MOLECULAR THERAPY CORE CENTERS
 
RELEASE DATE:  September 13, 2002
 
RFA NUMBER:  DK-02-034 (Reissued as RFA-DK-07-010)
 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (www.niddk.nih.gov) 
 
LETTER OF INTENT RECEIPT DATE:  January 13, 2003

APPLICATION RECEIPT DATE:  February 13, 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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
invites applications for Core Center Grants to support molecular therapy 
research to develop treatments for cystic fibrosis and other genetic diseases 
of interest to NIDDK.  Core Centers will provide shared resources to enhance 
the efficiency of research and foster collaborations within and among 
institutions with strong existing base of research relevant to gene transfer 
and gene correction technologies.  Centers will also support a Pilot and 
Feasibility Program and an Educational Enrichment Program.

This program is intended to foster research toward the goal of developing 
molecular therapies for the treatment of cystic fibrosis.  Therefore, 
applicants should propose a central focus on molecular therapy for cystic 
fibrosis.  Centers should also have a focus on development of new approaches 
for gene transfer and achieving gene correction.  Many common principles are 
involved in the development of safe methods for targeting and achieving long-
term expression of therapeutic genes for most genetic disease.  Therefore, 
Core Center resources may also be made available to scientists developing 
gene therapy and gene correction approaches for genetic endocrine, metabolic, 
digestive, liver, kidney, urologic, and hematologic diseases.
 
RESEARCH OBJECTIVES
 
Background

Cystic Fibrosis is one of the most common, life-limiting, genetic diseases, 
affecting 30,000 Americans.  Treatment has extended the mean life expectancy 
of patients with CF to 30 years but clearly additional improvements in care 
are needed.  Although the lung disease is the primary cause of death in CF, 
multiple organs systems have altered function in CF including the lung, 
liver, pancreas, sweat glands, GI and reproductive systems.  Treatment for CF 
will ultimately need to address many of its diverse problems.  The 
development of gene transfer or gene correction approaches to treating CF 
will also require a variety of techniques to target affected organs and cell 
types.  

Although the gene causing CF, the cystic fibrosis transmembrane conductance 
regulator (CFTR), has been known for many years, the function of the gene and 
its relationship to the pathophysiology of the disease is not completely 
understood.  New functions for CFTR throughout development are being 
uncovered and new interactions with other cellular proteins are being 
discovered.  Until the mechanism for the pathogenesis is understood, 
replacing or correcting the defective gene may be the most straightforward 
approach to therapy.

Several gene transfer strategies have been applied to CF.  Clinical trials 
have been conducted with viral vectors including adenovirus and AAV2 as well 
as DNA/cationic lipid formulations.  None of these methods corrected a large 
enough population of cells to show clinical improvement.  Preclinical studies 
are underway with new vectors such as lentivirus and new AAV serotypes with 
promising results.  New molecular technologies are being investigated to 
correct the genetic defect by homologous recombination, to correct CFTR RNA 
by trans-splicing, and to correct the CFTR protein by suppressing stop 
codons.  These are attractive choices since they would provide a means to 
correct the genetic defect while maintain normal gene regulation.  

In addition to testing the efficacy of gene delivery methods, it is crucial 
to assess toxicity.  Toxicity can result from many different causes including 
the presence of viral protein, the vehicle used to administer the DNA or the 
expression of the therapeutic gene product.  By identifying the cause and the 
mechanism of the toxicity, the elements that create problems can be altered 
to design more effective vectors.

Another important problem that has been identified is the lack of viral 
receptors on the cell types being targeted.  For example, the adenoviral 
receptor CAR is not found on the lung epithelial surface.  An understanding 
of the biology of the target cell, especially the polarized cell, is needed 
in order to design a compatible method for gene delivery. In addition, by 
altering the viral envelope proteins different receptors on cells or 
different cell types can be targeted to direct gene delivery.

