Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices 14811 

Application 

No. Drug Applicant Initial approval date 

Do. ................ DURANEST (epinephrine bitartrate; etidocaine hydrochloride) Injection 

1.5%.

......do .............................................. Do. 

Do. ................ DURANEST (epinephrine; etidocaine hydrochloride) Injection 0.5% ...... ......do .............................................. Do. 

Do. ................ DURANEST (etidocaine hydrochloride) Injection 0.5% ........................... ......do .............................................. Do. 

Do. ................ DURANEST (etidocaine hydrochloride) Injection 1% .............................. ......do .............................................. Do. 

NDA 21–384 DURANEST (epinephrine bitartrate; etidocaine hydrochloride) Injection 

1.5%.

DENTSPLY Pharmaceutical ........... Do. 

The drug products listed in the table 

in this document are currently listed in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. Lachman 

Consultant Services, Inc. submitted a 

citizen petition dated September 25, 

2008 (Docket No. FDA–2008–P–0527), 

under 21 CFR 10.30, requesting that the 

Agency determine whether DURANEST 

(etidocaine hydrochloride) Injection, 

0.5% and 1%, were withdrawn from 

sale for reasons of safety or 

effectiveness. Although the citizen 

petition did not request a determination 

for the other DURANEST drug products 

listed in the table in this document, 

those drug products have also been 

discontinued. On our own initiative, we 

have also determined whether those 

products were withdrawn for safety or 

effectiveness reasons. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that the DURANEST drug 

products listed in the table in this 

document were not withdrawn for 

reasons of safety or effectiveness. The 

petitioner has identified no data or other 

information suggesting that the 

DURANEST drug products were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of the 

DURANEST drug products from sale. 

We have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that the products were not 

withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

Agency will continue to list the 

DURANEST drug products listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to any of the DURANEST drug products 

listed in the table in this document may 

be approved by the Agency as long as 

they meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for these drug products should be 

revised to meet current standards, the 

Agency will advise ANDA applicants to 

submit such labeling. 

Dated: March 8, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6039 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–D–0022] 

Draft Guidance for Industry on Directto-Consumer Television 

Advertisements—the Food and Drug 

Administration Amendments Act of 

2007 Direct-to-Consumer Television Ad 

Pre-Dissemination Review Program; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Direct-to-Consumer 

Television Advertisements—FDAAA 

DTC Television Ad Pre-Dissemination 

Review Program.’’ This draft guidance is 

intended to assist sponsors of human 

prescription drug products, including 

biological drug products, who are 

subject to the pre-dissemination review 

of television advertisements (TV ads) 

provision of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act). (The term 

‘‘pre-dissemination review’’ is used 

throughout the guidance to refer to 

review under the FD&C Act, which is 

entitled ‘‘Prereview of Television 

Advertisements.’’) The draft guidance 

describes which TV ads FDA intends to 

make subject to this provision, explains 

how FDA will notify sponsors that an ad 

is subject to review under this 

provision, and describes the general and 

center-specific procedures sponsors 

should follow to submit their TV ads to 

FDA for pre-dissemination review in 

compliance with the FD&C Act. These 

proposed TV ads will be subject to a 45- 

calendar day review clock by FDA. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 14, 2012. 

Submit written comments on the 

proposed collection of information by 

May 14, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002, or to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit electronic comments on the 

draft guidance 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: 

Regarding human prescription drugs: 

Marci Kiester, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 3368, 

Silver Spring, MD 20993–0002, 301– 

796–1200. 

Regarding prescription human 

biological products: Stephen Ripley, 

Center for Biologics Evaluation and 

Research (HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

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14812 Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices 

suite 200N, Rockville, MD 20852, 301– 

827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Direct-to-Consumer Television 

Advertisements—FDAAA DTC 

Television Ad Pre-Dissemination 

Review Program.’’ The Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) added new section 503B 

to the FD&C Act, which gives FDA the 

authority to ‘‘* * * require the 

submission of any television 

advertisement for a drug * * * not later 

than 45 days before dissemination of the 

television advertisement.’’ In 

conducting a review of a TV ad under 

this section, FDA may make 

recommendations with respect to 

information included in the label of the 

drug on: 

• Changes that are necessary to 

protect the consumer good and wellbeing, or that are consistent with 

prescribing information for the product 

under review; and 

• Statements for inclusion in the 

advertisement to address the specific 

efficacy of the drug as it relates to 

specific population groups, including 

elderly populations, children, and racial 

and ethnic minorities, if appropriate 

and if such information exists. (21 

U.S.C. 353b(b)(1) and (b)(2)). 

