Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Notices 18633

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Submission for OMB Review;

Comment Request

Title: Low Income Home Energy

Assistance Program (LIHEAP)

Household Report.

OMB No.: 0970–0060.

Description: The report is an annual

activity which is required by law of

LIHEAP grantees for receipt of federal

LIHEAP block grant funds. Statistics are

to be reported for the previous federal

fiscal year on the number and income

levels of LIHEAP applicants and

assisted households, and the number of

LIHEAP assisted households with at

least one member who is elderly,

disabled, or a young child. The

information is being collected for the

Department’s annual LIHEAP report to

Congress and is used to provide

information about the need for and use

of LIHEAP funds. The information may

also be used as performance measures

under the Government Performance

Results Act of 1993.

Respondents: State, Local or Tribal

Government.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per

respondent

Average

burden hours

per response

Total

burden

hours

LIHEAP Assisted Long Form ........................................................................... 52 1 25 1,300

LIHEAP Assisted Short Form ........................................................................... 131 1 1 131

LIHEAP Application Household Report ............................................................ 52 1 13 676

Estimated Total Annual Burden

Hours: 2,107.

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, Division of

Information Resource Management

Services, 370 L’Enfant Promenade, S.W.,

Washington, D.C. 20447, Attn: ACF

Reports Clearance Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street,

N.W., Washington, D.C. 20503, Attn:

Ms. Wendy Taylor.

Dated: April 11, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–9823 Filed 4–15–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcement No. 93631–97–01]

Developmental Disabilities: Request

for Public Comments on Proposed

Developmental Disabilities Funding

Priorities for Projects of National

Significance for Fiscal Year 1997

AGENCY: Administration on

Developmental Disabilities (ADD),

Administration for Children and

Families (ACF).

ACTION: Notice of request for public

comments on developmental disabilities

tentative funding priority for Projects of

National Significance for Fiscal Year

1997.

SUMMARY: The Administration on

Developmental Disabilities,

Administration for Children and

Families, announced that public

comments are being requested on

tentative funding priorities for Fiscal

Year 1997 Projects of National

Significance prior to being announced

in its final form.

We welcome specific comments and

suggestions on this proposed

announcement and funding priority

which will assist in bringing about the

increased independence, productivity,

integration, and inclusion into the

community of individuals with

developmental disabilities.

DATES: The closing date for submission

of public comments is June 16, 1997.

ADDRESSES: Comments should be sent

to: Bob Williams, Commissioner,

Administration on Developmental

Disabilities, Administration for Children

and Families, Department of Health and

Human Services, Room 329–D, HHH

Building, 200 Independence Avenue,

S.W., Washington, D.C. 20201.

FOR FURTHER INFORMATION CONTACT:

Adele Gorelick, Program Development

Division, Administration on

Developmental Disabilities, 202/690–

5982.

SUPPLEMENTARY INFORMATION:

Part I

Background

A. Goals of the Administration on

Developmental Disabilities

The Administration on

Developmental Disabilities is located

within the Administration for Children

and Families, Department of Health and

Human Services (DHHS). Although

different from the other ACF program

administrations in the specific

constituency it serves, ADD shares a

common set of goals that promote the

economic and social well-being of

families, children, individuals and

communities. Through national

leadership, we see:

• Families and individuals

empowered to increase their own

economic independence and

productivity;

• Strong, healthy, supportive

communities having a positive impact

on the quality of life and the

development of children;

• Partnerships with individuals,

front-line service providers,

communities, States and Congress that

enable solutions which transcend

traditional agency boundaries;

• Services planned and integrated to

improve client access; and
18634 Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Notices

• A strong commitment to working

with Native Americans, individuals

with developmental disabilities,

refugees and migrants to address their

needs, strengths and abilities. Emphasis on these goals and progress

toward them will help more

individuals, including those with

developmental disabilities, to live

productive and independent lives

integrated into their communities. The

Projects of National Significance

Program is one means through which

ADD promotes the achievement of these

goals. Two issues are of particular concern

with these projects. First, there is a

pressing need for networking and

cooperation among specialized and

categorical programs, particularly at the

service delivery level, to ensure

continuation of coordinated services to

people with developmental disabilities.

