Food Safety Research; Investigations Focused on Promoting the Safety of Produce, 31490-31492 [E8-12159]
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<![CDATA[
31490
Federal Register / Vol. 73, No. 106 / Monday, June 2, 2008 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses
per respondent
Number of
respondents
Average burden
per response
(in hours)
Total burden
(in hours)
Form name
Type of respondent
Invasive
Methicillin-resistant
Staphylococcus aureus ABCs Case Report
Form.
ABCs Invasive Pneumococcal Disease in
Children Case Report Form.
Neonatal Group B Streptococcal Disease
Prevention Tracking Form.
State Health Department.
10
609
20/60
2030
State Health Department.
State Health Department.
10
41
10/60
68
10
37
20/60
123
Total ....................................................
..................................
............................
............................
............................
4918
Dated: May 23, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–12192 Filed 5–30–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
Advisory Committee on Immunization
Practices (ACIP)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:
Centers for Disease Control and
Prevention
Public Health Service Act (PHS);
Delegation of Authority
jlentini on PROD1PC65 with NOTICES
Notice is hereby given that I have
delegated to the Director, National
Center for Preparedness, Detection and
Control of Infectious Diseases
(NCPDCID), and the Director, Division
of Global Migration and Quarantine
(DGMQ), NCPDCID, with authority to
redelegate, the authorities vested in the
Director, Centers for Disease Control
and Prevention, under sections 361(a),
(b), (c), (d), and 362, Title III, of the PHS
Act (Control of Communicable Diseases,
42 U.S.C. 264 and 265. The authority
delegated under 361(a) does not include
the authority to promulgate regulations.
This delegation became effective upon
date of signature. In addition, I have
affirmed and ratified any actions taken
by the Director, NCPDCID, the Director,
DGMQ, NCPDCID, or their subordinates
which involved the exercise of
authorities delegated herein prior to the
effective date of the delegation.
Dated: May 20, 2008.
Julie Louise Gerberding,
Director, Centers for Disease Control and
Prevention.
[FR Doc. E8–12176 Filed 5–30–08; 8:45 am]
BILLING CODE 4160–18–M
VerDate Aug<31>2005
19:06 May 30, 2008
Jkt 214001
Centers for Disease Control and
Prevention
Times and Dates: 8 a.m.–6 p.m., June 25,
2008. 8 a.m.–5 p.m., June 26, 2008.
Place: CDC, Tom Harkin Global
Communications Center, 1600 Clifton Road,
NE., Building 19, Kent ‘‘Oz’’ Nelson
Auditorium, Atlanta, Georgia 30333.
Status: Open to the public, limited only by
the space available.
Purpose: The committee is charged with
advising the Director, CDC, on the
appropriate uses of immunizing agents. In
addition, under 42 U.S.C. 1396s, the
committee is mandated to establish and
periodically review and, as appropriate,
revise the list of vaccines for administration
to vaccine-eligible children through the
Vaccines for Children (VFC) program, along
with schedules regarding the appropriate
periodicity, dosage, and contraindications
applicable to the vaccines.
Matters to be Discussed: The agenda will
include discussions on Rotavirus Vaccines;
Combination Vaccines; MMRV Vaccine;
Human Papillomavirus Vaccines;
Pneumococcal Vaccines; Measles Outbreaks
in the United States (2008); Adult
Immunization Schedule; Anthrax Vaccine;
Influenza Vaccines; Rabies Vaccine and
Biologicals; Vaccine Supply; and
Immunization Safety Update. There may be
VFC voting on the Rotavirus, Combination
and Human Papillomavirus Vaccines.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Antonette Hill, Immunization Services
Division, National Center for Immunization
and Respiratory Diseases, CDC, 1600 Clifton
Road, NE., (E–05), Atlanta, Georgia 30333,
Telephone (404) 639–8836, Fax (404) 639–
8905.
The Director, Management Analysis and
Services Office, has been delegated the
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both the CDC and ATSDR.
Dated: May 27, 2008.
Elaine Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–12234 Filed 5–30–08; 8:45 am]
BILLING CODE 4160–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food Safety Research; Investigations
Focused on Promoting the Safety of
Produce
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA-Center for Food
Safety and Applied Nutrition (CFSAN))
is announcing the availability of
approximately $1.0 million in research
funds for fiscal year (FY) 2008. It is
anticipated that individual grants will
receive a total of $250,000 to $500,000
to cover both direct and indirect costs.
These funds will be used to support
research efforts to advance the safe
transportation and preparation of
produce and to help reduce the
incidence of foodborne illness that may
be associated with fresh produce
consumption. The award will provide
18 months of support. There will be no
additional years of noncompetitive
continuation support. A copy of the full
text of this announcement will be
posted in Grants.gov and on FDA’s
Center for Food Safety and Applied
Nutrition Web site at https://
www.cfsan.fda.gov/list.html.
Key Dates: Receipt Date: Applications
are due within 90 days after the
publication of the funding opportunity
in the Federal Register.
E:\FR\FM\02JNN1.SGM
02JNN1
Federal Register / Vol. 73, No. 106 / Monday, June 2, 2008 / Notices
I. Funding Opportunity Description
The Food and Drug Administration
(FDA) Center for Food Safety and
Applied Nutrition (CFSAN) maintains
an active intramural research program.
This research is focused on five primary
CFSAN program priorities; ensuring the
safety of food, dietary, supplements and
cosmetics; improving nutrition; and
promoting the security and integrity of
the food supply. When resources
permit, CFSAN supports extramural
research grants intended to help
advance these program priorities. The
extramural program endeavors to
support novel research efforts, expertise,
and resources not found within CFSAN.
In particular, it is intended that any
additional extramural research efforts in
food safety will complement the
Center’s intramural research efforts, and
generally enhance the Agency’s and the
Nation’s ability to reduce the incidence
of food borne illness and protect the
integrity of the nation’s food supply.
Applications submitted in response to
this Request for Application must be
submitted electronically through
Grants.gov (https://www.grants.gov)
using the SF 424 Research and Related
(R&R forms and the SF 424 (R&R)
Application Guide.) Paper applications
will not be accepted.
Project Emphasis
FDA is announcing the availability of
competitively awarded funding for FY
2008 to be used for research intended to
help enhance produce safety. Proposed
projects designed to fulfill the specific
objectives of either of the following
requested project topic categories will
be considered for funding. Applications
may address only one project and its
objectives per application. It should be
noted that CFSAN will place greater
value on those proposals addressing the
objectives in a manner that will lead to
practical solutions, which, if
implemented, will help improve the
safety of prepared and consumed freshcut produce. No proposed projects
should involve human research
subjects.
jlentini on PROD1PC65 with NOTICES
A. Project Topic Category 1
Conduct laboratory based studies
assessing the handling of fresh-cut
produce by consumers that may
compromise the microbiological safety
of the product prior to its consumption.
Quantifiable information is being sought
regarding the consequences of typical
consumer handling behaviors that
compromise fresh produce safety and
about practical alterations in consumer
behaviors that may be easily employed
to improve the safety of the product
VerDate Aug<31>2005
19:06 May 30, 2008
Jkt 214001
they eat. These must be laboratory based
studies and not consumer behavioral
studies involving human subjects.
B. Project Topic Category 2
Identify and assess problem(s) that
occur during the transportation of fresh
produce between producer processing
facilities and point of retail sale to the
consumer. The research may focus on
an individual problem and its impact on
a single commodity or a group of
commodities. Alternatively, the research
may focus on a set of related or
interdependent problems and their
impact on a single commodity or a
group of commodities. It is expected the
research effort will provide practical
solutions that can be used to enhance
product safety and integrity during the
transportation phase of its production.
II. Award Information
Mechanism of Support
This Request for Application will use
the Research Project Grant R01 award
mechanism. The applicant will be solely
responsible for planning, directing, and
executing the proposed project. FDA
will support the competitively awarded
grants under the authority of section 301
of the Public Health Service (PHS) Act
(42 U.S.C. 241).
