NCCAM EXPLORATORY/DEVELOPMENTAL GRANT FOR CLINICAL STUDIES (R21)
RELEASE DATE: July 17, 2003
PA NUMBER: PAR-03-153 (see addendum NOT-CA-04-006)
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006
submission date, all R03, R21, R33 and R34 applications must be
submitted through Grants.gov using the electronic SF424 (R&R)
application. Accordingly, the portion of this funding opportunity
relating to these mechanisms expires on the date indicated below.
Other mechanisms relating to this announcement will continue to be
accepted using paper PHS 398 applications until the stated expiration
date below, or transition to electronic application submission.
Replacement R21 (PAR-06-091), funding opportunity announcement
has been issued for the submission date of June 1, 2006 and submission
dates thereafter.
See NOT-OD-06-048 for information on May 1, 2006 Submission Date for AIDS and
AIDS-related R03 and R21 Applications.
EXPIRATION DATE: March 2, 2006
National Center for Complementary and Alternative Medicine (NCCAM)
(http://www.nccam.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.213
THIS PAR CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PAR
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PAR
The National Center for Complementary and Alternative Medicine (NCCAM)
invites high quality exploratory/developmental clinical research grant
applications, in all domains of complementary and alternative medicine
(CAM), in order to provide preliminary data that can be used as a
foundation for larger clinical studies. NCCAM defines five domains of
complementary and alternative medicine, which are alternative medical
systems; biologically-based therapies; energy medicine; manipulative
and body-based therapies; and mind-body medicine. These are described
more fully in the NCCAM five-year strategic plan (2001-2005)
http://nccam.nih.gov/about/plans/fiveyear/index.htm
While many CAM therapies are in extensive use by the public, few have
been thoroughly tested for safety and/or efficacy. One of the primary
missions of NCCAM is to support clinical research to test the efficacy
of CAM therapies being used by the public. However, before investing in
a large clinical study to test the efficacy of a CAM therapy, it is
necessary to first provide preliminary data from pilot studies and
small phase I and phase II trials as a basis for such a larger clinical
study. Thus, an important goal of this exploratory/developmental
research grant solicitation is to provide independent investigators, at
all career levels, with the opportunity to design rigorous feasibility
and developmental projects in the clinical area that will serve as the
basis for planning and scientifically justifying larger clinical
research projects to test the efficacy of CAM therapies. If the
results from preliminary studies submitted in response to this program
announcement, along with published reports in the literature, support
the performance of a larger clinical study, then a future grant
application soliciting support for such a study can be submitted
through the research project grant (R01) mechanism.
Examples of types of investigations appropriate for this clinical
exploratory/developmental program announcement include, but are not
limited to the following:
o Feasibility studies to test and optimize parameters such as accrual
rates, acceptance of randomization, compliance, delivery of the
intervention, appropriate inclusion/exclusion criteria, and
optimization of the overall protocol design for planned clinical
trials.
o Studies to develop and validate testing of biological and behavioral
outcome measures in humans for use in CAM clinical research. These
could include development and/or validation of both the measurement
procedure itself and delivery to subjects. Examples include
optimization of imaging methods and enzymatic assays; development and
validation of behavioral assessment tools to be used in clinical
trials, as well as development and validation of self report
questionnaires and survey instruments to be used in CAM epidemiological
and health services research, including health outcomes research.
o Studies to determine if the effect sizes described in the literature
or clinically significant effect sizes can be achieved.
o Small clinical trials to determine safety, toxicity,
pharmacokinetics, pharmacodynamics and the optimal dosage of an
intervention as a prelude to a larger efficacy trial. If the total
enrollment required is greater than approximately 60 subjects, the
applicant is strongly encouraged to contact an NCCAM Program Officer to
discuss whether the R21 or R01 mechanism is most appropriate for the
study.
o Qualitative research, such as detailed case studies and patient and
health care provider interviews or ethnographic/ethnobotanical studies,
to describe diagnostic and treatment approaches; to explore patient and
health care provider preferences, beliefs and attitudes; and to
investigate the relevance of those approaches to future clinical
studies.
