Federal Register / Vol. 63, No. 14 /Thursday, January 22, 1998 / Notices 3329

prescription or veterinary feed directive

antimicrobial drugs.

The PFL concept has been a topic of

discussion for many years. Recent

workshops on PFL were held in April

and December 1995 under the

cosponsorship of the Center for

Veterinary Medicine, the American

Academy of Veterinary Pharmacology

and Therapeutics, the Animal Health

Institute, and the American Veterinary

Medical Association.

A summary of the discussions and

opinions expressed in the April, 1995

workshop were published in the Journal

of the American Veterinary Medical

Association (JAVMA), October 1, 1995.

At the conclusion of the December, 1995

workshop, a task force prepared a report

on the PFL concept. The task force

report, which included a model drug

label, was published in the JAVMA on

July 1, 1996.

This draft guidance is intended to

describe how the PFL concept can be

applied to prescription antimicrobial

products to enable veterinary

practitioners to apply their expertise to

appropriately, effectively, and safely use

antimicrobials for specific clinical cases.

The draft document provides specific

guidance for drug sponsors on the

development of PFL labeling for

therapeutic veterinary prescription

antimicrobial drugs. Ultimately, the

labeling of products such as described

in this draft guidance will better

accommodate the needs of veterinary

practitioners in utilizing animal drugs to

treat animals in the course of their

professional practices.

Approaches to PFL may not be

equally applicable to all classes of

therapeutic prescription products (e.g.,

antimicrobials, antiparasitics,

physiologics). Therefore, CVM intends

to develop PFL guidances that are

specific to the various classes of drugs.

This draft guidance document

specifically addresses the application of

the PFL concept to prescription

therapeutic antimicrobial products.

A sponsor may follow the guidance

provided in this draft document, or a

sponsor may choose to follow alternate

procedures or practices. If a sponsor

elects to use alternate procedures or

practices, that sponsor may wish to

discuss the matter a priori with the

agency to prevent an expenditure of

money and effort on activities that may

later be determined to be unacceptable

to FDA.

This draft document represents

current FDA thinking on PFL for

antimicrobial drugs. This draft guidance

document does not create or confer any

rights for or on any person and does not

operate to bind FDA or the public. An

alternate approach may be used if such

an approach satisfies the requirements

of the applicable statute, regulations, or

both. FDA may amend this draft

guidance document based upon

comments submitted by interested

persons.

Request for Comments

Interested persons may, on or before

April 22, 1998, submit to the Dockets

Management Branch (address above)

written comments on the draft guidance

document. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document, and with the

full title of the guidance document.

The draft guidance and received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday. An electronic

version of this guidance is available on

the Internet at http://www.fda.gov. After

review of these comments, FDA will

finalize the guidance document with

any appropriate changes. Thereafter,

interested persons may submit written

comment on the guidance document

directly to the CVM Communications

Staff (address above).

Dated: January 14, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–1417 Filed 1-15-98; 3:51 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–226]

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: Evaluation of

Medicare Choices Demonstration; Form

No.: HCFA–R–226; Use: The objective of

the evaluation of the Medicare Choices

Demonstration is to determine whether

the newer types of managed care

delivery systems in the demonstration

are effective at attracting and retaining

Medicare enrollees and providing a high

quality, cost-effective care. The key

research questions HCFA will ask

Medicare enrollees include: (A)

Beneficiary choice, knowledge, and

biased selection. Why do beneficiaries

enroll (or not enroll) in plans? What

proportion of enrollees disenroll, and

why? What is the nature and extent of

biased selection in the demonstration,

and does it vary across plans? How well

do enrollees understand their plans and

the rules and procedures for obtaining

care? (B) Effects on service use. What

are the effects of the plans on the use

of Medicare-covered services? Are some

plans more effective at controlling

service use than others? (C) Effects on

Medicare costs. What are the effects of

the various payment methods being

tested in the demonstration on Medicare

costs? (D) Effects on satisfaction, access,

and quality. What are the effects of the

plans on enrollee satisfaction, access to

care, and quality of care? How does this

vary across plans? Frequency: one time;

Affected Public: Individuals or

Households; Number of Respondents:

10,000; Total Annual Responses:

10,000; Total Annual Hours: 3,880.

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 Information Services,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.
3330 Federal Register / Vol. 63, No. 14 /Thursday, January 22, 1998 / Notices

Dated: January 8, 1998

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Health Care

Financing Administration.

[FR Doc. 98–1516 Filed 1–21–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Notice of Meeting and Correction of

Meeting Notice

Pursuant to Public Law 92–463,

notice is hereby given of a correction of

a notice of meeting of the SAMHSA

National Advisory Council and of the

meeting of the Center for Substance

Abuse Treatment (CSAT) National

Advisory Council to be held in January

1998.

