SECTION 1. PURPOSE

This notice establishes the qualifying therapeutic discovery project program under § 48D of the Internal Revenue Code (Code), as added to the Code by section 9023(a) of the Patient Protec

tion and Affordable Care Act of 2010 (Pub. L. 111–148) (the Affordable Care Act). This notice provides the 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 for certain taxpayers, a grant under the program. The Service will consult with the Department of Health and

2010–23 I.R.B. 734 June 7, 2010

rules of § 46(c)(4) and (d) of the Code (as in effect on the day before the date of enactment of the Revenue Reconciliation Act of 1990) apply.

(6) An investment will be considered a qualified investment only if that investment is made in a taxable year beginning in 2009 or 2010.

.02 Qualifying Therapeutic Discovery Project . A qualifying therapeutic discovery project under § 48D(c)(1) of the Code means a project that is designed:

(1) To treat or prevent diseases or conditions by conducting pre-clinical activities, clinical trials, and clinical studies, or carrying out research protocols, for the purpose of securing approval of a product under section 505(b) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act,

(2) To diagnose diseases or conditions or to determine molecular factors related to diseases or conditions by developing molecular diagnostics to guide therapeutic decisions, or

(3) To develop a product, process, or technology to further the delivery or administration of therapeutics.

.03 Eligible Taxpayer . An eligible taxpayer is a taxpayer who employs not more than 250 employees in all businesses of the taxpayer at the time of the submission of the application under § 48D(d)(2) of the Code. All persons treated as a single employer under § 52(a) or (b), or § 414(m) or (o), must be so treated for purposes of the definition of an eligible taxpayer. For purposes of this section, the term “employee” includes both full-time and part-time employees but does not include leased employees.

.04 Facility Maintenance Expenses . Facility maintenance expenses are costs paid or incurred to maintain a facility, including (1) mortgage or rent payments, (2) insurance payments, (3) utility and maintenance costs, and (4) costs of employment of maintenance personnel.