ENDOCRINE DISRUPTORS: EPIDEMIOLOGIC APPROACHES

Release Date:  June 12, 2000

RFA:  OH-01-001

National Institute for Occupational Safety and Health (NIOSH), Center 
for Disease Control and Prevention (CDC)
National Center for Environmental Research (NCER), U.S. Environmental 
Protection Agency (EPA)
National Cancer Institute (NCI), National Institutes of Health
National Institute of Environmental Health Sciences (NIEHS), National 
Institutes of Health

Letter of Intent Receipt Date: August 11, 2000 
Application Receipt Date: September 22, 2000   

THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT 
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS 
THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

This joint interagency program by NIOSH, EPA, NIEHS, and NCI will 
support research on the relationship between exposure to endocrine 
disruptors and adverse health effects in humans, particularly 
reproductive and developmental, with a focus on epidemiologic 
approaches.

The following type of grant will be supported: traditional research 
projects (see “MECHANISMS OF SUPPORT” section).

HEALTHY PEOPLE 2010
			
The cooperating agencies are 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 the conference copy of “Healthy 
People 2010,” 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, including small, minority, and/or women-owned 
businesses, State and local governments or their bona fide agents, and 
federally recognized Indian tribal governments, Indian tribes, or 
Indian tribal organizations.  Please note that EPA funding will not be 
available to foreign organizations, Federal government agencies or 
for-profit organizations.

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 funding mechanisms to be used to assist the scientific community 
in participating in this grant program will be those of: 1) the 
National Institutes of Health (NIH) investigator-initiated research 
project grant (R01); or 2) the Environmental Protection Agency's 
Office of Research and Development STAR (Science to Achieve Results) 
program, administered in accordance with 40 CFR Part 30 and 40.  
Regardless of the mechanism for the award, all applicants should use 
the PHS 398. Policies that govern grant award programs of each agency 
will prevail for respective sources of support.  Responsibility for 
the planning, direction, and execution of the proposed project will be 
solely that of the applicant.

Applications which request up to $250,000 per year in direct costs 
must be submitted in the modular grant format.  Applications 
requesting budgets greater than $250,000 must submit detailed budget 
information with the application.

For administrative reasons, the primary assignment of all applications 
will initially be to the NIOSH.  After discussion with the other 
participating programs, applications will be reassigned where they are 
programmatically most appropriate. 

AVAILABILITY OF FUNDS 

Approximately $6 million is available in FY 2001 to fund the first 
budget year of 9-12 grants under this RFA.  Only applications that are 
found to be of high scientific merit will be considered for funding, 
and not all of the funds will be spent if there are not enough highly 
meritorious applications.  Although this program is provided for 
within the financial plans of the NIOSH, EPA, NCI, and NIEHS awards 
pursuant to this RFA are contingent upon the availability of funds for 
this purpose. 

It is anticipated that awards will be made for a 12-month budget 
period within a project period not to exceed four years.  Continuation 
awards within the project period will be made on the basis of 
satisfactory progress and availability of funds in future years.

Awards are anticipated to range from $400,000 to $600,000 in total 
costs (direct and facilities and administrative) per year. 

Applicants should include in their budgets funds for one trip per year 
for an annual meeting of grantees to be held in Washington, DC.

RESEARCH OBJECTIVES

Background

Concerns have been expressed in both the lay and scientific 
communities that some synthetic chemicals used or manufactured in the 
workplace and released into the environment may be causing adverse 
health effects in humans through their ability to interfere with the 
function of the endocrine system. These chemicals are collectively 
called Endocrine Disruptors (EDs) or Endocrine Disrupting Chemicals 
(EDCs) and are also referred to as hormonally active agents. They are 
thought to interfere with one or more aspects of the normal endocrine 
functions that are responsible for the maintenance of homeostasis and 
the regulation of developmental processes.


The cooperating agencies support research that examines human health
consequences of exposure to physical and chemical toxicants in the 
environment and in occupational settings as well as the underlying 
mechanisms involved in environmentally related disease and 
dysfunction.  Research on endocrine disrupting chemicals is a priority 
established by the Committee on Environmental and Natural Resources of 
the National Science and Technology Council, and the results obtained 
under this program should assist NIOSH in establishing occupational 
safety and health priorities and EPA in protecting human health and
the environment.

