Agency Forms Undergoing Paperwork Reduction Act Review, 35645-35646 [2018-16091]
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Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
Prevention, and the Agency for Toxic
Substances and Disease Registry.
Administration of erdafitinib
Administration of esketamine
hydrochloride nasal spray, for
intranasal use
Administration of ERLEADATM
(apalutamide), for oral use
Dia Taylor,
Acting Chief Operating Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2018–16102 Filed 7–26–18; 8:45 am]
BILLING CODE 4160–18–P
Addenda and Key Updates
ICD–10–CM Topics
Deep Vein Thrombosis
Dravet Syndrome
Latent Tuberculosis Infection
Pressure ulcer of mucosal membrane by
site
ICD–10–CM Addendum
Agenda items are subject to change as
priorities dictate.
Security Considerations: Due to
increased security requirements, CMS
has instituted stringent procedures for
entrance into the building by nongovernment employees.
Attendees will need to present valid
government-issued picture
identification, and sign-in at the
security desk upon entering the
building.
Attendees who wish to attend the
September 11–12, 2018, ICD–10–CM
C&M meeting must submit their name
and organization by September 3, 2018,
for inclusion on the visitor list. This
visitor list will be maintained at the
front desk of the CMS building and used
by the guards to admit visitors to the
meeting.
Participants who attended previous
Coordination and Maintenance meetings
will no longer be automatically added to
the visitor list. You must request
inclusion of your name prior to each
meeting you wish attend.
Please register to attend the meeting
on-line at: https://www.cms.hhs.gov/
apps/events/.
Please contact Mady Hue (410–786–
4510) or Marilu.hue@cms.hhs.gov for
questions about the registration process.
amozie on DSK3GDR082PROD with NOTICES1
Note: CMS and NCHS no longer provide
paper copies of handouts for the meeting.
Electronic copies of all meeting materials
will be posted on the CMS and NCHS
websites prior to the meeting at https://
www.cms.hhs.gov/ICD9Provider
DiagnosticCodes/03_
meetings.asp#TopOfPage and https://
www.cdc.gov/nchs/icd/icd10cm_
maintenance.htm.
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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
VerDate Sep<11>2014
17:38 Jul 26, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–0556]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Assisted
Reproductive Technology (ART)
Program Reporting System to the Office
of Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on May 10,
2018 to obtain comments from the
public and affected agencies. CDC did
not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
35645
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
Assisted Reproductive Technology
(ART) Program Reporting System (OMB
No. 0920–0556, expires 7/31/2018)—
Revision—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Section 2(a) of Public Law 102–493
(known as the Fertility Clinic Success
Rate and Certification Act of 1992
(FCSRCA), 42 U.S.C. 263a–1(a)) requires
that each assisted reproductive
technology (ART) program shall
annually report to the Secretary through
the Centers for Disease Control and
Prevention: (1) Pregnancy success rates
achieved by such ART program, and (2)
the identity of each embryo laboratory
used by such ART program and whether
the laboratory is certified or has applied
for such certification under the Act. The
required information is currently
reported by ART programs to CDC as
specified in the Assisted Reproductive
Technology (ART) Program Reporting
System (OMB No. 0920–0556, exp. 7/
31/2018). CDC seeks to extend OMB
approval for a period of three years. The
revised total burden estimate is lower
than under the previous approval, due
to removal of the burden associated
with a one-time system upgrade that
was completed under the prior
approval. However, some of this burden
reduction will be offset by an increase
in the number of ART clinics and cycles
reported, due to an increase in the
utilization of ART in the United States.
The currently approved program
reporting system, also known as the
National ART Surveillance System
(NASS), includes information about all
ART cycles initiated by any of the ART
programs in the United States. An ART
cycle is considered to begin when a
woman begins taking ovarian
stimulatory drugs or starts ovarian
monitoring with the intent of having
embryos transferred; for each cycle, CDC
collects information about the
pregnancy outcome, as well as a number
of data items deemed by experts in the
field to be important to explain
E:\FR\FM\27JYN1.SGM
27JYN1
35646
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
variability in success rates across ART
programs and individuals.
Each ART program reports its annual
ART cycle data to CDC in midDecember. The annual data reporting
consists of information about all ART
cycles that were initiated in the
previous calendar year. For example,
the December 2017 reports described
ART cycles that were initiated between
January 1, 2016, and December 31, 2016.
Data elements and definitions currently
in use reflect CDC’s prior consultations
with representatives of the Society for
Assisted Reproductive Technology
(SART), the American Society for
Reproductive Medicine, and RESOLVE:
The National Infertility Association (a
national, nonprofit consumer
organization), as well as a variety of
individuals with expertise and interest
in this field.
The estimated number of respondents
(ART programs or clinics) is 464, based
on the number of clinics that provided
information in 2015; the estimated
average number of responses (ART
cycles) per respondent is 350.
Additionally, approximately 5–10% of
responding clinics will be randomly
selected each year to participate in data
validation and quality control activities;
an estimated 35 clinics will be selected
to report validation data on 70 cycles
each on average. Finally, respondents
may provide feedback to CDC about the
usability and utility of the reporting
system. The option to participate in the
feedback survey is presented to
respondents when they complete their
required data submission. Participation
in the feedback survey is voluntary and
is not required by the FCSRCA. CDC
estimates that 75% of ART programs
will participate in the feedback survey.
The collection of ART cycle
information allows CDC to publish an
annual report to Congress as specified
by the FCSRCA and to provide
information needed by consumers. OMB
approval is requested for three years.
