Agency Forms Undergoing Paperwork Reduction Act Review, 47699-47701 [2013-18909]
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Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices
Dated: August 1, 2013.
James R. Park,
Executive Director.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2013–18987 Filed 8–5–13; 8:45 am]
Office of the Secretary
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Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
FEDERAL RESERVE SYSTEM
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The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than August 30,
2013.
A. Federal Reserve Bank of San
Francisco (Gerald C. Tsai, Director,
Applications and Enforcement) 101
Market Street, San Francisco, California
94105–1579:
1. People’s Utah Bancorp, American
Fork, Utah; to acquire 100 percent of the
voting shares of Lewiston Bancorp, and
thereby indirectly acquire voting shares
of Lewiston State Bank, both in
Lewiston, Utah.
Board of Governors of the Federal Reserve
System, July 31, 2013.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2013–18857 Filed 8–5–13; 8:45 am]
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Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Pratima Karnik, Ph.D., Case Western
Reserve University: Based on the
admission of the Respondent, ORI found
that Dr. Pratima Karnik, Assistant
Professor, Department of Dermatology,
Case Western Reserve University
(CWRU), engaged in research
misconduct in research submitted to the
National Institute of Arthritis and
Musculoskeletal and Skin Diseases
(NIAMS), National Institutes of Health
(NIH), in grant application R01
AR062378.
ORI found that the Respondent
engaged in research misconduct by
plagiarizing significant portions from
research grant application R21
AR061881 that she had reviewed for
NIAMS, NIH, and inserting that text into
her submitted grant application R01
AR062378–01. Respondent also
plagiarized significant portions of text
from the following scientific articles and
one U.S. patent application available on
the Internet:
• BMC Med Genomics 4:8, 2011
• J Am Col. Cardiol 52:117–123, 2008
• Nature 457:910–914, 2009
• J Autoimmun 29:310–318, 2007
• U.S. Patent Application No.
20090047269 (published Feb. 19, 2009)
• Toxicol Pathol 35:952–957, 2007
• BMC Med Genomics 1:10, 2008
• Open Systems Biology Journal 1:1–
8, 2008
• Endocrinology 146:4189–4191,
2005.
•
Dr. Karnik has entered into a
Voluntary Settlement Agreement and
has voluntarily agreed for a period of
two (2) years, beginning on July 22,
2013:
(1) To have her research supervised;
Respondent agreed that prior to the
submission of an application for U.S.
Public Health Service (PHS) support for
a research project on which her
participation is proposed and prior to
her participation in any capacity on
PHS-supported research, Respondent
shall ensure that a plan for supervision
of her duties is submitted to ORI for
approval; the supervision plan must be
designed to ensure the scientific
SUMMARY:
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
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integrity of her research contribution;
she agreed that she shall not participate
in any PHS-supported research until
such a supervision plan is submitted to
and approved by ORI; Respondent
agreed to maintain responsibility for
compliance with the agreed upon
supervision plan;
(2) That any institution employing her
shall submit in conjunction with each
application for PHS funds, or report,
manuscript, or abstract involving PHSsupported research in which
Respondent is involved, a certification
to ORI that the content is free of
plagiarized material, data provided by
Respondent are based on actual
experiments or are otherwise
legitimately derived, and that the data,
procedures, and methodology are
accurately reported in the application,
report, manuscript, or abstract; and
(3) To exclude herself voluntarily
from serving in any advisory capacity to
PHS including, but not limited to,
service on any PHS advisory committee,
board, and/or peer review committee, or
as a consultant.
FOR FURTHER INFORMATION CONTACT:
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8200.
David E. Wright,
Director, Office of Research Integrity.
[FR Doc. 2013–18979 Filed 8–5–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day-13–13IF]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to 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
Pilot Project to Evaluate the Use of
Exposure Control Plans for Bloodborne
Pathogens in Private Dental Practices
–New- National Institute for
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Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) estimates that
healthcare workers sustain nearly
600,000 percutaneous injuries annually
involving contaminated sharps. In
response to both the continued concern
over such exposures and the
technological developments which can
increase employee protection, Congress
passed the Needlestick Safety and
Prevention Act directing the
Occupational Safety and Health
Administration (OSHA) to revise the
Bloodborne Pathogens (BBP) Standard
to establish requirements that employers
identify and make use of effective and
safer medical devices. That revision was
published on Jan. 18, 2001, and became
effective April 18, 2001.
The revision to OSHA’s BBP Standard
added new requirements for employers,
including additions to the exposure
control plan and maintenance of a
sharps injury log. OSHA has determined
that compliance with these standards
significantly reduces the risk that
workers will contract a bloodborne
disease in the course of their work.
However, exposure control plans for
bloodborne pathogens, policies, and
standards for healthcare workers are
based primarily on hospital data.
Approximately one-half of the 11
million healthcare workers in the U.S.
are employed in non-hospital settings,
including physician offices, home
healthcare agencies, correctional
facilities, and dental offices and clinics.
Little information is known about the
risk management practices in these nonhospital settings. In a small study, the
National Institute for Occupational
Safety and Health (NIOSH) found that
although seven of the eight correctional
healthcare facilities visited had written
exposure control plans, only two were
reviewed and updated annually as
required by the OSHA BBP Standard.
One reason postulated for noncompliance was that hospital-based
standards, policies, and programs may
not be appropriate to non-hospital
settings. It is important to identify
effective methods for using exposure
control plans in non-hospital settings
and to verify whether the specificity and
relevance of bloodborne pathogen
training and educational materials for
non-hospital facilities can positively
impact compliance in dental settings.
The purposes of this proposal are to
insure that bloodborne pathogens
exposure control plans are effectively
implemented in private dental practices,
an important segment of the nonhospital based healthcare system; and to
understand how effective
implementation strategies may be
applied to other healthcare settings. The
proposed work will draw on researchto-practice principles and will be
assisted by a strong network of dental
professional groups, trade associations,
and government agencies. Specific
objectives are to:
(1) Inventory existing exposure
control plans in private dental practices;
(2) determine whether the exposure
control plan or other resource is actively
used to prevent occupational exposures;
(3) determine available resources and
barriers to use such as relevant
educational materials, knowledge, costs,
availability; and
(4) develop strategies to overcome key
barriers to compliance.
The Organization for Safety, Asepsis
and Prevention (OSAP) is a unique
group of dental educators and
consultants, researchers, clinicians,
industry representatives, and other
interested persons with a collective
mission to be the world’s leading
advocate for the safe and infection-free
delivery of oral care. OSAP supports
this commitment to dental workers and
the public through quality education
and information dissemination. OSAP’s
unique membership includes the variety
of partners critical to gather the data on
compliance with the OSHA bloodborne
pathogens standard, to identify barriers
and to develop strategies to overcome
barriers to compliance.
OSAP will be conducting a web
survey of private dental practices in the
United States. Information collected
will include: The use of existing
exposure control plans; whether the
plan or other resources actively used to
prevent occupation exposure to
bloodborne pathogens; availability of
resources such as relevant education
materials, and barriers to use such as
knowledge, costs, and availability.
OSAP is working with a publishing
partner that has an email distribution
list of 49,172 private practice dentists
representing general dentists and
specialists. This sampling frame
represents nearly 30% of the total
population of U.S. private practice
dentists. The survey sample, totaling
40,575 dentists, will include general
dentists, oral and maxillofacial
surgeons, pediatric dentists and
periodonists. The targeted number of
completed questionnaires is estimated
at about 20,287 (50% participation rate).
The survey is estimated to take about 15
minutes for respondents to complete.
There is no cost to respondents other
than their time. The total estimated
annualized burden hours are 5,072.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Number of
respondents
Number of
responses per
respondent
Avgerage Burden
per response
(in hrs)
Private Practice Dentists ..........................
