21382 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on Monday, May 16, 2011, from 

8 a.m. to 3 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel’s telephone number is 301–589– 

5200. 

Contact Person: Walter Ellenberg, 

Office of Pediatric Therapeutics, Office 

of the Commissioner, Food and Drug 

Administration, Bldg. 32, rm. 5154, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 301–796–0885, 

e-mail: Walter.Ellenberg@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). Please call 

the 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 hot 

line/phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On May 16, 2011, the 

Pediatric Advisory Committee will meet 

to discuss pediatric-focused safety 

reviews, as mandated by the Best 

Pharmaceuticals for Children Act (Pub. 

L. 107–109) and the Pediatric Research 

Equity Act (Pub. L. 110–85) for Bepreve 

(bepotastine besliate), Besivance 

(besifloxacin hydrochloride), Cetraxal 

(ciprofloxacin hydrochloride), Patanase 

Spray (olopatadine hydrochloride), 

Astepro Spray (azelastine 

hydrocholoride), Crestor (rosuvastatin 

calcium), Welchol (colesevelam 

hydrochloride), Intuniv (guanfacine), 

Lexapro (escitalopram oxalate), Actonel 

(risedronate), Hiberix [Haemophilus b 

Conjugate Vaccine (Tetanus Toxoid 

Conjugate)], and Valcyte 

(valganciclovir). The committee will 

also receive further followup on Topical 

Calcineurin Inhibitors: Elidel 

(pimecrolimus) and Protopic 

(tacrolimus). 

The Pediatric Advisory Committee 

will hear and discuss the 

recommendation of the Pediatric Ethics 

Subcommittee from its meeting on May 

11, 2011, regarding the Institutional 

Review Board process for clinical 

investigations that involve both an FDA 

regulated product and research 

involving children as subjects that is 

conducted or supported by HHS. The 

announcement of the May 11, 2011, 

Pediatric Ethics Subcommittee of the 

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 committee. Written 

submissions may be made to the contact 

person on or before May 2, 2011. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making 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 25, 

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 26, 2011. 

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. 2011–9150 Filed 4–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0184] 

Pediatric Ethics Subcommittee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Pediatric Ethics 

Subcommittee of the Pediatric Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Pediatric 

Advisory Committee on FDA and 

certain Department of Health and 

Human Services regulatory issues. 

DATES: The meeting will be held on 

Wednesday, May 11, 2011, from 8 a.m. 

to 3 p.m. 

FDA is opening a docket to allow for 

additional public comments to be 

submitted to the Agency on the issues 

before the Pediatric Ethics 

Subcommittee. Submit either electronic 

or written comments by May 5, 2011. 

ADDRESSES: The meeting will be held at 

the North Marriott Hotel & Conference 

Center, 5701 Marinelli Rd., Bethesda, 

MD 20852. 

Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Contact Person: Walter Ellenberg, 

Office of the Commissioner, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, rm. 5154, 

Silver Spring, MD 20993–0002, 301– 

796–0885, or by e-mail: Walter.Ellenberg 

@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). Please call the 


srobinson on DSKHWCL6B1PROD with NOTICES
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