[Federal Register Volume 78, Number 237 (Tuesday, December 10, 2013)]
[Notices]
[Page 74154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29395]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1434]
Draft Guidance for Industry on Size, Shape, and Other Physical
Attributes of Generic Tablets and Capsules; 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availability of a draft guidance for industry entitled ``Size, Shape,
and Other Physical Attributes of Generic Tablets and Capsules.'' This
guidance discusses FDA recommendations for the size, shape, and other
physical attributes of generic tablets intended to be swallowed intact.
FDA is concerned that these characteristics of generic drugs are too
varied compared to the originator drug and could affect patient
outcomes.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 10, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Debra Catterson, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 11919
Rockville Pike, Rockville, MD 20852, 240-402-3861; or Vilayat Sayeed,
Center for Drug Evaluation and Research (HFD-630), Food and Drug
Administration, 7520 Standish Pl., Rockville, MD 20855, 240-276-8486.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Size, Shape, and Other Physical Attributes of Generic
Tablets and Capsules.'' FDA is concerned that the differences in size,
shape, and other physical characteristics between the generic and the
originator could adversely affect patient outcomes. For example,
studies show that tablet size can affect ease of swallowing, and
generic tablets that are significantly larger than their corresponding
reference drug product may be more difficult to swallow, leading to
potential adverse events as well as noncompliance with treatment
regimens. FDA is recommending generic manufacturers consider the size,
shape, and other physical characteristics of the originator drug when
developing a generic version.
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 tablet size,
shape, and other physical attributes of generic solid oral dosage
forms. 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 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 314 and approved under OMB
control number 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
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: December 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29395 Filed 12-9-13; 8:45 am]
BILLING CODE 4160-01-P