Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
Centers for Disease Control and Prevention (CDC)
U.S. Food and Drug Administration (FDA)
Administration for Children and Families (ACF)
 

Components of Participating Organizations

National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Advancing Translational Sciences (NCATS)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
National Center on Birth Defects and Developmental Disabilities (NCBDDD/CDC)
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID/CDC)
National Center for Injury Prevention and Control (NCIPC/CDC)
National Institute for Occupational Safety and Health (NIOSH/CDC)
Center for Biologics Evaluation and Research (CBER/FDA)
Center for Drug Evaluation and Research (CDER/FDA)
Center for Food Safety and Applied Nutrition (CFSAN/FDA)
Center for Devices and Radiological Health (CDRH/FDA)
Center for Veterinary Medicine (CVM/FDA)
Office of Critical Path Programs, (CPI/FDA)
Office of Orphan Products Development (OPD/FDA)
Office of Planning, Research and Evaluation, Administration for Children and Families (OPRE/ACF

Funding Opportunity Title

Reissue PHS 2013-02 Omnibus Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])

Activity Code

R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track

Announcement Type

Reissue of PA-13-088

Related Notices

  • January 17, 2014 - This PA has been reissued as PA-14-071.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • May 30, 2013 - See Notice NOT-OD-13-071 HHS Reissues PHS 2013-02 SBIR and STTR Omnibus Grant Solicitations Implementing Venture Capital Provision and SBA Company Registry Requirement of the SBIR/STTR Reauthorization Act of 2011.

Funding Opportunity Announcement (FOA) Number

PA-13-234

Companion Funding Opportunity

PA-13-235, STTR R41/R42- Phase I, Phase II, and Fast Track

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103, 93.113, 93.121, 93.136, 93.172, 93.173, 93.184, 93.213, 93.233, 93.242, 93.262, 93.273, 93.279, 93.283, 93.286, 93.307, 93.350, 93.351, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.595, 93.647, 93.837, 93.838, 93.839, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879    

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) reissued by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the Administration for Children and Families (ACF) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH, CDC, FDA or ACF awarding components identified in this FOA are encouraged to submit SBIR grant applications in response to identified topics (see PHS 2013-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, FDA and ACF.  

Key Dates
Posted Date

May 30, 2013

Open Date (Earliest Submission Date)

July 5, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

January 8, 2014

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.

Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

The SBIR program is structured in three phases, the first two of which are supported using SBIR funds. The objective of Phase I is to establish the technical/scientific merit and feasibility of the proposed R/R&D efforts. The objective of Phase II is to continue the research or R&D efforts initiated in Phase I. An objective of the SBIR program is to increase private sector commercialization of innovations derived from Federal R/R&D. The objective of Phase III, where appropriate, is for the SBC to pursue with non-SBIR funds (either Federal or non-Federal) the commercialization objectives resulting from the results of the R/R&D funded in Phases I and II.  In some Federal agencies, Phase III may involve follow-on, non-SBIR funded R&D, or production contracts for products or processes intended for use by the U.S. Government.

The competition for SBIR Phase I and Phase II awards satisfies the competition requirement of the Armed Services Procurement Act, the Federal Property and Administrative Services Act, and the Competition in Contracting Act. Therefore, an agency that wishes to fund an SBIR Phase III project is not required to conduct another competition in order to satisfy those statutory provisions. As a result, in conducting actions relative to a Phase III SBIR award, it is sufficient to state for purposes of a Justification and Approval pursuant to FAR 6.302-5 that the project is a SBIR Phase III award that is derived from, extends, or logically concludes efforts performed under prior SBIR funding agreements and is authorized under 10 U.S.C. 2304(b)(2) or 41 U.S.C. 253(b)(2).

This Funding Opportunity Announcement (FOA) re-issued by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Administration for Children and Families (ACF) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase I, Phase II, Fast-Track (NIH only), and Phase IIB Competing Renewal (NIH only) grant applications.

