Draft “Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments;” Withdrawal of Guidance, 37102 [05-12763]
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37102
Federal Register / Vol. 70, No. 123 / Tuesday, June 28, 2005 / Notices
pertaining to announcements of meetings and
other committee management activities for
both CDC and the Agency for Toxic
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Dated: June 22, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–12689 Filed 6–27–05; 8:45 am]
Board of Scientific Counselors
Meeting, National Institute for
Occupational Safety and Health
(NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following committee
meeting:
Name: Board of Scientific Counselors
(BSC), NIOSH.
Time and Date: 10 a.m.–3:30 p.m., July 21,
2005.
Place: National Institute for Occupational
Safety and Health, Robert A. Taft
Laboratories, 4676 Columbia Parkway,
Cincinnati, Ohio 45226.
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 50 people.
Visiting members of the public must present
valid identification (U.S. Federal ID, State
Driver’s License, or other State-sanctioned
ID) for entry to Taft Laboratories and must be
escorted by facility staff at all times while
inside the facility.
Purpose: The Secretary, Department of
Health and Human Services; the Assistant
Secretary for Health; and by delegation the
Director, Centers for Disease Control and
Prevention, are authorized under Sections
301 and 308 of the Public Health Service Act
to conduct directly or by grants or contracts,
research, experiments, and demonstrations
relating to occupational safety and health and
to mine health. The Board of Scientific
Counselors shall provide guidance to the
Director, NIOSH, on research and
preventions programs. Specifically, the Board
shall provide guidance on the Institute’s
research activities related to developing and
evaluating hypotheses, systematically
documenting findings and disseminating
results. The Board shall evaluate the degree
to which the activities of NIOSH: (1) Conform
to appropriate scientific standards, (2)
address current, relevant needs, and (3)
produce intended results.
Matters To be Discussed: Agenda items
include a report from the Director of NIOSH;
progress reports by BSC working groups on
the National Occupational Research Agenda
and the health hazard evaluation program,
NIOSH emergency/terrorism preparedness, a
tour of the Taft Laboratories, and closing
remarks.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Roger Rosa, Executive Secretary, BSC,
NIOSH, CDC, 200 Independence Avenue,
SW., Room 715H, Washington, DC 20201,
telephone (202) 205–7856, fax (202) 260–
4464.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
VerDate jul<14>2003
16:46 Jun 27, 2005
Jkt 205001
BILLING CODE 4163–18–P
Dated: June 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–12763 Filed 6–27–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0240]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D–0262] (formerly Docket
No. 01–0262)
Draft ‘‘Guidance for Food and Drug
Administration Reviewers: Premarket
Notification Submissions for
Automated Testing Instruments Used
in Blood Establishments;’’ Withdrawal
of Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
withdrawal of a draft guidance that was
issued on August 3, 2001.
DATES: June 28, 2005.
FOR FURTHER INFORMATION CONTACT: Paul
E. Levine, Jr., Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
August 3, 2001 (66 FR 40708), FDA
announced the availability of a draft
document entitled ‘‘Guidance for FDA
Reviewers: Premarket Notification
Submissions for Automated Testing
Instruments Used in Blood
Establishments.’’ This draft guidance is
being withdrawn because it no longer
reflects the following: (1) All of the
information FDA reviewers should
expect to be included in a premarket
notification submitted to the Center for
Biologics Evaluation and Research for
such devices and (2) the recommended
approach FDA reviewers should take in
reviewing premarket submissions for
automated instruments testing used in
blood establishments. In the future, FDA
may issue for public comment draft
special control guidances on
instrumentation for blood borne
pathogen donor screening and
immunohematology testing.
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Draft Guidance for Industry on
Gingivitis: Development and
Evaluation of Drugs for Treatment or
Prevention; 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 ‘‘Gingivitis:
Development and Evaluation of Drugs
for Treatment or Prevention.’’ The draft
guidance is intended to assist sponsors
in developing clinical trials for drug
products that treat or prevent gingivitis.
It addresses specific protocol design
elements as well as general concerns
about drugs for this indication.
DATES: Submit written or electronic
comments on the draft guidance by
August 29, 2005. General comments on
agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft 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. Send one selfaddressed adhesive label to assist that
office in processing your requests.
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 https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Frederick Hyman, Center for Drug
Evaluation and Research (HFD–540),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–2020.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
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]]>Agencies
[Federal Register Volume 70, Number 123 (Tuesday, June 28, 2005)]
[Notices]
[Page 37102]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12763]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D-0262] (formerly Docket No. 01-0262)
Draft ``Guidance for Food and Drug Administration Reviewers:
Premarket Notification Submissions for Automated Testing Instruments
Used in Blood Establishments;'' Withdrawal of Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of a draft guidance that was issued on August 3, 2001.
DATES: June 28, 2005.
FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of August 3, 2001 (66 FR 40708), FDA announced the
availability of a draft document entitled ``Guidance for FDA Reviewers:
Premarket Notification Submissions for Automated Testing Instruments
Used in Blood Establishments.'' This draft guidance is being withdrawn
because it no longer reflects the following: (1) All of the information
FDA reviewers should expect to be included in a premarket notification
submitted to the Center for Biologics Evaluation and Research for such
devices and (2) the recommended approach FDA reviewers should take in
reviewing premarket submissions for automated instruments testing used
in blood establishments. In the future, FDA may issue for public
comment draft special control guidances on instrumentation for blood
borne pathogen donor screening and immunohematology testing.
Dated: June 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12763 Filed 6-27-05; 8:45 am]
BILLING CODE 4160-01-S
