RELEASE DATE:  December 17, 2002 (see addendum NOT-AI-03-011)  
RFA:  RR-03-003

National Center for Research Resources (NCRR)



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 Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations


The purpose of this Request for Applications (RFA) is to solicit 
proposals to establish a National Swine Research and Resource Center 
(NSRRC).  This resource will be for depositing, maintaining, 
preserving, and distributing swine models for studies of human 
diseases, as well as cryopreservation, storage, and reconstitution of 
embryos and germplasm.  These activities will be organized under the 
auspices of the NSRRC with the necessary administrative and quality 
control infrastructure.  Through appropriate research investigations, 
the NSRRC also will advance research and technologies to improve the 
utility of swine models for biomedical research.


Over the last several years, swine have become increasingly utilized as 
biomedical research models for human disease, partially replacing dogs 
and primates.  As research swine populations have experienced rapid and 
significant increases during the past few years, investigators have 
requested more resources for improving husbandry and medical care of 
new swine strains created by genetic technologies.  

As experimental subjects, swine have a number of advantages over other 
animal species.  They have a favorable reproductive capacity with a 
short gestation period, large litter size, and a poly-estrus cycle.  
Furthermore, swine anatomy and physiology are similar to humans, 
especially in cardiovascular, pulmonary, skeletal, and integumentary 
systems.  These similarities have made the swine the primary species of 
interest as organ, tissue, and cell donor species for xenograft 
transplantation procedures.  Genetically altered pigs for potential use 
in clinical xenotransplantation are now technically feasible as precise 
genetic modifications in the pig genome are achieved.  Thus, 
establishing a resource to supply needed swine organs would greatly 
support and advance these specific research goals.  The development and 
increased use of purpose-bred swine strains (i.e., inbred strains, 
various hybrid lines, and lines with genetically selected or altered 
genes) in biomedical research by investigators from around the world 
generate increased demands on animal breeding programs, specifically 
for specific-pathogen free (SPF) quality animals.  

These special swine models are often made available to other 
investigators by the researchers who generated a strain, but the 
demands for distribution and maintenance of swine are frequently beyond 
the physical or financial resources of these individual investigators.  
This may impose undesirable restrictions on the availability of 
potentially valuable purpose-bred swine strains and their scientific 

The objective of this RFA is to establish a National Swine Research and 
Resource Center (NSRRC) to ensure that biomedical investigators have 
enhanced access to critically needed swine models for studies involving 
human health and disease.  Besides numerous breeds of the domestic 
swine, Sus scrofa domestica, there are miniature breeds, such as the 
Yucatan minature, Sinclair, Pitman-Moore, and Hanford, as well as 
several genetically altered strains that are used in biomedical 
research.  The NSRRC will maintain purpose-bred swine strains and make 
them widely available to the national and international research 
community.  The swine resource center will eliminate the requirement of 
individual laboratories to maintain and distribute swine strains 
thereby ensuring the highest-level quality and uniformity of genetic 
and microbiological monitoring.  

Additionally, the NSRRC will serve as a central repository for 
materials (e.g., germ line and somatic cells, antibodies, gene probes 
and markers) and information (computer databases accessible via the 
World Wide Web, WWW) and make them available to the scientific 
community.  Another important objective of the NSRRC will be to develop 
methods for improving health of swine strains by establishing standards 
and procedures for generating specific-pathogen free and more vigorous 
swine strains and characterizing diseases endemic to laboratory swine 

The NSRRC will have a well-integrated and coordinated research program 
with active investigators who will effectively utilize swine models to 
generate new information that is relevant to the resource.  
Furthermore, because the resource is expected to maintain swine strains 
for xenograft transplantation procedures, it is essential that the 
center be able to accommodate the specific needs for isolation, growth, 
preservation, expansion, and distribution of cells, tissues and organs 
from these animals.

Plans for training and educational activities must be integrated in the 
proposed center.  Examples of appropriate training activities include: 
special training at the resource facilities for individual collaborators 
and users of the resource; potential routine training and education on 
the available technologies or methodologies through hands-on experience, 
seminars, or lectures; and short courses, symposia, and workshops 
involving multi-disciplinary areas for participants from academic 
institutions, hospitals, and industry.  Training can be offered 
periodically or in conjunction with meetings that the user community is 
likely to attend.  Funds to support courses given for credit may not be 
requested.  Individuals involved in the training experiences may not be 
paid a stipend nor may the training experience be a requirement for 
receipt of an academic degree.  Educational activities aimed at the 
general public and community about research activities performed at the 
NSRRC should be planned as part of the center's outreach program.  

This RFA will use the NIH "Animal Models, and Animal and Biological 
Materials Resource Cooperative Agreement" (U42).  The U42 is a 
cooperative agreement award mechanism in which the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NIH staff 
being substantially involved as a partner with the Principal 
Investigator, as described under the section "Cooperative Agreement 
Terms and Conditions of Award."  Applicants are solely responsible for 
planning, directing, and executing the proposed project.  This RFA is a 
one-time solicitation.  Future unsolicited, competing-continuation 
applications based on this project will compete with all investigator-
initiated applications and will be reviewed according to the customary 
peer review procedures.  The anticipated award date is September 2003.

This RFA uses just-in-time concepts.  All applications with annual 
direct costs of $250,000 or more must follow the instructions for non-
modular research grant applications 

In response to this RFA, it is anticipated that one U42 Research Center 
Grant will be funded.  An applicant may request a project period of up 
to five years and a budget for direct costs of up to $1,000,000 per 
year.  Because the nature and scope of the proposed center and research 
will vary from application to application, it is anticipated that the 
size of each application will vary.  Although the financial plans of 
the ICs 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 include domestic: 

o Non-profit or for-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Agencies of the Federal government  

Any individual with the skills, knowledge, training, 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.   

In response to the need for making swine models available to the 
biomedical research community, the NCRR will establish a National Swine 
Research and Resource Center (NSRRC).  The proposed NSRRC must have 
three basic characteristics.  First, the NSRRC must serve the needs of 
investigators in a variety of research areas where work is sponsored by 
NIH categorical Institutes.  Second, the NSRRC must be willing to make 
swine strains available to investigators on a local, regional, and 
national basis.  Third, the NSRRC must have a research component to 
generate new information that is relevant to the resource.  It is 
expected that some of the costs specifically associated with the 
establishment, improvement, or expansion of supply and long-term swine 
resource maintenance will be recovered from users through a charge 
schedule acceptable to the NIH.  

Applicants are encouraged to contact NCRR Program staff well in advance 
of the application submission date, to discuss the proposed research 
program, budget, organization of the resource, and its potential 
biomedical impact.  These contacts help to assure that applicants have a 
clear understanding of current program policies and priorities, 
especially with respect to any special situations, such as the 
maintenance and distribution of highest-quality swine strains, research 
activities, training and educational program, etc.  They also will allow 
staff to assess responsiveness to this RFA and provide appropriate 
guidance as needed.

This RFA will not cover any costs for facility construction or 
renovation for a swine resource.  Applications for funds for facility 
construction or renovation may be submitted to the Division of Research 
Infrastructure, NCRR, utilizing the extramural Research Facilities 
Improvement Program
where they will compete with all other construction applications.  

Cooperative Agreement Terms and Conditions of Award

These special Terms of Award are in addition to and not in lieu of 
otherwise applicable OMB administrative guidelines, HHS Grant 
Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, 
PHS, and NIH Grant Administration policy statements. 

The administrative and funding instrument used for this program is a 
cooperative agreement (U42), an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during 
performance of the activity.  Under the cooperative agreement, the NIH 
purpose is to support and/or stimulate the recipient's activity by 
involvement in and otherwise working jointly with the award recipient 
in a partner role, but it is not to assume direction, prime 
responsibility, or a role in the activity.  Consistent with this 
concept, the dominant role and prime responsibility for the activity 
resides with the awardee for the project as a whole, although specific 
tasks and activities in carrying out the studies will be shared among 
the awardee and the funding ICs project scientist(s). 

1. Awardee Rights and Responsibilities

The awardee will have primary authorities and responsibilities for the 
following elements:

o  Maintenance and distribution of the highest health status inbred 
swine strains, various hybrid and inbred lines, and swine lines with 
genetically selected or altered genes (subsequently all called swine 
strains) that will be housed in the NSRRC.  Establishment and 
maintenance of an animal barrier facility (SPF swine strains), and 
developing procedural and managerial husbandry techniques and practices 
appropriate for a state-of-the-art facility for various swine strains. 

o  Phenotypic characterization of swine strains with regard to 
development, function, and pathology, including surveillance for 
infectious agents in both animals and germplasm.

o  Maintenance of a local electronic database for live animals and for 
cryopreserved materials (such as embryos, DNA, antibodies).  This local 
NSRRC database should provide access to an NSRRC swine strain catalog 
and appropriate strain detail pages, information about requesting swine 
strains, application forms for submission of candidate strains to the 
NSRRC, and information on standard supply levels and pricing of NSRRC 
swine strains.  The local database must be connected to a web site and 
accessible from the WWW to allow investigators access to the database.

o  Development of capabilities for cryopreservation of embryo and sperm, 
storage facilities, and expertise for the reconstitution of 
cryopreserved embryos and gametes.

o  Implementing licensing terms, use-restrictions including patent 
technology, and material transfer agreements (MTAs).  The NSRRC will 
distribute strains under the least restrictive terms possible, 
resulting in minimal administrative delays.  Outgoing MTAs for all 
recipients of NSRRC strains or cryopreserved material will be 
established.  NSRRC swine strains will be distributed to all non-profit 
and for-profit institutions for internal, non-commercial biomedical 
research purposes under the supervision of an appropriate oversight 
body (e.g., an IACUC).  

o  Cost-recovery for supplies and long-term maintenance of the resource.  
The NSRRC will establish a distribution fee schedule that is intended to 
defray the costs associated with specialized swine breeding for swine 
stains and lines, genetic quality control, animal health monitoring, 
cryopreservation, customer service, and technical information and 
support that is acceptable to the NIH.

o  Conducting research related to the improvement of the resource 
activity.  Examples of such research would include the development of 
emerging technologies such as genotyping and phenotyping of swine animal 
models, infectious disease monitoring and prevention, production of new 
transgenic and knockout models, or investigations into optimal 
cryopreservation methods for germ cells and embryos.  These examples are 
not intended to be limiting.

o  The Principal Investigator for the resource is required to attend the 
annual meeting of resource directors of the Division of Comparative 
Medicine, NCRR, which is held at one of the resource funding sites.  

2. NIH Staff Responsibilities

Program Officers from each contributing NIH Institute or Center (IC) 
will appoint a member to the Steering Committee (as defined below), and, 
as determined by that committee, its subcommittees.  

The NCRR Program Officer will be responsible for normal stewardship of 
the award, including monitoring progress and reviewing progress reports, 
and may recommend withholding, suspension, or termination of support for 
lack of progress.  Each NIH IC that provides funding for the NSRRC, 
through its liaison on the Steering Committee as defined below, reserves 
the right to terminate or curtail the project in the event of 
substantial shortfall in effectively maintaining and distributing SPF 
inbred swine strains, research activities, collaborative efforts, data 
reporting, or any other major breach of protocol.  

The NCRR Scientific Coordinator, who may also be the NCRR Program 
Officer, will be substantially involved in establishing the NSRRC 
infrastructure including the following responsibilities above and beyond 
normal programmatic stewardship:

o  Participation in all NSRRC Steering Committee meetings as a voting 
o  Assistance with facilitating the coordination and management of the 
resource ensuring that overall management of the Center is in compliance 
with NIH policies
o  Coordination of and assistance with the establishing of operating 
procedures relating to sharing of swine models and related research data 
for use by other researchers 
o  Facilitating the development of networks among researchers, 
commercial interests, community interests, and governmental entities 

