Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 18989-18991 [2020-06992]
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Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
18989
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR part 1271; human cells, tissues, and
cellular and tissue-based products
Number of
disclosures per
respondent
Number of
respondents
Total annual
disclosures
Average burden per
disclosure
Total hours
1271.55(a) ..........................................................
1271.60(c) and (d)(2) .........................................
1271.290(c) ........................................................
1271.290(f) .........................................................
1271.370(b) and (c) ...........................................
1,632
1,611
2,109
2,109
2,109
1,589.715
355.06
1,163.781
1
1,163.781
2,594,415
572,000
2,454,415
2,109
2,454,415
0.5 (30 minutes) ..........
0.5 (30 minutes) ..........
0.083 (5 minutes) ........
1 ...................................
0.25 (15 minutes) ........
1,297,208
286,000
203,716
2,109
613,604
Total ............................................................
........................
............................
........................
......................................
2,402,637
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
to the nearest whole number.
2 Rounded
Our estimated burden for the
information collection reflects an
overall increase of 628,585 hours (111
reporting burden hours; 305,118
recordkeeping hours; and 323,356
disclosure burden hours) and a
corresponding increase of annual
responses, annual records, and annual
disclosures. We attribute this
adjustment to an increase in the number
of HCT/P establishments and an
increase in the number of HCT/Ps
distributed over the past few years.
Dated: March 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06981 Filed 4–2–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
Food and Drug Administration
[Docket No. FDA–2014–N–0487]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 collection of
information for the ‘‘Generic Clearance
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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for the Collection of Qualitative
Feedback on Agency Service Delivery.’’
DATES: Submit either electronic or
written comments on the collection of
information by June 2, 2020.
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 June 2, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 2, 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.
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’’).
PO 00000
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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–
2014–N–0487 for ‘‘Agency Information
Collection Actitivites; Proposed
Collection; Comment Request; Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery.’’ 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
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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
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18990
Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
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: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
SUPPLEMENTARY INFORMATION:
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
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.
Generic Clearance for the Collection of
Qualitative Feedback on Agency
Service Delivery
OMB Control Number 0910–0697—
Extension
The information collection activity
will garner qualitative customer and
stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative,
and actionable communications
between the Agency and its customers
and stakeholders. It will also allow
feedback to contribute directly to the
improvement of program management.
Feedback collected under this generic
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance. Such data uses require
more rigorous designs that address the
following: The target population to
which generalizations will be made, the
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
methods for assessing potential nonresponse bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results.
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.
These stakeholders include members of
the general public, healthcare
professionals, the industry, and other
stakeholders who are related to a
product under FDA’s jurisdiction.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Focus groups ....................................
Customer comment cards/forms .......
Small discussion groups ...................
Customer satisfaction surveys ..........
800
1,325
800
12,000
1
1
1
1
800
1,325
800
12,000
Total ...........................................
........................
........................
........................
1 There
Average burden per response
1.75
0.25
1.75
0.33
..................................................
(15 minutes) .............................
..................................................
(20 minutes) .............................
1,400
331.25
1,400
3,960
...........................................................
7,091.25
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
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: March 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06992 Filed 4–2–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3535]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Special Protocol
Assessment; Guidance for Industry
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:
Submit written comments
(including recommendations) on the
collection of information May 4, 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 0910–0470. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
jbell on DSKJLSW7X2PROD with NOTICES
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
20852, 301–796–5733, 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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Special Protocol Assessment
OMB Control Number 0910–0470—
Revision
This information collection request
supports Agency guidance entitled
‘‘Special Protocol Assessment’’
(Revision 1) (83 FR 16367, April 16,
2018), which describes procedures FDA
uses to evaluate issues related to the
adequacy (e.g., design, conduct,
analysis) of certain proposed studies. A
copy of the guidance is available from
our website at https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm. The guidance describes
procedures for sponsors to request
special protocol assessment and for FDA
to act on such requests. The guidance
provides information on how FDA
interprets and applies provisions of the
Food and Drug Administration
Modernization Act of 1997 and the
specific Prescription Drug User Fee Act
of 1992 (PDUFA) goals for special
protocol assessment associated with the
development and review of PDUFA
products. The guidance describes the
following two collections of
information: (1) The submission of a
notice of intent to request special
protocol assessment of a carcinogenicity
protocol; and (2) the submission of a
request for special protocol assessment.
I. Notification for a Carcinogenicity
Protocol
As described in the guidance, a
sponsor interested in an FDA
assessment of a carcinogenicity protocol
should notify the appropriate division
in FDA’s Center for Drug Evaluation and
Research (CDER) or the Center for
Biologics Evaluation and Research
(CBER) of an intent to request special
protocol assessment at least 30 days
prior to submitting the request. With
such notification, the sponsor should
submit relevant background information
so that FDA may review reference
material related to carcinogenicity
protocol design before receiving the
carcinogenicity protocol.
