OCCUPATIONAL EXPOSURE TO PUTATIVE REPRODUCTIVE/DEVELOPMENTAL TOXICANTS IN HUMANS

Release Date:  February 2, 2001

RFA:  RFA-OH-01-008

National Institute for Occupational Safety and Health

Letter of Intent Receipt Date:  March 1, 2001
Application Receipt Date:       April 18, 2001

THIS RFA USES THE DETAILED BUDGET FORMAT, RATHER THAN MODULAR GRANT BUDGET 
FORMAT.

PURPOSE

The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 funds for grant applications to support 
epidemiologic studies of workplace exposures to chemicals that may affect 
reproduction and/or development.  For this RFA, the chemicals of interest are 
limited to those commonly found in the workplace, where animal studies suggest 
the potential for reproductive/developmental harm, and there is inadequate 
data on human response to exposure.  Because data on animals exist, only 
studies that examine human responses are solicited.  

The research needs identified in this announcement are consistent with the 
National Occupational Research Agenda (NORA) developed by NIOSH and partners 
in the public and private sectors to provide a framework to guide occupational 
safety and health research in the new millennium towards topics which are most 
pressing and most likely to yield gains to the worker and the nation.  The 
agenda identifies 21 research priorities.  NORA priorities with specific 
relevance to this announcement are: Fertility and Pregnancy Abnormalities, 
Mixed Exposures and Exposure Assessment Methods.  Information about NORA is 
available through the NIOSH Home Page; http://www.cdc.gov/niosh/norhmpg.html.

HEALTHY PEOPLE 2010

CDC is committed to achieving the health promotion and disease prevention 
objectives of Healthy People 2010, a national activity to reduce morbidity and 
mortality and improve the quality of life.  This announcement is related to 
the focus area of Occupational Safety and Health.  For a copy of AHealthy 
People 2010"(Full Report: Stock No. 017-001-00547-9), write or call: 
Superintendent of Documents, Government Printing Office, Washington D.C. 
20402-9325, telephone (202) 512-1800 or visit the internet site: 
http://www.health.gov/healthypeople.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, public and private 
nonprofit and for-profit organizations and by governments and their agencies; 
that is, universities, colleges, research institutions, hospitals, other 
public and private nonprofit and for-profit organizations, State and local 
governments or their bona fide agents, federally recognized Indian tribal 
governments, Indian tribes, or Indian tribal organizations, and small, 
minority, and women-owned businesses that meet the above criteria.  
Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators.

Note:  Public Law 104-65 states that an organization described in section 
501(c)(4) of the Internal Revenue Code of 1986 which engages in lobbying 
activities is not eligible to receive Federal funds constituting an award, 
grant (cooperative agreement), contract, loan, or any other form.

MECHANISM OF SUPPORT

The mechanism of support will be the individual research project grant (R01). 
 Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The total requested project 
period for an application submitted in response to this RFA may not exceed   
five (5) years. 

This RFA is a one-time solicitation. 

FUNDS AVAILABLE

Approximately $2,000,000 is available in FY 2001 to fund 4-5 awards under this 
RFA.  The maximum amount that may be requested is $500,000 total cost (direct 
plus facilities and administration) per year. Awards are expected to begin 
September 1, 2001.

Awards will be made for a 12-month budget period within a project period up to 
five (5) years.  Continuation awards within the project period will be made on 
the basis of satisfactory progress and availability of funds in future years.

Use of Funds

Applicants should include funds in their overall budget request for one trip 
per year for an annual meeting of grantees to be held in Washington, D.C.

