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U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research


Genetic Susceptibility & Variability of Human Malformations

U.S. Environmental Protection Agency,
National Institute of Child Health and Human Development
National Institute of Dental and Craniofacial Research
National Institute of Environmental Health Sciences
Interagency Announcement of Opportunity for Grants

RFA: HD-99-002

Opening Date: May 25, 1999
Letter of Intent Receipt Date: July 1, 1999
Application Receipt Date: August 20, 1999



    The National Institute of Child Health and Human Development (NICHD), the National Institute of Dental and Craniofacial Research (NIDCR) and the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health (NIH) and the U.S. Environmental Protection Agency's (EPA) National Center for Environmnental Research and Quality Assurance invite research grant applications to study the genetic susceptibility and mechanisms of human congenital malformations including research on the contribution of potential genetic and environmental factors, identified at the molecular level, to the etiology, distribution and prevention of disease within families and across populations. EPA's participation in this soliciation is part of the Science To Achieve Results (STAR) Program. The research conducted as a result of this RFA will provide the direction and focus for future initiatives to dissect the molecular and genetic mechanisms underlying specific human malformations. The current initiative is designed to encourage collaborative, interdisciplinary, and innovative studies that integrate the latest advances in developmental genetics, functional genomics, epidemiology and high throughput biotechnology with the new mathematical, methodological, and statistical tools for analyzing and evaluating data related to the etiology and distribution of birth defects in populations. Applications limited to descriptive or traditional epidemiological approaches will be considered non-responsive. The primary objective of this initiative is to develop and use integrated multidisciplinary approaches to obtain information that will enhance our knowledge of and provide a basis for future initiatives focusing on the basic mechanisms and etiologies of human malformations. This RFA is part of a larger birth defects program which will include an upcoming initiative related to fundamental developmental mechanisms underlying the formation of structural anomalies.


    The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Genetic Susceptibility and Variability of Human Congenital Malformations, is related to many priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html.


    Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. (Note: The EPA will not be able to consider applications from for-profit organizations or Federal agencies.) Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators.


    This RFA will use the National Institutes of Health (NIH) individual research project grant (R01) award mechanism or the comparable EPA mechanism. Following peer review, applications selected for funding by the EPA will require additional certifications and responses to comments or suggestions offered by the peer reviewers. The EPA will contact Principal Investigators to obtain these materials.

    Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is March 1, 2000.

    This RFA is a one-time solicitation. Future unsolicited new or competing continuation applications will compete with all investigator-initiated
    applications and be referred and reviewed according to the customary peer review procedures by the Center for Scientific Review (CSR).


    It is anticipated that for Fiscal Year 2000, approximately $6.6 million (including direct and Facilities and Administrative costs) in total costs will be available for funding the first year of this initiative. Since the nature and scope of the proposed research may vary, it is anticipated that the size of the awards will vary as well. An applicant may request a project period of up to five years and a budget for direct costs of up to $700,000 per year. Applications requesting direct costs of more than $700,000 in any one year will be considered non-responsive. Facilities and Administrative costs will be awarded based on the negotiated rates. Although this program is provided for in the financial plans of the NICHD, NIDCR, NIEHS, and EPA, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. It is anticipated that approximately six awards will be made.



    In the United States, birth defects are the leading cause of infant mortality, accounting for one in five infant deaths. It is estimated that more than 120,000 babies in the United States (about four percent of all live births) are born with major birth defects each year. Birth defects are involved in about half of all pediatric hospital admissions and, next to accidents, are the leading cause of death in children. Moreover, the estimated lifetime cost of children born each year with any of 17 major birth defects or cerebral palsy to the U.S. economy is more than $8 billion.

    In order to address the impact of birth defects on public health, the Center for Research for Mothers and Children (CRMC), National Institute of Child Health and Human Development (NICHD), convened a workshop in October 1997. The purpose of the workshop was to review the status of clinical and epidemiological research on structural birth defects and to recommend and prioritize areas of future research. Genetic epidemiology of human malformations was identified as a high priority area for future research. This new field of research has recently emerged from the integration of genetics into traditional epidemiological research and focuses on the contribution of genetic and environmental factors, identified at the molecular level, to the etiology, distribution and prevention of disease within families and across populations. This RFA is designed to address that recommendation, namely, to encourage and support collaborative and interdisciplinary studies on human malformations that integrate the latest advances in developmental and molecular genetics with the new and innovative mathematical, methodological, and statistical developments for analyzing and evaluating epidemiologica data. The outcome of these studies will lay the foundation for the development of future initiatives that will focus on the molecular genetics and developmental biology of structural birth defects.

    A second workshop was held on 20-21 July, 1998, with the agenda of prioritizing national needs that the NICHD should address in formulating a comprehensive strategy for birth defects research. This conference and an upcoming initiative focus on the molecular genetics and basic developmental mechanisms associated with the formation of congenital anomalies. The NICHD sees these two approaches as necessary in enhancing our understanding of and, ultimately, devising prevention strategies for structural birth defects.

