82 FR 27508 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

Page Range		27508-27509
FR Document		2017-12450

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.''

Federal Register, Volume 82 Issue 114 (Thursday, June 15, 2017)

[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27508-27509]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-12450]

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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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 ``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 August 14, 2017. 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: You may submit comments as follows:

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): 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-N-0487 for ``Generic Clearance for the Collection of
Qualitative Feedback on Agency Service Delivery.'' Received comments,
those filed in a timely manner (see DATES), 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 for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and 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.thefederalregister.org/fdsys/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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

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, PRAStaff@fda.hhs.gov, 301-796-
8867.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the

[[Page 27509]]

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.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus groups................................ 800 1 800 1.75...................................... 1,400
Customer comment cards/forms................ 1,325 1 1,325 .25 (15 minutes).......................... 331.25
Small discussion groups..................... 800 1 800 1.75...................................... 1,400
Customer satisfaction surveys............... 12,000 1 12,000 .33 (20 minutes).......................... 3,960
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total................................... .............. .............. .............. .......................................... 7,091.25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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. 2017-12450 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27509

Office of Management and Budget ways to minimize the burden of the feedback to contribute directly to the
(OMB) for each collection of collection of information on improvement of program management.
information they conduct or sponsor. respondents, including through the use Feedback collected under this generic
‘‘Collection of information’’ is defined of automated collection techniques, clearance will provide useful
in 44 U.S.C. 3502(3) and 5 CFR when appropriate, and other forms of information, but it will not yield data
1320.3(c) and includes Agency requests information technology. that can be generalized to the overall
or requirements that members of the population. This type of generic
Generic Clearance for the Collection of
public submit reports, keep records, or clearance for qualitative information
Qualitative Feedback on Agency
provide information to a third party. will not be used for quantitative
Service Delivery—OMB Control
Section 3506(c)(2)(A) of the PRA (44 information collections that are
Number 0910–0697—Extension
U.S.C. 3506(c)(2)(A)) requires Federal designed to yield reliably actionable
Agencies to provide a 60-day notice in The information collection activity
will garner qualitative customer and results, such as monitoring trends over
the Federal Register concerning each
stakeholder feedback in an efficient, time or documenting program
proposed collection of information,
timely manner, in accordance with the performance. Such data uses require
including each proposed extension of an
Administration’s commitment to more rigorous designs that address the
existing collection of information,
improving service delivery. By following: The target population to
before submitting the collection to OMB
qualitative feedback we mean which generalizations will be made, the
for approval. To comply with this
information that provides useful sampling frame, the sample design
requirement, FDA is publishing notice
insights on perceptions and opinions, (including stratification and clustering),
of the proposed collection of
but are not statistical surveys that yield the precision requirements or power
information set forth in this document.
With respect to the following quantitative results that can be calculations that justify the proposed
collection of information, FDA invites generalized to the population of study. sample size, the expected response rate,
comments on these topics: (1) Whether This feedback will provide insights into methods for assessing potential non-
the proposed collection of information customer or stakeholder perceptions, response bias, the protocols for data
is necessary for the proper performance experiences and expectations, provide collection, and any testing procedures
of FDA’s functions, including whether an early warning of issues with service, that were or will be undertaken prior
the information will have practical or focus attention on areas where fielding the study. Depending on the
utility; (2) the accuracy of FDA’s communication, training or changes in degree of influence the results are likely
estimate of the burden of the proposed operations might improve delivery of to have, such collections may still be
collection of information, including the products or services. These collections eligible for submission for other generic
validity of the methodology and will allow for ongoing, collaborative, mechanisms that are designed to yield
assumptions used; (3) ways to enhance and actionable communications quantitative results.
the quality, utility, and clarity of the between the Agency and its customers FDA estimates the burden of this
information to be collected; and (4) and stakeholders. It will also allow collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Activity responses per Total hours
respondents responses response
respondent

Focus groups ........................................................... 800 1 800 1.75 ........................... 1,400
Customer comment cards/forms .............................. 1,325 1 1,325 .25 (15 minutes) ........ 331.25
Small discussion groups .......................................... 800 1 800 1.75 ........................... 1,400
Customer satisfaction surveys ................................. 12,000 1 12,000 .33 (20 minutes) ........ 3,960

Total .................................................................. ........................ ........................ ........................ .................................... 7,091.25
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: June 12, 2017. DEPARTMENT OF HEALTH AND certain information by the Agency.
Anna K. Abram, HUMAN SERVICES Under the Paperwork Reduction Act of
Deputy Commissioner for Policy, Planning, 1995 (PRA), Federal Agencies are
Legislation, and Analysis. Food and Drug Administration required to publish notice in the
[FR Doc. 2017–12450 Filed 6–14–17; 8:45 am] Federal Register concerning each
[Docket No. FDA–2014–N–1027]
proposed collection of information,
BILLING CODE 4164–01–P
Agency Information Collection including each proposed extension of an
Activities; Proposed Collection; existing collection of information, and
Comment Request; Infant Formula to allow 60 days for public comment in
Recall Regulations response to the notice. This notice
solicits comments on information
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AGENCY: Food and Drug Administration, collection provisions in FDA’s infant
HHS. formula recall regulations.
ACTION: Notice. DATES: Submit either electronic or
SUMMARY: The Food and Drug written comments on the collection of
Administration (FDA or Agency) is information by August 14, 2017.
announcing an opportunity for public ADDRESSES: You may submit comments
comment on the proposed collection of as follows. Please note that late,

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Document Created: 2017-06-15 01:03:37
Document Modified: 2017-06-15 01:03:37

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 14, 2017. 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.
Contact		Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected], 301-796- 8867.
FR Citation		82 FR 27508

82 FR 27508 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration