49774 Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 / Notices 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products 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, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

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 (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of July 30, 

2009 (74 FR 38033), FDA published a 

notice announcing the availability of a 

draft guidance entitled ‘‘E16 Genomic 

Biomarkers Related to Drug Response: 

Context, Structure, and Format of 

Qualification Submissions.’’ The notice 

gave interested persons an opportunity 

to submit comments by September 28, 

2009. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft of the guidance was 

submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory agencies in 

September 2010. 

The guidance provides 

recommendations on the context, 

structure, and format of qualification 

submissions as follows: 

• The proposed context of use of a 

biomarker corresponds to the data 

supporting its qualification. The context 

of use of a biomarker in a biomarker 

qualification can be narrow or broad— 

the biomarker(s) might be useful for 

only a single drug or biotechnology 

product, for several drug or 

biotechnology products in a drug class, 

or even across several drug classes. 

• The structure of the submission 

should be consistent regardless of the 

context proposed and flexible enough to 

deal with the specific attributes of each 

submission. In addition, use of the 

recommended structure should facilitate 

submission and review of future 

biomarker qualification submissions 

expanding the use of the biomarker to 

new contexts, as would be the case if, 

for example, a nonclinical context of use 

expands to a clinical context of use. 

• The format of the data for qualifying 

a biomarker can vary significantly 

depending on the context. The format 

should support an evaluation of the data 

and can include reports, tabulations, 

and raw data (if requested by regulatory 

authorities according to the relevant 

practices in place). 

The application structure described in 

this guidance is intended for biomarker 

qualification submissions after 

sufficient supporting data have been 

generated. However, this structure can 

also be considered for submissions 

intended to obtain scientific advice from 

regulatory authorities before or during 

the generation of the biomarker data 

intended to support qualification. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://www.

regulations.gov, http://www.fda.gov/

Drugs/GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm. 

Dated: August 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20386 Filed 8–10–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Cellular, Tissue and Gene Therapies 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Cellular, Tissue 

and Gene Therapies Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on September 22 and 23, 2011, 

from 8 a.m. to 5 p.m. 

Location: Hilton Hotel, Washington, 

DC North/Gaithersburg, 620 Perry 

Pkwy., Gaithersburg, MD 20977, 301– 

977–8900. For those unable to attend in 

person, the meeting will also be 

available by Web cast. On September 22, 

2011, the link for the Web cast is 

available at http://fda.yorkcast.com/

webcast/Viewer/?peid=637f14248dca

4236a5f9a3b622e6501e1d. On 

September 23, 2011, the link for the 

Web cast is available at http://fda.

yorkcast.com/webcast/Viewer/?peid

=2e8b3eb7638d42ca9652c328a854efb

51d. 

Contact Person: Gail Dapolito or 

Sheryl Clark (HFM–71), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20853, 

301–827–0314, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 / Notices 49775 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On September 22, 2011, the 

committee will discuss BLA 125397, 

Umbilical Cord Blood, New York Blood 

Center, indicated for hematologic 

malignancies, bone marrow failure, 

primary immunodeficiency diseases, 

beta thalassemia, Hurler syndrome, 

Krabbe disease, and X-linked 

adrenoleukodystrophy. On September 

23, 2011, the Committee will discuss 

HDE BH110018, CliniMACS CD34 

Selection System, Miltenyi Biotec, for 

processing allogeneic HLA-matched 

hematopoietic progenitor cells-apheresis 

(HPC–C) from a related donor to obtain 

a CD34+ Cell population intended for 

hematopoietic reconstitution following 

a Myeloablative preparative regimen 

without the need for additional graft-vshost disease (GVHD) prophylaxis in 

patients with acute myelogenous 

leukemia in first or second morphologic 

complete remission. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/default.

htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before September 15, 2011. 

Oral presentations from the public will 

be scheduled on September 22, 2011, 

between approximately 11 a.m. and 12 

noon and on September 23, 2011, 

between approximately 11:30 a.m. and 

12:30 p.m. Those individuals interested 

in making formal oral presentations 

should notify the contact person and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before September 7, 2011. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

September 8, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Gail Dapolito 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: August 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20399 Filed 8–10–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Food and Drug Administration/National 

Heart, Lung, and Blood Institute/ 

National Science Foundation Public 

Workshop on Computer Methods for 

Medical Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop entitled ‘‘FDA/NHLBI/ 

NSF Workshop on Computer Methods 

for Medical Devices.’’ FDA is 

cosponsoring the conference workshop 

with the National Heart, Lung, and 

Blood Institute (NHLBI) of the National 

Institutes of Health and the National 

Science Foundation (NSF). The purpose 

of the workshop is to facilitate 

discussion between FDA and other 

interested parties on the use of 

computational modeling in the design, 

development and evaluation of medical 

devices. 

Dates and Times: The public 

workshop will be held on September 7, 

8, and 9, 2011, from 9 a.m. to 5 p.m. An 

optional FDA Microstructure Modeling 

session will be held from 1 to 5 p.m. on 

September 6, 2011. Participants are 

encouraged to arrive early to ensure 

time for parking and security screening 

before the meeting. Security screening 

will begin at 8 a.m. Persons interested 

in attending this public workshop must 

register by 5 p.m. on August 30, 2011. 

Location: The public workshop and 

optional session will be held at the FDA 

White Oak Campus, 10903 New 

Hampshire Ave, Building 31 Conference 

Center, the Great Room (rm. 1503), 

Silver Spring, MD 20993–0002. 

Contact Persons: Donna R. Lochner, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 62, 

rm. 3220, Silver Spring, MD 20993– 

0002, 301–796–6309, e-mail: 

donna.lochner@fda.hhs.gov; or 

Tina M. Morrison, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1272, Silver Spring, 

MD 20993–0002, 301–796–6310, e-mail: 

tina.morrison@fda.hhs.gov. 

Registration: To register for the public 

workshop and optional session, please 

visit the following Web site: http:// 

www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm (or go to http://www.fda.gov 

and select the FDA Medical Devices 

News & Events—Workshops & 

Conferences calendar and select this 

public workshop from the posted events 

list). Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone number. For those 

without Internet access, please call the 

contact person to register. Registration is 

mandatory as space is limited and 

onsite registration will not be available. 

FDA may limit the number of 

participants from each organization. 

There is no registration fee for the 

public workshop. 

Registrants requesting to present 

written materials or to make oral 

presentations at the public workshop, 

please call the contact persons by 

August 23, 2011. 

If you need special accommodations 

because of a disability, please contact 

Susan Monahan, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 4321, Silver Spring, 


srobinson on DSK4SPTVN1PROD with NOTICES