METABOLOMICS TECHNOLOGY DEVELOPMENT
RELEASE DATE: September 29, 2003
RFA Number: RFA-RM-04-002 (formerly RFA-DK-04-001, see NOT-OD-04-008)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
This RFA is developed as a roadmap initiative. All NIH Institutes and
Centers participate in roadmap initiatives.
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.847
LETTER OF INTENT RECEIPT DATE: February 24, 2004
APPLICATION RECEIPT DATE: March 24, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The Institutes and Centers of the National Institutes of Health invite
applications for development and application of new technologies in
metabolomics to enable research aimed at elucidating biological
pathways and networks. The purpose of this initiative is to encourage
the development of highly innovative and sensitive tools for
identifying and quantifying cellular metabolites and their fluxes at
high anatomical, spatial, and temporal resolution.
The general aim of metabolomics is to identify, measure and interpret
the complex time-related concentration, activity and flux of endogenous
metabolites in cells, tissues, and other biosamples such as blood,
urine, and saliva. For the purposes of this solicitation, metabolites
include small molecules that are the products and intermediates of
metabolism, but also carbohydrates, peptides, and lipids. The need for
innovative technologies for measuring and quantifying metabolites
involved in cellular pathways and networks was articulated in the 2003
NIH Roadmapping Initiative. It is expected that the technologies
developed under this initiative will play a major role in transferring
capabilities to laboratories and research institutes that are
investigating the underlying pathways involved in cellular homeostasis,
perturbation, development, and aging.
Many ongoing research programs focus on development of new genomics and
proteomics tools and utilization of those approaches for studying
cellular function. In contrast, relatively few research programs focus
on metabolomics technology development and application. This initiative
is to encourage the development of highly innovative and sensitive
tools for identifying and quantifying cellular metabolites and their
fluxes at high anatomical resolution---extending to subcellular--- and
at a temporal resolution that would be appropriate to understanding
cellular processes at biologically relevant timescales. The scope of
projects that would be appropriate ranges from techniques for improving
and refining the process of sample separation and processing; to new
methods, reagents or instrumentation for identifying and measuring
metabolites and their fluxes; to the development and utilization of
data reduction, management, and analysis tools needed to establish
proof of principle for the technology. New technologies that, if
successful, have the potential to be scalable, either as high-
throughput applications or as advances that would be used in a large
number of laboratories, are especially encouraged. While it is also
important to develop data storage, data mining, and pathway modeling
capabilities for metabolomics, these issues are explicitly not included
in this particular solicitation.
RESEARCH OBJECTIVES
Metabolomics presents unique challenges for sample collection and
extraction and for determining analyte identity, concentration,
structure, activity and flux in cells. The cellular metabolome is
complex, involving several compound classes of small molecules
(peptides, lipids, amino acids, carbohydrates) that vary in subunit
concentration, size, structure, polarity, and functional groups.
Technologies currently in use for metabolomic analysis include NMR,
chromatography and mass spectrometry, each of which has significant
limitations in quantification, scope, and/or throughput. No one
technology can effectively measure, identify and quantify, with
sufficient sensitivity and precision, the diverse range of metabolites
and their dynamic fluctuations in cells. An integrated set of
technologies is needed to address the entire spectrum of challenges for
metabolomics. Ideally, new technologies should yield quantitative,
comprehensive data and be applicable to achieving anatomical resolution
at the cellular and subcellular level.
