[Federal Register: June 5, 2007 (Volume 72, Number 107)]
[Notices]
[Page 31079-31080]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jn07-56]
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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Draft Guidance for Industry on Providing Regulatory Submissions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availability of a draft guidance for industry entitled ``Providing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 This draft
guidance provides information on what FDA will consider to be the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the draft guidance, FDA will not consider a submission to be received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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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.
s/dockets/default.htm.
Dated: May 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10780 Filed 6-4-07; 8:45 am]
BILLING CODE 4160-01-S