51730 Federal Register / Vol. 78, No. 162 / Wednesday, August 21, 2013 / Notices 

comments regarding this 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. 

We are, however, requesting an 

emergency review of the information 

collection referenced below. In 

compliance with the requirement of 

section 3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, we have 

submitted to the Office of Management 

and Budget (OMB) the following 

requirements for emergency review. 

This is necessary to ensure compliance 

with an initiative of the Administration. 

We are requesting an emergency review 

under 5 CFR Part 1320(a)(2)(i) because 

public harm is reasonably likely to 

result if the normal clearance 

procedures are followed. The approval 

of this data collection process is 

essential to ensuring that Information 

Security (IS) incidents, which also 

include Personally Identifiable 

Information (PII) and Protected Health 

Information (PHI), are captured within 

the specified timeframe. In absence of 

this change, a significant number of 

incidents will not be detected; therefore 

causing harm and potential risk to the 

public’s identity with identity fraud. 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Title State 

Health Insurance Exchange Incident 

Report; Use: We have implemented a 

Computer Matching Agreement (CMA) 

with the State-Based Administering 

Entities (AEs). This agreement 

establishes the terms, conditions, 

safeguards, and procedures under which 

CMS will disclose certain information to 

the AEs in accordance with the Patient 

Protection and Affordable Care Act of 

2010 (Pub. L. 111–148), as amended by 

the Health Care and Education 

Reconciliation Act (Pub. L. 111–152), 

which are referred to collectively as the 

Affordable Care Act (ACA), 

amendments to the Social Security Act 

made by the ACA, and the 

implementing regulations. The AEs, 

which are state entities administering 

Insurance Affordability Programs, will 

use the data, accessed through the CMS 

Data Services Hub (Hub), to make 

Eligibility Determinations for Insurance 

Affordability Programs and certificates 

of exemption. 

The AEs shall report suspected or 

confirmed incidents affecting loss or 

suspected loss of PII within one hour of 

discovery to their designated Center for 

Consumer Information and Insurance 

Oversight State Officer who will then 

notify the affected Federal agency data 

sources, i.e., Internal Revenue Service, 

Department of Defense, Department of 

Homeland Security, Social Security 

Administration, Peace Corps, Office of 

Personnel Management and Veterans 

Health Administration. Additionally, 

AEs shall contact the office of the 

appropriate Special Agent-in-Charge, 

Treasury Inspector General for Tax 

Administration (TIGTA), and the IRS 

Office of Safeguards within 24 hours of 

discovery of any potential breach, loss, 

or misuse of Return Information. Form 

Number: CMS–10496 (OCN: 0938– 

New); Frequency: Occasionally; 

Affected Public: State, Local or Tribal 

governments; Number of Respondents: 

18; Total Annual Responses: 936; Total 

Annual Hours: 234. 

We are requesting OMB review and 

approval of this collection by September 

25, 2013, with a 180-day approval 

period. Written comments and 

recommendation will be considered 

from the public if received by the 

individuals designated below by the 

noted deadline below. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’s Web site 

address at http://www.cms.hhs.gov/

PaperworkReductionActof1995 or Email 

your request, including your address, 

phone number, OMB number, and CMS 

document identifier, to Paperwork@

cms.hhs.gov, or call the Reports 

Clearance Office on (410) 786–1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by September 20, 2013: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: 

CMS, Office of Strategic Operations 

and Regulatory Affairs, Division of 

Regulations Development, Attention: 

Document Identifier (CMS–10496), 

Room C4–26–05, 7500 Security 

Boulevard, Baltimore, Maryland 21244– 

1850. 

and, 

OMB Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, New Executive Office Building, 

Room 10235, Washington, DC 20503, 

Fax Number: (202) 395–6974. 

Dated: August 16, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–20396 Filed 8–20–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–194, CMS– 

10497 and CMS–10250] 

Agency Information Collection 

Activities: Proposed Collection; 

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 (the 

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 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates 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 must be received by 

October 21, 2013. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number (OCN). To be 

assured consideration, comments and 

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Federal Register / Vol. 78, No. 162 / Wednesday, August 21, 2013 / Notices 51731 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number __, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

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: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–R–194 Medicare 

Disproportionate Share Adjustment 

Procedures and Criteria and 

Supporting Regulations 

CMS–10497 Evaluation of the 

Medicare Health Care Quality 

(MHCQ) Demonstration Evaluation: 

Focus Group and Interview Protocols 

CMS–10250 Hospital Outpatient 

Quality Reporting (OQR) Program 

Under the 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 

requires federal agencies to publish a 

60-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. 

Information Collections 

1. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: 

Medicare Disproportionate Share 

Adjustment (DSH) Procedures and 

Criteria and Supporting Regulations; 

Use: Section 1886(d)(5)(F) of the Social 

Security Act established the Medicare 

disproportionate share adjustment 

(DSH) for hospitals, which provides 

additional payment to hospitals that 

serve a disproportionate share of the 

indigent patient population. This 

payment is an add-on to the set amount 

per case that we pay to hospitals under 

the Medicare Inpatient Prospective 

Payment System (IPPS). 

