Title 21

SECTION 20.27

20.27 Submission of records marked as confidential.

§ 20.27 Submission of records marked as confidential.

Marking records submitted to the Food and Drug Administration as confidential, or with any other similar term, raises no obligation by the Food and Drug Administration to regard such records as confidential, to return them to the person who has submitted them, to withhold them from disclosure to the public, or to advise the person submitting them when a request for their public disclosure is received or when they are in fact disclosed.

[42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003]