34390 Federal Register / Vol. 78, No. 110 / Friday, June 7, 2013 / Notices 

changes to the CMS EHR Incentive 

Programs and the 2014 Edition 

Certification Criteria for EHR 

technology. 

The information collection 

requirements contained in this 

information collection request are 

needed to implement the HITECH Act. 

In order to avoid duplicate payments, 

all EPs are enumerated through their 

National Provider Identifier (NPI), while 

all eligible hospitals and CAHs are 

enumerated through their CMS 

Certification Number (CCN). State 

Medicaid agencies and CMS use the 

provider’s tax identification number and 

NPI or CCN combination in order to 

make payment, validate payment 

eligibility and detect and prevent 

duplicate payments for EPs, eligible 

hospitals and CAHs. Form Number: 

CMS–10336 (OCN: 0938–1158). 

Frequency: Occasionally; Affected 

Public: Private sector. Number of 

Respondents: 214, 694; Total Annual 

Responses: 214,694. Total Annual 

Hours: 2,034,740.16. (For policy 

questions regarding this collection 

contact Travis Broome at 214–767–4450. 

For all other issues call 410–786–1326.) 

9. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Security 

Consent and Surrogate Authorization 

Form; Use: The primary function of the 

Medicare enrollment application is to 

obtain information about the Provider or 

supplier and whether they meet the 

Federal and/or State qualifications to 

participate in the Medicare program. In 

addition, the Medicare enrollment 

application gathers information 

regarding the provider or supplier’s 

practice location, the identity of the 

owners of the enrolling organization, 

and information necessary to establish 

the correct claims payment. 

Enrollees have the option of 

submitting either a CMS 855 form, or 

submitting information via a web based 

process. In establishing a web based 

application process, we allow providers 

and suppliers the ability to enroll in the 

Medicare program, revalidate their 

enrollment and make changes to their 

enrollment information via Internetbased Provider Enrollment, Chain and 

Ownership System (PECOS). Individual 

providers/suppliers (hereinafter referred 

to as ‘‘Individual Providers’’) log into 

Internet-based PECOS using their User 

IDs and passwords established when 

they applied on-line to the National 

Plan and Provider Enumeration System 

(NPPES) for their National Provider 

Identifiers (NPIs). Authorized Officials 

(AOs) of the provider or supplier 

organizations (hereinafter referred to as 

‘‘Organizational Providers’’) must 

register for a user account and 

authenticate their identity and 

connection to the organization they 

represent before being able to log into 

Internet-based PECOS. Once 

authenticated, AOs for Organizational 

Providers, receive complete access to 

their enrollment information via 

Internet-based PECOS. Individuals and 

AOs of Organizational Providers are not 

required to submit a Security Consent 

and Surrogate Authorization Form to 

enroll, revalidate or make changes to 

their Medicare enrollment information. 

Individual and Organizational 

Providers may complete their Medicare 

enrollment responsibilities on their own 

or elect to delegate this task to a 

Surrogate. A Surrogate is an individual 

or organization identified by an 

Individual or Organizational Provider as 

someone authorized to access CMS 

computer systems, such as Internetbased PECOS, National Provider Plan 

and Enumeration System (NPPES) and 

the Medicare and Medicaid Electronic 

Health Records (EHR) Incentive Program 

Registration and Attestation System 

(HITECH), on their behalf and to modify 

or view any information contained 

therein that the Individual or 

Organizational Provider may have 

permission or right to access in 

accordance with Medicare statutes, 

regulations, policies, and usage 

guidelines for any CMS system. 

Surrogates may consist of administrative 

staff, independent contractors, 3rd party 

consulting companies or credentialing 

departments. In order for an Individual 

or Organizational Provider to delegate 

the Medicare credentialing process to a 

Surrogate to access and update their 

enrollment information in the above 

mentioned CMS systems on their behalf, 

it is required that a Security Consent 

and Surrogate Authorization Form be 

completed, or Individual and 

Organizational Providers use an 

equivalent online process via the 

PECOS Identity and Access 

Management (I&A) system. The Security 

Consent and Surrogate Authorization 

form replicates business service 

agreements between Medicare 

providers, suppliers or both and 

Surrogates providing enrollment 

services. 

We are proposing one version of the 

Security Consent and Surrogate 

Authorization Form. The form, once 

signed, mailed and approved, grants a 

Surrogate access to all current and 

future enrollment data for the 

Individual or Organization Provider. 

Form Number: CMS–10220 (OCN: 

0938–1035). Frequency: Occasionlly. 

Affected Public: Individuals and Private 

Sector; Number of Respondents: 88,650; 

Total Annual Responses: 88,650; Total 

Annual Hours: 22,162. (For policy 

questions regarding this collection 

contact Alisha Banks at 410–786–0671. 

For all other issues call 410–786–1326.) 

10. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Certification 

Statement for Electronic File 

Interchange Organizations; Use: Health 

care providers can currently obtain a 

National Provider Identifier (NPI) via a 

paper application or over the Internet 

through the National Plan and Provider 

Enumeration System (NPPES). These 

applications must be submitted 

individually, on a per-provider basis. 

The Electronic File Interchange (EFI) 

process allows provider-designated 

organizations (EFIOs) to capture 

multiple providers’ NPI application 

information on a single electronic file 

for submission to NPPES. This process 

is also referred to as bulk enumeration. 

To ensure that the EFIO has the 

authority to act on behalf of each 

provider and complies with other 

federal requirements, an authorized 

official of the EFIO must sign a 

certification statement and mail it to us. 

Form Number: CMS–10175 (OCN: 

0938–0984). Frequency: Occasionally. 

Affected Public: Private Sector; Number 

of Respondents: 25; Total Annual 

Responses: 25; Total Annual Hours: 75. 

(For policy questions regarding this 

collection contact Leslie Jones at 410– 

786–6599. For all other issues call 410– 

786–1326.) 

Dated: June 4, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–13578 Filed 6–6–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10309, CMS– 

10475, CMS–R–5 and CMS–R–234] 

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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 110 / Friday, June 7, 2013 / Notices 34391 

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 July 8, 2013. 

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) 395–6974 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: Reinstatement with change of a 

previously approved collection. Title of 

Information Collection: Grandfathering 

Provisions of the Medicare DMEPOS 

Competitive Bidding Program. Use: 

Section 1847(a)(4) of the Social Security 

Act (the Act) requires (in the case of 

covered durable medical equipment 

(DME) items for which payment is made 

on a rental basis under section 1834(a) 

of the Act and in the case of oxygen for 

which payment is made under section 

1834(a)(5) of the Act) that the Secretary 

will establish a grandfathering process 

by which covered items and supplies 

that were rented by suppliers before the 

implementation of a competitive 

bidding program may be continued. 

We established the grandfathering 

process in the April 10, 2007 final rule 

for competitive bidding (72 FR 17992) 

for rented DME and oxygen and oxygen 

equipment when these items are 

included under the Medicare DMEPOS 

Competitive Bidding Program. This 

process only applies to suppliers that 

rented DME and oxygen and oxygen 

equipment to beneficiaries who 

maintain a permanent residence in a 

competitive bidding area (CBA) before 

the implementation of the competitive 

bidding program. 

The competitive bidding program will 

require some beneficiaries to change 

their suppliers. To avoid a beneficiary 

being without medically necessary 

equipment we believe it is necessary to 

establish this notification process. The 

notification to the beneficiaries is a 

beneficiary protection that will keep 

them informed of whether or not they 

can continue to rent an item from their 

current supplier or go to a contract 

supplier. The notification will also 

provide information to the beneficiary 

as to how to find a contract supplier in 

their CBA. In the event that the 

beneficiary must go to a contract 

supplier, the notification will identify 

the procedure for the pick-up of their 

current equipment and delivery of new 

equipment. Form Number: CMS–10309 

(OCN: 0938–1079). Frequency: Once; 

Affected Public: Private sector (business 

or other for-profits); Number of 

Respondents: 2,697; Total Annual 

Responses: 536,667; Total Annual 

Hours: 65. (For policy questions 

regarding this collection contact 

Michael Keane at 410–786–4495. For all 

other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: New collection (request for a 

new OMB control number). Title of 

Information Collection: Hospice 

Experience of Care Survey; Use: This 

survey supports the National Quality 

Strategy that was called for under the 

Affordable Care Act to create national 

aims and priorities to guide local, state, 

and national efforts to improve the 

quality of health care. This strategy has 

established six priorities that support a 

three-part aim focusing on better care, 

better health, and lower costs through 

improvement. Because the hospice 

survey focuses on experiences of care, 

implementation of the survey supports 

the following national priorities for 

improving care: Engaging patients and 

families in care and promoting effective 

communication and coordination. In 

addition, upon national implementation 

and public reporting of hospice survey 

results, the survey will provide data on 

experiences with hospice care that 

enable consumers to make meaningful 

comparisons between hospices across 

the nation. Form Number: CMS–10475 

(OCN: 0938–New); Frequency: Once; 

Affected Public: Individuals and 

households; Number of Respondents: 

730; Total Annual Responses: 730. Total 

Annual Hours: 185. (For policy 

questions regarding this collection 

contact Lori Teichman at 410–786– 

6684. For all other issues call 410–786– 

1326.) 

3. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection. 

Title of Information Collection: 

Physician Certification/Recertification 

in Skilled Nursing Facilities (SNFs) 

Manual Instructions and Supporting 

Regulation in 42 CFR 424.20; Use: The 

Medicare program requires, as a 

condition for Medicare Part A payment 

for post-hospital SNF services that a 

physician must certify and periodically 

recertify that a beneficiary requires a 

SNF level of care. The physician 

certification and recertification is 

intended to ensure that the beneficiary’s 

need for services has been established 

and then reviewed and updated at 

appropriate intervals. The 

documentation is a condition for 

Medicare Part A payment for posthospital SNF care. Form Number: CMS– 

R–5 (OCN: 0938–0454). Frequency: 

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34392 Federal Register / Vol. 78, No. 110 / Friday, June 7, 2013 / Notices 

Occasionally; Affected Public: Private 

sector (business or other for-profit and 

not-for-profit institutions); Number of 

Respondents: 1,796,502; Total Annual 

Responses: 1,796,502; Total Annual 

Hours: 559,713. (For policy questions 

regarding this collection contact Kia 

Sidbury at 410–786–7816. For all other 

issues call 410–786–1326.) 

4. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Subpart D— 

Private Contracts and Supporting 

Regulations Contained in 42 CFR 

405.410, 405.430, 405.435, 405.440, 

405.445, and 405.455. Use: Section 4507 

of Balancing Budget Act (BBA) 1997 

amended section 1802 of the Social 

Security Act to permit certain 

physicians and practitioners to opt-out 

of Medicare and to provide (through 

private contracts) services that would 

otherwise be covered by Medicare. 

Under such contracts the mandatory 

claims submission and limiting charge 

rules of section 1848(g) of the Act would 

not apply. Subpart D and the supporting 

regulations counters the effect of certain 

provisions of Medicare law that, absent 

section 4507 of BBA 1997, preclude 

physicians and practitioners from 

contracting privately with Medicare 

beneficiaries to pay without regard to 

Medicare limits. Physicians and/or 

practitioners use these information 

collection requirements to comply with 

the law. In addition, Medicare carriers 

use this information to determine if 

benefits should be paid or continued. 

Form Number: CMS–R–234 (OCN 0938– 

0730); Frequency: Biennially; Affected 

Public: Private sector (business or other 

for-profits); Number of Respondents: 

26,820. Total Annual Responses: 

26,820. Total Annual Hours: 7,197. (For 

policy questions regarding this 

collection contact Fred Grabau at 410– 

786–0206. For all other issues call 410– 

786–1326.) 

Dated: June 4, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–13577 Filed 6–6–13; 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: Guidance for Tribal TANF. 

OMB No.: 0970–0157. 

Description 

42 U.S.C. 612 (Section 412 of the 

Social Security Act) requires each 

Indian Tribe that elects to administer 

and operate a Temporary Assistance for 

Needy Families (TANF) program to 

submit a TANF Tribal Plan. The TANF 

Tribal Plan is a mandatory statement 

submitted to the Secretary by the Indian 

Tribe, which consists of an outline of 

how the Indian Tribes TANF program 

will be administered and operated. It is 

used by the Secretary to determine 

whether the plan is approvable and to 

determine that the Indian Tribe is 

eligible to receive a TANF assistance 

grant. It is also made available to the 

public. 

Respondents 

Indian Tribes applying to operate a 

TANF program. 

Annual Burden Estimates 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Request for State Data Needed to Determine the Amount of a Tribal Family 

Assistance Grant .......................................................................................... 23 1 68 1564 

Estimated Total Annual Burden 

Hours: 1,564. 

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. 2013–13536 Filed 6–6–13; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0179] 

Guidance for Industry and Food and 

Drug Administration Staff: Technical 

Considerations for Pen, Jet, and 

Related Injectors Intended for Use With 

Drugs and Biological Products; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a final guidance 

document entitled ‘‘Technical 

Considerations for Pen, Jet, and Related 

Injectors Intended for Use With Drugs 

and Biological Products,’’ dated June 

2013. The final guidance document 

provides technical and scientific 

mstockstill on DSK4VPTVN1PROD with NOTICES