Notice: 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

Federal Register: February 26, 2010 (Volume 75, Number 38)             
                  Page 8970-8971

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a 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 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: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the 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, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), 1401 
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that office in processing your requests. The 
guidance may also be obtained by mail by calling CBER at 1-800-835-4709 
or 301-827-1800. Submit written comments on the 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 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, or
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852, 301-827-6210; 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 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 guidance addresses the information that 
should be submitted in an NDA, ANDA, NADA, ANADA, or 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. FDA conducts scientific evaluation 
of the parametric release program as part of a cooperative effort 
between FDA product reviewers and the compliance program.

[[Page 8971]]

    On August 5, 2008 (73 FR 45454), FDA announced the availability of 
the draft version of this guidance. The public comment period closed on 
October 6, 2008. A number of comments were received, which the agency 
considered carefully as it finalized the guidance and made appropriate 
changes. Most of the changes to the guidance were made to clarify 
statements in the draft guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
agency's current thinking on inclusion of recommended 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 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 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/default.htm, or http://
www.regulations.gov.

    Dated: February 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3978 Filed 2-25-10; 8:45 am]
BILLING CODE 4160-01-S