
[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29763-29764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12553]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0327]


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 June 
22, 2011.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Generic Clearance for the Collection of Qualitative Feedback on 
Agency Service Delivery.'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, Jonnalynn.Capezzuto@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--NEW)

    The proposed information collection activity provides a means to 
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.
    The solicitation of feedback will target areas such as: Timeliness, 
appropriateness, accuracy of information, courtesy, efficiency of 
service delivery, and resolution of issues with service delivery. 
Responses will be assessed to plan and inform efforts to improve or 
maintain the quality of service offered to the public. If this 
information is not collected, vital feedback from customers and 
stakeholders on the Agency's services will be unavailable.
    The Agency will only submit a collection for approval under this 
generic clearance if it meets the following conditions:
     The collections are voluntary;
     The collections are low burden for respondents (based on 
considerations of total burden hours, total number of respondents, or 
burden hours per respondent) and are low cost for both the respondents 
and the Federal Government;
     The collections are noncontroversial and do not raise 
issues of concern to other Federal Agencies;
     Any collection is targeted to the solicitation of opinions 
from respondents who have experience with the program or may have 
experience with the program in the near future;
     Personally identifiable information (PII) is collected 
only to the extent necessary and is not retained;
     Information gathered is intended to be used only 
internally for general service improvement and program management 
purposes and is not intended for release outside of the Agency (if 
released, the Agency must indicate the qualitative nature of the 
information);
     Information gathered will not be used for the purpose of 
substantially informing influential policy decisions; and
     Information gathered will yield qualitative information; 
the collections will not be designed or expected to yield statistically 
reliable results or used as though the results are generalizable to the 
population of study.
    Feedback collected under this generic clearance provides useful 
information, but it does 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

[[Page 29764]]

actionable results, such as monitoring trends over time or documenting 
program performance. Such data uses require more rigorous designs that 
address: 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 nonresponse 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.
    As a general matter, information collections will not result in any 
new system of records containing privacy information and will not ask 
questions of a sensitive nature, such as sexual behavior and attitudes, 
religious beliefs, and other matters that are commonly considered 
private.
    Current Actions: New collection of information.
    Type of Review: New collection.
    Affected Public: Individuals and households, businesses and 
organizations, State, local, or Tribal Government.
    Estimated Number of Respondents: Following is a preliminary 
estimate of the aggregate burden hours for this generic clearance. This 
estimate based on a review of past behavior of the participating 
Agencies and by several individual Agencies' estimates for this 
information collection request. In recognition that individual Agencies 
will differ in how often they use this generic clearance, this burden 
estimate assumes that 10 Agencies would be the heaviest users and 
account for approximately 10 times as great a burden as the other 
Agencies combined. Agencies will provide more refined individual 
estimates of burden in their subsequent notices.
    Average Expected Annual Number of Activities: 25,000.
    Average Number of Respondents per Activity: 200.
    Annual Responses: 5,000,000.
    Frequency of Response: Once per request.
    Average Minutes per Response: 30.
    Burden Hours: 2,500,000.
    Request for Comments: Comments submitted in response to this 
document will be summarized and/or included in the request for OMB 
approval. Comments are invited on: (1) Whether the collection of 
information is necessary for the proper performance of the functions of 
the Agency, including whether the information shall have practical 
utility; (2) the accuracy of the Agency's estimate of the burden of the 
collection of information; (3) ways to enhance the quality, utility, 
and clarity of the information to be collected; (4) ways to minimize 
the burden of the collection of information on respondents, including 
through the use of automated collection techniques or other forms of 
information technology; and (5) estimates of capital or startup costs 
and costs of operation, maintenance, and purchase of services to 
provide information. Burden means the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, disclose 
or provide information to or for a Federal Agency. This includes the 
time needed to review instructions; to develop, acquire, install and 
utilize technology and systems for the purpose of collecting, 
validating and verifying information, processing and maintaining 
information, and disclosing and providing information; to train 
personnel and to be able to respond to a collection of information, to 
search data sources, to complete and review the collection of 
information; and to transmit or otherwise disclose the information.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number.
    In the Federal Register of December 22, 2010 (75 FR 80542), OMB 
published a 60-day notice requesting public comment on the proposed 
collection of information. All written comments will be available for 
public inspection at http://www.regulations.gov.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                          Annual                                         Total expected      Average
                  44 U.S.C. 3501                       Number of      frequency per     Total annual      Hours per      annual number     minutes per
                                                      respondents        response        responses         response      of activities       response
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                                                               200                1        5,000,000        2,500,000           25,000               30
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: May 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12553 Filed 5-20-11; 8:45 am]
BILLING CODE 4160-01-P


