3328 Federal Register / Vol. 63, No. 14 /Thursday, January 22, 1998 / Notices

Dated: January 7, 1998.

Donald Sykes,

Director, Office of Community Services.

[FR Doc. 98–1526 Filed 1–21–98; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0192]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Quality Mammography Standards’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(the PRA).

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 28, 1997 (62

FR 55851), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0309. The

approval expires on December 31, 2000.

Dated: January 14, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–1419 Filed 1–21–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0016]

Draft Guidance on Professional

Flexible Labeling of Antimicrobial

Drugs; Availability; Request for

Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft level 1 Guidance

for Industry entitled ‘‘Professional

Flexible Labeling of Antimicrobial

Drugs (#66).’’ This draft guidance is

intended to provide specific guidance

on the development of Professional

Flexible Labeling (PFL) for therapeutic

veterinary prescription antimicrobial

drugs. The agency is requesting

comments on this draft guidance.

DATES: Submit written comments by

April 22, 1998.

ADDRESSES: Submit written comments

on the draft guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857. Comments should be identified

with the full title of the draft guidance

and the docket number found in

brackets in the heading of this

document.

Submit written requests for single

copies of this draft guidance to the

Communications Staff (HFV–12), Center

for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send two selfaddressed adhesive labels to assist that

office in processing your requests.

Copies of this draft guidance

document may also be obtained from

the CVM Home Page (http://

www.cvm.fda.gov) on the Internet.

FOR FURTHER INFORMATION CONTACT: John

D. Baker, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0130. Email: jbaker@bangate.fda.gov.

SUPPLEMENTARY INFORMATION:

Background

For many years, CVM has approved

veterinary prescription antimicrobial

products labeled with single fixed

dosages for a narrow range of specific

diseases and organisms. The very

narrow label indications often failed to

address the fact that, while some

specific bacteria produce repeatable,

recognized disease, many organisms are

either opportunistic or are known to

produce a variety of clinical

manifestations. In addition, with the

approval of single fixed dosages, the

efficacy of some products could become

suboptimal as bacterial susceptibility

patterns change with time.

The basic concept of Professional

Flexible Labeling (PFL) is to provide

prescription veterinary products that

carry useful prescribing information for

the range of clinical situations included

within their approved conditions of use.

Implementation of PFL is based on the

recognition that, as a function of their

medical training, veterinarians possess

the knowledge, skills, and abilities to

interpret medical diagnostic and

prescribing information. Accordingly,

they are able to develop these data into

appropriate therapeutic regimens. In the

course of their professional studies,

veterinarians are trained in

microbiology, the interpretation of

bacterial culture and sensitivity

determinative procedures, and

pharmacokinetics. This knowledge gives

them the ability to determine the

appropriateness of a particular drug for

use in a specific case.

Under section 502 (f)(1) of the Federal

Food, Drug, and Cosmetic Act (the act),

a drug is deemed to be misbranded

unless its labeling bears adequate

directions for use (21 U.S.C. 352(f)(1)).

The regulations regarding veterinary

drugs at 21 CFR 201.105 exempt a drug

from this provision of the act if it is in

the possession of a licensed veterinarian

for use in the course of professional

practice, is dispensed in accordance

with section 503(f) of the act (21 U.S.C.

353(f)), and its label bears certain

stipulated information. Section 504 of

the act (21 U.S.C. 354) stipulates that a

veterinary feed directive drug, a drug

intended for use in or on animal feed

which is limited to use under the

supervision of a licensed veterinarian, is

exempt from section 502(f) when

labeled, distributed, held, and used in

accordance with the conditions set forth

in section 504.

Drugs labeled in accordance with the

PFL concept require the training of

licensed veterinarians to help ensure

appropriate clinical usage. Such labels

would not provide adequate directions

for use by the lay person. Therefore, use

of PFL on nonprescription or

nonveterinary feed directive drugs

would cause the drugs to be misbranded

under section 502 (f)(1) of the act, PFLlabeled drugs must be classified as

prescription animal drugs or veterinary

feed directive drugs. Accordingly, the

PFL concept discussed in this document

may apply to either veterinary
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.