Federal Register / Vol. 76, No. 75 / Tuesday, April 19, 2011 / Notices 21911 

in violation of 18 U.S.C. 1341 and 1346, 

adulterating a drug while held for sale, 

in violation of 21 U.S.C. 331(k) and 

333(a)(2), and misbranding a drug while 

held for sale, in violation of 21 U.S.C. 

331(k) and 333(a)(2). On December 11, 

2006, the U.S. District Court for the 

District of Idaho entered judgment 

against him. 

FDA’s finding that debarment is 

appropriate is based on the felony 

convictions referenced herein for 

conduct relating to the regulation of a 

drug product. The factual basis for those 

convictions is as follows: Dr. Wells was 

a physician licensed by the Idaho State 

Board of Medicine and he owned and 

operated the Skinovative Laser Center. 

Between late 2003 and early 2004, Dr. 

Wells attended training sponsored by 

TRI-toxin International (TRI), an 

Arizona corporation. During the TRI 

seminar he learned that the TRI 

Botulinum Toxin Type A (TRI-toxin) 

was not approved for use in humans. 

Beginning in February 2004, Wells 

began ordering TRI-toxin for use in 

treatments in human patients at his 

office. The TRI-toxin came with 

invoices and labels on the vials of toxin 

that stated the product was ‘‘for research 

purposes only, not for human use.’’ Dr. 

Wells mixed the TRI-toxin with 

BOTOX/BOTOX Cosmetic, causing the 

drug to become adulterated in violation 

of 21 U.S.C. 331(k) and 333(a)(2), and 

then he injected the mixture into 

patients, representing the injection as 

BOTOX/BOTOX Cosmetic. 

From February through November 

2004, Dr. Wells defrauded 

approximately 200 patients who 

received injection treatments intended 

to reduce wrinkles. Dr. Wells defrauded 

patients by representing and selling the 

Botulinum toxin mixture as BOTOX/ 

BOTOX Cosmetic. Patients injected with 

the Botulinum toxin mixture received 

pre-treatment consultations during 

which they were informed that they 

were receiving BOTOX/BOTOX 

Cosmetic and during which they were 

never informed that they would be 

injected with a Botulinum toxin mixture 

not approved for use in humans. 

Patients injected also signed a consent 

form entitled ‘‘Botox Consent form’’ and 

were told by Skinovative employees that 

they were receiving BOTOX/BOTOX 

Cosmetic. Patients who received the 

Botulinum toxin mixture were charged 

prices for treatments that were the same 

as, or similar to, patients who had 

received BOTOX/BOTOX Cosmetic. Dr. 

Wells misrepresentation of the 

Botulinum toxin mixture as BOTOX/ 

BOTOX Cosmetic resulted in the drug 

being misbranded in violation of 21 

U.S.C. 331(k) and 333(a)(2). 

As a result of his convictions, on 

November 22, 2010, FDA sent Dr. Wells 

a notice by certified mail proposing to 

permanently debar him 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(a)(2)(B) of the FD&C Act, that Dr. 

Wells was convicted of felonies under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. The proposal also offered Dr. 

Wells 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. Wells failed to respond 

within the timeframe prescribed by 

regulation and has, therefore, 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(a)(2)(B) of the 

FD&C Act, under authority delegated to 

him (Staff Manual Guide 1410.35), finds 

that Ivyl W. Wells has been convicted of 

a felony under Federal law for conduct 

relating to the regulation of a drug 

product under the FD&C Act. 

As a result of the foregoing finding, 

Dr. Wells is permanently debarred 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)(ii), (c)(2)(B), and section 

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. Wells in any 

capacity during Dr. Well’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. Wells 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. Wells during his 

period of debarment (section 

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

Any application by Dr. Wells for 

special termination of debarment under 

section 306(d)(4) of the FD&C Act 

should be identified with Docket No. 

FDA–2010–N–0407 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 28, 2011. 

Howard Sklamberg, 

Director, Office of Enforcement, Office of 

Regulatory Affairs. 

[FR Doc. 2011–9431 Filed 4–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–3318– 

EM; Docket ID FEMA–2011–0001] 

North Dakota; Amendment No. 1 to 

Notice of an Emergency Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of an emergency declaration for the 

State of North Dakota (FEMA–3318– 

EM), dated April 7, 2011, and related 

determinations. 

DATES: Effective Date: April 13, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Miller, Office of Response and 

Recovery, Federal Emergency 

Management Agency, 500 C Street, SW., 

Washington, DC 20472, (202) 646–3886. 

SUPPLEMENTARY INFORMATION: The notice 

of an emergency declaration for the 

State of North Dakota is hereby 

amended to include the following areas 

among those areas determined to have 

been adversely affected by the event 

declared an emergency by the President 

in his declaration of April 7, 2011. 

Grand Forks, Pembina, Walsh, and Ward 

Counties for emergency protective measures 

(Category B), limited to direct Federal 

assistance, under the Public Assistance 

program. 

