15994 Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

1-day public workshop, cosponsored 

with the American Thyroid Association 

(ATA), entitled ‘‘Propylthiouracyl 

(PTU)-Related Liver Toxicity.’’ This 

public workshop is intended to provide 

a public forum for discussion of the 

clinical, scientific, and regulatory issues 

pertaining to PTU-induced hepatitis to 

seek constructive input from academia, 

regulatory scientists, and other 

interested parties on the topic of PTUinduced hepatitis. The input from this 

public workshop will help the ATA to 

develop guidelines for the management 

of hyperthyroidism and help inform 

FDA about necessary changes to 

prescription drug labeling for PTU. 

DATES: This public workshop will be 

held on Saturday, April 18, 2009, from 

8 a.m. to 3:30 p.m. However, depending 

on the level of public participation, the 

meeting may be extended or may end 

early. Written or electronic comments 

will be accepted after the workshop 

until June 19, 2009. 

ADDRESSES: The public workshop will 

be held at the Madison Hotel at 1177 

15th St., NW., Washington, DC 20005, 

202–862–1600. We are opening a docket 

to receive your written or electronic 

comments. Written or electronic 

comments must be submitted to the 

docket by June 19, 2009. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to: http://www.regulations.gov. 

Comments should be identified with 

the docket number found in brackets in 

the heading of this document. 

Transcripts of the workshop will be 

available for review at the Division of 

Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 45 days after the 

workshop. 

FOR FURTHER INFORMATION CONTACT: Jeff 

O’Neill, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 6167, Silver Spring, 

MD 20903, 301–796–0777, FAX: 301– 

847–8753, e-mail: 

jeff.o’neill@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

PTU-related liver toxicity has been 

reported in the published literature, and 

while direct comparative studies to 

another approved anti-thyroid 

medication, methimazole, are lacking, 

case series and postmarketing adverse 

event reports suggest a greater risk 

associated with PTU than methimazole. 

From prescription usage data, it appears 

that PTU is used less frequently than 

methimazole with perhaps a preferential 

use during pregnancy because of 

concerns about a rare congenital defect 

described in case reports of 

methimazole use. However, some data 

question whether an advantage of PTU 

use over methimazole exists, even 

during pregnancy. 

FDA and ATA are sponsoring this 

open public discussion involving 

academia, regulatory scientists, and 

other interested parties on the topic of 

PTU-induced hepatitis, because it is 

important to the health of patients with 

thyroid disease that the applicable 

scientific, clinical, and regulatory issues 

are raised and fully elucidated, and, to 

the greatest extent possible, consensus 

is reached. 

The ATA serves clinicians, scientists, 

and patients to facilitate open 

interchange and dissemination of 

scientific knowledge. The workshop is 

intended to provide a forum for 

discussion of the clinical, scientific, and 

regulatory issues pertaining to PTUinduced hepatitis. 

II. Registration 

There is no fee to attend the 

workshop, and attendees do not need to 

register. Seating will be on a first-come, 

first-served basis. If you need special 

accommodations because of disability, 

please contact Jeff O’Neill (see FOR

FURTHER INFORMATION CONTACT) at least 7 

days before the workshop. 

Dated: April 2, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–7993 Filed 4–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Meeting; Advisory Council on 

Blood Stem Cell Transplantation 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of Meeting of the 

Advisory Council on Blood Stem Cell 

Transplantation. 

SUMMARY: Pursuant to Public Law 92– 

463, the Federal Advisory Committee 

Act, as amended (5 U.S.C. Appendix 2), 

notice is hereby given of the fourth 

meeting of the Advisory Council on 

Blood Stem Cell Transplantation 

(ACBSCT), Department of Health and 

Human Services (HHS). The meeting 

will be held from approximately 8:30 

a.m. to 5 p.m. on May 12, 2009, at the 

Bethesda North Marriott Hotel and 

Convention Center, 5701 Marinelli 

Road, Bethesda, MD 20852. The meeting 

will be open to the public; however, 

seating is limited and pre-registration is 

encouraged (see below). 

SUPPLEMENTARY INFORMATION: Pursuant 

to Public Law 109–129, 42 U.S.C. 274k 

(section 379 of the Public Health Service 

Act, as amended), the ACBSCT was 

established to advise the Secretary of 

HHS and the Administrator, HRSA, on 

matters related to the activities of the 

C.W. Bill Young Cell Transplantation 

Program (Program) and the National 

Cord Blood Inventory (NCBI) Program. 