Research Goals

Despite considerable public interest and research activity, the scope 
and magnitude of the impact of putative EDCs on human health are 
largely unknown. In wildlife, a number of adverse effects have been 
linked to specific EDCs (Kavlock, et. al., Environ. Health 
Perspectives 104, Supp. 4:715-740, 1996).  Exposures in some cases, 
however, have been unusually high, such as those from chemical spills 
or sewage out falls, and thus are not typical of the ambient exposures 
normally encountered by wildlife or human populations. In humans, an 
even greater uncertainty exists.  While it has been speculated that 
some endocrine-related diseases or conditions, such as breast and 
prostate cancer, decreased sperm counts, and hypospadias are caused by 
EDC exposure; no linkage has been established to date between exposure 
to a specific environmental EDC and an adverse health effect in 
humans.

Research applications are sought which will investigate the 
relationships between exposure to endocrine disruptors and adverse 
health effects, particularly reproductive/developmental effects in 
humans. For the purposes of this RFA, an endocrine disruptor is an 
exogenous agent found in the workplace or environment that can 
interfere with the function of the endocrine system. Studies may be 
conducted in working populations or the general population. 
Applications must include study designs that clearly differentiate 
exposure categories. Applicants are strongly encouraged to design 
studies that include a range of exposure levels; employ quantitative 
exposure assessment methodologies, such as biomarkers, that allow 
differentiation in exposure; 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 
specifically solicited that attempt to demonstrate quantitative 
relationships between chemical exposures and adverse effects in 
humans.

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 function, endometriosis or poor semen quality; 2) pregnancy 
outcomes and pre- and postnatal development of offspring of exposed 
women such as reproductive tract malformations; 3) evidence of latent 
effects on reproduction among offspring exposed in utero; such as 
infertility in both male and female offspring and decline in sperm 
count and semen quality; 4) hormonally mediated cancers of the 
reproductive tract and sex accessory glands and tissues among 
offspring exposed in utero; such as testicular cancer; and 5) 
endocrine related malignancies, such as breast and prostate cancer, in 
individuals exposed to exogenous EDCs. 	

Applications that investigate members of chemical classes (e.g. 
phthalates, polybrominated diphenyl ethers, and endocrine-active
fungicides, insecticides, and herbicides) that have not been 
extensively investigated for endocrine disrupting activity in humans 
are encouraged for this RFA.  However, applications that address new 
approaches (e.g. new cohorts, methods of analysis, or biological 
endpoints) for studying previously studied chemicals (e.g. dioxins, 
dibenzofurans, DES, and polyhalogenated biphenyls) are also welcome.

Applications that are collaborations between bench, clinical and field 
epidemiologist scientists are especially encouraged. 
						
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.  All applications must follow this 
policy. 

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 PHS-supported activities must file (or have on file) the 
Animal Welfare Assurance.  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). All applications must 
follow this policy.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the cooperating agencies (CDC, NIH, and EPA) to 
ensure that individuals of both sexes and the various racial and 
ethnic groups will be included in 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 exists 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.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS

It is the policy of NIH and EPA that children (i.e., individuals under 
the age of 21) must be included in all human subjects research they 
conduct or support, unless there are scientific and ethical reasons 
not to include children. This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines on the Inclusion of Children as 
Participants in Research Involving Human Subjects" that was published 
in the NIH Guide for Grants and Contracts, March 6, 1998, and is 
available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

URLS IN CDC, EPA or NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for funding must be self-contained 
within specified page limitations.  Unless otherwise specified in the 
solicitation, 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 August 11, 2000, 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, the identities of 
other key personnel and participating institutions.  Although a letter 
of intent is not required, is not binding, and does not enter into the 
review of a subsequent application, the information that it contains 
allows NIOSH staff to estimate the potential review workload and to 
plan the review.

The letter of intent is to be sent to:
Ms Ann Cronin 
Review Activity
Office of Extramural Coordination and Special Programs		
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 404-639-2277; Fax 404-639-0035
Email:   axc2@cdc.gov

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used 
for these grants.  These forms are available at most institutional 
offices of sponsored research and 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.

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

Specific application instructions for this RFA have been modified to 
reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being 
examined by the NIH.  Complete and detailed instructions and 
information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.  HOWEVER, IF 
THE DIRECT COSTS REQUESTED EXCEED $250,000 IN ANY YEAR, THE MODULAR 
GRANT FORMAT CANNOT BE USED.