The NIDDK-supported Molecular Therapy Core Centers (formerly called Gene 
Therapy Core Center) are part of an integrated program of cystic fibrosis and 
metabolic disease research.  These Core Centers provide increased, cost-
effective collaboration among multidisciplinary groups of investigators at 
institutions with an established, comprehensive research base in cystic 
fibrosis and other genetic diseases.  Additionally, NIDDK supports three 
Specialized Centers of Research (P50) and one Core Center Grant on cystic 
fibrosis.  NIDDK supports a large body of research on cystic fibrosis and 
genetic metabolic diseases and molecular therapies for these disorders through 
regular research and program project grants.  Molecular Therapy Core Center 
grants for cystic fibrosis and other genetic diseases are intended to improve 
the quality and multidisciplinary nature of research on molecular therapy of 
these disorders by providing shared access to specialized technical resources 
and expertise.

Objectives and Scope

The objective of the Molecular Therapy Core Centers is to provide shared 
resources to investigators with a wide variety of relevant expertise to promote 
a multifaceted approach to gene transfer and gene correction research.  Gene 
therapy research involves many specialized technologies that need to be 
integrated into a cohesive research program.  A Molecular Therapy Core Center 
would make these technologies available to many investigators to apply to their 
research.

In order to be competitive for a Molecular Therapy Core Center, the applicant 
institution must have a substantial research base in gene transfer and gene 
correction approaches for the treatment of cystic fibrosis and other genetic 
metabolic diseases.  Because current methods for gene transfer appear to be 
inadequate, a research base that is developing, testing, and improving 
methods for gene transfer and gene correction is important.

A biomedical research core is defined as a shared resource that provides 
essential services, techniques, or instrumentation to Center participants 
enabling them to conduct their funded individual research projects more 
efficiently and/or more effectively.  Cores provide specialized technologies 
and expertise needed to accomplish the stated goals of the Center toward 
molecular therapy for cystic fibrosis and other genetic diseases of interest to 
NIDDK.  Each core should provide services to multiple funded research projects.  
Examples of possible biomedical core resources that would be considered 
responsive to this Request for Applications include:

o  Vector core to develop and design new vectors, assist investigators with the 
construction of vectors, provide vectors for experimentation, and monitor 
vector preparations and patient samples for adventitious agents and replication 
competent viruses.

o  DNA Delivery core to develop, distribute and test new formulations for 
liposome or other DNA compacting and targeting reagents for delivery of DNA.

o  Animal Models core to develop, breed and maintain models for cystic 
fibrosis, to develop new models using knockout technology for other genetic 
metabolic diseases, and crossbreed mice on to new background strains to attain 
appropriate models for in vivo assessment of molecular therapies.

o  Histology core to assess the efficiency of gene transfer or gene correction 
to particular cell types by using enzymatic histochemistry, 
immunohistochemistry, in situ hybridization or in situ polymerase chain 
reaction (PCR).

o  Cell Transduction core to develop techniques for transduction or correction 
of cells ex vivo and techniques for re-implantation of modified cells.  This 
core may also support the development of techniques for ex vivo selection of 
transduced or corrected cells.

o  Electrophysiology core to measure the functional correction of CFTR in 
cystic fibrosis cell lines and patient samples.

o  Immunology core to analyze in vivo immunological responses to therapeutic 
genes, viral proteins, and DNA delivery agents and to study methods to suppress 
these reactions.

o  Clinical core to design, conduct, monitor and provide statistical support 
for molecular therapy clinical trials for cystic fibrosis and other genetic 
diseases.

These possible cores are not listed in any particular order nor do they 
represent a comprehensive list of cores that could be supported under this 
Request for Applications.  Applicants are encouraged to propose other cores 
that address the program objectives as stated above.

In addition to biomedical cores, an administrative core must be described which 
will be responsible for allocation of resources within the Center and 
distribution of resources to Center participants.  The Administrative core will 
also be responsible for planning the Educational Enrichment Program consisting 
of a seminar series, guest lectures, and workshops, and convening a Committee 
to oversee the solicitation, review and selection of the pilot projects.  
Although funds are not provided directly for training purposes, the core 
laboratories and program enrichment activities should provide training 
opportunities for Center members.

