Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices 28875

Dated: May 30, 1996.

Diane D. Porter,

Acting Director, National Institute for

Occupational Safety and Health, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 96–14170 Filed 6–5–96; 8:45 am]

BILLING CODE 4163–19–P

[Announcement 624]

National Institute for Occupational

Safety and Health Work Organization

Interventions To Prevent Work-Related

Musculoskeletal Disorders in Office

and Video Display Terminal Work

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for a cooperative agreement

program to develop work organization

interventions to prevent

musculoskeletal disorders in office and

video display terminal (VDT) workers.

The CDC is committed to achieving

the health promotion and disease

prevention objectives of Healthy People

2000, national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority area of

Occupational Safety and Health. (For

ordering a copy of Healthy People 2000,

see the section WHERE TO OBTAIN

ADDITIONAL INFORMATION.)

Authority

This program is authorized under

Sections 20(a) and 22(e)(7) of the

Occupational Safety and Health Act [29

U.S.C. 669(a) and 671(e)(7)].

Smoke-Free Workplace

The CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and 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

Applications may be submitted by

public and private, non-profit and forprofit organizations and governments,

and their agencies. Thus, universities,

colleges, research institutions, hospitals,

other public and private organizations,

State and local health departments or

their bona fide agents, federally

recognized Indian tribal governments,

Indian tribes or Indian tribal

organizations, and small, minority- and/

or women-owned businesses are eligible

to apply.

Availability of Funds

Approximately $140,000 is available

in FY 1996 to fund one award. It is

expected that the award will begin on or

about September 30, 1996, and will be

made for a 12-month budget period

within a project period of one year. The

funding estimate is subject to change.

Applications should be focused on

the research priorities described in the

section ‘‘FUNDING PRIORITIES’’ that

includes new research priorities

developed in a process which resulted

in defining a National Occupational

Research Agenda. Proposals in these

areas will compete for the available

funds as noted in the previous

paragraph.

Purpose

The purpose of this cooperative

agreement is to utilize the special

resources of the extramural research

community to conduct studies. The

funded project will focus on worksite

primary prevention efforts, replicating

and extending the CDC/NIOSH

interventions described in the

BACKGROUND Section of the Program

Announcement. This could include: (a)

replication/validation of CDC/NIOSH

findings on work-rest schedules and

task rotation, (b) extension of these

interventions to other types of VDT and

office tasks, and (c) examination of other

types of work organization

interventions.

Prior studies have indicated that some

types of VDT jobs may pose higher risk

for stress and work-related

musculoskeletal disorders (WRMD),

particularly jobs involving highly

repetitive and narrow tasks (e.g., data

entry or teleoperator tasks). Such jobs

are of particular interest for this project.

Project results, in combination with

NIOSH findings, will provide the basis

for recommendations regarding effective

work organization strategies for

reducing WRMDs, and improving

performance in repetitive VDT work.

Project results will also improve our

understanding of mechanisms

mediating between work organization

variables and musculoskeletal disorders

in VDT work.

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

activities under B. (CDC/NIOSH

Activities):

A. Recipient Activities

1. Evaluate the effectiveness of work

organization interventions in reducing

WRMDs and in improving productivity

among VDT workers. Both physical and

psychological symptoms will be

evaluated.

2. Develop a study protocol that

reviews the pertinent literature on VDTrelated musculoskeletal disorders and

work organization, describes the study

methodology, the data to be collected,

and the proposed analysis of the data.

Present the protocol to a panel of peer

reviewers and revise the protocol as

required for final approval.

3. Prepare necessary documentation

for reviews and/or clearances required

by CDC/NIOSH. (Depending on what is

proposed, it may be necessary to obtain

NIOSH peer review, Human Subjects

Review Board, or OMB approvals on

some protocols.)

4. Perform data collection and

management. Data is to include

measures of worker symptomatology

and performance and can additionally

include records data on factors such as

absenteeism, health care utilization, etc.

Symptomatology can include

musculoskeletal discomfort, upper

extremity musculoskeletal disorders,

and indicators of negative mental health

(e.g., depression, anxiety, tension).

Performance indicators can include

measures such as keystrokes/hour,

forms/hour, and errors.

5. Prepare a final report summarizing

the study methodology, results

obtained, and conclusions reached.

Develop recommendations regarding

effective work organization

interventions to reduce stress, fatigue,

and WRMDs among VDT workers.

6. Report study results to the

scientific community via presentations

at professional conferences and articles

in peer-reviewed journals.

B. CDC/NIOSH Activities

1. Provide scientific, epidemiologic,

work organization, ergonomic, and

medical collaboration for the successful

completion of this project.

2. Identify reviews and/or clearances

that must be fulfilled by the recipient,

and identify and convene a Peer Review

Panel to review draft study protocol.

3. Provide assistance in all stages of

the study including study design,

survey instrument design, collection,

tabulation, and analysis of data,

interpretation of the results and

preparation of the written reports.

4. Provide electromyograph (EMG) or

other instrumentation and data

collection assistance in investigating

physiological mechanisms in VDT

WRMDs.
28876 Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices

Evaluation Criteria

The application will be reviewed and

evaluated according to the following

criteria:

1. Understanding of the Problem

(25%)

Responsiveness to the objective of the

cooperative agreement including: (a)

applicant’s understanding of the general

objectives of the proposed cooperative

agreement, and (b) evidence of ability to

understand the problem and to

conceive/design effective interventions.

2. Program Personnel (30%)

(a) Applicant’s technical experience

(e.g., in the areas of work organization,

WRMDs and office and VDT

ergonomics), (b) the qualifications (e.g.,

in the areas of industrial engineering,

psychology and occupational safety and

health) and time allocation of the

professional staff to be assigned to this

project, and, (c) the applicant’s ability to

describe the approach to be used in

carrying out the responsibilities of the

applicant.

3. Study Design (20%)

Steps proposed in planning and

implementing this project and the

respective responsibilities of the

applicant for carrying out those steps.

Also, the adequacy of the applicant’s

evidence of access to study populations.

The degree to which the applicant has

met the CDC policy requirements

regarding the inclusion of women,

ethnic, and racial groups in the

proposed research. This includes:

(a) The proposed plan for the

inclusion of both sexes and racial and

ethnic minority populations for

appropriate representation.

(b) The proposed justification when

representation is limited or absent.

(c) A statement as to whether the

design of the study is adequate to

measure differences when warranted.

(d) A statement as to whether the

plans for recruitment and outreach

forstudy participants include the

process of establishing partnerships

with community(ies) and recognition of

mutual benefits will be documented.

4. Project Planning (15%)

The applicant’s schedule proposed for

accomplishing the activities to be

carried out in this project and for

evaluating the accomplishments.

5. Facilities and Resources (10%)

The adequacy of the applicant’s

facilities, equipment, and other

resources available for performance of

this project.

6. Human Subjects

Whether or not exempt from the

DHHS regulations, are procedures

adequate for the 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. (NOT

SCORED)

7. Budget Justification

The budget will be evaluated to the

extent that it is reasonable, clearly

justified, and consistent with the

intended use of funds. (NOT SCORED)

Executive Order 12372 Review

This program is not subject to the

Executive Order 12372 review.

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 number for this project is

93.283.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from ten or more

individuals and funded by this

cooperative agreement will be subject to

review and approval by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act.

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 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.

In addition to other applicable

committees, Indian Health Service (IHS)

institutional review committees also

must review the project if any

component of IHS will be involved or

will support the research. If any

American Indian community is

involved, its tribal government must

also approve that portion of the project

applicable to it.

Women, Racial and Ethnic Minorities

It is the policy of the Centers for

Disease Control and Prevention (CDC)

and the Agency for Toxic Substances

and Disease Registry (ATSDR) to ensure

that individuals of both sexes and the

various racial and ethnic groups will be

included in CDC/ATSDR-supported

research projects involving human

subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian,

Alaskan Native, Asian, Pacific Islander,

Black and Hispanic. Applicants shall

ensure that women, racial and ethnic

minority populations are appropriately

represented in applications for research

involving human subjects. Where clear

and compelling rationale exist that

inclusion is inappropriate or not

feasible, this situation must be

explained as part of the application.

This policy does not apply to research

studies when the investigator cannot

control the race, ethnicity and/or sex of

subjects. Further guidance to this policy

is contained in the Federal Register,

Vol. 60, No. 179, pages 47947–47951,

and dated Friday, September 15, 1995.

Funding Priorities

The NIOSH program priorities, listed

below, were developed by NIOSH and

its partners in the public and private

sectors to provide a framework to guide

occupational safety and health research

in the next decade—not only for NIOSH

but also for the entire occupational

safety and health community.

Approximately 500 organizations and

individuals outside NIOSH provided

input into the development of the

National Occupational Research Agenda

(NORA). This attempt to guide and

coordinate research nationally is

responsive to a broadly perceived need

to address systematically those topics

that are most pressing and most likely

to yield gains to the worker and the

nation. Fiscal constraints on

occupational safety and health research

are increasing, making even more

compelling the need for a coordinated

and focused research agenda. NIOSH

intends to support projects that facilitate

progress in understanding and

preventing adverse effects among

workers. The conditions or examples

listed under each category are selected

examples, not comprehensive

definitions of the category. Investigators

may also apply in other areas related to

occupational safety and health, but the
Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices 28877

rationale for the significance of the

research to the field of occupational

safety and health must be presented in

the grant application.

The Agenda identifies 21 research

priorities. These priorities reflect a

remarkable degree of concurrence

among a large number of stakeholders.

The NORA priority research areas are

grouped into three categories: Disease

and Injury, Work Environment and

Workforce, and Research Tools and

Approaches. The NORA document is

available through the NIOSH Home

Page; http://www.cdc.gov/niosh/

nora.html.

NORA Priority Research Areas

Disease and Injury

Allergic and Irritant Dermatitis

Asthma and Chronic Obstructive

Pulmonary Disease

Fertility and Pregnancy Abnormalities

Hearing Loss

Infectious Diseases

Low Back Disorders

Musculoskeletal Disorders of the

Upper Extremities

Traumatic Injuries

Work Environment and Workforce

Emerging Technologies

Indoor Environment

Mixed Exposures

Organization of Work

Special Populations at Risk

Research Tools and Approaches

Cancer Research Methods

Control Technology and Personal

Protective Equipment

Exposure Assessment Methods

Health Services Research

Intervention Effectiveness Research

Risk Assessment Methods

Social and Economic Consequences of

Workplace Illness and Injury

Surveillance Research Methods

Application Submission and Deadline

1. Preapplication Letter of Intent

Although not a prerequisite of

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. The letter should

be submitted to the Grants Management

Branch, CDC, at the address provided in

this section. It should be postmarked no

later than June 15, 1996. The letter

should identify the announcement

number, name of principal investigator,

and specify the priority area to be

addressed by the proposed project. The

letter of intent does not influence

review or funding decisions, but it will

enable CDC to plan the review more

efficiently and will ensure that each

applicant receives timely and relevant

information prior to application

submission.

The original and two copies of the

application PHS Form 5161–1 (Revised

7/92, 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 17, 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 Applicants: 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 624.

You will receive a complete program

description and information on

application procedures and application

forms. If you have questions after

reviewing the contents of all the

documents, business management

technical assistance may be obtained

from Oppie Byrd, Grants Management

Specialist, 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, telephone (404) 842–6546; fax:

(404) 842–6513; Internet:

oxb3@opspgo1.em.cdc.gov.

Programmatic technical assistance

may be obtained from Naomi G.

Swanson, Ph.D., Chief, Motivation and

Stress Research Section, Applied

Psychology and Ergonomics Branch,

Division of Biomedical and Behavioral

Science, National Institute for

Occupational Safety and Health, Centers

for Disease Control and Prevention

(CDC), Mailstop C–24, 4676 Columbia

Parkway, Cincinnati, OH 45226–1998,

telephone (513) 533–8165; fax: (513)

533–8596; Internet:

nws3@niobbs1.em.cdc.gov.

Please refer to Announcement 624

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,

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 section through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Dated: May 30, 1996.

Diane D. Porter,

Acting Director, National Institute for

Occupational Safety and Health, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 96–14171 Filed 6–5–96; 8:45 am]

BILLING CODE 4163–19–P

Food and Drug Administration

Clinical Studies of Safety and

Effectiveness of Orphan Products;

Availability of Grants; Request for

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

following changes to its Orphan

Products Development (OPD) grant

program for fiscal year (FY) 1997. The

previous announcement of this program,

which was published in the Federal

Register of August 15, 1994, is

superseded by this announcement. In

the future, a new announcement will be

published annually. This and future

announcements will provide the

programmatic requirements and criteria,

as well as the two dates for receipt of

applications, the estimated amount of

funds available, and the estimated

number of awards to be made in each

FY.

DATES: Application receipt dates are:

October 15, 1996, and March 15, 1997.

If the receipt date falls on a weekend, it

will be extended to Monday; if the date

falls on a holiday, it will be extended to

the following workday.