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Subpart G-Disclosure of Records

in Privacy Act Record Systems to Persons Other Than the Subject Individual


$21.70 Disclosure and intra-agency

of records in Privacy Act Record Systems; no accounting re

quired. (a) A record about an individual which is contained in a Privacy Act Record System may be disclosed:

(1) To the individual who is the subject of the record, or his legal guardian under $21.75;

(2) To a third party pursuant to a written request by, or within a written consent of, the individual to whom the record pertains, or his legal guardian under $21.75;

(3) To any person:

(i) Where the names and other identifying information are first deleted, and under circumstances in which the recipient is unlikely to know the identity of the subject of the record;

(ii) Where disclosure is required by part 20 of this chapter (the public information regulations); or

(4) Within the Department of Health and Human Services to officers and employees who have a need for the record in the performance of their duties in connection with the laws administered and enforced by the Food and Drug Administration or that govern the agency. For purposes of this section, officers or employees of the Department shall include the following categories of individuals, who shall thereafter be subject to the same restrictions with respect to disclosure as any Food and Drug Administration employee: Food and Drug Administration consultants and advisory Committees, State and local government employees for use only in their work with the Food and Drug Administration, and contractors and their employees to the extent that the records of such contractors are subject to the requirements of this part under $21.30.

(b) No accounting is required for any disclosure or use under paragraph (a) of this section.

$21.71 Disclosure of records in Pri

vacy Act Record Systems; account

ing required. (a) Except as provided in $21.70, a record about an individual that is contained in a Privacy Act Record System shall not be disclosed by any method of communication except under any of the following circumstances, which are subject to the limitations of paragraphs (b) and (c) of this section and to the accounting requirement of paragraph (d) of this section:

(1) To those officers and employees of the agency which maintains the record who have a need for the record in the perfomance of their duties;

(2) Required under section 552 of the Freedom of Information Act;

(3) For a routine use as described in the routine use section of each specific system notice;

(4) To the Bureau of Census for purposes of planning or carrying out a census or survey or related activity pursuant to the provisions of title 13 of the U.S. Code;

(5) To a recipient who has provided the agency with advance adequate written assurance that the record will be used solely as a statistical research or reporting record, and that the record is to be transferred in a form that is not individually identifiable;

(6) To the National Archives and Records Administration of the United States as a record which has sufficient historical or other value to warrant its continued preservation by the U.S. Government, or to the Archivist of the United States or his or her designee for evaluation to determine whether the record has such value;

(7) To another agency or to an instrumentality of any government jurisdiction within or under the control of the United States for a civil or criminal law enforcement activity if the activity is authorized by law, and if the head of the agency or instrumentality has made a written request to the agency which maintains the record specifying the particular portion desired and the law enforcement activity for which the record is sought;

(8) To a person pursuant to a showing of compelling circumstances affecting the health or safety of an individual if, upon such disclosure, notification is transmitted to the last known address of such individual;

(9) To either House of Congress or, to the extent of matter within its jurisdiction, any

committee or subcommittee thereof, any joint committee of Congress or subcommittee of any such joint committee;

(10) To the Comptroller General, or any of his or her authorized representatives in the course of the performance of the duties of the General Accounting Office;

(11) Pursuant to the order of a court of competent jurisdiction; or

(12) To a consumer reporting agency in accordance with section 3(d) of the Federal Claims Collection Act of 1966 (31 U.S.C. 952(d)). (This “Special Disclosure" statement does not apply to any FDA system of records.)

(b) The Food and Drug Administration may in its discretion refuse to make a disclosure permitted under paragraph (a) of this section, if the disclosure would in the judgment of the agency, invade the privacy of the individual or be inconsistent with the purpose for which the information was collected.

(c) The Food and Drug Administration may require any person requesting a disclosure of a record under paragraph (a) of this section to provide:

(1) Information about the purposes to which the disclosed record is to be put, and

(2) A written statement certifying that the record will be used only for the stated purposes and will not be further disclosed without the written permission of the Food and Drug Administration.

(e) Where an accounting is required under paragraph (d) of this section, the Food and Drug Administration shall:

(1) Record the name and address of the person or agency to whom the disclosure is made and the date, nature, and purpose of the disclosure. The accounting shall not be considered a Privacy Act Record System.

