Required Application Instructions

It is critical that applicants follow the 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). 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

Currently, there is no highly effective vaccine against HIV/AIDS. Over 30 years of extensive research effort have provided considerable information regarding the details of HIV infection and pathogenesis, and the nature of the host response and factors involved in progression to AIDS. The results of various AIDS vaccine trials have provided information that may lead to the development of vaccines with improved efficacy. These past accomplishments as well as new approaches suggest that highly effective HIV/AIDS vaccines can be developed in the near term, if appropriate products can be generated and tested as soon as possible. The NIH remains strongly committed to ending the AIDS pandemic and developing a cure for HIV/AIDS, as outlined in the NIH Director Notice NOT-OD-15-137. Priorities set in this Notice include the development and testing of effective vaccines against HIV/AIDS.

This FOA invites qualified academic institutions to seek support to upgrade existing functioning space (e.g., laboratory or office space) to Current Good Manufacturing Practice (CGMP) standards, to enable synthesis of immunogens, that can be used for Phase I clinical trials of next-generation candidates for HIV/AIDS vaccines. Applicants should demonstrate scientific excellence in HIV/AIDS biology, HIV/AIDS vaccine development and its translations to clinical trials, and the highest level of engineering expertise and skills to ensure that the proposed facility can yield high quality products meeting Federal and Industrial pharmaceutical standards.

While informative, candidate HIV/AIDS vaccines previously tested in clinical trials have not provided the requisite level of protection for diverse populations infected by HIV. However, there are promising vaccine products that need to be tested, but are not available, due to the difficulty in CGMP scale up from preclinical material.

Insights into HIV/AIDS biology have identified complex pathways of viral mutations driven by corresponding evolution of the human immune system in HIV infection. Current developments from several laboratories indicate that an effective HIV/AIDS vaccine must stimulate all arms of the human immune system to provide early innate signals, followed by protective antibody and cellular responses. Multiple groups that are trying to design immunogens that will trigger the appropriate immune responses, are discovering that immunization with multiple, sequential antigens which either mimic the evolution of HIV in human infection or that can effectively target the right kind of B cells that will elicit protective antibodies, are the most promising. These insights have led to the concept of a HIV/AIDS vaccine that utilizes sequential or combined inoculation with different immunogens. Parallel studies have indicated that conserved cellular responses in HIV-infected people, particularly to the capsid and polymerase genes of HIV, may have an ability to decrease virus levels and increase survival. Experiments using humanized mice and nonhuman primates indicate that these approaches hold promise for development of an effective HIV/AIDS vaccine.

A major challenge is production of multiple immunogens with sufficient yield and purity for use in small Phase I human clinical trials to test concepts. In particular, to overcome this challenge, facilities where HIV immunogens can be produced under CGMP conditions are required.

This FOA invites applications from academic institutions to seek support to upgrade existing functioning space to CGMP standards for synthesis of immunogens such as proteins and nucleic acids, with quality and sufficient quantities that will permit small Phase I clinical trials. Specifically, support may be requested to bring the mechanical, electrical and plumbing (MEP) systems up to standards, to meet relevant architectural specifications, and to purchase and install necessary fixed equipment.

To conceive, develop, conduct, and successfully complete the project, a Principal Director/Principal Investigator (PD/PI) should assemble a multi-disciplinary team with scientific and technical expertise related to all facets of the project and with proven leadership skills.

The project must be self-contained and upon the completion, the CGMP facility must be functional. The applicants are encouraged to follow sustainable design principles and to use green technologies.

An applicant may requests funds for costs of design and implementation of the project, including commissioning of the facility. The allowable costs include the architectural and engineering design fees and construction costs. An applicant may request funds for acquisition and installation of infrastructure equipment, such as HVAC units serving the facility and other large equipment connected to building structure and services. In addition, requests can be made for fixed laboratory equipment and its installation costs. Examples of such equipment include but are not limited to:

• autoclaves and other sterilizing equipment
• fume hoods
• incubators
• bioreactors
• biosafety cabinets.

