81 FR 39673 - Quality Attribute Considerations for Chewable Tablets; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 117 (June 17, 2016)

Page Range		39673-39675
FR Document		2016-14354

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Quality Attribute Considerations for Chewable Tablets.'' This guidance describes the Agency's thinking on the critical quality attributes that should be assessed when developing a chewable tablet dosage form and recommends that the selected acceptance criteria be appropriate and meaningful indicators of product performance throughout the shelf life of the product.

Federal Register, Volume 81 Issue 117 (Friday, June 17, 2016)

[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39673-39675]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-14354]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1490]

Quality Attribute Considerations for Chewable Tablets; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Quality
Attribute Considerations for Chewable Tablets.'' This guidance
describes the

[[Page 39674]]

Agency's thinking on the critical quality attributes that should be
assessed when developing a chewable tablet dosage form and recommends
that the selected acceptance criteria be appropriate and meaningful
indicators of product performance throughout the shelf life of the
product.

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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 16, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-1490 for ``Quality Attribute Considerations for Chewable
Tablets.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, 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.

FOR FURTHER INFORMATION CONTACT: Nallaperumal Chidambaram, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3112, Silver Spring, MD 20993-0002, 301-
796-1339.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Quality Attribute Considerations for Chewable Tablets.''
Chewable tablets are an immediate release oral dosage form intended to
be chewed and then swallowed by the patient, rather than swallowed
whole. They should be designed to have a pleasant taste and be easily
chewed and swallowed. Chewable tablets should be safe and easy to use
in a diverse patient population, pediatric, adults, or elderly
patients, who are unable or unwilling to swallow intact tablets due to
the size of the tablet or difficulty with swallowing. In addition,
certain tablets must be chewed before swallowing to avoid choking and
to ensure the release of the active ingredient. The availability of
safe, easy-to-use dosage forms is important in clinical practice, and
chewable tablet formulations are available as both over-the-counter and
prescription drug products.
A review of numerous applications for chewable tablet drug products
revealed that in certain cases, critical quality attributes such as
hardness, disintegration, and dissolution were not given as much
consideration as may have been warranted. This draft guidance describes
the critical quality attributes that should be assessed when developing
a chewable tablet dosage form. No single quality characteristic should
be considered sufficient to control the performance of a chewable
tablet. Instead, the goal should be to develop the proper combination
of these attributes to ensure the performance of the chewable tablet
for its intended use.
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 current thinking of FDA on Quality
Attribute Considerations for Chewable Tablets. It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

[[Page 39675]]

II. The 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
collection of information in investigational new drug applications is
approved under OMB control number 0910-0014; the collection of
information (including prescription drug labeling) in new drug
applications and abbreviated new drug applications, as well as
supplements to these applications, is approved under OMB control number
0910-0001; the collection of biologics license applications is approved
under OMB control number 0910-0338; and the format and content of
prescription drug labeling is approved under OMB control number 0910-
0572.

III. Electronic Access

Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14354 Filed 6-16-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39675

