Strengthen and Promote the Role of Local Health Departments in Retail Food Safety Regulation (U-50), 33307-33309 [2011-14059]
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Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Notices
Notice; extension of comment
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Food and Drug Administration
SUMMARY:
period.
[Docket No. FDA–2011–N–0017]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Voluntary National Retail Food
Regulatory Program Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Voluntary National Retail Food
Regulatory Program Standards’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUMMARY:
In the
Federal Register of March 28, 2011 (76
FR 17132), the Agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0621. The
approval expires on May 31, 2014. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: June 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14064 Filed 6–7–11; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sroberts on DSK5SPTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2010–N–0381]
Generic Drug User Fee; Notice of
Public Meeting; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
The Food and Drug
Administration (FDA) is extending the
comment period for the notice of public
meeting, that appeared in the Federal
Register of August 9, 2010 (75 FR
47820). In the notice, FDA requested
comments to gather stakeholder input
on the development of a generic drug
user fee program. The Agency is taking
this action to allow interested persons
additional time to submit comments.
DATES: Submit either electronic or
written comments by August 1, 2011.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2010–N–
0381, by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• Fax: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
docket number for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Peter C. Beckerman, Office of Policy,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm.
4238, Silver Spring, MD 20993, 301–
796–4830, Fax: 301–847–3541, e-mail:
peter.beckerman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
21:51 Jun 07, 2011
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33307
I. Background
In the Federal Register of August 9,
2010, 75 FR 47820, FDA published a
notice soliciting comment on
development of a generic drug user fee
program, and indicated an intent to
keep the docket open for the duration of
its negotiations.
FDA and the industry trade
organizations with which it is
negotiating have extended the
negotiations until the end of July 2011.
Consequently, FDA is extending the
comment period for the notice until
August 1, 2011. The Agency believes
this extension allows adequate time for
interested persons to submit comments
and reflects the Agency’s previouslyarticulated commitment to receiving
input from all interested parties.
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments on this document. It is only
necessary to send one set of comments.
It is no longer necessary to send two
copies of mailed comments. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: June 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14120 Filed 6–7–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0012]
Strengthen and Promote the Role of
Local Health Departments in Retail
Food Safety Regulation (U–50)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
support of a cooperative agreement
between the Center for Food Safety and
Applied Nutrition (CFSAN) and the
National Association of County and City
Health Officials (NACCHO). The goal of
the cooperative agreement for CFSAN is
to have NACCHO conduct work that
will strengthen the role of local health
departments and help FDA/CFSAN
SUMMARY:
E:\FR\FM\08JNN1.SGM
08JNN1
33308
Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Notices
promote effective city and county
regulatory programs responsible for
retail food protection in the United
States.
1. The application due date is
June 15, 2011.
2. The anticipated start date is August
2011.
3. The opening date is June 8, 2011.
4. The expiration date is June 16,
2011.
For Further Information and
Additional Requirements Contact:
Scientific/Programmatic Contact:
Peter A. Salsbury, Center for Food
Safety and Applied Nutrition (HFS–
320), Food and Drug Administration,
5100 Paint Branch Parkway, College
Park, MD 20740, 301–436–1655.
Grants Management Contact: Gladys
Melendez-Bohler, Office of Acquisition
and Grant Services (OAGS) (HFA–500),
Food and Drug Administration, 5630
Fishers Lane, rm. 1078, Rockville, MD
20857, 301–827–7175.
gladys.bohler@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at https://
www.fda.gov/Food/NewsEvents/
default.htm.
DATES:
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Funding Opportunity Number: RFA–
FY–FD–020.
Catalog of Federal Domestic
Assistance Number: 93.103.
sroberts on DSK5SPTVN1PROD with NOTICES
A. Background
The FDA is responsible for protecting
and promoting public heath. The public
health focus of the FDA Foods Program
integrates a comprehensive,
preventative, and risk-based approach to
safeguard the American food supply.
The goal is to identify potential threats
to the food supply and to counteract
them before they harm American
consumers. CFSAN administers the
FDA Foods Program with the assistance
of the Office of Regulatory Affairs’
(ORA) field offices nationwide.
