SOURCES SOUGHT
A -- Statistical and Clinical Coordinating Center
- Notice Date
- 7/26/2018
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6710B Rockledge Dr., Suite 1124, MSC7000, Bethesda, Maryland, 20892-7510, United States
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-DIPHR-SBSS-2019-4
- Archive Date
- 8/30/2018
- Point of Contact
- Cynthia L. Brown, Phone: 301-443-5239, Elizabeth D Osinski, Phone: 301-526-0347
- E-Mail Address
-
cb25b@nih.gov, eo43m@nih.gov
(cb25b@nih.gov, eo43m@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Background: The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead Federal agency for the conduct of basic, clinical and epidemiologic research to develop new contraceptives and to evaluate existing methods of contraception and reproductive health. The Center for Population Research (CPR), within NICHD, was established in 1968 by the Secretary of Health Education and Welfare, (formally Department of Health, Education and Welfare), with the important goal of developing new contraceptives using contracts and grants. Under the CPR mission, the Contraceptive Development Branch (CDB) supported preclinical contraceptive testing facilities as well as facilities for chemical and peptide synthesis. To further expand their contraceptive development capabilities, in 1996, CDB established the NICHD Contraceptive Clinical Trials Network (CCTN) consisting of a Statistical and Clinical Coordinating Center (SCCC) and 8 sites highly qualified to evaluate new contraceptive methods for women. The initial CCTN did not have any sites dedicated to male contraception. In 2004, the network was expanded through a competitive RFP, and sites for male contraceptive development were added. In 2013, the CCTN was again recompeted and expanded to 19 sites for female contraceptive evaluation and 2 sites for male contraception. In 2017, the NICHD established the Contraceptive Development Program (CDP) as a component of the Division of Intramural Population Health Research (DIPHR), with the mission to develop and evaluate new methods of contraception for women and men through the CCTN. As of 2018, the CCTN has completed 24 clinical trials including Phase I, II and III trials on novel female contraceptive methods and Phase I and II trials on male contraceptive methods. In addition, there are five actively enrolling clinical trials as well as three new trials that will begin enrollment in 2018. All clinical trials are coordinated and monitored by the SCCC under the technical direction of the Program Manager (Chief, CDP), the Contracting Officer's Representative (COR) and the Medical Officer (MO). Purpose of the Announcement: 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; 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. The requirement is assigned a code of 541715 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 1000 employees or less. Project Requirements: The proposed acquisition will involve the following types of activities: 1. Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment and facilities not otherwise provided by the Government under the terms of this contract as needed to provide statistical and clinical coordination and conduct of contraceptive clinical trials. Trials may involve male or female contraceptive drugs or devices in Phase I, II, III or IV of clinical evaluation. 2. Participate in study design of concept plans and protocols in collaboration with the NICHD COR, NICHD MO, and the Principal Investigators of the CCTN sites. Provide draft protocol and draft protocol amendments for each study. Develop draft informed consent documents that are consistent with government regulations. Coordinate site submissions to comply with submission to a single IRB for multi-site clinical trials. 3. Design data collection instruments and coordinate all data management and data analysis aspects of the trials. Ensure FISMA compliance (21 CFR Part 11). 4. Monitor, coordinate and conduct contraceptive clinical trials for novel male contraceptive or female contraceptive products. The Contractor shall monitor each clinical trial and shall maintain records in accordance with current FDA regulations and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. Information on current Food and Drug Administration (FDA) regulations applicable to clinical trials and ICH GCP guidelines can be found at the following Web sites: ICH GCP: http://www.ich.org/products/guidelines/ and FDA: http://www.fda.gov/ 5. Monitor training of clinical site personnel and quality assurance of data collected in clinical studies. 6. Coordinate tracking of laboratory specimens as required for specific studies, ensure that all protocol-specified laboratory tests are completed, and that the results are accurately reported as specified in the applicable study protocol. 