20988 Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices

leave your name, address, and

telephone number and instructed to

identify the announcement number of

interest.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance can be obtained from:

William Paradies, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 2920 Brandywine Road, Room

3000, Atlanta, Georgia 30341–

4146,Telephone (770) 488–2721,

Internet address: wep2@cdc.gov

General program assistance can be

obtained from: Joseph B. Smith,

Disability and Health Branch, National

Center for Environmental Health, CDC,

4770 Buford Highway, Building 101,

Mailstop F–29, Atlanta, Georgia 30341,

Telephone (770) 488–7082, Internet

address: jos4@cdc.gov

Research-related technical assistance

for Focus Areas 1 and 2 is available

from: John F. Hough, Dr.P.H., National

Center for Environmental Health, CDC,

4770 Buford Highway, Building 101,

Mailstop F–29, Atlanta, Georgia 30341,

Telephone (770) 488–7830, Internet

Address: jph7@cdc.gov

Research-related technical assistance

for Focus Area 3 is available from:

Donald J. Lollar, Ed.D., National Center

for Environmental Health, CDC, 4770

Buford Highway, Building 101, Mailstop

F–29, Atlanta, Georgia 30341,

Telephone (770) 488–7094, Internet

address: dcl5@cdc.gov

Dated: April 11, 2000.

John L. Williams,

Director, Procurement and Grants Office.

[FR Doc. 00–9456 Filed 4–18–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcement No. 93631–00–02]

Developmental Disabilities: Request

for Public Comments on Proposed

Developmental Disabilities Funding

Priorities for Projects of National

Significance for Fiscal Year 2000

AGENCY: Administration on

Developmental Disabilities (ADD), ACF,

DHHS.

ACTION: Notice of request for public

comments on developmental disabilities

tentative funding priorities for Projects

of National Significance for Fiscal Year

2000.

SUMMARY: The Administration on

Developmental Disabilities (ADD)

announced that public comments are

being requested on tentative funding

priorities for Fiscal Year 2000 Projects

of National Significance prior to being

announced in its final form.

We welcome comments and

suggestions on this proposed

announcement and funding priorities

that 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 comments is June 19, 2000.

ADDRESSES: Comments should be sent

to: Sue Swenson, Commissioner,

Administration on Developmental

Disabilities, Administration for Children

and Families, Department of Health and

Human Services, 370 L’Enfant

Promenade, SW, Room 300F,

Washington, DC 20447.

FOR FURTHER INFORMATION CONTACT:

Administration for Children and

Families (ACF), Pat Laird, 370 L’Enfant

Promenade, SW, Room 300F,

Washington, DC, 20447, 202/690–7447.

SUPPLEMENTARY INFORMATION: This

announcement consists of two parts:

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

administrators 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, health, 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

• A strong commitment to work 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 to 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 development 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 that promote

the self-sufficiency and protect the

rights of individuals with

developmental disabilities.

The 1996 Amendment (Public Law

104–183) to the Developmental

Disabilities Assistance and Bill of Rights

Act (42 U.S.C. 6000 et seq.) (the Act)

supports and provides assistance to

States and public and private nonprofit

agencies and organizations to assure

that individuals with developmental

disabilities and their families participate

in the design of 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 development period

frequently have severe disabilities that

are likely to continue indefinitely;

• Individual with developmental

disabilities often require lifelong

specialized services and assistance,

provided in a coordinated and

culturally competent manner by many

Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices 20989

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:

• Individual with developmental

disabilities, including those with the

most several 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;

• Individual 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

program that affect the lives of such

individuals and their families; and

• It is the nation’s interest for

individuals with developmental

disabilities to be employed, and to live

conventional and independent lives as a

part of 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, to

engage in leadership activities in their

communities, as well as to ensure the

protection of their legal and human

rights.

• Programs funded under the Act are:

• Federal assistance to State

developmental disabilities councils;

• State system for the protection and

advocacy of individual’s rights;

• Grants to university affiliated

programs for interdisciplinary training,

exemplary services, technical

assistance, and information

dissemination; and

• Grants for Projects of National

Significance.