The modular grant concept establishes specific modules in which direct 
costs may be requested as well as a maximum level for requested 
budgets. Only limited budgetary information is required under this 
approach.  The just-in-time concept allows applicants to submit 
certain information only when there is a possibility for an award.  It 
is anticipated that these changes will reduce the administrative 
burden for the applicants, reviewers and Institute staff.  In 
preparing Modular Grant Applications, the standard instructions for 
the R01 mechanism should be generally followed: with these specific 
modifications reflecting modular budget and just-in-time concepts:

Modular Grant Instructions

Modular Grant applications must request direct costs in $25,000 
modules, up to a total direct cost request of $250,000 per year.  
Applications that request more than $250,000 direct costs in any year 
must follow the traditional PHS 398 application instructions and not 
be formatted as a modular grant application. The total direct costs 
must be requested in accordance with the program guidelines for the 
individual R01 mechanism described in this RFA.  Applications accepted 
for funding by EPA will require a detailed budget at the time of 
award.  Successful applicants will be contacted by EPA regarding this 
requirement.

The total direct costs must be requested in accordance with the 
program guidelines and the modifications made to the standard PHS 398 
application instructions described below:

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct 
Costs (in $25,000 increments up to a maximum of $250,000) and total 
costs [Modular Total Direct plus Facilities and Administrative (F&A) 
costs] for the initial budget period Items 8a and 8b should be 
completed indicating the Direct and Total Costs for the entire 
proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete 
Form Page 4 of the PHS 398. It is not required and will not be 
accepted with the application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete 
the categorical budget table on Form Page 5 of the PHS 398.  It is not 
required and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget 
Narrative page.
(See http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages).  At the top of the page, enter the total direct costs 
requested for each year.  This is not a Form page. Provide an 
additional narrative budget justification for any variation in the 
number of modules requested. 

o  PERSONNEL - Under personnel, list key project personnel, including 
their names, percent of effort, and roles on the project.  No 
individual salary information should be provided. However, the 
applicant should use the NIH appropriation language salary cap and the 
NIH policy for graduate student compensation in developing the budget 
request.

o  CONSORTIUM/CONTRACT COSTS - For consortium/contractual costs, 
provide an estimate of total costs (direct plus facilities and 
administrative) for each year, each rounded to the nearest $1,000.  
List the individuals/organization with whom consortium or contractual 
arrangements have been made, the percent effort of key personnel, and 
the role on the project. Indicate whether the collaborating 
institution is foreign or domestic. The total cost for a 
consortium/contractual arrangement is included in the overall 
requested modular direct cost amount.

Biographical Sketch - The Biographical Sketch provides information 
used by reviewers in the assessment of each individual's 
qualifications for a specific role in the proposed project, as well as 
to evaluate the overall qualifications of the research team.  A 
biographical sketch is required for all key personnel, following the 
instructions below.  No more than three pages may be used for each 
person.  A sample biographical sketch may be viewed at:  
http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- list position(s)and any honors;
- provide information, including overall goals and responsibilities, 
for ongoing research projects and those completed during the last 
three years, and 
- list selected peer-reviewed publications, with full citations.

o  CHECKLIST - This page should be completed and submitted with the 
application.  If an F&A rate agreement has been established, indicate 
the type of agreement and the date.  All appropriate exclusions must 
be applied in the calculation of the F&A costs for the initial budget 
period and all future budget years.

o  Page Limitation - Page limitations for the R01 applications are as 
stated for the PHS 398 instructions for this mechanism. 
o  Appendix - An appendix or additional supporting materials will not 
be accepted with the exception of originals of photos used in the 
application.

o  Contact - The applicant should provide the name and phone number of 
the individual to contact concerning fiscal and administrative issues 
if additional information is necessary following the initial review.

o  Special Notes

1.  Applications not conforming to these guidelines will be considered 
unresponsive to this RFA and will be returned without further review. 

2.  After the completion of the peer review process, applications 
recommended for funding by EPA will require a detailed budget.  
Successful applicants will be contacted by EPA regarding this 
requirement.

Just in Time Instructions

Other Support pages of the PHS 398 will not be submitted with the 
application.  Information on research projects ongoing or completed 
during the last three years of the principal investigator and key 
personnel will be provided as part of the "Biographical Sketch."  This 
information will include the specific aims, overall goals and 
responsibilities and should include Federal and non-Federal support.  
This information will be used by reviewers in the assessment of each 
individual’s qualifications for a specific role in the proposed 
project.

Following peer review, information about Other Research Support will 
be requested from the applicant for applications being considered for 
award.  Additional budget information will be requested only under 
special circumstances.

