ESTABLISHMENT OF SPECIFIC PATHOGEN FREE RHESUS AND PIGTAILED MACAQUE 
COLONIES

Release Date:  February 28, 2002

RFA:  RR-02-005 

National Center for Research Resources (NCRR)
 (http://www.ncrr.nih.gov)

LETTER OF INTENT RECEIPT DATE:	March 25, 2002
APPLICATION RECEIPT DATE:  April 25, 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquires
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA
 
This RFA is a re-issuance of RFA RR-00-004 released on February 10, 
2000.  It is reissued to solicit applications for the establishment of 
ADDITIONAL colonies of SPF rhesus macaques.  (Colonies already being 
supported through the previous solicitation are eligible to apply).

Increased numbers of rhesus macaques particularly of Indian ancestry 
are needed for AIDS vaccine and pathogenesis studies.  The purpose of 
this Request for Applications (RFA) is to solicit proposals from 
prospective grantees who can breed rhesus and pigtailed macaques that 
are Specific Pathogen Free (SPF) and provide them to NIH grantees for 
AIDS-related research.  The term SPF in the context of this 
solicitation is defined as animals free (antibody negative) of herpes B 
virus; simian immunodeficiency virus (SIV); Type D simian retrovirus 
(SRV); and simian T-lymphotropic virus (STLV-1).  The presence of the 
retroviral infections makes the infected animals unsuitable for AIDS-
related research projects.  Thus, for the purposes of testing potential 
AIDS vaccines as well as studies regarding the pathogenesis of AIDS, 
investigators must have animals free of viruses that might compromise 
their research findings.  Although the herpes B virus does not appear 
to compromise AIDS-related investigations, the potential health risks 
for personnel dictates that the breeding colonies must be free of this 
virus as well.  Providing such animals for NIH grantees to do AIDS-
related research is the topmost priority of this RFA.
 
RESEARCH OBJECTIVES
 
Background

In response to the critical need for providing rhesus macaques with 
specific qualities, the NCRR will establish breeding colonies through a 
Cooperative Agreement Grant mechanism.  The rhesus and pigtailed 
macaques must be free of the following retroviruses: simian 
immunodeficiency virus (SIV); Type D simian retrovirus (SRV); and 
simian T-lymphoyte virus (STLV-1).  Because of prospective health risks 
to personnel, a further requirement is for these animals to be free of 
Herpesvirus simiae (herpes B virus).   

It is also recognized that there is a special need for Major 
Histocompatability Complex (MHC) defined rhesus macaques for certain 
types of AIDS-related research.  A major component of the evaluation of 
AIDS vaccines in non-human primates, and in humans, is the measurement 
of virus-specific T-cell immune responses.  The majority of immunogenic 
Cytotoxic T Lymphocytes (CTL) bind to MHC class I molecules.  Mamu-A 
*01 is an example of one MHC class I haplotype that is important in 
controlling viral replication.  Thus, the screening of such animals 
should be included as a component of the application.  This may involve 
establishing a collaborative arrangement with facilities that are 
capable of providing MHC screening.  Selected pedigree breeding for 
specific MHC type I haplotypes could then be initiated.  A specific 
example is if collaborative arrangements have been established for the 
screening of MHC-1 haplotype, such an arrangement would facilitate the 
genetic management of the colonies to provide genetically-defined 
animals for AIDS research.  Such animals could be invaluable for the 
AIDS research community.

MECHANISM OF SUPPORT
 
The NIH (U24) RFA "Animal Model and Animal and Biological Material 
Resource" uses a cooperative agreement award mechanism in which the 
Private 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".  The total project period for an 
application submitted in response to this RFA may not exceed 5 years.   
 
Because the nature and scope of the research proposed in response
to this RFA may vary, it is anticipated that the size of an award
will vary also.
 
This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-
initiated applications and be reviewed according to the customary
peer review procedures.   

FUNDS AVAILABLE
 
The NCRR anticipates making several awards to new or existing SPF 
colonies for project periods of up to five years.  NCRR intends to 
commit approximately $8.4 million total costs is expected to be set 
aside for funding these activities in the initial year.  The number of 
awards and the level of support will depend upon receipt of a 
sufficient number of applications of high scientific merit.  Although 
this program is provided for in the financial plans of the NCRR, awards 
pursuant to this RFA are contingent upon the availability of funds for 
this purpose in fiscal year 2002.  The anticipated award date is August 
30, 2002.   

