Agency Information Collection Activities: Proposed Collection; Comment Request, 44956-44957 [2013-17878]

Download as PDF 44956 Federal Register / Vol. 78, No. 143 / Thursday, July 25, 2013 / Notices Dated: July 19, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–17835 Filed 7–24–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request ehiers on DSK2VPTVN1PROD with NOTICES In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276– 1243. Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Fetal Alcohol Spectrum Disorders (FASD) Center for Excellence (CFE) Screening and Brief Intervention (SBI) Project and Project CHOICES Evaluation (OMB No. 0930– 0302)—Reinstatement Since 2001, SAMHSA’s Center for Substance Abuse Prevention has been operating the SAMHSA Fetal Alcohol Spectrum Disorders (FASD) Center for Excellence (CFE). The purpose of the FASD Center for Excellence is to prevent alcohol-exposed pregnancies among women of childbearing age and pregnant women and to improve the quality of life for individuals affected by FASD. Data will be collected from women served across approximately 10 sites in local/community-based agencies. Women will be screened for alcohol use, and provided appropriate VerDate Mar<15>2010 13:49 Jul 24, 2013 Jkt 229001 interventions based on their pregnancy status. The FASD CFE will be integrating Screening and Brief Intervention (SBI) for pregnant women and Project CHOICES for non-pregnant women through service delivery organizations and will monitor the results. Approximately 10 sites will implement the SBI program and/or Project CHOICES. At baseline, an assessment form will be administered by the counselor to screen women at the participating sites or health care delivery programs. Basic demographic data will be collected for all women screened (age, race/ethnicity, education, and marital status) at baseline by participating sites but no personal identification information will be transmitted to SAMHSA. Both quantity and frequency of drinking will be assessed for all women. Pregnant women will be assessed for risk of alcohol use using the TWEAK screening instrument, which has been used successfully with pregnant women. Non-pregnant women will be assessed for ability to conceive and use of effective birth control. SBI focuses on 10- to 15-minute counseling sessions, conducted by a counselor who will use a scripted manual to guide the program. Participants in SBI will be assessed throughout their pregnancy to monitor alcohol use, referred for additional services to support their efforts to stop drinking, and will be provided with the 10–15 minute program until the client abstains from alcohol. Clients will be followed up until their 36th week of pregnancy. At each process visit, the quantity and frequency of drinking will be assessed and the client’s goals for drinking will be recorded. In addition, process level variables will be assessed to understand how the program is being implemented (e.g., whether SBI was delivered; duration of the program; what referrals were made; client satisfaction). At the 36th week of pregnancy quantity and frequency of drinking will be assessed, and the client’s satisfaction with the program will be recorded. For those who screen positive for Project CHOICES (non-pregnant women 18–44 years who are at risk for an alcohol-exposed pregnancy), the program will provide two Motivational Interviewing (MI) sessions related to alcohol use, plus one contraceptive counseling session. The goal is to help these women prevent an alcoholexposed pregnancy by abstaining from alcohol and using contraceptive methods of their choice consistently and correctly. At the end of the Project CHOICES program, women are assessed PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 on their alcohol consumption and contraceptive use in the past 30 days, and their satisfaction with the program is recorded. At 3 months and 6 months after the end of the program, women are assessed on 30-day alcohol consumption and contraceptive use using the same core assessment form that was used at baseline. All participating sites will maintain personally identifiable information of their clients for service delivery purposes, but the sites will keep such information private to the maximum extent allowable by laws. Data will be collected at the site level and sites will be instructed to keep personal data secure in a specified location. To further ensure privacy of individual responses, all data will be reported at the aggregate level so that individual responses cannot be identified; no data will be reported at the individual participant level. Furthermore, data will be collected to meet the criteria of a ‘‘limited data set’’ as defined in the Privacy Regulations issued under the Health Insurance Portability and Accountability Act (HIPAA), (HIPAA Privacy Rule, 45 CFR _ 164.501) [45 CFR 164.514(e)(4)(ii)]. A computer generated coding system will be used to identify the records, and access to records will be limited only to authorized personnel. In addition, the identifiers will be stored separately from the data. No direct identifiers will be included in order for the data to be considered a ‘‘limited data set.’’ A summary of the actions the contractors will take in order to comply with HIPAA follows: • Ensure that the personal health information respondents disclose to outside entities does not violate the Privacy Rule. • When creating a unique identification code, ensure that the code does not contain information that can be used to identify the individual. • Sign a data agreement that states all HIPAA requirements will be adhered to consistent with a limited data set. • Agree to maintain the confidentiality of alcohol and drug abuse client records according to the provisions of Title 42 of the Code of Federal Regulations, Part II. The data collection is designed to monitor the implementation of the proposed programs by measuring whether abstinence from alcohol is achieved, and for Project CHOICES by measuring whether effective birth control practices are performed. Furthermore, the program will include process measures to monitor how the interventions were provided. E:\FR\FM\25JYN1.SGM 25JYN1 44957 Federal Register / Vol. 78, No. 143 / Thursday, July 25, 2013 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Instrument/activity Number of responses per respondent Total number of responses Average burden per response Total burden hours per collection Pregnant Women (SBI) Baseline Assessment (Form A) ........................................... Process Assessment for all Eligible women (Forms A and B) (26.6% of baseline) ..................................................... Process Assessment for women actively drinking (Forms A and B) (16% of 2,468 eligible women) ......................... End of Program Assessment (Forms A and C) (50% of eligible women) .................................................................... SBI Sub Total ............................................................... 9,273 1 9,273 .25 2,318 2,468 2 4,936 .21 1,037 395 1 395 .21 83 1,234 1 1,234 .16 197 9,273 ........................ 15,838 ........................ 3,635 Non-Pregnant Women (Project CHOICES) Baseline Assessment (Form A) ........................................... End of program Assessment (Forms A and C) (50% of 629 eligible women) ......................................................... Follow-up Assessment (Form A) (50% of 629 eligible women) ............................................................................. 1,220 1 1,220 .25 305 314 1 314 .25 79 314 2 628 .25 157 Project CHOICES Sub Total ........................................ 1,220 ........................ 2,162 ........................ 541 Totals ............................................................................ 10,493 ........................ 18,000 ........................ 4,176 Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 2–1057, One Choke Cherry Road, Rockville, MD 20857 or email her a copy at summer.king@samhsa.hhs.gov. Written comments should be received by September 23, 2013. Summer King, Statistician. [FR Doc. 2013–17878 Filed 7–24–13; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HOMELAND SECURITY Agency Information Collection Activities: BioWatch Filter Holder Log, Filter Holder Log DHS Form 9500 Office of Health Affairs, DHS. 60-Day Notice and request for comments; Extension without change of a currently approved collection. AGENCY: ACTION: The Department of Homeland Security, Office of Health Affairs/OCMO Early Detection Division, will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chapter 35). DATES: Comments are encouraged and will be accepted until September 23, 2013. This process is conducted in accordance with 5 CFR 1320.1 ehiers on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 13:49 Jul 24, 2013 Jkt 229001 Written comments and questions about this Information Collection Request should be forwarded to Office of Health Affairs/OCMO Early Detection Division, DHS Attn.: Daniel Yereb, djy1@dhs.gov 703–647–8052. SUPPLEMENTARY INFORMATION: Following collection, the filter samples are transported to a local Laboratory Response Network (LRN) laboratory for analysis. Should laboratory analysis determine the presence of one or more of the organisms of concern, additional analysis, collection, and response activities are conducted to determine the risk to public health, and to take appropriate public health, emergency response, and law enforcement actions. The BioWatch Program provides funding to participating jurisdictions for the cost of collection and laboratory analysis activities, including the preparation and maintenance of required documentation. The filter holder log form is part of the documentation required by federal law enforcement for the BioWatch Program. The filter holder log is required to create a unique record of the filter installed plus give a written chain-ofcustody record tied to each collected filter sample. In the event of a positive laboratory result and subsequent determination of the presence of an organism of concern, a variety of law enforcement organizations may become engaged in the process of determining if any criminal activity has taken place. The Federal Bureau of Investigation (FBI) instructed the BioWatch Program ADDRESSES: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 to maintain a written record for each collected filter sample to support law enforcement activities, including criminal prosecution in the case of a deliberate release of a biological warfare agent. In addition, filter holder logs (chain-of-custody records) should be consistent nationwide for all BioWatch jurisdictions. Written records are required to meet FBI evidentiary standards for establishing the chain of custody for any filter samples used for criminal prosecution (chain of custody is the tracking and documentation of the physical control of evidence at all stages in the collection and analysis process). The memorandum from the FBI to DHS directing the creation of written records is included in Attachment 1. Collection of written records establishing chain of custody for samples containing biological agents and toxins for the purpose of evidence in a criminal proceeding is consistent with the ‘‘Best Evidence Rule’’, Section 1002, of the federal Rules of Evidence (Attachment 2). The FBI requirement levied on the BioWatch Program is consistent with Section 7 of the FBI Quality Assurance Guidelines for Laboratories Performing Microbial Forensic Work, produced by the members of the Scientific Working Group on Microbial Genetics and Forensics (SWGMGF) Attachment 3. Such record keeping supports mandatory reporting requirements directed by The APHIS Interim Final Rule 7 CFR Part 331, repeated at 9 CFR E:\FR\FM\25JYN1.SGM 25JYN1

