RELEASE DATE:  August 6, 2004
RFA Number:  RFA-NS-05-003 (This RFA has been reissued, see RFA-NR-06-001)

EXPIRATION DATE:  November 23, 2004

Department of Health and Human Services (DHHS)
National Institutes of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ) 

Office of Research Integrity (ORI/DHHS)
National Institute of Neurological Disorders and Stroke (NINDS/NIH) 
National Institute of Nursing Research (NINR/NIH)
National Institute on Drug Abuse (NIDA/NIH)

93.853 (NINDS), 93.361 (NINR), 93.279 (NIDA), 93.226 (AHRQ) 


o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations


The Office of Research Integrity (ORI, DHHS), the National Institute of 
Neurological Disorders and Stroke (NINDS, NIH), the National Institute 
of Nursing Research (NINR, NIH), the National Institute on Drug Abuse 
(NIDA, NIH), and the Agency for Healthcare Research and Quality (AHRQ, 
DHHS) invite applications to support research on research integrity.  

The purpose of the proposed grant program is to foster empirical 
research on societal, organizational, group, and individual factors 
that affect, both positively and negatively, integrity in research.  
Proposals must have clear relevance to biomedical, behavioral health 
sciences, and health services research.  Applicants are strongly 
encouraged to take into consideration problems or issues that are 
relevant to the missions of DHHS, NIH, AHRQ, or specific NIH institutes 
and programs.

For the purposes of this RFA, "research" is interpreted broadly to 
include societal, organizational, group, and individual aspects of the 
enterprise.  "Integrity" is understood as "the use of honest and 
verifiable methods in proposing, performing, and evaluating research 
and reporting research results with particular attention to adherence 
to rules, regulations, guidelines, and commonly accepted professional 
codes or norms." 



“Integrity” requires acting correctly or properly.  In research, 
integrity requires adhering to responsible research practices or, 
following the definition above, "the use of honest and verifiable 
methods in proposing, performing, and evaluating research and reporting 
research results, with particular attention to adherence to rules, 
regulations, guidelines, and commonly accepted professional codes or 

While much is written about integrity in research and its importance, 
three key questions remain largely unanswered:

1.  What standards guide responsible practice and how are they set?
2.  To what extent is research, as a profession, effectively self-
3.  What are the key factors that influence the way researchers and 
research institutions conduct research and how can these factors be 
enhanced or mitigated as appropriate? 

This RFA seeks applications for empirical research that will provide 
answers to these questions, with particular interest in quantifiable 
information that is relevant to particular PHS research communities 
and/or research interests.  Projects that are relevant to the current 
NIH Roadmap Initiatives (New Pathways to Discovery, Research Teams of 
the Future, and Re-engineering the Clinical Research Enterprise) are 
also encouraged.

Areas of Interest

1.  Standards for responsible conduct.  The standards for responsible 
conduct in research are complex and not always apparent.  Some (e.g. 
Federal regulations for human and animal research or for handling 
misconduct) are clearly described and must be followed.  Others (e.g. 
Federal guidelines and professional codes) are clearly described but 
have no compelling authority.  Still others (e.g. for designing 
experiments; recording, storing, and interpreting data; or assigning 
authorship) are more customs than clearly defined standards and can 
vary from field to field or research setting to research setting.

The participating Institutes and Agencies are interested in knowing how 
standards for responsible conduct in research are formulated and the 
practices these standards endorse or discourage.  In proposing studies 
in this area, researchers should pay attention to and clearly 
distinguish ideal from actual practices.  What practices are ideally 
recommended?  What practices do researchers routinely accept and, by 
implication, assume are responsible?  There is particular interest in 
knowing more about the standards for:

o data collection, storage, and sharing;
o data selection, interpretation and reporting;
o the use of statistics in data interpretation and reporting 
significant results;
o assigning authorship; and
o collaboration with other researchers and laboratories, particularly 
in clinical trials and international research.

2.  Self-regulation.  Self-regulation plays a vital role in maintaining 
integrity in research and for ensuring the reliability of the research 
record.  Even in areas that are subject to Federal and local regulation 
(e.g. misconduct policies), regulators/administrators rely heavily on 
the research community to follow the rules and to report problems when 

The participating Institutes and Agencies are interested in knowing how 
self-regulation operates in different research areas and its 
effectiveness.  Studies proposed in this area should explore both 
ideals and real practices.  What responsibilities for self-regulation 
do researchers recommend?  Are researchers accepting their 
responsibilities for self-regulation?  How effective is self-
regulation?  There is particular interest in knowing more about self-
regulation as it pertains to:

o responding to/preventing research misconduct and questionable 
research practices;
o responding to/preventing inadvertent and careless errors;
o correcting the research literature; and
o promoting responsible mentoring and laboratory practices.

