MODIFICATION
A -- SBIR Topic 156b Development of a Standardized Electronic Cigarette for Clinical Research
- Notice Date
- 4/8/2015
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- N43DA-16-8925
- Point of Contact
- Brian H O'Laughlin, Phone: (301) 443-6677
- E-Mail Address
-
bo50d@nih.gov
(bo50d@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of offers is NOT extended. All other terms and conditions of the Request for Proposals (RFP) remain unchanged. PURPOSE OF AMENDMENT: To answer additional questions related to the Solicitation. The questions and answers below are focused on significant clarifying information. Any question from your inquiry that was not answered is due to the solicitation being clear and accurate on what is required at the completion of Phase 1, or due to the question addressing Phase 2 issues which are outside of this solicitation such as an IND. Question 4 : What is the likely regulatory jurisdiction (CDER or CDRH) that the offeror shall anticipate will manage regulation of the product? Answer 4: The FDA stated that the primary contact for electronic cigarettes is CDER. This information can be found here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM225263.pdf Question 5 : In the section “ Phase I Activities and Expected Deliverables”, the solicitation states, “A DMF for the device including all liquid formulations, completed to FDA specifications (see Drug Master File: Guidelines).” Our understanding is that the FDA would require a Master File for Device (MAF), not a DMF. Please clarify. Answer 5: The DMF is not for the device, but covers the liquid formulations and includes characterization of the aerosol generated. For Phase 1 of the solicitation, only a DMF (not an MAF) is a required deliverable. The DMF required is a Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product. Question 6: Please clarify the entity responsible for holding and maintaining the IND and DMF? Answer 6: All intellectual property including patents and FDA filings will follow the standard data rights clauses. Please see page(s) 20, 23-24 of the RFP. Question 7: Should the offeror obtain guidance concerning product characterization from the FDA as a component of the Phase 1 or Phase 2 scope of work? Answer 7: Meetings with the FDA may or may not be a deliverable for a Phase 2 award, but are not a deliverable in the Phase 1 solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-16-8925/listing.html)
- Record
- SN03693082-W 20150410/150408234829-796feff2bc03089a6cff667137975434 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |