Contraceptive Development Program NICHD Contraceptive Clinical Trials Network Female Sites
The CCTN has recurring requirements for clinical trials, but the number of trials, the duration of each trial, number of subjects required, etc. cannot always be determined in advance of issuing the resultant contract. The resultant IDIQ contract will allow for the issuance of severable and non-severable, cost-reimbursement type task orders. However, it is anticipated that because this is an R&D requirement, where the absence of precise specifications presents difficulties in estimating costs with accuracy, the task orders will be cost reimbursement type. Awarded contract 75N94020D00021 to UNIVERSITY OF UTAH, THE for 108666.00 on 2020-08-01.
75N940 Department of Health and Human Services National Institutes of Health National Institute of Child Health and Human Development
8/17/20, 6:29 PM Contraceptive Development Program NICHD Contraceptive Clinical Trials Network Female Sites
The CCTN has recurring requirements for clinical trials, but the number of trials, the duration of each trial, number of subjects required, etc. cannot always be determined in advance of issuing the resultant contract. The resultant IDIQ contract will allow for the issuance of severable and non-severable, cost-reimbursement type task orders. However, it is anticipated that because this is an R&D requirement, where the absence of precise specifications presents difficulties in estimating costs with accuracy, the task orders will be cost reimbursement type. Awarded contract 75N94020D00005 to TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE for 106922.00 on 2020-08-01.
75N940 Department of Health and Human Services National Institutes of Health National Institute of Child Health and Human Development
8/17/20, 5:27 PM Contraceptive Development Program NICHD Contraceptive Clinical Trials Network Female Sites
Small Business Sources Sought Number - NIH-NICHD-CDB-2020-1 Title: "Contraceptive Development Program NICHD Contraceptive Clinical Trials Network - Female Sites" This is a Small Business Sources Sought. This is NOT a Request for Proposals (RFP) and does not commit the Government to award a contract now or in the future. No solicitation is available at this time. The purpose of this synopsis is to identify small business organizations with requisite qualifications to provide the services stated herein. Based on capability statements received in response to this Sources Sought Announcement this acquisition may be solicited as a 100% small business set-aside. All small business organizations (SB, SOB, WOSB, HUBZone, VOSB, and SDVOSB) are encouraged to respond to this notice. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This 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 1,000 employees or less. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)/NIH, seeks capability statements from interested and qualified potential sources to conduct Phase I, II, Ill and IV contraceptive trials in females, and treatment trials for gynecologic conditions such as endometriosis or leiomyomata, and development of research protocols on a task order basis. The results of these clinical trials would be the bases for advancing candidate drugs and devices through development with the ultimate goal of submission to the FDA in support of a New Drug Application (NDA). The NICHD Contraceptive Development Program (CDP), formerly known as the Contraceptive Development Branch (CDB) or the Contraceptive Discovery and Development Branch (CDDB) , has long supported several pre-clinical contraceptive product testing facilities, as well as facilities for chemical and peptide synthesis. In 1996, the Contraceptive Development Branch (CDB) established the NICHD Contraceptive Clinical Trials Network (CCTN), which initially consisted of eight (8) sites, in order to conduct clinical trials of new contraceptive methods for women. In 2013, the CCTN expanded to nineteen (19) sites for evaluation of novel methods for women and two (2) sites for evaluation of contraceptive methods for men. The CCTN is an important component of the contraceptive development capability. Products that have undergone formulation and successful pre-clinical testing are candidates for clinical evaluation in the CCTN. The CCTN is also valuable for providing a venue for evaluating new contraceptive drugs and devices that have been developed by small companies that lack the resources to support large-scale clinical trials. 1. Organizations that submit capability statements in response to this notice must demonstrate and document: I. The qualifications and experience of the institution's staff to organize and manage clinical trials as well as the ability to recruit and retain subjects. II. As the products may include first-in-human exposure, as well as repeat dose finding safety and efficacy studies, the site should have the capability to conduct Pharmacokinetic studies (generally conducted in clinic with overnight stay). III. The site should have the capability to conduct extensive pharmacodynamic evaluation of surrogate markers for contraceptive effectiveness, including assessing follicle development, follicular collapse and endometrial thickness using trans-vaginal ultrasound. IV. The site should have the capability to perform other assessments, including evaluation of cervical mucus favorability, hormonal assessments, bleeding patterns and other markers that indicate contraceptive effectiveness in women. 2. Experience in female contraceptive research. 3. Experience in conducting clinical trials in compliance with a) Good Clinical Practice and FDA guidelines for the conduct of clinical trials; b) the overall clinical trials process; c) the data acquisition, data monitoring and data management processes; d) protection of patient confidentiality and data security; and e) tracking of pregnancy outcomes. 4. Experience with the development and implementation of a detailed management plan organizing the work, including staff hours or days planned per task and scheduling of deliverables that is reasonable and timely. 5. Experience with respect to similar projects, including project dates and sponsors, specific responsibilities with respect to these projects. 6. Ability to serve as a repository for biological samples and clinical data. 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 Deborah Brock, Contract Specialist at Deborah.Brock@nih.gov and Elizabeth Osinski, Contracting Officer at 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, May 17, 2019, 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. Deborah Brock, Contract Specialist, DHHS/NIH/NICHD/CMB, Email: Deborah.Brock@nih.gov, telephone 301-425-6961. 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 1129A, MSC7000 Bethesda, Maryland 20892 7510 United States Primary Point of Contact.: Deborah Brock Contract Specialist Deborah.Brock@nih.gov Phone: 301-435-6961.
NIH-NICHD-CDP-2020-1 Department of Health and Human Services National Institutes of Health
5/7/19, 2:47 PM