Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices 39759 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10516 and CMS– 

10561] 

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 September 10, 

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/ 

PaperworkReductionActof1995. 

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: 

Information Collection 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Program 

Integrity: Exchange, Premium 

Stabilization Programs, and Market 

Standards; Amendments to the HHS 

Notice of Benefit and Payment 

Parameters for 2014; Final Rule II; Use: 

The original approved ICR affiliated 

with this final rule was titled Program 

Integrity: Exchange, Premium 

Stabilization Programs, and Market 

Standards; Amendments to the HHS 

Notice of Benefit and Payment 

Parameters for 2014; Final Rule II and 

was approved on 8/26/2015. This 

request serves as the formal request for 

renewal of the clearance. This ICR 

includes some of the ICRs from the 

previously approved final rule. The 

program integrity data collections and 

third-party disclosure requirements will 

assist HHS in determining Exchange 

compliance with Federal standards. The 

data collection and third-party 

disclosure requirements will also assist 

HHS in monitoring QHP issuers in FFEs 

for compliance with Federal QHP issuer 

standards. The data collected by health 

insurance issuers and Exchanges will 

help to inform HHS, Exchanges, and 

health insurance issuers as to the 

participation of individuals, employers, 

and employees in the individual 

Exchange, and SHOP. Form Number: 

CMS–10516 (OMB Control Number: 

0938–1277); Frequency: Annually; 

Affected Public: Private Sector, State, 

Business, and Not-for Profits; Number of 

Respondents: 1,915; Number of 

Responses: 1,915; Total Annual Hours: 

48,732. (For questions regarding this 

collection, contact Leigha Basini at (301) 

492–4380.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved information collection; Title 

of Information Collection: Essential 

Community Provider Data Collection to 

Support QHP Certification for PYs 

2021–2023; Use: For plan years 

beginning on or after January 1, 2021, 

Health and Human Services (HHS) 

intends to continue collecting more 

complete provider data for inclusion on 

the HHS Essential Community Provider 

(ECP) list to ensure a more accurate 

reflection of the universe of qualified 

available ECPs in a given service area 

that can be counted toward an issuer’s 

satisfaction of the ECP standard. HHS 

intends to continue collecting these data 

on qualified and available ECPs directly 

from providers through the online ECP 

petition. Providers will submit an ECP 

petition to be added to the HHS ECP list 

or update required data fields to remain 

on the list. Form Number: CMS–10561 

(OMB control number: 0938–1295); 

Frequency: Annually; Affected Public: 

Private sector (Business or other forprofits and Not-for-profit Institutions); 

Number of Respondents: 14,260; Total 

Annual Responses: 14,260; Total 

Annual Hours: 7,468. (For policy 

questions regarding this collection 

contact Deborah Hunter at (202) 309– 

1098). 

Dated: August 7, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–17190 Filed 8–9–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Multi-site Implementation 

Evaluation of Tribal Home Visiting 

(MUSE). 


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39760 Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices 

OMB No.: New Collection. 

Description: The Administration for 

Children and Families (ACF) within the 

U.S. Department of Health and Human 

Services has launched a national multisite evaluation of Tribal Maternal, 

Infant, and Early Childhood Home 

Visiting (TMIECHV) programs. MUSE is 

the first multi-site, multi-model study 

that will systematically explore how 

home visiting programs are operating 

across diverse tribal contexts and 

identify factors that lead to programs’ 

success. The evaluation will provide 

information that will help the federal 

government design and support federal 

home visiting initiatives in tribal 

communities and similar populations. 

Evaluation findings will also assist 

programs with improving home visiting 

services for children and families. The 

aims of MUSE are to (1) identify and 

describe the primary influences shaping 

tribal home visiting program planning; 

(2) identify and describe how home 

visiting programs are being 

implemented; and (3) explore supports 

to home visiting implementation in 

tribal communities. To address these 

aims, the evaluation will gather data 

about participating home visiting 

programs from program staff and parent 

program participants and utilize 

administrative program data. 

The current Notice is specific to data 

collection efforts needed to address the 

MUSE aims. Quantitative and 

qualitative data will be collected from 

program staff and parent program 

participants at each program site. 

Program sites will also submit local 

administrative data to the evaluation 

team. After obtaining informed consent 

from all respondents, data collection 

will include: (1) A Caregiver Enrollment 

Form, (2) a survey of caregivers 

receiving home visiting services at 

enrollment (baseline), (3) a follow-up 

survey of caregivers receiving home 

visiting services at 6 and 12 months, (4) 

a Rapid Reflect self-completed 

questionnaire completed by caregivers 

after selected home visits; (5) a Rapid 

Reflect self-completed questionnaire 

completed by home visitors after 

selected home visits; (6) a one-time 

survey of home visitors; (7) a one-time 

survey of program coordinators/ 

managers; (8) a one-time survey of 

program directors; (9) a one-time survey 

of local program evaluators; (10) a onetime survey for program managers on 

program implementation, (11) 

qualitative interviews of home visitors 

at each site; (12) qualitative interviews 

of program coordinators/managers and 

program directors at each site; (13) 

qualitative interviews of local program 

evaluators at each site; (14) qualitative 

interviews of caregivers receiving home 

visiting services; (15) a log of 

implementation activities completed by 

program coordinators/managers on 

training, family group activities, and 

supervision; and 156 electronic 

compilation and submission of 

administrative program data. 

All data collection will be used to 

generate information about how tribal 

home visiting program services are 

planned and delivered, and about what 

individual, organizational, community, 

and external factors support successful 

program implementation. 

Respondents: Caregivers enrolled in 

TMIECHV programs and TMIECHV 

program staff (program directors, 

program coordinators/managers, home 

visitors, and local program evaluators). 

