Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices 32667 

recommended level. Further, the issues 

of whether or not to adjust fluoride in 

drinking water, as well as the 

recommended level to which fluoride 

should be adjusted, have previously 

been addressed in the Federal Register 

and are not part of this request.8

Note: Public water systems must 

continue to comply with Environmental 

Protection Agency (EPA) requirements 

for a special notice for exceedance of the 

secondary standard of 2 mg/L (40 CFR 

141.208) (https://www.epa.gov/ 

dwregdev/drinking-water-regulationsand-contaminants). 

CDC is seeking public comment on 

the following: 

1. Are there any evidence-based 

concerns about the appropriateness of 

the proposed operational control range 

and criteria for adherence based on 

measurement capacity or feasibility of 

maintaining the target level? 

References 

1. U.S. Public Health Service 

Recommendations for Fluoride 

Concentration in Drinking Water for the 

Prevention of Dental Caries. Public 

Health Reports. 2015 July– 

Aug;130(4):318–331. 

2. Department of Health, Education and 

Welfare (US) Public Health Service 

drinking water standards, revised 1962. 

Washington: Public Health Service (US); 

1962. PHS Publication No. 956. 

3. Barker LK, Duchon KK, Lesaja S, et al. 

Adjusted Fluoride Concentrations in 34 

States: 2006–2010 and 2015. Journal 

AWWA. 2017;109(8):2–17. 

4. Engineering and Administrative 

Recommendations for Water 

Fluoridation, MMWR Sept 29,1995/ 

44(RR–13:1–40. Fluoride 

Recommendations Work Group. 

Recommendations for using fluoride to 

prevent and control dental caries in the 

United States. MMWR Recomm Rep. 

2001;50(RR–14):1–42. 

5. Heller KE, Eklund SA, Burt BA. Dental 

caries and dental fluorosis at varying 

water fluoride concentrations. J Public 

Health Dent. 1997;57:136–43. 

6. Brown R, McTigue N, Graf K. Monitoring 

fluoride: how closely do utilities match 

target versus actual levels? Opflow, 

40;7:10. https://doi.org/10.5991/ 

OPF.2014.40.0042. 

7. Teefy S. Managing fluoridation within a 

stringent regulatory framework. Proc 

2013 AWWA Water Quality Technology 

Conference, Oakland, Calif. 

8. Public Health Service Recommendation for 

Fluoride Concentration in Drinking 

Water for the Prevention of Dental 

Caries. Fed Regist. 2015;80(84):24936– 

24947. Available at: https://

www.federalregister.gov/documents/ 

2015/05/01/2015-10201/public-healthservice-recommendation-for-fluorideconcentration-in-drinking-water-forprevention-of. Accessed 5/11/2018. 

Dated: July 9, 2018. 

Sandra Cashman, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2018–14968 Filed 7–12–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10531, CMS– 

R–43, CMS–10102, CMS–10143, CMS–10261, 

CMS–10500, and CMS–855I] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid 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 August 13, 2018. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: 

OMB, Office of Information and 

Regulatory Affairs 

Attention: CMS Desk Officer 

Fax Number: (202) 395–5806 OR 

Email: OIRA_submission@

omb.eop.gov 

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 

http://www.cms.hhs.gov/Paperwork

ReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

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: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Transcatheter 

Mitral Valve Repair (TMVR) National 

Coverage Decision (NCD); Use: The data 

collection is required by the Centers for 

Medicare and Medicaid Services (CMS) 

National Coverage Determination (NCD) 

entitled, ‘‘Transcatheter Mitral Valve 

Repair (TMVR)’’. The TMVR device is 

only covered when specific conditions 

are met including that the heart team 

and hospital are submitting data in a 

prospective, national, audited registry. 

The data includes patient, practitioner 

and facility level variables that predict 

outcomes such as all-cause mortality 

and quality of life. In order to remove 

the data collection requirement under 

this coverage with evidence 

development (CED) NCD or make any 

other changes to the existing policy, we 


sradovich on DSK3GMQ082PROD with NOTICES
32668 Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices 

must formally reopen and reconsider 

the policy. We are continuing to review 

and analyze the data collected since this 

NCD was effective in 2014 

We find that the Society of Thoracic 

Surgery/American College of Cardiology 

Transcatheter Valve Therapy (STS/ACC 

TVT) Registry, one registry overseen by 

the National Cardiovascular Data 

Registry, meets the requirements 

specified in the NCD on TMVR. The 

TVT Registry will support a national 

surveillance system to monitor the 

safety and efficacy of the TMVR 

technologies for the treatment of mitral 

regurgitation (MR). 

The data collected and analyzed in 

the TVT Registry will be used by CMS 

to determine if the TMVR is reasonable 

and necessary (e.g., improves health 

outcomes) for Medicare beneficiaries 

under section 1862(a)(1)(A) of the Act. 

The data will also include the variables 

on the eight item Kansas City 

Cardiomyopathy Questionnaire (KCCQ– 

10) to assess heath status, functioning 

and quality of life. In the KCCQ, an 

overall summary score can be derived 

from the physical function, symptoms 

(frequency and severity), social function 

and quality of life domains. For each 

domain, the validity, reproducibility, 

responsiveness and interpretability have 

been independently established. Scores 

are transformed to a range of 0–100, in 

which higher scores reflect better health 

status. 

The conduct of the STS/ACC TVT 

Registry and the KCCQ–10 is pursuant 

to Section 1142 of the Social Security 

Act (the ACT) that describes the 

authority of the Agency for Healthcare 

Research and Quality (AHRQ). Under 

section 1142, research may be 

conducted and supported on the 

outcomes, effectiveness, and 

appropriateness of health care services 

and procedures to identify the manner 

in which disease, disorders, and other 

health conditions can be prevented, 

diagnosed, treated, and managed 

clinically. Section 1862(a)(1)(E) of the 

Act allows Medicare to cover under 

coverage with evidence development 

(CED) certain items or services for 

which the evidence is not adequate to 

support coverage under section 

1862(a)(1)(A) and where additional data 

gathered in the context of a clinical 

setting would further clarify the impact 

of these items and services on the health 

of beneficiaries. Form Number: CMS– 

10531 (OMB control number: 0938– 

1274); Frequency: Annually; Affected 

Public: Private sector (Business or other 

for-profits); Number of Respondents: 

3,897; Total Annual Responses: 15,588; 

Total Annual Hours: 5,456. (For policy 

questions regarding this collection 

contact Sarah Fulton at 410–786–2749.) 

2. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Conditions of 

Coverage for Portable X-ray Suppliers 

and Supporting Regulations; Use: The 

requirements contained in this 

information collection request are 

classified as conditions of participation 

or conditions for coverage. Portable Xrays are basic radiology studies 

(predominately chest and extremity Xrays) performed on patients in skilled 

nursing facilities, residents of long-term 

care facilities and homebound patients. 

The CoPs are based on criteria described 

in the law, and are designed to ensure 

that each portable X-ray supplier has 

properly trained staff and provides the 

appropriate type and level of care for 

patients. We use these conditions to 

certify suppliers of portable X-ray 

services wishing to participate in the 

Medicare program. This is standard 

medical practice and is necessary in 

order to help to ensure the well-being, 

safety and quality professional medical 

treatment accountability for each 

patient. There is a significant increase in 

the burden due to burden that was not 

accounted for in the previous 

information collection request. Form 

Number: CMS–R–43 (OMB Control 

number: 0938–0338); Frequency: Yearly; 

Affected Public: Business or other forprofit and Not-for-profit institutions; 

Number of Respondents: 5,986,509; 

Total Annual Responses: 5,987,018; 

Total Annual Hours: 532,959. (For 

policy questions regarding this 

collections contact Sonia Swancy at 

410–786–8445.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: National 

Implementation of the Hospital CAHPS 

Survey; Use: The HCAHPS (Hospital 

Consumer Assessment of Healthcare 

Providers and Systems) Survey, also 

known as the CAHPS® Hospital Survey 

or Hospital CAHPS®, is a standardized 

survey instrument and data collection 

methodology that has been in use since 

2006 to measure patients’ perspectives 

of hospital care. While many hospitals 

collect information on patient 

satisfaction, HCAHPS created a national 

standard for the collection and public 

reporting of information that enables 

valid comparisons to be made across all 

hospitals to support consumer choice. 

Form Number: CMS–10102 (OMB 

control number 0938–0981); Frequency: 

Occasionally; Affected Public: Private 

sector (Business or other for-profits and 

Not-for-profit institutions); Number of 

Respondents: 4,200; Total Annual 

Responses: 3,100,000; Total Annual 

Hours: 413,230. (For policy questions 

regarding this collection contact 

William Lehrman at 410–786–1037.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: State Data for 

the Medicare Modernization Act 

(MMA); Use: The monthly data file is 

provided to CMS by states on dual 

eligible beneficiaries. The phase-down 

process requires a monthly count of all 

full benefit dual eligible beneficiaries 

with an active Part D plan enrollment in 

the month. CMS will make this 

selection of records using dual 

eligibility status codes contained in the 

person-month record to identify all fullbenefit dual eligible beneficiaries (codes 

02, 04 and 08). In the case where in a 

given month, multiple records were 

submitted for the same beneficiary in 

multiple file submittals, the last record 

submitted for that beneficiary shall be 

used to determine the final effect on the 

phase-down count. Form Number: 

CMS–10143 (OMB Control Number: 

0938–0958); Frequency: Monthly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

51; Total Annual Responses: 612; Total 

Annual Hours: 4,896. (For policy 

questions regarding this collection 

contact Linda King at 410–786–1312.) 

5. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Part C Medicare 

Advantage Reporting Requirements and 

Supporting Regulations in 42 CFR 

422.516(a); Use: Medicare Advantage 

Organizations (MAOs) must have an 

effective procedure to develop, compile, 

evaluate, and report to CMS, to its 

enrollees, and to the general public, at 

the times and in the manner that CMS 

requires, and while safeguarding the 

confidentiality of the doctor-patient 

relationship, statistics and other 

information with respect to: The cost of 

its operations; the patterns of service 

utilization; the availability, 

accessibility, and acceptability of its 

services; to the extent practical, 

developments in the health status of its 

enrollees; information demonstrating 

that the MAO has a fiscally sound 

operation; and other matters that CMS 

may require. CMS also has oversight 

authority over cost plans which 

includes establishment of reporting 

requirements. The changes for the 2019 

reporting requirements under 

Organization Determinations and 

Reconsiderations (ODR) will add 18 

new data elements to the reporting 

section. The new data elements will 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices 32669 

allow CMS to obtain more information 

about who is submitting requests for 

ODR and whether the service or claim 

is being provided by a contract or noncontract provider. The timeliness 

requirement for ODR will also be 

eliminated to be consistent with Part D 

reporting. In addition, the number of 

data reporting elements of grievances is 

reduced from 23 to 19. The reporting 

sections for Private Fee For Service 

(PFFS) Payment Dispute Resolution 

Process and Mid-Year Network Changes 

will also be suspended. Form Number: 

CMS–10261 (OMB control number: 

0938–1054); Frequency: Yearly and 

semi-annually; Affected Public: Private 

sector (business or other for-profits); 

Number of Respondents: 432; Total 

Annual Responses: 3,024; Total Annual 

Hours: 127,329. (For policy questions 

regarding this collection contact Maria 

Sotirelis at 410–786–0552.) 

6. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Consumer 

Assessment of Healthcare Providers and 

Systems Outpatient and Ambulatory 

Surgery (OAS CAHPS) Survey; Use: The 

information collected in the national 

implementation of Outpatient/ 

Ambulatory Surgery Patient Experience 

of Care Survey (A/ASPECS) will be used 

to: (1) Provide a source of information 

from which selected measures can be 

publicly reported to beneficiaries to 

help them make informed decisions for 

outpatient surgery facility selection; (2) 

aid facilities with their internal quality 

improvement efforts and external 

benchmarking with other facilities; and 

(3) provide us with information for 

monitoring and public reporting 

purposes. Form Number: CMS–10500 

(OMB control number: 0938–1240); 

Frequency: Once; Affected Public: 

Individuals and households; Number of 

Respondents: 633,304; Total Annual 

Responses: 633,304; Total Annual 

Hours: 153,592. (For policy questions 

regarding this collection contact 

Memuna Ifedirah at 410–786–6849). 

7. Type of Information Collection 

Request: New collection (Request for 

new OMB control number); Title of 

Information Collection: Medicare 

Enrollment Application for Physician 

and Non-Physician Practitioners; Use: 

The application is used by Medicare 

contractors to collect data to ensure that 

the applicant has the necessary 

credentials to provide the health care 

services for which they intend to bill 

Medicare, including information that 

allows the Medicare contractor to 

correctly price, process and pay the 

applicant’s claims. This application 

collects information to ensure that only 

legitimate physicians, non-physician 

practitioners, and other eligible 

professionals are enrolled in the 

Medicare program. It is meant to be the 

first line defense to protect our 

beneficiaries from illegitimate providers 

and to protect the Medicare Trust Fund 

against fraud. It also gathers information 

that allows Medicare contractors to 

ensure that the provider/supplier is not 

sanctioned from the Medicare and/or 

Medicaid program(s), or debarred, 

suspended or excluded from any other 

Federal agency or program. Form 

Number: CMS–855i (OMB control 

number: 0938–NEW); Frequency: On 

Occasion; Affected Public: State, Local, 

or Tribal Governments, Private Sector 

(not-for-profit institutions); Number of 

Respondents: 513,872; Total Annual 

Responses: 1,370,078; Total Annual 

Hours: 1,000,167. For policy questions 

regarding this collection contact 

Kimberly McPhillips at (410)-786–5374. 

Dated: July 10, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–15038 Filed 7–12–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–1156] 

Q3D(R1) Elemental Impurities; 

International Council for 

Harmonisation; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Q3D(R1) 

Elemental Impurities.’’ The draft 

guidance was prepared under the 

auspices of the International Council for 

Harmonisation (ICH), formerly the 

International Conference on 

Harmonisation. The draft guidance 

revises the existing ICH guidance for 

industry ‘‘Q3D Elemental Impurities’’ 

and provides an updated permitted 

daily exposure (PDE) for the cadmium 

inhalation route of exposure. The 

updated PDE of 3 micrograms (mg)/day 

is based on a modifying factor approach 

like that used for calculating the PDEs 

for the cadmium oral and parenteral 

routes of exposure. The draft guidance 

is intended to correct a calculation error 

in the PDE for cadmium by the 

inhalation route of exposure. Following 

deliberations within the Q3D Expert 

Working Group, the revised calculation 

is based on a modifying factor approach 

that is consistent with the oral and 

parenteral PDE calculations. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 13, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2013–D–1156 for ‘‘Q3D(R1) Elemental 

Impurities.’’ Received comments will be 

placed in the docket and, except for 


sradovich on DSK3GMQ082PROD with NOTICES