Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Notices 28183

participated in efforts to enhance

harmonization and has expressed its

commitment to seek scientifically based

harmonized technical requirements for

the development of pharmaceutical

products. One of the goals of

harmonization is to identify and then

reduce the differences in technical

requirements for drug development

among regulatory agencies in different

countries.

FDA has actively participated in the

ICH for several years to develop

harmonized technical requirements for

the approval of human pharmaceutical

and biological products among the

European Union, Japan, and the United

States. The VICH is a parallel initiative

for veterinary medicinal products. The

VICH is concerned with developing

harmonized technical requirements for

the approval of veterinary medicinal

products in the European Union, Japan,

and the United States, and includes

input from both regulatory and industry

representatives.

The VICH Steering Committee is

composed of member representatives

from the: European Commission;

European Medicines Evaluation Agency;

European Federation of Animal Health;

the U.S. FDA; the U.S. Department of

Agriculture; the Animal Health

Institute; the Japanese Veterinary

Pharmaceutical Association; the

Japanese Association of Veterinary

Biologics; and the Japanese Ministry of

Agriculture, Forestry and Fisheries.

Two observers are eligible to

participate in the VICH Steering

Committee: One representative from the

Government of Australia/New Zealand,

and one representative from the

industry in Australia/New Zealand. The

VICH Secretariat, which coordinates the

preparation of documentation, is

provided by the Confe ́de ́ration

Mondiale de L’Industrie de la Sante ́

Animale (COMISA). A COMISA

representative also participates in the

VICH Steering Committee meetings.

II. Guidance on Impurities: Residual

Solvents

In the Federal Register of October 12,

1999 (64 FR 55296), FDA published the

notice of availability of the draft

guidance entitled ‘‘Impurities: Residual

Solvents’’ (VICH GL18) giving interested

persons until November 12, 1999, to

submit comments. FDA received no

comments. The final guidance was

submitted to the VICH Steering

Committee. At a meeting held on June

14 through 16, 2000, the VICH Steering

Committee endorsed the final guidance

for industry, VICH GL18.

This guidance is intended to

recommend acceptable amounts of

residual solvents in new animal drugs

(referred to as pharmaceuticals or

veterinary medicinal products in the

final guidance) for the safety of the

target animal as well as for the safety of

human consumers of products derived

from treated food-producing animals.

The guidance is intended to assist in

developing new animal drug

applications (referred to as marketing

applications in the final guidance)

submitted to the European Union,

Japan, and the United States.

This final level 1 guidance is being

issued consistent with FDA’s good

guidance practices regulation (65 FR

56468, September 19, 2000). It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of applicable

statutes and regulations. Information

collected is covered under OMB control

number 0910–0032.

III. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/cvm.

IV. Comments

As with all of FDA’s guidances, the

public is encouraged to submit written

comments with new data or other new

information pertinent to this guidance.

FDA will periodically review the

comments in the docket and, where

appropriate, will amend the guidance.

The agency will notify the public of any

such amendments through a notice in

the Federal Register.

Interested persons may, at any time,

submit written or electronic comments

regarding this guidance. Written

comments should be submitted to the

Dockets Management Branch (address

above). Two copies of any comments are

to be submitted, except individuals may

submit one copy. Comments should be

identified with the docket number

found in the brackets in the heading of

this document. A copy of the document

and received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Comments may also be submitted

electronically on the Internet at http://

www.fda.gov/dockets/ecomments. Once

on this Internet site, select ‘‘99D–4071

Impurities: Residual Solvents in New

Veterinary Medicinal Products’’ and

follow the directions.

Dated: May 11, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12770 Filed 5–21–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–2125–N]

Medicaid Program; Infrastructure

Grant Program To Support the Design

and Delivery of Long Term Services

and Supports That Permit People of

Any Age Who Have a Disability or

Long-Term Illness To Live in the

Community

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of funding availability.

SUMMARY: This notice announces the

availability of approximately $70

million in grant funding through

‘‘Systems Change Grants for Community

Living’’. The ‘‘Systems Change’’ grants

include four distinct competitive grant

opportunities: (1) ‘‘Nursing Facility

Transitions’’; (2) ‘‘CommunityIntegrated Personal Assistance Services

and Supports’’; (3) ‘‘Real Choice

Systems Change’’; and (4) ‘‘National

Technical Assistance Exchange for

Community Living’’. The four grants are

designed to assist States to develop

enduring infrastructures that support

people of any age who have a disability

or long-term illness to live and

participate in their communities.

Applicants include States, State

instrumentalities, and other eligible

entities as further described in the

notice. This notice also contains

information about the application

process.

DATES: Deadline for Letter of Intent To

Apply: Applicants should submit a

letter of intent to apply for a grant no

later than June 8, 2001. Although it is

not mandatory for an applicant to

submit a letter of intent, we would

appreciate receiving a letter of intent

from each applicant because it will help

us to plan our review panels.

Deadlines for Submission of Grant

Applications: To be considered under

the Fiscal Year 2001 funding cycle,

grant applications must be submitted by

the deadlines listed below:

28184 Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Notices

Grants Application

deadline

• Nursing Facility Transitions ...........................................................................................................................................................

• Independent Living Partnerships

• State Program Grants

July 20, 2001.

• Community-integrated Personal Assistance Services and Supports ........................................................................................... July 20, 2001.

• Real Choice Systems Change ...................................................................................................................................................... July 20, 2001.

• National Technical Assistance Exchange for Community Living ................................................................................................. July 16, 2001.

ADDRESSES: Letter of Intent to Apply:

The letter of intent to apply is included

in the solicitation as Appendix Seven

‘‘Letter of Intent to Apply’’; the

solicitation may be found on the HCFA

web site at: http://www.hcfa.gov/

medicaid/systemschange. All letters of

intent to apply must be submitted to:

Jeremy Silanskis, Health Care Financing

Administration, Center for Medicaid

and State Operations, DEHPG/DASI,

Mail Stop: S2–14–26, 7500 Security

Boulevard, Baltimore, MD 21244–1850.

Letters of intent to apply may be

submitted by facsimile to Jeremy

Silanskis at (410) 786–9004. For those

unable to access the HCFA web site

containing the full solicitation

(including Appendices), copies of the

solicitation are available through Susan

Hill. (See FOR FURTHER INFORMATION

CONTACT.)

Application Materials: Standard

application forms and related

instructions are available through either:

(1) Judith Norris, Health Care Financing

Administration, Office of Internal

Customer Support, AGG, Grants

Management Staff, Mail Stop: C2–21–

15, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850, (410) 786–5130,

Internet:Jnorris1@hcfa.gov, or (2) the

HCFA web site at: http://www.hcfa.gov/

ord/grantop.htm.

Submission of Application:

Applicants are required to submit (1) an

original and two copies of the

application and (2) a 31⁄4′′ floppy disk

containing at least the narrative and the

budget. Although it is not mandatory

and does not impact on the scoring of

an application, we would appreciate

receiving an original and 14 copies of

the application. For further information

regarding the provisions of the grants,

application format and requirements,

review criteria and procedures,

explanation of timely submission, and

other relevant information, applicants

must refer to the grant solicitation

available on the HCFA web site at: http:/

/www.hcfa.gov/medicaid/

systemschange.

All application forms and related

materials must be submitted to: Judith

Norris, Health Care Financing

Administration, Office of Internal

Customer Support, AGG, Grants

Management Staff, Mail Stop: C2–21–

15, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850, (410) 786–5130,

Internet:Jnorris1@hcfa.gov.

Each type of grant has a specific

closing date. (See DATES section above.)

Applications mailed through the U.S.

Postal Service or a commercial delivery

service will be considered ‘‘on time’’ if

received by close of business on the

closing date, or postmarked (first class

mail) by the date specified and received

within five business days. If express,

certified, or registered mail is used, the

applicant should obtain a legible dated

mailing receipt from the U.S. Postal

Service. Private metered postmarks are

not acceptable as proof of timely

mailings. Applications that do not meet

the above criteria will be considered late

applications. Applicants who submit

late applications will be notified that

their applications were not considered

in the competition. Late applications

will not be reviewed and will be

returned to the applicant.

Web Site: To obtain up-to-date

information about the ‘‘Systems

Change’’ grants and a complete grant

solicitation, please check our web site

at: http://www.hcfa.gov/medicaid/

systemschange. For those unable to

access the HCFA web site containing the

full solicitation (including Appendices),

copies of the solicitation are available

through Susan Hill. (See FOR FURTHER

INFORMATION CONTACT.)

FOR FURTHER INFORMATION CONTACT:

Questions about the grant program may

be directed to: Susan Hill, Health Care

Financing Administration, Center for

Medicaid and State Operations, DEHPG/

DASI, Mail Stop: S2–14–26, 7500

Security Boulevard, Baltimore, MD

21244–1850, (410) 786–2754,

Internet:shill@hcfa.gov.

