Federal Register / Vol. 60, No. 79 / Tuesday, April 25, 1995 / Notices 20275

• Strategies for dealing with linguistic

barriers;

• Non-discriminatory fee structures;

and

• Procedures for a timely search for

prospective parents for a waiting child,

including the use of exchanges and

other interagency efforts, provided that

such procedures must insure that

placement of a child in an appropriate

household is not delayed by the search

for a same race or ethnic placement.

Agencies receiving Federal funds may

not use standards related to income, age,

education, family structure, and size or

ownership of housing, which exclude

groups of prospective parents on the

basis of race, color, or national origin,

where those standards are arbitrary or

unnecessary or where less exclusionary

standards are available.

Enforcement

As provided in Section 553(d)(1) of

MEPA, covered agencies or entities are

required to comply with the Act no later

than six months after publication of this

guidance or one year after the date of

the enactment of this Act, whichever

occurs first, i.e., October 21, 1995.

Pursuant to Section 553(d)(2) of MEPA,

if a state demonstrates to the satisfaction

of the Secretary of HHS that it is

necessary to amend state statutory law

in order to change a particular practice

that is inconsistent with MEPA, the

Secretary may extend the compliance

date for the state a reasonable number

of days after the close of the first state

legislative session beginning after April

25, 1995. In determining whether to

extend the compliance date, the

Secretary will take into account the

constitutional standards described in

Part A of this guidance. Because states

need not enforce unconstitutional

provisions of their laws, statutory

amendments are not an essential

precondition to coming into compliance

with respect to any such provisions.

HHS emphasizes voluntary

compliance with the law and recognizes

that covered agencies may want further

guidance on their obligations under

these laws. Accordingly, HHS is offering

technical assistance to any covered

agency seeking to better understand and

more fully comply with the Multiethnic

Placement Act. Organizations wishing

to be provided with technical assistance

on compliance with the

nondiscrimination provisions of MEPA

should contact Ronald Copeland of OCR

at 202–619–0553. Organizations wishing

to be provided with technical assistance

regarding required recruitment efforts

should contact Carol Williams or Dan

Lewis of the Administration on

Children and Families at 202–205–8618.

The Multiethnic Placement Act

provides two vehicles for enforcement

of its prohibition against discrimination

in adoption or foster care placement.

First, pursuant to Section 553(b), any

individual who is aggrieved by an

action he or she believes constitutes

discrimination in violation of the Act

has the right to bring an action seeking

equitable relief in a United States

district court of appropriate jurisdiction.

Second, the Act provides that

noncompliance with the prohibition is

deemed a violation of Title VI.

OCR has published regulations to

effectuate the provisions of Title VI. 45

CFR part 80. Any individual may file a

complaint with OCR alleging that an

adoption or foster care organization

funded by HHS makes placement

decisions in violation of the Multiethnic

Placement Act and Title VI. OCR may

also initiate compliance reviews to

determine whether violations have

occurred. If OCR determines that an

adoption or foster care organization

makes discriminatory placement

decisions, OCR will first seek voluntary

compliance with the law. Should

attempts at voluntary compliance prove

unsuccessful, OCR will take further

steps to enforce the law.

These steps may involve referring the

matter to the Department of Justice with

a recommendation that appropriate

court proceedings be brought. HHS may

also initiate administrative proceedings

leading to the termination of the

offending agency’s Federal financial

assistance. These proceedings include

the opportunity for a covered agency or

entity to have a hearing on any OCR

findings made against it. 45 CFR 80.8.

At any point in the complaint

investigation process or during the

pendency of fund termination

proceedings, organizations may agree to

come into voluntary compliance with

the law. OCR will work closely with

organizations to develop necessary

remedial actions, such as training of

staff in the requirements of Title VI and

MEPA, to ensure that their efforts at

compliance are successful.

When a state fails to develop an

adequate recruitment plan and expedite

the placement of children consistent

with MEPA, the Secretary through ACF

and OCR will provide technical

assistance to the state in the

development of the plan and where

necessary resolve through corrective

action major compliance issues. When

these efforts fail the Secretary will make

a determination of appropriate

proportional penalties.