The PHS 2013-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, FDA, and ACF represent scientific program areas that may be of interest to applicant SBCs in the development of projects that have potential for commercialization. Small business concerns that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH, CDC, FDA, or ACF awarding components identified in this FOA are encouraged to submit SBIR grant applications in these areas. SBIR grant applications will also be accepted and considered in any area within the mission of the Components of Participating Organizations listed for this FOA. In addition to the general research areas described above some NIH awarding components have identified additional, specific SBIR funding opportunities of potential interest to SBCs. See the NIH Special Announcements for Small Business Research Opportunities. Applicants are not required to identify a potential awarding component prior to submission of the application, but may request one in a cover letter. Staff within the NIH’s Center for Scientific Review (CSR) office, the single receiving point for all NIH, FDA, CDC, and ACF grant applications, will assign all applications to the most appropriate Agency and Institute/Center (IC) based on their mission and the science proposed.

Some NIH ICs offer Phase II SBIR/STTR awardees the opportunity to apply for Phase IIB Competing Renewal awards. These are available for those projects that require extraordinary time and effort in the R&D phase and may or may not require FDA approval for the development of such projects, including drugs, devices, vaccines, therapeutics, and medical implants related to the mission of the IC. Some ICs have announced this opportunity through the NIH Guide for Grants and Contracts (see link below), and some are using this Omnibus SBIR/STTR Grant Solicitation. Only those small business concerns who have been awarded a Phase II are eligible to apply for a Phase IIB Competing Renewal award. Prospective applicants are strongly encouraged to contact NIH staff prior to submission. Additional requirements and instructions (e.g., submission of a letter of intent) are available in the specific IC research topics section and in the specific IC Program Funding Opportunity Announcements.

The following NIH ICs will accept applications for Phase IIB Competing Renewal awards: NIA, NIAAA, NIAID (SBIR only), NICHD (SBIR only and only Competing Renewals of NICHD-supported Phase II awards), NIDA, NIDCD, NIDDK (only Competing Renewals of NIDDK-supported Phase II awards), NEI (SBIR only), NIGMS (SBIR only), NIMH (SBIR only), NCATS (SBIR only), and ORIP (SBIR only). NCI offers Phase IIB opportunities that focus on the commercialization of SBIR-developed technologies. Contact the NCI SBIR Development Center at 240-276-5300, NCISBIR@mail.nih.gov for additional information. NHLBI offers Phase IIB Competing Renewals that focus on the commercialization of technologies requiring regulatory approval through the NHLBI Bridge Award (RFA-HL-13-016) and the NHLBI Small Market Award (RFA-HL-14-012).  Contact Kurt Marek, Ph.D., at 301-443-8778 or kurt.marek@nih.gov for additional information. NINDS accepts Phase IIB SBIR/STTR Competing Renewal applications through specific opportunities that focus on the commercialization of SBIR and STTR developed technologies. These opportunities can be found on the NINDS SBIR webpage: http://www.ninds.nih.gov/funding/small-business/small_business_funding_opportunities.htm. Contact Stephanie Fertig, M.B.A., at 301-496-1779 or fertigs@ninds.nih.gov for additional information.

Government-wide SBIR policy is provided by the Small Business Administration (SBA) through its SBIR Program Policy Directive. Federal agencies with extramural research and development budgets over $100 million annually are required to administer SBIR programs using a set-aside of 2.8% (FY2014) for small companies to conduct innovative R/R&D that has potential for commercialization and public benefit.

The SBIR/STTR Reauthorization Act of 2011 (P.L. 112-81) provides for new provisions for the SBIR program, some of which are available in this FOA.  NIH is implementing the provisions in the reauthorization and an information website is available.

Frequently asked questions are available to assist applicants and can answer many basic questions about the program.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
 

New (Phase I, Fast-Track)
Renewal (Phase II)
Resubmission (all phases)
Phase IIB Competing Renewal (Phase IIB, formerly Phase II Competing Renewal)
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.  CDC, FDA, and ACF will not consider SBIR applications above these guidelines.  For NIH, 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, a hard cap).  Please refer to the appropriate Institute’s or Center’s topic section for additional budget guidance. Applicants are strongly encouraged to contact program officials prior to submitting any application. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.     

Phase IIB budgets must be submitted in accordance with participating IC-specific budget limitations described in the current SBIR/STTR Program Descriptions and Research Topics of the NIH, CDC and FDA.

Award Project Period

According to statutory guidelines, award periods normally may not exceed 6 months for Phase I and 2 years for Phase II. Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project.

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.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

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) NIH only and 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.

NIH only.  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 (NIH Only):

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 CDC, FDA, and ACF SBIR program and to the NIH STTR program.

Foreign Institutions

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.

Required Registrations

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.

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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:

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.

Contractual/Consortium Arrangements

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.

