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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Jun 07, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 1]
[CITE: 21CFR21.50]



Subpart E - Procedures for Requests for Amendment of Records

Sec. 21.50 Procedures for submitting requests for amendment of records.

(a) An individual who received access to a record about himself under subpart D of this part may request that the record be amended if he believes that the record or an item of information is not accurate, relevant to a Food and Drug Administration purpose, timely, or complete.

(b) Amendments under this subpart shall not violate existing statute, regulation, or administrative procedure.

(1) This subpart does not permit alteration of evidence presented in the course of judicial proceedings or Food and Drug Administration adjudicatory or rule making proceedings or collateral attack upon that which has already been the subject of any such proceedings.

(2) If the accuracy, relevancy, timeliness, or completeness of the records may be contested in any other pending or imminent agency proceeding, the Food and Drug Administration may refer the individual to the other proceeding as the appropriate means to obtain relief. If the accuracy, relevance, timeliness, or completeness of a record is, or has been, an issue in another agency proceeding, the request under this section shall be disposed of in accordance with the decision in the other proceeding, absent unusual circumstances.

(c) Requests to amend records shall be submitted, in writing, to the FDA Privacy Act Coordinator in accordance with § 21.40(b). Such requests shall include information sufficient to enable the Food and Drug Administration to locate the record, a brief description of the items of information requested to be amended, and the reasons why the record should be amended together with any appropriate documentation or arguments in support of the requested amendment. An edited copy of the record showing the described amendment may be included. Verification of identity should be provided in accordance with § 21.44.

(d) Written acknowledgement of the receipt of a request to amend a record shall be provided within 10 working days to the individual who requested the amendment. Such acknowledgement may request any additional information needed to verify identity or make a determination. No acknowledgement need be made if the request can be reviewed, processed, and the individual notified of the agency's agreement with the request or refusal within the 10-day period.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981]