Federal Register / Vol. 62, No. 47 / Tuesday, March 11, 1997 / Notices 11213

provided substantial assistance in the

investigations or prosecutions of

offenses relating to a matter under

FDA’s jurisdiction, and that special

termination of Dr. Shah’s debarment

serves the interest of justice and does

not threaten the integrity of the drug

approval process.

EFFECTIVE DATE: March 11, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Diane Sullivan-Ford, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In a

Federal Register notice dated December

5, 1994 (59 FR 62399), Dr. Atul Shah,

the former Director of Analytical

Research and Development at Par

Pharmaceutical, Inc. (Par), was

permanently debarred from providing

services in any capacity to a person with

an approved or pending drug product

application (21 U.S.C. 335a(c)(1)(B) and

(c)(2)(A)(ii) and 21 U.S.C. 321(dd)). The

debarment was based on FDA’s finding

that Dr. Shah was convicted of a felony

under Federal law for conduct relating

to the development, or approval of any

drug product, or otherwise relating to

the regulation of a drug product (21

U.S.C. 335a(a)(2)). On March 30, 1995,

Dr. Shah applied for special termination

of debarment, under section 306(d)(4) of

the act (21 U.S.C. 335a(d)(4)), as

amended by the Generic Drug

Enforcement Act.

Under section 306(d)(4)(C) and

(d)(4)(D) of the act, FDA may limit the

period of debarment of a permanently

debarred individual if the agency finds

that: (1) The debarred individual has

provided substantial assistance in the

investigation or prosecution of offenses

described in section 306(a) or (b) of the

act or relating to a matter under FDA’s

jurisdiction; (2) termination of the

debarment serves the interest of justice;

and (3) termination of the debarment

does not threaten the integrity of the

drug approval process. Special

termination of Dr. Shah’s debarment is

discretionary with FDA.

FDA considers a determination by the

Department of Justice concerning the

substantial assistance of a debarred

individual conclusive in most cases. At

Dr. Shah’s sentencing, the Assistant U.S.

Attorney prosecuting Dr. Shah,

recommended a reduced sentence based

on Dr. Shah’s ‘‘substantial assistance’’ to

the Government in its investigation.

Accordingly, FDA finds that Dr. Shah

provided substantial assistance as

required by section 306(d)(4)(C) of the

act.

The additional requisite showings,

i.e., that termination of debarment

serves the interest of justice and poses

no threat to the integrity of the drug

approval process, are difficult standards

to satisfy. In determining whether these

have been met, the agency weighs the

significance of all favorable and

unfavorable factors in light of the

remedial, public health-related purposes

underlying debarment. Termination of

debarment will not be granted unless,

weighing all favorable and unfavorable

information, there is a high level of

assurance that the conduct that formed

the basis for the debarment has not

recurred and will not recur, and that the

individual will not otherwise pose a

threat to the integrity of the drug

approval process.

Based on a thorough analysis of the

available evidence, Dr. Atul Shah has

demonstrated that termination of his

debarment serves the interest of justice

and will not pose a threat to the

integrity of the drug approval process.

Under section 306(d)(4)(D) of the act,

the period of debarment of an

individual who qualifies for special

termination may be limited to less than

permanent but to no less than 1 year. Dr.

Shah’s period of debarment, which

commenced on December 5, 1994, has

lasted more than 1 year. Accordingly,

the Deputy Commissioner for

Operations, under section 306(d)(4) of

the act and under authority delegated to

him (21 CFR 5.20), finds that Dr. Atul

Shah’s application for special

termination of debarment should be

granted, and that the period of

debarment should terminate

immediately, thereby allowing him to

provide services in any capacity to a

person with an approved or pending

drug product application. The Deputy

Commissioner for Operations further

finds that because the agency is granting

Dr. Shah’s application, an informal

hearing under section 306(d)(4)(C) of the

act is unnecessary.

As a result of the foregoing findings,

Dr. Atul Shah’s debarment is

terminated, effective (insert date of

publication in the Federal Register) (21

U.S.C. 335a(d)(4)(C) and (d)(4)(D)).

