83 FR 62867 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 234 (December 6, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 234 (December 6, 2018)
| Page Range | 62867-62869 | |
| FR Document | 2018-26351 |
[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)] [Notices] [Pages 62867-62869] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26351] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-19-19DO; Docket No. CDC-2018-0108] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Surveillance of Community Water Systems and Corresponding Populations with the Recommended Fluoridation Level. This surveillance collects the fluoridation status of the nation's approximately 52,000 community water systems (CWS) which serve the 50 states and the District of Columbia. It also collects fluoride level testing data for those CWS which adjust naturally occurring fluoride levels. The data are analyzed and published to inform the public and to support state and local governments' efforts to monitor community water fluoridation levels relative to the US Public Health Service recommended level to prevent tooth decay. DATES: CDC must receive written comments on or before February 4, 2019. ADDRESSES: You may submit comments, identified by Docket No. CDC-2018- 0108 by any of the following methods:Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. Mail: Jeffrey M. Zirger, Acting Lead, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov. Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]. 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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are [[Page 62868]] publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 1. 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; 2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. 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 submissions of responses. 5. Assess information collection costs. Proposed Project National Surveillance of Community Water Systems and Corresponding Populations with the Recommended Fluoridation Level--Existing Collection in use without an OMB Control Number--National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Dental caries is one of the most common chronic diseases throughout the lifespan in the United States, and disproportionately affects populations with low socioeconomic status, and racial and ethnic minority populations. Dental caries can lead to infection and diminished quality of life, and cause substantial societal cost due to absence from school and work, as well as expensive treatments. Naturally occurring fluoride is found in all surface and ground water sources, but typically is lower than the recommended concentration needed to prevent dental caries (tooth decay). Community water fluoridation is the process of adjusting the fluoride concentration of a community water system (CWS) to the level beneficial for prevention of dental caries as recommended by the US Public Health Service (PHS). CDC monitors CWS fluoride levels relative to the PHS recommended level under the Public Health Service Act. In 2000, CDC launched a Web-based data management tool--Water Fluoridation Reporting Systems (WFRS) in collaboration with the Association of State and Territorial Dental Directors. States may report their information to CDC using WFRS or via email. Respondents to the information collection are state fluoridation managers or other state government officials designated by the state dental director or drinking water administrator. State participation in the data collection is voluntary. Respondents are asked to update fluoridation status of, and counties and populations served by, each CWS in their state annually. All 50 states respond to this portion of the collection. Washington DC is not included in the data collection because water is supplied by a CWS from Virginia and therefore Virginia will collect data. Historically collected natural fluoride concentrations are available in WFRS for all CWS; once collected, they rarely change over time. Respondents also are asked to enter the high, low, and average fluoride testing level data annually for each month for their fluoride-adjusted CWS. Currently, two-thirds of the states respond to this portion of the collection. CDC analyzes and publishes results through interactive, public- facing web pages: (1) Biennial surveillance reports documenting the percentage of the population with fluoridated water at national, state, and local levels; and (2) My Water's Fluoride, which publishes the fluoridation status of individual CWS and some fluoride level data for states which choose to display it. CDC uses the information collection to (1) provide national fluoridation surveillance reports; (2) assist states manage their fluoride level data and monitor and improve quality of community water fluoridation programs; (3) measure national performance toward the fluoridation Healthy People objective; (4) evaluate outcomes of CDC's cooperative agreements with states; (5) facilitate creation of state-specific reports for states' programmatic and policy use. The information collection is also used to inform health care providers to determine targeted delivery of preventive care, for example, determining use of fluoride supplements for children living in fluoride-deficient areas. CDC's collection of CWS data is not duplicative of any other federal collection, including the US Environmental Protection Agency's (EPA) Safe Drinking Water Information System (SDWIS), as SDWIS receives state reports of CWS fluoride levels that exceed 4 mg/L but not those near the beneficial level of 0.7 mg/L recommended for dental caries prevention by the PHS. Thus, CDC's system is required to assess the degree to which the nation is reaching this PHS-recommended level. The total estimated annualized burden hours are 2,824, including (1) 1,900 hours for the validation or update of CWS fluoridation status and population served from 50 respondents, with estimated average burden hours of 38 per respondent; and (2) 924 hours for the annual entry of fluoride testing level data for fluoride-adjusted CWS conducted by 33 respondents with an estimated average burden of 28 hours per respondent. WFRS will be hosted and maintaineded by CDC. There are no maintenance costs to respondents, and 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 Total burden respondents respondent (in hours) (in hours) ---------------------------------------------------------------------------------------------------------------- State Official................ Fluoridation 50 1 38 1,900 status and population. State Official................ Fluoride testing 33 1 28 924 data. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 2,824 ---------------------------------------------------------------------------------------------------------------- [[Page 62869]] Jeffrey M. Zirger, Acting Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention (CDC). [FR Doc. 2018-26351 Filed 12-4-18; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices 62867
system to monitor and guide • Serve as a resource to NCEH when burden, age groups, geographic areas
participating state health departments. addressing congressional, departmental and other variables of interest.