Preliminary data are not required as a prerequisite for submission in
response to this announcement, because part of the goal of this program
announcement is to produce the preliminary data as the first necessary
step in the process required for planning a larger clinical study.
However, a clear rationale for the study must be presented. A rigorous
project design is required as well. A thorough summary of the published
literature that justifies initiating the specific clinical project
proposed must be presented in the grant application. In addition,
applicants should describe their future research plans as they relate
to how the results of this exploratory/developmental research will lead
to a larger clinical study. Furthermore, applicants should provide
justification regarding why it is important to perform this larger
clinical study in the context of the present knowledge of clinical
research on CAM therapies.
Large Phase II trials or Phase III trials, with the goal of determining
efficacy of a CAM therapy, should not be submitted in response to this
announcement. Such proposals should be submitted as research project
(R01) grants.
Exploratory/developmental CAM basic and preclinical studies, including
mechanistic studies in humans, should not be submitted in response to
this program announcement. Instead such studies should be submitted in
response to the NCCAM program announcement on "Basic and Preclinical
Research on Complementary and Alternative Medicine" (PA-02-124)
(http://grants.nih.gov/grants/guide/pa-files/PA-02-124.html)
RESEARCH OBJECTIVES
The research objective of this PA is to encourage the submission of
high quality, preliminary studies that will provide a solid foundation
and justification for larger clinical studies to determine the efficacy
of CAM therapies in all five CAM research domains.
MECHANISM OF SUPPORT
This NCCAM PA will use the NCCAM R21 (Exploratory/Developmental
Project) award mechanism (see
http://nccam.nih.gov/research/instructions/r21/index.htm). Please note
that this is different from the NIH-wide R21 program. The NCCAM R21
award is an exploratory/developmental research grant for support of
pilot and feasibility CAM research designed to provide investigators
with an opportunity to produce preliminary data in support of a larger
project that may be submitted in the future as a research
project(R01)grant application. The NIH-wide R21 program emphasizes
research characterized by novel ideas that may differ substantially
from current thinking in a field and thus bear considerable risk of
failure. While novel ideas are certainly welcome in response to this
specific program announcement, the emphasis is more on providing solid
data to support justification for a future clinical study.
For R21 grants awarded through this program announcement, applicants
may request a project period of up to three years with a combined
budget for direct costs of up $400,000 for the three-year period. The
budget request should be tailored to the needs of the project. For
example, you may request $100,000 in the first year, $200,000 in the
second year and $100,000 in the third year. However, no more than
$250,000 direct costs may be requested in any single year.
These grants may not be renewed. However, two revisions of a previously
reviewed exploratory/developmental R21 grant may be submitted as
defined in NIH Policy at
http://grants.nih.gov/grants/policy/amendedapps.htm. Competing
continuation of projects developed under this grant mechanism should be
submitted through the R01 research grant mechanism.
As an applicant, you will be solely responsible for planning,
directing, and executing the proposed project. Facilities and
Administrative (F&A) costs will be awarded based on the negotiated rate
at the time of award. Although the program is provided for in the
financial plans of the NCCAM, the award of grants pursuant to the PAR
is contingent upon the availability of funds for this purpose.
This PAR uses just-in-time concepts. It uses the modular budgeting
formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).
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.
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 or foreign
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
In addition to the required Federal Citations listed below related to
clinical research, applicants submitting applications in response to
this announcement should also follow the NCCAM Policy on Terms of Award
for Clinical Trials
http://nccam.nih.gov/research/policies/terms-of-awards.htm,
where applicable.
If the clinical study will involve a natural product, then the
applicant must follow the NCCAM Policy Announcement on Quality of
Natural Products:
http://nccam.nih.gov/research/policies/naturalproducts.htm
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this Program Announcement and
welcome the opportunity to answer questions from potential applicants.
Inquiries may fall into three areas: scientific/research, review of
application issues, and financial or grants management issues:
o For scientific/research questions:
Please contact the appropriate NCCAM program officer listed on this
website: http://nccam.nih.gov/research/contact/index.htm.
o Direct your questions about review of applications to:
Martin Goldrosen, Ph.D.
