[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR11.2]



[Page 111]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 11_ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents

 

                      Subpart A_General Provisions

 

Sec.  11.2  Implementation.



    (a) For records required to be maintained but not submitted to the 

agency, persons may use electronic records in lieu of paper records or 

electronic signatures in lieu of traditional signatures, in whole or in 

part, provided that the requirements of this part are met.

    (b) For records submitted to the agency, persons may use electronic 

records in lieu of paper records or electronic signatures in lieu of 

traditional signatures, in whole or in part, provided that:

    (1) The requirements of this part are met; and

    (2) The document or parts of a document to be submitted have been 

identified in public docket No. 92S-0251 as being the type of submission 

the agency accepts in electronic form. This docket will identify 

specifically what types of documents or parts of documents are 

acceptable for submission in electronic form without paper records and 

the agency receiving unit(s) (e.g., specific center, office, division, 

branch) to which such submissions may be made. Documents to agency 

receiving unit(s) not specified in the public docket will not be 

considered as official if they are submitted in electronic form; paper 

forms of such documents will be considered as official and must 

accompany any electronic records. Persons are expected to consult with 

the intended agency receiving unit for details on how (e.g., method of 

transmission, media, file formats, and technical protocols) and whether 

to proceed with the electronic submission.