SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS
 
RELEASE DATE:  April 9, 2004
 
RFA Number:  RFA-DK-04-014

EXPIRATION DATE:  November 17, 2004

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION: 
National Institute 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: 93.848
 
LETTER OF INTENT RECEIPT DATE: October 18, 2004 
APPLICATION RECEIPT DATE: November 16, 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 Silvio O. Conte Digestive Diseases Research Core 
Center grants.  Five competing Digestive Diseases Research Core Center Grants 
(P30) will be awarded in fiscal year 2006.

The Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs) are 
part of an integrated program of digestive diseases-related research support 
provided by the NIDDK.  The Centers currently funded in this program have 
provided a focus for increased collaboration and improved cost-effectiveness 
of supported research among groups of successful investigators at 
institutions with an established, comprehensive digestive diseases research 
base.
 
RESEARCH OBJECTIVES

The objective of the Core Centers is to bring together investigators from 
relevant disciplines to enhance and extend the effectiveness of research 
related to digestive diseases and their complications.  A Core Center must be 
an identifiable unit within a single university medical center or a 
consortium of cooperating institutions, including an affiliated university.  
The overall goal of the Core Center is to bring together clinical and basic 
science investigators in a manner that will enrich the effectiveness of 
digestive diseases research.  An existing program of excellence in biomedical 
research in the area of digestive diseases and disorders is required.  This 
research must be in the form of NIH funded research projects, program 
projects, or other peer-reviewed research that is already funded at the time 
of submission of a Center grant application.  Close cooperation, 
communication, and collaboration among all involved personnel of various 
professional disciplines are the ultimate objectives.

The Core Center must have a central focus of research investigation. The 
central focus must be a digestive disease, group of diseases or functional 
studies relating to digestive diseases; at least half of the research must 
relate to this central focus.  Examples of a gastrointestinal disease-related 
central focus of research investigation include (but are not restricted to) 
inflammatory bowel disease, functional bowel disorders, pancreatic disease, 
liver disease, pediatric gastrointestinal disease, and AIDS in 
gastrointestinal disease.  Examples of functional studies as the central 
focus include (but are not restricted to) gastrointestinal motility, 
gastrointestinal hormones, or gene therapy for digestive diseases.  
Applicants should consult with NIDDK staff concerning plans for the 
development of the Center and the organization of the application.

Silvio O. Conte Digestive Diseases Research Core Centers are based on the 
core concept.  Three to six cores are usually included in a Center.  Cores 
are defined as shared resources that enhance productivity or in other ways 
benefit a group of investigators working in a center to accomplish the stated 
goals of the Center.  Examples of such resources include imaging resources, 
transgenic animal facilities, and membrane preparation facilities.

Centers are encouraged to include a clinical component. This clinical 
component can exist as a stand-alone component or as a part of another core 
such as the Administrative core.  Besides leading to a better understanding 
of disease etiology and natural history of disease, clinical components might 
provide biostatistics support; enhance clinical study design; foster 
collaboration among researchers; aid in recruitment of subjects for clinical 
studies; support epidemiological studies in areas of digestive diseases; or 
provide modest funding for tissue, DNA, or serum storage. In addition, a 
clinical component may address more effectively NIH policies concerning 
issues of women, children, and ethnic minority population participation in 
clinical studies.

Two other types of activities also may be supported with Center funding:  a 
Pilot and Feasibility (P/F) program and an Enrichment program.  The P/F 
program provides modest support for new initiatives or feasibility research 
studies.  This program is directed at new investigators, at investigators 
established in other research disciplines with expertise that may be applied 
to digestive disease research, and, occasionally, at investigators already 
working in digestive diseases who wish to make a substantial change in the 
direction of their research.  In addition, temporary salary support for one 
Named New Investigator in a specified area of research with a defined P/F 
study may be requested for up to 24 months. Subsequent individuals for this 
position will be named by the Center Director and approved by the Center's 
External Advisory Board and the NIDDK.  

The Core Center grant may include limited funds for program enrichment such 
as seminars, visiting scientists, consultants, and workshops.
 
MECHANISM OF SUPPORT
 
This RFA will use the NIH Core Center grant (P30) award mechanism.  As an 
applicant you will be solely responsible for planning, directing, and 
executing the proposed center grant.  This RFA is a one-time solicitation.  
The earliest anticipated award date is December 1, 2005. 

This RFA uses just-in-time concepts as well as a non-modular budgeting 
format.

The receipt of five competing continuation applications is anticipated.  
These continuation applications will compete with all other applications 
received in response to this RFA.

