Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices 18557 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Division of Compliance 

Policy (HFC–230), Office of 

Enforcement, Office of Regulatory 

Affairs, 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 June 18, 2008, Dr. Ruetschi 

pleaded guilty to a misdemeanor offense 

of receipt and delivery of a misbranded 

drug in interstate commerce in violation 

of 21 U.S.C. 331(c), 333(a)(1), and 352(f). 

On July 2, 2008, the U.S. District Court 

for the Central District of California 

entered judgment against Dr. Ruetschi 

for receipt in interstate commerce of 

misbranded drug and delivery thereof. 

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. Ruetschi 

was a licensed medical doctor in the 

State of California and maintained an 

office in Palm Desert, CA. Beginning on 

or about January 20, 2004, and 

continuing until on or about October 20, 

2004, Dr. Ruetschi began ordering from 

Toxin International, Inc., (TRI) an 

unapproved drug product represented to 

be a Botulinum Toxin Type A product 

(TRI-toxin). Specifically, Dr. Ruetschi 

placed 11 orders for a total of 11 vials 

of TRI-toxin, which was shipped in 

interstate commerce from Tucson, AZ to 

her office in Palm Desert, CA. Dr. 

Ruetschi subsequently administered the 

TRI-toxin to her patients for the 

treatment of facial wrinkles. The TRItoxin bore warnings that it was not for 

human use and did not bear any 

directions for human use, and was 

misbranded under 21 U.S.C. 352(f) in 

that it lacked adequate directions for 

use. 

As a result of her convictions, on 

January 5, 2011, FDA sent Dr. Ruetschi 

a notice by certified mail proposing to 

debar her for 5 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 (21 

U.S.C. 335a(b)(2)(B)(i)(I)), that Dr. 

Ruetschi 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. Ruetschi an opportunity 

to request a hearing, providing her 30 

days from the date of receipt of the letter 

in which to file the request, and advised 

her that failure to request a hearing 

constituted a waiver of the opportunity 

for a hearing and of any contentions 

concerning this action. Dr. Ruetschi 

failed to respond within the timeframe 

prescribed by regulation and has, 

therefore, waived her opportunity for a 

hearing and waived any contentions 

concerning her 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 Maja S. Ruetschi 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. Ruetschi 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 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. 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. Ruetschi, in any capacity 

during Dr. Ruetschi’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. Ruetschi provides 

services in any capacity to a person with 

an approved or pending drug product 

application during her period of 

debarment she 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. Ruetschi during her 

period of debarment (section 

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

Any application by Dr. Ruetschi for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2010– 

N–0474 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: March 23, 2011. 

Howard Sklamberg, 

Director, Office of Enforcement, Office of 

Regulatory Affairs. 

[FR Doc. 2011–7782 Filed 4–1–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0476] 

Marilyn A. Mehlmauer: 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 

Marilyn Mehlmauer, MD for 4 years 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application. FDA 

bases this order on findings that Dr. 

Mehlmauer 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. Mehlmauer 

was given notice of the proposed 

debarment and an opportunity to 

request a hearing within the timeframe 

prescribed by regulation. Dr. Mehlmauer 

failed to respond. Dr. Mehlmauer’s 

failure to respond constitutes a waiver 

of her right to a hearing concerning this 

action. 

DATES: This order is effective April 4, 

2011. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 


Emcdonald on DSK2BSOYB1PROD with NOTICES
18558 Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Division of Compliance 

Policy (HFC–230), Office of 

Enforcement, Office of Regulatory 

Affairs, 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 November 13, 2007, Dr. 

Mehlmauer pleaded guilty to a 

misdemeanor offense of Receipt in 

Interstate Commerce of Misbranded 

Drug and Delivery thereof in violation of 

21 U.S.C. 331(c), 333(a)(1), and 352(f). 

On November 13, 2007 the U.S. District 

Court, for the Central District of 

California entered judgment against Dr. 

Mehlmauer for misdemeanor 

misbranding. 

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. Mehlmauer 

was a physician with an office located 

in Pasadena, CA. In August 2003, Dr. 

Mehlmauer began ordering an 

unapproved drug product represented to 

be a Botulinum Toxin Type A drug 

product (TRI-toxin) manufactured by 

Toxin Research International, Inc. (TRI), 

located in Tucson, AZ. From on or 

about August 27, 2003, and continuing 

to on or about November 22, 2004, Dr. 

Mehlmauer placed 12 orders for a total 

of 26 vials of TRI-toxin, which she had 

shipped to her office. The TRI-toxin did 

not come with labeling or directions on 

how to dilute the product for injection, 

and therefore was misbranded under 21 

U.S.C. 352(f) in that it lacked adequate 

directions for use. The TRI-toxin label 

stated ‘‘for research purposes only’’ and 

‘‘not for human use.’’ Dr. Mehlmauer 

admitted to injecting the unapproved 

TRI-toxin into patients and on some 

occasions to representing to patients 

that the TRI-toxin was BOTOX®/ 

BOTOX® Cosmetic, at that time the only 

approved Botulinum Toxin Type A 

drug. Dr. Mehlmauer delivered and 

proffered for delivery the unapproved, 

misbranded TRI-toxin when she 

ordered, received, and administered it 

to other persons, all in violation of 21 

U.S.C. 331(c), 333(a)(1), and 352(f). 

As a result of her convictions, on 

January 19, 2011, FDA sent Dr. 

Mehlmauer a notice by certified mail 

proposing to debar her for 4 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. Mehlmauer 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. Mehlmauer an 

opportunity to request a hearing, 

providing her 30 days from the date of 

receipt of the letter in which to file the 

request, and advised her that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Dr. 

Mehlmauer failed to respond within the 

timeframe prescribed by regulation and 

has, therefore, waived her opportunity 

for a hearing and waived any 

contentions concerning her 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 Marilyn Mehlmauer 

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. Mehlmauer is debarred for 4 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 section 306(c)(1)(B), 

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

Act (21 U.S.C. 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. Mehlmauer, in any 

capacity during Dr. Mehlmauer’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. 

Mehlmauer provides services in any 

capacity to a person with an approved 

or pending drug product application 

during her period of debarment she 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. Mehlmauer during her period of 

debarment (section 306(c)(1)(B) of the 

FD&C Act). 

Any application by Dr. Mehlmauer for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2010– 

N–0476 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: March 23, 2011. 

Howard Sklamberg, 

Director, Office of Enforcement, Office of 

Regulatory Affairs. 

[FR Doc. 2011–7783 Filed 4–1–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2006–D–0464] (Formerly 

Docket No. 2006D–0331) 

Guidance for Institutional Review 

Boards, Clinical Investigators, and 

Sponsors: Exception From Informed 

Consent for Emergency Research; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Guidance for Institutional Review 

Boards, Clinical Investigators, and 

Sponsors: Exception from Informed 

Consent for Emergency Research.’’ This 

guidance is intended to assist 

institutional review boards (IRBs), 

clinical investigators, and sponsors in 

the development, conduct, and 

oversight of research involving FDAregulated products (e.g., drugs, 

biological products, devices) in 

emergency settings when an exception 

from the informed consent requirements 

is requested under the Code of Federal 

Regulations (CFR). FDA determined that 


Emcdonald on DSK2BSOYB1PROD with NOTICES