    The National Institute of Environmental Health Sciences (NIEHS) is the principal Federal funding agency that supports research focused on understanding the mechanisms for human health consequences of exposure to physical and chemical agents in the environment. As part of this mission, the NIEHS initiated the Environmental Genome Project (EGP) to establish how genetic polymorphisms influence susceptibility or resistance of individuals following exposure to environmental agents. By understanding how genetic polymorphisms in the general population affect individual responses to environmental agents, scientists can better predict health risks and policy makers will have a science-based framework for the development of environmental policies to protect susceptible individuals. The environmental response genes that are under study as part of the EGP are in the following classes: DNA repair pathway genes, genes that control the metabolism distribution of toxicants in the body, genes for cell cycle control, genes for cell death and differentiation, receptor genes, and genes for the signal transduction systems controlling the expression of the genes in other categories. More information about the EGP is available at the following URL: http://www.niehs.nih.gov/envgenom/home.htm. Molecular epidemiology studies which determine the risk of birth defects from the interaction between these genes, factors and exposures to environmental chemicals and other exposures are of interest to NIEHS.

    The National Institute of Dental and Craniofacial Research (NIDCR) is the primary sponsor of oral biomedical and behavioral research and research training in the United States. As part of its mission, the NIDCR supports research to understand the development of the craniofacial-dental structure, and to identify the genetic and environmental contributions to craniofacial anomalies. Cleft lip and cleft palate are the most common craniofacial anomalies, affecting approximately one out of every 500 live births. It is clear that there are a number of interacting mechanisms, including genetic and environmental, that contribute to the risk of this malformation. In addition, there are numerous other craniofacial syndromes for which genetic mutations and additional environmental risk factors can be identified. Molecular epidemiology studies which identify risk factors for developmental anomalies of craniofacial structures are of interest to the NIDCR. Additional information about dental and craniofacial genetics is available on the NIDCR homepage: http://www.nidr.nih.gov

    The US Environmental Protection Agency (EPA) supports research both intramurally in its laboratories and extramurally through the STAR Program on the effects of environmental agents on children's health, including birth defects. EPA's efforts in this area have focused on identifying environmental agents that cause birth defects and other developmental disorders, the molecular mechanisms of birth defects, and how to use mechanistic and other data in the risk assessment process. In addition, susceptibility factors that influence the response of individuals or subpopulations is of great interest. The EPA is also concerned with the identification of exposure to environmental agents, and various exposure factors, including the sources of exposure, bioavailability, route, timing, and duration of exposure, and any lifestyle, behavioral, socioeconomic, ethnic, gender, or age factors that influence the exposure of individuals or subpopulations. Prevention and intervention measures that can be taken to reduce susceptibility and exposure are also of interest.

    While not officially participating in this initiative, the National Heart Lung and Blood Institute and the National Eye Institute, will consider an application in response to this RFA that would be of relevance to their programs on a case-by-case basis depending on the objectives of the study.

    Research Objectives and Scope

    This initiative encourages significant, innovative, and hypothesis-driven research to study the biology and genetic susceptibility of human congenital malformations. Applicants should develop approaches that integrate descriptive studies related to the causes and distribution of birth defects in populations with the recent advances in molecular and developmental genetics, genomics and bioinformatics, high throughput microscreening biotechnology, and methodological and biostatistical tools.

    Proposals to study the genetic susceptibility for malformations caused by or associated with environmental agents or factors are solicited. Investigators are encouraged to: 1) develop interdisciplinary approaches involving clinicians, epidemiologists, and basic biomedical scientists (e.g., geneticists, molecular and developmental biologists, etc.); and 2) collaborate with existing population-based birth defects registries, databases, and surveillance programs at the private, state, and Federal levels (especially the Centers for Disease Control and Prevention Centers of Excellence for Birth Defects). The proposed studies should develop, adapt, and use approaches to identify genetic contributions as well as environmental interactions and other nongenetic determinants that contribute to various human congenital malformations. The approaches and findings from these studies should be used to define, differentiate, and classify the genotypes and phenotypes of the malformations being studied. The long-term goals are to identify specific genetic and environmental causes of structural birth defects in human populations; focus on elucidating the underlying genetic and molecular mechanisms responsible for the anomalies; and use the information to develop effective screening, therapeutic, and prevention strategies.

