26520 Federal Register / Vol. 61, No. 103 / Tuesday, May 28, 1996 / Notices

Contracts,’’ Vol. 23, No. 18. Like the

original PORTs, PORT IIs are pragmatic,

methodologically sophisticated,

multidisciplinary projects that focus on

patient outcomes for common clinical

problems. They differ from the original

PORTs by their individualized research

strategies and are also distinguished by

their expected impact on clinical

practice, patient outcomes, and health

care policy. PORT IIs focus on the

establishment of direct linkages between

practice and outcomes and on research

methods that facilitate direct

comparisons of two or more distinct

clinical strategies. Clinical conditions

addressed to date by the AHCPR PORT

II program include:

• Localized Breast Cancer

• Cardiac Arrhythmia

• End-stage Renal Disease

• Depression

• Prostate Disease

• Infant Dehydration

• Cataract: Preoperative Testing

• Pelvic Inflammatory Disease

In addition to PORTs and PORT IIs,

AHCPR has funded approximately 130

other outcomes and effectiveness

research clinical studies. For clinical

subjects as diverse as AIDS, dental

disease, emergency medicine, and

cancer, these studies document patterns

of practice, describe the natural history

of diseases, synthesize the evidence for

various clinical strategies, or answer

relatively discrete effectiveness

questions. Major ongoing program areas

focus on pharmaceutical therapy,

minority health, and primary care.

AHCPR Process for Determining

Priority Topics

Topic selection for the original PORT

projects was guided by work of the

Institute of Medicine (IOM) which was

described in the 1990 IOM publication

entitled ‘‘National Priorities for the

Assessment of Clinical Conditions and

Medical Technologies.’’ A new process

to identify priorities for future outcomes

research was discussed at a November,

1995 expert panel meeting. During this

meeting, the AHCPR conferred with

health services and effectiveness

experts, representing multiple

disciplines, specialties, and institutions.

Alternative approaches for prioritizing

topic areas and identification of

populations whose major health

conditions have not yet been adequately

addressed (e.g., young children, the very

elderly, women, and ethnic minorities)

were considered.

Based on the IOM work and expert

discussions, AHCPR has initiated a

three stage process for identifying

topics:

1. Develop a preliminary list of

priority topics and reasons for

importance, representing the views of

health care providers, insurers, medical

and health specialty societies,

consumers, and the general public;

2. Convene an expert panel to review

and assess the preliminary research

priorities and suggested criteria; and

3. Identify which topic areas can be

most appropriately addressed using

outcomes and effectiveness research

methods.

This Notice initiates the first step, that

is, a solicitation of topics from health

care providers, insurers, health-related

societies, consumers, and the public.

Written suggestions for research topics

that fit within the parameters of

AHCPR’s outcomes and effectiveness

research program are invited.

For each suggestion, the nominee

should provide a clear rationale and

supporting evidence for the topic’s

importance and clinical relevance.

Responses should be submitted by July

29, 1996 to: Carolyn Clancy, M.D.,

Acting Director, Center for Outcomes

and Effectiveness Research, Agency for

Health Care Policy and Research, Suite

605, 2101 East Jefferson Street,

Rockville, Maryland 20852. All

responses will be available for public

inspection at the Center for Outcomes

and Effectiveness Research, Telephone

(301) 594–1485, weekdays between 8:30

a.m. and 5 p.m. The AHCPR will not

reply to individual responses, but will

consider all submissions in developing

the research priorities.

For further information on the

outcomes and effectiveness research

program, contact: Carolyn Clancy, M.D.,

Acting Director, Center for Outcomes

and Effectiveness Research, Agency for

Health Care Policy and Research, Suite

605, 2101 East Jefferson Street,

Rockville, Maryland 20852; Telephone

(301) 594–1485.

Dated: May 16, 1996.

Clifton R. Gaus,

Administrator.

[FR Doc. 96–13195 Filed 5–24–96; 8:45 am]

BILLING CODE 4160–90–M

Centers for Disease Control and

Prevention

[ANNOUNCEMENT 648]

National Institute for Occupational

Safety and Health; Fatality Surveillance

and Field Investigations at the State

Level Using the NIOSH Fatality

Assessment and Control Evaluation

(FACE) Model

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for cooperative agreements to

build State capacity for conducting

traumatic occupational fatality

surveillance, investigation, and

intervention activities through the

National Institute for Occupational

Safety and Health (NIOSH) Fatality

Assessment and Control Evaluation

(FACE) Model.

