[Federal Register Volume 71, Number 137 (Tuesday, July 18, 2006)]
[Notices]
[Page 40724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0169]


Guidance on Useful Written Consumer Medication 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 guidance entitled ``Useful Written Consumer 
Medication Information (CMI).'' CMI is written information developed 
for consumers about prescription drugs that is distributed to consumers 
when they have prescriptions filled. The guidance discusses general 
issues and makes recommendations on the content of useful written CMI.

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

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), 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. The guidance may also be obtained by mail by calling the 
Center for Biologics Evaluation and Research at 1-800-835-4709 or 301-
827-1800. Send one self-addressed adhesive label to assist the offices 
in processing your request. Submit written comments on 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: Paul Seligman, Center for Drug 
Evaluation and Research (HFD-001), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-5620.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``Useful 
Written Consumer Medication Information (CMI).'' This guidance is 
intended to assist individuals or organizations (e.g., pharmacies, 
private vendors, healthcare associations) in developing useful written 
consumer medication information to comply with Public Law 104-180. CMI 
is written information about prescription drugs developed by 
organizations or individuals, other than a drug's manufacturer, that is 
intended for distribution to consumers at the time of dispensing. Since 
neither FDA nor the drug's manufacturer reviews or approves CMI, FDA 
recommends that the developers of written medication information use 
the factors discussed in this guidance to help ensure that their CMI is 
useful to consumers.
    In the Federal Register of May 26, 2005 (70 FR 30467) (the May 2005 
guidance), FDA announced the availability of a draft version of this 
guidance. The May 2005 guidance gave interested persons an opportunity 
to submit comments through July 25, 2005. All comments received during 
the comment period have been carefully reviewed and incorporated in 
this revised guidance where appropriate. As a result of the public 
comment, we hope that the guidance is clearer and more concise than the 
draft version.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on useful written CMI. 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 regarding this document. 
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. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: July 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11329 Filed 7-17-06; 8:45 am]
BILLING CODE 4160-01-S