Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices 19673 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Pediatric Advisory Committee; 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 

Advisory Committee. 

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 May 7, 2012, from 8 a.m. to 5:30 

p.m. and May 8, 2012, from 8:30 a.m. to 

11:30 a.m. 

Location: Hilton Rockville Executive 

Meeting Center, 1750 Rockville Pike, 

Rockville, MD 20852. 

Contact Person: Walter Ellenberg, 

Office of Pediatric Therapeutics, Office 

of the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 5154, Silver Spring, 

MD 20993, 301–796–0885, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

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 7, 2012, the 

Pediatric Advisory Committee will meet 

to discuss pediatric-focused safety 

reviews, as mandated by the Best 

Pharmaceuticals for Children Act and 

the Pediatric Research Equity Act, for 

Differin Lotion (adapalene), Dulera 

Inhalation Aerosol (mometasone furoate 

and formotorol fumarate), MultiHance 

Injection (gadobenate dimeglumine), 

Nasonex (mometasone furoate 

monohydrate), Natazia (estradiol 

valerate and estradiol valerate/ 

dienogest), Omnaris Nasal Spray 

(ciclesonide), Protonix (pantoprazole), 

Tamiflu (oseltamivir phosphate), 

Taxotere (docetaxel) and Viread 

(tenofovir disoproxil fumarate). The 

committee will also receive an 

Informational Update on FDA’s KidNet 

pilot study. 

On May 8, 2012, the Pediatric 

Advisory Committee will meet 

regarding the pediatric-focused safety 

reviews, as mandated by the Pediatric 

Research Equity Act, for Gardasil 

Human Papillomavirus Quadrivalent 

(Types 6, 11, 16, 18) Vaccine, 

Recombinant, Isopto Carpine 

(pilocarpine hydrochloride), Menveo 

Meningococcal (Group A,C,Y, and W– 

135) Oligosaccharide Diphtheria 

CRM197 Conjugate Vaccine, Zylet 

(loteprednol etabonate and tobramycin) 

and Zymaxid (gatifloxacin). 

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 April 30, 2012. Oral 

presentations from the public will be 

scheduled between approximately 11:30 

a.m. and 12:30 p.m. on May 7, 2012. 

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 20, 2012. 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 23, 2012. 

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: March 23, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7765 Filed 3–30–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Generic Clearance To 

Conduct Voluntary Customer/Partner 

Surveys 

SUMMARY: In compliance with the 

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

the Paperwork Reduction Act of 1995 to 

provide opportunity for public comment 

on proposed data collection projects, the 

National Library of Medicine (NLM), the 

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: Generic 

Clearance to Conduct Voluntary 

Customer/Partner Surveys; Type of 

Information Collection Request: 

Extension of currently approved 

collection [OMB No. 0925–0476, 

expiration date 06/30/2012], Form 

Number: NA; Need and Use of 

Information Collection:: Executive 

Order 12962 directed agencies that 

provide significant services directly to 

the public to survey customers to 

determine the kind and quality of 

services they want and their level of 

satisfaction with existing services. 

Additionally, since 1994, the NLM has 

been a ‘‘Federal Reinvention 

Laboratory’’ with a goal of improving its 

methods of delivering information to the 

public. An essential strategy in 

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