14684 Federal Register / Vol. 62, No. 59 / Thursday, March 27, 1997 / Notices

approximate time required to make their

comments.

Open committee discussion. On April

17, 1997, the committee will hear

presentations and discuss the

teratogenicity and labeling issues

regarding approved NDA 19–821 for

Soriatane (acitretin capsules, HoffmanLaRoche, Inc.) for use in treating severe

psoriasis.

Closed presentation of data. On April

18, 1997, the committee will hear trade

secret and/or confidential commercial

information relevant to pending IND’s

or NDA’s. This portion of the meeting

will be closed to permit discussion of

this information (5 U.S.C. 552b(c)(4)).

Closed committee deliberations. On

April 18, 1997, the committee will

review trade secret and/or confidential

commercial information relevant to

pending IND’s and/or NDA’s. This

portion of the meeting will be closed to

permit discussion of this information (5

U.S.C. 552b(c)(4)).

Each public advisory committee

meeting listed above may have as many

as four separable portions: (1) An open

public hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. The dates and times reserved

for the separate portions of each

committee meeting are listed above.

The open public hearing portion of

the meeting(s) shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

The Commissioner has determined for

the reasons stated that those portions of

the advisory committee meetings so

designated in this notice shall be closed.

The Federal Advisory Committee Act

(FACA) (5 U.S.C. app. 2, 10(d)), permits

such closed advisory committee

meetings in certain circumstances.

Those portions of a meeting designated

as closed, however, shall be closed for

the shortest possible time, consistent

with the intent of the cited statutes.

The FACA, as amended, provides that

a portion of a meeting may be closed

where the matter for discussion involves

a trade secret; commercial or financial

information that is privileged or

confidential; information of a personal

nature, disclosure of which would be a

clearly unwarranted invasion of

personal privacy; investigatory files

compiled for law enforcement purposes;

information the premature disclosure of

which would be likely to significantly

frustrate implementation of a proposed

agency action; and information in

certain other instances not generally

relevant to FDA matters.

Examples of portions of FDA advisory

committee meetings that ordinarily may

be closed, where necessary and in

accordance with FACA criteria, include

the review, discussion, and evaluation

of drafts of regulations or guidelines or

similar preexisting internal agency

documents, but only if their premature

disclosure is likely to significantly

frustrate implementation of proposed

agency action; review of trade secrets

and confidential commercial or

financial information submitted to the

agency; consideration of matters

involving investigatory files compiled

for law enforcement purposes; and

review of matters, such as personnel

records or individual patient records,

where disclosure would constitute a

clearly unwarranted invasion of

personal privacy.

Examples of portions of FDA advisory

committee meetings that ordinarily shall

not be closed include the review,

discussion, and evaluation of general

preclinical and clinical test protocols

and procedures for a class of drugs or

devices; consideration of labeling

requirements for a class of marketed

drugs or devices; review of data and

information on specific investigational

or marketed drugs and devices that have

previously been made public;

presentation of any other data or

information that is not exempt from

public disclosure pursuant to the FACA,

as amended; and, deliberation to

formulate advice and recommendations

to the agency on matters that do not

independently justify closing.

This notice is issued under section

10(a)(1) and (a)(2) of the Federal

Advisory Committee Act (5 U.S.C. app.

2), and FDA’s regulations (21 CFR part

14) on advisory committees.

Dated: March 21, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–7790 Filed 3–26–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Special Project Grants; Traumatic

Brain Injury Demonstration Grants

AGENCY: Health Resources and Services

Administration (HRSA).

ACTION: Notice of availability of funds.

SUMMARY: The HRSA announces that

approximately $2.8 million in fiscal

year (FY) 1997 funds will be available

for demonstration projects to improve

access to health and other services for

people who have sustained a traumatic

brain injury (TBI). Discretionary grants
Federal Register / Vol. 62, No. 59 / Thursday, March 27, 1997 / Notices 14685

to States are authorized under section

1252 of the Public Health Service (PHS)

Act, as amended by Public Law 104–166

(42 USC 300d-52), which provides for

the conduct of expanded studies and the

establishment of innovative programs

with respect to TBI. Funds for TBI State

demonstration projects are appropriated

by Public Law 104–208. At present,

funding for this program is available for

one year. Within the HRSA, TBI grants

are administered by the Maternal and

Child Health Bureau (MCHB).

