Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Notices 10589

potentially detrimental to the study. The

CCF COMS project has received U.S.

Public Health Service support from

1985 to the present through subcontract

funds from a National Eye Institute

cooperative agreement award to the

COMS Coordinating Center, The Wilmer

Ophthalmological Institute, The Johns

Hopkins Medical Institutions,

Baltimore, Maryland. Because the

COMS is an ongoing study, no

publications were affected by the

falsfified or fabricated data, and no

clinical treatment has been based on the

results of the study.

FOR FURTHER INFORMATION CONTACT:

Director, Division of Research

Investigations, Office of Research

Integrity, 301–443–5330.

Lyle W. Bivens,

Director, Office of Research Integrity.

[FR Doc. 95–4765 Filed 2–24–5; 8:45 am]

BILLING CODE 4160–17–P

Centers for Disease Control and

Prevention

[Announcement Number 524]

Injury Control Research Program

Project Grants

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1995

funds for Injury Control Research

Program Project Grants (RPPGs). The

Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of ‘‘Healthy People 2000,’’ a

PHS-led national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority areas of Violent

and Abusive Behavior and

Unintentional Injuries. For ordering a

copy of ‘‘Healthy People 2000,’’ see the

Section Where to Obtain Additional

Information.

Authority

This program is authorized under

Sections 301 and 391–394 of the Public

Health Service Act (42 U.S.C. 241 and

280b-280b-3). Program regulations are

set forth in 42 CFR part 52.

Smoke-Free Workplace

PHS 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 include all

nonprofit and for-profit organizations.

Thus, universities, colleges, research

institutions, hospitals, other public and

private organizations, State and local

health departments, and small, minority

and/or women-owned businesses are

eligible for these grants. Applicants

from non-academic institutions should

provide evidence of a collaborative

relationship with an academic

institution. Special consideration may

be given to applicants that emphasize

the training of women and minorities.

Current recipients of CDC injury control

research program project grants are

eligible to apply.

Availability of Funds

Approximately $1,000,000 is available

in FY 1995 to fund one new and two

recompeting RPPG awards. At least one

of these three awards will be for a

successfully competing RPPG focusing

on youth violence. New and

recompeting awards will be made for a

12-month budget period within a project

period of up to three years. The amount

of funding available may vary and is

subject to change. Beginning award

dates for each submission are shown in

the ‘‘Receipt and Review Schedule’’

section of this announcement.

Continuation awards within the project

period will be made on the basis of

satisfactory progress and the availability

of funds.

RPPG awards will not exceed

$400,000 per year (total direct and

indirect costs) with a project period not

to exceed three years. Subject to

program needs and the availability of

funds, supplemental awards to expand/

enhance existing projects may be made.

Supplemental awards may range from

up to $100,000 to up to $200,000 per

year (total direct and indirect costs). The

range of supplemental funds is

dependent upon the degree of

comprehensiveness of the RPPG in

addressing: research and training or

research, training, and demonstration as

determined by the Injury Research

Grants Review Committee (IRGRC).

Incremental levels for supplemental

awards (subject to program needs and

the availability of funds) for

successfully competing or recompeting

RPPGs will be determined as follows:

RPPG addresses research and training—

Up to $100,000

RPPG addresses research, training, and

demonstration—Up to $200,000

Purpose

The purposes of this program are:

A. To support injury prevention and

control research on priority issues as

delineated in: ‘‘Healthy People 2000,’’

‘‘Injury Control in the 1990’s: A

National Plan for Action,’’ ‘‘Injury in

America,’’ ‘‘Injury Prevention: Meeting

the Challenge,’’ and ‘‘Cost of Injury: A

Report to the Congress.’’ Information on

these reports may be obtained from the

individuals listed in the section.

Where to Obtain Additional

Information

B. To support RPPGs as part of CDC’s

national extramural investment in

injury control research and training,

intervention development, and

evaluation;

C. To integrate collectively, in the

context of a national program, the

disciplines of engineering,

epidemiology, medicine, biostatistics,

public health, law and criminal justice,

and behavioral and social sciences in

order to prevent and control injuries

more effectively;

D. To identify and evaluate current

and new interventions for the

prevention and control of injuries;

E. To bring the knowledge and

expertise of RPPGs to bear on the

development and improvement of

effective public- and private-sector

programs for injury prevention and

control; and

F. To facilitate injury control efforts

supported by various governmental

agencies within a geographic region.

