Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications, 39449-39450 [2018-17044]
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Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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 guidance document.
FOR FURTHER INFORMATION CONTACT:
Richard Lostritto, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Avenue, Bldg. 51, Rm. 4132,
Silver Spring, MD 20993, 301–796–
1697.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Dissolution Testing and Acceptance
Criteria for Immediate-Release Solid
Oral Dosage Form Drug Products
Containing High Solubility Drug
Substances.’’ This guidance finalizes the
draft guidance for industry entitled
‘‘Dissolution Testing and Specification
Criteria for Immediate-Release Solid
Oral Dosage Forms Containing
Biopharmaceutics Classification System
Class 1 and 3 Drugs’’ (August 2015) (FR
80 46019), and the recommendations in
this guidance clarify the
recommendations in the guidance for
industry entitled ‘‘Dissolution Testing of
Immediate Release Solid Oral Dosage
Forms’’ (August 1997) (FR 62 44974) for
high solubility drug substances in IR
drug products that meet the conditions
described in section III of this guidance.
For drug substances that do not meet the
conditions in this guidance, sponsors/
applicants should follow the
recommendations provided in the
August 1997 guidance.
The title of this guidance has been
revised to better reflect its focus on the
solubility of the drug substance in the
drug product. Therefore, a direct
reference to biopharmaceutics
classification system class 1 and class 3
is not necessary because permeability
requirements are not within the focus of
this guidance.
Drug absorption from a solid dosage
form after oral administration depends
on the release of the drug substance
from the drug product, the dissolution
or solubilization of the drug under
physiological conditions, and the
permeation across the gastrointestinal
membrane. NDAs and ANDAs
submitted to FDA contain
bioavailability (BA) or bioequivalence
(BE) data and in vitro dissolution data
that, together with chemistry,
manufacturing, and controls data,
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characterize the quality and
performance of the drug product. In
vitro dissolution data are generally
obtained from: (1) Batches used in
pivotal clinical and/or BA/BE studies,
(2) batches used as stability registration
batches, and (3) batches used in other
human studies conducted during
product development. In general,
knowledge about the solubility,
permeability, dissolution, and
pharmacokinetics of a drug product is
considered when defining dissolution
acceptance criteria for the drug approval
process.
Immediate-release solid oral dosage
form drug products containing high
solubility drug substances are
considered to be relatively low risk
regarding the impact of dissolution on
in vivo performance, provided the in
vitro performance meets or exceeds the
recommendations discussed within this
guidance. This guidance establishes
standard dissolution methodology and
acceptance criteria that are appropriate
for highly soluble drug substances that
are formulated in IR dosage form. The
availability of these standards will
facilitate the rapid development of
dissolution methodology and related
acceptance criteria with no requirement
to show discriminatory ability of the
dissolution method for these products
during drug product development. In
addition, these standards will facilitate
FDA’s evaluation of the data submitted
in the application.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Dissolution Testing
and Acceptance Criteria for ImmediateRelease Solid Oral Dosage Form Drug
Products Containing High Solubility
Drug Substances.’’ 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. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
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 collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
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39449
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17025 Filed 8–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0180]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for the Collection of Quantitative Data
on Tobacco Products and
Communications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Fax written comments on the
collection of information by September
10, 2018.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0810. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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39450
Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
Generic Clearance for the Collection of
Quantitative Data on Tobacco Products
and Communications; OMB Control
Number 0910–0810—Extension
In order to conduct educational and
public information programs relating to
tobacco use as authorized by section
1003(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)), FDA’s Center for Tobacco
Products will create and use a variety of
media to inform and educate the public,
tobacco retailers, and health
professionals about the risks of tobacco
use, how to quit using tobacco products,
and FDA’s role in regulating tobacco.
To ensure that these health
communication messages have the
highest potential to be received,
understood, and accepted by those for
whom they are intended, the Center for
Tobacco Products will conduct research
and studies relating to the control and
prevention of disease. In conducting
such research, FDA will employ
formative pretests. Formative pretests
are conducted on a small scale, and
their focus is on developing and
assessing the likely effectiveness of
communications with specific target
audiences. This type of research
involves: (1) Assessing audience
knowledge, attitudes, behaviors, and
other characteristics for the purpose of
determining the need for and
developing health messages,
communication strategies, and public
information programs and (2) pretesting
these health messages, strategies, and
program components while they are in
developmental form to assess audience
comprehension, reactions, and
perceptions.
Formative pretesting is a staple of best
practices in communications research.
Obtaining voluntary feedback from
intended audiences during the
development of messages and materials
is crucial for the success of every
communication program. The purpose
of obtaining information from formative
pretesting is that it allows FDA to
improve materials and strategies while
revisions are still affordable and
possible. Formative pretesting can also
avoid potentially expensive and
dangerous unintended outcomes caused
by audiences’ interpreting messages in a
way that was not intended by the
drafters. By maximizing the
effectiveness of messages and strategies
for reaching targeted audiences, the
frequency with which tobacco
communication messages need to be
modified should be greatly reduced.
