Guidance on Useful Written Consumer Medication Information; Availability, 40724 [E6-11329]

Download as PDF 40724 Federal Register / Vol. 71, No. 137 / Tuesday, July 18, 2006 / Notices subjects that is conducted or supported by the Department of Health and Human Services and involves a product regulated by FDA. II. Qualifications Persons nominated for membership on the committees shall have scientific expertise in one or more of the following areas: Pediatric research, pediatric subspecialties, pediatric therapeutics, statistics, and/or biomedical ethics. There is a particular need for clinical and/or scientific expertise in pediatric neurology, adolescent medicine or statistics. The term of office is up to 4 years, depending on the appointment date. III. Nomination Procedures Any interested person may nominate one or more qualified persons for membership on the Pediatric Advisory Committee. Self-nominations are also accepted. Nominations shall include the name of the committee, a complete curriculum vitae of each nominee, current business address and telephone number, and shall state that the nominee is aware of the nomination, is willing to serve as a member, and appears to have no conflict of interest that would preclude membership. FDA will ask the potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: July 10, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. 06–6276 Filed 7–17–06; 8:45 am] BILLING CODE 4160–01–S 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. wwhite on PROD1PC61 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Useful Written Consumer Medication Information (CMI).’’ CMI is written VerDate Aug<31>2005 16:25 Jul 17, 2006 Jkt 208001 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 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 selfaddressed 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 https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. ADDRESSES: Paul Seligman, Center for Drug Evaluation and Research (HFD–001), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–443– 5620. FOR FURTHER INFORMATION CONTACT: 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/cder/guidance/ index.htm, https://www.fda.gov/cber/ guidelines.htm, or https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General Program Exclusions: June 2006 AGENCY: Office of Inspector General, HHS. ACTION: E:\FR\FM\18JYN1.SGM Notice of program exclusions. 18JYN1

Agencies

[Federal Register Volume 71, Number 137 (Tuesday, July 18, 2006)]
[Notices]
[Page 40724]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://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 https://www.fda.gov/cder/guidance/index.htm, https://www.fda.gov/
cber/guidelines.htm, or https://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

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