Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices 28867

Estimated Total Annual Burden

Hours: 38.7.

Additional Information: Copies of the

proposed collection may be obtained by

writing to the Administration for

Children and Families, Office of

Information Services, Division of

Information Resource Management

Services, 370 L’Enfant Promenade SW.,

Washington, DC 20447, Attn: ACF

Reports Clearance Officer, Larry

Guerrero.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street NW.,

Washington, DC 20503, Attn: Ms.

Wendy Taylor.

Dated: May 31, 1996.

Larry Guerrero,

Director, Office of Information Services.

[FR Doc. 96–14127 Filed 6–5–96; 8:45 am]

BILLING CODE 4184–01–M

Centers for Disease Control and

Prevention

[Announcement 646]

National Institute for Occupational

Safety and Health; Community

Partners for Healthy Farming

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for cooperative agreements for the

Community Partners for Healthy

Farming (CPHF), a program with a dual

purpose: to conduct community-based

and action-oriented health and safety

surveillance and to pilot and evaluate

interventions that can reduce or prevent

work related injuries and illnesses in

farm workers and their families.

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 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

Section 20(a) of the Occupational Safety

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

669(a)).

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, governments and

their agencies. Eligible applicants

include domestic nonprofit

organizations, official public health

agencies of States, universities, colleges,

research institutions, and other public

and private organizations or their bona

fide agents, federally recognized Indian

tribal governments, Indian tribes or

Indian tribal organizations, and small,

minority- and/or women-owned

businesses. CDC/NIOSH encourages the

formation of partnerships between

public health, research organizations

and community based groups serving

agricultural populations.

Note: Organizations described in Section

501(c)(4) of the Internal Revenue Code of

1986 which engage in lobbying activities are

not eligible for the receipt of Federal grants

or cooperative agreements.

Availability of Funds

Approximately $1,600,000 is available

in FY 1996 to fund approximately 9–16

awards. It is expected that for the seven

to twelve sentinel event surveillance

projects the average award will be

approximately $95,000, ranging from

$55,000 to $105,000. It is anticipated

that for the three to six intervention

research projects the average award will

be approximately $130,000, ranging

from approximately $45,000 to

$175,000. It is further expected that the

awards will be effective on or about

September 30, 1996 and will be made

for a 12-month budget period within a

project period of up to three years.

Funding estimates may vary and are

subject to change.

CDC/NIOSH does not intend to fund

more than one surveillance application

per State, and intervention funding

decisions may be made to assure an

appropriate geographic distribution of

awardees.

Continuation awards within the

project period will be made based on

satisfactory progress and the availability

of funds.

Recipient Financial Participation

CDC strongly encourages in-kind and

other financial support by non-Federal

agencies such as community and State

organizations as well as private

businesses (e.g., machinery and farm

implement dealers). Such support will

promote the continuation of efforts to

prevent illness and injury in agriculture

after the cessation of funding under this

announcement.

Purpose

Surveillance

The purpose of the surveillance

component of this announcement is to

conduct on-going, action-oriented

surveillance of agriculture-related

disease, injury, and hazards in

agricultural communities. This

component continues surveillance

efforts begun in 1990 under the

Occupational Health Nurses in

Agricultural Communities (OHNAC)

program. The OHNAC program

conducted community-based

surveillance and intervention efforts

and during a five-year period placed

approximately 32 nurses in

communities in ten States. These nurses

conducted surveillance for illness and

injury sentinel health events in their

communities, developed strong

partnerships with agricultural and

health-care communities, and have

focused public health attention on

problems affecting farmers, farm

workers, and farm families. Each State

conducted case-based surveillance with

varying methodologies as to case

definition, geographic regions targeted,

intensity of active vs. passive

surveillance, and reporting sources

(Connon et al., 1993). While generally

successful, some surveillance efforts

were limited by factors including the

lack of reporting laws in some States,

reliance on self-reporting of incidents by

workers themselves, and lack of

consistent case definitions between

States. There was more efficient use of

staff time for both surveillance and

interventions when nurses focused work

in a geographic region that kept travel

time to a minimum but permitted

expansion of both surveillance and

interventions to larger geographic

regions for investigation of specific

occurrences or dissemination of

findings.