The project should be consistent with the following criteria and documentation requirements:

• The project is essential for research activities supported and the space involved will be used for these activities.
• The building that contains the proposed CGPM facility has a useful life consistent with program purposes, and is architecturally and structurally suitable for conversion to the type of space required.
• If the space is rented, evidence is provided that the terms of the lease and expected subsequent use of the facility are consistent with the proposed project. Specifically, evidence must be provided that the terms of the lease agreement and subsequent use of the facility will comply with the 20-year term of the Notice of Federal Interest (NFI) requirements. A statement of agreement by the owner of the space must be included.
• If the project will affect a site listed in (or eligible for inclusion in) the National Register of Historic Places, the requirements specified in "Preservation of Cultural and Historic Resources" have been followed.

PDs/PIs are strongly encouraged to contact the Scientific/Research Contact listed in Section VII. Agency Contacts to discuss their planned projects before submitting applications.

SeeSection 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 in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

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/Principal Investigator (PD/PI) 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.

Multiple PDs/PIs are not allowed.

It is expected that the PD/PI will be a leader in the field of HIV/AIDS biology and AIDS vaccine development, capable to undertake scientific and managerial challenges associated with planning and executing the project.

Specifically, the PD/PI should have expertise in HIV/AIDS biology and the scientific goals of the project, including designing and formulating a vaccine, producing it, and bringing it to clinical trials. Also, this person should be capable of working with technical personnel who will oversee the technical design of the facility and its subsequent construction.

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

Only one application per institution (identified by NIH IPF number) is allowed.

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).

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. 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.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this FOA, there is no Research Strategy.
• The Project Narrative attachment of the SF424 (R&R) Other Project Information form is limited to 18 pages, excluding Line Drawings and specifically required Tables.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

Estimated Project Funding: Applicants must provide the 'Total Federal Funds Requested', 'Total Federal and Non-Federal Funds', and 'Estimated Program Income .

Is Application Subject to Review by State Executive Order 12372 Process: Applicants should indicate "yes" and provide the date the application was submitted to the State.

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

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

Project Narrative: The Project Narrative should consist of three sections: Overview, Scientific Justification, and Development of the Facility. The Overview section cannot exceed 1 page and must summarize the project, stating its goals and outlining the proposed approaches to achieve them. This section should include a description of the space affected by the project and any equipment which is requested in this application Tables 1 and 2 in Other Attachments may be referenced to simplify the presentation. This section should state how the project will enhance and contribute to the research infrastructure at the Institution and how it will benefit the specific scientific program.

It is up to the PD/PI to allocate the remaining 17 pages of the Project Narrative to the sections: Scientific Justification and Development of the Facility. A successful application does not need to reach the page limitation; however, it must justify the request from the scientific perspective and describe technical design approaches with sufficient details to make clear the merits of the overall project.

In addition, the applicant must demonstrate that this request is part of a broader research initiative and appropriate support for expert staff and production of immunogens will be in place when the new laboratory space is completed, so that small clinical trials will be feasible.

The Scientific Justification section should focus on how the needs for the development of a new HIV/AIDS vaccine drive the request. A brief overview of the state-of-the art in HIV/AIDS biology and the HIV/AIDS vaccine field should lead to a description of limitations of previous approaches to develop vaccines, scientific causes of these limitations, and the lessons learned. The PD/PI should explain how his/her proposed approach is different and its potential for success. To strengthen the case, the PD/PI should present more details about the specific immunogens and their quantities that will be needed for Phase I testing of the vaccine(s). Also, the PD/PI should describe methods and tools required for synthesis of immunogens, stability of these compounds, and other related topics, such as biohazards related to their production. If the laboratory can now create any of these compounds, the narrative should include challenges of scaling up their production to quantities needed for Phase I clinical trials. If laboratory-scale experiments are necessary before CGMP scale-up, these on-going efforts and the expected time frame for obtaining positive outcomes need to be addressed. The PD/PI should include details about the immunogens that can be produced and their quantities required for Phase I trials in this requested facility. In all cases, production of immunogens must be ready for scale-up by the time that the facility has been constructed and commissioned.

