Agency Forms Undergoing Paperwork Reduction Act Review, 55258-55259 [2013-21911]
Download as PDF
<![CDATA[
sroberts on DSK5SPTVN1PROD with NOTICES
55258
Federal Register / Vol. 78, No. 175 / Tuesday, September 10, 2013 / Notices
confidentiality requirements. In
particular, under § 3.404, a person who
discloses identifiable PSWP in knowing
or reckless violation of the Patient
Safety Act and 42 CFR part 3 shall be
subject to a civil money penalty (CMP)
of not more than $10,000 for each act
constituting a violation.
Congress enacted the Federal Civil
Penalties Inflation Adjustment Act of
1990 (28 U.S.C. 2461 note, as amended
by the Debt Collection Improvement Act
of 1996 (31 U.S.C. 3701)) (Inflation
Adjustment Act), based on its findings
that the impact of CMPs had been
reduced by inflation and that reducing
the impact of CMPs had weakened their
deterrent effect. Inflation Adjustment
Act section 2, 28 U.S.C. 2461 note. In
general, the Inflation Adjustment Act
requires Federal agencies to issue
regulations to adjust for inflation each
CMP provided by law within their
jurisdiction. The Inflation Adjustment
Act applies to civil penalties found
within the Public Health Service Act,
such as the Patient Safety Act’s CMP
provision. The Inflation Adjustment Act
directs agencies to issue regulations to
adjust CMPs under their authority by
October 23, 1996, and to make
additional adjustments at least once
every four years thereafter based on a
specific calculation set forth in the Act.
While the Inflation Adjustment Act
CMP adjustment requirements apply to
most federal statutes, they do not apply
to CMPs included in the Social Security
Act. The CMPs for title II, subtitle F
(Administrative Simplification) of the
Health Insurance Portability and
Accountability Act of 1996 (HIPAA) are
found at section 1176 of the Social
Security Act. Thus, the Inflation
Adjustment Act does not require, or
provide authority for, the Department to
adjust the HIPAA administrative
simplification CMPs.
Because the Patient Safety Act was
enacted after October 23, 1996, we
interpret the Inflation Adjustment Act
as requiring the Department to
determine whether an adjustment for
inflation is necessary for the Patient
Safety Act’s CMP amount at least once
every four years, beginning from the
Patient Safety Act’s date of enactment,
which was July 29, 2005. Accordingly,
on August, 25, 2009, we published a
direct final rule to amend the Patient
Safety and Quality Improvement Rule
by adjusting for inflation the maximum
CMP amount for violations of the
confidentiality provisions of the Rule.
(74 FR 42777 (Aug. 25, 2009).) We chose
to use direct final rulemaking because
we did not expect to receive any adverse
comment on the rule. The Department
did not receive any adverse comments,
VerDate Mar<15>2010
16:10 Sep 09, 2013
Jkt 229001
and the direct final rule became
effective and the Patient Safety and
Quality Improvement Rule was
amended on November 23, 2009. The
amendment increased the maximum
CMP amount from $10,000 to $11,000.
II. No Adjustment is Necessary
In accordance with the Inflation
Adjustment Act, the Office for Civil
Rights (OCR) has determined that an
adjustment to the maximum CMP
amount for violations of the
confidentiality provisions of the Patient
Safety and Quality Improvement Rule is
not required at this time.
The Inflation Adjustment Act
provides for the adjustment of a penalty
amount through a three-step process.1
First, we calculate an increase in the
penalty amount by a ‘‘cost-of-living
adjustment.’’ Inflation Adjustment Act
section 5(a), 28 U.S.C. 2461 note. The
Inflation Adjustment Act defines the
cost-of-living adjustment as ‘‘the
percentage (if any) for each civil
monetary penalty by which—(1) the
Consumer Price Index for the month of
June of the calendar year preceding the
adjustment, exceeds (2) the Consumer
Price Index for the month of June of the
calendar year in which the amount of
such civil monetary penalty was last set
or adjusted pursuant to law.’’ Inflation
Adjustment Act section 5(b), 28 U.S.C.
2461 note. Second, we round the
adjustment amount pursuant to the
methodology set forth in section 5(a) of
the Inflation Adjustment Act, which
rounds the increase based on the size of
the underlying penalty, as follows:
Any increase determined under this
subsection shall be rounded to the
nearest—
(1) multiple of $10 in the case of
penalties less than or equal to $100;
(2) multiple of $100 in the case of
penalties greater than $100 but less than
or equal to $1,000;
(3) multiple of $1,000 in the case of
penalties greater than $1,000 but less
than or equal to $10,000;
(4) multiple of $5,000 in the case of
penalties greater than $10,000 but less
than or equal to $100,000;
(5) multiple of $10,000 in the case of
penalties greater than $100,000 but less
than or equal to $200,000; and
(6) multiple of $25,000 in the case of
penalties greater than $200,000.
