83 FR 35645 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 83, Issue 145 (July 27, 2018)

Page Range		35645-35646
FR Document		2018-16091
Federal Register, Volume 83 Issue 145 (Friday, July 27, 2018)
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35645-35646]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16091]


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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
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35645

Administration of erdafitinib Prevention, and the Agency for Toxic of the information collection plan and
Administration of esketamine Substances and Disease Registry. instruments, call (404) 639–7570 or
hydrochloride nasal spray, for send an email to omb@cdc.gov. Direct
Dia Taylor,
intranasal use written comments and/or suggestions
Acting Chief Operating Officer, Centers for
Administration of ERLEADATM Disease Control and Prevention.
regarding the items contained in this
(apalutamide), for oral use notice to the Attention: CDC Desk
[FR Doc. 2018–16102 Filed 7–26–18; 8:45 am]
Officer, Office of Management and
Addenda and Key Updates BILLING CODE 4160–18–P
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
ICD–10–CM Topics
DEPARTMENT OF HEALTH AND 395–5806. Provide written comments
Deep Vein Thrombosis within 30 days of notice publication.
HUMAN SERVICES
Dravet Syndrome
Proposed Project
Latent Tuberculosis Infection Centers for Disease Control and
Pressure ulcer of mucosal membrane by Prevention Assisted Reproductive Technology
site (ART) Program Reporting System (OMB
[30Day–18–0556]
No. 0920–0556, expires 7/31/2018)—
ICD–10–CM Addendum
Agency Forms Undergoing Paperwork Revision—National Center for Chronic
Agenda items are subject to change as Reduction Act Review Disease Prevention and Health
priorities dictate. Promotion (NCCDPHP), Centers for
Security Considerations: Due to In accordance with the Paperwork Disease Control and Prevention (CDC).
increased security requirements, CMS Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC) Background and Brief Description
has instituted stringent procedures for
entrance into the building by non- has submitted the information Section 2(a) of Public Law 102–493
government employees. collection request titled Assisted (known as the Fertility Clinic Success
Reproductive Technology (ART) Rate and Certification Act of 1992
Attendees will need to present valid
Program Reporting System to the Office (FCSRCA), 42 U.S.C. 263a–1(a)) requires
government-issued picture
of Management and Budget (OMB) for that each assisted reproductive
identification, and sign-in at the review and approval. CDC previously
security desk upon entering the technology (ART) program shall
published a ‘‘Proposed Data Collection annually report to the Secretary through
building. Submitted for Public Comment and the Centers for Disease Control and
Attendees who wish to attend the Recommendations’’ notice on May 10, Prevention: (1) Pregnancy success rates
September 11–12, 2018, ICD–10–CM 2018 to obtain comments from the achieved by such ART program, and (2)
C&M meeting must submit their name public and affected agencies. CDC did the identity of each embryo laboratory
and organization by September 3, 2018, not receive comments related to the used by such ART program and whether
for inclusion on the visitor list. This previous notice. This notice serves to the laboratory is certified or has applied
visitor list will be maintained at the allow an additional 30 days for public for such certification under the Act. The
front desk of the CMS building and used and affected agency comments. required information is currently
by the guards to admit visitors to the CDC will accept all comments for this reported by ART programs to CDC as
meeting. proposed information collection project. specified in the Assisted Reproductive
Participants who attended previous The Office of Management and Budget Technology (ART) Program Reporting
Coordination and Maintenance meetings is particularly interested in comments System (OMB No. 0920–0556, exp. 7/
will no longer be automatically added to that: 31/2018). CDC seeks to extend OMB
the visitor list. You must request (a) Evaluate whether the proposed
approval for a period of three years. The
inclusion of your name prior to each collection of information is necessary
revised total burden estimate is lower
meeting you wish attend. for the proper performance of the
than under the previous approval, due
Please register to attend the meeting functions of the agency, including
to removal of the burden associated
on-line at: http://www.cms.hhs.gov/ whether the information will have
with a one-time system upgrade that
apps/events/. practical utility;
was completed under the prior
(b) Evaluate the accuracy of the
Please contact Mady Hue (410–786– approval. However, some of this burden
agencies estimate of the burden of the
4510) or Marilu.hue@cms.hhs.gov for reduction will be offset by an increase
proposed collection of information,
questions about the registration process. in the number of ART clinics and cycles
including the validity of the
reported, due to an increase in the
Note: CMS and NCHS no longer provide methodology and assumptions used;
paper copies of handouts for the meeting. (c) Enhance the quality, utility, and utilization of ART in the United States.
Electronic copies of all meeting materials clarity of the information to be The currently approved program
will be posted on the CMS and NCHS collected; reporting system, also known as the
websites prior to the meeting at http:// (d) Minimize the burden of the National ART Surveillance System
www.cms.hhs.gov/ICD9Provider collection of information on those who (NASS), includes information about all
DiagnosticCodes/03_ ART cycles initiated by any of the ART
meetings.asp#TopOfPage and https://
are to respond, including, through the
use of appropriate automated, programs in the United States. An ART
www.cdc.gov/nchs/icd/icd10cm_
maintenance.htm. electronic, mechanical, or other cycle is considered to begin when a
technological collection techniques or woman begins taking ovarian
amozie on DSK3GDR082PROD with NOTICES1

The Director, Management Analysis other forms of information technology, stimulatory drugs or starts ovarian
and Services Office, has been delegated e.g., permitting electronic submission of monitoring with the intent of having
the authority to sign Federal Register responses; and embryos transferred; for each cycle, CDC
notices pertaining to announcements of (e) Assess information collection collects information about the
meetings and other committee costs. pregnancy outcome, as well as a number
management activities, for both the To request additional information on of data items deemed by experts in the
Centers for Disease Control and the proposed project or to obtain a copy field to be important to explain

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Document Created: 2018-07-27 04:04:58
Document Modified: 2018-07-27 04:04:58
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
FR Citation		83 FR 35645
83 FR 35645 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 83, Issue 145 (July 27, 2018)

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