Federal Register: January 31, 2001 (Volume 66, Number 21)
DOCID: FR Doc 01-2631
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. 01D-0033]
ACTION: Reports and guidance documents; availability, etc.:
DOCUMENT ACTION: Notice.
Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format, Prescription Drug Advertising and Promotional Labeling; Availability
DATES: Submit written comments on the draft guidance by April 2, 2001. General comments on agency guidance documents are welcome at any time.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatPrescription Drug Advertising and Promotional Labeling.'' The draft guidance discusses how to submit promotional materials in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics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 This draft guidance is one of a series of guidances being developed by the agency to assist applicants who wish to make regulatory submissions in electronic format.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.
Prescription drug advertising and promotional labeling; regulatory submissions in electronic format; industry guidance,
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. 92S0251 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 FormatGeneral 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. 92S0251 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. 012631 Filed 13001; 8:45 am] BILLING CODE 416001S
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, 3018272831, Rumblew@cder.fda.gov. or
Michael B. Fauntleroy, Center for Biologic Evaluation and Research (HFM99), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 3018275101, email@example.com