Agency Forms Undergoing Paperwork Reduction Act Review, 5760-5761 [2015-02062]
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5760
Federal Register / Vol. 80, No. 22 / Tuesday, February 3, 2015 / Notices
SUPPLEMENTARY INFORMATION:
Pursuant
to the Federal Advisory Committee Act
(FACA) of 1972 (5 U.S. C., Appendix, as
amended), and section 2811A of the
Public Health Service (PHS) Act (42
U.S. C. 300hh–10a), as added by section
103 of the Pandemic and All Hazards
Preparedness Reauthorization Act of
2013 (Pub. L. 113–5), the HHS
Secretary, in consultation with the
Secretary of the U.S. Department of
Homeland Security, established the
National Advisory Committee on
Children and Disasters (NACCD). The
purpose of the NACCD is to provide
advice and consultation to the HHS
Secretary with respect to the medical
and public health needs of children in
relation to disasters. The Office of the
Assistant Secretary for Preparedness
and Response (ASPR) provides
management and administrative
oversight to support the activities of the
NACCD.
Background: This public meeting will
be dedicated to the members voting to
approve the report of findings of the
NACCD Surge Capacity Work Group.
Availability of Materials: The meeting
agenda and materials will be posted on
the NACCD Web site at: www.phe.gov/
naccd prior to the meeting.
Procedures for Providing Public Input:
All written comments must be received
prior to February 24, 2015. Please
submit comments via the NACCD
Contact Form located at www.phe.gov/
NACCDComments. Individuals who
plan to attend and need special
assistance should submit a request via
the NACCD Contact Form located at
www.phe.gov/NACCDComments.
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Dated: January 22, 2015.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response.
Proposed Project
[FR Doc. 2015–01615 Filed 2–2–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–15–0940]
rljohnson on DSK3VPTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
VerDate Sep<11>2014
14:46 Feb 02, 2015
Jkt 235001
Generic Clearance for the Collection
of Qualitative Feedback on Agency
Service Delivery (OMB No. 0920–0940,
exp. 06/30/2015)—Extension—Centers
for Disease Control and Prevention
(CDC), National Institute for
Occupational Safety and Health
(NIOSH), Health Hazard Evaluation
Program.
As part of a Federal Government-wide
effort to streamline the process to seek
feedback from the public on service
delivery, the CDC has submitted a
Generic Information Collection Request
(Generic ICR): ‘‘Generic Clearance for
the Collection of Qualitative Feedback
on Agency Service Delivery ’’ to OMB
for approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et.
seq.).
To request additional information,
please contact Leroy A. Richardson,
Centers for Disease Control and
Prevention, 1600 Clifton Road, MS–D74,
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Atlanta, GA 30333 or send an email to
omb@cdc.gov.
SUPPLEMENTARY INFORMATION:
Title: Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery.
Abstract: 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
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
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
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.
The Agency received no comments in
response to the 60-day notice published
in the Federal Register on April 30,
2014 (75 FR 24432).
This is a new collection of
information. Respondents will be
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03FEN1
5761
Federal Register / Vol. 80, No. 22 / Tuesday, February 3, 2015 / Notices
screened and selected from Individuals
and Households, Businesses,
Organizations, and/or State, Local or
Tribal Government. There is no cost to
respondents other than their time. The
estimated total burden hours for this
data collection activity are 268.
Type of collection
Average
number of
respondents
per activity
Annual
frequency
per response
Average
number of
activities
Average hours
per response
Online surveys, Telephone Surveys, Focus Groups, In person observation/
testing ...........................................................................................................
67
1
5
48/60
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–02062 Filed 2–2–15; 8:45 am]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General Licensing
Provisions; Section 351(k) Biosimilar
Applications
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
rljohnson on DSK3VPTVN1PROD with NOTICES
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
14:46 Feb 02, 2015
Jkt 235001
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 information collection in an
application for a proposed biosimilar
product and an application for a
supplement for a proposed
interchangeable product.
DATES: Submit either electronic or
written comments on the collection of
information by April 6, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the Board
of Scientific Counselors, National
Center for Environmental Health/
Agency for Toxic Substances and
Disease Registry, Department of Health
and Human Services, has been renewed
for a 2-year period through May 21,
2016.
For information, contact William
Cibulas, Ph.D., Designated Federal
Officer, Board of Scientific Counselors,
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry, Department of
Health and Human Services, 4770
Buford Highway, Mailstop F61,
Chamblee, Georgia 30341, telephone
(770) 488–0662 or fax (770) 488–3385.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
VerDate Sep<11>2014
Food and Drug Administration,
HHS.
Board of Scientific Counselors,
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry: Notice of
Charter Renewal
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[Docket No. FDA–2012–N–0129]
AGENCY:
Centers for Disease Control and
Prevention
[FR Doc. 2015–02026 Filed 2–2–15; 8:45 am]
Food and Drug Administration
PO 00000
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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.
SUPPLEMENTARY INFORMATION:
General Licensing Provisions; Section
351(k) Biosimilar Applications (OMB
Control Number 0910–0719)—Extension
The Patient Protection and Affordable
Care Act (Affordable Care Act) (Pub. L.
111–148) contains a subtitle called the
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act),
which amends the Public Health Service
Act (PHS Act) and establishes an
abbreviated licensure pathway for
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Agencies
[Federal Register Volume 80, Number 22 (Tuesday, February 3, 2015)]
[Notices]
[Pages 5760-5761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02062]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-0940]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
Generic Clearance for the Collection of Qualitative Feedback on
Agency Service Delivery (OMB No. 0920-0940, exp. 06/30/2015)--
Extension--Centers for Disease Control and Prevention (CDC), National
Institute for Occupational Safety and Health (NIOSH), Health Hazard
Evaluation Program.
As part of a Federal Government-wide effort to streamline the
process to seek feedback from the public on service delivery, the CDC
has submitted a Generic Information Collection Request (Generic ICR):
``Generic Clearance for the Collection of Qualitative Feedback on
Agency Service Delivery '' to OMB for approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
To request additional information, please contact Leroy A.
Richardson, Centers for Disease Control and Prevention, 1600 Clifton
Road, MS-D74, Atlanta, GA 30333 or send an email to omb@cdc.gov.
SUPPLEMENTARY INFORMATION:
Title: Generic Clearance for the Collection of Qualitative Feedback
on Agency Service Delivery.
Abstract: 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 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 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 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.
The Agency received no comments in response to the 60-day notice
published in the Federal Register on April 30, 2014 (75 FR 24432).
This is a new collection of information. Respondents will be
[[Page 5761]]
screened and selected from Individuals and Households, Businesses,
Organizations, and/or State, Local or Tribal Government. There is no
cost to respondents other than their time. The estimated total burden
hours for this data collection activity are 268.
----------------------------------------------------------------------------------------------------------------
Average number Annual
Type of collection of respondents frequency per Average number Average hours
per activity response of activities per response
----------------------------------------------------------------------------------------------------------------
Online surveys, Telephone Surveys, Focus 67 1 5 48/60
Groups, In person observation/testing......
----------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-02062 Filed 2-2-15; 8:45 am]
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