Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF APRIL 08, 2022 SAM #7434
SOLICITATION NOTICE

Q -- Metabolomic analysis in Physical Urticaria,

Notice Date

4/6/2022 10:30:32 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
 

ZIP Code

20892
 

Solicitation Number

NOI-NIAID-2122436
 

Response Due

4/15/2022 1:00:00 AM
 

Archive Date

04/30/2022
 

Point of Contact

DIANA ROHLMAN, Phone: 4063639366, Laura Grey, Phone: 4063759812
 

E-Mail Address

diana.rohlman@nih.gov, laura.grey@nih.gov
(diana.rohlman@nih.gov, laura.grey@nih.gov)
 

Description

This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Metabolon, Morrisville, NC 27560. � � �NIH is working to acquire FDA approval for drug development and are currently within a � � �phase of protocol #09-I- 0126 (Protocol Title: Pathogenesis and Genetic Basis of Physical� � �Urticarial Syndromes. NIH is in the process of developing a drug approval from FDA. The Mast� � �Cell Biology Section (MCBS) at NIH is currently working with Metabolon, Inc with Protocol 09- � �I- 0126 (Protocol Title: Pathogenesis and Genetic Basis of Physical Urticarial Syndromes. �FDA �� � �approvals for drug development require a four-phase process: discovery/concept, preclinical� � �research, clinical research, FDA review and FDA post-market safety monitoring. 1)Absorption,� � �2)Distribution, 3)Disposition, 4)Metabolism, & Excretion (ADME). MCBS is in the 4th phase of� � �drug development, Metabolism, & Excretion. Metabolon is the company used for these �� � �services and their continued service is required for Protocol# : 09-I- 0126 (Protocol Title: � � �Pathogenesis and Genetic Basis of Physical Urticarial Syndromes. �Metabolon is the approved � � �vendor to perform the testing and provide the quarterly test results required by the FDA. No � � �substitutions are accepted for this project. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. �All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-2122436) to Diana Rohlman, diana.rohlman@nih.gov, by 4:00 pm eastern standard time April 15, 2022. �All responses received by the closing date of this synopsis will be considered by the Government. �A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. �
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/1798758b1a1e4c508b6208162ae2da5b/view)
 

Place of Performance

Address: Bethesda, MD 20814, USA

Zip Code: 20814

Country: USA
 

Record

SN06290831-F 20220408/220406230104 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's SAM Daily Index Page |