SOURCES SOUGHT
A -- Analytical Chemistry and Stability Testing of Treatment Drugs for Substance Use Disorders
- Notice Date
- 10/22/2018
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and 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, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- 75N9502019R00003
- Archive Date
- 11/21/2018
- Point of Contact
- Megan Nathan, Phone: (301) 443-6677, Lisa V. Bielen, Phone: (301) 443-6677
- E-Mail Address
-
megan.nathan@nih.gov, lisa.bielen@nih.gov
(megan.nathan@nih.gov, lisa.bielen@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Project Requirements: The National Institute on Drug Abuse (NIDA) is seeking capability statements from qualified organizations having the capability to carry out the work for the development and validation of analytical methods, preparation of reference standards, carrying out quality control tests, storage and distribution of drug substances and drug products, and performing stability studies for the compounds and dosage forms to be used in the medications development program. The development of medications for the treatment of drug addiction is a major mission of NIDA. NIDA has been providing potential treatment drugs to investigators for use in preclinical toxicology evaluation, pharmacological studies and clinical trials. The treatment drugs include both bulk drug substances including new molecular entities and dosage forms. These drugs are acquired by the Government from private industry, Government contractors/grantees or independent investigators. In order to assure the identity, strength, quality and purity of these materials, the Government has been performing quality control tests before distributing them to the research community. The preparation of data and documents will support Drug Master File (DMF), Investigational New Drug (IND) or New Drug Application (NDA) submitted by NIDA or NIDA supported investigators to the FDA. Mandatory Requirements: NIDA and NIDA sponsored investigators use the data obtained for submission to the FDA. The reports shall be acceptable in format and substance for submission to the FDA in support of IND and NDA procedures. To handle substances under the Controlled Substances Act of 1970, it is mandatory that the organizations possess a Drug Enforcement Agency (DEA) Research Registration for Schedules II to V. Also, organizations must demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. Organizations should also possess DEA registrations to distribute, import and export controlled substances. In addition, please provide information on any available computerized shipment tracking system, availability of DEA approved vault securely to store controlled drug substances/products, and cGMP-compliance of the proposed facility. Capability Statement/Information Sought: The established NAICS code is 541715. Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous similar projects and work in the field of drug abuse; (2) Personnel: Name, professional qualifications and specific experience of scientists and/or technical personnel who may be assigned as project director and other key positions; (3) Facilities: Availability and description of facilities and equipment required to conduct this type of work. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. All capability statements must provide the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s); 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type of small business your organization classifies itself as (i.e.: women-owned, HUBZONE, etc.). All responses to this notice must be submitted electronically to Megan Nathan, Contract Specialist at megan.nathan@nih.gov and Lisa Bielen, Contracting Officer at lisa.bielen@nih.gov. Written responses and facsimile responses will NOT be accepted. Disclaimer and Important Notes: THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. 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. Any proprietary information should be so marked. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or to provide feedback to the 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/NIH/NIDA-01/75N9502019R00003/listing.html)
- Record
- SN05130791-W 20181024/181022230419-f72123e2b84019a0208b831c81c5dc25 (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 |