21 CFR 21.52 - Administrative appeals of refusals to amend records.

Status message

There is 1 rule appearing in the Federal Register for 21 CFR 21. View below or at eCFR (GPOAccess)
§ 21.52 Administrative appeals of refusals to amend records.
(a) If an individual disagrees with a refusal under § 21.51(a)(2) to amend a record, he or she may appeal that refusal to the Commissioner of Food and Drugs, Rm. 14-71, 5600 Fishers Lane, Rockville, MD 20857.
(b) If, upon appeal, the Commissioner upholds the refusal to amend the record as requested, he shall inform the individual:
(1) Of his decision and the reasons for it.
(2) Of the individual's right to file with the Food and Drug Administration a concise statement of the individual's reasons for disagreeing with the agency's decision not to amend the record as requested.
(3) That the statement of disagreement will be made available to all persons listed in an accounting as having previously received the record and any person to whom the record is subsequently disclosed together with, in the discretion of the Food and Drug Administration, a brief statement summarizing its reasons for refusing to amend the record. Any individual who includes false information in the statement of disagreement filed with the Food and Drug Administration may be subject to penalties under 18 U.S.C. 1001, the False Reports to the Government Act.
(4) That the individual has a right to seek judicial review of the refusal to amend the record.
(c) If the Commissioner on administrative appeal or a court on judicial review determines that the record should be amended in accordance with the individual's request, the Food and Drug Administration shall proceed in accordance with § 21.51(d).
(d) A final determination on the individual's administrative appeal of the initial refusal to amend the record shall be concluded within 30 working days of the request for such review under paragraph (a) of this section, unless the Commissioner extends such period for good cause and informs the individual in writing of the reasons for the delay and of the approximate date on which a decision of the appeal can be expected.
[42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985]

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2013-07-01; vol. 78 # 126 - Monday, July 1, 2013
    1. 78 FR 39184 - Privacy Act, Exempt Record System; Implementation
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary
      Final rule.
      This rule is effective July 31, 2013.
      21 CFR Part 21

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES
U.S. Code: Title 15 - COMMERCE AND TRADE
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 21 after this date.

  • 2013-07-01; vol. 78 # 126 - Monday, July 1, 2013
    1. 78 FR 39184 - Privacy Act, Exempt Record System; Implementation
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary
      Final rule.
      This rule is effective July 31, 2013.
      21 CFR Part 21