Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices 18613

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

FOR FURTHER INFORMATION CONTACT:

Annette Ragosta, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA

acknowledges that changes in product

manufacture may occur during product

development and subsequent to product

approval. Manufacturers frequently

upgrade and refine a product’s

production process as technology

advances and as they gain experience

with the product. Historically, because

of the limited ability to characterize the

identity and structure of the clinically

active component(s) and measure its

activity, a biological product was often

defined by its manufacturing process,

and manufacturers of biological

products sought to minimize changes to

the manufacturing process to avoid

performing additional clinical studies to

verify the safety, purity, and potency of

the finished product. Due to advances in

biologics research and manufacturing,

including the ability to make wellcharacterized biotechnology-derived

products, a manufacturer may change a

manufacturing process without FDA

requiring additional clinical studies if

test data demonstrate that the product is

comparable to the product

manufactured before the change.

Therefore, FDA is publishing this

guidance document to further clarify

situations in which sponsors may make

manufacturing changes and perform

comparability testing to assure that the

approved product is pure, potent, and

safe.

Manufacturers should perform

comparability testing to demonstrate

that identity, purity, potency, and safety

of the product have not been affected by

changes in the manufacturing process,

equipment, or facilities. This guidance

document discusses principles and

categories of tests which may be

performed to demonstrate product

comparability, but does not discuss

specific manufacturing changes.

Comparability testing programs may

include a combination of analytical

testing, bioassays, preclinical animal

studies, and clinical studies. Since each

product may present unique concerns,

the type of change, the relevance of

validated analytical and biological

assays used, the stage of product

development, and the clinical program

should be considered by manufacturers

when designing a comparability

program. FDA will take all of these into

consideration when reviewing the

comparability data that are submitted.

Sponsors are encouraged to discuss

proposed testing programs with FDA

before implementing them, especially in

those cases where they expect

differences to result from the

manufacturing changes. This document

does not describe how changes are to be

reported or which changes require prior

approval. Manufacturers should consult

current regulations and guidance

documents regarding reporting and

approval submissions.

As with other guidance documents,

FDA does not intend this document to

be all inclusive. The document is

intended to provide information and

does not set forth requirements.

Manufacturers may follow the

document or may choose to use

alternative procedures that are not

provided in this document. If a

manufacturer chooses to use alternative

procedures, that manufacturer may wish

to discuss the matter further with FDA

to prevent expenditure of resources to

generate data on activities that FDA may

later determine to be unacceptable.

Although this guidance document

does not create or confer any rights for

or on any person and does not operate

to bind FDA or the public, it does

represent the agency’s current thinking

on the demonstration of comparability

of human biological products, including

therapeutic biotechnology-derived

products.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the

guidance document. FDA will review

the comments received and if

appropriate consider preparing a revised

guidance document based upon that

review. However, CBER notes that it has

made comparability assessments when

approving /products in the past and will

continue to do so during the comment

period. FDA will announce the

availability of this revised guidance

document in the Federal Register if

FDA revises its comparability policy as

a result of public comment.

Dated: April 22, 1996

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–10426 Filed 4–25–96; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Maternal and Child Health Services;

Federal Set-Aside Program;

Continuing Education and

Development Cooperative Agreements

AGENCY: Health Resources and Services

Administration (HRSA), PHS.

ACTION: Notice of availability of funds.

SUMMARY: The HRSA announces that

applications will be accepted for fiscal

year (FY) 1996 funds for Maternal and

Child Health (MCH) Special Projects of

Regional and National Significance

(SPRANS) Continuing Education and

Development (CED) cooperative

agreements to support national

education, information, and public

policy projects in maternal and child

health. Awards will be made under the

program authority of section

502(a)(2)(A) of the Social Security Act,

the training provision of the MCH

Federal Set-Aside Program. SPRANS

training projects may be awarded only

to public or nonprofit private

institutions of higher learning. Within

the HRSA, MCH CED cooperative

agreements are administered by the

Maternal and Child Health Bureau

(MCHB). Awards under this

announcement are made for grant

periods of up to 5 years in duration.

This program announcement is

subject to the appropriation of funds.

