ANCILLARY PHARMACOGENETICS STUDIES IN HEART, LUNG, BLOOD, AND SLEEP
DISORDERS
RELEASE DATE: August 22, 2002
RFA: HL-03-001
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov/)
LETTER OF INTENT RECEIPT DATE: December 17, 2002
APPLICATION RECEIPT DATE: January 14, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism 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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:
PURPOSE OF THIS RFA: The goal of this RFA is to conduct pharmacogenetic studies
in ongoing or completed clinical trials/studies related to heart, lung, blood,
and sleep disorders. Specifically, this RFA focuses on the collection and
utilization of DNA from study participants to examine genetic influences on
inter-individual differences in prescription drug response. Such studies may
help elucidate basic mechanisms of drug effects and adverse reactions and may
facilitate optimal selection of therapy in individual patients as well as
mitigating serious adverse response or lack of response to therapy.
RESEARCH OBJECTIVES
Randomized controlled clinical trials and studies of pharmacologic agents
typically involve large numbers of well-characterized participants followed for
carefully defined, clinically important endpoints to produce statistically valid
comparisons of drug effects. The effects of prescription drug therapy can also
be assessed in carefully designed, non-randomized interventional studies and in
observational cohort studies involving participants treated with various drugs.
These studies constitute a substantial investment for the NHLBI and provide a
unique potential resource for pharmacogenetic studies.
According to a recent study, an estimated 2 million people were hospitalized in
one year alone for reactions to properly prescribed medications and 100,000 of
these people died, making unexpected adverse reactions to drugs a leading cause
of death in the United States. There is growing recognition that individual
drug responses are to a large degree modulated by proteins involved in drug
absorption, transport, availability, activation, metabolism, and excretion, and
that genetic variants in any of these pathways can lead to differences in
response. Interaction of these genetic variants with non-genetic environmental
determinants such as dietary factors, nicotine and alcohol use, pre-existing
illness, sleep history, and other drugs can also influence individual response.
Pharmacogenetic research focuses on identifying genetic influences on the
biological response (or lack of response) to pharmacologic interventions.
Understanding these genetic influences may permit better tailoring of medication
choice and dosing in individual patients and help avoid serious adverse or lack
of response to therapy. It may also aid in the development of drugs with
narrower and more targeted therapeutic actions and with fewer side effects.
Clinical phenotypes observed prior to initiation of drug treatment are often not
sufficient to predict an individual"s response to therapy. Assessment of
sequence variation in participants exhibiting a wide range of clinical drug
responses, including enhanced response, lack of response, or adverse reactions,
will allow the functional consequences of genetic variation to be examined.
Both variation in drug biotransformation and elimination pathways
(pharmacokinetics) and variation in the direct effects of drugs on cells and
tissues (pharmacodynamics) are of interest. Genetically-based circadian
variations in the pharmacokinetics and pharmacodynamics of drugs are also of
interest. The underlying theme of this RFA will be to search for
pharmacogenetically important sequence variation by correlating genotype with
treatment response.
Thus, several approaches are promising. There may be selected study
participants already phenotyped for a drug response or for disease progression,
who can be used to relate a characteristic drug response to a genetic variant.
Sequence variation in key genes involved in drug metabolism and response, such
as the cytochrome P450 superfamily and the ATP binding cassette (ABC) family,
can be examined in relation to measured phenotypic responses to determine which
variants are functional and how they contribute to individual differences in
drug response. This can be conducted efficiently by utilizing stored blood or
tissue samples from well-characterized and carefully monitored study
participants.
The biochemical significance of genetic sequence variation in coding and non-
coding regions should be examined. There may be a functional role for genetic
variation in altered transcription, structure, splicing, or stability of mRNA,
as well as changes in the structure, function, regulation, modification, or
degradation of the encoded protein(s). These biochemical effects may be
exhibited under specific pathophysiological conditions such as intermittent
hypoxia and ischemia.
Investigators trained in different areas and working as collaborative teams are
needed to achieve insights into the contribution of genetic variation on
individual drug responses. Rigorous studies, both basic and clinical, are
needed to correlate phenotype with genotype. Researchers working at the most
molecular to the most clinical levels in the fields of pharmacology, physiology,
genetics, genomics, medicine, epidemiology, statistics, bioinformatics, and
computational biology should combine talents to interpret functional protein and
gene variations having essential roles in determining drug response and to
translate these findings to improved therapeutic outcomes.
