
[Federal Register Volume 79, Number 82 (Tuesday, April 29, 2014)]
[Notices]
[Pages 23980-23981]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09693]


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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) 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 the collection of information 
involving a generic clearance for qualitative feedback on Agency 
service delivery.

DATES: Submit either electronic or written comments on the collection 
of information by June 30, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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

[[Page 23981]]

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.
    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..................             725               1             725  1 hour, 45                 1,269
                                                                                 minutes.
Customer comment cards/forms..           1,200               1           1,200  15 minutes......             300
Small discussion groups.......             725               1             725  1 hour, 45                 1,269
                                                                                 minutes.
Customer satisfaction surveys.           6,450               1           6,450  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: April 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09693 Filed 4-28-14; 8:45 am]
BILLING CODE 4160-01-P


