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, 29763-29764 [2011-12553]
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29763
Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Portion of study
Total annual
responses
Average
burden per
response (in
hours) 2
Total hours
Pretest ................................................................................
Survey ................................................................................
5
100
1
1
5
100
20/60
20/60
1.65
33
Total ............................................................................
........................
........................
........................
........................
34.65
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
FDA calculated the total annual
responses by multiplying the number of
respondents by the annual frequency.
FDA calculated the total hours by
multiplying the estimated hours per
response (20 minutes = 0.33 hours) by
the number of respondents.
Dated: May 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–12555 Filed 5–20–11; 8:45 am]
BILLING CODE 4160–01–P
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.
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.
SUMMARY:
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
srobinson on DSK4SPTVN1PROD with NOTICES
ADDRESSES:
VerDate Mar<15>2010
16:22 May 20, 2011
Jkt 223001
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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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
E:\FR\FM\23MYN1.SGM
23MYN1
29764
Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices
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
https://www.regulations.gov.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
1
Total annual
responses
Hours per
response
Total expected
annual number
of activities
Average
minutes per
response
1
5,000,000
2,500,000
25,000
30
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
srobinson on DSK4SPTVN1PROD with NOTICES
Annual
frequency per
response
200
44 U.S.C. 3501
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0322]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Manufacturer’s
Notification of the Intent To Use an
Accredited Person Under the
Accredited Persons Inspection
Program Authorized by Section 228 of
the Food and Drug Administration
Amendments Act of 2007
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
18:13 May 20, 2011
Jkt 223001
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
ACTION:
Notice.
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 eligibility criteria and the process to
be followed by establishments when
notifying FDA of a manufacturer’s intent
SUMMARY:
E:\FR\FM\23MYN1.SGM
23MYN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
200 1 5,000,000 2,500,000 25,000 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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