Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Allergy and Infectious Diseases (NIAID)
Funding Opportunity Title	NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)
Activity Code	U44 Small Business Innovation Research (SBIR) Cooperative Agreement Phase II and Fast-Track only
Announcement Type	New
Related Notices	May 18, 2016 - This PA has been reissued as PAR-16-271. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. February 24, 2014 - See Notice NOT-AI-14-038. Announcement of Q&As for this PAR. January 15, 2014 - See Notice NOT-AI-14-022. This Notice is to inform potential applicants that the NIAID is revising this FOA to clarify the exception of Fast-Track applications. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	PAR-13-250
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.855; 93.856
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program will utilize the cooperative agreement mechanism (U44) to enable support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and can be proposed under this program. However, not more than one clinical trial should be proposed within each grant application. The NIAID has a robust infrastructure for conducting clinical studies that includes independently managed resources provided through grants and contracts, as well as resources that are integrated within existing NIAID-supported clinical trial networks. Proposed clinical trials may use NIAID s independent infrastructure for clinical studies, however, support will not be provided for studies that propose to use dedicated resources that are part of a NIAID-supported clinical trial network. A Commercialization Plan must be included that details plans for promoting further commercialization of the intervention/product/technology to be derived from or associated with the proposed clinical trial, including plans for promoting and establishing partnerships between the SBIR Phase II awardee and third-party investors and/or strategic partners.

Posted Date	June 24, 2013
Open Date (Earliest Submission Date)	August 11, 2013
Letter of Intent Due Date(s)	30 days before the application due date
Application Due Date(s)	September 11, 2013; January 13, 2014; May 13, 2014; September 11, 2014; January 13, 2015; May 13, 2015; September 11, 2015; January 13, 2016; May 13, 2016, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	September 11, 2013; January 13, 2014; May 13, 2014; September 11, 2014; January 13, 2015; May 13, 2015; September 11, 2015; January 13, 2016; May 13, 2016, by 5:00 PM local time of applicant organization.
Scientific Merit Review	January 2014; May 2014; September 2014; January 2015; May 2015; September 2015; January 2016; May 2016; and September 2016
Advisory Council Review	January, 2014, May 2014; October 2014; January 2015; May 2015; October 2015; January 2016; May 2016; October 2016; January 2017
Earliest Start Date	July 2014; December 2014; March 2015; July 2015; December 2015; March 2016; July 2016; December 2016; March 2017
Expiration Date	May 14, 2016
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR 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

This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials.

A clinical trial is defined by NIH as: A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.

This program will utilize the cooperative agreement mechanism (U44) to enable support for milestone-driven, hypothesis-driven clinical trials related to the research mission of the NIAID that address a research area considered high priority by the Institute. This FOA will accept both SBIR Phase II and Fast-Track (Phase I/Phase II) applications. Applicants seeking only SBIR Phase II support must have received SBIR Phase I support that is appropriate and relevant (e.g., pre-clinical studies, planning activities, etc.) to this FOA.

Although clinical trials not considered high-risk (see NOT-AI-10-024) may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique attributes: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Additionally, mechanistic studies are encouraged and can be proposed under this program. Applicants may not propose more than one clinical trial per application.

The NIAID has a robust infrastructure for conducting clinical studies that includes independently managed resources provided through grants and contracts, as well as resources that are integrated within existing NIAID-supported clinical trial networks. Proposed clinical trials may use NIAID’s independent infrastructure for clinical studies; however, support will not be provided for studies that propose to use dedicated resources that are part of a NIAID-supported clinical trial network.

Over the past three years, the NIAID has committed over $2 billion to clinical research, of which $1.5 billion has been devoted to clinical trials. Clinical trials are one strategy the NIAID uses to improve the understanding of the clinical mechanisms of infectious, immunologic, and allergic diseases or to improve prevention, diagnosis, and treatment. For additional information about the mission, strategic plan, and research interests of the NIAID, applicants are encouraged to consult the NIAID Planning and Priorities web site.

Clinical Trial Infrastructure

Historically, the NIAID has supported a wide variety of clinical research activities through clinical trial networks funded through cooperative agreements, solicited under NIAID Requests for Applications (RFAs), and solicited under NIAID Requests for Proposals (RFPs). These networks focus on high-priority disease research areas. Examples include the HIV/AIDS Clinical Trial Networks supported by the Division of AIDS, the Division of Microbiology and Infectious Diseases Clinical Trials Programs and Networks, and the Immune Tolerance Network supported by the Division of Allergy, Immunology and Transplantation.

