Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices 14813 

accompany the TV ad submission 

package. This collection of information 

for Form FDA 2253 has been approved 

under OMB control number 0910–0001. 

Therefore, we estimate the annual 

reporting burden as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of submission Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Advertisements prepared in accordance with section 503B 

of the FD&C Act ............................................................... 32 2.56 82 25 2,050 

Resubmissions of incomplete submission packages .......... 6 1 6 5 30 

45-Day review clock decision letter ..................................... 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 2,581 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

III. 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. 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either http: 

//www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/default.htm, or http://

www.regulations.gov. 

Dated: March 8, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6040 Filed 3–12–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Public Workshop on Minimal Residual 

Disease; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

to provide a forum for discussion of the 

use of minimal residual disease (MRD) 

as a biomarker for evaluating new drugs 

for the treatment of acute lymphoblastic 

leukemia (ALL). The meeting is 

cosponsored with the American Society 

of Clinical Oncology and will be the 

first in a series of workshops intended 

to bring together scientific and advocacy 

communities and the pharmaceutical 

and in vitro diagnostic device industries 

to help develop processes and 

procedures to qualify MRD as a 

biomarker of efficacy and/or response to 

treatment in a group of hematological 

malignancies. 

DATES: Date and Time: The public 

workshop will be held on April 18, 

2012, from 8 a.m. to 4 p.m. 

Location: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave. Bldg. 31 

Conference Center, the Great Room (rm. 

1503), Silver Spring, MD 20993–0002. 

Contact Person: Christine Lincoln, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave. Bldg. 22, rm. 6413, Silver Spring, 

MD 20993–0002, 301–796–2340. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Clinical data from patients with 

certain subtypes of acute and chronic 

leukemia suggest that MRD can be 

established as a surrogate endpoint for 

clinical trials and drug approval. This 

public workshop will provide a forum 

for discussion among scientific and 

advocacy communities and the 

pharmaceutical and in vitro diagnostic 

device industries of issues related to the 

qualification (validation) of MRD as a 

biomarker (i.e., a measurable 

characteristic that is predictive of 

disease outcome) that can be used to 

determine efficacy and/or response in 

evaluation of new drugs for the 

treatment of ALL. Although the data 

related to the prognostic significance of 

MRD are most extensive in the pediatric 

population, and are currently used to 

stratify patients for risk-adjusted 

therapy, MRD may also be pertinent to 

subtypes of adult ALL; hematologists 

who treat adult patients have been 

invited to participate, as well as 

hematologists who treat pediatric 

patients. Topics to be discussed at the 

workshop include: (1) Evaluation of the 

prognostic biomarker data that is 

currently available to support the 

qualification of MRD as a marker of 

response and/or efficacy in both 

pediatric and adult ALL; (2) the 

specificity, sensitivity, and 

comparability of techniques that might 

be used in a standardized fashion to 

measure MRD; (3) the performance 

characteristics and proficiency 

assessment of current technology 

platforms; and (4) the design and 

analysis of the clinical trials needed to 

establish the use of postinduction MRD 

as an alternative endpoint for approval 

of new drugs to treat ALL. 

This workshop is part of a series in 

which FDA’s Office of Hematology and 

Oncology Products will explore the 

utility of MRD as a surrogate endpoint 

in ALL (including ALL that has 

recurred), chronic lymphocytic 

leukemia (CLL), and acute myeloid 

leukemia (AML). Given the diverse 

etiologies, pathophysiologies, and 

natural histories of these diseases and 

current practice standards, separate 

consideration of MRD as a surrogate 

endpoint in each disease is warranted. 

FDA is seeking representation from both 

North American and European 

academic investigators as well as 

cooperative groups at the workshops. 

The workshops for CLL and AML are 

tentatively scheduled for October 10 

and 11, 2012, respectively. 

II. Attendance and Registration 

FDA encourages patient advocates, 

representatives from industry, consumer 

groups, health care professionals, 

researchers, and other interested 

persons to attend this public workshop. 

Registration: There is no registration 

fee for the public workshop. To register 

electronically, please use the following 

Web site: http://www.zoomerang.com/ 

mstockstill on DSK4VPTVN1PROD with NOTICES

14814 Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices 

Survey/WEB22EJ4HRZLW9. (FDA has 

verified the Web site address, but we are 

not responsible for any subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.) 

Seats are limited and conference 

space will be filled in the order in 

which registrations are received. Onsite 

registration will be available to the 

extent that space is available on the day 

of the conference. 

Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Bldg. 1. 

Dated: March 8, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6038 Filed 3–12–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0212] 

Tobacco Product Analysis; Scientific 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

The Food and Drug Administration 

(FDA), Center for Tobacco Products is 

announcing a scientific workshop to 

solicit feedback on analysis of tobacco 

products. The analyses of tobacco 

products often involve tobacco reference 

products, which are used primarily as 

controls to ensure that the results of the 

analyses are reliable and accurate. This 

scientific workshop will focus on 

understanding how tobacco reference 

products are used and the testing 

methods used to analyze tobacco 

products. FDA will invite speakers to 

address scientific and technical matters 

relating to the testing of tobacco 

reference products and the analytical 

methods used to measure constituent 

levels in tobacco products and smoke. 

FDA is also opening a public docket to 

receive comments on these topics. 

DATES: Dates and Time: The public 

workshop will be held on April 11, 

2012, from 8:30 a.m. to 5:30 p.m., and 

on April 12, 2012, from 8:30 a.m. to 4 

p.m. Individuals who wish to attend the 

public workshop must register by close 

of business on March 30, 2012. Submit 

either electronic or written comments to 

the docket by May 11, 2012. 

Location: The public workshop will 

be held at 9200 Corporate Blvd., 

Rockville, MD 20850, 1–877–287–1373. 

Contact Person: Anuja Patel, Center 

for Tobacco Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD, 20850, 1–877–287–1373, 

FAX: 240–276–3761, email: 

workshop.CTPOS@fda.hhs.gov. 

Registration to Attend the Workshop 

and Requests for Oral Presentations: If 

you wish to attend the workshop or 

make an oral presentation at the 

workshop, please email your 

registration to 

workshop.CTPOS@fda.hhs.gov by close 

of business on March 30, 2012. Those 

without email access may register by 

contacting Anuja Patel (see Contact 

Person). Please provide contact 

information for each attendee, including 

name, title, affiliation, address, email 

address, and telephone number. 

Registration is free and will be on a firstcome, first-served basis. Early 

registration is recommended because 

seating is limited. FDA may limit the 

number of participants from each 

organization as well as the total number 

of participants based on space 

limitations. Registrants will receive 

confirmation once they have been 

accepted for the workshop. Onsite 

registration on the day of the workshop 

will be based on space availability. If 

registration reaches maximum capacity, 

FDA will post a notice closing 

registration for the workshop at http:// 

www.fda.gov/TobaccoProducts/ 

NewsEvents/ucm238308.htm. 

There will be opportunities for 

audience participation at this workshop. 

FDA has included topics for comment 

in section II of this document. FDA will 

do its best to accommodate requests to 

speak during the workshop sessions, 

although questions from the audience 

may be limited. In addition, we strongly 

encourage submitting comments to the 

docket (see Comments). 

If you need special accommodations 

because of disability, please contact 

Anuja Patel (see Contact Person) at least 

7 days before the workshop. 

Comments: Regardless of attendance 

at the public workshop, interested 

persons may submit either electronic or 

written comments on any of the topics 

for discussion in section II of this 

document by May 11, 2012. Submit 

electronic comments 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. It is only 

necessary to send one set of 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. 

SUPPLEMENTARY INFORMATION: 

I. Background and Workshop Topics 

The purpose of this scientific 

workshop is to obtain information and 

comments from appropriate scientific 

experts on analysis of tobacco products. 

Such experts could include, but are not 

limited to, scientists from academia, 

tobacco product manufacturers, and 

contract testing laboratories. The 

workshop will include scientific experts 

who will present scientific and 

technical information on testing of 

tobacco reference products for different 

types of tobacco products. The types of 

tobacco reference products to be 

discussed include, but are not limited 

to, smoked tobacco products, smokeless 

tobacco products, and other tobacco 

products not classified as either smoked 

or smokeless products. FDA would like 

to discuss how the tobacco reference 

products are used for testing purposes to 

ensure accuracy of analysis of tobacco 

products. Tobacco reference products 

are analyzed alongside test tobacco 

products (i.e., during every step of the 

analysis). Tobacco reference products 

are intended for use during analysis of 

tobacco products and are not intended 

for human consumption. Tobacco 

reference products are finished tobacco 

products and are distinct from internal 

reference standards, which are 

chemicals or mixtures of chemicals. 

Internal reference standards are used 

during only certain steps of the analysis 

of test tobacco products (e.g., when 

running samples). 

The scientific workshop will include 

discussion of analytical methods for 

measuring certain constituents in 

tobacco products and smoke. The 

aspects of analytical methods that will 

be discussed include extraction, 

separation, and detection methods. For 

example, FDA would like to get input 

from scientific experts on how tobaccospecific nitrosamines (TSNAs) are 

extracted from smokeless tobacco 

products and cigarette smoke particulate 

matter and what instrumentation (e.g., 

gas chromatography-mass spectrometry) 

is used to measure the levels of TSNAs. 

FDA is interested in receiving 

substantive scientific input at the 

workshop and in the docket. The input 

from the scientific workshop may assist 

us in developing future scientific 

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