Agency Information Collection Activities: Submission for OMB Review; Comment Request, 58326-58328 [2013-22958]
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Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices
under the age of consent) and youth,
conduct focus groups with youth with
substance use and/or mental health
conditions, and interview health care
professionals who treat youth with these
conditions. The screen will be
administered by telephone to parents
first and, as eligible, to youth and will
take 10 minutes to complete for parents
and for youth. Questions will include a
mix of open-ended and closed-ended
responses and are intended to gather
information on previous diagnosis and
symptomology of mental health
conditions and availability to
participate in the focus group. The focus
groups with youth will be conducted in
person and will take up to 90 minutes.
Questions are primarily open-ended and
intended to gather information on the
reasons youth with substance use and/
or mental health conditions use tobacco,
the barriers and facilitators to tobacco
use prevention and cessation, the appeal
of various tobacco use prevention and
cessation messages, and the best
dissemination strategies and
communication channels for a future
campaign aimed at this specialized
group. The interviews with health care
professionals who treat youth with
mental health and/or substance use
conditions will be conducted in person,
as feasible, or by telephone and will
Responses
per
respondent
Number of
respondents
Respondent
take up to 45 minutes. Questions are
primarily open-ended and intended to
gather information to better understand
how various health care professionals
screen for and address tobacco use in
youth receiving care in their practice,
identify messages and materials aimed
at health care professionals to address
tobacco use prevention and cessation in
youth with substance use and/or mental
health conditions, determine the most
efficient communication strategies and
channels to disseminate this
information. All data collections are
voluntary.
Below is the table of the estimated
total burden hours:
Average
burden
hour
Total hour
burden
Screener (Parent) ............................................................................................
Screener (Youth) .............................................................................................
Youth Focus Group .........................................................................................
Provider Interview ............................................................................................
576
144
*108
42
1
1
1
1
.15
.15
1.50
.75
86.4
21.6
162
31.5
Total ..........................................................................................................
762
........................
........................
301.5
*The 108 respondents identified for the youth focus groups are included in the 144 respondents for the youth screener.
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
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:
OIRA_Submission@omb.eop.gov.
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. 2013–23053 Filed 9–20–13; 8:45 am]
emcdonald on DSK67QTVN1PROD with NOTICES
BILLING CODE 4162–20–P
VerDate Mar<15>2010
20:16 Sep 20, 2013
Jkt 229001
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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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
E:\FR\FM\23SEN1.SGM
23SEN1
58327
Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices
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
on their alcohol consumption and
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.
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
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)
emcdonald on DSK67QTVN1PROD with NOTICES
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
Written comments and
recommendations concerning the
proposed information collection should
VerDate Mar<15>2010
20:16 Sep 20, 2013
Jkt 229001
be sent by October 23, 2013 to the
SAMHSA Desk Officer at the Office of
Information and Regulatory Affairs,
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Office of Management and Budget
(OMB). To ensure timely receipt of
comments, and to avoid potential delays
E:\FR\FM\23SEN1.SGM
23SEN1
58328
Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices
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:
OIRA_Submission@omb.eop.gov.
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.
of Commercial Vessel Compliance (CG–
CVC), 202–372–1128, email
MMCPolicy@uscg.mil. If you have
questions on viewing or submitting
material to the docket, call Barbara
Hairston, Program Manager, Docket
Operations, telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
I. Background and Purpose
General Waiver Criteria
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard regulations in 46 CFR
10.215 contain the medical standards
that merchant mariner applicants must
meet prior to being issued a merchant
mariner credential (MMC). In cases
where the applicant does not meet the
medical standards in 46 CFR 10.215, the
Coast Guard may issue a waiver when
extenuating circumstances exist that
warrant special consideration (see 46
CFR 10.215(g)).
Coast Guard
Anti-Tachycardia Devices and
Implantable Cardioverter Defibrillators
Summer King,
Statistician.
[FR Doc. 2013–22958 Filed 9–20–13; 8:45 am]
BILLING CODE 4162–20–P
[Docket No. USCG–2013–0499]
Change-1 to Navigation and Inspection
Circular 04–08
Coast Guard, DHS.
Notice of availability.
AGENCY:
ACTION:
The Coast Guard announces
the availability of Change-1 to
Navigation and Vessel Inspection
Circular 04–08, ‘‘Medical and Physical
Evaluation Guidelines for Merchant
Mariner Credentials’’ (NVIC 04–08).
Change-1 to NVIC 04–08 contains a
summary and clarification of Coast
Guard policies regarding the criteria for
granting medical waivers to merchant
mariner credential applicants who have
had either anti-tachycardia devices or
implantable cardioverter defibrillators
implanted, and to applicants who have
had a seizure. This notice also addresses
comments we received in response to
Coast Guard notices published in the
Federal Register on September 7, 2012,
and March 25, 2013 soliciting public
comments on these issues.