Annual Burden Estimates: We will 

request approval for three years, which 

will accommodate an approximate 27 

month data collection period and any 

potential delays in the data collection 

timeline. 

Instrument 

Total 

number of 

respondents 

Annual 

number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Caregiver Enrollment Form .................................................. 93 31 14 .08 35 

Caregiver Survey—Baseline ................................................ 565 188 1 .25 47 

Caregiver Survey—6 & 12 Month Follow-up ....................... 380 127 2 .50 127 

Rapid Reflect Self-Completed Home Visit Questionnaire 

for Caregivers ................................................................... 1,136 1 568 6 .08 273 

Rapid Reflect Self Completed Home Visit Questionnaire 

for Home Visitors .............................................................. 93 1 47 66 .2 620 

Home Visitor Survey ............................................................ 81 27 1 1.17 32 

Program Coordinator/Manager Survey ................................ 21 7 1 1 7 

Program Director Survey ..................................................... 21 7 1 .75 5 

Local Program Evaluator Survey ......................................... 30 10 1 .5 5 

Program Implementation Survey ......................................... 34 11 1 .25 3 

Qualitative Interviews of Home Visitors ............................... 42 14 1 2 28 

Qualitative Interviews of Program Coordinators/Managers 

and Program Directors ..................................................... 34 11 1 1.5 17 

Qualitative Interviews of Local Program Evaluators ............ 30 10 1 1.5 15 

Qualitative Interviews of Caregivers .................................... 51 17 1 1 17 

Implementation Logs ............................................................ 17 1 9 24 .67 145 

Administrative Program Data ............................................... 17 1 9 4 24 864 

1The annual number of respondents is annualized over 2 years for instruments that are completed by respondents on an ongoing basis. 

Estimated Total Annual Burden 

Hours: 2,240. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 330 

C Street SW, Washington, DC 20201, 

Attn: OPRE Reports Clearance Officer. 

All requests should be identified by the 

title of the information collection. Email 

address: OPREinfocollection@

acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices 39761 

Desk Officer for the Administration for 

Children and Families. 

Emily B. Jabbour, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2018–17121 Filed 8–9–18; 8:45 am] 

BILLING CODE 4184–74–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Proposed Projects 

Title: Supplemental Nutrition 

Assistance Program (SNAP) Matching 

Program Performance Outcomes. 

OMB No. 0970–0464. 

Description: State agencies 

administering the Supplemental 

Nutrition Assistance Program (SNAP) 

are mandated to participate in a 

computer matching program with the 

federal Office of Child Support 

Enforcement (OCSE). The matching 

program compares SNAP applicant and 

recipient information with employment 

and wage information maintained in the 

National Directory of New Hires 

(NDNH). The outcomes of the compared 

information help state SNAP agencies 

with administering the program and 

verifying and determining an 

individual’s benefit eligibility. To 

receive NDNH information, state 

agencies enter into a computer matching 

agreement and adhere to its terms and 

conditions, including providing OCSE 

with annual performance outcomes 

attributable to the use of NDNH 

information. 

The Office of Management and Budget 

(OMB) requires OCSE to periodically 

report performance measurements 

demonstrating how the use of 

information in the NDNH supports 

OCSE’s strategic mission, goals, and 

objectives. OCSE will provide the 

annual SNAP performance outcomes to 

OMB. 

The information collection activities 

for the SNAP performance outcomes 

reports are authorized by: (1) Subsection 

453(j)(10) of the Social Security Act (42 

U.S.C. 653(j)(10)), which allows the 

Secretary of the U.S. Department of 

Health and Human Services to disclose 

information maintained in the NDNH to 

state agencies administering SNAP 

under the Nutrition Act of 2008, as 

amended by the Agriculture Act of 

2014; (2) the Privacy Act of 1974, as 

amended by the Computer Matching 

and Privacy Protection Act of 1988 (5 

U.S.C. 552a), which sets forth the terms 

and conditions of a computer matching 

program; and, (3) the Government 

Performance and Results Modernization 

Act of 2010 (Pub. L. 111–352), which 

requires agencies to report program 

performance outcomes to the Office of 

Management and Budget and for the 

reports to be available to the public. 

Respondents: State SNAP Agencies. 

ANNUAL BURDEN ESTIMATES

Information collection title Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

SNAP Matching Program Performance Outcomes ......................................... 53 1 1.92 101.76 

Estimated Total Annual Burden 

Hours: 101.76. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to The Administration for 

Children and Families, Office of 

Information Services, 330 C Street SW, 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–17152 Filed 8–9–18; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2582] 

Human Dermal (Skin) Safety Testing 

for Topical Drug Products: Regulatory 

Utility and Evaluation; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the following 1-day public 

workshop entitled ‘‘Human Dermal 

(Skin) Safety Testing for Topical Drug 

Products: Regulatory Utility and 

Evaluation.’’ The purpose of the public 

workshop is to provide a forum to 

discuss the current state and future 

directions of the collection of human 

data on the potential skin toxicity with 

the use of medications applied 

topically. The workshop will review 

current approaches to the collection of 

human data during the clinical 

development of topical drug products. 

The workshop will also address the 

impact of human skin toxicity studies 

on drug labeling and consider 

alternative approaches to providing 

information about skin toxicity. 

DATES: The public workshop will be 

held on September 10, 2018, from 8:30 

a.m. to 4 p.m. Eastern Time. Submit 

either electronic or written comments 

on this public workshop by October 10, 

2018. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503, Section A), Silver Spring, 

MD 20993–0002. Entrance for the public 

workshop participants (non-FDA 

employees) is through Building 1, where 

routine security check procedures will 

be performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before October 10, 2018. The 


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