RESEARCH  OBJECTIVES

Background

While a large number of chemicals have been tested for reproductive/ 
developmental effects in animals, there are few studies of the effects of 
these chemicals in humans.  The total number of workers potentially exposed to 
reproductive hazards is difficult to estimate; however, three-quarters of 
employed women and an even greater proportion of employed men are of 
reproductive age.  More than half of U.S. children are born to working 
mothers.  The vast number of workers of reproductive age together with the 
substantial number of workplace chemical, physical, and biological agents 
suggest that a considerable number of workers are potentially at risk for 
adverse reproductive outcomes.  One method of prioritizing chemicals for study 
to determine if they pose potential for reproductive/developmental harm 
involves two criteria: the number of workers exposed and the potency of 
reproductive/developmental toxicity in animals.  Recently,  43 animal 
reproductive/developmental toxicants identified by the National Toxicology 
Program (NTP), were examined using these criteria (Moorman et al, see useful 
references).  From this study, thirteen chemicals were identified that had 1) 
medium to high reproductive/developmental toxicity in animal and 2) more than 
10,000 workers potentially exposed and/or greater than 500 tons produced per 
year.  These chemicals are: dibutyl pthalate (CAS Number 84-74-2); Boric Acid 
(CAS Number 10043-35-3); Tricresyl phosphate (CAS Number 1330-78-5); N,N-
Dimethylformamide (CAS Number 68-12-2); Acrylamide (CAS Number 79-06-1); N-
Hydroxymethylacrylamide (CAS Number 924-42-5); 4-Chloronitrobenzene (CAS 
Number 100-00-5); 2-Butoxyethanol  (CAS Number 111-76-2); Oxalaic Acid (CAS 
Number 144-62-7); Bisphenol A (CAS Number 80-05-7); Ethylene Glycol (CAS 
Number 107-21-1); P-Nitrobenzoic Acid  (CAS Number 62-23-7); and 2,2 bis(BM) 
1,3-propanediol (CAS Number 3296-90-0).  As a result of this study, there is 
now a rationale available for the selection of chemicals for study in humans. 
 Proposals to study chemicals structurally similar to those above that provide 
supportive data on reproductive or developmental toxicity also will be 
considered.

Research Goals

This RFA is focused on the support of research projects that investigate the 
relationships between occupational exposure to these high priority chemicals 
and adverse reproductive/developmental effects in humans.  Studies are 
encouraged that employ quantitative exposure assessment methodologies, such as 
biomarkers; allow differentiation in exposure routes; allow estimation of 
timing of exposure in relation to outcomes; and control for other risk 
factors, such as existing medical conditions and lifestyle factors.  Studies 
are needed that demonstrate quantitative relationships between chemical 
exposures and adverse reproductive or developmental effects in humans.  The 
research applications should include study populations that 1) have been 
identified as exposed to the chemicals of interest, 2) have clearly 
differentiated exposure categories, and 3) have a range of chemical exposure 
levels.  
 
Effects of interest include but are not limited to the following: 1) reduced 
fertility in exposed male and females or other indications of altered 
reproductive function such as changes in hormone levels, menstrual-cycle, 
endometriosis or poor semen quality; 2) pregnancy outcomes and pre- and 
postnatal development of offspring of exposed women such as reproductive tract 
malformations; and 3) evidence of latent effects on reproduction among 
offspring exposed in utero; such as infertility in both male and female 
offspring and abnormal sperm count and semen quality. 

Useful References

Moorman WJ, Ahlers HW, Chapin RE, Daston GP, Foster PMD, Kavlock RJ, Morawetz 
JS, Schnorr TM, Schrader SM.  Prioritization of NTP reproductive toxicants for 
field studies. Repro Toxicol 2000:14: 93-301.

HUMAN SUBJECTS REQUIREMENTS

If a project involves research on human subjects, assurance (in accordance 
with Department of Health and Human Services Regulations, 45 CFR Part 46) of 
the protection of human subjects is required.  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 with 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.  Unless the grantee holds a Multiple Project Assurance, a Single Project 
Assurance is required, as well as an assurance for each subcontractor or 
cooperating institution that has immediate responsibility for human subjects. 
 The Office of Human Research Protections (OHRP) negotiates assurances for all 
activities involving human subjects that are supported by the Department of 
Health and Human Services (Additional information is available at 
http://www.hhs.gov/ohrp/).