Program Requirements

Essential Requirements for RPPGs:

A. Applicants must demonstrate and

apply expertise (defined as: conducting

ongoing high quality injury research and

publication in peer reviewed scientific

and technical journals(s) in the phases

(prevention, acute care, or

rehabilitation) or disciplines (e.g.,

biomechanics and epidemiology) of

injury control which the research

program addresses.

B. Applicants must document ongoing

injury-related research projects or

control activities currently supported by

other sources of funding.

C. Applicants must provide a director

(Principal Investigator) who has specific

authority and responsibility to carry out

the project. The director should report

to an appropriate institutional official

(e.g., dean of a school, vice president of

a university, or commissioner of health).

The director must have no less than

30% effort devoted solely to this project

with an anticipated range of 30% to

50%.
10590 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Notices

D. Applicants must demonstrate

experience in: conducting, evaluating,

and publishing injury control research;

developing, conducting, and evaluating

injury control training curricula

(researcher and/or practitioner) ; and/or

designing, implementing, and

evaluating injury control demonstration

programs.

E. Applicants must provide evidence

of working relationships with outside

agencies and other entities which will

allow for implementation of any

proposed intervention activities.

F. Applicants must provide evidence

of involvement of specialists or experts

in medicine, engineering, epidemiology,

law and criminal justice, behavioral and

social sciences, biostatistics, and/or

public health as needed to complete the

plans of the RPPG. These are considered

the disciplines and fields for RPPGs.

G. Applicants must specify

mechanisms for linking the injury

control research findings with public

health ( i.e. State and local

organizations) and other intervention

efforts to facilitate rapid translation,

dissemination, and application of

research findings preferably within

three years of inception.

H. Applicants should clearly describe

and be able to demonstrate how several

proposed multiple research projects

interrelate and complement each other.

Outcome objectives of the research

should be stated such that

accomplishments clearly reflect

elements of each individual project

within the RPPG.

I. Applicants must have the ability to

disseminate injury control research

findings, translate them into

interventions, and evaluate their

effectiveness.

J. Applicants involved in training

activities must be able to accomplish AI above and have an established

curricula and graduate training

programs (researcher and/or

practitioner) in disciplines relevant to

injury control (e.g., epidemiology,

biomechanics, safety engineering, traffic

safety, behavioral sciences, or

economics).

K. Applicants involved in training

and demonstration activities must be

able to accomplish A-J above and

conduct demonstration projects

(including description of statistical/

epidemiologic methodology and data

sources to be used) aimed at

determining the effectiveness of

interventions, in terms of impact and

cost, as part of a national injury

prevention and control effort.

For the youth violence RPPG, in

addition to research, training, and

demonstration activities described in

the Essential Requirements for RPPGs,

of particular interest are projects

designed to: a) develop further

understanding of the relationship

between social and economic influences

( e.g., poverty, joblessness,

concentration of poverty) and violent

behavior, b) evaluate policies, programs,

or interventions for reducing the impact

of social and economic factors on

violent behavior among youth and c)

provide training for youth violence

prevention researchers and

practitioners.

Grant funds will not be made

available to support the provision of

direct care. Studies may be supported

which evaluate methods of care and

rehabilitation for potential reductions in

injury effects and costs. Studies can be

supported which identify the effect on

injury outcomes and cost of systems for

pre-hospital, hospital, and rehabilitative

care and independent living.

Eligible applicants may enter into

contracts, including consortia

agreements (as set forth in the PHS

Grants Policy Statement, dated October

1, 1990, as amended), as necessary to

meet the requirements of the program

and strengthen the overall application.

Evaluation Criteria

Upon receipt, applications will be

reviewed by CDC staff for completeness

and responsiveness as outlined under

the previous heading Program

Requirements, (A listing of where these

requirements are described and/or

documented in the application will

facilitate the review process.).

