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FAQ About the UH2/UH3 and UH3 Limited Competition Applications

Collaborations and Leveraging (UH2/UH3 and UH3 Limited Competition Applications)

Confidential Disclosure Agreement and Collaborative Research Agreement (UH2/UH3 and UH3 Limited Competition Applications)

Application Information (UH2/UH3 and UH3 Limited Competition Applications)

Application Review (UH2/UH3 and UH3 Limited Competition Applications)

Budget/Funding (UH2/UH3 and UH3 Limited Competition Applications)

Applicant Eligibility (UH2/UH3 and UH3 Limited Competition Applications)

NIH Intramural Research Program (IRP) (UH2/UH3 and UH3 Limited Competition Applications)

Collaborations and Leveraging (UH2/UH3 and UH3 Limited Competition Applications)

The NIH has indicated that each applicant needs to choose one pharma partner. Can the pharma partner choose more than one applicant partner for the same indication?

Yes. The pharma partner can be involved in more than one project for a compound. NIH will not require pharma partners to choose a single applicant if there is more than one application for the same indication.

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Having a small amount of the Agent would enable investigators to quickly generate preliminary data for a UH application before December 17, 2012. Can investigators execute an agreement now to facilitate transfer of materials for preliminary data generation?

No. Pharma partners should not be asked to provide Agent before the December 17, 2012 application receipt date. To be fair to all applicants, no application is expected to contain preliminary data on the Agent with the proposed new use.

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Confidential Disclosure Agreement and Collaborative Research Agreement (UH2/UH3 and UH3 Limited Competition Applications)

NCATS indicates that the Collaborative Research Agreement (CRA) must be in place with the pharma partner for the full UH2/UH3 proposal to be accepted. If more than one institution is involved, do all institutions need to have a CRA in place with the pharma partner? Would a CRA with one institution and/or lead investigator be permitted if there are co-principal investigators from different institutions?

Applicants must provide the NIH with documentation of access to the Agent, which was proposed in the X02 pre-application, and associated data needed for conducting the proposed pre-clinical studies and for filing an investigator-sponsored IND in order to conduct the proposed clinical trials (e.g., an executed CRA or letter from the pharma partner). The pharma partners vary in terms of which institutions they will execute a CRA with when multiple institutions are involved. Ultimately, the agreements have to provide for access to the Agent and the associated data. Documentation of that access must be provided as part of the UH application.

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Will NIH accept a UH2/UH3 or UH3 application if a confidential disclosure agreement (CDA) and collaborative research agreement (CRA) have not been executed?

UH2/UH3 and UH3 applications submitted without evidence of access to and ability to work with the compounds, such as evidence that a CRA or equivalent document has been executed will be deemed non-responsive and returned to the applicant without review.

It is recommended that X02 applicants consult with the appropriate office within their organization to consider their willingness to agree to the conditions in the appropriate CRA for the selected agent prior to submitting a pre-application.

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Are applicants required to use the template collaborative research agreements posted on the NCATS website?

One of the barriers encountered in moving projects that involve the private sector and the academic sector or other collaborator forward is the time it takes to execute a collaborative research agreement (CRA) or equivalent document. In recognition of this barrier, template agreements have been developed to streamline interactions among the parties for the program, and it is anticipated that applicants will use the agreements. X02 applicants should consider their willingness to agree to the conditions in the appropriate CRA for the selected agent prior to submitting a pre-application. Investigators should work with the appropriate office within their organization to finalize the terms and conditions of the CDA and CRA for the selected agent prior to submission of a UH2/UH3 or UH3 application.

Use of the template agreements is not required. However, UH2/UH3 and UH3 applications submitted without evidence of access to and ability to work with the compounds, such as evidence that a CRA or equivalent document has been executed will be deemed non-responsive and returned to the applicant without review.

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Application Information (UH2/UH3 and UH3 Limited Competition Applications)

How many X02 applications were accepted? How many were submitted?

NCATS received almost 160 X02 pre-applications in response to PAR-12-203. A fraction now has the opportunity to apply for a UH3 or UH2/UH3. This stage still will be very competitive.

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Will it be viewed positively by NCATS if the pharma partner personnel participate in the execution of aspects of the project, beyond providing the Agent and information, and if this is included as part of the grant application?

