SOURCES SOUGHT
A -- Regulatory Affairs Support
- Notice Date
- 10/31/2011
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SBSS-12-001
- Archive Date
- 11/18/2011
- Point of Contact
- Kara Anderson, Phone: 3014436677, Brian H O'Laughlin, Phone: (301) 443-6677
- E-Mail Address
-
kara.anderson@nih.gov, bo50d@nih.gov
(kara.anderson@nih.gov, bo50d@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is seeking capability statements from qualified Small Business organizations (NAICS code 541990, small business standard size is $7 million. For details of Small Business Size Standards see www.SBA.gov ). This is a SMALL BUSINESS SOURCES SOUGHT NOTICE to determine the availability of ALL small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUB Zone small businesses, small disadvantaged businesses, women-owned small businesses, and other small businesses) to provide services and resources to meet the regulatory needs of the Regulatory Affairs Branch in the Division of Pharmacotherapies and Medical Consequences on Drug Abuse (DPMCDA), and NIDA. The mission of DPMCDA is to accelerate the development and approval of new medications in the field of drug abuse. DPMCDA conducts studies to evaluate compounds for their potential use as treatment medications for drug abuse. The division also conducts pre-clinical studies to support the filing of Investigational New Drug (IND) applications to initiate studies of potential medications in humans. This project will provide regulatory support for the development and filing of regulatory submissions for NIDA. Interested organizations must show experience in medical writing, including but not limited to writing initial IND applications, investigator's brochures, annual reports, protocol amendments, information amendments, New Drug Applications (NDAs) and supplemental NDAs. All submissions are to be developed in accordance with the Food and Drug Administration (FDA) regulations, International Conference on Harmonization (ICH) guidances and Good Clinical Practice (GCP) guidelines. Offerors must also demonstrate knowledge of electronic submissions. In addition, capabilities must include ability to perform other support functions including but not limited to literature searches, Powerpoint presentations, preparation of regulatory standard operating procedures, and preparation of meeting minutes. Information sent should be relevant and specific in the technical area under consideration on each of the following qualifications: 1. Experience: Examples of previous projects (whether government or commercial), that the offeror has performed, including references such as names, titles, telephone numbers, etc.; 2. Personnel: Names, professional qualifications and specific experience of technical personnel who may be assigned as project officer; 3. Facilities: Availability and description of facilities required to perform 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 limited to, contracts both Government and commercial organizations performed, references, i.e. names, titles, telephone numbers, and any other information serving to document the organizations capability, e.g. awards, commendations, etc. THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for the preparation of any information sent for the Government's use. Any proprietary information should be so marked. All capability statements should 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(s) of business, if any (e.g.,: small, Veteran-owned, service-disabled Veteran-Owned, women-owned, 8(a), Small Disadvantaged Business (SDB), and Historically Underutilized Business Zone (HUBZone). Written capability statements must be submitted to Kara Anderson, whose contact information is included, NO LATER THAN November 15. Paper or electronic capability statements will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA-SBSS-12-001/listing.html)
- Record
- SN02615122-W 20111102/111031233926-aee4f93cf2c9336309eca72c61d1b5b2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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