Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/)
Food and Drug Administration (FDA), (http://www.fda.gov/)
Administration for Children and Families (ACF), (http://www.acf.hhs.gov)

Components of Participating Organizations
National Cancer Institute (NCI/NIH), (http://www.cancer.gov/)
National Eye Institute (NEI/NIH), (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI/NIH), (http://www.nhlbi.nih.gov/index.htm)
National Human Genome Research Institute (NHGRI/NIH), (http://www.genome.gov/)
National Institute on Aging (NIA/NIH), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID/NIH), (http://www3.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS/NIH), (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH), (http://www.nibib.nih.gov/)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD/NIH), (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD/NIH), (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR/NIH), (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH), (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA/NIH), (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS/NIH), (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS/NIH), (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH/NIH), (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS/NIH), (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR/NIH), (http://www.ninr.nih.gov/)
National Library of Medicine (NLM/NIH), (http://www.nlm.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM/NIH), (http://nccam.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD/NIH), (http://ncmhd.nih.gov/)
National Center for Research Resources (NCRR/NIH), (http://www.ncrr.nih.gov/)
National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (NCIPC/CDC) (http://www.cdc.gov/nceh/)
National Center for Health Statistics (NCHS/CDC), (http://www.cdc.gov/nchs/)
National Center for Public Health Informatics (NCPHI/CDC) (http://www.cdc.gov/ncphi/) (No Longer participating after the December 5, 2010 receipt date, per NOT-OD-10-131)
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP/CDC), (http://www.cdc.gov/nccdphp/)
National Institute for Occupational Safety and Health (NIOSH/CDC), (http://www.cdc.gov/niosh/homepage.html)
National Center for Environmental Health, (NCEH/CDC) (http://www.cdc.gov/nceh/)
Center for Biologics Evaluation and Research (CBER/FDA), (http://www.fda.gov/cber/)
Center for Drug Evaluation and Research (CDER/FDA), (http://www.fda.gov/cder/)
Center for Food Safety and Applied Nutrition (CFSAN/FDA), (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/default.htm)
Center for Devices and Radiological Health (CDRH/FDA), (http://www.fda.gov/cdrh/)
Center for Veterinary Medicine (CVM/FDA), (http://www.fda.gov/cvm/)
Office of Critical Path Programs, (http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm)
Office of Orphan Products Development (OPD/FDA), (http://www.fda.gov/orphan/)
Office of Planning, Research and Evaluation, Administration for Children and Families (OPRE/ACF) (http://www.acf.hhs.gov/programs/opre/index.html)

Title: PHS 2010-02 Omnibus Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PA-09-080.

Update: The following update relating to this announcement has been issued:

• January 24, 2011 - This PA has been reissued as PA-11-096.
• August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
• September 1, 2010 - See Notice NOT-OD-10-131 This notice amends the participating organizations. The National Center for Public Health Informatics (NCPHI/CDC) will not be accepting SBIR applications for the December 5, 2010 submission date.
• April 1, 2010: See Guide Notice NOT-OD-10-079 for updated information about SBIR award levels.

Program Announcement (PA) Number: PA-10-050

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

IMPORTANT: A registration process in Grants.gov and eRA Commons is necessary before submission. Applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.061, 93.103, 93.113, 93.121, , 93.143, 93.172, 93.173, 93.213, 93.242, 93.262, 93.273, 93.279, 93.283, 93.286, 93.307, 93.361, 93.389, 93.393, 93.394, 93.395, 93.396, 93.399, 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

Key Dates
Release/Posted Date: January 15, 2010
Opening Date: March 5, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable.
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: January 8, 2011

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

• Purpose. This Funding Opportunity Announcement (FOA) issued 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 and ACF awarding components identified in this FOA are encouraged to submit SBIR grant applications in response to identified topics (see PHS 2010-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, FDA and ACF.)
• Mechanism of Support. This FOA will utilize the SBIR (R43/R44) grant mechanisms for Phase I, Phase II, and Fast-Track applications and runs in parallel with a FOA of identical scientific scope, PA-10-051, which encourages applications under the Small Business Technology Transfer (STTR) (R41/R42) grant mechanisms. Note: STTR applications are accepted ONLY by the NIH. The CDC, FDA and ACF do not participate in the STTR program. SBIR Fast-Track and Phase II Competing Renewal grant applications are accepted by the NIH only.
• Funds Available and Anticipated Number of Awards: Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.
• Budget and Project Period. Phase I awards normally may not exceed $100,000 total for a period normally not to exceed 6 months. Phase II awards normally may not exceed $750,000 total for a period normally not to exceed 2 years. These award levels and project periods are statutory guidelines, not ceilings. Therefore, applicants are encouraged to propose a budget and project duration period that are reasonable and appropriate for completion of the research project. Phase II Competing Renewal 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.
• Eligible Institutions/Organizations. Only United States SBCs may submit SBIR applications and receive SBIR awards. A SBC is one that, on the date of award for both Phase I and Phase II funding agreements, meets ALL of the criteria as described in Section III.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their 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. On an SBIR application, the PD/PI must have his/her primary employment (more than 50%) with the SBC at the time of award and for the duration of the project.
• Number of PDs/PIs. More than one PD/PI, (i.e., multiple PDs/PIs), may be designated on the application.
• Number of Applications. Applicant SBCs may submit more than one application, provided each application is scientifically distinct.
• Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Only SBIR Phase II awardees are eligible to submit a SBIR Phase II Competing Renewal application, which should represent a continuation of support for research and development of the previous work funded by the original SBIR Phase II grant. SBIR Phase II Competing Renewal applications will be accepted by only those ICs described in the current SBIR/STTR Program Descriptions and Research Topics of the NIH, CDC and FDA. Phase II competing renewals are accepted only by NIH.
• Application Materials. See Section IV.1 for application materials.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired. Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The SBIR program, as established by law, is intended to meet the following goals:

• stimulate technological innovation in the private sector;
• strengthen the role of small business in meeting Federal research or research and development (R/R&D) needs;
• increase the commercial application of Federally-supported research results;
• foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns in the SBIR program; and
• improve the return on investment from Federally-funded research for economic and social benefits to the Nation.

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) 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 II Competing Renewal (NIH only) grant applications.

The PHS 2010-2 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, and 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. 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 Institute/Center (IC) based on their mission and the science proposed.

Some of the NIH ICs offer the opportunity to submit Phase II Competing Renewal applications that will provide additional funding for Phase II SBIR projects. These renewals are often offered for those projects that require regulatory approval for the product or service being developed or to support complex instrumentation, clinical research tools, and behavioral interventions/treatments. For those ICs that included these opportunities in the PHS 2010-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, FDA, and ACF, applications will be accepted through this Parent SBIR FOA. All others must be submitted in response to the specific FOA released by the IC. See the NIH Special Announcements for Small Business Research Opportunities for a list of these unique SBIR funding opportunities.

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 2.5% for small companies to conduct innovative R/R&D that has potential for commercialization and public benefit.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the Small Business Innovation Research (SBIR [R43/R44] grant mechanisms. Applications may be submitted for support as Phase I, Phase II, or Fast-Track grants as described in the SF424 (R&R) SBIR/STTR Application Guide.

Small business concerns that have received a Phase I SBIR grant may apply for Phase II funding of that project. The Phase II must be a logical extension of the Phase I research but not necessarily as a Phase I project supported in response to this funding opportunity. SBIR Phase II applications will compete with all SBIR applications and will be reviewed according to the customary peer review procedures. Applications for NIH SBIR Phase II Competing Renewal grants will be accepted by only those ICs described in the current SBIR/STTR Program Descriptions and Research Topics of the NIH, CDC, FDA, and ACF.

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses Just-in-Time information concepts. The modular budget format is not accepted for SBIR grant applications. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget component found in the application package attached to this FOA in Grants.gov/Apply.

2. Funds Available

Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.

The SF424 (R&R) SBIR/STTR Application Guide indicates the statutory guidelines of funding support and project duration periods for Phase I and Phase II SBIR awards. Phase I awards normally may not exceed $100,000 total for a period normally not to exceed 6 months. Phase II awards normally may not exceed $750,000 total for a period normally not to exceed 2 years. These award levels and project periods are statutory guidelines, not ceilings. Therefore, applicants are encouraged to propose a budget and project duration period that are reasonable and appropriate for completion of the research project.

SBIR Phase II Competing Renewal 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.

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

1.A. Eligible Institutions

Only United States small business concerns (SBCs) are eligible to submit SBIR applications. A small business concern is one that, at the time of award of SBIR 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 can be no more than 49 percent participation by foreign business entities in the joint venture;

3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;

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

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.

Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 C.F.R. 121.3-2(a). The term "number of employees" is defined in 13 C.F.R. 121.3-2(t).

Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Office of Size Standards (http://sba.gov/size).

One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an SBIR awardee organization must be space that is available to and under the control of the SBIR awardee for the conduct of its portion of the proposed project.

Title 13 CFR 121.3 also states that control or the power to control exists when key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise. Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.

For purposes of the SBIR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13 CFR 121.106 Small Business Size Regulations.

Note: In determining size, SBA considers stock options, convertible securities, and agreements to merge (including agreements in principle) to have a present effect on the power to control a concern. SBA treats such options, convertible securities, and agreements as though the rights granted have been exercised. See http://edocket.access.gpo.gov/cfr_2005/janqtr/pdf/13cfr121.103.pdf.

All SBIR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an SBIR award until the SBA provides a determination.

Note: An applicant organization that has been determined previously by SBA to be other than small for a size standard of not more than 500 employees or for purposes of the SBIR/STTR program, must be recertified by the SBA prior to any future SBIR/STTR awards.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

As defined in 42 CFR 52, the PD/PI is the single individual designated by the grantee in the grant application who is responsible for the scientific and technical direction of the project. When the proposed PD/PI clearly does not have sufficient qualifications to assume this role, the application is not likely to receive a favorable evaluation.

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 PD/PIs, at least one must meet the primary employment requirement. That individual will serve as the Contact PD/PI. Primary employment means that more than one half of the PD/PI’s time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization. Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.

If the application has the likelihood for funding, the awarding component will require documentation to verify the eligibility of the Contact PD/PI, if at the time of submission of the application, the Contact PD/PI is a less-than-full-time employee of the small business concern, is concurrently employed by another organization, or gives the appearance of being concurrently employed by another organization, whether for a paid or unpaid position.

If the Contact PD/PI is employed or appears to be employed by an organization other than the applicant organization in a capacity such as Research Fellow, Consultant, Adjunct Professor, Clinical Professor, Clinical Research Professor, or Associate, a letter must be provided by each employing organization confirming that, if an SBIR grant is awarded to the applicant small business concern, the Contact PD/PI is or will become a less-than-half-time employee of such organization and will remain so for the duration of the SBIR project. If the Contact PD/PI is employed by a university, such a letter must be provided by the Dean's office or equivalent; for other organizations, the letter must be signed by a corporate official.

All current employment and all other appointments of the Contact PD/PI must be identified in his or her Biographical Sketch required as part of the application. Be certain that correct beginning and ending dates are indicated for each employment record listed.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). All original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016

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).

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 PHS398 Research Plan component of SF424 (R&R) application forms.

Applicants may submit more than one application, provided that each application is scientifically distinct. The NIH will accept as many "different" applications as the applicant organization chooses. However, the 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 SBIR funding opportunity and any other HHS FOA, including the current SBIR and STTR Parent FOAs.

Likewise, identical or essentially identical grant applications submitted by different organizations will not be accepted. Applicant organizations should ascertain and assure that the materials they are submitting on behalf of the principal investigator are the original work of the principal investigator and have not been used elsewhere in the preparation and submission of a similar grant application. Applications to the NIH are grouped by scientific discipline for review by individual Scientific Review Groups and not by disease or disease state. The reviewers can thus easily identify multiple grant applications for essentially the same project. In these cases, application processing may be delayed or the application(s) may be returned to the applicant without review.

It is unlawful to enter into contracts or grants requiring essentially equivalent work or effort. Essentially equivalent work or effort occurs when (1) substantially the same research is proposed for funding in more than one contract proposal or grant application submitted to the same Federal agency; (2) substantially the same research is submitted to two or more different Federal agencies for review and funding consideration; or (3) a specific research objective and the research design for accomplishing an objective are the same or closely related in two or more proposals or awards, regardless of the funding source. If there is any question concerning essentially equivalent work or effort, it must be disclosed to the soliciting agency or agencies before award.

Only one Phase II award may be made for a single SBIR/STTR project.

You may submit a Phase II application either before or after expiration of the Phase I budget period, unless you elect 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 grantee organization should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.

SBIR Phase II awardees may submit an SBIR Phase II Competing Renewal application for 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. Applicants are strongly encouraged to contact NIH IC program staff prior to submitting SBIR Phase II Competing Renewal applications.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant SBC can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual(s) designated as PDs/PIs on the application must also be registered in the NIH eRA Commons and be assigned the PI role in the eRA Commons prior to the submission of the application. It is not necessary for PDs/PIs to register with Grants.gov.
• Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. When PDs/PIs are located at another institution, only the contact PI (the PI named on the SF424 (R&R) Cover) must be affiliated with the applicant small business concern; other PD/PIs need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or their designee who is already registered in the Commons.

To affiliate the PD/PI with the applicant small business concern:

• PD/PI gives Commons user ID to the administrator of the applicant organization/institution.
• Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the Accounts Administrator.)
• Administrator selects "Admin" tab, Accounts tab and then "Manage Accounts" tab.
• Administrator enters search criteria provided by PD/PI, removes the check from the Search within your institution checkbox, and clicks Search .
• Administrator locates the PD/PI entry in the search results and selects the Create Affiliation Action link.
• Administrator clicks Confirm on the Create Affiliation confirmation screen to complete the affiliation.

