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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Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices 55049 

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

Instrument/Activity Description 

Demographic Data ........................ The Demographic Questionnaire is administered after client enrollment. The questionnaire includes 

race, educational attainment, marital status, and an alcohol assessment. 

Process Monitoring: 

Weekly Advocate Time Summary The P–CAP Weekly Advocate Time Summary Sheet is administered on a weekly basis. The form 

tracks time spent on the phone, in person, or providing transportation to each client. 

Monthly Updates ........................... The Monthly Update form is administered on a monthly basis. The form records any changes in drug 

and alcohol use, pregnancy, child custody, and sources of income. 

Biannual Documentation of 

Progress (every 6 months).

The Biannual Documentation of Progress is administered every six months. The form documents 

changes in alcohol/drug treatment, abstinence from alcohol/drugs, birth control and pregnancy, connection to other services, and family stability and client activity. 

At Exit: 

Exit ASI ......................................... The Exit ASI Follow-Up is administered at the end of the program, at 36 months. The Exit ASI uses a 

format that is identical to the Addiction Severity Index administered at intake, providing pre- and posttest data for the intervention. 

Client Exit Close Out Form ........... The Client Exit Close-Out Form documents the total number of months the client spent in P–CAP, number of different advocates who worked with the client, and whether the client ever moved out of the 

area while enrolled in P–CAP. 

Ad hoc: 

Advocate Accounting of Tracing 

Activity on Missing Post-Exit Client.

The Advocate Accounting of Tracing Activity on Missing Post-Exit Client is used to track activity to locate a missing client. When a client is missing, the form is to be completed each month, instead of 

the Monthly Update form, until the missing post-exit client is brought in for an Exit Interview. 

Lost Post-Exit Client Form ............ The Lost Post-Exit Client Form is used when the client is at least six months past her three-year exit 

date in the program and has not completed the ASI exit interview. The form documents the reason 

the client has not completed the ASI exit interview. 

Two P–CAP subcontracts were 

awarded in February 2008. P–CAP uses 

an intensive paraprofessional home 

visitation model to reduce risk 

behaviors in pregnant women with 

substance abuse problems. The primary 

goal of P–CAP is to prevent future births 

of alcohol and drug exposed children to 

women who are at risk. The program 

uses a holistic case management 

approach, which is a complement to 

traditional substance abuse treatment. In 

addition to addressing alcohol and drug 

use, the program also aims at reducing 

other risk behaviors and addressing the 

health and social well being of mothers 

and their children. 

At the initial client visit, the women 

receive a comprehensive assessment 

which includes an assessment for 

alcohol consumption, contraception 

use, and use of community services. Atrisk women receive case management 

and every 4 months women are reevaluated to determine their clinical 

goals. Counselors complete 

‘‘Documentation of Client Progress’’ 

form every 6 months and a final 

‘‘Documentation of Client Progress’’ at 

36 months. In addition, the counselors 

complete a weekly advocate time sheet, 

summarizing their activities within the 

program. All forms are completed 

online using the web-portal. All 

participating subcontractors will 

maintain identifiable information on 

clients for service delivery purposes but 

no identifiable information will be 

transmitted to SAMHSA. 

The data collection is designed to 

evaluate the implementation of P–CAP 

by measuring whether abstinence from 

alcohol is achieved and risk for alcoholexposed births is eliminated. 

ESTIMATED ANNUALIZED BURDEN HOURS

Instrument/Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total number 

of responses 

Average 

burden per 

response 

Total burden 

hours 

collection 

At Baseline/Enrollment: 

CRSQ ............................................................................ 190 1 190 0.08 15 

ASI—Part A .................................................................. 190 1 190 2.75 523 

ASI—Part B & Twin ...................................................... 190 1 190 0.25 48 

Demographic Data ........................................................ 190 1 190 0.08 15 

Process Monitoring: 

Weekly Advocate Time Summary ................................ 190 52 9,880 0.50 4,940 

Intermediate Outcomes: 

Monthly Updates ........................................................... 190 12 2,280 0.50 1,140 

