11732 Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): The Incidence 

and Etiology of Influenza-Associated 

Pneumonia in Hospitalized Persons 

and Virologic Evaluation of the Modes 

of Influenza Virus Transmission 

Among Humans, Funding Opportunity 

Announcement (FOA) IP09–001 and 

IP09–003 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting. 

Time and Date: 8 a.m.–5 p.m., April 6, 

2009 (Closed). 

Place: Sheraton Gateway Hotel Atlanta 

Airport, 1900 Sullivan Road, Atlanta, Georgia 

30337. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters to be Discussed: The meeting will 

include the review, discussion, and 

evaluation of ‘‘The Incidence and Etiology of 

Influenza-Associated Pneumonia in 

Hospitalized Persons and Virologic 

Evaluation of the Modes of Influenza Virus 

Transmission Among Humans, FOA IP09– 

001 and IP09–003.’’ 

Contact Person for More Information: 

Gregory Anderson, M.S., M.P.H., Office of the 

Director, Coordinating Center for Infectious 

Diseases, CDC, 1600 Clifton Road, Mailstop 

E–60, Atlanta, GA 30333, Telephone: (404) 

498–2275. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: March 13, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–6047 Filed 3–18–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Influenza and 

Other Emerging Infectious Diseases in 

Vietnam; and Research and Public 

Health Practice on Influenza and Other 

Respiratory Infectious Diseases in the 

Middle East, Southeast Asia, and 

South American Regions, Funding 

Opportunity Announcement (FOA) 

IP09–002 and IP09–004 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting. 

Time and Date: 8 a.m.–5 p.m., April 7, 

2009 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters to be Discussed: The meeting will 

include the review, discussion, and 

evaluation of ‘‘Influenza and Other Emerging 

Infectious Diseases in Vietnam; and Research 

and Public Health Practice on Influenza and 

Other Respiratory Infectious Diseases in the 

Middle East, Southeast Asia, and South 

American Regions, FOA IP09–002 and IP09– 

004.’’ 

Contact Person for More Information: 

Gregory Anderson, M.S., M.P.H., Office of the 

Director, Coordinating Center for Infectious 

Diseases, CDC, 1600 Clifton Road, Mailstop 

E–60, Atlanta, GA 30333, Telephone: (404) 

498–2275. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: March 13, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–6049 Filed 3–18–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10164, CMS– 

10062, CMS–10137, CMS–416, CMS–1557, 

CMS–2786, CMS–437A&B and CMS–10259] 

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: Extension of a currently 

approved collection; 

Title of Information Collection: 

Electronic Data Interchange (EDI 

Enrollment Form and Medicare EDI 

Registration Form; Form No.: CMS– 

10164 (OMB # 0938–983); Use: Federal 

law requires that CMS take precautions 

to minimize the security risk to Federal 

information systems. Accordingly, CMS 

is requiring that trading partners who 

wish to conduct the Electronic Data 

Interchange (EDI) transactions provide 

certain assurances as a condition of 

receiving access to the Medicare system 

for the purpose of conducting EDI 

exchanges. Health care providers, 

clearinghouses, and health plans that 

wish to access the Medicare system are 

required to complete this form. The 

information will be used to assure that 

those entities that access the Medicare 

system are aware of applicable 

provisions and penalties; Frequency: 

Recordkeeping and Reporting—Other 

(one-time only); Affected Public: 

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

Respondents: 240,000; Total Annual 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices 11733 

Responses: 240,000; Total Annual 

Hours: 80,000. (For policy questions 

regarding this collection contact 

Michael Cabral at 410–786–6168. For all 

other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Collection of 

Diagnostic Data from Medicare 

Advantage Organizations for Risk 

Adjusted Payments: Use: CMS requires 

hospital inpatient, hospital outpatient 

and physician diagnostic data from 

Medicare Advantage (MA) organizations 

to continue making payment under the 

risk adjustment methodology as 

required by the Social Security Act, as 

amended by the Balanced Budget Act; 

the Medicare, Medicaid and SCHIP 

Benefits Improvement and Protection 

Act; and the Medicare Prescription Drug 

Benefit, Improvement and 

Modernization Act. CMS will use the 

data to make risk adjusted payment 

under Parts C. MA and MA–PD plans 

will use the data to develop their Parts 

C bids. As required by law, CMS also 

annually publishes the risk adjustment 

factors for plans and other interested 

entities in the Advance Notice of 

Methodological Changes for MA 

Payment Rates (every February) and the 

Announcement of Medicare Advantage 

Payment Rates (every April). Lastly, 

CMS issues monthly reports to each 

individual plan that contains the CMSHierarchical Condition Category (HCC) 

and RxHCC models’ output and the risk 

scores and reimbursements for each 

beneficiary that is enrolled in their plan. 

