CAUSES AND MECHANISMS OF COPD EXACERBATIONS
RELEASE DATE: September 16, 2004
RFA Number: RFA-HL-04-036
EXPIRATION DATE: January 12, 2005
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER
No. 93.838, Lung Diseases Research
LETTER OF INTENT RECEIPT DATE: December 13, 2004
APPLICATION RECEIPT DATE: January 11, 2005
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) 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 Submitting an Application
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 NHLBI invites applications for research projects that will
investigate the causes of and molecular pathways involved in acute
exacerbations of chronic obstructive pulmonary disease (COPD).
Clinical and basic research supported through this program must seek
new knowledge that may lead to the development of more effective
approaches to the prevention and treatment of exacerbations in COPD.
While the studies may be descriptive in part, all research projects
supported through this RFA must include hypothesis-based, mechanistic
investigations that lead toward the identification of molecular targets
for therapeutic intervention.
RESEARCH OBJECTIVES
Moderate-to-severe COPD is characterized by periods of profound
worsening of respiratory symptoms that may occur up to several times
per year. Most exacerbations are idiopathic, though some are due to
viral or bacterial infections. Some exacerbations are mild and may not
be reported by the patient, but others produce striking clinical
deterioration and require hospitalization. While recovery is
essentially complete in most cases, treatment failures account for many
of the 120,000 COPD deaths in this country each year. Approximately
$10 billion per year, or nearly two thirds of the total direct costs of
medical care in the U.S. related to COPD, is expended for the treatment
of exacerbations. Despite this, medical interventions appear to have
only a modest effect on the intensity, duration, and mortality of COPD
exacerbations. Hence, new approaches for preventing and treating
exacerbations are urgently needed to increase the quality and length of
life for COPD patients and possibly reduce the overall cost of their
care.
Little is known about what causes COPD exacerbations, what individual
factors determine risk or susceptibility, what cellular and molecular
mechanisms are involved, what mechanisms contribute to remission, or
how exacerbations may hasten the progressive loss of pulmonary function
seen in COPD. Better understanding of why exacerbations develop and
what pathways mediate their manifestations is needed to identify
targets for prevention strategies and more effective therapies. This
initiative will support a variety of studies related to the causes of
and pathways contributing to exacerbations of COPD. All research
projects supported through this RFA will include mechanistic studies of
molecular hypotheses. By improving understanding of the molecular
events involved in the initiation, development, and resolution of
exacerbations, these studies will aid in identifying specific targets
for more effective preventive and therapeutic interventions.
Anticipated approaches include development of novel methods for
detection and grading of exacerbations; clinical investigations of
instigating factors, manifestations, outcomes, and effects of
treatments; correlation of microbiological and biomarker measures with
clinical course; characterization of inflammatory cells and mediators;
assessments of host defense mechanisms before, during, and after an
exacerbation; testing of genotype associations; and in vitro and animal
studies of the molecular pathways involved. Research goals that are
relevant to this solicitation include, but are not limited to, the
following:
o Evaluate methods for detection and measurement of exacerbations;
possibly involving pulmonary mechanics, microphonic monitoring of cough
frequency, biomarkers in exhaled breath, and patient scoring of dyspnea
and sputum volume and color.
o Identify predisposing factors (e.g., immune dysfunction, comorbidity,
airway bacterial colonization) and triggers (e.g., upper respiratory
tract infection, exposure to airborne pollutants or allergens, improper
use of medications, or stress) of exacerbations.
o Study molecular pathways through which airway inflammation produces
worsening of respiratory symptoms during an exacerbation.
o Examine the involvement of specific molecules and pathways in the
onset, perpetuation, and remission of exacerbations.
o Perform genomic and proteomic surveys of molecular events that occur
in airways during the course of an exacerbation.
o Conduct genetic association studies of susceptibility to frequent
exacerbations.
o Test the contributions of specific viral proteins, bacterial
products, inflammatory cells and cytokines, proteases, mediators of
mucous secretions, endogenous bronchoconstrictors (e.g., endothelin-1),
or systemic mediators (e.g., tumor necrosis factor ?, fibrinogen) to
the progression and clinical manifestations of exacerbations.
o Carry out animal studies of the regulation and pathophysiological
effects of molecular pathways that are activated during a COPD
exacerbation.
MECHANISM OF SUPPORT
This RFA will use the NIH R01 award mechanism. 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, 2005. 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 modular
budgeting as well as the non-modular budgeting formats (see
http://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.