The CDC is committed to achieving

the health promotion and disease

prevention objectives of Healthy People

2000, a national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority areas of

Occupational Safety and Health, and

Surveillance and Data Systems. (To

order a copy of Healthy People 2000, see

the section Where to Obtain Additional

Information.)

Authority

This program is authorized under

section 20(a) of the Occupational Safety

and Health Act of 1970 (29 U.S.C.

669(a)) and sections 301 (42 U.S.C. 241)

and 317 (42 U.S.C. 247b) of the Public

Health Service Act, as amended.

Smoke-Free Workplace

The CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the nonuse of

all tobacco products, and Public Law

103–227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicants

Eligible applicants are State

Departments of Health, Departments of

Labor, Departments of Industry, etc.,

located within any State or territory of

the United States. Program activities,

however, may not be carried out by

departmental divisions that are

responsible for enforcement of

occupational safety and health

standards. Awards will be limited to
Federal Register / Vol. 61, No. 103 / Tuesday, May 28, 1996 / Notices 26521

1A Framework for Assessing the Effectiveness of

Disease and Injury Prevention. Morbidity and

Mortality Weekly Report (MMWR), March 27, 1992/

Vol.41/Jn. The MMWR can be accessed through

CDC’s DocView, World-Wide Web (http://

www.cdc.gov/epo/mmwr/mmwr.html).

those organizations that can exercise

public health authority for intervention

into occupational safety and health

problems. Only one application per

State will be accepted under this

announcement. Stronger consideration

will be given to those States or

territories submitting applications

which demonstrate coordination among

relevant State agencies.

Availability of Funds

Approximately $600,000 will be

available in FY 1996 to fund five to

seven awards. It is expected that the

awards will range from $60,000 to

$100,000 with an average award of

$80,000. Individual awards may vary by

State, and will be based upon the scope

and nature of traumatic occupational

fatalities documented by the

respondent, and upon proposed

personnel, administrative, and

associated costs. The awards will be

made on or about September 30, 1996,

with 12-month budget periods within

project periods of up to 5 years. Funding

estimates may vary and are subject to

change.

Continuation awards within the

project period will be determined on the

basis of satisfactory progress and the

availability of funds.

Purpose

The purpose of funding these

cooperative agreements is to expand the

State-based FACE project and

significantly strengthen the

occupational public health

infrastructure. This will be

accomplished by integrating resources

for occupational safety and health

research and public health prevention

programs at the State and local levels.

The ultimate goal of the project is to

reduce traumatic occupational fatalities

within the States. Over the past seven

years, State level personnel have shown

that the NIOSH FACE model for

investigation of occupational fatalities

can be successfully implemented in the

States. The most immediate products of

the State level FACE programs have

been accurate and timely surveillance

systems for detecting traumatic

occupational fatalities occurring within

the State, fatality investigations

identifying causal factors, and

recommendations for prevention

strategies. This program will permit

awardees to efficiently integrate

resources for prevention of occupational

fatalities at the State and local level.

Additionally, States will be encouraged

to target occupational traumatic injury

research and prevention programs based

on specific State priority areas. FACE

data will be shared with all award

recipients. The specific objectives for

this cooperative agreement are as

follows:

1. Develop a timely, comprehensive,

multiple source State level surveillance

system for identifying and recording

basic epidemiologic data on all

traumatic occupational fatalities

occurring within the State.

2. Conduct on-site investigations of

specific traumatic occupational fatalities

using the NIOSH FACE investigative

model.

3. Through case investigations,

identify factors common to selected

types of traumatic occupational

fatalities, leading to development and

prioritization of prevention strategies.

4. Develop and disseminate

prevention recommendations to reduce

the risk of fatal occupational injuries

within the State.

5. Develop and implement prevention

strategies and projects for reducing State

incidence of traumatic occupational

injuries and fatalities.

Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under A.(Recipient Activities), and

CDC/NIOSH will be responsible for the

activities under B. (CDC/NIOSH

Activities).

A. Recipient Activities

1. Develop a comprehensive multiplesource, State-level surveillance system

for prompt identification and reporting

of epidemiologic data on all traumatic

occupational fatalities occurring in the

State.

2. Conduct in-depth site

investigations of targeted occupational

fatalities as determined by NIOSH.

