[Federal Register Volume 62, Number 157 (Thursday, August 14, 1997)]
[Notices]
[Page 43534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21586]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0321]


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

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 (the PRA).

DATES: Submit written comments on the collection of information by 
September 15, 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, rm. 16B-19, 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:

Advisory Opinions--21 CFR 10.85 (OMB Control No. 0910-0193--
Reinstatement)

    Section 10.85 (21 CFR 10.85), issued under section 701(a) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(a)), provides that 
an interested person may request an advisory opinion from the 
Commissioner of Food and Drugs (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: August 8, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-21586 Filed 8-13-97; 8:45 am]
BILLING CODE 4160-01-F