1 Pursuant to the Debt Collection Improvement
Act’s amendment to the Federal Civil Penalties
Inflation Adjustment Act of 1990, the third-step in
adjusting a penalty amount requires that the first
adjustment of the penalty be limited to ten percent
of the penalty amount. This step is not applicable
here because the first adjustment to the CMP with
respect to the Patient Safety Act occurred on
September 24, 2009.
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
With respect to step 1 of the
adjustment, the Consumer Price Index
(CPI) for June of 2012 (the calendar year
preceding publication of this Notice)
was 229.478. The CPI for June of 2009
(the calendar year the CMP was last
adjusted for inflation) was 215.693. The
percent change in these CPIs is an
increase of 6.39 percent. This leads to
an unrounded increase in the Patient
Safety Act’s CMP of $702.90.
With respect to step 2 of the
adjustment, we rounded the amount of
the increase ($702.90) to the nearest
multiple of $5,000 because the current
maximum CMP is $11,000, which
places it in tier (4) above (i.e., penalties
greater than $10,000 but less than or
equal to $100,000). The nearest multiple
of $5,000 for the $702.90 increase is
zero.
Thus, based on the above, we are not
amending 42 CFR 3.404(b) at this time,
and the current maximum CMP remains
at $11,000. As required by the Inflation
Adjustment Act, we will consider
whether an adjustment is needed again
in four years.
Dated: September 3, 2013.
Leon Rodriguez,
Director.
[FR Doc. 2013–22006 Filed 9–9–13; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–13–13OE]
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
Image-Assisted Cytology Workload
Assessment and Measure—New—Office
of Surveillance, Epidemiology, and
Laboratory Services (OSELS), Centers
for Disease Control and Prevention
(CDC).
E:\FR\FM\10SEN1.SGM
10SEN1
55259
Federal Register / Vol. 78, No. 175 / Tuesday, September 10, 2013 / Notices
Background and Brief Description
CDC provides technical guidance to
the Department of Health and Human
Services (HHS) in coordination with the
Centers for Medicare & Medicaid
Services (CMS) and the Food and Drug
Administration (FDA) for the
implementation of the Clinical
Laboratory Improvement Amendments
(CLIA). The Clinical Laboratory
Improvement Amendments of 1988
(CLIA) directed the Secretary of Health
and Human Services to establish the
maximum number of cytology slides
that any individual may screen in a 24
hour period; to establish certain quality
assurance standards; to set personnel
standards; and to provide for periodic
proficiency testing of cytotechnologists
and pathologists involved in screening
and interpreting cytological
preparations.
The regulations implementing CLIA,
published in the Federal Register of
February 28, 1992, established that the
maximum number of slides examined
by an individual in each 24 hour period
was not to exceed 100 slides and could
not be examined in less than an eight
hour day. The regulation further
established that the technical supervisor
is required to evaluate the performance
of cytotechnologists at least every six
months and determine their individual
maximum daily workload limit. In 1992,
when the regulation was published, all
Pap slides were conventional ‘‘Pap
smears.’’ In a conventional Pap smear,
samples are smeared directly onto a
glass microscope slide after collection.
The cells are often obscured by blood or
the smear may be too thick and contain
contaminating artifacts. Today, almost
all Pap tests in the U.S. are collected
with a liquid-based method. Instead of
‘‘smearing’’ cervical cells directly onto a
glass microscope slide, the cells are sent
to the laboratory in a liquid preservative
and processed by an automated
processor. This processor disperses a
uniform thickness representative sample
on the slide that is free of obscuring
blood, mucus, and non-diagnostic
debris in a circle that covers less than
one half of the slide.
CLIA’s Federal Advisory Committee,
the Clinical Laboratory Improvement
Advisory Committee (CLIAC), has
discussed cytology workload on
numerous occasions from 1996 until
present. On August 29, 2011 the
American Society of Cytopathology’s
(ASC) Executive Board approved an
ASC task force recommendation that the
average laboratory cytotechnologist
productivity should not exceed 70
slides and that an individual’s screening
time should not exceed seven (7) hours
in a 24 hour period.
Each laboratory will receive an
advance request to participate in the
Image-Assisted Cytology Workload
Practices Survey from a DLSS contractor
that has been selected to collect the
survey data and conduct the time
measure study. Respondents will be
cytology supervisors from the 1,245
cytology laboratories in the Unites
States. Since a response to this survey
is voluntary we would expect an 80%
response rate or approximately 996
laboratories. Responses would be
submitted in written format. The
estimated burden per response is one
half hour. In addition, individual
cytotechnologists working in the
laboratory will be asked to complete the
Image-Assisted Cytology Workload
Assessment Survey. There are 6,064
cytotechnologists in the United States.
