Electronic Submissions; Establishment of Public Docket

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: [email protected]

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