20680 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 

medical need. Mostly, the Agency 

expects that information to support a 

designation request will have been 

gathered under existing provisions of 

the FD&C Act, the PHS Act, or the 

implementing regulations. If such 

information has already been submitted 

to the Agency, the information may be 

summarized in the fast track designation 

request. The guidance recommends that 

a designation request include, where 

applicable, additional information not 

specified elsewhere by statute or 

regulation. For example, additional 

information may be needed to show that 

a product has the potential to address an 

unmet medical need where an approved 

therapy exists for the serious or lifethreatening condition to be treated. 

Such information may include clinical 

data, published reports, summaries of 

data and reports, and a list of references. 

The amount of information and 

discussion in a designation request need 

not be voluminous, but it should be 

sufficient to permit a reviewer to assess 

whether the criteria for fast track 

designation have been met. 

After the Agency makes a fast track 

designation, a sponsor or applicant may 

submit a premeeting package which 

may include additional information 

supporting a request to participate in 

certain fast track programs. The 

premeeting package serves as 

background information for the meeting 

and should support the intended 

objectives of the meeting. As with the 

request for fast track designation, the 

Agency expects that most sponsors or 

applicants will have gathered such 

information to meet existing 

requirements under the FD&C Act, the 

PHS Act, or implementing regulations. 

These may include descriptions of 

clinical safety and efficacy trials not 

conducted under an investigational new 

drug application (IND) (i.e., foreign 

studies), and information to support a 

request for accelerated approval. If such 

information has already been submitted 

to FDA, the information may be 

summarized in the premeeting package. 

Consequently, FDA anticipates that the 

additional collection of information 

attributed solely to the guidance will be 

minimal. 

Under section 506(c) of the FD&C Act, 

a sponsor must submit sufficient 

clinical data for the Agency to 

determine, after preliminary evaluation, 

that a fast track product may be 

effective. Section 506(c) also requires 

that an applicant provide a schedule for 

the submission of information necessary 

to make the application complete before 

FDA can commence its review. The 

guidance does not provide for any new 

collection of information regarding the 

submission of portions of an application 

that are not required under section 

506(c) of the FD&C Act or any other 

provision of the FD&C Act. All forms 

referred to in the guidance have a 

current OMB approval: FDA Forms 1571 

(OMB control number 0910–0014); 356h 

(OMB control number 0910–0338); and 

3397 (OMB control number 0910–0297). 

Respondents to this information 

collection are sponsors and applicants 

who seek fast track designation under 

section 506 of the FD&C Act. The 

Agency estimates the total annual 

number of respondents submitting 

requests for fast track designation to the 

Center for Biologics Evaluation and 

Research and the Center for Drug 

Evaluation and Research is 

approximately 97, and the number of 

requests received is approximately 118 

annually. FDA estimates that the 

number of hours needed to prepare a 

request for fast track designation is 

approximately 60 hours per request. 

Not all requests for fast track 

designation may meet the statutory 

standard. Of the requests for fast track 

designation made per year, the Agency 

granted 77 from 64 respondents, and for 

each of these granted requests a 

premeeting package was submitted to 

the Agency. FDA estimates that the 

preparation hours are approximately 

100 hours per premeeting package. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Reporting activity Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours 

per response Total hours 

Designation Request ............................................................ 97 1.22 118 60 7,080 

Premeeting Packages .......................................................... 64 1.20 77 100 7,700 

Total .............................................................................. 14,780 

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

Dated: April 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8818 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–2010–N–0627] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Application for 

Food and Drug Administration 

Approval To Market a New Drug 

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 0910–0001. Also 

include the FDA docket number found 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 20681 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

P150–400B, Rockville, MD 20852, 301– 

796–3792, 

Elizabeth.Berbakos@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: 

Application for FDA Approval to 

Market a New Drug—(OMB Control 

Number 0910–0001)—Extension 

Under section 505(a) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 355(a)), a new 

drug may not be commercially marketed 

in the United States, imported, or 

exported from the United States, unless 

an approval of an application filed with 

FDA under section 505(b) or 505(j) of 

the FD&C Act is effective with respect 

to such drug. Under the FD&C Act, it is 

the sponsor’s responsibility to provide 

the information needed by FDA to make 

a scientific and technical determination 

whether the product is safe and effective 

for use. 

