Defense health program (dhp) 16. C small Business Technology Transfer (sttr) Program Proposal Submission Instructions

DEFENSE HEALTH PROGRAM (DHP)

16.C Small Business Technology Transfer (STTR) Program

Proposal Submission Instructions

The DHP STTR Program seeks small businesses with strong research and development capabilities to pursue and commercialize medical technologies.

The DHP STTR Program harnesses the collective knowledge and experience of scientists and engineers, to identify and put forward research and development (R&D) topics to stimulate a partnership of ideas and technologies between innovative Small Business Concerns (SBCs) and Research Institutions (RIs) through Federally-funded R&D to address DHP needs.
Broad Agency Announcement (BAA), topic, and general questions regarding the STTR Program should be addressed according to the DoD STTR Program BAA. For technical questions about the topic during the pre-release period, contact the Topic Authors listed for each topic in the BAA. To obtain answers to technical questions during the formal BAA period, visit https://sbir.defensebusiness.org/sitis.
Specific questions pertaining to the DHP STTR Program should be submitted to the DHP STTR Program Management Office (PMO) at:

E-mail - [e-mail]

Phone - [phone]
The DHP Program participates in two DoD STTR BAAs each year. Proposals not conforming to the terms of this BAA will not be considered. Only Government personnel will evaluate proposals with the exception of technical personnel from Laulima Government Solutions, LLC will provide Advisory and Assistance Services to DHP, providing technical analysis in the evaluation of proposals submitted against DHP topic number:

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  DHP16C-004 Integrated System for Field, Clinic and Laboratory Preparation of Biological Specimens for Microscopy
  

PHASE I PROPOSAL SUBMISSION
Follow the instructions in the DoD Program BAA for program requirements and proposal submission instructions at http://www.acq.osd.mil/osbp/sbir/solicitations/index.shtml.
STTR Phase I Proposals have four Volumes: Proposal Cover Sheets, Technical Volume, Cost Volume and Company Commercialization Report. The Technical Volume has a 20-page limit including: table of contents, references, letters of support, appendices, technical portions of subcontract documents (e.g., statements of work and resumes) and any other attachments. Do not include blank pages, duplicate the electronically generated Cover Sheets or put information normally associated with the Technical Volume in other sections of the proposal as these will count toward the 20-page limit.
Only the electronically generated Cover Sheets, Cost Volume and Company Commercialization Report (CCR) are excluded from the 20-page limit. The CCR is generated by the proposal submission website, based on information provided by small businesses through the Company Commercialization Report tool.

Technical Volumes that exceed the 20-page limit will be reviewed only to the last word on the 20^th page. Information beyond the 20^th page will not be reviewed or considered in evaluating the offeror’s proposal. To the extent that mandatory technical content is not contained in the first 20 pages of the proposal, the evaluator may deem the proposal as non-responsive and score it accordingly.

Companies submitting a Phase I proposal under this BAA must complete the Cost Volume using the on-line form, within a total cost not to exceed $150,000 over a period of up to six months.
The DHP STTR Program will evaluate and select Phase I proposals using the evaluation criteria in Section 6.0 of the DoD STTR Program BAA. Due to limited funding, the DHP STTR Program reserves the right to limit awards under any topic and only proposals considered to be of superior quality will be funded.
Proposals not conforming to the terms of this BAA, and unsolicited proposals, will not be considered. Awards are subject to the availability of funding and successful completion of contract negotiations.
If a small business concern is selected for a STTR award they must negotiate a written agreement between the small business and their selected Research Institution that allocates intellectual property rights and rights to carry out follow-on research, development, or commercialization.

