Public Health Service; Notice of Listing of Members of the Substance Abuse and Mental Health Services Administration's Senior Executive Service Performance Review Board (PRB), 59299 [07-5158]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 202 / Friday, October 19, 2007 / Notices
pwalker on PROD1PC71 with NOTICES
availability of a draft guidance for
industry entitled ‘‘The Use of
Mechanical Calibration of Dissolution
Apparatus 1 and 2 – Current Good
Manufacturing Practice (CGMP).’’ The
draft guidance is intended to aid drug
manufacturers and ancillary testing
laboratories in using mechanical
calibration as an alternate approach to
the use of calibrator tablets in
calibrating an apparatus used for
dissolution testing. The guidance
provides references to information on
critical tolerances that should be
achieved with mechanical calibration.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by January 17, 2008.
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single copies of the draft guidance to the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Submit written comments on the draft
guidance to the Division of Dockets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 either https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Albinus D’Sa, Center for Drug
Evaluation and Research (HFD–320),
Food and Drug Administration, 11919
Rockville Pike, Rockville, MD 20852,
301–827–9044.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘The Use of Mechanical Calibration of
Dissolution Apparatus 1 and 2 – Current
Good Manufacturing Practice (CGMP).’’
FDA regulations require that laboratory
apparatus be calibrated at suitable
intervals in accordance with established
written specifications (21 CFR
211.160(b)(4)). Historically, both
chemical and mechanical means have
been used in calibrating dissolution
apparatuses. Since 1978, chemical
calibration has been the predominant
method of calibration, consistent with
chapter 711 of the U. S. Pharmacopeia
VerDate Aug<31>2005
16:46 Oct 18, 2007
Jkt 214001
(USP), which describes the use of
calibrator tablets. Chemical calibration
of an apparatus is usually performed, in
addition to mechanical calibration,
every 6 months. Because the use of USP
chemical calibration tablets can lead to
variability in the dissolution
measurement system, FDA is providing
guidance on mechanical calibration as
an alternate approach to calibrating
dissolution equipment. As stated in the
draft guidance, instead of using an
external calibrator tablet, a firm can use
an appropriately rigorous method of
mechanical calibration as an alternative
to ensure ongoing acceptability of the
dissolution apparatus.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on the use of mechanical calibration of
dissolution apparatus 1 and 2 as related
to CGMP. 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 https://
www.fda.gov/cder/guidance/index.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: October 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–20664 Filed 10–18–07; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
59299
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Public Health Service; Notice of Listing
of Members of the Substance Abuse
and Mental Health Services
Administration’s Senior Executive
Service Performance Review Board
(PRB)
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) announces the persons who
will serve on the Substance Abuse and
Mental Health Services
Administration’s Performance Review
Board. This action is being taken in
accordance with Title 5, U.S.C., Section
4314(c)(4), which requires that members
of performance review boards be
appointed in a manner to ensure
consistency, stability, and objectivity in
performance appraisals, and requires
that notice of the appointment of an
individual to serve as a member by
published in the Federal Register.
The following persons will serve on
the SAMHSA Performance Review
Board, which is responsible for making
recommendations on performance
appraisal ratings, pay adjustments, and
performance awards for SAMHSA’s
Senior Executive Service (SES)
members:
Eric Broderick, D.D.S.—Chairperson.
Westley Clark, M.D., J.D., M.P.H.
Randy Grinnell.
Anna Marsh, Ph.D.
Dennis Romero, M.A.
For further information about the
SAMHSA Performance Review Board,
contact the Division of Management
Systems, Substance Abuse and Mental
Health Services Administration, 1
Choke Cherry Road, Room 3–1017,
Rockville, Maryland 20857, telephone
(240) 276–1124 (not a toll-free number).
Dated: October 15, 2007.
Terry L. Cline,
Administrator, SAMHSA.
[FR Doc. 07–5158 Filed 10–18–07; 8:45 am]
BILLING CODE 4160–01–M
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2007–0006]
Commercial Fishing Industry Vessel
Safety Advisory Committee
Coast Guard, DHS.
Notice of meeting.
AGENCY:
ACTION:
Frm 00061
Fmt 4703
Sfmt 4703
E:\FR\FM\19OCN1.SGM
19OCN1
]]>Agencies
[Federal Register Volume 72, Number 202 (Friday, October 19, 2007)]
[Notices]
[Page 59299]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5158]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Public Health Service; Notice of Listing of Members of the
Substance Abuse and Mental Health Services Administration's Senior
Executive Service Performance Review Board (PRB)
The Substance Abuse and Mental Health Services Administration
(SAMHSA) announces the persons who will serve on the Substance Abuse
and Mental Health Services Administration's Performance Review Board.
This action is being taken in accordance with Title 5, U.S.C., Section
4314(c)(4), which requires that members of performance review boards be
appointed in a manner to ensure consistency, stability, and objectivity
in performance appraisals, and requires that notice of the appointment
of an individual to serve as a member by published in the Federal
Register.
The following persons will serve on the SAMHSA Performance Review
Board, which is responsible for making recommendations on performance
appraisal ratings, pay adjustments, and performance awards for SAMHSA's
Senior Executive Service (SES) members:
Eric Broderick, D.D.S.--Chairperson.
Westley Clark, M.D., J.D., M.P.H.
Randy Grinnell.
Anna Marsh, Ph.D.
Dennis Romero, M.A.
For further information about the SAMHSA Performance Review Board,
contact the Division of Management Systems, Substance Abuse and Mental
Health Services Administration, 1 Choke Cherry Road, Room 3-1017,
Rockville, Maryland 20857, telephone (240) 276-1124 (not a toll-free
number).
Dated: October 15, 2007.
Terry L. Cline,
Administrator, SAMHSA.
[FR Doc. 07-5158 Filed 10-18-07; 8:45 am]
BILLING CODE 4160-01-M
