Preventing Occupational Latex Allergy in Health Care Workers Notice of Availability of Funds for Fiscal Year 1997

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement 756]

Preventing Occupational Latex Allergy in Health Care Workers

Notice of Availability of Funds for Fiscal Year 1997

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1997 funds for a cooperative agreement

to develop and evaluate the effectiveness of interventions to prevent

adverse health effects from latex allergies in health care workers.

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. In recognition of the impact of occupational latex allergies,

the National Occupational Research Agenda (NORA), published by the

National Institute for Occupational Safety and Health (NIOSH) in April

1996 specifically mentions occupational latex allergies under two of

the priority areas for research and prevention. (For ordering a copy of

NORA, or 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 of 1970 (29 U.S.C. 669(a) and

671(e)(7)).

Smoke-Free Workplace

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

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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

for-profit 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.

Note: Public Law 104-65, dated December 19, 1995, prohibits an

organization described in section 501(c)(4) of the IRS Code of 1986,

that engages in lobbying activities to influence the Federal

Government, from receiving Federal funds.

Availability of Funds

Approximately $200,000 is available in FY 1997 to fund one award to

develop and evaluate the effectiveness of interventions to prevent

adverse respiratory health effects from latex allergies in health care

workers.

The amount of funding available may vary and is subject to change.

This award is expected to begin on or about September 30, 1997. The

award will be made for a 12-month budget period within a project period

up to five years. Continuation awards within the project period will be

made on the basis of satisfactory progress and availability of funds.

Use of Funds

Restrictions on Lobbying

Applicants should be aware of restrictions on the use of HHS funds

for lobbying of Federal or State legislative bodies. Under the

provisions of 31 U.S.C. 1352 (which has been in effect since December

23, 1989), recipients (and their subtier contractors) are prohibited

from using appropriated Federal funds (other than profits from a

Federal contract) for lobbying Congress or any Federal agency in

connection with the award of a particular contract, grant, cooperative

agreement, or loan. This includes grants/cooperative agreements that,

in whole or in part, involve conferences for which Federal funds cannot

be used directly or indirectly to encourage participants to lobby or to

instruct participants on how to lobby.

In addition, the FY 1997 HHS Appropriations Act, which became

effective October 1, 1996, expressly prohibits the use of 1997

appropriated funds for indirect or ``grassroots'' lobbying efforts that

are designed to support or defeat legislation pending before State

legislatures. This new law, section 503 of Public Law 104-208, provides

as follows:

Section 503(a) No part of any appropriation contained in this

Act shall be used, other than for normal and recognized executive-

legislative relationships, for publicity or propaganda purposes, for

the preparation, distribution, or use of any kit, pamphlet, booklet,

publication, radio, television, or video presentation designed to

support or defeat legislation pending before the Congress, * * *

except in presentation to the Congress or any State legislative body

itself.

(b) No part of any appropriation contained in this Act shall be

used to pay the salary or expenses of any grant or contract

recipient, or agent acting for such recipient, related to any

activity designed to influence legislation or appropriations pending

before the Congress or any State legislature.

Department of Labor, Health and Human Services, and Education, and

Related Agencies Appropriations Act, 1997, as enacted by the Omnibus

Consolidated Appropriations Act, 1997, Division A, Title I, section

101(e), Public Law 104-208 (September 30, 1996).

Background

Surveys have shown that about 10 percent of all health care workers

are sensitized to latex. Latex allergy may have serious health and

personal consequences. Between 1988 and 1992, the Food and Drug

Administration received reports of 1000 systemic allergic reactions to

latex, 15 of which were fatal. Many approaches have been recommended

for the primary, secondary, and tertiary prevention of adverse health

outcomes from latex exposure, including provision of reduced protein or

latex antigen gloves, medical screening, respiratory protection

programs, and use of alternative glove lubricants (instead of glove

powders). Health care facilities and public health agencies need to

understand ``what works''; this project will seek applications that

formally evaluate the effectiveness of the elements of institution-

based comprehensive latex allergy prevention programs, with a

particular emphasis on quantitative estimates of latex glove associated

exposures.

Purpose

The purpose of this project is to formally evaluate elements of

institution-based comprehensive primary, secondary, and tertiary latex

allergy prevention strategies, e.g., provision of gloves with reduced

and defined levels of latex protein or antigen, provision of latex-free

gloves to certain units, health screening, respiratory protection

programs, and/or use of alternative glove lubricants instead of glove

powders. The existing data on the prevalence of allergic reactions to

latex among health care workers suggest that, based on preliminary

power calculations, a fairly large population will need to be involved,

in the range of five hundred to a thousand workers, including provision

for dropouts.

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. Develop and implement the protocol for occupational latex

allergy prevention.

2. Ensure appropriate scientific peer review of the protocol and

ensure continued review of any and all revisions that are made.

3. Conduct the study according to the revised protocol; implement

the proposed prevention strategies and conduct the proposed evaluation

component.

4. Report and disseminate research results and relevant health and

safety training information to the scientific community, health care

providers, relevant professional societies, affected industry and labor

representatives, and interested State and Federal agencies.

B. CDC/NIOSH Activities

1. Provide scientific, epidemiologic, and medical collaboration.

2. Provide technical assistance in obtaining, analyzing and

reporting of serum specimens for worker latex IgE antibody levels and/

or other markers of exposure or response.

3. Provide assistance in the review, analysis and interpretation of

the data and cooperate in the preparation and publication of the

written reports.

Technical Reporting Requirements

An original and two copies of semi-annual progress reports are

required. Timelines for the semi-annual reports will be established at

the time of award. Final financial status and performance reports are

required no later than 90 days after the end of the project period. All

reports are submitted to the Grants Management Branch, Procurement and

Grants Office, CDC.

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Semi-annual progress report should include:

A. A brief program description.

B. A listing of program goals and objectives accompanied by a

comparison of the actual accomplishments related to the goals and

objectives established for the period.

C. If established goals and objectives to be accomplished were

delayed, describe both the reason for the deviation and anticipated

corrective action or deletion of the activity from the project.

D. Other pertinent information, including the status of

completeness, timeliness and quality of data.

Application Content

The application must be developed in accordance with the

instructions for PHS Form 398 (OMB No. 0925-0001, revised 5/95),

information that is contained in this program announcement, and the

instructions outlined in the following section headings.

The entire application, including appendices, should not exceed 40

pages and the Proposal Narrative section contained therein should not

exceed 25 pages. Pages should be clearly numbered and a complete index

to the application and any appendices included. The original and each

copy of the application must be submitted unstapled and unbound. All

materials must be typewritten, double-spaced, with unreduced type (font

size 12 point) on 8\1/2\'' by 11'' paper, with at least 1'' margins,

headers, and footers, and printed on one side only. Do not include any

spiral or bound materials or pamphlets.

The applicant should provide a detailed description of first-year

activities and briefly describe future-years objectives and activities.

A. Title Page

The heading should include the title of grant program, project

title, organization, name and address, project director's name address

and telephone number.

B. Abstract

A one page, singled-spaced, typed abstract must be submitted with

the application. The heading should include the title of grant program,

project title, organization, name and address, project director and

telephone number. This abstract is not in lieu of (but in addition to)

the Proposal Narrative, and it should outline the major goals and

objectives of the proposal.

C. Proposal Narrative

1. Briefly state the applicant's understanding of the need or

problem to be addressed and the purpose of this cooperative agreement.

This may be reflected in the protocol, see C.3 below.

2. Describe clearly the objectives, timelines, and steps to be

taken in planning and implementing this project, and the respective

responsibilities of the applicant for carrying out those steps.

3. Prepare a protocol which covers 500--1000 health care facility

employees with potential latex exposure, and includes a review of the

literature, a description of the specific intervention to be

instituted, description of the type and frequency of health and

exposure data collection, the proposed methods of data management and

analysis, and an evaluation component.

4. Provide a well designed exposure assessment component as well as

a health surveillance component, with: (a) The prevalence of employee

allergy-related health outcomes associated with defined levels of glove

use and specific glove protein and, if feasible, antigen content; (b)

the respiratory, skin, and other symptoms that may be associated with

specific glove usage; and (c) markers of exposure or response, e.g.,

the prevalence of skin prick responses and/or IgE antibodies to latex

proteins in the participating workers with exposures to various glove

types and lots.

5. Inclusion of women, ethnic, and racial groups: Describe how the

CDC policy requirements will be met regarding the inclusion of women,

ethnic, and racial groups in the proposed research. (See Women, Racial

and Ethnic Minorities in the Evaluation Criteria and Other Requirements

sections.)

6. Provide letters of support or other documentation of access to

potential study sites with the sample characteristics specified.

Include documentation that reflects commitment of both management and

labor representatives to the proposed study.

7. Human Subjects: State whether or not humans are subjects in this

proposal. (See Human Subjects in the Evaluation Criteria and Other

Requirements sections.)

8. Document the applicant's expertise in the area of occupational

health, environmental hygiene, and project management.

9. Provide the name, qualifications, and proposed time allocation

of the Project Director who will be responsible for administering the

project. Describe staff, experience, facilities, equipment available

for performance of this project, and other resources that define the

applicant's capacity or potential to accomplish the requirements stated

above. List the names (if known), qualifications, and time allocations

of the existing professional staff to be assigned to (or recruited for)

this project, the support staff available for performance of this

project, and the available facilities including space.

