MOLECULAR LIBRARIES SCREENING INSTRUMENTATION

RELEASE DATE:  July 13, 2004
 
RFA Number:  RFA-RM-04-020 (see NOT-RM-04-015)

EXPIRATION DATE:  January 25, 2005
 
Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH) 
 (http://www.nih.gov)

This Request for Application (RFA) is developed as an NIH Roadmap 
initiative (http://nihroadmap.nih.gov). All NIH institutes and centers 
(ICs) participate in Roadmap initiatives. This RFA will be administered 
by the National Human Genome Research Institute (NHGRI) 
(http://www.genome.gov) on behalf of NIH.

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.172
 
LETTER OF INTENT RECEIPT DATE: January 4, 2005 (per NOT-RM-04-015)
APPLICATION RECEIPT DATE: January 24, 2005 (per NOT-RM-04-015)
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS RFA

The National Institutes of Health invites research applications to 
develop innovative instrumentation to accelerate the pace and maximize 
the efficiency of molecular library high throughput screening. This RFA 
is one component of the Molecular Libraries and Imaging Initiative of 
the NIH Roadmap.  Investigators are encouraged to collaborate, as 
appropriate, with investigators working on assay development and on 
establishment of screening centers for the Molecular Libraries and 
Imaging Initiative.  

Applications in response to this RFA should propose design-directed, 
discovery-driven, or hypothesis-driven research on high throughput 
screening instrumentation.  It is expected that research proposals will 
include specific aims with quantitative measures of anticipated 
achievements, and well-defined milestones that chart key steps toward 
the goal of innovative and substantial advances in instrumentation.

The NIH Roadmap initiatives encourage multidisciplinary approaches.  
Investigators who may be new to NIH and biomedical research, from 
fields such as physics, chemistry, or engineering, are encouraged to 
participate in this program.
 
RESEARCH OBJECTIVES

The NIH Roadmap is a series of new initiatives designed to identify 
major opportunities and gaps in biomedical research that no single NIH 
institute could tackle alone but which the agency as a whole can pursue 
to stimulate the progress of biomedical research and to catalyze 
changes that will serve to transform new scientific knowledge into 
tangible benefits for public health (http://nihroadmap.nih.gov/).

The Molecular Libraries and Imaging Initiative (MLII) 
(http://nihroadmap.nih.gov/molecularlibraries/index.asp) is one of the 
components comprising the Roadmap theme of  New Pathways to Discovery . 
Its goal is to build a better  toolbox  to advance our understanding of 
the interconnected networks of molecules that comprise cells and 
tissues, their interactions, regulation, and the combination of 
molecular events that lead to disease. One objective of the MLII is to 
develop a publicly available database of biological activities for 
small organic molecules and to provide access to these molecules to the 
scientific community.  This initiative is expected to promote the use 
of chemical probes to study cellular pathways in greater depth and to 
provide new options for investigating the functions of major components 
of the cell in health and disease.  Crucial to the objectives of the 
MLII is also the development of novel assays and instrumentation for 
assessing activities of small molecules and probes and for facilitating 
their application to studies of biology and pathophysiology. The MLII 
will provide unprecedented access for the academic community to such 
resources and knowledge, and ultimately will enable and catalyze the 
identification of novel targets for therapeutic intervention.

This announcement is focused on development of innovative 
instrumentation for high throughput screening of synthetic chemical and 
natural product libraries such as the ones that will be registered and 
housed in the NIH-sponsored molecular libraries screening centers.

High throughput molecular screening (HTS) is the automated, rapid 
testing of thousands of distinct small molecules or probes in cellular 
models of biological mechanisms or disease, or in biochemical or 
pharmacological assays. Active compounds identified through HTS can 
provide powerful research tools to elucidate biological processes 
through chemical genetic approaches, or can form the basis of 
therapeutics or imaging agent development programs.  HTS has 
experienced revolutionary changes in technology since the advent of 
molecular biology and combinatorial chemistry, and the incorporation of 
modern information management systems. Current HTS instrumentation 
allows screening of hundreds of thousands of compounds in a single day 
at a rate orders of magnitude greater than was possible a decade ago.  
However, there are still bottlenecks which currently limit HTS 
capacity, such as (a) compound collection maintenance, tracking, and 
disbursement, and (b) rapidity, accuracy, and content of assay 
instrumentation.