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR Application Guide for this FOA using the Apply for Grant Electronically button in this FOA or through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all SBIR applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) SBIR/STTR Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Failure to include this data field will cause the application to be rejected.

Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/ APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
SBIR/STTR Information

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project (see Section III.1.B). The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above. For SBIR, the contact PD/PI must be employed by the small business. All funding for SBIR projects goes to the small business awardee, so funding for PD/PIs from other organizations must be requested via a subcontract with the small business using the Research & Related Subaward Budget Attachment(s) Form.

Information for the Contact PD/PI should be entered on the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the Research Plan section and the Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: March 5, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants may use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4.

Note: Applications must only be submitted electronically.

PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

• Initial application submission must be on-time.
• The AOR/institution is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR). Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a resubmission for the SF424 (R&R).

4. Intergovernmental Review

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. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide are to be followed, with the following requirements.

SBIR Phase I Applications

• Although preliminary data are not required, they may be included.
• Introduction (required for a resubmission or revision application) is limited to 1 page.
• Specific Aims section is limited to one (1) page.
• The Research Strategy section may not exceed six (6) pages, including tables, graphs, figures, diagrams, and charts.
• The Biographical Sketch is limited to a maximum of four (4) pages for each senior/key person. (This includes the table at the top of the first page).
• There is no further limitation on the total number of pages for the entire Phase I application; however, applicants are encouraged to be succinct.

SBIR Phase II and Phase II Competing Renewal Applications

• Introduction (required for a resubmission or revision application) is limited to 1 page.
• Specific Aims section is limited to one (1) page.
• The Research Strategy section may not exceed twelve (12) pages, including tables, graphs, figures, diagrams, and charts.
• The Biographical Sketch is limited to a maximum of four (4) pages for each senior/key person. (This includes the table at the top of the first page.)
• The Phase II application must include a Commercialization Plan (maximum twelve (12) pages) that addresses specific points as described in the SF424 (R&R) SBIR/STTR Application Guide.
• There is no further limitation on the total number of pages for the entire Phase II application; however, applicants are encouraged to be succinct.

Applicants are strongly encouraged to contact program staff prior to submitting SBIR Phase II Competing Renewal applications.

SBIR Fast-Track Applications

• The NIH Fast-Track application is a single application consisting of Phase I and Phase II activities. See the section on Fast-Track Applications in the SF424 (R&R) SBIR/STTR Application Guide.
• Introduction (required for a resubmission or revision application) is limited to 1 page.
• Specific Aims section is limited to one (1) page.
• The Phase I portion of a Fast-Track must specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II work.
• The Research Strategy section may not exceed twelve (12) pages, including tables, graphs, figures, diagrams, and charts. That is, the combined Phase I and Phase II plans for Fast-Track applications must be contained within the 12-page limitation.
• The Fast-Track application must include a Commercialization Plan (maximum twelve (12 pages)) that addresses specific points as described in the SF424 (R&R) SBIR/STTR Application Guide.

Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) SBIR/STTR Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process. Phase I SBIR/STTR Appendix materials are not permitted unless specifically requested by NIH.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing (for example, human subject concerns, the Small Business Act provisions, etc.), this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with NIH Institute/Center (IC) program staff likely to accept assignment of their application (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications submitted for this funding opportunity will be assigned to the ICs for funding consideration on the basis of established PHS referral guidelines.

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the scientific peer review, all applications will:

• Undergo a selection 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/priority score;
• Receive a written critique; and
• Receive a second level of review by the appropriate national advisory council or board.

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support 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/priority 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 five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, 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) Protections for Human Subjects, 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 arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

For Phase II Applications Only. When reviewing 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?

For Phase I/Phase II Fast-Track Applications Only. When reviewing 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.

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.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), 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.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), 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 address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Select Agents 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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended SBIR or STTR applications. 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.

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his/her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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. See also Section IV.5., Funding Restrictions.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

For Fast-Track applications, the Phase II portion may not be funded until a Phase I final report and other documents necessary for continuation have been received and assessed by program staff that the Phase I milestones have been successfully achieved.

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.

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.

• Financial Status Report (OMB 269, http://www.whitehouse.gov/omb/grants/grants_forms.html)
• Final Progress Report
• Final Invention Statement and Certification (HHS 568)
• Annual Invention Utilization Reports
• Final Cash Transaction Report (PSC 272, http://www.dpm.psc.gov/Reports.aspx)
• Phase II Data Collection Requirement for Government Tech-Net Database (http://technet.sba.gov)

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 SF 424 (R&R) SBIR/STTR Application Guide.