Second, project findings and successful

innovative models of projects need to be

made available nationally to policy

makers as well as to direct service

providers.

B. Purpose of the Administration on

Developmental Disabilities

The Administration on

Developmental Disabilities is the lead

agency within ACF and DHHS

responsible for planning and

administering programs which promote

the self-sufficiency and protect the

rights of individuals with

developmental disabilities. The Developmental Disabilities

Assistance and Bill of Rights Act (42

U.S.C. 6000 et seq.) (the Act), as

amended provides assistance to States

and public and private nonprofit

agencies and organizations to assure

that individuals with developmental

disabilities and their families participate

in designing, and have access to,

culturally competent services, supports

and other assistance and opportunities

that promote independence,

productivity and integration and

inclusion into the community. The Act points out that:

• Disability is a natural part of the

human experience that does not

diminish the right of individuals with

developmental disabilities to enjoy the

opportunity for independence,

productivity and inclusion into the

community; • Individuals whose disabilities occur

during their developmental period

frequently have severe disabilities that

are likely to continue indefinitely; • Individuals with developmental

disabilities often require lifelong

specialized services and assistance,

provided in a coordinated and

culturally competent manner by many

agencies, professionals, advocates,

community representatives, and others

to eliminate barriers and to meet the

needs of such individuals and their

families;

The Act further finds that:

• Individuals with developmental

disabilities, including those with the

most severe developmental disabilities,

are capable of achieving independence,

productivity, and integration and

inclusion into the community, and often

require the provision of services,

supports and other assistance to achieve

such; • Individuals with developmental

disabilities have competencies,

capabilities and personal goals that

should be recognized, supported, and

encouraged, and any assistance to such

individuals should be provided in an

individualized manner, consistent with

the unique strengths, resources,

priorities, concerns, abilities and

capabilities of the individual;

• Individuals with developmental

disabilities and their families are the

primary decision makers regarding the

services and supports such individuals

and their families receive and play

decision-making roles in policies and

programs that affect the lives of such

individuals and their families; and

• It is in the nation’s interest for

individuals with developmental

disabilities to be employed, and to live

conventional and independent lives in

families and communities.

Toward these ends, ADD seeks: to

enhance the capabilities of families in

assisting individuals with

developmental disabilities to achieve

their maximum potential; to support the

increasing ability of individuals with

developmental disabilities to exercise

greater choice and self-determination

and to engage in leadership activities in

their communities; and to ensure the

protection of legal and human rights of

persons with developmental disabilities.

Programs funded under the Act are:

• Federal assistance to State

developmental disabilities councils;

• State system for the protection and

advocacy of individual rights;

• Grants to university affiliated

programs for interdisciplinary training,

community services, technical

assistance, and information

dissemination; and

• Grants for Projects of National

Significance.

• Technical assistance to enhance the

quality of State development disabilities

councils, protection and advocacy

systems, and university affiliated

programs; and

• Other projects of sufficient size and

scope that hold promise to expand or

improve opportunities for individuals

with developmental disabilities,

including:

—technical assistance for developing

information and referral systems;

—educating policy makers;

—Federal interagency initiatives;

—enhancing participation of racial and

ethnic minorities in public and

private sector initiatives in

developmental disabilities;

—transition of youth with

developmental disabilities from

school to adult life; and

—special pilots and evaluation studies

to explore the expansion of programs

under part B (State developmental

disabilities councils) to individuals

with severe disabilities other than

developmental disabilities.

Section 162(d) of the Act requires that

ADD publish in the Federal Register

proposed priorities for grants and

contracts to carry out Projects of

National Significance. The Act also

requires a 60-day period for public

comment on proposed priorities. After

analyzing and considering such

comments, ADD must publish in the

Federal Register final priorities and

solicit applications for funding based on

the final priorities selected.