Applicants are advised that this

program announcement is a contingency

action being taken to assure that should

funds become available for this purpose,

they can be awarded in a timely fashion

consistent with the needs of the

program as well as to provide for even

distribution of funds throughout the

fiscal year. At this time, given a

continuing resolution and the absence

of FY 1996 appropriations for the

SPRANS program, the amount of

available funding for this specific grant

program cannot be estimated.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of Healthy People 2000, a

PHS-led national activity for setting

priority areas. The MCH Block Grant

Federal Set-Aside Program addresses

issues related to the Healthy People

2000 objectives of improving maternal,

infant, child and adolescent health and

developing service systems for children

with special health care needs. Potential

applicants may obtain a copy of Healthy

People 2000 (Full Report: Stock No.

017–001–00474–0) or Healthy People

2000 (Summary Report: Stock No. 017–

001–00473–1) through the
18614 Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices

Superintendent of Documents,

Government Printing Office

Washington, DC 20402–9325

(telephone: 202 783–3238).

The PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and promote the non-use of

all tobacco products. In addition, Public

Law 103–227, the Pro-Children Act of

1994, prohibits smoking in certain

facilities (or in some cases, any portion

of a facility) in which regular or routine

education, library, day care, health care

or early childhood development

services are provided to children.

ADDRESSES: Grant application materials

for MCH CED cooperative agreements

must be obtained from and submitted to:

Chief, Grants Management Branch,

Office of Operations and Management,

Maternal and Child Health Bureau,

Health Resources and Services

Administration, Room 18–12, Parklawn

Building, 5600 Fishers Lane, Rockville,

Maryland 20857, (301) 443–1440.

Applicants will use Form PHS 6025–1,

approved by OMB under control

number 0915–0060. You must obtain

application materials in the mail.

Federal Register notices and

application guidance for MCHB

programs are available on the World

Wide Web via the Internet at address:

http://www.os.dhhs.gov/hrsa/mchb.

Click on the file name you want to

download to your computer. It will be

saved as a self-extracting (Macintosh or)

Wordperfect 5.1 file. To decompress the

file once it is downloaded, type in the

file name followed by a <return>. The

file will expand to a Wordperfect 5.1

file. If you have difficulty accessing the

MCHB Home Page via the Internet and

need technical assistance, please contact

Linda L. Schneider at 301–443–0767 or

‘‘lschneider@hrsa.ssw.dhhs.gov’’.

DATES: The deadline for receipt of

applications for CED cooperative

agreements is June 7, 1996.

Applications will be considered to

have met the deadline if they are either:

(1) Received on or before the deadline

date, or (2) postmarked on or before the

deadline date and received in time for

orderly processing. Applicants should

request a legibly dated receipt from a

commercial carrier or the U.S. Postal

Service, or obtain a legibly dated U.S.

Postal Service postmark. Private

metered postmarks will not be accepted

as proof of timely mailing. Late

applications or those sent to an address

other than specified in the ADDRESSES

section will be returned to the

applicant.

FOR FURTHER INFORMATION CONTACT:

Requests for technical or programmatic

information should be directed to the

contact persons identified below.

Requests for information concerning

business management issues should be

directed to: Acting Grants Management

Officer (GMO), MCHB, at the address

specified in the ADDRESSES section.

SUPPLEMENTARY INFORMATION:

Program Background and Objectives

Under Section 502 of the Social

Security Act, 15 percent of the funds are

to be set-aside by the Secretary to

support (through grants, contracts, or

otherwise) special projects of regional

and national significance, including

research, and training with respect to

maternal and child health and children

with special health care needs

(including early intervention training

and services development). The MCH

SPRANS set-aside was established in

1981. Support for projects covered by

this announcement will come from the

SPRANS set-aside.

Continuing Education and

Development (CED) training includes

efforts conducted by an institution of

higher learning such as short-term, nondegree programs, courses, workshops,

conferences, symposia, institutes, and

long distance learning strategies; and/or

development or enhancement of

curricula, guidelines, standards of

practice, and educational tools/

strategies. Continuing Education and

Development focuses on increasing

leadership skills of MCH professionals;

facilitating timely transfer and

application of new information,

research findings, and technology

related to MCH; and updating and

improving the knowledge and skills of

health and related professionals in

programs serving mothers and children,

including children with special health

care needs (CSHCN). As a result of the

CED, professionals and the public are

more adequately prepared to provide

comprehensive services and to provide

leadership in advancing the field to

better serve mothers and children.

The undertaking for which

applications are being solicited in this

notice is intended to expand on at least

one similar project in resource and

policy development—the National

Education and Information Project—

conducted since 1989 by the National

Center for Education in Maternal and

Child Health, Georgetown University.

