[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.7]

[Page 138-139]
 
                        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

[[Page 139]]

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]