Agencies

[Federal Register Volume 78, Number 143 (Thursday, July 25, 2013)]
[Notices]
[Pages 44956-44957]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17878]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Proposed Collection; 
Comment Request

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction 
Act of 1995 concerning opportunity for public comment on proposed 
collections of information, the Substance Abuse and Mental Health 
Services Administration (SAMHSA) will publish periodic summaries of 
proposed projects. To request more information on the proposed projects 
or to obtain a copy of the information collection plans, call the 
SAMHSA Reports Clearance Officer on (240) 276-1243.
    Comments are invited on: (a) Whether the proposed collections of 
information are necessary for the proper performance of the functions 
of the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

Proposed Project: Fetal Alcohol Spectrum Disorders (FASD) Center for 
Excellence (CFE) Screening and Brief Intervention (SBI) Project and 
Project CHOICES Evaluation (OMB No. 0930-0302)--Reinstatement

    Since 2001, SAMHSA's Center for Substance Abuse Prevention has been 
operating the SAMHSA Fetal Alcohol Spectrum Disorders (FASD) Center for 
Excellence (CFE). The purpose of the FASD Center for Excellence is to 
prevent alcohol-exposed pregnancies among women of childbearing age and 
pregnant women and to improve the quality of life for individuals 
affected by FASD. Data will be collected from women served across 
approximately 10 sites in local/community-based agencies. Women will be 
screened for alcohol use, and provided appropriate interventions based 
on their pregnancy status.
    The FASD CFE will be integrating Screening and Brief Intervention 
(SBI) for pregnant women and Project CHOICES for non-pregnant women 
through service delivery organizations and will monitor the results. 
Approximately 10 sites will implement the SBI program and/or Project 
CHOICES.
    At baseline, an assessment form will be administered by the 
counselor to screen women at the participating sites or health care 
delivery programs. Basic demographic data will be collected for all 
women screened (age, race/ethnicity, education, and marital status) at 
baseline by participating sites but no personal identification 
information will be transmitted to SAMHSA. Both quantity and frequency 
of drinking will be assessed for all women. Pregnant women will be 
assessed for risk of alcohol use using the TWEAK screening instrument, 
which has been used successfully with pregnant women. Non-pregnant 
women will be assessed for ability to conceive and use of effective 
birth control.
    SBI focuses on 10- to 15-minute counseling sessions, conducted by a 
counselor who will use a scripted manual to guide the program. 
Participants in SBI will be assessed throughout their pregnancy to 
monitor alcohol use, referred for additional services to support their 
efforts to stop drinking, and will be provided with the 10-15 minute 
program until the client abstains from alcohol. Clients will be 
followed up until their 36th week of pregnancy. At each process visit, 
the quantity and frequency of drinking will be assessed and the 
client's goals for drinking will be recorded. In addition, process 
level variables will be assessed to understand how the program is being 
implemented (e.g., whether SBI was delivered; duration of the program; 
what referrals were made; client satisfaction). At the 36th week of 
pregnancy quantity and frequency of drinking will be assessed, and the 
client's satisfaction with the program will be recorded.
    For those who screen positive for Project CHOICES (non-pregnant 
women 18-44 years who are at risk for an alcohol-exposed pregnancy), 
the program will provide two Motivational Interviewing (MI) sessions 
related to alcohol use, plus one contraceptive counseling session. The 
goal is to help these women prevent an alcohol-exposed pregnancy by 
abstaining from alcohol and using contraceptive methods of their choice 
consistently and correctly. At the end of the Project CHOICES program, 
women are assessed on their alcohol consumption and contraceptive use 
in the past 30 days, and their satisfaction with the program is 
recorded. At 3 months and 6 months after the end of the program, women 
are assessed on 30-day alcohol consumption and contraceptive use using 
the same core assessment form that was used at baseline.
    All participating sites will maintain personally identifiable 
information of their clients for service delivery purposes, but the 
sites will keep such information private to the maximum extent 
allowable by laws. Data will be collected at the site level and sites 
will be instructed to keep personal data secure in a specified 
location. To further ensure privacy of individual responses, all data 
will be reported at the aggregate level so that individual responses 
cannot be identified; no data will be reported at the individual 
participant level. Furthermore, data will be collected to meet the 
criteria of a ``limited data set'' as defined in the Privacy 
Regulations issued under the Health Insurance Portability and 
Accountability Act (HIPAA), (HIPAA Privacy Rule, 45 CFR -- 164.501) [45 
CFR 164.514(e)(4)(ii)]. A computer generated coding system will be used 
to identify the records, and access to records will be limited only to 
authorized personnel. In addition, the identifiers will be stored 
separately from the data. No direct identifiers will be included in 
order for the data to be considered a ``limited data set.'' A summary 
of the actions the contractors will take in order to comply with HIPAA 
follows:
     Ensure that the personal health information respondents 
disclose to outside entities does not violate the Privacy Rule.
     When creating a unique identification code, ensure that 
the code does not contain information that can be used to identify the 
individual.
     Sign a data agreement that states all HIPAA requirements 
will be adhered to consistent with a limited data set.
     Agree to maintain the confidentiality of alcohol and drug 
abuse client records according to the provisions of Title 42 of the 
Code of Federal Regulations, Part II.
    The data collection is designed to monitor the implementation of 
the proposed programs by measuring whether abstinence from alcohol is 
achieved, and for Project CHOICES by measuring whether effective birth 
control practices are performed. Furthermore, the program will include 
process measures to monitor how the interventions were provided.