FDA is issuing this guidance to 

communicate the categories of TV ads it 

generally intends to require sponsors to 

submit under this provision, to explain 

how it will notify sponsors that FDA is 

requiring review under section 503B of 

the FD&C Act for ads for a particular 

drug or group of drugs, and to provide 

sponsors with recommendations for the 

information they need to properly 

submit these ads to the Agency for predissemination review. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on which TV ads it intends to require 

be submitted under section 503B of the 

FD&C Act and on the submission 

process for these ads. 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. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501– 

3520), Federal Agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information that they conduct or 

sponsor. ‘‘Collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c), and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register for each proposed 

collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing this 

notice of the proposed collection of 

information set forth in this document. 

With respect to the collection of 

information associated with this draft 

guidance, FDA invites comments on 

these topics: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

FDA estimates the burden of this 

collection of information as follows: 

Based on the number of TV ads 

produced annually by sponsors of 

human prescription drug and biological 

products, we estimate that we will 

receive approximately 80 ads per year 

for pre-dissemination review from 

approximately 30 sponsors for the 

Center for Drug Evaluation and Research 

(CDER) and 2 ads from 2 sponsors for 

CBER. FDA professionals familiar with 

TV ads and the recommendations in the 

draft guidance estimate that it should 

take a sponsor approximately 25 hours 

to prepare and send the predissemination review package and 

documentation. This burden estimate 

includes all of the information specified 

for CDER and CBER in the draft 

guidance section entitled ‘‘Contents of a 

Complete Pre-Dissemination Review 

Package’’ and in the Appendix entitled 

‘‘Center-Specific Submission 

Procedures.’’ 

FDA cannot provide final comments 

on the acceptability of a TV ad without 

reviewing a final recorded version in its 

entirety. However, some sponsors may 

wish to receive comments from the 

Agency before producing a final 

recorded version. Once the final 

recorded version is produced, it should 

be submitted to the Agency for predissemination review. In this document, 

we have included in the table 1 burden 

estimate for section 503B of the FD&C 

Act the time necessary to prepare the 

final ad for submission. 

If FDA receives an incomplete 

submission package from a sponsor, we 

will inform that sponsor and request a 

submission package that contains the 

missing materials. We estimate that we 

will request a package containing 

missing materials a total of 6 times from 

6 different sponsors annually, and that 

it will take each sponsor 5 hours to 

prepare the resubmission with the 

missing materials. This resubmission 

with missing materials is included in 

table 1 of this document. 

There is a 45-day review clock for TV 

ads submitted under section 503B. 

Under this review clock, FDA must 

notify the sponsor if the Agency is not 

able to provide comments within a 45- 

day timeframe. When a sponsor is 

notified by FDA that the Agency is not 

able to provide comments, the sponsor 

should inform FDA whether it will 

disseminate the TV ad without waiting 

for FDA comments, or wait for the 

Agency’s comments before 

disseminating the ad. We anticipate that 

we will be able to review and comment 

on all TV ads submitted to the Agency 

within the 45-day review clock 

timeframe, but for the purposes of this 

collection of information, we are 

estimating that the Agency will be 

unable to provide comments within the 

45-day timeframe to one sponsor for one 

TV ad per year. We estimate that the 

time needed for a sponsor to prepare a 

letter informing FDA of its decision to 

disseminate or not to disseminate the 

TV ad will be 1 hour. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

In the draft guidance, the Agency has 

noted that sponsors subject to the 

section 503B pre-dissemination review 

provision may revise their TV ads after 

receiving comments from the Agency 

but before disseminating the ads, and 

may wish to request additional 

comments under the voluntary 

submission process delineated in 

§ 202.1(j)(4) (21 CFR 202.1(j)(4)). The 

collections of information in 

§ 202.1(j)(4) have been approved under 

OMB control number 0910–0686. For 

pre-dissemination review packages for 

biological drug products under the 

purview of CBER, the Agency is 

requesting a copy of the most current 

version of Form FDA 2253 to 

mstockstill on DSK4VPTVN1PROD with NOTICES

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