62836 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 

and fiscal year 2010 (FY10) (OMB No. 

0920–0776, exp. 03/31/2011). 

Respondents are the 68 programs 

participating in the NBCCEDP. 

Information is collected through a webbased Cost Assessment Tool (CAT) and 

includes: Staff and consultant salaries, 

screening costs, contracts and material 

costs, provider payments, in-kind 

contributions, administrative costs, 

allocation of funds and staff time 

devoted to specific program activities. 

CDC requests OMB approval for a sixmonth extension of the current approval 

period in order to complete the third 

year of data collection. Based on our 

experience with previous data 

collection cycles, 20 grantees (30% of 

the total 68 grantees) will not be able to 

meet the current data collection 

deadline of 3/31/2011. These programs 

will complete their fiscal year (FY) 

closeout process in April or May 2011. 

As a result, these programs will not be 

prepared to submit data to CDC until 

their FY is complete and records have 

been reconciled. The requested sixmonth extension period will provide the 

time they need to complete their 

closeout process and conduct data 

quality checks before submitting 

information to CDC. The requested sixmonth extension will improve the 

quality and completeness of information 

used for planned data analysis, and 

ensure CDC’s authority to receive late 

submissions. 

The activity-based cost data will be 

used to evaluate grantees to ensure the 

most appropriate use of limited program 

resources in delivering program services 

such as screening, diagnostic services, 

case management and outreach. The 

detailed cost data will allow CDC to 

determine the costs of various program 

components, identify factors that impact 

average cost, perform cost-effectiveness 

analysis and budget impact analysis of 

the program, and allocate program 

resources more effectively and 

efficiently. The collection of economic 

cost information complements the 

measures of NBCCEDP effectiveness 

collected as Minimum Data Elements 

(0920–0571, exp. 11/30/2012). 

In this Revision request, there are no 

proposed changes to the data collection 

instrument, data collection 

methodology, or the estimated burden 

per response. The only changes are a 

decrease in the estimated number of 

respondents (the number of late 

responders) and a six-month extension 

of the data collection period. All 

information is collected electronically. 

There are no costs to respondents other 

than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Number of 

respondents 

Number of responses per 

respondent 

Average 

burden 

(in hrs) 

Total burden 

(in hrs) 

NBCCEDP grantee .......................................................................................... 20 1 22 440 

Dated: October 6, 2010. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–25693 Filed 10–12–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Healthcare Integrity 

and Protection Data Bank for Final 

Adverse Information on Health Care 

Providers, Suppliers and Practitioners 

(45 CFR 61)—OMB No. 0915–0239— 

Revision 

This is a request for revision and 

extension of OMB approval of the 

information collections contained in 

regulations found in 45 CFR Part 61 

governing the Healthcare Integrity and 

Protection Data Bank (HIPDB) and the 

forms to be used in reporting 

information to and requesting 

information from the HIPDB cleared 

under OMB No. 0915–0239. An 

additional form entitled, ‘‘Instructions 

for Registering as an NPDB–HIPDB SelfQuerier,’’ has been included to meet 

identity proofing and e-authentication 

requirements stipulated in the E– 

Authentication Guidance for Federal 

Agencies (OMB M–04–04) and National 

Institutes of Standards and 

Technology’s (NIST) Draft Special 

Publication 800–63–1, Electronic 

Authentication Guidelines. The burden 

estimate for self-queriers has been 

adjusted from the original OMB 

approval to reflect this new registration 

process. The HIPDB is authorized by 

section 1128E of the Social Security Act 

(hereinafter referred to as section 

1128E), as added by section 221(a) of 

the Health Insurance Portability and 

Accountability Act of 1996. Section 

1128E directs the Secretary of Health 

and Human Services (the Secretary) to 

establish a national health care fraud 

and abuse data collection program for 

the reporting and disclosing of certain 

final adverse actions (excluding 

settlements in which no findings of 

liability have been made) taken against 

health care providers, suppliers, or 

practitioners. It also directs the 

Secretary to maintain a database of final 

adverse actions taken against health care 

providers, suppliers, or practitioners. 