Quality Assurance Statement - All applications must include this 
information. 

EPA regulations require the inclusion of a Quality Assurance Statement 
for any project involving data collection or processing, conducting 
surveys, environmental measurements, and/or modeling, or the 
development of environmental technology (whether hardware-based or via 
new techniques) for pollution control and waste treatment.  This 
statement should not exceed two consecutively numbered, 8.5x11-inch 
pages of single-spaced standard 12-point type with 1-inch margins.  
This statement is to be considered as additional information and is 
not counted against the 25 pages permitted for the Research Plan.  The 
Quality Assurance Narrative Statement should, for each item listed 
below, either present the required information or provide a 
justification as to why the item does not apply to the proposed 
research.  For awards that involve environmentally related 
measurements or data generation, a quality system that complies with 
the requirements of ANSI/ASQC E4, "Specifications and Guidelines for 
Quality Systems for Environmental Data Collection and Environmental 
Technology Programs," must be in place.

1.  Discuss the activities to be performed or hypothesis to be tested 
and criteria for determining acceptable data quality.  (Note: Such 
criteria may be expressed in terms of precision, accuracy, 
representativeness, completeness, and comparability.  These criteria 
must also be applied to determine the acceptability of existing or 
secondary data to be used in the project.)

2.  Describe the study design, including sample type and location 
requirements, any statistical analyses that were used to estimate the 
types and numbers of samples required for physical samples, or 
equivalent information for studies using survey and interview 
techniques.

3.  Describe the procedures for the handling and custody of samples, 
including sample collection, identification, preservation, 
transportation, and storage.

4.  Describe the procedures that will be used in the calibration and 
performance evaluation of the sampling and analytical methods and 
equipment to be used during the project.

5.  Discuss the procedures for data reduction and reporting, including 
a description of statistical analyses to be used and of any computer 
models to be designed or utilized with associated verification and 
validation techniques.

6.  Describe the quantitative and/or qualitative procedures that will 
be used to evaluate the success of the project, including any plans 
for peer or other reviews of the study design or analytical methods 
prior to data collection.

ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for 
Environmental Data Collection and Environmental Technology Programs" 
is available for purchase from the American Society for Quality 
Control, phone 1-800-248-1946, item T55.  Only in exceptional 
circumstances should it be necessary to consult this document.

SPECIAL REQUIREMENTS

This RFA is a joint announcement by NIOSH, EPA, NCI, and NIEHS and 
reflects our common research interest.  The program will be managed by 
the four agencies as a unified program, although the grants will be 
awarded by each agency separately. Applicants will be expected to 
budget for and participate in an annual All-Investigators’ Meeting 
with NIOSH, EPA, NCI, and NIEHS scientists and other grantees to 
report on research activities and to discuss issues of mutual 
interest.

The RFA label available in the PHS 398 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 is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf and has been 
modified to allow for this change.  Please note this is in pdf format.

Submit a signed, typewritten original, including the checklist, and 
three signed, clear, and single sided photocopies in one package to:

CENTER FOR SCIENTIFIC REVIEW
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 Ms. Ann Cronin at the address under LETTER OF 
INTENT.

Applications must be received by September 22, 2000. If an application 
is received after that date, it will be returned to the applicant 
without review.  The Center for Scientific Review (CSR) 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.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  
This does not preclude the submission of substantial revisions of 
applications already reviewed, but such applications must include an 
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness and 
responsiveness (applicants should clearly indicate in the project 
Description (page 2 of application) which priority area of this RFA is 
being addressed by their proposal).  Applications determined to be 
incomplete or unresponsive to this RFA will be returned to the 
applicant without further consideration.  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 that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by NIOSH in accordance with the review criteria 
stated below.  As part of the initial 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 the applications under review, will be 
discussed and assigned a priority score.

Following the initial review, applications will receive a secondary 
review for programmatic importance.  For applications assigned to 
NIOSH and EPA, the programmatic review will be conducted within their 
Agency.  For NCI and NIEHS, the review will be conducted by their 
Advisory Councils.

PEER REVIEW CRITERIA

The goals of CDC, EPA and NIH-supported research are to advance our 
understanding of biological systems, improve the control of disease, 
and enhance health.  In the written comments reviewers will be asked 
to discuss the following aspects of the application in order to judge 
the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals.  Each of these criteria will be 
addressed and considered in assigning the overall score, weighting 
them as appropriate for each application.  Note that the application 
does not need to be strong in all categories to be judged likely to 
have major scientific impact and thus deserve a high priority score.  
For example, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 
forward.

