Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 38449 

their annual registration using choices 

on the DRLM menu. Once you choose 

to register or update your annual 

registration the system will prompt you 

through the entry of information about 

your establishment and your devices. If 

you have any problems with this 

process, e-mail: reglist@cdrh.fda.gov or 

call 301–796–7400 for assistance. (Note: 

this e-mail address and this telephone 

number are for assistance with 

establishment registration only, and not 

for any other aspects of medical device 

user fees.) Problems with BER should be 

directed to bloodregis@fda.hhs.gov or 

call 301–827–3546. 

D. Step Four—Enter Your DFUF Order 

PIN and PCN 

After completing your annual or 

initial registration and device listing, 

you will be prompted to enter your 

DFUF order PIN and PCN, when 

applicable. This process does not apply 

to licensed biologic devices. CBER will 

send invoices for payment of the 

establishment registration fee to 

companies who only manufacture 

licensed biologics devices. Fees are only 

required for those establishments 

defined in section I of this document. 

Dated: July 28, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18456 Filed 7–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Meeting; Moving Into the 

Future—New Dimensions and 

Strategies for Women’s Health 

Research for the National Institutes of 

Health 

Notice is hereby given that the Office 

of Research on Women’s Health 

(ORWH), Office of the Director, National 

Institutes of Health, Department of 

Health and Human Services, in 

collaboration with the Warren Alpert 

Medical School of Brown University 

and the Women & Infants Hospital of 

Rhode Island, will convene a public 

hearing and scientific workshop on 

September 21–23, 2009, at the Women 

& Infants Hospital of Rhode Island 

Conference Center, Providence, Rhode 

Island. 

Purpose of the Meeting 

With rapid advances in science and 

wider global understanding of women’s 

health and sex/gender contributions to 

well-being and disease, the purpose of 

the meeting is to ensure that NIH 

continues to support cutting-edge 

women’s health research that is based 

upon the most advanced techniques and 

methodologies. The meeting format is 

designed to promote an interactive 

discussion involving leading scientists, 

advocacy groups, public policy experts, 

health care providers, and the general 

public. The Providence meeting is the 

third in a series that will be convened 

throughout the Nation to help the 

ORWH and NIH move into the next 

decade of women’s health research. 

As science and technology advance 

and fields such as computational 

biology demonstrate the power of 

interdisciplinary research, it remain 

critical for sex and gender factors to be 

integrated into broad experimental 

methodologies and scientific 

approaches across the lifespan. 

Biomedical and behavioral research are 

also necessary to understand how 

cultural, ethnic, and racial differences 

influence the causes, diagnosis, 

progression, treatment, and outcome of 

disease among different populations, 

including women of diverse geographic 

locations and socioeconomic 

backgrounds. Furthermore, health 

differences among diverse populations 

of women remain a critical area in need 

of continued focus and attention. 

The ORWH challenges all meeting 

attendees to assist the NIH in defining 

the women’s health research agenda of 

the future by thinking beyond 

traditional women’s health issues. The 

ORWH and NIH ask meeting 

participants to consider creative 

strategies to identify areas of research 

that are best poised for advancement, 

identify innovative ways in which 

persistent issues of health and disease 

can be addressed, and explore new 

horizons of scientific concepts and 

investigative approaches. Attention also 

needs to be paid to new areas of science 

application, new technologies, and 

continuing basic science investigations. 

Clinical questions that are not currently 

the focus of research priorities need to 

be considered to ensure that women’s 

health research is optimally served and 

that the ORWH can continue to provide 

leadership for the benefit of women’s 

health, nationally and internationally. 

Meeting Format 

The meeting will consist of public 

testimony, scientific panels, and eight 

concurrent scientific working groups. 

Specifically, on September 21, 

individuals representing a full spectrum 

of organizations interested in 

biomedical and behavioral research on 

women’s health issues will have an 

opportunity to provide public testimony 

from 1:30 to 5:30 p.m. On September 22 

and 23, plenary sessions will focus on 

the intersection of health care, public 

policy, and biomedical research; on 

emerging issues and trends in health 

care; and on research paradigms of the 

future. The eight concurrent afternoon 

sessions on September 22 will focus on 

a range of research areas, including 

Prenatal, Infancy, and Childhood Years; 

Adolescent Years; Reproductive and 

Middle Years; Pregnancy; Menopausal 

Transition; Elderly, Frail Elderly, and 

Healthy Aging; Oral Health and 

Systemic Conditions; and Careers in 

Dentistry, Bioengineering, and other 

Non-Medical Disciplines. 

On September 23 the morning session 

will be devoted to reports by the 

working group co-chairs regarding the 

recommendations emerging from 

working group deliberations on the 

previous day. The meeting will adjourn 

at 1:15 p.m. on September 23. 

