14952 Federal Register / Vol. 60, No. 54 / Tuesday, March 21, 1995 / Notices

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

The Commissioner has determined for

the reasons stated that those portions of

the advisory committee meetings so

designated in this notice shall be closed.

The Federal Advisory Committee Act

(FACA) (5 U.S.C. app. 2, 10(d)), permits

such closed advisory committee

meetings in certain circumstances.

Those portions of a meeting designated

as closed, however, shall be closed for

the shortest possible time, consistent

with the intent of the cited statutes.

The FACA, as amended, provides that

a portion of a meeting may be closed

where the matter for discussion involves

a trade secret; commercial or financial

information that is privileged or

confidential; information of a personal

nature, disclosure of which would be a

clearly unwarranted invasion of

personal privacy; investigatory files

compiled for law enforcement purposes;

information the premature disclosure of

which would be likely to significantly

frustrate implementation of a proposed

agency action; and information in

certain other instances not generally

relevant to FDA matters.

Examples of portions of FDA advisory

committee meetings that ordinarily may

be closed, where necessary and in

accordance with FACA criteria, include

the review, discussion, and evaluation

of drafts of regulations or guidelines or

similar preexisting internal agency

documents, but only if their premature

disclosure is likely to significantly

frustrate implementation of proposed

agency action; review of trade secrets

and confidential commercial or

financial information submitted to the

agency; consideration of matters

involving investigatory files compiled

for law enforcement purposes; and

review of matters, such as personnel

records or individual patient records,

where disclosure would constitute a

clearly unwarranted invasion of

personal privacy.

Examples of portions of FDA advisory

committee meetings that ordinarily shall

not be closed include the review,

discussion, and evaluation of general

preclinical and clinical test protocols

and procedures for a class of drugs or

devices; consideration of labeling

requirements for a class of marketed

drugs or devices; review of data and

information on specific investigational

or marketed drugs and devices that have

previously been made public;

presentation of any other data or

information that is not exempt from

public disclosure pursuant to the FACA,

as amended; and, deliberation to

formulate advice and recommendations

to the agency on matters that do not

independently justify closing.

This notice is issued under section

10(a)(1) and (2) of the Federal Advisory

Committee Act (5 U.S.C. app. 2), and

FDA’s regulations (21 CFR part 14) on

advisory committees.

Dated: March 16, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–7069 Filed 3–17–95; 3:46 pm]

BILLING CODE 4160–01–F

Health Care Financing Administration

Office of Research and

Demonstrations; Statement of

Organization, Functions, and

Delegations of Authority

Part F of the Statement of

Organization, Functions, and

Delegations of Authority for the

Department of Health and Human

Services, Health Care Financing

Administration (HCFA), (Federal

Register, Vol. 59, No. 60, pp. 14642–43,

dated Tuesday, March 29, 1994) is

amended to reflect various changes

resulting from the streamlining and

reorganization of the Office of Research

and Demonstrations (ORD).

These changes abolish the current

ORD substructure which consists of

three subordinate offices and one staff,

and establish a new substructure which

consists of four subordinate offices and

two subordinate staffs. These changes

will realign all current ORD functions

into the following activity areas:

information dissemination; financial,

administrative, and procurement

support; state health reform

demonstrations; payment, delivery, and

financing research and demonstrations;

beneficiary related research and

demonstrations; and ORD program

support activities.

The specific changes to Part F are:

• Section F.10.C.3.a, through Section

F.10.C.3.c.(2) is deleted in its entirety

and replaced by the following revised

functional statements. The new sections

F.10.C.3.a through F.10.C.3.f.(2) read as

follows:

A. Dissemination Staff (FKB–2)

• Produces and distributes ORD

publications, such as the Health Care

Financing Review, Status Report,

Publications Catalog, and Reports to

Congress.

• Coordinates ORD’s input for the

annual HCFA Report to Congress.

• Markets materials, including

electronically produced data and

publications to consumers, customers

and other individuals or organizations.

• Develops new dissemination

strategies that encourage the adoption

and diffusion of innovations in health

care financing and delivery.