These studies must not interfere with or overburden participants in the parent
study. Information regarding potential NHLBI studies available for these
studies can be found at the NHLBI Database to Facilitate Human Genetic Research
web site: http://webdev.nhlbi.nih.gov/Genetics/ and the NHLBI Population Studies
Database web site: http://apps.nhlbi.nih.gov/popstudies/. Appropriate power
calculations must be provided, acceptable informed consent ensured, and
ancillary study policies from the parent study followed. Studies may utilize
existing stored genetic material or collect samples from ongoing trial and/or
studies. Investigators should consider whether an independent Observational
Safety and Monitoring Board (OSMB) may be needed for their specific study,
particularly in the case where there is re-recruitment or samples from a
completed study are being used. If such a need is anticipated, funds for the
OSMB (one meeting per year in Bethesda, MD with 5-7 members) should be included
in the proposed budget. Additional phenotyping may be necessary for these
studies and funds must be included within the proposed budget.
For investigators who may require storage facilities at the end of the study,
the NHLBI Biologic Specimen Repository
(http://www.nhlbi.nih.gov/resources/medres/reposit/reposit.htm) is available for
long term storage of blood, serum, plasma, tissue, DNA, etc. There is no cost
to the investigator for storage. The investigator must arrange transportation
of samples and access of the samples should be coordinated with the parent
study.
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.
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, 2003.
This RFA uses just-in-time concepts. It also uses the modular as well as the
non-modular budgeting formats (see
https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you
are submitting an application with direct costs in each year of $250,000 or
less, use the modular format. Otherwise follow the instructions for non-modular
research grant applications.
FUNDS AVAILABLE
The NHLBI intends to commit approximately $6.0 million total costs in FY 2003 to
fund 6-8 new grants in response to this RFA. An applicant may request a project
period of up to four years. It is expected that applications will not exceed a
budget of $600,000 in direct costs, excluding Facilities and Administrative
costs on consortium arrangements, in the first year. Annual increases in non-
competing years are not allowed. Because the nature and scope of the proposed
research will vary from application to application, it is anticipated that the
size and duration of each award will also vary. Although the financial plans of
the 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. At this time, it is not known if this RFA will be
reissued.
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 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
To be responsive, the application must utilize clinical studies in progress or
completed, and not develop new cohorts or trials.
This award is limited to studying prescription drugs that are used to treat
heart, lung, blood, and sleep disorders or which cause side effects resulting in
heart, lung, blood, and sleep phenotypes. Studies evaluating solely alcohol
and/or smoking will be considered non- responsive.
Upon initiation of the program, the NHLBI will sponsor a yearly meeting to
encourage exchange of information among investigators who participate in
pharmacogenetic research. The NHLBI meeting will be in conjunction with the NIH
Pharmacogenetics Research Network and Knowledge Base meeting
(http://www.pharmgkb.org/meetings/2002/). Travel funds should be included for two
people (the Principal Investigator and one-co-investigator from the grant) to
attend a two-day meeting, once a year, most likely to be held in Bethesda,
Maryland. Applicants should also include a statement in their application
indicating their willingness to participate in this meeting and to interact
openly with other study participants.
In order to be responsive to this RFA, the applicant must provide adequate
documentation that patients, samples, data, and/or materials are available from
the parent clinical trial. Principal investigators of awards funded through this
RFA will be required to deposit their data into the PharmGKB, a knowledge base
for pharmacogenetic information (http://www.pharmgkb.org/) maintained by
Stanford University. Data sharing should adhere to the Pharmacogenetics Network
policy of that all data should be deposited within 90 days of discovery
(http://www.pharmgkb.org/do/serve?id=network.policies.2).
PharmGKB is organized around the principle that pharmacogenetic information can
be indexed by genes, drugs, and levels of evidence that drug response
differences are the phenotypic expression of genetic variation. PharmGKB
includes genotypic and phenotypic information collected in research studies
conducted by the Pharmacogenetics Research Network, as well as information
gathered from external sources relevant to pharmacogenetic studies. Several
institutes of the NIH, including NHLBI, support the Pharmacogenetics Research
Network. The PharmGKB is different from traditional clinical trial data centers
in that it does not store data for limited accessibility, all data must be
submitted in a format suitable for public dissemination on the World Wide Web.
PharmGKB entries consist of (1) genotypic data, suitably protected for
confidentiality, (2) linked phenotypic information, appropriately de-identified,
and (3) text summaries of study protocols. In cases where individual phenotypic
information is judged to be too sensitive to release, summary data tables will
be accepted. The PharmGKB team can work with investigators to define either
spreadsheet-based submission of data or XML-based submission of data.
Also, a computer specialist supported by NHLBI will be available to assist
grantees in data retrieval, processing, storage, and presentation of data into
PharmGKB at Stanford University, Palo Alto, CA. The specialist will assist
network submitters and users seeking information and training. The specialist
will be available to work with the grantee institution and at the annual
meetings.