SUPPLEMENTARY INFORMATION:

I. Background

People of all ages who have a

disability or long-term illness generally

express the same desire to live in the

community as do most other Americans.

They express a desire to live in their

own homes, make their own decisions

about daily activities, work, learn, and

maintain important social relationships.

They express a desire to contribute and

participate in their communities and

family life.

In 1990, the Congress enacted the

Americans with Disabilities Act (ADA)

(Pub. L. 101–336). The ADA recognized

that ‘‘society has tended to isolate and

segregate individuals with disabilities,

and, despite some improvements, such

forms of discrimination against

individuals with disabilities continue to

be a serious and pervasive social

problem’’ (42 U.S.C. section

12101(a)(2)). The ADA gave legal

expression to the desires and rights of

Americans to lead lives as valued

members of their own communities

despite the presence of disability.

Over the past few years, a consensus

for assertive new steps to improve the

capacity of our long-term support

systems to respond to the desires of our

citizenry has been building. Federal,

State, and local governments have

begun to take actions to renew and

reaffirm a commitment to improving the

systems that will support people of all

ages with disabilities or long-term

illnesses who wish to live in their

communities.

Several Federal and State initiatives

are underway to make community living

a reality for more people. We adopted a

number of Medicaid policy reforms and

issued grants to facilitate State efforts to

improve their community services

systems. Numerous States have

implemented home and communitybased waivers through the Medicaid

program. As States learn more from

these experiences, waivers will continue

to evolve. States are interested in

building in more consumer choice and

consumer-directed services. In addition,

the Substance Abuse and Mental Health

Services Administration (SAMHSA)

announced planning grants to assist

States in their planning efforts. The U.S.

Department of Housing and Urban

Development (HUD) entered into a

memorandum of understanding with

HHS to coordinate community housing

subsidies with human service funds in

a manner that will make transition from

nursing facilities to the community

more feasible. The Administration on

Aging (AoA) inaugurated a nationwide

caregiver support program.

Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Notices 28185

1 Independent Living Centers (ILCs) refer to those

ILCs recognized under State or Federal Law.

The Congress also recognized that

States face formidable challenges in

their efforts to fulfill their legal

responsibilities under the ADA. The

Congress appropriated funds for these

‘‘Systems Change’’ grants specifically to

improve community-integrated services.

In February 2001, President George

W. Bush announced a broad ‘‘New

Freedom Initiative’’ to ‘‘tear down

barriers to equality’’ and grant a ‘‘New

Freedom’’ to children and adults of all

ages who have a disability or long term

illness so that they may live and prosper

in their communities. For more

information on the President’s ‘‘New

Freedom Initiative’’, please visit the web

site at: http://www.whitehouse.gov.

The ‘‘Systems Change Grants for

Community Living’’ described in this

document represent an expression of

support for States’ efforts to provide

additional or improved support for

community living. In addition, these

grants support: the President’s ‘‘New

Freedom Initiative’’; the States’’ efforts

to fulfill the ADA; and the long-standing

desire of people of all ages who have a

disability or long-term illness to live

and participate in their communities

with dignity and value.

II. Overview and General Requirements

for All ‘‘Systems Change’’ Grants

Attached is a chart summarizing the

Systems Change Grants. The following

four distinct competitive grant

solicitations comprise the ‘‘Systems

Change’’ grants:

• ‘‘Nursing Facility Transitions

(TRANSITIONS)’’ grants: The purpose

of the ‘‘TRANSITIONS’’ grants is to help

eligible individuals make the transition

from nursing facilities to the

community. Between $10 to $14 million

in two types of grants are available from

HCFA: State Program grants and

Independent Living Partnership grants.

State Program grants can be used for a

wide range of activities, for example, a

State may wish to use State Program

grant funds to develop strategies for

linking individuals with disabilities to

Section 8 rental housing vouchers or

developing other coordinated housing

strategies. The Independent Living

Partnership grants are designed to

promote partnerships between States

and selected Independent Living

Centers (ILCs) 1 to support the transition

of individuals from nursing facilities to

their communities.

• ‘‘Community-Integrated Personal

Assistance Services and Supports

(Community PASS)’’ grants: Personal

assistance is the most frequently used

service that enables people with a

disability or long-term illness to live in

the community. Many States have taken

a leadership role in designing systems

that not only offer the basic personal

assistance service, but also make that

service available in a manner that

affords consumers maximum control

over the selection of individuals

working on their behalf and the manner

in which services are provided. These

grant funds will be used by States to

improve personal assistance services

that are consumer-directed or offer

maximum individual control. Grants

totaling $5 to $8 million are available to

support States’ efforts to improve

community-integrated personal

assistance services for children and

adults of any age who have a disability

or long-term illness.