(2) Retain the accounting for 5 years or for the life of the record, whichever is longer, following the disclosure.

(3) Notify those recipients listed in the accounting of amendments or disputes concerning the records previously disclosed to them pursuant to $21.51(d)(3), $21.53(c), or $21.54(c).

(4) Except when the record is exempt from individual access and contest under $21.61 or to the extent that the accounting describes a transfer for a law enforcement purpose pursuant to paragraph (a)(7) of this section, make the accounting available to the individual to whom the record pertains, in accordance with procedures of subpart D of this part.

(f) A single accounting may be used to cover disclosure(s) that consist of a continuing dialogue between two agencies over a prolonged period, such as discussion of an enforcement action between the Food and Drug Administration and the Department of Justice. In such cases, a general notation may be made that, as of a certain date, contract was initiated, to continue until resolution of the matter. [42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985; 54 FR 9038, Mar. 3, 1989]

Under 5 U.S.C. 552a(i)(3), any person who knowingly or willfully requests or obtains any record concerning an individual from an agency under false pretenses shall be guilty of a misdemeanor and fined not more than $5,000. Such person may also be subject to prosecution under the False Reports to the Government Act, 18 U.S.C. 1001.

(d) An accounting shall be made, in accordance with paragraph (e) of this section, of any disclosure under paragraph (a) of this section of a record that is not a disclosure under $21.70.

8 21.72 Individual consent to disclo

sure of records to other persons. (a) Individuals may consent to disclosure of records about themselves to other persons in several ways, for example:

(1) An individual may give consent at the time that the information is collected for disclosure for specific purposes or to specific persons.

(2) An individual may give consent for disclosure of his records to a specific person.

(3) An individual may request the Food and Drug Administration to transcribe a specific record for submission to another person.

the agency, if one has been prepared, of the reasons for not making the amendment(s) requested.

(b) In each case the consent shall be in writing and shall specify the individual, organizational unit, or class of individuals or organizational units to whom the record may be disclosed, which record may be disclosed, and, if applicable, for what time period. A blanket consent to release all of an individual's records to unspecified individuals or organizational units will not be honored. Verification of the identity of the individual and, where applicable, of the person to whom the record is to be disclosed shall be made in accordance with $21.44. Consent documents shall be retained for a period of at least 2 years. If such documents are used as a means of accounting for the disclosure, they shall be retained as provided in $21.71(e)(2).

$21.75 Rights of legal guardians.

For the purposes of this part, the parent of any individual who is a minor or the legal guardian of any individual who has been declared to be incompetent due to physical or mental incapacity or age by a court of competent jurisdiction may act on behalf of the individual.


Subpart A-General Provisions

Sec. 25.1 Purpose. 25.5 Terminology. 25.10 Policies and NEPA planning.

Subpart B-Agency Actions Requiring

Environmental Consideration

821.73 Accuracy, completeness, timeli

ness, and relevance of records disclosed from Privacy Act Record

Systems. (a) The Food and Drug Administration shall make reasonable efforts to assure that a record about an individual in a Privacy Act Record System is accurate, relevant to a Food and Drug Administration purpose, timely, and complete before such record is disclosed under $21.71.

(b) Paragraph (a) of this section shall not apply to disclosures that are required under part 20 of this chapter (the public information regulations) or made to other Federal Government departments and agencies. Where appropriate, the letter disclosing the information shall indicate that the Food and Drug Administration has not reviewed the record to assure that it is accurate, relevant, timely, and complete.

25.15 General procedures. 25.16 Public health and safety emergencies. 25.20 Actions requiring preparation of an

environmental assessment. 25.21 Extraordinary circumstances. 25.22 Actions requiring the preparation of

an environmental impact statement.

Subpart C–Categorical Exclusions

25.30 General. 25.31 Human drugs and biologics. 25.32 Foods, food additives, and color addi

tives. 25.33 Animal drugs. 25.34 Devices and electronic products.

Subpart D-Preparation of Environmental


25.40 Environmental assessments. 25.41 Findings of no significant impact. 25.42 Environmental impact statements. 25.43 Records of decision. 25.44 Lead and cooperating agencies. 25.45 Responsible agency official.