Dated: February 27, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–6066 Filed 3–10–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[Document Identifier: HCFA 668–B]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) the

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Reinstatement, with change, of

a previously approved collection for

which approval has expired; Title of

Information Collection: Post Laboratory

Survey Questionnaire—Laboratory, and

Supporting Regulation 42 CFR section

493; Form No.: HCFA 668–B; Use: This

form will allow Laboratories to assess

the CLIA survey process and report their

satisfaction with the survey process.

This information will help HCFA

evaluate the survey process from the

laboratory’s prospective. Frequency:

Biennially; Affected Public: Federal

Government, Business or other forprofit, Not-for-profit institutions, State,

Local or Tribal Govt.; Number of

Respondents: 40,000; Total Annual

Responses: 20,000; Total Annual Hours:

5,000.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Financial and Human
11214 Federal Register / Vol. 62, No. 47 / Tuesday, March 11, 1997 / Notices

Resources, Management Analysis and

Planning Staff, Attention: John Rudolph,

Room C2–25–05, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: March 3, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources.

[FR Doc. 97–5921 Filed 3–10–97; 8:45 am]

BILLING CODE 4120–03–P

[HCFA 3070 G–I]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) the necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: Revision of currently approved

collection; Title of Information

Collection: Intermediate Care Facility

for the Mentally Retarded or Persons

with Related Conditions Survey Report

Form and Supporting Regulations 42

CFR Sections 431, 435, 440, 442 and

483, Subpart I; Form No.: HCFA 3070

G–I; Use: The survey form and

supporting regulations are needed to

ensure provider compliance. In order to

participate in the Medicaid program as

an Intermediate Care Facility for the

Mentally Retarded (ICF/MR), providers

must meet Federal standards. The

survey report form is used to record

providers’ compliance with the

individual standard and report it to the

Federal Government. Frequency:

annually; Affected Public: Business or

other for-profit, Not for-profit

institutions, State, Local or Tribal Govt.;

Number of Respondents: ,7200; Total

Annual Responses: ,7200; Total Annual

Hours: 21,600.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

OMB Human Resources and Housing

Branch, Attention: Allison Eydt, New

Executive Office Building, Room 10235,

Washington, D.C. 20503

Dated: February 28, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–6063 Filed 3–10–97; 8:45 am]

BILLING CODE 4120–03–P

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 35, United

States Code, as amended by the

Paperwork Reduction Act of 1995, Pub.

L. 104–13), the Health Resources and

Services Administration (HRSA) will

publish periodic summaries of proposed

projects being developed for submission

to OMB under the Paperwork Reduction

Act of 1995. To request more

information on the proposed project or

to obtain a copy of the data collection

plans, call the HRSA Reports Clearance

Officer on (301) 443–1129.

Comments are invited on: (a) whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project

Consortia Development for Health

Professions Training in CommunityBased Settings—New—Consortia which

include academic institutions and

community-based providers have been

proposed as one mechanism for

improving collaboration between health

professions schools and communities,

enabling them to provide relevant

educational experiences and facilitating

meeting education and workforce goals.

The consortia should be based on a

formal association of academic health

professions training schools or programs

and community-based providers (e.g.,

community/migrant health centers,

managed care organizations) involved,

at least, in part, in the entry-level

education and/or continuing education

of health professionals. The purposes of

this project are (1) to prepare an

inventory of consortia for health

professions education, (2) to examine

the characteristics of successful

consortia, and (3) to examine the role

that consortia play in assisting health

professions schools or programs to

prepare health care providers for the

evolving health care system.

An initial survey will be conducted

by mail of consortia identified through

informal conversations with key

academic representatives, communitybased providers, and other

knowledgeable individuals, and a

literature review. The initial survey will

be used to gather information that

generally describes the consortia,

including their goals and

accomplishments. Consortia

respondents will also be asked to

identify additional consortia that should

receive the initial survey. From the

information gathered in the initial

survey, 20 consortia will be selected for

additional study as models of successful

consortia, based on criteria established

by an advisory workgroup.

The second survey will consist of

phone interviews with up to 20 of the

consortia identified as successful

models from the initial survey. These

data will describe the characteristics of

successful consortia in more detail

(leadership, organizational models,

missions and goals, financing

arrangements, facilitating factors, and

barriers). Data will also be collected to

determine the role that consortia play in

assisting health professional schools to

prepare health care providers for the

evolving health care system. The burden

estimates are as follows: