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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 30, 2013 FBO #4144
SOURCES SOUGHT

B -- Assessment of Tobacco Products Pharmacology and Behavior in Humans - FDA-RFI-1114590

Notice Date

3/28/2013
 

Notice Type

Sources Sought
 

NAICS

541720 — Research and Development in the Social Sciences and Humanities
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-RFI-1114590
 

Archive Date

4/30/2013
 

Point of Contact

Juana Quinteros, Phone: 3018276764
 

E-Mail Address

Juana.Quinteros@fda.hhs.gov
(Juana.Quinteros@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

Sources Sought in MS Word Format General Information: Document Type: SOURCES SOUGHT NOTICE Release Date: March 28, 2013 Response Date: April 15, 2013 at 4:30pm EST, via e-mail Contracting Office Address: Food and Drug Administration (FDA), Office of Acquisition and Grant Services Description: Assessment of Tobacco Products Pharmacology and Behavior in Humans NAICS Code: 541720-- Research and Development in the Social Sciences and Humanities Background: 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 range of clinical studies described below from initiation and conduct of the studies through the data analyses phase and preparation of the final reports. This request is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation. No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. Telephone inquiries will not be accepted. The FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned. History: The primary function of the Food and Drug Administration ("FDA" hereinafter) is to promote public health associated with the use of foods, dietary supplements, cosmetics, drugs, tobacco, and other products under its jurisdiction. FDA's Center for Tobacco Products ("CTP" hereinafter) implements PL 111-31 and H.R. 1256, Family Smoking Prevention and Tobacco Control Act, which was signed into law on June 22, 2009. The Tobacco Control Act granted FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health. Since tobacco products are not regulated as drugs, their effects on human behavior and pharmacology have not been evaluated by FDA. The Contractor will provide scientific support necessary to assist in the implementation of this law under the Federal Food, Drug, and Cosmetic Act Specifically the contractor will assist FDA by assessing tobacco product pharmacology and human dependence behaviors in healthy volunteer male and female tobacco users. The Office of Science Center for Tobacco Products (CTP), therefore, plans to initiate a series of clinical studies to evaluate the impact of tobacco products on human behavior and pharmacology. The first study will evaluate the dependence, craving, withdrawal relief and choice behavior in healthy adult male and female cigar smokers before and after smoking their usual type and brand of cigar. The contractor will also measure physiological effects, including blood pressure and heart rate, as well as biomarkers of exposure (including nicotine, cotinine, CO, NNAL) before and after cigar smoking. The contractor will perform all data analyses and write the resultant study reports. SCOPE Contractor tasks shall include, but not be limited to: The contractor shall provide input on scientific protocols and methodologies, provide human subjects protection including IRB (including consent form) documentation and approval, provide documentation for FDA RIHSC (Research in Human Subjects Committee), screen and select participants, administer the tobacco products, collect behavioral and pharmacological data, perform data analyses, and create scientific reports. Studies will assess the impacts of tobacco products on dependence, craving, withdrawal relief, choice behavior, physiological effects, and measurement of biomarkers of exposure (e.g., nicotine, cotinine, CO, TSNAs). Data collected under this contract will inform FDA on the behavioral and pharmacological effects associated with tobacco product use, and may guide tobacco product policies and regulations. Contractor Requirements: Contractors must respond to all of the following points, by indicating your experience and capability: 1. To perform human behavioral assessments, including but not limited to dependence, craving, withdrawal relief, choice behavior, and topography. 2. To assess tobacco constituents and/or metabolites in blood and/or urine samples using pharmacological measurements. 3. To recruit and identify staff (key personnel) with expertise in clinical study methodology. 4. To identify and recruit medical staff, laboratory technicians and other staff with the necessary capability and experience to perform the screening, behavioral assessments and laboratory tests, to collect specimen samples and to assay the biologic samples. 5. Demonstrate experience in performing clinical pharmacology studies, including but not limited to recruitment of male and female tobacco users (including difficult to recruit populations), assessment of their inclusion or exclusion in the study, and selecting a clinical research facility which is equipped to perform the study. Teaming Arrangements: All teaming arrangements shall include the above-cited information for each entity on the proposed team. Teaming arrangements are encouraged. This is not an invitation for bid, request for proposal or other solicitation and in no way obligates FDA to award a contract. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. 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. Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM website located at http://www.sam.gov 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. Responders should also include a statement about whether or not they have an approved Federal audited accounting system. If the responder has an approved accounting system, please provide the certification in which the accounting system was deemed adequate (e.g. the name of the audit agency and audit number). You may submit as an attachment, which will not count towards the overall page limit. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email to Attn: Juana Quinteros, Contract Specialist at Juana.Quinteros@fda.hhs.gov. CAPABILITY STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINED ABOVE. Please address each in order listed above. All capability statements shall be submitted via e-mail to the point of contact listed above. Responses shall be limited to 10 pages. Responses must be submitted no later than 4/15/13, Size of Business State whether your company is a large business, small business (and also state your under socioeconomic status), College/University, or a non-profit organization. Estimated Dollar Value Range Based on the government's mission, objectives, and scope of work, what dollar value range would you determine to be the most accurate rough estimate. Under $2,000,000.00 Over $2,000,000.00 and Under $4,000,000.00 Over $4,000,000.00 and Under $6,000,000.00
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFI-1114590/listing.html)
 

Place of Performance

Address: 9200 Corporate Blvd, Rockville, Maryland, 20850, United States

Zip Code: 20850
 

Record

SN03023373-W 20130330/130328235115-40557d98f94e0c1efb1b86263e667aaf (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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