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 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Register / Vol. 72, No. 202 / Friday, October 19, 2007 / Notices pwalker on PROD1PC71 with NOTICES availability of a draft guidance for industry entitled ‘‘The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP).’’ The draft guidance is intended to aid drug manufacturers and ancillary testing laboratories in using mechanical calibration as an alternate approach to the use of calibrator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on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 17, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 http:// www.fda.gov/dockets/ecomments or http://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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.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 SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP).’’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 http:// www.fda.gov/cder/guidance/index.htm or http://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]


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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