The estimated annualized Burden Hours
are 114,631 which is a decrease of 1,794
from the current OMB-approved
collection. There are no costs to
respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
ART Clinics .....................................................
NASS ..............................................................
Data Validation ...............................................
Feedback Survey ...........................................
Jeffrey M. Zirger,
Acting 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. 2018–16091 Filed 7–26–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–0222]
amozie on DSK3GDR082PROD with NOTICES1
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Collaborating
Center for Questionnaire Design and
Evaluation Research (CCQDER), to the
Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on March 1, 2018 to obtain
comments from the public and affected
agencies. CDC did not receive comments
related to the previous notice. This
notice serves to allow an additional 30
VerDate Sep<11>2014
17:38 Jul 26, 2018
Jkt 244001
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(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. Direct
written comments and/or suggestions
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Number of
responses
per
respondent
464
35
348
350
70
1
Average
burden per
response
(in hours)
42/60
23/60
2/60
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
Collaborating Center for Questionnaire
Design and Evaluation Research
(CCQDER) (OMB Control Number 0920–
0222, Expiration 07/31/2018)—
Revision—National Center for Health
Statistics (NCHS), Centers for Disease
Control and Prevention (CDC)
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall undertake
and support (by grant or contract)
research, demonstrations, and
evaluations respecting new or improved
methods for obtaining current data to
support statistical and epidemiological
activities for the purpose of improving
the effectiveness, efficiency, and quality
of health services in the United States.
The Collaborating Center for
Questionnaire Design and Evaluation
Research (CCQDER) is the focal point
within NCHS for questionnaire and
survey development, pre-testing, and
evaluation activities for CDC surveys
(such as the NCHS National Health
E:\FR\FM\27JYN1.SGM
27JYN1
]]>Agencies
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35645-35646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16091]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-0556]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Assisted Reproductive Technology (ART)
Program Reporting System to the Office of Management and Budget (OMB)
for review and approval. CDC previously published a ``Proposed Data
Collection Submitted for Public Comment and Recommendations'' notice on
May 10, 2018 to obtain comments from the public and affected agencies.
CDC did not receive comments related to the previous notice. This
notice serves to allow an additional 30 days for public and affected
agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(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 [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
Assisted Reproductive Technology (ART) Program Reporting System
(OMB No. 0920-0556, expires 7/31/2018)--Revision--National Center for
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Section 2(a) of Public Law 102-493 (known as the Fertility Clinic
Success Rate and Certification Act of 1992 (FCSRCA), 42 U.S.C. 263a-
1(a)) requires that each assisted reproductive technology (ART) program
shall annually report to the Secretary through the Centers for Disease
Control and Prevention: (1) Pregnancy success rates achieved by such
ART program, and (2) the identity of each embryo laboratory used by
such ART program and whether the laboratory is certified or has applied
for such certification under the Act. The required information is
currently reported by ART programs to CDC as specified in the Assisted
Reproductive Technology (ART) Program Reporting System (OMB No. 0920-
0556, exp. 7/31/2018). CDC seeks to extend OMB approval for a period of
three years. The revised total burden estimate is lower than under the
previous approval, due to removal of the burden associated with a one-
time system upgrade that was completed under the prior approval.
However, some of this burden reduction will be offset by an increase in
the number of ART clinics and cycles reported, due to an increase in
the utilization of ART in the United States.
The currently approved program reporting system, also known as the
National ART Surveillance System (NASS), includes information about all
ART cycles initiated by any of the ART programs in the United States.
An ART cycle is considered to begin when a woman begins taking ovarian
stimulatory drugs or starts ovarian monitoring with the intent of
having embryos transferred; for each cycle, CDC collects information
about the pregnancy outcome, as well as a number of data items deemed
by experts in the field to be important to explain
[[Page 35646]]
variability in success rates across ART programs and individuals.
Each ART program reports its annual ART cycle data to CDC in mid-
December. The annual data reporting consists of information about all
ART cycles that were initiated in the previous calendar year. For
example, the December 2017 reports described ART cycles that were
initiated between January 1, 2016, and December 31, 2016. Data elements
and definitions currently in use reflect CDC's prior consultations with
representatives of the Society for Assisted Reproductive Technology
(SART), the American Society for Reproductive Medicine, and RESOLVE:
The National Infertility Association (a national, nonprofit consumer
organization), as well as a variety of individuals with expertise and
interest in this field.
The estimated number of respondents (ART programs or clinics) is
464, based on the number of clinics that provided information in 2015;
the estimated average number of responses (ART cycles) per respondent
is 350. Additionally, approximately 5-10% of responding clinics will be
randomly selected each year to participate in data validation and
quality control activities; an estimated 35 clinics will be selected to
report validation data on 70 cycles each on average. Finally,
respondents may provide feedback to CDC about the usability and utility
of the reporting system. The option to participate in the feedback
survey is presented to respondents when they complete their required
data submission. Participation in the feedback survey is voluntary and
is not required by the FCSRCA. CDC estimates that 75% of ART programs
will participate in the feedback survey.
The collection of ART cycle information allows CDC to publish an
annual report to Congress as specified by the FCSRCA and to provide
information needed by consumers. OMB approval is requested for three
years. The estimated annualized Burden Hours are 114,631 which is a
decrease of 1,794 from the current OMB-approved collection. There are
no costs to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
ART Clinics........................... NASS.................... 464 350 42/60
Data Validation......... 35 70 23/60
Feedback Survey......... 348 1 2/60
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Acting 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. 2018-16091 Filed 7-26-18; 8:45 am]
BILLING CODE 4163-18-P