Section IV. Application and Submission Information


1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Page Limitations

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

Required and Optional Components

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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.  NIH Only - 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.

SF424(R&R) Senior/Key Person Profile Expanded

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

R&R Budget

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

Technical Assistance: NIH offers distinct technical assistance programs to SBIR and STTR Phase I and Phase II awardees.  These programs offer specialized, strategic business training and provide access to a vast network of industry experts possible through the efficiencies of scale that under a contract deliver the best value to the government and the intended small businesses seeking such assistance.  If you wish to utilize your own technical assistance provider, you are required to include this as a consultant in your budget and to provide a detailed budget justification.  You may request up to $5,000 for assistance. Reimbursement is limited to services received that comply with 15 U.S.C. § 638(q):

To provide small business concerns engaged in SBIR or STTR projects with technical assistance services, such as access to a network of scientists and engineers engaged in a wide range of technologies, or access to technical and business literature available through on-line data bases, for the purpose of assisting such concerns in:

To request technical assistance from your own provider:

1.  Label the requested cost of up to $5,000 “Technical Assistance” in the  Other Direct Costs section of the R&R Budget component on lines 8-10.

2.  Include a detailed description of the services your vendor will provide in  Budget Justification.

PHS 398 Cover Letter

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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 modification:

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

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.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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.

Overall Impact

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).

Scored Review Criteria

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?     

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?   

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?   

Additional Review Criteria

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

For Phase IIB Applications (formerly called Phase II Competing Renewals), the committee will consider the progress made in the last funding period.

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.

Additional Review Considerations

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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information


1. Award Notices

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.      

2. Administrative and National Policy Requirements

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.

Report fraud, waste and abuse

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

Not Applicable

3. Reporting

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.

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 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.

Scientific/Research & Financial Grants Management Contact(s)

Questions of a general nature about the NIH SBIR/STTR program may be directed to:

NIH SBIR/STTR Program Office
Phone:  301-435-2688
Fax: 301-480-0146
Email:  sbir@od.nih.gov

Awarding Component

Scientific/Research Contact

Financial/Grants Mgmt Contact

National Institute on Aging
http://www.nia.nih.gov

Dr. Michael-David A.R.R. Kerns
Phone: 301-402-7713
Fax:      301-402-2945
Email: 
Michael-David.Kerns@nih.gov

Ms. Linda Whipp
Phone: 301-496-1472
Fax:      301-402-3672
Email:  Linda.Whipp@nih.gov

National Institute on Alcohol Abuse and Alcoholism
http://www.niaaa.nih.gov

Dr. Gary Murray
Phone: 301-443-9940
Fax:      301-594-0673
Email:  Gary.Murray@nih.gov

Ms. Judy Fox
Phone: 301-443-4704
Fax:      301-443-3891
Email:  Judy.Fox@nih.gov

National Institute of Allergy and Infectious Diseases
http://www.niaid.nih.gov

Dr. Paula Strickland
Phone: 301-435-8563
Fax:      301-480-1993
Email:  pstrickland@nih.gov

Mr. Michael Wright
Phone: 301-451-2688
Fax:      301-493-0597
Email:mawright@mail.nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases
http://www.niams.nih.gov/

Dr. Xibin Wang
Phone: 301-451-3884
Fax:      301-480-1284
Email:  wangx1@mail.nih.gov

Ms. Sheila Simmons
Phone: 301-594-9812
Fax:      301-480-5450
Email:  simmonss@mail.nih.gov

Mr. Erik (Timothy) Edgerton
Phone: 301-594-3968
Fax:      301-480-5450
Email:edgertont@mail.nih.gov

National Institute of Biomedical Imaging and Bioengineering
http://www.nibib.nih.gov/

Mr. Todd Merchak
Phone: 301-496-8592
Fax:      301-480-1614
Email:merchakt@mail.nih.gov

Mr. James Huff
Phone: 301-451-4786
Fax:      301-451-5735
Email:  huffj@mail.nih.gov

National Cancer Institute
http://sbir.cancer.gov

Mr. Michael Weingarten
Dr. Greg Evans
Dr. Andrew Kurtz
Phone: 240-276-5300
Fax: 240-276-5236
Email: ncisbir@mail.nih.gov

Ms. Jacquelyn Boudjeda
Phone: 240-276-6312
Fax:      301-496-8662
Email: boudjedaj@mail.nih.gov