The PHS is committed to achieving

the health promotion and disease

prevention objectives of Healthy People

2000, a PHS lead national activity for

setting priority areas. The TBI grant

program will directly address the

Healthy People 2000 objectives related

to chronic disabling conditions,

particularly in relation to service system

expansion and objectives related to

secondary injury prevention. Potential

applicants may obtain a copy of Healthy

People 2000 (Full Report: Stock No.

017–001–00474–0) or Healthy People

2000 Midcourse Review and 1995

Revisions (Stock No. 017–001–00526–6)

through the Superintendent of

Documents, Government Printing

Office, Washington, D.C. 20402–9325

(telephone: 202–512–1800).

The PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and promote the non-use of

all tobacco products. In addition, Public

Law 103–227, the Pro-Children Act of

1994, prohibits smoking in certain

facilities (or in some cases, any portion

of a facility) in which regular or routine

education, library, day care, health care

or early childhood development

services are provided to children.

ADDRESSES: Federal Register notices

and application guidance for MCHB

programs are available on the World

Wide Web via the Internet at address:

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

Click on the file name you want to

download to your computer. It will be

saved as a self-extracting (Macintosh or)

WordPerfect 5.1 file. To decompress the

file once it is downloaded, type in the

file name followed by a <return>. The

file will expand to a WordPerfect 5.1

file.

For applicants for TBI Demonstration

Grants who are unable to access

application materials electronically, a

hard copy (Revised PHS form 5161–1,

approved under OMB clearance number

0937–0189) may be obtained from the

HRSA Grants Application Center. The

Center may be contacted by: Telephone

Number: 1–888–300-HRSA, FAX

Number: 301–309–0579, E-mail

Address: HRSA.GAC@ix.netcom.com.

Completed applications should be

returned to: Grants Management Officer

(CFDA #93.TBA–1), HRSA Grants

Application Center, 40 West Gude

Drive, Suite 100, Rockville, Maryland

20850.

DATES: The application deadline date is

May 30, 1997. Competing applications

will be considered to be on time if they

are either: (1) received on or before the

deadline date, or (2) postmarked on or

before the deadline date and received in

time for orderly processing. Applicants

should request a legibly dated receipt

from a commercial carrier or the U.S.

Postal Service, or obtain a legibly dated

U.S. Postal Service postmark. Private

metered postmarks will not be accepted

as proof of timely mailing.

FOR FURTHER INFORMATION CONTACT:

Requests for technical or programmatic

information from MCHB should be

directed to the Division of Maternal,

Infant, Child and Adolescent Health

(DMICAH), Maternal and Child Health

Bureau, Health Resources and Services

Administration, Room 18A–39,

Parklawn Building, 5600 Fishers Lane,

Rockville, Maryland 20857. The

DMICAH telephone number for TBI

inquiries is 301–443–5559. Requests for

information concerning fiscal, business

or administrative management issues

should be directed to: Maria E. Carter,

Grants Management Specialist, Grants

Management Branch, Maternal and

Child Health Bureau, 5600 Fishers Lane,

Room 18–12, Rockville, Maryland

20857, telephone: 301–443–3268.

SUPPLEMENTARY INFORMATION:

Program Background and Objectives

In July, 1996, Congress enacted Public

Law 104–166, ‘‘to provide for the

conduct of expanded studies and the

establishment of innovative programs

with respect to traumatic brain injury’’

(TBI). Under Public Law 104–166, a

program of grants to States for

demonstration projects to improve

access to health and other TBI-related

services for people of all ages is

established within HRSA. The National

Institutes of Health has responsibility

for conducting basic and applied

research regarding TBI. Responsibility

for activities related to prevention of

TBI is assigned to the Centers for

Disease Control and Prevention.

Information on CDC grant activities

which relate to TBI surveillance may be

obtained from David J. Thurman, M.D.,

M.P.H., Division of Acute Care,

Rehabilitation Research, and Disability

Prevention, National Center for Injury

Prevention and Control, CDC, 4770

Buford Highway, NE, Mailstop F–41,

Atlanta, GA 30341, telephone: 770–488–

4031. Public Law 104–166 also

mandates a national consensus

conference of appropriate PHS agencies

to study a range of TBI-related issues,

including development of a uniform

reporting system, evaluation of the

effectiveness of common therapeutic

interventions, assessment of the

adequacy of existing outcome measures,

and development of practice guidelines

for rehabilitation.

