12972 Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

David E. Berman, MD, for 3 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. Berman 

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. 

Dr. Berman was given notice of the 

proposed debarment and an opportunity 

to request a hearing within the 

timeframe prescribed by regulation. Dr. 

Berman failed to respond. Dr. Berman’s 

failure to respond constitutes a waiver 

of his right to a hearing concerning this 

action. 

DATES: This order is effective March 9, 

2011. 

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 (HFC–230), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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

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

permits FDA to debar an individual if it 

finds that the individual has been 

convicted of a misdemeanor under 

Federal law for conduct relating to the 

regulation of drug products under the 

FD&C Act and if FDA finds that the type 

of conduct that served as the basis for 

the conviction undermines the process 

for the regulation of drugs. 

On October 30, 2007, Dr. Berman 

pleaded guilty to a misdemeanor offense 

of the introduction into interstate 

commerce of a misbranded drug in 

violation of 21 U.S.C 331(a), 333(a)(1), 

and 352(i)(3), and judgment was entered 

against Dr. Berman by the U.S. District 

Court, Eastern District of Virginia. 

FDA’s finding that debarment is 

appropriate is based on the 

misdemeanor conviction referenced 

herein. The factual basis for the 

conviction is as follows: Dr. Berman is 

a medical doctor licensed by the 

Virginia Department of Health 

Professions, specializing in plastic 

surgery with an office in Sterling, VA. 

On or about January 16, 2004, and on or 

about February 16, 2004, Dr. Berman 

caused TRI-toxin, an unapproved 

botulinum toxin type A product, to be 

introduced into interstate commerce by 

causing Toxin Research International, 

Inc., to ship vials of TRI-toxin from 

Arizona to the Eastern District of 

Virginia. TRI-toxin was a misbranded 

drug in that Dr. Berman offered it for 

sale to, and used it on, thirty of his 

patients as BOTOX Cosmetic. Dr. 

Berman did not disclose to his patients 

that he was using a substitute, 

unapproved, unlicensed, and less 

expensive botulinum toxin type A 

product. TRI-toxin was not duly 

registered with the FDA and, therefore, 

the TRI-toxin is deemed misbranded. 

As a result of his convictions, on 

December 17, 2010, FDA sent Dr. 

Berman a notice by certified mail 

proposing to debar him for 3 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)(i)(I) of the FD&C Act, that 

Dr. Berman was convicted of a 

misdemeanor under Federal law for 

conduct relating to the regulation of 

drug products under the FD&C Act, and 

the conduct that served as a basis for the 

conviction undermines the process for 

the regulation of drugs. The proposal 

also offered Dr. Berman 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. Berman 

failed to respond within the timeframe 

prescribed by regulation and therefore 

has 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)(i)(I) 

of the FD&C Act, under authority 

delegated to him (Staff Manual Guide 

1410.35), finds that David E. Berman 

has been 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 that served as a basis for the 

conviction undermines the process for 

the regulation of drugs. 

As a result of the foregoing finding, 

Dr. Berman is debarred for 3 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 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 sections 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. Berman, in any capacity 

during Dr. Berman’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. Berman 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. Berman during his 

period of debarment (section 

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

Any application by Dr. Berman for 

termination of debarment under section 

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

identified with Docket No. FDA–2010– 

N–0473 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: February 16, 2011. 

Howard R. Sklamberg, 

Director, Office of Enforcement, Office of 

Regulatory Affairs. 

[FR Doc. 2011–5308 Filed 3–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Joint Meeting of the Nonprescription 

Drugs Advisory Committee and the 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 


Emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices 12973 

Name of Committees: 

Nonprescription Drugs Advisory 

Committee and the Pediatric Advisory 

Committee. 

General Function of the Committees: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 17, 2011, from 8 a.m. to 5 

p.m. and on May 18, 2011, from 8 a.m. 

to 12 noon. 

ADDRESSES: FDA is opening a docket for 

public comment on this meeting. The 

docket number is FDA–2011–N–0002. 

The docket will open for public 

comment on March 9, 2011. The docket 

will close on June 30, 2011. Interested 

persons may submit electronic or 

written comments regarding this 

meeting. Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management, Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments received will be posted 

without change, including any personal 

information provided. Submit a single 

copy of electronic comments or a paper 

copy of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this meeting 

notice. Received comments may be seen 

in the Division of Dockets Management 

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

through Friday. Comments received on 

or before May 3, 2011, will be provided 

to the committee before the meeting. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589– 

5200. 

Contact Person: Diem-Kieu Ngo, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., WO31–2417, Silver Spring, MD 

20993–0002, 301–796–9001, FAX: 301– 

847–8533, e-mail: 

diem.ngo@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On May 17 and 18, 2011, the 

committees will review pertinent 

pharmacokinetic (how drugs are 

absorbed, distributed, used, and 

eliminated by the body), safety and 

efficacy data, and discuss whether new 

dosing information for oral over-thecounter (OTC) drug products containing 

acetaminophen should be added to the 

label for children less than 2 years of 

age. In addition, the committees will 

consider adding a weight-based dosing 

regimen to the existing age-based dosing 

regimen for children 2 to 12 years of 

age. Dosing for children 12 years of age 

and older will not be discussed. Lastly, 

the committees will discuss ways that 

administration by caregivers can be 

improved so that medication errors can 

be minimized. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see the ADDRESSES section of 

this document) on or before May 3, 

2011, will be provided to the 

committees. Oral presentations from the 

public will be scheduled between 

approximately 3 p.m. and 5 p.m. on 

May 17, 2011. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before April 25, 

2011. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 26, 2011. 

FDA will work with sponsors of 

acetaminophen products who wish to 

make presentations to ensure that 

adequate time, separate from the 3 p.m. 

to 5 p.m. time slots for the general open 

public hearing, is provided. Sponsors 

interested in making formal 

presentations to the committees should 

notify the contact person on or before 

April 25, 2011. Sponsors with common 

interest are urged to coordinate their 

oral presentations. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Diem-Kieu 

Ngo at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5284 Filed 3–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Neurological Devices Panel of the 

Medical Devices Advisory Committee; 

Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of meeting of the 

Neurological Devices Panel of the 

Medical Devices Advisory Committee. 

This meeting was announced in the 

Federal Register of February 7, 2011 (76 

FR 6625). The amendment is being 


Emcdonald on DSK2BSOYB1PROD with NOTICES