Yes. NCATS would view this positively.

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Should applicants include a support letter from the pharma partner?

Yes. A letter indicating that applicants will have access to the compound (if the application is funded) is required. Applications that do not include such a letter will not be accepted for review.

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Should there be an introduction page with a response to the critiques from the X02? Should the UH application address the reviewers’ comments that were in the X02 summary statement?

No. It may be useful for you to consider the feedback from the X02, but do NOT prepare the UH application as a resubmission. The UH application is not considered a resubmission. Therefore, an introduction should not be included.

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The time-frame for UH2 grants may not be optimal for certain disease conditions that are age-dependent and chronically progressive (such as neurodegenerative disorders), in which case both the pre-clinical and clinical studies (e.g., Phase Ib) could take longer. What flexibility do applicants have to propose more time for the UH2 portion of the proposal?

As with any RFA, the solicitation will not be optimal for all projects. The UH2 must be completed within 12 months and the UH3 must be completed within 24 months. The clinical outcomes measured in the application need to conform to these timelines.

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How much detail is expected to describe the subsequent Phase IIa trial in a UH2/UH3 application?

Under the Confidential Disclosure Agreement (CDA), the applicant and the pharma partner will exchange confidential information, and the applicant will have access to the company’s relevant data on the Agent. Some of those data may be informative in designing the Phase IIa trial. However, applicants may need to propose alternative strategies for the Phase IIa trials.

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Can UH2 and UH3 overlap? Can UH3 support begin prior to clinical study to enable preparation (i.e., setting institutional review board approvals and investigational new drug applications in motion)?

The UH2 and UH3 may not overlap. However, the period for the UH2 can be less than 12 months.

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Should steering committee members be named in the application?

No. The committee will not be identified until after an award is made. Applicants should NOT name or contact potential steering committee members; only describe their type of role, experience and function.

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Based upon the introductory webinar, applicants may test only one Agent in their final study (if funded). Is this true?

Yes. In the UH application, applicants must propose only one Agent and write only one application (Applicants will have to choose between companies prior to submission).

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Can the formulation of the molecule be changed?

No, only the formulations listed for specific molecules provided by the pharmaceutical companies are available.

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When are full applications (UH2/UH3) due? What are the required formats?

Applications to the UH2/UH3 and UH3 RFAs are due December 17, 2012, by 5:00 p.m. local time of the applicant organization. Additional information about review and award dates as well as the elements required for the applications can be found within the funding announcements on the funding information page.

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Application Review (UH2/UH3 and UH3 Limited Competition Applications)

Will the reviewers of a UH application be the same individuals who reviewed the corresponding X02 application?

The Scientific Review Officer will make every effort to maintain continuity between the two reviews.

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What are the submission requirements for UH application acceptance?

An application must meet the following criteria to be accepted for review:

  • Use only one Agent
  • Use the same Agent or mechanism of action as described in the X02 pre-application
  • Be the same therapeutic use as proposed in the X02
  • Provide a letter of support from the pharmaceutical company partner documenting access to the Agent and associated data needed for conducting the proposed pre-clinical studies and for filing an investigational new drug (IND) application for conducting the proposed clinical trials

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Will post-submission materials be accepted for review?

The acceptance of post-submission materials will follow the policy in the Notice: NOT-OD-10-115. The only post-submission application materials that will be accepted are those from unforeseen administrative issues. This option is not to be used to correct oversights or errors discovered after the submission of the application.

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Budget/Funding (UH2/UH3 and UH3 Limited Competition Applications)

Should the pharma partner personnel be named in the application? Should the application budget page include support for the pharma partner personnel or other expenses?

If the partner company personnel will have a significant level of involvement in execution of the project, they may be named and biographical sketches provided. However, support for those personnel and resources should not be part of the application budget and will not be part of the NIH award.

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Will the Agent be provided by the pharma partner free of charge, or does this need to be negotiated and accounted for during budgeting?

The Agent and placebo will be provided by the company for the UH2 and UH3 studies at no cost to the NIH or applicant.

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What is the budget limitation if any? Any suggestions for ball-park of the budget?

NIH intends to commit up to $20 million in FY2013 to fund six to eight UH2/UH3 or UH3 awards in response to RFA-TR-12-004 and RFA-TR-12-005. Future year amounts will depend on annual appropriations.