CFSAN regulates $417 billion worth
of domestic food, $49 billion worth of
imported foods, and over $60 billion
worth of cosmetics sold across state
lines. This regulation takes place from
the products’ point of the United States
(U.S.) entry or processing to their point
of sale. There are over 377,000
registered food facilities (including
approximately 154,000 domestic
facilities and 223,000 foreign facilities)
that manufacture, process, pack, or hold
food consumed by humans or animals
in the United States and several
VerDate Mar<15>2010
21:51 Jun 07, 2011
Jkt 223001
thousand cosmetic firms. These figures
do not include restaurants, institutional
food service establishments, or
supermarkets, grocery stores, and other
food outlets regulated by almost 3,000
States, and local and tribal agencies that
have primary responsibility to regulate
the retail food and food service
industries in the United States. These
state and local agencies are responsible
for the inspection and oversight of over
1 million food establishments,
restaurants and grocery stores, as well as
vending machines, cafeterias, and other
outlets in health-care facilities, schools,
and correctional facilities. FDA strives
to promote the application of sciencebased food safety principles in retail
and food service settings to minimize
the incidence of foodborne illness. FDA
assists regulatory agencies and the
industries they regulate by providing a
model Food Code, scientifically-based
guidance, training, program evaluation,
and technical assistance.
B. Research/Cooperative Investigations
and Assessments Objectives
CFSAN’s Office of Food Safety (OFS)/
Retail Food and Cooperative Programs
Coordination Staff (RFCPCS) as part of
FDA’s National Retail Food Team,
works to promote the sharing of best
practices, including those regulatory
and industry interventions that are
targeted at improving the management
of food safety practices in the retail
setting. CFSAN/OFS desires to work
cooperatively with NACCHO to increase
partnerships and collaboration with our
regulatory partners at local and state
health and agriculture departments that
represent city and county health
departments, to identify best practices
and innovative approaches used to
implement the FDA Food Code and
Voluntary National Retail Food
Regulatory Program Standards (Retail
Program Standards) and begin to
examine the impact they have on the
reduction of foodborne illness risk
factors. NACCHO has the expertise
needed to provide expert advice and
recommendations to FDA that can be
shared and used by multiple local and
state health and agriculture departments
to help improve public heath in retail
and food service settings.
The Cooperative Agreement with
NACCHO will also help FDA examine
how the Retail Program Standards can
most effectively be integrated with
broadening efforts to establish
accreditation for health departments as
guided by the Public Health
Accreditation Board.
Other possible areas for collaboration
with NACCHO include working to
identify how to improve prevention,
PO 00000
Frm 00118
Fmt 4703
Sfmt 4703
performance, and response at the local
government level; establishing peer
mentoring opportunities that pair up
experienced local health department
officials who have experience
implementing the Retail Program
Standards with those who have
struggled or are just beginning the
process; and doing a comprehensive
study to assess the effectiveness of food
inspection grading and scoring systems
used by local health departments.
C. Eligibility Information
NACCHO is the only national
organization representing local health
departments, to include county, city,
district, metro, and tribal agencies.
Membership in NACCHO is limited to
the executive officer of the department
of health of any local health department.
NACCHO supports efforts that protect
and improve the health of all people
and all communities by promoting
national policy, developing resources
and programs, seeking health equity,
and supporting effective local public
health practice and systems.
In performing an internet search for
national organizations whose members
are local governmental health officials,
and whose mission includes efforts to
support and work with local health
departments to improve food safety and
prevent foodborne illness, no other
organizations were discovered. There
are organizations that represent local
boards of health, but no other
organization whose membership is
comprised of local governmental health
officials. NACCHO has been in
existence since 1994 and has always
been exclusively associated with local
health officials.
NACCHO values guide staff and
leadership in work to achieve optimal
health for all through an effective local
governmental presence for public
health. NACCHO believes that by
incorporating these values with a focus
on and commitment to their mission
and vision, NACCHO will effectively
influence improvements in health status
around the country. Another unique
aspect of NACCHO is its membership.