This information collection approval 

request is for all information 

requirements imposed on sponsors by 

the regulations under part 314 (21 CFR 

part 314), who apply for approval of a 

new drug application (NDA) or 

abbreviated new drug application 

(ANDA) in order to market or to 

continue to market a drug. 

Section 314.50(a) requires that an 

application form (Form FDA 356h) be 

submitted that includes introductory 

information about the drug as well as a 

checklist of enclosures. 

Section 314.50(b) requires that an 

index be submitted with the archival 

copy of the application and that it 

reference certain sections of the 

application. 

Section 314.50(c) requires that a 

summary of the application be 

submitted that presents a good general 

synopsis of all the technical sections 

and other information in the 

application. 

Section 314.50(d) requires that the 

NDA contain the following technical 

sections about the new drug: Chemistry, 

manufacturing, and controls; 

nonclinical pharmacology and 

toxicology; human pharmacokinetics 

and bioavailability; microbiology; 

clinical data; statistical; and pediatric 

use sections. 

Section 314.50(e) requires the 

applicant to submit samples of the drug 

if requested by FDA. In addition, the 

archival copy of the application must 

include copies of the label and all 

labeling for the drug. 

Section 314.50(f) requires that case 

report forms and tabulations be 

submitted with the archival copy. 

Section 314.50(h) requires that patent 

information, as described under 

§ 314.53, be submitted with the 

application. (The burden hours for 

§ 314.50(h) are already approved by 

OMB under OMB control number 0910– 

0513 and are not included in the burden 

estimates in table 1 of this document.) 

Section 314.50(i) requires that patent 

certification information be submitted 

in section 505(b)(2) applications for 

patents claiming the drug, drug product, 

or method of use. 

Section 314.50(j) requires that 

applicants that request a period of 

marketing exclusivity submit certain 

information with the application. 

Section 314.50(l) requires that an 

archival, review, and field copy of the 

application be submitted. 

Section 314.52 requires that any 

notice of certification of invalidity or 

noninfringement of a patent to each 

patent owner and the NDA holder be 

sent by a section 505(b)(2) applicant that 

relies on a listed drug. A 505(b)(2) 

applicant is required to amend its 

application at the time notice is 

provided to include a statement 

certifying that the required notice has 

been provided. A 505(b)(2) applicant 

also is required to amend its application 

to document receipt of the required 

notice. 

Section 314.54 sets forth the content 

requirements for applications filed 

under section 505(b)(2) of the FD&C Act. 

(The information collection burden 

estimate for 505(b)(2) applications is 

included in table 1 of this document 

under the estimates for § 314.50 (a), (b), 

(c), (d), (e), (f), and (k)). 

Section 314.60 sets forth reporting 

requirements for sponsors who amend 

an unapproved application. 

Section 314.65 states that the sponsor 

must notify FDA when withdrawing an 

unapproved application. 

Sections 314.70 and 314.71 require 

that supplements be submitted to FDA 

for certain changes to an approved 

application. 

Section 314.72 requires sponsors to 

report to FDA any transfer of ownership 

of an application. 

Section 314.80(c)(1) and (c)(2) sets 

forth requirements for expedited 

adverse drug experience postmarketing 

reports and follow-up reports, as well as 

for periodic adverse drug experience 

postmarketing reports (Form FDA 

3500A). (The burden hours for 

§ 314.80(c)(1) and (c)(2) are already 

approved by OMB under OMB control 

numbers 0910–0230 and 0910–0291 and 

are not included in the burden estimates 

in table 1 of this document.) 

Section 314.80(i) establishes 

recordkeeping requirements for reports 

of postmarketing adverse drug 

experiences. (The burden hours for 

§ 314.80(i) are already approved by 

OMB under OMB control numbers 

0910–0230 and 0910–0291 and are not 

included in the burden estimates in 

table 1 of this document.) 

Section 314.81(b)(1) requires that field 

alert reports be submitted to FDA (Form 

FDA 3331). 

Section 314.81(b)(2) requires that 

annual reports be submitted to FDA 

(Form FDA 2252). 