• Manages internal and external

inquiries.

• Provides conference support.

• Provides technical and editorial

support services.

• Coordinates with the Government

Printing Office and the National

Technical Information Service.

• Maintains resource material for

internal use.

• Develops and disseminates internal

communications and operational

procedures.

• Reviews, coordinates and serves as

liaison for administrative

correspondence.

B. Financial, Administrative and

Procurement Staff (FKB–3)

• Plans, directs and implements a

comprehensive office-wide human

resources and employee development

program.

• Coordinates ORD’s section of the

HCFA strategic plan.

• Coordinates the Federal Managers

Financial Integrity Act.

• Plans, directs and implements

office-wide facilities and property

management programs.

• Plans, directs and implements

comprehensive office-wide budget and

financial management programs.

• Coordinates grants, contracts,

cooperative agreements and waiver

activities.

• Plans and develops ORD’s

Acquisition Planning Document.

• Develops and implements the ORD

Waiver Compendium.

• Manages Freedom of Information

and Privacy Act issues.

C. Office of State Health Reform

Demonstrations (FKB4)

• Conducts research, demonstrations

and evaluations to support the

development and implementation of

State health and welfare reform

demonstrations.

• In partnership with other HCFA

bureaus and DHHS offices, directs the
Federal Register / Vol. 60, No. 54 / Tuesday, March 21, 1995 / Notices 14953

Department’s response to all aspects of

the State’s proposal and any proposed

changes to ongoing demonstration

activities.

• Monitors ongoing operations of the

State’s demonstration in partnership

with other HCFA bureaus and regional

offices.

• Funds technical assistance to States

in the implementation and evaluation of

these programs.

D. Office of Payment and Delivery

Research and Demonstrations (FKB5)

• Directs intramural and extramural

research, demonstrations and

evaluations of managed care and other

delivery systems including studies

supporting the development of

associated payment systems and the

development of infrastructure in

underserved areas.

• Directs intramural and extramural

research, demonstrations and

evaluations of broad reforms of the

Medicare and Medicaid programs,

studies to evaluate the impact of

proposals for reform of the health care

system and studies of health care

financing systems.

• Directs intramural and extramural

research, demonstrations and

evaluations to support the development,

implementation and refinement of

payment policies including the

extension of existing payment systems

to excluded providers and other payers.

• Directs and performs analyses to

assist in delivery and systems reform

and payment policy development.

D.(1) Division of Delivery Systems and

Financing (FKB51)

• Conducts intramural and

extramural research, demonstrations

and evaluations of managed care and

other delivery systems including the

development of infrastructure in

underserved areas (rural/inner-city

areas).

• Conducts intramural and

extramural research, demonstrations

and evaluations to support the

development and implementation of

payment systems associated with

delivery and systems reform.

• Conducts intramural and

extramural research, demonstrations

and evaluations to develop and

implement patient and other

classification systems, including risk

adjustment methodologies, for new

delivery and payment systems.

• Conducts intramural and

extramural research, demonstrations

and evaluations of broad reforms of the

Medicare and Medicaid programs.

• Conducts intramural and

extramural research studies to evaluate

the impact of proposals for reform of the

health care system.

• Conducts intramural and

extramural research, demonstrations

and evaluations of health care financing

issues.

• Performs analyses to assist in

delivery and systems reform policy

development.

D.(2) Division of Payment Systems

(FKB52)

• Conducts intramural and

extramural research, demonstrations

and evaluations to support the

development, implementation and

refinement of payment policy for

hospitals, physicians, drugs, outpatient

facilities, skilled nursing facilities,

home health agencies and other

providers.

• Conducts intramural and

extramural research, demonstrations

and evaluations to support the

extension of payment systems to

excluded providers and to other payers.

• Conducts intramural and

extramural research, demonstrations

and evaluations to develop and

implement patient and other

classifications for payment systems.

• Conducts intramural and

extramural research studies of the

impact of payment systems on providers

and other payers.

