18556 Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices 

administrative, provider, and customer 

services process. 

• Facilitate plans for IT Integration of 

data resources and data services. 

• Coordinate policy analysis, 

development and execution for CMS. 

• Build and maintain agency capacity 

to perform analysis of regional variation 

in the quality and cost of care. 

• Conduct and manage surveys to 

capture information about beneficiary 

populations that our programs serve that 

is not available in the administrative 

data. This includes the Medicare 

Current Beneficiary Survey (MCBS) and 

the Medicare Health Outcomes Survey 

(HOS). 

• Conduct and manage the Research 

Data Assistance Center (RESDAC), 

Research Data Distribution Center 

(RDDC) and Chronic Condition 

Warehouse (CCW) activities. 

• Operationalize research-usable files 

for Medicare, Medicaid, and CHIP 

administrative data. 

Dated: March 24, 2011. 

Marilyn Tavenner, 

Principal Deputy Administrator and Chief 

Operating Officer, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–7903 Filed 4–1–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Reunification Procedures for 

Unaccompanied Alien Children. 

OMB No.: 0970–0278. 

Description: Following the passage of 

the 2002 Homeland Security Act (Pub. 

L. 107–296), the Administration for 

Children and Families (ACF), Office of 

Refugee Resettlement (ORR), is charged 

with the care and placement of 

unaccompanied alien children in 

Federal custody, and implementing a 

policy for the release of these children, 

when appropriate, upon the request of 

suitable sponsors while awaiting 

immigration proceedings. In order for 

ORR to make determinations regarding 

the release of these children, the 

potential sponsors must meet certain 

conditions pursuant to section 462 of 

the Homeland Security Act and the 

Flores v. Reno Settlement Agreement 

No. CV85 4544–RJK (C.D. Cal. 1997). 

The proposed information collection 

requests information to be utilized by 

ORR for determining the suitability of a 

sponsor/respondent for the release of a 

minor from ORR custody. The proposed 

instruments are the Sponsors Agreement 

to Conditions of Release, Verification of 

Release, Family Reunification Packet, 

and the Authorization for Release of 

Information. 

Respondents: Sponsors requesting 

release of unaccompanied alien. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Verification of Release (UAC) .......................................................................... 4,595 1 0.25 1,148.75 

Authorization for Release of Information (Sponsor) ........................................ 4,595 1 0.25 1,148.75 

Family Reunification Packet (Sponsor) ........................................................... 4,595 1 1 4,595 

Sponsors Agreement to Conditions of Release (Sponsor) ............................. 4,595 1 0.25 1,148.75 

Verification of Release (Case Worker) ............................................................ 4,595 1 0.25 1,148.75 

Authorization for Release of Information (Case Worker) ................................ 4,595 1 0.25 

Family Reunification Packet (Case Worker) .................................................... 4,595 1 1 4,595 

Sponsors Agreement to conditions of Release (Case Worker) ...................... 4,595 1 0.25 1,148.75 

Estimated Total Annual Burden 

Hours: 16,082.50. 

Additional Information: 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7285, 

E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: March 29, 2011. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–7823 Filed 4–1–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0474] 

Maja S. Ruetschi: 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 

Maja S. Ruetschi, MD 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 findings that Dr. Ruetschi 

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. Ruetschi was given notice of the 

proposed debarment and an opportunity 

to request a hearing within the 

timeframe prescribed by regulation. Dr. 

Ruetschi failed to respond. Dr. 

Ruetschi’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– 


Emcdonald on DSK2BSOYB1PROD with NOTICES
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