Section 314.81(b)(3)(i) requires that 

drug advertisements and promotional 

labeling be submitted to FDA (Form 

FDA 2253). 

Section 314.81(b)(3)(iii) sets forth 

reporting requirements for sponsors 

who withdraw an approved drug 

product from sale. (The burden hours 

for § 314.81(b)(3)(iii) are already 

approved by OMB under OMB control 

number 0910–0045 and are not included 

in the burden estimates in table 1 of this 

document.) 

Section 314.90 sets forth requirements 

for sponsors who request waivers from 

FDA for compliance with §§ 314.50 

through 314.81. (The information 

collection burden estimate for NDA 

waiver requests is included in table 1 of 

this document under estimates for 

§§ 314.50, 314.60, 314.70, and 314.71.) 

Section 314.93 sets forth requirements 

for submitting a suitability petition in 

accordance with § 10.20 (21 CFR 10.20) 

and § 10.30. (The burden hours for 

§ 314.93 are already approved by OMB 

under 0910–0183 and are not included 

in the burden estimates in table 1 of this 

document.) 

Section 314.94(a) and (d) requires that 

an ANDA contain the following 

information: Application form; table of 

contents; basis for ANDA submission; 

conditions of use; active ingredients; 

route of administration, dosage form, 

and strength; bioequivalence; labeling; 

chemistry, manufacturing, and controls; 

samples; patent certification. 

Section 314.95 requires that any 

notice of certification of invalidity or 

noninfringement of a patent to each 

patent owner and the NDA holder be 

sent by ANDA applicants. 

Section 314.96 sets forth requirements 

for amendments to an unapproved 

ANDA. 

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20682 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 

Section 314.97 sets forth requirements 

for submitting supplements to an 

approved ANDA for changes that 

require FDA approval. 

Section 314.98(a) sets forth 

postmarketing adverse drug experience 

reporting and recordkeeping 

requirements for ANDAs. (The burden 

hours for § 314.98(a) are already 

approved by OMB under OMB control 

numbers 0910–0230 and 0910–0291 and 

are not included in the burden estimates 

in table 1 of this document.) 

Section 314.98(c) requires other 

postmarketing reports for ANDAs: Field 

alert reports (Form FDA 3331), annual 

reports (Form FDA 2252), and 

advertisements and promotional 

labeling (Form FDA 2253). (The 

information collection burden estimate 

for field alert reports is included in table 

1 of this document under § 314.81(b)(1); 

the estimate for annual reports is 

included under § 314.81(b)(2); the 

estimate for advertisements and 

promotional labeling is included under 

§ 314.81(b)(3)(i).) 

Section 314.99(a) requires that 

sponsors comply with certain reporting 

requirements for withdrawing an 

unapproved ANDA and for a change in 

ownership of an ANDA. 

Section 314.99(b) sets forth 

requirements for sponsors who request 

waivers from FDA for compliance with 

§§ 314.92 through 314.99. (The 

information collection burden estimate 

for ANDA waiver requests is included 

in table 1 of this document under 

estimates for § 314.94(a) and (d) and 

§§ 314.96 and 314.97.) 

Section 314.101(a) states that if FDA 

refuses to file an application, the 

applicant may request an informal 

conference with FDA and request that 

the application be filed over protest. 

Section 314.107(c) requires notice to 

FDA by the first applicant to submit a 

substantially complete ANDA 

containing a certification that a relevant 

patent is invalid, unenforceable, or will 

not be infringed of the date of first 

commercial marketing. 

Section 314.107(e) requires that an 

applicant submit a copy of the entry of 

the order or judgment to FDA within 10 

working days of a final judgment. 

Section 314.107(f) requires that 

ANDA or section 505(b)(2) applicants 

notify FDA immediately of the filing of 

any legal action filed within 45 days of 

receipt of the notice of certification. A 

patent owner may also notify FDA of the 

filing of any legal action for patent 

infringement. If the patent owner or 

approved application holder who is an 

exclusive patent licensee waives its 

opportunity to file a legal action for 

patent infringement within the 45-day 

period, the patent owner or approved 

application holder must submit to FDA 

a waiver in the specified format. 

