67494 Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Notices 

mail address, and fax number) at least 

5 workdays before the public meeting 

date. We encourage you to register 

online at http://www.cfsan.fda.gov/- 

comm/register.html. or to fax your 

registration directly to Marion V. Allen 

at 301–436–2605. We will accept 

registrations onsite. Space is limited and 

registration will be closed when 

maximum seating capacity is reached 

(250 people). If you need special 

accommodations due to a disability, 

please notify Marion V. Allen at least 7 

workdays in advance. 

We encourage individuals or firms 

with relevant data or information to 

present such information at the meeting 

or in written comments to the record. If 

you would like to make oral comments 

at the meeting, please specify your 

interest in speaking when you register. 

The amount of time for each oral 

presentation will be limited to 5 

minutes. 

IV. Transcripts 

A transcript will be made of the 

proceedings of the meeting. You may 

request a copy of the meeting transcript 

in writing approximately 30 working 

days after the public meeting at a cost 

of 10 cents per page from: 

FDA: FDA’s Freedom of Information 

Office (HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

12A–16, Rockville, MD 20857; or 

FSIS: FSIS, Freedom of Information 

Office, USDA, 1400 Independence Ave., 

SW., Room 1140 South Building, 

Washington, DC 20250. 

The transcript of the public meeting 

and all comments submitted will be 

available for public examination at the 

Agencies’ Docket Offices (see 

ADDRESSES for locations and hours). 

V. Comments 

In addition to presenting oral 

comments at the public meeting, 

interested persons may submit written 

or electronic comments on the subject of 

this meeting and Federal Register notice 

to a joint agency docket housed at FSIS. 

FSIS: Submit comments by any of the 

following methods: Mail, including 

floppy disks or CD–ROMs, and hand- or 

courier-delivered items. 

Comments are to be identified by the 

Docket No. 05–013N. All comments 

submitted in response to this notice will 

be available for public inspection in the 

Agencies’ Docket offices and web sites. 

[See ADDRESSES section for location and 

hours]. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that the public and in particular 

minorities, women, and persons with 

disabilities, are aware of this notice, 

FSIS will announce it on-line through 

the FSIS Web page located at http:// 

www.fsis.usda.gov/regulations/ 

2005_Notices_Index/index.asp. 

FSIS also will make copies of this 

Federal Register publication available 

through the FSIS Constituent Update, 

which is used to provide information 

regarding FSIS policies, procedures, 

regulations, Federal Register notices, 

FSIS public meetings, recalls, and other 

types of information that could affect or 

would be of interest to our constituents 

and stakeholders. The update is 

communicated via Listserv, a free e-mail 

subscription service consisting of 

industry, trade, and farm groups, 

consumer interest groups, allied health 

professionals, scientific professionals, 

and other individuals who have 

requested to be included. The update 

also is available on the FSIS web page. 

Through Listserv and the web page, 

FSIS is able to provide information to a 

much broader, more diverse audience. 

In addition, FSIS offers an e-mail 

subscription service which provides an 

automatic and customized notification 

when popular pages are updated, 

including Federal Register publications 

and related documents. This service is 

available at http://www.fsis.usda.gov/ 

news_and_events/email_subscription/ 

and allows FSIS customers to sign up 

for subscription options across eight 

categories. Options range from recalls to 

export information to regulations, 

directives and notices. 

Customers can add or delete 

subscriptions themselves and have the 

option to password protect their 

account. 

Done in Washington DC on: November 2, 

2005. 

Jeffrey E. Shuren, 

Assistant Commissioner for Policy, Food and 

Drug Administration. 

Sean Altekruse, 

Deputy Executive Associate Administrator, 

OPPED, Food Safety Inspection Service. 