The general purpose of that project was

to gather, classify, store, and

disseminate information on maternal

and child health. Major services

included dissemination of information

and education through workshops and

conferences, and production of

publications drawn from customized

databases.

Special Concerns

In its administration of the MCH

Services Block Grant, the MCHB places

special emphasis on improving service

delivery to women and children from

racial and ethnic minority populations

who have had limited access to care.

This means that SPRANS projects are

expected to serve and appropriately

involve in project activities individuals

from the populations to be served,

unless there are compelling

programmatic or other justifications for

not doing so. The MCHB’s intent is to

ensure that project interventions are

responsive to the cultural and linguistic

needs of special populations, that

services are accessible to consumers,

and that the broadest possible

representation of culturally distinct and

historically underrepresented groups is

supported through programs and

projects sponsored by the MCHB. This

same special emphasis applies to

improving service delivery to children

with special health care needs.

In keeping with the goals of

advancing the development of human

potential, strengthening the Nation’s

capacity to provide high quality

education by broadening participation

in MCHB programs of institutions that

may have perspectives uniquely

reflecting the Nation’s cultural and

linguistic diversity, and increasing

opportunities for all Americans to

participate in and benefit from Federal

public health programs, a funding

priority will be placed on projects from

Historically Black Colleges and

Universities (HBCU) or Hispanic

Serving Institutions (HSI) in both

categories in this notice. An approved

proposal from a HBCU or HSI will

receive a 0.5 point favorable adjustment

of the priority score in a 5 point range

before funding decisions are made.

Evaluation Protocol

An MCH discretionary project,

including a SPRANS, is expected to

incorporate a carefully designed and

well planned evaluation protocol

capable of demonstrating and

documenting measurable progress

toward achieving the project’s stated

goals. The protocol should be based on

a clear rationale relating the project

activities, the project goals, and the

evaluation measures. Wherever

possible, the measurements of progress

toward goals should focus on health

outcome indicators, rather than on

intermediate measures such as process

or outputs. A project lacking a complete

and well-conceived evaluation protocol
Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices 18615

as part of the planned activities will not

be funded.

Project Review and Funding

Within the limit of funds determined

by the Secretary to be available for the

activities described in this

announcement, the Secretary will

review applications for funds as

competing applications and may award

Federal funding for projects which will,

in her judgment, best promote the

purpose of Title V of the Social Security

Act, with special emphasis on

improving service delivery to women

and children from culturally distinct

populations; best address achievement

of Healthy Children 2000 objectives

related to maternal, infant, child and

adolescent health and service systems

for children at risk of chronic and

disabling conditions; and otherwise best

promote improvements in maternal and

child health.

Criteria for Review

The criteria which follow are used, as

pertinent, to review and evaluate

applications for awards under all

SPRANS cooperative agreement

categories announced in this notice.

Further guidance in this regard is

supplied in application guidance

materials.

—The quality of the project plan or

methodology.

—The need for the training.

—The extent to which the project will

contribute to the advancement of

maternal and child health and/or

improvement of the health of children

with special health care needs;

—The extent to which the project is

responsive to policy concerns

applicable to MCH grants and to

program objectives, requirements,

priorities and/or review criteria for

specific project categories, as

published in program announcements

or guidance materials.

—The extent to which the estimated

cost to the Government of the project

is reasonable, considering the

anticipated results.

—The extent to which the project

personnel are well qualified by

training and experience for their roles

in the project and the applicant

organization has adequate facilities

and personnel.

—The extent to which, insofar as

practicable, the proposed activities, if

well executed, are capable of attaining

project objectives.

—The strength of the project’s plans for

evaluation.

—The extent to which the project will

be integrated with the administration

of the MCH Block Grant, State

primary care plans, public health, and

prevention programs, and other

related programs in the respective

State(s).

—The extent to which the application is

responsive to the special concerns

and program priorities specified in

this notice.

Award Categories

For FY 1996, CED cooperative

agreements will be awarded in two

categories: one concerned with resource,

educational and analytic activities; and

the other concerned with populationfocused analytic and related activities.

There will be substantial Federal

programmatic involvement in these

cooperative agreements. This means that

after award, awarding office staff

provide technical assistance and

guidance to, or coordinate and

participate in, certain programmatic

activities of award recipients beyond

their normal stewardship

responsibilities in the administration of

grants. Federal involvement may

include, but is not limited to, planning,

guidance, coordination and

participation in programmatic activities.