This initiative seeks to encourage technology developments to address
three interrelated components of metabolomics: (1) sample collection,
extraction, recovery and validation for specific classes of
metabolites; (2) analyte detection, identification, quantification, and
structure elucidation; and (3) and data management, reduction and
analysis. Specific areas of research emphasis include approaches to
address the large dynamic range of metabolite concentration in
biological samples, the complexity of metabolite mixtures, the inherent
noise of the metabolite profile, the vast number of unidentified
compounds present within single samples, and the rapidly changing
temporal and spatial variability (flux) of the cell's metabolite
complement. It is imperative that new technology incorporate
approaches for data management, reduction and analysis to support the
technology development. This initiative encourages applications that
seek to improve existing technologies, including scaling up to high
throughput application, as well as those that seek to develop new
approaches that have the potential for measuring entire cellular
metabolomes or subsets (e.g., amino acid derivatives, peptide
derivatives) whose analysis provides enabling technologies, including
appropriate tools for data reduction and analysis. Applications will be
evaluated for the potential of the proposed activities to address all
three components of metabolomics that are listed above. However, it is
anticipated that these components, collectively, might be too broad for
a single application to address all three comprehensively. Accordingly,
applications may focus on any of the components of metabolomics listed
above and may propose single or multiple technologies. Investigators
will be expected to clearly define the scope of their activities, and
to justify why the specific type(s) of data that the technologies will
address are likely to be important to understanding cellular pathways
and networks.
This initiative encourages applications involving multi-disciplinary
teams representing self-assembled groups of collaborating
investigators, at one or several sites, with specific expertise in
metabolomics technology as well as data management and statistical
approaches relevant to the proposed technology. Partnerships between
academia and industry are encouraged, to facilitate technology transfer
and capacity building at academic institutions.
This solicitation seeks to encourage highly innovative and potentially
risky approaches. However, it is likely that some proposed technologies
will be more mature, at the onset, than others. Accordingly, this RFA
will use the NIH Phased Innovation (R21/R33) and
Exploratory/Development Research Grant Phase 2 (R33) award mechanisms.
Applicants may submit a combined R21/R33 application, or a stand-alone
R33 application if technological feasibility can be documented at the
time of submission. Applicants may request up to three years of
funding, either using the R33 mechanism for the entire time, or via a
phased format that begins as an R21 award and transitions to an R33
award. The duration of the R21 phase may be either one year or two
years. A grant may be considered for renewal or supplementation after
the three year period of support if it is obvious that a newly
developed technology will have exceptionally high impact on the field,
but additional time is required to optimize it. Applicants for a phased
award cannot request more than $800,000 in direct costs per year of the
R21 phase. Applicants may not request more than $1.5 million in direct
costs per year of the R33 phase, or per year of the entire award if it
is solely R33. It is emphasized that the figures above are a maximum.
We envisage that a range of activities could be appropriate for this
solicitation, from an individual well-focused goal, to a set of closely
related or well-integrated technology development aims.
The R21 award mechanism supports innovative, high-risk/high-impact
research requiring preliminary testing or development; exploration of
the use of approaches and concepts new to a specific substantive area;
or research and development of new technologies, techniques, or
methods. Applications will be considered high-impact if they
demonstrate the potential for ground-breaking significance, and high-
risk because they either lack sufficient preliminary data to ensure
their feasibility, or propose use of a new model or a unique system.
Eligibility for transition to the R33 phase will be based on successful
completion of the negotiated milestones, which must be specified in the
application, and programmatic review. The objective of the R33 phase is
continuation of innovative exploratory and developmental research
initiated during the R21 mechanism. Research conducted in the R33 phase
will focus on demonstrating proof of principle for application of the
technology to elucidate functional components and interactions of
metabolites within biological pathways and networks. While the intent
of the R21 award is to encourage the development of highly innovative
technologies, the potential for the proposed technology to advance our
understanding of biological pathways and networks will be an important
criterion for evaluating the R33 phase of an application or the entire
application, if it is for a stand alone R33 award. Development of
complex, integrated technologies for metabolomics problems will require
a context within which methods development can proceed. Accordingly,
investigators should select a model system, defined at the cellular or
subcellular level, to serve as a framework for demonstrating the
technological capabilities of the resource.
MECHANISM OF SUPPORT
This RFA will use the NIH Phased Innovation (R21/R33) and
Exploratory/Development Research Grant Phase 2 (R33) award mechanisms.