[FR Doc. 05–22123 Filed 11–3–05; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Women’s Health Initiative 

Observational 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, Office 

of the Director, the National Heart, 

Lung, and Blood Institute (NHLBI), 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: Women’s 

Health Initiative (WHI) Observational 

Study. Type of Information Collection 

Request: Revision OMB #0925–0414 

Exp: 04/06. Need for Use of Information 

Collection: This study will be used by 

the NIH to evaluate risk factors for 

chronic disease among older women by 

developing and following a large cohort 

of postmenopausal women and relating 

subsequent disease development to 

baseline assessments of historical, 

physical, psychosocial, and physiologic 

characteristics. In addition, the 

observational study will complement 

the clinical trial (which has received 

clinical exemption) and provide 

additional information on the common 

causes of frailty, disability and death for 

postmenopausal women, namely, 

coronary heart disease, breast and 

colorectal cancer, and osteoporotic 

fractures. Continuation of follow-up 

years for ascertainment of medical 

history update forms will provide 

essential data for outcomes assessment 

for this population of aging women. 

Frequency of Response: On occasion. 

Affected Public: Individuals and 

physicians. Type of Respondents: 

Women, next-of-kin, and physician’s 

office staff. The annual reporting burden 

is as follows: 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of responses per 

respondent 

Average burden 

hours per 

response 

Estimated total 

annual burden 

hours requested 

OS Participants ............................................................................................ 85,786 1 .21 18,195 

Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Notices 67495 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of responses per 

respondent 

Average burden 

hours per 

response 

Estimated total 

annual burden 

hours requested 

Next-of-kin .................................................................................................... 1,483 1 .0835 124 

Physician’s Office Staff ................................................................................ 4 1 .0835 .33 

Total ...................................................................................................... 87,273 ........................ .......................... 18,319 

The annualized cost burden to 

respondents is $290,230. There are no 

annual Capital Costs, Operating Costs 

and/or Maintenance Costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection is necessary for the 

proper performance of the function of 

the agency, including whether the 

information will have practical utility; 

(2) evaluate the accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) enhance the 

quality, utility, and clarity of the 

information to be collected; and (4) 

minimize the burden of the collection of 

information on those who are to 

respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

For Further Information Contact: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Dr. Linda Pottern, 

Project Officer, Women’s Health 

Initiative Program Office, National 

Institutes of Health, 6701 Rockledge 

Drive, 2 Rockledge Centre, Suite 8204, 

MSC 7935, Bethesda, MD 20892–7935, 

or call 301–402–2900 or E-mail your 

request, including your address to: 

potternl@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60-days of the date of 

this publication. 

Dated: October 28, 2005. 

Jacques Rossouw, 

NHLBI, WHI Project Officer, National 

Institutes of Health. 

[FR Doc. 05–22078 Filed 11–4–05; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Human 

Genome Research Institute Special Emphasis 

Panel, SEP (ZHG1 HGR N J1). 

Date: November 10, 2005. 

Time: 1:30 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Ken D. Nakamura, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, National Human Genome 

Research Institute, National Institutes of 

Health, 5635 Fishers Lane, Suite 4076, MSC 

9306, Rockville, MD 20852, 301–402–0838. 

Name of Committee: National Human 

Genome Research Institute Special Emphasis 

Panel, Design and Analysis RFA. 

Date: December 5–6, 2005. 

Time: 8:30 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Double Tree Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Rudy O. Pozzatti, PhD, 

Scientific Review Administrator, Office of 

Scientific Review, National Human Genome 

Research Institute, National Institutes of 

Health, Bethesda, MD 20892, 301 402–0838. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS) 

Dated: October 26, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–22076 Filed 11–04–05; 8:45am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel, Program 

Project. 

Date: December 1, 2005. 

Time: 3 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6101 

Executive Boulevard, Rockville, MD 20852, 

(Telephone Conference Call). 

Contact Person: Mark Swieter, PhD, Chief, 

Training and Special Projects Review Branch, 

Office of Extramural Affiars, National 

Institute on Drug Abuse, NIH, DHHS, 6101 

Executive Boulevard, Suite 220, Bethesda, 

MD 20892–8401, (301) 435–1389, 

ms80x@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878; 93.892, 93.893, National 

Institutes of Health, HHS)