• Conducts intramural and

extramural research studies on

developments/changes in the health

care sector and evaluate the

implications for payment policy.

• Assists in the development and

implementation of payment policies to

expand access and develop

infrastructure in underserved areas

(rural/inner-city areas).

• Performs analyses to assist in

payment policy development.

E. Office of Beneficiary and Program

Research and Demonstrations (FKB6)

• Directs intramural and extramural

research, demonstrations and

evaluations on the Medicare and

Medicaid programs and beneficiary

populations that include, but are not

limited to, maternal and child health,

End Stage Renal Disease (ESRD),

persons with Acquired Immune

Deficiency Syndrome (AIDS), prescribed

drugs, persons with cancer, persons

with mental and physical chronic

disease and disabilities, where the

issues to be studied include, but are not

limited to, health status and outcomes,

information, eligibility, service use,

access to care, coverage, expenditures

and quality of care.

• Directs intramural and extramural

studies on the impact of existing and

new HCFA programs and payment

systems on the beneficiaries.

• Directs intramural and extramural

research, demonstrations and

evaluations on ways to improve the

decision-making process by which

consumers select health insurance

coverage, providers and treatments, and

beneficiary satisfaction.

• Directs intramural and extramural

research, demonstrations and

evaluations related to new measures of

quality of care.

• Directs intramural and extramural

research, demonstrations and

evaluations to support coverage policy

for new and existing technology and

procedures.

• Directs and performs the policy

analyses of findings on issues that affect

beneficiary populations and programs.

E.(1) Division of Health, Information

and Outcomes (FKB61)

• Conducts intramural and

extramural research, demonstrations

and evaluations related to issues that

affect the health status, outcomes,

eligibility, access to, and use and costs

of services for Medicare and Medicaid

beneficiaries and special populations,

such as, maternal and child health,

persons with AIDS and cancer patients.

• Conducts intramural and

extramural research, demonstrations

and evaluations related to issues that

affect the ESRD program.

• Conducts intramural and

extramural research, demonstrations

and evaluations related to beneficiary

satisfaction.

• Conducts intramural and

extramural studies on the impact of

existing and new HCFA programs and

payment systems on the beneficiaries.

• Conducts intramural and

extramural research, demonstrations

and evaluations on ways to improve the

decision-making process by which

consumers select health insurance

coverage, providers and treatments.

• Carries out and analyzes the results

of the Medicare Health Status Registry.

• Conducts intramural and

extramural research, demonstrations

and evaluations on health information

for providers.

• Conducts intramural and

extramural research, demonstrations

and evaluations related to new measures

of quality of care (not related to the aged

and disabled).

• Conducts intramural and

extramural research, demonstrations

and evaluations to support coverage

policy for new and existing

technologies, procedures and

pharmaceuticals.
14954 Federal Register / Vol. 60, No. 54 / Tuesday, March 21, 1995 / Notices

• Analyzes the policy implications of

findings on health, information,

outcomes, access, coverage and quality.

E.(2) Division of Aging and Disability

(FKB62)

• Conducts intramural and

extramural research, demonstrations

and evaluations on issues that affect

program eligibility for populations that

include persons with mental and

physical chronic disease and

disabilities.

• Conducts intramural and

extramural research, demonstrations

and evaluations on issues that affect

coverage for populations that include

persons with mental and physical

chronic disease and disabilities.

• Conducts intramural and

extramural research, demonstrations

and evaluations on issues that affect

cost of care for populations that include

persons with mental and physical

chronic disease and disabilities.

• Conducts intramural and

extramural research, demonstrations

and evaluations on issues that affect

access to care for populations that

include persons with mental and

physical chronic disease and

disabilities.

• Conducts intramural and

extramural research, demonstrations

and evaluations on issues that affect

quality of health and long-term care

services for populations that include

persons with mental and physical

chronic disease and disabilities.

• Conducts intramural and

extramural research, demonstrations

and evaluations related to new measures

of quality of care for populations that

include persons with mental and

physical chronic disease and

disabilities.

• Analyzes trends in long-term care

programs and market characteristics.

