40106 Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices 

Information Collection 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Solicitation for 

Applications for Medicare Prescription 

Drug Plan 2015 Contracts; Use: The 

information will be collected under the 

solicitation of proposals from PDP, MA– 

PD, Cost Plan, PACE, and EGWP 

applicants. We will use the information 

to ensure that applicants meet our 

requirements and support the 

determination of contract awards. 

Participation in the Part D program is 

voluntary in nature. Only organizations 

that are interested in participating in the 

program will respond to the solicitation. 

The MA–PDs that voluntarily 

participate in the Part C program must 

submit a Part D application and 

successful bid. Form Number: CMS– 

10137 (OMB control number: 0938— 

0936); Frequency: Yearly; Affected 

Public: Private sector—Business or other 

for-profits and Not-for-profit 

institutions; Number of Respondents: 

254; Total Annual Responses: 254; Total 

Annual Hours: 2,193. (For policy 

questions regarding this collection 

contact Arianne Spaccarelli at 410–786– 

5715). 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Part C— 

Medicare Advantage and 1876 Cost Plan 

Expansion Application; Use: The 

information will be collected under the 

solicitation of Part C applications from 

MA, EGWP Plan, and Cost Plan 

applicants and will be used to ensure 

that applicants meet our requirements 

and support the determination of 

contract awards. Participation in all 

programs is voluntary in nature; only 

organizations that are interested in 

participating in the program will 

respond to the solicitation. The MA– 

PDs that voluntarily participate in the 

Part C program must submit a Part D 

application and successful bid. Form 

Number: CMS–10237 (OMB control 

number: 0938–0935); Frequency: Yearly; 

Affected Public: Private sector— 

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

Respondents: 566; Total Annual 

Responses: 566; Total Annual Hours: 

22,625. (For policy questions regarding 

this collection contact Melissa Staud at 

410–786–3669). 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Generic 

Clearance for Medicaid and CHIP State 

Plan, Waiver, and Program Submissions; 

Use: State Medicaid and CHIP agencies 

are responsible for developing 

submissions to CMS, including State 

plan amendments and requests for 

waivers and program demonstrations. 

States use templates when they are 

available and submit the forms to 

review for consistency with statutory 

and regulatory requirements (or in the 

case of waivers and demonstrations 

whether the proposal is likely to 

promote the objectives of the Medicaid 

program). If the requirements are met, 

we approve the States’ submissions 

giving the States the authority to 

implement the flexibilities. For a State 

to receive Medicaid Title XIX funding, 

there must be an approved Title XIX 

State plan. 

The development of streamlined 

submissions forms enhances the 

collaboration and partnership between 

States and CMS by documenting our 

policy for States to use as they are 

developing program changes. 

Streamlined forms improve efficiency of 

administration by creating a common 

and user-friendly understanding of the 

information we need to quickly process 

requests for State plan amendments, 

waivers, and demonstration, as well as 

ongoing reporting. Form Number: CMS– 

10398 (OMB control number: 0938– 

1148); Frequency: Collection specific, 

but generally the frequency is yearly, 

once, and occasionally; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 56; Total 

Annual Responses: 1,120; Total Annual 

Hours: 28,747. (For policy questions 

regarding this collection contact 

Annette Pearson at 410–786–6858). 

4. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Executive 

Summary Form for Research Identifiable 

Data; Use: The Centers for Medicare & 

Medicaid Services (CMS) is responsible 

for administering the Medicare, 

Medicaid and State Children’s Health 

Insurance Programs. We collect data to 

support the Agency’s mission and 

operations. These data include 

information about Medicare 

beneficiaries, Medicare claims, 

Medicare providers, and Medicaid 

eligibility and claims. We disclose the 

identifiable data consistent with the 

routine uses identified in the Privacy 

Act Systems of Records notices that are 

published in the Federal Register and 

the limitations on uses and disclosures 

that are set out in the HIPAA Privacy 

Rule. 

All requests for identifiable data are 

received and reviewed by the Division 

of Privacy Operations & Compliance 

(DPOC) in the Office of E-Health 

Standards and Services. The DPOC staff 

and the CMS Privacy Officer review the 

requests to determine if there is legal 

authorization for disclosure of the data. 

If legal authorization exists, the request 

is reviewed to ensure that the minimal 

data necessary is requested and 

approved for the project. Requests for 

identifiable data for research purposes 

must be submitted to and approved by 

the CMS Privacy Board. To assist the 

CMS Privacy Board with its review of 

research data requests, OIPDA has 

developed the Executive Summary (ES) 

forms. The ES collects all the 

information that the CMS Privacy Board 

needs to review and make a 

determination on whether the request 

meets the requirements for release of 

identifiable data for research purposes. 

We currently have three versions of the 

ES Form and an ES Supplement for 

Requestors of the National Death Index 

(NDI) Causes of Death Variables. Each 

meets the need for a different type of 

requestor. Form Number: CMS–10522 

(OMB control number: 0938–New); 

Frequency: On occasion; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

325; Total Annual Responses: 325; Total 

Annual Hours: 650. (For policy 

questions regarding this collection 

contact Kim Elmo at 410–786–0161). 

Dated: July 3, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–16076 Filed 7–10–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–304/CMS–304a, 

CMS–368/CMS–R–144 and CMS–10517] 

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 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices 40107 

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 11, 2014. 

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: Extension of a currently 

approved collection; Title of 

Information Collection: Reconciliation 

of State Invoice and Prior Quarter 

Adjustment Statement; Use: Form CMS– 

304 (Reconciliation of State Invoice) is 

used by manufacturers to respond to the 

state’s rebate invoice for current quarter 

utilization. Form CMS–304a (Prior 

Quarter Adjustment Statement) is 

required only in those instances where 

a change to the original rebate data 

submittal is necessary. Form Number: 

CMS–304 and –304a (OMB control 

number: 0938–0676); Frequency: 

Quarterly; Affected Public: Private 

sector—Business or other for-profits; 

Number of Respondents: 1,037; Total 

Annual Responses: 4,148; Total Annual 

Hours: 187,880. (For policy questions 

regarding this collection contact Andrea 

Wellington at 410–786–3490.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicaid Drug 

Rebate Program Forms; Use: We develop 

the rebate amount per drug unit from 

information supplied by the drug 

manufacturers and distributes these data 

to the states. States then must report 

quarterly to the drug manufacturers and 

report to us the total number of units of 

each dosage form/strength of their 

covered outpatient drugs reimbursed 

during a quarter and the rebate amount 

to be refunded. This report is due 

within 60 days of the end of each 

calendar quarter. The information in the 

report is based on claims paid by the 

state Medicaid agency during a calendar 

quarter. Form CMS–R–144 (Quarterly 

Report Data) is required from states 

quarterly to report utilization for any 

drugs paid for during that quarter. Form 

CMS–368 (Administrative Data) is 

required only in those instances where 

a change to the original data submittal 

is necessary. Form Number: CMS–368 

and –R–144 (OMB control number: 

0938–0582); Frequency: Quarterly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 224; Total 

Annual Hours: 12,101. (For policy 

questions regarding this collection 

contact Andrea Wellington at 410–786– 

3490.) 

3. Type of Information Collection 

Request: New collection (Request for a 

new control number); Title of 

Information Collection: The Predictive 

Learning Analytics Tracking Outcome 

(PLATOTM); Use: The Predictive 

Learning Analytics Tracking Outcome 

(PLATOTM) is a web-based application 

tool that will serve as the centerpiece of 

the advanced analytics initiative with 

the Centers for Medicare & Medicaid 

Services (CMS) and Health Integrity, 

LLC, the National Benefit Integrity 

Medicare Integrity Contractor (NBI 

MEDIC). Developed by Health Integrity, 

LLC and licensed for one of its 

contracts—the NBI MEDIC—PLATOTM

utilizes a cutting-edge advanced 

analytics fraud detection process in 

conjunction with a state-of-the-art webbased user interface tool to present 

fraud and abuse lead information 

visually to Medicare Part D plan 

sponsors. Summary data, based on 

National Prescription Drug Event Data 

and actions from all Part D plan 

sponsors, is shared with law 

enforcement, CMS, NBI MEDIC, and 

Part D plan sponsors to review historic 

actions taken against providers who are 

enrolled in the Medicare Part D 

program, which will assist in detecting 

and preventing fraud, waste, and abuse. 

Form Number: CMS–10517 (OMB 

control number: 0938—New); 

Frequency: Monthly; Affected Public: 

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

Number of Respondents: 1,550; Total 

Annual Responses: 1,550; Total Annual 

Hours: 18,600. (For policy questions 

regarding this collection contact Delois 

Newkirk at 410–786–1247.) 

Dated: July 3, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–16083 Filed 7–10–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0125] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Establishing That a 

Tobacco Product Was Commercially 

Marketed in the United States as of 

February 15, 2007 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


tkelley on DSK3SPTVN1PROD with NOTICES