Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Notices 6401 

ANNUAL BURDEN ESTIMATES—Continued 

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

OMB #0970–0323 State Improper Authorizations for Payment Report .......... 17 1 639 10,863 

Estimated Total Annual Burden 

Hours: 84,205.96 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: February 4, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–2761 Filed 2–8–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–M–0513] 

Medical Devices Regulated by the 

Center for Biologics Evaluation and 

Research; Availability of Summaries of 

Safety and Effectiveness Data 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 by the 

Center for Biologics Evaluation and 

Research (CBER). This list is intended to 

inform the public of the availability 

through the Internet and FDA’s Division 

of Dockets Management of summaries of 

safety and effectiveness data of 

approved PMAs. 

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 include 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 data. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Reisman, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, suite 

200N, 1401 Rockville Pike, Rockville, 

MD 20852–1448, 301–827–6210. 

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, 

providing instead to post this 

information on the Internet at http:// 

www.fda.gov. In addition, the 

regulations provide that FDA publish a 

quarterly list of available safety and 

effectiveness summaries of PMA 

approvals and denials that were 

announced during the quarter. 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 

administrative 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 following is a list of PMAs 

approved by CBER for which summaries 

of safety and effectiveness data were 

placed on the Internet from July 1, 2009, 

through September 30, 2009. 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. 

TABLE 1.—LIST OF SUMMARIES OF SAFETY AND EFFECTIVENESS DATA FOR APPROVED PMAS MADE AVAILABLE JULY 1, 

2009, THROUGH SEPTEMBER 30, 2009. 

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

BP090022/0/ 

FDA–2009–M–0513 

Avioq, Inc., Rockville, MD Avioq HIV–1 Microelisa System September 21, 2009 


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6402 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Notices 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/BiologicsBloodVaccines/ 

BloodBloodProducts/Approved

Products/PremarketApprovalsPMAs/ 

ucm185249.htm 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–2757 Filed 2–8–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Health Marketing 

(BSC, NCHM) 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), and pursuant to the 

requirements of 42 CFR 83.15(a), the 

Centers for Disease Control and 

Prevention (CDC), announces the 

following meeting of the 

aforementioned committee: 

Times and Dates: 

9 a.m.–5 p.m., February 25, 2010. 

8:30 a.m.–1 p.m., February 26, 2010. 

Place: CDC, 2400 Century Parkway, 

Building 2400, Room 1A (1023), Atlanta, 

Georgia 30345. 

Status: Open to the public, limited only by 

the space available. The meeting room 

accommodates approximately 60 people. The 

toll free dial-in number is 1 (877) 617–5977 

with a pass code of 3468113. 

Purpose: The Secretary, Department of 

Health and Human Services (HHS), and, by 

delegation, the Director, CDC, are authorized 

under Section 301 (42 U.S.C. 241) and 

Section 311 (42 U.S.C. 243) of the Public 

Health Service Act (PHSA), as amended to: 

Develop and implement disease prevention 

and control, environmental health, and 

health promotion and health education 

activities designed to improve the health of 

the people of the United States. Under these 

and additional PHSA and other authorities, 

CDC acts by identifying and defining 

preventable health problems, maintaining 

active surveillance of diseases through 

epidemiologic and laboratory investigations 

and data collection, analysis, and 

distribution; conducting operational research 

aimed at developing and testing effective 

disease prevention, control, and health 

promotion programs; administering a 

national occupational safety and health 

program; controlling the introduction and 

spread of infectious diseases, and providing 

consultation and assistance to other nations 

and international agencies to assist in 

improving their disease prevention and 

control, environmental health, and health 

promotion activities. CDC carries out these 

functions through a number of National 

Centers, Institutes and Offices with expertise 

and responsibilities in specific areas. 

Matters To Be Discussed: The agenda will 

include: A discussion of the recent 

organizational changes at CDC, specifically 

presentations on the vision, mission, goals 

and organizational structure of the new 

Office of Communications; discussions on 

program activities, including scientific 

programs, that will enable the board to 

provide recommendations and advice on the 

future course for health communications and 

marketing at CDC; and a discussion of focus 

areas and new ideas to implement and 

expand health marketing science at CDC. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: 

Dionne R. Mason, Committee Management 

Specialist, NCHM, CDC, 1600 Clifton Road, 

NE., Mail Stop E–21, Atlanta, Georgia 30333; 

Telephone: (404) 498–2314, Fax (404) 498– 

2221; E-mail: zsu0@cdc.gov. The deadline for 

notification of attendance is February 17, 

2010. 

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: February 1, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–2766 Filed 2–8–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Council for the Elimination of 

Tuberculosis (ACET) 

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 following meeting of the 

aforementioned committee: 

Times and Dates: 8:30 a.m.–5:30 p.m., 

March 2, 2010. 8:30 a.m.–2:30 p.m., March 3, 

2010. 

Place: CDC, Corporate Square, Building 8, 

1st Floor Conference Room, Atlanta, Georgia 

30333, telephone (404) 639–8317. 

Status: Open to the public, limited only by 

the space available. The meeting room 

accommodates approximately 100 people. 

Purpose: This council advises and makes 

recommendations to the Secretary of Health 

and Human Services, the Assistant Secretary 

for Health, and the Director, CDC, regarding 

the elimination of tuberculosis. Specifically, 

the Council makes recommendations 

regarding policies, strategies, objectives, and 

priorities; addresses the development and 

application of new technologies; and reviews 

the extent to which progress has been made 

toward eliminating tuberculosis. 

Matters To Be Discussed: Agenda items 

include issues pertaining to regionalization 

of tuberculosis care; the role of genetics in 

tuberculosis; tuberculosis control updates 

from the U.S. affiliated Pacific Islands; 

tuberculosis research updates; and other 

related tuberculosis issues. 

Agenda items are subject to change as 

priorities dictate. 

For More Information Contact: Margie 

Scott-Cseh, CDC, 1600 Clifton Road, NE., 

Mail Stop E–07, Atlanta, Georgia 30333, 

telephone (404) 639–8317. 

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: February 1, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–2768 Filed 2–8–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Fogarty International Center; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the Fogarty 

International Center Advisory Board. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications 

and/or contract proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Fogarty International 

Center Advisory Board. 


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