[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.52]

[Page 235-236]
 
                        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

[[Page 236]]

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 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]