[Federal Register Volume 64, Number 18 (Thursday, January 28, 1999)]
[Notices]
[Pages 4433-4434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2059]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0075]


Guidance for Industry on General Considerations for Providing 
Regulatory Submissions in Electronic Format; 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--General Considerations.'' This 
guidance discusses issues common to all submissions in electronic 
format to the Center for Drug Evaluation and Research (CDER) and the 
Center for Biologics Evaluation and Research (CBER). A notice of 
availability for a related guidance entitled ``Providing Regulatory 
Submissions in Electronic Format--NDA's'' is being published elsewhere 
in this issue of the Federal Register. 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 may be submitted at any time.

ADDRESSES: Copies of ``Guidance for Providing Regulatory Submissions in 
Electronic Format--General Considerations'' can be obtained on the 
Internet at ``http://www.fda.gov/cder/guidance/index.htm'' or ``http://
www.fda.gov/cber/guidelines.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, or to the Office of Communication, 
Training and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448. 
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.

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]; or Michael B. Fauntleroy, Center for Biologics 
Evaluation and Research, Office of the Director, (HFM-99), Food and 
Drug Administration, rm. 200N, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-5101, e-mail: E[email protected].

SUPPLEMENTARY INFORMATION: Traditionally, FDA has required that 
regulatory submissions, such as IND's and new drug applications 
(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 on submitting a 
complete archival copy of the NDA in electronic format, including CRF's 
and CRT's. In June 1998, CBER published four guidances on electronic 
submissions: (1) ``Electronic Submissions of a Biologics License 
Application (BLA) Product License Application (PLA)/Establishment 
License Application

[[Page 4434]]

(ELA) to the Center for Biologics Evaluation and Research'' (63 FR 
29741, June 1, 1998); (2) ``Electronic Submissions of Case Report Forms 
(CRF's), Case Report Tabulations (CRT's), and Data to the Center for 
Biologics Evaluation and Research'' (63 FR 29739, June 1, 1998); (3) 
``Pilot Program for Electronic Investigational New Drug Applications 
(eIND) for Biological Products'' (63 FR 29740, June 1, 1998); and (4) 
``Instructions for Submitting Lot Release Protocols to the Center for 
Biologics Evaluation and Research'' (63 FR 29742, June 1, 1998).
    As part of agency efforts to harmonize the procedures for making 
electronic submissions, FDA has decided to combine certain information 
from the CDER and CBER guidances into this guidance on general 
considerations common to all submission types. The agency has 
considered received comments on the CDER and CBER guidances as it 
finalized this guidance document. Because of the ever changing nature 
of electronic submission technology and the need, for now, to recognize 
existing differences in CDER and CBER systems, the agency has decided 
to maintain separate guidances on CDER's NDA submissions and CBER's 
marketing application submissions. The agency will harmonize the 
concepts in the guidances to the extent our electronic systems permit.
     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 issued in final. This 
final guidance incorporates information from the earlier draft CDER and 
CBER documents and takes into account comments received on them.
    As in the past, applicants planning to make submissions in the 
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 
general considerations for providing regulatory 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.
     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 the 
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. 99-2059 Filed 1-27-99; 8:45 am]
BILLING CODE 4160-01-F