Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 21383 

Information Line for up-to-date 

information on this meeting. A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site and call the 

appropriate advisory committee hotline/ 

phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On May 11, 2011, the 

Pediatric Ethics Subcommittee of the 

Pediatric Advisory Committee will meet 

to discuss the general topic of the ethics 

of administering subtherapeutic doses of 

investigational products to children for 

the purpose of determining, for 

example, drug metabolism, disposition, 

and targeting (e.g., exploratory 

investigational new drug (IND) studies). 

In this context, the subcommittee will 

also discuss the referral of such 

protocols by an Institutional Review 

Board for review by a Federal panel 

under 21 CFR 50.54. 

The subcommittee’s 

recommendations will then be 

presented to the FDA Pediatric Advisory 

Committee on Monday, May 16, 2011. 

The announcement of the May 16, 2011, 

Pediatric Advisory Committee meeting 

can be found elsewhere in this issue of 

the Federal Register. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the subcommittee. Written 

submissions may be made to the contact 

person on or before April 28, 2011. Oral 

presentations from the public will be 

scheduled between approximately 

11 a.m. and 12 noon on May 11, 2011. 

Those desiring to make formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before April 20, 

2011. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 21, 2011. 

Comments: FDA is opening a docket 

to allow for additional public comments 

to be submitted to the Agency on issues 

before the Pediatric Ethics 

Subcommittee beginning April 15, 2011, 

and closing May 5, 2011. All comments 

received on or before May 5, 2011, will 

be provided to the committee members. 

All comments received after May 5, 

2011, will be taken into consideration 

by the Agency. Interested persons are 

encouraged to use the docket to submit 

either electronic or written comments 

regarding this meeting (see ADDRESSES). 

Submit electronic comments to http:// 

www.regulations.gov. Submit written 

comments to Division of Dockets 

Management (see ADDRESSES). It is 

necessary to submit only 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. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Walter 

Ellenberg at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(5 U.S.C. app. 2). 

Dated: April 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9149 Filed 4–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Food Reporting Comparison 

Study (FORCS) and Food and Eating 

Assessment Study (FEAST) (NCI) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI), 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: Food 

Reporting Comparison Study (FORCS) 

and Food and Eating Assessment Study 

(FEAST) (NCI). Type of Information 

Collection Request: Extension. Need and 

Use of Information Collection: The title 

of this collection was previously, ‘‘24- 

hour Dietary Recall Method Comparison 

and the National Cancer Institute (NCI) 

Observational Feeding Studies.’’ The 

objective of the two studies is to 

compare the performance of the newly 

developed computerized Automated 

Self-Administered 24-Hour Recall 

(ASA24) approach to collecting 24 hour 

recall (24HR) data with the current 

standard, the interviewer-administered 

Automated Multiple Pass Method 

(AMPM). The ultimate goal is to 

determine to what extent the new 

automated instrument can be used 

instead of the more expensive 

interviewer-administered instrument in 

the collection of dietary intake data. 

Frequency of Response: Twice. Affected 

Public: Individuals. Type of 

Respondents: For the FORCS study, 

approximately 1,200 adult members 

from three health maintenance 

organization plans (in Minnesota, 

California, and Michigan) between ages 

20 and 70 years. For the FEAST study, 

approximately 90 adult residents from 

the Washington, DC metropolitan area 

between ages 20 and 70 years. The 

annual reporting burden is estimated at 

866 hours (see table below). This 

amounts to an estimated 2,598 burden 

hours over the 3-year data collection 

period with a total cost to the 

respondents of $54,293. There are no 

Capital costs, Operating costs, and/or 

Maintenance Costs to report. 


srobinson on DSKHWCL6B1PROD with NOTICES
21384 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 

Participants and study Questionnaire Number of 

respondents 

Frequency of 

response 

Average time 

per response 

minutes/hour 

Annual 

hour 

burden 

General Public for FORCS ... Refusal Reasons and Demographics (Attach 4A, Screen 8).1,770 1 5/60 (0.083) 148 

Contact Information (Attach 4A, 

Screen 5).

400 1 5/60 (0.083) 33 

Screener (Attach 5) ....................... 400 1.00 5/60 (0.083) 33 

AMPM (Attach 1) .......................... 400 1.00 30/60 (0.50) 200 

ASA24 (Attach 2) .......................... 400 1.00 30/60 (0.50) 200 

Demographics and Health Questionnaire (Attach 6).360 1.00 10/60 (0.167) 60 

Demographics, Health and Preference Questionnaire (Attach 7).360 1.00 15/60 (0.25) 90 

General Public for FEAST .... Screener (Attach 8) ....................... 33 1.00 5/60 (0.083) 6 

Reminder Telephone Call (Attach 

10).

33 1.00 5/60 (0.083) 6 

Eating 3 meals .............................. 33 1.00 135/60 (2.25) 151 

Either AMPM or ASA24 (Attach 1 

or 2).

33 1.00 30/60 (0.50) 34 

Demographics and Health Questionnaire (Attach 12).33 1.00 10/60 (0.167) 11 

....................................................... 3,485 ............................ ............................ 866 

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 proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; (2) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

FOR FURTHER INFORMATION CONTACT: 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 60-days of this 

publication. 

Dated: April 8, 2011. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2011–9204 Filed 4–14–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of 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 Council 

of Councils. 

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: Council of Councils. 

Date: June 29, 2011. 

Open: 8:30 a.m. to 12:30 p.m. 

Agenda: Call to Order and Introductions; 

Announcements and Future Meeting Dates; 

DPCPSI Update; Remarks by the Director, 

NIH; and Review of NIH Common Fund 

Initiative Concepts: Process and Criteria. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 6, Bethesda, MD 20892. 

Closed: 1:30 p.m. to 2:20 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 6, Bethesda, MD 20892. 

Open: 2:20 p.m. to 5:30 p.m. 

Agenda: Overall Discussion & 

Recommendations and Closing Remarks. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 6, Bethesda, MD 20892. 

Contact Person: Robin Kawazoe, Executive 

Secretary, Division Of Program Coordination, 

Planning, And Strategic Initiatives, Office Of 

The Director, NIH, Building 1, Room 260B, 

Bethesda, MD 20892. 

kawazoer@mail.nih.gov. 

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. 

Information is also available on the Council 

of Council’s home page at http:// 

dpcpsi.nih.gov/council/, where an agenda 

and proposals to be discussed will be posted 

before the meeting date. 

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, 


srobinson on DSKHWCL6B1PROD with NOTICES