Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79005 

Dated: December 13, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31693 Filed 12–16–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0235] 

Ehigiator O. Akhigbe: Debarment 

Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Ehigiator O. Akhigbe, MD for 25 years 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application. We 

base this order on a finding that Dr. 

Akhigbe was convicted of 17 felonies for 

conduct involving fraud, false statement 

and falsification or destruction of 

records. Dr. Akhigbe was given notice of 

the proposed debarment and an 

opportunity to request a hearing within 

the timeframe prescribed by regulation. 

Dr. Akhigbe failed to respond. Dr. 

Akhigbe’s failure to respond constitutes 

a waiver of his right to a hearing 

concerning this action. 

DATES: This Order is effective December 

17, 2010. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Office of Regulatory 

Affairs, Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 240–632–6844. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(2)(B)(ii)(I) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(ii)(I)) 

permits FDA to debar an individual if it 

finds that the individual has been 

convicted of a felony which involves 

bribery, payment of illegal gratuities, 

fraud, perjury, false statement, 

racketeering, blackmail, extortion, 

falsification or destruction of records, or 

interference with, obstruction of an 

investigation into, or prosecution of, any 

criminal offense, and it finds, on the 

basis of the conviction and other 

information, that such individual has 

demonstrated a pattern of conduct 

sufficient to find that there is reason to 

believe that individual may violate 

requirements under the Act relating to 

drug products. 

On March 19, 2010, the United States 

District Court for the District of 

Columbia entered judgment against Dr. 

Akhigbe for one count of health care 

fraud in violation of 18 U.S.C. 1347, and 

16 counts of false statements in health 

care matters in violation of 18 U.S.C. 

1035. 

FDA’s finding that debarment is 

appropriate is based on the felony 

convictions referenced herein. The 

factual basis for those convictions is as 

follows: Dr. Akhigbe was a medical 

doctor with licenses to practice in the 

District of Columbia, Maryland, 

Pennsylvania, and Virginia. The District 

of Columbia Medicaid Program 

contracted with Amerigroup Corp. 

(Amerigroup) to act as its fiscal agent for 

the processing and payment of claims 

submitted by Medicaid providers. On or 

about December 6, 2001, Dr. Akhigbe 

entered into a Participating Physician 

Agreement with Amerigroup whereby 

he agreed to provide healthcare services 

to District of Columbia Medicaid 

beneficiaries. 

Dr. Akhigbe prepared and submitted 

his own billing to Amerigroup for 

medical services he purportedly 

provided to his patients. For each billed 

visit, Dr. Akhigbe or others acting at his 

direction, generated insurance claim 

forms which included his certification 

that all of the information on the claim 

forms was accurate. From on or about 

December 6, 2001, until the termination 

of his contract with Amerigroup on June 

24, 2004, Dr. Akhigbe submitted 

approximately 3,957 claims to 

Amerigroup for services he purportedly 

provided to Medicaid patients and 

sought approximately $807,347.00 from 

Amerigroup. 

Beginning in approximately December 

2002, and continuing to approximately 

May 2005, in the District of Columbia 

and elsewhere, Dr. Akhigbe knowingly, 

willfully, and with intent to defraud, 

executed a scheme and artifice to 

defraud Amerigroup as to material 

matters in connection with the delivery 

of any payment for health care benefits, 

items, and services, and to obtain 

money from Amerigroup by means of 

material false and fraudulent pretenses 

and representations and the 

concealment of material facts in 

connection with the delivery of and 

payment for health care benefits, items, 

and services. As part of his scheme, Dr. 

Akhigbe repeatedly prepared and 

submitted false claims in which he 

purported to have performed surgical or 

invasive medical procedures on District 

of Columbia Medicaid patients that 

were never performed, he billed for 

office visits that never occurred, and he 

continued to bill for a period of time 

after a minor or major procedure during 

which no additional bills could be 

submitted. In order to conceal from 

Amerigroup that he was billing for 

procedures that he had not performed, 

Dr. Akhigbe created false progress notes 

indicating the dates, times and medical 

procedures that he claimed to have 

performed and inserted the false 

progress notes into his patients’ medical 

files to corroborate a number of false 

claims. 

As a result of his convictions, on 

September 13, 2010, FDA sent Dr. 

Akhigbe a notice by certified mail 

proposing to debar him for 25 years 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application. The 

proposal was based on a finding, under 

section 306(b)(2)(B)(ii)(I) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(ii)(I)), that 

Dr. Akhigbe was convicted of felonies 

for conduct involving fraud, false 

statement and falsification or 

destruction of records and that Dr. 

Akhigbe has demonstrated a pattern of 

conduct sufficient to find that there is 

reason to believe that individual may 

violate requirements under the FD&C 

Act relating to drug products. The 

proposal also offered Dr. Akhigbe an 

opportunity to request a hearing, 

providing him 30 days from the date of 

receipt of the letter in which to file the 

request, and advised him that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Dr. 

Akhigbe failed to respond within the 

timeframe prescribed by regulation and 

has, therefore, waived his opportunity 

for a hearing and waived any 

contentions concerning his debarment 

(21 CFR part 12). 

II. Findings and Order 

Therefore, the Director, Office of 

Enforcement, Office of Regulatory 

Affairs, under Section 306(b)(2)(B)(ii)(I) 

of the FD&C Act (21 U.S.C. 

335a(b)(2)(B)(ii)(I)) under authority 

delegated to him (Staff Manual Guide 

1410.35), finds that Ehigiator O. 

Akhigbe has been convicted of felonies 

for conduct involving fraud, false 

statement and falsification or 

destruction of records. 

As a result of the foregoing finding, 

Dr. Akhigbe is debarred for 25 years 

from providing services in any capacity 

to a person with an approved or 


emcdonald on DSK2BSOYB1PROD with NOTICES
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 


emcdonald on DSK2BSOYB1PROD with NOTICES