Agency Information Collection Activities: Submission for OMB Review; Comment Request, 49403-49404 [2018-21253]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21314 Filed 9–28–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
amozie on DSK3GDR082PROD with NOTICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
substance abuse treatment and mental
health treatment facilities known to
SAMHSA. (The N–MHSS data
collection is covered under OMB No.
0930–0119.)
The information in I–BHS and
N–SSATS is needed to assess the nature
and extent of these resources, to identify
gaps in services, and to provide a
database for treatment referrals. Both
I–BHS and N–SSATS are components of
the Behavioral Health Services
Information System (BHSIS).
The request for OMB approval will
include a request to update the I–BHS
facility listing on a continuous basis and
to conduct the N–SSATS and the
between cycle N–SSATS (N–SSATS BC)
in 2019, 2020, and 2021. The N–SSATS
BC is a procedure for collecting services
data from newly identified facilities
between main cycles of the survey and
will be used to improve the listing of
treatment facilities in the online
Behavioral Health Treatment Services
Locator.
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.
Planned Changes
I–BHS: Only minor form changes
corresponding with updated technology
are planned.
N–SSATS: The N–SSATS with client
counts will continue to be conducted in
alternate years, as in the past, and the
Treatment Locator will be updated
monthly.
Project: National Survey of Substance
Abuse Treatment Services (N–SSATS)
(OMB No. 0930–0106)—Revision
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) is requesting a revision of
the National Survey of Substance Abuse
Treatment (N–SSATS) data collection
(OMB No. 0930–0106), which expires
on December 31, 2018. N–SSATS
provides both national and state-level
data on the numbers and types of
patients treated and the characteristics
of facilities providing substance abuse
treatment services. It is conducted
under the authority of Section 505 of the
Public Health Service Act (42 U.S.C.
290aa-4) to meet the specific mandates
for annual information about public and
private substance abuse treatment
providers and the clients they serve.
This request includes:
• Collection of N–SSATS, which is an
annual survey of substance abuse
treatment facilities; and
• Updating of the Inventory of
Behavioral Health Services (I–BHS)
which is the facility universe for the
N–SSATS as well as the annual survey
of mental health treatment facilities, the
National Mental Health Services Survey
(N–MHSS). The I–BHS includes all
Version A (2019 and 2021)
The following items have been added
compared to the 2017 N–SSATS: Add
questions about: Where clients obtain
their medications for opioid use
disorder if they originate elsewhere;
how facilities treat alcohol use disorder;
where clients obtain their medications
for alcohol use disorder if they originate
elsewhere; whether the facility only
treats alcohol use disorder;
detoxification from opioids of abuse
with lofexidine or clonidine; the percent
of clients on MAT for opioid use
disorder that receive maintenance
services, detoxification, and relapse
prevention; testing for metabolic
syndrome; drug and alcohol oral fluid
testing; professional interventionist/
educational consultant; recovery coach;
vocational training or educational
support; Naloxone and overdose
education; ‘‘Outcome follow-up after
discharge’’ which was moved from
another question; medications for HIV
treatment; medications for Hepatitis C
treatment; the medications lofexidine
and clonidine; Hepatitis A and B
vaccinations; Buprenorphine (extendedrelease, injectable, for example,
Sublocade®)’’; clients with co-occurring
pain and substance use; Federally
VerDate Sep<11>2014
17:50 Sep 28, 2018
Jkt 247001
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
49403
Qualified Health Centers (FQHC);
Disulfiram, Naltrexone, or Acamprosate
for alcohol use disorder for outpatient,
inpatient, and residential. Also,
response categories were added to select
that services are not provided, and for
medication services provided, an
‘‘other’’ category was added.
The following items have been
deleted compared to the 2017
N–SSATS: Questions about religious
affiliation, standard operating
procedures, outpatient capacity, how
(paper/electronic/both) a facility
performs selected activities, and the
item asking about Access To Recovery
(ATR) client payments have been
deleted.