In addition, NIAID’s clinical research infrastructure includes independently managed coordinating centers, statistical units, data centers, central laboratories, clinical centers, and other specialized resources. For additional information on NIAID supported clinical research resources refer to the Preclinical and Clinical Research Resources page.

Investigator-Initiated Clinical Trials

Although clinical trial infrastructure is crucial to furthering the Institute’s research, the NIAID recognizes that additional means to support clinical research may be important to advancing its research mission. Therefore, the NIAID has established the investigator-initiated clinical trial program for clinical trials that cannot or will not be conducted through existing NIAID-supported clinical trial networks. This FOA supports applications that propose clinical trials to be conducted outside of NIAID s existing clinical trial infrastructure; support will not be provided for clinical trials that propose to use dedicated resources that are part of a NIAID-supported clinical trial network.

This FOA provides a unique and focused opportunity for small business concerns (SBCs) interested in conducting clinical trials. If a clinical trial is ready for implementation, and readiness is adequately supported by appropriate documentation, SBCs are encouraged to submit applications to this FOA.

For additional information about NIAID s investigator-initiated clinical trial program, see the Investigator-Initiated Clinical Trial Resources Page.

The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) program supports implementation of clinical trials from small business concerns (SBCs) that propose clinical trials in research areas that are well matched with the mission and goals of the NIAID.

The proposed clinical trial should be hypothesis-driven and milestone-driven. Clear primary and secondary endpoints should be identified, including a description of the study population, justification for selecting the study group to address the research question(s) posed, subject eligibility, inclusion and exclusion criteria, and a feasible recruitment and enrollment plan. Statistical methods appropriate for the study design, and adequate plans for data monitoring and safety should be included.

All clinical trial planning activities must be completed prior to the time of application submission and all requested documentation needs to be provided for an application to be considered complete.

Investigators are referred to NIAID s Clinical Research Toolkit website for protocol templates and guidance, clinical research resources, and links to program divisions. Investigators are strongly encouraged to contact the NIAID Scientific/Research Contact(s) for information regarding division-specific clinical research policies and procedures.

This program will support implementation of proposed clinical trials not considered high-risk. However, applicants are encouraged to propose high-risk clinical trials. A high-risk clinical trial as defined by the NIAID (NOT-AI-10-024) does not imply human subject or patient risk, but rather defines a study as having one or more of the following attributes:

• provision of a non-routine intervention, that is, an intervention or non-routine use of an intervention that would not otherwise be provided for the condition under study in the local facility where the study is being conducted;
• administration of an unlicensed product; or
• administration of a licensed product for an unapproved indication.

For the purposes of this FOA, implementation support is defined as support for the conduct, completion, and analysis of a clinical trial, including activities related to the conduct of the clinical trial, which include but are not limited to the following:

• training of study personnel;
• enrollment and recruitment of study subjects;
• investigational product costs;
• data collection, management and quality control;
• laboratory work and data analyses;
• study management and oversight;
• establishment of committees to manage the complexity of the trial;
• preparation of the final study report; and
• other related post-enrollment activities.

Milestones

Delineation of milestones is a key characteristic of awards made in support of the NIAID’s investigator-initiated clinical trial program, including this NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) FOA. A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity.

Proposed clinical trial milestones provide a clear delineation of the criteria used to identify completed activities, but also provide for contingency plans to accommodate anticipated impediments that could require a revision in the timeline. Recognizing and indicating potential problems and obstacles are important aspects in identifying and discussing alternative approaches. The milestones will undergo peer review and will be incorporated into the terms of award.

Commercialization Plan

Applications must include a Commercialization Plan (see SF424 (R&R) SBIR/STTR Application Guide) that provides a strategy for promoting further commercialization beyond the SBIR Phase II support period, including details on any independent third-party investor and/or strategic partner funding that will or has already been secured. Full commercialization of the intervention/product/technology should be carried out with non-SBIR funds.

Since conducting a clinical trial needed to commercialize an intervention/product/technology may be capital-intensive, this FOA also aims to encourage business relationships between applicant SBCs and third-party investors/strategic partners who can provide substantial financing (co-funding) to help accelerate the commercialization of promising new interventions, products, and technologies initiated with NIH SBIR funding. In light of these goals, applicants are encouraged to promote and establish business relationships with investors and/or strategic partners that have appropriate prior experience in the commercialization of emerging biomedical technologies. The Commercialization Plan should include details on any co-funding, from public or private institutions that have already been secured or are anticipated.

