[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Notices]
[Pages 16512-16513]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05970]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1108]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Interstate Shellfish 
Dealer's 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 April 
15, 2013.

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. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400, 
Rockville, MD 20850, 301-796-5733, domini.bean@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 section 243 of the Public Health Service Act (42 U.S.C. 243), 
FDA is required to cooperate with and aid State and local authorities 
in the enforcement of their health regulations

[[Page 16513]]

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 November 15, 2012 (77 FR 68129), FDA 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. FDA received one letter in 
response to the notice, containing multiple comments on the testing 
methods used by certified shellfish processors in the NSSP. These 
comments were outside the scope of the four collection-of-information 
topics on which the notice requested comments, and will not be 
discussed in this document. FDA estimates 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   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  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.

    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: March 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05970 Filed 3-14-13; 8:45 am]
BILLING CODE 4160-01-P