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Type of respondents
BBP Exposure Control Plan Survey .........
20,287
1
15/60
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2013–18909 Filed 8–5–13; 8:45 am]
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Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0879]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Procedures for the
Safe and Sanitary Processing and
Importing of Fish and Fishery Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on our proposed collection of
certain information. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies must publish a
notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and allow 60 days for
public comment. This notice invites
comments on the information collection
provisions of our regulations requiring
reporting and recordkeeping for
processors and importers of fish and
fishery products.
DATES: Submit either electronic or
written comments on the collection of
information by October 7, 2013.
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:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
SUMMARY:
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
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SUPPLEMENTARY INFORMATION:
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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, we are publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the following
collection of information we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our 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.
Procedures for the Safe and Sanitary
Processing and Importing of Fish and
Fishery Products—21 CFR Part 123
(OMB Control Number 0910–0354)—
Extension
FDA regulations in part 123 (21 CFR
part 123) mandate the application of
hazard analysis and critical control
point (HACCP) principles to the
processing of seafood. HACCP is a
preventive system of hazard control
designed to help ensure the safety of
foods. The regulations were issued
under FDA’s statutory authority to
regulate food safety, including section
402(a)(1) and (a)(4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
342(a)(1) and (a)(4)).
Certain provisions in part 123 require
that processors and importers of seafood
collect and record information. The
HACCP records compiled and
maintained by a seafood processor
primarily consist of the periodic
observations recorded at selected
monitoring points during processing
and packaging operations, as called for
in a processor’s HACCP plan (e.g., the
values for processing times,
temperatures, acidity, etc., as observed
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at critical control points). The primary
purpose of HACCP records is to permit
a processor to verify that products have
been produced within carefully
established processing parameters
(critical limits) that ensure that hazards
have been avoided.
HACCP records are normally
reviewed by appropriately trained
employees at the end of a production lot
or at the end of a day or week of
production to verify that control limits
have been maintained, or that
appropriate corrective actions were
taken if the critical limits were not
maintained. Such verification activities
are essential to ensure that the HACCP
system is working as planned. A review
of these records during the conduct of
periodic plant inspections also permits
FDA to determine whether the products
have been consistently processed in
conformance with appropriate HACCP
food safety controls.
Section 123.12 requires that importers
of seafood products take affirmative
steps and maintain records that verify
that the fish and fishery products they
offer for import into the United States
were processed in accordance with the
HACCP and sanitation provisions set
forth in part 123. These records are also
to be made available for review by FDA
as provided in § 123.12(c).
The time and costs of these
recordkeeping activities will vary
considerably among processors and
importers of fish and fishery products,
depending on the type and number of
products involved, and on the nature of
the equipment or instruments required
to monitor critical control points. The
burden estimate in table 1 of this
document includes only those
collections of information under the
seafood HACCP regulations that are not
already required under other statutes
and regulations. The estimate also does
not include collections of information
that are a usual and customary part of
businesses’ normal activities. For
example, the tagging and labeling of
molluscan shellfish (21 CFR 1240.60) is
a customary and usual practice among
seafood processors. Consequently, the
estimates in table 1 account only for
information collection and recording
requirements attributable to part 123.
Description of respondents:
Respondents to this collection of
information include processors and
importers of seafood.
FDA estimates the burden of this
collection of information as follows:
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]]>Agencies
[Federal Register Volume 78, Number 151 (Tuesday, August 6, 2013)]
[Notices]
[Pages 47699-47701]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18909]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-13-13IF]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to 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
Pilot Project to Evaluate the Use of Exposure Control Plans for
Bloodborne Pathogens in Private Dental Practices -New- National
Institute for
[[Page 47700]]
Occupational Safety and Health (NIOSH), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC) estimates that
healthcare workers sustain nearly 600,000 percutaneous injuries
annually involving contaminated sharps. In response to both the
continued concern over such exposures and the technological
developments which can increase employee protection, Congress passed
the Needlestick Safety and Prevention Act directing the Occupational
Safety and Health Administration (OSHA) to revise the Bloodborne
Pathogens (BBP) Standard to establish requirements that employers
identify and make use of effective and safer medical devices. That
revision was published on Jan. 18, 2001, and became effective April 18,
2001.