Section VII. Agency Contact(s)

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues.

1. Scientific/Research Contact(s):

Scientific/Research and Financial/Grants Management contacts for this funding opportunity are listed below.

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 National Institute on Aging, NIH Gateway Building, Suite 2C218 7201 Wisconsin Ave., MSC 9205 Bethesda, MD 20892-9205 Phone: 301-496-9322 Fax: 301-402-2945 Email: [email protected]	Ms. Linda Whipp Grants Management Officer National Institute on Aging, NIH Gateway Building, Room 2N212 7201 Wisconsin Ave., MSC 9205 Bethesda, MD 20892 Phone: 301-496-1472 Fax: 301-402-3672 Email: [email protected]
National Institute on Alcohol Abuse and Alcoholism http://www.niaaa.nih.gov	Dr. Max Q. Guo National Institute on Alcohol Abuse and Alcoholism Room 2021 5635 Fishers Lane Bethesda, MD 20892 Phone: 301-443-0639 Fax: 301-594-0673 Email: [email protected]	Ms. Judy Fox Chief, Grants Management Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Room 3023 5635 Fishers Lane Bethesda, MD 20892 Phone: 301-443-4704 Fax: 301-443-3891 Email: [email protected]
National Institute of Allergy and Infectious Diseases http://www.niaid.nih.gov	Dr. Gregory Milman Division of Extramural Activities National Institute of Allergy and Infectious Diseases, NIH Room 2153 6700-B Rockledge Drive Bethesda, MD 20892-7610 Phone: 301-496-8666 Fax: 301-402-0369 Email: [email protected]	Mr. Michael Wright Grants Management Specialist National Institute of Allergy and Infectious Diseases, NIH 6700B Rockledge Dr, Rm 2249 Bethesda, MD 20892-7614 Phone: 301-451-2688 Fax: 301-493-0597 Email: [email protected]
National Institute of Arthritis and Musculoskeletal and Skin Diseases http://www.niams.nih.gov/	Xibin Wang, Ph.D. SBIR/STTR Program Coordinator Division of Musculoskeletal Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases Democracy 1, Democracy Plaza 6701 Democracy Blvd, Suite 800 Bethesda, MD 20892-4892 Telephone: (301) 594-5055 Fax: (301) 480-1284 Email: [email protected]	Ms. Sheila Simmons Grants Management Specialist National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH 6701 Democracy Blvd. Suite 800 Bethesda, Maryland 20892 Phone: 301-594-9812 Fax: 301-480-5450 Email: [email protected] Mr. Erik (Timothy) Edgerton Grants Management Specialist National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH 6701 Democracy Blvd. Suite 800 Bethesda, Maryland 20892 Phone: 301-594-3968 Fax: 301-480-5450 Email: [email protected]
National Institute of Biomedical Imaging and Bioengineering http://www.nibib.nih.gov/	Mr. Todd Merchak Program Director National Institute of Biomedical Imaging and Bioengineering, NIH Two Democracy Plz 6707 Democracy Blvd Suite 200 Bethesda, MD 20892-5477 Phone: 301-496-8592 Fax: 301-480-1614 Email: [email protected]	Ms. Florence Turska Grants Management Specialist National Institute of Biomedical Imaging and Bioengineering, NIH 6707 Democracy Blvd. Suite 900 Bethesda, MD 20892-5469 Phone: 301-496-9314 Fax: 301-480-4974 Email: [email protected]
National Cancer Institute http://www.nci.nih.gov or http://www.cancer.gov	Mr. Michael Weingarten Program Manager SBIR Development Center National Cancer Institute, NIH 31 Center Drive Room 10A52 Bethesda, MD 20892 Phone: 301-594-7709 Fax: 301- 496-7807 Email: [email protected]	Ms. Rosemary Ward Grants Management Specialist National Cancer Institute, NIH MSC 7150 6120 Executive Blvd Rockville, MD 20892-7150 Phone: 301-496-3182 Fax: 301-496-8662 Email: [email protected]
National Institute of Child Health and Human Development http://www.nichd.nih.gov	Dr. Louis A. Quatrano Program Director, BSRE National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development, NIH 6100 Executive Boulevard, Room 2A03 Bethesda, MD 20892-7510 Phone: 301-402-4221 Fax: 301-402-0832 Email: [email protected]	Mr. Ted Williams Grants Management Specialist Grants Management Branch Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH 6001 Executive Blvd., Rm. 8A07EA Rockville, MD 20852 Phone: 301-435-6966 Fax: 301-451-5110 Email: [email protected]
