Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration-Regulated Products), 51450-51451 [2020-18243]
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51450
Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
Customer/Partner Service Surveys
OMB Control Number 0910–0360—
Extension
Under section 1003 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393), FDA is authorized to conduct
research and public information
programs about regulated products and
responsibilities of the Agency.
Executive Order 12862, entitled ‘‘Setting
Customer Service Standard,’’ directs
Federal Agencies that ‘‘provide
significant services directly to the
public’’ to ‘‘survey customers to
determine the kind and quality of
services they want and their level of
satisfaction with existing services.’’ FDA
is seeking extension of an existing OMB
clearance to conduct a series of surveys
to implement Executive Order 12862.
Participation in the surveys is
voluntary. This request covers
customer/partner service surveys of
regulated entities, such as food
processors; cosmetic, drug, biologic, and
medical device manufacturers;
consumers; and health professionals.
The request also covers ‘‘partner’’ (State
and local governments) customer
service surveys.
FDA will use the information from
these surveys to identify strengths and
weaknesses in service to customers/
partners and to make improvements.
The surveys will measure timeliness,
appropriateness and accuracy of
information, courtesy, and problem
resolution in the context of individual
programs.
FDA estimates conducting 15
customer/partner service surveys per
year, each requiring an average of 15
minutes for review and completion. We
estimate respondents to these surveys to
be between 100 and 20,000 customers.
Some of these surveys will be repeats of
earlier surveys for purposes of
monitoring customer/partner service
and developing long-term data.
Respondents to this collection of
information cover a broad range of
stakeholders who have specific
characteristics related to certain
products or services regulated by FDA.
In the Federal Register of January 21,
2020 (85 FR 3389), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of survey
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Mail, telephone, web-based .................................................
55,000
1
55,000
0.25 (15
minutes)
1 There
Dated: August 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18244 Filed 8–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1206]
Electronic Study Data Submission;
Data Standards; Support and
Requirement Begin for Study Data
Tabulation Model Version 1.7
Implementation Guide 3.3 and for
Define-Extensible Markup Language
Version 2.1; Requirement Ends for
Study Data Tabulation Model Version
1.3 Implementation Guide 3.1.3;
Correction
jbell on DSKJLSW7X2PROD with NOTICES
Food and Drug Administration,
HHS.
ACTION:
13,750
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.
AGENCY:
Total hours
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
document that appeared in the Federal
Register of July 7, 2020. The document
SUMMARY:
VerDate Sep<11>2014
18:01 Aug 19, 2020
Jkt 250001
announced the dates that support and
requirement will begin for version 1.7 of
the Clinical Data Interchange Standards
Consortium (CDISC) for Study Data
Tabulation Model (SDTM)
Implementation Guide (IG) 3.3, and for
version 2.1 of the Define-Extensible
Markup Language (Define-XML). The
document provided the incorrect dates
for these electronic study data
standards. This document corrects those
errors.
FOR FURTHER INFORMATION CONTACT:
Chenoa Conley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117,
Silver Spring, MD 20993–0002, 301–
796–0035, cderdatastandards@
fda.hhs.gov, or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION: In the
Federal Register of July 7, 2020 (85 FR
40658), in FR Doc. 2020–14512, the
following correction is made:
On page 40659, in the first column,
the last three sentences of the document
are corrected to read as follows:
‘‘Support for version 1.7 of the CDISC
SDTM IG 3.3 and version 2.1 of the
Define-XML will begin on March 15,
2021, and the date that the requirement
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
begins for CDISC version 1.7 SDTM IG
3.3 and version 2.1 of the Define-XML
for new drug applications, abbreviated
new drug applications, certain biologics
license applications, and
noncommercial investigational new
drug applications will be March 15,
2022. Support and requirement for
version 1.3 of the CDISC SDTM IG 3.1.3
will end on March 15, 2021.’’
Dated: August 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18236 Filed 8–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–6098]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration (All Food and Drug
Administration-Regulated Products)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\20AUN1.SGM
Notice.
20AUN1
Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
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:
Submit written comments
(including recommendations) on the
collection of information by September
21, 2020.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0497. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10:00 a.m.–12:00 p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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:
Focus Groups as Used by the Food and
Drug Administration (All FDARegulated Products)
OMB Control Number 0910–0497—
Extension
FDA conducts focus group interviews
on a variety of topics involving FDAregulated products, including drugs,
biologics, devices, food, tobacco, and
veterinary medicine.
Focus groups provide an important
role in gathering information because
they allow for a more indepth
understanding of consumers’ 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 consumer information
that is useful for developing variables
and measures for quantitative studies,
• to better understand consumers’
attitudes and emotions in response to
topics and concepts, and
• to further explore findings obtained
from quantitative studies.
51451
FDA will use focus group findings to
test and refine their ideas 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.
Respondents to this collection of
information will include members of the
general public, healthcare professionals,
the industry, and other stakeholders
who are related to a product under
FDA’s jurisdiction. Inclusion and
exclusion criteria will vary depending
on the research topic.
In the Federal Register of January 8,
2020 (85 FR 916), we published a 60day notice requesting public comment
on the proposed collection of
information. FDA received three
comments. FDA thanks the commenters
for their comments and provides our
response below. The first and second
comments strongly support the
proposed information collection related
to focus groups used by the FDA. The
third comment was not responsive to
the four collection of information topics
solicited and therefore will not be
discussed in this document.
FDA estimates the burden of this
collection of information 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 Interviews .......................................................
8,800
1
8,800
1.75
15,400
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: August 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18243 Filed 8–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Reports of Corrections and Removals
Food and Drug Administration,
HHS.
jbell on DSKJLSW7X2PROD with NOTICES
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:
VerDate Sep<11>2014
18:01 Aug 19, 2020
Jkt 250001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0359. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
[Docket No. FDA–2016–N–4620]
AGENCY:
Submit written comments
(including recommendations) on the
collection of information by September
21, 2020.
DATES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
E:\FR\FM\20AUN1.SGM
20AUN1
]]>Agencies
[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Pages 51450-51451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18243]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-6098]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Focus Groups as Used
by the Food and Drug Administration (All Food and Drug Administration-
Regulated Products)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 51451]]
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: Submit written comments (including recommendations) on the
collection of information by September 21, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0497. 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, 10:00 a.m.-12:00
p.m., 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 as Used by the Food and Drug Administration (All FDA-
Regulated Products)
OMB Control Number 0910-0497--Extension
FDA conducts focus group interviews on a variety of topics
involving FDA-regulated products, including drugs, biologics, devices,
food, tobacco, and veterinary medicine.
Focus groups provide an important role in gathering information
because they allow for a more indepth understanding of consumers'
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 consumer information that is useful for
developing variables and measures for quantitative studies,
to better understand consumers' attitudes and emotions in
response to topics and concepts, and
to further explore findings obtained from quantitative
studies.
FDA will use focus group findings to test and refine their ideas
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.
Respondents to this collection of information will include members
of the general public, healthcare professionals, the industry, and
other stakeholders who are related to a product under FDA's
jurisdiction. Inclusion and exclusion criteria will vary depending on
the research topic.
In the Federal Register of January 8, 2020 (85 FR 916), we
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received three comments. FDA thanks the
commenters for their comments and provides our response below. The
first and second comments strongly support the proposed information
collection related to focus groups used by the FDA. The third comment
was not responsive to the four collection of information topics
solicited and therefore will not be discussed in this document.
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 Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus Group Interviews............................................. 8,800 1 8,800 1.75 15,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: August 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18243 Filed 8-19-20; 8:45 am]
BILLING CODE 4164-01-P