Eunice Kennedy Shriver
National Institute of Child Health and Human Development
http://www.nichd.nih.gov

Louis A. Quatrano, Ph.D.
Phone: 301-402-4221
Fax:      301-402-0832
Email:Quatranol@mail.nih.gov

Mr. Ted Williams
Phone: 301- 435-6996
Fax:      301- 451-5510
Email:  williate@mail.nih.gov

National Institute on Drug Abuse
http://www.nida.nih.gov

Elena Koustova, Ph.D., MBA
Phone: 301-496-8768
Email:koustovae@nida.nih.gov

Ms. Diana Haikalis, M.B.A.
Phone:             301-443-6710
Fax:      301-594-6849
Email:  dhaikali@nida.nih.gov

National Institute on Deafness and Other Communication Disorders
http://www.nidcd.nih.gov

Dr. Roger L. Miller
Phone: 301-402-3458
Fax:      301-402-6251
Email:  Roger.Miller@nih.gov

Mr. Christopher P. Myers
Phone: 301-435-0713
Fax:      301-402-1758
Email: Christopher.Myers@nih.gov

National Institute of Dental and Craniofacial Research
http://www.nidcr.nih.gov

Dr. R. Dwayne Lunsford
Phone: 301-594-2421
Fax:      301-480-8319
Email:  lunsfordr@mail.nih.gov

Ms. Mary Greenwood
Phone: 301-594-4808
Fax:      301-480-3562
Email:  mary.daley@nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases
http://www.niddk.nih.gov

Ms. Christine Densmore
Phone: 301-402-8714
Fax:      301-480-8300
Email: densmorec@niddk.nih.gov

Mr. Gene McGeehan
Phone: 301-594-0417
Fax:      301-594-9523
Email: mcgeehane@niddk.nih.gov

National Institute of Environmental Health Sciences
http://www.niehs.nih.gov

Dr. Daniel T. Shaughnessy
Phone: 919-541-2506
Fax:      919-541-4606
Email: shaughn1@niehs.nih.gov

Ms. Pam Clark
Phone: 919-541-7629
Fax:      919-541-2860
Email:  evans3@niehs.nih.gov

National Eye Institute
http://www.nei.nih.gov

Dr. Jerome Wujek
Phone: 301-451-2020
Fax:      301-496-2297
Email:  wujekjer@nei.nih.gov

Mr. William Darby
Phone: 301-451-2020
Fax:      301-496-9997
Email:  wwd@nei.nih.gov

National Institute of General Medical Sciences
http://www.nigms.nih.gov/

Dr. Scott Somers
Phone: 301-594-3827
Fax:      301-480-2802
Email:somerss@nigms.nih.gov

Ms. Patrice Molnar
Phone: 301-594-5136
Fax:      301-480-2554
Email: molnarp@nigms.nih.gov

National Heart, Lung, and Blood Institute
http://www.nhlbi.nih.gov

Kurt Marek, Ph.D.
Phone: 301-443-8778
Fax:      301-480-0422
Email:  Kurt.Marek@nih.gov

Andre Walker
Phone: 301-435-0166
Fax:      301-451-5462
Email:  Andre.Walker@nih.gov

Hubert Walters
Phone: 301-435-0166
Fax:      301-451-5462
Email: waltersh@nhlbi.nih.gov

National Human Genome Research Institute
http://www.genome.gov

Bettie J. Graham, Ph.D.
Phone: 301-496-7531
Fax:      301-480-2770
Email: Bettie_graham@nih.gov

Ms. Cheryl Chick
Phone: 301-435-7858
Fax:      301-402-1951
Email:  ChickC@mail.nih.gov

National Institute of Mental Health
http://www.nimh.nih.gov

Dr. Margaret C. Grabb
Phone: 301-443-3563
Fax:      301-443-1731
Email:  mgrabb@mail.nih.gov

Ms. Rebecca Claycamp
Phone: 301-443-2811
Fax:      301-443-6885
Email:  rclaycam@mail.nih.gov

National Institute on Minority Health and Health Disparities
http://www.nimhd.nih.gov/

Mr. Vincent A. Thomas, Jr.
MSW, MPA
Phone: 301-402-2516
Fax:      301-480-4049
Email:thomasvi@mail.nih.gov

Ms. Priscilla Grant, J.D., C.R.A.
Phone: 301-594-8412
Fax:      301-480-4049
Email:  Priscilla.Grant@nih.gov

National Institute of Neurological Disorders and Strokehttp://www.ninds.nih.gov

Ms. Stephanie Fertig
Phone: 301-496-1779
Fax:      301-402-1501
Email:  fertigs@ninds.nih.gov

Ms. Tijuanna Decoster
Phone: 301-496-9231
Fax:      301-402-4370
Email:decostert@mail.nih.gov

National Institute of Nursing Research
http://www.nih.gov/ninr

Dr. Paul A. Cotton
Phone: 301-402-6423
Fax:      301-480-8260
Email:  Paul.Cotton@nih.gov

Mr. Brian Albertini
Phone: 301-594-6869
Fax:      301-402-4502
Email:  albertib2@mail.nih.gov

National Center for Advancing Translational Sciences
http://www.ncats.nih.gov

Lili M. Portilla, MPA
Director, Strategic Alliances
Phone :   301-402-0304
Fax : 301-480-3661
Email: Portilll@mail.nih.gov

Mrs. Tiffany Walker
Phone: 301-402-0839
Fax:      301-480-3777
Email:  walkerti@mail.nih.gov

National Center for Complementary and Alternative Medicine
http://www.nccam.nih.gov/

Dr. Craig Hopp
Phone: 301-496-5825
Fax:      301-480-1587
Email:  hoppdc@mail.nih.gov

Mr. George Tucker, MBA
Phone: 301-594-8853
Fax:      301-480-1552
Email: George.Tucker@nih.gov

National Library of Medicine
http://www.nlm.nih.gov

Dr. Jane Ye
Phone: 301-594-4882
Fax:      301-402-2952
Email:  yej@mail.nih.gov

Mr. Dwight Mowery
Phone: 301-496-4221
Fax:      301-402-0421
Email:moweryd@mail.nih.gov

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs
http://dpcpsi.nih.gov/ORIP/index.aspx

Dr. Miguel Contreras
Phone: 301-594-9410
Fax:      301-480-3819
Email:  contre1@mail.nih.gov

Mr. Long Nguyen
Phone: 301-402-6737
Fax:      301-480-3777
Email: nguyen1@mail.nih.gov

Centers for Disease Control and Prevention (CDC)
http://www.cdc.gov

Dr. Brenda Colley Gilbert
(NCBDDD)
Phone:  770-488-8390
Fax:      770-488-8046
Email: BColleyGilbert@cdc.gov

Ms. Barbara Stewart (NCEZID)
Phone:  404-718-8832
Fax:      404-498-2626
Email:   BStewart@cdc.gov

Dr. Paul Smutz (NCIPC)
Phone:  770-488-4850
Fax:      770-488-1665
Email:   wsmutz@cdc.gov

Dr. Allen Robison (NIOSH)
Phone:  404-498-2509
Fax:      404-498-0751
Email:   WRobison@cdc.gov

Roslyn Curington (NCBDDD)
Phone: 770-488-2745
Fax: 770-488-2777
Email: RCurington@cdc.gov

Tracey Sims (NCBDDD)
Phone: 770-488-2739
Fax: 770-488-2777
Email: TraceySims@cdc.gov

Mr. Hector Buitrago (NCEZID)
Phone: 770-488-2921
Fax:      770-488-2777
Email:   HBuitrago@cdc.gov

Ms. Sharron Orum (NCIPC)
Phone: 770-488-2716
Fax: 770-488-2847
Email: SOrum@cdc.gov

Ms. Mary Pat Shanahan (NIOSH)
Phone:  412-386-4453
Fax:      412-386-6429
Email:   MShanahan@cdc.gov

Food and Drug Administration (FDA)
http://www.fda.gov

Ms. Kimberly Pendleton Chew
Phone: 301-827-9363
Fax:      301-827-1044
Email: kimberly.pendleton@fda.hhs.gov

Mr.  Martin Bernard
Phone: 301-443-5869
Fax:      301-827-0505
Email: artin.Bernard@fda.hhs.gov

Administration for Children and Families
http://www.acf.hhs.gov

Anne F. Bergan
Phone: 202-260-8515
Fax:      202-205-3598
Email: abergan@acf.hhs.gov

Edeltraud Fernandez
Phone: 202-401-2346
Fax:      202-205-3598
Email:efernandez@acf.hhs.gov



Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Section VIII. Other Information

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.

Authority and Regulations

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.


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