60d FRN - published

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Federal Register / Vol. 83, No. 91 / Thursday, May 10, 2018 / Notices
• Tracking data reports will no longer
be sent to CDC, as this information is no
longer needed.
• The average token of appreciation
for participants has been increased from
$25 to $50.
• Non-substantive changes have been
made to recruitment materials to
decrease the reading comprehension
level, simplify and standardize
procedures, and incorporate a userfriendly eligibility checklist.
• Changes have been made to the
respondent consent form to decrease the
reading comprehension level and clarify
whom participants should contact for
different concerns.
• Forty-three data elements were
removed from the minimum data set
and thirty-seven data elements were
added. Because these data elements are

extracted from the HIV surveillance
system from which they are sampled,
these changes do not affect the burden
of the project.
• Revisions to the interview
questionnaire were made to improve
coherence, boost the efficiency of the
data collection, and increase the
relevance and value of the information.
Based on an evaluation of the currently
approved MMP interview instrument
118 questions were added to the
interview form and 221 questions were
removed. However, the average amount
of time to complete the interview did
not change.
• Thirty-nine data elements were
removed from the MRA data structure
because they were not found to be
useful. No new elements were added.

Because the medical records are
abstracted by MMP staff, these changes
do not affect the burden of the project.
This proposed data collection would
supplement the National HIV
Surveillance System (NHSS, OMB
Control No. 0920–0573, Exp. 6/30/2019)
in 23 selected state and local health
departments, which collect information
on persons diagnosed with, living with,
and dying from HIV infection and AIDS.
Through their participation,
respondents will help to improve
programs to prevent HIV infection as
well as services for those who already
have HIV. The total burden hours are
6,354 hours. The participation of
respondents is voluntary. There is no
cost to the respondents other than their
time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
hours per
response

Form name

Sampled, Eligible HIV-Infected Persons .........
Facility office staff looking up contact information.
Facility office staff approaching sampled persons for enrollment.
Facility office staff pulling medical records .....

Interview Questionnaire (att 8a) .....................
Look up contact information ...........................

7,760
1,940

1
1

45/60
2/60

Approach persons for enrollment ...................

970

1

5/60

Pull medical records .......................................

7,760

1

3/60

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. 2018–09914 Filed 5–9–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–FY–0556; Docket No. CDC–2018–
0037]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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Number of
respondents

Type of respondent

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing

SUMMARY:

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information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled ‘‘Assisted Reproductive
Technology (ART) Program Reporting’’
that collects information on ART cycles
to publish information on pregnancy
success rates as required under Section
2(a) of the Federal Clinic Success Rate
and Certification Act (FCSRCA).
DATES: CDC must receive written
comments on or before July 9, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0037 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.

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To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy A.
Richardson, Information Collection
Review Office, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; Email:
omb@cdc.gov.

FOR FURTHER INFORMATION CONTACT:

Under the
Paperwork Reduction Act of 1995 (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. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:

SUPPLEMENTARY INFORMATION:

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21780

Federal Register / Vol. 83, No. 91 / Thursday, May 10, 2018 / Notices

1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. 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 submissions
of responses.
5. Assess information collection costs.
Proposed Project
Assisted Reproductive Technology
(ART) Program Reporting System—
Extension—(OMB# 0920–0556, exp. 7/
31/2018). 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)

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 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
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

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 and
there are no costs to respondents other
than their time.

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Average
burden per
response
(in hours)

Number of
responses per
respondent

Total
burden
(in hours)

Type of
respondents

Form name

(ART programs or clinics ..................

NASS ................................................
Data Validation .................................
Feedback Survey .............................

464
35
348

350
70
1

42/60
23/60
2/60

113,680
939
12

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

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

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

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

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

114,631

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. 2018–09916 Filed 5–9–18; 8:45 am]
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