II. The Paperwork Reduction Act of DATES: Fax written comments on the information collected is integral to that
1995 collection of information by July 18, evaluation.
2016. FDA is in the process of conducting
This draft guidance refers to three studies to evaluate the
previously approved collections of ADDRESSES: To ensure that comments on
the information collection are received, effectiveness of its youth tobacco
information found in FDA regulations. prevention campaigns: (1) An outcome
These collections of information are OMB recommends that written
comments be faxed to the Office of evaluation study of its General Market
subject to review by the Office of Youth Tobacco Prevention Campaign,
Management and Budget (OMB) under Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX: (2) an outcome evaluation of the Rural
the Paperwork Reduction Act of 1995 Male Youth Smokeless Tobacco
(44 U.S.C. 3501–3520). The collection of 202–395–7285, or emailed to oira_
submission@omb.eop.gov. All Campaign, and (3) a media tracking
information in investigational new drug survey. The timing of these studies
applications is approved under OMB comments should be identified with the
OMB control number 0910–0753. Also follows the multiple, discrete waves of
control number 0910–0014; the media advertising planned for the
collection of information (including include the FDA docket number found
in brackets in the heading of this campaigns.
prescription drug labeling) in new drug
applications and abbreviated new drug document. Evaluation of the General Market Youth
applications, as well as supplements to FOR FURTHER INFORMATION CONTACT: FDA Tobacco Prevention Campaign
these applications, is approved under PRA Staff, Office of Operations, Food The General Market Youth Tobacco
OMB control number 0910–0001; the and Drug Administration, 8455 Prevention Campaign targets youth who
collection of biologics license Colesville Rd., COLE–14526, Silver are at-risk for smoking, or who have
applications is approved under OMB Spring, MD 20993–0002, PRAStaff@ experimented with but not progressed to
control number 0910–0338; and the fda.hhs.gov. regular smoking. The outcome
format and content of prescription drug SUPPLEMENTARY INFORMATION: In evaluation of the campaign consists of
labeling is approved under OMB control compliance with 44 U.S.C. 3507, FDA an initial baseline survey of youth aged
number 0910–0572. has submitted the following proposed 11 to 16 before campaigns launch,
collection of information to OMB for followed by a number of longitudinal
III. Electronic Access
review and clearance. follow-up surveys of the same youth at
Persons with access to the Internet approximate 8 month intervals. To date,
Evaluation of FDA’s General Market the baseline and three follow-up surveys
may obtain the draft guidance at either
Youth Tobacco Prevention have been conducted. A baseline survey
http://www.fda.gov/Drugs/
Campaigns—OMB Control Number was also conducted with the parent or
GuidanceCompliance
0910–0753—Revision legal guardian of each youth, to collect
RegulatoryInformation/Guidances/
default.htm or http:// The 2009 Family Smoking Prevention data on household characteristics and
www.regulations.gov. and Tobacco Control Act (Tobacco media use. Because the cohort aged over
Control Act) (Pub. L. 111–31) amends the study period, data have been
Dated: June 13, 2016.
the Federal Food, Drug, and Cosmetic collected from youth aged 11 to 18.
Leslie Kux, Act (the FD&C Act) to grant FDA Information has been collected about
Associate Commissioner for Policy. authority to regulate the manufacture, youth awareness of and exposure to
[FR Doc. 2016–14354 Filed 6–16–16; 8:45 am] marketing, and distribution of tobacco campaign advertisements and about
BILLING CODE 4164–01–P products to protect public health and to youth knowledge, attitudes, and beliefs
reduce tobacco use by minors. Section related to tobacco use. In addition, the
1003(d)(2)(D) of the FD&C Act (21 surveys have measured tobacco use
DEPARTMENT OF HEALTH AND U.S.C. 393(d)(2)(D)) supports the susceptibility and current use.
HUMAN SERVICES development and implementation of Information has been collected on
FDA public education campaigns demographic variables including age,
Food and Drug Administration related to tobacco use. Accordingly, sex, race/ethnicity, grade level, and
FDA is currently developing and primary language.
[Docket No. FDA–2013–N–0717] implementing youth-targeted public
education campaigns to help prevent Evaluation of the Rural Male Youth
Agency Information Collection tobacco use among youth and thereby Smokeless Tobacco Campaign
Activities; Submission for Office of reduce the public health burden of Baseline data collection for the Rural
Management and Budget Review; tobacco. The campaigns feature Male Youth Smokeless Campaign
Comment Request; Evaluation of the televised advertisements along with evaluation will begin in January 2016.
Food and Drug Administration’s complementary ads on radio, on the The three follow up surveys will begin
General Market Youth Tobacco Internet, in print, and through other in August 2016, March 2017, and
Prevention Campaigns forms of media. October 2017. The evaluation of the
Evaluation is an essential Rural Male Youth Smokeless Campaign
AGENCY: Food and Drug Administration, organizational practice in public health differs from the General Market
HHS. and a systematic way to account for and Campaign evaluation, in that only males
ACTION: Notice. improve public health actions. in the age range will be considered
Comprehensive evaluation of FDA’s
sradovich on DSK3TPTVN1PROD with NOTICES

eligible.
SUMMARY: The Food and Drug public education campaigns will be
Administration (FDA) is announcing used to document whether the intended Media Tracking Survey
that a proposed collection of audience is aware of and understands The media tracking survey consists of
information has been submitted to the campaign messages; and whether assessments of youth aged 13 to 18
Office of Management and Budget campaign exposure influences beliefs conducted periodically during the
(OMB) for review and clearance under about tobacco, susceptibility to tobacco campaign period. The tracking survey
the Paperwork Reduction Act of 1995. use, and tobacco use behavior. All of the assesses awareness of the campaign and

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Document Created: 2016-06-17 01:05:22
Document Modified: 2016-06-17 01:05:22

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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 August 16, 2016.
Contact		Nallaperumal Chidambaram, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3112, Silver Spring, MD 20993-0002, 301- 796-1339.
FR Citation		81 FR 39673

81 FR 39673 - Quality Attribute Considerations for Chewable Tablets; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 117 (June 17, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration