Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealers Certificate, 26407-26408 [E9-12796]
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26407
Federal Register / Vol. 74, No. 104 / Tuesday, June 2, 2009 / Notices
manufacturer, packer, or distributor of
the dietary supplement that bears such
a statement on its label or in its labeling.
FDA estimates that, each year,
approximately 2,200 firms will submit
the information required by section 403
of the act. We estimate that a firm will
require 0.75 hours to gather the
information needed and prepare a
communication to FDA, for a total of
1,650 hours (2,200 x 0.75). This estimate
is based on the average number of
notification submissions received by the
agency in the preceding 2 years.
Dated: May 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–12797 Filed 6–1–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0232]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Interstate Shellfish
Dealers Certificate
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 Dealers
Certificate.
DATES: Submit written or electronic
comments on the collection of
information by August 3, 2009.
Submit electronic
comments on the collection of
information to https://
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:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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
ADDRESSES:
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).
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 BURDEN1
Activity
FDA Form No.
Submission of
Interstate
Shellfish
Dealer’s
Certificate
1 There
No. of Respondents
3,038
Annual Frequency
per Response
40
57
Total Annual
Responses
Hours per
Response
2,280
0.10
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total Hours
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228
26408
Federal Register / Vol. 74, No. 104 / Tuesday, June 2, 2009 / Notices
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: May 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–12796 Filed 6–1–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0671]
Cooperative Agreement to Support the
Illinois Institute of Technology’s
National Center for Food Safety and
Technology (U01)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
intention to receive and consider a
single source application for the award
of a cooperative agreement in fiscal year
2009 (FY09) to the Illinois Institute of
Technology (IIT) to support the National
Center for Food Safety and Technology
(NCFST). The estimated amount of
support in FY09 will be for up to $7
million (direct plus indirect costs), with
the possibility of 4 additional years of
support for up to $28 million, subject to
the availability of funds. This award
will improve public health by continued
support of an applied research,
education, and outreach program related
to the safety of food processing
technologies and processed foods.
DATES: The application due date is June
28, 2009. The anticipated start date is
September 2009. The opening date was
May 28, 2009.
FOR FURTHER INFORMATION AND
ADDITIONAL REQUIREMENTS CONTACT:
For
more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at https://
www.cfsan.fda.gov/list.html.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Request for Application Number: RFA–
FD–09–004
Catalog of Federal Domestic Assistance:
93.103
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16:43 Jun 01, 2009
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A. Background
FDA has supported the NCFST under
five previously awarded cooperative
agreements (53 FR 15736; 56 FR 46189;
59 FR 24703; 64 FR 39512; and 69 FR
25405). NCFST was established by IIT to
bring together the food safety and
technology expertise of academia,
industry and FDA for the purpose of
enhancing the safety of the food supply
in the common goal of enhancing and
improving the safety of the food for U.S.
consumers. NCFST is structured so that
representatives of participating
organizations play a role in establishing
policy and administrative procedures as
well as identifying long- and short-term
research needs. With this organizational
structure, NCFST is able to build
cooperative food safety programs on a
foundation of knowledge about current
industrial trends in food processing and
packaging technologies, regulatory
perspectives from public health
organizations, and fundamental
scientific expertise from academia.
B. Research Objectives
The FDA recognizes that food
production and processing technology is
rapidly changing, that globalization of
the food supply is increasing, and that
the number and nature of the hazards
associated with foods are rapidly
evolving. FDA intends to maintain and
facilitate the further development of
NCFST for the purpose of enhancing
food safety to benefit the public. NCFST
is uniquely positioned as a key
component of FDA’s food protection
program. Specifically, through the
center’s science platforms, the research
at NCFST focuses on the development
and validation of food processing and
packaging technologies for safety and
quality; investigation and development
of preventive technologies targeted to
reduce or eliminate harmful chemical
and microbial contamination of foods;
and the effects of processing on the
stability and safety of bioactive
ingredients added to or naturally
occurring in foods. Additionally, the
development of an integrated
collaborative food protection research/
education/outreach program will
provide fundamental food safety
information, in the public domain, for
use by all segments of the food science
community in product and process
development, regulatory activities,
academic programs and consumer
programs.
C. Eligibility Information
Competition is limited to the IIT. FDA
believes that continued support of
NCFST at IIT is appropriate because IIT
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
is uniquely qualified to fulfill the
objectives of the proposed cooperative
agreement. IIT’s Moffet Center, where
NCFST is located, is a unique research
facility which includes an industrialsize pilot plant and smaller pilot plants
for food processing and packaging
equipment, a pathogen containment
pilot plant, a packaging laboratory,
analytical laboratories, offices,
containment facilities, classrooms, and
support facilities which permit research
from bench-top to industrial-scale. The
industrial-size pilot plant is built to
accommodate routine food processing
and packaging research in a commercial
atmosphere. The physical layout of the
facility provides maximum versatility in
the use and arrangement of equipment
of both commercial and pilot size, and
in the capability to simultaneously
operate several different pieces of
equipment without interference with
each other. Additionally, NCFST has a
BL3 pilot plant and laboratory as well
as a select agent laboratory to conduct
studies with C. botulinum and other
selected agents. NCFST researchers have
access to nutritional clinical facilities on
the IIT campus for validating in humans
how processing may impact the
availability of bioactive ingredients
added to or naturally occurring in foods.
II. Award Information/Funds Available
A. Award Amount
The estimated amount of funds
available for support in FY 2009 will be
for up to $7 million (direct plus indirect
costs), with the possibility of 4
additional years of support for up to $28
million, subject to the availability of
funds. Future year amounts will depend
on annual appropriations and successful
performance.
This award will be funded based on
the quality (e.g., how well the grantee
responds to the RFA (request for
application) requirements) of the
application received and is subject to
availability of Federal funds to support
the project. In addition, if a cooperative
agreement is awarded, the grantee will
be informed of any additional
documentation that should be submitted
to FDA. This cooperative agreement
program requires that the applicant
substantially share in the project costs if
an award is made.
FDA grants policies as described in
the DHHS (Department of Health and
Human Services) Policy Statement,
https://www.hhs.gov/grantsnet/adminis/
gpd/index.htm, will apply to the
applications submitted and awards
made in response to this FOA.
E:\FR\FM\02JNN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 104 (Tuesday, June 2, 2009)]
[Notices]
[Pages 26407-26408]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12796]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0232]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Interstate Shellfish Dealers Certificate
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 Dealers Certificate.
DATES: Submit written or electronic comments on the collection of
information by August 3, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to https://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: Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3794.
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.
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).
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
Activity FDA Form No. No. of Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Interstate Shellfish 3,038 40 57 2,280 0.10 228
Dealer's Certificate
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 26408]]
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: May 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12796 Filed 6-1-09; 8:45 am]
BILLING CODE 4160-01-S
