SOURCES SOUGHT
A -- Pediatric Trials Network
- Notice Date
- 3/20/2017
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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-SBSS-2018-02
- Point of Contact
- Angela Wish, Phone: 301-435-6947, Alice M. Pagán, Phone: 301-435-6959
- E-Mail Address
-
angela.wish@nih.gov, ap425k@nih.gov
(angela.wish@nih.gov, ap425k@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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, service-disabled, veteran-owned small businesses; 8(a) small businesses, veteran owned small businesses; HUBZone 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. This requirement is assigned a code of 541712 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 1000 employees or less. Background: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) provides direct support for clinical research and clinical research networks that focus on particular diseases or public health issues. One of the goals of NICHD is to conduct research to better understand the effects and effectiveness of pharmaceuticals on maternal and child health. This initiative will ensure that NICHD is able to access quickly and efficiently experts with the ability to support studies relating to pediatric drug and device development. The NICHD is seeking for small businesses capable of designing, conducting and overseeing the clinical, scientific, and technical aspects of pediatric drug development, including, but not limited to, pre-clinical studies, formulations development, and Phase 1-3 pediatric clinical trials. Purpose and Objectives: The purpose of this initiative will be to create a Pediatric Trials Network (PTN) with experts knowledgeable in pediatric drug development, who through their knowledge and experience, can design, conduct and manage pre-clinical and pediatric clinical trial activities in various pediatric therapeutics areas. This "Network" will support NICHD pediatric drug development activities, primarily, but not limited to, trials that can achieve the objectives of the Best Pharmaceuticals for Children Act (BPCA), which was reauthorized in September 2012 to improve labeling information for drugs used to treat children. NICHD anticipates the clinical studies conducted by the Network will focus on the pharmacokinetics (PK), pharmacodynamics (PD), safety and efficacy of therapeutics (drugs and devices) used in children. Under the current contract, 45 Task Orders have been awarded resulting in 21 clinical trials and 32 other projects. The PTN subcontracted with over 160 pediatric study sites in the United States and four other countries enrolling over 6,000 children. Data for 10 molecules (e.g. Acyclovir, Ampicillin, Clindamycin obesity) and one device (i.e. Mercy Tape) has been submitted to the Food and Drug Administration (FDA). In addition, over 20 products are planned for submission in 2017. Under this requirement, NICHD anticipates the need to initiate activities in approximately five (5) to ten (10) therapeutic areas with multiple approaches for each therapeutic area. These activities will require multiple scientific and clinical investigators with expertise in various disease areas such as, cardiovascular diseases (including the treatment of hypertension), infectious diseases, respiratory diseases, (including the treatment of asthma), gastroenterology, acute care; neonatal therapeutic areas, obesity related pharmacology, biodefense and neuro/psych. A data coordinating center (DCC) will be awarded under a separate contract that will provide data management, data monitoring, auditing, electronic data submission to FDA and regulatory document support to/for ongoing and proposed clinical trials, and therefore, will not be a requirement of this initiative. Project Requirements: Small businesses that believe they possess the capabilities necessary to undertake this project must demonstrate and document the following in their capability statements, the ability to: manage a complex, clinical "Network" of approximately 50 on-going pediatric clinical trials/projects and up to 10 additional new trials/projects added yearly with approximately 15 clinical study sites, per clinical trial; 2) develop pediatric formulations; 3) provide researchers who possess experience in pediatric drug development; 4) coordinate diverse clinical trial activities with other contractors, including the DCC and the NICHD repository; 5) design, perform and analyze results of pre-clinical studies and pediatric clinical trials (both domestically and internationally); and 6) identify and subcontract with investigators/clinical sites who will recruit neonates, infants, children, and adolescents in the various pediatric therapeutic areas described above. Organizations that submit capability statements in response to this notice will be evaluated on demonstrated evidence of their ability to provide the following areas of expertise and experience: Technical Requirements: • Requisite personnel and dedicated staff with experience in managing, designing, conducting, maintaining, and coordinating clinical trial activities in the areas of PK/ PD, safety and efficacy studies for pediatric patients both in the US and abroad. • Evidence of experience in managing special complexities associated with the design and conduct of multiple and concurrent pediatric clinical trials including patient recruitment and retention, and ethical issues including those related to parental permission and patient assent. In some instances, the pediatric trials may be conducted with exemption from informed consent. Respondents should state their understanding and experience with the informed consent exemption process. • Evidence of knowledge and experience in producing new pediatric-friendly formulations according to Good Manufacturing Practice (GMP) standards. • Experience conducting clinical trials in accordance with Good Clinical Practice (GCP) standards and in conformance to FDA Guidance on performing drug trials in pediatric populations, which includes the maintenance of a communications system in compliance with FDA requirements for the submission of Adverse Event Reports. • An understanding of the resources and expertise needed for pre-clinical and pediatric clinical trial simulation for PK/PD, safety and efficacy trials. • Evidence of personnel and services capable of performing statistical analyses of pediatric clinical trials. • Ability to manage a pediatric clinical trial that will include multiple principal investigators. • An understanding of adherence to Federal regulations pertaining to human research, and requirements for security and confidentiality of research records. • Ability to solicit, negotiate, award, administer, and monitor multiple, ongoing subcontracts • Experience providing technical support for research activities that may include: planning and conducting meetings with protocol committees; creating protocol development plans and operating protocol development teams; drafting and editing protocols; and developing site-specific, protocol-specific budgets for each protocol. • Ability to acquire or develop pediatric-friendly formulations of drugs with FDA approval as needed at specific clinical sites. Demonstrate the need to assure that pediatric-friendly formulations are manufactured in accordance with GMP. • Ability to conduct bioavailability and bioequivalence studies, as needed. • Ability to generate a plan for acquiring, distributing, dispensing, handling, and administrating study drugs. • Ability to generate, maintain and present data necessary to the DCC in order to meet all regulatory and reporting requirements of the FDA for labeling of pediatric indications; including maintenance of necessary datasets for submission to FDA and Investigational New Drug (IND) applications. Anticipated Period of Performance: The Government expects to award an Indefinite Delivery Indefinite Quantity (IDIQ) contract in January 2018 with an ordering period of eight (8) years. Capability Statement/Information Sought: Small Businesses that meet the applicable size standard and believe that they possess the capabilities described above are required to submit one electronic version via email of their capability statements to the attention of Angela Wish, Contract Specialist, and Alice Pagán, Contracting Officer, at the addresses provided below by 4:00 PM EST on April 4, 2017. See http://www.sba.gov for information on what is a small business and 13 CFR §121.106 of the Small Business Size Regulations on how the SBA calculates the number of employees. Capability statements must identify the business status of the organization and should be limited to no more than fifteen (15) pages, excluding an Appendix for resumes. Resumes may be included in an Appendix which does not count in the fifteen (15) total page limit. The Appendix, which may only include resumes, is limited to fifteen (15) pages. 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 pre-solicitation 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-SBSS-2018-02/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN04440435-W 20170322/170320234114-e7183982d986197801db0dc80b45cbb7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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