
[Federal Register Volume 78, Number 237 (Tuesday, December 10, 2013)]
[Notices]
[Page 74154]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry on Size, Shape, and Other Physical 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availability of a draft guidance for industry entitled ``Size, Shape, 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 10, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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


