28976 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Notices 

acquire voting shares of Georgia Central 

Bank, both of Social Circle, Georgia. 

C. Federal Reserve Bank of St. Louis 

(Glenda Wilson, Community Affairs 

Officer) 411 Locust Street, St. Louis, 

Missouri 63166-2034: 

1. MRV Financial Corp, Genevieve, 

Missouri; to become a bank holding 

company by acquiring 100 percent of 

the voting shares of MRV Banks,. 

Genevieve, Missouri (in organization). 

D. Federal Reserve Bank of Kansas 

City (Donna J. Ward, Assistant Vice 

President) 925 Grand Avenue, Kansas 

City, Missouri 64198-0001 

1. First Centralia Bancshares, Inc., 

Centralia, Kansas; to acquire 100 

percent of the voting shares of 

Vermillion Bankshares, Inc., and 

thereby indirectly acquire Vermillion 

State Bank, both in Vermillion, Kansas. 

E. Federal Reserve Bank of San 

Francisco (Tracy Basinger, Director, 

Regional and Community Bank Group) 

101 Market Street, San Francisco, 

California 94105-1579: 

1. Franklin Resources, Inc., San 

Mateo, California; to retain 16 percent 

of the voting shares of The BANKshares, 

Inc., Melbourne, Florida, and thereby 

indirectly retain shares of The Bank 

Brevard, Melbourne, Florida, and 

BankFIRST, Winter Park, Florida. 

Board of Governors of the Federal Reserve 

System, May 18, 2007. 

Jennifer J. Johnson, 

Secretary of the Board. 

[FR Doc. E7–9936 Filed 05–22–07; 8:45 am] 

BILLING CODE 6210–01–S 

FEDERAL RESERVE SYSTEM 

Notice of Proposals to Engage in 

Permissible Nonbanking Activities or 

to Acquire Companies that are 

Engaged in Permissible Nonbanking 

Activities 

The companies listed in this notice 

have given notice under section 4 of the 

Bank Holding Company Act (12 U.S.C. 

1843) (BHC Act) and Regulation Y (12 

CFR Part 225) to engage de novo, or to 

acquire or control voting securities or 

assets of a company, including the 

companies listed below, that engages 

either directly or through a subsidiary or 

other company, in a nonbanking activity 

that is listed in § 225.28 of Regulation Y 

(12 CFR 225.28) or that the Board has 

determined by Order to be closely 

related to banking and permissible for 

bank holding companies. Unless 

otherwise noted, these activities will be 

conducted throughout the United States. 

Each notice is available for inspection 

at the Federal Reserve Bank indicated. 

The notice also will be available for 

inspection at the offices of the Board of 

Governors. Interested persons may 

express their views in writing on the 

question whether the proposal complies 

with the standards of section 4 of the 

BHC Act. Additional information on all 

bank holding companies may be 

obtained from the National Information 

Center Web site at www.ffiec.gov/nic/. 

Unless otherwise noted, comments 

regarding the applications must be 

received at the Reserve Bank indicated 

or the offices of the Board of Governors 

not later than June 18, 2007. 

A. Federal Reserve Bank of Chicago 

(Burl Thorton, Assistant Vice President) 

230 South LaSalle Street, Chicago, 

Illinois 60690-1414: 

1. Capitol Bancorp LTD. Lansing, 

Michigan and Capitol Development 

Bancorp Limited VI, Lansing, Michigan 

; to acquire 51 percent of High Desert 

Bank, (in organization), Bend, Oregon, 

and thereby operate a savings 

association, pursuant to section 225.28 

(b)(4)(ii) of Regulation Y. 

Board of Governors of the Federal Reserve 

System, May 18, 2007. 

Jennifer J. Johnson, 

Secretary of the Board. 

[FR Doc.E7–9934 Filed 05–22–07; 8:45 am] 

BILLING CODE 6210–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Food and Drug Administration 

[Docket No. 2007N–0179] 

Implementation of Risk Minimization 

Action Plans (RiskMAPs) to Support 

Quality Use of Pharmaceuticals: 

Opportunities and Challenges; Public 

Workshop 

AGENCIES: Agency for Healthcare 

Research and Quality; Food and Drug 

Administration, HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) and the 

Food and Drug Administration (FDA) 

are announcing a 2-day joint public 

workshop entitled ‘‘Implementation of 

Risk Minimization Action Plans 

(RiskMAPs) to Support Quality Use of 

Pharmaceuticals: Opportunities and 

Challenges.’’ This public workshop is 

intended to seek constructive input 

from a wide range of stakeholders, 

including clinicians, pharmacists, 

patients, third party payers of care, the 

pharmaceutical and biotechnology 

industries, researchers, and innovators 

in health information technology (HIT), 

to help in the development and 

implementation of mechanisms to 

minimize the risks of pharmaceuticals 

with unusual safety and patient 

monitoring concerns. This meeting is an 

initial step that is part of FDA’s 

commitment to monitor the 

performance of RiskMAPs consistent 

with the goal articulated in the 

proposed PDUFA IV agreement to 

undertake regular follow up of these 

plans. 

DATES: The public workshop will be 

held on June 25 and 26, 2007, from 8:30 

a.m. to 5 p.m. See section III of this 

document for information on deadline 

and on how to register to attend or 

present at the meeting. 

We are opening a docket to receive 

your written or electronic comments. 

Written or electronic comments must be 

submitted to the docket by July 31, 

2007. 

ADDRESSES: The public workshop will 

be held at the Agency for Healthcare 

Research and Quality (AHRQ), 540 

Gaither Rd., John M. Eisenberg Bldg., 

Rockville, MD 20850. Submit electronic 

comments to http:// 

www.accessdata.fda.gov/scripts/oc/ 

dockets/comments/commentdocket.cfm. 

Submit written comments to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. All comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Lee 

Lemley, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–443–5392, 

FAX: 301–827–4312, e-mail: 

Coralee.Lemley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Risk minimization action plans 

(RiskMAPs) are safety programs 

designed to minimize significant risks of 

a product by using one or more risk 

minimization tools. A variety of risk 

minimization tools have been used; 

these tools are broadly categorized as 

follows: (1) Education and outreach 

tools intended to inform patients and 

healthcare practitioners (HCPs) about a 

product’s risks and measures that 

should be taken to prevent or mitigate 

the risks; (2) Reminder systems 

intended to prompt or guide HCPs and/ 

or patients in prescribing, dispensing, or 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Notices 28977 

using a product in ways that minimize 

risk; and (3) performance-linked access 

(PLA) systems that link product access 

to required laboratory testing or other 

documentation. The latter two 

categories have exhibited some success 

in minimizing risk, but may lead to 

disruptions in medical and pharmacy 

practice and unintended consequences, 

such as obstructing patient access to a 

product’s benefits. It is the latter two 

tool categories (Reminder and PLA 

systems) that are the primary focus of 

this workshop. The following are a few 

of the products with Reminder or PLA 

systems: Isotretinoin (iPLEDGE), 

Thalidomide (STEPS), and Tysabri 

(TOUCH). 

The workshop objectives are as 

follows: (1) Initiate constructive 

dialogue and information-sharing 

among regulators, researchers, and 

organizations and individuals affected 

by RiskMAP programs, particularly 

those using Reminder and PLA systems; 

(2) share key lessons learned about how 

to design and implement effective risk 

management systems to accommodate 

and promote quality healthcare and 

pharmacy practices; and (3) explore 

how tools being actively developed 

(such as electronic prescribing and 

integrated electronic health and medical 

records) and used to support highquality, evidence-based practice may 

improve the development of RiskMAPs 

where Reminder and PLA systems are 

used or being considered for use. 

Panel discussions as well as 

stakeholder presentations and testimony 

will focus on implementation strategies 

using Reminder and PLA systems to 

promote appropriate behavior changes 

to optimize patient outcomes, 

autonomy, access, cost, and logistics 

while reducing drug risks. We invite 

presentations that suggest ways to 

mitigate drug safety risks by improving 

healthcare system processes or emerging 

health information technologies. 

Examples might include linkages of 

electronic prescribing to laboratory or to 

patient electronic health records 

designed to improve the effectiveness of 

risk minimization efforts. 

AHRQ and FDA are working together 

to refine the conference agenda and 

invite speakers. The agenda will be 

made available at http://www.fda.gov/ 

cder/meeting/riskMAPs.htm not later 

than June 15, 2007. We are seeking 

broad participation by physicians, 

pharmacists, patients, health care 

quality and safety researchers, health 

systems officials, and payers of care. We 

anticipate issuing a summary of the 

conference findings, including a 

discussion of implications and next 

steps for further research or regulatory 

guidance development. 

II. Comments 

The agency is interested in hearing 

comments at the public workshop or 

receiving written comments (see 

ADDRESSES) on the following issues: 

(1) Based on the diversity of 

experiences of different groups in 

implementing existing Reminder and 

PLA system RiskMAPs, what lessons 

have been learned that can be applied 

to future programs in the following 

areas: 

• Minimizing risks; 

• Maintaining provider and patient 

access to therapeutic choices; 

• Minimizing burdens on the 

healthcare system; 

• Being compatible with diverse 

technologies and settings of care; 

• Avoiding adverse unintended 

consequences. 

(2) How can healthcare information 

technology be used to assist quality 

prescribing, dispensing, and patient use 

to improve the effectiveness of 

RiskMAPs for drugs with risks where 

Reminder and PLA systems are used or 

likely to be used? How might HIT 

solutions be pursued and applied in 

light of the underdeveloped use of this 

technology in healthcare? 

(3) How might professional 

organizations, third party payers of care, 

and others support the appropriate use 

of medications with processes or 

requirements such as those used with 

Reminder and PLA system RiskMAPs? 

(4) Who are the relevant stakeholders 

in healthcare to involve in the design 

and choice of risk minimization tools? 

How can these stakeholders be best 

engaged in meaningful and productive 

partnerships and collaborations? 

(5) Which activities and research 

should be pursued to develop a strong 

evidence base of healthcare system 

approaches, processes, and tools that 

support appropriate use of medications 

with safety problems where Reminder 

and PLA RiskMAPs are being used or 

considered for use? 

(6) What partnerships will support 

evaluations of effectiveness of 

RiskMAPs or pilot interventions to 

minimize risk and promote appropriate 

medication prescribing, dispensing, and 

use? 

(7) What future actions should AHRQ 

and FDA take to promote continued 

collaborations and contributions to the 

high-quality, appropriate use of 

medications with RiskMAPs? 

III. Registration 

The AHRQ Conference Center is a 

Federal facility with limited seating and 

security procedures for entrance. For 

these reasons, pre-registration is 

necessary for all attendees. Registration 

is available on a first-come basis. 

Individuals who wish to speak during 

the open public hearing must register on 

or before June 8, 2007; all other 

attendees must register on or before June 

15, 2007. To register, contact 

register@consolidatedsafety.com or call 

703–877–3345. 

Ample time will be allowed during 

the scheduled agenda for attendees to 

ask questions of panelists. In addition, 

we strongly encourage written 

comments to the docket. 

If you need special accommodations 

because of disability, please contact Lee 

Lemley (see CONTACT FOR FURTHER

INFORMATION) at least 7 days before the 

workshop. 

IV. Workshop Transcripts 

The workshop will be transcribed. 

The transcript will be available for 

review at the Division of Dockets 

Management (see ADDRESSES) and on 

the Internet at http://www.fda.gov/ 

ohrms/dockets approximately 30 days 

after the workshop. 

Dated: May 10, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

Dated: May 16, 2007. 

Carolyn Clancy, 

Director, Agency for Healthcare Research and 

Quality, Department of Health and Human 

Services. 

[FR Doc. 07–2574 Filed 5–22–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Statement of Organization, Functions 

and Delegation of Authority 

Notice is hereby given that I have 

redelegated to the Director, Program 

Operations Division, Office of Head 

Start, the following authorities vested in 

me by the Assistant Secretary of 

Administration for Children and 

Families in the memoranda dated 

February 16, 2007. 

(a) Authorities Delegated 

1. Approve and disapprove refunding 

and supplemental funding applications 

for existing grantees, not including 

designated interim grantees. 

2. Approve and disapprove 

collaboration grant applications 

authorized under 42 U.S.C. 9835. 


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