79006 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 

pending drug product application under 

sections 505, 512, or 802 of the FD&C 

Act (21 U.S.C. 355, 360b, or 382), or 

under section 351 of the Public Health 

Service Act (42 U.S.C. 262), effective 

(see DATES), (see section 306(c)(1)(B), 

(c)(2)(A)(iii), and 201(dd) of the FD&C 

Act (21 U.S.C. 335a(c)(1)(B), 

(c)(2)(A)(iii), and 321(dd))). Any person 

with an approved or pending drug 

product application who knowingly 

employs or retains as a consultant or 

contractor, or otherwise uses the 

services of Dr. Akhigbe, in any capacity 

during Dr. Akhigbe’s debarment, will be 

subject to civil money penalties (section 

307(a)(6) of the FD&C Act (21 U.S.C. 

335b(a)(6))). If Dr. Akhigbe provides 

services in any capacity to a person with 

an approved or pending drug product 

application during his period of 

debarment he will be subject to civil 

money penalties (section 307(a)(7) of the 

FD&C Act). In addition, FDA will not 

accept or review any abbreviated new 

drug applications submitted by or with 

the assistance of Dr. Akhigbe during his 

period of debarment (section 

306(c)(1)(B) of the FD&C Act (21 U.S.C. 

335a(c)(1)(B)). 

Any application by Dr. Akhigbe for 

termination of debarment under section 

306(d)(4) of the FD&C Act should be 

identified with Docket No. FDA–2010– 

N–0235 and sent to the Division of 

Dockets Management (see ADDRESSES). 

All such submissions are to be filed in 

four copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). 

Publicly available submissions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: November 19, 2010. 

Howard R. Sklamberg, 

Director, Office of Enforcement, Office of 

Regulatory Affairs. 

[FR Doc. 2010–31776 Filed 12–16–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Council on Graduate Medical 

Education; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Council on Graduate Medical 

Education (COGME). 

Dates and Times: January 19, 2011, 

8:30 a.m.–4 p.m., January 20, 2011, 8:30 

a.m.–12:15 p.m. 

Place: Hilton Washington DC/ 

Rockville Executive Meeting Center, 

1750 Rockville Pike, Rockville, MD 

20852. Telephone: (301) 468–1100. 

Status: The meeting will be open to 

the public. 

Agenda: On the morning of January 

19, following welcoming remarks from 

the COGME Chair, HRSA senior 

management, and the Executive 

Secretary of COGME, there will be an 

introduction of COGME members. 

The rest of the first day will consist 

of presentations covering various 

aspects of graduate medical education, 

Bureau of Health Professions activities 

concerning health workforce issues, a 

study of primary care physician 

projections by state, and work of the 

Medicare Payment and Advisory 

Commission on GME issues. 

On January 20, there will be 

presentations on the findings and 

recommendations of COGME’s 20th 

report, Advancing Primary Care (cover 

date December 2010). It is expected that 

the rest of the morning will be taken up 

in discussions in exploring the topic for 

COGME’s next report. 

Agenda items are subject to change as 

priorities dictate. 

FOR FURTHER INFORMATION CONTACT: 

Anyone interested in obtaining a roster 

of members or other relevant 

information should write or contact 

Jerald M. Katzoff, Executive Secretary, 

COGME, Division of Medicine and 

Dentistry, Bureau of Health Professions, 

Parklawn Building, Room 9A–27, 5600 

Fishers Lane, Rockville, Maryland 

20857, Telephone (301) 443–4443. The 

Web address for information on the 

Council and the January 19–20, 2011 

meeting agenda is http://cogme.gov. 

Dated: December 9, 2010. 

Robert Hendricks, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–31712 Filed 12–16–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; TransfusionTransmitted Retrovirus and Hepatitis 

Virus Rates and Risk Factors: 

Improving the Safety of the U.S. Blood 

Supply Through Hemovigilance 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Heart, Lung, and Blood Institute 

(NHLBI), the National Institutes of 

Health (NIH) has submitted to the Office 

of Management and Budget (OMB) a 

request to review and approve the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on September 28, 2010, 

Volume 75, No. 187, pages 59724–59725 

and allowed 60 days for public 

comment. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a current valid 

OMB control number. 

Proposed Collection: Title: 

Transfusion-transmitted retrovirus and 

hepatitis virus rates and risk factors: 

Improving the safety of the U.S. blood 

supply through hemovigilance. Type of 

Information Collection Request: NEW. 

Need and Use of Information Collection: 

Information on current risk factors in 

blood donors as assessed using 

analytical study designs is largely 

unavailable in the U.S. Studies of risk 

factor profiles among HIV-infected 

donors were funded by the CDC for 

approximately 10 years after 

implementation of serologic screening 

in the mid-1980s, whereas studies of 

HTLV- and HCV-seropositive (and 

indeterminate) donors, funded by NIH, 

were conducted in the early 1990s, but 

unfortunately, none of these studies is 

ongoing. Infection trend analyses have 

been conducted by the American Red 

Cross (ARC). The findings show 

continued HIV risk with the prevalence 

of HIV in first time donors hovering 

around 10 per 100,000 donations in 

each of the last 10 years and the 

incidence in repeat donors increasing 

from 1.49 per 100,000 person-years in 

1999–2000 to 2.16 per 100,000 personsyears in 2007–2008. While the 

prevalence of HCV in first time donors 

decreased over this time interval from 

345 to 163 per 100,000 donations, the 

incidence in repeat donors did not 

decrease and evidence of incident 

infection in first time donors increased. 

Moreover specific age, gender and race/ 

ethnicity groups were over-represented. 

Significantly increased incidence of 

both HIV and HCV were observed in 

2007/2008 compared to 2005/2006. 

Similar analyses for HBV have shown 

an incidence in all donors of 3.4 per 

100,000 person-years which is lower 


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