[Federal Register Volume 71, Number 85 (Wednesday, May 3, 2006)]
[Notices]
[Pages 26102-26103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6705]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0385]


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 final guidance for industry entitled ``Guidance for 
Industry: Using Electronic Means to Distribute Certain Product 
Information'' dated March 2006. The final guidance explains that 
persons can distribute certain product information, such as for recalls 
and product 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 guidance that 
manufacturers and others may disseminate communications by electronic 
means, including e-mail or other electronic methods.

DATES: Submit written or electronic comments on agency guidance 
documents at any time.

ADDRESSES: Submit written requests for single copies of the 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 concerning the 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://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy (HF-
11), Office of the Commissioner, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3360.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 30, 2005, we published a notice of availability for a 
draft guidance entitled ``Guidance for Industry: Using Electronic Means 
to Distribute Certain Product Information'' (70 FR 57300). The draft 
guidance requested comments by November 29, 2005. We received comments 
from individuals, associations, companies that provide safety and drug 
notices, and the pharmaceutical industry. We have reviewed these 
comments and have modified the guidance in response to those comments.
    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 encourage manufacturers to provide such 
information in a timely manner to distributors, doctors, and others. 
Over the years, we have worked with manufacturers and distributors to 
promote the use of electronic methods of communication and encourage 
the

[[Page 26103]]

use of innovative technologies to disseminate safety information, 
particularly when doing so can provide a public health benefit. We are 
making clear in the guidance that manufacturers and distributors may 
disseminate the communications discussed in Sec. Sec.  7.49 and 200.5 
(21 CFR 7.49 and 200.5) by various electronic methods, including e-
mail. The 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 can be more efficient and timelier than 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 
through various means such as delivery or read receipt confirmation, or 
other electronic receipt acknowledgement mechanisms. Any necessary 
followup (such as when receipt of the e-mail is not acknowledged in 
some fashion) also can be accomplished electronically. If receipt of 
the electronic communication is not acknowledged appropriately by the 
recipient (as determined by the sender) or the electronic communication 
is undeliverable, the sender can resort to more traditional 
notification methods to ensure the communication is received.
    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 
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, with appropriate safeguards and the use of 
acknowledgement mechanisms, is a viable alternative to more traditional 
methods.

II. Comments/Responses

    We received a number of comments on the guidance and have modified 
the guidance to address some of the comments. Other comments are 
outside the scope of the guidance and thus are not addressed in the 
guidance. We have made changes on our own initiative to provide clarity 
to certain statements and recommendations.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C 3501-
3520). The collection of information in this guidance has been approved 
under OMB control number 0910-0249 which expires October 18, 2008.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/oc/guidance/electronic.html or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6705 Filed 5-2-06; 8:45 am]
BILLING CODE 4160-01-S