7. Prepare Clinical Study Reports of clinical trials in a manner acceptable to FDA and equivalent stringent regulatory agencies for drugs, including initiation and maintenance of IND applications and NDAs; and, for devices, Premarket notifications 510K, PMAs, and IDEs. 8. Provide, through subcontractors if necessary, ancillary services to assist in the organization or acquisition of materials and services required to conduct contraceptive clinical trials or provide clinical data. Such services might include drug or device procurement, drug formulation (including encapsulation), drug packaging, distribution, facilities for central lab and stability testing, consultants for histology or pathology, etc., as required for a specific study. Where IND holders do not have product liability insurance, the SCCC may be required to assist in the acquisition of such insurance. 9. Work in close collaboration with the clinical sites, laboratory contractors, the Data and Safety Monitoring Board and the Scientific Consulting Group to assist NICHD in coordinating activities of the network. 10. All work performed by the SCCC for the CCTN shall be monitored by the NICHD COR and Contracting Officer (CO). 11. Only de-identified data shall be collected under all current and future task orders under this contract. Anticipated Period of Performance: The anticipated period of performance is seven years, 9/1/2019 - 8/31/2028. Capability Statement/Information: The NICHD is seeking Small Businesses capable of meeting the following criteria. Small Business organizations must submit Capability Statements in response to this notice and that will be evaluated against the following technical areas of experience and expertise: Provide a description and documented evidence of the experience and expertise of the staff to perform the tasks listed below. Provide names of projects and references. Response must include sufficient detail to demonstrate: 1. Demonstrated experience of the offeror (as organization) with respect to similar projects. Evidence that the offeror has the capacity to coordinate and monitor research of this type. 2. Demonstrated experience of the proposed staff in the development of research protocols for evaluating potential male contraceptive products and novel female contraceptive products. 3. Demonstrated experience of the proposed staff in the coordination of large scale multi-site Phase I, II, III and IV contraceptive clinical trials. 4. Demonstrated experience of the proposed staff in the site monitoring of large scale multi-site Phase I, II, III and IV contraceptive clinical trials. 5. Demonstrated experience and ability to implement a data management system for collection, checking, editing, analyzing and correcting data from individual sites, ensuring collection of high-quality data, protection of participants' confidentiality, and data security. 6. Demonstrated experience of the proposed staff in the statistical analysis of large scale multi-site Phase I, II, III and IV contraceptive clinical trials. 7. Demonstrated experience in preparation of reports of clinical studies for new drugs and devices in accordance with FDA requirements and GCP guidelines. 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 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). Interested Small Business organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies to Cynthia Brown, Contract Specialist, (Email: cb25b@nih.gov) and Elizabeth Osinski, Contracting Officer, (Email: eo43m@nih.gov). Please limit responses to 20 pages or less. These pages exclude resumes. Electronic capability statements should be electronically received by the Contracting Officer by 4:00PM, August 15, 2018, EST. Capability statements must identify the business status of the organization, NAICS code along with DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.). Inquiries should be directed to: Ms. Cynthia Brown, Contract Specialist, DHHS/NIH/NICHD/CMB, Email: cb25b@nih.gov, telephone 301-443-5239 OR, Secondary Point of Contact: Ms. Elizabeth Osinski, Contracting Officer, DHHS/NIH/NICHD/CMB, Email: eo43m@nih.gov, telephone 301-526-0347. Contracting Office Address: Contracts Management Branch 6710B Rockledge Dr., Suite 1124, MSC7000 Bethesda, Maryland 20892 7510 United States Place of Performance: To be determined United States Primary Point of Contact.: Cynthia L. Brown Contract Specialist cb25b@nih.gov Phone: 301-443-5239 Secondary Point of Contact: Elizabeth J. Osinski, Contracting Officer eo43m@nih.gov Phone: 301-526-0347
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-DIPHR-SBSS-2019-4/listing.html)
- Place of Performance
- Address: To be determined., United States
- Record
- SN05008052-W 20180728/180726230920-ea13cdc94cca07e236baaaad1971e5af (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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