The voluntary information collected
will serve the primary purpose of
providing FDA information about the
perceived effectiveness of messages,
advertisements, and materials in
reaching and successfully
communicating with their intended
audiences. Quantitative testing
messages and other materials with a
sample of the target audience will allow
FDA to refine messages, advertisements,
and materials, including questionnaires
or images, directed at consumers while
the materials are still in the
developmental stage.
In the Federal Register of February
13, 2018 (83 FR 6190), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One PRA-related comment
was received.
Comment: The comment recommends
that FDA should research and develop
communications about educating adults
about the continuum of risk, and
educating adults to not provide tobacco
products to youth.
Response: FDA appreciates the
comment. The content and focus on
studies submitted through this generic
clearance will depend on Agency
priorities and needs, and is not yet
determined at this time.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Screener ...............................................................................
130,500
1
130,500
Self-Administered Surveys ...................................................
27,000
1
27,000
Total ..............................................................................
........................
........................
........................
1 There
Total hours
0.083 (5
minutes)
0.33 (20
minutes)
10,831
........................
19,741
8,910
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents to be
included in each new survey will vary,
depending on the nature of the material
or message being tested and the target
audience. The burden for this
information collection extension is
proposed to increase by 12,613 hours
since the last OMB approval. The
burden increase is due to an increase in
the number of respondents and the
categories of respondents.
sradovich on DSK3GMQ082PROD with NOTICES
Average
burden per
response
Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2495]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary Labeling
Indicating Whether Foods Have or
Have Not Been Derived From
Genetically Engineered Plants
AGENCY:
Food and Drug Administration,
HHS.
Notice.
[FR Doc. 2018–17044 Filed 8–8–18; 8:45 am]
ACTION:
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SUMMARY:
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18:11 Aug 08, 2018
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
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comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection associated with the guidance
to assist manufacturers who wish to
voluntarily label their foods (human and
animal) as being made with or without
bioengineering, or the use of
bioengineered ingredients, to ensure
that labeling is truthful and not
misleading.
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]]>Agencies
[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Notices]
[Pages 39449-39450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17044]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0180]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
the Collection of Quantitative Data on Tobacco Products and
Communications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
September 10, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0810.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
[[Page 39450]]
Generic Clearance for the Collection of Quantitative Data on Tobacco
Products and Communications; OMB Control Number 0910-0810--Extension
In order to conduct educational and public information programs
relating to tobacco use as authorized by section 1003(d)(2)(D) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA's
Center for Tobacco Products will create and use a variety of media to
inform and educate the public, tobacco retailers, and health
professionals about the risks of tobacco use, how to quit using tobacco
products, and FDA's role in regulating tobacco.
To ensure that these health communication messages have the highest
potential to be received, understood, and accepted by those for whom
they are intended, the Center for Tobacco Products will conduct
research and studies relating to the control and prevention of disease.
In conducting such research, FDA will employ formative pretests.
Formative pretests are conducted on a small scale, and their focus is
on developing and assessing the likely effectiveness of communications
with specific target audiences. This type of research involves: (1)
Assessing audience knowledge, attitudes, behaviors, and other
characteristics for the purpose of determining the need for and
developing health messages, communication strategies, and public
information programs and (2) pretesting these health messages,
strategies, and program components while they are in developmental form
to assess audience comprehension, reactions, and perceptions.
Formative pretesting is a staple of best practices in
communications research. Obtaining voluntary feedback from intended
audiences during the development of messages and materials is crucial
for the success of every communication program. The purpose of
obtaining information from formative pretesting is that it allows FDA
to improve materials and strategies while revisions are still
affordable and possible. Formative pretesting can also avoid
potentially expensive and dangerous unintended outcomes caused by
audiences' interpreting messages in a way that was not intended by the
drafters. By maximizing the effectiveness of messages and strategies
for reaching targeted audiences, the frequency with which tobacco
communication messages need to be modified should be greatly reduced.
The voluntary information collected will serve the primary purpose
of providing FDA information about the perceived effectiveness of
messages, advertisements, and materials in reaching and successfully
communicating with their intended audiences. Quantitative testing
messages and other materials with a sample of the target audience will
allow FDA to refine messages, advertisements, and materials, including
questionnaires or images, directed at consumers while the materials are
still in the developmental stage.
In the Federal Register of February 13, 2018 (83 FR 6190), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One PRA-related comment was received.
Comment: The comment recommends that FDA should research and
develop communications about educating adults about the continuum of
risk, and educating adults to not provide tobacco products to youth.
Response: FDA appreciates the comment. The content and focus on
studies submitted through this generic clearance will depend on Agency
priorities and needs, and is not yet determined at this time.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Screener........................ 130,500 1 130,500 0.083 (5 10,831
minutes)
Self-Administered Surveys....... 27,000 1 27,000 0.33 (20 8,910
minutes)
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 19,741
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The number of respondents to be included in each new survey will
vary, depending on the nature of the material or message being tested
and the target audience. The burden for this information collection
extension is proposed to increase by 12,613 hours since the last OMB
approval. The burden increase is due to an increase in the number of
respondents and the categories of respondents.
Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17044 Filed 8-8-18; 8:45 am]
BILLING CODE 4164-01-P
