Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 63953

Under Part P, Section P–20,

Functions, change the following:.

Under Chapter PF, Information

Technology Service (PF), delete the

titles and functional statements for the

Division of Systems and Network

Management (PFC) and the Division of

Information Systems and Technology

(PFH) in their entirety.

Under Chapter PE, Administrative

Operations Service (PE), delete item (9)

in its entirety and insert a new item (9)

as follows: ‘‘(9) a wide range of voice,

data, and video services.’’

Delete the functional statement in its

entirety for the Division of Technical

Support (PEF) and insert the following:

‘‘The Division manages the

Telecommunications Improvement

Project and provides a variety of support

services for HHS and other customers

located in the Washington, D.C.

Metropolitan Area and nationwide. (1)

Provides the following: voice, data, and

video services; visual aids and graphic

art services; photography services;

library services; printing and

reproduction, including operation of

copy centers; mail and messenger

services; support services for conference

room facilities; and (2) carries out

printing management and records

management responsibilities for the

PSC.’’

Under Chapter PC, Financial

Management Service (PC), after the

statement for the Division of Financial

Operations (PCE), add the following

title and functional statement:

Division of Information Systems and

Technology (PCF) (1) Provides fee-forservice information technology (IT)

support to HHS OPDIVs and other

Government agencies. Services include

providing information from the HHS

personnel/payroll system and providing

technological support in utilizing

evolving IT areas; (2) provides analysis,

design, development, implementation

and ongoing support of information

reporting in various areas, such as

personnel and payroll; and (3) provides

analysis, design, development,

implementation and support in utilizing

evolving technology.

This reorganization is effective upon

date of signature.

Dated: November 21, 1997.

Lynnda M. Regan,

Director, Program Support Center.

[FR Doc. 97–31718 Filed 12–2–97; 8:45 am]

BILLING CODE 4160–17–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–372]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS. 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 this

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: Extension of a currently

approved collection; Title of

Information Collection: Annual Report

on Home and Community Based

Services Waivers and Supporting

Regulations in 42 CFR 440 and 441;

Form No.: HCFA–372 (OMB# 0938–

0272); Use: States request waivers in

order for beneficiaries to have the

option of receiving hospital services in

their homes. States with an approved

waiver under section 1915(c) of the Act

are required to submit the HCFA–372 or

HCFA–372(S) annually in order for

HCFA to: (1) verify that State assurances

regarding waiver cost-neutrality are met,

and (2) determine the waiver’s impact

on the type, amount and cost of services

provided under the State plan and

health and welfare of recipients.;

Frequency: Annually; Affected Public:

State, local or tribal government;

Number of Respondents: 50; Total

Annual Responses: 223; Total Annual

Hours: 16,725.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, E-mail your request,

including your address, phone number,

OMB number, and HCFA document

identifier, 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: Louis

Blank, Room C2–26–17, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: November 24, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 97–31623 Filed 12–2–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1024–N]

Medicare Program; December 15, 1997,

Meeting of the Practicing Physicians

Advisory Council

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the Practicing Physicians Advisory

Council. This meeting is open to the

public.

DATES: The meeting is scheduled for

December 15, 1997, from 8:30 a.m. until

5 p.m. E.S.T.

ADDRESSES: The meeting will be held in

Room 800, 8th Floor, Hubert H.

Humphrey Building, 200 Independence

Avenue, SW, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT:

Jeffrey Kang, M.D., Executive Director,

Practicing Physicians Advisory Council,

Room 435–H, Hubert H. Humphrey

Building, 200 Independence Avenue,

S.W., Washington, DC 20201, (202) 690–

7874.

SUPPLEMENTARY INFORMATION: The

Secretary of the Department of Health

and Human Services (the Secretary) is

mandated by section 1868 of the Social

Security Act to appoint a Practicing

Physicians Advisory Council (the

Council) based on nominations

submitted by medical organizations

representing physicians. The Council

meets quarterly to discuss certain

proposed changes in regulations and
63954 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

carrier manual instructions related to

physicians’ services, as identified by the

Secretary. To the extent feasible and

consistent with statutory deadlines, the

consultation must occur before

publication of the proposed changes.

The Council submits an annual report

on its recommendations to the Secretary

and the Administrator of the Health

Care Financing Administration not later

than December 31 of each year.

The Council consists of 15 physicians,

each of whom has submitted at least 250

claims for physicians’ services under

Medicare or Medicaid in the previous

year. Members of the Council include

both participating and nonparticipating

physicians, and physicians practicing in

rural and underserved urban areas. At

least 11 members must be doctors of

medicine or osteopathy authorized to

practice medicine and surgery by the

States in which they practice. Members

have been invited to serve for

overlapping 4-year terms. In accordance

with section 14 of the Federal Advisory

Committee Act, terms of more than 2

years are contingent upon the renewal

of the Council by appropriate action

before the end of the 2-year term.

The Council held its first meeting on

May 11, 1992.

The current members are: Richard

Bronfman, D.P.M.; Wayne R. Carlsen,

D.O.; Gary C. Dennis, M.D.; Catalina E.