The PD/PI shall present the plan for the use of the proposed facility by giving details about the formulation of the vaccine(s) and a timeline for synthesis of individual compounds therein. Specifically, if various compounds will be created at the same time, details should be included about proposed procedures to prevent cross-contamination. Similarly, if the facility will be used at different times for the generation of different compounds, plans to clean the space and adapt the facility for running different protocols should be presented. These plans and procedures should follow best pharmaceutical standards for production of compounds suitable for human Phase I clinical trials so that the technical design of the proposed facility and requested equipment can also be justified in terms of protocols and practices to be implemented there.

The PD/PI and scientific collaborators should also demonstrate that they are well aware of challenges associated with conduct of Phase I clinical trials.

To justify the need for the development of the CGMP-level facility, the PD/PI should also describe the laboratory space currently available to him/her and its deficiencies in supporting Phase I HIV/AIDS vaccine trial. Also, the PD/PI should explain why the vaccine production project cannot be contracted to an outside vendor.

This section should conclude with a paragraph about how the PD/PI will work with Key Personnel on overseeing the planning process and its execution. Also, describe any synergistic scientific and technical expertise of the team as a whole. Their individual roles and responsibilities at different stages of the project should show their expected contribution towards the overall goal. Describe how the team will be organized and how its members will work together at different stages of the project. It is important for the PD/PI to document that the team as a group has expertise and skills necessary to design and construct the CGMP-level facility to meet the scientific objectives.

All requests must be justified in terms of both the scientific needs to further the development of next generation candidates for human HIV/AIDS vaccines and the corresponding technical requirements for the facility. In particular, to address the rationale for the technical design, plans for the use of the facility must be clearly outlined, by giving details of the types and quantity of immunogens to be produced and the time frame for their production. Attention must be paid to Federal and Industry standards and codes, so upon the completion of this project, the facility becomes ready to serve its purpose of facilitating HIV/AIDS vaccine clinical trials.

The section Development of the Facility should present technical specifications, details of the architectural and engineering design and proposed construction processes, to complete a CGMP-level space. The PD/PI should provide sufficient details about implementation of the project, including any technical challenges that will need to be overcome. This narrative should start with the location of the building in which the facility is to be housed in relation to other buildings in the immediate area and the location of the facility in the building. The design specifications must meet the requirements set by processes and operating procedures described in the section Scientific Justification, according to the Federal and Industry standards. The level of detail of the application's Line Drawings, data in Tables 1 and 2 (See "Other Attachments", below), and the narrative of this section must provide sufficient information for reviewers to determine the functionality of the overall design plans, and the safety and reliability of the proposed facility.

In the narrative, all requested equipment should be justified as being relevant to the function of the facility. Also, the needs of all equipment in the context of the engineering aspects of the project such as mechanical, electrical and plumbing (MEP) specifications for their installation should be presented - compare data in Table 2 (See "Other Attachments", below).

The PD/PI should provide Engineering and Architectural Criteria as relevant to the project, including:

• MEP specifications such as hot and cold water, and steam requirements; number of air changes per hour and any special ventilation requirements;
• Fire protection requirements; building automation systems; security/surveillance;
• Biohazard and radiation safety requirements; chemicals used;
• Width of corridors and doors and surface finishes;
• Quality of life issues (e.g., light levels, natural lighting, noise, vibration);
• Functional relationships and zoning of the area.

All these criteria should be justified in the context of the specific function of the requested facility and explained how the requirements for a CGMP-level facility will be met.

Useful documents giving design guidelines, codes and standards are:

• the NIH Design Requirements Manual (DRM),
• Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations,
• 21 Code of Federal Regulations.

This list is not all inclusive regarding guidelines and regulations on CGMP-level facilities and operating procedures therein. The design documents should follow the most recently published standards.

Other Attachments: In the Other Attachments section, the PD/PI should include the following documents, each as a separate attachment: attachments must be given a file name using the headings below (e.g., Line Drawings, Budget Justification):

1) Line Drawings: Each line drawing must fit on an 8.5 x 11 sheet of paper. (Do not submit "blueprints".) All floor plans must be legible with the scale clearly indicated on each page. The floor plans must indicate the location of equipment and illustrate safety clearances and workspace. If applicable, submit drawings of the existing and proposed space. The drawings must indicate:

• size dimensions, function, and the net and gross square feet for each room;
• location of the proposed construction/renovation area in the existing building;
• changes or additions to existing mechanical, electrical and plumbing systems; notes that annotate these changes may be made directly on the plan;
• functional layout of the proposed facility showing the location of entries and exits, egress routes, clearances, and the location of fixed equipment.

Although the line drawings do not count toward the page limits, do not include additional text to circumvent these limits.

2) Table 1: list the size (dimensions) and square footage of each component (e.g., clean room, laboratory, closet etc.) that will be directly affected by the project.

3) Table 2: list of requested fixed equipment. Table 2 should include information such as the manufacturer, model number, size, capacity, total cost, and location in the facility. Total cost of each item must be supported by Vendor Quotes in the Budget Justification Section.

4) Budget Justification and Vendor Quotes: All vendor quotes should be attached here along with justification for each piece of equipment.

5) Institutional endorsement letter. No institutional cost sharing is required, but proof of strong support for the HIV/AIDS vaccine program and an endorsement of this request must be documented in a letter from a high-ranking institutional official. If laboratory or other type of space will be displaced by this project (for example by conversion of laboratory space to the CGMP facility), the letter should address overall institutional approaches to space management as it relates to this project.

6) Certification of Title to Site: Applicants must include a legal opinion describing the interest the applicant has in the performance site. The legal opinion should describe any mortgages or other foreclosable liens on the property, including the principal amount of the mortgage (and rate of interest); the dates of the mortgage; the terms and conditions of repayment; the appraised value of the property; and any provisions designed to protect the Federal interest in the property. The facility must be utilized for biomedical research purposes for which it was improved for at least 20 years beginning on the date of beneficial occupancy of the space. Any lease agreement must cover a time period sufficient for the usage requirement and be a minimum of 20 years in length from the completion of the facility.

7) Project timeline to demonstrate how the project will be completed within the three-year budget and award period.

8) A maximum of 5 optional support letters may be attached.

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

The PD/PI must recruit Key Personnel with complementary scientific and technical skills. The team must include a PhD-level scientist who will manage the facility and oversee all aspects of immunogens production. Also, an individual with technical proficiency in engineering or architectural matters related to the design and oversight of the CGMP-level facilities must be identified for this application. A project role for this person should be specified as Other or Other Professional and a biosketch with relevant information about professional qualifications and expertise should be attached.

A PhD-level researcher who will manage the facility, and all aspects of production and quality control testing of immunogens therein, must be identified among Key Personnel to ensure that appropriate expertise is in place to assist with setting scientific requirements for the technical design and to make possible the immediate use of the completed facility. Key Personnel must also include a person with engineering/architectural expertise who as a member of the applicant team will closely work with an outside consulting firm on all technical aspect of the projects; including planning, designing, carrying out, completing, and commissioning a CGMP-level facility.

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

The Budget Information for Construction Programs (SF424C) must be used to attach an overall application budget page for the total requested funds.

Applicants must provide the Total Federal Funds Requested ,  Total Federal and Non-Federal Funds , and Estimated Program Income on the SF424 (R&R) Cover form.

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

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). 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 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.

For example, pre-award costs are allowable only for design and engineering fees.

F&A costs are NOT allowed. Funds may be requested for design of the facility, its construction, purchases of fixed equipment and its installation, and allowable fees.

Funds will be awarded in a single action using a three year budget and project period.

The requested budget can support design, construction activity and purchase of fixed equipment and its installation costs. Allowable costs also include:

• Appraisals
• Bid advertising
• Inspection and commissioning fees
• Project management
• Contingency fees (Allowable contingency fees are limited to 15 percent of the total allowable costs before bids are received and must be reduced to 10 percent after a construction contract has been awarded.)
• Filing fees for recording of Notice of Federal Interest (NFI).

Not-allowable costs include:

• Personnel costs not related to actual construction
• Bonus payments to contractors
• Consultant fees not related to actual construction
• Damage judgement suits
• Movable equipment
• FDA approval process following the completion of the construction project
• F&A costs
• Supplies
• Fund-raising expenses
• Interior and exterior decorating fees (e.g., purchase of artwork, sculpture, etc.).

