Federal Register / Vol. 75, No. 5 / Friday, January 8, 2010 / Notices 1059 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10142, CMS–R– 

262, CMS–R–0282 and CMS–R–64] 

Agency Information Collection 

Activities: Submission for OMB 

Review; 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), Department of Health 

and Human Services, 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 function; 

(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: Revision of a currently 

approved collection; Title of 

Information Collection: CY 2011 Bid 

Pricing Tool (BPT) for Medicare 

Advantage (MA) Plans and Prescription 

Drug Plans (PDP); Use: Under the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA), and implementing 

regulations at 42 CFR, Medicare 

Advantage organizations (MAO) and 

Prescription Drug Plans are required to 

submit an actuarial pricing ‘‘bid’’ for 

each plan offered to Medicare 

beneficiaries for approval by CMS. 

MAOs and PDPs use the Bid Pricing 

Tool (BPT) software to develop their 

actuarial pricing bid. The information 

provided in the BPT is the basis for the 

plan’s enrollee premiums and CMS 

payments for each contract year. The 

tool collects data such as medical 

expense development (from claims data 

and/or manual rating), administrative 

expenses, profit levels, and projected 

plan enrollment information. By statute, 

completed BPTs are due to CMS by the 

first Monday of June each year. CMS 

reviews and analyzes the information 

provided on the Bid Pricing Tool. 

Ultimately, CMS decides whether to 

approve the plan pricing (i.e., payment 

and premium) proposed by each 

organization. Refer to the supporting 

document attachment ‘‘C’’ for a list of 

changes. Form Number: CMS–10142 

(OMB#: 0938–0944); Frequency: 

Reporting—Yearly; Affected Public: 

Business or other for-profit and Not-forprofit institutions; Number of 

Respondents: 550; Total Annual 

Responses: 6,050; Total Annual Hours: 

42,350. (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: CY 2011 Plan 

Benefit Package (PBP) Software and 

Formulary Submission; 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 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. 

CMS requires that MA and PDP 

organizations submit a completed PBP 

and formulary as part of the annual 

bidding process. During this process, 

organizations prepare their proposed 

plan benefit packages for the upcoming 

contract year and submit them to CMS 

for review and approval. 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. Refer to the 

supporting document ‘‘Appendix B’’ for 

a list of changes. Form Number: CMS– 

R–262 (OMB#: 0938–0763); Frequency: 

Reporting—Yearly; Affected Public: 

Business or other for-profit and Not-forprofit institutions; Number of 

Respondents: 475; Total Annual 

Responses: 4988; Total Annual Hours: 

12,113. (For policy questions regarding 

this collection contact Sara Walters at 

410–786–3330. For all other issues call 

410–786–1326.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare 

Advantage Appeals and Grievance Data 

Disclosure Requirements (42 CFR 

§ 422.111); Use: Medicare Advantage 

(MA) organizations must disclose 

information pertaining to the number of 

disputes, and their disposition in the 

aggregate, with the categories of 

grievances and appeals to any 

individual eligible to elect an MA 

organization who requests this 

information. Medicare demonstrations 

also are required to conform to MA 

appeals regulations and thus are 

included in the count of organizations 

affected by this requirement. MA 

organizations also are required by the 

statute and the MA regulation to 

provide aggregate grievance data to MA 

eligible beneficiaries upon request. MA 

eligible individuals will use this 

information to help them make 

informed decisions about their 

organization’s performance in the area 

of appeals and grievances. Form 

Number: CMS–R–0282 (OMB#: 0938– 

0778); Frequency: Reporting—Semiannually and Yearly; Affected Public: 

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

Respondents: 629; Total Annual 

Responses: 47,175; Total Annual Hours: 

4,931.36. (For policy questions 

regarding this collection contact 

Stephanie Simons at 206–615–2420. For 

all other issues call 410–786–1326.) 

4. Type of Information Collection 

Request: Extension of the currently 

approved collection; Title of 

Information Collection: Indirect Medical 

Education (IME) and Supporting 

Regulations at 42 CFR 412.105; Direct 

Graduate Medical Education (GME) and 

Supporting Regulations at 42 CFR 

413.75 through 413.83; Use: The 

information collected on interns and 

residents (IRs) is used by the Medicare 

Part A fiscal intermediaries (FI) and Part 

A Medicare Administrative Contractors 

(MAC) to verify the number of IRs used 

in the calculation of Medicare program 

payments for indirect medical education 

(IME) as well as direct graduate medical 

education (GME). The IR data collected 

from the hospitals is processed through 

computers at FIs/MACs to identify any 

duplicated time based upon the 

accumulated time of each individual 

that worked at one or more hospitals. 

The identification of duplicate IRs is 

necessary to ensure that no IR is 

counted more than once. 

The FIs/MACs use the information 

collected on IRs to help ensure that all 


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1060 Federal Register / Vol. 75, No. 5 / Friday, January 8, 2010 / Notices 

program payments for IME and GME are 

based upon an accurate number of FTE– 

IRs, determined in accordance with 

Medicare regulations. The IR data 

submitted by the hospitals are used by 

the FIs/MACs during their audits of the 

providers’ cost reports. The audit 

procedures help assure that the 

information reported was correct, and 

that IRs who should not have been 

reported by the hospitals (or portions of 

the IRs’ time) are not included in the 

FTE count. The FIs/MACs also use 

reports of duplicate IRs to prevent 

improper payment for IME and GME. 

Form Number: CMS–R–64 (OMB#: 

0938–0456); Frequency: Reporting— 

Yearly; Affected Public: Business or 

other for-profit and Not-for-profit 

institutions; Number of Respondents: 

1,190; Total Annual Responses: 1,190; 

Total Annual Hours: 2,380. (For policy 

questions regarding this collection 

contact Milton Jacobson at 410–786– 

7553. 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 

E-mail 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 8, 2010. 

OMB, Office of Information and 

Regulatory Affairs. Attention: CMS Desk 

Officer. Fax Number: 202–395–6974. Email: OIRA_submission@omb.eop.gov. 

Dated: December 24, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–31299 Filed 1–7–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–906] 

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: Revision of a currently 

approved collection; Title of 

Information Collection: The Fiscal 

Soundness Reporting Requirements; 

Use: CMS is assigned responsibility for 

overseeing all Medicare Advantage 

Organizations (MAO), Prescription Drug 

Plan (PDP) sponsors, 1876 Cost Plans, 

Demonstration Plans and PACE 

organizations on-going financial 

performance. Specifically, CMS needs 

the requested collection of information 

to establish that contracting entities 

within those programs maintain fiscally 

sound organizations. Refer to the 

supporting documents for a list of 

changes to this collection. Form 

Number: CMS–906 (OMB#: 0938–0469); 

Frequency: Reporting—Yearly and 

Quarterly; Affected Public: Private 

Sector: Business or other for-profits and 

Not-for-profit institutions; Number of 

Respondents: 514; Total Annual 

Responses: 1039; Total Annual Hours: 

346. (For policy questions regarding this 

collection contact Robert Ahern at 410– 

786–0073. 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 

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

PaperworkReductionActof1995, or 

E-mail 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 9, 2010: 

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: December 24, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–31301 Filed 1–7–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0568] 

Draft Guidance for Industry on 

Planning for the Effects of High 

Absenteeism to Ensure Availability of 

Medically Necessary Drug Products; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Planning for the 

Effects of High Absenteeism to Ensure 

Availability of Medically Necessary 

Drug Products.’’ The draft guidance 

encourages manufacturers of medically 

necessary drug products (MNPs) and 

components to develop contingency 

production plans in the event of an 

emergency that results in high 

absenteeism at one or more production 


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