MODIFICATION
A -- CLINICAL RESEARCH PRODUCTS MANAGEMENT CENTER (CRPMC) - Amendment 1
- Notice Date
- 3/6/2012
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- RFP-NIAID-DAIDS-NIHAI2011444
- Archive Date
- 3/31/2012
- Point of Contact
- Kishan Patel, Phone: 3014960612, Michelle A Scala, Phone: 301-496-0612
- E-Mail Address
-
patelki@niaid.nih.gov, mscala@niaid.nih.gov
(patelki@niaid.nih.gov, mscala@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice Amendment 1 SOURCES SOUGHT NOTICE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) CLINICAL RESEARCH PRODUCTS MANAGEMENT CENTER (CRPMC) RFP NIAID DAIDS NIHAI2011444 Type of Requirement 0 New Requirement 1 Re-competition (Contract No.:HHSN266200600002C) 0 Expansion of (Contract/RFP No.:______________) Place of Performance 1 Place of performance is unknown at this time 0 Place of performance is known Recompetition (if applicable) Fisher BioServices, Inc. 14665 Rothgeb Drive Rockville, MD 20850 Contracting Office Address Department of Health and Human Services National Institutes of Health National Institute of Allergy and Infectious Diseases Office of Acquisitions 6700-B Rockledge Drive, Room 3214, MSC 7612 Bethesda, MD 20892-7612 Sources Sought Notice Information General Information Document Type: Sources Sought Notice Solicitation Number: Reference Number: HHS-NIH-NIAID(AI)-SBSS-1444 Posted Date: March 02, 2012 Original Response Date: March 16, 2012 Current Response Date: March 16, 2012 Original Archive Date: Current Archive Date: Classification Code: A -- Research & Development NAICS Code: 541712 -Research and Development in the Physical, Engineering and Life Sciences 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 there are small businesses; HUBZone small businesses; service disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; women-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 (DAIDS), 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 very high priority on ensuring the integrity of study endpoint and safety data. The quality and integrity of clinical study products is a cornerstone of patient safety and study data. The purpose of this contract is to continue to provide a broad range of pharmaceutical and study product management services to the current and evolving NIAID/DAIDS supported clinical research portfolio. This includes the clinical trials networks of DAIDS, as well as some non-network studies. In addition, this contract will support the clinical site pharmacy oversight responsibilities of the Division of AIDS. The Clinical Research Products Management Center (CRPMC) contract was initially awarded in 1988 and has been renewed at the expiration of each contract period (the current contract number is HHSN266200600002C with Fisher Bioservices, Inc., Rockville, Maryland). Purpose and Objectives This contract will support the continuation of cognitive pharmaceutical services including evaluating draft protocols; reviewing site pharmacy monitoring reports, and maintaining a site audit pharmacy report database; providing study product storage and stability information, guidance in research pharmacy practice and study product management activities to clinical site pharmacists; and conducting Current Good Manufacturing Practice (cGMP) audits of manufacturing facilities. Additionally, the CRPMC will provide technical expertise for the receipt of study products; storage under cGMP; validate containers for the shipment of study products; evaluate orders, and distribute study products; design and labeling of study products and product kits; packaging and repackaging of study products under GMP; monitor product inventories and expiration dates; recall and process of study product returns, and maintain a database to track study product activities. The CRPMC will train staff in critical procedures and under limited circumstances, purchase drugs. Options are included to accommodate additional work in support of pharmacy oversight responsibilities, as well as for the provision of limited study product management functions for the AIDS Malignancy Consortium (AMC) in the areas of drug acquisition/sourcing, study product storage, and shipment/distribution Project Requirements The CRPMC must have the capabilities 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, you may assume that this contract will be required per year to repackage 25 different study products consisting of 50,000 individual units, label 200 different study products consisting of 150,000 individual units, and process approximately 12,000 shipments within the U.S. and internationally. Performance Requirement and Anticipated Period of Performance The performance requirement will be for the delivery of 24 full time equivalents (FTEs) per year for the base period (Year 1) and option periods (Year 2 through Year 7), which may be unilaterally exercised by the Government. The option periods may extend the term of the contract beyond the base period for up to 7 years. 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 2.25 FTEs per option that may be exercised up to two times in a performance year; 2) increased level of effort to support pharmacy oversight responsibilities in the amount of 2.25 FTEs per option that may be exercised up to two times in a performance year; and 3) increased level of effort to provide limited study product management functions to the AIDS Malignancy Consortium (AMC) in the amount of 2 FTEs per option that may be exercised one time per performance year. 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 (five 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. Each response should include the following Business Information: a. DUNS number b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Current GSA Schedule appropriate to this Sources Sought f. Do you have a Government-approved accounting system? If so, please identify the agency that approved the system. g. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must be registered in the CCR, located at http://www.ccr.gov/ Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors and consultants. The Contractor will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Responses must be submitted no later than 4:00 PM, March 16, 2012 Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Kishan Patel, Contract Specialist. He can be emailed at the address provided below. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line, please reference: HHS-NIH-NIAID(AI)-SBSS-1444. A paper copy can be sent via regular mail to the address provided below. If sending a paper copy, please send an original and one copy. Kishan Patel Contract Specialist Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 6700B Rockledge Drive, Room 3224, MSC 7612 Bethesda, Maryland 20892-7612 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 Presolicitation synopsis and solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contract Specialist: Kishan Patel Email Address: patelki@niaid.nih.gov Contracting Officer: Michelle L. Scala Email Address: mscala@niaid.nih.gov   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.
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