To protect the Federal interest in improved real property, grantees will be required to file a Notice of federal Interest (NFI) in the Land Record Office of the jurisdiction where the facility will be located as required by 45 CFR 75.323 and the NIH GPS. The NFI is required when use and disposition conditions apply to the property as stated in the NoA. The time of recordation shall be when construction begins. A copy of the recorded NFI must be provided to the Grants Management Office within 10 days following the date of recordation - see Section VII Agency Contacts. Upon completion and occupancy, the facility will be monitored annually for 20 years in order to determine whether the facility is used for biomedical research.

If awarded, all funds will be restricted except for Project Design and Engineering Fees. NIH must approve the design documents before releasing the restricted funds. The awardee will be asked to submit the design documents for technical review. The purpose of the NIH design review is to ensure that applicable design standards are incorporated into the drawings and specifications so that the program requirements can be met. It is expected that the technical review process will be conducted in 3 stages for:

• Schematic Design Documents (SDDs) (15-30%),
• Development Design Documents (DDDs) (50-65%), and
• Construction Design Documents (CDDs) (95-100%).

Review at each stage may take 4 6 weeks. The applicant must submit SDDs within 4 months following the receipt of the Notice of Award (NoA), but considering the technical review timeline, the earliest possible submission of the design documents is encouraged following the receipt of the NoA.

The environmental analysis form is not required at the time of the application submission. Instead, a Grants Management Specialist will request this information as part of the Just-in-Time process (NOT-OD-10-120).

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

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 PDs/PIs 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.

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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 through the NIH peer review system.

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.

Scientific Merit and Organization of the Total Program and Its Component Parts to be Carried Out in the Facility

Does the applicant provide sufficient evidence of meritorious research program(s) that will benefit from completion of the project? How well are the component parts of the research program (that will be carried out in the facility) coordinated and managed? How will the proposed repair, renovation, or modernization activity facilitate the applicant institution’s ability to conduct, expand, improve, or maintain biomedical or behavioral research?

Is there sufficient justification for improving this core facility?  To what extent will the proposed change in the research environment facilitate the applicant institution’s ability to conduct, expand, improve, or maintain biomedical or behavioral research? How will the proposed repair, renovation, or modernization activity increase efficiency in the use of energy, water, and/or materials to reduce adverse effects on the environment? 

Does the applicant provide scientifically sound and convincing arguments for the development of new generations of candidate HIV/AIDS vaccines? Does the applicant sufficiently justify the need to develop a CGMP-level facility to advance research on HIV/AIDS vaccines?

Administrative and Leadership Capabilities of the Applicant’s Officers and Staff

How effective is the facility manager likely to be, based on 1) the administrative approach to managing the facility, 2) the ability to interact with appropriate institutional officials to see that the ongoing needs of the facility are satisfied, and 3) the skills necessary to complete the project on time and within budget?

How effective is the PD/PI likely to be, based on 1) leadership qualities and experience, 2) institutional commitment and support, and 3) the appropriate scientific and fiscal administration skills necessary to complete this project on time and within budget? Does the applicant provide evidence of future commitment in maintaining this facility?

Does the applicant document his/her scientific knowledge and abilities to move forward the HIV/AIDS research field? Is the PD/PI qualified to lead a multidisciplinary team of experts (e.g., biologists, translational researchers, and engineers) within a collaborative environment, and to oversee the requested project from its design to completion? Do the PD/PI and Key Personnel have the complementary expertise necessary to plan for and to design a CGMP-level facility? Do Key Personnel demonstrate the highest level of engineering expertise and skills to ensure that the proposed facility can meet the CGMP-level Federal and Industrial pharmaceutical standards? Does a letter from a high-ranking Institutional official assure Institutional engagement in the project and long-term support for the HIV/AIDS research program?

Anticipated Effect of the Project on Other Relevant Research Programs and Facilities in the Geographic Area and Nationwide

How likely is the proposed activity to benefit research at other institutions in the local geographic area, given the availability or absence of similar or related facilities? In which ways is the proposed activity likely to affect similar or related national facilities or benefit research nationwide?

