55046 Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices 

factors for physical, non-physical, and 

electronic WPV in teachers and 

paraprofessionals in Pennsylvania; (3) 

Measure the impact of WPV on job 

satisfaction and quality of life. These 

goals are solely based on the State of 

Pennsylvania and are not based on a 

nation wide study. 

NIOSH is proposing to conduct a 

population-based, cross-sectional survey 

among teachers and paraprofessionals in 

the State of Pennsylvania. Paper-andpencil surveys will be mailed to 

potential participants through the 

Pittsburgh Federation of Teachers (PFT), 

Philadelphia Federation of Teachers 

(PA–AFT), and the Pennsylvania State 

Education Association (PSEA). Since 

approximately 90% of teachers and 65% 

of paraprofessionals in the State of 

Pennsylvania hold membership in one 

of these three unions and no known 

State-wide database exists that includes 

both teachers and paraprofessionals, a 

sample of eligible participants will be 

drawn using State-based union records. 

A stratified random sample will be 

drawn to ensure representativeness on 

important dimensions such as gender of 

participant and urban-rural status of the 

school district. In conjunction with each 

participating union, study packets 

consisting of an introduction letter, 

paper-and-pencil survey, and nonresponse form will be mailed to eligible 

participant’s home addresses. The 

questionnaire is a paper-and-pencil 

survey and provides information on the 

following categories: demographics, 

occupation, physical assault 

characteristics, non-physical assault 

characteristics, electronic aggression 

characteristics, job satisfaction, and 

quality of life. 

The sample size for the crosssectional survey is estimated to be 

approximately 5,000 teachers and 

paraprofessionals. This estimate is 

based on the number of reported 

teachers and paraprofessionals 

represented by the three unions 

participating in this study and on an 

80% response rate that is comparable to 

the response rate of previously 

conducted surveys in similar 

populations. Pilot test data 

demonstrates that respondents should 

take approximately 30 minutes to 

complete the paper-and-pencil survey, 

resulting in an annualized burden 

estimate of 2,500 hours. Participation in 

the study is completely voluntary. 

This survey will also utilize the skills 

and time of a variety of union office and 

administrative staff for the preparation 

of the survey packets. The exact number 

of administrative staff utilized at each 

union location, as well as the additional 

work demands placed on them has yet 

to be determined, though our best guess 

is 13 individuals. It is estimated that 

three office support staff from the 

Pittsburgh Federation of Teachers, six 

from the Pennsylvania State Education 

Association, and four from the 

Philadelphia Federation of Teachers 

will be needed for a grand total of 13 

support staff personnel. Additional 

work activities could include: 

Preparation of the sampling frame 

database and non-respondent database, 

printing of mailing labels, affixation of 

mailing labels onto survey packets, and 

e-mail and/or phone communication 

with NIOSH. For each mailing, we 

estimate that each of the 13 

administration assistants will dedicate 

two hours to the mailing. So, for each 

mailing, a grand total of 26 hours will 

be burdened. There will be three 

separate mailings for a grand total 

burden of 78 burden hours. 

There are no costs to the respondents 

other than their time. The total 

estimated annual burden hours are 

2,578. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Elementary and Secondary School Employees .......................................................................... 5,000 1 30/60 

Office & Administrative Support Occupations ............................................................................. 13 3 2 

Dated: October 19, 2009. 

Maryam Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–25649 Filed 10–23–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0512] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Antimicrobial 

Animal Drug Distribution Reports 

Under Section 105 of the Animal Drug 

User Fee Amendments of 2008 

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 and including each 

proposed extension of a collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

reporting and recordkeeping 

requirements for antimicrobial animal 

drug distribution as required by Section 

105 of the Animal Drug User Fee 

Amendments of 2008 (ADUFA). 

DATES: Submit written or electronic 

comments on the collection of 

information by December 28, 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 

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Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices 55047 

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 

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. 

