Federal Register / Vol. 78, No. 12 / Thursday, January 17, 2013 / Notices 3899 

continue its use of the BPT for the 

collection of information for CY2014 

through CY2016. Form Number: CMS– 

10142 (OCN: 0938–0944); Frequency: 

Yearly; Affected Public: Private Sector— 

Business or other for-profits and not-forprofit institutions; Number of 

Respondents: 555; Total Annual 

Responses: 4,995; Total Annual Hours: 

149,850. (For policy questions regarding 

this collection contact Diane Spitalnic at 

410–786–5745. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Plan Benefit 

Package (PBP) and Formulary 

Submission for Medicare Advantage 

(MA) Plans and Prescription Drug Plans 

(PDP); Use: Under the Medicare 

Modernization Act (MMA), Medicare 

Advantage (MA) and Prescription Drug 

Plan (PDP) organizations are required to 

submit plan benefit packages for all 

Medicare beneficiaries residing in their 

service area. The plan benefit package 

submission consists of the Plan Benefit 

Package (PBP) software, formulary file, 

and supporting documentation, as 

necessary. MA and PDP organizations 

use the PBP software to describe their 

organization’s plan benefit packages, 

including information on premiums, 

cost sharing, authorization rules, and 

supplemental benefits. They also 

generate a formulary to describe their 

list of drugs, including information on 

prior authorization, step therapy, 

tiering, and quantity limits. 

Additionally, CMS uses the PBP and 

formulary data to review and approve 

the plan benefit packages proposed by 

each MA and PDP organization. 

After receiving OMB clearance in 

spring 2000, CMS implemented the PBP 

as part of the Contract Year (CY) 2001 

Adjusted Community Rate Proposal 

(ACRP) process. In addition, 

information collected via the PBP and 

formulary has been used to support the 

marketing material review process, the 

National Medicare Education Program, 

and other program oversight and 

development activities. For instance, the 

PBP software automatically generates 

the standardized sentences for the 

Summary of Benefits (SB) by using the 

plan benefit package data entered into 

the PBP software by the organization’s 

user. These standardized sentences are 

used by the MA organizations in their 

SB marketing materials and by CMS to 

generate plan benefits data for display 

in the Medicare & You handbook and on 

the www.medicare.gov Web site. 

CMS is requesting to continue its use 

of the PBP software and formulary 

submission for the collection of benefits 

and related information for CY 2014 

through CY 2016. CMS estimates that 

578 MA organizations and 63 PDP 

organizations will be required to submit 

the plan benefit package information in 

CY 2014. Based on operational changes 

and policy clarifications to the Medicare 

program and continued input and 

feedback by the industry, CMS has 

made the necessary changes to the plan 

benefit package submission. Form 

Number: CMS–R–262 (OCN: 0938– 

0763); Frequency: Yearly; Affected 

Public: Private Sector—Business or 

other for-profits and not-for-profit 

institutions; Number of Respondents: 

641; Total Annual Responses: 6,169; 

Total Annual Hours: 56,708. (For policy 

questions regarding this collection 

contact Kristy Holtje at 410–786–2209. 

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

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

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

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html, 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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on February 19, 2013. OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: January 11, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–00858 Filed 1–16–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10437] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

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. 

1. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Generic Social 

Marketing & Consumer Testing 

Research; Use: The purpose of this 

submission is to request an Information 

Collection Request (ICR) generic 

clearance for a program of consumer 

research aimed at a broad audience of 

those affected by CMS programs 

including Medicare, Medicaid, 

Children’s Health Insurance Program 

(CHIP), and health insurance exchanges. 

This program extends strategic efforts to 

reach and tailor communications to 

beneficiaries, caregivers, providers, 

stakeholders, and any other audiences 

that would support the Agency in 

improving the functioning of the health 

care system, improve patient care and 

outcomes, and reduce costs without 

sacrificing quality of care. With the 

clearance, CMS will create a fast track, 

streamlined, proactive process for 

collection of data and utilizing the 

feedback on service delivery for 

continuous improvement of 

communication activities aimed at 

diverse CMS audiences. 

The generic clearance will allow rapid 

response to inform CMS initiatives 

using a mixture of qualitative and 

quantitative consumer research 

strategies (including formative research 

studies and methodological tests) to 

improve communication with key CMS 

audiences. As new information 

resources and persuasive technologies 

are developed, they can be tested and 

evaluated for beneficiary response to the 

materials and delivery channels. Results 

will inform communication 

development and information 

architecture as well as allow for 

continuous quality improvement. The 

overall goal is to maximize the extent to 

which consumers have access to useful 

sources of CMS program information in 


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3900 Federal Register / Vol. 78, No. 12 / Thursday, January 17, 2013 / Notices 

