[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: 21CFR21.53]
[Page 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. 21.53 Notation and disclosure of disputed records.
When an individual has filed a statement of disagreement under Sec.
21.52(b)(2), the Food and Drug Administration shall:
(a) Mark any portion of the record that is disputed to assure that
the record will clearly show that portion is disputed whenever the
record is disclosed.
(b) In any subsequent disclosure under Sec. 21.70 or Sec.
21.71(a), provide a copy of the statement of disagreement and, if the
Food and Drug Administration deems it appropriate, a concise statement
of the agency's reasons for not making the amendment(s) requested. While
the individual shall have access to any such statement, it shall not be
subject to a request for amendment under Sec. 21.50.
(c) If an accounting was made under Sec. 21.71(d) and (e) of a
disclosure of the record under Sec. 21.71(a), provide to all previous
recipients of the record a copy of the statement of disagreement and the
agency statement, if any.
Back to Top
© 2007 Betterchem Corp.
|