Announcement Type: New Competing
Research Grant (R01)
Request for Applications (RFA) Number:
RFA-FD-08-005
Catalog of Federal Domestic Assistance
Number: 93.103
III. Eligibility Information
A. Eligible Applicants
The grants are available to any foreign
or domestic, public or private, for-profit
or nonprofit entity (including State and
local units of government). Federal
agencies that are not part of the
Department of Health and Human
Services (HHS) may apply. Agencies
that are part of HHS may not apply. Forprofit entities must commit to excluding
fees or profit in their request for support
to receive grant awards. Organizations
that engage in lobbying activities, as
described in section 501(c) (4) of the
Internal Revenue Code of 1968, are not
eligible to receive grant awards.
B. Cost Sharing or Matching
Cost sharing is not required.
C. Other-Special Eligibility Criteria
Applicants may submit more than one
application, provided each application
is scientifically distinct.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
31491
IV. Application and Submission
A. Request Application Information
Applicants must download the SF424
(R&R) application forms and SF424
(R&R) Application Guide for this
funding opportunity through the
Grants.gov Apply https://www.grants.gov
Web site. Only the forms package
directly attached to this specific funding
opportunity in Grants.gov can be used.
Your organization will need to obtain
a Data Universal Number System
(DUNS) number and register with the
Central Contractor Registration (CCR) as
part of the Grants.gov registration
process.
Direct questions regarding Grants.gov
registration should be directed to
Grants.gov Customer Support at 800–
518–4726 or e-mail support@grants.gov.
1. Dun and Bradstreet Number (DUNS)
Applicants are now required to have
a DUNS number to apply for a grant or
cooperative agreement from the Federal
Government. The DUNS number is a 9–
digit identification number that
uniquely identifies business entities. To
obtain a DUNS number, call Dun and
Bradstreet at 1–866–705–5711. Be
certain that you identify yourself as a
Federal grant applicant when you
contact Dun and Bradstreet. For foreign
entities the Web site is https://
eupdate.DNB.com.
2. Central Contractor Registration
Applicants must register with the CCR
database. You must have a DUNS
number to begin your registration. This
database is a government-wide
warehouse of commercial and financial
information for all organizations
conducting business with the Federal
Government. The preferred method for
completing a registration is through the
Web site at https://www.ccr.gov. This
Web site provides a CCR handbook with
detailed information on data you will
need prior to beginning the online preregistration, as well as steps to walk you
through the registration process. In
order to access grants.gov an applicant
will be required to register with the
Credential Provider. Information about
this is available at https://www.grant.gov/
CredentialProvider.
B. Content and Form of Application
Submission
The SF424 (R&R) has several
components. Some components are
required, others are optional. The forms
package associated with this Request for
Application in Grants.gov/APPLY
includes all applicable components
(required and optional). The package
should be labeled ‘‘Response to RFA-
E:\FR\FM\02JNN1.SGM
02JNN1
31492
Federal Register / Vol. 73, No. 106 / Monday, June 2, 2008 / Notices
FD–08–005.’’ If you experience
technical difficulties with your online
submission you should contact Gladys
Melendez-Bohler by telephone 301–
827–7168 or by e-mail gladys.melendezbohler@fda.hhs.gov.
Data and information included in the
application will generally not be
publicly available prior to the funding
of the application. After funding has
been awarded, data and information
included in the application will be
given confidential treatment to the
extent permitted by the Freedom of
Information Act (5 U.S.C. 552(b)) and
FDA’s implementing regulations
(including 21 CFR Part 20 and §§ 20.61,
20.105, and 20.106). By accepting
funding, the applicant agrees to allow
FDA to publish specific information
about the grant. Collecting information
on Form SF424 (R&R) has been
approved and assigned OMB control
number 4040–0001.
C. Submission Dates and Times
D. Intergovernmental Review
The regulations issued under
Executive Order 12372,
Intergovernmental Review of Federal
Program (45 CFR Part 100) do not apply.
jlentini on PROD1PC65 with NOTICES
E. Funding Restrictions
This agreement will be subject to all
policies and requirements that govern
the research grant programs of the PHS,
including Provisions of 42 CFR Part 52
and 45 CFR Parts 74 and 92. All grants
are subject to the terms and conditions,
cost principles, and other
considerations described in the January
6, 2007, HHS Grants Policy Statement
that are applicable based on your
recipient type and the purpose of this
award. This includes any requirements
in Parts I and II (available at https://
www.hhs.gov/grantsnet/adminis/gpd/
index.htm).
