21 CFR 21.61 - Exempt systems.
(a) Investigatory records compiled for law enforcement purposes, including criminal law enforcement purposes, in the Food and Drug Administration Privacy Act Record Systems listed in paragraph (b) of this section are exempt from the following provisions of the Privacy Act ( 5 U.S.C. 552a) and of this part:
(1) Such records are exempt from 5 U.S.C. 552a(c)(3) and § 21.71(e)(4), requiring that an individual be provided with the accounting of disclosures of records about himself from a Privacy Act Record System.
(2) Except where access is required under 5 U.S.C. 552a(k)(2) and § 21.65(a)(2), (such records are exempt from 5 U.S.C. 552a(d)(1) through (4) and (f)) and §§ 21.40 through 21.54, requiring procedures for an individual to be given notification of and access to records about himself in a Privacy Act Record System and to be allowed to challenge the accuracy, relevance, timeliness, and completeness of such records.
(3) Such records are exempt from 5 U.S.C. 552a(e)(4)(G) and (H) and § 21.20(b)(1) requiring inclusion in the notice for the system of information about agency procedures for notification, access, and contest.
(4) Such records are exempt from 5 U.S.C. 552a(e)(3) requiring that individuals asked to supply information be provided a form outlining the authority for the request, the purposes for which the information will be used, the routine uses in the notice for the Privacy Act Record System, and the consequences to the individual of not providing the information, but only with respect to records compiled by the Food and Drug Administration in a criminal law enforcement investigation where the conduct of the investigation would be prejudiced by such procedures.
(b) Records in the following Food and Drug Administration Privacy Act Record Systems that concern individuals who are subject to Food and Drug Administration enforcement action and consist of investigatory records compiled for law enforcement purposes, including criminal law enforcement purposes, are exempt under 5 U.S.C. 552a(j)(2) and (k)(2) from the provisions enumerated in paragraph (a) of this section:
(1) Bio-research Monitoring Information System - HHS/FDA/09-10-0010.
(2) Regulated Industry Employee Enforcement Records - HHS/FDA/ACMO/09-10-002.
(3) Employee Conduct Investigative Records - HHS/FDA/ACMO/09-10-0013.
(c) The system described in paragraph (b)(3) of this section includes investigatory records compiled solely for the purpose of determining suitability, eligibility, or qualification for Federal civilian employment, military service, Federal contracts, and access to classified information. These records are exempt from disclosure under 5 U.S.C. 552a(k)(5) to the extent that the disclosure would reveal the identity of a source who furnished information to the Government under a promise of confidentiality, which must be an express promise if the information was furnished after September 27, 1975. Any individual who is refused access to a record that would reveal a confidential source shall be advised in a general way that the record includes information that would reveal a confidential source.
(d) Records in the following Food and Drug Administration Privacy Act Records Systems are exempt under 5 U.S.C. 552a(k)(2) and (k)(5) from the provisions enumerated in paragraph (a)(1) through paragraph (a)(3) of this section: FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC, 09-10-0020.
Title 21 published on 10-May-2017 03:43
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 21 after this date.
- 21 CFR 21.71 — Disclosure of Records in Privacy Act Record Systems; Accounting Required.
- 21 CFR 21.65 — Access to Records in Exempt Systems.
- 21 CFR 21.40 — Procedures for Submitting Requests for Notification and Access.
- 21 CFR 21.20 — Procedures for Notice of Food and Drug Administration Privacy Act Record Systems.
- 21 CFR 21.42 — Responses to Requests.
- 21 CFR 21.32 — Personnel Records.
- 21 CFR 20.80 — Applicability of Limitations on Exemptions.