Antimicrobial Animal Drug 

Distribution Reports Under Section 105 

of the Animal Drug User Fee 

Amendments of 2008—Federal Food, 

Drug, and Cosmetic Act, Section 

512(1)(3) (OMB Control Number 0910– 

NEW) 

Section 105 of ADUFA amended 

section 512 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

360b) to require that the sponsor of each 

new animal drug that contains an 

antimicrobial agent submit an annual 

report to FDA on the amount of each 

antimicrobial active ingredient in the 

drug that is sold or distributed for use 

in food-producing animals, including 

information on any distributor-labeled 

product. The legislation was enacted to 

address the problem of antimicrobial 

resistance and to help ensure that FDA 

has the necessary information to 

examine safety concerns related to the 

use of antibiotics in food-producing 

animals (154 Congressional Record 

H7534). 

Each report must specify: (1) The 

amount of each antimicrobial active 

ingredient by container size, strength, 

and dosage form, (2) quantities 

distributed domestically and quantities 

exported and (3) a listing of the target 

animals, indications, and production 

classes that are specified on the 

approved label of the product. 

The first report must be submitted not 

later than March 31, 2010. The report 

must cover the period of the preceding 

calendar year and include separate 

information for each month of the 

calendar year. The reports required 

under section 105 of ADUFA are 

required to be separate from periodic 

drug experience reports that are 

required under 21 CFR 514.80(b)(4) 

(OMB Control No. 0910–0284). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

FD&C Act 

Section 512(1)(3) 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response 

Total 

Hours 

Capital 

Cost 

Annual Reports for 

Sponsors with Active Applications 29 6.7 194 80 15,520 $107,880 

Annual Reports for 

Sponsors with Inactive Applications 23 4.0 92 1 92 

Total 15,612 $107,880 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

FD&C Act 

Section 512(1)(3) 

No. of 

Respondents 

Annual Frequency of 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

All Applicants 34 1 34 2 68 

Total 68 

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

The reporting burden estimates, 

including the total number of annual 

responses, are based on the number of 

sponsors and approved applications for 

antimicrobial drug products in foodproducing animals. The annual 

frequency of responses was calculated 

as the total annual responses divided by 

the number of respondents. 

The agency arrived at the estimates 

for reporting as follows: There are 34 

sponsors with approved applications for 

antimicrobial drugs for food-producing 

animals. There are 29 animal drug 

manufacturers with 194 approved 

applications for antimicrobial drugs for 

food-producing animals for which the 

drugs are being actively marketed 

(active applications). Additionally, there 

are 93 approved applications for 

antimicrobial drugs for food-producing 

animals for which the drugs are not 

being marketed (inactive applications), 

owned by 23 animal drug 

manufacturers. 

Regarding the reporting burden 

associated with the collection of 

information, FDA believes that the large 

majority of the burden will be incurred 

by industry in the first year in which 

reporting is required to design a report 

that meets the requirements of section 

512(l)(3) of the act. The agency has 

estimated this burden at 80 hours per 

applicant with active applications. The 

agency has factored into this estimate 

the time it will take industry to identify 

and locate the necessary information 

within existing records, and to develop 

a report that complies with section 

512(l)(3) of the act. Once this has been 

accomplished, FDA believes that the 

process for producing reports in 

subsequent years will essentially be 

automated, and that it will take 

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55048 Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices 

1BLS Occupation Employment and Wages, May 

2006, by occupation, for all industries (http:// 

www.bls.gov). Wage ($46.50) includes mean hourly 

wage of $33.22 for Standard Occupational 

Classification 15–0000, computer and mathematics 

occupations, all industries; we add 40 percent to 

account for benefits. 

approximately 3 hours to run a report 

that satisfies the act’s requirements. For 

sponsors of approved applications that 

are inactive (i.e., the approved drug is 

not being marketed), the sponsor would 

only have to submit a report stating that 

the drug is not being marketed, which 

FDA estimates will take approximately 

1 hour. 

FDA has developed a form to report 

the information required by section 

512(l)(3) of the act. FDA plans to make 

the form available to animal drug 

manufacturers through FDA’s website 

however, use of the form would be 

entirely voluntary. The form contains 

various fields for information, including 

the drug manufacturer’s name, new 

animal drug approval number, active 

ingredient name, National Drug Code 

number, container size, potency, and 

the number of units sold by month. 

