Small Business Innovation Research (SBIR) Grant Applications for the modification or development of new screening technologies for mild hearing loss in infants and young children

Small Business Innovation Research (SBIR) Grant Applications for the modification or development of new screening technologies for mild hearing loss in infants and young children is sponsored by National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC). This Funding Opportunity Announcement (FOA) solicits Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) for the modification or development of new screening technologies that are better able to consistently detect mild hearing loss (…

Expired PA-06-547: New Technology to Screen for Mild Hearing Loss in Children (STTR [R41/R42]) This notice has expired. Check the NIH Guide for active opportunities and notices. Part I Overview Information Department of Health and Human Services Participating Organizations Institutes of Health (NIH) ( http://www.

nih. gov ) Components of Participating Organizations Institute on Deafness and Other Communication Disorders (NIDCD) ( http://www. nidcd.

nih. gov ) Title: New Technology to Screen for Mild Hearing Loss in Children Update: The following update relating to this announcement has been issued: September 17, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093.

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) SBIR/STTR Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT. 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). A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date.

See Section IV . Program Announcement (PA) Number: PA-06-547 Catalog of Federal Domestic Assistance Number(s) Release/Posted Date: September 8, 2006 Opening Date: November 1, 2006 (Earliest date an application may be 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 Submission Date(s): Standard dates apply, please see http://grants. nih. gov/grants/funding/submissionschedule.

htm#SBIR for details. AIDS Application Submission Date(s): Not Peer Review Date(s): Standard dates apply. Please see http://grants.

nih. gov/grants/funding/submissionschedule. htm#reviewandaward .

Council Review Date(s) : Standard dates apply. Please see http://grants. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward . Earliest Anticipated Start Date(s): Standard dates apply.

Please see http://grants. nih. gov/grants/funding/submissionschedule.

htm#reviewandaward .

Additional Information To Be Available Date (Activation Date): Not Applicable Expiration Date: August 2, 2009 (now September 8, 2009 per NOT-OD-07-093 ) Announcement (FOA) solicits Small Business Technology Transfer (STTR) grant applications from small business concerns (SBCs) for the modification or development of new screening technologies that are better able to consistently detect mild hearing loss (i.e., The National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH) and the Early Hearing Detection and Intervention (EHDI) program within the National Center for Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control (CDC) is working to ensure infants and children with mild forms of hearing loss are identified as soon as possible.

Part of this effort involves having screening technology available that can reliably detect these hearing losses. This FOA will utilize the STTR (R41/R42) grant mechanisms for Phase I, Phase II, and Fast-Track applications and runs in parallel with an FOA of identical scientific scope, PA-06-546 that solicits applications under the Small Business Innovation Research (SBIR [R43/R44]) grant mechanisms.

Note that CDC does not accept STTR applications so is participating only in PA-06-546. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Eligible Organizations: Only United States SBCs are eligible to submit STTR applications.

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 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 STTR application, the PD/PI may be employed with the SBC or the participating non-profit research institution as long as he/she has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the small business concern and that individual. Applicant SBCs may submit more than one application, provided each application is scientifically distinct. IV.

1 for application materials. The SF424 (R&R) SBIR/STTR Application Guide for this FOA is located at these Web sites: http://grants. nih.

gov/grants/funding/424/SF424_RR_Guide_SBIR_STTR_Ver2. doc (MS Word) http://grants. nih.

gov/grants/funding/424/SF424_RR_Guide_SBIR_STTR_Ver2. pdf (PDF) 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/ Telecommunications for the hearing impaired is available at: TTY 301-451-5936. Part II Full Text of Announcement Section I. Funding Opportunity Section II.

Award Information Section III. Eligibility Information 2. Cost Sharing or Matching Other - Special Eligibility Criteria Section IV.

Application and 1. Request Application Information 2. Content and Form of Application Submission 3.

Submission Dates and Times A. Submission, Review and B. Submitting an Application Electronically C.

