Federal Register / Vol. 74, No. 152 / Monday, August 10, 2009 / Notices 39963 

Study Questionnaire Number of 

respondents 

Frequency 

of 

response 

Average 

time 

response 

(Minutes) 

Annual hour 

burden 

Preference survey .................................................................................... 243 1 3/60 12.15 

Subtotal ............................................................................................. ........................ ........................ ........................ 789.65 

NCI validation and observational feeding study: 

Screener ................................................................................................... 100 1 3/60 5.00 

Reminder Telephone Call ......................................................................... 90 1 3/60 4.50 

Eating 3 meals .......................................................................................... 90 1 135/60 202.50 

Dietary Recall ........................................................................................... 80 1 30/60 40.00 

Demographics questionnaire .................................................................... 80 1 8/60 10.67 

Subtotal ............................................................................................. ........................ ........................ ........................ 262.67 

Total ................................................................................................... ........................ ........................ ........................ 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. 

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] 

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 http:// 

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 


rmajette on DSK29S0YB1PROD with NOTICES
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. 

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 http://www.fda.gov/oc/ 

initiatives/criticalpath/. Persons 

interested in applying for a grant may 

obtain an application at http:// 

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 http://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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Clinical Center; Notice of Meeting 

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. 

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 

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 

National Institute of Mental Health; 

Notice of Meeting 

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., 


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