Since implementation in 2010, AIRS and institutional inquiries. • Provide feedback to the grantees
and the technical assistance provided by • Help the branch align its current about their performance relative to
CDC staff have provided states with interventions with CDC goals and others through the distribution of two
uniform data reporting methods and allowed the monitoring of progress written reports and several
linkages to other states’ asthma program toward these goals. presentations (webinar and in-person)
information and resources. Thus, AIRS summarizing the results.
• Allow the NACP and the state • Customize and provide technical
has saved state resources and staff time asthma programs to make more
when asthma programs embark on assistance and support materials to
informed decisions about activities to address implementation challenges.
asthma activities similar to those done achieve objectives.
elsewhere. There will be no cost to respondents
• Facilitate communication about other than their time to complete the
In the past three years, AIRS data interventions across states, and enable three AIRS spreadsheets annually. The
were used to: inquiries regarding interventions by estimated annualized burden hours are
populations with a disproportionate 89.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
State Asthma Program Awardees .... AIRS Performance Measures Re- 25 1 150/60 63
porting Spreadsheets.
AIRS Emergency Department Visits 25 1 30/60 13
Reporting Form.
AIRS Hospital Discharge Reporting 25 1 30/60 13
Forms.
Total ........................................... ........................................................... ........................ ........................ ........................ 89
Jeffrey M. Zirger, proposed information collection project Docket Number. CDC will post, without
Acting Lead, Information Collection Review titled National Surveillance of change, all relevant comments to
Office, Office of Scientific Integrity, Office Community Water Systems and Regulations.gov.
of Science, Centers for Disease Control and Corresponding Populations with the Please note: Submit all comments
Prevention. Recommended Fluoridation Level. This through the Federal eRulemaking portal
[FR Doc. 2018–26352 Filed 12–4–18; 8:45 am] surveillance collects the fluoridation (regulations.gov) or by U.S. mail to the
BILLING CODE 4163–18–P status of the nation’s approximately address listed above.
52,000 community water systems (CWS)
FOR FURTHER INFORMATION CONTACT: To
which serve the 50 states and the
DEPARTMENT OF HEALTH AND request more information on the
District of Columbia. It also collects
HUMAN SERVICES proposed project or to obtain a copy of
fluoride level testing data for those CWS
the information collection plan and
which adjust naturally occurring
Centers for Disease Control and instruments, contact Jeffrey M. Zirger,
fluoride levels. The data are analyzed
Prevention Information Collection Review Office,
and published to inform the public and
[60Day–19–19DO; Docket No. CDC–2018– Centers for Disease Control and
to support state and local governments’
0108] Prevention, 1600 Clifton Road NE, MS–
efforts to monitor community water
D74, Atlanta, Georgia 30329; phone:
fluoridation levels relative to the US
Proposed Data Collection Submitted 404–639–7570; Email: omb@cdc.gov.
