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All proposals will be evaluated and judged on a competitive basis. Using the technical evaluation criteria specified below, a panel of primarily nongovernment experts knowledgeable in the disciplines or fields under review will evaluate proposals to determine the most promising technical and scientific approaches. Each proposal will be judged on its own merit. The Agency is under no obligation to fund any proposals or any specific number of proposals in a given topic. It may also elect to fund several or none of the proposed approaches to the same topic.

6.1 Evaluation Process

Each proposal will be peer reviewed by an external panel of experts selected for their competence in relevant scientific and technical fields. Each peer review panel will be responsible for evaluating proposals for scientific and technical merit. When relevant, reviewers will be instructed to comment on the reasonableness of the following items, which reviewers will factor into the determination of a proposal’s scientific and technical merit:

Resource Sharing https://grants.nih.gov/grants/peer/guidelines_general/Resource_sharing_plans.pdf o Data Sharing Plan http://grants.nih.gov/grants/policy/data_sharing

o Model Organism Sharing Plan http://grants.nih.gov/grants/policy/model_organism/ o Genome Data Sharing http://gds.nih.gov/

Human Subject Protection http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

Data Safety Monitoring Plan http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

Inclusion of Women and Minorities http://grants.nih.gov/grants/funding/women_min/women_min.htm

Inclusion of Children https://grants.nih.gov/grants/funding/children/children.htm

Animal Welfare http://grants.nih.gov/grants/oer_offices/olaw.htm

Biohazards/Select Agents/Recombinant DNA http://grants.nih.gov/grants/guide/notice-files/not95-209.html

The peer review panel provides a rating for each proposal and makes specific recommendations related to the scope, direction and/or conduct of the proposed research. For those proposals found technically acceptable, the peer review panel may provide a commentary about the funding level, labor mix, duration of the proposed contract project, vertebrate animal and human subject research protection, and inclusion issues. The program staff of the awarding component will conduct a second level of review. Recommendations of the peer review panel and program staff are based on judgments about not only the technical merit of the proposed research but also its relevance and potential contributions to the mission and programs of the awarding component and commercial potential. A contract may be awarded only if the proposal has been recommended as technically acceptable by the peer review panel. Funding for any/all technically acceptable proposals is not guaranteed.

Proposals that are found to be technically unacceptable by the peer review panel will not be considered further for award.

Selection of an offeror for contract award will be based on an evaluation of proposals against two factors. The factors in order of importance are: technical and cost/price. While technical factors are of paramount consideration, cost/price may become a critical factor in source selection in the event that two or more offerors are determined to be essentially equal following the evaluation of all factors other than cost or price. In any event, the Government reserves the right to make an award to that offeror whose response provides the best overall value to the Government.

The Phase I proposal and the Phase II proposal in a Fast Track submission will be evaluated and scored individually. However, if a Phase I proposal is evaluated and found to be Technically Unacceptable, the corresponding Phase II portion of the Fast Track proposal will not be evaluated.

6.2 Phase I Technical Evaluation Criteria

FACTORS FOR PHASE I PROPOSALS WEIGHT

1. The soundness and technical merit of the proposed approach, including the identification of clear, measureable goals (i.e., milestones) that have a reasonable chance of meeting the topic objective in Phase I.

25%

2. The potential of the proposed research for technological innovation. 25%

3. The potential of the proposed research for commercial application, including: b. Whether the outcome of the proposed research activity will likely lead to a

marketable product or process; and,

c. The offeror’s discussion of the potential barriers to entry in the competitive market landscape as well as method to overcome.

20%

4. The qualifications of the proposed Project Directors/Principal Investigators, supporting staff

and consultants. 20%

5. The adequacy and suitability of the proposed facilities, equipment, and research

environment. 10%

Technical reviewers will base their conclusions only on information contained in the proposal. It cannot be assumed that reviewers are acquainted with the firm or key individuals or any referenced experiments. Relevant supporting data such as journal articles, literature, including Government publications, etc., should be contained or referenced in the proposal and will count toward the page limit.

6.3 Phase II Technical Evaluation Criteria

Phase II proposals will be evaluated based on the criteria outlined below. This includes Direct to Phase II proposals, Phase II proposals included in Fast Track submissions, and Phase II proposals subsequently submitted by contractors who are

awarded a Phase I contract under this solicitation.

FACTORS FOR PHASE II PROPOSALS WEIGHT

1. The soundness and technical merit of the proposed approach, including the identification of clear, measureable goals (i.e., milestones) that have a reasonable chance of meeting the topic objective in Phase II.

For NIH Direct to Phase II only: Demonstrated feasibility of the methodology or technology equivalent to meeting Phase I-level objectives, providing a solid foundation for the proposed Phase II activity.

25%

FACTORS FOR PHASE II PROPOSALS WEIGHT

3. The potential of the proposed research for commercialization, as documented in the offeror’s Commercialization Plan and evidenced by:

(a) the offeror’s record of successfully commercializing its prior SBIR/STTR or other research projects;

(b) commitments of additional investment during Phase I and Phase III from private sector or other non-SBIR funding sources; and/or

(c) any other indicators of commercial potential for the proposed research.

25%

4. The qualifications of the proposed PDs/PIs, supporting staff and consultants.

The leadership approach (including the designated roles and responsibilities, governance, and organizational structure) being consistent with and justified by the aims of the project and expertise of each of the PDs/PIs.

15%

5. The adequacy and suitability of the facilities and research environment. 10%

Technical reviewers will base their conclusions only on information contained in the proposal. It cannot be assumed that reviewers are acquainted with the firm or key individuals or any referenced experiments. Relevant supporting data such as journal articles, literature, including Government publications, etc., should be contained or referenced in the proposal and will count toward the page limit.

6.4 Award Decisions

For proposals recommended for award, the awarding component considers the following: 1. Ratings resulting from the scientific/technical evaluation process;

2. Areas of high program relevance;

3. Program balance (i.e., balance among areas of research); 4. Availability of funds, and.

5. Cost/Price

The Government anticipates that prospective offerors will develop unique proposals in response to the topics of research set forth in this solicitation. The agency is not under any obligation to fund any proposal or make any specific number of contract awards in a given research topic area. The agency may also elect to fund several or none of the proposals received within a given topic area.

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