80_FR_57812 80 FR 57627 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

80 FR 57627 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration

Federal Register Volume 80, Issue 185 (September 24, 2015)

Page Range57627-57628
FR Document2015-24290

Federal Register, Volume 80 Issue 185 (Thursday, September 24, 2015)
[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Pages 57627-57628]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24290]


-----------------------------------------------------------------------

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: Hospital Data Abstraction Form, Formerly Entitled Evaluation 
of Emergency Department Crisis Center Follow-Up--(OMB No. 0930-0337)--
Revision

    The Substance Abuse and Mental Health Services Administration's 
(SAMHSA), Center for Mental Health Services (CMHS) will conduct an 
evaluation to assess the impact of crisis center follow-up with 
patients admitted to emergency departments following a suicide attempt.

[[Page 57628]]

    The overarching purpose of the Hospital Data Abstraction Form, 
formerly entitled Evaluation of Emergency Department Crisis Center 
Follow-up, is to examine the impact of crisis center follow-up with 
patients admitted to emergency departments or inpatient behavioral 
health units following a suicide attempt or serious suicidal ideation 
on subsequent readmissions for suicidal behavior. This effort assesses 
the capacity of follow-up to save both lives and critical hospital 
resources. This evaluation effort includes one data collection 
activity. Clearance is being requested for the continuation and 
expansion of the already-approved abstraction form of hospital data on 
patients admitted to emergency departments or inpatient behavioral 
health units following a suicide attempt or serious ideation. This 
effort will continue to examine the impact of crisis center follow-up 
on readmissions for suicidal behavior. The data collected through this 
project will ultimately help SAMHSA to understand and direct crisis 
center follow-up lifesaving initiatives. The data collection activity 
is described below.
    Hospitals collaborating with two cohorts (cohorts IV and V) of 
Lifeline crisis centers will participate in this expanded initiative. 
Fifteen hospitals per cohort will participate for a total of 30. 
Patient data will be collected for patients admitted for a suicide 
attempt in the two years prior to collaboration between the hospital 
and crisis center and for patients admitted for a suicide attempt for 
the two-year period after collaboration.
    The Hospital Data Abstraction Form will be utilized to collect 
systematic patient data for patients seen in the 30 participating 
hospitals' emergency departments or inpatient behavioral health units. 
Information to be abstracted from patient data include: Demographic 
data, historical data, and subsequent suicidal behavioral and admission 
data. Data will be de-identified. Hospital staff will review patient 
data for qualifying (i.e., admission to the emergency department for 
suicide attempt) records. Records to be reviewed will include emergency 
department or inpatient behavioral health unit admissions for the two 
years prior to crisis center and hospital collaboration and for two 
years following collaboration. It is expected that a total of 30,000 
records will be abstracted by hospital staff and provided to the 
evaluation team.
    This revision involves an increase in the number of participating 
hospital respondents and burden associated with the continuation/
expansion of the already-approved Hospital Data Abstraction Form (OMB 
No. 0930-0337; Expiration 09/30/2016), as well as the discontinuation 
of data collection and burden associated with the Crisis Center Data 
Abstraction Form.
    The estimated response burden to collect this information is as 
follows annualized over the requested three-year clearance period is 
presented below:

                                            Total and Annualized Averages: Respondents, Responses, and Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of      Responses per     Total number      Burden per
                             Instrument                                respondents      respondent *     of responses       response     Annual burden *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hospital Data Abstraction Form.....................................              30              334           10,020              .04              401
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Rounded to the nearest whole number

    Written comments and recommendations concerning the proposed 
information collection should be sent by October 26, 2015 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. 2015-24290 Filed 9-23-15; 8:45 am]
BILLING CODE 4162-20-P



                                                                       Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices                                                 57627

