40482 Federal Register / Vol. 78, No. 129 / Friday, July 5, 2013 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Social and community service managers ....... 300 1 12/60 60 

TOTAL ......................... ......................................................................... ........................ ........................ ........................ 1,882 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2013–16106 Filed 7–3–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10316] 

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 August 5, 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: Revision of a currently 

approved collection; Title of 

Information Collection: Implementation 

of the Medicare Prescription Drug Plan 

(PDP) and Medicare Advantage (MA) 

Plan Disenrollment Reasons Survey; 

Use: This data collection complements 

the satisfaction data collected through 

the Medicare Consumer Assessment of 

Healthcare Providers and Systems 

survey by providing dissatisfaction data 

in the form of reasons for disenrollment 

from a Prescription Drug Plan. The data 

collected in this survey can be used to 

improve the operation of Medicare 

Advantage (MA) (both MA and MA–PD) 

contracts and standalone prescription 

drug plans (PDPs) through the 

identification of beneficiary 

disenrollment reasons. Plans can use the 

information to guide quality 

improvement efforts. The data can also 

be used by beneficiaries who need to 

choose among the different MA and PDP 

options. To the extent that these data 

identify areas for improvement at the 

contract level they can be used for 

contract oversight. Form Number: CMS– 

10316 (OCN: 0938–1113); Frequency: 

Yearly; Affected Public: Individuals or 

households; Number of Respondents: 

88,492; Total Annual Responses: 

88,492; Total Annual Hours: 22,887. 

(For policy questions regarding this 

collection contact Sai Ma at 410–786– 

1479.) 

Dated: June 28, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–16084 Filed 7–3–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10171, CMS– 

10207, CMS–10476 and CMS–855(C)] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 129 / Friday, July 5, 2013 / Notices 40483 

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 

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 

September 3, 2013. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number (OCN). To be 

assured consideration, comments and 

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 llll, 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–10171 Coordination of Benefits 

Between Part D Plans and Other 

Prescription Coverage Providers. 

CMS–10207 Physician Self-Referral 

Exceptions for Electronic Prescribing 

and Electronic Health Records. 

CMS–10476 Medical Loss Ratio 

(MLR) Report for Medicare Advantage 

(MA) Plans and Prescription Drug Plans 

(PDP). 

CMS–855(C) Medicare Enrollment 

Application for Registration of Eligible 

Entities That Provide Health Insurance 

Coverage Complementary to Medicare 

Part B 

Under the Paperwork Reduction Act 

(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: Revision of a currently 

approved collection; Title of 

Information Collection: Coordination of 

Benefits Between Part D Plans and 

Other Prescription Coverage Providers; 

Use: We will use the information along 

with Part D plans, other health insurers 

or payers, and pharmacies to coordinate 

prescription drug benefits provided to 

the Medicare beneficiary. Form Number: 

CMS–10171 (OCN: 0938–0978): 

Frequency: Occasionally; Affected 

Public: Private sector—Business or other 

for-profits; Number of Respondents: 

57,116; Total Annual Responses: 

2,402,582; Total Annual Hours: 

5,205,128. (For policy questions 

regarding this collection contact Heather 

Rudo at 410–786–7627.) 

2. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: 

Physician Self-Referral Exceptions for 

Electronic Prescribing and Electronic 

Health Records; Use: The collected 

information would be used for 

enforcement purposes. Specifically, if 

we were investigating the financial 

relationships between donors and 

physicians to determine whether the 

provisions in the exceptions at 42 CFR 

411.357(v) and (w) were met, first, we 

would review the written agreements 

that indicate what items and services 

each entity intended to provide. Form 

Number: CMS–10207 (OCN: 0938– 

1009); Frequency: Monthly; Affected 

Public: Private sector—Business or other 

for-profits and Not-for-profit 

institutions; Number of Respondents: 

9,409; Total Annual Responses: 17,744; 

Total Annual Hours: 1,896. (For policy 

questions regarding this collection 

contact Michael Zleit at 410–786–2050.) 

3. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Medical Loss 

Ratio (MLR) Report for Medicare 

Advantage (MA) Plans and Prescription 

Drug Plans (PDP); Use: We will use the 

data collection of annual reports 

provided by plan sponsors for each 

contract to ensure that beneficiaries are 

receiving value for their premium dollar 

by calculating each contract’s medical 

loss ratio (MLR) and any remittances 

due for the respective MLR reporting 

year. The recordkeeping requirements 

will be used to determine plan sponsors’ 

compliance with the MLR requirements, 

including compliance with how plan 

sponsors’ experience is to be reported, 

and how their MLR and any remittances 

are calculated. Form Number: CMS– 

10476 (OCN: 0938-New); Frequency: 

Yearly; Affected Public: Private sector— 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 616; Total Annual 

Responses: 616; Total Annual Hours: 

28,980. (For policy questions regarding 

this collection contact Ilina Chaudhuri 

at 410–786–8628.) 

4. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Medicare 

Enrollment Application for Registration 

of Eligible Entities That Provide Health 

Insurance Coverage Complementary to 

Medicare Part B; Use: The primary 


tkelley on DSK3SPTVN1PROD with NOTICES
40484 Federal Register / Vol. 78, No. 129 / Friday, July 5, 2013 / Notices 

function of a Medicare enrollment 

application is to gather information 

from a provider, supplier or other entity 

that tells us who it is, whether it meets 

certain qualifications to be a health care 

provider, supplier or entity, where it 

practices or renders its services, the 

identity of the owners of the enrolling 

entity, and information necessary to 

establish correct claims payments. We 

are adding a new CMS–855 Medicare 

Registration Application, the CMS– 

855C: Medicare Enrollment Application 

for Registration of Eligible Entities That 

Provide Health Insurance Coverage 

Complementary to Medicare Part B. 

This Medicare registration application is 

to be completed by all entities that 

provide a complimentary health benefit 

plan and intend to bill Medicare as an 

indirect payment procedure (IPP) biller 

and the entity or health plan meets all 

Medicare requirements to submit claims 

for indirect payments. The entity must 

furnish the name of at least one 

authorized official, preferably the 

administrator of the health plan, who 

must sign this registration application 

attesting that the registering entity meets 

the requirements to register as an 

indirect payment procedure biller and 

will also abide by the requirements 

stated in the Certification & Attestation 

Statement in Section 10 of the 

application. 

The CMS–855C will be submitted at 

the time the applicant first requests a 

Medicare identification number for the 

sole purpose of submitting claims under 

the ‘‘Indirect Payment Procedure (IPP)’’ 

for reimbursement, and when necessary 

to report any changes to information 

previously submitted. The application 

will be used by Medicare contractors to 

collect data to ensure the applicant has 

the necessary credentials to submit 

Medicare claims for reimbursement, 

including information that allows 

Medicare contractors to ensure that the 

entity and its owners and administrators 

are not sanctioned from the Medicare 

program, or debarred, suspended or 

excluded from any other Federal agency 

or program. Form Number: CMS–855(C) 

(OCN: 0938-New); Frequency: 

Occasionally; Affected Public: Private 

sector—Business or other for-profits and 

Not-for-profit institutions; Number of 

Respondents: 440; Total Annual 

Responses: 440; Total Annual Hours: 

500. (For policy questions regarding this 

collection contact Kim McPhillips at 

410–786–5374.) 

Dated: June 28, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–16085 Filed 7–3–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–P–0303] 

Determination That METADATE ER 

(Methylphenidate Hydrochloride) 

Extended-Release Tablet, 10 

Milligrams, Was Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that METADATE ER (methylphenidate 

hydrochloride (HCl)) extended-release 

tablet, 10 milligrams (mg), was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for 

methylphenidate HCl extended-release 

tablet, 10 mg, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Reena Raman, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6238, 

Silver Spring, MD 20993–0002, 301– 

796–7577. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products with 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

METADATE ER (methylphenidate 

HCl) extended-release tablet, 10 mg, is 

the subject of ANDA 40–306, held by 

UCB, Inc., and initially approved on 

October 20, 1999. METADATE ER is 

indicated as an integral part of a total 

treatment program which typically 

includes other remedial measures 

(psychological, educational, social) for a 

stabilizing effect in children with a 

behavioral syndrome characterized by 

the following group of developmentally 

inappropriate symptoms: Moderate-tosevere distractibility, short attention 

span, hyperactivity, emotional lability, 

and impulsivity. 

In a letter dated November 4, 2011, 

UCB, Inc., notified FDA that 

METADATE ER (methylphenidate HCl) 

extended-release tablet, 10 mg, had been 

discontinued, and FDA moved the drug 

product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Tedor Pharma Inc. submitted a citizen 

petition dated March 6, 2013 (Docket 

No. FDA–2013–P–0303), under 21 CFR 

10.30, requesting that the Agency 

determine whether METADATE ER 

(methylphenidate HCl) extended-release 

tablet, 10 mg, was withdrawn from sale 

for reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that METADATE ER 

(methylphenidate HCl) extended-release 

tablet, 10 mg, was not withdrawn for 

reasons of safety or effectiveness. The 

petitioner has identified no data or other 

information suggesting that METADATE 

ER (methylphenidate HCl) extendedrelease tablet, 10 mg, was withdrawn for 


tkelley on DSK3SPTVN1PROD with NOTICES