Applicants should request the amount of money needed to conduct the proposed studies.

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How will the UH2/UH3 grant proposals be selected for funding?

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

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If an applicant does not need full funding support from the NIH to evaluate a molecule, but is able to get funding separately that can complement the NIH funds, is this helpful for his or her application? Is it allowed?

Yes, leveraging additional funds is encouraged and is allowed provided that other support does not constitute scientific overlap with the potential NIH-funded support. The likelihood of NIH funding for a specific application is based on the overall impact/priority score provided by the review committee and programmatic priorities. Budget issues are review considerations that are not factored into the overall impact/priority score. However, non-budgetary issues related to the credibility and value of collaborations may affect the score.

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Applicant Eligibility (UH2/UH3 and UH3 Limited Competition Applications)

What is a Limited Competition?

All investigators listed in the X02 FOA are eligible to submit a pre-application. However, only those investigators whose X02 pre-applications are judged to be the most meritorious will be notified by NCATS program staff to submit a UH2/UH3, RFA-TR-12-004, or UH3, RFA-TR-12-005 application.

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Can UH2/UH3 and UH3 applicants change the program director/principal investigator on the X02 pre-application when applying for the UH2/UH3 or U3 funding opportunities? Can the contact PD/PI in a multiple PI application be changed between the X02 pre-application and the UH2/UH3 or UH3 application?

For invited UH2/UH3 and UH3 applications, the program director/principal investigator (PD/PI) must be the same listed on the X02 pre-application unless permission to change is granted by the NCATS Program Director. For UH2/UH3 and UH3 applications proposing multiple PD/PIs, the contact PD/PI must be the same as listed in the X02 pre-application unless permission to change is granted by the NCATS Program Director. The contact PD/PI is strongly encouraged to continue leadership structure identified in the X02 pre-application if invited to submit a UH2/UH3 application.

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NIH Intramural Research Program (IRP) — (UH2/UH3 and UH3 Limited Competition Applications)

Are there special requirements for IRP investigator applicants?

Yes. The IRP investigator will need an official letter from his or her Scientific Director indicating approval of the IRP investigator’s role as a PD/PI or collaborator on the project. This letter must be included in the X02 pre-application. If the IRP investigator’s application is selected, he or she will need to contact the pharmaceutical company partner to execute a confidential disclosure agreement to exchange confidential information as well as negotiate a Public Health Service (PHS) Cooperative Research and Development Agreement (CRADA), Clinical Trials CRADA, or similar type of agreement to incorporate the terms of the collaborative research agreement. Intellectual property will be managed according to established NIH policy.

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If an IRP investigator's application is selected, will the IRP investigator receive a Notice of Award with funds?

No. IRP investigators and laboratories cannot request extramural funds. The IRP investigator’s application must include a letter of support from his or her Scientific Director indicating approval of the IRP scientist’s role on the project as well as specifying the Scientific Director’s commitment of intramural research funds to support the IRP investigator’s proposed project.

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If an IRP investigator is a collaborator on an extramural investigator's application, can the extramural investigator request funds for the IRP investigator's portion of the project?

No. Should an extramural application include collaboration with an IRP scientist, no extramural funds may be requested to support the IRP scientist of IRP laboratory. The extramural application also must include a letter from the IRP scientist’s or laboratory’s Scientific Director indicating approval of the IRP scientist’s role on the extramural investigator’s project as well as specifying the Scientific Director’s commitment of intramural research funds to support the IRP investigator’s portion of the project.

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Do NIH IRP investigators need to execute a collaborative research agreement with the pharmaceutical company?

If selected, NIH IRP scientists, in conjunction with their respective technology transfer representative, will need to contact the pharmaceutical company providing the selected Agent made available through this FOA to execute a confidential disclosure agreement to exchange confidential information and to negotiate a PHS CRADA, Clinical Trials CRADA, or other similar type of agreement to incorporate, as appropriate, the terms of the collaborative research agreement.

Additionally, if the NIH IRP investigator will collaborate with an extramural investigator as multiple PDs/PIs on an application, the IRP investigator will need to have an agreement in place with the pharmaceutical company partner to demonstrate that the IRP investigator also has access to the Agent and pertinent data.

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