[Federal Register: September 30, 2005 (Volume 70, Number 189)]
[Notices]
[Page 57300-57301]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se05-98]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0385]
Draft Guidance for Industry on Using Electronic Means to
Distribute Certain Product Information; 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availability of a draft guidance for industry entitled ``Guidance for
Industry: Using Electronic Means to Distribute Certain Product
Information,'' dated September 2005. The draft guidance explains that
persons can distribute certain product information, such as for recalls
and drug safety, by electronic means. We encourage the use of
electronic communications for conveying all such important product
safety information. We are making clear in this draft guidance that
manufacturers may disseminate communications by e-mail or other
electronic methods.
DATES: Submit written or electronic comments on the draft guidance by
November 29, 2005, to ensure their adequate consideration in
preparation of the final guidance. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Policy (HF-11), Office of the Commissioner,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your requests. Submit phone requests to 301-827-3360. Submit
written comments on the draft guidance to the Division of Dockets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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3360.
SUPPLEMENTARY INFORMATION:
I. Background
The timely dissemination of communications about recalls of FDA
regulated products, important drug safety information, and other
important product safety information is essential for the protection of
the public health. We have encouraged manufacturers to provide such
information in a timely manner to distributors, doctors, and others.
Over the years, we have worked with manufacturers to promote the use of
electronic methods of communication and encourage the use of innovative
technologies to disseminate safety information, particularly those that
provide a public health benefit. We are making clear in the draft
guidance that manufacturers may disseminate the communications
discussed in Sec. Sec. 7.49 and 200.5 (21 CFR 7.49 and 200.5) by e-
mail or other electronic methods. The draft guidance also applies to
those instances, not addressed in any regulation, where we recommend
that manufacturers and distributors voluntarily convey certain safety
information about their products to members of the public.
The use of e-mail and other electronic communications has
dramatically changed how we and the public convey information.
Electronic communications have a number of advantages over paper-based
communications. They can significantly shorten the time between an
event and the public's knowledge of the event. When the event involves
product safety, it is even more important that accurate safety
information be transmitted rapidly. E-mail and other electronic
communications are generally considered more efficient and more timely
than regular or traditional mail. These communications involve
considerably less cost to the sender than older, more traditional
delivery services. Verification of receipt or delivery is less
expensive and can be automatically accomplished. Any necessary followup
(such as when receipt of the e-mail is not acknowledged) also can be
accomplished electronically. If receipt is never acknowledged, the
sender can resort to more traditional methods of notification.
We interpret the provisions of Sec. Sec. 7.49 and 200.5 to allow
the use of e-mail and other electronic communication methods, such as
fax or text messaging, to accomplish any recall notification or
distribution of important safety information. Section 7.49(b) provides
[[Page 57301]]
that ``A recall communication can be accomplished by telegrams,
mailgrams, or first class letters* * *.'' Given the use of the term
``can,'' we read the three examples as being illustrative rather than
the sole means of accomplishing recall communications. Electronic
notification is a viable alternative to more traditional methods.
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 using
electronic means to distribute certain product information. 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 on the draft guidance.
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. The draft guidance and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/guidance/electronic.html or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/ohrms/dockets/default.htm.
Dated: September 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19731 Filed 9-28-05; 1:53 pm]
BILLING CODE 4160-01-S