SOURCES SOUGHT
B -- Assessment of Patient’s Perception of Dry Powder Inhaler Airflow Resistance - FDA-SS-1163047
- Notice Date
- 3/17/2016
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-1163047
- Archive Date
- 4/15/2016
- Point of Contact
- NAOMI CARTER, Phone: 2404027575
- E-Mail Address
-
NAOMI.CARTER@FDA.HHS.GOV
(NAOMI.CARTER@FDA.HHS.GOV)
- Small Business Set-Aside
- N/A
- Description
- Assessment of Patient’s Perception of Dry Powder Inhaler Airflow Resistance TITLE: Sources Sought Notice FDA SS-1163047 This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to perform all facets of the work described below. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541712, Research and Development in the physical Engineering, and Life Sciences (except Biotechnology), with a small business size standard of 1000 employees. This is not an invitation for bid, request for proposal, or other solicitation, and in no way obligates the Food and Drug Administration (FDA) to award a contract. BACKGROUND: The Food and Drug Administration's Office of Acquisitions and Grants Services have a requirement for: Assessment of Patient's Perception of Dry Powder Inhaler Airflow Resistance Project objectives are: (1) Develop an optimal method for collection of inspiratory flow profiles through passive DPIs (2) Develop a questionnaire and a scoring method for qualitative and quantitative evaluation of patient perception of airflow resistance (3) Record inspiratory flow profiles in conjunction with perception of airflow resistance of various patient populations, inhaling through varied airflow resistances by conducting a drug-free clinical study that uses the methods developed through Objectives 1 and 2. (4) Produce a standardized method for collection of inspiratory flow profiles through DPIs and a standardized questionnaire for assessment of patient perception of DPI airflow resistance. Both, questionnaire and method for measurement of PIF, will provide a clear and reliable regulatory path for assessment of patient perception of new DPI product under 505 (b) pathway and a comparative matrix for assessment of patient perception of generic DPIs that has different airflow resistance than reference product. Please provide the follow Business information: 1. DUNS Number 2. Company Name 3. Company Address. 4. Company Point of Contact, phone number and email address 5. Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract shall be registered on the SAM located at http://www.sam.gov/index.asp. 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7. Current GSA Schedules appropriate to this Sources Sought 8. Current Government Wide Agency Contracts (GWACs) 9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. 10. Provide documentation to demonstrate your company's capability to perform the objective requirements defined above. Interested parties having the capabilities necessary to provide the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Responses shall be received not later than 3:00 PM EST, March 31ST, 2016. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Naomi.Carter@fda.hhs.gov with subject line titled "Sources Sought 1163047".
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1163047/listing.html)
- Place of Performance
- Address: TBD., United States
- Record
- SN04053381-W 20160319/160317234430-13567e53d199aea576f050a5462cff23 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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