Regulatory Affairs Support

***SOURCES SOUGHT NOTICE AMENDMENT*** -- The purpose of this amendment is to change the sources sought notice number from N01DA-17-8933 to HHS-NIH-NIDA-SBSS-17-003.

Please use the updated sources sought notice number when submitting capability statement.

All other parts of this sources sought notice remains unchanged.

 

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 $15 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 Therapeutics and Medical Consequences (DTMC), and NIDA.
The purpose of this contract is to provide services and resources to meet the regulatory needs of the Regulatory Affairs Branch in the Division of Therapeutics and Medical Consequences (DTMC), National Institute on Drug Abuse (NIDA). The mission of DTMC is to accelerate the development and approval of new medications in the field of drug abuse. NIDA, DTMC 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 contract will provide regulatory support the development and filing of regulatory submissions for NIDA. The submissions may include initial investigational New Drug (IND) applications, annual reports, protocol amendments, information amendments, New Drug Applications (NDAs) and supplemental NDAs. This contract will ensure that the submissions are 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 regulatory submissions. In addition, capabilities must include the ability to perform other support functions including but not limited to literature searches, PowerPoint presentations, preparation of regulatory standard operating procedures, and preparations 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 the 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 contract, 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) types(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 Ndidi Okeagu, whose contract information is provided, NO LATER THAN DECEMBER 2, 2016. Paper or electronic capability statements will be accepted.