Source: https://grants.nih.gov/grants/guide/pa-files/PA-15-077.html
Timestamp: 2017-01-18 10:26:37
Document Index: 78843467

Matched Legal Cases: ['§ 121', '§ 121', 'art 121', '§ 3703', '§ 3705', 'art 52', 'arts 74']

PA-15-077: New Technologies for Viral Hepatitis SBIR (R43/R44)
New Technologies for Viral Hepatitis 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-12-090 Related Notices
October 4, 2016 - Notice to Inform the Applicant Community that NIDDK Will Not Accept Clinical Trial Applications in Response to Current Small Business Announcements. See Notice NOT-DK-16-030.
April 7, 2016 - Notice of Availability of Administrative Supplements on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). See Notice NOT-AI-16-046. 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)
PA-15-077 Companion Funding Opportunity
PA-15-076, STTR R41/R42- Phase I, Phase II, and Fast Track
See Section III. 3. Additional Information on Eligibility. Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.847, 93.865, 93.839 Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business companies to address viral hepatitis research opportunities as delineated in the Department of Health and Human Services Action Plan for the Prevention, Care and Treatment of Viral Hepatitis and within the research missions of the participating institutes. Key Dates
Scientific Merit Review Standard dates apply. Advisory Council Review
Standard dates apply. Earliest Start Date Standard dates apply Expiration Date
Despite advances in the treatment of chronic viral hepatitis B and C, the persistence of these and the emergence of other hepatitis viruses continue to remain a public health challenge in the United States. Currently, it is estimated that 3.5 to 5.3 million persons in the United States are afflicted by viral hepatitis. The consequences of acute and chronic viral hepatitis vary, but can be severe and lead to acute liver failure, cirrhosis of the liver, and predispose afflicted persons to hepatocellular carcinoma. Once liver failure ensues from either acute or chronic viral hepatitis or if liver cancer emerges predisposed by cirrhosis from chronic viral hepatitis, liver transplantation becomes the only viable option, a costly and resource intensive therapy. Even with advances in medical care, approximately 12,000 to 15,000 Americans succumb to the complications of acute or chronic viral hepatitis each year. In January 2010, the Institute of Medicine (IOM) released the report "Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C" (http://www.iom.edu/ ). This report identified and highlighted viral hepatitis as a national health concern and outlined barriers that hinder health care delivery for viral hepatitis patients. In response to the Institute of Medicine report, the Department of Health and Human Services under the direction of Dr. Howard Koh, Assistant Secretary for Health, convened a working group that generated the report "Combating the Silent Epidemic of viral Hepatitis: U.S. Department of Health and Human Services Action Plan for the Prevention, Care and Treatment of Viral Hepatitis" (Viral Hepatitis Action Plan), which was released on May 12, 2011 (http://www.hhs.gov/ash/initiatives/hepatitis/ ). The Viral Hepatitis Action Plan represented an integrated Federal government response to the public health implications of acute and chronic viral hepatitis. Furthermore, the Viral Hepatitis Action Plan provided a framework to coordinate the Federal government wide approach to address the challenges raised in the IOM report regarding the public health implications of acute and chronic viral hepatitis. Integrated into the Viral Hepatitis Action Plan were several action items germane to the research mission of the National Institutes of Health. The topics ranged from basic, translational, and clinical research to coordination of disseminating research findings into the clinical realm. These action items and overall progress in achieving public health objectives in viral hepatitis were recently updated in 2014. Specific research topics assigned to the National Institutes of Health can be found in the updated Action Plan for the Prevention, Care & Treatment of Viral Hepatitis (http://aids.gov/pdf/viral-hepatitis-action-plan.pdf ).