National Institute on Drug Abuse http://www.nida.nih.gov	Dr. Cathrine Sasek National Institute on Drug Abuse, NIH 6001 Executive Boulevard Room 5230, MSC 9591 Bethesda, Maryland 20892-9591 Phone: 301-443-6071 Fax: 301-443-6277 Email: [email protected]	Ms. Diana Haikalis Grants Management Specialist National Institute on Drug Abuse, NIH 6001 Executive Boulevard, Room 4218, MSC 9560 Bethesda, Maryland 20892-9560 Phone: 301-443-6710 Fax: 301-594-6849 Email: [email protected]
National Institute on Deafness and Other Communication Disorders http://www.nidcd.nih.gov	Dr. Roger Miller Program Director, Hearing Program National Institute on Deafness and Other Communication Disorders, NIH 6120 Executive Blvd., 400-C Rockville, MD 20852 Phone: 301-402-3458 Fax: 301-402-6251 Email: [email protected]	Mr. Christopher P. Myers Chief Grants Management Officer National Institute on Deafness and Other 6120 Executive Blvd., 400-B Rockville, MD 20852 Phone: 301-435-0713 Fax: 301-402-1758 Email: [email protected]
National Institute of Dental and Craniofacial Research http://www.nidcr.nih.gov	Dr. R. Dwayne Lunsford Coordinator, SBIR/STTR Program Director, Microbiology Program Integrative Biology and Infectious Disease Branch Division of Extramural Research National Institute of Dental and Craniofacial Research-NIH 6701 Democracy Blvd., Rm. 626Bethesda, MD 20892-4978 Phone : 301-594-2421 Fax: 301-480-8319 Email: [email protected]	Ms. Mary Daley-Greenwood Chief Grants Management Officer National Institute of Dental and Craniofacial Research, NIH 6701 Democracy Blvd., Rm. 658 45 Center Drive Bethesda, MD 20892-4878 Phone: 301-594-4808 Fax: 301-480-3562 Email: [email protected]
National Institute of Diabetes and Digestive and Kidney Diseases http://www.niddk.nih.gov	Ms. Christine Densmore Director, SBIR/STTR and Training Programs National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Rm 649 Bethesda, MD 20892-5450 Phone: (301) 402-8714 Fax: (301) 480-8300 Email: [email protected]	Mr. Gene McGeehan Senior Grants Management Specialist Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases, NIH 2 Democracy Plaza, Room # 732 6707 Democracy Blvd., MSC 5456 Bethesda, MD 20892-5456 Phone: 301-594-0417 Fax: 301-594-9523 Email: [email protected]
National Institute of Environmental Health Sciences http://www.niehs.nih.gov	Dr. Daniel Shaughnessy Program Administrator Susceptibility and Population Health Branch, NIEHS MD K3-12 PO Box 12233 Research Triangle Park, NC 27709 Phone: 919-541-2506 Fax: 919-541-4606 Email: [email protected]	Ms. Pam Clark Grants Management Specialist National Institute of Environmental Health Sciences, NIH POB 121233 (K3-11) Research Triangle Park, NC 27709 Phone: 919-541-7629 Fax: 919-541-2860 Email: [email protected]
National Eye Institute http://www.nei.nih.gov	Dr. Jerome R. Wujek Research Resources Officer National Eye Institute, NIH 5635 Fishers Lane, Suite 1300 Rockville, MD 20892-9300 Phone: 301-451-2020 Fax: 301-496-2297 Email: [email protected]	Mr. William Darby Chief, Grants Management Branch National Eye Institute, NIH 5635 Fishers Lane, Suite 1300 Bethesda, MD 20892-9300 Phone: 301-451-2020 Fax: 301-496-9997 Email: [email protected]
National Institute of General Medical Sciences http://www.nigms.nih.gov/	Dr. Matthew E. Portnoy Program Director Division of Genetics and Developmental Biology National Institute of General Medical Sciences, NIH Natcher Building, Rm. 2AS-25P 45 Center Drive MSC 6200 Bethesda, MD 20892-6200 Phone: 301-594-0943 Fax: 301-480-2228 Email: [email protected]	Ms. Patrice Molnar Grants Management Specialist National Institute of General Medical Sciences, NIH Natcher Building, Rm. 2AN-38C 45 Center Drive MSC 6200 Bethesda, MD 20892-6200 Phone: 301-594-5136 Fax: 301-480-2554 Email: [email protected]