This RFA seeks to develop HTS instrumentation that is not only faster 
and more efficient than currently available systems, but also 
substantially more sensitive with high levels of specificity, 
reproducibility, and accuracy. Other important criteria include greater 
screening capacity, flexibility, and multiplexing capabilities. 
Examples of potential research areas that are responsive to this RFA 
include, but are not limited to:

o novel high throughput screening system integration
o innovative methods for highly parallel ligand/target binding 
detection
o innovative microfluidics and lab-on-chip technologies
o improved cell-based  high-content  assay formats to acquire many 
outputs in parallel
o innovative methods for data acquisition and management

All applications are expected to describe clearly advantages in 
efficiency and/or scale versus current technologies.  A description of 
the practical application of instrumentation derived from the proposed 
research must also be included.
 
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. NIH encourages multidisciplinary research. It is 
expected that the PI will bring together the necessary physical, 
engineering and biological expertise and resources to successfully 
achieve the goals of the RFA. 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 
earliest expected award date is June, 2005. Applications that are not 
funded in the competition described in this RFA may be resubmitted as 
NEW investigator-initiated applications using the standard receipt 
dates for NEW applications described in the instructions to the PHS 398 
application form.

The initial support for an R01 award in response to this RFA may be up 
to four years. 

This RFA uses just-in-time concepts.  It also uses the modular 
budgeting 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 budget format.  
Otherwise follow the instructions for non-modular budget research grant 
applications.  This program does not require cost sharing as defined in 
the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.

FUNDS AVAILABLE 
 
The NIH intends to commit approximately $4M to fund new competitive 
grants in response to this RFA. An applicant may request a project 
period of up to four years. The number of awards and level of support 
will depend on the number of applications of high scientific merit that 
are received. 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 NIH 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.
   
ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:
   
o Domestic 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

Foreign institutions may not apply; however, participating 
collaborators can be located at foreign institutions.

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

o Milestones that chart key steps towards the goal of innovative and 
substantial advances in high throughput molecular screening 
instrumentation
o 25% minimum effort level by the PI
o Investigators are encouraged to collaborate, as appropriate, with 
investigators in other components of the Molecular Libraries and 
Imaging Initiative, such as those involved in assay development 
(RFA RM-04-012) and in establishment of screening centers (RFA RM-04-017).  
These collaborations need not be formalized at the time of the grant 
application, but funds should be budgeted for this effort.  Public and 
private partnership is also encouraged.

All applications that list direct costs of $500,000 or more per year 
must also have a plan to address intellectual property and 
accessibility of research resources, as described below.

Intellectual Property Rights and Accessibility of Research Resources 
NIH is interested in ensuring that the research resources developed 
through this RFA become readily available to the research community.  
Applicants who respond to this RFA must include a plan addressing if, 
or how, they will exercise their intellectual property rights, should 
any intellectual property be generated, while making such research 
resources available to the broader scientific community for research 
purposes consistent with the goals of the NIH Molecular Libraries and 
Imaging Initiative. A reasonable time frame for release of materials 
should be specified in the sharing plan and will be considered during 
the review. Furthermore, transfers of research resources must be made 
consistent with the NIH Research Tools Policy 
(http://www.ott.nih.gov/policy/rt_guide_final.html) and other NIH 
sharing policies. In the development of the sharing and intellectual 
property plans, applicants should confer with their own institution's 
office(s) responsible for handling technology transfer related matters 
and/or their sponsored research office. If applicants or their 
representatives require additional guidance in preparing these plans, 
they are encouraged to make further inquiries to the appropriate 
contacts listed below for such matters. 

The scientific review group will evaluate the adequacy of the proposed 
plan for handling intellectual property rights. Comments on the plan 
and any concerns will be presented in an administrative note in the 
Summary Statement. These comments will not affect the priority score of 
the application. NIH program staff, in determining whether the 
application shall be awarded, will consider the adequacy of the 
proposed plan. The plan as approved, after negotiation with the 
applicant when necessary, will be part of the terms and conditions of 
the award. Evaluation of non-competing continuation applications will 
include assessment of the awardee's adherence to the proposed plan, and 
will be a criterion for continued funding of the award. Applicants also 
are reminded that the grantee institution is required to disclose each 
subject invention to NIH within two months after the inventor discloses 
it in writing to grantee institutional personnel responsible for patent 
matters. The awarding Institute reserves the right to monitor awardee 
activity in this area to ascertain if patents or patent applications 
are adversely affecting the goals of this RFA. Principles and 
guidelines for recipients of NIH research awards on obtaining and 
disseminating biomedical research resources can be found at 
http://www.ott.nih.gov/policy/rt_guide_final.html. This document also 
defines terms, parties, responsibilities, prescribes the order of 
disposition of rights, prescribes a chronology of reporting 
requirements, and delineates the basis for and extent of government 
actions to retain rights. Patent rights clauses may be found at 37 CFR 
Part 401.14 and are accessible from the Interagency Edison web page, 
http://www.iedison.gov. 
 