3.  Factors that enhance or undermine integrity.  Integrity is 
primarily a personal responsibility, but it can be and often is 
influenced by other factors, such as the attitudes of mentors, 
colleagues, and institutional leaders; institutional priorities; the 
availability of different types of research funding; local, national 
and/or world events; and personal obligations.

The participating Institutes and Agencies are interested in knowing 
which factors play primary roles in either encouraging or discouraging 
the adoption of high standards for integrity in research.  Studies 
proposed in this area should not only explore what these factors are 
but also how they can be influenced or changed.  Does education about 
responsible research practices make a difference, and if so what 
approaches to education have the most impact?  Are institutional 
factors important and if so how can they be changed?  How do different 
incentives (interests) promote or undermine integrity?  There is 
particular interest in knowing more about factors that enhance 
integrity in relation to:

o RCR (responsible conduct of research) education;
o mentoring;
o conflicts of interest, particularly those that involve financial 
o the effectiveness of research regulations;
o the organization of individual laboratories and clinical research 
settings; and
o the organization of large research collaborations (clinical trials, 
multi-site research, international research).

4.  Relevant Research Perspectives and Disciplines.  Relevant research 
perspectives and disciplines include, but are not limited to: 
anthropology, applied philosophy, business, economics, education, 
information studies, law, organizational studies, health services, 
political science, psychology, public health, sociology, and survey and 
evaluation research, plus the physical, biomedical, and clinical 
sciences, including nursing.  The NINR is particularly interested in 
research done by nurses on these areas of interest.  The AHRQ is 
particularly interested in research done by health services researchers 
on these areas of interest.


This RFA will use NIH R01 award mechanism.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  Future unsolicited, 
competing-continuation applications based on this project will compete 
with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures.  The anticipated 
award date is July 2005.  

This RFA uses just-in-time concepts.  It also uses the modular 
budgeting format. (see  
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  


The ORI intends to commit approximately $1,500,000 in FY 2005 to fund 
new grants in response to this RFA.  NINDS, NINR, NIDA, and AHRQ may 
provide additional funding for projects relevant to their research 
programs.  Awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of 
meritorious applications.

An applicant may request a project period of up to 2 years and a budget 
for direct costs of up to $175,000 per year excluding Fiscal and 
Administrative costs 
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 vary.  

Applicants developing new research areas or assembling new, 
interdisciplinary project teams should consider proposing limited, 
short-term projects to establish the methods for and validity of the 
work they propose to do (e.g., $75,000-100,000/year for one or two 
years).  Larger, longer-term applications should be limited to major 
data collection efforts that involve multiple institutions, phased 
surveys, detailed direct or on site analysis, or other major research 
work that cannot be accomplished in smaller studies.

In addition to new applications, amended applications for unfunded 
projects previously submitted to NIH in response to preceding RFAs from 
NIH/ORI will be accepted.  Competitive continuations of existing 
projects are not eligible under this RFA.  

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 institutions/organizations
o Faith-based or community-based organizations 

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.  


Successful applicants should plan to participate in future ORI- 
sponsored conferences on research on research integrity to report 
progress, discuss problems, and share information related to the 
conduct of their grants.  It is therefore strongly recommended that 
costs associated with attendance of the principal investigator at one 
conference each year be included as part of the budget proposal.  
Applicants are also encouraged to include funds for at least one 
additional professional presentation of research results over the 
course of the grant period.


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:

Mary D. Scheetz, Ph.D.
Office of Research Integrity 
1101 Wootton Parkway, Suite 750 
Rockville, MD 20852 
(301) 443-5302 

Claudia S. Moy, Ph.D.  
NINDS/NIH Neuroscience Center, Room 2214 
6001 Executive Boulevard, MSC 9520
Bethesda, MD 20892-9520 
(301) 496-2789 

Alexis D. Bakos, Ph.D., M.P.H., R.N.
Program Director
Office of Extramural Programs  
National Institute of Nursing Research
One Democracy Plaza 
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870 
(301) 594-2542 

Noble Jones, M.Ed.  
Center for AIDS and Other Medical Consequences 
NSC, Suite 5198, MSC 9593
National Institute on Drug Abuse 
Bethesda, MD 20892-9593 
(301) 402-0807 

