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
Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices 18559 

guidance is needed in interpreting and 

complying with these regulations, 

particularly in the areas of planning and 

conducting community consultation 

and public disclosure activities, and the 

establishment of informed consent 

procedures to be used when feasible. 

The guidance announced in this notice 

finalizes the draft guidance of the same 

title, dated July 2006. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002 (1–888– 

463–6332 or 301–796–3400), or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448 (1–800–835–4709 or 

301–827–1800); or the Division of Small 

Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4613, 

Silver Spring, MD 20993 (1–800–638– 

2041 or 301–796–7100). Send one selfaddressed adhesive label to assist the 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Sara 

Goldkind, Office of Good Clinical 

Practice, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

Rm. 5129, Silver Spring, MD 20993– 

0002, 301–796–8340. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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 IRBs, clinical investigators, and 

sponsors in the development, conduct, 

and oversight of research involving 

FDA-regulated products (e.g., drugs, 

biological products, devices) in 

emergency settings when an exception 

from the informed consent requirements 

is requested under title 21 of the CFR 

(21 CFR 50.24). The exception applies to 

investigations to determine the safety 

and/or effectiveness of FDA-regulated 

products used in emergency settings 

(emergency research). These 

investigations involve human subjects 

who have a life-threatening medical 

condition (for which available 

treatments are unproven or 

unsatisfactory), and who, because of 

their condition (e.g., traumatic brain 

injury), cannot give informed consent. 

The research involves an investigational 

product that, to be effective, must be 

administered before informed consent 

from the subjects’ legally authorized 

representatives can be obtained. 

In the Federal Register of August 29, 

2006 (71 FR 51198), FDA announced the 

availability of the draft guidance of the 

same title, dated July 2006. The same 

Federal Register (71 FR 51143) 

announced a public hearing, held on 

October 11, 2006, on emergency 

research conducted without informed 

consent under FDA’s emergency 

research regulations. 

FDA received numerous comments on 

the draft guidance. All comments 

received during the comment period, 

questions received by Agency staff 

related to implementation of the 

regulations, and information presented 

at the public hearing have been 

carefully reviewed and, where 

appropriate, incorporated into the 

guidance. A summary of changes 

includes the following: (1) Additional 

discussion of the goals and purpose of 

community consultation and public 

disclosure, information that should be 

included, and how community 

consultation and public disclosure 

activities may be implemented; (2) 

clarification of ‘‘unproven’’ and 

‘‘unsatisfactory’’ with respect to 

available therapy; and (3) discussion of 

trial design issues (e.g., study endpoints, 

therapeutic window. This guidance 

incorporates comments received on 

earlier drafts of the guidance document, 

questions received by Agency staff 

related to implementation of the 

regulations, and information presented 

at the October 11, 2006, public meeting 

on emergency research studies. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 56 have been approved 

under OMB control number 0910–0130, 

the collections of information in 21 CFR 

part 312 have been approved under 

OMB control number 0910–0014, and 

the collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078. 

Modifications to these approved 

information collection requirements are 

underway or will be made at the time 

that each information collection is 

renewed. The Agency believes that this 

is appropriate because this guidance has 

only a minor impact on these existing 

collections of information. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/default.htm, or http:// 

www.regulations.gov. 

Dated: March 29, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7846 Filed 4–1–11; 8:45 am] 

BILLING CODE 4160–01–P 


Emcdonald on DSK2BSOYB1PROD with NOTICES