The following section presents the

proposed priority areas for Fiscal Year

1997 Projects of National Significance.

We welcome specific comments and

suggestions. We would also like to

receive suggestions on timely topics

related to specific needs in the

development disabilities field.

Please be aware that the development

of the final funding priority is based on

the public comment response to this

notice, current agency and Departmental

priorities, needs in the field of

developmental disabilities and the

developmental disabilities network, etc.,

and the availability of funds for this

fiscal year.

Part II

Fiscal Year 1997 Proposed Priority

Areas for Projects of National

Significance

ADD is interested in all comments

and recommendations which address

areas of existing or evolving national

significance related to the field of

developmental disabilities.

ADD also solicits recommendations

for project activities which will

advocate for public policy change and

community acceptance of all

individuals with developmental

disabilities and families so that such

individuals receive the culturally

competent services, supports, and other
Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Notices 18635

assistance and opportunities necessary

to enable them to achieve their

maximum potential through increased

independence, productivity, and

integration into the community.

ADD is also interested in activities

which promote the inclusion of all

individuals with developmental

disabilities, including individuals with

the most severe disabilities, in

community life; which promote the

interdependent activity of all

individuals with developmental

disabilities and individuals who are not

disabled; and which recognize the

contributions of these individuals

(whether they have a disability or not),

as such individuals share their talents at

home, school, and work, and in

recreation and leisure time.

No proposals, concept papers or other

forms of applications should be

submitted at this time. Any such

submission will be discarded.

ADD will not respond to individual

comment letters. However, all

comments will be considered in

preparing the final funding solicitation

announcement and will be

acknowledged and addressed in that

announcement.

Please be reminded that, because of

possible funding limitations, the

proposed priority areas listed below

may not be published in a final funding

solicitation for this fiscal year.

Comments should be addressed to:

Bob Williams, Commissioner,

Administration on Developmental

Disabilities, Department of Health and

Human Services, Room 329–D HHH

Building, 200 Independence Avenue,

S.W., Washington, D.C. 20201.

Proposed Fiscal Year 1997 Priority Area

1: Managed Care and Disability

The delivery systems and financing

through which health care is provided

to the nation’s population have

undergone monumental changes over

the past three decades. For the majority

of its history, the health care system in

the United States has utilized a fee-forservice model; services are provided

and then the bill is paid based on what

was done (retrospective payment

system). We are now moving toward a

prospective or prepayment based

approach where a provider is paid a set

fee based on the number of patients to

be served and services are rendered only

as needed. This system is synonymous

with managed care which promises to

control costs and improve access to a

coordinated continuum of services. To

the public and private sectors it presents

a solution to uncontrollable

expenditures. For children and adults

with developmental disabilities and

their families, the trend towards

managed care presents a mix of risks,

challenges and opportunities.

If the managed care system of health

delivery is to meet the expectations of

the public and private sectors and

provide appropriate quality acute health

care and long-term services to people

with developmental disabilities and

their families, a number of challenges

and fundamental questions must be

addressed:

• How can community long-term

services and supports that are consumer

responsive and non-medical be

integrated in acute health care under a

managed care plan?

How can managed care avoid

imposing a medical model of care that

is inconsistent with extensive,

inclusive, consumer responsive,

community long-term services and

supports?

• How will the core values of

disability policy (non-discrimination,

inclusion/participation, consumer

choice) be incorporated into managed

care if it is to provide quality,

appropriate acute and long-term

services and supports?

• How can States and others best

ensure the meaningful involvement of

people with developmental disabilities

and their families throughout the

process of designing and planning a

managed care system?

• What are the elements of a managed

care system that is cost-effective,

outcomes-oriented, and consumersensitive to the segment of the

population with developmental

disabilities?

• What is ‘‘state-of-the-art managed

care’’ for this special health care group?

• How do we ensure the practices

under managed care (i.e., gatekeepers,

restrictive definitions of medical

necessity, biased utilization review

criteria) when applied to individuals

with developmental disabilities who

may need more, or different, health care

services to maintain their health and

function effectively is nondiscriminatory?

