Document ID: FDA-2014-N-0487-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Generic Clearance
for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery
Posted Date: 2014-09-22T04:00Z

[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Notices]
[Pages 56587-56588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22461]

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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 Food and Drug Administration 
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 (PRA).

DATES: Fax written comments on the collection of information by October 
22, 2014.

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 oirasubmission@omb.eop.gov. 
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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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 FDA 
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, FDA means information that provides 
useful insight on perceptions and opinions, not statistical surveys 
that yield quantitative results that can be generalized to the 
population of study. This feedback will provide insight 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. This information collection will 
allow for ongoing collaborative and actionable communications among the 
FDA 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 the 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, the 
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 April 29, 2014 (79 FR 23980), 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:

[[Page 56588]]

                                                     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.............................             725               1             725  1.75.........................................           1,269
Customer comment cards/forms.............           1,200               1           1,200  0.25 (15 minutes)............................             300
Small discussion groups..................             725               1             725  1.75.........................................           1,269
Customer satisfaction surveys............           6,450               1           6,450  0.33 (20 minutes)............................           2,129
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    Total................................  ..............  ..............  ..............  .............................................           4,967
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: September 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22461 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P