ANIMAL SUBJECTS REQUIREMENTS

If the proposed project involves research on animal subjects, compliance with 
the "PHS Policy on Humane Care and Use of Laboratory Animals by Awardee 
Institutions" is required.  An applicant (as well as each subcontractor or 
cooperating institution that has immediate responsibility for animal subjects) 
proposing to use vertebrate animals in CDC-supported activities must file (or 
have on file) the Animal Welfare Assurance with the Office of Laboratory 
Animal Welfare (OLAW) at the National Institutes of Health. The applicant must 
provide in the application the assurance of compliance number and evidence of 
review and approval (including the date of the most recent approval) by the 
Institutional Care and Use Committee (IACUC).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the CDC to ensure that individuals of both sexes and the 
various racial and ethnic groups will be included in 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 or Alaska Native, Asian, Black or African American, Hispanic 
or Latino, Native Hawaiian or Other Pacific Islander.  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.

URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES

All applications must be self-contained within specified page limitations.  
Unless otherwise specified, internet addresses (URLs) should not be used to 
provide information necessary to the review because reviewers are under no 
obligation to view the internet sites.  Reviewers are cautioned that their 
anonymity may be compromised when they directly access an internet site.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 1, 2001, a letter of 
intent that includes the number and title of the RFA, a descriptive title of 
the proposed research, the name, address, and telephone number of the 
Principal Investigator, and the identities of other key personnel and 
participating institutions.  Although a letter of intent is not required, is 
not binding, and is not used in the review of an application, the information 
that it contains is used to estimate the potential review workload and avoid 
conflict of interest in the review.

The letter of intent is to be submitted to: 

Pervis Major, Ph.D.
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA  30333
Telephone 304-285-5979
Fax 304-285-6047
Email: Pmajor@CDC.gov

APPLICATION PROCEDURES

Applicants must use Form PHS 398 (rev. 4/98).  Application kits are available 
at most institutional offices of sponsored research and may be obtained from 
the Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, 
telephone 301/435-0714,  Email: grantsinfo@nih.gov.  Application kits are also 
available at: http://grants.nih.gov/grants/forms.htm.

The forms may also be downloaded from the Internet at:
http://grants.nih.gov/grants/funding/phs398/phs398.html

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Failure to use 
this label could result in delayed processing of the application such that it 
may not reach the review committee in time for review.  In addition, the RFA 
title and number must be typed on line 2 of the face page of the application 
form and the "YES" box must be marked.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

Submit a signed original of the application, including the Checklist, and 
three signed photocopies, in one package to:

Center for Scientific Review (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must also
be sent to:

Pervis Major, Ph.D.
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA  30333
Telephone 304-285-5979
Fax 304-285-6047
Email: Pmajor@CDC.gov

Applications must be received by April 18, 2001.  If an application is 
received after that date, it will be returned to the applicant without review. 
 CSR and NIOSH will not accept any application in response to this RFA that is 
essentially the same as one currently pending initial review, unless the 
applicant withdraws the pending application.  CSR and NIOSH will not accept 
any application that is essentially the same as one already reviewed.  This 
does not preclude the submission of a substantial revision of an application 
already reviewed, but such an application must follow the guidance in the PHS 
Form 398 application instructions for the preparation of revised applications, 
including an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by NIOSH.  If the proposed project involves organizations or 
persons other than those affiliated with the applicant organization, letters 
of support and/or cooperation must be included.  Applications determined to be 
incomplete or unresponsive to this RFA will be returned to the applicant 
without further consideration.  Applications that are complete and responsive 
to the RFA will be reviewed for technical merit by a scientific review group 
convened by NIOSH.

All applications will be judged on the basis of the scientific merit of the 
proposed project and the documented ability of the investigators to meet the 
RESEARCH OBJECTIVES of the RFA.  As part of the scientific merit review, all 
applications will receive a written critique and undergo a process in which 
only those applications deemed to have the highest scientific merit, generally 
the top half of applications under review, will be discussed and assigned a 
priority score.

Following the scientific merit review, applications will then be reviewed by 
NIOSH according to the programmatic review criteria below.

Scientific Review Criteria

o  Significance.  Does this study address an important problem? If the aims of 
the application are achieved, how will scientific knowledge be advanced?  What 
will be the effect of these studies on the concepts or methods that drive this 
field?  Is the chemical(s) studied a priority chemical?

o  Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  Is the study population well defined?  Can the chemical 
exposures be adequately assessed and differentiated?  Are the investigators 
using the most appropriate reproductive/developmental outcomes? 

o  Innovation - Does the project employ novel concepts, approaches or methods? 
 Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?

o  Investigator - Is the investigator appropriately trained and well-suited to 
carry out this work?  Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers, if any?

o  Environment - Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there documentation of cooperation from 
industry, unions, communities, or other participants in the project, where 
applicable?  Is there evidence of institutional support and availability of 
resources necessary to perform the project?

