Federal Register / Vol. 78, No. 180 / Tuesday, September 17, 2013 / Notices 57163 

Title of Information Collection: Request 

for Termination of Premium Hospital 

and Supplementary Medical Insurance; 

Use: The CMS–1763 provides us and the 

Social Security Administration (SSA) 

with the enrollee’s request for 

termination of Part B, Part A or both 

Part B and A premium coverage. The 

form is completed by an SSA claims or 

field representative using information 

provided by the Medicare enrollee 

during an interview. The purpose of the 

form is to provide to the enrollee with 

a standardized format to request 

termination of Part B, Part A premium 

coverage or both, explain why the 

enrollee wishes to terminate such 

coverage, and to acknowledge that the 

ramifications of the decision are 

understood. Form Number: CMS–1763 

(OCN: 0938–0025); Frequency: Once; 

Affected Public: Individuals or 

households; Number of Respondents: 

14,000; Total Annual Responses: 

14,000; Total Annual Hours: 5,833. (For 

policy questions regarding this 

collection contact Lindsay Smith at 

410–786–6843.) 

3. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Medicare 

Advantage Program Requirements; Use: 

Medicare Advantage (MA) organizations 

and potential MA organizations 

(applicants) use the information to 

comply with the application 

requirements and the MA contract 

requirements. We will use this 

information to: approve contract 

applications, monitor compliance with 

contract requirements, make proper 

payment to MA organizations, 

determine compliance with the new 

prescription drug benefit requirements, 

and to ensure that correct information is 

disclosed to Medicare beneficiaries 

(both potential enrollees and enrollees). 

Form Number: CMS–R–267 (OCN: 

0938–0753); Frequency: Yearly; Affected 

Public: Individuals or households and 

Business or other for-profits; Number of 

Respondents: 18,043,776; Total Annual 

Responses: 21,935,728; Total Annual 

Hours: 8,529,541. (For policy questions 

regarding this collection contact Dana 

Burley at 410–786–4547.) 

4. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: 

Medicare Secondary Payer Information 

Collection and Supporting Regulations; 

Use: We are seeking to renew approval 

to collect information from 

beneficiaries, providers, physicians, 

insurers, and suppliers on health 

insurance coverage that is primary to 

Medicare. Collecting this information 

allows us to identify those Medicare 

beneficiaries who are in situations 

where Medicare is statutorily required 

to be a secondary payer (MSP), thereby 

safeguarding the Medicare Trust Fund. 

Specifically, we use the information to 

accurately process and pay Medicare 

claims and to make necessary recoveries 

in accordance with § 1862(b) of the Act 

(42 U.S.C.1395y(b)). If an active MSP 

situation is identified and Medicare is 

inappropriately billed as primary, the 

claim will be rejected. The hospitals, 

other providers, physicians, pharmacies, 

and suppliers use the information 

collected (and furnished to them on the 

denial) to properly bill the appropriate 

primary payer. Completing an MSP 

questionnaire and making an accurate 

MSP determination helps hospitals, 

other providers, physicians, pharmacies, 

and suppliers to bill correctly the first 

time, saving the Medicare Program 

money and affording Medicare 

beneficiaries an enhanced level of 

customer service (which, again, is 

particularly important in Part D due to 

the real-time adjudication of claims and 

the complicated nature of its benefit 

administration). Insurers, underwriters, 

third party administrators, and selfinsured/self-administered employers 

use the information to ensure 

compliance with the law by refunding 

any identified mistaken payments to 

Medicare. Form Number: CMS–250–254 

(OCN: 0938–0214); Frequency: 

Occasionally; Affected Public: 

Individuals and Households, Private 

Sector, State, Local or Tribal 

Governments; Number of Respondents: 

143,070,217; Total Annual Responses: 

143,070,217; Total Annual Hours: 

1,788,057. (For policy questions 

regarding this collection contact Ward 

Marsh at 410–786–6473.) 

Dated: September 11, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–22515 Filed 9–16–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10069] 

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 

November 18, 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 llllll, 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. 


tkelley on DSK3SPTVN1PROD with NOTICES
57164 Federal Register / Vol. 78, No. 180 / Tuesday, September 17, 2013 / Notices 

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–10069 Medicare Waiver 

Demonstration Application 

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: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare 

Waiver Demonstration Application; Use: 

The currently approved application has 

been used for several congressionally 

mandated and Administration high 

priority demonstrations. The 

standardized format is not controversial 

and will reduce burden on applicants 

and reviewers. Responses are strictly 

voluntary. The standard format will 

enable us to select proposals that meet 

our objectives and show the best 

potential for success. Form Number: 

CMS–10069 (OCN: 0938–0880); 

Frequency: Once; Affected Public: 

Private Sector—Business or other forprofits and Not-for-profit institutions; 

Number of Respondents: 75; Total 

Annual Responses: 75; Total Annual 

Hours: 6,000 (For policy questions 

regarding this collection contact Steven 

Johnson at 410–786–3332). 

Dated: September 11, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–22516 Filed 9–16–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0662] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Applications for 

Food and Drug Administration 

Approval To Market a New Drug: 

Patent Submission and Listing 

Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 17, 

2013. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0513. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850, 

PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Applications for FDA Approval To 

Market a New Drug: Patent Submission 

and Listing Requirements and 

Application of 30-Month Stays on 

Approval of Abbreviated New Drug 

Applications Certifying That a Patent 

Claiming a Drug Is Invalid or Will Not 

Be Infringed—(OMB Control Number 

0910–0513)—Extension 

Section 505(b)(1) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 355(b)(1)) requires all new 

drug application (NDA) applicants to 

file, as part of the NDA, ‘‘the patent 

number and the expiration date of any 

patent which claims the drug for which 

the applicant submitted the application 

or which claims a method of using such 

drug and with respect to which a claim 

of patent infringement could reasonably 

be asserted if a person not licensed by 

the owner engaged in the manufacture, 

use, or sale of the drug.’’ Section 

505(c)(2) of the FD&C Act (21 U.S.C. 

355(c)(2)) imposes a similar patent 

submission obligation on holders of 

approved NDAs when the NDA holder 

could not have submitted the patent 

information with its application. Under 

section 505(b)(1) of the FD&C Act, we 

publish patent information after 

approval of an NDA in the list entitled 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations’’ 

(the Orange Book). If patent information 

is submitted after NDA approval, 

section 505(c)(2) of the FD&C Act 

directs us to publish the information 

upon its submission. 

FDA regulations at §§ 314.50(h) (21 

CFR 314.50(h)) and 314.53 (21 CFR 

314.53) clarify the types of patent 

information that must and must not be 

submitted to FDA as part of an NDA, an 

amendment, or a supplement, and 

require persons submitting an NDA, an 

amendment, or a supplement, or 

submitting information on a patent after 

NDA approval, to make a detailed 

patent declaration using Forms FDA 

3542 and 3542a. 

The reporting burden for submitting 

an NDA, an amendment, or a 

supplement in accordance with § 314.50 

(a) through (f) and (k) has been 

estimated by FDA and the collection of 

information has been approved by OMB 

under OMB control number 0910–0001. 

We are not reestimating these approved 

burdens in this document. Only the 

reporting burdens associated with 

patent submission and listing, as 

explained in the following paragraphs, 

are estimated in this document. 

The information collection reporting 

requirements are as follows: 

Section 314.50(h) requires that an 

NDA, an amendment, or a supplement 


tkelley on DSK3SPTVN1PROD with NOTICES