[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49841-49842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23443]


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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: Fax written comments on the collection of information by 
November 27, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#1976706b78466a6c7b74706a6a7076775976747b377c7669377e766f"><span class="__cf_email__" data-cfemail="1e71776c7f416d6b7c73776d6d7771705e71737c307b716e30797168">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0697. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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, 301-796-8867, 
<a href="/cdn-cgi/l/email-protection#67373526341306010127010306490f0f1449000811"><span class="__cf_email__" data-cfemail="81d1d3c0d2f5e0e7e7c1e7e5e0afe9e9f2afe6eef7">[email protected]</span></a>.

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 voluntary 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,

[[Page 49842]]

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.
    In the Federal Register of June 15, 2017 (82 FR 27508), FDA 
published a 60-day 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\
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                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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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 minutes).........................          331.25
Small discussion groups.....................             800               1             800  1.75......................................           1,400
Customer satisfaction surveys...............          12,000               1          12,000  0.33 (20 minutes).........................           3,960
Usability studies...........................             800               1             800  1.75......................................           1,400
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................        8,491.25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23443 Filed 10-26-17; 8:45 am]
 BILLING CODE 4164-01-P


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