Awards made under the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) FOA will NOT provide support for:

• clinical trial planning tasks, such as:
  • Development of study design
  • Identification of collaborators and enrollment sites
  • Development of the clinical protocol and informed consent form
  • Development of the statistical analysis plan
  • Development of the data management plan
  • Development of the Investigator’s brochure or equivalent
• clinical trials that fall outside the mission and goals of the NIAID;
• clinical trials that propose to use dedicated resources that are part of an existing NIAID-supported clinical trial network; or
• more than one proposed clinical trial per application (applicants should not propose more than one clinical trial within an application).

The NIAID reserves the right to specify: 1) whether an IND (Investigational New Drug)/IDE (Investigational Device Exemption) application should be submitted to an appropriate regulatory agency; 2) the entity (NIAID, primary awardee, etc.) who will hold the IND/IDE; and 3) the requirements for the establishment of a DSMB (Data Safety Monitoring Board)/SMC (Safety Monitoring Committee).

All research and development activities associated with awards made under this NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) FOA must be performed within the United States.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New (Fast-Track) Renewal (Phase II) Resubmission (all phases) Revision The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% ($225,000 for Phase I and $1,500,000 for Phase II). As written in the statute and under appropriate circumstances, NIH can apply for a waiver from SBA to issue an award exceeding $225,000 for Phase I or $1,500,000 for Phase II, if this cap will interfere with NIH’s ability to meet its mission. Award waivers from the SBA are not guaranteed and may delay the release of funds. Applicants are strongly encouraged to contact NIH program officials prior to submitting any application in excess of the guidelines. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.
Award Project Period	Durations up to 1 year for Phase I and up to 3 years for Phase II may be requested.

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.

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:

1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;

2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;

3. (i) SBIR and STTR. Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR

(ii) SBIR-only. Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR

(iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements.

4. Has, including its affiliates, not more than 500 employees.

If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.

If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner.

If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.

Definitions:

• Hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
• Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.
• Private equity firm has the meaning given the term private equity fund in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
• Venture capital operating company means an entity described in 121.103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.

SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.

Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the STTR program.

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, may be allowed.

Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• System for Award Management (SAM) must maintain an active entity registration(formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• SBA Company Registry New requirement. See Section IV. Application and Submission Information, SF424(R&R) Other Project Information form for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a DUNS number to complete this registration. SBA Company registration is NOT required before SAM, Grants.gov or eRA Commons registration.
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

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.

Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PDs/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.

The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR 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.

NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I awardee should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.

In Phase I, normally, a minimum of two-thirds or 67% of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 33% of the total amount requested (direct, F&A/indirect, and fee).

In Phase II, normally, a minimum of one-half or 50% of the research or analytical effort must be carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).

A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above. A Federal laboratory, as defined in 15 U.S.C. 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.

The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS 398 Research Plan component of SF424 (R&R) application forms.

Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.

Applicants must download 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) SBIR/STTR Application Guide, 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.

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

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Priti Mehrotra, M.Sc, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3G40, MSC 9823
5601 Fishers Lane
Rockville, MD 20892-9823
(For Express Couriers: 20852-9823)
Telephone: 240-669-5066
Email: pm158b@nih.gov

All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) SBIR/STTR Application Guide to ensure you complete all appropriate optional components.

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

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

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

Other Attachments:

1. SBA Company registry

All applicants to the SBIR and STTR programs are required to register at the SBA Company Registry prior to application submission and attach proof of registration. Completed registrations will receive a unique SBC Control ID and .pdf file. If applicants have previously registered, you are still required to attach proof of registration. The SBA Company Registry recommends verification with SAM, but a SAM account is not required to complete the registration. In order to be verified with SAM, your email address must match one of the contacts in SAM. If you are unsure what is listed in SAM for your company, you may verify the information on the SAM site. Confirmation of your company's DUNS is necessary to verify your email address in SAM. Follow these steps listed below to register and attach proof of registration to your application.

a. Navigate to the SBA Company Registry.

b. If you are a previous SBIR/STTR awardee from any agency, search for your small business by Company Name, EIN/Tax ID, DUNS, or Existing SBIR/STTR Contract/Grant Number in the search fields provided. Identify your company and click Proceed to Registration .

c. If you are a first time applicant, click the New to the SBIR Program? link on lower right of registry screen.

d. Fill out the required information on the Basic Information and Eligibility Statement screens.

e. Press Complete Registration on the lower right of the Eligibility Statement screen and follow all instructions.

f. Download and save your SBA registry PDF locally. The name will be in the format of SBC_123456789.pdf, where SBC_123456789 (9 digit number) is your firm’s SBC Control ID. DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.

g. When you are completing the application package, attach this SBA registry PDF as a separate file by clicking Add Attachments located to the right of Other Attachments on the Research and Related Other Project Information form.

For questions and for technical assistance concerning the SBA Company Registry, please contact the SBA at http://sbir.gov/feedback?type=reg.

2. SBIR Application Certification for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms

Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at time of their application submission per the SBIR Policy Directive. Follow the instructions below.

Applicants small business concerns who are more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these (i.e. NOT majority VCOC-owned) should NOT fill out this certification and should NOT attach it their application package.

a. Download the SBIR Application VCOC Certification.pdf at the NIH SBIR Forms webpage.

b. Answer the 3 questions and check the certification boxes.

c. The authorized business official must sign the certification.

d. Save the certification using the original file name. The file must be named SBIR Application VCOC Certification.pdf . DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.

e. When you are completing the application package, attach this certification as a separate file by clicking Add Attachments located to the right of Other Attachments on the Research and Related Other Project Information form.

Additionally, applications must contain all of the following Other Project Information items: Statistical Analysis Plan, Data and Safety Monitoring (DSM) Plan, Milestone Plan, and Complete Clinical Protocol. Applications lacking any of the Other Project Information items will be considered incomplete and will not be reviewed.

3. Statistical Analysis Plan

The filename "Statistical Analysis Plan.pdf" should be used and will be reflected in the final image with bookmarking for easy access for reviewers. The Statistical Analysis Plan is limited to 12 pages.

This plan must clearly specify all important details of the protocol design and the principal features of the proposed statistical analysis. It should describe selection of the cohort size based on proper power calculations and the ability to make conclusions of primary outcomes other than safety, particularly in small studies. Include in the discussion the statistical methods that are appropriate for the study design, including sample size, power calculations and the underlying assumptions (and data) used to link these calculations to the endpoints and to the hypothesis(es) being tested.

4. Data and Safety Monitoring (DSM) Plan

The filename "Data and Safety Monitoring Plan.pdf" should be used and will be reflected in the final image with bookmarking for easy access for reviewers. The DSM Plan is limited to 12 pages.

The DSM plan should be commensurate with the risk level of the proposed clinical research and must be included for all clinical trials (see http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Include within the application a general description of the monitoring plan, policies, procedures, responsible entities, and approaches to identifying, managing and reporting reportable events (adverse events and unanticipated problems), to the applicable regulatory agencies (e.g., Institutional Review Board (IRB)), the Office of Biotechnology Activities (as appropriate), the Office of Human Research Protections, the U.S. Food and Drug Administration, and the Data and Safety Monitoring Board (if one is used).

The DSM Plan must address the following areas:

• Who will manage and conduct the monitoring;
• What will be monitored;
• Proposed monitoring time points;
• Where the monitoring will occur;
• How the reportable events will be managed and reported; and
• How sites/centers, and participating facilities (labs, pharmacies) will be monitored.

5. Milestone Plan

The filename "Milestone Plan.pdf" should be used and will be reflected in the final image with bookmarking for easy access for reviewers.

Applicants are required to provide detailed project performance and timeline objectives in a section entitled Milestone Plan. The Milestone Plan is limited to 12 pages.

This section must include a timeline for the following general milestones, as applicable:

• Completion of regulatory approvals;
• Enrollment of the first subject;
• Enrollment of 25%, 50%, 75% and 100% of the projected recruitment time period for all study subjects, including women, minorities and children (as appropriate);
• Completion of data collection time period;
• Completion of primary endpoint and secondary endpoint data analyses time period;
• Completion of final study report; and
• Detailed protocol-specific performance milestones and timeline.

Discuss the feasibility and appropriateness of achieving and completing each milestone on-time, including alternate approaches and contingencies for dealing with potential problems and impediments.

Milestones will be negotiated at the time of the award. During the execution of the project, NIAID staff will assess progress toward and achievement of these milestones. As indicated in Section VI.2., NIAID reserves the right to terminate the award contingent upon the awardee’s ability to show adequate progress towards milestone accomplishment.

6. Complete Clinical Protocol

The filename "Complete Clinical Protocol.pdf" should be used and will be reflected in the final image with bookmarking for easy access for reviewers. Investigators should use the NIAID clinical protocol template when preparing the complete clinical protocol, and are urged to be succinct.

Investigators are referred to the Trans-NIAID Clinical Research Toolkit website for clinical protocol guidance and templates.

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

Biographical Sketch: The Biographical Sketches of the PD(s)/PI(s) should reflect expertise in study coordination, data management and statistics. The Biographical Sketches of the Senior/Key Persons should reflect expertise in the clinical problem under study; the administration of complex projects and study design; statistics, data management and study coordination.

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

Investigators are to submit complete, justified, individual budgets for each year of support requested, taking into account the scientific and operational plans of the trial, as well as the budgetary needs for the data analysis period. All costs requested and all changes in budgets after the first year should be clearly identified and justified. Prepare separate itemized budgets for each subcontract and/or for each collaborating site, if multiple sites or cores are proposed. If parts of the costs of the trial are to be borne by sources other than NIH, present these contributions in detail along with supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution (see Letters of Support in the PHS 398 Research Plan below). These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

Further information concerning budget preparation may be obtained from the Financial/Grants Management Contact(s).

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

If prior consultation with the NIAID has occurred before application submission, include a letter that summarizes the discussion. This letter may be obtained from the appropriate NIAID Division Director and attached as a .pdf file to the PHS398 Cover Letter form.

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

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

Commercialization Plan: Applications submitted to this program must include a Commercialization Plan that identifies the future steps and strategies necessary for full commercialization of the intervention/ product/technology to be derived from or associated with the proposed clinical trial, and describes plans for promoting and establishing partnerships between the SBIR Phase II awardee and third party investors and/or strategic partners.

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

Specific Aims: Concisely state the goals of the clinical trial and the expected outcome(s). Clearly and succinctly present the specific objectives of the clinical trial, including specifying the primary and major secondary endpoints to be measured. There should be a clear explanation of the importance of various endpoints.

Research Strategy: Present an overview of the state of the science, current status and relevance of the trial, discussion of the clinical protocol, and relevance to the research mission of the NIAID. Applicants must propose a hypothesis-driven and milestone-driven clinical trial, show that the clinical trial is ready for implementation at the time of award, and describe the clinical trial stages, criteria for completion of the stages and contingency plans for each stage to accommodate any anticipated impediments that could require a revision in the timeline. Include in the discussion potential impediments and problems that may occur and accompany each by a discussion of alternative approaches. Identify and clearly indicate the primary and secondary endpoints, including a description of the study population, justification for selecting the appropriate group to study the research question(s) posed, subject eligibility, inclusion and exclusion criteria, and a feasible recruitment and enrollment plan. A summary of both statistical methods appropriate for the study design, and plans for data monitoring and safety are required. More detailed descriptions of the statistical methods, and plans for data and safety monitoring must be presented in separate documents, as described above for the SF424 (R&R) Other Project Information form.

The Research Strategy should discuss, address, and/or summarize the following:

• Prior Studies and Rationale for Development: The major findings of the pre-clinical and clinical studies that led to the proposed clinical trial should be presented. Data from pre-clinical and pilot studies demonstrating the need for and the feasibility of the trial should also be presented. Conceptualization and planning must have progressed to a stage sufficient to allow for an overall assessment of the likelihood of trial success. Indicate the significance of the problem being studied, the need for the trial, and the potential impact of the results of the trial, including adequate definition of the study objective(s) and how well the clinical trial will test the hypothesis(es) proposed;
• The overall strategy, methodology and analyses to be used to accomplish the goals and specific aims of the trial, including addressing all aspects of the proposed clinical trial, e.g., the study population, inclusion/exclusion criteria, plans for recruitment outreach, enrollment, retention, informed consent or assent form, differences in the intervention effect due to sex/gender and race/ethnicity as applicable, and primary and secondary endpoints;
• Plans for recruitment and ensuring availability of study participants, including plans for recruitment and retention of children, women, and minorities, if these are included in the study; indicate plans for recruitment outreach and follow-up procedures;
• The process to be used for obtaining informed consent and, if applicable, assent;
• A description of and rationale for the proposed study design;
• A description and justification of the intervention and/or study agent(s) to be tested and the protocol to be followed in each arm of the trial, including a discussion of potential biases or challenges in the protocol and how they will be addressed;
• Plans for acquisition and handling of study agent(s);
• For proposed mechanistic studies: Discuss the feasibility of the approach(es) and how these studies contribute to the understanding or treatment of the disease/condition;
• For proposed multi-center clinical trials: Discuss the methods for ensuring adherence to the clinical protocol, and standardization and quality control of distribution of study agent(s) and data collection;
• The study organization and administration, including, but not limited to: a description of committee structures needed to manage the complexity of the trial; the role of any internal or external advisory committees; the oversight, responsibilities, and coordination of any sites or cores proposed; and the role of any sub-contractors or service providers for personnel or facilities; include plans for professional training of study staff (including, if applicable, staff at multi-center locations);
• A description of expertise in areas to include the clinical problem under study, administration of complex projects and study design, statistics, data management, and study coordination;
• A description of the plans to implement and monitor Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP) and Good Manufacturing Practices (GMP), as appropriate; and
• Demonstrated consideration of ethical issues involving the disease/condition under study.