• Analyzes the policy implications of

findings on issues that affect aging and

disability.

F. Office of Research and

Demonstrations Support (FKB7)

• Directs the Fiscal Intermediary and

Carrier activities for demonstrations.

• Directs the development,

implementation and ongoing operations

of demonstrations.

• Directs the design and development

of payment methodologies for

demonstrations, special cost reports and

operational manuals.

• Directs the design, development

and implementation of mainframe and

personal computer (PC) based claims

processing systems and collation of

evaluation data.

• Directs the development of data

programs to monitor and evaluate trends

in Medicare/Medicaid and the health

care system.

• Oversees programming and dataset

technical assistance.

• Directs the control and support for

PC’s, local area networks (LAN’s),

computer communications and

mainframe computer hardware/software

packages.

• Participates with the Bureau of Data

Management and Strategy (BDMS) in

providing support and access to HCFA’s

data bases as required by research and

demonstration activities.

F.(1) Division of Demonstrations

Support (FKB71)

• Serves as Fiscal Intermediary and

Carrier for demonstrations.

• Participates in the development,

implementation and ongoing operations

of demonstrations.

• Designs and develops payment

methodologies when needed for

demonstrations and studies, such as

special cost reports, special operational

manuals and participates in facilitating

demonstrations.

• Designs, develops and implements

mainframe and PC claims processing

systems and collates data for

evaluations.

• Conducts on-site audits of

submitted costs reports and validates

services rendered.

F.(2) Division of Data Systems

Resources (FKB72)

• Develops, manages and maintains a

variety of data programs to monitor and

evaluate trends in Medicare/Medicaid

and the health care system.

• Provides and participates in a

variety of data support activities related

to quality control and data verification.

• Provides programming and dataset

technical assistance.

• Provides control and support for

PCs, LAN, computer communications

and mainframe computer hardware/

software packages.

• Participates with BDMS in

providing necessary support and access

to HCFA’s data bases as required by

research and demonstration activities.

• Coordinates ORD’s participation in

computer-based systems.

• Designs and develops a variety of

analytic data bases.

Dated: March 8, 1995.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 95–6885 Filed 3–20–95; 8:45 am]

BILLING CODE 4120–01–P

National Institutes of Health

National Cancer Institute; Opportunity

for a Cooperative Research Agreement

(CRADA) for the Scientific and

Commercial Development of

Diagnostic and/or Therapeutic Agents

for Hyperpigmentary Lesions

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice.

SUMMARY: The National Cancer Institute

(NCI), seeks a pharmaceutical or

cosmetic company that can effectively

pursue the scientific and commercial

generation and development of agents

inhibiting pigmentation. The project is

of scientific importance since it will

characterize mechanisms whereby

melanocyte function is compromised to

produce hyperpigmented lesions. As

such, this research will seek to provide

insights into mechanisms responsible

for clinically abnormal

hyperpigmentation such as occurs in

postinflammatory hyperpigmentation

and other pigmentary diseases. NCI has

successfully characterized the

melanogenetic functions of several

pigmentary genes that are important to

the regulation of mammalian

pigmentation. The NCI has produced a

number of specific antibodies which

recognize those gene products as well as

a number of oligonucleotides and

cDNAs whereby expression of their

encoding genes can be quantitated. The

selected sponsor will collaborate in a

project aimed at using those probes to

characterize melanocyte function in

hyperpigmentary conditions and to

develop agents useful commercially to

down regulate melanogenic function.

ADDRESSES: Inquiries and proposals

regarding this opportunity should be

addressed to Mark Noel or Bert Zbar

(Telephone (301) 496–0477, Facsimile

(301) 402–2117), Office of Technology

Development, National Cancer Institute,

Bldg 31, Room 4A49, National Institutes

of Health, 9000 Rockville Pike,

Bethesda, MD 20892

DATES: Proposals must be received at the

above address by no later than May 22,

1995.

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

October 10, 1987 to collaborate on the

specific research project described

below.

The NCI is seeking a pharmaceutical

or cosmetic company which can lend