    Applications limited to traditional or descriptive epidemiology will be considered non-responsive to this RFA. Development and implementation of new and innovative genetic and molecular biotechnology for identifying and characterizing genetic and environmental factors responsible for the epidemiology of malformations should be significant components of the application. Similarly, state-of-the-art methods for the assessment of environmental exposures, including sources, route, duration, and timing of exposure, and lifestyle or other factors that influence exposure should be an integral part of the application. In addition, a component that includes prevention or intervention strategies is encouraged. The full complement of structural birth defects, including skeletal, neural tube, and craniofacial abnormalities are of interest. Examples of research areas that are responsive to this RFA are listed below. However, the list is not intended to be all- inclusive, but is designed merely to provide guidance and direction for applicants:
    • Research which seeks to understand the relationship between genetic polymorphisms and risk of birth defects in the population.
    • Hypothesis-driven research of specific gene-environment interactions and birth defects. Use of biomarkers of exposure, effect and susceptibility are encouraged.
    • Epidemiologic studies which focus on classes of genes identified by the Environmental Genome Program as environmental response genes and relevant environmental exposures are encouraged. (see Background section).
    • Identification of genes and gene product interactions critical to development, differentiation, patterning or other critical metabolic characteristics related to structural birth defects. Examples include BMP, MSX, homeobox genes.
    • Identification of modifier genes influencing susceptibility and variability of expression of structural birth defects
    • Interactions of factors controlling developmental processes (e.g., Sonic hedgehog) with metabolites (e.g., cholesterol) in the formation of structural malformations.
    • Susceptibility to and molecular bases of disorders of cell migration and differentiation, such as neural crest cells in developmental, neurological, and craniofacial syndromes and disorders.
    • Altered gene expression, imprinting, and epigenetic factors as effectors of anomalous embryonic development resulting in aberrant fetal growth.
    • Genetic basis for multifaceted, complex malformations and risk from environmental exposures for associated malformations.
    • Projects focusing on differences in susceptibility factors for developmental anomalies in minority populations or other susceptible subgroups of the population.
    • Environmental exposures and lifestyle factors of both the father and mother and how these are linked to birth defects in the offspring.


    Principal Investigators should budget funds to attend an annual NIH/EPA-sponsored two-day meeting in Bethesda, MD. Also attending this meeting will be investigators, supported by a separate RFA, who are studying fundamental developmental processes using animal models. These meetings will provide an opportunity for the RFA-funded investigators to discuss the progress of their research, exchange ideas and information, and foster collaborations that are relevant to the research goals of the birth defects initiative. This requirement is designed to establish an interactive network of investigators who are interested in multidisciplinary approaches to advancing our understanding of the etiology of birth defects.

    Quality Assurance

    For any project considered for funding by the EPA involving data collection or processing, conducting surveys, environmental measurements, and/or modeling, EPA will require a statement on how quality processes or products will be assured. For awards that involve environmentally related measurements or data generation, a quality system that complies with the requirements of ANSI/ASQCE4, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs," must be in place. EPA will contact applicants being considered for EPA funding to obtain this statement.

    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. There are EPA requirements (R-series) and guidance (G-series) documents available which address in detail how to comply with ANSI/ASQC E4. These may be found on the Internet at http://www.epa.gov/quality1/qa_docs.html. R-5, "EPA Requirements for Quality Assurance Project Plans," and G-4, "Guidance for the Data Quality Objectives Process," are particularly pertinent to the QA requirements.


    It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

    All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, and is available at the following URL address: http://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html.


    It is the policy of the NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by NIH, unless there are scientific and ethical reasons not to include them. 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://www.nih.gov/grants/guide/notice-files/not98-024.html.

    Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy.


    Prospective applicants are asked to submit, by July 1, 1999, a letter of intent that includes 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; and the number and title of this RFA.

    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 NICHD staff to estimate the potential review workload and avoid conflict of interest in the review.

    The letter of intent is to be sent to:

    Dr. Deborah B. Henken
    Center for Research for Mothers and Children
    National Institute of Child Health and Human Development
    Executive Building, Room 4B01, MSC-7510
    6100 Executive Boulevard
    Bethesda, MD 20892-7510
    Telephone: (301) 496-5541
    FAX: (301) 480-0303
    E-mail: dh50g@nih.gov


    The research grant application form PHS 398 (rev. 4/98) is to be used in applying 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, E-mail: grantsinfo@nih.gov, and on the Internet at: http://www.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. The label should indicate the RFA number. 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://www.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format.

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

    6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
    BETHESDA, MD 20892-7710
    BETHESDA, MD 20817 (for express/courier service)

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

    Dr. Scott Andres
    Division of Scientific Review
    National Institute of Child Health and Human Development
    Executive Building, Room 5E03, MSC 7510
    6100 Executive Boulevard
    Bethesda, MD 20892-7510
    Rockville, MD 20852 (for express/courier service)
    Telephone: (301) 496-1485
    FAX: (301) 402-4104

    Applications must be received by August 20, 1999. 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.


