[Federal Register Volume 79, Number 50 (Friday, March 14, 2014)]
[Notices]
[Pages 14517-14518]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry on Allowable Excess Volume and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availability of a draft guidance for industry entitled ``Allowable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draft guidance before it begins work on the final version of the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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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