a form that can help them make the 

most of their benefits and options 

The activities under this clearance 

involve social marketing and consumer 

research using samples of self-selected 

customers, as well as convenience 

samples, and quota samples, with 

respondents selected either to cover a 

broad range of customers or to include 

specific characteristics related to certain 

products or services. All collection of 

information under this clearance will 

utilize a subset of items drawn from a 

core collection of customizable items 

referred to as the Social Marketing and 

Consumer Testing Item Bank. This item 

bank is designed to establish a set of 

pre-approved generic question that can 

be drawn upon to allow for the rapid 

turn-around consumer testing required 

for CMS to communicate more 

effectively with its audiences. The 

questions in the item bank are divided 

into two major categories. One set 

focuses on characteristics of individuals 

and is intended primarily for participant 

screening and for use in structured 

quantitative on-line or telephone 

surveys. The other set is less structured 

and is designed for use in qualitative 

one-on-one and small group discussions 

or collecting information related to 

subjective impressions of test materials. 

A Study Initiation Request Form 

detailing each specific study 

(description, methodology, estimated 

burden) conducted under this clearance 

will be submitted before any testing is 

initialed. Results will be compiled and 

disseminated so that future 

communication can be informed by the 

testing results. We will use the findings 

to create the greatest possible public 

benefit. Form Number: CMS–10437 

(OCN: 0938–New); Frequency: Yearly; 

Affected Public: Individuals. Number of 

Respondents: 41,592. Number of 

Responses: 28,800. Total Annual Hours: 

21,488. (For policy questions regarding 

this collection contact Chris Koepke at 

410–786–5877. For all other issues call 

410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ 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 March 18, 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/OMB 

Control Number ___, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: January 11, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–00860 Filed 1–16–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0007] 

Generic Drug User Fee—Active 

Pharmaceutical Ingredient and 

Finished Dosage Form Facility Fee 

Rates for Fiscal Year 2013 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

rate for the generic drug active 

pharmaceutical ingredient (API) and 

finished dosage form (FDF) facilities 

user fees for fiscal year (FY) 2013. The 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act), as amended by the 

Generic Drug User Fee Amendments of 

2012 (GDUFA), enacted the Food and 

Drug Administration Safety and 

Innovation Act, as further amended by 

the FDA User Fee Corrections Act of 

2012, authorizes FDA to assess and 

collect user fees for certain applications 

and supplements associated with 

human generic drug products, on 

applications in the backlog as of October 

1, 2012, on finished dosage form (FDF) 

and active pharmaceutical ingredient 

(API) facilities, and on Type II API drug 

master files (DMF) to be made available 

for reference. GDUFA directs FDA to 

establish each year the generic drug user 

fee rates for the upcoming year. In the 

first year of GDUFA (FY 2013), some 

rates will be published in separate 

Federal Register notices because of the 

timing specified in the statute. Each 

year thereafter the GDUFA fee rates will 

be published 60 days before the start of 

the fiscal year. This document 

establishes the FY 2013 rate for API and 

FDF facility fees. These fees are due on 

March 4, 2013. 

FOR FURTHER INFORMATION CONTACT: 

David Miller, Office of Financial 

Management (HFA–100), Food and Drug 

Administration, 1350 Piccard Dr., PI50, 

Rm. 210J, Rockville, MD 20850, 301– 

796–7103. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 744A and 744B of the FD&C 

Act, as added by GDUFA (21 U.S.C. 

379j–41 and 379j–42), establish user 

fees associated with human generic drug 

products. Fees are assessed on: (1) 

Certain applications in the backlog as of 

October 1, 2012; (2) certain types of 

applications and supplements 

associated with human generic drug 

products; (3) certain facilities where 

human generic drug APIs and FDFs are 

produced; and (4) certain Type II API 

DMFs associated with human generic 

drug products. This notice focuses on 

the API and FDF facility fees. 

II. Fee Revenue Amount for FY 2013 

The total fee revenue amount for FY 

2013 is $299,000,000, as set in the 

statute. GDUFA directs FDA to use the 

yearly revenue amount as a starting 

point to set the fees. GDUFA states that 

the backlog fee will make up 

$50,000,000 of the total revenue 

collected for FY 2013. Therefore, the 

rest of the fees will make up a 

percentage of the remaining 

$249,000,000 of the total fee revenue. 

For more information about GDUFA, 

please refer to the FDA Web site 

(http://www.fda.gov/gdufa). The API 

and FDF facility fee calculations for FY 

2013 are described in this document. 

III. Foreign Differential 

Under GDUFA, the fee for a facility 

located outside the United States and its 

territories and possessions shall be not 

less than $15,000 and not more than 

$30,000 higher than the amount of the 

fee for a facility located in the United 

States and its territories and 

possessions, as determined by the 

Secretary. The basis for this differential 

is the extra cost incurred by conducting 

an inspection outside the United States 

and its territories and possessions. For 

FY 2013 FDA has determined that the 

differential for foreign facilities will be 

$15,000. The differential may be 

adjusted in future years. 


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