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. 


pwalker on PROD1PC71 with NOTICES
28978 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Notices 

3. Approve and disapprove contract 

proposals for award, not including 

proposals for national interim grantee 

contracts. 

4. Approve and disapprove quality 

improvement plans (QIP) as required 

under 42 U.S.C. 9836A(d)(2)(B). 

5. Conduct, as the responsible HHS 

official, informal meetings with current 

grantees or current or prospective 

delegate agencies as authorized by 45 

CFR part 1303.11 and 1303.12. 

6. Conduct, as the responsible HHS 

official, informal meetings authorized 

by 45 CFR part 1303.21 related to 

appeals by current or prospective 

delegate agencies. 

7. Serve as the Approving Official to 

sign audit determination letters only 

where resolution does not involve a cost 

disallowance. 

8. Approve and issue termination and 

suspension actions resulting from 

monitoring review reports approved and 

issued by the Regional Office. 

(b) Limitations 

1. The approval of grant applications 

requires concurrence of the appropriate 

Grants Officer. 

2. The approval of contract proposals 

and awards are subject to the 

requirements of the Federal Acquisition 

Regulations and require consultation 

with the Director, Office of Head Start 

and the concurrence of the Contracting 

Officer. 

3. The approval and issuance of 

terminations and suspensions resulting 

from monitoring review reports 

approved and issued by the Regional 

Office require the concurrence of the 

Director, Office of Head Start. 

4. This redelegation shall be exercised 

under financial and administrative 

requirements applicable to all 

Administration for Children and 

Families authorities. 

5. Any redelegation shall be in writing 

and prompt notification must be 

provided to all affected managers, 

supervisors, and other personnel, and 

requires the concurrence of the Deputy 

Assistant Secretary for Administration. 

(c) Effective Date 

This redelegation was effective on 

April 26, 2007. 

(d) Effect on Existing Delegations 

This redelegation of authority 

supersedes all previous delegations 

from the Director, Office of Head Start, 

on these subjects. 

I hereby affirm and ratify any actions 

taken by the Director, Program 

Operations Division which, in effect, 

involved the exercise of these 

authorities prior to the effective date of 

this redelegation. 

Dated: May 15, 2007. 

Channell Wilkins, 

Director, Office of Head Start. 

[FR Doc. E7–9925 Filed 5–22–07; 8:45 am] 

BILLING CODE 4184–01–P 

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 Regional Program 

Managers, American Indian Alaska 

Native Program Branch Chief, and 

Migrant and Seasonal Program Branch 

Chief, Office of Head Start, the 

following authorities vested in me by 

the Director, Office of Head Start, in the 

memoranda dated April 26, 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. 

3. Approve and disapprove contract 

proposals for award, not including 

proposals for national interim grantee 

contracts. 

4. Approve and disapprove quality 

improvement plans (QIP) as required 

under 42 U.S.C. 9836A(d)(2)(B). 

5. Conduct, as the responsible HHS 

official, informal meetings with current 

grantees or current or prospective 

delegate agencies as authorized by 45 

CFR 1303.11 and 1303.12. 

6. Conduct, as the responsible HHS 

official, informal meetings authorized 

by 45 CFR part 1303.21 related to 

appeals by current or prospective 

delegate agencies. 

7. Serve as the Approving Official to 

sign audit determination letters only 

where resolution does not involve a cost 

disallowance. 

8. Approve and issue termination and 

suspension actions resulting from 

monitoring review reports approved and 

issued by the Regional Office. 

(b) Limitations 

1. The approval of grant applications 

requires concurrence of the appropriate 

Grants Officer. 

2. The approval of contract proposals 

and awards are subject to the 

requirements of the Federal Acquisition 

Regulations and require consultation 

with the Director, Office of Head Start 

and the concurrence of the Contracting 

Officer. 

3. The approval and issuance of 

terminations and suspensions resulting 

from monitoring review reports 

approved and issued by the Regional 

Office require the concurrence of the 

Director, Office of Head Start. 

4. This redelegation shall be exercised 

under financial and administrative 

requirements applicable to all 

Administration for Children and 

Families authorities. 

5. Any redelegation shall be in writing 

and prompt notification must be 

provided to all affected managers, 

supervisors, and other personnel, and 

requires the concurrence of the Deputy 

Assistant Secretary for Administration. 

(c) Effective Date 

This redelegation was effective on 

April 26, 2007. 

(d) Effect on Existing Delegations 

This redelegation of authority 

supersedes all previous delegations 

from the Director, Office of Head Start, 

on these subjects. 

I hereby affirm and ratify any actions 

taken by any Regional Program 

Manager, the American Indian Alaska 

Native Program Branch Chief or the 

Migrant and Seasonal Program Branch 

Chief which, in effect, involved the 

exercise of these authorities prior to the 

effective date of this redelegation. 

Dated: May 14, 2007. 

Renee Perthuis, 

Director, Program Operations Division. 

[FR Doc. E7–9928 Filed 5–22–07; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0260] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ORENCIA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ORENCIA and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 


pwalker on PROD1PC71 with NOTICES