The regulations implementing section 

1128E governing the operation of the 

HIPDB are codified at 45 CFR Part 61. 

The HIPDB became operational 

November 22, 1999. 

Approval is requested to continue the 

following reporting data collection and 

disclosure requirements and the ensuing 

HIPDB forms along with the 

instructions. The recordkeeping, 

reporting, and disclosure requirements 

are specified in the regulations to 

implement the HIPDB. Numbers in the 

table may not add up exactly due to 

rounding. Please note the burden for 

Administrative Forms has been 

accounted for in the NPDB OMB 

clearance renewal submission. 

The annual estimate of burden is as 

follows: 

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Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 62837 

DISTRIBUTION OF BURDEN BY REGULATORY CITATION

Regulation citation Number of respondents 

Responses 

per respondent 

Total 

responses 

Hours per response 

(in minutes) 

Total burden 

hours Wage rate Total cost 

§ 61.6(a), (b) Errors & 

Omissions ................. 188 4.4 817 15 204.25 $25 $5,106 

§ 61.6 Revisions/Appeal Status ............... 130 26.9 3,492 30 1,746 25 43,650 

§ 61.7 Reporting By 

State Licensure 

Boards ...................... 305 80.8 24,640 45 18,480 25 462,000 

§ 61.8 Reporting of 

State Criminal Convictions ...................... 45 56 2,518 45 1,888.5 43 81,205 

§ 61.9 Reporting of 

Civil Judgments ........ 4 2.5 10 45 7.5 43 322 

§ 61.10(b) Reporting 

Exclusions from participation in Federal 

and State Health 

Care Programs ......... 9 320.3 2,883 20 961.0 38 36,518 

§ 61.11 Reporting of 

Adjudicated Actions/ 

Decisions .................. 92 17 1,562 45 1,171.5 43 50,375 

§ 61.12 Request for 

Information: State 

and Federal Agencies ........................... 855 279.3 238,814 5 19,901.26 25 497,531.50 

§ 61.12 Request for 

Information Health 

Plans ......................... 1,239 532.4 659,617 5 54,968.1 30 1,649,043 

§ 61.12 Request for 

Information Health 

Care Providers, Suppliers and Practitioners (self-query) ... 50,416 1 50,416 55 46,214.7 45 2,079,661.50 

§ 61.12(a)(4) Requests by Researchers for Aggregate 

Data .......................... 1 1 1 30 .5 38 19 

§ 61.15 Dispute Report ........................... 300 1 300 5 25 45 1,125 

§ 61.15 Add Report 

Statement ................. 669 1 669 45 501.8 100 50,180 

§ 61.15 Request for 

Secretarial Review ... 15 1 15 480 120 200 24,000 

Administrative Forms ... 0 0 0 0 0 0 0 

Total ...................... 54,268 ........................ 985,754 ........................ 146,190.11 ........................ 4,980,736 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 

or by fax to 202–395–6974. Please direct 

all correspondence to the ‘‘attention of 

the desk officer for HRSA.’’ 

Dated: October 6, 2010. 

Wendy Ponton, 

Director, Office of Management. 

[FR Doc. 2010–25657 Filed 10–12–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0499] 

Cooperative Agreement To Support 

Building Global Capacity for the 

Surveillance and Monitoring of 

Counterfeit/Falsified Medicines and 

Supply Chain Threats 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing its 

intention to accept and consider a single 

source application for award of a 

cooperative agreement to the World 

Health Organization (WHO) in support 

of building a global surveillance and 

monitoring system for combating 

counterfeit/falsified medicines and risks 

and breaches in the supply. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: 

Program Contact: Deborah Autor, or 

Ilisa Bernstein, Office of Compliance, 

Center for Drugs Evaluation and 

Research, Food and Drug 

Administration, White Oak Bldg. 51, rm. 

5270, 10903 New Hampshire Ave., 

Silver Spring, MD 20993, 301–796– 

3100, e-mail: 

Deborah.Autor@fda.hhs.gov or 

Ilisa.Bernstein@fda.hhs.gov. 

Management Contact: Katherine C. 

Bond, Office of the Commissioner, 

mstockstill on DSKH9S0YB1PROD with NOTICES