GENERAL CLINICAL RESEARCH CENTER COMPLEMENTARY AND ALTERNATIVE MEDICINE
RESEARCH PROGRAM
RELEASE DATE: April 6, 2004
PA NUMBER: PAR-04-087
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, this funding opportunity
expires on the date indicated below. A replacement R21 (PAR-06-090) 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
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Center for Complementary and Alternative Medicine (NCCAM)
(http://www.nccam.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.213
THIS PAR CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PAR
o Research Objectives
o Mechanism 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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PAR
The 80 General Clinical Research Centers (GCRC s) supported by the
National Center for Research Resources (NCRR) are described by Congress
as "critical" resources for providing optimal venues and essential
infrastructure for patient-oriented research. The GCRC’s are expected
to be a driving force for future biomedical research, technologies and
resources, and are in the forefront of clinical research training.
They may also play a prominent part in implementation of the NIH
Roadmap on translational research.
Historically, some of the first complementary and alternative medicine
(CAM) clinical research supported by NIH was through GCRC’s in the
1970s and 1980s. Such support has continued to the present day.
However, the support is limited both in the number of projects funded
(out of the thousands of GCRC projects funded) and the numbers of
GCRC’s involved.
The purpose of this PAR, General Clinical Research Center Complementary
and Alternative Medicine Research Program, is to solicit projects from
investigators poised to use GCRC resources to pursue clinical research
investigating CAM. As used by the U.S. public, CAM is made up of many
heterogeneous systems of medicine as well as numerous stand-alone
therapies (for examples, see http://nccam.nih.gov/health/whatiscam).
Research on the entire range of CAM is encouraged by this PAR. It will
be important for each applicant to consider how the development of a
CAM research program will impact on their communities, placing special
emphasis, when possible, on minority and underserved populations in the
community.
RESEARCH OBJECTIVES
The primary goal of this PAR is to stimulate submission of high
quality, preliminary studies of CAM at GCRC’s nation-wide. These
studies will provide solid foundation and justification for larger
clinical studies. In addition, this initiative is expected to
facilitate and expand the evaluation of CAM treatments for the wide
array of diseases and conditions currently being evaluated at GCRC s,
as well as to explore mechanisms of action of promising CAM therapies.
Other goals are to attract GCRC investigators to the field of CAM
research and to provide a stable scientific environment where CAM
practitioners can actively participate in rigorous research.
Examples of types of investigations appropriate for this 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, adherence, delivery of the
intervention, appropriate inclusion/exclusion criteria, and
optimization of the overall protocol design for planned clinical trials
of CAM interventions.
o Studies to develop and validate biological and behavioral outcome
measures in humans for use in CAM clinical research. Examples include
optimization of imaging methods and enzymatic assays; development and
validation of behavioral assessment tools to be used in clinical
trials; development and validation of self-report questionnaires and
survey instruments, including the use of new computerized interview
assessment technologies (e.g., ACASI), to be used in CAM
epidemiological and health services research.
o Studies to determine if the effect sizes described in the literature
or clinically significant effect sizes can be achieved in CAM research.
o Small clinical trials to determine safety, toxicity,
pharmacokinetics, pharmacodynamics, and the optimal dosage of
biologically-based interventions, as well as the optimal dose for
mind/body and other CAM interventions as a prelude to a larger efficacy
trial.
o Studies that explore mechanisms of action of CAM interventions, such
as investigations of the immunomodulatory, neurophysiological,
neuroendocrinological, and/or biochemical pathways that may mediate CAM
therapies.
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
the subsequent 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.
MECHANISM OF SUPPORT
This PAR will use the NCCAM NIH R21 award mechanism (Exploratory/
Developmental Project) award mechanism (see PAR-03-153)
http://grants.nih.gov/grants/guide/pa-files/PAR-03-153.html . Note
that this is different from the NIH-wide R21 program. As an applicant,
you will be solely responsible for planning, directing, and executing
the proposed project.
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.
This PAR uses just-in-time concepts. It also uses the modular
budgeting format. (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. 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 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 institutions/organizations
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
Letters of support stating that GCRC resources are available for the
proposed research are required from the GCRC Principal Investigator and
Program Director at the time of application. Applications without
these letters will not be considered for support.
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
If the proposed research is investigating practitioner-based CAM (e.g.,
acupuncture, chiropractic, massage therapy, etc.), qualified CAM
practitioners must be included as active members of the research team.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA 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 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:
Mr. George Tucker
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). 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 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.
The title and number of this program announcement must be typed on line
2 of the face page of the application form and the YES box must be
checked.
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.
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.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS:
Applications requesting up to $250,000 per year in direct costs must be
submitted in a modular budget grant format. The modular budget 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 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 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 PAR 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
unfunded version 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 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 written critique
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 evaluate
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.
In addition, preliminary data are not required as a prerequisite for
submission in response to this PAR, because part of the goal of this
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)? Are CAM
practitioners adequately integrated into the research team when
appropriate?
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? What advantage is there to doing the work on
the GCRC? Does the GCRC have expertise in the required areas to
facilitate the research? Is there evidence indicating that the
investigators will have access to GCRC facilities?
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.
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
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).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking $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 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, 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).
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.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)(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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