Currently, falls from elevations and

machinery-related incidents are targeted

fatality types. These are among the

leading causes of work-place fatalities,

as identified by national surveillance

systems; however, they may change over

the term of the agreement. Greatest

emphasis must be placed on the

determined targets; however, States may

choose, in cooperation with NIOSH, to

conduct in-depth investigations of other

fatality types identified.

3. In specified format, develop and

submit to NIOSH a narrative report of

each in-depth fatality investigation

which describes the fatal incident and

includes recommendations for

preventing future similar occurrences.

4. Submit first reports of fatalities,

investigative narrative reports, and

supplementary investigative data

electronically to NIOSH through CDC’s

WONDER/PC system.

5. Evaluate surveillance data and

investigative findings to identify

specific worker populations to which

prevention programs should be

addressed.1

6. Identify entities such as employers,

unions, and trade associations that can

effect change in the workplace.

7. Communicate recommended

preventions to those who can affect

change in the workplace and to those at

risk through targeted dissemination.

8. Prepare and submit periodic status

reports of activities in designated format

and an annual report that summarizes

the activities and progress made by the

State toward meeting the objectives for

the State FACE program.

9. Participate in annual NIOSHconducted FACE project workshop/

conference in Morgantown, West

Virginia, or other selected site.

B. CDC/NIOSH Activities

1. Provide formats for data reporting

forms, coding formats, computer

software, and State personnel training

for electronic transmission of FACE

surveillance and investigative data to

the NIOSH data base.

2. Provide assistance to awardee staff

in establishing traumatic occupational

fatality notification networks.

3. Provide initial training in

procedures and subsequent technical

assistance for conducting on-site fatality

investigations using the FACE

investigative methodology (including

the use of FACE investigative data

collection instruments).

4. Provide assistance in identifying

sentinel events resulting from industrial

applications of new and emerging

technologies.

5. Provide technical assistance in the

dissemination of summary reports and

other published findings to State and

local health and labor officials,

voluntary health groups, workers,

unions, employers and professional

organizations.

6. Provide technical assistance in

identifying and evaluating effective

intervention strategies.

7. CDC will provide funds to purchase

one IBM-compatible, Pentium-based

personal computer, printer,

telecommunications equipment, and

needed software for use on appropriate

activities related to this cooperative

agreement, if necessary.
26522 Federal Register / Vol. 61, No. 103 / Tuesday, May 28, 1996 / Notices

Evaluation Criteria

Evaluation of the applications will be

based on the following criteria:

1. Ability to communicate the scope

and nature of traumatic occupational

fatalities in the State as evidenced by

the quality of the narrative and

documented research and experience.

(10%)

2. The qualifications and time

commitment of proposed project staff

(principal investigator, field investigator

(if already identified), administrative

and technical support staff). (30%—

Total)

a. The existence of or potential for

acquiring expertise in investigation of

occupational fatalities. There should be

a full-time field investigator dedicated

to the project. (15%)

b. The existence of or potential for

acquiring safety expertise relevant to

formulation of injury prevention

strategies. (15%)

3. Applicant’s collaborative

relationships with various relevant State

or territorial agencies or organizations in

addressing the problem of traumatic

occupational fatality surveillance,

investigation, and intervention. (30%—

Total)

a. The existence of or potential for

establishment of a multiple-source

network for identification and reporting

of traumatic occupational fatalities.

(15%)

b. The existence of or potential for

establishment of relationships with

public safety departments, safety

compliance agencies, and other entities

that can provide background and

supplementary data relating to specific

fatality cases. (15%)

4. Demonstrated ability to

communicate recommended

preventions to those at risk through

targeted dissemination. (25%)

5. Additional personnel/facilities/

equipment already in place that can

contribute to successful implementation

of the project. (5%)

6. Human Subjects. (Not Scored)

Whether or not exempt from the

DHHS regulations, are procedures

adequate for protection of human

subjects. Recommendations on the

adequacy of protections include: (1)

Protections appear adequate, and there

are no comments to make or concerns to

raise, (2) protections appear adequate,

but there are comments regarding the

protocol, (3) protections appear

inadequate and the Objective Review

Group has concerns related to human

subjects, or (4) disapproval of the

application is recommended because

the research risks are sufficiently

serious and protection against the risks

are inadequate as to make the entire

application unacceptable.

7. Budget Justification. (Not Scored)

The budget will be evaluated to the

extent that it is reasonable, clearly

justified, and consistent with the

intended use of funds.

