[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)]
[Notices]
[Pages 49695-49696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25126]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Guidance for Industry on Archiving 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 ``Archiving 
Submissions in Electronic Format--NDA's.'' This guidance is intended to 
describe how to submit records and other documents in electronic format 
to the Center for Drug Evaluation and Research (CDER) for archival 
purposes. Guidance is provided on submitting case report forms and case 
report tabulations as part of new drug applications (NDA's). This is 
the first in a series of guidances for industry that will address 
archiving NDA submissions in electronic format. Guidance for industry 
on other submission types will be made available as they are completed. 
The submission of records 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 at any time.


[[Page 49696]]


ADDRESSES: Submit written requests for single copies of the guidance 
for industry entitled ``Archiving 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. Submit written comments 
on the 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, e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``Archiving Submissions in Electronic 
Format--NDA's.'' Traditionally, FDA has required that regulatory 
submissions, such as investigational new drug applications and NDA's, 
be submitted as paper documents. The regulations in part 314 (21 CFR 
part 314), for example, set forth the requirements and procedures for 
submitting applications to obtain approval for the marketing of new 
drugs to FDA. These regulations require the submission of three copies 
of an application for marketing approval: (1) A complete archival copy, 
(2) a review copy, and (3) a field copy (Sec. 314.50(k)).
    In the Federal Register of March 20, 1997 (62 FR 13430), FDA 
published the Electronic Records; Electronic Signatures regulation that 
provides 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 so the agency can 
maintain a list of the specific types of records and submissions that 
can be accepted in electronic format (62 FR 13467, March 20, 1997). The 
agency unit(s) that are prepared to receive electronic submissions are 
to identify themselves in that docket. The regulation states that 
persons should consult with the intended agency receiving unit for 
details on how to proceed with the electronic submission. The guidance 
is intended to reduce the need on the part of sponsors to consult CDER 
for details on archiving electronic submissions. The guidance 
specifically addresses the NDA and includes subsections on how to 
submit case report forms and case report tabulations in electronic 
format to CDER for the archive. Conforming to the guidance in this 
document will help ensure that submissions provided to CDER in 
electronic format can be accessed, handled, reviewed, and maintained 
efficiently.
    The guidance is the first in a series that will be issued on 
archiving electronic submissions to CDER. As a result, it is not all 
inclusive. CDER anticipates that, as this effort proceeds, sponsors, 
investigators, and CDER staff may develop alternative and more 
effective procedures for submitting electronic applications for the 
archive. For this reason, the guidance will be updated periodically.
    The guidance represents the agency's current thinking on electronic 
submissions for the archive for NDA's. 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 requirement of the applicable statute, regulations, or both.
    Interested persons may, at any time, submit written comments on the 
guidance 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.
    An electronic version of the guidance also is available on the 
Internet at ``http://www.fda.gov/cder/guidance/index.htm''.

    Dated: September 17, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-25126 Filed 9-17-97; 4:58 pm]
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