
[Federal Register Volume 79, Number 50 (Friday, March 14, 2014)]
[Notices]
[Pages 14517-14518]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0248]


Draft Guidance for Industry on Allowable Excess Volume and 
Labeled Vial Fill Size in Injectable Drug and Biological Products; 
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availability of a draft guidance for industry entitled ``Allowable 
Excess Volume and Labeled Vial Fill Size in Injectable Drug and 
Biological Products.'' This guidance clarifies the FDA requirements and 
regulations pertaining to allowable excess volume in injectable vials 
and reinforces the importance of appropriate packaging sizes for 
injectable drug \1\ and biological products.
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    \1\ The term drug used throughout this guidance refers to drugs 
and biological products.

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draft guidance before it begins work on the final version of the 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 either electronic or written comments on the draft 
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guidance by June 12, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 requests. 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Pallavi Nithyanandan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4171, Silver Spring, MD 20993-0002, 301-
796-7546, or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
Suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Allowable Excess Volume and Labeled Vial Fill Size in 
Injectable Drug and Biological Products.'' FDA is concerned that 
injectable vial misuse, including unsafe handling and injection 
techniques, has led to an increase in vial contamination and an 
increased risk of bloodborne illness transmission between patients. 
This guidance clarifies the FDA requirements and regulations pertaining 
to allowable excess volume in injectable vials and describes when 
justification is needed for a proposed excess volume in an injectable 
drug or biological product. This guidance also discusses the importance 
of appropriate packaging sizes for injectable drug and biological 
products and recommends that labeled vial fill sizes be appropriate for 
the use and dosing of the drug and biological product. This guidance 
specifically addresses fill and packaging issues for injectable drug 
and biological products packaged in vials and ampules.
    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 this topic. 
It does not create or confer any rights for or on any person and does

[[Page 14518]]

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 (the PRA) (44 U.S.C. 3501-
3520). The collection of information requested in the draft guidance is 
covered under FDA regulations at 21 CFR parts 312 and 314 and is 
approved under OMB Control Numbers 0910-0014 and 0910-0001. In 
accordance with the PRA, prior to publication of any final guidance 
document, FDA intends to solicit public comment and obtain OMB approval 
for any information collections recommended in this guidance that are 
new or that would represent material modifications to those previously 
approved collections of information found in FDA regulations or 
guidances.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

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

    Dated: March 11, 2014.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2014-05700 Filed 3-13-14; 8:45 am]
BILLING CODE 4160-01-P


