Contraceptive Development Program NICHD Contraceptive Clinical Trials Network (CCTN) Statistical and Clinical Coordinating Center (SCCC)

Description: THIS IS A REQUEST FOR PROPOSALS (RFP). This is a 100% total small business set-aside IDIQ Task Order contract. 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 eight actively enrolling clinical trials, three of which began enrollment in 2018. This procurement is for the recompetition of the SCCC to provide the support for the new CCTN as described below. The CCTN conducts Phase I, II, and III clinical trials of new female or male contraceptive methods. With the recompetition of the CCTN, contractors with the capability and experience of coordinating and monitoring both female and male contraceptive trials will be sought. Experience in protocol development for new chemical entities to evaluate male contraception or female contraception is a critical element, including expertise related to the regulatory requirements associated with transition from preclinical to first in human studies as well as the requirements for evaluation of products in Phase I, II and III trials. For large capacity trials, it may be necessary and desirable to expand to international sites, therefore experience in working with other regulatory agencies is valuable. The network will consist of up to 19 sites focused on female contraceptive clinical research and up to 9 sites focused on male clinical research, therefore the SCCC must have capability to coordinate and monitor both small and large clinical trials of investigational drugs or devices for male or female contraception. The goal of the NICHD's CCTN is to systematically evaluate the safety and efficacy of new or existing female and male contraceptive drugs and devices as well as treatments of selected gynecologic conditions in Phase I, II, III and IV trials conducted under Good Clinical Practices guidelines. The results of these clinical trials on new entities would be the basis for advancing candidate drugs and devices through clinical development with the ultimate goal of submission to the FDA in support of an Investigational New Drug (IND) application and initiation of New Drug Application (NDA) for a new drug for male or female contraception; and for a device, Premarket notification 510K, Premarket approval (PMA), and Investigation Device Exemption (IDE). The goal of this contract is to obtain the necessary technical support and services needed by the NICHD and the CCTN sites, such as the development of research protocols, on-site monitoring of clinical trials, the statistical analysis of data from these trials, the development of IND applications, NDAs, Premarket notifications 510K, PMAs, IDEs and other ancillary services, in order to successfully achieve the goals of the CCTN. The purpose of this acquisition is to provide support and services to the CCTN and NICHD for a variety of tasks related to the development and conduct of clinical trials of male and female contraceptive products under Good Clinical Practices guidelines, as well as to provide ancillary services for the trials, such as product formulation, packaging, distribution, insurance and stability testing. Additional services supporting clinical evaluation and regulatory approval of candidate entities will be provided as needed for individual products. The general requirements are as follows: 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 site: ICH: https://www.ich.org/home.html 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 Task Order. 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, 510K Premarket notifications, PMAs, and IDEs. 8. Provide 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. As a result of this announcement, the NICHD anticipates awarding a single cost reimbursement IDIQ type contract with an ordering period of seven (7) years. The NICHD anticipates the Request for Proposals (RFP) for this study will be available through the Federal Business Opportunities website (https://www.fbo.gov/) on or about January 23, 2019. Proposals will be due April 1, 2019. Information in the anticipated RFP supersedes any information in this pre- solicitation announcement. This acquisition has been designated as a 100% small business set-aside under North American Industry Classification System (NAICS) code is 541715 with a size standard of 1,000 employees or less. Any responsible small business may submit a proposal that will be considered by the Government. No collect calls or facsimile transmissions will be accepted. Any questions concerning this announcement must be submitted in writing to Cynthia L. Brown, Contract Specialist, at cb25b@nih.gov. The secondary point of contact is eo43m@nih.gov for the RFP No. is NIH-NICHD-DIPHR-2019-4. All correspondence must cite the RFP Number.