Each Core Center must develop a cohesive Pilot and Feasibility Program to 
develop new research directions or provide an opportunity for new investigators 
or established investigators to enter the field of gene therapy.  A pilot and 
feasibility project is intended to provide modest support that will allow an 
investigator the opportunity to develop sufficient preliminary data as a basis 
for an application for independent research support.  Pilot and feasibility 
projects are not intended to support or supplement ongoing research of an 
established investigator.  This Program should be integrated into the overall 
research goals of the Center and make use of the resources provided by the 
cores.  Each Core Center application must include a minimum of two up to a 
maximum of five pilot projects.  Each pilot project may request a maximum of 
$50,000 direct costs per year for up to two years. A comprehensive description 
of the Pilot and Feasibility Program can be found in the Administrative 
Guidelines.
 
MECHANISM OF SUPPORT
 
This RFA will use NIH core center research grant (P30) award mechanism.  
Applicants will be solely responsible for planning, directing, and executing 
the proposed project.  This RFA is a one-time solicitation.  The anticipated 
award dates are September 30, 2003 and/or January 1, 2004.

FUNDS AVAILABLE
 
The NIDDK intends to commit approximately $2,150,000 in FY 2003 and 
$1,700,000 in FY 2004 to fund up to 2 new and/or competing continuation 
grants in each year in response to this RFA.  The receipt of four competing 
continuation applications is anticipated.  An applicant must request a 
project period of up to 5 years and a budget for direct costs of up to 
$750,000 per year.  Any indirect costs related to subcontracts are not 
included in the $750,000 direct cost limit.  Because the nature and scope of 
the proposed research will vary from application to application, it is 
anticipated that the size of each award will also vary. Although the 
financial plans of the NIDDK 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

An outstanding existing program of biomedical research in the area of 
molecular therapy for cystic fibrosis and other genetic diseases is required.  
The research base for the Center must consist of at least $1,000,000 total 
annual costs of peer reviewed research projects employing gene transfer or 
gene correction approaches to treating CF.
 
You may submit an application if your institution has any of the following 
characteristics:
	
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic
 
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 

An existing program of excellence in biomedical research in the area of gene 
transfer and gene correction for cystic fibrosis and related genetic 
metabolic diseases is required.  This research base must consist of the NIH 
and other peer-reviewed funded research projects and be substantial to 
justify the requested Core support.  Suggestions for describing and 
presenting this research base in the application are included in the 
Administrative Guidelines.
  
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:

Catherine McKeon, Ph.D.
Senior Advisor for Genetic Research
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
9707 Democracy Boulevard, Room 6103
Bethesda, MD  20892-5460
Telephone:  (301) 594-8810
FAX:  (301) 480-3503
Email: cm67w@nih.gov 

o Direct your questions about peer review issues to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone:  (301) 594-8897
FAX:  (301) 480-3505
Email: fc15y@nih.gov 

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

Kieran Kelley
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 721
Bethesda, MD  20892-5456
Telephone:  (301) 594-0417
FAX:  (301) 480-3504
Email: kk27g@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:

Chief, Review Branch 
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452
(For express/courier service: Bethesda, MD  20817)
Telephone:  (301) 594-8897
FAX:  (301) 480-3505

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: GrantsInfo@nih.gov.
 
SUPPLEMENTAL INSTRUCTIONS: Applicants should consult the "Administrative 
Guidelines for Molecular Therapy Core Centers" located at 
http://www.niddk.nih.gov/fund/other/centers/mtcc/mtcc.pdf.  These guidelines 
contain important additional information on the format, content, and review 
of the applications and review criteria.
 
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 must be 
sent to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD 20817)

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.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIDDK.  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 NIDDK 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 Diabetes and Digestive and 
Kidney Diseases Advisory Council.
 