To support our goal of independence,

productivity, and integration, ADD is

interested in ideas to empower

individuals with developmental

disabilities and their families to take a

leadership role in their States on

managed care, welfare reform, and other

emerging concerns. This could be

accomplished through a national center

to provide technical assistance in

leadership development to enable the

people most affected to be effective

players in their communities and States.

This center should be directed from a

consumer perspective yet represent a

consortium of the developmental

disabilities network, independent

living, self-advocates, parents, and

organizations representing minority

communities. This consortium should

be replicated at the State level in a

collaboration to develop and implement

strategies to foster/facilitate disability

and parent leadership in managed care,

welfare reform, and other significant

areas.

Leadership development requires not

only skills but knowledge. This center

must acquire state-of-the-art general and

technical information and numerous

aspects and issues that individuals with

developmental disabilities and parents

of children with developmental

disabilities will need to participate in

State-level activities and processes. It

will be necessary to have a resource

pool of consultants that can be utilized

as needed.

PNS projects on leadership

development and individuals of color

with developmental disabilities,

cultural competency of the DD network,

and personal assistance service have

developed training materials, curricula,

strategies, linkages, legislative

proposals, policies, and more. The

center should build upon these projects.

This is one idea that ADD has

concerning this topic but it is also

interested in any proposed priorities

and approaches addressing this area.

Proposed Fiscal Year 1997 Priority Area

2: Technical Assistance and Knowledge

Transfer on Welfare Reform and

Individuals with Developmental

Disabilities and their Families

Over a million children and adults

with disabilities and their families will

be directly affected by the

implementation of all aspects of the

Personal Responsibility and Work

Opportunity Reconciliation Act. Such

individuals and families should have an

equal opportunity to realize the full

promise of Welfare Reform, including

the chance to work their way out of

poverty, while keeping their families

health, safe and intact.

Significant research, best practices

and lessons learned exist in regard to

assisting children and adults with the

full range of disabilities to live, work

and become contributing members of

their families, communities and nation.

States, communities, businesses,

disability constituencies and others can

benefit from technical assistance aimed

at assisting them to transfer, adapt and

apply such knowledge and practice to

Welfare Reform activities.

Such technical assistance should seek

to better equip these major stakeholders

with the skills, knowledge and expertise
18636 Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Notices

necessary to apply what is already

known to work for persons with

developmental disabilities and their

families to the Welfare Reform context

in respect to:

(1) Assuring the basic civil rights of,

and equal opportunity for, individuals

with developmental disabilities and

their families on the Temporary

Assistance for Needy Families (TANF)

Program;

(2) Making work pay for low-income

parents with developmental disabilities

and parents of children with

developmental disabilities on TANF;

(3) Encouraging job/business creation

by and for low-income families and

individuals with developmental

disabilities;

(4) Increasing the access and

responsiveness of Head Start and Child

Care Programs to families of children

with developmental disabilities and

parents with developmental disabilities;

(5) Supporting and strengthening poor

families experiencing developmental

disabilities;

(6) Promoting the healthy and safe

development of children with

developmental disabilities and their

families;

(7) Making welfare reform work for

teen parents and other at-risk young

people with developmental disabilities;

(8) Making tribal welfare reform work

for Native Americans with

developmental disabilities and their

families;

(9) Making welfare reform work for

refugees and legal immigrants with

developmental disabilities and their

families; and

(10) Enhancing child support

enforcement.

