28050 Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–N–0377] (formerly 

Docket No. 2007N–0299) 

Allyn M. Norman; 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 act) debarring Dr. 

Allyn M. Norman for 5 years from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application. FDA bases 

this order on a finding that Dr. Norman 

was convicted of a misdemeanor under 

Federal law for conduct relating to the 

development or approval, including the 

process for development or approval, of 

a drug product or otherwise relating to 

the regulation of drug products under 

the act, and that the type of conduct that 

served as the basis for the conviction 

undermines the process for the 

regulation of drugs. Dr. Norman failed to 

request a hearing and, therefore, has 

waived his opportunity for a hearing 

concerning this action. 

DATES: This order is effective June 12, 

2009. 

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: 

Robert L. Hummel, Sr., Division of 

Compliance Policy (HFC–230), Office of 

Enforcement, Office of Regulatory 

Affairs, Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 240–632–6845. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On October 28, 2002, the U.S. District 

Court for the Western District of New 

York accepted Dr. Norman’s plea of 

guilty to one count of failure to maintain 

adequate and accurate records relating 

to the use of investigational new drugs, 

a Federal misdemeanor offense under 21 

U.S.C. 331(e) and 333(a)(1). On February 

5, 2003, the U.S. District Court for the 

Western District of New York entered a 

judgment of conviction against Dr. 

Norman for this offense. 

The basis of this conviction was Dr. 

Norman’s creation and submission of 

falsified study data in required reports 

to the sponsor of an investigational new 

drug application (IND) study, in 

violation of section 505(i) of the act (21 

U.S.C. 355(i)) and 21 CFR 312.62(a) and 

(b). Dr. Norman failed to conduct the 

study according to the approved 

protocol, reported the enrollment of 

nonexistent subjects in the study, and 

fabricated all of the pertinent study 

records associated with these subjects. 

Dr. Norman’s failure to comply with the 

requirements of the act and FDA 

regulations concerning the conduct of 

an IND study is the type of conduct that 

undermines confidence in the results of 

clinical studies that are relied on in the 

approval process for drug products. 

As a result of Dr. Norman’s 

conviction, FDA sent to Dr. Norman, by 

certified letter on October 10, 2007, a 

proposal to debar Dr. Norman for 5 

years from providing services in any 

capacity to a person that has an 

approved or pending drug product 

application. The letter also offered Dr. 

Norman notice of an opportunity for a 

hearing on the proposal in accordance 

with section 306 of the act (21 U.S.C. 

335a) and 21 CFR part 12. FDA based 

the debarment proposal on the findings, 

under section 306(b)(2)(B)(i)(I) of the 

act, that Dr. Norman was convicted of a 

misdemeanor under Federal law for 

conduct relating to the development or 

approval, including the process for 

development or approval, of a drug 

product or otherwise relating to the 

regulation of drug products under the 

act, and that the type of conduct which 

served as the basis for the conviction 

undermines the process for the 

regulation of drugs. The letter notified 

Dr. Norman that he had 30 days from 

the date of receipt of the letter to request 

a hearing. Dr. Norman did not request 

a hearing. His failure to request a 

hearing constitutes a waiver of his 

opportunity for a hearing and a waiver 

of any contentions concerning his 

debarment. 

II. Findings and Order 

Therefore, the Acting Director, Office 

of Enforcement, Office of Regulatory 

Affairs, under section 306(b)(2)(B)(i)(I) 

of the act and under authority delegated 

to the Acting Director (Staff Manual 

Guide 1410.35), finds that Dr. Allyn M. 

Norman has been convicted of a 

misdemeanor under Federal law for 

failure to maintain adequate and 

accurate records relating to the use of 

investigational new drugs, that Dr. 

Norman’s conduct relates to the 

development or approval, including the 

process for development or approval, of 

a drug product or otherwise relates to 

the regulation of drug products under 

the act, and that Dr. Norman’s conduct, 

which served as the basis for his 

conviction, is the type of conduct that 

undermines the process for the 

regulation of drugs. 