ACBSCT is composed of up to 25 

members, including the Chair, serving 

as Special Government Employees. The 

current membership includes 

representatives of marrow donor centers 

and marrow transplant centers; 

representatives of cord blood banks and 

participating birthing hospitals; 

recipients of a bone marrow transplant; 

recipients of a cord blood transplant; 

persons who require such transplants; 

family members of such a recipient or 

family members of a patient who has 

requested the assistance of the Program 

in searching for an unrelated donor of 

bone marrow or cord blood; persons 

with expertise in bone marrow and cord 

blood transplantation; persons with 

expertise in typing, matching, and 

transplant outcome data analysis; 

persons with expertise in the social 

sciences; basic scientists with expertise 

in the biology of adult stem cells; 

ethicists; hematology and transfusion 

medicine researchers with expertise in 

adult blood stem cells; persons with 

expertise in cord blood processing; and 

members of the general public. 

The Council will hear reports from 

three ACBSCT Work Groups: Cord 

Blood Accreditation Organization and 

Recognition Process, Scientific Factors 

Necessary to Define a Cord Blood Unit 

as High Quality, and Informed Consent. 

The Council also will hear presentations 

and discussions on the following topics: 

recent clinical developments and 

current issues, adult donor recruitment: 

Strategies and challenges, and future 

council activities. 

The draft meeting agenda and a 

registration form will be available on or 

about April 13, 2009, on HRSA’s 

Program Web site at http:// 

bloodcell.transplant.hrsa.gov/ABOUT/ 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices 15995 

AdvisoryCouncil/index.html. The 

completed registration form should be 

submitted by facsimile to Professional 

and Scientific Associates (PSA), the 

logistical support contractor for the 

meeting, at fax number (703) 234–1701 

ATTN: Rebecca Pascoe. Registration can 

also be completed electronically at 

https://www.team-psa.com/dot/ 

spring2009/acbsct/. Individuals without 

access to the Internet who wish to 

register may call Rebecca Pascoe with 

PSA at (703) 234–1747. 

Individuals who plan to attend the 

meeting and need special assistance, 

such as sign language interpretation or 

other reasonable accommodations, 

should notify the ACBSCT Executive 

Secretary, Remy Aronoff, in advance of 

the meeting. Mr. Aronoff may be 

reached by telephone at 301–443–3264, 

e-mail: Remy.Aronoff@hrsa.hhs.gov or 

in writing at the address provided 

below. Management and support 

services for ACBSCT functions are 

provided by the Division of 

Transplantation, Healthcare Systems 

Bureau, Health Resources and Services 

Administration, 5600 Fishers Lane, 

Parklawn Building, Room 12C–06, 

Rockville, Maryland 20857; telephone 

number 301–443–7577. 

After the presentations and Council 

discussions, members of the public will 

have an opportunity to provide 

comments. Because of the Council’s full 

agenda and the timeframe in which to 

cover the agenda topics, public 

comment will be limited. All public 

comments will be included in the 

record of the ACBSCT meeting. Meeting 

summary notes will be made available 

on HRSA’s Program Web site at http:// 

bloodcell.transplant.hrsa.gov/ABOUT/ 

Advisory_Council/index.html. 

Dated: April 1, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–7964 Filed 4–7–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Office of Rural Health Policy; Notice of 

Meetings 

Name: Office of Rural Health Policy, 

Health Resources and Services 

Administration (HRSA), HHS. 

Dates and Times: April 24, 2009, 8 a.m.— 

3 p.m. in Albuquerque, NM. May 18, 2009, 

8 a.m.—3 p.m. in Seattle, WA. June 26, 2009, 

8 a.m.—3 p.m. in Omaha, NE. 

Place: The Albuquerque Marriott, 2101 

Louisiana Boulevard, NE., Albuquerque, NM 

87110, Phone: 505–881–6800. 

The Seattle Airport Marriott, 3201 South 

176th Street, Seattle, WA 98188, Phone: 206– 

241–2000. 

The Omaha Marriott, 10220 Regency 

Circle, Omaha, NE 68114, Phone: 402–399– 

9000. 

Status: The meetings will be open to the 

public. 

Purpose: The Office of Rural Health Policy 

(ORHP) will hold a series of meetings to 

gather information on potential definitions of 

the terms Frontier or Remote Areas. 

Currently the most widely used definition 

within the Department of Health and Human 

Services (DHHS) requires that the population 

density of a county consist of six or fewer 

persons per square mile. The use of whole 

counties as the unit of measurement can lead 

to inclusion of large population centers in 

large area counties that still have a low 

overall population density. 

Use of population density alone as a 

measure of remoteness is also inappropriate 

for islands as the population density can far 

exceed 6 persons per square mile even 

though the island is isolated and lacks access 

to services and resources. 

ORHP has used the Rural-Urban 

commuting area (RUCA) codes to identify 

rural areas located in Metropolitan counties. 

Metropolitan counties are defined by the 

Office of Management and Budget of the 

White House but can contain substantial 

rural areas due to geographic barriers, 

distance or other factors. RUCAs are based on 

a sub-county unit, the Census Tract, and take 

into account population density, 

urbanization, and daily commuting patterns. 

Every Census tract is assigned a code based 

on these factors. While ORHP has chosen to 

define Metropolitan tracts with RUCA codes 

from 4 through 10 as ‘‘rural’’ for purposes of 

grant eligibility, the codes have not been 

used to identify ‘‘Frontier’’ or remote areas. 

In order to pursue a more accurate 

definition of Frontier/Remote areas, ORHP 

has entered into agreements with L. Gary 

Hart and the Economic Research Service 

(ERS) of the US Department of Agriculture 

(USDA). Dr. Hart and ERS also developed the 

RUCAs with support from ORHP. As work on 

this definition proceeds ORHP will hold a 

series of meetings to gather information from 

interested parties and the public. 

While a robust, quantitative definition of 

Frontier/Remote areas may have future 

programmatic uses, the immediate goal of 

ORHP and ERS is to make this work available 

for research purposes. 

For Further Information Contact: Direct 

requests for additional information to Mr. 

Steven Hirsch, Health Resources and 

Services Administration, Office of Rural 

Health Policy, Room 9A–55, 5600 Fishers 

Lane, Rockville, MD 20857, (301) 443–7322. 

E-mail: shirsch@hrsa.gov. 

Dated: April 3, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–8013 Filed 4–7–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Part C Early Intervention Services 

Grant Under the Ryan White HIV/AIDS 

Program 

AGENCY: Health Resources and Services 

Administration (HHS). 

ACTION: Notice of noncompetitive 

transfer of Part C funds from Cathedral 

Healthcare System to Saint Michael’s 

Medical Center. 

SUMMARY: HRSA will be transferring 

Part C funds to Saint Michael’s Medical 

Center as a noncompetitive replacement 

award in order to ensure continuity of 

critical HIV medical care and treatment 

services and to avoid a disruption of 

HIV clinical care to clients in 

Metropolitan Newark, and Essex County 

in New Jersey. 

SUPPLEMENTARY INFORMATION: Grantee of 

record: Cathedral Healthcare System. 

Intended recipient of the award: Saint 

Michael’s Medical Center, Newark, New 

Jersey. 

Amount of the award: $537,607 to 

ensure ongoing clinical services to the 

target population. 

Authority: Section 2651 of the Public 

Health Service Act, 42 U.S.C. 300ff–51. 

CFDA Number: 93.918. 

Project period: April 1, 2005 to March 

31, 2010. The period of support for the 

replacement award is from April 1, 2009 

to March 31, 2010. 

Justification for the Exception to 

Competition: Critical funding for HIV 

medical care and treatment services to 

clients in Metropolitan Newark and 

Essex County in New Jersey will be 

continued through a noncompetitive 

supplement to Saint Michael’s Medical 

Center, a prior sub-contractor of 

Cathedral Healthcare System, the 

grantee of record in Newark, New 

Jersey. This is a temporary replacement 

award as the previous grant recipient 

serving this population notified HRSA 

that they will not continue providing 

services after March 31, 2009. The 

Cathedral Healthcare System, the former 

grantee, has ceased governance and 

operations of its three hospitals. Saint 

Michael’s Medical Center is the best 

qualified recipient for this supplement, 

as it already serves most of the former 

grantee’s patients ensuring continuity of 

care, and can continue to provide 

critical services with the least amount of 

disruption to the service population 

while the service area is re-competed. 

This supplement will cover the time 

period from April 1, 2009, through 


rwilkins on PROD1PC63 with NOTICES