Although consistent with the HHS
Grants Policy Statement (GPS), any
applicable statutory or regulatory
requirements, including 45 CFR parts 74
or 92, directly apply to this award apart
from any coverage in the HHS GPS.
19:06 May 30, 2008
Jkt 214001
Dated: May 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–12159 Filed 5–30–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
The application submission receipt
date is within 90 days after the date of
the publication of the Funding
Opportunity Announcement in the
Federal Register. The application will
be accepted electronically until the
established receipt date.
On time submission requires that
applications be successfully submitted
to Grants.gov no later than 5 p.m local
time (of the applicant’s institution/
organization).
VerDate Aug<31>2005
V. Agency Contacts
For issues regarding the programmatic
aspects of this notice: Mark Wirtz,
Center for Food Safety and Applied
Nutrition (HFS–002), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301–
436–2001, e-mail:
mark.wirtz@fda.hhs.gov. For issues
regarding the administrative and
financial management aspects of this
notice contact, Gladys Melendez-Bohler
at 301–827–7168 or by e-mail at
gladys.melendez-Bohler@fda.hhs.gov.
[Docket No. FDA–2007–D–0364] (formerly
Docket No. 2007D–0080)
Guidance for Industry on Indexing
Structured Product Labeling;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Indexing Structured Product
Labeling.’’ This guidance explains that
the Center for Biologics Evaluation and
Research (CBER) and the Center for
Drug Evaluation and Research (CDER)
will index structured product labeling
(SPL) in the product labeling for human
drug and biologic products. This
guidance also makes recommendations
to industry on how to submit input
regarding the indexing information in
the SPL.
DATES: Submit written or electronic
comments on agency guidance
documents at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 2201, Silver Spring
MD 20993–0003, or the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist that office in processing your
requests. The guidance can also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Laurie Burke, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6462,
Silver Spring, MD 20993–0002,
laurie.burke@fda.hhs.gov, or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Indexing Structured Product
Labeling.’’ This guidance explains that
CBER and CDER will index SPL in the
product labeling for human drug and
biological products. This guidance also
makes recommendations to industry on
how to submit input regarding the
indexing information in the SPL.
A Health Level Seven (HL7) standard,
SPL enables the electronic exchange of
the content of labeling and other
regulated product information using the
extensible markup language. The SPL
standard enables the inclusion of
indexing elements with product
labeling. These machine readable
identifiers enable users with clinical
decision support tools and electronic
prescribing systems to rapidly search
and sort product information found in
product labeling. Indexing the content
of labeling with SPL will greatly
facilitate the efficient communication of
important drug information to the
public, helping create a more robust
nationwide system for promoting the
safe and effective use of drugs.
After completing a 6-month pilot
project evaluating how best to add
indexing elements, FDA determined
that the most efficient strategy is for
FDA, not individual applicants, to index
the SPL using a phased approach. We
will index the pharmacological class
during the first phase. We are adding
E:\FR\FM\02JNN1.SGM
02JNN1
]]>Agencies
[Federal Register Volume 73, Number 106 (Monday, June 2, 2008)]
[Notices]
[Pages 31490-31492]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12159]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Food Safety Research; Investigations Focused on Promoting the
Safety of Produce
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA-Center for Food Safety
and Applied Nutrition (CFSAN)) is announcing the availability of
approximately $1.0 million in research funds for fiscal year (FY) 2008.
It is anticipated that individual grants will receive a total of
$250,000 to $500,000 to cover both direct and indirect costs. These
funds will be used to support research efforts to advance the safe
transportation and preparation of produce and to help reduce the
incidence of foodborne illness that may be associated with fresh
produce consumption. The award will provide 18 months of support. There
will be no additional years of noncompetitive continuation support. A
copy of the full text of this announcement will be posted in Grants.gov
and on FDA's Center for Food Safety and Applied Nutrition Web site at
https://www.cfsan.fda.gov/list.html.