The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund; 97.032, Crisis Counseling; 

97.033, Disaster Legal Services; 97.034, 

mstockstill on DSKH9S0YB1PROD with NOTICES

21912 Federal Register / Vol. 76, No. 75 / Tuesday, April 19, 2011 / Notices 

Disaster Unemployment Assistance (DUA); 

97.046, Fire Management Assistance Grant; 

97.048, Disaster Housing Assistance to 

Individuals and Households In Presidentially 

Declared Disaster Areas; 97.049, 

Presidentially Declared Disaster Assistance— 

Disaster Housing Operations for Individuals 

and Households; 97.050 Presidentially 

Declared Disaster Assistance to Individuals 

and Households—Other Needs; 97.036, 

Disaster Grants—Public Assistance 

(Presidentially Declared Disasters); 97.039, 

Hazard Mitigation Grant. 

W. Craig Fugate, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. 2011–9427 Filed 4–18–11; 8:45 am] 

BILLING CODE 9111–23–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form I–363; Extension of an 

Existing Information Collection; 

Comment Request 

ACTION: 60-Day Notice of Information 

Collection Under Review: Form I–363, 

Request to Enforce Affidavit of 

Financial Support and Intent To 

Petition for Custody for Public Law 97– 

359 Amerasian; OMB Control No. 1615– 

0022. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) will be 

submitting the following information 

collection request for review and 

clearance in accordance with the 

Paperwork Reduction Act of 1995. The 

information collection is published to 

obtain comments from the public and 

affected agencies. Comments are 

encouraged and will be accepted for 60 

days until June 20, 2011. 

During this 60-day period, USCIS will 

be evaluating whether to revise the 

Form I–363. Should USCIS decide to 

revise Form I–363 we will advise the 

public when we publish the 30-day 

notice in the Federal Register in 

accordance with the Paperwork 

Reduction Act. The public will then 

have 30 days to comment on any 

revisions to the Form I–363. 

Written comments and suggestions 

regarding items contained in this notice, 

and especially with regard to the 

estimated public burden and associated 

response time should be directed to the 

Department of Homeland Security 

(DHS), USCIS, Chief, Regulatory 

Products Division, Office of the 

Executive Secretariat, Clearance Officer, 

20 Massachusetts Avenue, NW., 

Washington, DC 20529–2020. 

Comments may also be submitted to 

DHS via facsimile to 202–272–0997 or 

via e-mail at rfs.regs@dhs.gov. When 

submitting comments by e-mail please 

add the OMB Control Number 1615– 

0022 in the subject box. 

Note: The address listed in this notice 

should only be used to submit comments 

concerning this information collection. 

Please do not submit requests for individual 

case status inquiries to this address. If you 

are seeking information about the status of 

your individual case, please check ‘‘My Case 

Status’’ online at: https://egov.uscis.gov/cris/ 

Dashboard.do, or call the USCIS National 

Customer Service Center at 1–800–375–5283. 

Written comments and suggestions 

from the public and affected agencies 

concerning the collection of information 

should address one or more of the 

following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(2) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

Extension of an existing information 

collection. 

(2) Title of the Form/Collection: 

Request to Enforce Affidavit of 

Financial Support and Intent to Petition 

for Custody for Public Law 97–359 

Amerasian. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: Form I–363, 

U.S. Citizenship and Immigration 

Services (USCIS). 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individuals or 

households. Form I–363 is used by 

applicants to ensure the financial 

support of a U.S. citizen. Without the 

use of Form I–363, the USCIS is not able 

to ensure the child does not become a 

public charge. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 50 responses at 30 minutes 

(0.50 hours) per response. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 25 annual burden hours. 

If you need a copy of the information 

collection instrument, please visit the 

Web site at: http:// 

www.regulations.gov/. 

We may also be contacted at: USCIS, 

Regulatory Products Division, Office of 

the Executive Secretariat, 20 

Massachusetts Avenue, NW., Room 

5012, Washington, DC 20529–2020, 

Telephone number 202–272–8377. 

Dated: April 14, 2011. 

Sunday A. Aigbe, 

Chief, Regulatory Products Division, Office 

of the Executive Secretariat, U.S. Citizenship 

and Immigration Services, Department of 

Homeland Security. 

[FR Doc. 2011–9437 Filed 4–18–11; 8:45 am] 

BILLING CODE 9111–97–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form I–765, Extension of an 

Existing Information Collection; 

Comment Request 

ACTION: 60-Day Notice of Information 

Collection Under Review: Form I–765, 

Application for Employment 

Authorization; OMB Control No. 1615– 

0040. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) will be 

submitting the following information 

collection request for review and 

clearance in accordance with the 

Paperwork Reduction Act of 1995. The 

information collection is published to 

obtain comments from the public and 

affected agencies. Comments are 

encouraged and will be accepted for 

sixty days until June 20, 2011. 

During this 60 day period, USCIS will 

be evaluating whether to revise the 

Form I–765. Should USCIS decide to 

revise Form I–765 we will advise the 

public when we publish the 30-day 

notice in the Federal Register in 

accordance with the Paperwork 

Reduction Act. The public will then 

have 30 days to comment on any 

revisions to the Form I–765. 

mstockstill on DSKH9S0YB1PROD with NOTICES