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

Administration of erdafitinib 

Administration of esketamine 

hydrochloride nasal spray, for 

intranasal use 

Administration of ERLEADATM 

(apalutamide), for oral use 

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: http://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. 

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 http://

www.cms.hhs.gov/ICD9Provider

DiagnosticCodes/03_

meetings.asp#TopOfPage and https://

www.cdc.gov/nchs/icd/icd10cm_

maintenance.htm. 

The Director, Management Analysis 

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 

Prevention, and the Agency for Toxic 

Substances and Disease Registry. 

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 

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 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 


amozie on DSK3GDR082PROD with NOTICES1
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

Type of respondents Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–18–0222] 

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 

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 

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 


amozie on DSK3GDR082PROD with NOTICES1