Executive Order 12372 Review

Applications are subject to the

Intergovernmental Review of Federal

Programs as governed by Executive

Order (E.O.) 12372. E.O. 12372 sets up

a system for State and local government

review of proposed Federal assistance

applications. Applicants (other than

federally recognized Indian tribal

governments) should contact their State

Single Point of Contact (SPOC) as early

as possible to alert them to the

prospective applications and receive

any necessary instructions on the State

process. Indian tribes are strongly

encouraged to request tribal government

review of the proposed application. For

proposed projects serving more than one

State, the applicant is advised to contact

the SPOC for each affected State. A

current list of SPOCs is included in the

application kit.

If SPOCs or tribal governments have

any State process recommendations on

applications submitted to CDC, they

should forward them to Ron Van Duyne,

Grants Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), Room

300, 255 East Paces Ferry Road, NE.,

Atlanta, GA 30305, no later than 60 days

after the application deadline date. The

granting agency does not guarantee to

‘‘accommodate or explain’’ State or

tribal process recommendations it

receives after that date.

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance for this program is 93.283.

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (OMB

Number 0937–0189) must be submitted

to Ron Van Duyne, Grants Management

Officer, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), Mailstop E–13, 255 East Paces

Ferry Road, NE., Room 300, Atlanta, GA

30305, on or before July 11, 1996:

1. Deadline: Applications will be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date, or

(b) Sent on or before the deadline date

and received in time for submission to

the objective review group. (The

applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or the U.S. Postal

Service. Private metered postmarks will

not be acceptable as proof of timely

mailing.)

2. Late Applications: Applications

that do not meet the criteria in 1.(a) or

1.(b) above are considered late

applications. Late applications will not

be considered in the current

competition and will be returned to the

applicants.

Where To Obtain Additional

Information

To receive additional written

information, call (404) 332–4561. You

will be asked to leave your name,

address, and telephone number and will

need to refer to Announcement 648.

You will receive a complete program

description and information on

application procedures and forms.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from Oppie

M. Byrd, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), Mailstop E–13, Room 300, 255

East Paces Ferry Road, NE., Atlanta, GA

30305, telephone (404) 842–6546,

Internet: oxb3@opspgo1.em.cdc.gov.

Programmatic technical assistance

may be obtained from Ted A. Pettit,

State FACE Project Officer, Chief,

Trauma Investigations Section,

Surveillance and Field Investigations

Branch, NIOSH/Division of Safety

Research, Mailstop 180P, 1095

Willowdale Road, Morgantown, WV

26505–2888, telephone (304) 285–5972,

Internet: TAP3@NIOSR1.EM.CDC.GOV,

or Dr. Nancy Stout, Acting Chief,

Surveillance and Field Investigations

Branch, NIOSH/Division of Safety

Research, Mailstop 180P, 1095

Willowdale Road, Morgantown, WV

26505–2888, telephone (304) 285–5916.

Please refer to Announcement

Number 648 when requesting

information and submitting an

application.

There may be delays in mail delivery

as well as difficulty in reaching the CDC

Atlanta offices during the 1996 Summer

Olympics (July 19–August 4). Therefore,
Federal Register / Vol. 61, No. 103 / Tuesday, May 28, 1996 / Notices 26523

CDC suggests the following to get more

timely responses to any questions: use

Internet/email, follow all instructions in

this announcement, and leave messages

on the contact person’s voice mail.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) referenced

in the Introduction through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Dated: May 17, 1996.

Diane D. Porter,

Acting Director, National Institute for

Occupational Safety and Health, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 96–13196 Filed 5–24–96; 8:45 am]

BILLING CODE 4163–19–P

Food and Drug Administration

[Docket No. 95N–0200]

Guidance on Applications for Products

Comprised of Living Autologous Cells

Manipulated Ex Vivo and Intended for

Structural Repair or Reconstruction;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled

‘‘Guidance on Applications for Products

Comprised of Living Autologous Cells

Manipulated Ex Vivo and Intended for

Structural Repair or Reconstruction.’’

The guidance was prepared by the

Center for Biologics Evaluation and

Research (CBER) in consultation with

the Center for Devices and Radiological

Health. The document is intended to

provide guidance on FDA’s approach to

the regulation of living autologous cells

manipulated ex vivo and intended for

structural repair or reconstruction

(Manipulated Autologous cells or MAS

cells). The agency is also inviting

comments on the guidance.