Sally Flanzer, Ph.D.  
Agency for Health Care Research and Quality
Office of Extramural Research, Education and Priority Populations 
540 Gaither Road, Room 2-2042 
Rockville, Maryland 20850 
(301) 427-1538 

o Direct your questions about peer review issues to:

Philip F. Wiethorn, Ph.D.  
Scientific Review Branch 
National Institute of Neurological Disorders and Stroke 
6001 Executive Boulevard, Suite 3208 
Bethesda, MD 20892-9529 
Telephone: (301) 496-9223 

o Direct your questions about financial or grants management matters 

Ms. Sheila Simmons 
Grants Management Branch 
National Institute of Neurological Disorders and Stroke 
Neuroscience Center, Room 3290 
6001 Executive Boulevard 
Bethesda, Maryland 20892-9537 
Telephone: (301) 496-9231 


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:

Claudia S. Moy, Ph.D.  
NINDS/NIH, Neuroscience Center, Room 2214
6001 Executive Boulevard
Bethesda, MD  20892-9520  (for courier, use Rockville, MD 20852)
(301) 496-2789 


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 D&B number can be obtained by calling (866) 
705-5711 or through the web site at  
The D&B number should be entered on line 11 of the face page of the PHS 
398 form. The PHS 398 document is available at in an 
interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:
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 includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at

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:

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
At the time of submission, two additional copies of the application and 
all copies of the appendix material must be sent to:

Chief, Scientific Review Branch, NINDS
6001 Executive Blvd, Suite 3208
Bethesda, MD 20892-9529
Rockville, MD 20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.  


Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NINDS and ORI.  Incomplete applications will 
not be reviewed.  If the application is not responsive to the RFA, NIH 
staff may contact the applicant to determine whether to return the 
application to the applicant or submit it for review in competition 
with unsolicited applications at the next appropriate NIH review cycle.

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by NINDS in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate National Advisory 
Council or Board. 

The purpose of the proposed grant program is to foster empirical 
research on societal, organizational, group, and individual factors 
that affect, both positively and negatively, integrity in research.  
Studies will be evaluated on their relevance to one or more of the 
identified areas of interest (above), to biomedical and behavioral 
research, and to the missions of DHHS and NIH.  Successful applications 
do not need to address all three areas.  Projects that provide 
carefully controlled and substantive answers to specific questions are 

In the written comments, reviewers will be asked to evaluate the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  The 
scientific review group will address and consider each of the following 
criteria in assigning the application’s overall score, weighting them 
as appropriate for each application. 

SIGNIFICANCE: Does this study address an important problem?  Will it 
enhance understandings of how standards are set and function in 
research?  Will it further understandings of self-regulation?  Will it 
make a significant contribution to understandings of research behaviors 
that adversely affect the research record and on the effect of efforts 
to change these behaviors through education and/or institutional 

METHOD: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of 
the project?  Will the study result in significant generalizable 
empirical information?  Has the applicant conducted a thorough review 
of the existing literature?  Does the applicant acknowledge potential 
problem areas and consider alternative tactics? 

INNOVATION: Are the aims original and innovative?  Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?  Does the project employ novel concepts, approaches or 

INVESTIGATORS: Is the principal 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 appropriate or necessary collaborations in 
place?  Does the research team include appropriate expertise for the 
scope of the project?

ENVIRONMENT: Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed 
investigations take advantage of unique features of the intellectual 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and the priority score:

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).  

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).

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.  


BUDGET: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.


Letter of Intent Receipt Date: October 22, 2004
Application Receipt Date: November 22, 2004
Peer Review Date: March 2005
Council Review: May 2005
Earliest Anticipated Start Date: July 2005


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.


ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on 
Humane Care and Use of Laboratory Animals 
as mandated by the Health Research Extension Act of 1985 
(, and the 
USDA Animal Welfare Regulations 
(, as applicable.

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.
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:  

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 
a complete copy of the updated Guidelines are available at  
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.

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.  

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

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 

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at 
and at
Only research using hESC lines that are registered in the 
NIH Human Embryonic Stem Cell Registry will be eligible for Federal 
funding (see  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.

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

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.

The Department of Health and Human Services (DHHS) issued final 
modification to the "Standards for Privacy of Individually Identifiable 
Health Information", the "Privacy Rule," on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR).    

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution.  The OCR website 
( 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


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.


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


This program is described in the Catalog of Federal Domestic Assistance 
at and is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency 
review.  Awards are made under the authorization of Sections 301 and 
405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  
All awards are subject to the terms and conditions, cost principles, 
and other considerations described in the NIH Grants Policy Statement.  
The NIH Grants Policy Statement can be found at  

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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NIH Funding Opportunities and Notices

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