60 day FRN

Att B1. FRN 07 21 2014 Proposed Changes.pdf

Assisted Reproductive Technology (ART) Program Reporting System

60 day FRN

OMB: 0920-0556

Document [pdf]
Download: pdf | pdf
42328

Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices

planning and implementation of CDC
Pre-Pandemic Guidance on the use of
school related measures, including
school closures, to slow transmission
during an influenza pandemic.
School closures were considered an
important measure during the earliest
stage of the 2009 H1N1 pandemic,
because a pandemic vaccine was not
available until October (6 months later),
and sufficient stocks to immunize all
school-age children were not available
until December. However, retrospective
review of the U.S. government response
to the pandemic identified a limited
evidence-base regarding the
effectiveness, acceptability, and
feasibility of various school related

measures during mild or moderately
severe pandemics. Guidance updates
will require an evidence-based rationale
for determining the appropriate triggers,
timing, and duration of school related
measures, including school closures,
during a pandemic.
CDC staff proposes that the
information collection for this package
will target adult and child populations
in a school district in Wisconsin. CDC
will collect reports of individual student
symptoms, vaccination status, recent
travel, recent exposure to people with
influenza symptoms and duration of
illness; this will be accomplished
through telephone and in-person
interviews.

Findings obtained from this
information collection will be used to
inform the update CDC’s Pre-pandemic
Guidance on the implementation of
school related measures to prevent the
spread of influenza, especially school
closures. This Guidance is used as an
important planning and reference tool
for both State and local health
departments in the United States.
CDC estimates that 1,500 participants
could be recruited by information
collections covered by this information
collection. It is estimated that
information collection activities will
total 3,500 burden hours per year. There
is no cost to respondents other than
their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

Parents of children/adolescents
schools (Wisconsin).
Parents of children/adolescents
schools (Wisconsin).

1,500

4

5/60

attending

Acute Respiratory Infection and Influenza
Surveillance Form.

1,500

4

30/60

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–14–0556]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

emcdonald on DSK67QTVN1PROD with NOTICES

Average
burden per
response
(in hours)

Screening Form ..............................................

[FR Doc. 2014–17051 Filed 7–18–14; 8:45 am]

The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden, invites the general public and
other Federal agencies to take this
opportunity to comment on proposed
and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995. To
request more information on the below
proposed project or to obtain a copy of
the information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].

17:14 Jul 18, 2014

Number of
responses per
respondent

attending

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.

VerDate Mar<15>2010

Number of
respondents

Form name

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Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. 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; (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; and (e) estimates of capital
or start-up 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

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data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
Proposed Project
Assisted Reproductive Technology
(ART) Program Reporting System (OMB
No. 0920–0556, expires 8/31/2015)—
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 reported by ART
programs to CDC as specified in the
Assisted Reproductive Technology
(ART) Program Reporting System (OMB
No. 0920–0556, exp. 8/31/2015).
The currently approved program
reporting system, also known as the

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Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices
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 be initiated when
a woman begins taking ovarian
stimulatory drugs or starts ovarian
monitoring with the intent of
transferring one or more embryos. CDC
also collects information about the
pregnancy outcome of each cycle, as
well as a number of data items deemed
important to explain variability in
success rates across ART programs and
across 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 2013 reports described
ART cycles that were initiated between
January 1, 2012, and December 31, 2012.
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.
CDC, the data collection contractor,
and partner organizations engage in

be deferred until January 1, 2016.
During the period of this revision, the
estimated number of respondents (ART
programs or clinics) will increase from
440 to 450; the estimated number of
ART cycles reported by each clinic will
increase from 339 to 360; and the
estimated burden per response will
increase from 39 minutes to 40 minutes.
In addition, 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. However, 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.
Overall, the proposed changes will
support CDC’s ability to generate timely,
accurate, and relevant information about
fertility clinic success rates and improve
user satisfaction with the NASS
interface.
OMB approval is requested for three
years and there are no costs to
respondents other than their time.

ongoing dialogue to identify
opportunities for improvement. As a
result of these discussions, a number of
changes to the NASS data elements and
the NASS reporting platform are under
consideration and will be submitted to
OMB for approval. Changes to the NASS
data elements are essential to keep pace
with changes in medical practice,
ensure that reported success rates reflect
standardized definitions, and provide
additional insight into factors that may
affect success rates. Specific changes to
the NASS data elements include the
addition of new items as well as
modification or discontinuation of
selected items. CDC also plans to
redesign the graphical interface for
NASS. In addition to reflecting the
changes in data items, NASS data entry
pages will be redesigned for more
intuitive grouping of data items and will
employ embedded skip logic to route
users to the minimum number of
applicable questions. Respondents will
have the option of entering data directly
into the Web-based NASS interface or of
transmitting system-compatible files
extracted from other record systems. On
an annual basis, approximately ten
percent of responding clinics are also
selected to participate in data validation
and quality control activities.
Implementation of these changes for
ART cycles initiated on or after January
1, 2015, is under consideration, but may

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
burden
hours

Form name

ART Programs ..................................

NASS ................................................
Feedback Survey .............................

450
338

360
1

40/60
2/60

108,000
11

Total ...........................................

...........................................................

........................

........................

........................

108,011

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.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2014–17033 Filed 7–18–14; 8:45 am]

Board of Scientific Counselors,
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry (BSC, NCEH/
ATSDR)

BILLING CODE 4163–18–P

emcdonald on DSK67QTVN1PROD with NOTICES

Number of
respondents

Type of respondent

Centers for Disease Control and
Prevention

In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following teleconference
meeting of the aforementioned
committee:

VerDate Mar<15>2010

17:14 Jul 18, 2014

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Time And Date: 2:00 p.m.–4:00 p.m.,
August 11, 2014.
Place: Teleconference.
Status: Open to the public, limited only by
the conference lines available. The toll-free,
dial-in number is 1–877–315–6535 and the
passcode is 383520.
Purpose: The Secretary, Department of
Health and Human Services (HHS) and by
delegation, the Director, CDC and
Administrator, NCEH/ATSDR, are authorized
under Section 301(42 U.S.C. 241) and Section
311(42 U.S.C. 243) of the Public Health
Service Act, as amended, to: (1) Conduct,
encourage, cooperate with, and assist other
appropriate public authorities, scientific
institutions, and scientists in the conduct of
research, investigations, experiments,
demonstrations, and studies relating to the
causes, diagnosis, treatment, control, and
prevention of physical and mental diseases

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