e-CFR Navigation Aids


Simple Search

Advanced Search

 — Boolean

 — Proximity


Search History

Search Tips


Latest Updates

User Info


Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

e-CFR data is current as of January 14, 2021

Title 21Chapter ISubchapter APart 21Subpart E → §21.52

Title 21: Food and Drugs
Subpart E—Procedures for Requests for Amendment of Records

§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,(see the address on the agency's web site at http://www.fda.gov).

(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; 79 FR 68115, Nov. 14, 2014]

Need assistance?