REVIEW CRITERIA

The goals of the MTCC are to facilitate development of gene transfer and gene 
correction approaches to treat CF and other genetic metabolic diseases.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighing them as appropriate for each application.   The most 
important component of MTCCs is the quality (strengths, breadth and depth) of 
its established, independently supported, ongoing base of research to develop 
molecular therapies for CF at the institution(s) to be served by the center.

Specific review criteria are:

o   Scientific excellence of the Center"s research base that must have a 
broad and central focus in molecular therapy for CF and may extend to related 
research in other genetic metabolic disease.  The relevance of the separately 
funded research to the Center objectives (see above) and the likelihood for 
meaningful collaboration among Center investigators must be demonstrated.

o  Potential of the cores for contribution to ongoing research, including 
their appropriateness, impact, relevance, uniqueness, modes of operation, and 
suitability of facilities.  Renewal applications must document the use, 
impact, quality control, and cost effectiveness of each core, and demonstrate 
progress of any developmental research in the cores.  Progress will be judged 
in part by the publications supported by the cores.  While a minimum of two 
users (exclusive
of Pilot and Feasibility projects) are required to establish a core, a 
greater number of users will be considered to be more cost effective.

o  Scientific and administrative abilities of the Center Director and 
Associate Director and their commitment and ability to devote adequate time 
to the effective management of the Molecular Therapy Core Center.

o  The qualifications, experience, accomplishments, and commitment of the 
Center investigators and their inter-relatedness and collaborations.

o   The Administrative organization proposed, including: coordination of 
ongoing research, establishment and maintenance of internal communication and 
cooperation among MTCC investigators, mechanisms for prioritizing usage of 
shares resources, mechanisms of selecting and replacing essential personnel 
within the Center, mechanisms for reviewing the use of and administering 
funds for the pilot and feasibility program, and management capabilities.
 
o   The appropriateness of the MTCC budgets for the proposed and approved 
work to be done in core facilities, for pilot and feasibility studies, and 
for enrichment in relation to the total Center program.

o   Institutional commitment to the program, including lines of 
accountability regarding management of the MTCC grant and a commitment  to 
establish new positions as necessary.

o   For new applications, the pilot and feasibility program is judged on the 
basis of:  (1) scientific merit of the studies as submitted and (2) the merit 
of the administrative process for selecting subsequent studies.   The 
scientific merit of the submitted pilot and feasibility studies will be 
evaluated for:

(1) Significance:  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) 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?

(3) Innovation:  Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies? 

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?  Does the 
PI meet one of the eligibility criteria set out in the Administrative 
Guidelines for pilot and feasibility studies?

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

In competing renewal applications, emphasis is placed on the pilot and 
feasibility program as a whole, including past track record and management of 
the program.

o  Although the MTCCs do not specifically support research training, 
demonstration of accomplishments and future plans related to the training of 
investigators necessary to conduct research in cystic fibrosis and related 
metabolic diseases will be considered in assessing the potential to meet 
Center objectives.  The integration of these efforts into the overall Center, 
including core facilities is of particular importance.  Efficient and 
effective use and/or planned use of the limited enrichment funds, including 
the contribution of these activities in enhancing the objectives of the 
Center will also be considered.

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  Adequacy of plans to include both genders, minorities and their subgroups, 
and children as appropriate for the scientific goals of the research.  Plans 
for the recruitment and retention of subjects will also be evaluated.  

o  The reasonableness of the proposed budget and duration to the proposed 
research.

o  The adequacy of the proposed protection of humans, animals, or the 
environment, to the extent that they may be adversely affected by the project 
proposed in the application.
	
RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: January 13, 2003
Application Receipt Date: February 13, 2003
Peer Review Date: June or July, 2003
Council Review: September 24 and 25, 2003
Earliest Anticipated Start Date: September 30, 2003 and/or January 1, 2004

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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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 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 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. 93.847, 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.

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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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