Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration, 72369-72370 [2019-28247]
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72369
Federal Register / Vol. 84, No. 250 / Tuesday, December 31, 2019 / Notices
Section 830.360 requires each labeler
to retain records showing all UDIs used
to identify devices that must be labeled
with a UDI and the particular version or
model associated with each device
identifier, until 3 years after it ceases to
market a version or model of a device.
Respondents who are required to
submit data to the Agency under certain
other approved information collections
(listed below) are required to include
UDI data elements for the device that is
the subject of such information
collection. Addition of the UDI data
elements is included in this burden
estimate for the conforming
amendments in the following 21 CFR
parts:
Part 803—Medical Device Reporting
(OMB control number 0910–0437),
Part 806—Medical Devices; Reports of
Corrections and Removals (OMB control
number 0910–0359),
Part 814—Premarket Approval of
Medical Devices (OMB control number
0910–0231),
Part 820—Quality System Regulation
(OMB control number 0910–0073),
Part 821—Medical Device Tracking
Requirements (OMB control number
0910–0442), and
Part 822—Postmarket Surveillance
(OMB control number 0910–0449).
In the Federal Register of July 31,
2019 (84 FR 37315), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL BURDEN
Number of
respondents 1
Reporting ..........................................................................
Recordkeeping .................................................................
Third-Party Disclosure ......................................................
Number of
responses per
respondent 2
6,199
5,987
5,987
51
51
51
Total annual
responses 3
316,149
305,337
305,337
Average burden
per response 4
0.023 (1 minute) .........
0.989 (59 minutes) .....
0.885 (53 minutes) .....
Total
hours 5
7,289
302,121
270,143
Total capital
costs and
operating and
maintenance
costs
$425,000
14,733,333
13,033,333
1 Maximum number of respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may involve fewer
respondents.
2 Maximum number of responses for any regulatory requirement within each category. Individual regulatory requirements within the category may involve fewer responses.
3 Maximum total annual responses for any regulatory requirement within each category. Individual regulatory requirements within the category may involve fewer
total annual responses.
4 Rounded to three decimals. Total hours reflects a more precise, non-rounded average burden per response. An approximate (non-rounded) conversion to minutes
is shown in parentheses.
5 Total hours is based on a more precise burden per response than the rounded value show in this table.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–28246 Filed 12–30–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3586]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Focus Groups
About Drug Products as Used by the
Food and Drug Administration
AGENCY:
Food and Drug Administration,
khammond on DSKJM1Z7X2PROD with NOTICES
The Food and Drug
Administration (FDA or Agency) 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
(PRA).
SUMMARY:
18:32 Dec 30, 2019
Focus Groups About Drug Products as
Used by the Food and Drug
Administration
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 0910–0677. Also
include the FDA docket number found
in brackets in the heading of this
document.
OMB Control Number 0910–0677—
Extension
Focus groups provide an important
role in gathering information because
they allow for a more indepth
understanding of individuals’ attitudes,
beliefs, motivations, and feelings than
do quantitative studies. Focus groups
serve the narrowly defined need for
direct and informal opinion on a
specific topic and, as a qualitative
research tool, have three major
purposes:
• To obtain information that is useful
for developing variables and measures
for quantitative studies;
• to better understand people’s
attitudes and emotions in response to
topics and concepts; and
• to further explore findings obtained
from quantitative studies.
We use information gathered from
focus group findings to test and refine
ideas and to help develop messages and
other communications, 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.
Our Center for Drug Evaluation and
Research, as well as other Agency
components, engage focus groups about
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, 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:
Notice.
VerDate Sep<11>2014
Fax written comments on the
collection of information by January 30,
2020.
FOR FURTHER INFORMATION CONTACT:
HHS.
ACTION:
DATES:
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72370
Federal Register / Vol. 84, No. 250 / Tuesday, December 31, 2019 / Notices
regulated drug products on a variety of
topics related to consumer, patient, or
healthcare professional perceptions and
use of drug products and related
materials. These materials may include,
but are not limited to direct-toconsumer prescription drug promotion,
physician labeling of prescription drugs,
medication guides, over-the-counter
drug labeling, emerging risk
communications, patient labeling,
online sales of medical products, and
consumer and professional education.
