[Federal Register Volume 76, Number 190 (Friday, September 30, 2011)]
[Notices]
[Pages 60847-60848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25196]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance on Media Fills for Validation of Aseptic 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availability of a draft guidance entitled ``Media Fills for Validation 
of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.'' 
This draft guidance is intended to help manufacturers of PET drugs meet 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: 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

[[Page 60848]]

guidance before it begins work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
December 29, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. Send 
one self-addressed adhesive label to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6155, Silver Spring, MD 20993-0002, 301-
796-3416.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Media Fills for 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 micro-
organisms and toxic microbial byproducts, most notably 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 draft 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 (part 212 (21 CFR part 212)) 
regarding media fills.
    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 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. It is no 
longer necessary to send two copies of mailed 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 draft 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 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: September 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25196 Filed 9-29-11; 8:45 am]
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