3.  Collaborative Responsibilities  

o  Training and collaborative research capacity.  To ensure the broadest 
possible access for investigators to SPF swine strains, the NSRRC is 
responsible for collaborating with investigators nationwide.  Such 
collaborations include advising on maintenance and breeding of 
particular swine strains as well as on-site collaborative research 
procedures, as appropriate.  The NSRRC may explore the future expansion 
potential of the center in terms of establishing R01-type research 
collaborations.  Additionally, education of the general public about 
research activities performed at the NSRRC should be planned.

o  Establishing a Steering Committee (SC) as defined below.  The SC is 
responsible for reviewing the final standard operating procedures (SOPs) 
for quality control in husbandry, veterinary care, maintenance of the 
animal facility, shipping and receiving of animals and germplasm, 
maintenance of the electronic database, administrative directions, and 
reporting procedures.  The SC will also be responsible for selecting 
members and coordinating activities of the NSRRC Advisory Panel (AP) as 
described below.

The SC initially will consist of the Principal Investigator, up to two 
additional investigators associated with the NSRRC, one representative 
each from every IC contributing to the funding of the NSRRC, one expert 
scientist representing another NCRR-funded resource, and a qualified 
veterinarian.  The number of NIH voting members of the SC will be 
limited to a maximum of two; one vote will be represented by the NCRR 
Scientific Coordinator.  NIH SC members may not chair the SC.  The 
structure of the SC should be established at the first SC meeting, which 
should take place within the first six months of funding.  The SC will 
elect a chairperson who will be responsible for SC activities, preparing 
meeting agendas, and for scheduling and chairing meetings.  The SC will 
meet periodically to map strategies, to develop operating procedures, 
and to evaluate progress.  

The NSRRC AP will be responsible for reviewing and approving requests 
from investigators to have swine strains accepted into the center and 
deciding whether to maintain live animals or only cryopreserved 
germplasm.  The AP also will review and decide on requests for banked 
DNA, antibodies, or other materials.  The SC will determine the 
composition of the AP.  Members must have appropriate expertise in 
molecular genetics, laboratory or clinical research, animal care, or 
other areas as deemed necessary by the SC.  Members of the SC may also 
serve on the AP, but may not constitute the majority.

4. Arbitration 

Any disagreement that may arise on scientific/programmatic matters 
(within the scope of the award), between award recipients and the 
funding ICs may be brought to arbitration.  An arbitration panel will 
be composed of three members   one selected by the Steering Committee 
(with the funding ICs representing members not voting) or by the 
individual awardee in the event of an individual disagreement, a second 
member selected by the funding ICs, and the third member selected by 
the two prior selected members.  This special arbitration procedure in 
no way affects the awardee's right to appeal an adverse action that is 
otherwise appealable in accordance with the PHS regulations at 42 CFR 
Part 50, Subpart D and HHS regulation at 45 CFR Part 16.


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:

Franziska B. Grieder, DVM, PhD
Division of Comparative Medicine
National Center for Research Resources 
6705 Rockledge Drive, Suite 6050
Bethesda, MD  20892-7965
Telephone:  (301) 435-0744
FAX:  (301) 480-3819

o Direct your questions about peer review issues to:

John L. Meyer, PhD
Office of Review
National Center for Research Resources 
6705 Rockledge Drive
Bethesda, MD  20892-7965
Telephone:  (301) 435-0807
FAX:  (301) 480-3660

o Direct your questions about financial or grants management matters 

Irene Grissom
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, Room 6086
Bethesda, MD  20892-7965
Telephone:  (301) 435-0844
FAX:  (301) 480-3777

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:
The section entitled "RESOURCES" Form Page 8 of the PHS 398 for the 
overall NSRRC should be completed.  Briefly describe the features of 
the institutional environment that are or would be relevant to the 
effective implementation of the proposed program.  As appropriate, 
describe available resources, such as laboratory facilities, 
participating and affiliated units, geographical distribution of space 
and personnel, and consultative resources.  Include information on the 
support and commitment of the parent institution for the center.  Use 
continuation pages as needed.  Include any supporting letters from the 

The application must include a plan to document users and all resource-
related publications resulting from use of the resource on a yearly 
basis, to be submitted with the annual progress report.  Users include 
both investigators depositing materials and investigators ordering 
materials.  These results must be reported yearly to the Program 
Director, NCRR, to show activity of the resource with respect to 
materials deposited and investigators who have used the materials from 
the resource, as well as to demonstrate the impact of the resource on 
biomedical research.