    Upon receipt, applications will be reviewed for completeness by CSR, and for responsiveness to the RFA by the NICHD, NIDCR, NIEHS and EPA staff. Incomplete applications will be returned to the applicant without further consideration. If staff finds that the application is not responsive to the RFA, they will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle.

    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 NICHD in accordance with the review criteria for scientific/technical merit stated below. As part of the initial merit review, a process may be used by the scientific review group in which applications receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development (NACHHD) Council, the National Advisory Dental and Craniofacial Research (NADCR) Council, the National Advisory Environmental Health Sciences (NAEHS) Council or programmatic review by the EPA's National Center for Environmental Research and Quality Assurance.

    Review Criteria

    The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. EPA's research programs focus on reduction of risks to human health and ecosystems and on the reduction of uncertainty in risk assessment. In their 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 a 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.

      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?

      Approach: Are the conceptual framework, design, methods, and analyses appropriate and adequate to accomplish the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

      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?

      Investigator: Is the Principal 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)?

      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 evidence of institutional support?

    In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following:

      The adequacy of plans to include both genders, minorities and their subgroups and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated.

      The reasonableness of the proposed budget and duration in relation to the proposed research.

      The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application.

    The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment.

    Applications may also be reviewed with respect to the following:

      Availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources will be considered in the review.

      Whether the scientific and technical merit of the research as proposed is sufficient to achieve the objectives of this RFA.


    Letter of Intent Receipt Date: July 1, 1999
    Application Receipt Date: August 20, 1999
    Date of Initial Review: Oct/Nov 1999
    Institute Council Review: Jan/Feb 2000
    Earliest Anticipated Award Date: March 1, 2000


    The anticipated date of award is March 1, 2000. Factors that will be used to make award decisions are as follows:

      Scientific and technical merit of the proposed project as determined by peer review;

      Cost effectiveness of the proposed strategy;

      Program priorities and program balance;

      Availability of funds.


    Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome.

    Direct inquiries regarding programmatic issues to:

    Dr. Deborah B. Henken
    Center for Research for Mothers and Children
    National Institute of Child Health and Human Development
    Executive Building, Room 4B01, MSC-7510
    6100 Executive Boulevard
    Bethesda, MD 20892-7510
    Telephone: (301) 496-5541
    FAX: (301) 480-0303
    E-mail: dh50g@nih.gov

    Dr. Judy Small
    Craniofacial Anomalies and Injury Branch
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN-24J MSC 6402
    Bethesda, MD 20892-6402
    Telephone: (301) 594-2425
    Fax: (301) 480-8318
    E-mail: judy.small@nih.gov

    Dr. Gwen W. Collman
    Chemical Exposures and Molecular Biology Branch
    Division of Extramural Research and Training
    National Institute of Environmental Health Sciences
    P.O. Box 12233
    Research Triangle Park, NC 27709
    Telephone: (919) 541-4980
    Fax: (919) 541-4937
    E-mail: collman@niehs.nih.gov

    Dr. Chris Saint
    National Center for Environmental Research & Quality Assurance, Room 51179
    Mail Code 8701R
    U.S. Environmental Protection Agency
    1300 Pennsylvania Avenue
    Washington, DC 20004
    Telephone: 202-564-9839
    Fax: 202-565-2448
    E-mail: saint.chris@epa.gov

    Direct inquiries regarding fiscal and administrative matters to:

    Mr. E. Douglas Shawver
    Grants Management Branch
    National Institute of Child Health and Human Development
    6100 Executive Boulevard, Room 8A17, MSC-7510
    Bethesda, MD 20892-7510
    Telephone: (301) 496-1303
    Fax: (301) 402-0915
    E-mail: shawverd@mail.nih.gov

    Ms. Eileen Teng
    Grants Management Office
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN044
    Bethesda, MD 20892
    Telephone: (301) 594-4800
    Fax: (310) 480-8301
    E-mail: eileen.teng@nih.gov

    Mr. David L. Mineo
    Grants Management Officer
    Division of Extramural Research and Training
    National Institute of Environmental Health Sciences
    P.O. Box 12233
    Research Triangle Park, NC 27709
    Telephone (919) 541-1373
    Fax (919) 541-2860
    E-mail: mineo@niehs.nih.gov

    Mr. John Puzak
    U.S. Environmental Protection Agency (8701R)
    Washington, DC 20460
    Telephone: 202-564-6825
    Fax: 202-565-2444
    E-mail: puzak.jack@epa.gov

    This program is described in the Catalog of Federal Domestic Assistance Nos. 93.865 (Research for Mothers and Children, National Institute of Child Health and Human Development), 93.121 (National Institute of Dental and Craniofacial Research), 93.113 (Biological Response to Environmental Health Hazards, National Institute of Environmental Health Sciences), and 66.500 (Environmental Protection Agency). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 or by EPA under the authority of 40 CFR parts 30 and 40. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

    The PHS and EPA strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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