                                              determined by information indicating                    ACTION:   Notice.                                     would benefit from harmonization,
                                              that the submission is written by an                                                                          consistency, clarity, simplification and/
                                              individual, for example, the comment is                 SUMMARY:   Pursuant to Section 10(a) of               or coordination.
                                              identified with the category ‘‘Individual               the Federal Advisory Committee Act, 5
                                                                                                                                                               The meeting will adjourn at 4:30 p.m.
                                              Consumer’’ under the field titled                       U.S.C. App 2, notice is hereby given that
                                                                                                                                                            October 22, 2015. Time for public
                                              ‘‘Category (Required),’’ on the ‘‘Your                  the Secretary’s Advisory Committee on
                                                                                                                                                            comment sessions will be allotted both
                                              Information’’ page on                                   Human Research Protections (SACHRP)
                                                                                                                                                            days.
                                              www.regulations.gov. For this docket,                   will hold a meeting that will be open to
                                                                                                      the public. Information about SACHRP                     Public attendance at the meeting is
                                              however, FDA will not be following this
                                                                                                      and the full meeting agenda will be                   limited to space available. Individuals
                                              general practice. Instead, FDA will post
                                                                                                      posted on the SACHRP Web site at:                     who plan to attend and need special
                                              on http://www.regulations.gov
                                                                                                      http://www.dhhs.gov/ohrp/sachrp/                      assistance, such as sign language
                                              comments to this docket that have been
                                              submitted by individuals in their                       mtgings/index.html.                                   interpretation or other reasonable
                                              individual capacity. If you wish to                     DATES: The meeting will be held on
                                                                                                                                                            accommodations, should notify one of
                                              submit any information under a claim of                 Wednesday, October 21, 2015, from 8:30                the designated SACHRP points of
                                              confidentiality, please refer to 21 CFR                 a.m. until 5:00 p.m. and Thursday,                    contact at the address/phone number
                                              10.20.                                                  October 22, 2015, from 8:30 a.m. until                listed above at least one week prior to
                                                                                                      4:30 p.m.                                             the meeting. Pre-registration is required
                                              C. Information Identifying the Person                                                                         for participation in the on-site public
                                              Submitting the Comment                                  ADDRESSES: Fishers Lane Conference
                                                                                                                                                            comment session; individuals may pre-
                                                                                                      Center, Terrace Level, 5635 Fishers                   register the day of the meeting.
                                                Please note that your name, contact                   Lane, Rockville, Maryland 20852.
                                              information, and other information                                                                            Individuals who would like to submit
                                                                                                      FOR FURTHER INFORMATION CONTACT: Jerry                written statements should email or fax
                                              identifying you will be posted on http://
                                                                                                      Menikoff, M.D., J.D., Director, Office for            their comments to SACHRP at
                                              www.regulations.gov if you include that
                                                                                                      Human Research Protections (OHRP), or                 SACHRP@hhs.gov at least five business
                                              information in the body of your
                                                                                                      Julia Gorey, J.D., Executive Director,                days prior to the meeting.
                                              comments. For electronic comments
                                                                                                      SACHRP; U.S. Department of Health
                                              submitted to http://                                                                                            Dated: September 18, 2015.
                                                                                                      and Human Services, 1101 Wootton
                                              www.regulations.gov, FDA will post the                                                                        Jerry Menikoff,
                                                                                                      Parkway, Suite 200, Rockville,
                                              body of your comment on http://                                                                               Executive Secretary, Secretary’s Advisory
                                                                                                      Maryland 20852; telephone: 240–453–
                                              www.regulations.gov along with your                                                                           Committee on Human Research Protections,
                                                                                                      8141; fax: 240–453–6909; email address:
                                              state/province and country (if                                                                                Director, Office for Human Research
                                                                                                      SACHRP@hhs.gov.
                                              provided), the name of your                                                                                   Protections.
                                              representative (if any), and the category               SUPPLEMENTARY INFORMATION: Under the
                                                                                                                                                            [FR Doc. 2015–24264 Filed 9–23–15; 8:45 am]
                                              identifying you (e.g., individual,                      authority of 42 U.S.C. 217a, Section 222
                                                                                                                                                            BILLING CODE 4150–36–P
                                              consumer, academic, industry). For                      of the Public Health Service Act, as
                                              written submissions submitted to the                    amended, SACHRP was established to
                                              Division of Dockets Management, FDA                     provide expert advice and                             DEPARTMENT OF HEALTH AND
                                              will post the body of your comments on                  recommendations to the Secretary of                   HUMAN SERVICES
                                              http://www.regulations.gov, but you can                 Health and Human Services, through
                                              put your name and/or contact                            the Assistant Secretary for Health, on                Substance Abuse and Mental Health
                                              information on a separate cover sheet                   issues and topics pertaining to or                    Services Administration
                                              and not in the body of your comments.                   associated with the protection of human
                                                                                                      research subjects.                                    Agency Information Collection
                                              IV. Electronic Access                                      The meeting will open to the public                Activities: Submission for OMB
                                                Persons with access to the Internet                   at 8:30 a.m., on Wednesday, October 21,               Review; Comment Request
                                              may obtain an electronic version of this                followed by opening remarks from Dr.
                                              guidance document at http://                            Jerry Menikoff, Executive Secretary of                  Periodically, the Substance Abuse and
                                              www.fda.gov/TobaccoProducts/                            SACHRP and OHRP Director, and Dr.                     Mental Health Services Administration
                                              Labeling/RulesRegulationsGuidance/                      Jeffrey Botkin, SACHRP Chair. The                     (SAMHSA) will publish a summary of
                                              ucm281147.htm or http://                                Committee will hear the Subpart A                     information collection requests under
                                              www.regulations.gov.                                    Subcommittee (SAS) and Subcommittee                   OMB review, in compliance with the
                                                                                                      on Harmonization (SOH) reports on the                 Paperwork Reduction Act (44 U.S.C.
                                                Dated: September 16, 2015.                                                                                  Chapter 35). To request a copy of these
                                                                                                      recent Notice of Proposed Rulemaking
                                              Leslie Kux,                                                                                                   documents, call the SAMHSA Reports
                                                                                                      (NPRM) titled Federal Policy for the
                                              Associate Commissioner for Policy.                      Protection of Human Subjects (80 FR                   Clearance Officer on (240) 276–1243.
                                              [FR Doc. 2015–24218 Filed 9–23–15; 8:45 am]             53933, Sep. 8, 2015). Both days will be               Project: Hospital Data Abstraction
                                              BILLING CODE 4164–01–P                                  devoted to the discussion of the NPRM.                Form, Formerly Entitled Evaluation of
                                                                                                         SAS was established by SACHRP in                   Emergency Department Crisis Center
                                                                                                      October 2006 and is charged with                      Follow-Up—(OMB No. 0930–0337)—
                                              DEPARTMENT OF HEALTH AND                                developing recommendations for
                                              HUMAN SERVICES                                                                                                Revision
                                                                                                      consideration by SACHRP regarding the
                                                                                                      application of subpart A of 45 CFR part                 The Substance Abuse and Mental
                                              Meeting of the Secretary’s Advisory
tkelley on DSK3SPTVN1PROD with NOTICES




