[Federal Register Volume 66, Number 21 (Wednesday, January 31, 2001)]
[Notices]
[Pages 8411-8412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2631]


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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Draft Guidance for Industry on Providing Regulatory Submissions 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availability of a draft guidance for industry entitled ``Providing 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 The draft guidance discusses 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 This draft guidance is one of a series 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DATES: Submit written comments on the draft guidance by April 2, 2001.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ADDRESSES: Copies of this draft guidance are available on the Internet 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://www.fda.gov/cder/guidance/index.htm or 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 Written requests for copies of the draft guidance 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 Submit written comments on the draft guidance 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, [email protected]. 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, [email protected]

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