[Federal Register Volume 63, Number 81 (Tuesday, April 28, 1998)]
[Notices]
[Page 23293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11198]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0233]


Guidance for Industry on PAC-ATLS: Postapproval Changes--
Analytical Testing Laboratory Sites; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``PAC-ATLS: 
Postapproval Changes--Analytical Testing Laboratory Sites.'' This 
guidance provides recommendations to pharmaceutical sponsors of new 
drug applications (NDA's) and abbreviated new drug applications 
(ANDA's) who intend to change an analytical testing laboratory site for 
components, drug product containers, closures, packaging materials, in-
process materials, or drug products during the postapproval period. 
This guidance is intended to ease the burden of notification, under 
certain circumstances, for analytical testing laboratory site changes 
currently requiring prior approval supplements under the human drug 
regulations.

DATES: Written comments may be submitted at any time.

ADDRESSES: Copies of this guidance for industry are available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm. Submit written 
requests for single copies of the guidance for industry entitled ``PAC-
ATLS: Postapproval Changes--Analytical Testing Laboratory Sites,'' to 
the Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Send one self-addressed adhesive label to assist that office 
in processing your requests. Submit written comments on the guidance to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug 
Evaluation and Research (HFD-357), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5629.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``PAC-ATLS: Postapproval Changes--
Analytical Testing Laboratory Sites.'' This guidance is intended to 
ease the burden of notification, under certain circumstances, for 
analytical testing laboratory site changes currently requiring prior 
approval supplements under Sec. 314.70 (21 CFR 314.70). FDA regulations 
at Sec. 314.70(a) provide that applicants may make changes to an 
approved application in accordance with a guidance, notice, or 
regulation published in the Federal Register that provides for a less 
burdensome notification of the change (for example, by notification at 
the time a supplement is submitted or in the next annual report).
    This guidance for industry represents the agency's current thinking 
on postapproval changes in analytical testing laboratory sites. 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 statute, 
regulations, or both.
    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 21, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-11198 Filed 4-27-98; 8:45 am]
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