57804 Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices 

harmonization among three regions: The 

European Union, Japan, and the United 

States. The six ICH sponsors are the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 

Health, Labor and Welfare; the Japanese 

Pharmaceutical Manufactures 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations. The ICH 

Steering Committee includes 

representatives from each of the ICH 

sponsors and Health Canada, the 

European Free Trade Area and the 

World Health Organization. The ICH 

process has achieved significant 

harmonization of the technical 

requirements for the approval of 

pharmaceuticals for human use in the 

three ICH regions. 

The current ICH process and structure 

can be found at the following Web site: 

http://www.ich.org. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Public oral presentations will 

be scheduled between approximately 4 

p.m. and 4:30 p.m. Time allotted for oral 

presentations may be limited to 10 

minutes. Those desiring to make oral 

presentations should notify the contact 

person by 5 p.m. e.s.t. on October 11, 

2010, and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses, telephone 

number, fax, and email of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation. 

The agenda for the public meeting 

will be made available on the Internet 

at: http://www.fda.gov/Drugs/ 

NewsEvents/ucm225322.htm. 

Dated: September 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23642 Filed 9–21–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0486] 

Safe Use Initiative; Public Workshop; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop entitled ‘‘Safe Use 

Initiative.’’ This public workshop, 

organized and hosted by FDA’s Safe Use 

Initiative Team, will communicate the 

status of ongoing activities and the 

future vision for Safe Use Initiative 

projects. The workshop will also offer 

an opportunity for the Safe Use 

Initiative Team to gather input and 

perspectives for future directions and 

develop collaborative, cross-sector safe 

medication use activities with health 

care stakeholders. 

DATES: The public workshop will be 

held on November 16, 2010, from 8:30 

a.m. to 4:45 p.m., and November 17, 

2010, from 8:30 a.m. to 12 noon. 

Suggestions for safe use topics received 

by October 15, 2010, may become the 

focus for indepth discussions during the 

workshop breakout sessions held the 

afternoon of November 16, 2010 (see 

section II of this document). Electronic 

or written comments will be accepted 

until January 31, 2011 (see section IV of 

this document). 

ADDRESSES: The public workshop will 

be held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

rm. 1503, Silver Spring, MD 20993– 

0002. 

Submit electronic comments on this 

document to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Sharon Bakayoko, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 1353, 

Silver Spring, MD 20993–0002, 301– 

796–7600, 

CDERSafeUseInitia@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The mission of the Safe Use Initiative 

is to reduce preventable harm from 

FDA-regulated medications. The Safe 

Use Initiative seeks to create and 

facilitate public and private 

collaborations aimed at reduction of 

preventable harm. 

FDA announced the ‘‘FDA’s Safe Use 

Initiative—Collaborating to Reduce 

Preventable Harm From Medications’’ 

(the Safe Use Report) on November 5, 

2009 (74 FR 57319). The Safe Use 

Report calls for an open and transparent 

process with health care stakeholders to 

identify candidate drug/drug classes or 

therapeutic areas that could benefit from 

a collaborative approach to harm 

reduction. 

The first steps in public engagement 

involved outreach to the health care 

community—through public meetings, 

teleconferences, and listening sessions 

with stakeholder groups (e.g., health 

care professionals, consumer groups, 

insurers, and industry). The goals were 

to inform organizations about the Safe 

Use Initiative, to obtain feedback about 

medication safety and preventable 

medication harm, and to seek 

opportunities for collaboration. The 

suggestions that emerged from the safe 

use outreach activities ranged from 

preventing a specific drug-related 

adverse event to broad and overarching 

themes in health care. 

II. Scope of the Public Workshop 

This public workshop expands the 

Safe Use Initiative outreach efforts. It 

will provide a forum to engage the 

health care community about 

collaborations, interventions, and 

metrics for ongoing and future projects 

to make medications safer. 

We are soliciting input in advance of 

the public workshop about topics for 

potential safe use collaborations. FDA 

will consider all topics. However, if 

submitted by October 15, 2010, some 

topics may become the focus for more 

indepth discussions and partnership 

development during the public 

workshop. Please submit topic 

suggestions (identified with the docket 

number found in brackets in the 

heading of this document) to the 

Division of Dockets Management (see 

ADDRESSES). When submitting a topic 

for consideration, please suggest how it 

could become a safe use project, e.g., 

other health care partners who might 

have an interest in the issue, kinds of 

interventions to reduce preventable 

harm, metrics, etc. 

III. Attendance and Registration to 

Speak 

The FDA Conference Center at the 

White Oak location is a Federal facility 

with security procedures. There is no 

fee to attend the workshop, and 

attendees who do not wish to make an 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices 57805 

oral presentation do not need to register. 

Seating is limited and will be on a firstcome, first-served basis. 

If you would like to make an oral 

presentation during the public session 

on November 17, 2010, you must 

register and provide an abstract of your 

presentation by the close of business on 

October 15, 2010. To speak, submit your 

name, title, business or organization 

affiliation (if applicable), address, 

telephone number, fax number, and 

email address to Sharon Bakayoko (see 

FOR FURTHER INFORMATION CONTACT). 

FDA has included areas of interest in 

section II of this document. Please 

indicate the topic area you wish to 

address in your presentation. FDA will 

do its best to accommodate requests to 

speak. Individuals and organizations 

with common interest are urged to 

consolidate or coordinate their 

presentations and to request time for a 

joint presentation. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. Persons registered to make an 

oral presentation should check in at the 

registration desk before the workshop. 

Time will be allowed during the 

scheduled agenda for attendees to ask 

questions of panelists. In addition, we 

strongly encourage electronic or written 

comments to the docket (see section IV 

of this document). 

If you need special accommodations 

because of a disability, please contact 

Sharon Bakayoko at least 7 days before 

the workshop. 

IV. Comments 

Regardless of attendance at the 

workshop, interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments 

regarding this document, including 

suggestions for workshop topics. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Information about the Safe Use 

Initiative, including the Safe Use 

Report, is available on the Internet at 

http://www.fda.gov/safeuseinitiative. 

Information about the workshop will be 

posted on this Web site when it is 

available. 

VI. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http://www.fda.gov/ 

safeuseinitiative and http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to the Division 

of Freedom of Information (HFI–35), 

Office of Management Programs, Food 

and Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

Dated: September 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23641 Filed 9–21–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Part D Grant for Coordinated HIV 

Services and Access to Research for 

Women, Infants, Children, and Youth 

Part D Funds Under the Ryan White 

HIV/AIDS Program 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of Non-competitive 

Award of Part D Funds for the 

University of Utah. 

SUMMARY: HRSA will be awarding, noncompetitively, Part D Funds to support 

family-centered primary medical care, 

treatment, and support services (directly 

or through contracts) for women, 

infants, children, and youth with HIV/ 

AIDS, to the University of Utah in order 

to ensure continuity of critical HIV 

medical care and support services, to 

women, infants, children and youth in 

Salt Lake City, Utah and the 

surrounding counties. 

SUPPLEMENTARY INFORMATION: 

Grantee of record: Utah Department of 

Health, Salt Lake City, Utah. 

Intended recipient of the award: 

University of Utah, Salt Lake City, Utah. 

Amount of the award: $350.000 to 

ensure continuity of medical care and 

support services to the target 

population. 

Authority: Section 2671 of the Public 

Health Service Act, 42 U.S.C. 300ff–71. 

CFDA Number: 93.918. 

Project period: August 1, 2010, to July 

31, 2011. The period of support for this 

award is from August 1, 2010, to July 

31, 2011. 

Justification for the Exception to 

Competition 

Funding for critical HIV medical care 

and support services to women, infants, 

children and youth in Salt Lake City, 

Utah and the surrounding areas will be 

continued through a non-competitive 

award to the University of Utah. The 

Utah Department of Health is currently 

contracting all of these services to the 

University of Utah. The University of 

Utah has the clinical, fiscal, and 

administrative infrastructure to 

administer the Part D Grant since it is 

currently the Part C Early Intervention 

Services Grant recipient. This is a 

temporary replacement award, as the 

previous grant recipient serving this 

population notified HRSA that it could 

not continue as the grantee of record 

after July 31, 2010. HRSA’s HIV/AIDS 

Bureau identified the University of Utah 

as the best qualified entity for this 

temporary grant. Since the grant’s 

inception, the Utah Department of 

Health has contracted with the 

University of Utah to provide all Part D 

services, and the University can 

continue to ensure family-centered care 

involving outpatient or ambulatory care 

(directly or through contracts) for 

women, infants, children, and youth 

living with HIV/AIDS. The University is 

able to provide critical services with the 

least amount of disruption to the service 

population while the service area is recompeted. 

This supplement will cover the time 

period from August 1, 2010, through 

July 31, 2011. This service area will be 

included in the upcoming competition 

for the Part D Coordinated HIV Services 

and Access to Research for Women, 

Infants, Children, and Youth for project 

periods starting August, 2011. 

FOR FURTHER INFORMATION CONTACT: Dora 

Ober, by e-mail dober@hrsa.gov, or by 

phone, 301–443–0759. 

Dated: September 15, 2010. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2010–23715 Filed 9–21–10; 8:45 am] 

BILLING CODE 4165–15–P 


emcdonald on DSK2BSOYB1PROD with NOTICES