74728 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Notices 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

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. 

Requirements for Submission of In 

Vivo Bioequivalence Data—21 CFR 

parts 314 and 320. 

OMB Control Number 0910–0630— 

Extension 

In the Federal Register of January 16, 

2009 (74 FR 2849), the Agency 

published a final rule revising FDA 

regulations to require applicants to 

submit data on all bioequivalence (BE) 

studies, including studies that do not 

meet passing bioequivalence criteria, 

which are performed on a drug product 

formulation submitted for approval 

under an abbreviated new drug 

application (ANDA), or in an 

amendment or supplement to an ANDA 

that contains BE studies. In the final 

rule, FDA amended 314.94(a)(7)(i), 

314.96(a)(1), 320.21(b)(1), and 314.97 

(21 CFR 314.94(a)(7)(i), 314.96(a)(1), 

320.21(b)(1), and 314.97) to require an 

ANDA applicant to submit information 

from all BE studies, both passing and 

nonpassing, conducted by the applicant 

on the same drug product formulation 

as that submitted for approval under an 

ANDA, amendment, or supplement. 

In table 1, FDA has estimated the 

reporting burden associated with each 

section of this requirement. FDA 

believes that the majority of additional 

BE studies will be reported in ANDAs 

(submitted under 314.94), rather than 

supplements (reported in 314.97) 

because it is unlikely than an ANDA 

holder will conduct BE studies with a 

drug after the drug has been approved. 

With respect to the reporting of 

additional BE studies in amendments 

(submitted under 314.96), this should 

also account for a small number of 

reports because most BE studies will be 

conducted on a drug prior to the 

submission of the ANDA and will be 

reported in the ANDA itself. 

FDA estimates applicants will require 

approximately 120 hours of staff time to 

prepare and submit each additional 

complete BE study report and 

approximately 60 hours of staff time for 

each additional BE summary report. The 

Agency believes that a complete report 

will be required approximately 20 

percent of the time, while a summary 

will suffice approximately 80 percent of 

the time. Based on a weighted-average 

calculation using the information 

presented previously in this document, 

the submission of each additional BE 

study is expected to take 72 hours of 

staff time ([120 × 0.2] + [60 × 0.8]). 

In the Federal Register of June 26, 

2014 (79 FR 36320), 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 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

314.94(a)(7) ......................................................................... 84 1 84 72 6,048 

314.96(a)(1) ......................................................................... 1 1 1 72 72 

314.97 .................................................................................. 1 1 1 72 72 

Total .............................................................................. ........................ ........................ ........................ ........................ 6,192 

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

Dated: December 10, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29425 Filed 12–15–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1409] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Records and 

Reports Concerning Experiences With 

Approved New Animal Drugs: Adverse 

Event Reports 

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 January 15, 

2015. 

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 emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0284. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Road; COLE–14526, Silver 

Spring, MD 20993–0002 PRAStaff@

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. 

Records and Reports Concerning 

Experiences With Approved New 

Animal Drugs: Adverse Event Reports 

on Paper Forms FDA 1932, 1932a, and 

2301—21 CFR 514.80; OMB Control 

Number 0910–0284—Extension 

Section 512(l) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360b(l) and 514.80 (21 CFR 

514.80) of FDA regulations require 

applicants of approved new animal drug 

applications (NADAs) and abbreviated 

new animal drug applications 

(ANADAs) to report adverse drug 

experiences and product/manufacturing 

defects (see 514.80)(b)). Additionally, 

section 571(e)(3) of the FD&C Act (21 

U.S.C. 360ccc(e)(3)) requires that 

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Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Notices 74729 

applicants for conditional approval of 

new animal drugs (CNADAs) maintain 

adequate reports and records of adverse 

drug experiences and product/

manufacturing defects as applicable 

under section 512(l) of the FD&C Act. 

The continuous monitoring of 

approved NADAs, ANADAs, and 

CNADAs affords the primary means by 

which FDA obtains information 

regarding potential problems with the 

safety and efficacy of marketed 

approved new animal drugs as well as 

potential product/manufacturing 

problems. Post-approval marketing 

surveillance is important because data 

previously submitted to FDA may not be 

adequate as animal drug effects can 

change over time and less apparent 

effects may take years to manifest. 

Under 514.80(d), an applicant must 

report adverse drug experiences and 

product/manufacturing defects on Form 

FDA 1932, ‘‘Veterinary Adverse Drug 

Reaction, Lack of Effectiveness, Product 

Defect Report.’’ Periodic drug 

experience reports and special drug 

experience reports must be 

accompanied by a completed Form FDA 

2301, ‘‘Transmittal of Periodic Reports 

and Promotional Material for New 

Animal Drugs,’’ (see 514.80). Form FDA 

1932a, ‘‘Veterinary Adverse Drug 

Reaction, Lack of Effectiveness or 

Product Defect Report,’’ allows for 

voluntary reporting of adverse drug 

experiences or product/manufacturing 

defects. 

In 2010, electronic versions of Forms 

FDA 1932 and 1932a were incorporated 

into the FDA Safety Reporting Portal. 

This electronic system is used for 

collecting, submitting, and processing 

adverse event reports and other safety 

information for all FDA regulated 

products. Burden for the electronic 

version of these forms is accounted for 

under OMB control number 0910–0645. 

This approval request accounts for the 

collection of information using existing 

paper Forms FDA 1932, 1932a, and 

2301 and is currently approved under 

OMB control number 0910–0284. FDA 

estimates that, at this time, 

approximately 50 percent of the 

respondents utilize paper forms for 

submitting this information. We expect 

this number to decrease as more 

respondents avail themselves of the 

FDA Safety Reporting Portal. 

In the Federal Register of September 

29, 2014 (79 FR 58355), 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/section of the FD&C act FDA 

form No. 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

514.80(b)(1), 514.80(b)(2)(i) and (ii), 

514.80(b)(3) .......................................... 1932 22 81.05 1,783 1 1,783 

Voluntary reporting FDA Form 1932a for 

the public .............................................. 1932a 197 1 197 1 197 

514.80(b)(4) ............................................. 2301 200 8.11 1,622 16 25,952 

514.80(b)(5)(i) .......................................... 2301 200 0.57 114 2 228 

514.80(b)(5)(ii) ......................................... 2301 200 20.12 4,024 2 8,048 

514.80(b)(5)(iii) ......................................... 2301 190 0.1 20 2 40 

Total Hours ....................................... ........................ ........................ ........................ ........................ ........................ 36,248 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

514.80(e) .............................................................................. 646 7.20 4651 14 65,117 

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

Dated: December 10, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29426 Filed 12–15–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1842] 

Crabmeat—Fresh and Frozen— 

Adulteration With Filth, Involving the 

Presence of Escherichia coli; 

Compliance Policy Guide; Draft 

Guidance for Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a draft 

guidance for FDA staff entitled 

‘‘Compliance Policy Guide Crabmeat— 

Fresh and Frozen—Adulteration with 

Filth, Involving the Presence of 

Escherichia coli.’’ The draft Compliance 

Policy Guide (CPG), when finalized, 

will update the previously issued ‘‘CPG 

Crabmeat—Fresh and Frozen— 

Adulteration with Filth, Involving the 

Presence of the Organism Escherichia 

coli.’’ This revised draft provides 

guidance for FDA staff on the level of 

Escherichia coli (E. coli) in crabmeat at 

which we may consider the crabmeat to 

be adulterated with filth. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

mstockstill on DSK4VPTVN1PROD with NOTICES