Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices 14529 

Europe, Japan, and the United States 

without compromising the regulatory 

obligations of safety and effectiveness. 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for medical product 

development among regulatory 

Agencies. ICH was organized to provide 

an opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. ICH is concerned with 

harmonization among three regions: The 

European Union, Japan, and the United 

States. The six ICH sponsors are the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 

Health, Labor, and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations. The ICH 

Steering Committee includes 

representatives from each of the ICH 

sponsors and Health Canada, the 

European Free Trade Area, and the 

World Health Organization. The ICH 

process has achieved significant 

harmonization of the technical 

requirements for the approval of 

pharmaceuticals for human use in the 

three ICH regions. 

The current ICH process and structure 

can be found at the following Web site: 

http://www.ich.org. (FDA has verified 

the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

The agenda for the public meeting 

will be made available on the Internet 

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

NewsEvents/ucm291624.htm. 

Dated: March 6, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5857 Filed 3–9–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Arthritis 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: Arthritis 

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 9, 2012, from 8 a.m. to 5 

p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(rm. 1503), Silver Spring, MD 20993– 

0002. Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Philip Bautista, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, Bldg. 31, rm. 2417, Silver 

Spring, MD 20993–0002, 301–796–9001, 

FAX: (301) 847–8533, email: 

AAC@fda.hhs.gov, 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: The committee will discuss 

new drug application (NDA) 203214, 

tofacitinib tablets, Pfizer Inc., for the 

treatment of adult patients with 

moderately to severely active 

rheumatoid arthritis who have had an 

inadequate response to one or more 

disease-modifying anti-rheumatic drugs. 

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 25, 2012. 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 17, 

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 18, 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 Philip 

Bautista 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 


pmangrum on DSK3VPTVN1PROD with NOTICES
14530 Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices 

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 6, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–5818 Filed 3–9–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; New Proposed 

Collection; Comment Request; 

Environmental Science Formative 

Research Methodology Studies for the 

National Children’s Study 

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 Institute of Child Health and 

Human Development (NICHD), 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: Environmental Science 

Formative Research Methodology 

Studies for the National Children’s 

Study (NCS). Type of Information 

Collection Request: Generic Clearance. 

Need and Use of Information Collection: 

The Children’s Health Act of 2000 (Pub. 

L. 106–310) states: 

(a) Purpose.—It is the purpose of this 

section to authorize the National Institute of 

Child Health and Human Development* to 

conduct a national longitudinal study of 

environmental influences (including 

physical, chemical, biological, and 

psychosocial) on children’s health and 

development. 

(b) In General.—The Director of the 

National Institute of Child Health and 

Human Development* shall establish a 

consortium of representatives from 

appropriate Federal agencies (including the 

Centers for Disease Control and Prevention, 

the Environmental Protection Agency) to— 

(1) Plan, develop, and implement a 

prospective cohort study, from birth to 

adulthood, to evaluate the effects of both 

chronic and intermittent exposures on child 

health and human development; and 

(2) Investigate basic mechanisms of 

developmental disorders and environmental 

factors, both risk and protective, that 

influence health and developmental 

processes. 

(c) Requirement.—The study under 

subsection (b) shall— 

(1) Incorporate behavioral, emotional, 

educational, and contextual consequences to 

enable a complete assessment of the physical, 

chemical, biological, and psychosocial 

environmental influences on children’s wellbeing; 

(2) Gather data on environmental 

influences and outcomes on diverse 

populations of children, which may include 

the consideration of prenatal exposures; and 

(3) consider health disparities among 

children, which may include the 

consideration of prenatal exposures. 

To fulfill the requirements of the 

Children’s Health Act, the results of 

formative research will be used to 

maximize the efficiency (measured by 

scientific robustness, participant and 

infrastructure burden, and cost) of 

environmental sample collection 

procedures and technology, storage 

procedures, accompanying 

questionnaires, and assays, and thereby 

inform data collection methodologies 

for the National Children’s Study (NCS) 

Vanguard and Main Studies. With this 

submission, the NCS seeks to obtain 

OMB’s generic clearance to collect 

environmental samples from homes and 

child care settings, and conduct 

accompanying short surveys related to 

the physical and chemical environment. 

The NCS has obtained OMB’s generic 

clearance to conduct survey and 

instrument design and administration, 

focus groups, cognitive interviews, and 

health and social service provider 

feedback information collection 

surrounding outreach, recruitment and 

retention (OMB # 0925–0590; Expiration 

Date 9/30/2014). Under separate notice, 

the NCS is also requesting generic 

clearance to conduct formative research 

featuring biospecimen and physical 

measures (OMB # 0925–0647, 

Expiration Date 1/31/2015), 

neurodevelopmental (pending 

clearance), and study logistic (pending 

clearance) information collection. 

Separate and distinct generic clearances 

are requested to facilitate the efficiency 

of submissions and review of these 

projects as requested by the Office of 

Information and Regulatory Affairs. 

Background: 

The National Children’s Study is a 

prospective, national longitudinal study 

of the interaction between environment, 

genetics on child health and 

development. The Study defines 

‘‘environment’’ broadly, taking a 

number of natural and man-made 

environmental, biological, genetic, and 

psychosocial factors into account. By 

studying children through their 

different phases of growth and 

development, researchers will be better 

able to understand the role these factors 

have on health and disease. Findings 

from the Study will be made available 

as the research progresses, making 

potential benefits known to the public 

as soon as possible. The National 

Children’s Study is led by a consortium 

of federal partners: The U.S. Department 

of Health and Human Services 

(including the Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development and the National 

Institute of Environmental Health 

Sciences of the National Institutes of 

Health and the Centers for Disease 

Control and Prevention), and the U.S. 

Environmental Protection Agency. 

To conduct the detailed preparation 

needed for a study of this size and 

complexity, the NCS was designed to 

include a preliminary pilot study 

known as the Vanguard Study. The 

purpose of the Vanguard Study is to 

assess the feasibility, acceptability, and 

cost of the recruitment strategy, study 

procedures, and outcome assessments 

that are to be used in the NCS Main 

Study. The Vanguard Study begins prior 

to the NCS Main Study and will run in 

parallel with the Main Study. At every 

phase of the NCS, the multiple 

methodological studies conducted 

during the Vanguard phase will inform 

the implementation and analysis plan 

for the Main Study. 

In this request, the NCS is requesting 

generic approval from OMB for 

formative research activities relating to 

the collection, storage, management, 

and assay of environmental samples and 

accompanying questionnaires. The 

results from these formative research 

projects will inform the feasibility 

(scientific robustness), acceptability 

(burden to participants and study 

logistics) and cost of NCS Vanguard and 

Main Study environmental sample and 

information collection in a manner that 

minimizes public information collection 

burden compared to burden anticipated 

if these projects were incorporated 

directly into either the NCS Vanguard or 

Main Study. 

Frequency of Response: Annual [As 

needed on an on-going and concurrent 

basis]. Affected Public: Members of the 

public, researchers, practitioners, and 

other health professionals. Type of 

Respondents: Women of child-bearing 

age, fathers, public health and 

environmental science professional 

organizations and practitioners, and 

schools and child care organizations. 

These include both persons enrolled in 

the NCS Vanguard Study and their peers 

who are not participating in the NCS 

Vanguard Study. Annual reporting 

burden: See Table 1. The annualized 

cost to respondents is estimated at: 

$780,000 (based on $10 per hour). There 


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