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:

Bradley A. Ozenberger, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
National Institutes of Health, DHHS
Suite 4076 - MSC 9305
5635 Fishers Lane 
Bethesda, MD  20892-9305
(express/courier services should be directed to Rockville, MD 20852)
Telephone: (301) 496-7531
FAX: (301) 480-2770
Email: [email protected]

Fei Wang, Ph.D. 
Division of Discovery Science & Technology
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health, DHHS
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892-5477 (20817 for express/courier services)
Telephone: (301)451-4778
Fax: (301)480-4973
Email: [email protected]

o Direct your questions about peer review issues to:

David T. George, Ph.D.
Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health, DHHS
6707 Democracy Boulevard, Suite 920, MSC5469
Bethesda, MD 20892-5469 (20817 for express/courier services)
Telephone: (301) 496-8633
Fax: (301) 480-0675
Email: [email protected]

o Direct your questions about financial or grants management matters 
to:

Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute
National Institutes of Health, DHHS
Suite 4076 - MSC 9306
5635 Fishers Lane
Bethesda, MD  20892-9306
Telephone: (301) 435-7858
FAX: (301) 402-1951
Email: [email protected]
 
LETTER OF INTENT

Prospective applicants are strongly advised 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. Bradley A. Ozenberger 
Division of Extramural Research
National Human Genome Research Institute
National Institutes of Health, DHHS
Suite 4076 - MSC 9305
5635 Fishers Lane 
Bethesda, MD  20892-9305
Telephone: (301) 496-7531
FAX: (301) 480-2770
Email: [email protected]  

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. The PHS 398 document is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email: [email protected].

APPLICATION PREPARATION INSTRUCTIONS:  Follow the PHS 398 instructions 
for "Preparing Your Application" with the following modifications and 
additions:

1. Page limitations for applications in response to this RFA have been 
increased to a maximum of 30 pages from the usual 25-page limit for 
sections A-D of the "Research Plan".  Applicants are encouraged to be 
concise and use fewer pages.

2. A program plan should list major tasks with a timeline of 
quantitative milestones for the entire project period.  This 
information should be included in the Research, Design, and Methods 
section of the application.

3. Budget Items: The PI is expected to devote a minimum of 25% effort 
to the proposed research.  Information documenting and justifying the 
level of effort on the proposed research activities for all personnel 
should be included in the application.

4. Applications must include a plan for making available to the 
research community any technologies developed or enhanced by work 
conducted as part of this RFA.  Investigators using PHS funds are 
required to make unique research resources readily available for 
research purposes to qualified individuals within the scientific 
community when the results have been published.  The intent of this 
policy is not to discourage, impede, or prohibit the organization that 
develops the unique research resources or intellectual property from 
commercializing the products.  
 
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/labels.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 (20817 for express/courier services)
 
At the time of submission, two additional copies of the application and 
all copies of the appendix material must be sent to:

David T. George, Ph.D.
Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health, DHHS
6707 Democracy Boulevard, Suite 920, MSC5469
Bethesda, MD  20892-5469 (20817 for express/courier services)
Telephone: (301) 496-8633
Fax: (301) 480-0675
Email: [email protected]

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.
 
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.  However, when a previously unfunded application, 
originally submitted as an investigator-initiated application, is to be 
submitted in response to an RFA, it is to be prepared as a NEW 
application.  That is, the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text 
must not be marked to indicate the changes from the previous unfunded 
version of the application. 

PEER REVIEW PROCESS 
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the sponsoring ICs. Incomplete applications 
and/or non-responsive applications will be returned to the applicant 
without further consideration.

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

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 NHGRI National Advisory Council 
or Board.
 
