SOURCES SOUGHT
A -- Evaluation of Drug Product Formulation
- Notice Date
- 6/4/2013
- 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-1116096
- Archive Date
- 7/2/2013
- 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
- General Information: Document Type: SOURCES SOUGHT NOTICE Release Date: June 4, 2013 Response Date: June 17, 2013 at 4:30pm EST, via e-mail Contracting Office Address: Food and Drug Administration (FDA), Office of Acquisition and Grant Services Description: Evaluation of Drug Product Formulation 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 an Evaluation of drug product formulation and in-vitro performance characteristics related to abuse-deterrence for solid oral dosage forms of opioids. 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: Opioid analgesics, which are commonly prescribed for pain in both cancer and non-cancer patients, carry a high risk of abuse and misuse and have accounted for increase in visits to the emergency departments and deaths related to drug overdose. Drug overdose rates have been rising steadily in the Unites States since 1970 with more than 15,500 deaths reported in 2009. One of several Agency efforts to reduce the abuse and misuse of opioid prescription drugs is encouraging development of abuse-deterrent formulations of opioids. Abuse-deterrent formulations are intended to prevent manipulation of the drug product for extraction of the active with the purpose to employ alternate routes of administration, such as snorting, injection, and smoking. In the recent past, the Agency has approved several new formulations of opioids that are designed to deter abuse. According to FDA commissioner, Margaret Hamburg, if the FDA concludes that the newly approved opioid formulations significantly deter abuse, the agency will have the legal authority to require generic versions of those products to also have abuse-deterrent properties. The science of abuse deterrence through formulation modification is relatively new, therefore, requiring research in this area. Specifically, understanding the influence of role of excipients in the formulation, coupled with the manufacturing process, in conjunction with in vitro methods used to determine the consequences of product tampering would greatly assist in the development of risk models to assist in the Agency's evaluation of abuse-deterrent products. Information generated from this research will assist in the assessment of innovator product claiming to have tamper resistant properties. It will also enable the development of needed equivalence standards to evaluate generic versions claiming abuse-deterrent properties. OBJECTIVE: The project will investigate the effect of physicochemical properties of the active and excipients and composition of the drug product, along with the drug product manufacturing technology on the manipulation of the drug product for extraction of the active ingredient for putative abuse. SCOPE: Contractor tasks shall include, but not be limited to: 1. Formulation development -A variety of "abuse-deterrent" formulations will be prepared using different drug-excipient ratios and manufacturing process using model drugs. 2. These formulations will be tested and compared to both marketed abuse-deterrent formulations as well as traditional formulations for physico-chemical properties related to product tampering such as hardness, and dissolution. These products will also be compared via a battery of in vitro physical manipulation and chemical extraction tests to determine the influence of formulation design features on potential tampering. 3. The results of these studies comparing different formulation designs will be used to develop a graded risk assessment model and standards to evaluate abuse-deterrent formulations. 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 6/17/13. 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 $200,000.00 Over $200,000.00 and Under $400,000.00 Over $400,000.00 and Under $600,000.00
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFI-1116096/listing.html)
- Place of Performance
- Address: 7519 Standish Place, Rockville, Maryland, 20855, United States
- Zip Code: 20855
- Zip Code: 20855
- Record
- SN03078722-W 20130606/130604235253-81097151079184467f03b5fcb431b4f2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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