Incomplete applications and

applications that are not responsive will

be returned to the applicant without

further consideration.

Applications which are complete and

responsive may be subjected to a

preliminary evaluation by reviewers

from the Injury Research Grants Review

Committee (IRGRC) to determine if the

application is of sufficient technical and

scientific merit to warrant further

review. CDC will withdraw from further

consideration applications judged to be

noncompetitive and promptly notify the

principal investigator/program director

and the official signing for the applicant

organization.

Those applications judged to be

competitive will be further evaluated by

a dual review process. The primary

review will be a peer evaluation

(IRGRC) of the scientific and technical

merit of the application. The final

review will be conducted by the CDC

Advisory Committee for Injury

Prevention and Control (ACIPC), which

will consider the results of the peer

review together with program need and

relevance. Funding decisions will be

made by the Director, National Center

for Injury Prevention and Control

(NCIPC), based on merit and priority

score ranking by the IRGRC, program

review by the ACIPC, and the

availability of funds.

A. Review by the Injury Research Grants

Review Committee (IRGRC)

Peer review of RPPG grant

applications will be conducted by the

IRGRC, which may recommend the

application for further consideration or

not for further consideration. Site visits

will be a part of this process for

recompeting RPPGs. Site visits may be

a part of this process for new applicants.

Factors to be considered by IRGRC

include:

1. The specific aims of the

application, e.g., the long-term

objectives and intended

accomplishments.

2. The scientific and technical merit

of the overall application, including the

significance and originality (e.g., new

topic, new method, new approach in a

new population, or advancing

understanding of the problem) of the

proposed research.

3. The extent to which the evaluation

plan will allow for the measurement of

progress toward the achievement of

stated objectives.

4. Qualifications, adequacy, and

appropriateness of personnel to

accomplish the proposed activities.

5. The soundness of the proposed

budget in terms of adequacy of

resources and their allocation.

6. The appropriateness (e.g.,

responsiveness, quality, and quantity) of

consultation, technical assistance, and

training in identifying, implementing,

and/or evaluating intervention/control

measures that will be provided to public

and private agencies and institutions,

with emphasis on state and local health

departments, as evidenced by letters

detailing the nature and extent of this

commitment and collaboration. Specific

letters of support or understanding from

appropriate governmental bodies must

be provided.

7. Evidence of other public and

private financial support.

8. Progress thus far made as detailed

in the application if the applicant is

submitting a competitive renewal

application. Documented success

examples include: development of pilot

projects; completion of high quality

research projects; publication of

findings in peer reviewed scientific and

technical journals; number of

professionals trained; integration of

disciplines; translation of research into

implementation; impact on injury
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Notices 10591

control outcomes including legislation/

regulation, treatment, or behavior

modification interventions.

B. Review by CDC Advisory Committee

for Injury Prevention and Control

(ACIPC)

Factors to be considered by ACIPC

include:

1. The results of the peer review.

2. The significance of the proposed

activities as they relate to national

program priorities and the achievement

of national objectives.

3. National and programmatic needs

and geographic balance.

4. Overall distribution of the thematic

focus of competing applications; the

nationally comprehensive balance of the

program in addressing: the three phases

of injury control (prevention, acute care,

and rehabilitation); the control of injury

among populations who are at increased

risk, including minority groups, the

elderly and children; the major causes

of intentional and unintentional injury;

and the major disciplines of injury

control (e.g., biomechanics and

epidemiology).

5. Within budgetary considerations

the ACIPC will establish annual funding

levels as detailed under the heading,

Availability of Funds.

C. Applications for Supplemental

Funding

Supplemental grant awards may be

made when funds are available, to

support research work or activities.

Applications should be clearly labeled

to denote their status as requesting

supplemental funding support. These

applications will be reviewed by the

IRGRC and the ACIPC.