ADD proposes to fund a national

technical assistance and knowledge

transfer center on effective Welfare

Reform for people with developmental

disabilities and their families. The

mission of such a center would be to

work with States, the disability

community, businesses and others to

enhance the likelihood that adults and

children with developmental

disabilities as well as their families on

TANF would have an opportunity to

benefit from all aspects of Welfare

Reform. Specifically, the center would

work with all relevant stakeholders to:

• Track and report on trends and

practices in welfare reform affecting

children and adults with developmental

disabilities;

• Convene working conferences to

develop and share strategies for

responding to opportunities and risks in

Welfare Reform for such individuals

and families;

• Conduct, sponsor, assist in and

disseminate relevant research findings

pertaining to: (i) the effects of Welfare

Reform on persons with developmental

disabilities and their families; and, (ii)

relationships between disability,

poverty, gender, ethnicity and

dependency on Aid to Families with

Dependent Children (AFDC) and TANF;

• Function as a clearinghouse on all

relevant information, emerging

knowledge, policy, best practices and

research;

• Broker technical assistance,

especially peer-to-peer consultations,

designed to assist such stakeholders to

work together to apply to Welfare

Reform research and best practices

regarding what works for persons with

developmental disabilities and their

families;

• Assist researchers conducting largescale evaluations of Welfare Reform to

assure that such studies are designed

and carried out with sensitivity to a

wide range of disability policy concerns;

• Track, synthesize, disseminate,

facilitate the adaptation and/or

replication of best or promising

approaches, as well as lessons learned,

especially those supported by

investments of ADD in DD Councils,

Protection and Advocacy Systems,

University Affiliated Programs, Projects

of National Significance and other

Federal or State agencies or foundations;

• Expand leadership development

opportunities among individuals and

families experiencing developmental

disabilities in economically

disadvantaged communities; and,

• Sponsor forums, on-line

conferences and other ongoing

exchanges to facilitate a greater

understanding of the impacts of Welfare

Reform on individuals with

developmental disabilities and their

families on the part of States, the

disability community, foundations,

researchers and others.

Proposed Fiscal Year 1997 Priority Area

3: Technical Assistance and Knowledge

Transfer on Self-Determination and

Responsible Leadership by and for

Individuals with Developmental

Disabilities and Families of Children

with Developmental Disabilities

All Americans, including people with

developmental and other disabilities,

should experience opportunities and a

sense of community and responsibility

in their lives. In fact, one of the central

tasks facing us is to devise ways we as

individuals, families, communities and

a nation can actively promote the

responsibility people with disabilities

have for their own and our collective

lives and futures. Federal legislation

such as the Developmental Disabilities

Act, the Individuals with Disabilities

Education Act and the Americans with

Disabilities Act are all grounded in the

fundamental principle that persons with

disabilities and their families have a

critical need, and as a matter of right

ought, to be primary decision-makers in

any decision affecting their lives and

futures.

The majority of the progress we have

made as a society in this regard in the

past quarter century has shown us that

responsible leadership for and by

people with developmental and other

disabilities and their families is a

prerequisite to increasing

independence, productivity, integration

and inclusion of such individuals and

their families. ADD and individual DD

Councils, Protection and Advocacy

Systems and University Affiliated

Programs have found that developing,

nurturing and sustaining strategic,

creative and responsible leadership on

the part of individuals with

developmental and other disabilities

and their families have been among the

most high-yielding long-term

investments made.

Through Projects of National

Significance, in particular, ADD has

assisted its grantees to develop and

replicate a variety of innovative,

successful approaches to develop

leadership and self-determination

among people with developmental

disabilities and their families. Most

notably, this has taken the form of early

and formative support of such

endeavors as Partners in Policy, the

active participation of families of

children with developmental

disabilities in designing and

implementing of State family support

policies and programs, the Home of

Your Own initiative, personal assistance

system change projects, and targeted

leadership efforts among people of color

with developmental disabilities.

Now more than ever, the States, the

disability community and others require

support and assistance in strategically

working through the cumulative effects

Welfare Reform, SSI changes, managed

care and Medicaid restructuring might

have on adults and children with

developmental disabilities as well as

their families. Responsible leadership

by people with developmental and other

disabilities and their families, is value

driven and recognizes the new and

emerging realities facing State and local

governments today. Such leadership is

critical to finding responsible and cost

effective ways to strengthen the abilities

and opportunities of individuals with

developmental disabilities and families

of children with developmental
Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Notices 18637

disabilities to exercise choice and selfdetermination throughout their daily

lives. This is true in respect to most

people with developmental disabilities

and families of children with

developmental disabilities, but is

particularly the case in regard to those

living in poverty.

