[Federal Register Volume 64, Number 18 (Thursday, January 28, 1999)]
[Notices]
[Pages 4432-4433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2060]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0054]


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 guidance for industry entitled ``Providing Regulatory 
Submissions in Electronic Format--NDA's.'' The guidance discusses in 
detail how to submit a new drug application (NDA) in electronic format 
to the Center for Drug Evaluation and Research (CDER). A notice of 
availability for a related guidance entitled ``Providing Regulatory 
Submissions in Electronic Format--General Considerations'' is being 
published elsewhere in this issue of the Federal Register. It discusses 
issues common to all submissions in electronic format to CDER and the 
Center for Biologics Evaluation and Research (CBER). Both guidances are 
part of a series of guidances being developed by the agency to assist 
applicants who wish to make regulatory submissions in electronic 
format. Guidances addressing other submission types, such as biologics 
license applications, abbreviated new drug applications (ANDA's), and 
investigational new drug applications (IND's), are being developed and 
will be issued in the future. Although submissions in electronic format 
are voluntary, the agency encourages them as a way to improve the 
efficiency of handling and reviewing documents and data.

DATES: Written comments on agency guidance documents may be submitted 
at any time.

ADDRESSES: Copies of this guidance for industry can be obtained on the 
Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Submit 
written requests for single copies of the guidance 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. Submit written comments on the guidance to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments are to be 
identified with the docket number found in brackets in the heading of 
this notice.

FOR FURTHER INFORMATION CONTACT: Kenneth Edmunds, Center for Drug 
Evaluation and Research (HFD-73), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3276, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Traditionally, FDA has required that 
regulatory submissions, such as IND's and NDA's, be submitted as paper 
documents. In the Federal Register of March 20, 1997 (62 FR 13430), FDA 
published the electronic records and 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 No. 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, 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.
     In the Federal Register of April 8, 1998 (63 FR 17184), CDER 
published a draft guidance entitled ``Providing Regulatory Submissions 
in Electronic Format--NDA's''. This draft guidance expanded on the 
September 1997 guidance and provided new information

[[Page 4433]]

on submitting a complete archival copy of the NDA in electronic format, 
including CRF's and CRT's. The comment period, which closed on June 8, 
1998, was extended 30 days to allow interested parties to review CDER's 
document together with guidances on electronic submissions published by 
CBER (63 FR 29741, June 1, 1998). The agency considered received 
comments as it finalized this guidance. Because of the ever changing 
nature of this technology, the agency believes that the procedures for 
submitting electronic applications will continue to evolve over time. 
To facilitate the updating of guidances on electronic submissions in a 
timely and efficient manner, the agency has decided to develop one 
guidance on those topics common to all submission types and to create 
individual guidances on specific submission types.
     Subsequent guidances on other submission types will be issued as 
they are developed. Consistent with the agency's Good Guidance 
Practices (62 FR 8961, February 27, 1997), guidances will be issued 
first in draft for comment, then revised and published in final.
     As in the past, applicants planning to make submissions in 
electronic format should consult public Docket No. 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 guidance document represents the agency's current thinking on 
providing NDA's in electronic format to CDER. 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.
     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. The guidance document and received 
comments may be seen in the office above between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: January 22, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-2060 Filed 1-27-99; 8:45 am]
BILLING CODE 4160-01-F