Code of Federal Regulations Title 21. Food and Drugs § 21.21.52 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:

(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.