and stating briefly why an action, not otherwise excluded, will not significantly affect the human environment and for which, therefore, an EIS will not be prepared. A FONSI includes the EA or a summary of it and a reference to any other related environmental documents.

(b) If the EA has been prepared by an applicant or petitioner, the agency may choose to include additional evidence in the FONSI. Any remaining unknowns or uncertainties will be identified.

(c) The agency official(s) responsible for the preparation and approval of the FONSI will sign the document, thereby establishing that the official(s) approve(s) the conclusions not to prepare an EIS for the action under consideration.

(a) As defined by CEQ regulations (40 CFR 1508.22), the Notice of Intent notifies the public that the agency has determined that an EIS will be prepared. This determination may be based on information contained in an EA or on other information available to the agency which indicates that potentially significant effects may be associated with a proposed action.

(b) As required by 40 CFR 1508.22, the Notice of Intent will describe the proposed action, possible alternatives, the agency's proposed scoping process, which may include a request for information or suggestions regarding the scope of the EIS and notice of public meetings, and the identification of persons within the agency to contact for further information.

§ 25.34 Draft, final, and supplemental environmental impact statements.

(a) The CEQ regulations (40 CFR Part 1502) provide detailed requirements for the preparation of an EIS. CEQ's format for EIS's (40 CFR 1502.10) will be followed unless the agency determines that there is a compelling reason to do otherwise.

(b) When chemical substances enter the environment as a result of a proposed action or other regulatory alternatives, the portion of the EIS format on "environmental consequences" (40 CFR 1502.10(g)) will include discussion

of the environmental fates and effects of those substances similar to that described in § 25.31a.

(c) Any final EIS will contain any additional information gathered by the agency after the publication of the draft EIS, a copy of or a summary of the comments received on the draft EIS, and the agency's responses to the comments as required in 40 CFR 1503, including any revisions resulting from comments or other information.

(d) Draft and final supplemental EIS's will conform to the EIS format (40 CFR 1502.10) unless there is a compelling reason to do otherwise.

Subpart D-Agency Decisionmaking

§ 25.40 Procedures for incorporating environmental considerations into agency decisionmaking.

(a) These procedures are to ensure that environmental information is provided to decisionmakers in a timely manner. The NEPA process is an integral part of FDA's decisionmaking. Agency decisionmakers ensure that the policies and purpose of NEPA and CEQ regulations are complied with by: (1) Completing or assuring the completion of an EA, determining whether an EIS is required and, ordinarily, completing a draft EIS (if one is required) prior to or at the time of proposing an action subject to §§ 25.21 and 25.22.

(2) Including in decision documents and supporting environmental documents a discussion of all alternatives considered in the decision as required by 40 CFR 1502.14. Every action memorandum proposing an agency action included under § 25.21 or § 25.22 will contain an evaluation of the environmental impact of the proposed action and will be accompanied by a draft or final EIS if one is required.

(3) Submitting relevant environmental documents, comments, and responses with other decision documents through the review process.

(4) Including in the records of proceedings any appropriate environmental documents, comments, and responses.

(5) Completing and circulating a final EIS before the decision to imple

ment an action that significantly affects the quality of the human environment.

(b) There are certain regulatory actions which, because of their immediate importance to the public health, make adherence to the requirements of the CEQ regulations and these regulations concerning minimum periods of public review impractical. Compliance with the requirements for environmental analysis under NEPA is impossible where emergency circumstances require immediate regulatory action to safeguard the public health. For such actions, the responsible agency official shall consult with the CEQ about alternative arrangements before the action is taken, or after the action is taken, if time does not permit prior consultation with CEQ.

(c) Certain FDA actions are subject to statutory time limits that sometimes do not provide sufficient time to complete the required environmental document. Should the responsible agency official be unable to complete environmental consideration of the proposed action before a notice of filing of a food or color additive petition is required to be published, and if the subsequent environmental analysis leads to the conclusion that no EIS is necessary, the FEDERAL REGISTER document publishing the final regulation rather than the notice of filing shall state that no EIS is necessary and that the FONSI and the EA are available upon request and filed in the FDA Dockets Management Branch. If it is concluded that an EIS is necessary, the final regulation, final EIS, and record of decision shall be made available as prescribed in 40 CFR 1506.10.

§ 25.41 Actions for which a finding of no significant impact and an environmental assessment are prepared.

of action that offer less environmental risk or that are environmentally preferable to the proposed action.

(a) As required by 40 CFR 1501.4(e), a FONSI is prepared for an individual action or groups of related actions that will not significantly affect the quality of the human environment. If potentially adverse environmental impacts are identified for an action or group of related actions, the EA supporting the FONSI will, as required by 40 CFR 1508.9, include a consideration of any reasonable alternative courses

(b) FONSI's and EA's will be available to the public in accordance with 40 CFR 1506.6 as follows:

(1) When the proposed action is the subject of a notice of proposed rulemaking or a notice of filing published in the FEDERAL REGISTER, the notice shall state that no EIS is necessary and that the FONSI and the EA are available for public inspection at the FDA Dockets Management Branch.