Application Processing 4. Intergovernmental Review 6. Other Submission Requirements Section V.

Application Review 2. Review and Selection Process A. Additional Review Criteria D.

Sharing Research Resources 3. Anticipated Announcement and Award Dates Section VI. Award Administration 2.

Administrative and National Policy Requirements 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 - Full Text of Announcement Section I.

Funding Opportunity Description The National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH) and the Early Hearing Detection and Intervention (EHDI) program within the National Center for Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control (CDC) are working to ensure infants and children with mild forms of hearing loss are identified as soon as possible.

Part of this effort involves having screening technology available that can reliably detect these hearing losses.

Applications are invited for the modification or development of new screening technologies that are better able to consistently detect mild hearing loss (i.e., Background The EHDI program of the Centers for Disease Control and Prevention (CDC) and the Marion Downs Hearing Center cosponsored the National Workshop on Mild and Unilateral Hearing Loss on July 26 and 27, 2005.

The NIDCD was a participant in the workshop and is working with the CDC to implement some of the research recommendations of that workshop. The main goal of the workshop was to review and discuss current information related to the identification and appropriate intervention for children with mild and unilateral hearing loss. More information about this workshop may be found at: http://www.

cdc. gov/ncbddd/ehdi/unilateralhi. htm#workshop .

When left undetected, hearing loss in children can have an impact on speech, language, auditory, social and/or emotional development. Currently, over 90% of newborns in the United States are being screened for hearing loss, with the majority tested before discharge from the birthing facility.

The primary target for these hearing screening programs are typically infants and children with permanent hearing loss of a moderate degree or greater (i.e., > 40 dB HL). Based on this and the need to maintain a low false positive rate, existing screening technology has been designed to primarily detect hearing losses worse than 40 dB HL.

However, research indicates that children with milder forms of hearing loss (e.g., Applications should include: 1) a plan to modify or develop new technology to detect hearing loss below 40 dB HL; 2) documentation of the sensitivity and specificity of screening technology; 3) evidence that the technology is usable in hospitals and healthcare provider offices and can be easily operated by a variety of people; and, 4) details pertaining to the costs (e.g., development and purchase) and reliability of the technology.

See Section VIII, Other Information - Required Federal Citations for policies related to this announcement. 1. Mechanism(s) of Support will use the Small Business Technology Transfer (STTR [R41/R42]) 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 may not simultaneously submit identical/essentially identical applications under both this funding opportunity and another Department of Health and Human Services (HHS) FOA, including the current SBIR or STTR Parent FOAs.

II applications in response to this funding opportunity will only be accepted as competing renewals (formerly competing continuations ) of previously funded Phase I STTR awards.

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 The applicant small business concern (SBC) will be solely responsible for planning, directing, and executing the proposed project.

Future unsolicited, competing renewal applications based on this project will compete with all STTR applications and will be reviewed according to the customary peer review procedures. Applications that are not funded in the competition described in this FOA may be submitted as RESUBMISSION applications through Grants.

gov/Apply using the standard NIH submission dates of April 1, August 1, and December 1 (or January 2, May 1, and September 1 for AIDS and AIDS-related STTR applications). funding opportunity uses Just-in-Time information concepts. The modular budget format is no longer accepted for STTR 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 The SF424 (R&R) SBIR/STTR Application Guide indicates the statutory guidelines of funding support and project duration periods for Phase I and III. Eligibility Information 1. A.

Eligible Institutions Only United States small business concerns (SBCs) are eligible to submit STTR applications.

A small business concern is one that, at the time of award for both Phase I and Phase II awards, meets all of the following criteria: owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit.

at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States. affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in Title 13 Code of Federal Regulations (CFR) Part 121.

Business concerns are generally considered to be 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. be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 CFR 121.

