United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 1997_register executive 2010-09-24 article Part II Rules and Regulations D09002ee1be02275f D09002ee1be022887 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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 . 62 FR 13430 https://www.govinfo.gov/app/details/FR-1997-03-20/97-6833 97-6833 fr20mr97-25 RIN 0910-AA29 4160-01-F Docket No. 92N-0251 https://www.govinfo.gov/app/details/FR-1997-03-20/97-6833 https://www.govinfo.gov/content/pkg/FR-1997-03-20/html/97-6833.htm https://www.govinfo.gov/content/pkg/FR-1997-03-20/pdf/97-6833.pdf 37 p. 13430 13466 62 FR 13430 Title 21 Part 11 21 CFR Part 11 RIN 0910-AA29 Electronic Records; Electronic Signatures; Federal Register Vol. 62, Issue RULE 97-6833 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 1997-08-20 1997-05-19 Docket No. 92N-0251 4160-01-F 97-6833 Final rule.

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 .

Effective August 20, 1997. Submit written comments on the information collection provisions of this final rule by May 19, 1997. Paul J. Motise, Center for Drug Evaluation and Research (HFD-325), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, Vol. 62, no. 54 Office of the Federal Register, National Archives and Records Administration 1997-03-20 continuing daily deposited born digital 250 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1997-03-20 P0b002ee180a42479 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr20mr97 https://www.govinfo.gov/app/details/FR-1997-03-20 https://www.govinfo.gov/content/pkg/FR-1997-03-20/pdf/FR-1997-03-20.pdf fdlp 13289 13529 DGPO 2010-09-24 2023-05-06 FR-1997-03-20 machine generated eng FR FR-1997-03-20 62 54