To address this set of challenges and

opportunities, ADD proposes to fund a

national technical assistance and

knowledge transfer center on selfdetermination and 21st Century

leadership development. The mission of

such a center would be to work with all

relevant stakeholders to expand and

sustain responsible leadership by and

for people with developmental

disabilities and families of children

with developmental disabilities in

shaping and guiding the

implementation of policies, practices

and approaches which enhance their

own self-determination and selfefficacy.

Specifically, the center would seek to

strengthen and expand leadership for

the 21st Century by and for people with

developmental disabilities and families

of children with developmental

disabilities through:

• Building, expanding and

strengthening what works in this regard.

• Brokering technical assistance,

especially peer-to-peer consultations,

designed to assist such stakeholders to

work together to apply research and best

practices to enhance the selfdetermination and self-efficacy of

persons with developmental disabilities

and families of children with

developmental disabilities (especially in

States and communities that have not

taken part in similar initiatives relating

to Partners in Policy, family support,

home ownership, personal assistance,

self-determination, etc.).

• Expanding self-determination

opportunities and roles for young

people with and without developmental

disabilities (ages 12–25) as well as

individuals with significant

developmental disabilities and families

of children with developmental

disabilities from economically

disadvantaged communities.

• Convening working conferences to

develop and share strategies for

enhancing self-determination in the

context of the changing roles of the State

and Federal Governments, governmental

reinvention activities, a heightened

focus on achieving results and cost

effectiveness, welfare reform, changes in

SSI, managed care and proposals for

Medicaid restructuring.

• Conducting, sponsoring, assisting in

and disseminating relevant research

findings pertaining to the prospects for

enhancing self-determination and

influencing policy in the changing

Federal and State context described

above.

• Functioning as a clearinghouse on

all relevant information, emerging

knowledge, policy, best practices and

research.

• Tracking, synthesizing,

disseminating, facilitating the

adaptation and/or replication of best or

promising approaches, and lessons

learned, especially those supported by

investments of ADD in DD Councils,

Protection and Advocacy Systems

University Affiliated Programs, Projects

of National Significance and other

Federal or State agencies or foundations.

• Sponsoring forums, on-line

conferences and other ongoing

exchanges to facilitate a greater

understanding of the impacts of welfare

reform on individuals with

developmental disabilities and their

families on the part of States, the

disability community, foundations,

researchers and others.

Proposed Fiscal Year 1997 Priority Area

4: The National Center for the Analysis

of Major Trends and Outcomes Data

Regarding Individuals with

Developmental Disabilities and Their

Families

ADD together with Developmental

Disabilities Councils, Protection and

Advocacy Systems, University Affiliated

Programs and Projects of National

Significance are responsible for helping

to bring about the increased

independence, productivity, integration

and inclusion of all individuals with

developmental disabilities in every

aspect of American life. In enacting

Federal legislation such as the

Developmental Disabilities Act, the

Individuals with Disabilities Education

Act and the Americans with Disabilities

Act, the Congress also has found that

persons with disabilities and their

families have a critical need and as a

matter of right should be primary

decision-makers in any decision

affecting their lives and futures. ADD

and its grantees, therefore, have

significant roles in strengthening the

capabilities and expanding the

opportunities of individuals with

developmental disabilities and families

of children with developmental

disabilities to exercise choice and selfdetermination throughout their daily

lives. It is critical to recognize that a

variety of other broad governmental,

economic and social forces influence

much more directly the achievement of

these vital national aims.

Accurately measuring, tracking and

reporting on the extent to which our

society is progressing toward these goals

is crucial to assessing both the overall

effectiveness of the ADD programs and

that of the Nation as a whole in carrying

on this endeavor.

