20684 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 

Dated: April 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8907 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0049] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Presubmission 

Conferences, New Animal Drug 

Applications and Supporting 

Regulations, and Food and Drug 

Administration Form 356V 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 13, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0032. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

Juanmanuel.vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Presubmission Conferences, New 

Animal Drug Applications and 

Supporting Regulations, and FDA Form 

356V—(OMB Control Number 0910– 

0032)—Extension 

Under section 512(b)(3) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 360b(b)(3)), any 

person intending to file a new animal 

drug application (NADA) or 

supplemental NADA or a request for an 

investigational exemption under section 

512(j) is entitled to one or more 

conferences with FDA to reach an 

agreement acceptable to FDA 

establishing a submission or 

investigational requirement. FDA and 

industry have found that these meetings 

have increased the efficiency of the drug 

development and drug review 

processes. 

Section 514.5 (21 CFR 514.5) 

describes the procedures for requesting, 

conducting, and documenting 

presubmission conferences. Section 

514.5(b) describes the information that 

must be included in a letter submitted 

by a potential applicant requesting a 

presubmission conference, including a 

proposed agenda and a list of expected 

participants. Section 514.5(d) describes 

the information that must be provided 

by the potential applicant to FDA at 

least 30 days prior to a presubmission 

conference. This information includes a 

detailed agenda, a copy of any materials 

to be presented at the conference, a list 

of proposed indications and, if 

available, a copy of the proposed 

labeling for the product under 

consideration, and a copy of any 

background material that provides 

scientific rationale to support the 

potential applicant’s position on issues 

listed in the agenda for the conference. 

Section 514.5(f) discusses the content of 

the memorandum of conference that 

will be prepared by FDA and gives the 

potential applicant an opportunity to 

seek correction to or clarification of the 

memorandum. 

Under section 512(b)(1) of the FD&C 

Act, any person may file an NADA 

seeking approval to legally market a 

new animal drug. Section 512(b)(1) of 

the FD&C Act sets forth the information 

required to be submitted in an NADA. 

FDA allows applicants to submit a 

complete NADA or to submit 

information in support of an NADA for 

phased review followed by submission 

of an Administrative NADA when FDA 

finds all the applicable technical 

sections are complete. 

The regulations under 21 CFR 514.1 

interpret section 512(b)(1) of the FD&C 

Act and further describe the information 

that must be submitted as part of an 

NADA and the manner and form in 

which the NADA must be assembled 

and submitted. The application must 

include safety and effectiveness data, 

proposed labeling, product 

manufacturing information, and where 

necessary, complete information on 

food safety (including microbial food 

safety) and any methods used to 

determine residues of drug chemicals in 

edible tissue from food-producing 

animals. Guidance #152 entitled 

‘‘Evaluating the Safety of Antimicrobial 

New Animal Drugs With Regard to 

Their Microbiological Effects on 

Bacteria of Human Health Concern’’ 

outlines a risk assessment approach for 

evaluating the microbial food safety of 

antimicrobial new animal drugs. FDA 

requests that an applicant accompany 

NADAs, supplemental NADAs, and 

requests for phased review of data to 

support NADAs, with the FDA Form 

356V to ensure efficient and accurate 

processing of information to support 

new animal drug approval. 

In the Federal Register of February 8, 

2011 (76 FR 6798), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section/FDA Form No. Number of 

respondents 4

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in Hours) 

Total hours 

514.5(b), (d) and (f) ......................................................... 154 .6 92 .4 50 4,620 

514.1 and 514.6 ............................................................... 154 .1 15 .4 212 3,265 

514.4 2 .............................................................................. 154 0 0 0 0 

514.8(b) ............................................................................ 154 2 .84 437 .36 35 15,308 

514.8(c)(1) ........................................................................ 154 .1 15 .4 71 1,093 

514.8(c)(2) and (c)(3) ....................................................... 154 .7 107 .8 20 2,156 

514.11 .............................................................................. 154 .2 30 .8 1 31 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 20685 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR Section/FDA Form No. Number of 

respondents 4

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in Hours) 

Total hours 

558.5(i) ............................................................................. 154 .01 1 .54 5 8 

514.1(b)(8) and 514.8(c)(1) 3 ........................................... 154 .21 32 .34 90 2,911 

FDA Form 356V ............................................................... 154 5 .1 785 .4 5 3,927 

Total .......................................................................... ........................ .......................... .......................... ........................ 33,319 

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

2Substantial Evidence—Because 21 CFR 514.4 only defines substantial evidence, it should not be viewed as creating additional collection burden. 3 NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as 

part of the overall preapproval safety evaluation. 4Based on the number of sponsors subject to animal drug user fees, FDA estimates that there was an average of 154 annual respondents 

during the 5 fiscal years, from October 1, 2005, through September 30, 2010, on which these estimates were made. We use this estimate consistently throughout the table and calculate the ‘‘annual frequency per respondent’’ by dividing the total annual responses by the number of 

respondents. 

Dated: April 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8906 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–P–0485] 

Determination That NOVANTRONE 

(Mitoxantrone Hydrochloride) Injection, 

Equivalent to 25 Milligrams Base/12.5 

Milliliter and Equivalent to 30 

Milligrams Base/15 Milliliter, Was Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that NOVANTRONE (mitoxantrone 

hydrochloride) Injection, equivalent to 

(EQ) 25 milligrams (mg) base/12.5 

milliliters (mL) and EQ 30 mg base/15 

mL, was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of abbreviated new drug applications 

(ANDAs) that refer to this drug product, 

and it will allow FDA to continue to 

approve ANDAs that refer to the 

product as long as they meet relevant 

legal and regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Bressler, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6302, 

Silver Spring, MD 20993–0002, 301– 

796–4288. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). The only clinical data required 

in an ANDA are data to show that the 

drug that is the subject of the ANDA is 

bioequivalent to the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

NOVANTRONE (mitoxantrone 

hydrochloride) Injection, EQ 25 mg 

base/12.5 mL and EQ 30 mg base/15 mL, 

is the subject of NDA 19–297, held by 

EMD Serono, and initially approved on 

December 23, 1987. NOVANTRONE is 

indicated for reducing neurologic 

disability and/or the frequency of 

clinical relapses in patients with 

secondary (chronic) progressive, 

progressive relapsing, or worsening 

relapsing-remitting multiple sclerosis 

(i.e., patients whose neurologic status is 

significantly abnormal between 

relapses). NOVANTRONE 

(mitoxantrone hydrochloride) Injection, 

EQ 25 mg base/12.5 mL and EQ 30 mg 

base/15 mL, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. There are 

approved ANDAs for NOVANTRONE 

(mitoxantrone hydrochloride) Injection, 

EQ 25 mg base/12.5 mL and EQ 30 mg 

base/15 mL; these ANDAs are listed in 

the Orange Book. 

Apotex, Inc., submitted a citizen 

petition dated September 3, 2008 

(Docket No. FDA–2008–P–0485), under 

21 CFR 10.30, requesting that the 

Agency determine whether 

NOVANTRONE (mitoxantrone 

hydrochloride) Injection, 25 mg/12.5 mL 

and 30 mg/15 mL, was withdrawn from 

sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records, FDA has 

determined under § 314.161 that 

NOVANTRONE (mitoxantrone 

hydrochloride) Injection, EQ 25 mg 

base/12.5 mL and EQ 30 mg base/15 mL, 

was not withdrawn for reasons of safety 

or effectiveness. The petitioner has 

identified no data or other information 

suggesting that NOVANTRONE 

mstockstill on DSKH9S0YB1PROD with NOTICES