[Federal Register Volume 62, Number 151 (Wednesday, August 6, 1997)]
[Notices]
[Pages 42257-42258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20600]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0320]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 42258]]

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 (the PRA).

DATES: Submit written comments on the collection of information by 
September 5, 1997.
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: 
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 section 3507 of the PRA 
(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--21 CFR Part 12--(OMB Control Number 0910-0184--Extension)

    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.
     FDA estimates the burden of this collection of information as 
follows:

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
12.22                                  60               1              60              20           1,200       
----------------------------------------------------------------------------------------------------------------
There are no capital costs 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: July 30, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-20600 Filed 8-5-97; 8:45 am]
BILLING CODE 4160-01-F