Key Dates: Receipt Date: Applications are due within 90 days after
the publication of the funding opportunity in the Federal Register.
[[Page 31491]]
I. Funding Opportunity Description
The Food and Drug Administration (FDA) Center for Food Safety and
Applied Nutrition (CFSAN) maintains an active intramural research
program. This research is focused on five primary CFSAN program
priorities; ensuring the safety of food, dietary, supplements and
cosmetics; improving nutrition; and promoting the security and
integrity of the food supply. When resources permit, CFSAN supports
extramural research grants intended to help advance these program
priorities. The extramural program endeavors to support novel research
efforts, expertise, and resources not found within CFSAN. In
particular, it is intended that any additional extramural research
efforts in food safety will complement the Center's intramural research
efforts, and generally enhance the Agency's and the Nation's ability to
reduce the incidence of food borne illness and protect the integrity of
the nation's food supply.
Applications submitted in response to this Request for Application
must be submitted electronically through Grants.gov (https://
www.grants.gov) using the SF 424 Research and Related (R&R forms and
the SF 424 (R&R) Application Guide.) Paper applications will not be
accepted.
Project Emphasis
FDA is announcing the availability of competitively awarded funding
for FY 2008 to be used for research intended to help enhance produce
safety. Proposed projects designed to fulfill the specific objectives
of either of the following requested project topic categories will be
considered for funding. Applications may address only one project and
its objectives per application. It should be noted that CFSAN will
place greater value on those proposals addressing the objectives in a
manner that will lead to practical solutions, which, if implemented,
will help improve the safety of prepared and consumed fresh-cut
produce. No proposed projects should involve human research subjects.
A. Project Topic Category 1
Conduct laboratory based studies assessing the handling of fresh-
cut produce by consumers that may compromise the microbiological safety
of the product prior to its consumption. Quantifiable information is
being sought regarding the consequences of typical consumer handling
behaviors that compromise fresh produce safety and about practical
alterations in consumer behaviors that may be easily employed to
improve the safety of the product they eat. These must be laboratory
based studies and not consumer behavioral studies involving human
subjects.
B. Project Topic Category 2
Identify and assess problem(s) that occur during the transportation
of fresh produce between producer processing facilities and point of
retail sale to the consumer. The research may focus on an individual
problem and its impact on a single commodity or a group of commodities.
Alternatively, the research may focus on a set of related or
interdependent problems and their impact on a single commodity or a
group of commodities. It is expected the research effort will provide
practical solutions that can be used to enhance product safety and
integrity during the transportation phase of its production.
II. Award Information
Mechanism of Support
This Request for Application will use the Research Project Grant
R01 award mechanism. The applicant will be solely responsible for
planning, directing, and executing the proposed project. FDA will
support the competitively awarded grants under the authority of section
301 of the Public Health Service (PHS) Act (42 U.S.C. 241).
Announcement Type: New Competing Research Grant (R01)
Request for Applications (RFA) Number: RFA-FD-08-005
Catalog of Federal Domestic Assistance Number: 93.103
III. Eligibility Information
A. Eligible Applicants
The grants are available to any foreign or domestic, public or
private, for-profit or nonprofit entity (including State and local
units of government). Federal agencies that are not part of the
Department of Health and Human Services (HHS) may apply. Agencies that
are part of HHS may not apply. For-profit entities must commit to
excluding fees or profit in their request for support to receive grant
awards. Organizations that engage in lobbying activities, as described
in section 501(c) (4) of the Internal Revenue Code of 1968, are not
eligible to receive grant awards.
B. Cost Sharing or Matching
Cost sharing is not required.
C. Other-Special Eligibility Criteria
Applicants may submit more than one application, provided each
application is scientifically distinct.
IV. Application and Submission
A. Request Application Information
Applicants must download the SF424 (R&R) application forms and
SF424 (R&R) Application Guide for this funding opportunity through the
Grants.gov Apply https://www.grants.gov Web site. Only the forms package
directly attached to this specific funding opportunity in Grants.gov
can be used.