(Applicants should note the requirement for a “Quality Assurance 
Statement” in the application.  See APPLICATION PROCEDURES HEADING.)

o  Significance - Does this study address an important problem related 
to the topical research issues outlined in this solicitation?  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?

o  Approach - Are the conceptual framework, design (including 
composition of study population), 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?

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, or other 
participants in the project, where applicable?  Is there evidence of 
institutional support and availability of resources necessary to 
perform the project?

o  Quality Assurance Statement - The panel will review the quality 
assurance statement for completeness and adequacy in addressing the 
objectives of the EPA Quality Assurance Program.  

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.  Any budgetary adjustments recommended by the reviewers will be 
in $25,000 modules.  The duration of support will be reviewed to 
determine if it is appropriate to ensure successful completion of the 
requested scope of the project.

AWARD CRITERIA

Applications will compete for available funds with all other approved 
applications. The following will be considered in making funding 
decisions:

- quality of the proposed project as determined by scientific review, 
- availability of funds, and
- institutional program priority

SCHEDULE
						
Letter of Intent Receipt Date:  August 11,, 2000 
Application Receipt Date:       September 22, 2000
Anticipated Award Date:         July 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 
(www.cdc.gov) under the “Funding” section.  This RFA can also be found 
on the NIOSH HomePage (www.cdc.gov/niosh) under "Funding 
Opportunities", the NIEHS HomePage (www.niehs.nih.gov) under "Grants 
and Contracts”, and the NCER homepage (www.epa.gov/ncerqa) under 
“Announcements.”

Potential applicants may obtain a copy of the "National Occupational 
Research Agenda" (HHS, CDC, NIOSH Publication No.96-115) from the 
National Institute for Occupational Safety and Health, telephone (800) 
356-4674.  It is also available on the internet at 
"http://www.cdc.gov/niosh/nora.html".

Direct inquiries regarding programmatic issues to:

Michael J. Galvin, Ph.D.
Research Grants Program
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA  30333
Telephone: (404) 639-3343
FAX: (404) 639-4616
Email: mtg3@cdc.gov

David Reese, Ph.D.
U.S. Environmental Protection Agency
National Center for Environmental Research
1200 Pennsylvania Avenue, N.W.
Washington, D.C.  20460
Telephone: (202) 564-6919
FAX: (202) 565-2448
Email: reese.david@epa.gov

Kumiko Iwamoto, M.D., Dr.P.H.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard
Building Executive Plaza North (EPN), Room 539
Bethesda, MD 20892-7395
Telephone: (301) 435-4911
Fax: (301) 402-4279
Email: ki6n@nih.gov

Gwen Collman, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Science
Box 12233, MD EC-21
Research Triangle Park, NC 27709
Telephone: (919) 541-4980
FAX: (919) 316-4606
Email: collman@niehs.nih.gov

Direct inquiries regarding grants management matters to:

Ms. Joanne Wojcik
CDC Announcement No. 01-006
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
FAX: (770) 488-2777
Email: jcw6@cdc.gov

Mr. Jack Puzak
National Center for Environmental Research
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W. (8701R)
Washington, D.C.  20460
Telephone: 202/565-6825
FAX: (202) 565-2444
Email: puzak.jack@epamail.epa.gov
Mr. William Wells
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 243
Bethesda, MD 20892
Telephone: (301) 496-8796
Fax: (301) 496-8601
Email: wellsw@gab.nci.nih.gov

Ms. Dorothy G. Duke
Division of Extramural Research and Training
National Institute of Environmental Health Science
Box 12233, MD EC-22
Research Triangle Park, NC 27709
Telephone: (919) 541-2749
FAX:  (919)541-2860
Email: duke3@niehs.nih.gov                                  

AUTHORITY AND REGULATIONS

The Catalog of Federal Domestic Assistance number is:
93.262 for the National Institute for Occupational Safety and Health 
(NIOSH), 66.500 for Environmental Protection Agency (EPA), 93.393 for 
the National Cancer Institute (NCI), and 93.113 and 93.866 for the 
National Institute of Environmental Health Sciences (NIEHS).  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.  EPA awards are made under 
authority of 40 CFR Part 30 and 40.  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/EPA funds 
for lobbying of Federal or State legislative bodies. Under the 
provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier 
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 HHS/EPA 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, EPA, and NIH strongly encourage 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.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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