[Federal Register: March 20, 1997 (Volume 62, Number 54)]
[Notices]               
[Page 13467]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20mr97-152]



[[Page 13467]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 92S-0251]

 
Electronic Submissions; Establishment of Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket to provide information on submissions the agency is 
prepared to accept electronically. FDA is taking this action to provide 
easily accessible notice to the public when agency receiving units are 
prepared to accept electronic submissions and to promote the use of 
electronic technology.

ADDRESSES: The public docket is available under the docket number found 
in brackets in the heading of this notice and is located in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. The public docket is also 
posted to the agency's Internet World Wide Web site at http://
www.fda.gov

FOR FURTHER INFORMATION CONTACT: Paul J. Motise, Center for Drug 
Evaluation and Research (HFD-325), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 301-594-1089, or e-mail address via 
Internet: Motise@CDER.FDA.GOV

SUPPLEMENTARY INFORMATION: Elsewhere in this issue of the Federal 
Register FDA is finalizing part 11 (21 CFR part 11) providing the 
conditions under which the agency will accept electronic signatures, 
electronic records, and handwritten signatures executed to electronic 
records as equivalent to paper records and handwritten signatures 
executed to paper. Part 11 applies to any required records submissions 
under the Federal Food, Drug, and Cosmetic Act (the act), the Public 
Health Service Act (the PHS Act), or Title 21 of the Code of Federal 
Regulations (CFR) and supersedes any paper record requirements by 
providing that electronic records may be used in lieu of paper records. 
Electronic signatures that meet the requirements of part 11 will be 
considered to be equivalent to full handwritten signatures, initials, 
and other general signings required by agency regulations. Part 11 also 
provides that, for records required to be maintained but not submitted 
to the agency, electronic records and accompanying signatures may be 
used in lieu of traditional records and signatures provided certain 
requirements are met.
    Records and signatures submitted to the agency must satisfy the 
requirements of part 11 and must be identified in public docket number 
92S-0251 as the type of submission the agency will accept in electronic 
form. The public docket will contain information pertaining to 
submissions for such agency units as the Centers for Drug Evaluation 
and Research, Biologics Evaluation and Research, Devices and 
Radiological Health, Food Safety and Applied Nutrition, Veterinary 
Medicine, and the Office of Regulatory Affairs. The information 
available will include a description of the document that may be 
submitted electronically; a citation, if any, to that section of the 
act, the PHS Act, or the CFR under which the document is submitted; the 
agency unit prepared to accept the document electronically (the 
receiving unit); and the address of the receiving unit. Unless records 
are identified in this public docket as acceptable for electronic 
submission, only paper records will be regarded as official 
submissions.
    Several comments submitted to FDA on the proposed rule on 
electronic records and signatures (59 FR 45160, August 31, 1994) 
requested that the public docket provide more specific information and 
that submission procedures be uniform throughout the agency. FDA has 
decided not to include such uniform and specific requirements at this 
time because of the rapid advances in electronic technology, the 
variety of information required by different receiving units, and the 
number of different electronic systems used in the agency and regulated 
industry. Instead, FDA will maintain only basic information in the 
public docket because the agency expects that persons planning to 
submit a document will be in direct contact with the agency unit 
assigned to receive the submission. The receiving unit will provide 
details on the technical aspects of submissions such as media, method 
of transmission, file format, archiving needs, and technical protocols.
    The agency will update the public docket periodically as FDA units 
acquire the ability to accept electronic submissions. Persons should, 
however, consult the appropriate receiving units directly to obtain the 
most current and detailed information on electronic submissions.
    The public docket is available for public review in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: December 12, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-6847 Filed 3-19-97; 8:45 am]
BILLING CODE 4160-01-F