NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The NIH funds a vigorous research program to study the basic pathobiology of HIV/AIDS, the development of the infectious disease, the impact of co-infections and co-morbidities, and development and testing of new treatments/therapies and approaches to prevention, such as vaccines and microbicides. Macaque monkeys are closely related to humans in terms of anatomy, genetics and physiology, and thus provide useful models to facilitate many aspects of AIDS research. For example, rhesus macaques (Macaca mulatta) infected with the Simian Immunodeficiency Virus (SIV, the nonhuman primate (NHP) virus equivalent of HIV) are used to examine many aspects of viral pathogenesis, including early events not readily studied in human patients, as well as development of AIDS vaccines and other prevention approaches. Macaques, particularly pigtails (Macaca nemestrina), are also used to investigate concepts for vaginal mucosal microbicides before testing in human subjects. The influence of the vaginal microbiome, which is similar to that expressed in women, can be investigated in these animals to understand their role in HIV infection and prevention.

The presence of certain viruses in the monkey experimental subject can confound the results of AIDS-related studies. Therefore, the NIH/ORIP has supported the development of specific pathogen free (SPF) macaque colonies, through the use of U42 Cooperative Agreements beginning in the year 2000, and U24 Cooperative Agreements in 2002. The U24 colonies have been converted to the U42 activity, so that all colonies are under a single U42 FOA that more aligns with the focus on the development and support of a biomedical research resource. Collectively, the colonies comprise a consortium of ORIP-funded resources that provide SPF macaques for AIDS research.

As judged by current state-of-the-art assays, the SPF macaques are free of SIV, Type D simian retrovirus (SRV) and simian T-lymphotropic virus (STLV-1). The SPF animals are also required to be free of herpes B virus (Macacine herpesvirus-1), a potential health risk for personnel handling the animals. The major emphasis of the breeding colonies has been on the production of SPF Indian origin rhesus macaques, which are a preferred model to study the entire course of SIV infection, leading to AIDS. The SPF cooperative agreements have also supported smaller numbers of SPF Chinese origin rhesus and pigtail macaques, which have specialized uses for various aspects of AIDS research, such as the development of microbicides and exploration of sexually transmitted virus. Finally, some investigators have derived sub colonies of macaques that are SPF for additional viruses, such as cytomegalovirus (CMV), human papillomavirus (HPV), and herpes simplex virus (HSV). These expanded SPF animals are used for investigations of novel vector studies as well as co-infection research.

SPF macaques are also characterized regarding certain MHC class I types, responsible for antigen presentation (peptides) to T cells. An important aspect of the evaluation of AIDS vaccines in NHPs and in humans is the measurement of virus-specific T-cell immune responses. The majority of immunogenic cytotoxic T-lymphocytes bind to MHC class I molecules. Certain MHC Class I alleles such as Mamu-A*01, Mamu-B*08 and Mamu-B*17 are associated with slow disease progression in rhesus macaques. It is therefore important when designing an experiment to know if a subject harbor the MHC alleles that can affect the immune response to SIV infection. Due to its pivotal role in the immune response, understanding MHC genetics is essential for infectious disease research.

Most of the SPF macaque resources are now closed colonies that do not take in new animals. These colonies derive animals for AIDS investigations strictly through the breeding stock that was developed using the U42 and U24 cooperative agreements.

This FOA invites applications for the continued support and breeding of SPF colonies originally funded through the U42 and U24 mechanisms. Continuity of the SPF colonies will ensure that HIV/AIDS investigators have access to these critically needed macaque resources.

Applicants should include, but are not limited to, the following areas of service and support:

• Breeding and maintaining the SPF colonies, minimally at current levels;
• Allocating of animals to AIDS researchers, giving priority to NIH-funded investigators;
• Preserving the SPF status by assaying for the presence of specific viruses;
• Typing animals for specific major histocompatibility complex loci; and
• Plans for sustainability of the colony operations.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Only grantees funded under an ORIP-supported SPF colony FOA (PAR-14-066) are eligible to apply.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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 support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Core (Use for Husbandry and Management Core, Viral Testing Core, and MHC Genetic Typing Core)	12

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required
• Husbandry and Management Core: required, maximum of 1
• Viral Testing Core: required, maximum of 1
• MHC Genetic Typing Core: required, maximum of 1

When preparing your application in ASSIST, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Introduction to Application: For Resubmission and Revision applications, an Introduction to the Application is required in the Overall component.