D. Budget

Provide a detailed budget which indicates anticipated costs for

personnel, equipment, travel, communications, supplies, postage, and

the sources of funds to meet these needs. The applicant should be

precise about the program purpose of each budget item. For contracts

described within the application budget, applicants should name the

contractor, if known; describe the services to be performed; and

provide an itemized breakdown and justification for the estimated costs

of the contract; the kinds of organizations or parties to be selected;

the period of performance; and the method of selection. Place the

budget narrative pages showing, in detail, how funds in each object

class will be spent, directly behind form PHS 398, page 5, Budget for

Entire Proposed Period of Support Direct Cost Only. Do not put these

pages in the body of the application. CDC may not approve or fund all

proposed activities.

Evaluation Criteria

The application will be reviewed and evaluated according to the

following criteria:

A. Understanding of the Problem (20%)

(1) Applicant's understanding of the general objectives of the

proposed cooperative agreement, (2) Evidence of ability to understand

the problem and to conceive/design and evaluate effective

interventions, and (3) Information about the occurrence of occupational

latex allergies and any steps taken to prevent it in the proposed study

population.

B. Program Personnel (25%)

(1) Applicant's technical experience (e.g., in the areas of

occupational health, allergy, industrial hygiene, project management),

(2) The qualifications (e.g., in the areas of industrial engineering,

occupational safety and health) and time allocation of the professional

staff to be assigned to this project, and (3) The applicant's ability

to describe the approach to be used in carrying out the

responsibilities of the applicant in this project.

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C. Study Design (30%)

Steps proposed in planning and implementing this project and the

respective responsibilities of the applicant for carrying out those

steps. The degree to which efficient and innovative approaches are

proposed to address the problem; the adequacy of the applicant's

evidence of access to appropriate study populations; and 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.

D. Goals, Objectives, Methods and Evaluation (15%)

The extent to which the proposed goals and objectives are clearly

stated, time-phased, measurable and include process and outcome

evaluation. The extent to which the methods are sufficiently detailed

to allow assessment of whether the objectives can be achieved for the

budget period. The extent to which a qualified plan is proposed that

will help achieve the goals stated in the proposal.

E. Facilities and Resources (10%)

The adequacy of the applicant's facilities, equipment, and other

resources available for performance of this project.

F. Human Subjects (Not Scored)

Whether or not exempt from the Department of Health and Human

Services (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.

G. 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

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 DHHS 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.

Application Submission and Deadline

A. 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

listed in this section. It should be postmarked no later than July 10,

1997. The letter should identify Program Announcement number 756 and

name of principal investigator. 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.

B. Application

The original and two copies of the application PHS Form 398

(Revised 5/95, OMB Number 0925-0001) must be submitted to Victoria

Sepe, Grants Management Specialist, Grants Management Branch,

Procurement and Grants Office, Centers for Disease Control and

Prevention (CDC), Mailstop E-13, 255 East Paces Ferry Road, NE., Room

321, Atlanta, GA 30305, on or before July 28, 1997.

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 and will be returned to the

applicants.

Where To Obtain Additional Information

To receive additional written information call 1-404-332-4561. You

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will be asked to leave your name, address, and telephone number and

will need to refer to NIOSH Announcement 756. You will receive a

complete program description, information on application procedures,

and application forms. CDC will not send application kits by facsimile

or express mail. Please refer to NIOSH Announcement Number 756 when

requesting information and submitting an application.

If you have questions after reviewing the contents of all the

documents, business management technical assistance may be obtained

from Victoria Sepe, Grants Management Specialist, Grants Management

Branch, Procurement and Grants Office, Centers for Disease Control and

Prevention (CDC), Mailstop E-13, Room 321, 255 East Paces Ferry Road,

NE., Atlanta, GA 30305, telephone (404) 842-6804, Internet:

[email protected].

Programmatic technical assistance may be obtained from Dr. Lee

Petsonk, Division of Respiratory Disease Studies, National Institute

for Occupational Safety and Health, Centers for Disease Control and

Prevention (CDC), 1095 Willowdale Road, Mailstop 240, Morgantown, WV

26505, telephone (304) 285-5714, Internet address: [email protected].

This and other CDC announcements are available through the CDC

homepage on the Internet. The address for the CDC homepage is: http://

www.cdc.gov.

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) 512-1800.

National Occupational Research Agenda: Copies of this publication

may be obtained from the National Institute for Occupational Safety and

Health, Publications Office, 4676 Columbia Parkway, Cincinnati, OH

45226-1998 or telephone 1-800-356-4674, and is available through the

NIOSH Home Page: http://www.cdc.gov/niosh/nora.html.

Dated: June 11, 1997.

Diane D. Porter,

Acting Director, National Institute for Occupational Safety and Health

Centers for Disease Control and Prevention (CDC).

[FR Doc. 97-15888 Filed 6-17-97; 8:45 am]

BILLING CODE 4163-19-P