In addition, applicants are to discuss activities related to the conduct of the clinical trial, which are defined in this FOA as functions acceptable for implementation support.

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators. In addition, if co-funding or in-kind support is planned from non-NIH sources, include letter(s) outlining details of the commitment (e.g., type, amount and source of support), signed by a business official on organization letterhead in the Letters of Support section.

Resource Sharing Plans: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) SBIR/STTR Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide, with the following modifications:

Include in the Appendix the following additional documents and materials in the order listed below. Place all documents in a single pdf file:

• the informed consent form(s) and, if applicable, assent form(s)
• identification and qualifications of clinical trial site(s), pharmacies and laboratories
• copies of data collection forms, questionnaires or other relevant materials
• the Investigator’s Brochure or equivalent for the study products(s)
• the Table of Contents of the Manual of Operations
• documentation of availability of study agents, as well as plans and support for acquisition and administration of study agent(s)
• documentation of co-funding of clinical trials from partners, as appropriate.

Part I. Overview Information contains information about Key Dates. 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.

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.

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) SBIR/STTR 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) SBIR/STTR Application Instructions. 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.

Important reminders:

All PD(s)/PI(s) 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) SBIR/STTR Application Guide.

See more tips for avoiding common errors.

Responsive applications include an appropriate Statistical Analysis Plan, Data and Safety Monitoring (DSM) Plan, Milestone Plan, and Complete Clinical Protocol. Applications that omit any of these components in the SF 424 Application Other Project Information Form under the section entitled "Other Attachments" will be considered non-responsive and will not be reviewed.

Consultation with NIAID staff at least 10 weeks prior to the application due date is strongly encouraged for submission of the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) application, including new and resubmission applications. If requested, NIAID staff will consider whether the proposed clinical trial meets the goals and mission of the Institute, whether it addresses one or more high priority research areas, and whether it is appropriate to conduct as an investigator-initiated clinical trial. NIAID staff will not evaluate the technical and scientific merit of the proposed trial; technical and scientific merit will be determined during peer review using the review criteria indicated in this FOA. NIAID staff members are also available to work with potential applicants to determine the risk level of the proposed trial and delineate all documentation that will be needed at the time of application submission. During the consultation phase, if the proposed trial does not meet NIAID’s programmatic needs or is not appropriate as an investigator-initiated clinical trial, applicants will be strongly encouraged to consider other Funding Opportunities.

A letter that summarizes the discussion during prior consultation may be obtained from the appropriate NIAID Division Director and attached as a .pdf file to the PHS398 Cover Letter form.

For further information on prior consultation with NIAID program staff, refer to the NIAID Standard Operating Procedure for Investigator Initiated Clinical Trial Planning and Implementation Awards.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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.

