[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Pages 70181-70182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24422]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0487]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 December 4, 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 0910-0697. 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

[[Page 70182]]

20852, 301-796-7726, PRAStaff@fda.hhs.gov.

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.

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 to 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.
    In the Federal Register of April 3, 2020 (85 FR 18989), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although two comments were received, they 
were 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\
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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           * .25          331.25
Small discussion groups.........             800               1             800            1.75           1,400
Customer satisfaction surveys...          12,000               1          12,000    [dagger] .33           3,960
Usability Studies...............             800               1             800            1.75           1,400
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    Total.......................  ..............  ..............  ..............  ..............        8,491.25
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* (15 minutes).
[dagger] (20 minutes).

    In the 60-day notice published on April 3, 2020, the number of 
responses and number of burden hours did not match OMB approved 
inventory. This notice corrects the burden in table 1 of that notice. 
In addition, the burden for this collection of information has 
increased by 800 responses from 14,925 to 15,725 responses due to an 
inadvertent omission of responses of usability studies for this 
collection. This addition to responses will correct the number of 
responses for this collection. The burden hours in OMB's inventory will 
remain the same.

    Dated: October 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24422 Filed 11-3-20; 8:45 am]
BILLING CODE 4164-01-P