FUNDS AVAILABLE

The NIDDK intends to commit approximately $6 million in FY 2006 to fund 5 new 
and/or competing continuation applications 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. 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 Domestic institutions
o Foreign institutions are not eligible to apply 

For the purpose of this RFA, the NIDDK will not support more than one DDRCC 
center grant (P30) in an applicant institution.  More details on the DDRCC 
program are available in the SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE 
CENTER GUIDELINES available on the Internet at 
http://www.niddk.nih.gov/fund/other/centers/ddrcguidetoc.htm or from the 
program director listed under WHERE TO SEND INQUIRIES, below. 

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 always are 
encouraged to apply for NIH programs.   
 
SPECIAL REQUIREMENTS 

o The DDRCC Director, who is the Principal Investigator of the P30 application 
and Director of the Administrative Core, should be a scientist who can provide 
effective administrative and scientific leadership.  The Director will be 
responsible for the organization and operation of the DDRCC and for 
communication with the NIDDK on scientific and operational matters. Center 
Directors are required, and their administrators are strongly encouraged, to 
attend an annual meeting to be held at a location to be determined by the 
NIDDK.  Funds for travel to this meeting should be included in the budget for 
the Administrative Core of the Center. 

o Applications for DDRCC grants must propose a theme for the Center that is 
relevant to digestive diseases research and supported by the research projects 
comprising the research base for the DDRCC.  The research base grants must be 
summarized in accordance with the DDRCC guidelines found at 
http://www.niddk.nih.gov/fund/other/centers/ddrcguidetoc.htm

o At least 50 percent of the already funded research base in a new 
application must be supported by the NIDDK.  In competing continuation 
applications the percent may be less than 50 percent due to, for example, a 
growing research base of investigators entering digestive diseases from other 
fields.  The initial review group will determine the significance of the 
research base.

o Scientific personnel and institutional resources capable of supporting the 
research base must be available.  In addition, the institution and pertinent 
departments must show a strong commitment to the Center's support.  Such 
commitment may be provided as dedicated space, staff recruitment, salary 
support for investigators, dedicated equipment, or other financial support for 
the proposed Center.

o Each core unit proposed for funding under the DDRCC must be utilized by a 
minimum of three federally funded research projects. A detailed description of 
each core unit proposed as part of the Center must be provided, with detailed 
budget and budget justification.  A core director must be named for each core 
proposed.  The description of each core unit proposed should include a 
rationale, indicating how it will support the research effort in a cost-
effective manner.  Facilities must be available for the primary needs of the 
DDRCC Program because funds for new construction are not available.

o Promoting interdisciplinary collaboration among scientists working within a 
Center is a major goal of the DDRCC Program.  Each Center application should 
describe how continuing and new interactions will be fostered and encouraged 
by the DDRCC. 

o Another goal of the DDRCC is to attract scientists to the field of digestive 
diseases research.  Therefore, both a Pilot and Feasibility (PF) program as 
well as an Enrichment Program may be supported within the DDRCC program.
 
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:

Judith Podskalny, Ph.D.
Program Director
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 667
Bethesda, MD  20892-5450
Telephone:  (301) 594-8876 
Email: jp53s@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
Two Democracy Plaza, Room 752
Bethesda, MD  20892-5452
Telephone:  (301) 594-8897
Email: fc15y@nih.gov

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

Donald Ellis
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 743
Bethesda, MD  20892-5456
Telephone:  (301) 594-8849
Email: de30z@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 center
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel (Associate Directors, Core Directors)
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
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: The Silvio O. Conte Digestive Diseases Research 
Core Center guidelines provide more detailed information on the Centers 
program and on preparing the application.  The guidelines are accessible at  
http://www.niddk.nih.gov/fund/other/centers/ddrcguidetoc.htm.
 
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three signed photocopies, in 
one package to:
 
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application 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.  This 
does not preclude the submission of substantial revisions of applications 
already reviewed in response to a previous Centers RFA, 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 
for responsiveness to the RFA by the NIDDK.  Incomplete and/or non-responsive 
applications will be returned to the applicant without being 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.  No site visits 
are planned in the review of these applications; all information required for 
evaluation must be contained in the application.  As part of the initial merit 
review, all applications will:

o Undergo a process in which all applications 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

All applications responding to this RFA will be evaluated according to the 
review criteria as outlined in the SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH 
CORE CENTER GUIDELINES available on the Internet at 
http://www.niddk.nih.gov/fund/other/centers/ddrcguidetoc.htm or from the 
program director listed under WHERE TO SEND INQUIRIES, above.
 