                                                                                                      46 in the current research environment.               Health Services Administration’s
                                              Committee on Human Research
                                                                                                         SOH was established by SACHRP at                   (SAMHSA), Center for Mental Health
                                              Protections
                                                                                                      its July 2009 meeting and charged with                Services (CMHS) will conduct an
                                              AGENCY:  Office of the Assistant                        identifying and prioritizing areas in                 evaluation to assess the impact of crisis
                                              Secretary for Health, Office of the                     which regulations and/or guidelines for               center follow-up with patients admitted
                                              Secretary, Department of Health and                     human subjects research adopted by                    to emergency departments following a
                                              Human Services.                                         various agencies or offices within HHS                suicide attempt.


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                                              57628                        Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices

                                                 The overarching purpose of the                             and direct crisis center follow-up                    admission to the emergency department
                                              Hospital Data Abstraction Form,                               lifesaving initiatives. The data                      for suicide attempt) records. Records to
                                              formerly entitled Evaluation of                               collection activity is described below.               be reviewed will include emergency
                                              Emergency Department Crisis Center                               Hospitals collaborating with two                   department or inpatient behavioral
                                              Follow-up, is to examine the impact of                        cohorts (cohorts IV and V) of Lifeline                health unit admissions for the two years
                                              crisis center follow-up with patients                         crisis centers will participate in this               prior to crisis center and hospital
                                              admitted to emergency departments or                          expanded initiative. Fifteen hospitals                collaboration and for two years
                                              inpatient behavioral health units                             per cohort will participate for a total of            following collaboration. It is expected
                                              following a suicide attempt or serious                        30. Patient data will be collected for                that a total of 30,000 records will be
                                              suicidal ideation on subsequent                               patients admitted for a suicide attempt               abstracted by hospital staff and
                                              readmissions for suicidal behavior. This                      in the two years prior to collaboration               provided to the evaluation team.
                                              effort assesses the capacity of follow-up                     between the hospital and crisis center
                                                                                                                                                                    This revision involves an increase in
                                              to save both lives and critical hospital                      and for patients admitted for a suicide
                                              resources. This evaluation effort                                                                                   the number of participating hospital
                                                                                                            attempt for the two-year period after
                                              includes one data collection activity.                        collaboration.                                        respondents and burden associated with
                                              Clearance is being requested for the                             The Hospital Data Abstraction Form                 the continuation/expansion of the
                                              continuation and expansion of the                             will be utilized to collect systematic                already-approved Hospital Data
                                              already-approved abstraction form of                          patient data for patients seen in the 30              Abstraction Form (OMB No. 0930–0337;
                                              hospital data on patients admitted to                         participating hospitals’ emergency                    Expiration 09/30/2016), as well as the
                                              emergency departments or inpatient                            departments or inpatient behavioral                   discontinuation of data collection and
                                              behavioral health units following a                           health units. Information to be                       burden associated with the Crisis Center
                                              suicide attempt or serious ideation. This                     abstracted from patient data include:                 Data Abstraction Form.
                                              effort will continue to examine the                           Demographic data, historical data, and                  The estimated response burden to
                                              impact of crisis center follow-up on                          subsequent suicidal behavioral and                    collect this information is as follows
                                              readmissions for suicidal behavior. The                       admission data. Data will be de-                      annualized over the requested three-
                                              data collected through this project will                      identified. Hospital staff will review                year clearance period is presented
                                              ultimately help SAMHSA to understand                          patient data for qualifying (i.e.,                    below:

                                                                              TOTAL AND ANNUALIZED AVERAGES: RESPONDENTS, RESPONSES, AND HOURS
                                                                                                                                               Responses
                                                                                                                            Number of                           Total number              Burden per       Annual bur-
                                                                            Instrument                                                            per
                                                                                                                           respondents                          of responses               response          den *
                                                                                                                                              respondent *

                                              Hospital Data Abstraction Form ...........................................        30                   334           10,020                    .04               401
                                                 * Rounded to the nearest whole number


                                                Written comments and                                        DEPARTMENT OF HOMELAND                                FOR FURTHER INFORMATION CONTACT:
                                              recommendations concerning the                                SECURITY                                              Approved Gauger and Accredited
                                              proposed information collection should                                                                              Laboratories Manager, Laboratories and
                                              be sent by October 26, 2015 to the                            U.S. Customs and Border Protection                    Scientific Services Directorate, U.S.
                                              SAMHSA Desk Officer at the Office of                                                                                Customs and Border Protection, 1300
                                                                                                            Accreditation and Approval of Amspec                  Pennsylvania Avenue NW., Suite
                                              Information and Regulatory Affairs,
                                                                                                            Services, LLC, as a Commercial                        1500N, Washington, DC 20229, tel. 202–
                                              Office of Management and Budget
                                                                                                            Gauger and Laboratory                                 344–1060.
                                              (OMB). To ensure timely receipt of
                                              comments, and to avoid potential delays                       AGENCY:  U.S. Customs and Border                      SUPPLEMENTARY INFORMATION: Notice is
                                              in OMB’s receipt and processing of mail                       Protection, Department of Homeland                    hereby given pursuant to 19 CFR 151.12
                                              sent through the U.S. Postal Service,                         Security.                                             and 19 CFR 151.13, that AmSpec
                                              commenters are encouraged to submit                           ACTION: Notice of accreditation and                   Services, LLC, 100 Wheeler St., Unit G,
                                                                                                            approval of AmSpec Services, LLC, as a                New Haven, CT 06512, has been
                                              their comments to OMB via email to:
                                                                                                            commercial gauger and laboratory.                     approved to gauge petroleum and
                                              OIRA_Submission@omb.eop.gov.
                                                                                                                                                                  certain petroleum products and
                                              Although commenters are encouraged to
                                                                                                            SUMMARY:   Notice is hereby given,                    accredited to test petroleum and certain
                                              send their comments via email,                                pursuant to CBP regulations, that                     petroleum products for customs
                                              commenters may also fax their                                 AmSpec Services, LLC, has been                        purposes, in accordance with the
                                              comments to: 202–395–7285.                                    approved to gauge petroleum and                       provisions of 19 CFR 151.12 and 19 CFR
                                              Commenters may also mail them to:                             certain petroleum products and                        151.13. AmSpec Services, LLC is
                                              Office of Management and Budget,                              accredited to test petroleum and certain              approved for the following gauging
                                              Office of Information and Regulatory                          petroleum products for customs                        procedures for petroleum and certain
                                              Affairs, New Executive Office Building,                       purposes for the next three years as of               petroleum products from the American
                                              Room 10102, Washington, DC 20503.                             April 29, 2015.                                       Petroleum Institute (API):
tkelley on DSK3SPTVN1PROD with NOTICES




                                              Summer King,                                                  DATES: Effective Dates: The
                                                                                                            accreditation and approval of AmSpec                   API chapters                        Title
                                              Statistician.
                                                                                                            Services, LLC, as commercial gauger                   1 ...................   Vocabulary.
                                              [FR Doc. 2015–24290 Filed 9–23–15; 8:45 am]
                                                                                                            and laboratory became effective on                    3 ...................   Tank Gauging.
                                              BILLING CODE 4162–20–P                                        April 29, 2015. The next triennial                    7 ...................   Temperature Determination.
                                                                                                            inspection date will be scheduled for                 8 ...................   Sampling.
                                                                                                            April 2018.                                           12 .................    Calculations.



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Document Created: 2018-02-26 10:18:03
Document Modified: 2018-02-26 10:18:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation80 FR 57627 

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