[FR Doc. 95–10155 Filed 4–24–95; 8:45 am]

BILLING CODE 4150–04–M

Agency for Health Care Policy and

Research

Meeting of the National Advisory

Council for Health Care Policy,

Research, and Evaluation

AGENCY: Agency for Health Care Policy

and Research.

ACTION: Notice of public meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the National Advisory Council for

Health Care Policy, Research, and

Evaluation.

DATES: The meeting will be open to the

public on Tuesday, May 16, from 12:30

p.m. to 5:30 p.m., and on Wednesday,

May 17, from 8:30 a.m. to 10:15 a.m.

In accordance with the provisions set

forth in section 552b(c)(6), title 5, U.S.

Code, and section 10(d) of the Federal

Advisory Committee Act, a meeting

closed to the public will be held on May

17, 1995, from 10:15 a.m. to 12:00 p.m.

to discuss the relative emphasis and

focus of topics in the AHCPR grant

portfolio. The discussion could reveal

confidential personal information, the

disclosure of which would constitute a

clearly unwarranted invasion of

personal privacy.

ADDRESSES: The meeting will be held at

the Madison Hotel, 1177 15th Street,

NW., Washington, DC 20005.

FOR FURTHER INFORMATION CONTACT:

Deborah L. Queenan, Executive

Secretary of the Advisory Council at the

Agency for Health Care Policy and

Research, 2101 East Jefferson Street,

suite 603, Rockville, Maryland 20852,

(301) 594–1459.

In addition, if sign language

interpretation or other reasonable

accommodation for a disability is

needed, please contact Linda Reeves,

the Assistant Administrator for Equal

Opportunity, AHCPR, on (301) 594–

6666 no later than May 5, 1995.

SUPPLEMENTARY INFORMATION:

I. Purpose

Section 921 of the Public Health

Service Act (42 U.S.C. 299c) establishes

the National Advisory Council for

Health Care Policy, Research, and

Evaluation. The Council provides

advice to the Secretary and the

Administrator, Agency for Health Care

Policy and Research (AHCPR), on

matters related to AHCPR activities to

enhance the quality, appropriateness,

and effectiveness of health care services

and access to such services through

scientific research and the promotion of

improvements in clinical practice and
20276 Federal Register / Vol. 60, No. 79 / Tuesday, April 25, 1995 / Notices

in the organization, financing, and

delivery of health care services.

The Council is composed of public

members appointed by the Secretary.

These members are: Robert A. Berenson,

M.D.; F. Marion Bishop, Ph.D.; Linda

Burnes Bolton, Dr. P.H.; John W.

Danaher, M.D.; Helen Darling, M.A.;

Nancy J. Kaufman, M.S.; William S.

Kiser, M.D.; Robert M. Krughoff; Risa J.

Lavizzo-Mourey, M.D.; W. David Leak,

M.D.; Harold S. Luft, Ph.D.; Barbara J.

McNeil, M.D.; Walter J. McNerney,

M.H.A.; Edward B. Perrin, Ph.D.; Louis

F. Rossiter, Ph.D.; Albert L. Siu, M.D.;

and Ellen B. White, M.B.A.

There also are Federal ex officio

members. These members are:

Administrator, Substance Abuse and

Mental Health Services Administration;

Director, National Institutes of Health;

Director, Centers for Disease Control

and Prevention; Administrator, Health

Care Financing Administration;

Commissioner, Food and Drug

Administration; Assistant Secretary of

Defense (Health Affairs); and Chief

Medical Director, Department of

Veterans Affairs.

II. Agenda

On Tuesday, May 16, 1995, the open

portion of the meeting will begin at

12:30 p.m. with the call to order by the

Council Chairman. The Administrator,

AHCPR, will update the status of

current Agency issues and program

initiatives. The meeting will adjourn at

5:30 p.m.

On Wednesday, May 17, 1995, the

open portion of the Council meeting

will resume at 8:30 a.m. with a

discussion of the AHCPR grant

application review process. The open

meeting will adjourn at 10:15 a.m. The

Council will begin the closed portion of

the meeting to discuss the AHCPR grant

portfolio from 10:15 a.m. to 12:00 p.m.

The meeting will then adjourn at 12:00

p.m.