Specific Aims: State concisely the goals of the proposed resource and summarize the expected outcome(s), including the impact that the results of the proposed resource will exert on the HIV/AIDS research.

Research Strategy: Applicants should include:

• Describe the management of the colony and how the output of SPF animals available to AIDS researchers will be determined. Some colonies are at or near a steady state level of breeders from which the output of animals for assignment for experiments will be relatively constant. Other colonies are still increasing the size of the breeding pool and will therefore be able to increase output over time, until reaching a steady state. An increase of the size and output of the colony through addition of animals is allowable, but is not a requirement.
• Describe the process by which the awardee allocates animals to specific researchers. The ORIP expects that allocation is on a first come first served basis, with NIH-funded AIDS researchers having first priority. Animals in excess of the demands of NIH researchers can be provided to researchers funded by other sources, only with prior approval of the ORIP Program Officer.
• Justify the inclusion of an expanded SPF component beyond the required 4 viruses, if applicable. Describe the additional pathogen(s) to be excluded, how this will be accomplished, and the proposed impact on AIDS research. An expanded SPF component is not required and should not result in expansion of the colony.

Letters of Support: Statements of Institutional Commitment, Letters of Support from the past and potential future users of the resources, Letters of Collaborations, and other similar documents, if appropriate, should be included in this section as attachment (rather than in the Cores Section).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

If you have FOA-specific instructions for any of the study record fields, add the field label and specific instruction here within the study record section.

Full study records include a number of fields and attachments related to human subjects and clinical trials. FOA-specific instructions can be provided to add to the information requested. Do not repeat or contradict information requested in the Application Guide. Be mindful of character limits noted in the Application Guide for text entry fields. This internal reference document (https://nih-extramural-intranet.od.nih.gov/d/sites/default/files/study-record-field-notes-internal-use.docx )

lists specific field labels, the format of information submitted, and system restrictions.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

•     Applicant Information
•     Type of Applicant (optional)
•     Descriptive Title of Applicant’s Project
•     Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

•     In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
•     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
•     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
•     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: State concisely the goals for Husbandry and Management of the colony. List succinctly the specific objectives of the financial plan, e.g., to solve a specific problem, address a critical barrier to progress in the field that the resource supports, or develop new components (expanded SPF components), if applicable.

Research Strategy: Applicants should include:

• A sustainability plan for the colony. Provide a table that shows how colony operations are currently funded, including support from: the current U42 or U24 cooperative agreements, Program Income, and other sources, if applicable. Program Income is defined as gross income earned by the recipient that is directly generated or earned as a result of the award. For the SPF colonies, Program Income is usually derived from animal sales, per diem charges, lease fees and/or shipping costs. Support for the colony from sources other than the cooperative agreement and Program Income is not required.
• A financial plan. Different colonies have grown at various rates and have accumulated different numbers of animals for breeding. Therefore, colonies may be at various stages regarding the amount of Program Income that can be generated, which depends on the size and breeding capacity of the colony. Regardless of the current baseline, the financial plan should provide a strategy for the renewal period such that Program Income and/or other sources of support, if applicable, generate approximately half of the amount of direct costs requested. The sum of the direct costs requested plus contributions from the financial plan should equal the costs associated with all the functions of the SPF colony. Support for the colony from sources other than the Cooperative Agreement and Program Income is not required. The requirement for support in addition to that provided by the Cooperative Agreement and Program Income can be waived by the ORIP Program Officer in exceptional circumstances.
• Provide a description of the colony management including husbandry and veterinary care that insure maintenance of the SPF status, breeding protocols that preserves genetic diversity, parentage, ancestry, and MHC genotype, and environmental and behavioral enrichment provided to the animals.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Address the Resource and Data Sharing Plan in the Overall Section.

Appendix:

Limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Inclusion Enrollment Report (Husbandry and Management Core)

Use only for applications with due dates on or before January 24, 2018. When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

The PHS Human Subjects and Clinical Trials Information form replaces the Human Subjects section of the Research Plan form. FOAs that do not allow clinical trials use this form for human subjects. See https://nih-extramural-intranet.od.nih.gov/d/sites/default/files/PHSHumanSubjectsandClinicalTrialsInformationForm-Internal_Use_Only.pptx for more information.

Use only for applications with due dates on or after January 25, 2018. Can be deleted if all due dates are on/after January 25

PHS Human Subjects and Clinical Trials Information (Husbandry and Management Core)

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

If you have FOA-specific instructions for any of the study record fields, add the field label and specific instruction here within the study record section.

Full study records include a number of fields and attachments related to human subjects and clinical trials. FOA-specific instructions can be provided to add to the information requested. Do not repeat or contradict information requested in the Application Guide. Be mindful of character limits noted in the Application Guide for text entry fields. This internal reference document (https://nih-extramural-intranet.od.nih.gov/d/sites/default/files/study-record-field-notes-internal-use.docx )

lists specific field labels, the format of information submitted, and system restrictions.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Viral Testing Core)

Complete only the following fields:

•     Applicant Information
•     Type of Applicant (optional)
•     Descriptive Title of Applicant’s Project
•     Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Viral Testing Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Viral Testing Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Viral Testing Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Viral Testing Core)

•     In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
•     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
•     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
•     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Viral Testing Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Viral Testing Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: List succinctly the specific objectives of the assays proposed, e.g., to solve a specific problem, challenge an existing paradigm, address a critical barrier to progress in the field, or use new technology to validate end results.

Research Strategy: Applicants should include:

• The current state-of-the-art assays utilized for the detection of: SIV, SRV, STLV-1 and herpes B virus (see https://www.ncbi.nlm.nih.gov/pubmed/26932456 for a review on viral testing of SPF Macaques).
• Alternatives to validate the testing end-result.
• Additional testing required to maintain the viral-free status of additional pathogens in expanded SPF colonies, if applicable.
• Any proposed improvements to current viral testing assays including proposed benefits and measures to ensure rigor and reproducibility.

Letters of Support: Provide them in the Overall Section.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: Address the Resource and Data Sharing Plan in the Overall Section.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Inclusion Enrollment Report (Viral Testing Core)

Use only for applications with due dates on or before January 24, 2018. When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

The PHS Human Subjects and Clinical Trials Information form replaces the Human Subjects section of the Research Plan form. FOAs that do not allow clinical trials use this form for human subjects. See https://nih-extramural-intranet.od.nih.gov/d/sites/default/files/PHSHumanSubjectsandClinicalTrialsInformationForm-Internal_Use_Only.pptx for more information.

Use only for applications with due dates on or after January 25, 2018. Can be deleted if all due dates are on/after January 25

PHS Human Subjects and Clinical Trials Information (Viral Testing Core)

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

If you have FOA-specific instructions for any of the study record fields, add the field label and specific instruction here within the study record section.

Full study records include a number of fields and attachments related to human subjects and clinical trials. FOA-specific instructions can be provided to add to the information requested. Do not repeat or contradict information requested in the Application Guide. Be mindful of character limits noted in the Application Guide for text entry fields. This internal reference document (https://nih-extramural-intranet.od.nih.gov/d/sites/default/files/study-record-field-notes-internal-use.docx )

lists specific field labels, the format of information submitted, and system restrictions.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (MHC Genetic Typing Core)

Complete only the following fields:

•     Applicant Information
•     Type of Applicant (optional)
•     Descriptive Title of Applicant’s Project
•     Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (MHC Genetic Typing Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (MHC Genetic Typing Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (MHC Genetic Typing Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (MHC Genetic Typing Core)

•     In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
•     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
•     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
•     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (MHC Genetic Typing Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (MHC Genetic Typing Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: List succinctly the specific objectives of the genetic typing proposed, e.g., to test novel markers, solve a specific problem, challenge an existing paradigm, address a critical barrier to progress in the field.

Research Strategy: Applicants should include:

• The current state-of-the-art assays utilized for genetic typing and any plans for additional testing or improvements to testing including their proposed benefits as well as measures to insure rigor and reproducibility.
• Current practice for the characterization/identification of MHC Class I and II alleles, as appropriate, associated with disease progression in macaques.
• Any plan to expand the identification of specific MHC alleles that can affect the immune response to SIV infection.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: Address the Resource and Data Sharing Plan in the Overall Section.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Inclusion Enrollment Report (MHC Genetic Typing Core)

Use only for applications with due dates on or before January 24, 2018. When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

The PHS Human Subjects and Clinical Trials Information form replaces the Human Subjects section of the Research Plan form. FOAs that do not allow clinical trials use this form for human subjects. See https://nih-extramural-intranet.od.nih.gov/d/sites/default/files/PHSHumanSubjectsandClinicalTrialsInformationForm-Internal_Use_Only.pptx for more information.

Use only for applications with due dates on or after January 25, 2018. Can be deleted if all due dates are on/after January 25

PHS Human Subjects and Clinical Trials Information (MHC Genetic Typing Core)

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

If you have FOA-specific instructions for any of the study record fields, add the field label and specific instruction here within the study record section.

Full study records include a number of fields and attachments related to human subjects and clinical trials. FOA-specific instructions can be provided to add to the information requested. Do not repeat or contradict information requested in the Application Guide. Be mindful of character limits noted in the Application Guide for text entry fields. This internal reference document (https://nih-extramural-intranet.od.nih.gov/d/sites/default/files/study-record-field-notes-internal-use.docx )

lists specific field labels, the format of information submitted, and system restrictions.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

The U42 application is a multicomponent application, with an "Overall" component that is the aggregate of the 3 Cores (Husbandry and Management, Viral Testing, and MHC Genetic Typing). During the review process, reviewers will first consider each of the review criteria listed for each of the Cores and provide an overall impact score for each one. Once the Cores are completed, scoring will be assigned for the Overall application

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the proposed resource address the needs of the research [program] that it will [serve]? Is the scope of activities proposed for the resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research [program]? Does the proposed resource address the needs of the research community that it will serve? Is the scope of the colony management proposed for the resource appropriate to meet those needs? Will successful completion of the aims strengthen the resource and the value of the colony? Will the colonies provide animals to investigators on a local, regional, and national basis? Are the plans for maintaining and funding the colony adequate to meet the stated goals for distribution of SPF macaques to the research community? If an expanded SPF component is proposed, will its use enhance an important aspect of HIV/AIDS research?

RFA/PAR only: Additional Questions may be added.

Are the PD(s)/PI(s) and other personnel well suited to their roles in the resource? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing [the resource]? Do the investigators demonstrate significant experience with coordinating collaborative [] research? If the resource is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their [leadership approach, governance, plans for conflict resolution, and organizational structure] appropriate for the resource? Does the applicant have experience overseeing selection and management of subawards, if needed? Do they have appropriate experience and expertise to accomplish the overarching goals of the resource? Have they demonstrated a record of accomplishments managing the resource? Do the investigators demonstrate significant expertise to allocate the animals requested by the research community? Are the PD(s)/PI(s) and the Core Leads collaborating effectively to provide an unified leadership of the resources? Are lines of communications and plans for conflict resolution included?

RFA/PAR only: Additional Questions may be added.

Does the application propose novel [management strategies, or instrumentation] in supporting the research [program] the resource will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of [management strategies or instrumentation] proposed? Are the models created having an impact in biomedical research? Are plans for colony management and production in accord with current standards of practice and efficiency?

RFA/PAR only: Additional Questions may be added.

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research [program] the resource will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the [resource], as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the [resource] is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the [resource]? Is an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects? Are they participating in the Resource Identification Initiative, to support Rigor and Reproducibility in science? Is the allocation plan for distribution of SPF animals aligned with NIH priorities and goals to impact AIDS Research? If an expanded SPF component is proposed, is it well justified? Will the financial plan meet the stated objectives?"

RFA/PAR only: Additional Questions may be added.

Will the institutional environment in which the resource will operate contribute to the probability of success in facilitating the research [program] it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the resource proposed? Will the resource benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

RFA/PAR only: Additional Questions may be added.

For [resources] involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and provide an overall impact score for the Core. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

• Are the different aspects of the Husbandry and Management Core adequately described?
• Are procedures in place to maintain SPF status? Are plans for environmental and psychological enrichment of the NHPs adequate?
• Does the financial plan for each of years 2, 3 and 4 of the renewal include a component comprised of a Program Income and/or other sources of support, if applicable, that generates approximately half of the amount of direct costs requested for each given year?
• Does the facility have the infrastructure for holding, breeding and care of the colony animals?
• Does the applicant adequately address how prioritization of the animal allocation process will be done?
• Did the allocations during the past grant life cycle demonstrate that priority was given to HIV/AIDS NIH-funded investigators?
• Is there sufficient evidence of the ability of the colony to produce the target number of animals indicated to be allocated annually?
• Is the proposed plan for the continuation of the colony adequate to maintain the SPF status?
• Is there evidence of appropriate management experience to support and maintain the colony for another 4 years?
• Are key personnel responsibilities clearly delineated for the different aspects of the colony management including: husbandry and veterinary care that insure maintenance of the SPF status, breeding protocols that preserves genetic diversity, parentage, ancestry, and MHC genotype, and environmental and behavioral enrichment provided to the animals?
• If additional pathogen(s) are proposed to be excluded, is the scientific justification sound? How this will be accomplished and how this will impact AIDS research?
• Does the Core Leader have the proven experience and expertise to continue directing the Core?
• Are adequate plans provided for the regular evaluation of colony self-sufficiency; prioritization of animal allocations; biosecurity; detailed cost-recovery program; and internet site to promote and display information on the models available?