Under current regulations at 42 CFR 

412.106, in order to meet the qualifying 

criteria for this additional DSH 

payment, a hospital must prove that a 

disproportionate percentage of its 

patients are low income using 

Supplemental Security Income (SSI) 

and Medicaid as proxies for this 

determination. This percentage includes 

two computations: (1) The ‘‘Medicare 

fraction’’ or the ‘‘SSI ratio’’ which is the 

percent of patient days for beneficiaries 

who are eligible for Medicare Part A and 

SSI and (2) the ‘‘Medicaid fraction’’ 

which is the percent of patient days for 

patients who are eligible for Medicaid 

but not Medicare. Once a hospital 

qualifies for this DSH payment, we also 

determine a hospital’s payment 

adjustment. Form Number: CMS–R–194 

(OCN: 0938–0691); Frequency: 

Occasionally; Affected Public: Private 

sector—business or other for-profits and 

not-for-profit institutions; Number of 

Respondents: 800; Total Annual 

Responses: 800; Total Annual Hours: 

400. (For policy questions regarding this 

collection contact JoAnne Cerne at 410– 

786–4530.) 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Evaluation of 

the Medicare Health Care Quality 

(MHCQ) Demonstration Evaluation: 

Focus Group and Interview Protocols; 

Use: The Medicare Health Care Quality 

(MHCQ) Demonstration was developed 

to address concerns about the U.S. 

health care system, which typically 

fragments care while also encouraging 

both omissions in and duplication of 

care. To rectify this situation, Congress 

has directed us to test major changes to 

the delivery and payment systems to 

improve the quality of care while also 

increasing efficiency across the health 

care system. This would be achieved 

through several types of interventions: 

Adoption and use of information 

technology and decision support tools 

by physicians and their patients, such as 

evidence-based medicine guidelines, 

best practice guidelines, and shared 

decision-making programs; reform of 

payment methodologies; improved 

coordination of care among payers and 

providers serving defined communities; 

measurement of outcomes; and 

enhanced cultural competence in the 

delivery of care. 

The MHCQ Demonstration programs 

are designed to examine the extent to 

which major, multifaceted changes to 

traditional Medicare’s health delivery 

and financing systems lead to 

improvements in the quality of care 

provided to Medicare beneficiaries 

without increasing total program 

expenditures. Each demonstration site 

uses a different approach for changing 

health delivery and financing systems, 

but all share the goal of improving the 

quality and efficiency of medical care 

provided to Medicare beneficiaries. 

Focus groups and individual interviews 

will be conducted at 2 demonstration 

sites that are active in the 

demonstration: Gundersen Health 

System (GHS) and Meridian Health 

System (MHS). 

This MHCQ Demonstration evaluation 

will include analysis of both 

quantitative and qualitative sources of 

information. This multifaceted approach 

will enable this evaluation to consider 

a broad variety of evidence for 

evaluating the nature and impact of 

each site’s interventions. We are seeking 

approval to conduct in-person focus 

groups and individual interviews with 

beneficiaries and their caregivers to 

inform our evaluation of the MHCQ 

Demonstration at the GHS and MHS 

demonstration sites. Form Number: 

CMS–10497 (OCN: 0938-New); 

Frequency: Occasionally; Affected 

Public: Individuals or households; 

Number of Respondents: 36; Total 

Annual Responses: 36; Total Annual 

Hours: 108. (For policy questions 

regarding this collection contact 

Normandy Brangan at 410–786–6640.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Hospital 

Outpatient Quality Reporting (OQR) 

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51732 Federal Register / Vol. 78, No. 162 / Wednesday, August 21, 2013 / Notices 

Program; Use: Section 109(a) of the Tax 

Relief and Health Care Act of 2006 

(TRHCA) (Pub. L. 109–432) amended 

section 1833(t) of the Social Security 

Act by adding a new subsection (17) 

that affects the payment rate update 

applicable to Outpatient Prospective 

Payment System (OPPS) payments for 

services furnished by hospitals in 

outpatient settings on or after January 1, 

2009. Section 1833(t)(17)(A) of the Act, 

which applies to hospitals as defined 

under section 1886(d)(1)(B) of the Act, 

requires that hospitals that fail to report 

data required for quality measures 

selected by the Secretary in the form 

and manner required by the Secretary 

under section 1833(t)(17)(B) of the Act 

will incur a reduction in their annual 

payment update (APU) factor to the 

hospital outpatient department fee 

schedule by 2.0 percentage points. 

Sections 1833(t)(17)(C)(i) and (ii) of the 

Act require the Secretary to develop 

measures appropriate for the 

measurement of the quality of care 

furnished by hospitals in outpatient 

settings. Such measures must reflect 

consensus among affected parties and, 

to the extent feasible and practicable, 

must be set forth by one or more 

national consensus building entities. 