As part of the initial scientific review, which will result in one overall 
priority score for the P30 application, reviewers will rate each individual 
research core and, if requested, the clinical component, as well as the P/F 
program.  The evaluation of the Enrichment Program will be reflected in the 
adjectival score of the Administrative Core. The merit descriptors for each of 
these components will appear in the summary statement.  The review group will 
assign a descriptor, rather than a score, for the research base, scientific 
cores, the P/F program, and the Center Director. 

Review Criteria

The most important component of a DDRCC is an ongoing, strong base of 
digestive disease-related research. 

Specific review criteria for Silvio O. Conte Digestive Diseases Research Core 
Centers are: 

o the scientific excellence of the Center's research base (its strengths, its 
breadth and depth) as well as the relevance and interrelation of these 
separately funded research projects to the central theme(s) or focus of the 
Center and the likelihood for meaningful collaborations among Center 
investigators.  The existence of a base of established, independently 
supported biomedical research of high quality is a prerequisite for the 
establishment of a Silvio O. Conte Digestive Diseases Research Core Center 
and is the most important component of the review. The results of previous 
peer reviews of its content will weigh heavily in the assessment of the 
application's overall strength as a potential recipient of an award.

o the qualifications, experience, and commitment of the Center investigators 
responsible for the individual research projects, and their willingness to 
interrelate with each other and contribute to the overall objectives of the 
Silvio O. Conte Digestive Diseases Research Core Center.

o the appropriateness and relevance of the proposed Cores and their modes of 
operation (such as how usage will be prioritized), facilities, and potential 
for contribution to ongoing research.  Competing continuation applications 
must document the use, utility, quality control, and cost effectiveness of 
each Core requested to continue as part of the Center.  Progress will be 
judged in part by the list of publications arising from the cores.  At least 
two users are required to establish a core.  However, a greater number of 
users will be considered to be more cost effective.

o for all applications, four P/F studies should be submitted for evaluation 
as part of the review of the P/F program.  In general for new applications, 
the proposed P/F projects will be examined to assess the eligibility of the 
P/F applicant and the adequacy of the selection process by which the 
individual studies were selected.  Applicants should refer to the 
Administrative Guidelines for DDRCCs for specific details regarding the P/F 
program and its review by the Scientific Review Group (SRG).

o the Named New Investigator, if requested, will be considered separately.

o  the scientific and administrative leadership abilities of the proposed 
Center Director and Associate Director and their commitment and ability to 
devote adequate time to the effective management of the program.

o the administrative organization proposed for the following:

(a) Coordination of ongoing research between the separately funded projects 
and the Center, including mechanisms for internal monitoring;

(b) Establishment and maintenance of internal communication and cooperation 
among the Center investigators;

(c) Mechanism for selecting and replacing professional or technical personnel 
within the Core Center;

(d) Mechanism for reviewing the use and administration of funds for the P/F 
program;

(e) Management capabilities that include fiscal administration, procurement, 
property and personnel management, planning, budgeting, and other appropriate
capabilities;

o The institutional commitment to the program, including lines of 
accountability regarding management of the Center grant and the institution's 
contribution to the management capabilities of the Center;

o The academic environment and resources in which the activities will be 
conducted, including the availability of space, equipment, facilities, and 
the potential for interaction with scientists from other departments and
institutions;

o 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;

o The appropriateness of the budgets for the proposed and approved work to be 
done in Core facilities, for P/F studies (these are restricted funds and are 
capped at $150,000), and for enrichment in relation to the total Center 
program. 

Total requested direct costs are limited to $750,000 (including the P/F 
program). For both new and competing continuation applications, total 
requested direct costs should not exceed the $750,000 cap. 

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.  

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 16, 2004
Peer Review Date:                       March – April, 2005  
Council Review:                         May 2005
Earliest Anticipated Start Date:        December 2005

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Relevance to research areas of high programmatic interest to the Division of 
Digestive Diseases and Nutrition, NIDDK and research areas targeted by 
Congress;
o Availability of funds
o Geographic distribution

REQUIRED FEDERAL CITATIONS 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on Humane Care 
and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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

DATA AND SAFETY MONITORING PLAN: 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.  

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. 

Because P30 funds do not directly support research projects, the 
issues of minority/gender representation, inclusion of children as 
participants in research involving human subjects, required education on the 
protection of human subject participants, and the use of human embryonic stem 
cells will have been addressed at the individual project level (i.e., R01 
level).  However, the application must specifically address these issues for 
any P/F projects or cores as appropriate.

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). 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.

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.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.


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