32666 Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices 

received to both notices, as well as new 

literature, we revised the previous draft 

profile (including a revised Minimal 

Risk Level (MRL)); therefore, on June 21, 

2018, ATSDR released a revised draft 

profile for public comment (83 FR 

28849). Because the substantive 

revisions were limited to the MRLs 

Appendix, and given the public health 

demand for the updated toxicological 

profile, we opted for a 30 day comment 

period. ATSDR has received requests to 

extend the comment period for this 

profile. Accordingly, ATSDR is 

extending the comment period an 

additional 30 days. Comments must be 

submitted by August 20, 2018. 

Availability 

The Draft Toxicological Profiles are 

available online at http://

www.atsdr.cdc.gov/ToxProfiles and at 

www.regulations.gov, Docket No. 

ATSDR–2015–0004. 

Pamela I. Protzel Berman, 

Director, Office of Policy, Partnerships and 

Planning, Agency for Toxic Substances and 

Disease Registry. 

[FR Doc. 2018–15002 Filed 7–12–18; 8:45 am] 

BILLING CODE 4163–70–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2018–0064] 

Proposed Guidance Regarding 

Operational Control Range Around 

Optimal Fluoride Concentration in 

Community Water Systems That 

Adjust Fluoride 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice; request for comment. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) in the 

Department of Health and Human 

Services (HHS) announces in this 

Federal Register Notice a proposed 

operational control range around 

optimal fluoride concentration in 

community water systems that adjust 

fluoride, and monthly adherence to that 

range. The proposal is based on analysis 

of available data, provided in the 

Background document. CDC is opening 

a docket to obtain comment on the 

existence of evidence-based concerns 

about the appropriateness of the 

proposed operational control range and 

criteria for adherence based on 

measurement capacity or feasibility of 

maintaining a target level. The 

operational control range specifies 

upper and lower limits of variation 

around a target concentration of 

fluoride. Managers of adjusted water 

systems at state and local levels need 

this updated operational control range 

to ensure the maintenance of consistent 

monthly averages in fluoride 

concentration that maximize prevention 

of tooth decay and minimize the 

possibility of dental fluorosis. The 

proposed operational control range is 

0.6 mg/L to 1.0 mg/L. CDC bases this 

guidance on the following 

considerations: (1) Concentration of 

fluoride in water shown to prevent tooth 

decay and (2) Ability of water systems 

to control variation in fluoride 

concentration. 

DATES: Written comments must be 

received on or before October 11, 2018. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2018– 

0064 by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Division of Oral Health, 

Centers for Disease Control and 

Prevention, 4770 Buford Highway, MS 

S107–8, Atlanta, Georgia 30341. Attn: 

Docket Number: CDC–2018–0064. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. All relevant comments 

received will be posted without change 

to http://regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Valerie Robison, D.D.S., M.P.H., Ph.D., 

Dental Officer, Division of Oral Health, 

Centers for Disease Control and 

Prevention, 4770 Buford Highway, MS 

S107–8, Atlanta, GA 30341. Email: 

OPTOL2018@cdc.gov, telephone: (770) 

488–6054. 

SUPPLEMENTARY INFORMATION: In 2015, 

the U.S. Public Health Service (PHS) 

recommended that community water 

systems maintain a concentration of 0.7 

mg/L to achieve a beneficial fluoride 

level.1 This recommendation, which 

updated and replaced the 1962 Drinking 

Water Standards related to community 

water fluoridation, did not include an 

operational control range associated 

with the recommended level of 0.7 mg/ 

L.1 2

After the 2015 PHS recommendation 

was issued, several state water 

fluoridation and drinking water 

programs contacted the Centers for 

Disease Control and Prevention (CDC) to 

request development of revised 

operational control range guidance 

around the 0.7 mg/L target level. As part 

of the range-setting process, these 

programs requested that CDC consider 

how consistently water treatment 

systems can stay within an operational 

control range on a daily basis. A 

detailed summary of the information 

CDC considered in developing a 

proposed operational control range 

recommendation is available in the 

Background document found in the 

Supplement Material tab of the docket. 

Recommended Operational Control 

Range 

Since water systems tend to favor an 

operating strategy that has a lower feed 

rate, or the rate at which product is 

added, CDC recommends an 

asymmetrical operational control range 

of 0.6 mg/L to 1.0 mg/L in order for 

public water systems to consistently 

meet the recommended concentration of 

0.7 mg/L.3

The lowest concentration of 0.6 mg/L 

(¥0.1 mg/L below the target level of 0.7 

mg/L) will allow public water systems 

to maintain the oral health benefits of 

water fluoridation. A lowest 

concentration of 0.6 mg/L in an 

operational control range has been in 

effect since 1962 and water systems 

have demonstrated experience in 

meeting it in normal operations.2 3

The highest concentration of 1.0 mg/ 

L (+0.3 mg/L above the target level of 

0.7 mg/L) will reduce the possibility of 

dental fluorosis.4 5

An operational control range of 0.4 

mg/L (¥0.1 mg/L to +0.3 mg/L) [actual 

values (0.6 mg/L to 1.0 mg/l)] will 

provide operational flexibility. This is 

based on data demonstrating the ability 

of water systems to stay successfully 

within a particular operational control 

range.467 A detailed summary of these 

findings is available in the Background 

document. 

CDC has received requests for criteria 

that demonstrate compliance with the 

operational control range. Published 

studies have shown that water systems 

are able to maintain at least 80% of 

daily measurements during the month 

within the proposed operational control 

range.6 7 Based on these findings, CDC 

recommends the following operational 

criteria; the monthly average fluoride 

level is maintained within the proposed 

operational control range, and 80% of 

daily measurements of fluoride are 

maintained within the proposed 

operational control range. 

In this docket, we are only concerned 

with the operational control range for 

water systems that adjust the fluoride 

level in the water. This request does not 

apply to water systems that have natural 

fluoride levels that exceed this 


sradovich on DSK3GMQ082PROD with NOTICES
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