The law requires any State seeking

TBI demonstration grant funds to agree

to establish an advisory board within

the appropriate health department of the

State or within another department as

designated by the chief executive officer

of the State. The Board’s composition is

specified; it must include:

representatives of the involved State

agencies; public and nonprofit private

health related organizations; disability

advisory or planning groups; members

of an organization or foundation

representing TBI survivors; State and

local injury control programs if they

exist, and a substantial number of TBI

survivors or their family members. The

State must also make available matching

funds, in cash non-Federal

contributions, in an amount that is not

less than $1 for each $2 of Federal funds

provided under the grant.

Definitions

1. State: For purposes of this grant

program, the term ‘‘State’’ includes the

50 States, the District of Columbia, the

Commonwealth of Puerto Rico, the

Virgin Islands, the Northern Mariana

Islands, Guam, American Samoa, the

Republic of Palau, the Republic of the

Marshall Islands, and the Federated

States of Micronesia.

2. Traumatic Brain Injury: For

purposes of this grant program

‘‘Traumatic Brain Injury’’ (TBI) means

an acquired injury to the brain. Such

term does not include brain dysfunction

caused by congenital or degenerative

disorders, nor birth trauma, but may

include brain injuries caused by anoxia

due to near drowning.

3. Survivor: For purposes of this grant

program the term ‘‘survivor’’ refers to a

person who has sustained and has

survived a traumatic brain injury.

4. Person-and family-centered care:

For purposes of this grant program

‘‘person-and family-centered care’’

requires: involvement of survivors and

their families in all phases of the TBI

continuum of care; clear and continuous

communication between family

members and the care team; attention to

the psychosocial needs of survivors and

family members; and cultural

competence of providers.
14686 Federal Register / Vol. 62, No. 59 / Thursday, March 27, 1997 / Notices

5. Core Capacity: Core capacity

includes 4 components: (1) a statewide

TBI Advisory Board which meets the

requirements set forth earlier in this

Notice; (2) designation of a State agency

and a designated staff position

responsible for State TBI activities; (3) a

Statewide needs assessment of the full

spectrum of care/services from initial

acute treatment through community

reintegration for individuals with TBI;

and (4) a Statewide action plan to

develop a comprehensive, communitybased system of care that encompasses

physical, psychological, educational,

vocational, and social aspects of TBI

services and addresses the needs of the

family as well as the TBI survivor.

Eligible Applicants

Only State governments are eligible to

apply for funding under the TBI

demonstration grant program. The

application for implementation funds

may only come from the State agency

designated as the lead for TBI services,

while planning grant applications may

emanate from an agency or office within

the State responsible for planning and/

or program coordination. The

involvement of the State MCH program

in both grant categories is expected.

Only one application from each State

may enter the review process and be

considered for an award under this

program.

Funding Categories

Approximately $2.8 million will be

available in FY 1997 to fund two

categories of grants—Category 1: State

planning grants; and Category 2: State

implementation grants.

The major funding emphasis is on

implementation activities which will

move States toward Statewide systems

that assure access to comprehensive and

coordinated TBI services. It is

recognized, however, that States are in

different stages of development and that

some will need assistance in

establishing infrastructure as a

prerequisite to implementation.

Therefore, planning grants, as well as

implementation grants, are being

offered.

Applicants may apply for either

Category 1 or Category 2 funding as

appropriate, but not both.

Category (1): State Planning Grants

Planning grants are intended to

support the development of 4 State level

core capacity components to provide

TBI services (see DEFINITIONS section,

above). States may apply for a planning

grant for one year. Up to 15 planning

grants will be awarded. Planning grants

will range from $20,000 to $75,000 per

year. States should apply for an amount

within that range which is appropriate

to their needs in establishing full core

capacity.

Category (2): State Implementation

Grants

Implementation grants are intended

for States that have the 4 core capacity

components in place. These grants will

support activities that represent the next

logical step(s) in building a Statewide

system to assure access to

comprehensive and coordinated TBI

services.