Public notice was given in the Federal

Register on January 8, 1998 (Volume 63,

Number 5, page 1120) that the SAMHSA

National Advisory Council would be

meeting on January 21, 1998, at the

Parklawn Building, Room 17–89. The

date of this meeting has subsequently

changed to January 22, 1998. The

agenda of the meeting and the contact

for additional information remain as

announced.

With regard to the CSAT National

Advisory Council meeting, a portion of

the meeting will be open and include

discussion of the Center’s policy issues

and current administrative, legislative,

and program developments. If anyone

needs special accommodations for

persons with disabilities please notify

the Contact listed below.

The meeting will include the

discussion of information about the

Center for Substance Abuse Treatment’s

procurement plans. Therefore a portion

of the meeting will be closed to the

public as determined by the

Administrator, SAMHSA, in accordance

with Title 5 U.S.C. 552b(c)(3) and 5

U.S.C. App. 2, section 10(d).

A summary of the meeting and roster

of council members may be obtained

from: Mrs. Marjorie Cashion, CSAT,

National Advisory Council, Rockwall II

Building, Suite 619, 5600 Fishers Lane,

Rockville, Maryland 20857, Telephone:

(301) 443–8923.

Substantive program information may

be obtained from the contact whose

name and telephone number is listed

below.

Committee Name: Center for

Substance Abuse Treatment, National

Advisory Council.

Meeting Date: January 27, 1998—8:30

a.m.–5:00 p.m; January 28, 1998—9:00

a.m.–2:00 p.m.

Place: Omni Shoreham Hotel,

Hampton Room, 2500 Calvert Street,

N.W., Washington, D.C. 20008.

Type: Closed: January 27, 1998—8:30

a.m.–9:00 a.m. Open: January 27, 1998—

9:00 a.m.–5:00 p.m.; January 28, 1998—

9:00 a.m.–2:00 p.m.

Contact: Marjorie M. Cashion,

Executive Secretary, Telephone: (301)

443–8923, and FAX: (301) 480–6077.

This notice is being published with

less than 15 days prior to the meeting

due to the urgent need to meet timing

limitations imposed by the review and

funding cycle.

Dated: January 20, 1998.

Jeri Lipov,

Committee Management Officer, Substance

Abuse and Mental Health Services

Administration.

[FR Doc. 98–1611 Filed 1–20–98; 12:12 pm]

BILLING CODE 4162–20–U

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4263–N–72]

Submission for OMB Review:

Comment Request

AGENCY: Office of Administration, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due date: February

23, 1998.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments must be

received within thirty (30) days from the

date of this Notice. Comments should

refer to the proposal by name and/or

OMB approval number and should be

sent to: Joseph F. Lackey, Jr., OMB Desk

Officer, Office of Management and

Budget, Room 10235, New Executive

Office Building, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Wayne Eddins, Reports Management

Officer, Department of Housing and

Urban Development, 451 7th Street,

Southwest, Washington, DC 20410,

telephone (202) 708–1305. This is not a

toll-free number. Copies of the proposed

forms and other available documents

submitted to OMB may be obtained

from Mr. Eddins.

SUPPLEMENTARY INFORMATION: The

Department has submitted the proposal

for the collection of information, as

described below, to OMB for review, as

required by the Paperwork Reduction

Act (44 U.S.C. Chapter 35).

The Notice lists the following

information: (1) The title of the

information collection proposal; (2) the

office of the agency to collect the

information; (3) the OMB approval

number, if applicable; (4) the

description of the need for the

information and its proposed use; (5)

the agency form number, if applicable;

(6) what members of the public will be

affected by the proposal; (7) how

frequently information submissions will

be required; (8) an estimate of the total

number of hours needed to prepare the

information submission including

number of respondents, frequency of

response, and hours of response; (9)

whether the proposal is new, an

extension, reinstatement, or revision of

an information collection requirement;

and (10) the names and telephone

numbers of an agency official familiar

with the proposal and of the OMB Desk

Officer for the Department.

Authority: Section 3507 of the Paperwork

Reduction Act of 1995, 44 U.S.C. 35, as

amended.

Dated: January 15, 1998.

David S. Cristy,

Director, Information Resources, Management

Policy and Management Division.

Notice of Submission of Proposed

Information Collection to OMB

Title of Proposal: Survey Instructions

and Certificate.

Office: Housing.

OMB Approval Number: 2502–0010.

Description of the Need for the

Information and its Proposed Use: A

land survey and related information are

necessary to secure a marketable title

and title insurance for the property that

provides security for project mortgage

insurance furnished under the FHA

multifamily programs. Form HUD–2457

provides a uniform method for

acceptably meeting program criteria to

minimize risk to the insurance fund and

the U.S. Treasury that might arise from

inadequate project land surveys and

related data.

Form Number: HUD–2457.

Respondents: Business or Other ForProfit and Not-For-Profit Institutions.

Frequency of Submission: On

Occasion.

Reporting Burden: