05-19340. Memorandum of Understanding Between the Food and Drug Administration and the National Library of Medicine

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration and the National Library of Medicine (NLM). The purpose of this MOU is to assign responsibilities to FDA's Center for Drug Evaluation and Research (CDER) and NLM for the distribution of product labeling.

DATES:

The agreement became effective July 6, 2005, and supplements the agreement signed and dated November 21, 2001, and December 3, 2001, by NLM and CDER representatives, respectively.

FOR FURTHER INFORMATION CONTACT:

For FDA: Lisa Stockbridge, Food and Drug Administration (HFD-140), 5600 Fishers Lane, Rockville, MD 20857, 301-827-7761; or Catherine Miller, Food and Drug Administration (HFD-140), 5600 Fishers Lane, Rockville, MD 20857, 301-827-7772.

For NLM: Simon Liu, Bldg. 38A, rm. 2N221, 8600 Rockville Pike, Bethesda, MD 20894, 301-402-1698; or Stuart Nelson, Bldg. 38A, rm. B2E17, 8600 Rockville Pike, Bethesda, MD 20894, 301-496-1495.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 20.108(c), which states that all written agreements and MOU's between FDA and others shall be published in the Federal Register, the agency is publishing notice of this MOU.

Dated: September 20, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.