Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 11

[Docket No. 92N–0251]

RIN 0910–AA29

Electronic Records; Electronic Signatures

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is issuing regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to promote and protect public health. The use of electronic records as well as their submission to FDA is voluntary. Elsewhere in this issue of the Federal Register, FDA is publishing a document providing information concerning submissions that the agency is prepared to accept electronically.

DATES: Effective August 20, 1997. Submit written comments on the information collection provisions of this final rule by May 19, 1997.

ADDRESSES: Submit written comments on the information collection provisions of this final rule to the Dockets Management Branch (HFA–305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1–23, Rockville, MD 20857.

The final rule is also available electronically via Internet: http://www.fda.gov.

FOR FURTHER INFORMATION CONTACT:

Paul J. Motise, Center ...