Federal Register / Vol. 72, No. 202 / Friday, October 19, 2007 / Notices 59299 

availability of a draft guidance for 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draft guidance is intended to aid drug 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draft guidance by January 17, 2008.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single copies of the draft guidance to the 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electronic access to the draft guidance 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a draft guidance for industry entitled 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 

(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 

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 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of meeting. 


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