As governmental health officials,
NACCHO is able to join forces with
other governmental health officials to
improve the effectiveness of public
health at the local and state level.
II. Award Information/Funds Available
A. Award Amount
The estimated amount of this
cooperative agreement award with
NACCHO in fiscal year 2011 will be for
up to $400,000 (direct plus indirect
costs).
E:\FR\FM\08JNN1.SGM
08JNN1
Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Notices
B. Length of Support
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
This Cooperative Agreement
established with NACCHO has the
possibility of 4 additional years of
support for up to $400,000 per year,
subject to the availability of funds.
Future year amounts will depend on
annual appropriations and successful
performance.
Food and Drug Administration
[Docket No. FDA–2009–D–0008]
Guidance for Industry on Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic Act;
Availability
III. Paper Application, Registration,
and Submission Information
AGENCY:
To submit a paper application in
response to this FOA, applicants should
first review the full announcement
located at https://www.fda.gov/Food/
NewsEvents/default.htm. (FDA has
verified the Web site addresses
throughout this document, but FDA is
not responsible for any subsequent
changes to the Web sites after this
document publishes in the Federal
Register.) Persons interested in applying
for a grant may obtain an application at
https://grants.nih.gov/grants/forms.htm,
for all paper application submissions,
the following steps are required:
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number.
• Step 2: Register With Central
Contractor Registration.
• Step 3: Register With Electronic
Research Administration (eRA)
Commons.
Steps 1 and 2, in detail, can be found
at https://www07.grants.gov/applicants/
organization_registration.jsp. Step 3, in
detail, can be found at https://
commons.era.nih.gov/commons/
registration/registrationInstructions.jsp.
After you have followed these steps,
submit paper applications to the
following. Please note that the
application should not be submitted
through Grants.gov or eRA Commons:
Gladys Melendez-Bohler, Office of
Acquisition and Grant Services (OAGS)
(HFA–500), Food and Drug
Administration, 5630 Fishers Lane, rm.
1078, Rockville, MD 20857, 301–827–
7175, gladys.bohler@fda.hhs.gov.
Dated: June 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
sroberts on DSK5SPTVN1PROD with NOTICES
[FR Doc. 2011–14059 Filed 6–7–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
21:51 Jun 07, 2011
Jkt 223001
Food and Drug Administration,
HHS.
ACTION:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kimberly K. Thomas, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6223,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION:
I. Background
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a
guidance for industry entitled ‘‘Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic Act.’’
The Food and Drug Administration
Amendments Act (FDAAA) added new
provisions to the Federal Food, Drug,
and Cosmetic Act (the FD&C Act)
addressing the Agency’s treatment of
certain citizen petitions and petitions
for stay of agency action (collectively,
petitions), as well as related
applications. The guidance describes
how FDA will determine if the new
provisions apply to a particular petition
and how FDA will determine if a
petition would delay approval of a
pending abbreviated new drug
application (ANDA) or 505(b)(2)
application. The guidance also describes
how FDA will interpret the
requirements that such petitions include
a certification and that supplemental
information or comments to such
petitions include a verification. The
guidance also addresses the relationship
between the review of petitions and
pending ANDAs and 505(b)(2)
applications for which the Agency has
not yet made a decision on
approvability.
SUMMARY:
Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
DATES:
PO 00000
33309
Frm 00119
Fmt 4703
Sfmt 4703
FDA is announcing the availability of
a guidance for industry entitled ‘‘Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic Act.’’
In the Federal Register of January 21,
2009 (74 FR 3611), FDA announced the
availability of a draft version of this
guidance and provided interested
parties an opportunity to submit
comments. As described in the January
21, 2009, Federal Register notice, the
guidance provides information
regarding FDA’s current thinking on
interpreting section 914 of Title IX of
FDAAA (Pub. L. 110–85). Section 914 of
FDAAA added new section 505(q) to the
FD&C Act (21 U.S.C. 355(q)) and
governs certain citizen petitions and
petitions for stay of Agency action that
request that FDA take any form of action
related to a pending application
submitted under section 505(b)(2) or
505(j) of the FD&C Act. The guidance
describes FDA’s interpretation of
section 505(q) of the FD&C Act
regarding how the Agency will
determine if: (1) The provisions of
section 505(q) addressing the treatment
of citizen petitions and petitions for stay
of agency action (collectively, petitions)
apply to a particular petition and (2) a
petition would delay approval of a
pending ANDA or a 505(b)(2)
application. The guidance also describes
how FDA will interpret the provisions
of section 505(q) requiring that: (1) A
petition includes a certification and (2)
supplemental information or comments
to a petition include a verification.
