Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997 / Notices 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.

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