The Secretary also has the authority to 

replace measures or indicators as 

appropriate and requires the Secretary 

to establish procedures for making the 

data submitted available to the public. 

Such procedures must provide the 

hospitals the opportunity to review such 

data prior to public release. Our 

program established under these 

amendments is referred to as the 

Hospital Outpatient Quality Reporting 

(OQR) Program. 

Hospital OQR Program payment 

determinations are made based on OQR 

quality measure data reported and 

supporting forms submitted by hospitals 

as specified through rulemaking. To 

reduce burden, a variety of different 

data collection mechanisms are 

employed, with every consideration 

taken to employ existing data and data 

collection systems. The complete list of 

measures and data collection forms are 

organized by type of data collected and 

data collection mechanism. 

The Medicare program has a 

responsibility to ensure that Medicare 

beneficiaries receive the health care 

services of appropriately high quality 

that are comparable to that received by 

those under other payers. The Hospital 

OQR Program seeks to encourage care 

that is both efficient and of high quality 

in the hospital outpatient setting 

through collaboration with the hospital 

community to develop and implement 

quality measures that are fully and 

specifically reflective of the quality of 

hospital outpatient services. Form 

Number: CMS–10250 (OCN: 0938– 

1109); Frequency: Occasionally; 

Affected Public: Private sector—Forprofit and not for institutions; Number 

of Respondents: 3,200; Total Annual 

Responses: 3,200; Total Annual Hours: 

949,590. (For policy questions regarding 

this collection contact Anita Bhatia at 

410–786–7236.) 

Dated: August 16, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–20400 Filed 8–20–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0001] 

The Food and Drug Administration/

European Medicines Agency Orphan 

Product Designation and Grant Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration’s 

(FDA) Office of Orphan Products 

Development is announcing the 

following meeting entitled ‘‘The Food 

and Drug Administration/European 

Medicines Agency Orphan Product 

Designation and Grant Workshop.’’ This 

1-day workshop is intended to provide 

valuable information about the FDA and 

European Medicines Agency (EMA) 

Orphan Drug Designation programs, the 

FDA Humanitarian Use Device (HUD) 

Designation program, and the FDA 

Orphan Products Grant program to 

participants representing 

pharmaceutical, biotechnology, and 

device companies, as well as academics. 

Date and Time: The meeting will be 

held on October 4, 2013, from 8:30 a.m. 

to 4 p.m. 

Location: The meeting will be held at 

FDA White Oak Campus, 10903 New 

Hampshire Ave., Bldg. 31 Conference 

Center, the Great Room (rm. 1503), 

Silver Spring, MD 20993–0002. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

Contact Person: Eleanor Dixon-Terry, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, rm. 

5279, Silver Spring, MD 20993–0002, 

301–796–8660, FAX: 301–847–8621, 

Eleanor.Dixon-Terry@fda.hhs.gov. 

Registration: Interested participants 

may register for this meeting at the 

following Web site: https://eventssupport.com/events/FDA_Orphan_

Workshop. If you need sign language 

interpretation during this meeting, 

please contact Eleanor Dixon-Terry at 

Eleanor.Dixon-Terry@fda.hhs.gov by 

September 20, 2013. 

Attendance: Online registration for 

the workshop will be limited to 240 

participants for the morning session, of 

which approximately 50 teams (up to 

150 participants) may register for the 

one-on-one sessions. There will be no 

registration fee for the workshop. 

For participants who cannot attend 

the morning meetings, simultaneous 

live interactive Webcasts will be made 

available. Participants may access the 

drug and biologics Webcast by visiting 

the following site: https://

collaboration.fda.gov/odd100413/. The 

medical devices Webcast can be 

accessed by visiting: https://

collaboration.fda.gov/hudd100413/. 

SUPPLEMENTARY INFORMATION: The FDA/ 

EMA Orphan Product Designation and 

Grant Workshop is being conducted in 

partnership with the European 

Organisation for Rare Diseases, Genetic 

Alliance, and the National Organization 

for Rare Disorders. 

The morning program includes two 

simultaneous sessions. The first will 

provide an overview of the FDA and 

EMA Orphan Drug Designation 

programs, respectively, while the 

second will provide an overview of the 

FDA HUD Designation Program and 

Pediatric Device Consortia Grant 

Program. Both morning sessions will 

also cover the Orphan Products Grant 

Program as they relate to drugs, 

biologics, and devices. Both of these 

morning sessions will also be available 

by Webcast. 

The afternoon session (no Webcast), 

provides an opportunity for 

appropriately registered participants to 

have one-on-one meetings with FDA 

staff members onsite, to discuss the 

specifics on how to apply for an orphan 

product grant, a HUD designation, or 

orphan drug designation. It also 

provides for videoconference sessions 

with EMA staff representatives on EMA 

orphan drug designation. Participants 

requesting one-on-one meetings are 

expected to bring information for at 

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