[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.52]
[Page 229-230]
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
[[Page 230]]
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 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]
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