[Federal Register Volume 61, Number 236 (Friday, December 6, 1996)]
[Notices]
[Pages 64752-64753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31054]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0426]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Extension

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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, 
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 
February 4, 1997.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1686.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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

[[Page 64753]]

of the proposed collection of information listed 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 the collection of information 
provisions for these regulations as follows:

                                        Estimated Annual Reporting Burden                                       
----------------------------------------------------------------------------------------------------------------
                                                      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: November 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31054 Filed 12-5-96; 8:45 am]
BILLING CODE 4160-01-F