[Federal Register Volume 61, Number 236 (Friday, December 6, 1996)]
[Notices]
[Page 64750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0429]


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

AGENCY: Food and Drug Administration, HHS.

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, 
Federal agencies are required to publish notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed reinstatement 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 parties seeking an advisory 
opinion from the Commissioner of Food and Drugs (the Commissioner).

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 
(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 Paperwork Reduction Act (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 reinstatement 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 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.

Advisory Opinions--21 CFR 10.85 (OMB Control Number 0910-0193--
Reinstatement)

    Section 10.85 (21 CFR 10.85), issued under section 701(a) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(a), 
provides that an interested person may request an advisory opinion from 
the Commissioner on a matter of general applicability. Section 10.85 
sets forth the format and instructions for making an advisory opinion 
request. When making a request, the petitioner must provide a concise 
statement of the issues and questions on which an opinion is requested 
and a full statement of the facts and legal points relevant to the 
request. An advisory opinion represents the formal position of FDA on a 
matter of general applicability.
    Respondents to this collection of information are parties seeking 
an advisory opinion from the Commissioner on the agency's formal 
position for matters of general applicability.
    FDA estimates the burden of the collection of information 
provisions for these regulations 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                   
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10.85                                   8               1               8              16             128       
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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 the processing of requests for 
an advisory opinion, estimate approximately eight requests are received 
annually by the agency, each requiring an estimated 16 hours of 
preparation time.

    Dated: November 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31050 Filed 12-5-96; 8:45 am]
BILLING CODE 4160-01-F