Biannual Documentation of Progress (every 6 

months) ..................................................................... 161 2 322 0.33 106 

At Exit: 

Exit ASI ......................................................................... 190 1 190 2.25 428 

Client Exit Close Out Form ........................................... 161 1 161 0.25 40 

Ad hoc: 

Advocate Accounting of Tracing Activity on Missing 

Post-Exit Client .......................................................... 29 1 29 0.25 7 

Lost Post-Exit Client Form ............................................ 29 1 29 0.25 7 

Total ....................................................................... 190 13,651 7,269 

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55050 Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by November 25, 2009 to: 

SAMHSA Desk Officer, Human 

Resources and Housing Branch, Office 

of Management and Budget, New 

Executive Office Building, Room 10235, 

Washington, DC 20503; due to potential 

delays in OMB’s receipt and processing 

of mail sent through the U.S. Postal 

Service, respondents are encouraged to 

submit comments by fax to: 202–395– 

5806. 

Dated: October 19, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–25667 Filed 10–23–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0496] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tobacco Product 

Standard for Flavored Cigarettes 

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 

the proposed extension of an existing 

collection of information pertaining to 

the tobacco product standard for 

flavored cigarettes under the Family 

Smoking Prevention and Tobacco 

Control Act (FSPTCA). 

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: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794, 

Jonnalynn.Capezzuto@fda.hhs.gov. 

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 extension of an existing 

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. 

Title: Tobacco Product Standard on 

Flavored Cigarettes (OMB Control 

Number 0910–0647—Extension) 

On June 22, 2009, the President 

signed the FSPTCA (Public Law 111–31) 

into law. The FSPTCA amended the 

Federal Food, Drug, and Cosmetic Act 

(FDCA) by adding a new chapter 

granting FDA important new authority 

to regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

FDA is requesting an extension of an 

existing collection of information 

pertaining to section 907(a)(1)(A) of the 

FDCA, as amended by the FSPTCA, 

which provides a general tobacco 

standard special rule for cigarettes that 

became effective on September 22, 2009. 

This special rule for cigarettes states in 

part that: ‘‘* * * a cigarette or any of 

its component parts (including the 

tobacco, filter, or paper) shall not 

contain, as a constituent (including a 

smoke constituent) or additive, an 

artificial or natural flavor (other than 

tobacco or menthol) or an herb or spice, 

including strawberry, grape, orange, 

clove, cinnamon, pineapple, vanilla, 

coconut, licorice, cocoa, chocolate, 

cherry, or coffee, that is a characterizing 

flavor of the tobacco product or tobacco 

smoke.’’ 

As part of our enforcement strategy, 

FDA created a Tobacco Call Center 

(with a toll-free number) to accept 

information from the public about 

violations of this provision, known as 

the cigarette flavor ban. Callers are able 

to report violations of the cigarette 

flavor ban and FDA will determine 

whether to conduct targeted followup 

investigations based on information the 

agency receives. Members of the public 

who wish to report a violation will be 

asked for certain information: Name and 

contact information, which are optional, 

date that the caller observed or 

purchased the alleged violative product, 

description of the tobacco product, and 

address of the retail outlet or Internet 

address where the violative product was 

available. FDA developed a form (FDA 

Form 3734) that Call Center 

representatives use to record this 

information. Additionally, this form is 

posted on FDA’s Internet (http:// 

www.accessdata.fda.gov/scripts/email/ 

TobaccoProducts/flavored

Cigarettes.cfm), which allows the public 

to report violations of the cigarette 

flavor ban by filling out the form online. Others may simply choose to send 

a letter to FDA. (Information about how 

to contact FDA’s Center for Tobacco 

Products is posted at http:// 

www.fda.gov/TobaccoProducts/ 

default.htm). FDA described how to 

report information about possible 

violations in a Federal Register notice 

reminding regulated industry of the 

effective date of the ban on certain 

flavored cigarettes (September 25, 2009; 

74 FR 48974). FDA also included this 

information in the following outreach 

materials: 

• Letter to our tobacco control 

partners announcing the cigarette flavor 

ban and soliciting information on 

possible violations, 

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