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

74730 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Notices 

10.115(g)(5)), to ensure that FDA 

considers your comment on this draft 

CPG before it begins work on the final 

version of the CPG, submit either 

electronic or written comments on the 

draft CPG by February 17, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft CPG to the 

Office of Policy and Risk Management, 

Office of Regulatory Affairs, Office of 

Global Regulatory Operations and 

Policy, Food and Drug Administration, 

12420 Parklawn Dr., Rockville, MD 

20857. Send two self-addressed 

adhesive labels to assist that office in 

processing your request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the CPG. 

Submit electronic comments on the 

draft CPG to http://www.regulations.gov. 

Submit written comments on the draft 

CPG to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Mary E. Losikoff, Center for Food Safety 

and Applied Nutrition (HFS–325), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

240–402–2300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

the draft CPG entitled ‘‘Compliance 

Policy Guide Sec. 540.275 Crabmeat— 

Fresh and Frozen—Adulteration with 

Filth, Involving the Presence of 

Escherichia coli.’’ The draft CPG, when 

finalized, will update the previously 

issued ‘‘CPG Sec. 540.275 Crabmeat— 

Fresh and Frozen—Adulteration with 

Filth, Involving the Presence of the 

Organism Escherichia coli,’’ which 

provides guidance for FDA staff on the 

level of E. coli in crabmeat (i.e., 3.6 Most 

Probable Number per gram (MPN/g) of 

E. coli) at which FDA may consider the 

crabmeat to be adulterated with filth 

under section 402(a)(4) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 342(a)(4)). We 

revised the CPG for clarity and to 

update the format. Revisions generally 

include the addition of sections on 

Background and Policy, updates to the 

sections on Regulatory Action Guidance 

and Specimen Charges, and FDA office 

names. Specifically, in the section on 

Regulatory Action Guidance, we clarify 

that FDA’s Districts have direct 

reference authority for both domestic 

seizure and import refusal based on the 

criteria described in the draft CPG. We 

also clarify the specific types of legal 

action to which the criteria for 

recommendations apply. In addition, we 

provide specimen charges relating to 

domestic seizure and import refusal. 

The draft CPG also contains information 

that may be useful to the regulated 

industry and to the public. 

We are issuing the draft CPG 

consistent with our good guidance 

practices regulation (21 CFR 10.115). 

The draft CPG, when finalized, will 

represent our current thinking on the 

level of E. coli in fresh or frozen 

crabmeat at which we may consider the 

crabmeat to be adulterated with filth 

under section 402(a)(4) of the FD&C Act. 

The draft CPG does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternate approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit either 

electronic comments regarding the draft 

CPG to http://www.regulations.gov or 

written comments to the Division of 

Dockets Management (see ADDRESSES). 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, and 

will be posted to the docket at http://

www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document from FDA’s 

Office of Regulatory Affairs CPG history 

page at http://www.fda.gov/ICECI/

ComplianceManuals/CompliancePolicy

GuidanceManual/default.htm or http://

www.regulations.gov. Use the FDA Web 

site listed in the previous sentence to 

find the most current version of the 

guidance. 

Dated: December 10, 2014. 

Melinda K. Plaisier, 

Associate Commissioner for Regulatory 

Affairs, Office of Regulatory Affairs. 

[FR Doc. 2014–29314 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–1697] 

Privacy Act of 1974; Report of a New 

System of Records; Food and Drug 

Administration Commissioning of 

State and Local Officials; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of December 8, 2014. The 

document misstated the effective date of 

the new system of records. This notice 

corrects that error. 

FOR FURTHER INFORMATION CONTACT: 

Joyce Strong, Regulations Editorial 

Section, Regulations Policy and 

Management Staff, Office of Policy, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–9148. 

SUPPLEMENTARY INFORMATION: The 

December 8, 2014 (79 FR 72687) notice 

published with an incorrect effective 

date of December 8, 2014, for the new 

system of records. This document 

corrects that error. For the convenience 

of the reader, the complete DATES

language is set out below. 

In 79 FR 72687, published on 

December 8, 2014, we are correcting the 

DATES section to read as follows: 

DATES: Effective Date: The new system 

of records and related routine uses will 

be effective on January 22, 2015. Submit 

either electronic or written comments 

by January 22, 2015. 

Dated: December 10, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29424 Filed 12–15–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

comment request; Generic Clearance 

for Satisfaction Surveys of Customers 

(CSR) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

mstockstill on DSK4VPTVN1PROD with NOTICES