The scientific review group will also examine the appropriateness of proposed 
project budget and duration; the adequacy of plans to include both genders, 
minorities and their subgroups, and children as appropriate for the  
scientific goals of the research and plans for the recruitment and retention 
of subjects; the provisions for the protection of human and animal subjects; 
and the safety of the research environment.

The personnel category will be reviewed for appropriate staffing based on the 
requested percent effort.  The direct costs budget request will be reviewed 
for consistency with the proposed methods and specific aims.  The duration of 
support will be reviewed to determine if it is appropriate to ensure 
successful completion of the requested scope of the project.

Programmatic Review Criteria

o  Magnitude of the problem in terms of numbers of workers affected.

o  Severity of the disease or injury in the worker population.

o  Likelihood of developing applied technical knowledge for the prevention of 
occupational safety and health hazards on a national or regional basis.

AWARD CONSIDERATIONS

Applications will be considered for award based upon (a) scientific merit, (b) 
program importance, (c) program balance, and (d) availability of funds.  

SCHEDULE

Letter of Intent Receipt Date:  March 1, 2001
Application Receipt Date:       April 18, 2001
Anticipated Award Date:         September 1, 2001

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.  This RFA and other 
CDC Announcements can be found on the CDC HomePage (http://www.cdc.gov) under the 
"Funding" section (see "Grants and Cooperative Agreements" scroll down to 
"Occupational Safety and Health").  This RFA can also be found on the NIOSH 
HomePage (http://www.cdc.gov/niosh) under "Extramural Programs", "Current Funding 
Opportunities".

Direct inquiries regarding programmatic issues to:

Lee M. Sanderson, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-28
Atlanta, GA  30333
Telephone: 404/639-1528
FAX: 404/639-4616
Email: lsanderson@cdc.gov

Direct inquiries regarding grants management matters to:

Joanne Wojcik
Grants Management Branch
Procurement and Grants Office
Centers for Disease Control and Prevention
2920 Brandywine Road, Suite 3000
Atlanta, GA 30341-4146
Telephone: 770/488-2717
Email: jcw6@cdc.gov

AUTHORITY AND REGULATIONS

The Catalog of Federal Domestic Assistance number is: 93.262 for the National 
Institute for Occupational Safety and Health (NIOSH).  This program is 
authorized under the Public Health Service Act, as amended, Section 301(a) [42 
U.S.C. 241(a)], and the Occupational Safety and Health Act of 1970, Section 
20(a) [29 U.S.C. 669(a)].  The applicable program regulation is 42 CFR Part 
52.  This program is not subject to the intergovernmental review requirements 
of executive order 12372 or Health Systems Agency Review.

LOBBYING RESTRICTIONS

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. Section 1352, 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, no part of PHS appropriated funds 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 or any 
State or local legislature, except in presentation to the Congress or any 
State or local legislature itself.  No part of the appropriated funds 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 or 
local legislature.

SMOKE-FREE WORKPLACE

CDC strongly encourages all grant recipients to provide a smoke-free workplace 
and promote the non-use 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.

SMALL, MINORITY, AND WOMEN-OWNED BUSINESS

It is a national policy to place a fair share of purchases with small, 
minority and women-owned business firms. The Department of Health and Human 
Services is strongly committed to the objective of this policy and encourages 
all recipients of its grants and cooperative agreements to take affirmative 
steps to ensure such fairness. In particular, recipients should:

1. Place small, minority, women-owned business firms on bidders mailing lists.

2. Solicit these firms whenever they are potential sources of supplies, 
equipment, construction, or services.

3. Where feasible, divide total requirements into smaller needs, and set 
delivery schedules that will encourage participation by these firms.

4. Use the assistance of the Minority Business Development Agency of the 
Department of Commerce, the Office of Small and Disadvantaged Business 
Utilization, DHHS, and similar state and local offices.


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