6400 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Notices 

safety, permanency, and well-being for 

children, youth, and families. The 

Children’s Bureau desires to assess the 

quality and effectiveness of the 

technical assistance it supports, and 

several of these programs and projects 

are required to be evaluated, including 

those funded under Section 105 of The 

Child Abuse Prevention and Treatment 

Act, as amended [42 U.S.C. 5106]. 

Beginning in fiscal year (FY) 2010, the 

T/TA Network will comprise a group of 

30 T/TA providers funded entirely or 

partially by the Children’s Bureau 

through grants, contracts, and 

interagency agreements. 

The cross-site evaluation uses a 

mixed-method, longitudinal approach to 

examine the ICs (funded in FY 2009) 

and a new cohort of NRCs (funded in FY 

2010). Proposed data collection methods 

are a longitudinal telephone survey of 

State child welfare directors (or their 

designees) and Tribal Child Welfare/ 

Social Service Directors (or their 

designees), a Web-based survey of State 

and Tribal T/TA recipients, and 

aggregation of outputs from a Web-based 

technical assistance tracking system 

(OneNet) that will be used by the five 

ICs and 11 NRCs. A Web-based survey 

will be also administered to members of 

the T/TA Network. Data collected 

through these instruments will be used 

by the Children’s Bureau to evaluate the 

effectiveness of technical assistance 

delivered to State, local, Tribal, and 

other publicly administered or publicly 

supported child welfare agencies and 

family and juvenile courts and the 

overall functioning of the T/TA 

Network. 

Respondents: Respondents to two of 

the survey instruments will be State and 

Tribal governments. Respondents to the 

third survey will be private institutions, 

including universities, not-for-profit 

organizations, and private companies. 

Private institutions, including 

universities and not-for-profit 

organizations will be respondents to the 

forms in the OneNet tracking system. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

OneNet Form: General T/TA Event ................................................................. 16 26 0.25 104 

OneNet Form: NRC T/TA Work Plan .............................................................. 11 45 0.20 99 

OneNet Form: NRC T/TA Close-Out ............................................................... 11 45 0.08 39.60 

OneNet Form: NRC T/TA Activity .................................................................... 11 528 0.20 1,161.60 

OneNet Form: Implementation Project Monthly Report .................................. 5 62.40 0.17 53.04 

Agency Results Survey ................................................................................... 74 1 1 74 

Training and Technical Assistance (T/TA) Activity Survey ............................. 160 3 0.25 120 

Web-Based Network Survey ............................................................................ 30 1 0.25 7.50 

OneNet Form: Implementation Project Information ......................................... 5 5.40 0.50 13.50 

OneNet Form: Implementation Project T/TA Activity ...................................... 5 280.80 0.33 463.32 

Estimated Total Annual Burden 

Hours: 2,135.56. 

Additional Information: 

Copies of the proposed collection may 

be obtained 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. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7245, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: February 4, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–2804 Filed 2–8–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: CCDF—Reporting Improper 

Payments—Instructions for States. 

OMB No.: 0970–0323. 

Description: The Improper Payments 

Information Act of 2002 requires 

Federal agencies to annually report error 

rate measures. Section 2 of the Improper 

Payments Information Act provides for 

estimates and reports of improper 

payments by Federal agencies. Subpart 

K of 45 CFR, Part 98 requires 

preparation and submission of a report 

of errors occurring in the administration 

of CCDF grant funds once every three 

years. The information collected will be 

used to prepare the annual Agency 

Financial Report (AFR) and will provide 

information necessary to offer technical 

assistance to grantees. 

Respondents: State grantees, the 

District of Columbia, and Puerto Rico. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

OMB #0970–0323 Record Review Worksheet ................................................ 17 276.38 15.43 72,497.24 

OMB #0970–0323 Data Entry Form ................................................................ 17 276.38 0.18 845.72 


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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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