Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JUNE 02, 2023 SAM #7857
SPECIAL NOTICE

99 -- Intravenous Stable Isotope

Notice Date

5/31/2023 12:37:14 PM
 

Notice Type

Special Notice
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

NATIONAL INSTITUTES OF HEALTH NICHD BETHESDA MD 20817 USA
 

ZIP Code

20817
 

Solicitation Number

75N94023Q00060
 

Response Due

6/9/2023 1:00:00 PM
 

Archive Date

06/24/2023
 

Point of Contact

Kimesha Leake
 

E-Mail Address

Kimesha.leake@nih.gov
(Kimesha.leake@nih.gov)
 

Description

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) supports a wide range of medical research through grants to universities and other medical research institutions across the country. The Institute also supports government scientists who conduct basic, translational, and clinical research across a broad spectrum of research topics and serious, chronic diseases and conditions related to the Institute's mission. In addition, the NIDDK supports research training for students and scientists at various stages of their careers and a range of education and outreach programs to bring science-based information to patients and their families, health care professionals, and the public. Stable isotopes have been used safely in clinical research for decades and have contributed seminal insights into human metabolism.� In many cases, stable isotopes allow a generation of knowledge that may not be possible by any other method.� Under the directive of the NIH Sterile Products for Human Administration (SPHA) Executive Committee and the NIH Office of Research Services and Compliance (approved 10/2021), stable isotopes used in clinical human metabolic studies must meet certain specified minimum requirements. Pine pharmaceuticals was initially approved by the NIH Office of Deputy Director of Clinical Care in August 2016 and the decision re-affirmed by the NIH Sterile Products for Human Research Committee (SPHA) on July 24th, 2018.� The decision to continue using Pine Pharmaceuticals, LLC followed extensive year-long vetting and an external audit commissioned by the NIH CC Office of Research Support and Compliance (ORSC). A quality agreement was implemented in February 2019 and is in place between Pine Pharmaceuticals, LLC and NIH Pharmacy and NIDDK.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/364aedee5b8d436c974d53cec3a0d71c/view)
 

Place of Performance

Address: Bethesda, MD 20892, USA

Zip Code: 20892

Country: USA
 

Record

SN06699178-F 20230602/230531230108 (samdaily.us)
 

Source

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

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