[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.52]

[Page 236-237]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 21--PROTECTION OF PRIVACY--Table of Contents
 
       Subpart E--Procedures for Requests for Amendment of Records
 
Sec. 21.52  Administrative appeals of refusals to amend records.

    (a) If an individual disagrees with a refusal under Sec. 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 Sec. 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

[[Page 237]]

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]