Section 314.110(b)(3) states that, after 

receipt of an FDA complete response 

letter, an applicant may request an 

opportunity for a hearing on the 

question of whether there are grounds 

for denying approval of the application. 

(The burden hours for § 314.110(b)(3) 

are included under parts 10 through 16 

(21 CFR parts 10 and 16) hearing 

regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.110(c) states that, after 

receipt of a complete response letter, an 

applicant may notify FDA that it agrees 

to an extension of the review period so 

that it can determine whether to 

respond further. 

Section 314.122(a) requires that an 

ANDA or a suitability petition that 

relies on a listed drug that has been 

voluntarily withdrawn from sale must 

be accompanied by a petition seeking a 

determination whether the drug was 

withdrawn for safety or effectiveness 

reasons. (The burden hours for 

§ 314.122(a) are already approved by 

OMB under OMB control number 0910– 

0183 and are not included in the burden 

estimates in table 1 of this document.) 

Section 314.122(d) sets forth 

requirements for relisting petitions for 

unlisted discontinued products. (The 

burden hours for § 314.122(d) are 

already approved by OMB under OMB 

control number 0910–0183 and are not 

included in the burden estimates in 

table 1 of this document.) 

Section 314.126(c) sets forth 

requirements for a petition to waive 

criteria for adequate and well-controlled 

studies. (The burden hours for 

§ 314.126(c) are already approved by 

OMB under 0910–0183 and are not 

included in the burden estimates in 

table 1 of this document.) 

Section 314.151(a) and (b) set forth 

requirements for the withdrawal of 

approval of an ANDA and the 

applicant’s opportunity for a hearing 

and submission of comments. (The 

burden hours for § 314.151(a) and (b) are 

included under parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.151(c) sets forth the 

requirements for withdrawal of approval 

of an ANDA and the applicant’s 

opportunity to submit written objections 

and participate in a limited oral hearing. 

(The burden hours for § 314.151(c) are 

included under parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.153(b) sets forth the 

requirements for suspension of an 

ANDA when the listed drug is 

voluntarily withdrawn for safety and 

effectiveness reasons, and the 

applicant’s opportunity to present 

comments and participate in a limited 

oral hearing. (The burden hours for 

§ 314.152(b) are included under parts 10 

through 16 hearing regulations, in 

accordance with § 314.201, and are not 

included in the burden estimates in 

table 1 of this document.) 

Section 314.161(b) and (e) sets forth 

the requirements for submitting a 

petition to determine whether a listed 

drug was voluntarily withdrawn from 

sale for safety or effectiveness reasons. 

(The burden hours for § 314.161(b) and 

(e) are already approved by OMB under 

OMB control number 0910–0183 and 

are not included in the burden estimates 

in table 1 of this document.) 

Section 314.200(c), (d), and (e) 

requires that applicants or others subject 

to a notice of opportunity for a hearing 

who wish to participate in a hearing file 

a written notice of participation and 

request for a hearing as well as the 

studies, data, and so forth, relied on. 

Other interested persons may also 

submit comments on the notice. This 

section also sets forth the content and 

format requirements for the applicants’ 

submission in response to notice of 

opportunity for hearing. (The burden 

hours for § 314.200(c), (d), and (e) are 

included under parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.200(f) states that 

participants in a hearing may make a 

motion to the presiding officer for the 

inclusion of certain issues in the 

hearing. (The burden hours for 

§ 314.200(f) are included under parts 10 

through 16 hearing regulations, in 

accordance with § 314.201, and are not 

included in the burden estimates in 

table 1 of this document.) 

Section 314.200(g) states that a person 

who responds to a proposed order from 

FDA denying a request for a hearing 

provide sufficient data, information, and 

analysis to demonstrate that there is a 

genuine and substantial issue of fact 

which justifies a hearing. (The burden 

hours for § 314.200(g) are included 

under parts 10 through 16 hearing 

regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 20683 

Section 314.420 states that an 

applicant may submit to FDA a drug 

master file in support of an application, 

in accordance with certain content and 

format requirements. 

