SOURCES SOUGHT
B -- Sources Sought Notice: Sunscreen Clinical Study
- Notice Date
- 12/13/2017
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- 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-18-SS-1192863
- Archive Date
- 1/4/2018
- Point of Contact
- Christopher R. McGucken, Phone: (240) 402-7566
- E-Mail Address
-
christopher.mcgucken@fda.hhs.gov
(christopher.mcgucken@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice: Sunscreen Clinical Study MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is conducting market research to support the Center for Drug Evaluation and Research (CDER) requirement for contractor support to conduct a two-part clinical study on sunscreen. This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the required supply item/services. This notice is for planning purposes only, and does not constitute an invitation for Bids, Request for Proposal or Request for Quotation or an indication the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Scope of Work: Contractor's respondent to this notice shall have the capabilities to furnish the necessary personnel, materials, services, equipment, facilities, and otherwise do all things necessary for the performance of the work described below. Capabilities Required: Contractor's respondent to this notice shall have the following capabilities- 1.)Capability to recruit and screen participants in the study through various means (e.g. internet, radio, print, social media, etc.) 2.)Have the appropriate facilities and equipment to collect blood samples. 3.)Experience or capability to draft a protocol; at a minimum the following shall be included: Informed Consent Form, Clinical Site Identification, Key Personnel, Demographics, Inclusion and Exclusion Criteria, Method of Subject Selection, Study Design, Confidentiality of subject information, Data Safety Monitoring Plan, Subject Recruitment Oversight, Subject Discontinuation Criteria and Adverse Event Reporting Plan (via MedWatch) Capability Statements: Responses to this sources sought shall unequivocally demonstrate the respondent's capabilities to provide the services/data above. Though the target audience is small business, all interested parties may respond. At a minimum, responses shall include the following: 1. Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm. 2. Past Performance information shall include date of services, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include DUNS number and size status) if not the respondent. 3. Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing. 4. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response. Response Instructions: Interested parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 1:00 PM Eastern Time on December 20th, 2017 to Christopher.mcgucken@fda.hhs.gov. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-18-SS-1192863/listing.html)
- Record
- SN04766166-W 20171215/171213231535-dcc32a08ca325f89823c8da344024aa8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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