[Federal Register Volume 62, Number 117 (Wednesday, June 18, 1997)]
[Notices]
[Pages 33088-33092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15888]


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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

[[Page 33089]]

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.

[[Page 33090]]

    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

[[Page 33092]]

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