Public Health Service recommended
for Public Comment and level to prevent tooth decay. SUPPLEMENTARY INFORMATION: Under the
Recommendations Paperwork Reduction Act of 1995 (PRA)
DATES: CDC must receive written
AGENCY: Centers for Disease Control and comments on or before February 4, (44 U.S.C. 3501–3520), Federal agencies
Prevention (CDC), Department of Health 2019. must obtain approval from the Office of
and Human Services (HHS). Management and Budget (OMB) for each
ADDRESSES: You may submit comments, collection of information they conduct
ACTION: Notice with comment period.
identified by Docket No. CDC–2018– or sponsor. In addition, the PRA also
SUMMARY: The Centers for Disease 0108 by any of the following methods: requires Federal agencies to provide a
Control and Prevention (CDC), as part of • Federal eRulemaking Portal: 60-day notice in the Federal Register
its continuing effort to reduce public Regulations.gov. Follow the instructions concerning each proposed collection of
burden and maximize the utility of for submitting comments. information, including each new
khammond on DSK30JT082PROD with NOTICES
government information, invites the • Mail: Jeffrey M. Zirger, Acting Lead, proposed collection, each proposed
general public and other Federal Information Collection Review Office, extension of existing collection of
agencies the opportunity to comment on Centers for Disease Control and information, and each reinstatement of
a proposed and/or continuing Prevention, 1600 Clifton Road NE, MS– previously approved information
information collection, as required by D74, Atlanta, Georgia 30329. collection before submitting the
the Paperwork Reduction Act of 1995. Instructions: All submissions received collection to the OMB for approval. To
This notice invites comment on a must include the agency name and comply with this requirement, we are
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![Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices 62869
Jeffrey M. Zirger, Acquisition Cost (AAC), using the Director
Acting Lead, Information Collection Review National Average Drug Acquisition Cost State of Washington, Health Care
Office, Office of Scientific Integrity, Office (NADAC) without a change in the new Authority
of Science, Centers for Disease Control and requirements for a professional 626 8th Avenue PO Box 45502
Prevention (CDC). dispensing fee. In addition, SPA 17– Olympia, WA 98504–5050
[FR Doc. 2018–26351 Filed 12–4–18; 8:45 am] 0002 included proposed changes to Dear Ms. Lindeblad:
BILLING CODE 4163–18–P reimbursement for 340B drugs, I am responding to your November 5,
physician-administered drugs, clotting 2018 request for reconsideration of the
factor, federal supply schedule, and decision to disapprove Washington’s
DEPARTMENT OF HEALTH AND drugs purchased at nominal price. State Plan amendment (SPA) 17–0002.
HUMAN SERVICES The issues to be considered at the Washington SPA 17–0002 was
hearing are whether Washington SPA submitted to the Centers for Medicare &
Centers for Medicare & Medicaid
17–0002 is inconsistent with the Medicaid Services (CMS) on June 26,
Services
requirements of: 2017, and disapproved on September
Notice of Hearing: Reconsideration of • Section 1902(a)(30)(A) of the Social 10, 2018. I am scheduling a hearing on
Disapproval Washington Medicaid Security Act (the Act) which requires, in your request for reconsideration to be
State Plan Amendment (SPA) 17–0002 part, that states have a state plan that held on January 15, 2019, at the
provides such methods and procedures Department of Health and Human
AGENCY: Centers for Medicare & to assure that payment rates are Services, Centers for Medicare &
Medicaid Services (CMS), HHS. consistent with efficiency, economy, Medicaid Services, Division of Medicaid
ACTION: Notice of hearing: and quality of care and are sufficient to and Children’s Health, Seattle Regional
reconsideration of disapproval. enlist enough providers so that care and Office, 701 Fifth Avenue, Suite 1600,
services are available under the plan at Seattle, WA 98104.
SUMMARY: This notice announces an least to the extent that such care and
administrative hearing to be held on I am designating Mr. Benjamin R.
services are available to the general Cohen as the presiding officer. If these
January 15, 2019, at the Department of population in the geographic area.
