15914 Federal Register / Vol. 62, No. 64 / Thursday, April 3, 1997 / Notices

conditions suggested in its proposed

labeling; (2) lacks evidence consisting of

adequate and well-controlled

investigations that Deprenyl will have

the effect it is represented to have in the

NDA; (3) fails to contain bioavailability

data required by § 320.21; (4) fails to

contain information that establishes that

the methods to be used in, and the

facilities and controls used for, the

manufacture, processing, packing, or

holding of the drug substance and the

drug product are adequate to preserve

their identity, strength, quality, purity,

stability, and bioavailability; and (5)

does not contain the proposed labeling

for the bulk drug substance and the

packaged drug product. I also find that

Discovery was not in compliance with

FDA’s CGMP regulations published at

parts 210 and 211.

Therefore, under the Federal Food,

Drug, and Cosmetic Act (section 505(d))

and under the authority delegated to me

in 21 CFR 5.10, Discovery’s request for

a hearing is denied and approval of

NDA 20–242 is denied.

Dated: February 28, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–8517 Filed 4-2-97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[HCFA–R–204]

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: New Collection; Title of

Information Collection: Data Collection

for the Second Generation Social Health

Maintenance Organization

Demonstration; Form No.: HCFA–R–

204; Use: The data collected under this

effort will be used to support the

operational and evaluation needs of the

Congressionally-Mandated Second

Generation of the Social Health

Maintenance Organization

Demonstration. Frequency: On occasion,

Annually; Affected Public: Individuals

or Households; Number of Respondents:

157,056; Total Annual Responses:

157,056; Total Annual Hours: 133,652.

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

Resources, Management Analysis and

Planning Staff, Attention: John Rudolph,

Room C2–26–17, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: March 26, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources.

[FR Doc. 97–8526 Filed 4–2–97; 8:45 am]

BILLING CODE 4120–03–P

[HCFA–R–203]

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: New Collection; Title of

Information Collection: Data Collection

Forms for a Project to Develop a CaseMix Adjustment System for a National

Home Health Prospective Payment

Program; Form No.: HCFA–R–203; Use:

The data collection from this form will

support analysis of home health

utilization patterns and develop

predictive models of home health

resource use. That will serve as the basis

for a system to adjust payments for

Medicare home health services for

differences/changes in patient service

needs; Frequency: On Occasion;

Affected Public: Not-for-profit, Business

or other for-profit; Number of

Respondents: 893,629; Total Annual

Responses: 893,629; Total Annual

Hours: 52,156.

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: March 11, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–8525 Filed 4–2–97; 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
Federal Register / Vol. 62, No. 64 / Thursday, April 3, 1997 / Notices 15915

Paperwork Reduction Act of 1995,

Public Law 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: Performance

Outcome Demonstration Study—New

Through Titles VII and VIII programs,

the Bureau of Health Professions

provides both policy leadership and

support for health professions workforce

enhancement and educational

infrastructure development. An

outcome-based performance

measurement system is central to the

ability of the Bureau to measure

whether program support is meeting its

national health workforce objectives,

and to signal where program course

correction is necessary.

In addition, the Government

Performance and Results Act (GPRA)

requires each agency to develop

comprehensive strategic plans, to

submit annual performance plans that

set specific performance goals for each

program activity, and to report annually

on the actual performance achieved

compared to the performance goals.

The Bureau of Health Professions has

developed a comprehensive program

which consists of cross-cutting

indicators designed to capture the

common activities across programs,

cluster level indicators designed to

capture common activities for programs

with a similar focus, and program

specific indicators designed to capture

activities which are specific to selected

individual programs. At the core of the

Bureau’s performance measurement

system are four cross-cutting goals with

respect to workforce quality, supply,

diversity and distribution. External

customer input was utilized to validate

the Bureau’s proposed outcomes and

indicators, and to assist with a

preliminary assessment of the suitability

of data sources. A pilot study of nine

program sites within the Washington

metropolitan area was completed to

determine the availability of the data

along with the clarity of the definitions

and instructions. The results of the pilot

indicate that these data can be collected

from grantees.

A wider demonstration will be done

to assess the ability of current grantees,

in the second year of the project period

or later, to supply the data without the

benefit of a site visit and to further

refine the definitions and instructions.

Since data are collected by discipline,

the estimate of burden hours per

response is different for projects that

involve a single discipline and projects

that involve multiple disciplines.

It is expected that the data collection

tool for the demonstration may be

distributed through the Internet, as has

been done for the grant application

materials for these programs, and

returned to the Bureau in the mail.

However, when this data collection

system is fully implemented, it is

expected that the distribution and

submission will be fully automated and

that the data collection tool will be an

interactive program which prompts

respondents to report only those data

relevant to their programs. Burden

estimates are as follows:

Type of respondent No. of respondents

Responses

per respondent

Burden hours

per response

Total burden hours

Projects involving a single discipline .............................................................................. 400 1 8 3,200

Projects involving multiple disciplines ............................................................................ 16 1 40 640

Total ......................................................................................................................... 416 1 9.2 3,840

Send comments to Patricia Royston,

HRSA Reports Clearance Officer, Room

14–36, Parklawn Building, 5600 Fishers

Lane, Rockville, MD 20857. Written

comments should be received within 60

days of this notice.

Dated: March 27, 1997.

J. Henry Montes,

Director, Office of Policy and Information

Coordination.

[FR Doc. 97–8449 Filed 4–2–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Availability of Record of

Decision and Statement of Findings on

the Environmental Impact Statement

on Reintroduction of the Mexican Wolf

to its Historic Range in the

Southwestern United States

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of availability of record

of decision.

SUPPLEMENTARY INFORMATION: Pursuant

to regulations implementing the

National Environmental Policy Act (40

CFR 1505.2), the Department of the

Interior, Fish and Wildlife Service

announces the availability of the Record

of Decision and Statement of Findings

on the Environmental Impact Statement

on Reintroduction of the Mexican Wolf

to its Historic Range in the

Southwestern United States.

The Record of Decision authorizes

implementation of the Preferred

Alternative (Alternative A) as set forth

in the Final Environmental Impact

Statement. As soon as practicable, the

U.S. Fish and Wildlife Service will

reintroduce Mexican gray wolves,

classified as a nonessential

experimental population, in eastern

Arizona for the purpose of establishing

a population of at least 100 wolves

distributed throughout the Blue Range

Wolf Recovery Area, which includes

portions of western New Mexico. If

feasible and necessary to achieve the

population objective of 100 wolves, a

subsequent reintroduction of Mexican

gray wolves into the White Sands Wolf

Recovery Area in southern New Mexico

will be conducted.