Surveillance-driven prevention efforts

in OHNAC have included the

dissemination of surveillance findings
28868 Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices

and recommendations for intervention

including publications in trade

periodicals; peer reviewed journals, an

issue of a nursing journal dedicated to

agricultural health (AAOHN, 1993);

CDC’s Morbidity and Mortality Weekly

Report; and targeted mailings of NIOSH

Updates and Alerts. Some of these

sentinel events have included scalpings

of women from inadequately protected

rotating shafts; fatalities and injuries

related to grain bins, manure pits, forage

wagons, and augers; nicotine poisoning

from dermal absorption during tobacco

harvesting; cumulative trauma related to

hand harvesting; eye injuries; tetanus;

stress; carbon monoxide (CO) poisoning

related to the use of small engines; and

children on farms. Because of OHNAC

and other NIOSH surveillance, The U.S.

Environmental Protection Agency

(EPA), Consumer Product Safety

Commission (CPSC), Occupational

Safety and Health Administration

(OSHA) and NIOSH are collaborating on

prevention of CO poisoning related to

the use of small engines. Some of these

findings (i.e., scalpings, CO poisoning,

and nicotine poisoning), by virtue of

their not being among commonly

reported or researched occurrences in

agriculture, may not have been detected

by other than such community-based

surveillance.

Intervention

The prevention intervention

component contributes to the

prevention of occupationally related

disease and injury in the agriculture

industry through community-based

demonstration or intervention projects

aimed at piloting and evaluating

regulatory, behavioral, education,

control or other preventive

interventions. It is intended that this be

accomplished by linking those with

research expertise to agricultural

community groups or populations in

order that prevention interventions are

piloted and evaluated within the

agricultural working population. The

focus for agricultural workplace safety

and health intervention efforts can

include specific engineering control

technologies, information dissemination

and health communication practices,

worker/management participatory safety

and health programs, and family and

community safety and health training.

Although many intervention strategies

have been applied to various work

settings, knowledge about what works

best is limited. Employers, owneroperators, agricultural workers, public

decision makers, cooperative extension

services agents, and others need this

information to make informed decisions

about which prevention strategies work

well and support the use of limited

resources. Research is needed to pilot

and evaluate prevention intervention

efforts which, if successful, will be

adoptable on a wider scale in a region

or throughout the nation. This work

should be done in cooperation with

agricultural workers and employers to

assure consideration of the economic

and organizational factors that

determine if interventions will be

adopted. Cultural, educational, gender,

geographical and other related attributes

of targeted populations will influence

how safety and health messages are

designed, distributed and received.

Farm workers (including migrant,

seasonal, minority, and permanent

employees as well as women and

children of the agricultural community)

and agricultural organizations should

join efforts to identify appropriate

techniques for information

dissemination and develop outcome

measurements which can be utilized to

determine the effectiveness of various

dissemination efforts.

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 listed under B. (CDC/NIOSH

Activities):

A. Recipient Activities

Surveillance

1. Select community-based staff with

appropriate expertise who have the

skills to communicate effectively with

both individuals and groups in those

communities, and preferably, with

occupational and public health

expertise. While in the OHNAC project,

nurses, supplemented by partners in

State health departments, Cooperative

Extension, Agricultural Centers, the

community, etc. effectively assumed

this responsibility, NIOSH realizes that

individuals with various backgrounds

and training may also be appropriate.

2. Identify a suitable location, as

appropriate, for the physical assignment

of community-based staff, most likely in

a local or county health department or

community health center, an

agricultural extension service office,

hospital or other location that serves the

needs of that agricultural community,

and where access to agricultural,

migrant and seasonal workers, their

families, and extension agents would be

facilitated.

3. Collaborate with other on-going

occupational and agricultural health

and safety activities in the State or

region. These could include the

following CDC/NIOSH-supported

programs: the Farm Family Health and

Hazard Surveillance (FFHHS) project;

Agricultural Health Promotion Systems

(AHPS); regional Centers for

Agricultural Disease and Injury

Research, Education and Prevention, the

Sentinel Event Notification System for

Occupational Risks (SENSOR) and the

Fatality Assessment, Control and

Epidemiology (FACE) program. In the

OHNAC program, members of the

Cooperative Extension Service, at both

the State and local level, were

invaluable partners in successful efforts.

4. Develop and adhere to a timetable

for planning and implementing this

project.

5. Provide training and orientation of

staff to occupational safety and health

principles and concepts in surveillance

and reporting; in securing expertise and

assistance to community-based staff and

local health officials; in securing

appropriate technical support

(engineering/industrial hygiene

expertise and data analysis) ranging

from site investigations to supplying

handout literature; and in the final

evaluation of proposed activities.