PHASE II PROPOSAL SUBMISSION
Phase II is the demonstration of the technology found feasible in Phase I. All DHP STTR Phase I awardees from this BAA will be allowed to submit a Phase II proposal for evaluation and possible selection. The details on the due date, content, and submission requirements of the Phase II proposal will be provided by the DHP STTR Program Office either in the Phase I award or by subsequent notification.
Small businesses submitting a Phase II Proposal must use the DoD electronic proposal submission system (https://sbir.defensebusiness.org/). This site contains step-by-step instructions for the preparation and submission of the Proposal Cover Sheets, the Company Commercialization Report, the Cost Volume, and how to upload the Technical Volume. For general inquiries or problems with proposal electronic submission, contact the DoD SBIR/STTR Help Desk at (1-800-348-0787) or Help Desk email at [e-mail] (9:00 am to 6:00 pm ET).
Phase II proposals will be reviewed for overall merit based upon the criteria in section 8.0 of this BAA.  STTR Phase II proposals have four Volumes:  Proposal Cover Sheet, Technical Volume, Cost Volume and Company Commercialization Report.  The Technical Volume has a 40-page limit including: table of contents, pages intentionally left blank, technical references, letters of support, appendices, technical portions of subcontract documents (e.g., statements of work and resumes) and any attachments.  However, offerors are instructed to NOT leave blank pages, duplicate the electronically generated cover pages or put information normally associated with the Technical Volume in others sections of the proposal submission as these will count toward the 40-page limit.  ONLY the electronically generated Cover Sheets, Cost Volume and CCR are excluded from the 40-page limit. The CCR is generated by the submission website based on information provided by small businesses through the “Company Commercialization Report” tool.
Technical Volumes that exceed the 40-page limit will be reviewed only to the last word on the 40^th page. Information beyond the 40^th page will not be reviewed or considered in evaluating the offeror’s proposal. To the extent that mandatory technical content is not contained in the first 40 pages of the proposal, the evaluator may deem the proposal as non-responsive and score it accordingly.
Small businesses submitting a proposal are also required to develop and submit a technology transition and commercialization plan describing feasible approaches for transitioning and/or commercializing the developed technology in their Phase II proposal.
DHP Phase II Cost Volumes must contain a budget for the entire 24-month Phase II period not to exceed the maximum dollar amount of $1,000,000. These costs must be submitted using the Cost Volume format (accessible electronically on the DoD submission site), and may be presented side-by-side on a single Cost Volume Sheet.  The total proposed amount should be indicated on the Proposal Cover Sheet as the proposed cost. Phase II proposals should be structured as follows: the first 10-12 months (base effort) should be approximately $500,000; the second 10-12 months of funding should also be approximately $500,000. The entire Phase II effort should not exceed $1,000,000.
PHASE II ENHANCEMENTS
The DHP STTR Program has a Phase II Enhancement Program which provides matching STTR funds to expand an existing Phase II contract that attracts investment funds from a DoD Acquisition Program, a non-SBIR/non-STTR government program or private sector investments. Phase II Enhancements allow for an existing DHP STTR Phase II contract to be extended for up to one year per Phase II Enhancement application, to perform additional research and development. Phase II Enhancement matching funds will be provided on a dollar-for-dollar basis up to a maximum $500,000 of STTR funds. All Phase II Enhancement awards are subject to acceptance, review, and selection of candidate projects, are subject to availability of funding, and successful negotiation and award of a Phase II Enhancement contract modification.
DISCRETIONARY TECHNICAL ASSISTANCE (DTA)

The DHP STTR Program does not participate in the Discretionary Technical Assistance Program. Contractors should not submit proposals that include Discretionary Technical Assistance.

The DHP STTR Program has a Technical Assistance Advocate (TAA) who provides technical and commercialization assistance to small businesses that have Phase I and Phase II projects.
RESEARCH INVOLVING HUMAN OR ANIMAL SUBJECTS
The DHP STTR Program discourages offerors from proposing to conduct human subject or animal research during Phase I due to the significant lead time required to prepare regulatory documentation and secure approval, which will significantly delay the performance of the Phase I award.
The offeror is expressly forbidden to use or subcontract for the use of laboratory animals in any manner without the express written approval of the US Army Medical Research and Material Command's (USAMRMC), Animal Care and Use Review Office (ACURO). Written authorization to begin research under the applicable protocol(s) proposed for this award will be issued in the form of an approval letter from the USAMRMC ACURO to the recipient. Furthermore, modifications to already approved protocols require approval by ACURO prior to implementation.
Research under this award involving the use of human subjects, to include the use of human anatomical substances or human data, shall not begin until the USAMRMC’s Office of Research Protections (ORP) provides authorization that the research protocol may proceed. Written approval to begin research protocol will be issued from the USAMRMC ORP, under separate notification to the recipient. Written approval from the USAMRMC ORP is also required for any sub-recipient that will use funds from this award to conduct research involving human subjects.
Research involving human subjects shall be conducted in accordance with the protocol submitted to and approved by the USAMRMC ORP. Non-compliance with any provision may result in withholding of funds and or termination of the award.