II. Request for Special Protocol
Assessment
The guidance asks that a request for
special protocol assessment be
submitted as an amendment to the
investigational new drug application
(IND) for the underlying product and
that it be submitted to FDA in triplicate
with Form FDA 1571 (https://
www.fda.gov/downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM083533.pdf) attached. The
guidance also suggests that the sponsor
submit the cover letter to a request for
special protocol assessment via Fax to
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18991
the appropriate division in CDER or
CBER. FDA regulations (21 CFR
312.23(d)) state that information
provided to us as part of an IND is to
be submitted in triplicate and with the
appropriate cover form, Form FDA
1571. An IND is submitted to FDA
under existing regulations in part 312
(21 CFR part 312), which specifies the
information that manufacturers must
submit so that FDA may properly
evaluate the safety and effectiveness of
investigational drugs and biological
products. The information collection
requirements resulting from the
preparation and submission of an IND
under part 312 have been estimated by
FDA, and the reporting and
recordkeeping burden has been
approved by OMB under OMB control
number 0910–0014.
FDA suggests that the cover letter to
the request for special protocol
assessment be submitted via Fax to the
appropriate division in CDER or CBER
to enable FDA staff to prepare for the
arrival of the protocol for assessment.
FDA recommends that a request for
special protocol assessment be
submitted as an amendment to an IND
for two reasons: (1) To ensure that each
request is kept in the administrative file
with the entire IND and (2) to ensure
that pertinent information about the
request is entered into the appropriate
tracking databases. Use of the
information in FDA’s tracking databases
enables the appropriate Agency official
to monitor progress on the evaluation of
the protocol and to ensure that
appropriate steps will be taken in a
timely manner.
The guidance recommends that the
following information should be
submitted to the appropriate Center
with each request for special protocol
assessment so that the Center may
quickly and efficiently respond to the
request:
• Questions to FDA concerning
specific issues regarding the protocol.
• All data, assumptions, and
information needed to permit an
adequate evaluation of the protocol,
including: (1) The role of the study in
the overall development of the drug; (2)
information supporting the proposed
trial, including power calculations, the
choice of study endpoints, and other
critical design features; (3) regulatory
outcomes that could be supported by
the results of the study; (4) final labeling
that could be supported by the results
of the study; and (5) for a stability
protocol, product characterization and
relevant manufacturing data.
Description of Respondents: A
sponsor, applicant, or manufacturer of a
drug or biologic product that FDA
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]]>Agencies
[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18989-18991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06992]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0487]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for the Collection of Qualitative
Feedback on Agency Service Delivery
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 collection of information for the
``Generic Clearance for the Collection of Qualitative Feedback on
Agency Service Delivery.''
DATES: Submit either electronic or written comments on the collection
of information by June 2, 2020.
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 June 2, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 2, 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 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-2014-N-0487 for ``Agency Information Collection Actitivites;
Proposed Collection; Comment Request; Generic Clearance for the
Collection of Qualitative Feedback on Agency Service Delivery.''
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 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and
[[Page 18990]]
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
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: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
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.
Generic Clearance for the Collection of Qualitative Feedback on Agency
Service Delivery
OMB Control Number 0910-0697--Extension
The information collection activity will garner qualitative
customer and stakeholder feedback in an efficient, timely manner, in
accordance with the Administration's commitment to improving service
delivery. By qualitative feedback we mean information that provides
useful insights on perceptions and opinions but are not statistical
surveys that yield quantitative results that can be generalized to the
population of study. This feedback will provide insights into customer
or stakeholder perceptions, experiences and expectations, provide an
early warning of issues with service, or focus attention on areas where
communication, training or changes in operations might improve delivery
of products or services. These collections will allow for ongoing,
collaborative, and actionable communications between the Agency and its
customers and stakeholders. It will also allow feedback to contribute
directly to the improvement of program management.
Feedback collected under this generic clearance will provide useful
information, but it will not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address the following: The
target population to which generalizations will be made, the sampling
frame, the sample design (including stratification and clustering), the
precision requirements or power calculations that justify the proposed
sample size, the expected response rate, methods for assessing
potential non-response bias, the protocols for data collection, and any
testing procedures that were or will be undertaken prior fielding the
study. Depending on the degree of influence the results are likely to
have, such collections may still be eligible for submission for other
generic mechanisms that are designed to yield quantitative results.
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. These stakeholders include
members of the general public, healthcare professionals, the industry,
and other stakeholders who are related to a product under FDA's
jurisdiction.
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 groups.................. 800 1 800 1.75............ 1,400
Customer comment cards/forms.. 1,325 1 1,325 0.25 (15 331.25
minutes).
Small discussion groups....... 800 1 800 1.75............ 1,400
Customer satisfaction surveys. 12,000 1 12,000 0.33 (20 3,960
minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 7,091.25
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 18991]]
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: March 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06992 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P
