[Federal Register Volume 62, Number 152 (Thursday, August 7, 1997)]
[Notices]
[Pages 42560-42561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20868]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0317]


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 8, 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: Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1223.

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.

Interstate Shellfish Dealers Certificate--(OMB Control Number 0910- 
0021)--Reinstatement

     Under 42 U.S.C. 243, FDA is required to cooperate with and aid 
State and local authorities in the enforcement of their health 
regulations and is authorized to assist States in the prevention and 
suppression of communicable diseases. Under this authority, FDA 
participates with State regulatory agencies, some foreign nations, and 
the molluscan shellfish industry in the National Shellfish Sanitation 
Program (NSSP). The NSSP is a voluntary, cooperative program to promote 
the safety of molluscan shellfish by providing for the classification 
and patrol of shellfish growing waters and for the inspection and 
certification of shellfish processors. Each participating State and 
foreign nation monitors its molluscan shellfish processors and issues 
certificates for those that meet the State or foreign shellfish control 
authority's criteria. Each participating State and nation provides a 
certificate of its certified shellfish processors to FDA on Form FDA 
3038, ``Interstate Shellfish Dealer's Certificate.'' FDA uses this 
information to publish the ``Interstate Certified Shellfish Shippers 
List,'' a monthly comprehensive listing of all molluscan shellfish 
processors certified under the cooperative program. If FDA did not 
collect the information necessary to compile this list, participating 
States would not be able to identify and keep out shellfish processed 
by uncertified processors in other States and foreign nations. 
Consequently, the NSSP would not be able to control the distribution of 
uncertified and possibly unsafe shellfish in interstate commerce, and 
its effectiveness would be nullified.

[[Page 42561]]



                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
            Form No.                  No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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FDA 3038                               33              70           2,310                .10          231       
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There are no capital costs or operating and maintenance costs associated with this collection.                  

    This estimate is based on the number of certificates received in 
1996.

    Dated: July 31, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-20868 Filed 8-6-97; 8:45 am]
BILLING CODE 4160-01-F