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FBO DAILY ISSUE OF MARCH 25, 2009 FBO #2676
SOLICITATION NOTICE

A -- BPCA Data Coordinating Center short term extension

Notice Date

3/23/2009
 

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

2009-33351
 

Archive Date

5/31/2009
 

Point of Contact

Megan Gnall,, Phone: 301-435-6924, Elizabeth J. Osinski,, Phone: 301-435-6947
 

E-Mail Address

gnallm@mail.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 Center for Research for Mothers and Children, Obstetric and Pediatric Pharmacology Branch, within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, intends to negotiate on a sole source basis, under the authority of 41 U.S.C. 253 (c) (1) and FAR 6.302-1(a) (2) (ii) and HHSAR 306.302-1 (a) (2) (ii), a modification to its current contract with Premier Research Group, Philadelphia, PA, entitled “Best Pharmaceuticals for Children Act (BPCA) – Data Coordinating Center.” This three month contract extension is necessary in order to avoid a lapse in contract performance and continue services in its operations of the Data Coordinating Center. This modification the existing contract will allow Premier Research Group to continue uninterrupted services in supporting ongoing BPCA pediatric clinical trials until a new competitive contract can be awarded and the services transitioned. This modification is to continue services until approximately August 31, 2009 or until this new competitive contract can be awarded. Also, it may be necessary to continue data coordinating support and analysis of the data of some ongoing clinical trials that are near completion beyond the award date of the new competitive contract. This is because a few trials that are near completion may be at a critical juncture as monitoring data, tracking study progress, formatting the data for FDA, and providing study drugs (including placebos) could pose specific risks to the study, data and/or patients, if a new Contractor were brought in before completion or until a smooth transition could be effected. A contract extension will allow NICHD to closely supervise the continued activities of the Data Coordinating Center, including monitoring patient records, analyzing collected data, submitting data and final study reports to the FDA, and closing out specific study phases in an orderly fashion. This additional time will allow for a transition to the selected offeror under the new competitive procurement. It is critical that the services provided by the Data Coordinating Center not be interrupted as the data coordinating center is integral to the success of the pediatric clinical trials that it supports and these consist of multiple pediatric clinical trials, which to-date, include activities that support approximately fifteen ongoing clinical studies, involving approximately 110 Pediatric Off-Patent Drug Study (PODS) clinical study site centers, with as many as 1400 children, (many in intensive care settings). A primary responsibility of the Data Coordinating Center is to ensure that pediatric clinical trials are performed and documented according to the Good Clinical Practice (GCP) standards as described by FDA and the International Conference on Harmonization (ICH) GCP Guidelines. The Contractor regularly gathers, monitors, and formats the study data generated from each POD Center clinical study site and is responsible for submitting the data to FDA for regulatory approval and label modification. A break in the services of the data coordinating center would result in unacceptable delays in fulfilling the needs of these ongoing clinical pediatric trials. Interested persons may identify their interest and capability to respond to the requirement by submitting information (5 page limit) within 45 days of publication of this synopsis. This notice of intent is not a request for competitive proposals. However, all proposals received within 45 days of publication of this synopsis will be considered solely for the purpose of determining whether to conduct a competitive procurement. 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. Deliveries should be sent to: Hand Delivered or Delivery Service U.S. Postal Service Contracting Officer Office of Acquisitions, NIDDK NICHD Contracts Management Branch National Institutes of Health 6100 EXECUTIVE BLVD, Suite 7A07 ROCKVILLE MD 20852 Contracting Officer Office of Acquisitions, NIDDK NICHD Contracts Management Branch 6100 Executive Boulevard, Suite 7A07 MSC 7510 Bethesda, Maryland 20892-7510 No collect calls or facsimile transmissions will be accepted. Contracting Office Address: Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510 Bethesda, Maryland 20892-7510 Place of Performance: Philadelphia, PA Philadelphia, Pennsylvania 19103 United States Primary Point of Contact: Megan Gnall Contract Specialist GnallM@mail.nih.gov Phone: 301-435-6924 Fax: 301-402-3676 Secondary Point of Contact: Elizabeth D Osinski, Contracting Officer eo43m@nih.gov Phone: 301-435-6947 Fax: 301-402-3676
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=73859bf29f481178da526279b5450e5a&tab=core&_cview=1)
 

Place of Performance

Address: Philadelphia, PA., Philadelphia, Pennsylvania, 19103, United States

Zip Code: 19103
 

Record

SN01775188-W 20090325/090323215111-73859bf29f481178da526279b5450e5a (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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