The following additional changes
have been made compared to the 2017
N–SSATS: Removed the asterisk from
the question about primary focus of
facilities, which means the information
will no longer be published on the
N–SSATS treatment locator; reorganized
the question about services offered;
moved the question on types of
counseling to the question about
services offered; changed the wording
from Screening for Hepatitis B and C to
Testing for Hepatitis B and C; changed
‘‘Screening for mental health disorders’’
to ‘‘Screening for mental disorders’’;
changed the question about clinical/
therapeutic approaches to a ‘‘mark all
that apply’’ format; changed the
wording from ‘‘Computerized substance
abuse treatment/telemedicine’’ to
‘‘Telemedicine/telehealth’’; changed the
question wording about the number of
outpatient clients so it states, ‘‘As of
March 29, 2019, how many active
clients were receiving each of the
following outpatient substance abuse
services at this facility?’’ and changed
the instructions to state ‘‘An active
client is a client who received treatment
in March and is still enrolled in
treatment on March 29, 2019.’’; and
changed the question about halfway
houses so it states, ‘‘Does this facility
operate transitional housing, a halfway
house, or a sober home for substance
abuse clients at this location, that is, the
location listed on the front cover?’’
For the question about how facilities
treat opioid use disorder, information
was added about the question that
states, ‘‘For this question, MAT refers to
any or all of these medications unless
specified.’’ Also, category 5 was
reworded to say ‘‘This facility
administers naltrexone to treat opioid
use disorder. Naltrexone use is
authorized through any medical staff
who have prescribing privileges.’’ In
addition, a category was added, ‘‘This
facility prescribes buprenorphine to
treat opioid use disorder.
E:\FR\FM\01OCN1.SGM
01OCN1
49404
Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
Buprenorphine use is authorized
through a DATA 2000 waivered
physician, physician assistant, or nurse
practitioner.’’ Finally, for the last
option, the wording was changed to
‘‘This facility is a federally-certified
Opioid Treatment Program (OTP). (Most
OTPs administer/dispense methadone;
some only use buprenorphine.)’’
Version B (2020)
All changes to the 2019 N–SSATS
were made for the 2020 N–SSATS
except: Add the question asking if a
facility is part of an organization with
multiple facilities or sites, and if
applicable, the question asking
information about the parent site;
remove the question about the percent
of clients on MAT for opioid use
disorder that receive maintenance
services, detoxification, and relapse
prevention; All of Section B (Reporting
Client Counts) has been deleted which
includes: How the facility will complete
client counts; number of facilities in
client counts; names and addresses of
additional facilities reported for;
number of hospital inpatient client
counts by category, by number under
age 18, number receiving methadone,
buprenorphine, or naltrexone, and
number of dedicated beds; number of
residential client counts by category, by
number under age 18, and number
receiving methadone, buprenorphine, or
naltrexone, and number of dedicated
beds; number of outpatient client counts
by category, by number under age 18,
and number receiving methadone,
buprenorphine, or naltrexone; type of
substance abuse problem, percent of cooccurring clients; and 12-month
admissions; remove questions about
how many hospital inpatients,
residential clients, and outpatient
clients received Disulfiram, Naltrexone,
and Acamprosate for alcohol use
disorder; and add several new electronic
health record questions.
N–SSATS (Between Cycles—BC)
The same changes to the 2020
N–SSATS (Version B) are requested for
the N–SSATS BC except the electronic
health record questions will not be
added.
ESTIMATED ANNUAL BURDEN FOR THE BHSIS ACTIVITIES IS SHOWN BELOW
Number of
respondents
Type of respondent and activity
States:
I–BHS Online 1 ..............................................................
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
56
75
4,200
0.08
336
State Subtotal ........................................................
Facilities:
I–BHS application 2 .......................................................
Augmentation screener .................................................
N–SSATS questionnaire ...............................................
N–SSATS BC ...............................................................
56
........................
4,200
........................
336
800
1,300
17,000
1,000
1
1
1
1
800
1,300
17,000
1,000
0.08
0.08
0.66
0.58
64
104
11,333
580
Facility Subtotal .....................................................
20,100
........................
20,100
........................
12,081
Total ................................................................
20,156
........................
24,300
........................
12,417
1 States
amozie on DSK3GDR082PROD with NOTICES
use the I–BHS Online system to submit information on newly licensed/approved facilities and on changes in facility name, address,
status, etc.
2 New facilities complete and submit the online I–BHS application form in order to get listed on the Inventory.
Written comments and
recommendations concerning the
proposed information collection should
be sent by October 31, 2018 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
VerDate Sep<11>2014
17:50 Sep 28, 2018
Jkt 247001
Affairs, New Executive Office Building,
Room 10102, Washington, DC 20503.
Summer King,
Statistician.