National Heart, Lung, and Blood Institute http://www.nhlbi.nih.gov	Ms. Susan Pucie Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute, NIH 6701 Rockledge Dr Two Rockledge Ctr, Room 10166 Bethesda, MD 20892-7950 Phone: 301-435-0079 Fax: 301-480-0867 Email: [email protected]	Mr. Robert Vinson Robert Vinson, Jr. Section Chief, DBDR Team NHLBI, DERA, Office of Grants Management Rockledge Centre Two, Suite 7044 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0169 Fax: (301) 451-5462 Email: [email protected] Mr. David Ruane Grants Management Specialist NHLBI, DERA, Office of Grants Management Rockledge Centre Two, Suite 7044 Rm. 7134 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0150 Fax: (301) 451-5462 Email: [email protected]
National Human Genome Research Institute http://www.genome.gov	Dr. Bettie J. Graham Program Director National Human Genome Research Institute, NIH Suite 4076 5635 Fishers Lane Rockville, MD 20852 Phone: 301-496-7531 Fax: 301-480-2770 Email: [email protected]	Ms. Cheryl Chick Chief Grants Management Officer National Human Genome Research Institute, NIH 5635 Fishers Lane Ste. 4076 Rockville, MD 20852 Phone: 301-435-7858 FAX: 301-402-1951 Email: [email protected]
National Institute of Mental Health http://www.nimh.nih.gov	Dr. Michael F. Huerta Associate Director National Institute of Mental Health, NIH 6001 Executive Blvd. Room 7202 Bethesda, MD 20892-9645 Phone: 301-443-3563 Fax: 301-443-1731 Email: [email protected]	Ms. Rebecca Claycamp Chief Grants Management Officer National Institute of Mental Health, NIH 6001 Executive Boulevard Room 6122 Bethesda, Maryland 20892-9605 Phone: 301-443-2811 Fax: 301-443-6885 Email: [email protected]
National Institute of Neurological Disorders and Stroke http://www.ninds.nih.gov	Ms.Stephanie Fertig Small Business Program National Institute of Neurological Disorders and Stroke, NIH NSC, Room 2228 6001 Executive Blvd. Bethesda, MD 20892-9521 Phone: 301-496-1447 Fax: 301- 480-1080 Email: [email protected]	Ms. Tijuanna DeCoster, MPA Chief Grants Management Officer, NINDS 6001 Executive Boulevard, Suite 3290, MSC 9537 Bethesda, Maryland 20892-9537 Phone: 301-496-9231 Fax: 301-402-0219 Email: [email protected]
National Institute of Nursing Research http://www.ninr.nih.gov	Dr. Paul Cotton Program Director Office of Extramural Programs National Institute of Nursing Research, NIH 6701 Democracy Blvd, Room 710 One Democracy Plaza Bethesda, MD 20892 Phone: 301-402-6423 Fax: 301-480-8260 Email: [email protected]	Mr. Brian Albertini Chief, Grants and Contracts Management National Institute of Nursing Research, NIH 6701 Democracy Boulevard Room 710 One Democracy Plaza Bethesda, MD 20892-4870 Phone: 301-594-6869 Fax: 301-402-4502 Email: [email protected]
National Center for Research Resources http://www.ncrr.nih.gov	Dr. Amy L. Swain Program Director National Center for Research Resources, NIH 6701 Democracy Blvd., Room 964 Bethesda, MD 20892-4874 Phone: 301-435-0755 Fax: 301-480-3659 E-mail [email protected]	Ms. Leslie Le Grants Management Specialist National Center for Research Resources, NIH 6701 Democracy Blvd, Room 1051 Bethesda, MD 20892-4874 Phone: 301-435-0856 Fax: 301-480-3777 Email: [email protected]
National Center for Complementary and Alternative Medicine http://www.nccam.nih.gov/	D. Craig Hopp, Ph.D. Program Officer National Center for Complementary and Alternative Medicine, NIH 6707 Democracy Blvd., Suite 401, MSC 5475 Bethesda, MD 20892-5475 phone: 301-496-5825 fax: 301-480-1587 Email: [email protected]	Mr. George Tucker, M.B.A. Grants Management Officer Complementary and Alternative Medicine, NIH 6707 Democracy Blvd. Suite 401, MSC 5475 Bethesda, MD 20892-5475 Phone: 301-594-8853 Fax: 301-480-1552 Email: [email protected]