• ‘‘Real Choice Systems Change (Real

Choice)’’ grants: The goal of these grants

is to help design and implement

effective and enduring improvements in

community long-term support systems

to enable children and adults of any age

who have a disability or long-term

illness to live and participate in their

communities. Direct grants totaling $41

to $43 million are available to assist

States and their disability and aging

communities to work together to find

viable ways to expand or improve the

design and delivery of communityintegrated services. The funds will also

support the public-private partnerships

and broad public participation

(including a consumer task force) that

are generally needed to accomplish such

an ambitious undertaking.

• ‘‘National Technical Assistance

Exchange for Community Living (The

Exchange)’’ grant: This national

technical assistance grant will support

the ‘‘Real Choice Systems Change’’

grants, the ‘‘Nursing Facility

Transitions,’’ and the ‘‘CommunityIntegrated Personal Assistance Services

and Supports’’ efforts. The purpose of

this national technical assistance

initiative will be to provide technical

assistance, training, and information to

States, Grantees, consumers, families,

and other agencies and organizations.

Funding for technical assistance will

range from $4 to $5 million.

A. Timing and Duration of Awards

We expect all grant awards to be made

before to October 1, 2001. Grantees may

expend grant funds over a 36-month

period from the date of the award.

B. Match Requirements

Grantees of the Nursing Facility

Transitions, Community PASS, and

‘‘Real Choice’’ grants are required to

make a nonfinancial recipient

contribution of 5 percent of the total

grant award. Nonfinancial recipient

contributions may include the value of

goods and/or services contributed by the

Grantee, for example, salary and fringe

benefits of staff devoting a percentage of

their time to the grant not otherwise

included in the budget or derived from

Federal funds. Recipient contributions

must be included in the Applicant’s

Budget on Standard Form 424A. The

nonfinancial match requirement may

also be satisfied if a third party

participating in the grant makes an ‘‘inkind contribution,’’ provided that the

Grantee’s contribution and/or the thirdparty in-kind contribution equals 5

percent of the total grant award. Thirdparty ‘‘in-kind contributions’’ may

include the value of the time spent by

consumer task force members (using

appropriate cost allocation methods to

the extent that non-Federal funds are

involved) who specifically contribute to

the design, development, and

implementation of the grant.

Grantees applying for the National

Technical Assistance Exchange for

Community Living grant will be

required to make a nonfinancial

recipient contribution of 1 percent of

the total grant award. Applicants must

specify these required recipient

contributions in their Budget on

Standard Form 424A.

C. Indirect Costs

Reimbursement of indirect costs

under each of the four grant solicitations

is governed by the provisions of the U.S.

Department of Health and Human

Services, Grants Policy Directive (GPD)

Part 3.01: Post-Award—Indirect Costs

and Other Cost Policies. We recommend

that applicants review the provisions of

this policy directive and applicable

Office of Management and Budget

(OMB) circulars in preparing budget

information. This information is

available in the solicitation and online

at: http://www.hhs.gov/grantsnet/

adminis/gpd/gpd301.htm.

D. Who May Apply

States may apply for any grant, except

the Independent Living Partnership

portion of the ‘‘TRANSITIONS’’ grant.

By ‘‘State’’ we refer to the definition

provided under 45 CFR 74.2 as ‘‘any of

the several States of the United States,

the District of Columbia, the

Commonwealth of Puerto Rico, any

territory or possession of the United

States, or any agency or instrumentality

of a State exclusive of local

governments.’’ By ‘‘territory or

possession’’ we mean Guam, the U.S.

Virgin Islands, American Samoa, and

28186 Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Notices

the Commonwealth of the Northern

Mariana Islands.

For the ‘‘Real Choice Systems

Change’’ grants and the State Program

portion of the ‘‘Nursing Facility

Transitions’’ grant, only State agencies

or instrumentalities may apply. These

agencies must have the support and

active participation of one of the

following: the Governor, the State

Medicaid agency, or the State agency

administering a relevant section of the

1915(c) home and community-based

waiver.

For the Independent Living

Partnership portion of the ‘‘Nursing

Facility Transitions’’ grant, only

Independent Living Centers may apply.

Each Applicant must have (1) the

support and active participation from

the State Medicaid agency or the State

agency administering a relevant section

of the 1915(c) home and communitybased waiver, and (2) the support and

active participation of at least two other

consumer-governed organizations.

