News Column

Sources Sought Notice - Pathology Services

January 28, 2014



Notice Type: Sources Sought Notice

Posted Date: 27-JAN-14

Office Address: Department of Health and Human Services; Food and Drug Administration; Office of Acquisitions and Grants Services; 3900 NCTR Road, HFT-320 Bldg 50 | Rm 421 Jefferson AR 72079

Subject: Pathology Services

Classification Code: B - Special studies and analysis - not R&D

Solicitation Number: FDA1128423

Contact: Crystal G. McCoskey, Phone 8705437267, Email crystal.mccoskey@fda.hhs.gov

Description: Department of Health and Human Services

Food and Drug Administration

Office of Acquisitions and Grants Services

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a sources sought to determine the availability and capability of small businesses to provide on-site pathology services. The associated North American Industry Classification System (NAICS) Code is- 541990 All Other Professional, Scientific and Technical Services; Small Business Size Standard is $14.0 million.

Part I: General Information

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.

Part II: Work Requirements Summary 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.

Estimated 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

Part III: Instructions to Prospective Respondents

Responses to this sources sought shall unequivocally demonstrate that respondent has the capability, staff (ability to recruit and maintain), experience, property management processes, and accounting system to perform the services under any type of contract. Though the target audience is small businesses, all interested parties may respond. At a minimum, responses shall include the following:

* Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address;

* Three (3) years of past performance information for the service of same or substantially similar projects to include date of services, description, dollar value, contract type (e.g., fixed-price, cost reimbursement, time-and-materials, labor hours, etc.), details demonstrating ability to recruit, retain, and fairly compensate suitable professional employees as defined in 29 CFR 541,client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address;

* Evidence that accounting system has been determined adequate for determining costs applicable to a cost reimbursement contract or otherwise suitable for a time-and-materials or labor-hour arrangement;

* Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the services the responding firm is regularly engaged in providing;

* If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement;

* If a large business, identify the subcontracting opportunities that would exist for small business concerns;

* Although this is not a request for quote, informational pricing can be provided;

* The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

The Government is not responsible for locating or securing any information, not identified in the response.

Interested Parties must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before February 3, 2014 by 1:00 PM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Crystal G. McCoskey, 3900 NCTR Road, Bldg 50/Room 426, HFT-320, Jefferson, AR 72079-9502 or email crystal.mccoskey@fda.hhs.gov. Reference #FDA1128423 in all correspondence with the point of contact listed above.

Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether the acquisition approach, ie, small business set-aside, 8(a) set-aside, full and option competition, etc.

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 solicitation may be published via FedBizOpps. 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).

Link/URL: https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1128423/listing.html


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