[Federal Register Volume 77, Number 70 (Wednesday, April 11, 2012)]
[Notices]
[Pages 21783-21784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0691]


Guidance on Media Fills for Validation of Aseptic Preparations 
for Positron Emission Tomography Drugs; 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 entitled ``Media Fills for Validation of 
Aseptic Preparations for Positron Emission Tomography (PET) Drugs.'' 
This guidance is intended to help manufacturers of PET drugs meet the 
requirements for the Agency's current good manufacturing practice 
regulations for PET drugs.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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. Send one self-addressed 
adhesive label to assist that office in processing your request. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, Center for Drug 
Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm. 
6164, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
3416.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``Media 
Fills for

[[Page 21784]]

Validation of Aseptic Preparations for Positron Emission Tomography 
(PET) Drugs.'' Most PET drugs are designed for parenteral 
administration and are produced by aseptic processing. The goal of 
aseptic processing is to make a product that is free of microorganisms 
and toxic microbial byproducts, such as bacterial endotoxins. The media 
fill is the performance of an aseptic manufacturing procedure using a 
sterile microbiological growth medium in place of the drug solution to 
test whether the aseptic procedures are adequate to prevent 
contamination during actual drug production. This guidance takes the 
form of questions and answers written specifically to help 
manufacturers comply with the Agency's current good manufacturing 
practices for PET drugs (21 CFR part 212) regarding media fills.
    A draft guidance of the same title was announced in the Federal 
Register on September 30, 2011 (76 FR 60847), and Docket No. FDA 2011-
D-0691 was open for comments until December 29, 2011. We received 
comments from industry and professional societies. We have carefully 
considered, and where appropriate, we have made corrections, added 
information, or clarified the information in this guidance in response 
to the comments or on our own initiative.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on media fills and process simulations for 
PET drugs. 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments 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. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
collections of information in 21 CFR part 212 have been approved under 
OMB control number 0910-0667.

IV. Electronic Access

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

    Dated: April 6, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-8702 Filed 4-10-12; 8:45 am]
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