ADD has supported a number of

initiatives particularly through PNS,

and ongoing projects designed to

strengthen, expand and sustain our

collective understanding of the

changing status of Americans with

developmental disabilities. This has

taken the form of both the formative and

ongoing support for such endeavors as:

• The three national data collection

and dissemination projects;

• The development of the ADD

Management Information System;

• The Data Trends Conference

cosponsored with NIDRR;

• The AAUAP data collection project;

and

• The disability supplement to the

National Health Interview Survey.

To build on these and other efforts

and to further foster the pursuit of

excellence through its leadership and

that of its programs, ADD proposes to

fund a National Center for the Analysis

of Major Trends and Outcomes Data

Regarding Individuals with

Developmental Disabilities and Their

Families. The mission of such a center

would be to work with all relevant

stakeholders around a number of tasks

that could include the following:

(1) Build and expand upon all current

and past efforts undertaken by ADD and

all others in this area;

(2) Identify, synthesize, and report on

major data sources on major trends

affecting the lives, well being and

futures of all Americans, including

those with developmental and other

disabilities as well as their families;

(3) Identify, synthesize, and report on

major data sources on major trends

specific to the lives, well-being and

futures of individuals with

developmental disabilities and their

prospects for their increased

independence, productivity, integration

and inclusion and greater choice and

self-determination throughout their

everyday lives;

(4) Develop, continually improve, and

work with ADD, its programs and all

other relevant Federal, State and private

entities to infuse outcome measures and

other indicators accurately reflecting the

status of persons with developmental

disabilities and the families of children

with developmental disabilities into

major surveys and studies;

(5) Develop in close consultation and

collaboration with individuals with

developmental disabilities and families

of children with developmental

disabilities a prototypical survey
18638 Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Notices

instrument to assess the extent to which

such individuals and families believe

they have opportunities to exercise

meaningful choice and selfdetermination and to carry out personal

responsibilities in life; and

(6) Develop a prototypical public

opinion survey instrument which can be

reliably and cost effectively

administered to a representative

national sample of the general public at

least once every five years.

(Federal Catalog of Domestic Assistance

Number 93.631—Developmental

Disabilities—Projects of National

Significance)

Dated: April 10, 1997.

Bob Williams,

Commissioner, Administration on

Developmental Disabilities.

[FR Doc. 97–9801 Filed 4–15–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0139]

Genzyme Corp.; Premarket Approval of

SeprafilmTM Bioresorbable Membrane

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Genzyme

Corp., Cambridge, MA, for premarket

approval, under the Federal Food, Drug,

and Cosmetic Act (the act), of

SeprafilmTM Bioresorbable Membrane.

After reviewing the recommendation of

the General and Plastic Surgery Devices

Panel, FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of August 12, 1996,

of the approval of the application.

DATES: Petitions for administrative

review by May 16, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Stephen P. Rhodes, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–3090.

SUPPLEMENTARY INFORMATION: On

October 27, 1995, Genzyme Corp.,

Cambridge, MA 02139–1562, submitted

to CDRH an application for premarket

approval of SeprafilmTM Bioresorbable

Membrane. The device is an absorbable

adhesion barrier and is indicated for use

in patients undergoing abdominal or

pelvic laparotomy as an adjunct

intended to reduce the incidence,

extent, and severity of postoperative

adhesions between the abdominal wall

and the underlying viscera such as

omentum, small bowel, bladder, and

stomach, and between the uterus and

surrounding structures such as tubes

and ovaries, large bowel and bladder.

On March 25, 1996, the General and

Plastic Surgery Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application. On August 12, 1996, CDRH

approved the application by a letter to

the applicant from the Director of the

Office of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 21 CFR

part 12 of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under 21 CFR 10.33(b).

A petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before May 15, 1997, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: March 17, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–9726 Filed 4–15–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–2552, HCFA–R–88]

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.

1. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Hospital and

Hospital Health Care Complex Cost

Report, 42 CFR 413.20 and 413.24; Form

No.: HCFA–2552–96; Use: This form is