NIOSH: Occup Exp to Potential Repro/Devel Toxicants RFA

Gary Greenberg Gary.Greenberg at Duke.edu
Sat Feb 10 23:58:35 EST 2001


OCCUPATIONAL EXPOSURE TO PUTATIVE REPRODUCTIVE/DEVELOPMENTAL TOXICANTS
IN HUMANS

http://grants.nih.gov/grants/guide/rfa-files/RFA-OH-01-008.html

Release Date:  February 2, 2001

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.

...

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.

...

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 at 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 at cdc.gov

-- 
Gary N. Greenberg, MD MPH    Sysop / Moderator Occ-Env-Med-L MailList
gary.greenberg at duke.edu     Duke Occupat, Environ, Int & Fam Medicine
OEM-L Maillist Website:                      http://occhealthnews.com


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