How likely is the proposed activity to benefit HIV/AIDS NIH-funded research?

Need for the Project or Additional Space

How compelling are: 1) the identified need(s) in the research capabilities in the applicant organization and elsewhere that the proposed repair, renovation, or modernization activity is intended to address; 2) tangible benefits to the institutional research capability of the proposed activity; and 3) state-of-the-art research capabilities or efficiencies that would otherwise not be available?

Are requests for equipment justified and of direct benefit to the facility?  Will the requested equipment remedy identified deficiencies or fill gaps in the animal facility?

Does the applicant demonstrate the immediate need for the requested space? Does the applicant demonstrate the ability to scale up the production of specific immunogens? Does the applicant request necessary fixed equipment? How likely will the completion of the requested CGMP-level facility enable future small scale Phase I clinical trials?

Project Design

Design Plan: How likely is the design plan to meet the identified need(s), based on: 1) proposed demolition areas and/or renovation areas, including associated room adjacencies, traffic patterns for the movement of people, animals, and materials (clean and dirty) through the facility, and relative location of needed ancillary areas (e.g., changing rooms for animal facilities); 2) total net and gross square feet of space to be renovated; 3) proposed timeline and sequence of construction; 4) potential problems, alternative strategies, and benchmarks for success presented; and 5) implement sustainable design principles?

Engineering Criteria: How likely are the engineering systems to meet the identified need(s), based on: 1) the engineering criteria, including information about the mechanical, electrical, and plumbing systems, and utilities in the renovation; 2) descriptions of changes or additions to existing mechanical and electrical systems; and 3) the number of air changes per hour, electrical power, light levels, hot and cold water, and steam?

Architectural Criteria: How likely are the architectural criteria and finishes to meet the identified need(s), based on: 1) the size dimensions, function, and net and gross square feet for each component; 2) architectural criteria such as the width of corridors and doors and surface finishes for the project; and 3) quality of life issues (e.g., natural lighting, noise, vibration)?

Line Drawings: How likely are the line drawings to meet the identified need(s), based on: 1) the indicated function of the space; 2) the scale of the line drawings, and indication of adjacencies and operational relationships of equipment; 3) changes to be made to the space; and 4) location of major equipment, fume hoods, sinks, showers, and other major items indicated in the drawings?

How likely is the overall design of the facility to meet CGMP Federal and industrial standards? Does the design support the production of various types of immunogens, meeting purity standards for human Phase I clinical trials? Does the design support the production of various types of immunogens in desired quantities? Does the design support de-contamination procedures to ensure clean transitions between productions of different types of immunogens?

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

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children 

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Resource Sharing Plans

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Budget and Period of Support

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 by (an) appropriate Scientific Review Group(s), 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:

• May undergo a selection process in which only those applications deemed to have the merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Impact score assigned to the application by the NIH peer review group
• Relevance of the project for which construction is proposed to the objectives and priorities of
• the particular program authorized by the Public Health Service Act
• Scientific or professional standing or reputation of the applicant and of its existing or proposed officers and research staff
• Availability, by affiliation or other association, of other scientific or health personnel and facilities to the extent necessary to carry out effectively the program proposed for the facility, including the adequacy of an acceptable biohazard control and containment program when warranted
• The need for the facility and its total effects on similar or related facilities in the locale, and the need for appropriate geographic distribution of similar facilities
• The project cost and design
• Availability of funds.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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

Not Applicable

Progress reports for multiyear funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multiyear funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report are posted at http://grants.nih.gov/grants/policy/myf.htm.

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 progress report 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. Following completion and occupancy of the facility, grantees must certify on a yearly basis for 20 years that the facility is used to conduct biomedical research.

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 Commons Help Desk (Questions regarding 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
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Willie D. McCullough, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0783
Email: [email protected]

Ross D. Shonat, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-2786
Email: [email protected]

Gloria Velez
National Center for Advancing Translational Sciences (NCATS)
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0875
Email: [email protected]

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), 42 USC 283k, and under Federal Regulations 42 CFR Part 52b and 45 CFR Part 75.