[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Pages 68129-68130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27722]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1108]
Agency Information Collection Activities; Proposed Collection;
Comment Request; 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 an
opportunity for public comment on the 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 Dealer's Certificate.
DATES: Submit either electronic or written comments on the collection
of information by January 14, 2013.
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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, [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, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites 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.
[[Page 68130]]
Interstate Shellfish Dealer's Certificate (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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
Activity FDA Form No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Submission of Interstate Shellfish Dealer's Certificate....... 3038 40 57 2,280 0.10 228
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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: November 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27722 Filed 11-14-12; 8:45 am]
BILLING CODE 4160-01-P