As a result of the foregoing findings, 

Dr. Norman is debarred for 5 years from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under sections 

505, 512, or 802 of the 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 

sections 306(c)(1)(B) and (c)(2)(A)(iii) 

and 201(dd) of the act (21 U.S.C. 

321(dd)). Any person with an approved 

or pending drug product application 

who knowingly uses the services of Dr. 

Norman, in any capacity, during his 

period of debarment, will be subject to 

civil money penalties (section 307(a)(6) 

of the act (21 U.S.C. 355b(a)(6))). If Dr. 

Norman, during his period of 

debarment, provides services in any 

capacity to a person with an approved 

or pending drug product application, he 

will be subject to civil money penalties 

(section 307(a)(7) of the act). In 

addition, FDA will not accept or review 

any abbreviated new drug applications 

submitted by or with the assistance of 

Dr. Norman during his period of 

debarment. 

Any application by Dr. Norman for 

termination of debarment under section 

306(d)(4) of the act should be identified 

with Docket No. FDA–2007–N–0377 

(formerly Docket No. 2007N–0299) 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: June 4, 2009. 

Alyson L. Saben, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. E9–13766 Filed 6–11–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; 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 the following meeting. 

Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Notices 28051 

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: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Progression of 

Gestational Diabetes to Type 2 Diabetes. 

Date: July 6, 2009. 

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

Agenda: To provide concept review of 

proposed concept review. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Room 5B01, Rockville, 

MD 20852 (Telephone Conference Call). 

Contact Person: Sathasiva B. Kandasamy, 

PhD, Scientific Review Administrator, 

Division of Scientific Review, National 

Institute of Child Health, and Human 

Development, 6100 Executive Boulevard, 

Room 5B01, Bethesda, MD 20892–9304, (301) 

435–6680, skandasa@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: June 4, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–13759 Filed 6–11–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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 of 

Child Health and Human Development 

Special Emphasis Panel; Extramural 

Associates Research Development Award 

(EARDA). 

Date: July 9, 2009. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Carla T. Walls, PhD, 

Scientific Review Administrator, Division of 

Scientific Review, National Institute of Child 

Health, and Human Development, NIH, 6100 

Executive Blvd., Room 5B01, Bethesda, MD 

20892, (301) 435–6898, wallsc@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: June 5, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–13760 Filed 6–11–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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 Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel; ARRA P30 Faculty 

Development Grants. 

Date: June 22, 2009. 

Time: 2:30 p.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Martin H. Goldrosen, PhD, 

Director, Office of Scientific Review, 

National Center for Complementary and 

Alternative Medicine, National Institutes of 

Health, 6707 Democracy Blvd., Ste., 106, 

Bethesda, MD 20892–5475, (301) 451–6331, 

goldrosm@mail.nih.gov. 

This notice is being published less than 15 

days prior to meeting due to scheduling 

conflicts. 

Name of Committee: National Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel; ARRA SEP 3P01/ 

3R01. 

Date: July 16, 2009. 

Time: 12 p.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Martina Schmidt, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Center for Complementary 

& Alternative Medicine, NIH, 6707 

Democracy Blvd., Suite 401, Bethesda, MD 

20892, 301–594–3456, 

schmidma@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.701, ARRA Related 

Biomedical Research and Research Support 

Awards.; 93.213, Research and Training in 

Complementary and Alternative Medicine, 

National Institutes of Health, HHS) 

Dated: June 5, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–13761 Filed 6–11–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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 Institute of 

Mental Health Special Emphasis Panel; 

ARRA—The Biomarkers of Autism at 12 

Months: From Brain Overgrowth to Genes. 

Date: June 18, 2009. 

Time: 8 p.m. to 9 p.m. 

Agenda: To review and evaluate grant 

applications.