This FOA encourages small business establishments to submit applications that address any of the specific research topics in the updated Action Plan for the Prevention, Care & Treatment of Viral Hepatitis that are assigned to the NIH and germane to the research mission of the respective NIH Institutes and Centers in order to facilitate the development, evaluation, and validation of products that would be implemented in the public health efforts to reduce the burden of viral hepatitis in the United States. Applications that propose studies above a Phase I Clinical Trial will be beyond the scope of this FOA. A sampling of research objectives and strategies appropriate for this FOA from the Viral Hepatitis Action Plan include, but are not limited to:
Develop new diagnostic tests for viral hepatitis that would aid in clinical management, such as tests that would discriminate between acute and chronic infection, identify viral hepatitis infected infants among infants born to women with viral hepatitis, or would allow for better assessment of need for treatment and monitoring, such as tests for IgM antibodies to hepatitis C, D or E, or means of measurement of HBV, HCV, HDV and HEV levels that are as reliable but less expensive and resource demanding than current molecular assays. Develop non-invasive and practical tests that could be used to monitor patients for complications of chronic viral hepatitis, such as portal hypertension, esophageal varices and hepatocellular carcinoma.
Develop computer algorithms that would help in the practical diagnosis, management, monitoring and therapy of viral hepatitis. Develop candidate vaccines for hepatitis C or innovative means of prevention.
Develop tests for the frequency of aberrant hypermethylation and hypomethylation of specific genes that are associated with HCV infection and the development of HCC tumors and that may be useful in prognosis and treatment. Section II. Award Information
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. 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.
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 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
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
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.
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.
Phase I to Phase II Transition Rate Benchmark In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011. This Transition Rate requirement applies to SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years, excluding the most recently-completed fiscal year. For these companies, the benchmark establishes a minimum number of Phase II awards the company must have received for a given number of Phase I awards received during the 5-year time period in order to be eligible to receive a new Phase I award. This requirement does not apply to companies that have received 20 or fewer Phase I awards over the 5 year period. Companies that apply for a Phase I award and do not meet or exceed the benchmark rate will not be eligible for a Phase I award for a period of one year from the date of the application submission. The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently-completed year. The benchmark minimum Transition Rate is 0.25. SBA calculates individual company Phase I to Phase II Transition Rates daily using SBIR and STTR award information across all federal agencies. For those companies that have received more than 20 Phase I awards over the past 5 years, SBA posts the company transition rates on the Company Registry at SBIR.gov. Information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov. Applicants to this FOA that may have received more than 20 Phase I awards across all federal SBIR/STTR agencies over the past five (5) years should, prior to application preparation, verify that their company’s Transition Rate on the Company Registry at SBIR.gov meets or exceeds the minimum benchmark rate of 0.25. Foreign Institutions
System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. SBA Company Registry – New requirement. See Section IV. Application and Submission Information, "SF424(R&R) Other Project Information Component" 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. eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. 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
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. The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
A 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 or IIB support, a Phase I awardee should submit a Phase II application, and a Phase II awardee should submit a Phase IIB application, within the first six due dates following the expiration of the Phase I or II budget period, respectively. 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 following section supplements the instructions found in the SF 424 (R&R) SBIR/STTR Application Guide and should be used for preparing an application to this FOA. 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: 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.
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.
Download the "SBIR Application VCOC Certification.pdf" at the NIH SBIR Forms webpage. Answer the 3 questions and check the certification boxes.
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.
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 field 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. R&R Subaward Budget
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed. PHS 398 Research Plan
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, Note that Phase I SBIR/STTR Appendix materials are not permitted.
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)
Post Submission Materials Applicants are required to follow our Post Submission Application Materials policy. Section V. Application Review Information
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)
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
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
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 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, the committee will consider the progress made in the last funding period. Revisions
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.
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.
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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions: Scientific and technical merit of the proposed project as determined by scientific peer review.
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.
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
Final Progress Report (requirements have recently changed - please see the NOT-OD-12-152) Final Invention Statement and Certification (HHS 568)
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 Part III. Section 5, "SBIR/STTR Award Guidelines, Reporting Requirements, and Other Considerations," in the Supplement Grant Applications For All Competing Applications and Progress Reports. 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 Statementfor additional information on this reporting requirement.
Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages) Contact Center Telephone: 800-518-4726 Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources) Telephone: 301-945-7573
Email: commons@od.nih.gov SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Christine L. Densmore, M.S. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-435-0074
Email: siberryg@mail.nih.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).
Andre D. Walker
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. Weekly TOC for this Announcement