[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Pages 50640-50641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 or we) is announcing an 
opportunity for public comment on our proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
provisions of the Interstate Shellfish Dealers Certificate.

DATES: Submit either electronic or written comments on the collection 
of information by October 19, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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.
    We estimate the burden of this collection of information as 
follows:

[[Page 50641]]



                                                     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 per        Total hours
                                                            respondents       respondent       responses              response
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Submission of Interstate Shellfish                 3038               40               57            2,280   0.10......................             228
 Dealer's Certificate.                                                                                       (6 minutes)...............
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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: August 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20562 Filed 8-19-15; 8:45 am]
BILLING CODE 4164-01-P