Typical/Disordered Language: Phenotype Assessment Tools

RFA Number: RFA-DC-05-001

Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations:
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)

Announcement Type
New

Catalog of Federal Domestic Assistance Number(s)
93.173 (NIDCD) , 93.865 (NICHD)

Key Dates
Release Date: October 29, 2004
Letters Of Intent Receipt Date: January 24, 2005
Application Receipt Dates: February 24, 2005
Peer Review Date: June-July, 2005
Council Review Date: September, 2005
Anticipated Start Date: December 1, 2005
Expiration Date: February 25, 2005


Executive Summary

The NIDCD and NICHD jointly are providing $500,000 to support R21 Developmental/Exploratory grant awards to begin the process of adapting, norming, and/or developing language measures that can be used in the characterization of the behavioral phenotypes of language disorders and specific aspects of typical language acquisition. It is anticipated that 2-4 grants will be awarded in response to this solicitation. Eligible organizations include domestic for-profit and non-profit public and private institutions. Eligible principal investigators include those with the skills, knowledge and resources necessary to carry out the proposed research.

Application materials may be obtained at URL https://grants.nih.gov/grants/funding/phs398/phs398.html

Telecommunications for the hearing impaired: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2. Cost Sharing
    3. Other - Special Eligibility Criteria

  Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Award Criteria
    4. Reporting

  Section VII. Agency Contact(s)

    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

 Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Nature of the research opportunity

The investigation of the genetic bases of language and language disorders requires clear delineation of behavioral phenotypes, identification of neurocognitive substrates, synthesis of emerging discoveries across different clinical diagnoses (e.g., Williams Syndrome, Fragile X, autism, specific language impairment), develop of new models and methods for the genetic investigation, and new quantitative techniques for estimation of genetic effects and effect sizes. Despite ongoing progress, there remain many factors that impede the research, the most fundamental roadblock being the limited number of robust assessment tools with which to define behavioral phenotypes in language and language disorders. Therefore, the NIDCD and NICHD are seeking exploratory/ developmental applications to address adapting, norming, and/or developing language measures that can be used in the characterization of the behavioral phenotypes of language disorders and specific aspects of typical language acquisition.

Pertinent background information that establishes the need for the research

In September, 2003, a workshop "The Relationship of Genes, Environments, and Developmental Language Disorders: Planning for the Future" brought together leaders from various scientific disciplines relevant to child development and disorders of childhood, including child language disorders. This workshop, a follow-up to a May, 2002 workshop, Developmental Language Disorders: From Phenotypes to Etiologies, identified a number of research needs related to design issues; behavioral measures of language and cognition; neurocognition; and, etiology. Participants were asked to identify unresolved issues, suggest priorities, and formulate a research agenda. In effect, this group of leading researchers was asked to identify obstacles and actions needed to facilitate progress in understanding language development and disorders.

Workshop participants identified the development, refinement, and/or revision of language measurement tools as the highest priority in moving forward with the investigation of the genetic bases of language development and disorders. Problems with currently available tools included:

1) Lack of measurement tools for particular age ranges, or particular aspects of development. For example, available measures, because of restricted ranges of behaviors assessed (floor and ceiling effects) may insufficiently estimate the abilities of children with impairments. As a result, rehabilitation recommendations and expectations may be inappropriate, and an inaccurate picture of the developmental trajectory for those children may result.

2) Currently available measures tend to employ a dichotomous approach. Valuable information about the child's behavior could be gained by increased utilization of unscorable responses. Such information about how a child responds to tasks which are difficult for him or her could be instrumental in diagnosing and treating language disorders.

Scientific knowledge to be achieved through research supported by the special program

Better measurement tools are needed to better define behavioral phenotypes. These tools are crucial to the future research investigations of the genetic contributions to language abilities and language disorders. Appropriate and adequate measurement tools are also critical to the more general investigations of language development and language disorders. Without such tools, future research will be inhibited and delayed. For example, identification of commonalities across disorders, determining onset of a particular behavior, identification of language disorder subtypes; all rely heavily on appropriate, sensitive and accurate measurements of language and language-related behaviors.

Objectives of this research program

To address this critical roadblock in research in child language development and language disorders, the NIDCD and NICHD are combining resources to solicit R21 applications to begin the development, adaptation, and/or preliminary norming of measures, to address the above issues, through small exploratory research grants, which may include cross-site collaboration and planning.

Illustrative e xamples of topics that would be responsive to this solicitation include but are not limited to the bullets listed below. These examples are presented in two broad areas: Adaptation and/or Norming of Existing Measures and Development of New Measures and/or Assessment Strategies. It is recognized that few, if any, of these examples fit exclusively in either of these areas. It is also recognized that this solicitation provides support for the beginning stages of investigation.

1. Adaptation and/or Norming of Existing Measures

2. Development of New Measures and/or Assessment Strategies

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the R21 Exploratory/ Developmental award mechanism (https://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions. (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions.


2. Funds Available

The participating ICs intend to commit approximately 500,000 dollars in FY 05 to fund 2 -4 new grants in response to this RFA. An applicant may request a project period of up to three years and a budget for direct costs up to $100,000 dollars per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information
1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing
Cost sharing is not required.

3. Other-Special Eligibility Criteria
None.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.


2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See also Subsection VI.2. Administrative Requirements for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.


3. Submission Dates
3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: January 24, 2005
Application Receipt Date(s): February 24, 2005
Peer Review Date: June-July, 2005
Council Review Date: September, 2005
Earliest Anticipated Start Date: December 1, 2005


3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Judith A. Cooper, Ph.D.
Director, Division of  Scientific Programs, NIDCD
6120 Executive Blvd., MSC-7180
EPS, Suite 400-C
Bethesda MD 20892-7180
Voice: 301-496-5061
FAX: 301-402-6251
Email: Cooperj@NIDCD.NIH.GOV

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:


Melissa Stick, Ph.D., MPH
Chief, Scientific Review Branch
6120 Executive Blvd., MSC-7180
EPS, Suite 400-C
Bethesda MD 20892-7180
Voice: 301-496-8683
FAX: 301-402-6250
Email: Stickm@NIDCD.NIH.GOV

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review.

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCD and NICHD . Incomplete and non-responsive applications will not be reviewed.

The NIH 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Award Criteria)

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at https://grants.nih.gov/grants/funding/modular/modular.htm.

Section V. Application Review Information


1. Criteria
See below.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDCD. Incomplete applications will not be reviewed.

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 NIDCD and NICHD in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

3. Merit Review Criteria

The goals of NIH's supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria 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 an 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.

Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators. Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Likelihood that the data collected or work proposed will provide sufficient basis for continuation in an R01 format for full instrument development, adaptation, or norming.

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research:The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

3.B. Additional Review Considerations
None.

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a summary statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Indicate the means of transmission (postal, e-mail, other electronic means) and to whom it will be sent.


2. Administrative Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

3. Award Criteria

The following will be considered in making funding decisions:

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually:
https://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Staff Contact Name for applications on disordered language:

Judith A. Cooper, Ph.D.
Director, Division of  Scientific Programs, NIDCD
6120 Executive Blvd., MSC-7180
EPS, Suite 400-C
Bethesda MD 20892-7180
Voice: 301-496-5061
FAX: 301-402-6251
Email: Cooperj@NIDCD.NIH.GOV

Staff Contact Name for applications on typical language:

Peggy McCardle, Ph.D., MPH
Associate Chief, Child Development & Behavior Branch
http://www.nichd.nih.gov/crmc/cdb/cdb.htm
National Institute of Child Health and Human Development
4B05, 6100 Exec. Blvd., MSC 7510, Rockville, MD 20852-7510 (FedEx Zip code is 20852-7510 for Rockville address) National Institutes of Health
Phone: 301-435-6863
FAX: 301-480-0230
Email: pm43q@nih.gov

2. Peer Review Contacts:

Staff Contact Name
Melissa Stick, Ph.D., MPH
Chief, Scientific Review Branch
NIDCD
EPS, Rm 400 C
6120 Executive Blvd, MSC-7180
Bethesda , MD 20892-7180
Telephone: (301) 496-8683
FAX: 301-402-6250
Email: Stickm@nidcd.nih.gov

3. Financial or Grants Management Contacts:

Staff Contact Name: NIDCD
Christopher Meyers
Grants Management Of ficer
NIDCD
EPS, Rm 400 C
6120 Executive Blvd, MSC-7180
Bethesda , MD 20892-7180
Telephone: (301) 402-0909
FAX: 301-402-1758
Email: myersc@mail.nih.gov

Staff Contact Name: NICHD
Lisa Moeller
Grants Management Branch
NICHD
8A01, 6100 Executive Blvd., MSC 7510
Rockville MD 20852-7510
Phone 301-435-6995
Fax 301-451-5510
Email: lm236j@nih.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

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 is available at https://grants.nih.gov/grants/funding/children/children.htm.

Required Education on The Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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