Reviewers will consider each of the review criteria below in the determination of scientific merit, and provide an overall impact score for the Core. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

• Are there detailed plans describing the proposed viral testing and how this will enhance the colony?
• Are the proposed plans for viral testing adequate to assure that animals are free of SIV, SRV, STLV-1 and herpes B virus?
• Will the proposed technologies lead to improvement in detection and validation of any outbreak or biosafety of the animal colony?
• Does the Core Leader have the proven experience and expertise to continue directing the Core?
• Are the proposed viral assays state-of-the-art? Do plans for viral testing adequately address rigor and reproducibility?
• If an expanded SPF component is proposed, are the plans for viral testing adequate to assure that animals are free of the indicated viruses? Will the biomedical community benefit from the expanded viral testing?

Reviewers will consider each of the review criteria below in the determination of scientific merit, and provide an overall impact score for the Core. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

• Does the Core Leader have the proven experience and expertise to continue directing the Core?
• Is the proposed MHC genetic typing state-of-the-art? Do plans for genetic typing adequately address rigor and reproducibility?
• Is the plan to expand the MHC genetic typing feasible, if proposed? How will the expanded typing impact AIDS Research?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period.

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the NIH Council of Councils. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

The PD(s)/PI(s) will have the primary responsibility for:

• Planning the activities, defining the aims and objectives, describing the methods, techniques and other resources to be used and for carrying out the work described.
• Performing all aspects of colony management, characterizing animals in regard to viral status and MHC type, distributing animals to researchers and deriving Program Income. It is understood that other personnel at the grantee institution (e.g., the business office) are involved in some of these activities.
• Establishment and maintenance of an animal barrier facility (SPF), as well as procedural and managerial husbandry techniques and practices appropriate for maintaining a state-of-the-art facility for the SPF colony.
• Providing colony data on a yearly basis or as requested by the ORIP in a format to be specified by the ORIP. These data will include colony demographics, the number of animals distributed and the grants that were supported.
• Meeting with NIH staff and the other members of the SPF macaque consortium at least once per year to discuss consortium-based activities that will help coordinate activities common to the SPF macaque grants. These annual meetings will take place at the ORIP Offices in Bethesda Maryland, at one of the awardee institutions, or by video or teleconference. Additional meetings, which may be necessary for coordination of cooperative agreement activities, may be scheduled.
• Maintenance of a local electronic database for live animals (including health records).

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal

stewardship role in awards, as described below:

The ORIP Project Scientists will:

• Assist with facilitating the coordination and management of the resource ensuring that overall management of the resource is in compliance with NIH policies.
• Coordinate and assist with establishing operating procedures regarding sharing of SPF animals and related research data for use by other researchers.
• Have the option to recommend to the Program Officer withholding of support to the resource if aims are not met.
• Have substantial scientific involvement during conduct of this cooperative agreement, through technical assistance, advice, and coordination above and beyond normal program stewardship of grants.

Additionally, an ORIP Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The ORIP Program Officer will:

• Be responsible for the normal scientific and programmatic stewardship of the award.
• Carry out continuous review of all activities to ensure the project aims are being met.
• Pursue enforcement actions including withholding of support for failure to meet the terms and conditions of the award or failure to show satisfactory progress in achieving the aims.

Areas of Joint Responsibility include:

• Coordination of the activities of the SPF macaque grantee consortium. This will be accomplished through a Steering Committee comprised of each U42 grant PD/PI, or their designees and the NIH Project Scientist and Program Officer, or their designees. The function of the steering committee is to coordinate consortium activities through consultation and discussion, and to identify common problems and solutions as they arise.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Sheri Hild, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-594-8937
Email: sheri.hild@nih.gov

Robert Freund, Ph.D.
Center for Scientific Review
Telephone: 301-435-1050
Email: robert.freund@nih.gov

Shannon Oden
National Center for Advancing Translational Sciences (NCATS)
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-594-3028
Email: Odens@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 52 and 45 CFR Part 75.