Health and Human Services, Centers for arrangements present any problems,
• Federal regulations at 42 CFR please contact Mr. Cohen at (410) 786–
Medicare & Medicaid Services, Division 447.502, 447.512 and 447.518 which
of Medicaid and Children’s Health, 3169. In order to facilitate any
provide that payments for drugs are to communication that may be necessary
Seattle Regional Office, 701 Fifth be based on the ingredient cost of the
Avenue, Suite 1600, Seattle, WA 98104 between the parties prior to the hearing,
drug based on AAC and a Professional please notify the presiding officer to
to reconsider CMS’ decision to Dispensing Fee (PDF).
disapprove Washington’s Medicaid SPA indicate acceptability of the hearing
Section 1116 of the Act and federal date that has been scheduled and
17–0002. regulations at 42 CFR part 430 establish provide names of the individuals who
DATES: Requests to participate in the Department procedures that provide an will represent the State at the hearing.
hearing as a party must be received by administrative hearing for If the hearing date is not acceptable, Mr.
the presiding officer by December 20, reconsideration of a disapproval of a Cohen can set another date mutually
2018. state plan or plan amendment. CMS is agreeable to the parties. The hearing
FOR FURTHER INFORMATION CONTACT: required to publish in the Federal will be governed by the procedures
Benjamin R. Cohen, Presiding Officer, Register a copy of the notice to a state prescribed by federal regulations at 42
CMS, 2520 Lord Baltimore Drive, Suite Medicaid agency that informs the CFR part 430.
L, Baltimore, Maryland 21244, agency of the time and place of the This SPA requested CMS approval to
Telephone: (410) 786–3169. hearing, and the issues to be considered. bring Washington into compliance with
SUPPLEMENTARY INFORMATION: This If we subsequently notify the state the pharmacy reimbursement
notice announces an administrative Medicaid agency of additional issues requirements in the Covered Outpatient
hearing to reconsider CMS’ decision to that will be considered at the hearing, Drugs final rule with comment period
disapprove Washington’s Medicaid state we will also publish that notice in the (CMS–2345–FC) (Final Rule).
plan amendment (SPA) 17–0002, which Federal Register. Specifically, SPA 17–0002 proposed to
was submitted to the Centers for Any individual or group that wants to revise the current pharmacy
Medicare & Medicaid Services (CMS) on participate in the hearing as a party reimbursement methodology from
June 26, 2017 and disapproved on must petition the presiding officer reimbursing for ingredient costs based
September 10, 2018. This SPA requested within 15 days after publication of this on Estimated Acquisition Cost (EAC),
CMS approval to: Bring Washington into notice, in accordance with the plus a tiered dispensing fee (High-
compliance with the pharmacy requirements contained at 42 CFR volume pharmacies $4.24/Rx, Mid-
reimbursement requirements in the 430.76(b)(2). Any interested person or volume pharmacies $4.56/Rx, Low-
Covered Outpatient Drugs final rule organization that wants to participate as volume pharmacies $5.25/Rx, and Unit
with comment period (CMS–2345–FC) amicus curiae must petition the Does System $5.25/Rx), to reimbursing
(Final Rule). Specifically, SPA 17–0002 presiding officer before the hearing for ingredient cost based on Actual
proposed to revise the current pharmacy begins in accordance with the Acquisition Cost (AAC), using the
reimbursement methodology from requirements contained at 42 CFR National Average Drug Acquisition Cost
reimbursing for ingredient costs based 430.76(c). If the hearing is later (NADAC) without a change in the new
khammond on DSK30JT082PROD with NOTICES
on Estimated Acquisition Cost (EAC), rescheduled, the presiding officer will requirements for a professional
plus a tiered dispensing fee (High- notify all participants. dispensing fee. In addition, SPA 17–
volume pharmacies $4.24/Rx, Mid- The notice to Washington announcing 0002 included proposed changes to
volume pharmacies $4.56/Rx, Low- an administrative hearing to reconsider reimbursement for 340B drugs,
volume pharmacies $5.25/Rx, and Unit the disapproval of its SPA reads as physician-administered drugs, clotting
Does System $5.25/Rx), to reimbursing follows: factor, federal supply schedule, and
for ingredient cost based on Actual Ms. MaryAnne Lindeblad drugs purchased at nominal price.
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Document Created: 2018-12-05 02:36:22
Document Modified: 2018-12-05 02:36:22
| 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 | |
| Action | Notice with comment period. | |
| Dates | CDC must receive written comments on or before February 4, 2019. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected] | |
| FR Citation | 83 FR 62867 |
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