[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58326-58328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22958]
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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: 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
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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.
Estimated Annualized Burden Hours
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Number of Average Total burden
Instrument/activity Number of responses per Total number burden per hours per
respondents respondent of responses response collection
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Pregnant Women (SBI)
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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).........
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SBI Sub Total............... 9,273 .............. 15,838 .............. 3,635
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Non-Pregnant Women (Project CHOICES)
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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............ 314 2 628 .25 157
(Form A)........................
(50% of 629 eligible women).....
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Project CHOICES Sub Total... 1,220 .............. 2,162 .............. 541
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Totals.................. 10,493 .............. 18,000 .............. 4,176
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Written comments and recommendations concerning the proposed
information collection should be sent by October 23, 2013 to the SAMHSA
Desk Officer at the Office of Information and Regulatory Affairs,
Office of Management and Budget (OMB). To ensure timely receipt of
comments, and to avoid potential delays
[[Page 58328]]
in OMB's receipt and processing of mail sent through the U.S. Postal
Service, commenters are encouraged to submit their comments to OMB via
email to: [email protected]. Although commenters are
encouraged to send their comments via email, commenters may also fax
their comments to: 202-395-7285. Commenters may also mail them to:
Office of Management and Budget, Office of Information and Regulatory
Affairs, New Executive Office Building, Room 10102, Washington, DC
20503.
Summer King,
Statistician.
[FR Doc. 2013-22958 Filed 9-20-13; 8:45 am]
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