Your organization will need to obtain a Data Universal Number
System (DUNS) number and register with the Central Contractor
Registration (CCR) as part of the Grants.gov registration process.
Direct questions regarding Grants.gov registration should be
directed to Grants.gov Customer Support at 800-518-4726 or e-mail
support@grants.gov.
1. Dun and Bradstreet Number (DUNS)
Applicants are now required to have a DUNS number to apply for a
grant or cooperative agreement from the Federal Government. The DUNS
number is a 9-digit identification number that uniquely identifies
business entities. To obtain a DUNS number, call Dun and Bradstreet at
1-866-705-5711. Be certain that you identify yourself as a Federal
grant applicant when you contact Dun and Bradstreet. For foreign
entities the Web site is https://eupdate.DNB.com.
2. Central Contractor Registration
Applicants must register with the CCR database. You must have a
DUNS number to begin your registration. This database is a government-
wide warehouse of commercial and financial information for all
organizations conducting business with the Federal Government. The
preferred method for completing a registration is through the Web site
at https://www.ccr.gov. This Web site provides a CCR handbook with
detailed information on data you will need prior to beginning the
online pre-registration, as well as steps to walk you through the
registration process. In order to access grants.gov an applicant will
be required to register with the Credential Provider. Information about
this is available at https://www.grant.gov/CredentialProvider.
B. Content and Form of Application Submission
The SF424 (R&R) has several components. Some components are
required, others are optional. The forms package associated with this
Request for Application in Grants.gov/APPLY includes all applicable
components (required and optional). The package should be labeled
``Response to RFA-
[[Page 31492]]
FD-08-005.'' If you experience technical difficulties with your online
submission you should contact Gladys Melendez-Bohler by telephone 301-
827-7168 or by e-mail gladys.melendez-bohler@fda.hhs.gov.
Data and information included in the application will generally not
be publicly available prior to the funding of the application. After
funding has been awarded, data and information included in the
application will be given confidential treatment to the extent
permitted by the Freedom of Information Act (5 U.S.C. 552(b)) and FDA's
implementing regulations (including 21 CFR Part 20 and Sec. Sec.
20.61, 20.105, and 20.106). By accepting funding, the applicant agrees
to allow FDA to publish specific information about the grant.
Collecting information on Form SF424 (R&R) has been approved and
assigned OMB control number 4040-0001.
C. Submission Dates and Times
The application submission receipt date is within 90 days after the
date of the publication of the Funding Opportunity Announcement in the
Federal Register. The application will be accepted electronically until
the established receipt date.
On time submission requires that applications be successfully
submitted to Grants.gov no later than 5 p.m local time (of the
applicant's institution/organization).
D. Intergovernmental Review
The regulations issued under Executive Order 12372,
Intergovernmental Review of Federal Program (45 CFR Part 100) do not
apply.
E. Funding Restrictions
This agreement will be subject to all policies and requirements
that govern the research grant programs of the PHS, including
Provisions of 42 CFR Part 52 and 45 CFR Parts 74 and 92. All grants are
subject to the terms and conditions, cost principles, and other
considerations described in the January 6, 2007, HHS Grants Policy
Statement that are applicable based on your recipient type and the
purpose of this award. This includes any requirements in Parts I and II
(available at https://www.hhs.gov/grantsnet/adminis/gpd/index.htm).
Although consistent with the HHS Grants Policy Statement (GPS), any
applicable statutory or regulatory requirements, including 45 CFR parts
74 or 92, directly apply to this award apart from any coverage in the
HHS GPS.
V. Agency Contacts
For issues regarding the programmatic aspects of this notice: Mark
Wirtz, Center for Food Safety and Applied Nutrition (HFS-002), Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740,
301-436-2001, e-mail: mark.wirtz@fda.hhs.gov. For issues regarding the
administrative and financial management aspects of this notice contact,
Gladys Melendez-Bohler at 301-827-7168 or by e-mail at gladys.melendez-
Bohler@fda.hhs.gov.
Dated: May 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12159 Filed 5-30-08; 8:45 am]
BILLING CODE 4160-01-S