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Do the PD(s)/PI(s) and key personnel demonstrate the expertise and ability to organize, manage, and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For multi-center clinical trials, is the organizational structure appropriate and does the application identify a core of potential center investigators and staff necessary to manage a coordinating center? Are there sufficient professional training and experience of clinical trial organizers in such areas as the clinical problem under study, administration of complex projects and study design; statisticians, data managers and study coordinators; committees (e.g., Planning, Steering, Executive Committees)?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are the study objective(s) and hypothesis(es) adequately defined? Does the application adequately address and justify the following: the intervention, study agent(s), and plans for acquisition and handling of study agent(s)? Does the application adequately address all aspects of the proposed clinical trial, e.g., the study population, inclusion/exclusion criteria, plans for recruitment outreach and follow-up procedures to ensure collection of data at stated intervals, enrollment, retention, informed consent or assent form, differences in the intervention effect due to sex/gender and race/ethnicity as applicable and primary and secondary endpoints? Are potential ethical issues adequately addressed? Are proposed mechanistic studies feasible and would they contribute to the understanding of the disease or treatment? Does the application adequately address the statistical hypothesis and analysis, including sample size justification and power calculation? Are the proposed milestones and timelines appropriate? Does the application adequately address Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), and Good Manufacturing Practices (GMP) compliance as appropriate? For multi-center clinical trials, does the application adequately address adherence to the clinical protocol, and standardization/quality control of data collection and distribution guidelines?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangement?

Is the requisite eligible patient pool available? Are there adequate and appropriate plans for training of study staff?

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.

Phase II Applications

For Phase II Applications, how well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?

Phase I/Phase II Fast-Track Applications

For Phase I/Phase II Fast-Track Applications, reviewers will consider the following:

1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II?

2. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization?

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

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.

Phase IIB Competing Renewals

Not Applicable

Revisions

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.

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

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) Genome Wide Association Studies (GWAS).

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 for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIAID , 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:

• May undergo a committee process in which only those applications deemed to have the highest scientific and technical 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. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council l. 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.

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.

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.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

The Office of Inspector General Hotline accepts tips from all sources about potential fraud, waste, abuse and mismanagement in Department of Health & Human Services programs. The reporting individual should indicate that the fraud, waste and/or abuse concerns an SBIR/STTR grant or contract, if relevant. Report Fraud.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients 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 prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

• All aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators. The awardee agrees to accept close coordination, cooperation, and participation of NIAID staff in those aspects of scientific and technical management of the study as stated in these terms and conditions.
• Meeting the requirements of Public Law 110-85 (also known as the FDA Amendments Act (FDAAA) of 2007), which mandates registration and results reporting of certain "applicable clinical trials" in ClinicalTrials.gov. The implementation of FDAAA requires:
  • the registration of applicable clinical trials in ClinicalTrials.gov no later than 21 days after the first subject is enrolled;
  • the reporting of summary results information (including adverse events) no later than 1 year after the completion date for registered applicable clinical trials involving drugs that are approved under section 505 of the Food, Drug and Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or of devices that are cleared under section 510k of FDCA; and
  • annual progress report forms shall include a certification that the responsible party has made all required submissions to ClinicalTrials.gov.
• Meeting NIAID policy requiring that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. An updated NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.
• Upon implementation of the protocol, ensuring that each field center, whether a single institution or a consortium of institutions, will follow the procedures required by the protocol regarding study conduct and monitoring, volunteer management, data collection, and quality control.
• Support or other involvement of industry or any other third party in the study--e.g., participation by the third party; involvement of project resources or citing the name of the project or the NIAID support; or special access to project results, data, findings, or resources--may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by the NIAID.
• Putting all study materials and procedure manuals into the public domain. Awardees are expected to publish and publicly disseminate results, data, and other products of the study, concordant with governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NIAID/NIH.
• Obtaining prior written approval of the NIAID Grants Management Specialist in consultation with the NIAID Program Officer for any change in any of the key personnel identified in the Notice of Grant Award.

