7126 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices 

permits some beneficiaries to selfadminister the immunoglobulin (IG) 

safely at home without an attending 

healthcare professional. SCIG at home is 

reimbursed by Medicare. However, 

there are limitations to SCIG—e.g., the 

need for more frequent administration 

and higher volumes of solution, which 

can reach a maximum absorbable level 

for some patients that is below their 

optimum IG treatment level—that 

inhibit more widespread use of SCIG. 

Under the Medicare Patient IVIG 

Access Demonstration project, by 

paying for the items and services 

needed to administer the IVIG drug inhome, Medicare will enable 

beneficiaries and their physicians to 

have greater flexibility in choosing the 

option that is most appropriate for the 

beneficiary. With the exception of 

coverage of these items and services, no 

other aspects of Medicare coverage for 

IVIG (e.g., drugs approved for coverage 

or PIDD diagnoses covered) will change 

under the demonstration. 

The Medicare Patient IVIG Access 

Demonstration project mandates CMS 

to: 

• Evaluate the impact of the Medicare 

IVIG Access Demonstration project on 

Medicare beneficiary access to IVIG at 

home, 

• Determine the appropriateness of 

implementing a new payment 

methodology for IVIG in all settings and 

determining an appropriate payment 

amount, and 

• Update the existing 2007 Office of 

the Assistant Secretary for Planning and 

Evaluation (ASPE) report Analysis of 

Supply, Distribution, Demand, and 

Access Issues Associated with Immune 

Globulin Intravenous (IGIV) (2007 ASPE 

Report). 

The impact evaluation seeks to 

understand the experiences of 

demonstration participants and nonparticipants, to update the 2007 ASPE 

report, and to support the payment 

methodology through the use of 

qualitative and quantitative data 

collection. The qualitative data 

collection will consist of a series of 

stakeholder interviews. Interviews with 

IVIG/SCIG physicians and nurses will 

provide information on the experiences 

of beneficiaries from the perspective of 

those who have significant, in-depth 

and practical hands-on experience with 

delivering IG to Medicare beneficiaries 

with and without access to home 

infusions. We will be able to gather their 

knowledge of beneficiaries’ experiences 

with the care, as well as information on 

any potential health consequences due 

to changes in IG medication or 

participation in the Demonstration. 

Lastly, we will gather the physicians 

and nurses’ views of the degree to 

which beneficiaries believe the program 

is effective, including the cost 

effectiveness for beneficiaries who use 

the services provided under the 

Demonstration. Form Number: CMS– 

10600 (OMB control number: 0938– 

NEW); Frequency: Annually; Affected 

Public: Individuals and Households; 

State, Local or Tribal Governments; 

Private Sector (Business or other forprofit); Number of Respondents: 2,488; 

Total Annual Responses: 2,488; Total 

Annual Hours: 483. (For policy 

questions regarding this collection 

contact Pauline Karikari-Martin at 410– 

786–1040). 

Dated: February 5, 2016. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2016–02686 Filed 2–9–16; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–1728–94] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

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 any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) 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 March 11, 2016. 

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’ Web site 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: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Home Health 

Agency Cost Report; Use: Providers of 

Services participating in the Medicare 

program are required under sections 

1815(a), 1833(e) and1861(v)(1)(A) of the 

Social Security Act (42 U.S.C. 1395g) to 

submit annual information to achieve 


asabaliauskas on DSK9F6TC42PROD with NOTICES2
Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices 7127 

settlement of costs for health care 

services rendered to Medicare 

beneficiaries. In addition, regulations at 

42 CFR 413.20 and 413.24 require 

adequate cost data and cost reports from 

providers on an annual basis. The Form 

CMS–1728–94 cost report is needed to 

determine a provider’s reasonable cost 

incurred in furnishing medical services 

to Medicare beneficiaries and 

reimbursement due to or from a 

provider. Form Number: CMS–1728–94 

(OMB control number: 0938–0022); 

Frequency: Annually; Affected Public: 

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

Number of Respondents: 11,352; Total 

Annual Responses: 11,352; Total 

Annual Hours: 2,576,904. (For policy 

questions regarding this collection 

contact Angela DiGorgio at 410–786– 

4516.) 

Dated: February 5, 2016. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2016–02685 Filed 2–9–16; 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: State Self-Assessment Review 

and Report. 

OMB No.: 0970–0223. 

Description: Section 454(15)(A) of the 

Social Security Act, as amended by the 

Personal Responsibility and Work 

Opportunity Reconciliation Act of 1996, 

requires each State to annually assess 

the performance of its child support 

enforcement program in accordance 

with standards specified by the 

Secretary of the Department of Health 

and Human Services, and to provide a 

report of the findings to the Secretary. 

This information is required to 

determine if States are complying with 

Federal child support mandates and 

providing the best services possible. The 

report is also intended to be used as a 

management tool to help States evaluate 

their programs and assess performance. 

Respondents: State Child Support 

Enforcement Agencies or the 

Department/Agency/Bureau responsible 

for Child Support Enforcement in each 

State. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Self-assessment report .................................................................................... 54 1 4 216 

Estimated Total Annual Burden 

Hours: 216. 

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, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. All 

requests should be identified by the title 

of the information collection. Email 

address: infocollection@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, Fax: 202–395–7285, 

Email: OIRA_SUBMISSION@

OMB.EOP.GOV, Attn: Desk Officer for 

the Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2016–02629 Filed 2–9–16; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Refugee Microenterprise and 

Refugee Home-Based Child Care 

Microenterprise Development Programs 

OMB No.: New 

Description: The Office of Refugee 

Resettlement (ORR) within the 

Administration for Children and 

families (ACF) is responsible for 

resettling thousands of refugees every 

year from all over the world. The main 

goal of the ORR (US) refugee domestic 

resettlement program is to assist the 

refugees in becoming self-reliant at the 

shortest time possible. ORR has many 

different discretionary grants that it 

employs to accomplish this goal. Two of 

the discretionary grants are the Refugee 

Microenterprise Development (MED) 

and the Refugee Home-Based Child Care 

Microenterprise Development (HBCC 

MED) Programs. The goals of the MED 

program are to assist refugees in 

becoming economically self-sufficient, 

assist refugee serving organizations 

galvanize resources to strengthen their 

capacities to expand and continue their 

microenterprise services at an expanded 

and sustainable level, and enhance the 

integration to the mainstream and 

realize the American Dream. The focus 

of the HBCC Program is on women that 

have limited opportunity to get 

employment at livable wages because of 

limited transferable skills and lack of 

knowledge of the English language. 

Through the program women refugees 

are provided basic training in child care 

and development, state and local legal 

requirements to get a license and to 

establish a home-based child care 

service. The ultimate goal of the 

program is to enable the women 

refugees establish a home-based child 

care service in their neighborhood. 

ORR works with nonprofit 

organizations in implementing these 

projects. Currently, there are 22 projects 

in the Refugee Microenterprise 

Development Program and 23 projects 

in the Refugee Home-Based Child Care 

Microenterprise Development Program. 

It is critical to collect data through a 

semi-annual report in order to 

determine whether or not the programs 

are achieving their intended goals, to 

address concerns, issues, and challenges 


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