Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration, 27492-27493 [2017-12446]
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27492
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
State Petitions for Exemption From
Preemption—21 CFR 100.1(d)
OMB Control Number 0910–0277—
Extension
Under section 403A(b) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 343–1(b)), States
may petition FDA for exemption from
Federal preemption of State food
labeling and standard-of-identity
requirements. Section 100.1(d) (21 CFR
100.1(d)) sets forth the information a
State is required to submit in such a
petition. The information required
under § 100.1(d) enables FDA to
determine whether the State food
labeling or standard-of-identity
requirement satisfies the criteria of
section 403A(b) of the FD&C Act for
granting exemption from Federal
preemption.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR 100.1(d)
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total
hours
Form of petition ....................................................................
1
1
1
40
40
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for § 100.1(d) is
minimal because petitions for
exemption from preemption are seldom
submitted by States. In the last 3 years,
we have received one new petition for
exemption from preemption; therefore,
we estimate that one or fewer petitions
will be submitted annually.
Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12445 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2683]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Data To Support
Social and Behavioral Research as
Used by the Food and Drug
Administration
AGENCY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Food and Drug Administration,
pmangrum on DSK3GDR082PROD with NOTICES
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:
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
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—NEW and
‘‘Data to Support Social and Behavioral
Research as Used by the Food and Drug
Administration.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
HHS.
ACTION:
Fax written comments on the
collection of information by July 17,
2017.
DATES:
Data To Support Social and Behavioral
Research as Used by the Food and Drug
Administration—OMB Control Number
0910—NEW
Understanding patients, consumers,
and health care professionals’
perceptions and behaviors plays an
important role in improving FDA’s
regulatory decisionmaking processes
and communications impacting various
stakeholders. The methods to be
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employed to achieve these goals include
individual indepth interviews, general
public focus group interviews, intercept
interviews, self-administered surveys,
gatekeeper surveys, and focus group
interviews. The methods to be used
serve the narrowly defined need for
direct and informal opinion on a
specific topic and as a qualitative and
quantitative research tool, and have two
major purposes:
(1) To obtain information that is
useful for developing variables and
measures for formulating the basic
objectives of social and behavioral
research; and
(2) To assess the potential
effectiveness of FDA communications,
behavioral interventions, and other
materials in reaching and successfully
communicating and addressing
behavioral change with their intended
audiences.
FDA will use these methods to test
and refine its ideas and to help develop
communication and behavioral
strategies research, but will generally
conduct further research before making
important decisions such as adopting
new policies and allocating or
redirecting significant resources to
support these policies.
FDA’s Center for Drug Evaluation and
Research, Center for Biologics
Evaluation and Research, Office of the
Commissioner, and potentially other
Agency components will use this
mechanism to test communications and
social and behavioral methods about
regulated drug products on a variety of
subjects related to consumer, patient, or
health care professional perceptions,
beliefs, attitudes, behaviors, and use of
E:\FR\FM\15JNN1.SGM
15JNN1
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
drug and biological products and related
materials, including, but not limited to,
social and behavioral research,
decisionmaking processes, and
communication and behavioral change
strategies.
Annually, FDA estimates about 45
social and behavioral studies using the
variety of test methods listed in this
document. FDA is requesting this
burden so as not to restrict the Agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
In the Federal Register of September
19, 2016 (81 FR 64166), FDA published
a 60-day notice requesting public
27493
comment on the proposed extension of
this collection of information. No
comments were received in response to
the notice.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Interviews/Surveys .....................................................
1 There
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0329]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Fees for Human Drug
Compounding Outsourcing Facilities
Under the Federal Food, Drug, and
Cosmetic Act
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
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 in the guidance on Fees for
Human Drug Compounding Outsourcing
Facilities Under the Federal Food, Drug,
and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by August 14, 2017.
SUMMARY:
pmangrum on DSK3GDR082PROD with NOTICES
14.6
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 14,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 14, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
ADDRESSES:
[FR Doc. 2017–12446 Filed 6–14–17; 8:45 am]
ACTION:
2,520
Average
burden per
response
Total annual
responses
36,792
0.25 (15 minutes) ....
Total hours
9,198
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
AGENCY:
Number of
responses per
respondent
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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’’).
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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–
2014–D–0329 for ‘‘Guidance for
Industry on Fees for Human Drug
Compounding Outsourcing Facilities
Under Sections 503B and 744K of the
Federal Food, Drug, and Cosmetic Act.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://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
E:\FR\FM\15JNN1.SGM
15JNN1
]]>Agencies
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27492-27493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12446]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2683]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Data To Support
Social and Behavioral Research as Used by the Food and Drug
Administration
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 July
17, 2017.
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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910--NEW and
``Data to Support Social and Behavioral Research as Used by the Food
and Drug Administration.'' Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
PRAStaff@fda.hhs.gov.
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.
Data To Support Social and Behavioral Research as Used by the Food and
Drug Administration--OMB Control Number 0910--NEW
Understanding patients, consumers, and health care professionals'
perceptions and behaviors plays an important role in improving FDA's
regulatory decisionmaking processes and communications impacting
various stakeholders. The methods to be employed to achieve these goals
include individual indepth interviews, general public focus group
interviews, intercept interviews, self-administered surveys, gatekeeper
surveys, and focus group interviews. The methods to be used serve the
narrowly defined need for direct and informal opinion on a specific
topic and as a qualitative and quantitative research tool, and have two
major purposes:
(1) To obtain information that is useful for developing variables
and measures for formulating the basic objectives of social and
behavioral research; and
(2) To assess the potential effectiveness of FDA communications,
behavioral interventions, and other materials in reaching and
successfully communicating and addressing behavioral change with their
intended audiences.
FDA will use these methods to test and refine its ideas and to help
develop communication and behavioral strategies research, but will
generally conduct further research before making important decisions
such as adopting new policies and allocating or redirecting significant
resources to support these policies.
FDA's Center for Drug Evaluation and Research, Center for Biologics
Evaluation and Research, Office of the Commissioner, and potentially
other Agency components will use this mechanism to test communications
and social and behavioral methods about regulated drug products on a
variety of subjects related to consumer, patient, or health care
professional perceptions, beliefs, attitudes, behaviors, and use of
[[Page 27493]]
drug and biological products and related materials, including, but not
limited to, social and behavioral research, decisionmaking processes,
and communication and behavioral change strategies.
Annually, FDA estimates about 45 social and behavioral studies
using the variety of test methods listed in this document. FDA is
requesting this burden so as not to restrict the Agency's ability to
gather information on public sentiment for its proposals in its
regulatory and communications programs.
In the Federal Register of September 19, 2016 (81 FR 64166), FDA
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received
in response to the notice.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys........................... 2,520 14.6 36,792 0.25 (15 minutes)........................ 9,198
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12446 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P
