CYSTIC FIBROSIS RESEARCH AND TRANSLATION CORE CENTERS
 
RELEASE DATE:  March 11, 2004
 
RFA Number:  RFA-DK-04-008 (This RFA has been reissued, see RFA-DK-06-009)

EXPIRATION DATE:  November 19, 2004

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.847. 
 
LETTER OF INTENT RECEIPT DATE: October 18, 2004
APPLICATION RECEIPT DATE:  November 18, 2004 
 
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 Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
invites applications for Cystic Fibrosis Research and Translation Core 
Centers to support both basic and clinical research on Cystic Fibrosis (CF).  
Core Centers provide shared resources to support research to develop and test 
new therapies for CF and foster collaborations among institutions with a 
strong existing research base in CF. The Center will also support pilot and 
feasibility studies to develop and test new approaches to therapy.
 
RESEARCH OBJECTIVES

Cystic Fibrosis is one of the most common, life-limiting genetic diseases 
affecting 30,000 Americans.  Patients with CF have two mutated copies of the 
gene, CFTR, in every tissue of the body. Although lung disease is the primary 
cause of death in CF, multiple organs systems have altered functions 
including the lung, liver, pancreas, sweat glands, GI, and reproductive 
systems.  

Treatment of the pancreatic symptoms and lung infections has extended the 
mean life expectancy of patients to 30 years. Some states have instituted 
newborn screening for CF to provide presymptomatic support for nutrition and 
infection that may further improve the quality of life for these patients.  
Children identified at birth avoid the malnutrition that is a common 
presenting symptom for CF. In addition, these patients could benefit from 
many new forms of therapy that are being developed to aggressively eradicate 
bacterial colonization of the lung, control inflammation, treat diabetes and 
provide nutritional support to prevent muscle wasting. 

In addition to treating the symptoms of CF, researchers are investigating 
molecular and pharmacologic methods to treat the underlying cause of CF. 
Methods to increase expression, processing and or trafficking of CFTR or 
other complementary channels are being tested. Several recent studies have 
shown some promising results. A recent clinical trial tested the ability of 
the drug, gentamicin, to suppress stop mutations in CFTR.  This study showed 
evidence of functional correction when administered to the nasal epithelium 
of CF patients with stop mutations in CFTR. Another study has reported the 
identification of small molecules that can correct plasma-membrane channel 
activity in the most common mutation in CFTR, ?F508. Two gene therapy trials 
using AAV to deliver CFTR to the lung have reported some evidence of improved 
lung function. These encouraging early findings suggest that collaborative 
efforts between basic and clinical research could stimulate the translation 
of basic findings to clinical applications.

The goal of these Cystic Fibrosis Research and Translation Core Centers is to 
support research to develop and test therapies for CF.  These Centers will 
provide resources for communication and collaboration between basic and 
clinical researchers. Core Centers will provide shared resources to enhance 
the efficiency of research and foster collaborations within and among 
institutions with strong existing bases of research on cystic fibrosis.  
Centers may be located in a single institution or in multiple institutions 
with complementary research bases.

Project Organization

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 the 
development of therapies for CF. Each core should provide services to multiple 
funded research projects.  Centers may propose either Institutional Cores or 
Regional/National/International Cores. Whereas Institutional Cores support 
research at a single institution or a set of cooperating institutions, 
Regional/National/International Shared Resources serve specific scientific 
communities on a regional, national, or international level. A new category 
of research base for cores that are used as a regional, national, or 
international resource should be considered the "extended research base". The 
extended research base for a regional, national or international core could 
include all investigators who might expect to use the core in some way. This 
might include investigators who would be expected to fully compensate the 
core service through a charge-back, and thus would not be obtaining direct 
financial assistance from the Center. The list could include investigators 
who use the core services but otherwise have no collaborative interactions 
with other Center investigators. The extended research base should be defined 
as an entity separate from the institutional research base. For review 
purposes, it should be evaluated as part of the proposed 
International/National/Regional core, in order to distinguish it from the 
local institutional research base.  Examples of types of biomedical core 
resources that would be considered responsive to this Request for Applications 
include:

o Collection, analysis, storage and distribution of data and samples;
o Provision of specialized tools and technologies or access to specialized 
expertise; 
o Development, standardization and distribution of reagents and/or protocols;
o Provision of technical assistance, training, and enrichment programs; 
o Recruitment of patients and coordination of patient studies;
o Development, beta-testing and dissemination of specialty assays, methods, 
and services on an institutional level;
o Increase interdisciplinary interactions at the institution through cross-
project/laboratory exchange; 
o Sharing of specialized tools, technologies and expertise between 
collaborating investigators.

