Office of Critical Path Programs-Critical Path Initiative, 39963-39964 [E9-19010]
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39963
Federal Register / Vol. 74, No. 152 / Monday, August 10, 2009 / Notices
Average
time
response
(Minutes)
Frequency
of
response
Number of
respondents
Study Questionnaire
Annual hour
burden
243
1
3/60
12.15
Subtotal .............................................................................................
........................
........................
........................
789.65
NCI validation and observational feeding study:
Screener ...................................................................................................
Reminder Telephone Call .........................................................................
Eating 3 meals ..........................................................................................
Dietary Recall ...........................................................................................
Demographics questionnaire ....................................................................
100
90
90
80
80
1
1
1
1
1
3/60
3/60
135/60
30/60
8/60
5.00
4.50
202.50
40.00
10.67
Subtotal .............................................................................................
........................
........................
........................
262.67
Total ...................................................................................................
rmajette on DSK29S0YB1PROD with NOTICES
Preference survey ....................................................................................
........................
........................
........................
1,052.32
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proposed performance of the
functions of the agency, including
whether the information may have
practical utility; (2) The accuracy of the
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 those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the
Attention: NIH Desk Officer, Office of
Management and Budget, at
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans, contact Frances E. Thompson,
PhD, Project Officer, National Cancer
Institute, NIH, EPN 4095A, 6130
Executive Boulevard MSC 7335,
Bethesda, Maryland 20892–7335, or call
non-toll-free number 301–594–4410, or
FAX your request to 301–435–3710, or
e-mail your request, including your
address, to thompsof@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
VerDate Nov<24>2008
15:09 Aug 07, 2009
Jkt 217001
Dated: July 31, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E9–19022 Filed 8–7–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0366]
Food and Drug Administration,
HHS.
ACTION:
Important dates are as follows:
1. The application due date is
September 7, 2009.
2. The anticipated start date is in
September 2009.
3. The opening date is August 10,
2009.
4. The expiration date is September 8,
2009.
DATES:
FOR FURTHER INFORMATION AND
ADDITIONAL REQUIREMENTS CONTACT:
Nancy Stanisic, Office of Critical Path
Programs (HF–18), rm. 14B45, Food
and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–1660.
Gladys M. Bohler, Grants
Management Specialist, Office of
Frm 00049
Fmt 4703
Funding Opportunity Description
Number: RFA FD–09–019
Catalog of Federal Domestic Assistance
Number: 93.103
A. Background
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
support of Office of Critical Path
Programs (OCPP). The goal of OCPP is
to develop an administrative and
scientific infrastructure to support the
creation and execution of a series of
projects under the FDA’s Critical Path
Initiative.
PO 00000
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Office of Critical Path Programs—
Critical Path Initiative
AGENCY:
Acquisitions and Grants Services
(HFA–500), Food and Drug
Administration, 5630 Fishers Lane,
rm. 2105, Rockville, MD 20857,
301–827–7168.
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/oc/initiatives/criticalpath/
.
Sfmt 4703
The Critical Path Initiative, launched
by FDA in 2004, has the objective of
helping modernize the development,
evaluation, manufacture, and use of
FDA-regulated products. Through
nationwide collaboration with other
Federal, academic, scientific, and
industry organizations, the initiative
seeks to develop new tools to facilitate
innovation in FDA-regulated product
development. Examples of tools include
novel biomarkers, laboratory assays,
genetic tests, and state-of-the art
information technologies, etc. In this
initiative, FDA plays the role of a
facilitator in the creation of partnerships
and collaborations to support specific
scientific projects.
B. Research Objectives
FDA’s Office of the Commissioner is
announcing its intent to accept and
consider a single source application for
the award of a Cooperative Agreement
to the Critical Path Institute (C-Path).
FDA anticipates providing up to $1.5
million (direct and indirect costs
combined) during fiscal year (FY) 2009
to support research and related efforts of
E:\FR\FM\10AUN1.SGM
10AUN1
39964
Federal Register / Vol. 74, No. 152 / Monday, August 10, 2009 / Notices
identified projects that are part of the
Critical Path Initiative.
This Cooperative Agreement ensures
substantial FDA involvement in this
program, and will include, but will not
be limited to, co-development of study
priorities, protocols, decisionmaking,
reports, and publications at specified
program milestones related to
performance. FDA will support research
covered by this document under the
authority of section 301 of the Public
Health Service Act (42 U.S.C. 341).
Administrative regulations found in 45
CFR parts 74 and/or 92 are applicable.
C. Eligibility Information
The following organization/institution
is eligible to apply: Critical Path
Institute.
Competition is limited because of
FDA’s ongoing collaboration with the
University of Utah and the Critical Path
Institute, in support of FDA’s Critical
Path Initiative, and the combined ability
of these parties to leverage existing
databases, specimen repositories,
clinical, and other technical expertise in
support of this program.
II. Award Information/Funds Available
A. Award Amount
It is anticipated that FDA will fund
this Cooperative Agreement up to $1.5
million (direct and indirect costs) in FY
09 based on the quality of the
application received and the availability
of Federal funds.
rmajette on DSK29S0YB1PROD with NOTICES
B. Length of Support
Funding beyond the first year (up to
5 years) will be noncompetitive and will
depend on: (1) Satisfactory performance
during the preceding year and (2) the
availability of Federal fiscal year funds.
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/oc/
initiatives/criticalpath/. 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://
VerDate Nov<24>2008
15:09 Aug 07, 2009
Jkt 217001
commons.era.nih.gov/commons/
registration/registrationInstructions.jsp.
