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 
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 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 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
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 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular grants 
is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label could 
result in delayed processing of the application such that it may not reach the 
review committee in time for review.  In addition, the RFA title and number must 
be typed on line 2 of the face page of the application form and the YES box must 
be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/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 http://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: 
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 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 
(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.

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 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 
http://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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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