(2) For actions for which notice is not published in the FEDERAL REGISTER, the FONSI and the EA shall be made available to the public upon request according to the procedures in 40 CFR 1506.6.

(3) For a limited number of actions, the agency may make the FONSI and EA available for public review (including review by State and areawide information clearinghouses) for 30 days before the agency makes its final determination whether to prepare an EIS and before the action may begin, as described in 40 CFR 1501.4(e). This procedure will be followed when the proposed action is, or is closely similar to, one that normally requires an EIS or when the proposed action is one without precedent.

(c) Program area officials and environmental staff prepare or ensure that the information contained in an EA is complete and accurate, and they prepare the FONSI. The responsible agency official designated in Part 5 examines the environmental risks of the proposed action and the alternative courses of action, selects a course of action, and ensures that any necessary mitigating measures are implemented as a condition for approving the selected course of action.

(1) A Notice of Intent to prepare an EIS is prepared for publication in the FEDERAL REGISTER and serves as the first public notification that an EIS will be prepared.

(2) The scoping process, as announced in the Notice of Intent, allows the public and Federal, State, and local government agencies to participate in determining the issues to be considered in the EIS.

(3)(i) Draft EIS's are filed with the EPA, sent to parties having an interest in the document, and are available to the public upon request for the purpose of receiving substantive comment, corrections, and additional information on the issues covered.

(ii) If the subject of a draft EIS is also the subject of a notice of proposed rulemaking, the FEDERAL REGISTER notice of proposed rulemaking will state that the draft EIS is available upon request, and will solicit comments from all interested persons.

(iii) If the subject of a draft EIS is not also the subject of a notice of proposed rulemaking published in the FEDERAL REGISTER, FDA will publish a notice in the FEDERAL REGISTER describing the proposed action and possible alternatives, stating that the draft EIS is available upon request, and soliciting comments from all interested persons.

(iv) FDA will solicit comments from any Federal agency having jurisdiction by law or having expertise on the environmental impact of a proposed action by sending it a copy of a draft EIS.

(v) Two copies of all comments on draft EIS's shall be submitted to the Dockets Management Branch (HFA305), Food and Drug Administration, Department of Health and Human Services, 5600 Fishers Lane, Rockville,

MD 20857 (except individuals may submit one copy) where they will be available for public inspection from 9 a.m. to 4 p.m., Monday through Friday.

(vi) Draft EIS's will be prepared, forwarded to EPA for filing, and made available to the public early enough in the consideration of the proposed action to permit meaningful review of the environmental issues involved. Except in emergencies, no final action will be taken on the proposal earlier than 90 days after a draft EIS has been prepared, forwarded to the EPA, and made available to the public.

(4) The final text of an EIS will be prepared by the responsible agency official after comments on the draft statement have been reviewed and will receive full consideration in the agency's decisionmaking process. The responsible agency official will forward 10 copies of the final statement to the Office of the Secretary of the Department of Health and Human Services and 10 copies to the EPA, and FDA will make copies of the final statement available for public inspection in the Dockets Management Branch. Copies of each final EIS will be available upon request and will be forwarded to those persons who submitted comments on the pertinent draft statements.

(5)(i) The weighing of any environmental impacts of alternatives in selecting a final course of action, as described in paragraph (a) of this section, will be reflected in the agency record of formal decisionmaking as required by 40 CFR 1505.2.

(ii) Except in emergencies, no agency action will be effective earlier than 30 days after the final statement has been filed for public inspection by EPA. If the subject of a final statement is also the subject of a regulation published in the FEDERAL REGISTER, this requirement may be met by simultaneous publication of the regulation and of a notice of availability of the final statement and the record of decision, provided that the regulation becomes effective no sooner than 30 days after the date of publication.

(iii) If the subject of an EIS is an FDA action governed by specific time requirements under statute or regula

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tions, those time requirements will be extended, if at all, only as long as necessary to permit the agency to consider or issue an EIS for the action.

(c) As described in 40 CFR 1505.3, the agency may provide for monitoring to ensure that its decisions, any mitigating measures, and other conditions are carried out.

(d) Under the conditions prescribed in 40 CFR 1502.9(c), the agency will prepare a supplement for a draft or final EIS and introduce the supplement into its administrative record.

(e)(1) The agency official to whom authority for the action is delegated in Part 5 will ensure both that there is balancing of environmental impacts with the agency's objective in choosing an appropriate course of action and that the public is involved and notified of the decision, as described in paragraphs (a) through (d) of this section.

