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
Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices 11735 

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1, 

2008, THROUGH DECEMBER 31, 2008. 

PMA No./Docket No. Applicant TRADE NAME Approval Date 

P070015 

FDA–2008–M–0535 

Abbott Vascular Inc. XIENCE V EVEROLIMUS ELUTING CORONARY STENT 

SYSTEM & PROMUS ELUTING CORONARY STENT SYSTEM 

July 2, 2008 

P030025 (S28) 

FDA–2008–M–0547 

Boston Scientific Corp. TAXUS EXPRESS2 PACLITAXEL ELUTING CORONARY 

STENT SYSTEM 

September 24, 2008 

P080004 

FDA–2008–M–0536 

Hoya Surgical Optics, Inc. HOYA ISPHERIC MODEL YA–60BB INTRAOCULAR LENS September 26, 2008 

H070004 

FDA–2008–M–0563 

Levitronix, LLC LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST 

SYSTEM (RVAS) 

October 7, 2008 

P060008 

FDA–2008–M–0593 

Boston Scientific Corp. TAXUS LIBERTE’ PACLITAXEL ELUTING CORONARY 

STENT SYSTEM 

October 10, 2008 

P050029 

FDA–2008–M–0601 

Stereotaxis, Inc. HELIOS II ABLATION CATHETER October 10, 2008 

H040004 

FDA–2008–M–0562 

Medtronic Sofamor Danek 

USA, Inc. 

INFUSE/MASTERGRAFT POSTEROLATERAL REVISION 

DEVICE 

October 10, 2008 

P050019 

FDA–2008–M–0596 

Boston Scientific Corp. CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS October 23, 2008 

H060002 

FDA–2008–M–0579 

Spiration, Inc. IBV VALVE SYSTEM October 24, 2008 

P060025 

FDA–2008–M–0594 

ATS Medical, Inc. ATS 3F AORTIC BIOPROSTHESIS October 30, 2008 

P080011 

FDA–2008–M–0608 

Coopervision Manufacturing, Ltd. BIOFINITY COMFILCON A (EXTENDED WEAR SOFT CONTACT LENSES) November 19, 2008 

P080007 

FDA–2008–M–0645 

Bard Peripheral Vascular 

Inc. 

BARD E-LUMINEXX VASCULAR STENT December 4, 2008 

P060006 

FDA–2008–M–0646 

Boston Scientific Corp. BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL 

PREMOUNTED STENT SYSTEM 

December 11, 2008 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: March 10, 2009. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E9–6026 Filed 3–18–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Simulations for Drug Related 

Science Education 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institute on Drug Abuse (NIDA), the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. This proposed 

information collection was previously 

published in the Federal Register on 

June 26, 2008, (Vol. 73 No. 124, page 

36337) and allowed 60 days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after November 15, 

2008, unless it displays a currently valid 

OMB control number. 

Proposed Collection: Title: 

Simulations for Drug Related Science 

Education. Type of Information 

Collection Request: NEW. Need and Use 

of Information Collection: This is a 

request for a one-time clearance to 

evaluate an interactive multimedia 

module developed by ArchieMD. This 

evaluation seeks to determine whether 

the multimedia module Archie MD: The 

Science of Drugs (1) Increases students’ 

knowledge in brain and heart biology 

and the effects drugs have on the body 

(2) Increases positive attitudes towards 

science education for high school 

students (3) Reinforce or instill negative 

attitudes towards substance abuse. In 

order to test the effectiveness of the 

interactive multimedia module, data 

will be collected in the form of pre and 

post test surveys from 10th and 11th 

grade high school students utilizing the 

developed module. The findings will 

provide valuable information regarding 

information pertaining to the use of 

interactive multimedia educational 

modules in high school science 

classrooms and their ability to increase 

knowledge and change attitudes and 

perceptions. 

Frequency of Response: 4. Affected 

Public: High school students engaged 

with the ArchieMD: The Science of 


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