Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices 52967 

Dated: October 7, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24825 Filed 10–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0488] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Records and 

Reports Concerning Experience With 

Approved New Animal Drugs; Adverse 

Event Reports on Forms FDA 1932, 

1932a, and 2301 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements for recordkeeping and 

reports concerning experience with 

approved new animal drugs. The 

information contained in the reports 

required by the regulation enables FDA 

to monitor the use of new animal drugs 

after approval and to ensure their 

continued safety and efficacy. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 14, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley Jr, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: Under 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 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 concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, 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. 

Records and Reports Concerning 

Experience With Approved New 

Animal Drugs; Adverse Event Reports 

on Forms FDA 1932, 1932a, and 2301— 

21 CFR Section 514.80 (OMB No. 0910– 

0284)—Extension 

Sections 512(l) of the Federal Food, 

Drug, and Cosmetic Act (the 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)). 

This continuous monitoring of 

approved NADAs and ANADAs 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. Postapproval 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(d)). 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. 

The electronic versions of Forms FDA 

1932 and 1932a have been incorporated 

into the agency-wide information 

collection (MedWatchPlus Portal and 

Rational Questionnaire) that was 

announced for public comment in the 

Federal Register of October 23, 2008 (73 

FR 63153). MedWatchPlus Portal and 

Rational Questionnaire is part of a new 

electronic system for collecting, 

submitting, and processing adverse 

event reports and other safety 

information for all FDA-regulated 

products. In the Federal Register of May 

20, 2009 (74 FR 23721), FDA announced 

the submission for OMB review and 

clearance of the electronic data 

collection using MedWatchPlus Portal 

and Rational Questionnaire. 

Burden hours for the electronic 

versions of these forms were included as 

part of the MedWatchPlus Portal and 

Rationale Questionnaire information 

collection approved under OMB control 

number 0910–0645. It is estimated that, 

during the first 3 years that the 

MedWatchPlus Portal is in use, half of 

the reports will be submitted in paper 

format and half will be submitted 

electronically. In order to avoid double 

counting, an estimated 50 percent of 

total annual responses for FDA Form 

1932 (404) and FDA Form 1932a (81.5) 

are counted here as part of OMB control 

number 0910–0284 for the paper 

versions of Forms FDA 1932 and 1932a, 

and an estimated 50 percent of the total 

annual responses (404) and (81.5) for 

Form FDA 1932 and FDA Form 1932a 

respectively, are counted as part of OMB 

control number 0910–0645 for the 

electronic reporting of these adverse 

reports using the MedWatchPlus Portal. 

The paper versions of Forms FDA 

1932 and 1932a, as well as Form FDA 

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52968 Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices 

2301, will continue to be counted as 

part of OMB control number 0910–0284. 

The reporting and recordkeeping 

burden estimates, including the total 

number of annual responses, are based 

on the submission of reports to the 

Division of Surveillance, Center for 

Veterinary Medicine. The annual 

frequency of responses was calculated 

as the total annual responses divided by 

the number of respondents. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section or Section of 

the Act FDA Form No. No. of Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

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

(b)(2)(ii), and (b)(3) 19322 404 44 .26 17,882 .5 1 17,882 .5 

Voluntary reporting FDA Form 

1932a for the public 1932a2 81 .5 1 81 .5 13 81 .5 

514.80(b)(4) 2301 84 17 .0 1,428 16 22,848 

514.80(b)(5)(i) 2301 84 0 .31 26 2 52 

514.80(b)(5)(ii) 2301 84 33 .92 2,849 2 5,698 

514.80(b)(5)(iii) 2301 646 0 .08 49 2 98 

Total Hours 46,660 

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

2Burden hours were determined as explained above. 

3The hours per response for paper versions of Forms FDA 1932 and 1932a are assumed to be 1 hour. The hours per response for the electronic version of Form FDA 1932 is assumed to be 1 hour, while the electronic version of Form FDA 1932a is assumed to take .6 hours to complete the form and gather the required information as part of the MedWatchPlus Portal information collection (see 74 FR 23721 at 23727, May 20, 

2009). 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

514.80(e)2 646 7.20 4651 14 65,116 .8 

Total 1,541 

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

2Section 514.80(e) covers all recordkeeping hours for all adverse event reporting. 

Dated: October 7, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24734 Filed 10–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Health Disparities Subcommittee, 

Advisory Committee to the Director 

(ACD), Centers for Disease Control 

(CDC); Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting of the 

aforementioned subcommittee. 

Time and Date: 2 p.m.–4:30 p.m., October 

28, 2009. 

Place: The meeting will be convened at the 

CDC, 1600 Clifton Road, NE., Atlanta, GA 

30333, Building 19, Auditorium B1, Global 

Communications Center. Please see 

Supplementary Information for details on 

accessing the meeting location. 

Status: Open to the public, limited only by 

the availability of space. The meeting room 

accommodates approximately 90 people. 

Purpose: The Subcommittee will provide 

advice to the CDC Director through the 

Advisory Committee to the Director on 

strategic and other broad issues facing CDC. 

Matters To Be Discussed: ACD Health 

Disparities Subcommittee 2009 Action 

Agenda; CDC Director’s Health Disparity 

Indicator Project Update, Director’s Priorities 

and Reorganization/Structure. 

Agenda items are subject to change as 

priorities dictate. 

Supplementary Information: To participate 

in the meeting, please plan to register with 

CDC Security Officials at the Visitor’s Center 

at least one hour prior to the meeting. A 

government-issued picture ID will be 

required. All persons who do not have a 

CDC/Health and Human Services 

identification will have to be escorted to the 

meeting. 

Contact Person for More Information: 

Walter W. Williams, M.D., M.P.H., 

Designated Federal Officer, Health 

Disparities Subcommittee, ACD, CDC, 1600 

Clifton Road, NE., M/S E–67, Atlanta, 

Georgia 30333. Telephone 404/498–2310, Email: http://www1@cdc.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: October 8, 2009. 

Andre Tyler, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E9–24859 Filed 10–14–09; 8:45 am] 

BILLING CODE 4163–18–P 

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