Agenda items are subject to change as

priorities dictate.

Dated: April 19, 1995.

Clifton R. Gaus,

Administrator.

[FR Doc. 95–10121 Filed 4–24–95; 8:45 am]

BILLING CODE 4160–90–M

National Institutes of Health

National Cancer Institute: Opportunity

for a Cooperative Research and

Development Agreement (CRADA) for

the Scientific and Commercial

Development of Monoclonal

Antibodies for the Therapy and/or

Diagnosis of Cancer

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Advertisement.

SUMMARY: The Laboratory of Tumor

Immunology and Biology (LTIB),

National Cancer Institute is seeking

pharmaceutical or biotechnology

collaborator(s) which can effectively

pursue the scientific and commercial

development of a panel of monoclonal

antibodies generated against tumor

associated antigens for use in the

therapy and/or diagnosis of a range of

human cancers. The primary focus of

these collaborations will be the

development and commercialization of

a panel of monoclonal antibodies

consisting of two major groups: (A)

Monoclonal antibodies directed against

the pancarcinoma antigen, TAG–72.

TAG–72 is expressed on a range of

human carcinomas including colorectal,

gastric, pancreatic, ovarian,

endometrial, breast, non-small cell lung,

and prostate. Monoclonal antibody

CC49 is the prototype monoclonal

antibody of this group. Humanized and

other genetically engineered variants of

monoclonal antibody CC49 have already

been developed. (B) Monoclonal

antibodies directed against human

carcinoembryonic antigen, which is

expressed on the following carcinomas:

colorectal, pancreatic, gastric, non-small

cell lung, and breast carcinoma. The

prototype for this group of monoclonal

antibodies is COL–1. (C) Additionally, it

may likely be a further goal of these

collaborations to develop novel

recombinant forms of these monoclonal

antibodies.

It is anticipated that because of the

magnitude, diversity, and expense of

these proposed research projects the

collaboration(s) may take the form of

multiple CRADAs. The collaboration(s)

will involve all aspects of diagnostic

and/or therapeutic development from

basic scientific inquiry to late stage

clinical trials which selected sponsor(s)

will be required to partially support.

The selected sponsor(s) will collaborate

in the development of one or more of

the following diagnostic or therapeutic

forms of these monoclonal antibodies:

(1) Radiolabeled monoclonal antibodies

(diagnostic (oncologic imaging) and/or

therapeutics); (2) Drug and/or toxin

conjugated monoclonal antibodies; (3)

Pro-drug conjugated monoclonal

antibodies; (4) Unconjugated

monoclonal antibodies (including

bifunctional forms).

Sponsors will be selected based upon

their ability to collaborate with NCI for

the development of any of these

therapeutic or diagnostic forms in

accordance with the corporate role and

selection criteria outlined below. It is

emphasized that selection of a

collaborator will not be dependent upon

an entity’s ability to perform the largest

portion of the research project. Rather,

a collaborator will be selected based

upon the scientific merit and

intellectual contributions brought to

each individual project(s). Potential

collaborators are, therefore, urged to

submit proposals which focus on

particular area(s) of expertise in a wellorganized and precise manner which

clearly outlines a development and

commercialization plan. Finally, it is

also possible that logical extensions of

these research protocols may be

considered as potential collaborative

projects. Accordingly, proposals must

address the requested criteria and

protocols, but in addition, may include

any additional unique development

projects relating to the core technology.

The term of the CRADA(s) is

anticipated to be three (3) to five (5)

years.

ADDRESSES: Inquiries and proposals

regarding this opportunity should be

addressed to either Michael Christini or

Mark Noel (Tel #301–496–0477, Fax

#301–402–2117), Office of Technology

Development, National Cancer Institute,

Building 31, Room 4A49, NIH, 9000

Rockville Pike, Bethesda, MD 20892.

DATES: Proposals must be received at the

above address by 5 p.m. June 26, 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. Under the present proposal, the

Government is seeking collaborator(s),

which in accordance with the

requirements of the regulations

governing the transfer of technology in

which the Government has taken an

active role in developing (37 CFR

404.8), can further develop this

technology to a commercially available

status to best meet the needs of the

public.

This technology has been the focal

point of much research and