(2)(i) The director of each FDA center is responsible for preparing a draft or final EIS on actions delegated to that center by the Commissioner under Subpart B of Part 5 of this chapter or in which the center is a party in an administrative proceeding under Part 12, 13, 14, 15, or 16 of this chapter in which a draft or final EIS is required.

(ii) The Director, Office of Regional Operations, FDA, is responsible for preparing a draft or final EIS on the destruction of articles condemned after seizure, subject to an injunction, under import detention, or under detention or recalled at agency request.

(iii) The Office of the Commissioner of Food and Drugs is responsible for preparing or assigning the task of preparing a draft or final EIS on actions not otherwise assigned in this section.

Subpart E-Other Requirements

§ 25.50 Environmental effects abroad of major agency actions.

(a) In accordance with E.O. 12114, "Environmental Effects Abroad of Major Federal Actions" of January 4, 1979 (44 FR 1957, Jan. 9, 1977), the responsible agency official, in analyzing actions under his or her program, shall consider the environmental ef

fects abroad, including whether the actions involve:

(1) Potential environmental effects on the global commons and areas outside the jurisdiction of any nation, e.g., oceans and the upper atmosphere.

(2) Potential environmental effects on a foreign nation not participating with or otherwise involved in an FDA activity.

(3) The export of products (or emissions) that in the United States are prohibited or strictly regulated because their effects on the environment create a serious public health risk.

(4) Potential environmental effects on natural and ecological resources of global importance designated under the Executive Order.

(b) Before deciding on any action falling into the categories specified in paragraph (a) of this section, the responsible agency official shall determine in accordance with section 2-3 of the Executive Order whether such actions may have a significant environmental effect abroad.

(c) If the responsible agency official determines that an action may have a significant environmental effect abroad, the responsible agency official shall determine in accordance with section 2-4(a) and (b) of the Executive Order, whether the subject action calls for:

(1) An EIS;

(2) A bilateral or multilateral environmental study; or

(3) A concise environmental review. (d) In preparing environmental documents under this subpart, the responsible official shall:

(1) Determine, as provided in section 2-5 of the Executive Order, whether proposed actions are subject to the exemptions, exclusions, and modification in contents, timing, and availability of documents.

(2) Coordinate all communications with foreign governments concerning environmental agreements and other arrangements in implementing the Executive Order.

50.44 Restrictions on clinical investigations involving prisoners.

50.46 Composition of institutional review boards where prisoners are involved. 50.48 Additional duties of the institutional review boards where prisoners are involved.

AUTHORITY: Secs. 201, 406, 409, 502, 503, 505, 506, 507, 510, 513-516, 518-520, 701(a), 706, and 801, Pub. L. 717, 52 Stat. 1040-1042 as amended, 1049-1054 as amended, 1055, 1058 as amended, 55 Stat. 851 as amended, 59 Stat. 463 as amended, 72 Stat. 1785-1788 as amended, 74 Stat. 399-407 as amended, 76 Stat. 974-795 as amended, 90 Stat. 540-560, 562-574 (21 U.S.C. 321, 346, 348, 352, 353, 355, 356, 357, 360, 360c-360f, 360h-360j, 371(a), 376, and 381); secs. 215, 351, 354360F, Pub. L. 410, 58 Stat. 690, 702 as amended, 82 Stat. 1173-1186 as amended (42 U.S.C. 216, 262, 263b-263n); 21 CFR 5.10.

SOURCE: 45 FR 36390, May 30, 1980, unless otherwise noted.

Subpart A-General Provisions § 50.1 Scope.

(a) This part applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i), 507(d), and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Adminis

tration, including food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Additional specific obligations and commitments of, and standards of conduct for, persons who sponsor or monitor clinical investigations involving particular test articles may also be found in other parts (e.g., Parts 312 and 812). Compliance with these parts is intended to protect the rights and safety of subjects involved in investigations filed with the Food and Drug Administration pursuant to sections 406, 409, 502, 503, 505, 506, 507, 510, 513-516, 518-520, 706, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354360F of the Public Health Service Act.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21, unless otherwise noted.

[45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27, 1981]

§ 50.3 Definitions.

As used in this part:

(a) "Act" means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq. as amended (21 U.S.C. 321–392)).

(b) "Application for research or marketing permit" includes:

(1) A color additive petition, described in Part 71.

(2) A food additive petition, described in Parts 171 and 571.

(3) Data and information about a substance submitted as part of the procedures for establishing that the substance is generally recognized as safe for use that results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in §§ 170.30 and 570.30.

(4) Data and information about a food additive submitted as part of the procedures for food additives permitted to be used on an interim basis pending additional study, described in § 180.1.

(5) Data and information about a substance submitted as part of the procedures for establishing a tolerance