SOLICITATION NOTICE
A -- Pediatric Off-Patent Drug Study (PODS) Center - Lorazepam for Treatment of Status Epilepticus
- Notice Date
- 3/31/2011
- Notice Type
- Presolicitation
- 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, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-CRMC-11-16
- Point of Contact
- Megan Gnall, Phone: 301-435-6924, Elizabeth D Osinski, Phone: 301-435-6947
- E-Mail Address
-
megan.gnall@nih.gov, eo43m@nih.gov
(megan.gnall@nih.gov, eo43m@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Obstetric and Pediatric Pharmacology Branch (ORBP), within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Health, intends to negotiate on a sole source basis, under the authority of 42 U.S.C. 253-(1) and FAR 6.302 - 1(a)(2)(ii), a new contract for the continuation of the Pediatric Off-Patent Drug Study (PODS) Center - Lorazepam for Treatment of Status Epilepticus to the Children's National Medical Center (CNMC) in Washington, D.C. A new contract is necessary for CNMC's continuation of effort in order to enroll an adequate number of patients and acquire the additional time to complete the study analysis. The study consists of two sequential phases: Study 1 is a pharmacokinetic study (which has been completed) and Study 2 is a double blind safety and efficacy trial. The results from this study will provide the scientific basis for the determination of the lorazepam dose that is used in the efficacy trial. The Best Pharmaceuticals for Children Act (BPCA) of 2002 (Public Law 107-109) was enacted to enhance pediatric clinical studies leading to new pediatric labeling in accordance with FDA rules and regulations. Lorazepam as therapy for pediatric (SE) has been chosen by the Secretary of the Department of Health and Human Services, acting through the Director of the National Institutes of Health (NIH) and in consultation with the Commissioner of the FDA and experts in pediatric research, as a priority "off-patent" drug for which pediatric studies are most urgently needed. In recognition of the unique circumstances pertaining to research in emergency situations, the Food and Drug Administration (FDA) has established regulations that provide a narrow exception to the requirement for informed consent from subjects or their legally authorized representatives in such situations. These regulations, known as the Exception from Informed Consent (EFIC) for Emergency Research (21 CFR 50.24), are harmonized with the regulations set forth by the Department of Health and Human Services (DHHS) and known as the Waiver of Informed Consent Requirements in Certain Emergency Research (45 CFR 46.101(i)). Since this study is the first to be conducted under a waiver from informed consent, the experience accrued by the current investigators will inform the implementation of future studies performed in life-threatening conditions in pediatrics. Award to new contractors would interrupt continuity in enrollment, collection of information and activities required by 21 CFR 50.24 and thus compromise their ability to complete the study in a timely and fiscally responsible manner. In addition, the lack of precedence in the implementation of procedures and the process for community involvement mandated under 21 CFR 50.24, provided the current group of investigators with the incentive to innovate and create a well structured program that includes activities to be conducted at the end of the study. A separate contractor, unlikely to be familiar with the process, would be required to develop and complete an EFIC plan and program for each site with consequent delays and lack of continuity. It would cost the Government significant time and effort to train, recruit and duplicate the expertise acquired by CNMC over the past six and half years.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-CRMC-11-16/listing.html)
- Place of Performance
- Address: If any contractor believes it can perform the above requirement, it may submit, within 15 days of publication of this notice, three (3) copies of a capability statement, which will be considered by this agency (plus an electronic copy to megan.gnall@mail.nih.gov ) to: Megan Gnall, Contracting Officer, NICHD, CMB, NIH, 6100 Executive Building, MSC 7510, Bethesda, Maryland 20892-7510 (or overnight courier: 6100 Executive Blvd., Rockville, Maryland 20852). Phone number: 301-435-6924, and FAX number: 301-402-3676. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Authority: 41 U.S.C. 253(c)(1) as set forth in FAR 6.302-1(a)(2)(ii). No collect calls will be accepted. This requirement is defined as code 541712 under the North American Industry Classification System (NAICS)., Rockville, Maryland, 20852, United States
- Zip Code: 20852
- Zip Code: 20852
- Record
- SN02414461-W 20110402/110331234936-21385324d7431c3b5ac38f81f54872d7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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