[Federal Register Volume 64, Number 237 (Friday, December 10, 1999)]
[Notices]
[Page 69271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32026]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-2553]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Citizen Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
January 10, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Citizen Petition--21 CFR 10.30 (OMB Control Number 0910-0183)--
Extension

     The Administrative Procedures Act (5 U.S.C. 553(e)) provides that 
every agency shall accord any interested person the right to petition 
for issuance, amendment, or repeal of a rule. Section 10.30 provides 
that any person may submit to the agency a citizen petition requesting 
the Commissioner of Food and Drugs to issue, amend, or revoke a 
regulation or order, or to take or refrain from taking any other form 
of administrative action. The information is used by the agency to 
determine the need or desirability of the requested action and also to 
determine if the submitted information is sufficient to support the 
action. FDA determines if the submitted information is sufficient to 
support the action. FDA determines whether or not to grant the petition 
based on the information submitted. The affected respondents are 
individuals or households, State or local governments, nonprofit 
institutions and businesses or other for-profit institutions or groups.
     In the Federal Register of June 9, 1998 (63 FR 31502), the agency 
requested comments on the proposed collections of information. No 
significant comments were received.
     FDA estimates the burden of this collection of information as 
follows:
    Dated: December 6, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-32026 Filed 12-9-99; 8:45 am]
BILLING CODE 4160-01-F