D. Continued Funding

Continuation awards within the

project period will be made on the basis

of the availability of funds and the

following criteria:

1. The accomplishments of the

current budget period show that the

applicant’s objectives as prescribed in

the yearly workplans are being met;

2. The objectives for the new budget

period are realistic, specific, and

measurable;

3. The methods described will clearly

lead to achievement of these objectives;

4. The evaluation plan allows

management to monitor whether the

methods are effective by having clearly

defined process, impact, and outcome

objectives, and the applicant

demonstrates progress in implementing

the evaluation plan; and

5. The budget request is clearly

explained, adequately justified,

reasonable, and consistent with the

intended use of grant funds.

Award Priorities

Special consideration will be given to

recompeting Injury Control Research

Program Projects Grants.

E.O. 12372 Review

Applications are not subject to the

review requirements of Executive Order

12372, entitled Intergovernmental

Review of Federal Programs.

Public Health System Reporting

Requirement

This program is not subject to the

Public Health System Reporting

Requirement.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance Number is 93.136.

Other Requirements

A. Human Subjects

If the proposed project involves

research on human subjects, the

applicant must comply with the

Department of Health and Human

Services Regulations, 45 CFR part 46,

regarding the protection of human

subjects. Assurance must be provided to

demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and form provided in the

application kit.

B. Animal Subjects

If the proposed project involves

research on animal subjects, the

applicant must comply with the ‘‘PHS

Policy on Humane Care and Use of

Laboratory Animals by Awardee

Institutions.’’ An applicant organization

proposing to use vertebrate animals in

PHS-supported activities must file an

Animal Welfare Assurance with the

Office for Protection from Research

Risks at the National Institutes of

Health.

Application Submission and Deadlines

A. Preapplication Letter of Intent

In order to schedule and conduct site

visits as part of the formal review

process, potential applicants are

encouraged to submit a nonbinding

letter of intent to apply to the Grants

Management Officer (whose address is

given in this section Item B). It should

be postmarked no later than one month

prior to the submission deadline (April

1, 1995, for May 1, 1995, submission

deadline). The letter should identify the

relevant announcement number for the

response, indicate the submission

deadline which will be met, name the

principal investigator, and specify the

injury control theme or emphasis of the

proposed RPPG (e.g., acute care,

biomechanics, epidemiology,

prevention, or rehabilitation). The letter

of intent does not influence review or

funding decisions, but it will enable

CDC to plan the review more efficiently.

B. Applications

Applicants should use Form PHS–398

(Rev. 9/91, OMB Number 0925–0001)

and adhere to the ERRATA Instruction

Sheet for PHS–398 contained in the

Grant Application Kit. The narrative

section for each project within an RPPG

should not exceed 25 typewritten pages.

Refer to section 4, page 10, of PHS–98

instructions for font type and size.

Applications not adhering to these

specifications may be returned to

applicant. Applicants should submit an

original and five copies to Henry S.

Cassell, III, Grants Management Officer,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E–13, Atlanta, GA

30305, in accordance with the

submission date shown in the ‘‘Receipt

and Review Schedule’’ listed below.

C. Deadlines

Applications shall be considered as

meeting the deadline above if they are

either:

1. Received on or before the deadline

date; or

2. Sent on or before the deadline date

and received in time for submission to

the peer review committee. Applicants

should 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 shall not be

acceptable as proof of timely mailing.

Applications which do not meet the

criteria in C.1. or C.2. above are

considered late applications and will be

returned to the applicant. Supplemental

materials received later than thirty days

after the application receipt date are

considered late and will be returned to

the applicant.

D. Receipt and Review Schedule

This is a continuous announcement.

Consequently, these receipt dates will

be ongoing until further notice. The

proposed timetables for receiving

applications and awarding grants are as

follows:
10592 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Notices

Receipt of

new/revised/

supplementary/

competitive renewal applications

Initial

review

Secondary

review

Earliest

award

date

May 1, 1995 ... June .. July ... Aug. 1,

1995.

FUTURE RECEIPT DATES ARE AS FOLLOWS:

Receipt of

new/revised/

supplementary/

competitive renewal applications

Initial

review

Secondary

review

Earliest

award

date

April ................ June .. July ... Aug.