C. Description of Projects of National

Significance

Under Part E of the Act,

demonstration grants and contracts are

awarded for projects of national

significance that support the

development of national and State

policy to enhance the independence,

productivity, and integration and

inclusion of individuals with

developmental disabilities through:

• Data collection and analysis;

• Technical assistance to enhance the

quality of State developmental

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 the

development of information and

referral systems;

—educating policy makers;

—Federal interagency initiatives;

—the enhancement of 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.

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 period of 60 days for public

comment concerning such proposed

priorities. After analyzing and

considering such comments, ADD must

publish in the Federal Register final

priorities for such grants and contracts,

and solicit applications for funding

based on the final priorities selected.

The following section presents the

proposed priority areas for Fiscal Year

2000 Projects of National Significance.

We welcome specific comments and

suggestions. We would also like to

receive suggestions on topics which are

timely and relate to specific needs in the

developmental 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.,

as well as the availability of funds for

this fiscal year.

Part II

Fiscal Year 2000 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

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 development

disabilities, including individuals with

the most severe disabilities, in

community life; which promote the

interdependent activity of people with

developmental disabilities and people

without disabilities; and which

recognize the contributions of these

people (whether they have a disability

or not), who 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:

Sue Swenson, Commissioner,

Administration on Developmental

Disabilities, Administration for Children

and Families, Department of Health and

Human Services, 370 L’Enfant

Promenade, SW, Room 300F,

Washington, DC 20447.

Proposed Fiscal Year 2000 Priority Area

1: Mobilizing for Change/Rapid

Deployment of Good Ideas

In March of 1993, President Clinton

unveiled his new initiative to reinvent

the federal government. He proposed a

leaner, more efficient government that

viewed the American people as its

customers. The President discussed how

all of us to some extent count on the

government to do certain things such as,

‘‘protect the environment, to provide

education and health care and other

basic needs.’’ However, he pointed out

that a ‘‘democracy can become quickly

an empty phrase, if those who are

elected to serve cannot meet the needs

20990 Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices

of the people except with Government

that costs too much or is too slow or too

arrogant or too unresponsive.’’ Federal

workers were empowered to reinvent

their agencies in ways that would put

customers first, cut red tape, get results,

and get back to basics.

At ADD, our agency efforts resulted in

a document called ‘‘The Roadmap to the

Future,’’ which was developed together

with the programs it funds, establishes

a course of action for ADD and for its

programs. The Roadmap defines the

mission and vision of ADD, of the State

Developmental Disabilities Councils

(DDCs), of the Protection and Advocacy

Systems (P&As), of the Universities

Affiliated Programs (UAPs), and of the

Projects of National Significance (PNS),

and it identifies goals created to

increase the independence,

productivity, and integration and

inclusion of people with developmental

disabilities and their families. Program

activities will be directed toward

achieving the Roadmap goals.

The Projects of National Significant

(PNS) Program is one of the activities of

ADD. Every year since 1975 there have

been model demonstration projects

funded to increase the independence,

productivity, and integration and

inclusion of people with developmental

disabilities. These projects have

generated inventive approaches,

strategies, and methodologies in

addressing pervasive problems or needs

of individuals with developmental

disabilities and their families. Over the

years, PNS projects have contributed to

the knowledge base of the

developmental disabilities field and the

larger disability field as well. In the past

decade, the leadership capacity of

individuals with developmental

disabilities, especially self-advocates,

has been nourished and strengthened by

the funding of PNS projects.

Although dissemination of

information from these projects has

been a requirement of funding, it is a

concern of ADD’s that the rich volume

of knowledge and information produced

by these projects has not reached a

broader of people who either could

directly benefit form it or are in a

position to replicate it. More important,

depending on the target audience, we

have not been successful in influencing

permanent behavioral changes. The

explosion of communications arts and

technology offer new possibilities for

reaching a broader audience. A major

challenge lies in connecting with those

segments of our population who do not

have easy access to a computer or

English is not their primary language or

there are cultural differences. New

design models of transferring knowledge

and fostering utilization must be

explored if we are to meet the needs of

Americans with disabilities and their

families. ADD is extremely interested in

supporting this ‘‘reinvention ’’ of new

models under this priority area.

