[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