Applicants should describe their plans for data deposits, and should indicate
their plans for obtaining adequate informed consent for posting de-identified
data to PharmGKB. Samples of model informed consent language used by the
Pharmacogenetics Research Network can be found at
http://www.pharmgkb.org/do/serve?id=network.policies.3. Protection of
participant confidentiality and arrangements for sample and data sharing will be
subject to peer review.
Arrangements for data sharing will be specified in the terms and conditions of
award and finalized in the first year of the study. Award of non-competing
continuations (type 5) will be contingent on satisfactory completion of this
requirement.
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:
Mariana Gerschenson, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 9180
MSC 7940
6701 Rockledge Drive
Bethesda, MD 20892-7940
Phone: 301-435-0515
FAX: 301-480-1336
Email: gerschem@nhlbi.nih.gov
Susan Banks-Schlegel, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 10018
MSC 7952
6701 Rockledge Drive
Bethesda, MD 20892-7952
Phone: 301-435-0202
FAX: 301-480-3557
Email: schleges@nhlbi.nih.gov
Pankaj Qasba, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Rockledge II, Room 10161
MSC 7950
6701 Rockledge Drive
Bethesda, MD 20892-7950
Phone: 301-435-0050
FAX: 301-480-0868
Email: qasbap@nhlbi.nih.gov
Ebony Bookman, Ph.D.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
Rockledge II, Room 8166
MSC 7934
6701 Rockledge Drive
Bethesda, MD 20892-7934
Telephone: 301-435-0446
FAX: 301-480-3667
Email: bookmane@nhlbi.nih.gov
Carl E. Hunt, M.D.
National Center on Sleep Disorders Research
National Heart, Lung, and Blood Institute
Rockledge II, Suite 10138
6701 Rockledge Drive
Bethesda, MD 20892
Phone: (301) 443-0199
Fax: (301) 480-3557
E-mail: huntc@nhlbi.nih.gov
o Direct your questions about peer review issues to:
Anne Clark, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Dr., Room 7214 (MSC 7924)
Bethesda, MD 20892-7924 (20817 for express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: ClarkA@nhlbi.nih.gov
Direct your questions about financial or grants management matters to:
John Diggs
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive Suite 7172, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0177
FAX: (301) 480-3310
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 IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to Dr. Anne Clark at the address
listed under Where to Send Inquiries.
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
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: mailto:GrantsInfo@nih.gov.
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
https://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 https://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:
https://grants.nih.gov/grants/funding/phs398/label-bk.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 as well as
five collated sets of Appendix material must be sent to Dr. Anne Clark at the
address listed under Where to Send Inquiries.
Please note that applications delivered by individuals are no longer accepted,
all applications must either come via courier delivery or the United States
Postal Service https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
APPLICATION PROCESSING: Applications must be received by 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.
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. The CSR
will not accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
Introduction addressing the previous critique.
Principal investigators should not send supplementary material without first
contacting the Scientific Review Administrator (SRA). The SRA will be
identified in the letter sent to you indicating your application has been
received. If you have not received such a letter within three weeks after
submitting the application, contact Dr. Anne Clark at the address listed under
Where to Send Inquiries.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NHLBI.
Incomplete and/or non-responsive applications will be returned to the applicant
without further consideration.
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 Receive a written critique
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 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 discuss the following aspects of
your 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 your application"s overall score, weighting them as appropriate for
each application. Your 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, you may propose to carry out important work that
by its nature is not innovative but is essential to move a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the aims of
your application are achieved, how do they advance scientific knowledge? What
will be the effect of these studies on the concepts or methods that drive this
field?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does your project challenge existing
paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your 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?
(6) COLLABORATIONS AND DATA SHARING: The adequacy of the proposed plan and time
line to share data. The willingness to work and collaborate with the
Pharmacogenetics Research Network and the PharmGKB database maintained at
Stanford University. The willingness to provide data to a central data base and
otherwise to disseminate resulting data and analytic tools.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application
will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
o INCLUSION: 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 included in the section
on Federal Citations, below)
o 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 17, 2002
Application Receipt Date: January 14, 2003
Peer Review Date: May/June, 2003
Council Review: September, 2003
Earliest Anticipated Start Date: September 30, 2003
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
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:
https://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 AMENDMENT "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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete
copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research, updated racial and ethnic categories in compliance with the new OMB
standards, clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398, and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable, and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN 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
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH 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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to provide
public access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA 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.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for
NIH funding must be self-contained within specified page limitations. Unless
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not
be used to provide information necessary to the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People 2010,"
a PHS-led national activity for setting priority areas. This RFA is related to
one or more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance No. 93.837, 93.838, 93.839 and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review. Awards are made under authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and administered
under NIH grants policies described at
https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42
CFR 52 and 45 CFR Parts 74 and 92.
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.