Finally, the guidance addresses the
relationship between the review of
petitions and pending ANDAs and
505(b)(2) applications for which the
Agency has not yet made a decision on
approvability.
The Agency has carefully reviewed
and considered the comments it
received in response to the draft
guidance in developing this final
version of the guidance. The Agency has
added information in sections III.C and
III.D of the guidance to further explain
how FDA will apply the certification
E:\FR\FM\08JNN1.SGM
08JNN1
]]>Agencies
[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Pages 33307-33309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14059]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0012]
Strengthen and Promote the Role of Local Health Departments in
Retail Food Safety Regulation (U-50)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of a cooperative agreement
between the Center for Food Safety and Applied Nutrition (CFSAN) and
the National Association of County and City Health Officials (NACCHO).
The goal of the cooperative agreement for CFSAN is to have NACCHO
conduct work that will strengthen the role of local health departments
and help FDA/CFSAN
[[Page 33308]]
promote effective city and county regulatory programs responsible for
retail food protection in the United States.
DATES: 1. The application due date is June 15, 2011.
2. The anticipated start date is August 2011.
3. The opening date is June 8, 2011.
4. The expiration date is June 16, 2011.
For Further Information and Additional Requirements Contact:
Scientific/Programmatic Contact: Peter A. Salsbury, Center for Food
Safety and Applied Nutrition (HFS-320), Food and Drug Administration,
5100 Paint Branch Parkway, College Park, MD 20740, 301-436-1655.
Grants Management Contact: Gladys Melendez-Bohler, Office of
Acquisition and Grant Services (OAGS) (HFA-500), Food and Drug
Administration, 5630 Fishers Lane, rm. 1078, Rockville, MD 20857, 301-
827-7175. gladys.bohler@fda.hhs.gov.
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at https://www.fda.gov/Food/NewsEvents/default.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Funding Opportunity Number: RFA-FY-FD-020.
Catalog of Federal Domestic Assistance Number: 93.103.
A. Background
The FDA is responsible for protecting and promoting public heath.
The public health focus of the FDA Foods Program integrates a
comprehensive, preventative, and risk-based approach to safeguard the
American food supply. The goal is to identify potential threats to the
food supply and to counteract them before they harm American consumers.
CFSAN administers the FDA Foods Program with the assistance of the
Office of Regulatory Affairs' (ORA) field offices nationwide.
CFSAN regulates $417 billion worth of domestic food, $49 billion
worth of imported foods, and over $60 billion worth of cosmetics sold
across state lines. This regulation takes place from the products'
point of the United States (U.S.) entry or processing to their point of
sale. There are over 377,000 registered food facilities (including
approximately 154,000 domestic facilities and 223,000 foreign
facilities) that manufacture, process, pack, or hold food consumed by
humans or animals in the United States and several thousand cosmetic
firms. These figures do not include restaurants, institutional food
service establishments, or supermarkets, grocery stores, and other food
outlets regulated by almost 3,000 States, and local and tribal agencies
that have primary responsibility to regulate the retail food and food
service industries in the United States. These state and local agencies
are responsible for the inspection and oversight of over 1 million food
establishments, restaurants and grocery stores, as well as vending
machines, cafeterias, and other outlets in health-care facilities,
schools, and correctional facilities. FDA strives to promote the
application of science-based food safety principles in retail and food
service settings to minimize the incidence of foodborne illness. FDA
assists regulatory agencies and the industries they regulate by
providing a model Food Code, scientifically-based guidance, training,
program evaluation, and technical assistance.
