Source: https://www.irs.gov/uac/qualifying-therapeutic-discovery-project-and-hhs-determination-process-questions-and-answers
Timestamp: 2017-02-19 23:23:51
Document Index: 453570474

Matched Legal Cases: ['§ 48', '§ 48', '§ 48', '§ 48', '§ 48', '§ 48']

the same therapeutic or diagnostic designed to treat or prevent different diseases or conditions; the same molecular diagnostic to guide therapeutic decisions related todiseases or conditions; or
Question 4 in the Project Information Memorandum focuses on the requirement of § 48D(c)(1)(C). To qualify under question 4, a product, process, or technology must further the delivery or administration of therapeutics. For the purposes of § 48D(c)(1)(C), the term “therapeutics” means drugs or medical devices, as those terms are defined in Section 201(g) and (h) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 321(g) and (h). Biologics that are licensed under the Public Health Service Act (PHSA) will generally be either drugs or medical devices. Thus, a drug-eluting stent or infusion pump would be an example of a product that furthers the delivery or administration of a drug and would meet the requirements of this provision. However, a medical device, or other product, process or technology that does not further the delivery or administration of a drug or medical device would not meet the requirements of this provision because such products do not deliver or administer a therapeutic within the meaning of § 48D(c)(1)(C). The term “therapeutic” is narrower than the term “therapy,” which appears elsewhere in § 48D. Therefore, products, processes or technologies that deliver other therapies which are not therapeutics, such as speech, physical, and cognitive therapies, would for the same reasons be excluded. A non-diagnostic medical device may be a “qualifying therapeutic discovery project” if such project is designed to “further the delivery or administration of therapeutics.” An applicant seeking certification for a non-diagnostic medical device will need to explain how the product furthers the delivery or administration of a drug or device.
A. A non-diagnostic medical device may be a “qualifying therapeutic discovery project” if such project is designed to “further the delivery or administration of therapeutics.” For the purposes of § 48D(c)(1)(C), the term “therapeutics” means drugs or medical devices, as those terms are defined in Section 201(g) and (h) of the FFDCA, 21 U.S.C. 321(g) and (h). Biologics that are licensed under the PHSA will generally be either drugs or medical devices. However, a medical device, or other product, process or technology that does not further the delivery or administration of a drug or medical device would not meet the requirements of this provision because such products do not deliver or administer a therapeutic within the meaning of § 48D(c)(1)(C). The term “therapeutic” is narrower than the term “therapy,” which appears elsewhere in section 48D. Therefore, products, processes or technologies that deliver other therapies which are not therapeutics, such as speech, physical, and cognitive therapies, would for the same reasons be excluded. Consistent with this guidance, non-diagnostic devices that are used to deliver “therapy,” but not “therapeutics,” would not meet the statutory definition of a qualifying therapeutic discovery project. An applicant seeking certification for a non-diagnostic medical device will need to explain how the product furthers the delivery or administration of a drug or device.
Q9. The first sentence of this paragraph reads; "For each of questions 9. 10. and 11 provide a short statement, not to exceed a total of 250 words, including responses to bulleted items." Does this mean that applicants are given 250 words for each question, or a total of 250 words for all questions? A. Question 9 is limited to 250 words. However, note that the list of literature citations (5 maximum) is excluded from the 250-word limit. Question 10 is limited to 250 words, and applicants should include the following information within that 250 word description:
A. For further information regarding the Project Information Memorandum, please contact JoAnne Goodnight, Department of Health and Human Services (HHS), at QTDP@mail.nih.gov. Page Last Reviewed or Updated: 02-Nov-2016