Niaid clinical research products management center

Sources Sought Notice Information

Introduction
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.

Background
The Division of AIDS of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), plans, sponsors, and directs national and international extramural research programs involving the testing of vaccines, therapeutics, and prevention modalities. Through these programs, clinical trials in over 28 countries at more than 300 clinical research sites are supported.

NIAID places a high priority on ensuring the integrity of study endpoint and safety data. The quality and integrity of study products is a cornerstone of patient safety and study data. The proposed contract is for the continuation of a Clinical Research Products Management Center (CRPMC) that provides pharmaceutical services and study product management expertise and services that adhere to current Good Manufacturing Practice (cGMP), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines, the Food and Drug Administrations (FDA), Code of Federal Regulations (CFR), European Medicines Agency (EMA) and any applicable local or international regulation in support of NIAID supported clinical trials networks and programs.

The Clinical Research Products Management Center contract was initially awarded in 1988. The current contract (number HHSN272201300011C) is with Fisher BioServices, Inc., Rockville, Maryland.

Purpose and Objectives
This contract is for the management and operation of the Clinical Research Products Management Center (CRPMC) to support NIAID sponsored clinical research trials both domestic and international, with a core focus of HIV/AIDS and its co-morbidities by providing a cGMP-compliant facility, for the receipt, storage, labeling, packaging, repackaging, shipping, acquiring, and disposition of study products. Through the exercise of Options, the contract may provide for additional clinical site pharmacy oversight responsibilities, as well as support for other high-priority, NIAID sponsored clinical trials on a limited, as-needed basis. All functions must be conducted in accordance with federal, local and international regulations governing study product including but not limited to, the CFR, ICH, Good Clinical Practice (GCP), cGMP, Good Distribution Practices (GDP), Good Documentation Practices and all applicable regulation or guidance.

Project Requirements
The Division of AIDS (DAIDS), of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is seeking capability statements from qualified organizations to support NIAID sponsored clinical research trials both domestic and international, with a core focus of HIV/AIDS and its co-morbidities by providing pharmaceutical services and study product management a cGMP-compliant facility, receipt, storage, labeling, packaging, repackaging, shipping and distributing, acquiring, and disposition of study products. For the purposes of the proposed contract, study product is defined as investigational product (IP) or investigational medicinal product (IMP) as defined by the study.

The Contractor must have the capability to provide a cGMP facility to carry out the scope of work both domestically within the United States (U.S.) and internationally, including countries in Africa, Asia, South America, the Caribbean, and Europe. All functions must be conducted in accordance with federal, local and international regulations governing study products. For the purposes of determining your related capabilities, your organization must have the capabilities to support over 80 clinical trials, conducted at more than 300 clinical research sites in over 28 countries. The organization must provide a broad range of pharmaceutical and study product management services to the current and evolving clinical research portfolio, including adult, pediatric, vaccine and prevention trials. A capable organization must securely ship these products successfully to various countries with varying climates at all times of the year. This ensures the timely continuation of NIAID supported studies. The organization must also play an important role in the regulatory management of the study products section of the Trial Master File (TMF) for NIAID sponsored, DAIDS held IND studies and will be responsible for maintaining a readily accessible, organized and current electronic system for document management. The Contractor must be able to provide regulatory guidance and expertise as it pertains to ICH, CFR and international regulations with regards to the study product management and distribution.

Anticipated period of performance
It is anticipated that a cost reimbursement, term/level of effort, type contact will be awarded. The period of performance will be for one-year (Base Period) plus six (6) one-year options to extend the term of the contract that may be exercised by the Government unilaterally, for a total possible period of performance of seven (7) years, beginning approximately March 15, 2020. The requirement will be the delivery of 27 full time equivalents (FTEs) per year for the base period (Year 1) and 27 FTEs per year for Options 1-6 (Years 2-7). In addition to the services outlined above to be provided in the base requirement, options for additional services under the contract may be exercised at the discretion of the Government as follows: 1) increased level of effort to accommodate significant increases in work in the amount of 2 FTEs per option that may be exercised up to four times in each performance year (Options 7 through 34, during years 1-7); and 2) increased level of effort to accommodate significant increases in work in the amount of .5 FTE per option that may be exercised up to two times in a performance year (Options 35 through 48, during years 1-7). Should the Government elect to exercise these options, the Contractor shall provide resources as stated above.

Capability statement / information sought
Capability Statements should clearly convey information regarding the respondent's capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information.

Interested contractors must submit a capability statement (eight page limitation, excluding resumes) describing their company's experience and ability to perform this effort that includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work.

Page Limitations:
Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 8 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such.

Required Business Information:
• DUNS.
• Company Name.
• Company Address.
• Company Point of Contact, Phone and Email address.
• Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought.
• Do you have a Government approved accounting system? If so, please identify the agency that approved the system.
• Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address).

Number of Copies:
Please submit one (1) electronic copy of your response as follows:

All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Kishan Patel, Contracting Officer, at patelki@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify the Sources Sought Reference Number HHS-NIH-NIAID-SBSS-18-016. Facsimile responses will not be accepted.

Common Cut-off Date:
Electronically submitted tailored capability statements are due no later than 3:00 PM, Eastern Standard Time on August 9, 2018. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.

Disclaimer and Important Notes
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. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to 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).

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