[Federal Register Volume 65, Number 40 (Tuesday, February 29, 2000)]
[Notices]
[Page 10811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4669]



[[Page 10811]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-4329]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Filing Objections and Requests for a Hearing 
on a Regulation or Order

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 
March 30, 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.

Filing Objections and Requests for a Hearing on a Regulation or 
Order

    Under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 371(e)(2)), within 30 days after publication of a 
regulation or order, any person adversely affected by such regulations 
or order may file objections and request a public hearing. The 
implementing regulations for these statutory requirements are found at 
21 CFR 12.22, which sets forth the format and instructions for filing 
objections and requests for a hearing. Each objection for which a 
hearing has been requested must be separately numbered and specify with 
particularity the provision of the regulation or the proposed order 
objected to. In addition, each objection must include a detailed 
description and analysis of the factual information to be presented in 
support of the objection as well as any report or other document relied 
on, with some exceptions. Failure to include this information 
constitutes a waiver of the right to a hearing on that objection. FDA 
uses the description and analysis only for the purpose of determining 
whether a hearing request is justified. The description and analysis do 
not limit the evidence that may be presented if a hearing is granted. 
Respondents to this information collection are those parties that may 
be adversely affected by an order or regulation.
    In the Federal Register of October 25, 1999 (64 FR 57467), 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:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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   21 CFR                          Annual Frequency      Total Annual
   Section    No. of Respondents     per Response          Responses      Hours per Response      Total Hours
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12.22                60                   1                  60                  20              1,200
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.

    The burden estimate for this collection of information is based on 
agency data received on this administrative procedure for the past 3 
years. Agency personnel responsible for processing the filing of 
objections and requests for a public hearing on a specific regulation 
or order, estimate approximately 60 requests are received by the agency 
annually, with each requiring approximately 20 hours of preparation 
time.

    Dated: February 23, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-4669 Filed 2-28-00; 8:45 am]
BILLING CODE 4160-01-F