and Human Services (HHS)
EXPIRED
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 301/710-0267, 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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