103. The term "number of employees" is defined in 13 CFR 121. 106.

concern may be in the form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative. Further information may be obtained at http://sba.

gov/size , or by contacting the Small Business Administration's (SBA) Government Contracting Area Office or Office of 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 STTR awardee organization must be space that is available to and under the control of the STTR awardee for the conduct of its portion of the 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. of the STTR 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. All STTR 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 STTR award until the SBA provides a determination. 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.

For a STTR application, the Project Director/Principal Investigator (PD/PI) may be employed with the SBC or the participating non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant 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. PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual.

Such a relationship does not necessarily involve a salary or other form of remuneration. In all cases, however, the PD/PI’s official relationship with the grantee must entail sufficient opportunity for the PD/PI to carry out his or her responsibilities for the overall scientific and technical direction of the project.

Documentation (e.g., consultant, consortium and contractual arrangements) describing the official relationship of the PD/PI with the applicant small business concern should NOT be submitted with the grant application, but a copy must be furnished upon the request of the NIH awarding component .

following are examples of situations describing the official relationship of the PD/PI with the applicant small business organization: PD/PI with a full-time, university appointment may also have appointments with other organizations (with or without salary) and still appropriately consider his or her commitment to the university to be full-time, consistent with the personnel policies and procedures of the university applied on a routine basis.

The PD/PI’s commitment to the university and other organizations (including the applicant small business concern) cannot exceed 100% of his or her total professional effort. PD/PI with a full-time, 12-month appointment with a small business concern would be considered to have a commitment to the applicant organization of 100% of his or her total professional effort.

PD/PI who has a part-time appointment with a small business concern and has concurrent commitments or appointments with organizations in addition to the small business concern would deem each commitment as a portion of 100% of his or her total professional effort. 2. Cost Sharing or Matching require cost sharing as defined in the current NIH Grants Policy Statement .

3. Other-Special Eligibility Criteria In STTR Phase I and Phase II, at least 40% of the work must be performed by the small business concern and at least 30% of the work must be performed by the single, partnering research institution.

The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and F&A/indirect costs attributable to each party, unless otherwise described and justified in Item 12, Consortium/Contractual Arrangements, of the PHS398 Research Plan component of the SF424 (R&R) application forms. 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 funding opportunity and another HHS FOA, including the current SBIR or 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, link to http://www. grants.

gov/Apply/ and follow the directions provided on that Web site. A one-time registration is required for institutions/organizations at both: Grants. gov ( http://www.

grants. gov/GetStarted ) eRA Commons ( http://era. nih.

gov/ElectronicReceipt/preparing. htm ) should work with their institutions/organizations to make sure they are registered in the NIH 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 Your organization will need to 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 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 Business Hours: M-F 7:00 a. m. - 9:00 p.

m. Eastern Time 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 Phone: 301-402-7469 or 866-504-9552 (Toll Free) Business hours M-F 7:00 a.

m. 8:00 p. m.

Eastern Time 3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants. gov. The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization.

This account cannot have any other role attached to it other This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization.

Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the 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 institution is already registered in both Grants. gov and the Commons .

The NIH will accept electronic applications only from organizations that have completed all Request Application Information the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR Application Guide for this FOA 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 STTR applications using the SF424 (R&R) application forms and the SF424 (R&R) SBIR/STTR Application Guide ( MS 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 ). Agency-specific instructions for such fields are clearly identified in the Application Guide.

For additional information, see Frequently Asked Questions Application Guide, Electronic Submission The SF424 (R&R) application is comprised of data arranged in separate 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: Research & Related Project/Performance Site Locations & Related Other Project Information & Related Senior/Key Person & Related Subaward Budget Form 3. Submission Dates and Times See Section IV.

