21 CFR 21.51 - Responses to requests for amendment of records.
(a) The Food and Drug Administration shall take one of the following actions on a request for amendment of records as promptly as possible:
(1) Amend any portion of the record which the agency has determined, based upon a preponderance of the evidence, is not accurate, relevant to a Food and Drug Administration purpose, timely, or complete, and, in accordance with paragraph (d)(3) of this section, inform the individual and previous recipients of the record that has been amended of the amendment.
(2) Inform the individual of its refusal to amend any portion of the record in the manner requested, the reason for the refusal, and the opportunity for administrative appeal to the Commissioner of Food and Drugs. Except as provided in § 21.32, such refusal may only be issued by the Associate Commissioner for Public Affairs or his or her designate.
(3) Where another agency was the source of and has control of the record, refer the request to that agency.
(b) The agency may, for good cause, extend the period for taking action an additional 30 working days if notice is provided to the individual explaining the circumstances of the delay.
(c) The officials charged with reviewing a record to determine how to respond to a request to amend it, shall assess its accuracy, relevance to a Food and Drug Administration purpose, timeliness, or completeness. The determination shall be made in the light of the purpose for which the records or system is used, the agency's need for the record, and the possible adverse consequences to the individual from the record if not amended. Whenever the Food and Drug Administration receives a request for deletion of a record, or portions of a record, it shall consider anew whether the contested information in the record is relevant and necessary to a Food and Drug Administration purpose.
(1) So inform the individual in writing.
(2) In accordance with statute, regulation, or procedure, amend the record to make it accurate, relevant to a Food and Drug Administration purpose, timely, or complete, making note of the date and fact of the amendment.
(3) If an accounting was made under § 21.71(d) of a disclosure of the record under § 21.71(a), provide a copy of the record as amended, to all previous recipients of the record.