10944 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 

[FR Doc. E9–5492 Filed 3–12–09; 8:45 am] 

BILLING CODE 4160–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Clinical Trials Endpoints for Acute 

Graft-Versus-Host Disease After 

Allogeneic Hematopoietic Stem Cell 

Transplantation; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) and National Institutes of Health 

(NIH) in co-sponsorship with the Center 

for International Blood and Marrow 

Transplantation Research (CIBMTR) and 

the American Society for Blood and 

Marrow Transplantation (ASBMT) are 

announcing a public workshop entitled 

‘‘Clinical Trials Endpoints for Acute 

Graft-Versus-Host Disease (GVHD) After 

Allogeneic Hematopoietic Stem Cell 

Transplantation.’’ This is a 1-day 

workshop for academics, government 

researchers, clinical trial experts, 

government regulators, and industry 

representatives. The purpose of the 

public workshop is to review the data 

that will serve as the foundation for 

protocol design and clinical trial 

evidence-based endpoints intended to 

support the approval of new drugs or 

biologics to prevent or treat acute 

GVHD. The public workshop also will 

inform FDA and assist investigators in 

facilitating clinical development 

programs for products to prevent or treat 

acute GVHD indications. 

Date and Time: The public workshop 

will be held on May 19, 2009, from 8:30 

a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Hilton Washington DC/ 

Rockville Executive Meeting Center, 

1750 Rockville Pike, Rockville, MD 

20852. 

Overnight accommodations can be 

booked at the Hilton under group code 

‘‘MCW’’ for the conference rate by 

calling 1–800–445–8667 or by using the 

Reservation Web site athttp:// 

www.hilton.com/en/hi/groups/ 

personalized/IADMRHF–MCW– 

20090518/index.jhtml. Accommodation 

agreement courtesy of CIBMTR. (FDA 

has verified the Web site address, but is 

not responsible for subsequent changes 

to the Web site after this document 

publishes in the Federal Register). 

Contact Person: Leslie Haynes, Center 

for Biologics Evaluation and Research 

(HFM–43), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–2000, FAX: 301–827–3079; email: CBERTraining@fda.hhs.gov 

(Subject line: Acute GVHD Workshop). 

Registration: Mail or fax your 

registration information (including 

name, title, firm name, address, 

telephone and fax numbers) to the 

Contact Person by April 18, 2009. There 

is no registration fee for the public 

workshop. Early registration is 

recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space available basis beginning at 8:15 

a.m. 

If you need special accommodations 

due to a disability, please contact Leslie 

Haynes at least 7 days in advance. 

SUPPLEMENTARY INFORMATION: At the 

present time, there are no drugs or 

biologics approved for prevention or 

treatment of acute GVHD. Development 

of products to prevent or treat acute 

GVHD poses several challenges. First, 

the market is not very big, so there is 

little incentive for investment if the 

process is cumbersome; second, 

analyses of these studies are 

complicated by confounding factors; 

and third, there is a lack of evidencebased endpoints that can be used to 

demonstrate a clinically meaningful 

benefit of any therapy. 

The Center for Biologics Evaluation 

and Research is the FDA Center with 

regulatory responsibility for vaccines, 

blood and blood products, allergenic 

products, and therapies involving cells, 

tissues, and genes. The mission of FDA 

is to protect and enhance the public 

health including the safety and purity of 

medical products and the Nation’s 

blood supply. The purpose of this event 

is to review the data that can be used 

to develop evidence-based endpoints for 

clinical trials targeting acute GVHD. 

ASBMT is a professional organization 

that promotes advancement of the field 

of blood and bone marrow 

transplantation. Its members are both in 

clinical practice and in research. 

CIBMTR is a research network 

comprised of the National Marrow 

Donor Program© and the International 

Bone Marrow Transplant Registry and 

Autologous Blood and Marrow 

Transplant Registry. Its activities 

include support for the National Heart, 

Lung and Blood Institute (NHLBI)- 

funded Blood and Marrow 

Transplantation Clinical Trials Network 

and Health Resources and Services 

Administration’s C.W. Bill Young Cell 

Transplantation Program. The goals of 

the CIBMTR include defining key areas 

for future research in collaboration with 

leading scientists, physicians, and 

others in the blood and marrow 

transplant community; the design and 

implementation of clinical studies; and 

making available research resources 

including a clinical database of related 

blood and marrow transplants, along 

with repositories of matched tissue 

samples from transplant recipients and 

their donors. 

The NHLBI, National Institute of 

Allergy and Infectious Diseases (NIAID), 

National Cancer Institute (NCI), and 

Office of Rare Diseases (ORD) are at the 

National Institutes of Health (NIH), the 

primary Federal agency for conducting 

and supporting medical research. NIH’s 

mission is science in pursuit of 

fundamental knowledge about the 

nature and behavior of living systems 

and the application of that knowledge to 

extend healthy life and reduce the 

burdens of illness and disability. 

The public workshop will feature 

presentations by FDA, CIBMTR, and 

members of ASBMT. The topics to be 

discussed include the following: (1) 

Regulatory requirements for clinical 

trials, (2) extant data which support the 

endpoints currently used in clinical 

trials, (3) data analyses to support the 

validity of the proposed endpoints, (4) 

statistical approaches to minimize 

confounding factors in stem cell 

transplantation study analysis, (5) 

biomarkers for acute GVHD, and (6) 

patient-reported outcomes for acute 

GVHD prevention and treatment trials. 

Presentations: Presentations from the 

public workshop will be maintained on 

the CIBMTR’s Web site for at least 1 

year. 

Dated: March 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–5496 Filed 3–12–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Women’s Health 

Initiative Observational Study 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Office of the 

Director, the National Heart, Lung, and 

Blood Institute (NHLBI), the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 


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