DATES: Written comments by August 26,

1996.

ADDRESSES: Submit written requests for

single copies of the guidance entitled

‘‘Guidance on Applications for Products

Comprised of Living Autologous Cells

Manipulated Ex Vivo and Intended for

Structural Repair or Reconstruction’’ to

the Division of Congressional and

Public Affairs (HFM–44), Center for

Biologics Evaluation and Research,

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448. Send one self-addressed adhesive

label to assist that office in processing

your requests. The guidance may also be

obtained by mail or FAX by calling the

CBER Voice Information System at 1–

800–835–4709.

Persons with access to the INTERNET

may obtain the document in several

ways. Users of ‘‘Web Browser’’ software,

such as Mosaic, Netscape, or Microsoft

Internet Explorer may obtain this

document via the World Wide Web by

using the following Uniform Resource

Locators:

http://www.fda.gov/cber/cberftp.html

ftp://ftp.fda.gov/CBER/

The document may also be obtained

via File Transfer Protocol (FTP).

Requestors should connect to FDA’s

FTP Server,

FTP.FDA.GOV(192.73.61.21). CBER

documents are maintained in a

subdirectory called ‘‘CBER’’ on the

server. Logins with the user name of

anonymous are permitted, and the

user’s e-mail address should be sent as

the password. The ‘‘READ.ME’’ file in

that subdirectory describes the available

documents that may be available as an

ASCII text file (*.TXT), or a WordPerfect

5.1 or 6.x document (*.w51,wp6), or

both. Finally, the guidance can be

obtained by ‘‘bounce-back e-mail’’. A

message should be sent to:

GDEXV@al.cber.fda.gov’’.

Submit written comments on the

guidance to the Dockets Managements

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Requests and

comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

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

Friday.

FOR FURTHER INFORMATION CONTACT:

Sharon A. Carayiannis, Center for

Biologics Evaluation and Research

(HFM–630), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–594–

3074.

SUPPLEMENTARY INFORMATION:

FDA had recently become aware of

the clinical use of MAS cell products.

MAS cells are defined as cells derived

from a patient’s tissues, which are

manipulated ex vivo, and then

implanted locally into the same patient

with the intent of providing repair or

reconstruction of a structure. The repair

and reconstruction does not involve

systemic action by the MAS cell

product. Examples of MAS cells include

chondrocytes expanded ex vivo and

implanted in focal cartilage defects (see

60 FR 36808 at 36809 for additional

information and references). The

commercialization and distribution of

expanded cartilage cells to provide a

potential solution to a relatively

common medical injury suggested that

numerous patients could be receiving

these cells within a short period of time.

In light of the potential public health

significance of the MAS cell products,

the growth of a commercial industry

potentially affecting a large number of

patients, and the need to decide which

existing regulatory authorities (e.g.,

device versus biologics) would be

appropriate to apply or whether a new

regulatory framework was required, the

agency held a public hearing on

November 16 and 17, 1995 (60 FR

36808). The intent of the meeting was to

solicit information on the nature and

diversity of these products, and to

receive comments on the formulation

and implementation of any new

regulatory requirements. The public

hearing had 8 panels with 24 speakers,

and there was general consensus that

the establishment, the production

process, and the MAS cell products

should be of the highest quality. The

speakers and attendees also agreed that

MAS cell products should benefit the

patient, but there was little consensus

on the appropriate mechanism that

should be used to show this benefit.

In the Federal Register of March 7,

1996 (61 FR 9185), after reviewing the

comments and further internal

discussions, the agency published a

notice announcing a Commissioner’s

roundtable to be held on March 15,

1996. The roundtable was held to

present the elements of a planned

regulatory framework intended to

ensure patient safety and to demonstrate

patient benefit, while accommodating

the development of these therapies and

the need for a flexible regulatory

approach. Many of the concepts

presented at the roundtable were

derived from ongoing FDA Reinventing

Government (REGO) initiatives. In the

same Federal Register notice, FDA also

invited the submission of written

comments concerning FDA’s draft plan

for the regulation of MAS cells. Based

on the discussions at the March 15,

1996, roundtable and on a review of all

comments received, FDA has decided

that, in light of the existing and

increased flexibility provided by REGO

initiatives, FDA will apply the

regulatory framework as detailed and

explained in the guidance. CBER is