[Federal Register Volume 72, Number 107 (Tuesday, June 5, 2007)]
[Notices]
[Pages 31079-31080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10780]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0213]


Draft Guidance for Industry on Providing Regulatory Submissions 
in Electronic Format--Receipt Date; 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availability of a draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Receipt Date.'' This draft 
guidance provides information on what FDA will consider to be the 
receipt date for certain submissions provided in electronic format to 
the Center for Drug Evaluation and Research (CDER) and the Center for 
Biologics Evaluation and Research (CBER). The receipt date of these 
submissions has a number of important regulatory implications. Under 
the draft guidance, FDA will not consider a submission to be received 
until it has passed a technical validation check to ensure that the 
submission can be opened, processed, and archived.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115 (g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by August 6, 2007.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, or the Office of Communication, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research, Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label 
to assist that office in processing your requests. The guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Submit written comments on the guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT:
    Gary Gensinger, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 1112, 
Silver Spring, MD 20993-0002, 301-796-0589; or
    Michael Fauntleroy, Center for Biologics Evaluation and Research 
(HFM-25), 11400 Rockville Pike,Rockville, MD 20852, 301-827-5132.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Receipt Date.'' This draft guidance provides information on what FDA 
will consider to be the receipt date for submissions provided in 
electronic format to CDER and CBER. When FDA receives a submission, the 
receipt date is used to determine important regulatory milestones 
(e.g., 30-day safety review cycle for an investigational new drug 
application, review performance goal date for a new drug application or 
biologics license application). Occasionally, however, submissions in 
electronic format have technical deficiencies that prevent FDA from 
being able to open, process, and archive them. When this occurs, FDA's 
review cannot begin until these technical deficiencies are corrected. 
To encourage sponsors to ensure that electronic submissions are free of 
technical deficiencies that can delay FDA review of the submission, FDA 
is changing its policy on the receipt date for submissions provided in 
an electronic format. The guidance provides that FDA will not consider 
a submission to be received until it has passed a technical validation 
check to ensure that the submission can be opened, processed, and 
archived.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on determining 
the receipt date for 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 statutes and 
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

[[Page 31080]]

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, orhttp://www.fda.gov/ohrms/dockets/default.htm.

    Dated: May 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10780 Filed 6-4-07; 8:45 am]
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