3. A . for details.

3. A. Submission, Review, and Anticipated Start Dates Opening Date: November 1, 2006 (Earliest date an application may be submitted to Grants.

gov) of Intent Receipt Date(s): Not applicable Application Submission/Receipt Date(s): Standard dates apply, please see http://grants. nih. gov/grants/funding/submissionschedule.

htm AIDS Application Submission/Receipt Review Date(s): Standard dates apply, please see http://grants. nih. gov/grants/funding/submissionschedule.

htm Council Review Date(s): Standard dates apply, please see http://grants. nih. gov/grants/funding/submissionschedule.

htm Start Date(s): Standard dates apply, please see http://grants. nih. gov/grants/funding/submissionschedule.

htm not required for the funding opportunity. Application Electronically to the NIH to this FOA may only be submitted to Grants. gov through Grants.

gov/Apply . PAPER APPLICATIONS WILL NOT BE ACCEPTED. 3.

C. Application Processing Applications may be submitted on or after the successfully received by Grants. gov no later than 5:00 p.

m. local institution/organization) on the application submission/receipt date(s). (See Section IV.

3. A. for all dates.)

If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed. Once an application package has been successfully submitted through Grants.

gov, any 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 business days to view the application image. If everything is acceptable, no further action is necessary.

The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after two business days. 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 the AOR/SO determines that warnings should be addressed.

Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.

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

an acknowledgement of receipt of applications from Grants. gov and the Commons . Information related to the assignment of an application to a Scientific Review Group is also in the 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 This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in 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 competing 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 competing 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. STTR applications submitted in response to this FOA will only be considered by the NIH.

CDC does not participate in STTR so will only accept SBIR applications in response to this FOA’s parallel announcement (see Executive Summary for parallel FOA number). The NIH requires the PD/PI 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.

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 .

All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide ( MS are to be followed, with the following requirements. preliminary data are not required, they may be included. 2-5 of the Research Plan component may not exceed 15 pages, including tables, graphs, figures, diagrams, Introduction (required for a resubmission application) is limited to one (1) page.

The Biographical Sketch is limited to a maximum of 4 pages for each senior/key person. (This includes the table at the top of the first page.) further limitation on the total number of pages for the entire Phase I application; however, applicants are encouraged to be succinct.

Items 2-5 of the Research Plan component may not exceed 25 pages, including tables, graphs, figures, diagrams, Introduction (required for a resubmission application) is limited to three (3) pages. 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 The Phase II application must present a Commercialization Plan (maximum 15 pages) that addresses specific points as described in the SF424 (R&R) SBIR/STTR Application Guide and the SBIR/STTR Information component.

There is no further limitation on the total number of pages for the entire Phase II application; however, applicants are encouraged to be The NIH Fast-Track application is a single application consisting of Phase I and Phase II activities. See Section 1. 3.

2. , Fast-Track Applications, of the SF424 (R&R) SBIR/STTR Application 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 Fast-Track application must present a Commercialization Plan (maximum 15 pages) that addresses specific points as described in the SF424 (R&R) SBIR/STTR Application Guide.

Introduction (required for a resubmission application) is limited to three (3) pages. Items 2-5 of the Research Plan component may not exceed 25 pages.

That is, the combined Phase I and Phase II plans for Fast-Track applications (for Items 2-5) must be contained within the 25-page Note: While each section of the Research Plan component needs to eventually be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files.

This approach will enable applicants to better monitor formatting requirements such as page limits. Applicants requesting $500,000 or more in direct costs in any year should include a brief one paragraph description of how final research data will be shared, or explain why data-sharing is not possible. The specific nature of the data to be collected will determine whether or not the final dataset may be shared.

If the final data are not amenable to sharing, for example, if they are proprietary, this must be explained in the application.

The Small Business Act requires NIH to protect from disclosure and nongovernmental use all SBIR and STTR data developed from work performed under an SBIR and STTR funding agreement for a period of four (4) years after the closeout of either a Phase I or Phase II grant unless NIH obtains permission from the awardee to disclose these data.

The data rights protection period lapses only upon expiration of the protection period applicable to the SBIR and STTR award, or by agreement between the small business concern and NIH. Applicants are encouraged to discuss their data-sharing plan with the Institute/Center