[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]


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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.

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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, 
PRAStaff@fda.hhs.gov.

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\
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                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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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).
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    Total.....................  ..............  ..............  ..............  ................        7,091.25
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\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


