's regulations to ensure responsible stewardship of the environment for present and future generations.

(b) Assessment of environmental factors continues throughout planning and is integrated with other program planning at the earliest possible time to ensure that planning and decisions reflect environmental values, to avoid delays later in the process, and to avoid potential conflicts.

(c) For actions initiated by the agency, the NEPA process will begin when the agency action under consideration is first identified. For actions initiated by applicants or petitioners, NEPA planning begins when FDA receives from an applicant or petitioner an EA or a claim that a categorical exclusion applies, or when FDA personnel consult with applicants or petitioners on the NEPA-related aspects of their requested actions. FDA may issue a public call for environmental data or otherwise consult with affected individuals or groups when a contemplated action in which it is or may be involved poses potential significant environmental effects.

(d) Environmental documents shall concentrate on timely and significant issues, not amass needless detail.

(e) If a proposed action for which an EIS will be prepared involves possible environmental effects that are required to be considered under statutes or Executive Orders other than those referred to under "Authority" in this part, these effects shall be considered in the NEPA review, consistent with 40 CFR 1502.25 and the HHS General Administration Manual, part 30: Environmental Protection.

Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360.
Source: 62 FR 40592, July 29, 1997, unless otherwise noted.