33300 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substances and 

Disease Registry 

[30Day–21–0062] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Agency for 

Toxic Substances and Disease Registry 

(ATSDR) has submitted the information 

collection request titled ‘‘Supplemental 

Measurements for Exploratory Research 

Regarding Exposure During Activities 

Conducted on Synthetic Turf Fields 

with Tire Crumb Rubber Infill’’ to the 

Office of Management and Budget 

(OMB) for review and approval. ATSDR 

previously published a ‘‘Proposed Data 

Collection Submitted for Public 

Comment and Recommendations’’ 

notice on February 12, 2021 to obtain 

comments from the public and affected 

agencies. ATSDR received one comment 

related to the previous notice. This 

notice serves to allow an additional 30 

days for public and affected agency 

comments. 

ATSDR 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. 

Comments and recommendations for the 

proposed information collection should 

be sent within 30 days of publication of 

this notice to www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 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 

Supplemental Measurements for 

Exploratory Research Regarding 

Exposure During Activities Conducted 

on Synthetic Turf Fields with Tire 

Crumb Rubber Infill (OMB Control No. 

0923–0062, Exp. Date 10/31/2021)— 

Extension—Office of Community Health 

and Hazard Assessment, Agency for 

Toxic Substances and Disease Registry 

(ATSDR). 

Background and Brief Description 

ATSDR is requesting a two-year 

extension for the research study, titled 

‘‘Supplemental Measurements for 

Exploratory Research Regarding 

Exposure During Activities Conducted 

on Synthetic Turf Fields with Tire 

Crumb Rubber Infill.’’ (OMB Control No. 

0923–0062, expiration date 10/31/2021). 

ATSDR is seeking Paperwork Reduction 

Act (PRA) clearance to extend the data 

collection period due to delays 

encountered with the COVID–19 

pandemic. 

Currently in the United States, there 

are more than 12,000 synthetic turf 

fields in use. While the Synthetic Turf 

Council has set guidelines for the 

content of crumb rubber used as infill in 

synthetic turf fields, manufacturing 

processes result in differences among 

types of crumb rubber. Additionally, the 

chemical composition may vary highly 

between different processes and source 

materials and may vary even within 

granules from the same origin. 

The research protocol, Collections 

Related to Synthetic Turf Fields with 

Crumb Rubber Infill, has been 

conducted previously under two 

information collection requests (ICRs): 

Activity 1 under OMB Control No. 

0923–0054 (expiration date 01/31/2017) 

and Activities 2 and 3 under OMB 

Control No. 0923–0058 (expiration date 

08/13/2018), which were limited to 

collections from August to October, 

2017. Activities 2 and 3 aimed to 

evaluate and characterize the human 

exposure potential to constituents in 

crumb rubber infill among a 

convenience sample of 60 field users 

(Activity 2) and to collect biological 

specimens (blood and urine) from 45 

participants (Activity 3). Due to the 

limited enrollment and collection 

period, the target Activity 2 and Activity 

3 sample sizes were not met in 2017. 

The current request seeks to conduct 

supplemental measurements to expand 

the exploratory analysis conducted 

under OMB 0923–0058. The current 

request allows for further investigation 

of patterns observed in the preliminary 

data from the 2017 pilot-scale exposure 

measurements of individuals playing on 

synthetic turf fields with crumb rubber 

infill and includes collecting data from 

a small number of individuals who play 

on grass fields. 

In December 2020, ATSDR submitted 

a change request to OMB to incorporate 

COVID–19 prevention and protection 

measures. The change request was 

approved on 2/22/2021. The COVID–19 

prevention and protection measures will 

be implemented before data collection 

begins. 

The current study is a larger-scale 

supplemental assessment of exposure 

potential for individuals who use/play 

on synthetic turf fields with tire crumb 

rubber infill. The study includes 

persons who use synthetic turf with 

crumb rubber infill (e.g., facility users) 

and who routinely perform activities 

that would result in a high level of 

contact to crumb rubber. The study also 

includes persons who use natural grass 

fields. This allows for evaluation of 

potential high-end exposures to 

constituents in synthetic turf among this 

group of users and for comparison to 

individuals who do not play on 

synthetic turf fields with tire crumb 

rubber infill. The respondents are 

administered a detailed questionnaire 

on activity patterns on synthetic turf 

with crumb rubber infill. This 

instrument allows ATSDR to 

characterize exposure scenarios, 

including the nature and duration of 

potential exposures. Additionally, we 

are collecting urine samples pre- and 

post-activity. The urine samples will be 

analyzed for polyaromatic hydrocarbons 

and then archived for future analysis. 

For the extension request, there are no 

changes to the instruments, the total 

burden hours, and to the total number 

of respondents. The research study aims 

to screen a total of 220 participants for 

eligibility. The sample size for synthetic 

turf field users is 150 and 50 for the 


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Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 33301 

natural grass field users. The total 

burden hours for the research study is 

184 hours among all of the 220 

respondents. There is no cost to the 

respondents other than their time in the 

study. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Avg. burden 

per response 

(in hrs.) 

Adult/Adolescent Facility Users ................................ Eligibility Screening Script .................... 110 1 5/60 

Adult and Adolescent Questionnaire .... 100 1 30/60 

Exposure Measurement Form .............. 100 1 20/60 

Parents/Guardians of Youth/Child Facility Users ..... Eligibility Screening Script .................... 110 1 5/60 

Youth and Child Questionnaire ............ 100 1 30/60 

Youth/Child Facility Users ........................................ Exposure Measurement Form .............. 100 1 20/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–13435 Filed 6–23–21; 8:45 am] 

BILLING CODE 4163–70–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10185] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by July 26, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at: 

https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork

ReductionActof1995/PRA-Listing.html. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

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. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a previously 

approved collection; Title of 

Information Collection: Medicare Part D 

Reporting Requirements; Use: Section 

1860D–12(b)(3)(D) of the Act provides 

broad authority for the Secretary to add 

terms to the contracts with Part D 

sponsors, including terms that require 

the sponsor to provide the Secretary 

with information as the Secretary may 

find necessary and appropriate. 

Pursuant to our statutory authority, we 

codified these information collection 

requirements for Part D sponsors in 

regulation at 42 CFR 423.514(a). 

Data collected via the Medicare Part D 

reporting requirements will be an 

integral resource for oversight, 

monitoring, compliance, and auditing 

activities necessary to ensure quality 

provision of the Medicare Prescription 

Drug Benefit to beneficiaries. For all 

reporting sections (Enrollment and 

Disenrollment, Medication Therapy 

Management (MTM) Programs, 

Grievances, Improving Drug Utilization 

Review Controls, Coverage 

Determinations and Redeterminations, 

and Employer/Union Sponsored 

Sponsors), data are reported 

electronically to CMS. The data 

collected via the MTM and Grievances 

reporting sections are used in the 

Medicare Part C and D Star Ratings and 

Display Measures. The other reporting 

sections’ data are analyzed for program 

oversight to ensure the availability, 

accessibility, and acceptability of 

sponsors’ services, such as coverage 

determinations and appeals processes, 

and opioid safety edits at the time of 

dispensing. Form Number: CMS–10185 

(OMB control number: 0938–0992); 

Frequency: Yearly; Affected Public: 

Business or other for-profits; Number of 

Respondents: 814; Total Annual 

Responses: 12,575; Total Annual Hours: 

16,463. (For policy questions regarding 

this collection contact Chanelle Jones at 

410–786–8008). 


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