These models must surpass our

standard methods of communication

best practices and practical solutions to

those we serve and those who serve

them. Projects must be outcome

driven—demonstrating effectiveness

and behavioral changes of the targeted

population. Content area is open to any

proven, positive results-based practice,

methodology or processing the field of

developmental or other disabilities or

directly related field such as universal

design. It can be an expansive as

systems change cr a new paradigm.

These new models should consider

creative partnering implementing the

project. A few examples of this by the

Federal government are the JedI project

under the U.S. Geological Survey and

The Knowledge Loom under the U.S.

Department of Education/Office of

Educational Research and Improvement.

The former, which stands for joint

education initiative, utilized CD–ROM

technology containing different types of

data and in conjunction with teachers

developed educational materials that

could be used in the classroom. The

latter is a recent project funded to create

an electronic interactive workspace for

anyone interested in the education

environment.

In the last century we were the

beneficiaries of extraordinary human

developments that would have been

considered inconceivable by many; it

has raised our level of expectation for

this new century. This is no less true for

people with developmental disabilities

and their families who, in this age of the

Internet, the PC, and satellite

downlinks, expect there will be new

models available to everyone who needs

them. ADD views this priority area as an

unprecedented opportunity to take what

we have learned through federally

funded projects and find enterprising,

inventive, and imaginative ways of

using the knowledge so that all will

benefit—people with developmental

disabilities and other disabilities,

professionals who serve them, their

families, and the communities in which

they live.

Proposed Fiscal Year 2000 Priority Area

2: Bridging the Digital Divide: Building

Content

In a White House speech on February

2, 2000, President Clinton stated:

‘‘Access to computers and the Internet

and the ability to effectively use this

technology are becoming increasingly

important for full participation in

America’s economic, political and social

life. People are using the Internet to find

lower prices for goods and services,

work from home or start their own

business, acquire new skills using

distance learning, and make better

informed decisions about their

healthcare needs.’’

The President expressed his concern

over the widening gap of access:

‘‘Access to computers and the Internet

has exploded during the Clinton-Gore

Administration. Unfortunately, there is

strong evidence of a ‘digital divide’—a

gap between those individuals and

communities that have access to these

Information Age tools and those who

don’t. In some instances, this divide is

actually widening.’’ The President has

proposed three basic approaches to

narrowing the digital divide: (1) Provide

hardware and connections to people

who do not yet have them; (2) provide

training in the use of computers and the

internet; and (3) build relevant content

on the Internet, to attract new users.

ADD continues to encourage its grantees

and partners in all three of these

strategies, but realizes that a national

approach is necessary to the third

strategy of building relevant content.

A person with a developmental

disability is legislatively defined as

someone whose disability occurred

before age 22; is severe and lifelong; and

is likely to result in an ongoing, longterm need for services and supports. In

other words, people with developmental

disabilities are likely to need to rely on

multiple systems of supports in order

simply to live their lives. And yet,

information that could be used to

improve decision-making is not easily

accessible to people with developmental

disabilities, their families, their

advocates, their providers of services

and supports, or even to the

policymakers who design and fund

systems. For people with developmental

disabilities, Internet access to relevant

information is limited.

For the majority of people with

developmental disabilities and their

families, Medicaid is the most relevant

system; it is their lifeline. Yet it is a very

complex system whose possibilities

change almost constantly, and quite

rapidly. As States submit new ideas to

the Health Care Finance Administration

(HCFA) in Home and Community-Based

Services (HCBS) waiver plans, and as

these state-generated plans are

approved, possibilities for all other

States and all other citizens shift. In

addition, the Medicaid program is

complex due to the ‘‘patchwork quilt of

incremental statutory amendments and

Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices 20991

administrative policy changes spread

over several decades.’’ (GAO, 1996)

Nevertheless, many (though not all) of

the Medicaid questions to which people

need answers are repetitive and

sometimes simple. Clear, honest, userfriendly answers to frequently asked

questions are often a feature of Web

sites on any topic and may be one of the

best uses of the Internet.

ADD is proposing to fund one project

to build an Internet site that will

provide relevant content and attractive

information on what is possible under

the Medicaid program. The site should

be user-friendly and useful to a broad

range of users, including people with

developmental and other related

disabilities, their families, their

advocates, DD network members, state

policymakers, regional HCFA staff, and

other interested persons. The site

should be responsive to the needs and

wants of its users, and should collect

and measure user satisfaction. It should

post frequently asked questions (FAQs)

about Medicaid with their answers, and

should encourage frank and open

‘‘human’’ interchanges between users.

