
[Federal Register: January 26, 2010 (Volume 75, Number 16)]
[Notices]               
[Page 4087]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ja10-65]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0232]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Interstate Shellfish 
Dealers Certificate

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
February 25, 2010.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0021. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

SUPPLEMENTARY INFORMATION:  In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Interstate Shellfish Dealers Certificate (42 U.S.C. 243) (OMB Control 
Number 0910-0021)--Extension

    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).
    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, NSSP would not be able to control the distribution of 
uncertified and possibly unsafe shellfish in interstate commerce, and 
its effectiveness would be nullified.
    In the Federal Register of June 2, 2009 (74 FR 26407), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one letter in response, which 
contained multiple comments. One comment was generally supportive of 
the Interstate Certified Shellfish Shippers List program and 
recommended maintaining the program as it currently exists. Another 
comment noted that it requires little effort to input information into 
the form and that the Interstate Shellfish List is critically important 
to the National Shellfish Sanitation Program. FDA agrees with the 
comments.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                        FDA  Form         No. of        Annual Frequency   Total Annual       Hours per
                       Activity                            No.         Respondents        per Response       Responses         Response      Total Hours
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Submission of Interstate Shellfish Dealer's                   3038                 40                 57           2,280               0.10          228
 Certificate
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that 40 respondents will submit 2,280 Interstate 
Shellfish Dealer's Certificates annually, for a total burden of 228 
hours (2,280 submissions x 0.10 hours = 228 hours). This estimate is 
based on FDA's experience and the number of certificates received in 
the past 3 years.

    Dated: January 20, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1437 Filed 1-25-10; 8:45 am]
BILLING CODE 4160-01-S

