[Federal Register Volume 63, Number 117 (Thursday, June 18, 1998)]
[Notices]
[Page 33375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16140]



[[Page 33375]]

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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Draft Guidance for Industry on Providing Regulatory Submissions 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; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until July 
8, 1998, the comment period for a notice announcing the availability of 
a draft guidance for industry entitled ``Providing Regulatory 
Submissions in Electronic Format--NDA's'' that appeared in the Federal 
Register of April 8, 1998 (63 FR 17184). FDA is taking this action in 
response to a request for an extension and to allow interested parties 
additional time for review and to submit comments.

DATES: Written comments by July 8, 1998. General comments on the agency 
guidance documents are welcome at any time.

ADDRESSES: Copies of the draft guidance for industry are available on 
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of the draft guidance to the Drug 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 Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

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; [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of April 8, 1998 (63 
FR 17184), FDA's Center for Drug Evaluation and Research (CDER) 
published a notice announcing the availability of a draft guidance for 
industry entitled ``Providing Regulatory Submissions in Electronic 
Format--NDA's.'' The draft guidance is intended to assist applicants 
who wish to submit new drug applications (NDA's) in electronic format. 
Although voluntary, submissions of NDA's in electronic format should 
reduce the amount of paperwork for applicants and the agency. The April 
8, 1998, notice invited interested persons to submit written comments 
on the draft guidance within 60 days.
    On April 20, 1998, FDA received a letter from Pharmaceutical 
Research and Manufacturers of America, requesting that the agency 
extend the comment period on the draft guidance 90 days. In addition, 
in the Federal Register of June 1, 1998 (63 FR 29741), FDA's Center for 
Biologics Evaluation and Research (CBER) published a draft guidance for 
industry entitled ``Guidance for Industry: Electronic Submissions of a 
Biologics License Application (BLA) or Product License Application 
(PLA)/Establishment License Application (ELA) to the Center for 
Biologics Evaluation and Research.''
    Because a number of NDA sponsors have expressed the wish to see the 
draft guidance become final as soon as possible and because the agency 
considers this to be a dynamic document, which will be updated in the 
future, the agency does not believe it is necessary to extend the 
comment period an additional 90 days. However, the agency agrees that 
an additional period will provide time for interested parties to review 
both CDER and CBER's guidances. Therefore, the agency is reopening the 
comment period for an additional 30 days, until July 8, 1998.
    Interested persons may, on or before July 8, 1998, submit to the 
Dockets Management Branch (address above) written comments on the draft 
guidance. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
draft guidance and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: June 9, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-16140 Filed 6-17-98; 8:45 am]
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