Response to this survey is voluntary, so
we would expect an 80% response rate
or approximately 4,581
cytotechnologists. Responses would be
submitted in written format. The
estimated burden per response is one
half hour. CDC requests OMB approval
to collect information for one year.
There are no costs to respondents
other than their time.
The total estimated annual burden
hours are 2,789.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Cytology Supervisor ........................................
Cytotechnologists ............................................
Image-Assisted Cytology Workload Practices
Image-Assisted Cytology Workload Assessment.
Leroy 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. 2013–21911 Filed 9–9–13; 8:45 am]
Centers for Disease Control and
Prevention
[60-Day–13–0199]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
BILLING CODE 4163–18–P
sroberts on DSK5SPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
VerDate Mar<15>2010
16:10 Sep 09, 2013
Jkt 229001
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
996
4,581
Number of
responses per
respondent
1
1
Average
burden per
response
(in hrs.)
30/60
30/60
instruments, call 404–639–7570 and
send comments to LeRoy Richardson,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an email to omb@
cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) 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. Written comments should
E:\FR\FM\10SEN1.SGM
10SEN1
]]>Agencies
[Federal Register Volume 78, Number 175 (Tuesday, September 10, 2013)]
[Notices]
[Pages 55258-55259]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21911]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-13-13OE]
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
Image-Assisted Cytology Workload Assessment and Measure--New--
Office of Surveillance, Epidemiology, and Laboratory Services (OSELS),
Centers for Disease Control and Prevention (CDC).
[[Page 55259]]
Background and Brief Description
CDC provides technical guidance to the Department of Health and
Human Services (HHS) in coordination with the Centers for Medicare &
Medicaid Services (CMS) and the Food and Drug Administration (FDA) for
the implementation of the Clinical Laboratory Improvement Amendments
(CLIA). The Clinical Laboratory Improvement Amendments of 1988 (CLIA)
directed the Secretary of Health and Human Services to establish the
maximum number of cytology slides that any individual may screen in a
24 hour period; to establish certain quality assurance standards; to
set personnel standards; and to provide for periodic proficiency
testing of cytotechnologists and pathologists involved in screening and
interpreting cytological preparations.
The regulations implementing CLIA, published in the Federal
Register of February 28, 1992, established that the maximum number of
slides examined by an individual in each 24 hour period was not to
exceed 100 slides and could not be examined in less than an eight hour
day. The regulation further established that the technical supervisor
is required to evaluate the performance of cytotechnologists at least
every six months and determine their individual maximum daily workload
limit. In 1992, when the regulation was published, all Pap slides were
conventional ``Pap smears.'' In a conventional Pap smear, samples are
smeared directly onto a glass microscope slide after collection. The
cells are often obscured by blood or the smear may be too thick and
contain contaminating artifacts. Today, almost all Pap tests in the
U.S. are collected with a liquid-based method. Instead of ``smearing''
cervical cells directly onto a glass microscope slide, the cells are
sent to the laboratory in a liquid preservative and processed by an
automated processor. This processor disperses a uniform thickness
representative sample on the slide that is free of obscuring blood,
mucus, and non-diagnostic debris in a circle that covers less than one
half of the slide.
CLIA's Federal Advisory Committee, the Clinical Laboratory
Improvement Advisory Committee (CLIAC), has discussed cytology workload
on numerous occasions from 1996 until present. On August 29, 2011 the
American Society of Cytopathology's (ASC) Executive Board approved an
ASC task force recommendation that the average laboratory
cytotechnologist productivity should not exceed 70 slides and that an
individual's screening time should not exceed seven (7) hours in a 24
hour period.
Each laboratory will receive an advance request to participate in
the Image-Assisted Cytology Workload Practices Survey from a DLSS
contractor that has been selected to collect the survey data and
conduct the time measure study. Respondents will be cytology
supervisors from the 1,245 cytology laboratories in the Unites States.
Since a response to this survey is voluntary we would expect an 80%
response rate or approximately 996 laboratories. Responses would be
submitted in written format. The estimated burden per response is one
half hour. In addition, individual cytotechnologists working in the
laboratory will be asked to complete the Image-Assisted Cytology
Workload Assessment Survey. There are 6,064 cytotechnologists in the
United States. Response to this survey is voluntary, so we would expect
an 80% response rate or approximately 4,581 cytotechnologists.
Responses would be submitted in written format. The estimated burden
per response is one half hour. CDC requests OMB approval to collect
information for one year.
There are no costs to respondents other than their time.
The total estimated annual burden hours are 2,789.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs.)
----------------------------------------------------------------------------------------------------------------
Cytology Supervisor................... Image-Assisted Cytology 996 1 30/60
Workload Practices.
Cytotechnologists..................... Image-Assisted Cytology 4,581 1 30/60
Workload Assessment.
----------------------------------------------------------------------------------------------------------------
Leroy 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. 2013-21911 Filed 9-9-13; 8:45 am]
BILLING CODE 4163-18-P