After you have followed these steps,
submit paper applications to: Gladys M.
Bohler (see FOR FURTHER INFORMATION
AND ADDITIONAL REQUIREMENTS CONTACT).
Dated: August 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19010 Filed 8–7–09; 8:45 am]
BILLING CODE 4160–01–P
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Dated: August 4, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–19080 Filed 8–7–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Clinical Center; Notice of Meeting
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the NIH
Advisory Board for Clinical Research.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended to
discuss personnel matters, the
disclosure of which would constitute a
clearly unwarranted invasion of privacy.
National Institute of Mental Health;
Notice of Meeting
Name of Committee: NIH Advisory Board
for Clinical Research.
Date: September 21, 2009.
Open: 10 a.m. to 1:15 p.m.
Agenda: To review the Clinical Center
budget plans and updates on selected
organizational initiatives.
Place: National Institutes of Health,
Building 10, 10 Center Drive, CRC Medical
Board Room 4–2551, Bethesda, MD 20892.
Closed: 1:15 p.m. to 2 p.m.
Agenda: To review and evaluate to discuss
personnel matters.
Place: National Institutes of Health,
Building 10, 10 Center Drive, CRC Medical
Board Room 4–2551, Bethesda, MD 20892.
Contact Person: Maureen E Gormley,
Executive Secretary, Mark O. Hatfield,
Clinical Research Center, National Institutes
of Health, Building 10, Room 6–2551,
Bethesda, MD 20892, (301) 496–2897.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Mental Health
Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Mental Health Council.
Date: September 24, 2009.
Open: 10 a.m. to 12 p.m.
Agenda: Presentation of NIMH Director’s
report and discussion on NIMH program and
policy issues.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Conference Room C/D/E,
Rockville, MD 20852.
Closed: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Contact Person: Jane A. Steinberg, PhD,
Director, Division of Extramural Activities,
National Institute of Mental Health, NIH,
Neuroscience Center, 6001 Executive Blvd.,
E:\FR\FM\10AUN1.SGM
10AUN1
Agencies
[Federal Register Volume 74, Number 152 (Monday, August 10, 2009)]
[Notices]
[Pages 39963-39964]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19010]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0366]
Office of Critical Path Programs--Critical Path Initiative
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 Office of Critical Path
Programs (OCPP). The goal of OCPP is to develop an administrative and
scientific infrastructure to support the creation and execution of a
series of projects under the FDA's Critical Path Initiative.
DATES: Important dates are as follows:
1. The application due date is September 7, 2009.
2. The anticipated start date is in September 2009.
3. The opening date is August 10, 2009.
4. The expiration date is September 8, 2009.
FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:
Nancy Stanisic, Office of Critical Path Programs (HF-18), rm.
14B45, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-1660.
Gladys M. Bohler, Grants Management Specialist, Office of
Acquisitions and Grants Services (HFA-500), Food and Drug
Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301-
827-7168.
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/oc/initiatives/criticalpath/.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Funding Opportunity Description Number: RFA FD-09-019
Catalog of Federal Domestic Assistance Number: 93.103
A. Background
The Critical Path Initiative, launched by FDA in 2004, has the
objective of helping modernize the development, evaluation,
manufacture, and use of FDA-regulated products. Through nationwide
collaboration with other Federal, academic, scientific, and industry
organizations, the initiative seeks to develop new tools to facilitate
innovation in FDA-regulated product development. Examples of tools
include novel biomarkers, laboratory assays, genetic tests, and state-
of-the art information technologies, etc. In this initiative, FDA plays
the role of a facilitator in the creation of partnerships and
collaborations to support specific scientific projects.
B. Research Objectives
FDA's Office of the Commissioner is announcing its intent to
accept and consider a single source application for the award of a
Cooperative Agreement to the Critical Path Institute (C-Path).
FDA anticipates providing up to $1.5 million (direct and indirect
costs combined) during fiscal year (FY) 2009 to support research and
related efforts of
[[Page 39964]]
identified projects that are part of the Critical Path Initiative.
This Cooperative Agreement ensures substantial FDA involvement in
this program, and will include, but will not be limited to, co-
development of study priorities, protocols, decisionmaking, reports,
and publications at specified program milestones related to
performance. FDA will support research covered by this document under
the authority of section 301 of the Public Health Service Act (42
U.S.C. 341). Administrative regulations found in 45 CFR parts 74 and/or
92 are applicable.
C. Eligibility Information
The following organization/institution is eligible to apply:
Critical Path Institute.
Competition is limited because of FDA's ongoing collaboration with
the University of Utah and the Critical Path Institute, in support of
FDA's Critical Path Initiative, and the combined ability of these
parties to leverage existing databases, specimen repositories,
clinical, and other technical expertise in support of this program.
II. Award Information/Funds Available
A. Award Amount
It is anticipated that FDA will fund this Cooperative Agreement up
to $1.5 million (direct and indirect costs) in FY 09 based on the
quality of the application received and the availability of Federal
funds.
B. Length of Support
Funding beyond the first year (up to 5 years) will be
noncompetitive and will depend on: (1) Satisfactory performance during
the preceding year and (2) the availability of Federal fiscal year
funds.
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/oc/initiatives/criticalpath/. 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: Gladys M. Bohler (see FOR FURTHER
INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT).
Dated: August 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19010 Filed 8-7-09; 8:45 am]
BILLING CODE 4160-01-P