Notice Number: NOT-OD-10-114

Key Dates
Release Date: July 14, 2010

Issued by
Office of Laboratory Animal Welfare (OLAW), (http://olaw.nih.gov/), Office of Extramural Research

Other Relevant Notice

February 12, 2001 – See NOT-OD-01-017, Office of Extramural Research Guidance Regarding Administrative IACUC Issues and Efforts to Reduce Regulatory Burden

This Notice informs Public Health Service (PHS) grantee institutions regarding applicability of the U.S. Department of Defense (DoD) and Food and Drug Administration (FDA) Shelf Life Extension Program (SLEP). SLEP was developed to defer drug replacement costs of date sensitive military reserve stock by extending the useful shelf life of medical materials, including pharmaceutical products. This program involves testing of selected pharmaceutical products by the FDA and if warranted the extension of product expiration dates.

The scope and orientation of the program has significantly changed since its inception in 1986. Participation in the program is limited to Federal organizations and applies primarily to “militarily significant” materials currently stockpiled. Although OLAW has previously recognized the validity of the extension data, this information is no longer publicly accessible and has little applicability to PHS-Assured institutions.

Inquiries

For questions or further information, contact:

Office of Laboratory Animal Welfare
Office of Extramural Research
National Institutes of Health
RKL1, Suite 360
6705 Rockledge Drive
Bethesda, MD 20892-7982
phone: 301-496-7163
fax: 301-915-9481
e-mail: [email protected]
web:  http://olaw.nih.gov/