Public Testimony 

The ORWH invites individuals with 

an interest in research related to 

women’s health to provide written and/ 

or oral testimony on these topics and/ 

or on issues related to the sustained 

advancement of women in various 

biomedical careers. Due to time 

constraints, only one representative 

from an organization or professional 

specialty group may give oral testimony. 

Individuals not representing an 

organized entity but a personal point of 

view are similarly invited to present 

written and/or oral testimony. A letter 

of intent to present oral testimony is 

necessary and should be sent 

electronically to http:// 

www.orwhmeetings.com/ 

movingintothefuture/ or by mail to Ms. 

Jory Barone, Educational Services, Inc., 

4350 East-West Highway, Suite 1100, 

Bethesda, MD 20814, no later than 

September 13, 2009. The date of receipt 

of the communication will establish the 

order of those selected to give oral 

testimony at the September meeting. 

Those wishing to present oral 

testimony are also asked to submit a 

written form of their testimony that is 

limited to a maximum of 10 pages, 

double spaced, 12-point font, and 

should include a brief description of 

their organization. Electronic 

submission to the above Web site is 

preferred; however, for those who do 

not have access to electronic means, 

written testimony, bound by the 

restrictions previously noted and 

postmarked no later than September 13, 

2009, can be mailed to Ms. Jory Barone 

at the above address. All written 

presentations must meet the established 


sroberts on DSKD5P82C1PROD with NOTICES
38450 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 

page limitations. Submissions exceeding 

this limit will not be accepted and will 

be returned. Oral testimony of this 

material at the meeting will be limited 

to no more than 5–6 minutes in length. 

Because of time constraints for oral 

testimony, testifiers may not be able to 

present the complete information as it is 

contained in their written form 

submitted for inclusion in the public 

record for the meeting. Therefore, 

testifiers are requested to summarize the 

major points of emphasis from the 

written testimony, not to exceed 6 

minutes of oral testimony. Those 

individuals or organizations that have 

indicated they will present oral 

testimony at the meeting in Providence 

will be notified prior to the meeting 

regarding the approximate time for their 

oral presentation. 

Individuals and organizations wishing 

to provide written statements only 

should send a copy of their statements, 

electronically or by mail, to the above 

Web site or address by September 13, 

2009. Written testimony received by 

that date will be made available at the 

September 21–23 meeting. Logistics 

questions related to this meeting should 

be addressed to Ms. Jory Barone at ESI, 

while program-specific questions 

should be addressed to Ms. Maureen 

Pearlman at the Warren Alpert Medical 

School of Brown University, 

Providence, Rhode Island, 401–276– 

7800, ext. 123, mpearlman@wihri.org. 

At the conclusion of the regional 

meetings, the ORWH will hold a 

meeting at the NIH to summarize the 

deliberations from the regional 

conferences. The resulting report to the 

ORWH and the NIH will ensure that 

women’s health research in the coming 

decade continues to support a vigorous 

research agenda incorporating the latest 

advances in technology and cuttingedge science. 

Dated: July 28, 2009. 

Raynard S. Kington, 

Acting Director, National Institutes of Health. 

[FR Doc. E9–18535 Filed 7–31–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

President’s Cancer Panel. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: President’s Cancer 

Panel. 

Date: September 22, 2009. 

Time: 8 a.m. to 4:10 p.m. 

Agenda: America’s Demographic and 

Cultural Transformation: Implications for the 

Cancer Enterprise. 

Place: The Westin Seattle, 1900 Fifth 

Avenue, Seattle, WA 98101. 

Contact Person: Abby B. Sandler, PhD, 

Executive Secretary, Chief, Institute Review 

Office, Office of the Director, 6116 Executive 

Blvd., Suite 220, MSC 8349, National Cancer 

Institute, NIH, Bethesda, MD 20892–8349. 

(301) 451–9399. sandlera@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: 

deainfo.nci.nih.gov/advisory/pcp/pcp.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: July 28, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–18531 Filed 7–31–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Council for 

Biomedical Imaging and Bioengineering. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the 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/or contract proposals 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 and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council for Biomedical Imaging and 

Bioengineering. NACBIB, September 2009. 

Date: September 11, 2009. 

Open: 9 a.m. to 1 p.m. 

Agenda: Report from the Institute Director, 

other Institute Staff and presentations of 

working group reports. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Closed: 1 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Anthony Demsey, PhD, 

Director, National Institute of Biomedical 

Imaging, and Bioengineering, 6701 

Democracy Boulevard, Room 241, Bethesda, 

MD 20892. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nibib1.nih.gov/about/NACBIB/ 

NACBIB.htm, where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.701, ARRA Related 

Biomedical Research and Research Support 

Awards. National Institutes of Health, HHS) 

Dated: July 28, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–18529 Filed 7–31–09; 8:45 am] 

BILLING CODE 4140–01–P 


sroberts on DSKD5P82C1PROD with NOTICES