[Federal Register: September 30, 2005 (Volume 70, Number 189)]
[Page 57300-57301]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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Draft Guidance for Industry on Using Electronic Means to 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.


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availability of a draft guidance for industry entitled ``Guidance for 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 The draft guidance explains that 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 We are making clear in this draft guidance that 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Policy (HF-11), Office of the Commissioner, 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written comments on the draft guidance to the Division of Dockets 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.

section for electronic access to the draft guidance document.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.


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 

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

    Dated: September 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19731 Filed 9-28-05; 1:53 pm]