83 FR 21779 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 91 (May 10, 2018)

Page Range		21779-21780
FR Document		2018-09916

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 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).

Federal Register, Volume 83 Issue 91 (Thursday, May 10, 2018)

[Federal Register Volume 83, Number 91 (Thursday, May 10, 2018)]
[Notices]
[Pages 21779-21780]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-09916]

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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

AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: 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 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.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION: 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:

[[Page 21780]]

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) 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 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 and 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 Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
(ART programs or clinics...... NASS............ 464 350 42/60 113,680
Data Validation. 35 70 23/60 939
Feedback Survey. 348 1 2/60 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]
BILLING CODE 4163-18-P

Federal Register / Vol. 83, No. 91 / Thursday, May 10, 2018 / Notices 21779

• Tracking data reports will no longer extracted from the HIV surveillance Because the medical records are
be sent to CDC, as this information is no system from which they are sampled, abstracted by MMP staff, these changes
longer needed. these changes do not affect the burden do not affect the burden of the project.
• The average token of appreciation of the project. This proposed data collection would
for participants has been increased from • Revisions to the interview supplement the National HIV
$25 to $50. questionnaire were made to improve Surveillance System (NHSS, OMB
• Non-substantive changes have been
coherence, boost the efficiency of the Control No. 0920–0573, Exp. 6/30/2019)
made to recruitment materials to
data collection, and increase the in 23 selected state and local health
decrease the reading comprehension
relevance and value of the information. departments, which collect information
level, simplify and standardize
Based on an evaluation of the currently on persons diagnosed with, living with,
procedures, and incorporate a user-
approved MMP interview instrument and dying from HIV infection and AIDS.
friendly eligibility checklist.
• Changes have been made to the 118 questions were added to the Through their participation,
respondent consent form to decrease the interview form and 221 questions were respondents will help to improve
reading comprehension level and clarify removed. However, the average amount programs to prevent HIV infection as
whom participants should contact for of time to complete the interview did well as services for those who already
different concerns. not change. have HIV. The total burden hours are
• Forty-three data elements were • Thirty-nine data elements were 6,354 hours. The participation of
removed from the minimum data set removed from the MRA data structure respondents is voluntary. There is no
and thirty-seven data elements were because they were not found to be cost to the respondents other than their
added. Because these data elements are useful. No new elements were added. time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of
Type of respondent Form name responses per hours per
respondents respondent response

Sampled, Eligible HIV-Infected Persons ......... Interview Questionnaire (att 8a) ..................... 7,760 1 45/60
Facility office staff looking up contact informa- Look up contact information ........................... 1,940 1 2/60
tion.
Facility office staff approaching sampled per- Approach persons for enrollment ................... 970 1 5/60
sons for enrollment.
Facility office staff pulling medical records ..... Pull medical records ....................................... 7,760 1 3/60

Jeffrey M. Zirger, information collection, as required by FOR FURTHER INFORMATION CONTACT: To
Acting Chief, Information Collection Review the Paperwork Reduction Act of 1995. request more information on the
Office, Office of Scientific Integrity, Office This notice invites comment on a proposed project or to obtain a copy of
of the Associate Director for Science, Office proposed information collection project the information collection plan and
of the Director, Centers for Disease Control titled ‘‘Assisted Reproductive instruments, contact Leroy A.
and Prevention.
Technology (ART) Program Reporting’’ Richardson, Information Collection
[FR Doc. 2018–09914 Filed 5–9–18; 8:45 am] that collects information on ART cycles Review Office, Centers for Disease
BILLING CODE 4163–18–P to publish information on pregnancy Control and Prevention, 1600 Clifton
success rates as required under Section Road NE, MS–D74, Atlanta, Georgia
2(a) of the Federal Clinic Success Rate 30329; phone: 404–639–7570; Email:
DEPARTMENT OF HEALTH AND and Certification Act (FCSRCA). omb@cdc.gov.
HUMAN SERVICES
DATES: CDC must receive written SUPPLEMENTARY INFORMATION: Under the
Centers for Disease Control and comments on or before July 9, 2018. Paperwork Reduction Act of 1995 (PRA)
Prevention ADDRESSES: You may submit comments, (44 U.S.C. 3501–3520), Federal agencies
[60-Day–FY–0556; Docket No. CDC–2018– identified by Docket No. CDC–2018– must obtain approval from the Office of
0037] 0037 by any of the following methods: Management and Budget (OMB) for each
• Federal eRulemaking Portal: collection of information they conduct
Proposed Data Collection Submitted Regulations.gov. Follow the instructions or sponsor. In addition, the PRA also
for Public Comment and for submitting comments. requires Federal agencies to provide a
Recommendations • Mail: Leroy A. Richardson, 60-day notice in the Federal Register
Information Collection Review Office, concerning each proposed collection of
AGENCY: Centers for Disease Control and
Centers for Disease Control and information, including each new
Prevention (CDC), Department of Health
Prevention, 1600 Clifton Road NE, MS– proposed collection, each proposed
and Human Services (HHS).
D74, Atlanta, Georgia 30329. extension of existing collection of
ACTION: Notice with comment period. information, and each reinstatement of
Instructions: All submissions received
SUMMARY: The Centers for Disease must include the agency name and previously approved information
daltland on DSKBBV9HB2PROD with NOTICES

Control and Prevention (CDC), as part of Docket Number. CDC will post, without collection before submitting the
its continuing effort to reduce public change, all relevant comments to collection to the OMB for approval. To
burden and maximize the utility of Regulations.gov. comply with this requirement, we are
government information, invites the Please note: Submit all comments publishing this notice of a proposed
general public and other Federal through the Federal eRulemaking portal data collection as described below.
agencies the opportunity to comment on (regulations.gov) or by U.S. mail to the The OMB is particularly interested in
a proposed and/or continuing address listed above. comments that will help:

VerDate Sep<11>2014 16:29 May 09, 2018 Jkt 244001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\FR\FM\10MYN1.SGM 10MYN1

Document Created: 2018-11-02 09:47:39
Document Modified: 2018-11-02 09:47:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		CDC must receive written comments on or before July 9, 2018.
Contact		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: [email protected]
FR Citation		83 FR 21779

83 FR 21779 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 83, Issue 91 (May 10, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention