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

62838 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 

White Oak Bldg. 32, rm. 3300, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, 301–796–8318, FAX: 301–595– 

5058, e-mail: 

Katherine.Bond@fda.hhs.gov. 

Grants Contact: Kimberly Pendleton, 

Division of Acquisition and Grants, 

Food and Drug Administration, 5630 

Fishers Lane (HFA–500), Rm. 2104, 

Rockville, MD 20857, 301–827–9363, 

FAX: 301–827–7101, e-mail: 

kimberly.pendleton@fda.hhs.gov. 

For more information on this funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

contact Kimberly Pendleton. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

[RFA–FD–10–008] 

[Catalog of Federal Domestic Assistance 

Number(s): 93.103 https://www.cfda.gov] 

A. Background 

The problem of counterfeit/falsified 

medicines was first addressed at the 

international level in 1985 at the 

Conference of Experts on the Rational 

Use of Drugs in Nairobi. The meeting 

recommended that the WHO and 

relevant stakeholders should study the 

feasibility of setting up a clearinghouse 

to collect data and to inform 

governments about the nature and 

extent of counterfeiting. This project 

represents a collaborative agreement 

between WHO and FDA in building 

global rapid alert surveillance/ 

monitoring system(s) for combating 

counterfeit/falsified medicines and risks 

in the supply chain security that will 

assist in developing the global 

landscape and identifying areas of 

public health risk, including such 

challenges and threats as diversion, 

intentional adulteration, and the 

increasing complexity and reduced 

transparency of the supply chain due to 

globalization and limited regulatory 

capacity (such as in resourceconstrained countries and/or countries 

where regulatory infrastructure lack 

robustness). 

B. Research Objectives 

• Support WHO technical 

cooperation with member states to 

attain better data and improve data 

sharing about the public health risks 

surrounding counterfeit/falsified 

medicine and supply chain security, 

through the development of surveillance 

and monitoring system(s) of counterfeit/ 

falsified medicines and risks in supply 

chains and rapid alert system(s). 

• This could include a phased-in 

approach for implementation, testing 

and assessment of a system, as well as 

subsequent refinements to the system 

based on assessments the WHO may 

consider relevant. 

• Support WHO’s work internally to 

identify and possibly adapt current 

global surveillance/monitoring systems 

that may exist in other programs (e.g., 

those that the industry uses to collect 

information on counterfeit/falsified 

medicines), as well as other public 

health areas (e.g., infectious diseases), 

and may be relevant in applicability to 

a surveillance/monitoring system for 

counterfeit/falsified medicines and 

supply chain integrity. 

• Work with member states 

strategically over time to establish the 

necessary processes, protocols and 

commitment to collect and contribute 

data, share/exchange data routinely and 

consistently, and use the data emanating 

from a surveillance and monitoring 

system for counterfeit/falsified 

medicines and supply chain risks in 

support of national, sub-regional and 

global strategies and decision-making to 

prevent and address the incidence of 

counterfeit/falsified medicines and risks 

within supply chains in a sustainable 

and measurable way. 

• Recognizing the importance of 

WHO’s Anti-counterfeiting Programme, 

support WHO’s contribution to the 

design, development and/or 

implementation of a global surveillance/ 

monitoring system to better address the 

challenges and risks of counterfeit/ 

falsified medicines and supply chain 

integrity. 

• Promote development of consistent 

terminology around counterfeit/falsified 

medicines to enable comparable data 

collection and analyses; standardized 

methods for data collection; and a 

harmonized approach to data analyses 

in support of populating and utilizing a 

global surveillance/monitoring system 

for counterfeit/falsified medicines and 

supply chain security. Work with 

Member States for the implementation 

of these methods at the country-level to 

enable successful and sustainable 

implementation of a global surveillance/ 

monitoring system to better address 

counterfeit/falsified medicines and 

supply chain integrity. 

• Recognizing that active 

commitment, participation and 

engagement of national medicine 

regulatory authorities in any WHO 

surveillance/monitoring system for 

counterfeit/falsified drugs is essential, 

WHO will need to work with Member 

States as appropriate, for 

implementation, assessment, and 

refinement of a surveillance/monitoring 

system for counterfeit/falsified drugs 

and supply chain integrity that is of 

utility to national medicine regulatory 

authorities and other relevant national 

government stakeholders. 

• Promote the development of peerreviewed published articles on the 

growing complexities and threats 

addressing counterfeit/falsified 

medicines and supply chain security 

with a goal to initiate dialogue and 

expand the thinking among 

policymakers and experts on ways to 

address this public health threat with a 

forward-look toward sustainable 

solutions through global collaboration 

and evidence-based approaches. 

C. Eligibility Information 

The following organizations/ 

institutions are eligible to apply: The 

World Health Organization. 

II. Award Information/Funds Available 

A. Award Amount 

FDA anticipates providing one award 

of $960,500 (total costs including 

indirect costs) in fiscal year (FY) 2010 

in support of this project. Subject to the 

availability of funds and successful 

performance, 3 additional years of 

support up to $847,500 per year will be 

available. 

B. Length of Support 

The support will be 1 year with the 

possibility of an additional three years 

of noncompetitive support. 

Continuation beyond the first year will 

be based on satisfactory performance 

during the preceding year, receipt of a 

non-competing continuation application 

and available Federal FY 

appropriations. 

Dated: October 6, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–25687 Filed 10–12–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Award of a Single-Source Expansion 

Supplement to the Research 

Foundation of CUNY on Behalf of 

Hunter College School of Social Work 

AGENCY: Children’s Bureau, ACYF, ACF, 

HHS. 

ACTION: Notice. 

CFDA Number: 93.556. 

Legislative Authority: Fostering 

Connections to Success and Increasing 

Adoptions Act of 2008 (Pub. L. 110– 

351). 

Amount of Award: $229,877. 

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