Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 11991 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center For Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Neurobiology of Addictions. 

Date: March 11, 2015. 

Time: 11:30 a.m. to 12:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Boris P. Sokolov, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5217A, 

MSC 7846, Bethesda, MD 20892, 301–408– 

9115, bsokolov@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Neurobiology of Psychiatric 

Disorders. 

Date: March 11, 2015. 

Time: 12:30 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Boris P. Sokolov, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5217A, 

MSC 7846, Bethesda, MD 20892, 301–408– 

9115, bsokolov@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflicts and Continuous Submissions. 

Date: March 25, 2015. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Olga A. Tjurmina, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4138, 

MSC 7814, Bethesda, MD 20892, (301) 451– 

1375, ot3d@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–13– 

009: Secondary Dataset Analyses in Heart, 

Lung, and Blood Diseases and Sleep 

Disorders. 

Date: March 26, 2015. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Melrose Georgetown Hotel, 2430 

Pennsylvania Avenue NW., Washington, DC 

20037. 

Contact Person: George Vogler, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3140, 

MSC 7770, Bethesda, MD 20892, (301) 237– 

2693, voglergp@csr.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) 

Dated: February 25, 2015. 

Carolyn Baum, 

Program Analyst. Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05005 Filed 3–4–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0302] 

Jeffrey L. Rockmore; Denial of 

Hearing; Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying a 

request for a hearing submitted by Dr. 

Jeffrey L. Rockmore, and is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) debarring Dr. 

Rockmore for 2 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. Rockmore 

was convicted of a misdemeanor under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act and that the type of conduct 

underlying the conviction undermines 

the process for the regulation of drugs. 

In determining the appropriateness and 

period of Dr. Rockmore’s debarment, 

FDA has considered the relevant factors 

listed in the FD&C Act. Dr. Rockmore 

has failed to file with the Agency 

information and analyses sufficient to 

create a basis for a hearing concerning 

this action. 

DATES: The order is effective March 5, 

2015. 

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: 

Nathan Doty, Office of Scientific 

Integrity, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–8556. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On August 11, 2009, in the U.S. 

District Court for the Northern District 

of New York, Dr. Rockmore, a 

physician, pled guilty to a misdemeanor 

under the FD&C Act, namely 

misbranding a drug in violation of 

sections 301(k), 502(i)(3) and 303(a)(1) 

of the FD&C Act (21 U.S.C. 331(k), 

352(i)(3), 333(a)(1)) and 18 U.S.C. 2. The 

basis for this conviction was conduct 

surrounding his injection of patients 

seeking treatment with BOTOX/BOTOX 

Cosmetic (BOTOX) with a product, TRItoxin, distributed by Toxin Research 

International, Inc. BOTOX is a 

biological product derived from 

Botulinum Toxin Type A that is 

manufactured by Allergan, Inc., and was 

approved by FDA for use on humans for 

the treatment of facial wrinkles in 1991. 

According to the records of the criminal 

proceedings, Dr. Rockmore’s colleague 

in the same medical practice, The 

Plastic Surgery Group (TPSG), directed 

a nurse to obtain 31 vials of TRI-toxin, 

an unapproved drug product, which 

was represented by its distributor as 

‘‘Botulinum Toxin Type A’’. Dr. 

Rockmore then proceeded to inject 

approximately 26 patients, who 

believed they were being injected with 

BOTOX, with TRI-toxin as a substitute. 

Dr. Rockmore is subject to debarment 

based on a finding, under section 

306(b)(2)(B)(i)(I) of the FD&C Act (21 

U.S.C. 335a(b)(2)(B)(i)(I)): (1) That he 

was convicted of a misdemeanor under 

Federal law relating to the regulation of 

a drug product under the FD&C Act and 

(2) that the type of conduct underlying 

the conviction undermines the process 

for the regulation of drugs. By notice to 

Dr. Rockmore dated November 30, 2010, 

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