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 has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An NIAID Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards, subject to Government rights of access consistent with HHS, PHS, and NIH policies.
• Provide guidance and support in the development, assembly, and submission of all required regulatory documents, e.g., those regarding the use of investigational drugs, to the U.S. Food and Drug Administration (FDA).
• Serve as a resource to provide scientific/programmatic support during the accomplishment of the research by participating in the design of the activities, advising in the selection of sources or resources (e.g., determining where a particular reagent can be found), provision of research resources and reagents available from NIAID grantees and contractors, advising in management and technical performance, or participating in the preparation of publications.
• Provide medical monitoring by a NIAID Medical Officer who will monitor the clinical trials and serve as the Medical Monitor; should a pharmaceutical or biotechnology company sponsoring a clinical trial choose to name its own Medical Monitor, then the NIAID Medical Officer will work with the company-assigned Medical Monitor.
• Oversee the adequacy of adverse event management and reporting, and have regular communications with the PD/PI and study team, which may include attendance at the safety monitoring (or DSMB) and related committee meetings.
• Review the progress of the study, and of each participating facility, through consideration of the annual reports, site visits, volunteer logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting.
• Monitor progress of study milestones; as with any award, continuation, even during the period recommended for support, is contingent upon satisfactory progress. Progress will be monitored by an internal panel with outside consultants as needed and determined by the NIAID. The schedule for these interim reviews will be based upon the duration of the clinical trial period. Continuation of funding will be dependent upon the awardee’s ability to show adequate progress towards milestone accomplishment.
• At each scheduled interim review, compare actual enrollment to the benchmarks and criteria identified in the application and negotiated prior to award; awardees who do not accomplish the negotiated milestones shall submit a milestone report which will include a discussion of why the milestones were not met in the agreed upon timeframe, and propose a corrective recruitment action plan. The corrective recruitment action plan shall include: amended milestones, plans to achieve the amended milestones and any additional items required by NIAID staff. The plan shall be provided to NIAID staff no later than two (2) months following the missed milestone.
• Studies in which recruitment milestones are not met as per criteria established pre-award, or for which regulatory approval has not been met within one year, and are deemed unlikely to improve sufficiently to bring the study to completion within an acceptable budget or time frame, may be closed for lack of progress following review and consideration by NIAID staff.
• If a study is finally determined to lack feasibility and will no longer accrue subjects, awardees are required to submit a close-out plan to NIAID staff within two (2) months of the decision either by NIAID staff or the grantee that an awarded study is no longer feasible. The plan must be approved and signed by the Institutional Official and the PD(s)/PI(s) listed on the award prior to submission.

NIAID reserves the right to terminate or curtail the study (or an individual award) and require the awardee to submit a close-out plan within two (2) months of the decision to terminate in the event of (a) failure to implement the study protocol, (b) a substantial shortfall in participant recruitment, follow-up, data reporting and dissemination, quality control, or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which NIAID does not concur, (d) reaching a major study objective substantially before schedule with persuasive statistical evidence, or (e) human subject ethical issues that may dictate a premature termination.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

For multi-site trials, the PD(s)/PI(s) is (are) encouraged to form a Steering Committee (SC) to assist in oversight and management of the trial. A SC, if constituted , will be composed of the PD(s)/PI(s), as well as the principal investigators of the various clinical sites, and specialized core facilities (if any), and one NIAID representative (the Project Scientist). The NIAID Project Scientist will have voting membership on the SC and, as appropriate, its subcommittees. The SC will have primary responsibility for facilitating the conduct and monitoring of studies and reporting study results. Awardees will be required to accept and implement the common protocol and procedures approved by the SC. As the components of the SC may be geographically dispersed, the SC should meet with monthly conference calls, supplemented as deemed necessary by face to face meetings.

Each full member will have one vote. Awardee members of the SC will be required to accept and implement policies approved by the SC.

For single-site trials, a SC is not necessary, but the NIAID Project Scientist may request regular communication with the PD(s)/PI(s) that may include additional individuals who participate in the clinical trial activities (e.g., project managers, biostatisticians, clinical coordinators).

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.

NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.

• Final Progress Report (requirements have recently changed - please see the NOT-OD-12-152)
• Final Invention Statement and Certification (HHS 568)
• Annual Invention Utilization Reports
• Federal Financial Report (FFR) replaced the Final Cash Transaction Report (PSC 272)
• Phase II Data Collection Requirement for Government Tech-Net Database

Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.

For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF424 (R&R) SBIR/STTR Application Guide.

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.

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg.

Alkis Togias, M.D.
Division of Allergy, Immunology and Transplantation (DAIT)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (240) 627-3571
Email: togiasa@niaid.nih.gov

Mr. Martin Gutierrez
Division of Acquired Immunodeficiency Syndrome (DAIDS)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (240) 292-4844
Email: mgutierrez@niaid.nih.gov

Shy Shorer, M.D.
Division of Microbiology and Infectious Diseases (DMID)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (240) 627-3371
Email: ss932c@nih.gov

Priti Mehrotra, M.Sc., Ph.D.
Division of Extramural Activities (DEA)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5066
Email: pmehrotra@NIAID.nih.gov

Ms. Artisha Eatmon
Division of Extramural Activities (DEA)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2953
Email: Artisha.wright@nih.gov

Deanna Ingersoll
Division of Extramural Activities (DEA)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2989
Email: ingersolld@niaid.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 Parts 74 and 92.

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, and P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011). The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.