e-CFR banner


e-CFR Navigation Aids


Simple Search

Advanced Search

 — Boolean

 — Proximity


Search History

Search Tips


Latest Updates

User Info


Agency List

Incorporation By Reference

eCFR logo

Related Resources


Electronic Code of Federal Regulations

e-CFR data is current as of June 2, 2020

Title 21Chapter ISubchapter APart 21Subpart E → §21.53

Title 21: Food and Drugs
Subpart E—Procedures for Requests for Amendment of Records

§21.53   Notation and disclosure of disputed records.

When an individual has filed a statement of disagreement under §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 §21.70 or §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 §21.50.

(c) If an accounting was made under §21.71(d) and (e) of a disclosure of the record under §21.71(a), provide to all previous recipients of the record a copy of the statement of disagreement and the agency statement, if any.

Need assistance?