REVIEW CRITERIA

The goal of this RFA is to develop innovative instrumentation to 
accelerate the pace and maximize the efficiency of molecular library 
high throughput screening.  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 
this goal. 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. The application 
does not need to be strong in all categories to be judged likely to 
have major scientific impact and thus deserve a high priority score. 

o Significance 
o Approach 
o Innovation
o Investigators
o Environment
 
SIGNIFICANCE: If the specific aims of the application are achieved, 
will they provide significant advances in Molecular Libraries Screening 
Instrumentation? Is the research likely to have a significant impact on 
other areas of this field? Will the technological advances have a 
significant impact on human health?

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of 
the project? Does the applicant acknowledge potential problem areas and 
consider alternative tactics? Is a timetable with adequate research 
milestones proposed? Are appropriate specifications and evaluation 
procedures provided for assessing technological progress? Is there a 
plan for coordination with assay development and implementation 
components of the public screening centers?  If partnership with 
industry or small business is included, does this positively affect the 
research goals and technology dissemination?

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

INVESTIGATORS: Is the PI capable of coordinating and managing the 
proposed research? Is there evidence of successful collaboration among 
the investigation team? Are the investigators appropriately trained in 
their disciplines and capable of conducting and contributing to the 
management of the proposed work?

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

ADDITIONAL REVIEW CRITERIA

MILESTONES: The research proposals in response to this RFA must have 
specific aims which include quantitative measures of anticipated 
achievements and well-defined milestones that chart key steps to 
achieving the specific aims as specified in the application. Are the 
milestones achievable? Will Molecular Libraries Screening 
Instrumentation be significantly advanced by achieving the milestones?

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy 
of plans to include subjects from both genders, all racial and ethnic 
groups (and subgroups), and children as appropriate for the scientific 
goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the 
sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed. 

ADDITIONAL REVIEW CONSIDERATIONS

TECHNOLOGY SHARING AND DISSEMINATION: Applicants must include a plan in 
their proposal for the sharing and dissemination of developed 
technology. The reasonableness of the technology sharing and 
dissemination plan or the rationale for not sharing research findings 
and technologies will be assessed by the reviewers. However, reviewers 
will not factor the proposed sharing and dissemination plan into the 
determination of scientific merit or priority score. 

INTELLECTUAL PROPERTY RIGHTS:  Applicants must include a plan 
addressing if, or how, they will exercise their intellectual property 
rights, should any intellectual property be generated, while making 
such research resources available to the broader scientific community 
for research purposes consistent with the goals of the NIH Molecular 
Libraries and Imaging Initiative. The reasonableness of the 
intellectual property rights plan will be assessed by the reviewers. 
However, reviewers will not factor the proposed intellectual property 
rights plan into the determination of scientific merit or priority 
score. 

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: September 22, 2004  (see change NOT-RM-04-015)
Application Receipt Date: October 22, 2004  (see change NOT-RM-04-015)
Peer Review Date: February - March, 2005  (see change NOT-RM-04-015)
Council Review: May, 2005  (see change NOT-RM-04-015)
Earliest Anticipated Start Date: June, 2005

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 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated 
with reference to the risks to the subjects, the adequacy of protection 
against these risks, the potential benefits of the research to the 
subjects and others, and the importance of the knowledge gained or to 
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide 
for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 

SHARING RESEARCH DATA: Investigators submitting an NIH application 
seeking $500,000 or more in direct costs in any single year are 
expected to include a plan for data sharing or state why this is not 
possible. http://grants.nih.gov/grants/policy/data_sharing  
Investigators should seek guidance from their institutions, on issues 
related to institutional policies, local IRB rules, as well as local, 
state and Federal laws and regulations, including the Privacy Rule. 
Reviewers will consider the data sharing plan but will not factor the 
plan into the determination of the scientific merit or the priority 
score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy 
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided 
indicating that inclusion is inappropriate with respect to the health of 
the subjects or the purpose of the research. This policy results from 
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. 

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at http://stemcells.nih.gov/index.asp and 
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov).  It is the responsibility of the applicant to 
provide, in the project description and elsewhere in the application as 
appropriate, the official NIH identifier(s) for the hESC line(s)to be 
used in the proposed research.  Applications that do not provide this 
information will be returned without review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom of 
Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

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

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on  Am 
I a covered entity?   Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts 
can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, Internet 
addresses (URLs) should not be used to provide information necessary to 
the review because reviewers are under no obligation to view the 
Internet sites.  Furthermore, we caution reviewers that their anonymity 
may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284)(cite appropriate authorizations) and 
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 (cite 
relevant regulations). All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be 
found at http://grants.nih.gov/grants/policy/policy.htm.

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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