Agency Information Collection Activities: Submission for OMB Review; Comment Request, 55048-55050 [E9-25667]

Download as PDF 55048 Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices 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] 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. BILLING CODE 4160–01–S DESCRIPTION OF INSTRUMENTS/ACTIVITY FOR PARENT-CHILD ASSISTANCE PROGRAM (P–CAP) Instrument/Activity Description At Baseline/Enrollment: CRSQ ............................................ mstockstill on DSKH9S0YB1PROD with NOTICES ASI—Part A ................................... ASI—Part B & Twin ...................... 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. 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. 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. 1 BLS Occupation Employment and Wages, May 2006, by occupation, for all industries (https:// www.bls.gov). Wage ($46.50) includes mean hourly VerDate Nov<24>2008 15:19 Oct 23, 2009 Jkt 220001 wage of $33.22 for Standard Occupational Classification 15–0000, computer and mathematics PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 occupations, all industries; we add 40 percent to account for benefits. E:\FR\FM\26OCN1.SGM 26OCN1 55049 Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices DESCRIPTION OF INSTRUMENTS/ACTIVITY FOR PARENT-CHILD ASSISTANCE PROGRAM (P–CAP)—Continued Instrument/Activity Description Demographic Data ........................ Process Monitoring: Weekly Advocate Time Summary Monthly Updates ........................... Biannual Documentation Progress (every 6 months). of At Exit: Exit ASI ......................................... Client Exit Close Out Form ........... Ad hoc: Advocate Accounting of Tracing Activity on Missing Post-Exit Client. Lost Post-Exit Client Form ............ The Demographic Questionnaire is administered after client enrollment. The questionnaire includes race, educational attainment, marital status, and an alcohol assessment. 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. 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. 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. 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. 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. 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. 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 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. 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 ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents mstockstill on DSKH9S0YB1PROD with NOTICES Instrument/Activity At Baseline/Enrollment: CRSQ ............................................................................ ASI—Part A .................................................................. ASI—Part B & Twin ...................................................... Demographic Data ........................................................ Process Monitoring: Weekly Advocate Time Summary ................................ Intermediate Outcomes: Monthly Updates ........................................................... Biannual Documentation of Progress (every 6 months) ..................................................................... At Exit: Exit ASI ......................................................................... Client Exit Close Out Form ........................................... Ad hoc: Advocate Accounting of Tracing Activity on Missing Post-Exit Client .......................................................... Lost Post-Exit Client Form ............................................ 15:19 Oct 23, 2009 Jkt 220001 PO 00000 Frm 00100 Total number of responses Average burden per response Total burden hours collection 190 190 190 190 1 1 1 1 190 190 190 190 0.08 2.75 0.25 0.08 15 523 48 15 190 52 9,880 0.50 4,940 190 12 2,280 0.50 1,140 161 2 322 0.33 106 190 161 1 1 190 161 2.25 0.25 428 40 29 29 Total ....................................................................... VerDate Nov<24>2008 Number of responses per respondent 1 1 29 29 0.25 0.25 7 7 190 Fmt 4703 Sfmt 4703 13,651 E:\FR\FM\26OCN1.SGM 26OCN1 7,269 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. mstockstill on DSKH9S0YB1PROD with NOTICES 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 https:// 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 VerDate Nov<24>2008 15:19 Oct 23, 2009 Jkt 220001 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. PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 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 (https:// 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 https:// 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, E:\FR\FM\26OCN1.SGM 26OCN1

Agencies

[Federal Register Volume 74, Number 205 (Monday, October 26, 2009)]
[Notices]
[Pages 55048-55050]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25667]

-----------------------------------------------------------------------

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 evidence-based practices into service
delivery organizations is being accomplished through subcontracts. One
such intervention which integrates prevention strategies into service
delivery organizations is the Parent-Child 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.

[[Page 55049]]

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
post-test 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 The Advocate Accounting of Tracing Activity on
Post-Exit Client. 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. At-risk women receive
case management and every 4 months women are re-evaluated 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 alcohol-exposed births is eliminated.

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Total burden
Instrument/Activity Number of responses per Total number Average burden hours
respondents respondent of responses per response 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 161 2 322 0.33 106
Progress (every 6 months)..
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 29 1 29 0.25 7
Tracing Activity on Missing
Post-Exit Client...........
Lost Post-Exit Client Form.. 29 1 29 0.25 7
-------------------------------------------------------------------------------
Total................... 190 .............. 13,651 .............. 7,269
----------------------------------------------------------------------------------------------------------------

[[Page 55050]]

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

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