6. Ensure that community-based staff

have personal computers and modems

with the capability to link with CDC/

NIOSH, the State or Territorial Health

Department for reporting cases,

requesting technical assistance, and

other needs. This will permit timely

responses from health personnel and

timely requests for site investigations

when appropriate. Each award recipient

will participate in an electronic forum

(currently via CDC/WONDER) for

communication among and between

CDC/NIOSH, other award recipients,

and community-based staff.

7. Develop, implement and maintain

a community-based system of reporting

agricultural job-related diseases and

injuries in locales that are representative

of agriculture in the State or are

otherwise appropriate for selected

condition(s) and would most benefit

from such surveillance.

a. Incident reports should be sought

systematically in accordance with the

planned surveillance system and other

appropriate sources. These may include,

but are not limited to: emergency rooms,

hospital admission and discharge

summaries, physicians’ offices and

directly from agricultural workers (who

may not seek professional health

services for occupational health

concerns).

b. Incident reports should range from

brief summaries of relatively

unimportant events to detailed

descriptions of more notable events or
Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices 28869

conditions. Current exposure

information on machinery and

equipment used by agricultural workers,

including typical operating times and

circumstances, may also be included.

c. Ensure, regardless of selected

topics, that the proposed surveillance

system maintains a strong capacity to

recognize and respond to unforseen

occurrences in the target communities.

8. Develop a plan for selecting events

that, because of their public health

importance (severity, number of workers

potentially affected, potential

preventability, likelihood of providing

new information, need to increase

awareness in health or agricultural

communities, etc.) merit further

investigation. These events could

include fatalities, multiple occurrences

or single occurrences affecting multiple

individuals, occurrences of new or

emerging problems, conditions that are

of particular importance to agriculture.

a. Report such important events to

CDC/NIOSH within one week of

ascertainment by project staff. Such

reporting is not expected for all events

but is especially important for events

that may require timely responses,

involve CDC/NIOSH in its investigation,

or potential need to expand

investigation or public health response

to other States. These reports are

expected to be brief descriptions and

may be transmitted electronically.

(Examples from the OHNAC project

include carbon monoxide poisoning

related to small engines, green tobacco

sickness, and suffocation in wells

related to flooding.)

9. Develop a process of follow-back

investigations of selected cases with

agricultural workers and families. The

purpose of such investigations is to

ascertain preventable causes of illnesses

and injuries leading to the development

and dissemination of disease and injury

prevention strategies. Depending on the

importance of the problem, follow-back

could range from a brief review of

records and/or telephone contact to a

detailed site investigation involving

multiple disciplines. As indicated,

applicants will collaborate with

appropriate public health professionals,

technical advisors (e.g., agricultural

engineers), county extension agents,

agricultural workers, agricultural

worksite owners, CDC/NIOSH staff,

other health department personnel in

plan development and implementation.

a. Data could include descriptive

information on prevention efforts that:

(a) could have prevented injury or

illness, (b) could have diminished

injuries or illness, (c) were used that

prevented further illness or injury in

this (e.g., machine guard may have

prevented amputation) or (d) have been

initiated since the incident and are

likely to diminish the risk for further

incidents.

10. Provide sensitive, confidential

attention to reported cases, including

case confirmation and determination of

appropriate follow-up.

11. Evaluate the scientific and

operational aspects of the surveillance

project, including aspects of

completeness, public health impact and

the generalizability of methods and

findings to other settings.

12. Transmit data (case reports, etc.)

in an electronic format to CDC/NIOSH

in established timeframes (e.g.,

quarterly).

13. Disseminate, via appropriate

media and partners, findings and

recommendations to affected

populations, public health authorities

and the scientific community.

Intervention

1. Develop a scientific protocol for the

specific intervention which

encompasses the following elements:

a. Design and implementation of

intervention(s) based on a collaborative

effort between those with scientific

expertise and those who form the

community base; and

b. Identification of the target

population and specific description of

the procedures to recruit the target

population into the study.

2. Develop and conduct an

appropriate independent peer review of

the scientific protocol.

3. Conduct the project and evaluation

according to the protocol and assess

results.

4. Disseminate the final results of the

project to a wide audience including,

but not limited to, peer-reviewed

journal articles, presentations at

professional conferences, and

presentations to agricultural or other

client groups.

B. CDC/NIOSH Activities

1. Secure the materials and services of

other personnel necessary to assist and

support the activities of the staff.

2. Provide technical assistance,

through site visits and other

communication, in all phases of the

development, implementation and

maintenance of these cooperative

agreements including, but not limited

to: (a) providing guidance on

occupational conditions appropriate for

reporting; (b) recommending reporting

guidelines; developing case reporting

formats; (c) participating in peer review

panels; and (d) providing CDC/NIOSH

publications, educational materials, and

other documents, when appropriate and

needed.

3. Foster and facilitate linkages

between recipients and other groups,

organizations and agencies involved in

agricultural research and outreach.

4. Provide expertise and assistance to

site staff and local partners, as needed

and as resources permit, to assist in

problem identification and resolution,

and provide technical support.

5. Participate in the decisions to

conduct field investigations and

prevention efforts and respond to

incident reports requiring field followup.

6. Provide technical assistance in the

evaluation of the results of the

surveillance and intervention activities.

7. Promote and facilitate scientific

collaboration, as appropriate.

8. Assist in disseminating

surveillance and intervention research

results and relevant health and safety

education and training information to

appropriate Federal, State and local

agencies, health care providers, the

scientific community, agricultural

workers and their families, management

and union representatives and other

CDC/NIOSH collaborators.

9. Collaborate in training and

orienting staff to occupational safety

and health principles and concepts in

surveillance and reporting; in securing

expertise and assistance to communitybased staff and local health officials; in

securing appropriate technical support

(engineering/ industrial hygiene

expertise and data analysis) ranging

from site investigations to supplying

handout literature; and in the final

evaluation of proposed activities.

10. Cooperate in the development of

case definitions that would allow

aggregation of data among States.

Review Process

Upon receipt, applications will be

reviewed by CDC staff for:

1. Completeness and Responsiveness

Incomplete applications and

applications that are not responsive to

the announcement will be returned to

the applicant without further

consideration.

2. Triage

Applications that are determined to

be complete and responsive to the

announcement may be subjected to a

preliminary evaluation by reviewers to

determine if the application is of

sufficient technical and scientific merit

to be competitive. The CDC will

withdraw from further consideration

applications judged to be

noncompetitive and promptly notify the
28870 Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices

principal investigator/program director

and the official signing for the applicant

organization.

3. Objective Review Process

Those applications judged to be

competitive will be further evaluated by

the objective review process. The review

will be an evaluation of the scientific

and technical merit of the application

based on the following criteria:

Surveillance

(To fund 7–12 awards at $55,000—

$105,000 for up to 3 years)

1. Understanding of the Objectives of

the Proposed Agreement (Total

percentage for this section: 12%)

A. Provides a comprehensive

statement of the target problem(s),

scope, and purpose of the proposed

project to demonstrate complete

understanding of the intent and

requirements. This understanding

indicates a clear awareness of the

cooperative agreement objectives. (4%)

B. Ability and willingness to

incorporate surveillance for agricultural

occupational health and safety concerns

as an integral part of public health

programs for identification,

investigation, control and prevention of

agriculture related health injury, illness,

and hazard exposure. (4%)

C. In-kind support by community and

State organizations as well as private

businesses (e.g., machinery and farm

implement dealers) will promote the

building of the infrastructure for both

surveillance and interventions that are

likely to continue after the completion

of Federal funding of this. (4%)

2. Soundness of Approach (Total

percentage for this section: 66 %)

A. Documentation of a State reporting

requirement that incorporates

agriculturally related injuries and

illnesses. Ease of data collection, followback case investigation, and the absence

of barriers to contacting victims are

important. (5%)

B. Documented experience

conducting surveillance in agriculture.

(4%)

C. Capability to access surveillance

data on agricultural injuries, illnesses,

and hazards. Regardless of the presence

of reporting requirements, a clearly

defined and preferably tested means of

collecting data is described and

documented. This will include easy

access to data sources and health

records of victims. Applicants must

document the ability to conduct timely

follow-back investigations of cases and

gain access to work sites and

agricultural workers to assess health and

safety hazards or to investigate

exposures that have resulted in injury or

illness. (6%)

D. Selection of an efficient, costeffective means of surveillance. Extent

to which surveillance system makes

efficient use of staff time. Ideally,

routine activities would encompass a

geographic area that does not require

excessive travel time though with

provisions for flexibility. Geographic

area(s) is suitable for the selected

surveillance activity. (6%)

E. Documented capacity for creative

collaboration and coordination with

local community and/or cooperating

organizations and expertise for the

purposes of implementing the proposed

surveillance and follow-back

investigations where indicated. (5%)

F. There is a collaborative effort

involving the State or territorial public

health agency of the State or its bona

fide agent and other agricultural safety

and health projects, e.g., those funded

by CDC/NIOSH. (6%)

G. Valid basis for selection of

condition(s); industry subgroups; and/or

populations (children, seasonal

workers) to focus upon in this project,

i.e., documented or perceived risk to

agricultural workers and their families

in the area. Applicants are encouraged

to select at least one illness-related topic

(e.g., respiratory hazards, pesticides,

prevention of noise-induced hearing

loss). Efforts targeting specific industries

(e.g., poultry, dairy, pork production)

and special populations are also

encouraged. Although the majority of

effort is to be on the selected conditions,

participants will be willing and able to

conduct follow-back investigations on

other agriculturally related sentinel

events. (7%)

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:

1. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representation.

2. The proposed justification when

representation is limited or absent.

3. A statement as to whether the

design of the study is adequate to

measure differences when warranted.

4. A statement as to whether the plans

for recruitment and outreach for study

participants include the process of

establishing partnerships with

community(ies) and recognition of

mutual benefits will be documented.

H. Flexibility regarding target

condition, geographic region, and

population with documented ability to

respond to important though relatively

rare sentinel events. (5%)

I. Documented technical support or

capability (e.g., industrial hygiene,

safety engineering, agricultural

engineering) for investigations of

sentinel events and health and safety

hazards. Such support shall be readily

available for telephone consultation and

on-site investigations. (6%)

J. A feasible schedule for initiating

and accomplishing the activities of the

cooperative agreement. (9%)

K. A feasible approach to evaluation

of the surveillance system. (7%)

3. Personnel (Total percentage points for

this section: 22%)

A. Appropriate designation and

selection of staff for conducting

community and/or State-wide

surveillance activities. Staff will need

(supported by documentation):

1. The expertise, education, and

psychosocial skills in order to

effectively interact with the agricultural

community and health professionals

alike. (4%)

2. Experience/education in

epidemiology, public health,

occupational health and safety, and

agriculture. (5%)

3. To have support of the agricultural

communities, health professionals, and

others with whom they would interact.

(4%)

4. The ability to access and

understand medical records. (4%)

5. Documented capacity to conduct

epidemiological studies and to

coordinate activities involving State or

Territorial Offices, members of the

agricultural community, and health care

providers. Staff must provide assurance

of substantial time and resource

commitment to the program. (5%)

B. Human Subjects (Not Scored).

Whether or not exempt from the

Department of Health and Human

Services (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, or (2) protections appear adequate,

but there are comments regarding the

protocol, or (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.

C. Budget (Not Scored).

The budget will be evaluated to the

extent that it is reasonable, clearly
Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices 28871

justified, and consistent with the

intended use of funds.

Intervention (To Fund 3–6 awards at

$45,000—$175,000 for up to 3 years)

Applications will be reviewed and

evaluated according to the following

criteria:

1. The extent to which the applicant

understands the purpose of the

cooperative agreement and the

relevance of the proposal to that

purpose. (10%)

2. The extent to which the proposed

goals and objectives are clearly stated,

time-phased, and measurable. The

extent to which they encompass both

process and outcome features of the

intervention. The extent to which

specific research questions and/or

hypotheses are described. (10%)

3. The extent to which the potential

effectiveness of the intervention is

theoretically justified and supported

with epidemiologic, methodological, or

behavior research. The extent to which

the intervention is feasible and can be

expected to produce the expected

results in the target group. The extent to

which the intervention, its

implementation, the development of all

necessary materials, and all necessary

training are clearly described. The

extent to which the desired outcomes

are specified and definitions of

measurable endpoints are provided. The

extent to which the setting in which the

intervention is to be implemented is

clearly described and shown to be

adequate for reaching the target group

and achieving the desired objectives.

(25%)

4. The extent to which the target

group is described and access to the

target group is demonstrated. The extent

to which it is demonstrated that the

participation of the target group will be

sufficient to evaluate the intervention in

an unbiased fashion.

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 for study

participants include the process of

establishing partnerships with

community(ies) and recognition of

mutual benefits will be documented.

(15%)

5. The extent to which an evaluation

plan has been developed to determine

the success of the pilot intervention or

demonstration project(s) and determine

its utility as a public health prevention

strategy with broader application in

other communities. (15%)

6. The extent to which the

management staff and their working

partners are clearly described,

appropriately assigned and have

pertinent skills and experiences. The

extent to which the applicant proposes

to involve appropriate researchers and

other personnel who reflect the racial/

ethnic composition of the target

population. The extent to which the

applicant or a full working partner has

the capacity and facilities to design,

implement and evaluate the proposed

intervention. (10%)

7. The extent to which the

participants are clearly described and

their qualifications for their component

of the proposed work are explicitly

stated. The extent to which the

applicant provides proof of support (e.g.

letters of support and/or memoranda of

understanding) for proposed activities

as well as commitment to participate

from proposed partners. (15%)

8. 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: (a)

protections appear adequate, and there

are no comments to make or concerns to

raise, or (b) protections appear adequate,

but there are comments regarding the

protocol, or (c) protections appear

inadequate and the Objective Review

Group has concerns related to human

subjects; or (d) 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.

9. Budget (Not Scored).

The extent to which the program

budget 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 12372. Executive Order 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 Contacts (SPOCs)

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 subject to the Public

Health System Reporting Requirements.

Under these requirements, all

community-based nongovernmental

applicants must prepare and submit the

items identified below to the head of the

appropriate State and/or local health

agency(s) in the program area(s) that

may be impacted by the proposed

project no later than the receipt date of

the Federal application. The appropriate

State and/or local health agency is

determined by the applicant. The

following information must be

provided:

A. A copy of the face page of the

application (SF 424).

B. A summary of the project that

should be titled ‘‘Public Health System

Statement’’ (PHSIS), not to exceed one

page, and include the following:

1. A description of the population to

be served;

2. A summary of the services to be

provided; and

3. A description of the coordination

plans with the appropriate State and/or

local health agencies.

If the State and/or local health official

should desire a copy of the entire

application, it may be obtained from the

State SPOC or directly from the

applicant.

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic

Assistance Number is 93.283.
28872 Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices

Other Requirements

Paperwork Reduction Act

Projects funded through a cooperative

agreement that involve collection of

information from ten or more

individuals will be subject to review

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 Regulation, 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. 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. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines provided in the application

kit.

Women and Minority Inclusion Policy

It is the policy of the CDC to ensure

that women and racial and ethnic

groups will be included in CDC

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 population are appropriately

represented 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. In conducting the

review of applications for scientific

merit, review groups will evaluate

proposed plans for inclusion of

minorities and both sexes as part of the

scientific assessment and assigned

score. This policy does not apply to

research studies when the investigator

cannot control the race, ethnicity and/

or sex of subjects. Further guidance on

this policy is contained in the Federal

Register, Vol. 60, No. 179, Friday,

September 15, 1995, pages 47947–

47951.

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (Revised

7/92, OMB Control 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

E13, 255 East Paces Ferry Road, NE.,

Room 300, Atlanta, Georgia 30305, on or

before July 10, 1996.

1. Deadline: Applications shall 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 independent review group.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing.)

2. Late Applications: Applications

which 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

applicant.

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 646.

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,

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

(404) 842–6513.

Programmatic technical assistance for

surveillance may be obtained from Janet

Ehlers, R.N., M.S.N., Occupational

Health Nurse, National Institute for

Occupational Safety and Health, Centers

for Disease Prevention and Control

(CDC), Division of Surveillance, Hazard

Evaluations and Field Studies, 4676

Columbia Parkway, R–21, Cincinnati,

OH 45226, telephone (513) 841–4205,

fax (513) 841–4489, Internet:

jje0@nioshe2.em.cdc.gov.

Programmatic technical assistance for

intervention may be obtained from Teri

Palermo, R.N., Public Health Advisor,

National Institute for Occupational

Safety and Health, Centers for Disease

Control and Prevention (CDC), Division

of Respiratory Disease Studies, Office of

the Director, 1095 Willowdale Road,

Mailstop 219, Morgantown, WV 26505–

2888, telephone (304) 285–5836, fax

(304) 285–5723, Internet:

btp0@niords1.em.cdc.gov.

Please refer to Announcement 646

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 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. 96–14172 Filed 6–5–96; 8:45 am]

BILLING CODE 4163–19–P

[Announcement 649]

National Institute for Occupational

Safety and Health; Prevention of

Silicosis in Surface Miners

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for a cooperative agreement

program for prevention of silicosis in

surface miners. 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

area of Occupational Safety and Health.

(For ordering a copy of Healthy People

2000, see the Section Where to Obtain

Additional Information.)