For the ‘‘Community PASS’’ grants,

any State agency or any other

organization may apply if it has the

support and active participation of one

of the following: the Governor, the State

Medicaid agency, or the State agency

administering a relevant section of the

1915(c) home and community-based

waiver.

For the ‘‘National Technical

Assistance Exchange for Community

Living’’ grant, any organization may

apply. However, according to 45 CFR

74.81, no funds may be paid as profit to

any recipient organization.

States may and are encouraged to

apply for more than one type of grant.

For example, a State may apply for a

‘‘Real Choice Systems Change’’ grant

and also apply for a ‘‘Nursing Facility

Transitions’’ grant. Also, different State

agencies may apply for different types of

grants. For example, the Medicaid

agency might apply for a ‘‘Community

PASS’’ grant, and the agency

administering the section 1915(c)

waiver might apply for a ‘‘Nursing

Facility Transitions’’ grant. However, no

State may be awarded more than one

grant per State per type of grant. For

example, a State may not receive two

‘‘Real Choice Systems Change’’ grants or

two ‘‘Community PASS’’ grants. Neither

an Independent Living Partnership grant

nor a technical assistance grant will

count against this limit.

In addition, a State, or other eligible

entity, may submit a single application

for any one type of grant that is

composed of multiple, interrelated

projects. For example, a State might

submit an application for the ‘‘Real

Choice Systems Change’’ grant that is

composed of a ‘‘one-stop shopping’’

demonstration and a separate but

related project to solve the shortage of

front-line workers. While only one

entity may receive the grant, the Grantee

agency may subcontract portions of the

award consistent with the Applicant’s

proposed project. A potential Applicant

may request written clarification from

us in advance of the application due

date if it is unclear whether it is eligible

to apply for a particular grant.

HCFA reserves the right to assure

reasonable balance in the awarding of

grants, in terms of key factors such as

geographic distribution, broad target

group representation, etc.

E. Involvement of Consumers,

Stakeholders, and Public-Private

Partnerships

For all grant solicitations, we strongly

encourage the continuous, active

involvement of consumers in both

project design and implementation. We

encourage processes that promote the

active involvement of all other

stakeholders. In addition, we encourage

the development of public-private

partnerships that make the most

effective use of each partner’s expertise.

For the ‘‘Real Choice Systems

Change’’ grants, the Congress expressed

its preference that the grant applications

‘‘be developed jointly by the State and

the Consumer Task Force. The Task

Force should be composed of

individuals with disabilities from

diverse backgrounds, representatives

from organizations that provide services

to individuals with disabilities,

consumers of long-term services and

supports, and those who advocate on

behalf of such individuals’’ (H. Conf.

Rep. No. 106–1033 at 150).

We encourage collaboration with a

broad range of public and private

organizations whose primary purpose is

advocating for people with disabilities

or long-term illnesses. Examples of

these organizations include State

Independent Living Councils, Area

Agencies on Aging (AAAs),

Developmental Disabilities Councils,

State Mental Health Planning Councils,

State Assistive Technology Act Projects

(AT Act Projects), and other national

and statewide consumer disability and

aging organizations. We also encourage

Applicants to partner with volunteer

groups, employers, faith-based service

providers, private philanthropic

organizations, and other communitybased organizations.

For more information regarding the

options available to States relative to the

consumer task force and other more

detailed questions related to these

grants, please visit our web site at http:/

/www.hcfa.gov/medicaid.

F. Executive Order 12372

Applications for these grants are not

subject to review by States under

Executive Order 12372,

‘‘Intergovernmental Review of Federal

Programs’’ (45 CFR Part 100).

G. Information Collection Requirements

The information collection

requirements associated with the

solicitation are under review by the

Office of Management and Budget. We

published a notice in the Federal

Register on May 10, 2001, to solicit

comments on the collection.

Authority: These grants are authorized

under section 1110 of the Social Security

Act. Funding and Congressional language

was provided in the Consolidated

Appropriations Act, 2001 (Pub. L. 106–554)

(including H.R. 5656 Labor, HHS, and

Education Appropriations), and in the

accompanying Report, H. Conf. Rep. No.

106–1033. HCFA is the designated HHS

agency with administrative responsibility for

this grant program.

(Catalog of Federal Domestic Assistance

Number: 93.779; Research and

Demonstrations)

Dated: May 10, 2001.

Michael McMullan,

Acting Deputy Administrator, Health Care

Financing Administration.

BILLING CODE 4120–03–U

Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Notices 28187

[FR Doc. 01–12882 Filed 5–17–01; 4:37 pm]

BILLING CODE 4120–03–C