[Federal Register Volume 64, Number 205 (Monday, October 25, 1999)]
[Notices]
[Pages 57467-57468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27698]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-4329]


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

AGENCY: Food and Drug Administration, HHS.


[[Page 57468]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on requirements for filing 
objections and requests for a hearing on a regulation or order.

DATES: Submit written comments on the collection of information by 
December 27, 1999.
ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506 
(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information set forth below.
     With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

 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:

                                   Table 1.--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
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12.22                                  60               1              60              20           1,200
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\1\ 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: October 18, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-27698 Filed 10-22-99; 8:45 am]
BILLING CODE 4160-01-F