Periodic meetings, conferences, and/or

communications with the award

recipient are held to review mutually

agreed upon goals and objectives and to

assess progress. Additional details on

the scope of Federal programmatic

involvement in cooperative agreements,

consistent with HRSA grants

administration policy, will be included

in the application guidance for these

cooperative agreements.

Purpose

The purpose of these cooperative

agreements is to support a program of

continuing education and development

(CED) through interrelated national

education, information and public

policy projects in maternal and child

health. This effort would build on the

National Education and Information

Project, which has been conducted by

the National Center for Education in

Maternal and Child Health, at

Georgetown University. The cooperative

agreements seek to improve the health

status of mothers and children through:

—Development and dissemination of

new information,

—Initiation or demonstration of new or

improved ways of delivering care or

otherwise enhancing the capacity of

Title V and related programs to

provide or assure the provision of

appropriate services, or

—Advancing the knowledge, skills and

leadership of personnel in specialities

relevant to MCH.

Based on state-of-the-art analysis, the

continuing education offered is

intended to develop or improve

standards, practices or delivery of

health care for the MCH population, and

may be provided through such activities

as workshops, seminars, institutes, and

other relevant activities.

Awardees for these cooperative

agreements will be expected to work

closely with a national maternal and

child health clearinghouse and with

each other in handling referrals of

inquiries and requests for publications

and other information.

Categories/Priorities

The following two categories of

cooperative agreements will be funded

through this announcement:

—Category I: Resource, educational, and

analytic activities to assist in policy

formulation and program

development across target

populations. These would focus on

such functional areas as child health

supervision, nutrition, oral health,

injury prevention, immunizations,

mental health, community systems,

financing, and economics.

—Category II: Population-focused

education and analytic, and related

activities to assist in policy

formulation and program

development to advance a national

agenda concentrating on the following

maternal and child health

subpopulations: perinatal and

women, infancy and early childhood,

and middle childhood and

adolescence. These would focus on

such issues as those relating to

program content, systems

development, accountability/quality

improvement, and special concerns

noted earlier.

Project Period

Project durations are up to 5 years.

Contact

For programmatic or technical

information, contact Woodie Kessel,

M.D., telephone 301–443–2340, or

David Heppel, M.D., telephone 301–

443–2250.

Public Comment

The categories, priorities, special

considerations and preferences

described above are not being proposed

for public comment this year. In July

1993, following publication of the

Department’s Notice of Proposed

Rulemaking to revise the MCH special

project grant regulations at 42 CFR 51a,

the public was invited for a 60-day

period to submit comments regarding all

aspects of the SPRANS application and
18616 Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices

review process. In responding to those

comments, the Department noted the

practical limits on Secretarial discretion

in establishing SPRANS categories and

priorities owing to the extensive

prescription in both the statute and

annual Congressional directives.

Comments on this SPRANS notice

which members of the public wish to

make are welcome at any time and may

be submitted to: Director, MCHB, at the

address listed in the ADDRESSES section.

Suggestions will be considered when

priorities are developed for the next

solicitation.

Eligible Applicants

MCH training awards may be made

only to public or nonprofit private

institutions of higher learning.

Executive Order 12372

The MCH Federal set-aside program

has been determined to be a program

which is not subject to the provisions of

Executive Order 12372 concerning

intergovernmental review of Federal

programs.

The OMB Catalog of Federal Domestic

Assistance number is 93.110.

Dated: April 22, 1996.

Ciro V. Sumaya,

Administrator.

[FR Doc. 96–10425 Filed 4–25–96; 8:45 am]

BILLING CODE 4160–15

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–3778–N–82]

Office of the Assistant Secretary for

Community Planning and

Development; Federal Property

Suitable as Facilities To Assist the

Homeless

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: This Notice identifies

unutilized, underutilized, excess, and

surplus Federal property reviewed by

HUD for suitability for possible use to

assist the homeless.

EFFECTIVE DATE: April 26, 1996.

FOR FURTHER INFORMATION CONTACT:

Mark Johnston, Department of Housing

and Urban Development, Room 7256,

451 Seventh Street SW., Washington,

DC 20410; telephone (202) 708–1226;

TDD number for the hearing- and

speech-impaired (202) 708–2565, (these

telephone numbers are not toll-free), or

call the toll-free Title V information line

at 1–800–927–7588.