Garcia, M.D.; Mary T. Herald, M.D.;

Ardis Hoven, M.D.; Sandral Hullett,

M.D.; Jerilynn S. Kaibel, D.C.; Marie G.

Kuffner, M.D.; Marc Lowe, M.D.;

Katherine L. Markette, M.D.; Derrick K.

Latos, M.D.; Susan Schooley, M.D.;

Maisie Tam, M.D.; and Kenneth M.

Viste, Jr., M.D. The chairperson is

Kenneth M. Viste, Jr., M.D.

Council members will receive an

update on documentation guidelines,

physician practice expense, private

contracting, physician self referral rules,

privacy and confidentiality, regional

labaratory carriers, and other issues

related to implementation of the

Balanced Budget Amendment.

Individuals or organizations that wish

to make 5-minute oral presentations on

the agenda issues should contact the

Executive Director by 12 noon,

December 4, 1997, to be scheduled. The

number of oral presentations may be

limited by the time available. A written

copy of the oral remarks should be

submitted to the Executive Director no

later than 12 noon, December 10, 1997.

Anyone who is not scheduled to speak

may submit written comments to the

Executive Director by 12:00 noon,

December 10, 1997. The meeting is open

to the public, but attendance is limited

to the space available.

(Section 1868 of the Social Security Act (42

U.S.C. 1395ee) and section 10(a) of Pub. L.

92–463 (5 U.S.C. App. 2, section 10(a)); 45

CFR Part 11)

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: November 27, 1997.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 97–31594 Filed 12–2–97; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Opportunity

for a Cooperative Research and

Development Agreement (CRADA) for

the Scientific and Commercial

Development of Transgenic Mice That

Express Human Cytochrome P450

Genes

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice.

SUMMARY: The Department of Health and

Human Services (DHHS) seeks an

agreement with a pharmaceutical or

biotechnology company to effectively

pursue the development and

characterization of transgenic mice that

express human cytochrome P450 genes

CYP2D6 and CYP3A4. The National

Cancer Institute has data suggesting that

these animals may be useful in drug

development, carcinogen bioassays for

risk assessment, and the determination

of genetic regulatory mechanisms.

ADDRESSES: Proposals and questions

about this opportunity may be

addressed to Robert Dell’Orco, Ph.D.,

Technology Development and

Commercialization Branch, National

Cancer Institute, Executive Plaza South,

Suite 450, 6120 Executive Blvd.,

Rockville, MD 20852, tel: 301–496–

0477, fax: 301–402–2117.

DATES: In view of the important priority

of developing new drugs for the

treatment of cancer and methods for

determining carcinogenic risk,

interested parties should notify this

office in writing not later that January 2,

1998. Respondents will then be

provided an additional 30 days for filing

of formal proposals.

SUPPLEMENTARY INFORMATION:

‘‘Cooperative Research and

Development Agreement’’ or ‘‘CRADA’’

means the anticipated joint agreement to

be entered into by NCI pursuant to the

Federal Technology Transfer Act of

1986 and Executive Order 12591 of

April 10, 1987 as amended by the

National Technology Transfer

Advancement Act of 1995 to collaborate

on the specific research project

described below.

The National Cancer Institute seeks an

agreement with a pharmaceutical or

biotechnology company for joint

development and evaluation of

transgenic mice that express human

cytochrome P450 genes CYP2D6 and

CYP3A4 in a tissue specific manner that

reflects the expression in humans.

These two human P450 enzymes are

involved in the metabolism of over 75%

of the drugs that are now on the market;

however, these two enzymes are poorly

conserved between rodents and

humans. This poor conservation

precludes the use of unmodified rodent

model systems for the analysis of new

drugs with respect to their metabolism

by these two enzymes. The development

of a human P450 transgenic mouse

system will allow for the determination

of human metabolism and toxicity of

new drugs, the prediction of drug

interactions, and the definition of

pharmacokinetic parameters in an intact

animal system. Additionally, such a

system would avoid the utilization of

human liver tissue samples which forms

the basis of the current methods used in

the pharmaceutical industry. The

animal model would also form the basis

of carcinogen bioassays for human risk

assessment and allow for the analysis of

P450 gene regulation. In the proposed

studies, the animals will be used to

determine the tissue specific

degradation of drugs. Drugs known

through in vitro metabolism studies to

be metabolized by CPY2D6 and CYP3A4

will be administered to the transgenic

mice, and their pharmacokinetics will

be studied.

The Laboratory of Metabolism has

many years of experience in cloning and

characterizing human P450 genes. More

recently, the laboratory has developed a

series of knockout and transgenic mice

to study various aspects of the role of

cytochrome P450 enzymes in

carcinogenesis and drug metabolism;

and the development of transgenic mice

with the human CYP2D6 and CYP3A4

enzymes is a continuation of the

laboratory’s commitment to this

research area. The Laboratory of

Metabolism is interested in establishing

a CRADA with a company to assist in

the continuing development of transgeic

animals containing human cytochrome

P450 enzymes to study known drug

substrates and proprietary drug

candidates. The Government will