[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: 21CFR14.7]
[Page 139]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE--Table of Contents
Subpart A General Provisions
Sec. 14.7 Administrative remedies.
A person who alleges noncompliance by the Commissioner or an
advisory committee with any provision of this part or the Federal
Advisory Committee Act may pursue the following administrative remedies:
(a) If the person objects to any action, including a failure to act,
other than denial of access to an advisory committee document, the
person shall submit a petition in the form and in accordance with the
requirements of Sec. 10.30. The provisions of Sec. 10.45 relating to
exhaustion of administrative remedies are applicable.
(1) If the person objects to past action, the person shall submit
the petition within 30 days after the action objected to. If the
Commissioner determines that there was noncompliance with any provision
of this subpart or of the Federal Advisory Committee Act, the
Commissioner will grant any appropriate relief and take appropriate
steps to prevent its future recurrence.
(2) If the person objects to proposed future action, the
Commissioner will expedite the review of the petition and make a
reasonable effort to render a decision before the action concerned in
the petition.
(3) If the person objects to action that is imminent or occurring
and which could not reasonably have been anticipated, e.g., the closing
of a portion of a meeting which is made known for the first time on the
day of the meeting, the matter may be handled by an oral petition in
lieu of a written petition.
(b) If the person objects to a denial of access to an advisory
committee document, administrative review is in accordance with the
procedures established by the Department of Health and Human Services
under 45 CFR 5.34.
[44 FR 22351, Apr. 13, 1979, as amended at 55 FR 1404, Jan. 16, 1990]
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