Otherwise 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_2003/NIHGPS_Part2.htm.
FUNDS AVAILABLE
The NHLBI intends to commit approximately $2,500,000 in FY 2005 to fund
5 to 7 new grants in response to this RFA. An applicant may request a
project period of up to 5 years and a budget for direct costs of up to
$275,000 in the first year, $500,000 in years 02-04, and $275,000 in
the fifth 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. Applications
requesting 5 years of support must provide a specific justification for
that project duration. Although the financial plans of the NHLBI
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 Units of State and local governments
o Eligible agencies of the Federal government
o Domestic institutions/organizations
o Foreign institutions that offer unusual talent, resources,
populations, or environmental conditions that are not readily available
in the United States or that augment existing U.S. resources.
o Faith-based or community-based 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
Applicants must propose an operational definition of COPD exacerbations
and a system for grading the severity of exacerbations. The NHLBI will
coordinate discussions among investigators and convene a meeting during
the first year of the program to encourage the development of a
consensus definition and grading system for use in all clinical studies
of this program.
The proposed research plan may include the validation of methods for
detecting and grading COPD exacerbations and descriptive studies that
seek to demonstrate associations between exacerbations and predisposing
or aggravating factors. However, the research projects supported
through this solicitation may not be entirely methodological and
descriptive in nature. All applications must include studies that are
based on stated hypotheses that involve particular molecular pathways
or events.
All studies must be relevant to COPD exacerbations in humans. The new
knowledge to be gained must serve to enable the development of better
approaches for the prevention and/or clinical management of COPD
exacerbations. Studies of animal models or in vitro systems will be
allowed only if their relevance to human COPD exacerbations is
established.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA 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:
o Direct your questions about scientific/research issues to:
Tom Croxton, Ph.D., M.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 10208
6701 Rockledge Drive
Bethesda, MD 20892-7952
Telephone: (301) 435-0202
FAX: (301) 480-3557
Email: croxtont@nhlbi.nih.gov
o Direct your questions about peer review issues to:
Valerie Prenger, Ph.D.
Chief Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge II, Room 7194
6701 Rockledge Drive
Bethesda, MD 20892-7924
Telephone: (301) 435-0288
FAX: (301) 480-4755
Email: prengerv@nhlbi.nih.gov
o Direct your questions about financial or grants management matters
to:
Mr. John Diggs
Grants Management Specialist
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge II, Room 7155
6701 Rockledge Drive
Bethesda, MD 20892-7926
Telephone: (301) 435-0159
FAX: (301) 480-0422
Email: diggsj@nhlbi.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 NHLBI 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:
Valerie Prenger, Ph.D.
Chief Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge II, Room 7194
6701 Rockledge Drive
Bethesda, MD 20892-7924
Telephone: (301) 435-0288
FAX: (301) 480-4755
Email: prengerv@nhlbi.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.
SUPPLEMENTARY INSTRUCTIONS:
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in
a modular grant format. The modular grant 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
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants. Additional information
on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
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 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
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and
all copies of the appendix material must be sent to:
Valerie Prenger, Ph.D.
Chief Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge II, Room 7194
6701 Rockledge Drive
Bethesda, MD 20892-7924
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 by the CSR
and responsiveness by the NHLBI. Incomplete applications will not be
reviewed. If the application is not responsive to the RFA, NIH staff
may 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 appropriate NIH 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 the NHLBI 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 National Heart, Lung, and Blood
Advisory Council.
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 items will be considered in the determination of scientific
merit and the priority score:
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
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: December 13, 2004
Application Receipt Date: January 11, 2005
Peer Review Date: May-June 2005
Council Review: September 1, 2005
Earliest Anticipated Start Date: September 30, 2005
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
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is
required for all types of clinical trials, including physiologic,
toxicity, and dose-finding studies (phase I); efficacy studies (phase
II); efficacy, effectiveness and comparative trials (phase III). The
establishment of data and safety monitoring boards (DSMBs) is required
for multi-site clinical trials involving interventions that entail
potential risk to the participants. (NIH Policy for Data and Safety
Monitoring, NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 - Amended, October, 2001," published in the NIH Guide for
Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://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 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. Because COPD is a disease of
adults, it is anticipated that studies supported through this program
will not include children as research participants. 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:
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
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.healthypeople.gov/.
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 http://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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