Implementation grants can address a

wide range of activities and should

reflect gaps or needed system

enhancements identified through the

Statewide TBI needs assessment. The

grant may be used for Statewide

implementation or targeted

implementation in a specific locality

within the State prior to Statewide

implementation. Proposals under this

category may address one or more of the

following:

—Develop and implement protocols for

point of entry personnel to improve

early identification and appropriate

triage, care and management of

patients.

—Develop a replicable, pre-discharge

model to be used in acute care sites

in the development of long term

resource plans for TBI survivors. Such

a model should include person- and

family-centered care coordination and

resource management services.

—Develop and implement a plan to

increase the number of public and

private payers, including major

managed care plans in the State,

which will coordinate financial

resources to provide services that

most effectively meet the needs of TBI

survivors.

—Improve data collection through:

linking existing data systems;

improving information on currently

underserved populations; or

improving ongoing tracking of service

needs, patient outcomes, or program

evaluation.

—Develop and implement education

and training programs to address

various stages of recovery along the

continuum of care (acute care,

rehabilitation, education, vocational,

psychosocial, long term care and

community reintegration) for

survivors, families, and/or

professionals. Such programs are

expected to recognize culturally

diverse populations, address currently

underserved populations, and

promote person- and family-centered

care.

—Develop (or translate), implement and

evaluate materials specifically

directed at TBI survivors and their

families to meet the specific needs of

low literacy and culturally or

ethnically distinct populations.

—Increase interagency collaboration

and linkages to improve access to

comprehensive individual and familycentered services along the

continuum of care.

Up to 8 State implementation grants,

not to exceed $200,000 per grant for a

one-year period, will be awarded in FY

1997. The planned project period for

State implementation grants is one year.

Applicants should be aware that, at

present, funding for this program is

available only for one year. Therefore,

applicants must clearly identify the

accomplishments they can achieve in

one year’s time and identify approaches

that could be used to continue activities

in the absence of future Federal funding.

If additional Federal funds become

available in the next fiscal year,

planning grants will be considered for

renewal for up to an additional year and

implementation grants will be

considered for renewal for an additional

two years. If applicants will require

greater than one year to complete their

projects,they should include proposed

plans for their second and third years of

funding in their applications.

Special Concerns

HRSA’s Maternal and Child Health

Bureau places special emphasis on

improving service delivery to people

from communities with limited access

to comprehensive care. In order to

assure access and cultural competence,

projects must involve individuals from

the populations to be served in the

planning and implementation of the

project. The Bureau’s intent is to ensure

that project interventions are responsive

to the cultural and linguistic needs of

special populations, that services are

accessible to consumers, and that the

broadest possible representation of

culturally distinct and historically

underrepresented groups is supported

through programs and projects

sponsored by the MCHB.

Evaluation Protocol

A project awarded as part of the TBI

Demonstration Grants program is

expected to incorporate a carefully

designed and well planned evaluation

protocol capable of demonstrating and

documenting measurable progress

toward achieving the project’s stated

goals. The protocol should be based on

a clear rationale relating the grant

activities, the project goals, and the

evaluation measures. Wherever
Federal Register / Vol. 62, No. 59 / Thursday, March 27, 1997 / Notices 14687

possible, the measurements of progress

toward goals should focus on health

outcome indicators, rather than on

intermediate measures such as process

or outputs. A project lacking a complete

and well-conceived evaluation protocol

as part of the planned activities may not

be funded.

Project Review and Funding

The Department will review

applications in the preceding categories

as competing applications and will fund

those which, in the Department’s view,

are consistent with the statutory

purpose of the program, which best

promote a comprehensive and

coordinated system that assures access

to appropriate care for TBI survivors

and their families, and which address

achievement of applicable Healthy

People 2000 objectives related to

chronic disabling conditions and

secondary injury prevention.

Review Criteria

Specific review criteria have been

established for each of the two TBI

demonstration grant categories as

follows:

Category 1: State Planning Grants

—The strength of the required Statewide

Advisory Board as evidenced by:

—The composition of the Board.

—Commitments from all identified

organizations or individuals.

—Organizational and meeting

arrangements.

—The adequacy of the State’s proposed

method for developing a Statewide

needs assessment that includes—and

a plan of action that emphasizes—the

physical, psychosocial, educational,

vocational and social needs of TBI

survivors and their families.

—The adequacy of the State’s proposed

method for linking its plan of action

to the findings of the Statewide needs

assessment.