In the Federal Register of July 17,
2019 (84 FR 34186), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
Annually, we project that 20 studies
will be initiated using 160 focus groups
with an average of 9 persons per group.
We assume each focus group will last an
average of 1.75 hours.
We estimate the burden for the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Focus Group Study ..............................................................
1,440
1
1,440
1.75
2,520
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: December 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–28247 Filed 12–30–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5955]
International Drug Scheduling;
Convention on Psychotropic
Substances; Single Convention on
Narcotic Drugs; World Health
Organization; Scheduling
Recommendations; AB-FUBINACA; 5FAMB-PINACA; 5F-MDMB-PICA; 4-FMDMB-BINACA; 4-CMC; Nethylhexedrone; alpha-PHP; DOC;
Crotonyl Fentanyl; Valeryl Fentanyl;
Flualprazolam and Etizolam; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is providing
interested persons with the opportunity
to submit written comments concerning
recommendations by the World Health
Organization (WHO) to impose
international manufacturing and
distributing restrictions, under
international treaties, on certain drug
substances. The comments received in
response to this notice will be
considered in preparing the United
States’ position on these proposals for a
meeting of the United Nations
Commission on Narcotic Drugs (CND) in
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:30 Dec 30, 2019
Jkt 250001
Vienna, Austria, in March 2020. This
notice is issued under the Controlled
Substances Act (CSA).
DATES: Submit either electronic or
written comments by January 30, 2020.
The short time period for the
submission of comments is needed to
ensure that Health and Human Services
(HHS) may, in a timely fashion, carry
out the required action and be
responsive to the United Nations.
ADDRESSES: 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 January 30,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 30, 2020.
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.
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
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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’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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-2019N-5955 for ‘‘International Drug
Scheduling; Convention on
Psychotropic Substances; Single
Convention on Narcotic Drugs; World
Health Organization; Scheduling
Recommendations; AB-FUBINACA; 5FAMB-PINACA; 5F-MDMB-PICA; 4-FMDMB-BINACA; 4-CMC; Nethylhexedrone; alpha-PHP; DOC;
Crotonyl Fentanyl; Valeryl Fentanyl;
Flualprazolam and Etizolam; Request
for Comments.’’ 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 Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
E:\FR\FM\31DEN1.SGM
31DEN1
Agencies
[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Notices]
[Pages 72369-72370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28247]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-3586]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Focus Groups About
Drug Products as Used by the Food and Drug Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 (PRA).
DATES: Fax written comments on the collection of information by January
30, 2020.
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 0910-0677.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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.
Focus Groups About Drug Products as Used by the Food and Drug
Administration
OMB Control Number 0910-0677--Extension
Focus groups provide an important role in gathering information
because they allow for a more indepth understanding of individuals'
attitudes, beliefs, motivations, and feelings than do quantitative
studies. Focus groups serve the narrowly defined need for direct and
informal opinion on a specific topic and, as a qualitative research
tool, have three major purposes:
To obtain information that is useful for developing
variables and measures for quantitative studies;
to better understand people's attitudes and emotions in
response to topics and concepts; and
to further explore findings obtained from quantitative
studies.
We use information gathered from focus group findings to test and
refine ideas and to help develop messages and other communications, 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.
Our Center for Drug Evaluation and Research, as well as other
Agency components, engage focus groups about
[[Page 72370]]
regulated drug products on a variety of topics related to consumer,
patient, or healthcare professional perceptions and use of drug
products and related materials. These materials may include, but are
not limited to direct-to-consumer prescription drug promotion,
physician labeling of prescription drugs, medication guides, over-the-
counter drug labeling, emerging risk communications, patient labeling,
online sales of medical products, and consumer and professional
education.
In the Federal Register of July 17, 2019 (84 FR 34186), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
Annually, we project that 20 studies will be initiated using 160
focus groups with an average of 9 persons per group. We assume each
focus group will last an average of 1.75 hours.
We estimate the burden for the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus Group Study.................................................. 1,440 1 1,440 1.75 2,520
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: December 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28247 Filed 12-30-19; 8:45 am]
BILLING CODE 4164-01-P