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Federal Register / Vol. 70, No.

101 / Thursday, May 26, 2005 / Notices 30467

the role of amplification; models of improvements in the delivery of occupational guidance documents are welcome at any
early intervention; and the need for safety and health services, and the time.
future research. prevention of work-related injury and illness.
ADDRESSES: Submit written requests for
Agenda items are subject to change as It is anticipated that research funded will
promote these program goals. single copies of the draft guidance to the
priorities dictate. Matters to be Discussed: The meeting will Division of Drug Information (HFD–
FOR FURTHER INFORMATION CONTACT: convene in open session from 8–8:15 a.m. on 240), Center for Drug Evaluation and
Marcus Gaffney, M.P.H., National June 21, 2005, to address matters related to Research, Food and Drug
Center on Birth Defects and the conduct of Study Section business. The Administration, 5600 Fishers Lane,
Developmental Disabilities, CDC, 1600 remainder of the meeting will proceed in Rockville, MD 20857. Send one self-
Clifton Road, NE., M/S E–88, Atlanta, closed session. The purpose of the closed addressed adhesive label to assist that
Georgia 30333. Telephone: (404) 498– sessions is for the study section to consider office in processing your requests.
safety and occupational health-related grant
3031. Submit written comments on the draft
applications. These portions of the meeting
The Director, Management Analysis guidance to the Division of Dockets
will be closed to the public in accordance
and Services Office, has been delegated with provisions set forth in Section Management (HFA–305), Food and Drug
the authority to sign Federal Register 552b(c)(4) and (6), Title 5 U.S.C., and the Administration, 5630 Fishers Lane, rm.
notices pertaining to announcements of Determination of the Director, Management 1061, Rockville, MD 20852. Submit
meetings and other committee Analysis and Services Office, Centers for electronic comments to http://
management activities for both CDC and Disease Control and Prevention, pursuant to www.fda.gov/dockets/ecomments. See
the Agency for Toxic Substances and Section 10(d) Pub. L. 92–463. the SUPPLEMENTARY INFORMATION section
Disease Registry. Agenda items are subject to change as for electronic access to the draft
priorities dictate.
Dated: May 20, 2005. guidance document.
For Further Information Contact: Price
Alvin Hall, Connor, Ph.D., NIOSH Health Scientist, 1600 FOR FURTHER INFORMATION CONTACT:
Director, Management Analysis and Services Clifton Road, NE., Mailstop E–74, Atlanta, Ellen Tabak, Center for Drug Evaluation
Office, Centers for Disease Control and Georgia 30333, telephone 404/498–2511, fax and Research (HFD–410), Food and
Prevention. 404/498–2569. Drug Administration, 5600 Fishers
[FR Doc. 05–10541 Filed 5–25–05; 8:45 am] The Director, Management Analysis and Lane, Rockville, MD 20857, 301–827–
Services Office, has been delegated the 7843.
BILLING CODE 4163–18–P
authority to sign Federal Register notices
pertaining to announcements of meetings and SUPPLEMENTARY INFORMATION:
other committee management activities for I. Background
DEPARTMENT OF HEALTH AND both CDC and the Agency for Toxic
HUMAN SERVICES Substances and Disease Registry. FDA is announcing the availability of
Dated: May 20, 2005.
a draft guidance entitled ‘‘Useful
Centers for Disease Control and Written Consumer Medication
Prevention Alvin Hall,
Information (CMI).’’ This draft guidance
Director, Management Analysis and Services is intended to assist individuals or
National Institute for Occupational Office, Centers for Disease Control and
Prevention.
organizations (e.g., pharmacies, private
Safety and Health, Safety and vendors, healthcare associations) in
Occupational Health Study Section [FR Doc. 05–10542 Filed 5–25–05; 8:45 am]
developing useful written CMI. CMI is
BILLING CODE 4163–18–P
In accordance with section 10(a)(2) of written information about prescription
the Federal Advisory Committee Act drugs developed by organizations or
(Pub. L. 92–463), the Centers for Disease individuals, other than a drug’s
DEPARTMENT OF HEALTH AND
Control and Prevention (CDC) manufacturer, that is intended for
HUMAN SERVICES
announces the following committee distribution to consumers at the time of
meeting. Food and Drug Administration dispensing. Since neither FDA nor the
Name: Safety and Occupational Health
drug’s manufacturer reviews or
[Docket No. 2005D–0169] approves CMI, FDA recommends that
Study Section (SOHSS), National Institute for
Occupational Safety and Health (NIOSH). the developers of written medication
Draft Guidance on Useful Written
Times and Dates: 8 a.m.–5 p.m., June 21, information use the factors discussed in
Consumer Medication Information
2005. 8 a.m.–5 p.m., June 22, 2005. this guidance to ensure that their CMI
Place: Embassy Suites Hotel, 1900 AGENCY: Food and Drug Administration, is useful to consumers.
Diagonal Road, Alexandria, Virginia, 22314, HHS. Traditionally, FDA has believed that
telephone 703/684–5900, fax 703/684–1403. when people are well-informed about
ACTION: Notice.
Status: Open 8 a.m.–8:15 a.m., June 21, the medications they take, they are able
2005. Closed 8:15 a.m.–5 p.m., June 21, 2005. SUMMARY: The Food and Drug to make better decisions about their
Closed 8 a.m.–5 p.m., June 22, 2005. Administration (FDA) is announcing the
Purpose: The Safety and Occupational
healthcare and better use of the
Health Study Section will review, discuss,
availability of a draft guidance entitled prescription medications available to
and evaluate grant application(s) received in ‘‘Useful Written Consumer Medication them. Access to useful written
response to the Institute’s standard grants Information (CMI).’’ CMI is written information about prescription
review and funding cycles pertaining to information developed for consumers medications is important to ensuring
research issues in occupational safety and about prescription drugs that is appropriate use of these products. In
health, and allied areas. distributed to consumers when they 1996, a steering committee comprised of
It is the intent of NIOSH to support broad- have prescriptions filled. The guidance interested stakeholders (including
based research endeavors in keeping with the discusses general issues and makes healthcare professionals, consumer
Institute’s program goals. This will lead to recommendations on the content of
improved understanding and appreciation for
organizations, voluntary health
the magnitude of the aggregate health burden
useful written CMI. agencies, pharmaceutical
associated with occupational injuries and DATES: Submit written or electronic manufacturers, prescription drug
illnesses, as well as to support more focused comments on the draft guidance by July wholesalers, drug information database
research projects, which will lead to 25, 2005. General comments on agency companies, CMI developers, and

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