Where to Obtain Additional

Information

All application procedures and

guidelines are contained within this

program announcement. Business

management technical assistance may

be obtained from Maggie Slay, Grants

Management Specialist, Centers for

Disease Control and Prevention (CDC),

255 East Paces, Ferry Road, NE.,

Mailstop E13, Atlanta, GA 30305,

telephone (404) 842–6797.

Programmatic technical assistance may

be obtained from Tom Voglesonger,

Program Manager, Injury Control

Research Centers, National Center for

Injury Prevention and Control, Centers

for Disease Control and Prevention

(CDC), 4770 Buford Highway, Mailstop

K58, Atlanta, GA 30341–3724,

telephone (404) 488–4265.

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)

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 783–3238.

Dated: February 21, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–4684 Filed 2–24–95; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 94D–0386]

Revised FDA Form 3210 Application

for Establishment License for

Manufacture of Biological Products (4/

94); Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the revised FDA Form

3210 Application for Establishment

License for Manufacture of Biological

Products (4/94). This form replaces the

previous edition of FDA Form 3210 (12/

88). FDA Form 3210 is used by

manufacturers to apply for licensure of

a facility for the manufacture of

biological products regulated under the

Public Health Service Act. The form has

been revised because of inadequacies in

the previous form that resulted in

requests by the agency for supplemental

information. The revised form is

intended to shorten review time and

decrease expenditure of resources for

both the agency and industry.

DATES: FDA will continue to accept

submissions using the previous Form

3210 (12/88) until August 28, 1995.

FOR FURTHER INFORMATION CONTACT:

Timothy W. Beth, Center for Biologics

Evaluation and Research (HFM–635),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

ADDRESSES: Submit written requests for

single copies of the revised FDA Form

3210 Application for Establishment

License for Manufacture of Biological

Products (4/94) to Division of

Congressional and Public Affairs (HFM–

11), Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–594–

1800. Requests should be identified

with the docket number found in

brackets in the heading of this

document. Send two self-addressed

adhesive labels to assist that office in

processing your requests. The form may

also be obtained by calling the CBER

FAX Information System at 301–594–

1939 from a FAX machine with a touch

tone phone attached or built in. FDA

Form 3210 Application for

Establishment License for Manufacture

of Biological Products (4/94) is available

for public examination in the Dockets

Managements Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857, between 9 a.m. and 4 p.m.,

Monday through Friday.

SUPPLEMENTARY INFORMATION: FDA is

making available revised FDA Form

3210 Application for Establishment

License for Manufacture of Biological

Products (4/94). The form was revised

due to inadequacies in the old form

which made the application review

process cumbersome and difficult for

both the agency and industry. In the

past, the review process was often

significantly lengthened because of

requests by the agency for supplemental

information from the manufacturer in

order to ensure the safety, purity,

potency, and efficacy of manufactured

biological products. The revised form

details more specifically the information

that is required for establishment

licensure. FDA believes that the revised

form will expedite the review process

by reducing the need for supplemental

information requests and responses.

The revised form solicits information

from the manufacturer in the following

areas: (1) General information (names

and addresses); (2) water systems; (3)

heating ventilation and air conditioning

systems; (4) raw materials and ancillary

facilities; (5) source materials; (6)

propagation of host systems; (7)

intermediate processing; (8) formulation

and final product preparation; (9)

computer systems; (10) support areas;

(11) quality control areas; (12) animal

facilities for testing; (13) animal

facilities for production; (14) calibration

and validation; and (15) records.

In addition, the revised form also

requires the following information to be

submitted: A description of the lot

numbering system, an organizational

chart, an environmental assessment

report, written agreements, curriculum

vitae for key manufacturing and

responsible personnel, and an overview

of the current good manufacturing

practices (CGMP) training program. A

comments section is provided on the

revised form for additional information

that the manufacturer deems to be

appropriate but may not be covered

under other sections.

Manufacturers preparing to submit

applications for establishment licensure

should now utilize the revised (4/94)

form. FDA will continue to accept

submissions using the previous (12/88)

form until August 28, 1995. Because the

old form does not address specific

questions and issues that are present on

the revised form, additional review

cycles should be anticipated when using

the previous form.

Under the Paperwork Reduction Act

of 1980 (Pub. L. 96–511) all forms

requesting a collection of information