The animal drug manufacturers can 

meet the statutory requirements by 

submitting their information in paper 

format using the FDA-provided form, 

one of their own designs, or by 

designing their own electronic form 

whose results could be submitted to the 

agency on a compact disc or on paper. 

The cost to animal drug sponsors for 

gathering the necessary information for 

report design and preparation or for 

completing FDA’s form in the first year 

of reporting is $107,880 (29 active 

sponsors times 80 hours times $46.50 

per hour = $107,880). This is a one-time 

cost for a computer or mathematic 

employees to design and prepare a 

report that satisfies the statutory 

requirements of section 512(l)(3) of the 

act.1 For subsequent years, the 

preparation of the report should take 

approximately 3 hours. Thus, the total 

cost in subsequent years would be 

$139.50. 

Regarding the recordkeeping burden 

associated with this collection of 

information, FDA believes that most of 

the necessary information for the annual 

report required to be submitted under 

section 512(l)(3) of the act is already 

collected and maintained by animal 

drug manufacturers under existing 

requirements. 

Animal drug manufacturers are 

already required to maintain 

distribution records for their drug 

products to comply with FDA’s current 

good manufacturing practice regulations 

under § 211.196 (21 CFR § 211.96) (OMB 

Control No. 0910–0139), and to comply 

with regulations for periodic drug 

experience reports under 

§ 514.80(b)(4)(i) (21 CFR 

§ 514.80(b)(4)(i)) (OMB Control No. 

0910–0284) of FDA regulations. 

Therefore, FDA believes that 

manufacturers of animal drugs already 

possess the computers, software, and 

additional equipment necessary to 

collect and maintain the necessary 

records, and to make reports. 

Section 512(l)(3) of the act differs 

from § 514.80(b)(4)(i) in that it requires 

that records include separate 

information for each month of the 

calendar year. Under § 211.196 (OMB 

Control No. 0910–0139), manufacturers 

currently are required to maintain 

distribution records that include the 

dosage form and date the drug is 

distributed. Additionally, FDA believes 

that manufacturers already keep 

detailed records of the dates when 

antimicrobial drugs are distributed for 

marketing and recall purposes from 

which monthly reports can be prepared 

as part of their usual and customary 

practice. However, FDA estimates 

additional hourly burden required by 

section 512(l)(3) of the Act as shown in 

table 2 of this document. 

Dated: October 16, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25671 Filed 10–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: Parent-Child Assistance 

Program (P–CAP) in the Fetal Alcohol 

Spectrum Disorder (FASD) Center of 

Excellence—New 

Since 2001, SAMHSA’s Center for 

Substance Abuse Prevention has been 

operating a Fetal Alcohol Spectrum 

Disorder (FASD) Center of Excellence 

which addresses FASD mainly by 

providing trainings and technical 

assistance; and developing and 

supporting systems of care that respond 

to FASD using effective evidence based 

practices and interventions. 

Currently the integration of evidencebased practices into service delivery 

organizations is being accomplished 

through subcontracts. One such 

intervention which integrates 

prevention strategies into service 

delivery organizations is the ParentChild Assistance Program (P–CAP) 

targeting pregnant or postpartum 

women. The P–CAP program uses the 

following 11 data collection tools. 

DESCRIPTION OF INSTRUMENTS/ACTIVITY FOR PARENT-CHILD ASSISTANCE PROGRAM (P–CAP) 

Instrument/Activity Description 

At Baseline/Enrollment: 

CRSQ ............................................ The Community Referral Screening Questionnaire (CRSQ) is a screening form administered to individuals referred to P–CAP. The purpose of the form is to determine eligibility for enrollment in P–CAP. 

ASI—Part A ................................... The Addiction Severity Index (ASI) Part A is an intake interview administered at client enrollment. The 

ASI Part A includes questions about past 30-day alcohol use, lifetime use, age at first use, month 

and year of last use, range of use (T–ACE), and use during pregnancy, thereby providing a thorough 

assessment of alcohol consumption. 

ASI—Part B & Twin ...................... The Addiction Severity Index (ASI) Part B is an intake interview administered as soon as possible after 

the target child birth. The ASI Part B includes questions about the target child at birth and alcohol 

use during the pregnancy. If the target birth is of twins then the Twins Addendum form is administered. 

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