Chief, Office of Scientific Review
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892 (for express/courier service use 20817)
Telephone: (301) 594 2014
Fax: (301) 480 2419
Email: goldrosm@nccam.nih.gov
o Direct your questions about financial or grants management matters
to:
Ms. Victoria Carper
Grants Management Branch
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892 (for express/courier service use 20817)
Telephone:
Fax: 301 480 2419
Email: carperv@nccam.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 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.
APPLICATION RECEIPT DATES: Applications submitted in response to this
program announcement will be accepted at the standard application
deadlines, which are available at
http://grants.nih.gov/grants/dates.htm. Application deadlines are also
indicated in the PHS 398 application kit.
SUPPLEMENTAL INSTRUCTIONS FOR NCCAM EXPLORATORY/DEVELOPMENTAL GRANT FOR
CLINICAL STUDIES (R21)APPLICATIONS: All application instructions
outlined in the PHS 398 application kit are to be followed, along with
the following requirements for R21 applications:
1. R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME"
concepts, with direct costs requested in $25,000 modules. Applicants
may request a project period of up to three years with a combined
budget for direct costs of up $400,000 for the three-year period. For
example, you may request $100,000 in the first year, $200,000 in the
second year and $100,000 in the third year. The request should be
tailored to the needs of your project. However, no more than $250,000
may be requested in any single year.
2. Although preliminary data are not required for an R21 application,
they may be included.
3. Sections a-d of the Research Plan of the R21 application may not
exceed 20 pages, including tables and figures.
4. R21 appendix materials should be limited, as is consistent with the
exploratory nature of the R21 mechanism, and should not be used to
circumvent the page limit for the research plan. Copies of appendix
material will only be provided to the primary reviewers of the
application and will not be reproduced for wider distribution among
reviewers. The following materials may be included in the appendix:
o Up to five publications, including manuscripts (submitted or
accepted for publication), abstracts, patents, or other printed
materials directly relevant to the project. These may be stapled as
sets.
o Surveys, questionnaires, and data collection instruments. These
may be stapled as sets.
o Original glossy photographs or color images of gels, micrographs,
etc., provided that a photocopy (may be reduced in size) is also
included within the 20-page limit of items a-d of the research plan.
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.
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)
Two copies should also be sent to:
Martin Goldrosen, Ph.D.
Chief, Office of Scientific Review
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892 (for express/courier service use 20817)
APPLICATION PROCESSING: Applications must be mailed on or before the
receipt dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR
will not accept any application in response to this Program
Announcement that is essentially the same as one currently pending
initial review unless the applicant withdraws the pending application.
The CSR will not accept any application that is essentially the same as
one already reviewed. This does not preclude the submission of a
substantial revision of an application already reviewed, but such
application must include an Introduction addressing the previous
critique.
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.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review
group within NCCAM convened in accordance with the standard NIH peer
review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate
applications for scientific and technical merit.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed
to have the highest scientific merit, generally the top half of
applications under review, will be discussed and assigned a priority
score
o Receive a second level review by the National Advisory Council for
Complementary and Alternative Medicine.
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 discuss the
following aspects of the application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these
criteria in assigning the application's overall score, weighting them
as appropriate for each application. 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. In
addition, preliminary data are not required as a prerequisite for
submission in response to this announcement, because part of the goal
of this program announcement is to produce the preliminary data as the
first necessary step in the process required for planning a larger
clinical study.
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? Specifically, does the applicant
describe how the results of this exploratory/development research will
lead to the development of a larger clinical study? Does the applicant
provide justification as to why it is important to perform this larger
clinical study in the context of the present knowledge of clinical
research on CAM therapies?
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? Does the applicant provide a thorough
summary of the published literature that justifies initiating this
specific clinical project? Is a clear rationale for the study
presented? Is a rigorous study design described?
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 will be assessed. 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 CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data.
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PAR will compete for available
funds with all other recommended applications. The following will be
considered in making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program 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
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research
components involving Phase I and II clinical trials must include
provisions for assessment of patient eligibility and status, rigorous
data management, quality assurance, and auditing procedures. In
addition, it is NIH policy that all clinical trials require data and
safety monitoring, with the method and degree of monitoring being
commensurate with the risks (NIH Policy for Data Safety and 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. 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 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).
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 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
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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