DATES: Change-1 to NVIC 04–08 is
effective on September 23, 2013.
ADDRESSES: NVIC 04–08 is available in
the docket and can be viewed by going
to https://www.regulations.gov and using
‘‘USCG–2013–0499’’ as your search
term. Locate this notice in the search
results. NVIC 04–08 is available by
clicking the ‘‘Supporting Documents’’
link. NVIC 04–08 is also available on the
Coast Guard’s Web site at:
www.uscg.mil/nmc.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice, call
or email Lieutenant Ashley Holm, Office
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
20:16 Sep 20, 2013
Jkt 229001
Coast Guard guidance in NVIC 04–08
provides that anti-tachycardia devices
and implantable cardioverter
defibrillators (ICDs) are generally not
waiverable. Prior to issuing Change-1 to
NVIC 04–08, Coast Guard guidance did
not identify waiver criteria associated
with anti-tachycardia devices or ICDs,
rendering it difficult for Coast Guard
personnel to consistently evaluate
merchant mariner applicants with antitachycardia devices or ICDs, and assess
whether an applicant’s medical
condition warranted granting a medical
waiver under 46 CFR 10.215(g).
Enclosure (7) to NVIC 04–08 now
provides guidelines to use when
assessing an applicant’s eligibility for a
waiver.
On September 7, 2012 we published
a notice in the Federal Register
requesting public comments on this
issue (77 FR 55174). On December 17,
2012, we re-opened and extended the
public comment period for an
additional 30 days to provide additional
opportunity to comment (77 FR 74630).
We summarize the policy in Enclosure
(7) to NVIC 04–08 and address the
public comments below.
Seizures
Coast Guard regulations in 46 CFR
10.215(d) state that a convulsive
disorder (i.e., seizure disorder) could
lead to an applicant’s disqualification
from receiving a credential. Prior to
issuing Change-1 to NVIC 04–08, Coast
Guard guidance did not identify waiver
criteria associated with applicants that
had a history of seizures rendering it
difficult for Coast Guard personnel to
consistently evaluate merchant mariner
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
applicants with seizures and assess
whether an applicant’s medical
condition warranted granting a medical
waiver under 46 CFR 10.215(g).
Enclosure (8) to NVIC 04–08 now
provides guidelines to use when
assessing an applicant’s eligibility for a
waiver.
On March 25, 2013 we published a
notice in the Federal Register
requesting public comments on this
issue (78 FR 17917). We summarize the
policies in Enclosure (8) to NVIC 04–08
and address the public comments
below.
II. Discussion
ICD Policy
Prior to Change-1, NVIC 04–08
referred applicants to the Coast Guard’s
National Maritime Center (NMC) for
guidance on the treatment of ICDs. ICDs
were generally not waiverable.
Enclosure (7) provides a list of criteria
to be considered when evaluating an
application from a mariner with an ICD.
While the policy remains that ICDs are
generally not waiverable, the criteria in
Enclosure (7) will identify those limited
situations where a waiver will be
considered. The criteria that must be
met to be considered for a waiver are:
(1) The applicant does not have a
diagnosis of a cardiac channelopathy
affecting the electrical conduction of the
heart (to include Brugada syndrome,
Long QT syndrome, etc.);
(2) The applicant does not have a
prior history of ventricular fibrillation
or episodes of sustained ventricular
tachycardia within the last three years;
(3) The ICD or anti-tachycardia device
was implanted more than three years
ago;
(4) The ICD has not fired nor has the
applicant required anti-tachycardia
pacing therapy within the last three
years;
(5) There are no additional risk factors
for inappropriate shock such as
uncontrolled atrial fibrillation;
(6) The applicant’s left ventricular
ejection fraction (EF) 1 is greater than
35% with a steady or improving trend;
(7) There is no history of any
symptomatic or clinically significant
heart failure in the past two years;
(8) There is no evidence of significant
reversible ischemia on myocardial
perfusion imaging exercise stress
testing;
(9) The applicant’s exercise capacity
on formal stress testing (using standard
1 The left ventricular ejection fraction measures
the percentage of blood that the left ventricle of the
heart is able to pump with each beat. A normal
ejection fraction is greater than 50%.
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58326-58328]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22958]
-----------------------------------------------------------------------
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
[[Page 58327]]
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
----------------------------------------------------------------------------------------------------------------
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............ 314 2 628 .25 157
(Form A)........................
(50% of 629 eligible women).....
-------------------------------------------------------------------------------
Project CHOICES Sub Total... 1,220 .............. 2,162 .............. 541
-------------------------------------------------------------------------------
Totals.................. 10,493 .............. 18,000 .............. 4,176
----------------------------------------------------------------------------------------------------------------
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: OIRA_Submission@omb.eop.gov. 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]
BILLING CODE 4162-20-P
