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