$ 21.74 Providing notice that a record

is disputed. Whenever an individual has filed a statement of disagreement with the Food and Drug Administration concerning a refusal to amend a record under $21.51(a)(2) or with another agency that provides the record to the Food and Drug Administration, the Food and Drug Administration shall in any subsequent disclosure under this subpart provide a copy of the statement of disagreement and a concise statement by

Subpart E-Public Participation and Notification of Environmental Documents

25.50 General information. 25.51 Environmental assessments and find

ings of no significant impact. 25.52 Environmental impact statements.

Subpart F-Other Requirements 25.60 Environmental effects abroad of major

agency actions.

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.

Subpart A-General Provisions

8 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 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).

(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 part 5 of this chapter.

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

(1) CEQ-Council on Environmental Quality.


8 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).


(2) CGMP_Current good manufac- applies, or when FDA personnel consult turing practice.

with applicants or petitioners on the (3) EA-Environmental assessment. NEPA-related aspects of their

(4) EIS—Environmental impact state- quested actions. FDA may issue a pubment.

lic call for environmental data or oth(5) The act-Federal Food, Drug, and erwise consult with affected individCosmetic Act.

uals or groups when a contemplated ac(6) FIFRA-Federal Insecticide, Fun- tion in which it is or may be involved gicide, and Rodenticide Act.

poses potential significant environ(7) FONSI—Finding of no significant mental effects. impact.

(d) Environmental documents shall (8) GLP-Good laboratory practice. concentrate on timely and significant

(9) GRAS–Generally recognized as issues, not amass needless detail. safe.

(e) If a proposed action for which an (10) HACCP–Hazard analysis critical EIS will be prepared involves possible control point.

environmental effects that are required (11) IDE-Investigational device ex- to be considered under statutes or Exemption.

ecutive Orders other than those re(12) IND—Investigational new drug ferred to under “Authority” in this application.

part, these effects shall be considered (13) INAD—Investigational new ani- in the NEPA review, consistent with 40 mal drug application.

CFR 1502.25 and the HHS General Ad(14) NADA-New animal drug applica- ministration Manual, part 30: Environtion.

mental Protection. (15) NDA-New drug application.

(16) NEPA-National Environmental Subpart B-Agency Actions RePolicy Act of 1969.

quiring Environmental Consid(17) OTC—Over-the-counter.

eration (18) PDP—Product development protocol.

$ 25.15 General procedures. (19) PMA–Premarket approval application.

(a) All applications or petitions re

questing agency action require the sub[62 FR 40592, July 29, 1997, as amended at 64 mission of an EA or a claim of categorFR 399, Jan. 5, 1999]

ical exclusion. A claim of categorical

exclusion shall include a statement of $ 25.10 Policies and NEPA planning.

compliance with the categorical exclu(a) All FDA's policies and programs sion criteria and shall state that to the will be planned, developed, and imple- applicant's knowledge, extraormented to achieve the policies declared dinary circumstances exist. Failure to by NEPA and required by CEQ's regula- submit an adequate EA for an applications to ensure responsible stewardship tion or petition requesting action by of the environment for present and fu- the agency of a type specified in $25.20, ture generations.

unless the agency can determine that (b) Assessment of environmental fac- the action qualifies for exclusion under tors continues throughout planning $8 25.30, 25.31, 25.32, 25.33, or 25.34, is sufand is integrated with other program ficient grounds for FDA to refuse to planning at the earliest possible time file or approve the application or petito ensure that planning and decisions tion. An EA adequate for filing is one reflect environmental values, to avoid that addresses the relevant environdelays later in the process, and to mental issues. An EA dequate for apavoid potential conflicts.

proval is one that contains sufficient (c) For actions initiated by the agen- information to enable the agency to decy, the NEPA process will begin when termine whether the proposed action the agency action under consideration may significantly affect the quality of is first identified. For actions initiated the human environment. by applicants or petitioners, NEPA (b) The responsible agency officials planning begins when FDA receives will evaluate the information confrom an applicant or petitioner an EA tained in the EA to determine whether or a claim that a categorical exclusion it is accurate and objective, whether


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