B. Research/Cooperative Investigations and Assessments Objectives
CFSAN's Office of Food Safety (OFS)/Retail Food and Cooperative
Programs Coordination Staff (RFCPCS) as part of FDA's National Retail
Food Team, works to promote the sharing of best practices, including
those regulatory and industry interventions that are targeted at
improving the management of food safety practices in the retail
setting. CFSAN/OFS desires to work cooperatively with NACCHO to
increase partnerships and collaboration with our regulatory partners at
local and state health and agriculture departments that represent city
and county health departments, to identify best practices and
innovative approaches used to implement the FDA Food Code and Voluntary
National Retail Food Regulatory Program Standards (Retail Program
Standards) and begin to examine the impact they have on the reduction
of foodborne illness risk factors. NACCHO has the expertise needed to
provide expert advice and recommendations to FDA that can be shared and
used by multiple local and state health and agriculture departments to
help improve public heath in retail and food service settings.
The Cooperative Agreement with NACCHO will also help FDA examine
how the Retail Program Standards can most effectively be integrated
with broadening efforts to establish accreditation for health
departments as guided by the Public Health Accreditation Board.
Other possible areas for collaboration with NACCHO include working
to identify how to improve prevention, performance, and response at the
local government level; establishing peer mentoring opportunities that
pair up experienced local health department officials who have
experience implementing the Retail Program Standards with those who
have struggled or are just beginning the process; and doing a
comprehensive study to assess the effectiveness of food inspection
grading and scoring systems used by local health departments.
C. Eligibility Information
NACCHO is the only national organization representing local health
departments, to include county, city, district, metro, and tribal
agencies. Membership in NACCHO is limited to the executive officer of
the department of health of any local health department. NACCHO
supports efforts that protect and improve the health of all people and
all communities by promoting national policy, developing resources and
programs, seeking health equity, and supporting effective local public
health practice and systems.
In performing an internet search for national organizations whose
members are local governmental health officials, and whose mission
includes efforts to support and work with local health departments to
improve food safety and prevent foodborne illness, no other
organizations were discovered. There are organizations that represent
local boards of health, but no other organization whose membership is
comprised of local governmental health officials. NACCHO has been in
existence since 1994 and has always been exclusively associated with
local health officials.
NACCHO values guide staff and leadership in work to achieve optimal
health for all through an effective local governmental presence for
public health. NACCHO believes that by incorporating these values with
a focus on and commitment to their mission and vision, NACCHO will
effectively influence improvements in health status around the country.
Another unique aspect of NACCHO is its membership. As governmental
health officials, NACCHO is able to join forces with other governmental
health officials to improve the effectiveness of public health at the
local and state level.
II. Award Information/Funds Available
A. Award Amount
The estimated amount of this cooperative agreement award with
NACCHO in fiscal year 2011 will be for up to $400,000 (direct plus
indirect costs).
[[Page 33309]]
B. Length of Support
This Cooperative Agreement established with NACCHO has the
possibility of 4 additional years of support for up to $400,000 per
year, subject to the availability of funds. Future year amounts will
depend on annual appropriations and successful performance.
III. Paper Application, Registration, and Submission Information
To submit a paper application in response to this FOA, applicants
should first review the full announcement located at https://www.fda.gov/Food/NewsEvents/default.htm. (FDA has verified the Web site
addresses throughout this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.) Persons interested in applying for a grant may
obtain an application at https://grants.nih.gov/grants/forms.htm, for
all paper application submissions, the following steps are required:
Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
Step 2: Register With Central Contractor Registration.
Step 3: Register With Electronic Research Administration
(eRA) Commons.
Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp.
After you have followed these steps, submit paper applications to
the following. Please note that the application should not be submitted
through Grants.gov or eRA Commons: Gladys Melendez-Bohler, Office of
Acquisition and Grant Services (OAGS) (HFA-500), Food and Drug
Administration, 5630 Fishers Lane, rm. 1078, Rockville, MD 20857, 301-
827-7175, gladys.bohler@fda.hhs.gov.
Dated: June 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14059 Filed 6-7-11; 8:45 am]
BILLING CODE 4160-01-P
