
[Federal Register Volume 80, Number 213 (Wednesday, November 4, 2015)]
[Notices]
[Page 68323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28109]


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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 
December 4, 2015.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0021 and 
title ``Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Interstate Shellfish 
Dealers Certificate.'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 Dealer's Certificate

OMB Control Number 0910-0021--Extension

    Under 42 U.S.C. 243, we are required to cooperate with and aid 
State and local authorities in the enforcement of their health 
regulations and are authorized to assist States in the prevention and 
suppression of communicable diseases. Under this authority, we 
participate 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.'' We use 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 we 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 August 20, 2015 (80 FR 50640), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                     Activity                         FDA Form No.      Number of      responses per     Total annual   Avg. burden per    Total hours
                                                                       respondents       respondent       responses         response
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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.

    We estimate 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 our experience with this information collection and the number 
of certificates received in the past 3 years, which has remained 
constant.

    Dated: October 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28109 Filed 11-3-15; 8:45 am]
BILLING CODE 4164-01-P


