[Federal Register Volume 63, Number 67 (Wednesday, April 8, 1998)]
[Notices]
[Pages 17184-17185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9103]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food And Drug Administration
[Docket No. 97D-0381]


Draft Guidance for Industry on Providing Regulatory Submissions 
in Electronic Format--NDA's; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Providing 
Regulatory

[[Page 17185]]

Submissions in Electronic Format--NDAs.'' The draft guidance is 
intended to assist applicants who wish to submit new drug applications 
(NDA's) in electronic format. Submissions of NDA's in electronic format 
should reduce the amount of paperwork for applicants and the agency. 
Submissions in electronic format are voluntary.

DATES: Written comments may be submitted on this draft guidance 
document by June 8, 1998. General comments on the agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Kenneth Edmunds, Center for Drug 
Evaluation and Research (HFD-350), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3276, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Traditionally, FDA has required that regulatory submissions, such 
as investigational new drug applications and NDA's, be submitted as 
paper documents. In the Federal Register of March 20, 1997 (62 FR 
13430), FDA published the electronic records; electronic signatures 
regulation, which provided for the voluntary submission of parts or all 
of an application, as defined in the relevant regulations, in 
electronic format without an accompanying paper copy (21 CFR part 11). 
The agency also established public docket number 92S-0251 to provide a 
list of the agency unit(s) that are prepared to receive electronic 
submissions and the specific types of records and submissions that can 
be accepted in electronic format (62 FR 13467, March 20, 1997). Shortly 
after establishing the docket, the Center for Drug Evaluation and 
Research (CDER) published a guidance for industry entitled ``Archiving 
Submissions in Electronic Format--NDA's'' (62 FR 49695, September 23, 
1997), to assist applicants wishing to make electronic submissions. The 
September 1997 guidance provided specific information on submitting 
case report forms (CRF's) and case report tabulations (CRT's) as part 
of the NDA archival submission.
    This draft guidance for industry expands on the September 1997 
guidance and provides information on submitting a complete archival 
copy of the NDA in electronic format, including CRF's and CRT's. This 
draft guidance for industry contains much new information on submitting 
NDA's in electronic format. As a result, the agency is publishing the 
guidance in draft and is soliciting comments. Once comments have been 
received and addressed, a final guidance will be published that will 
replace the guidance on case report forms and case report tabulations 
issued on September 23, 1997.
    CDER anticipates that as this effort proceeds, sponsors, 
investigators, and CDER staff will improve procedures for submitting 
electronic applications. As a result, CDER believes that guidance on 
electronic submissions will be updated periodically.
    Applicants planning to submit parts or all of their NDA's in 
electronic format should consult public docket number 92S-0251 to 
determine which agency units are prepared to receive electronic 
submissions and the specific types of documents that can be submitted 
in electronic format.
    This draft guidance represents the agency's current thinking on 
providing regulatory NDA submissions in electronic format. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statute, 
regulations, or both.

II. Comments

    Interested persons may submit written comments to the Dockets 
Management Branch (address above). Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments and 
requests are to be identified with the docket number found in brackets 
in the heading of this document. Submit written requests for single 
copies of the draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--NDA's'' to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. The guidance document and received comments 
may be seen in the office above between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document using 
the World Wide Web (WWW). For WWW access connect to CDER at ``http://
www.fda.gov/cder/guidance/index.htm''.

    Dated: April 1, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-9103 Filed 4-7-98; 8:45 am]
BILLING CODE 4160-01-F