[FR Doc. 2018–21253 Filed 9–28–18; 8:45 am]
BILLING CODE 4162–20–P
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.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Project: Testing of Electronic Health
Records Questions for the National
Survey of Substance Abuse Treatment
Services (N–SSATS) and the National
Mental Health Services Survey (N–
MHSS)—NEW
The Substance Abuse and Mental
Health Services Administration
(SAMHSA), Center for Behavioral
Health Statistics and Quality (CBHSQ),
is requesting approval for conducting
cognitive testing on the use of electronic
health records (EHRs) by substance
abuse and mental health treatment
facilities in the United States. The final
goal of this cognitive testing is to
incorporate questions on electronic
health records to SAMHSA’s National
Survey of Substance Abuse Treatment
Services (N–SSATS) and the National
Mental Health Services Survey (N–
MHSS).
Currently, there is a lack of national
level data that exists on behavioral
health care providers’ progress toward
interoperability. The National Council
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49403-49404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21253]
-----------------------------------------------------------------------
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: National Survey of Substance Abuse Treatment Services (N-
SSATS) (OMB No. 0930-0106)--Revision
The Substance Abuse and Mental Health Services Administration
(SAMHSA) is requesting a revision of the National Survey of Substance
Abuse Treatment (N-SSATS) data collection (OMB No. 0930-0106), which
expires on December 31, 2018. N-SSATS provides both national and state-
level data on the numbers and types of patients treated and the
characteristics of facilities providing substance abuse treatment
services. It is conducted under the authority of Section 505 of the
Public Health Service Act (42 U.S.C. 290aa-4) to meet the specific
mandates for annual information about public and private substance
abuse treatment providers and the clients they serve.
This request includes:
Collection of N-SSATS, which is an annual survey of
substance abuse treatment facilities; and
Updating of the Inventory of Behavioral Health Services
(I-BHS) which is the facility universe for the N-SSATS as well as the
annual survey of mental health treatment facilities, the National
Mental Health Services Survey (N-MHSS). The I-BHS includes all
substance abuse treatment and mental health treatment facilities known
to SAMHSA. (The N-MHSS data collection is covered under OMB No. 0930-
0119.)
The information in I-BHS and N-SSATS is needed to assess the nature
and extent of these resources, to identify gaps in services, and to
provide a database for treatment referrals. Both I-BHS and N-SSATS are
components of the Behavioral Health Services Information System
(BHSIS).
The request for OMB approval will include a request to update the
I-BHS facility listing on a continuous basis and to conduct the N-SSATS
and the between cycle N-SSATS (N-SSATS BC) in 2019, 2020, and 2021. The
N-SSATS BC is a procedure for collecting services data from newly
identified facilities between main cycles of the survey and will be
used to improve the listing of treatment facilities in the online
Behavioral Health Treatment Services Locator.
Planned Changes
I-BHS: Only minor form changes corresponding with updated
technology are planned.
N-SSATS: The N-SSATS with client counts will continue to be
conducted in alternate years, as in the past, and the Treatment Locator
will be updated monthly.
Version A (2019 and 2021)
The following items have been added compared to the 2017 N-SSATS:
Add questions about: Where clients obtain their medications for opioid
use disorder if they originate elsewhere; how facilities treat alcohol
use disorder; where clients obtain their medications for alcohol use
disorder if they originate elsewhere; whether the facility only treats
alcohol use disorder; detoxification from opioids of abuse with
lofexidine or clonidine; the percent of clients on MAT for opioid use
disorder that receive maintenance services, detoxification, and relapse
prevention; testing for metabolic syndrome; drug and alcohol oral fluid
testing; professional interventionist/educational consultant; recovery
coach; vocational training or educational support; Naloxone and
overdose education; ``Outcome follow-up after discharge'' which was
moved from another question; medications for HIV treatment; medications
for Hepatitis C treatment; the medications lofexidine and clonidine;
Hepatitis A and B vaccinations; Buprenorphine (extended-release,
injectable, for example, Sublocade[supreg])''; clients with co-
occurring pain and substance use; Federally Qualified Health Centers
(FQHC); Disulfiram, Naltrexone, or Acamprosate for alcohol use disorder
for outpatient, inpatient, and residential. Also, response categories
were added to select that services are not provided, and for medication
services provided, an ``other'' category was added.
The following items have been deleted compared to the 2017 N-SSATS:
Questions about religious affiliation, standard operating procedures,
outpatient capacity, how (paper/electronic/both) a facility performs
selected activities, and the item asking about Access To Recovery (ATR)
client payments have been deleted.