[[Page 44957]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average      Total burden
       Instrument/activity           Number of     responses per   Total number     burden per       hours per
                                    respondents     respondent     of responses      response       collection
----------------------------------------------------------------------------------------------------------------
                                              Pregnant Women (SBI)
----------------------------------------------------------------------------------------------------------------
Baseline Assessment (Form A)....           9,273               1           9,273             .25           2,318
Process Assessment for all                 2,468               2           4,936             .21           1,037
 Eligible women (Forms A and B)
 (26.6% of baseline)............
Process Assessment for women                 395               1             395             .21              83
 actively drinking (Forms A and
 B) (16% of 2,468 eligible
 women).........................
End of Program Assessment (Forms           1,234               1           1,234             .16             197
 A and C) (50% of eligible
 women).........................
                                 -------------------------------------------------------------------------------
    SBI Sub Total...............           9,273  ..............          15,838  ..............           3,635
----------------------------------------------------------------------------------------------------------------
                                      Non-Pregnant Women (Project CHOICES)
----------------------------------------------------------------------------------------------------------------
Baseline Assessment (Form A)....           1,220               1           1,220             .25             305
End of program Assessment (Forms             314               1             314             .25              79
 A and C) (50% of 629 eligible
 women).........................
Follow-up Assessment (Form A)                314               2             628             .25             157
 (50% of 629 eligible women)....
                                 -------------------------------------------------------------------------------
    Project CHOICES Sub Total...           1,220  ..............           2,162  ..............             541
                                 -------------------------------------------------------------------------------
    Totals......................          10,493  ..............          18,000  ..............           4,176
----------------------------------------------------------------------------------------------------------------

    Send comments to Summer King, SAMHSA Reports Clearance Officer, 
Room 2-1057, One Choke Cherry Road, Rockville, MD 20857 or email her a 
copy at summer.king@samhsa.hhs.gov. Written comments should be received 
by September 23, 2013.

Summer King,
Statistician.
[FR Doc. 2013-17878 Filed 7-24-13; 8:45 am]
BILLING CODE 4162-20-P