14528 Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per 

response 

Total annual 

burden hours 

Performance measure reporting form (for private sector affected public) ...... 103 2 0.8 165 

Performance measure reporting form (for State, local, and tribal government 

affected public) ............................................................................................. 15 2 0.8 30 

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 195 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; 

(c) the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–5835 Filed 3–9–12; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Preparation for International 

Conference on Harmonization Steering 

Committee and Expert Working Group 

Meetings in Fukuoka, Japan; Regional 

Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

The Food and Drug Administration 

(FDA) is announcing a public meeting 

entitled ‘‘Preparation for ICH Steering 

Committee and Expert Working Group 

Meetings in Fukuoka, Japan’’ to provide 

information and receive comments on 

the International Conference on 

Harmonization (ICH) as well as the 

upcoming meetings in Fukuoka, Japan. 

The topics to be discussed are the topics 

for discussion at the forthcoming ICH 

Steering Committee Meeting. The 

purpose of the meeting is to solicit 

public input prior to the next Steering 

Committee and Expert Working Group 

meetings in Fukuoka, Japan, scheduled 

on June 2 through 7, 2012, at which 

discussion of the topics underway and 

the future of ICH will continue. 

DATES: Date and Time: The public 

meeting will be held on May 14, 2012, 

from 2 p.m. to 4 p.m. 

Location: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

Conference Center, the Great Room (rm. 

1503), Silver Spring, MD 20993. 

Information regarding visitor parking 

and transportation may be accessed at: 

http://www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm; under the heading 

‘‘Public Meetings at the White Oak 

Campus.’’ Please note that visitors to the 

White Oak Campus must enter through 

Building 1. 

Contact Person: All participants must 

register with Kimberly Franklin, Office 

of the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

FAX: 301–595–7937, email: Kimberly.

Franklin@fda.hhs.gov. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), written material, and requests 

to make oral presentations to the contact 

person (see Contact Person) by May 9, 

2012. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Public oral presentations will 

be scheduled between approximately 

3:30 p.m. and 4 p.m. Time allotted for 

oral presentations may be limited to 10 

minutes. Those desiring to make oral 

presentations should notify the contact 

person (see Contact Person) by May 9, 

2012, and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses, telephone 

number, fax, and email of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation. 

If you need special accommodations 

due to a disability, please contact 

Kimberly Franklin (see Contact Person) 

at least 7 days in advance. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://www.regulations.

gov. It may be viewed at the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD. A 

transcript will also be available in either 

hardcopy or on CD–ROM, after 

submission of a Freedom of Information 

request. Written requests are to be sent 

to Division of Freedom of Information 

(ELEM–1029), Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Bldg., Rockville, MD 20857. 

SUPPLEMENTARY INFORMATION: The ICH 

was established in 1990 as a joint 

regulatory/industry project to improve, 

through harmonization, the efficiency of 

the process for developing and 

registering new medicinal products in 


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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