[Federal Register Volume 62, Number 55 (Friday, March 21, 1997)]
[Notices]
[Page 13648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7137]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0098]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Extension
6AGENCY: 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 Form FDA 3038, ``Interstate
Shellfish Dealer's Certificate.''
DATES: Submit written comments on the collection of information by May
20, 1997.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,
301-827-1223.
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 listed below.
With respect to the following collection of information, FDA
invites comments on: (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 Dealers 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). The 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, the 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:
Estimated Annual Reporting Burden
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Annual
Form No. No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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FDA 3038 33 70 2,310 .10 231
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There are no capital costs or operating and maintenance costs associated with this collection.
This estimate is based on the numbers of certificates received in
1996.
Dated: March 13, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-7137 Filed 3-20-97; 8:45 am]
BILLING CODE 4160-01-F