The site must be accessible to people

with a broad range of disabilities.

Proposing organizations must show that

they (1) are credible sources of

information to people with

developmental disabilities and (2) that

they intend to comply with accessibility

standards and go beyond compliance to

improve access as much as possible.

Special care should be taken to make

the site useful and attractive to young

persons with developmental and other

disabilities.

Proposed Fiscal Year 2000 Priority Area

3: Managing Our Program Knowledge

Through Web Improvement

The Developmental Disabilities

Assistance and Bill of Rights Act (DD

Act) provides authorization for three

State Programs and a national program

that seek to increase the independence,

productivity, and inclusion of persons

with developmental disabilities.

A Developmental Disabilities Council

(DD Council) in each State promotes,

through systemic change, capacity

building, and advocacy activities, the

development of a comprehensive

consumer-centered system of

coordinated and culturally competent

services, supports, and other assistance.

The priority areas addressed by DD

Councils include employment,

community living, child development,

and system coordination and

community education.

The Protection and Advocacy (P&A)

System provides for the protection and

advocacy of legal and human rights. The

P&A System advocate on behalf of, and

provide advocacy services to persons

with developmental disabilities in issue

areas related to their disabilities,

including: education, abuse and neglect,

institutional and habitation services,

guardianship issues, and housing issues.

The University Affiliated Program

(UAPs) are public and private non-profit

agencies in the States and territories,

each affiliated with a university. Each

UAP receives annual discretionary

funding for operational and

administrative support, which provides

a platform for interdisciplinary training,

clinical and community-based service

activities, technical assistance to

community services personnel, and

information/dissemination activities.

In addition to State-based programs,

ADD funds research and demonstration

grants in an effort to address and

increase our understanding of issues of

national scope. The Projects of National

Significance (PNS) program focuses on

the most pressing issues affecting

people with developmental disabilities

and their families. Project issues

transcend the borders of States and

territories, while project designs are

oriented to permit local implementation

of practical solutions.

Each of these programs has a

uniqueness and breadth of knowledge

that if managed through modern

technology would result in a knowledge

resource warehouse. The nation cannot

afford a digital divide between these

programs and between these programs

and those they serve. With these

programs in mind, ADD is interested in

funding a project for the development or

enhancement of a model website whose

design features are easily employable by

each program; its approach on the

cutting edge. It should be seen as the

beginning of a new form of cyber

architecture with a focus on continuous

improvement that will enable those

programs to improve their use of the

web and their ability to hyperlink to

others.

This new model website would

enhance the ability of ADD’s programs

to exchange information and build upon

ongoing diverse enterprises throughout

the developmental disabilities

community. At the same time, the

contributions and achievements of these

programs towards the quality of life of

persons with disabilities and their

families should be easily disseminated

and accessible. It should support the

development of strategies, technologies,

and media channels for the management

of knowledge generated/produced by

these programs. This site should operate

as an information center as well as a

networking tool for the programs and

others. This website is not about

outcomes exclusively but content and

access to content that affects the lives of

people with developmental disabilities

and their families. ADD envisions that

the first year would begin with the

UAPs and the PNS projects with the

understanding the model website be

inclusive of the other programs over the

duration of the project. It is expected

that the site would be open to everyone;

including the average citizen, people

working in each program, and people

working in related programs. Also, it

should be accessible to people with a

broad range of disabilities utilizing the

most current accessibility standards.

ADD would be supportive of applicants

that represent a consortia of UAPSs and

DD Councils.

(Federal Catalog of Domestic Assistance

Number 93.631—Developmental

Disabilities—Projects of National

Significance)

Dated: April 7, 2000.

Sue Swenson,

Commissioner, Administration on

Developmental Disabilities.

[FR Doc. 00–9748 Filed 4–18–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–4202]

Agency Information Collection

Activities; Announcement of OMB

Approval; Application to Market a New

Drug, Biologic, or an Antibiotic Drug

for Human Use

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Application to Market a New Drug,

Biologic, or an Antibiotic Drug for

Human Use’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 2, 2000 (65

FR 4979), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. An