Section 314.430 states that data and 

information in an application are 

disclosable under certain conditions, 

unless the applicant shows that 

extraordinary circumstances exist. (The 

burden hours for § 314.430 are included 

under parts 10 through 16 hearing 

regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.530(c) and (e) states that 

if FDA withdraws approval of a drug 

approved under the accelerated 

approval procedures, the applicant has 

the opportunity to request a hearing and 

submit data and information. (The 

burden hours for § 314.530(c) and (e) are 

included under parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.530(f) requires that an 

applicant first submit a petition for stay 

of action before requesting an order 

from a court for a stay of action pending 

review. (The burden hours for 

§ 314.530(f) are already approved by 

OMB under 0910–0194 and are not 

included in the burden estimates in 

table 1 of this document.) 

Section 314.610(b)(1) requires that 

applicants include a plan or approach to 

postmarketing study commitments in 

applications for approval of new drugs 

when human efficacy studies are not 

ethical or feasible, and provide status 

reports of postmarketing study 

commitments. (The information 

collection burden estimate for 

§ 314.610(b)(1) is included in table 1 of 

this document under the estimates for 

§§ 314.50 (a), (b), (c), (d), (e), (f), and (k) 

and 314.81(b)(2)). 

Section 314.610(b)(3) requires that 

applicants propose labeling to be 

provided to patient recipients in 

applications for approval of new drugs 

when human efficacy studies are not 

ethical or feasible. (The information 

collection burden estimate for 

§ 314.610(b)(3) is included in table 1 of 

this document under the estimates for 

§ 314.50(e)). 

Section 314.630 requires that 

applicants provide postmarketing safety 

reporting for applications for approval 

of new drugs when human efficacy 

studies are not ethical or feasible. (The 

burden hours for § 314.630 are already 

approved by OMB under OMB control 

numbers 0910–0230 and 0910–0291 and 

are not included in the burden estimates 

in table 1 of this document.) 

Section 314.640 requires that 

applicants provide promotional 

materials for applications for approval 

of new drugs when human efficacy 

studies are not ethical or feasible. (The 

information collection burden estimate 

for § 314.640 is included in table 1 of 

this document under the estimates for 

§ 314.81(b)(3)(i)). 

Respondents to this collection of 

information are all persons who submit 

an application or abbreviated 

application or an amendment or 

supplement to FDA under part 314 to 

obtain approval of a new drug, and any 

person who owns an approved 

application or abbreviated application. 

In the Federal Register of December 

17, 2010 (75 FR 79001), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section; 

[Form Number] 

Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

314.50(a), (b), (c), (d), (e), (f), and (k) .............................. 92 1 .36 126 1,917 241,542 

314.50(i) and 314.94(a)(12) ............................................... 96 9 .61 923 2 1,846 

314.50(j) ............................................................................. 71 4 .02 286 2 572 

314.52 and 314.95 ............................................................. 71 3 .66 260 16 4,160 

314.60 ................................................................................ 349 21 .67 7,564 80 605,120 

314.65 ................................................................................ 10 1 .20 12 2 24 

314.70 and 314.71 ............................................................. 620 4 .91 3,050 150 457,500 

314.72 ................................................................................ 104 2 .98 310 2 620 

314.81(b)(1) [3331] ............................................................ 147 2 .57 378 8 3,024 

314.81(b)(2) [2252] ............................................................ 656 13 .84 9,084 40 363,360 

314.81(b)(3)(i) [2253] ......................................................... 490 61 .48 30,130 2 60,260 

314.94(a)(1)–(11) and (d) .................................................. 110 7 .83 862 480 413,760 

314.96 ................................................................................ 292 35 .82 10,461 80 836,880 

314.97 ................................................................................ 197 26 .23 5,169 80 413,520 

314.99(a) ............................................................................ 53 2 .30 122 2 244 

314.101(a) .......................................................................... 1 1 1 .50 .50 

314.107(c)– ........................................................................ 56 4 .1 230 .50 115 

314.107(e)– ........................................................................ 25 3 .92 98 .50 49 

314.107(f)– ......................................................................... 56 4 .1 230 .50 115 

314.110(c) .......................................................................... 11 1 .36 15 .50 7.5 

314.420 .............................................................................. 524 1 .98 1,038 61 63,318 

Total ............................................................................ ........................ .......................... ........................ ........................ 3,466,037 

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

mstockstill on DSKH9S0YB1PROD with NOTICES

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 

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