The following additional changes have been made compared to the
2017 N-SSATS: Removed the asterisk from the question about primary
focus of facilities, which means the information will no longer be
published on the N-SSATS treatment locator; reorganized the question
about services offered; moved the question on types of counseling to
the question about services offered; changed the wording from Screening
for Hepatitis B and C to Testing for Hepatitis B and C; changed
``Screening for mental health disorders'' to ``Screening for mental
disorders''; changed the question about clinical/therapeutic approaches
to a ``mark all that apply'' format; changed the wording from
``Computerized substance abuse treatment/telemedicine'' to
``Telemedicine/telehealth''; changed the question wording about the
number of outpatient clients so it states, ``As of March 29, 2019, how
many active clients were receiving each of the following outpatient
substance abuse services at this facility?'' and changed the
instructions to state ``An active client is a client who received
treatment in March and is still enrolled in treatment on March 29,
2019.''; and changed the question about halfway houses so it states,
``Does this facility operate transitional housing, a halfway house, or
a sober home for substance abuse clients at this location, that is, the
location listed on the front cover?''
For the question about how facilities treat opioid use disorder,
information was added about the question that states, ``For this
question, MAT refers to any or all of these medications unless
specified.'' Also, category 5 was reworded to say ``This facility
administers naltrexone to treat opioid use disorder. Naltrexone use is
authorized through any medical staff who have prescribing privileges.''
In addition, a category was added, ``This facility prescribes
buprenorphine to treat opioid use disorder.
[[Page 49404]]
Buprenorphine use is authorized through a DATA 2000 waivered physician,
physician assistant, or nurse practitioner.'' Finally, for the last
option, the wording was changed to ``This facility is a federally-
certified Opioid Treatment Program (OTP). (Most OTPs administer/
dispense methadone; some only use buprenorphine.)''
Version B (2020)
All changes to the 2019 N-SSATS were made for the 2020 N-SSATS
except: Add the question asking if a facility is part of an
organization with multiple facilities or sites, and if applicable, the
question asking information about the parent site; remove the question
about the percent of clients on MAT for opioid use disorder that
receive maintenance services, detoxification, and relapse prevention;
All of Section B (Reporting Client Counts) has been deleted which
includes: How the facility will complete client counts; number of
facilities in client counts; names and addresses of additional
facilities reported for; number of hospital inpatient client counts by
category, by number under age 18, number receiving methadone,
buprenorphine, or naltrexone, and number of dedicated beds; number of
residential client counts by category, by number under age 18, and
number receiving methadone, buprenorphine, or naltrexone, and number of
dedicated beds; number of outpatient client counts by category, by
number under age 18, and number receiving methadone, buprenorphine, or
naltrexone; type of substance abuse problem, percent of co-occurring
clients; and 12-month admissions; remove questions about how many
hospital inpatients, residential clients, and outpatient clients
received Disulfiram, Naltrexone, and Acamprosate for alcohol use
disorder; and add several new electronic health record questions.
N-SSATS (Between Cycles--BC)
The same changes to the 2020 N-SSATS (Version B) are requested for
the N-SSATS BC except the electronic health record questions will not
be added.
Estimated Annual Burden for the BHSIS Activities Is Shown Below
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Type of respondent and activity respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
States:
I-BHS Online \1\............ 56 75 4,200 0.08 336
-------------------------------------------------------------------------------
State Subtotal.......... 56 .............. 4,200 .............. 336
Facilities:
I-BHS application \2\....... 800 1 800 0.08 64
Augmentation screener....... 1,300 1 1,300 0.08 104
N-SSATS questionnaire....... 17,000 1 17,000 0.66 11,333
N-SSATS BC.................. 1,000 1 1,000 0.58 580
-------------------------------------------------------------------------------
Facility Subtotal....... 20,100 .............. 20,100 .............. 12,081
-------------------------------------------------------------------------------
Total............... 20,156 .............. 24,300 .............. 12,417
----------------------------------------------------------------------------------------------------------------
\1\ States use the I-BHS Online system to submit information on newly licensed/approved facilities and on
changes in facility name, address, status, etc.
\2\ New facilities complete and submit the online I-BHS application form in order to get listed on the
Inventory.
Written comments and recommendations concerning the proposed
information collection should be sent by October 31, 2018 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:
[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. 2018-21253 Filed 9-28-18; 8:45 am]
BILLING CODE 4162-20-P