The revision to OSHA's BBP Standard added new requirements for
employers, including additions to the exposure control plan and
maintenance of a sharps injury log. OSHA has determined that compliance
with these standards significantly reduces the risk that workers will
contract a bloodborne disease in the course of their work. However,
exposure control plans for bloodborne pathogens, policies, and
standards for healthcare workers are based primarily on hospital data.
Approximately one-half of the 11 million healthcare workers in the
U.S. are employed in non-hospital settings, including physician
offices, home healthcare agencies, correctional facilities, and dental
offices and clinics. Little information is known about the risk
management practices in these non-hospital settings. In a small study,
the National Institute for Occupational Safety and Health (NIOSH) found
that although seven of the eight correctional healthcare facilities
visited had written exposure control plans, only two were reviewed and
updated annually as required by the OSHA BBP Standard. One reason
postulated for non-compliance was that hospital-based standards,
policies, and programs may not be appropriate to non-hospital settings.
It is important to identify effective methods for using exposure
control plans in non-hospital settings and to verify whether the
specificity and relevance of bloodborne pathogen training and
educational materials for non-hospital facilities can positively impact
compliance in dental settings. The purposes of this proposal are to
insure that bloodborne pathogens exposure control plans are effectively
implemented in private dental practices, an important segment of the
non-hospital based healthcare system; and to understand how effective
implementation strategies may be applied to other healthcare settings.
The proposed work will draw on research-to-practice principles and will
be assisted by a strong network of dental professional groups, trade
associations, and government agencies. Specific objectives are to:
(1) Inventory existing exposure control plans in private dental
practices;
(2) determine whether the exposure control plan or other resource
is actively used to prevent occupational exposures;
(3) determine available resources and barriers to use such as
relevant educational materials, knowledge, costs, availability; and
(4) develop strategies to overcome key barriers to compliance.
The Organization for Safety, Asepsis and Prevention (OSAP) is a
unique group of dental educators and consultants, researchers,
clinicians, industry representatives, and other interested persons with
a collective mission to be the world's leading advocate for the safe
and infection-free delivery of oral care. OSAP supports this commitment
to dental workers and the public through quality education and
information dissemination. OSAP's unique membership includes the
variety of partners critical to gather the data on compliance with the
OSHA bloodborne pathogens standard, to identify barriers and to develop
strategies to overcome barriers to compliance.
OSAP will be conducting a web survey of private dental practices in
the United States. Information collected will include: The use of
existing exposure control plans; whether the plan or other resources
actively used to prevent occupation exposure to bloodborne pathogens;
availability of resources such as relevant education materials, and
barriers to use such as knowledge, costs, and availability. OSAP is
working with a publishing partner that has an email distribution list
of 49,172 private practice dentists representing general dentists and
specialists. This sampling frame represents nearly 30% of the total
population of U.S. private practice dentists. The survey sample,
totaling 40,575 dentists, will include general dentists, oral and
maxillofacial surgeons, pediatric dentists and periodonists. The
targeted number of completed questionnaires is estimated at about
20,287 (50% participation rate). The survey is estimated to take about
15 minutes for respondents to complete. There is no cost to respondents
other than their time. The total estimated annualized burden hours are
5,072.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avgerage Burden
Type of respondents Form name Number of responses per per response (in
respondents respondent hrs)
----------------------------------------------------------------------------------------------------------------
Private Practice Dentists........ BBP Exposure Control 20,287 1 15/60
Plan Survey.
----------------------------------------------------------------------------------------------------------------
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013-18909 Filed 8-5-13; 8:45 am]
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