[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45454-45455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17855]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0391]


Draft Guidance for Industry on Submission of Documentation in 
Applications for Parametric Release of Human and Veterinary Drug 
Products Terminally Sterilized by Moist Heat Processes; 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availability of a draft guidance for industry entitled ``Submission of 
Documentation in Applications for Parametric Release of Human and 
Veterinary Drug Products Terminally Sterilized by Moist Heat 
Processes.'' This draft guidance provides recommendations to applicants 
on information to include in support of parametric release for sterile 
products terminally sterilized by moist heat when submitting a new drug 
application (NDA), abbreviated new drug application (ANDA), new animal 
drug application (NADA), abbreviated new animal drug application 
(ANADA), or biologics license application (BLA).

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 October 6, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; the 
Communications Staff (HFV-12), Center for Veterinary Medicine, 7519 
Standish Pl., Rockville, MD 20855; the Office of Communication, 
Training, and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448. 
The draft guidance may also be obtained by mail by calling CBER at 1-
800-835-4709 or 301-827-1800. Send one self-addressed 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on the draft guidance to the Division of Dockets Management (HFA-305), 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 http://www.regulations.gov. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Marla Stevens-Riley, Center for Drug Evaluation and Research (HFD-
600), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855, 240-276-9310;
    Deborah Trout, Center for Biologics Evaluation and Research (HFM-
675), Food and Drug Administration, 8800 Rockville Pike, Rockville, MD 
20892, 301-827-3031; or
    Mai Huynh, Center for Veterinary Medicine (HFV-142), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8273.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Submission of Documentation in Applications for Parametric 
Release of Human and Veterinary Drug Products Terminally Sterilized by 
Moist Heat Processes.'' The draft guidance addresses the information 
that should be submitted in an approved new drug application (NDA), 
abbreviated new drug application (ANDA), new animal drug application 
(NADA), abbreviated new animal drug application (ANADA), or biologics 
license application (BLA) in support of parametric release for sterile 
products terminally sterilized by moist heat.
    ``Parametric release'' is defined as a sterility assurance release 
program where demonstrated control of the sterilization process enables 
a firm to use defined critical process controls, in lieu of the 
sterility test, to fulfill the intent of 21 CFR 211.167(a). Under this 
strategy, market release of terminally sterilized products can be based 
upon meeting the defined sterilization parameters and not on performing 
an approved sterility test. Meeting the requirements of the parametric 
release process can provide greater assurance that a batch meets the 
sterility requirement than can be achieved with a sterility test of 
finished units drawn from the batch.
    Parametric release allows manufacturers to replace sterility 
testing of samples drawn from the finished product as a release 
criterion with acceptance criteria for the control of identified 
process parameters. Parametric release of the batch is then based on 
documented evidence of the control of critical parameters, removing the 
need for testing of samples drawn from the finished product.
    An application to FDA is required to obtain approval for parametric 
release. The approval of parametric release is based on an assessment 
of the applicant's proposed critical process parameters and how they 
are controlled. Demonstrated reliability of the production terminal 
sterilization cycle, microbiological control and monitoring, and 
control of production cycle parameters within established validated 
limits is part of this assessment.
    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 inclusion of 
recommended

[[Page 45455]]

information to support applications for parametric release of human and 
veterinary drug products terminally sterilized by moist heat processes. 
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. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information requested in the draft guidance is covered 
under FDA regulations at 21 CFR 314.50, 314.70, and 314.81(b)(2) for 
human drugs, 21 CFR 514.1, 514.8, 514.8(b)(4) and (c) for animal drugs, 
and 21 CFR 601.2 and 601.12 for biologics. The collection of 
information is approved under the following OMB control numbers: 0910-
0001 for human drugs, 0910-0600 for animal drugs, and 0910-0338 for 
biologics.

III. 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments and submissions will be accepted by FDA 
only through FDMS at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.regulations.gov.

    Dated: July 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17855 Filed 8-4-08; 8:45 am]
BILLING CODE 4160-01-S