ELIGIBLE INSTITUTIONS

You may submit an application(s) 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
Current SPF colony grantees may use this solicitation to apply for 
additional funds to expand their colonies and increase their screening 
capabilities.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS

The cooperative agreements (U24s) will require cooperation between the 
NCRR representative (NCRR Program Administrator) and the Principal 
Investigators (PIs) of the individual projects in order to assure 
smooth interactions among cooperating organizations.  The NCRR Program 
Administrator will assist in coordinating the activities of the 
awardees and in facilitating exchange of animals.

COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD

The following terms and conditions will be incorporated into the U24 
award statement, and will be provided to the PI and the awardee 
institutional official at the time 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.  (Part 92 applies 
when state and local governments are eligible to apply as a "domestic 
organization.")

1. COLLABORATIVE RESPONSIBILITIES

Coordinating Committee (CC)

In response to the previous RFA (RR-00-004), six SPF Colonies were 
established.  As part of the award conditions, a Coordinating Committee 
(CC) consisting of the NCRR and the principal investigator (P.I.) of 
the grants was formed.  The Program Administrator and P.I.s of any new 
awards will automatically become active members of the CC.  The CC is 
expected to meet at least twice a year.

The CC is responsible for implementation oversight and coordination in 
the establishment and operation of the SPF colonies as proposed in the 
individual applications of the awardees.  They CC develops uniform 
procedures for quality control in animal husbandry and in the 
maintenance of the animal facilities.  The CC is responsible for the 
oversight to ensure standardization of the viral screening assays.  The 
CC continually reviews and monitors the operating procedures proposed 
by individual awardee organizations in order to ensure that they are 
compatible with the overall goals of the RFA.

The CC consists of the PI of each SPF colony and NCRR Program 
Administrator.  Additional members may be added by action of the CC.  
The structure of the CC was established at the first meeting.  The 
Chair of the CC is responsible for coordinating the Committee 
activities, for preparing meeting agendas, and for scheduling and 
chairing meetings.  The NCRR Program Administrator attends and 
participates in all meetings of the CC and should be informed of any 
major interactions.  The CC prepares an annual progress report which 
will include individual reports from each awardee.  Each awardee is 
responsible for timely preparation of this report.

The NCRR Program Administrator, as a member of the CC, will assure that 
operating policies are acceptable to the NCRR.  An arbitration system, 
as detailed below, will be available to resolve disagreements between 
awardees and NCRR staff.

2. AWARDEE RIGHTS AND RESPONSIBILITIES

o Awardees will have primary and lead responsibilities for the project 
as a whole, including selection and maintenance of rhesus macaques, 
husbandry, microbiological and genetic monitoring, data quality control 
and reporting to the CC, any research to enhance the resource, 
preparation of publications, as well as collaboration with the other 
awardees with assistance from the NCRR Program Administrator.

o Awardees must comply with the operating policies and procedures 
developed by the CC.

o Awardees will retain custody of, and have primary rights to, the 
data developed under these awards, subject to Government rights of 
access consistent with current HHS, PHS, and NIH policies.  
Investigators conducting biomedical research frequently develop unique 
research resources.  The policy of the PHS is to make available to the 
public the results and accomplishments of the activities that it funds.  
All awardees must adhere to PHS policy for the distribution of unique 
research resources produced with PHS funding and is available at the 
following internet address:  
http://grants2.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm
#AvailabilityofResearchResults

3. NCRR PROGRAM ADMINISTRATOR RESPONSIBILITIES

o The NCRR Program Administrator will coordinate and facilitate the 
programs supported by these cooperative agreements, will attend and 
participate as a voting member in all meetings of the CC and SPF Colony 
Directors, and will provide liaison between them and the NCRR.

o The NCRR Program Administrator will ensure that there is effective 
communication between the CC and NCRR.

o The NCRR Program Administrator will assist the CC in developing and 
drafting operating policies and procedures for dealing with recurring 
situations that require coordinated action, e.g., standardized genetic 
and microbiological monitoring.

o The NCRR Program Administrator in conjunction with CC activities 
will play a significant role in ensuring the equitable distribution of 
SPF animals to NIH grantees.

o The NCRR Program Administrator may review the operations of 
individual U24 grants for compliance with the operating policies 
developed by the CC and may recommend withholding of support, 
suspension, or termination of an award for lack of progress or failure 
to adhere to policies established by the CC.