—The extent to which the proposal

reflects the involvement of necessary

public/private organizations and

agencies to assure a comprehensive

approach.

—The qualifications and experience

established for the designated lead

person for TBI within the State.

—The reasonableness of the proposed

budget, soundness of the

arrangements for fiscal management,

effectiveness of use of personnel and

likelihood of project completion

within the proposed grant period.

—The adequacy of proposed

methodology to assure full core

capacity is developed during the grant

period.

Category 2: State Implementation

Grants

—The adequacy of the State’s evidence

that the four components for core

capacity are in place.

—The relevance of the goals and

objectives to the identified needs

described in the Statewide needs

assessment.

—The soundness of the plan for

evaluating progress in achieving

project objectives and outcomes.

—The adequacy of the plan for

organizing and carrying out the

project, including: (a) Reasonableness

of proposed budget and soundness of

the plan for fiscal management; (b)

adequacy of proposed methodology

for achieving project goals and

outcome objectives; and (c)

qualifications and experience of the

Project Director and staff.

—The extent to which the involvement

and participation of TBI survivors,

families and organizations are

considered in project implementation.

—Extent of collaboration and

coordination among the entities in the

TBI continuum identified by the State

as necessary to carry out the proposed

plan.

—The extent to which the project

involves a multi-disciplinary and

multi-system approach to TBI

development.

—Adequacy of the plan for sustaining

the proposed project.

Allowable Costs

The HRSA may support reasonable

and necessary costs of TBI

Demonstration Grant projects within the

scope of approved projects. Allowable

costs may include salaries, equipment

and supplies, travel, contracts,

consultants, and others, as well as

indirect costs as negotiated. The HRSA

adheres to administrative standards

reflected in the Code of Federal

Regulations, 45 CFR Part 92 and 45 CFR

Part 74.

Executive Order 12372

This program has been determined to

be a program which is subject to the

provisions of Executive Order 12372

concerning intergovernmental review of

Federal programs by appropriate health

planning agencies, as implemented by

45 CFR Part 100. Executive Order 12372

allows States the option of setting up a

system for reviewing applications from

within their States for assistance under

certain Federal programs. The

application packages to be made

available under this notice will contain

a listing of States which have chosen to

set up such a review system and will

provide a single point of contact (SPOC)

in the States for review. Applicants

(other than federally-recognized Indian

tribal governments) should contact their

State SPOCs as early as possible to alert

them to the prospective applications

and receive any necessary instructions

on the State process. For proposed

projects serving more than one State, the

applicant is advised to contact the SPOC

of each affected State. The due date for

State process recommendations is 60

days after the application deadline for

new and competing awards. The

granting agency does not guarantee to

‘‘accommodate or explain’’ for State

process recommendations it receives

after that date. (See Part 148,

Intergovernmental Review of PHS

Programs under Executive Order 12372

and 45 CFR Part 100 for a description

of the review process and requirements).

The OMB Catalog of Federal Domestic

Assistance number is 93.TBA–1.

Dated: March 21, 1997.

Claude Earl Fox, M.D., M.P.H.,

Acting Administrator.

[FR Doc. 97–7727 Filed 3–26–97; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

1997/98 World Health Organization

Study of Health Behavior in School

Children (WHO–HBSC)

In compliance with Section 3506

(c)(2)(A) of the Paperwork Reduction

Act of 1995, the National Institute of

Child Health and Human Development

(NICHD), National Institutes of Health

(NIH) is publishing this notice to solicit

public comment on the data collection

proposed for U.S. participation in the

‘‘1997/98 World Health Organization

Study of Health Behavior in School

Children (WHO–HBSC)’’ for the

Epidemiology Branch. To request copies

of the data collection plans and

instruments, call Dr. Mary Overpeck,

(301) 496–1711 (not a toll-free number).

Comments are invited on: (a) Whether

the proposed collection is necessary,

including whether the information has a

practical use; (b) ways to enhance the

clarity, quality, and use of the

information to be collected; (c) the

accuracy of the agency estimate of

burden of the proposed collection; and

(d) ways to minimize the collection

burden of the respondents. Written

comments are requested within 60 days

of the publication of this notice. Send

comments to Dr. Mary Overpeck,

Epidemiology Branch, Division of

Epidemiology, Statistics, and Prevention

Research (DESPR), NICHD, NIH,

Building 6100, Room 7B03, 6100