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 CF research.  
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.

Pilot and Feasibility projects could include clinical projects to investigate 
basic research findings in a clinical setting. The National Center for 
Research Resources (NCRR) supports approximately 80 General Clinical Research 
Centers (GCRC) nationwide, which provide services and resources to enhance 
clinical research (http://www.ncrr.nih.gov/clinical/cr_gcrc.asp).  Research 
Centers supported by the NIDDK are encouraged to collaborate with GCRCs to 
avoid duplication of effort and enhance utilization of services and 
resources.    

MECHANISM OF SUPPORT
 
This RFA will use NIH core center research grant (P30) 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. The 
anticipated award date is July 1, 2005.

This RFA uses just-in-time concepts and non-modular budgets.  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_2001/part_i_1.htm.  

FUNDS AVAILABLE 
 
The NIDDK intends to commit up to $1,400,000 in FY 2005 to fund 1 to 2 new 
grants in response to this RFA. An applicant may request a project period of 
up to 5 years and a budget for direct costs of up to $750,000 per year.  
Equipment costs requested in the first year and indirect costs on 
subcontracts are not included in the $750,000 direct cost cap. 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.  
 
ELIGIBLE INSTITUTIONS
 
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 Foreign institutions are not eligible to apply as the applicant 
organization however; consortia agreements to foreign institutions are 
permitted
 
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.  Because the Center has a complex 
administrative structure, the principal investigator should have a 
demonstrated ability to manage a large, multicomponent project. 
 
SPECIAL REQUIREMENTS 

An existing program of biomedical research in cystic fibrosis is required.  
This research base must consist of NIH and other peer-reviewed funded 
research projects and be substantial to justify the requested Core support. A 
clinical research base is not required but would be considered a strength. 
Suggestions for describing and presenting this research base in the 
application are included in the Administrative Guidelines.

All applications that list direct costs greater than $500,000 in any year of 
the proposed research, must have a data sharing plan.
 
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.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 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
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD  20892-5452
Telephone:  (301) 594-8897
FAX:  (301) 480-3505
Email: fc15y@nih.gov 

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

Randi Freundlich
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 724
Bethesda, MD  20892-5452
Telephone:  (301) 594-8825
FAX:  (301) 480-3504
Email: rf160d@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 NIDDK 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
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
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). 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) 435-0714, 
Email: GrantsInfo@nih.gov.
 
SUPPLEMENTARY INSTRUCTIONS: Applicants should consult the “Administrative 
Guidelines for Cystic Fibrosis Research and Translation Core Centers” located 
at: http://www.niddk.nih.gov/fund/other/centers.htm#CFR 

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/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
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, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD 20817)
 
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 NIDDK. Incomplete and/or nonresponsive applications 
will not be reviewed.  

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 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 National Diabetes and Digestive and 
Kidney Diseases Advisory Council. 

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to 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. 

The goals of the CF Research and Translation Core center are to facilitate 
development and testing of therapies for CF. Because the Core Center 
mechanism supports infrastructure, the most important component of Center is 
the quality (strengths, breadth and depth) of its established, independently 
supported, ongoing base of research on CF at the institution(s) to be served 
by the center.

The initial review group will review each application using the criteria 
stated below:

o  Scientific excellence of the Center's research base that must have a broad 
and central focus in basic and/or clinical research in CF.  The relevance of 
the separately funded research to the Center objectives 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  Regional/National/International Cores should be judged by their ability to 
provide a unique resource or service; their use by the extended research 
base; and their potential impact on the field.

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 CF Research and Translation 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 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 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 Core Center 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 Core Center does not specifically support research training, 
demonstration of accomplishments and future plans related to the training of 
investigators necessary to conduct research in cystic fibrosis 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 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. 

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 core, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research must include a data sharing plan in their application. The 
reasonableness of the data sharing plan or the rationale for not sharing 
research data will be assessed by the reviewers. However, reviewers will not 
factor the proposed data sharing plan into the determination of scientific 
merit or priority score. (See information below)
 
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:          October 18, 2004
Application Receipt Date:               November 18, 2004
Peer Review Date:                       February – March 2005
Council Review:                         May 2005
Earliest Anticipated Start Date:        July 1, 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: Starting with the October 1, 2003 receipt date, 
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. 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://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 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.

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). Those who must comply with the Privacy Rule (classified 
under the Rule as “covered entities”) must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

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)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 
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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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