4. ARBITRATION PROCEDURES

An arbitration panel of external consultants will be created as needed 
to resolve any irreconcilable differences of opinion related to 
scientific/programmatic matters between the NCRR Program Administrator 
and the CC with respect to implementation of a proposed operating 
policy.  The panel will include one member selected by the CC, one 
member selected by NCRR, and a third member chosen by the other two 
members of the arbitration procedures in no way affect the awardee's 
right to appeal an adverse determination in accordance with PHS 
regulations at 42 CFR Part 50, subpart D and HHS regulations at 45 CFR 
Part 16.
 
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:

Jerry A. Robinson, Ph.D.
Division of Comparative Medicine
National Center for Research Resources
One Rockledge Centre, Room 6164
6705 Rockledge Drive
Bethesda, MD  20892
Telephone:  (301) 435-0744
FAX:  (301) 480-3819
e-mail: jerryr@ncrr.nih.gov

o Direct your questions about per review issues to:

Camille M. King, Ph.D.
Scientific Review Administrator
Division of Office of Review
National Center for Research Resources
One Rockledge Centre, Room 6114
6705 Rockledge Drive, 
Bethesda, MD  20892
Telephone:  (301) 435-0811
FAX:  (301) 480-3660
e-mail: kingc@ncrr.nih.gov
 
o Direct your questions about financial or grants management matters 
to:

Paul Karadbil
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, Room 6086
Bethesda, MD   20892-7965
Telephone: (301) 435-0840
Email:  paulk@ncrr.nih.gov
 
LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows IC staff to estimate the potential review 
workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent is to be sent to:
 
Jerry A. Robinson, Ph.D.
Division of Comparative Medicine
National Center for Research Resources
One Rockledge Centre, Room 6164
6705 Rockledge Drive
Bethesda, MD  20892
Telephone:  (301) 435-0744
FAX:  (301) 480-3819
e-mail: jerryr@ncrr.nih.gov

Applicants who wish to use express mail or courier service should 
change the zip code to 20817.

SUBMITTING AN APPLICATION
 
Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact Grants Info, 
Telephone 301/435-0714, Email:  GrantsInfo@nih.gov.

The RFA label available in the PHS 398 application (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 (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817-7710 (for express/courier service)

At the time of submission, two additional copies of the application
must be sent to:
 
Camille M. King, Ph.D.
Scientific Review Administrator
Division of Office of Review
National Center for Research Resources
One Rockledge Centre, Room 6114
6705 Rockledge Drive, MSC 7965
Bethesda, MD  20892-7965 
(Zip Code 20817-7965 for express mail)
 
APPLICATION PROCESSING:  Applications must be received by April 25, 
2002.  If an application is received after that date, it will be 
returned to the applicant without review. 

The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.

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

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

o Receive a written critique

o Undergo a process in which only those applications deemed to have 
the highest scientific merit, generally the top half of the 
applications under review, will be discussed and assigned a priority 
score

o Receive a second level review of the NCRR National Advisory Research 
Resource 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 discuss the 
following aspects of your application in order to judge the likelihood 
the proposed research will have a substantial impact on the pursuit of 
these goals:

o Significance
o Approach
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your 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.  For example, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.
 
o Significance.  What will be the impact of this resource on the AIDS 
biomedical research community?
 
o Approach.  Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project?  Is the resource designed to effectively provide 
the required service to the research community?  Is the approach 
sufficient to ensure that the types of animals specified with the 
appropriate "SPF" validation will be made available.  Does the 
applicant acknowledge potential problem areas and consider alternative 
tactics?  Timelines and available number projections will be review 
considerations.  Documentation of the animal's housing history will 
also be required.    
 
o Innovation.  Is the design of the resource and the method of 
providing service innovative?
 
o 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?

o Environment.  Does the environment contribute to the probability
of success of the resource?  Is there evidence of institutional support 
for the resource?

ADDITIONAL REVIEW CRITERIA
 
In addition to the above criteria, your application will also 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 Inclusion.  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.  

o 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:  March 25, 2002
Application Receipt Date:  April 25, 2002
Peer Review Date:  May/June 2002
Council Review:  September 2002
Earliest Anticipated Start Date:  September 30, 2002
  
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

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 

URLs IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained 
within specified pages 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 he 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 the "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.306.  Awards are made under authorization of the 
Public Health Service Act, Title IV, Part A (Public Law 78-410, as 
amended by Public Law 99-158, 42 USC 241 and 285) and administered 
under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR 
Part 74.  This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.
 
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in come 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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