NABR Submits Comments to FDA on GLP Proposed Rule

Last August, the Food and Drug Administration (FDA) published a proposed rule the in the Federal Register (Vol. 81, No. 164) titled, “Good Laboratory Practice for Nonclinical Laboratory Studies” [Docket No. FDA–2010–N–0548]. FDA has proposed amending the current regulations to require a complete quality system approach which they refer to as a GLP Quality System.

The proposed system would be required for safety and toxicity studies to support applications or submissions to the FDA. Proposed changes that would impact animal research facilities include additional management responsibilities, changes to SOP procedures and changes to address the management of multisite nonclinical laboratory studies.

NABR submitted comments to the FDA this afternoon, expressing concern that creating additional rules would be redundant with existing regulations and confusing for researchers, as research facilities are already governed by numerous other animal welfare requirements. A copy of our comments can be found here and NABR members are encouraged to use them as a basis for filing their own at regulations.gov. Comments must be submitted by January 21, 2017.