9948 Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0528] 

International Conference on 

Harmonisation; Guidance on E7 

Studies in Support of Special 

Populations; Geriatrics; Questions and 

Answers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘E7 

Studies in Support of Special 

Populations: Geriatrics; Questions and 

Answers.’’ The guidance was prepared 

under the auspices of the International 

Conference on Harmonisation of 

Technical Requirements for Registration 

of Pharmaceuticals for Human Use 

(ICH). The questions and answers (Q&A) 

guidance addresses special 

considerations for the design and 

conduct of clinical trials of drugs likely 

to have significant use in the elderly. 

The Q&As are intended to provide 

guidance on the use of geriatric data to 

adequately characterize and represent 

the safety and efficacy of a drug for a 

marketing application, including data 

collected postmarketing. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002, or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance 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. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: 

Robert Temple, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4212, 

Silver Spring, MD 20993–0002 301– 

796–2270; or 

Nisha Jain, Center for Biologics 

Evaluation and Research (HFM–392), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–6110. 

Regarding the ICH: 

Michelle Limoli, Office of International 

Programs, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 32, rm. 3506, 

Silver Spring, MD 20993–0002, 301– 

796–4600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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 drug development 

among regulatory Agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products 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, Labour, 

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 (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of November 

10, 2009 (74 FR 58024), FDA published 

a notice announcing the availability of 

a draft guidance entitled ‘‘E7 Studies in 

Support of Special Populations: 

Geriatrics Questions & Answers.’’ The 

notice gave interested persons an 

opportunity to submit comments by 

January 11, 2010. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft of the guidance was 

submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory Agencies in July 

2010. 

The Q&A guidance addresses special 

considerations for the design and 

conduct of clinical trials of drugs that 

are likely to have significant use in the 

elderly. The Q&As are intended to 

provide guidance on the use of geriatric 

data to adequately characterize and 

represent the safety and efficacy of a 

drug for a marketing application, 

including data collected postmarketing. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, or http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Notices 9949 

Dated: February 14, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3955 Filed 2–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(Section 3506(c)(2)(A) of Title 44, 

United States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, email 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1984. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the Agency; (b) the accuracy of the 

Agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance 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. 

Proposed Project: Rural Health 

Information Technology Network 

Development (OMB No. 0915–xxxx) Ø 

[New] 

The purpose of the Rural Health 

Information Technology Network 

Development (RHITND) Program, 

authorized under the Public Health 

Service Act, Section 330A(f) (42 U.S.C. 

254c) as amended by Section 201, 

Public Law 107–251 of the Health Care 

Safety Net Amendments of 2002, is to 

improve health care and support the 

adoption of Health Information 

Technology (HIT) in rural America by 

providing targeted HIT support to rural 

health networks. HIT plays a significant 

role in the advancement of the 

Department of Health and Human 

Services’ (HHS) priority policies to 

improve health care delivery. Some of 

these priorities include: improving 

health care quality, safety, and 

efficiency, reducing disparities, 

engaging both patients and families in 

managing their health, enhancing care 

coordination, improving population and 

public health, and ensuring adequate 

privacy and security of health 

information. 

The intent of RHITND is to support 

the adoption and use of electronic 

health records (EHR) in coordination 

with the ongoing HHS activities related 

to the Health Information Technology 

for Economic and Clinical Health 

(HITECH) Act (Pub. L. 111–5). This 

legislation provides HHS with the 

authority to establish programs to 

improve health care quality, safety, and 

efficiency through the promotion of 

health information technology, 

including EHR. 

For this program, performance 

measures were drafted to provide data 

useful to the program and to enable 

HRSA to provide aggregate program data 

required by Congress under the 

Government Performance and Results 

Act (GPRA) of 1993 (Pub. L. 103–62). 

These measures cover the principal 

topic areas of interest to the Office of 

Rural Health Policy (ORHP), including: 

(a) Access to care; (b) the underinsured 

and uninsured; (c) workforce 

recruitment and retention; (d) 

sustainability; (e) health information 

technology; (f) network development; 

and (g) health-related clinical measures. 

Several measures will be used for this 

program. These measures will speak to 

ORHP’s progress toward meeting the 

goals set. 

The annual estimate of burden is as 

follows: 

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Rural Health Information Technology Network Development Program ................................................................... 41 1 41 4.12 168.92 

Total .............................................................................. 41 1 41 4.12 168.92 

Email comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–29, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 

Dated: February 14, 2012. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2012–3919 Filed 2–17–12; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2011–1074] 

Collection of Information Under 

Review by Office of Management and 

Budget 

AGENCY: Coast Guard, DHS. 

ACTION: Thirty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995 the 

U.S. Coast Guard is forwarding 

Information Collection Requests (ICRs), 

abstracted below, to the Office of 

Management and Budget (OMB), Office 

of Information and Regulatory Affairs 

(OIRA), requesting approval of a 

revision to the following collection of 

information: 1625–0010, Defect/ 

Noncompliance Report and Campaign 

Update Report. Our ICRs describe the 

information we seek to collect from the 

public. Review and comments by OIRA 

ensure we only impose paperwork 

burdens commensurate with our 

performance of duties. 

DATES: Comments must reach the Coast 

Guard and OIRA on or before March 22, 

2012. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number [USCG–2011–1074 to the 

Docket Management Facility (DMF) at 

the U.S. Department of Transportation 

(DOT) and/or to OIRA. To avoid 

mstockstill on DSK4VPTVN1PROD with NOTICES