[Federal Register: January 31, 2001 (Volume 66, Number 21)]
[Notices]
[Page 8411-8412]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31ja01-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0033]
Draft Guidance for Industry on Providing Regulatory Submissions
in Electronic Format, Prescription Drug Advertising and Promotional
Labeling; 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availability of a draft guidance for industry entitled ``Providing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--Prescription Drug
Advertising and Promotional Labeling.'' The draft guidance discusses
how to submit promotional materials in electronic format to the Center
for Drug Evaluation and Research (CDER) and the Center for Biologics
Evaluation and Research (CBER). This draft guidance is one of a series
of guidances being developed by the agency to assist applicants who
wish to make regulatory submissions in electronic format. 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DATES: Submit written comments on the draft guidance by April 2, 2001.
General comments on agency guidance documents are welcome at any time.
ADDRESSES: Copies of this draft guidance are available on the Internet
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm. Written requests for copies of the draft guidance
should be submitted to the Drug Information Branch (HFD-210), 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, Rockville, MD 20852-1448, Fax: 1-888-CBERFAX or 301-827-3844.
Send one self-addressed adhesive label to assist the office in
processing your request. Submit written comments on the draft guidance
to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Warren F. Rumble, Center for Drug Evaluation and Research (HFD-
001), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-2831, Rumblew@cder.fda.gov. or
Michael B. Fauntleroy, Center for Biologic Evaluation and Research
(HFM-99), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852, 301-827-5101, esubprep@cber.fda.gov
SUPPLEMENTARY INFORMATION: Traditionally, regulations have required
that submissions, such as investigational new drug application (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
[[Page 8412]]
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).
In the Federal Registerof January 28, 1999 (64 FR 4433), CDER and
CBER jointly published a guidance entitled ``Providing Regulatory
Submissions in Electronic Format--General Considerations.'' Since that
time, CDER and CBER have included NDA's and BLA's on the docket as
submission types that we are able to accept in electronic format.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September
19, 2001). This draft guidance represents the agency's current thinking
on providing promotional materials in electronic format to CDER and
CBER. 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, regulations, or both.
Interested persons may 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 and requests 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. As in the past, applicants planning to make submissions in
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.
Dated: January 24, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-2631 Filed 1-30-01; 8:45 am]
BILLING CODE 4160-01-S