SUPPLEMENTAL INSTRUCTIONS: The review will include an assessment of the 
academic and physical environment.  As part of the review process, a 
site visit may occur.  The adequacy of facilities to implement the 
goals of the NSRRC to perform the proposed research, including 
laboratory and/or clinical facilities, will be a factor considered in 
the appraisal of the application.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at:

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

John L. Meyer, PhD
Office of Review
National Center for Research Resources 
6705 Rockledge Drive
Bethesda, MD  20892-7965
Bethesda, MD  20817 (for express/courier service)

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.
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NCRR.  

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 NCRR in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 

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 NCRR National Advisory Council. 


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 discuss the 
following aspects of your application to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of 
these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
o Research Component
   The scientific review group will address and consider each of these 
criteria in assigning the application's overall score, weighting them 
as appropriate for each application.  An application does not need to 
be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  

(1) SIGNIFICANCE:  Does your study address an important problem?  If 
the aims of your application are achieved, how do they advance 
scientific knowledge?  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?  Do you acknowledge potential problem areas and 
consider alternative tactics?

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

(4) INVESTIGATOR: Are you appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to your 
experience level as the principal investigator and to that of other 
researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work 
will be done contribute to the probability of success?  Is an 
appropriate animal care and veterinary support program described?  Do 
the proposed experiments take advantage of unique features of the 
scientific environment or employ useful collaborative arrangements?  Is 
there evidence of institutional support?  

(6) RESEARCH COMPONENT:  Does the center propose a research component 
to generate new information that is relevant to the resource and 
contributes to the improvement of the resource's value to the 
scientific community?  

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application also will be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

o DATA SHARING:  The NIH encourages the timely dissemination of research 
tools and results in support of further research and development.  The 
NIH has issued a policy document that addresses these concerns 

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


o  Will this resource maintain and distribute the highest health status 
swine strains?  Will the proposed animal barrier facilities and 
husbandry management techniques result in state-of-the-art SPF hybrid, 
inbred, and genetically altered swine strains? 

o  Will the resource provide importation capabilities for live animals 
and cryopreservation of embryos and sperm that are based on the latest 
scientific knowledge? 

o  Will the resource engage in phenotypic characterization of swine 
strains, including surveillance for infectious agents? 

o  Will the resource be able to distribute efficiently animals and 
other materials to the scientific community?  Are appropriate 
priorities planned for importation and distribution of swine strains?  

o  Is the number of proposed swine strains to be maintained and 
distributed to the scientific community appropriate to the scope of the 

o  Will the resource maintain an electronic database for live animals 
and cryopreserved germplasm that can be accessed by investigators in the 
scientific community to deposit and request swine strains? 

o  Will the resource establish a Steering Committee and Advisory Panel 
as defined under Special Requirements?  

o  Will the resource provide for licensing terms, use restrictions, and 
material transfer agreements to ensure that swine strains are 
distributed under the least restrictive terms possible?  

o  Will the resource establish a cost-recovery system for supplies and 
long-term maintenance of the resource?  

o  Will the resource engage in research activities related to the 
improvement of the resource and the scientific advancement of the swine 

o  Is the organizational, scientific, and operational framework 
reasonable, well-integrated and appropriate to the aims of the NSRRC?  

o  Does the NSRRC employ novel approaches or methods for facilitating 
scientific interaction?  

o  Is the NSRRC Director and leadership appropriately trained and well 
suited to the organizational and scientific responsibilities associated 
with this project?  

o  If collaborative arrangements are proposed, is there a convincing 
demonstration that these interactions will be sufficiently consistent 
and feasible to meet the needs of the NSRRC?

Application Receipt Date:  February 26, 2003
Peer Review Date:  June 2003
Council Review:  September 2003
Earliest Anticipated Start Date:  September 2003


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.

The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom of 
Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at

Applicants may wish to place data collected under this 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.

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.306, 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 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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