The North American Industry Classification System (NAICS) code for this acquisition is 541990; Small Business Standard is $14.0 Million. Award of contract is subject to availability of funding. Acquisition is set-aside 100% for small business concerns. All responsible small business sources may submit a proposal, which shall be considered by the agency. The issued date for solicitation 14-223-SOL-00045 is expected on or about July 30, 2014 with a closing date on or about August 30, 2014. Award anticipated by 30 Sept 2014. A pre-proposal conference is anticipated but not scheduled. Notice of the date of conference will be provided in the solicitation when it is issued. The formal written solicitation and all necessary technical data will be posted to FedBizopps when it is released. Interested parties are responsible to monitor this website for further information concerning this procurement. Any resultant contract is expected to be a Labor Hour (LH) contract. No electronic proposals will be accepted. Point of contact for this solicitation is Crystal McCoskey, Contract Specialist, 870-543-7267, [email protected].

Attached is the draft Performance Work Statement (PWS) and related appendices. Interested offerors are strongly encouraged to review and provide any constructive feedback, ideas for improvement, additional information required, etc. on the documents. Any such input is welcomed and will be taken into consideration when finalizing the solicitation documentation.

Background: The U.S. Department of Health and Human Services, Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Office of Scientific Coordination has a requirement for pathology services in support of FDA's mission. NCTR is located at the Jefferson Laboratories of the FDA in Jefferson, Arkansas, approximately 35 miles south of Little Rock and 28 miles north of Pine Bluff. NCTR is an internationally recognized FDA research center that conducts toxicological research studies and other research activities designed to support the FDA's mission to protect the public's health. NCTR investigators collaborate with researchers elsewhere in the FDA as well as other government agencies, industry, and academia. FDA/NCTR and the National Institute of Environmental Health Sciences (NIEHS) have had an interagency agreement (IAG) since 1992, through which the FDA collaborates with the National Toxicology Program (NTP) to design and conduct toxicological studies involving compounds of regulatory interest to the FDA. Many of the studies at NCTR must follow the FDA's Good Laboratory Practices (GLP) guidelines. NCTR is comprised of six research divisions and has facilities including: 132 general or special purpose research laboratories; Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)-accredited animal facilities, including, but not limited to, rodent facilities accommodating conventional housing, specific pathogen free rodent production colony, isolators for germ-free rodents, and quarantine; a non-human primate research center; a zebrafish production facility; a phototoxicology research center; an imaging center including microPET, MRI, and CT scanner; a nanotechnology core facility; and an inhalation toxicology facility.

Historical Information: On-site pathology services for the animal studies performed at NCTR have been obtained through contracts since the Center's inception in 1972, and most currently by Toxicological Pathology Associates, Inc. (TPA) under a cost-plus-fixed-fee (CPFF) contract. The existing workforce performing the services consists of approximately forty (40) employees made up of both professional and service employee positions. In 2011, 2012, and 2013, the number of studies per year with pathology requirements was 48, 76, and 64, respectively. At any given time, pathology services are being conducted on approximately 10-15 different studies. The majority of pathology studies are conducted on rodents; however, some studies involve non-human primates, other mammals, and/or zebrafish. Facilities, property, and utilities have historically been government-furnished. A complete list of GFP will be included in any resultant solicitation.

Brief Scope: NCTR requires on-site pathology services, for a base period plus up to four (4) 1-year option periods, on various animals in, but not limited to, the following areas: 1) necropsy and gross pathology; 2) histology; 3) pathologist services; 4) clinical chemistry; 5) immunohistochemistry and special procedures; 6) molecular pathology; 7) digital imaging; 8) data management; 9) archive management (wet tissue and block/slide); 10) quality assurance; 11) quality control; and 12) administrative services and management. The Contractor shall conduct the pathology services on each study to the requirements/parameters established by the NCTR Principal Investigators (PIs). The Contractor shall work closely with the Contracting Officer's Representative (COR) and PI to plan, implement, perform, report and archive the research protocols. Planning includes, but is not limited to, developing cost estimates, schedules, and work plans to be performed for each study. Research protocols written by the PIs will determine the pathology support requirements, which may range from necropsy and collection of a few tissues of only a small number of animals to complete necropsy (collection of ≥44 tissues) of over a thousand animals requiring special handling of tissues, histopathology, special staining or other techniques (immunohistochemistry, digital imaging, etc.), hematology, urinalysis, and/or clinical chemistry. Other requested techniques may include, but are not limited to, teratology techniques, respiratory pathology techniques (inhalation toxicology studies), sperm morphology and motility analysis, vaginal cytology, vaginal smears for sperm evaluations, and mammary whole mounts.

Period of Performance:

Base Period: November 1, 2014 through October 31, 2015
Option Period 1: November 1, 2015 through October 31, 2016
Option Period 2: November 1, 2016 through October 31, 2017
Option Period 3: November 1, 2017 through October 31, 2018
Option Period 4: November 1, 2018 through October 31, 2019

Place of Performance:

U.S. Food and Drug Administration
National Center for Toxicological Research (NCTR)
3900 NCTR Road
Jefferson, AR 72079

Bid Protests Not Available