National Center on Minority Health and Health Disparities http://www.ncmhd.nih.gov	Mr. Vincent A. Thomas, Jr., MSW, MPA Program Manager, National Center on Minority Health and Health Disparities, NIH 6707 Democracy Blvd. Suite 800, MSC 5465 Bethesda, MD 20892-5465 Phone: 301-402-2516 Fax: 301-480-4049 Email: [email protected]	Ms. Priscilla Grant, J.D., C.R.A. Grants Management Specialist National Center on Minority Health & Health Disparities, NIH 6707 Democracy Blvd. Suite 800, MSC 5464 Bethesda, MD 20892-5464 Phone: 301-594-8412 Fax: 301-480-4049 Email: [email protected]
National Library of Medicine http://www.nlm.nih.gov	Dr. Jane Ye Program Officer Division of Extramural Programs National Library of Medicine/NIH 6705 Rockledge Drive, Suite 301 Bethesda, MD 20892 Tel: 301-594-4882 Fax: 301-402-2952 Email: [email protected]	Mr. Dwight Mowery Grants Management Officer National Library of Medicine, NIH RKL1 - One Rockledge Ctr Room 301 6705 Rockledge Dr Bethesda, MD 20892 Phone: 301-496-4221 Fax: 301-402-0421 Email: [email protected]
Centers for Disease Control and Prevention (CDC) http://www.cdc.gov	Dr. Adele Childress (NCIPC) Phone: 770-488-4233 Fax: 770-488-1665 Email: [email protected] Dr. Virginia Cain (NCHS) Phone: 301-458-4395 Fax: 301-458-4020 Email: [email protected] Dr. Lee Husting (NCPHI) Phone: 404-498-1186 Email: [email protected] Dr. Brenda Colley Gilbert (NCCDPHP) Phone: 770-488-8390 Fax: 770-488-8046 Email: [email protected] Ms. Sheila Jones (NCCDPHP) Phone: 770-488-6426 Fax: 770-488-8046 Email: [email protected] Ms. Lata Kumar (NIOSH) Phone: 404-498-2530 Fax: 404-498-2569 Email: [email protected] Dr. Paul Mehta (NCEH) Phone: 770-488-0556 Fax: 770-488-1665 Email: [email protected]	Ms. Pamela Robbins-Render (NCIPC) Phone: 770-488-2712 Fax: 770-488-2670 Email: [email protected] Ms. Nealean Austin (NCHS) Phone: 770-488-2771 Fax: 770-488-2777 Email: [email protected] Ms. Nealean Austin (NCPHI) Phone: 770-488-2771 Fax: 770-488-2777 Email: [email protected] Mr. Hector A. Buitrago (NCCDPHP) Phone: 770-488-2921 Fax: 770-488-2777 Email: [email protected] Mr. Larry Guess (NIOSH) Phone: 412-386-6826 Fax: 412-386-6429 Email: [email protected] Ms. Pamela Robbins-Render (NCEH) Phone: 770-488-2712 Fax: 770-488-2670 Email: [email protected]
Food and Drug Administration (FDA) http://www.fda.gov	Ms. Michelle Hawley Phone: 301-827-1991 Fax: 301-827-7101 Email: [email protected]	Ms. Gladys Melendez-Bohler Phone 301-827-7168 Fax: 301-827-7101 Email: [email protected]
Administration for Children and Families http://www.acf.hhs.gov	Ms. Anne F. Bergan Social Science Research Analyst Office of Planning, Research and Evaluation Administration for Children and Families 370 L'Enfant Promenade, SW Washington, DC 20447 Phone: 202-260-8515 Fax: 202-205-3598 E-mail: [email protected]	Edeltraud Fernandez Budget Officer/Staff Assistant Office of Planning, Research and Evaluation Administration for Children and Families 370 L'Enfant Promenade, SW Washington, DC 20447 Phone: 202-401-2346 Fax: 202-205-3598 E-mail: [email protected]

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

Ms. Kay Etzler
NIH SBIR/STTR Program
6705 Rockledge Drive
Rockledge I, Room 3522
Bethesda, MD 20892
Phone: 301-435-2713, Fax: 301-480-0146
Email: [email protected]

Dr. Lenka Fedorkova
NIH SBIR/STTR Program
6705 Rockledge Drive
Rockledge I, Room 3524
Bethesda, MD 20892
Phone: 301-435-0921
Fax: 301-480-0146
Email: [email protected]

Ms. Jo Anne Goodnight
NIH SBIR/STTR Program Coordinator
6705 Rockledge Drive
Rockledge I, Room 3538
Bethesda, MD 20892
Phone: 301-435-2688
Fax: 301-480-0146
Email: [email protected]

PHS SBIR/STTR Solicitation Office
Email: [email protected]

Grants Information
Division of Extramural Outreach and Information Resources
Office of Extramural Research
National Institutes of Health
Phone: (301) 710-0267, Fax: (301) 480-0525
Email: [email protected]

2. Peer Review Contact(s):

Not Applicable

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.