Release of New Guidance for Applying For New Therapeutic Discovery Project Program Created By The Affordable Care Act

Notice Number: NOT-OD-10-100

Key Dates
Release Date: May 21, 2010

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

The U.S. Department of the Treasury today released a Notice 2010-45 establishing the guidelines for applying for the new, $1 billion Therapeutic Discovery Project Program created by the Patient Protection and Affordable Care Act of 2010 (P.L. 111-148).

The notice provides procedures under which an eligible taxpayer may apply for certification from the Internal Revenue Service (Service) of a qualified investment with respect to a qualifying therapeutic discovery project as eligible for a credit or grant under the program. The definition of eligible taxpayer is provided in Section 4.3 of Notice 2010-45.

Applications to the Service for certification may be submitted beginning June 21, 2010 (or earlier if Form 8942 is made available before that date), and applications must be postmarked no later than July 21, 2010.

The applicant must submit (to the Service) a Form 8942 in accordance with the instructions to the form and the Project Information Memorandum (PIM), which includes questions and requires short narratives to certain questions. Form 8942 and the PIM form will be released no later than June 21, 2010, and will be available to the public on www.irs.gov. These forms include specific information about the therapeutic discovery project and taxpayer eligibility. In addition, if the applicant elects to consent to certain limited disclosure (see Section 10.2 of Notice 2010-45), a properly executed copy of the Consent to Public Disclosure of Certain Qualifying Therapeutic Discovery Project Program Application Information (Consent) contained in Appendix B to the Notice.

A complete application must be submitted for each qualifying therapeutic discovery project that the applicant sponsors for which the applicant is requesting a credit or a grant.

As part of the application review process for projects, the Department of Health and Human Services (HHS) will review information provided by the applicant in the Project Information Memorandum in order to determine whether a project meets the definition of "qualifying therapeutic discovery project" and whether the applicant has demonstrated that its project shows a "reasonable potential" to meet one or more of the goals specified in the statute. The Service will issue certifications by the end of October based on the determinations made by HHS.

The following additional information is available on the U.S. Department of the Treasury’s Web site:

Inquiries

Jo Anne Goodnight
Office of Extramural Research
National Institutes of Health
Department of Health and Human Services
QTDP@mail.nih.gov