SUPPLEMENTARY INFORMATION: In

accordance with the December 12, 1988

court order in National Coalition for the

Homeless v. Veterans Administration,

No. 88–2503–OG (D.D.C.), HUD

publishes a Notice, on a weekly basis,

identifying unutilized, underutilized,

excess and surplus Federal buildings

and real property that HUD has

reviewed for suitability for use to assist

the homeless. Today’s Notice is for the

purpose of announcing that no

additional properties have been

determined suitable or unsuitable this

week.

Dated: April 19, 1996.

Jacquie M. Lawing,

Deputy Assistant Secretary for Economic

Development.

[FR Doc. 96–10241 Filed 4–25–96; 8:45 am]

BILLING CODE 4210–29–M

DEPARTMENT OF THE INTERIOR

Western Water Policy Review Advisory

Commission Meeting

AGENCY: Department of the Interior.

ACTION: Notice of open meeting.

SUMMARY: Pursuant to the Federal

Advisory Committee Act, notice is

hereby given that the Western Water

Policy Review Advisory Commission

(Commission), established by the

Secretary of the Interior under the

Reclamation Projects Authorization and

Adjustment Act of 1992, will hold its

second meeting. The meeting will be

open to the public.

DATES: The meeting will be Thursday,

May 16, 1996, from 1:00 to 5 p.m. and

Friday, May 17, 1996, from 8:30 a.m. to

12:00 noon.

ADDRESSES: The Commission meeting

will be at the Executive Tower Hotel,

1405 Curtis Street, Denver, Colorado.

FOR FURTHER INFORMATION CONTACT:

Western Water Policy Review Office, PO

Box 25007, Denver, Colorado, 80225,

(303) 236–6211.

SUPPLEMENTARY INFORMATION: The

Reclamation Projects Authorization and

Adjustment Act of 1992, Public Law

102–575, Section 30 directs the

President to undertake a comprehensive

review of Federal activities in the 19

Western States which affect the

allocation and use of water resources,

and to submit a report on the President’s

finding and recommendations to

Congress. The Secretary of the Interior

established the Commission to provide

assistance regarding the President’s

report to Congress. The President’s

report is due to Congress by October 2,

1997.

At this meeting, the Commission will

discuss the information obtained at a

series of scoping of meetings held

recently throughout the Western United

States to obtain suggestions for the

Commission’s work plan. A final work

plan will be proposed and discussed by

the Commission. Members of the public

may submit written statements to the

Commission at the address listed above,

or at the meeting. There will be an

opportunity for public comment to the

Commission on Friday morning, May

17, 1996. If you are interested in

addressing the Commission, please

notify the Commission office by May 10,

1996, to facilitate scheduling. Seating at

the meeting will be limited and

therefore on a first come basis.

Dated: April 22, 1996.

Lawrence J. MacDonnell,

Executive Director, Western Water Policy

Review Advisory Commission.

[FR Doc. 96–10357 Filed 4–25–96; 8:45 am]

BILLING CODE 4310–94–M

Fish and Wildlife Service

Endangered and Threatened Species

Permit Application

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of document availability;

request for comments.

Availability of an Environmental

Assessment and Receipt of an

Application for a Permit to Authorize

Incidental Take of Threatened and

Endangered Species by Port Blakely

Tree Farms, L. P., on the Robert B. Eddy

Tree Farm, Pacific and Grays Harbor

Counties, Washington.

SUMMARY: This notice advises the public

that Port Blakely Tree Farms, L. P., of

Seattle, Washington (Applicant) has

applied to the U.S. Fish and Wildlife

Service (FWS) for an incidental take

permit pursuant to section 10(a)(1)(B) of

the Endangered Species Act of 1973, as

amended (Act). The application has

been assigned permit number PRT–

813744. The Applicant has also

requested to enter into a consensual

agreement with the U.S. National

Marine Fisheries Service (NMFS) to

address the needs of anadromous

salmonids being considered for listing

under the Act, and with the FWS to

conserve other fish and wildlife species

which may be associated with habitats

on their Robert B. Eddy Tree Farm in

Pacific and Grays Harbor Counties,

Washington (Tree Farm). The requested

permit would authorize the incidental

take of northern spotted owls (Strix

occidentalis caurina), marbled