As an applicant you will be solely responsible for planning, directing,
and executing the proposed project. This RFA is a one-time
solicitation. Future unsolicited, competing-continuation applications
based on this project will compete with all investigator-initiated
applications and will be reviewed according to the customary peer
review procedures. The anticipated award date is September 30, 2004.
Applications that are not funded in the competition described in this
RFA may be resubmitted as NEW investigator-initiated applications using
the standard receipt dates for NEW applications described in the
instructions to the PHS 398 application.
This RFA uses just-in-time concepts. It also uses the non-modular
budgeting format. Please follow the instructions for non-modular
budget research grant applications. This program does not require cost
sharing as defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
The participating ICs intend to commit approximately $7.4 million in FY
2004 to fund 6 to 8 new grants in response to this RFA. An applicant
may request a project period of 3 years and a budget for direct costs
of up to $800,000 per year for the one or two year R21 phase, and up to
$1.5 million per year for the R33 phase or for each year of a stand-
alone R33 award. Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the
size 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.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Eligible agencies of the federal government
o Domestic or foreign institutions/organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
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.
SPECIAL REQUIREMENTS
Principal investigators, plus key personnel if appropriate, are
expected to participate in an annual meeting of grantees. The purpose
of these meetings is to discuss scientific advances; the potential for
collaborations, data and technology sharing; and other research
opportunities. Funds for travel to the meeting should be requested in
the budget.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
two areas: scientific/research and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Maren R. Laughlin, Ph.D.
Division of Diabetes, Endocrinology and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 6101, MSC 5460
Bethesda, MD 20892-5460
Telephone: (301) 594-8802
FAX: (301) 480-3503
Email: laughlinm@extra.niddk.nih.gov
o Direct your questions about financial or grants management matters
to:
Ms. Kathleen Shino
Grants Administration Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 708, MSC 5456
Bethesda, MD 20892-5456
Telephone: (301) 594-8869
FAX: (301) 594-9523
Email: shinok@extra.niddk.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o 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 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:
Maren R. Laughlin, Ph.D.
Division of Diabetes, Endocrinology and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 6101, MSC 5460
Bethesda, MD 20892-5460
Telephone: (301) 594-8802
FAX: (301) 480-3503
Email: laughlinm@extra.niddk.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 document is
available at http://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.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form 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:
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and five 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
Bethesda, MD 20817 (for express/courier service)
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.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
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. 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.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness and
responsiveness by the NIH). Incomplete and nonresponsive 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) in accordance with the review criteria stated below. As
part of the initial merit review, all applications will:
o 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
o Receive a written critique
o Receive a second level review by the an appropriate National Advisory
Council or Board
REVIEW CRITERIA
The goals of 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 evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application's overall score, weighting them
as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
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.
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
adequately developed, well-integrated, and appropriate to 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 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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following item will be considered in the determination of scientific
merit and the priority score, for applications utilizing the R21/R33
phased innovation mechanism:
Milestones: How appropriate are the proposed milestones against which
to evaluate the demonstration of feasibility for transition to the R33
development phase?
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 criteria
included in the section on Federal Citations, below).
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. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of
the proposed research must include a data sharing plan in their
application. The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the
reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or priority score. The
NIH policy on data sharing, as well as guidance on this subject, can be
found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 24, 2004
Application Receipt Date: March 24, 2004
Peer Review Date: June/July 2004
Council Review: September 2004
Earliest Anticipated Start Date: September 30, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
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
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking more than $500,000
or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing Investigators should
seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers
will consider the data sharing plan but will not factor the plan into
the determination of the scientific merit or the priority score.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the 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 is available at
http://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 proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide, in the project description and elsewhere in the application as
appropriate, the official NIH identifier(s) for the hESC line(s) to be
used in the proposed research. Applications that do not provide this
information will be returned without review.
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
http://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:
(if applicable) 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). Those who must comply with the Privacy Rule (classified under
the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
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
http://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 RFA 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)(cite appropriate authorizations) and
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 (cite
relevant regulations). 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 http://grants.nih.gov/grants/policy/policy.htm (also cite
other relevant policies)
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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