Form Number: CMS–10062 (OMB# 

0938–0878); Frequency: Quarterly; 

Affected Public: Business or other forprofit and Not-for-profit institutions; 

Number of Respondents: 852; Total 

Annual Responses: 22,097,070; Total 

Annual Hours: 10,826.1. (For policy 

questions regarding this collection 

contact Henry Thomas at 410–786– 

0086. For all other issues call 410–786– 

1326.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Application for 

Prescription Drug Plans (PDP); 

Application for Medicare Advantage 

Prescription Drug (MA–PD); 

Application for Cost Plans to Offer 

Qualified Prescription Drug Coverage; 

Application for Employer Group Waiver 

Plans to Offer Prescription Drug 

Coverage; Service Area Expansion 

Application for Prescription Drug 

Coverage; Use: Collection of this 

information is mandated in Part D of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 and under supporting regulations 

Subpart K of 42 CFR 423 entitled 

‘‘Application Procedures and Contracts 

with PDP Sponsors.’’ Coverage for the 

prescription drug benefit is provided 

through contracted prescription drug 

plans (PDPs) or through Medicare 

Advantage (MA) plans that offer 

integrated prescription drug and health 

care coverage (MA–PD plans). Cost 

Plans that are regulated under Section 

1876 of the Social Security Act, and 

Employer Group Waiver Plans (EGWP) 

may also provide a Part D benefit. 

Organizations wishing to provide 

services under the Prescription Drug 

Benefit Program must complete an 

application, negotiate rates and receive 

final approval from CMS. Existing Part 

D Sponsors may also expand their 

contracted service area by completing 

the Service Area Expansion (SAE) 

application. The information will be 

collected under the solicitation of 

proposals from PDP, MA–PD, Cost Plan, 

PACE, and EGWP Plan applicants. The 

collected information will be used by 

CMS to: (1) Ensure that applicants meet 

CMS requirements, (2) support the 

determination of contract awards. Form 

Number: CMS–10137 (OMB#: 0938– 

0936); Frequency: Reporting—Once; 

Affected Public: Business or other forprofit and Not-for-profit institutions; 

Number of Respondents: 455; Total 

Annual Responses: 455; Total Annual 

Hours: 11,890. (For policy questions 

regarding this collection contact Marla 

Rothouse at 410–786–8063. For all other 

issues call 410–786–1326.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Annual Early 

and Periodic Screening, Diagnostic and 

Treatment (EPSDT) Report; Use: States 

are required to submit an annual report 

on the provision of EPSDT services 

pursuant to section 1902(a)(43)(D) of the 

Social Security Act. These reports 

provide CMS with data necessary to 

assess the effectiveness of State EPSDT 

programs, to determine a State’s results 

in achieving its participation goal and to 

respond to inquiries. This collection is 

being submitted as a revision based on 

minor changes made to the form and 

instructions. CMS has added three 

additional lines of data to the form 

(lines 12d, 12e and 12f). This 

information is currently being collected; 

however, CMS expanded the lines to 

obtain a better understanding for the 

utilization of dental services. CMS 

believes there will be no additional 

burden for the changes made to the 

form. The changes were necessary to 

accommodate a need for more specific 

dental data and to preliminary notify 

States of a change in CPT codes. A 

clarification was also made to line 14 of 

the instructions. Form Number: CMS– 

416 (OMB# 0938–0354); Frequency: 

Yearly; Affected Public: State, Local or 

Tribal Governments; Number of 

Respondents: 56; Total Annual 

Responses: 56; Total Annual Hours: 

1,568. (For policy questions regarding 

this collection contact Cindy Ruff at 

410–786–5916. For all other issues call 

410–786–1326.) 

5. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Survey Report 

Form for Clinical Laboratory 

Improvement Amendments (CLIA) and 

Supporting Regulations in 42 CFR 

493.1–493.2001; Use: This form is used 

by the State to determine a laboratory’s 

compliance with CLIA. This 

information is needed for a laboratory’s 

CLIA certification and recertification. 

Form Number: CMS–1557 (OMB# 0938– 

0544); Frequency: Biennially; Affected 

Public: Business or other for-profit, Notfor-profit institutions, State, Local or 

Tribal Governments and Federal 

Government; Number of Respondents: 

21,000; Total Annual Responses: 

10,500; Total Annual Hours: 5,248. (For 

policy questions regarding this 

collection contact Kathleen Todd at 

410–786–3385. For all other issues call 

410–786–1326.) 

6. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Fire Safety 

Survey Reports; Use: The Life Safety 

Code (LSC) is a compilation of fire 

safety requirements for new and existing 

buildings and is updated and published 

every 3 years by the National Fire 

Protection Association (NFPA), a 

private, non-profit organization 

dedicated to reducing loss of life due to 

fire. The Medicare regulations have 

historically incorporated by reference 

these requirements along with 

Secretarial waiver authority. 

The statutory basis for incorporating 

NFPA’s LSC for our providers is under 

the Secretary’s general rulemaking 

authority at Sections 1102 and 1871 of 

the Social Security Act. These forms are 

used by the State Agencies to record 

data collected to determine compliance 

with standards specified in 416.44(b) for 

ambulatory surgical centers (ASCs), and 

494.60(e) for End-Stage Renal Disease 

(ESRD) facilities. The Medicare Health 

Insurance Program is authorized by 

Title XVIII of the Social Security Act. 

The CMS–2786U form is being revised 

to include ESRD information. Form 

Number: CMS–2786 (OMB# 0938– 


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11734 Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices 

0242); Frequency: Weekly; Affected 

Public: Individuals or households and 

State, Local or Tribal Government; 

Number of Respondents: 54; Total 

Annual Responses: 2442; Total Annual 

Hours: 4884. (For policy questions 

regarding this collection contact JoAnn 

Perry at 410–786–3336. For all other 

issues call 410–786–1326.) 

7. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Rehabilitation 

Hospital Criteria Worksheet and 

Rehabilitation Hospital Criteria 

Worksheet; Use: The rehabilitation 

hospital and rehabilitation unit criteria 

worksheets are necessary to verify that 

these facilities/units comply and remain 

in compliance with the exclusion 

criteria for the Medicare prospective 

payment system. Form Number: CMS– 

437A and 437B (OMB# 0938–0986); 

Frequency: Annually; Affected Public: 

Business or other for-profit; Number of 

Respondents: 1227; Total Annual 

Responses: 1227; Total Annual Hours: 

307. (For policy questions regarding this 

collection contact Georgia Johnson at 

410–786–6859. For all other issues call 

410–786–1326.) 

8. Type of Information Collection 

Request: New collection; Title of 

Information Collection: State Plan 

Amendment Template for 1915(i) State 

Plan Home and Community-Based 

Services (HCBS) Benefit; Use: Section 

6086 of the Deficit Reduction Act 

(DRA), expanded access to HCBS for the 

elderly and disabled and added a new 

section 1915(i) to the Social Security 

Act. Under 1915(i), States can amend 

their State plans to add these services. 

The template includes the information 

needed by CMS to determine whether 

the State’s services will meet the 

requirements under 1915(i). Form 

Number: CMS–10259 (OMB# 0938- 

NEW); Frequency: Once; Affected 

Public: State, Local or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 3; Total 

Annual Hours: 240. (For policy 

questions regarding this collection 

contact Kathy Poisal at 410–786–5940. 

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. 

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 April 20, 2009. 

OMB, Office of Information and 

Regulatory Affairs. 

Attention: CMS Desk Officer. 

Fax Number: (202) 395–6974. 

E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: March 12, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–6041 Filed 3–18–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2008–M–0535, FDA– 

2008–M–0547, FDA–2008–M–0536, FDA– 

2008–M–0563, FDA–2008–M–0593, FDA– 

2008–M–0601, FDA–2008–M–0562, FDA– 

2008–M–0596, FDA–2008–M–0579, FDA– 

2008–M–0594, FDA–2008–M–0608, FDA– 

2008–M–0645, FDA–2008–M–0646] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in Table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices and 

Radiological Health (HFZ–402), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4010. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register. Instead, 

the agency now posts this information 

on the Internet on FDA’s home page at 

http://www.fda.gov. FDA believes that 

this procedure expedites public 

notification of these actions because 

announcements can be placed on the 

Internet more quickly than they can be 

published in the Federal Register, and 

FDA believes that the Internet is 

accessible to more people than the 

Federal Register. 

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the act. 

The 30 day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

Internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 30 

day period. Reconsideration of a denial 

or withdrawal of approval of a PMA 

may be sought only by the applicant; in 

these cases, the 30 day period will begin 

when the applicant is notified by FDA 

in writing of its decision. 

The regulations provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from October 1, 2008, through 

December 31, 2008. There were no 

denial actions during this period. The 

list provides the manufacturer’s name, 

the product’s generic name or the trade 

name, and the approval date. 


sroberts on PROD1PC70 with NOTICES