Agency Information Collection Activities: Submission for OMB Review; Comment Request, 57627-57628 [2015-24290]
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Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices
determined by information indicating
that the submission is written by an
individual, for example, the comment is
identified with the category ‘‘Individual
Consumer’’ under the field titled
‘‘Category (Required),’’ on the ‘‘Your
Information’’ page on
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however, FDA will not be following this
general practice. Instead, FDA will post
on https://www.regulations.gov
comments to this docket that have been
submitted by individuals in their
individual capacity. If you wish to
submit any information under a claim of
confidentiality, please refer to 21 CFR
10.20.
C. Information Identifying the Person
Submitting the Comment
Please note that your name, contact
information, and other information
identifying you will be posted on https://
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information in the body of your
comments. For electronic comments
submitted to https://
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body of your comment on https://
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IV. Electronic Access
Persons with access to the Internet
may obtain an electronic version of this
guidance document at https://
www.fda.gov/TobaccoProducts/
Labeling/RulesRegulationsGuidance/
ucm281147.htm or https://
www.regulations.gov.
Dated: September 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–24218 Filed 9–23–15; 8:45 am]
BILLING CODE 4164–01–P
tkelley on DSK3SPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
AGENCY:
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16:45 Sep 23, 2015
Jkt 235001
ACTION:
Notice.
Pursuant to Section 10(a) of
the Federal Advisory Committee Act, 5
U.S.C. App 2, notice is hereby given that
the Secretary’s Advisory Committee on
Human Research Protections (SACHRP)
will hold a meeting that will be open to
the public. Information about SACHRP
and the full meeting agenda will be
posted on the SACHRP Web site at:
https://www.dhhs.gov/ohrp/sachrp/
mtgings/.
DATES: The meeting will be held on
Wednesday, October 21, 2015, from 8:30
a.m. until 5:00 p.m. and Thursday,
October 22, 2015, from 8:30 a.m. until
4:30 p.m.
ADDRESSES: Fishers Lane Conference
Center, Terrace Level, 5635 Fishers
Lane, Rockville, Maryland 20852.
FOR FURTHER INFORMATION CONTACT: Jerry
Menikoff, M.D., J.D., Director, Office for
Human Research Protections (OHRP), or
Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health, on
issues and topics pertaining to or
associated with the protection of human
research subjects.
The meeting will open to the public
at 8:30 a.m., on Wednesday, October 21,
followed by opening remarks from Dr.
Jerry Menikoff, Executive Secretary of
SACHRP and OHRP Director, and Dr.
Jeffrey Botkin, SACHRP Chair. The
Committee will hear the Subpart A
Subcommittee (SAS) and Subcommittee
on Harmonization (SOH) reports on the
recent Notice of Proposed Rulemaking
(NPRM) titled Federal Policy for the
Protection of Human Subjects (80 FR
53933, Sep. 8, 2015). Both days will be
devoted to the discussion of the NPRM.
SAS was established by SACHRP in
October 2006 and is charged with
developing recommendations for
consideration by SACHRP regarding the
application of subpart A of 45 CFR part
46 in the current research environment.
SOH was established by SACHRP at
its July 2009 meeting and charged with
identifying and prioritizing areas in
which regulations and/or guidelines for
human subjects research adopted by
various agencies or offices within HHS
SUMMARY:
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57627
would benefit from harmonization,
consistency, clarity, simplification and/
or coordination.
The meeting will adjourn at 4:30 p.m.
October 22, 2015. Time for public
comment sessions will be allotted both
days.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify one of
the designated SACHRP points of
contact at the address/phone number
listed above at least one week prior to
the meeting. Pre-registration is required
for participation in the on-site public
comment session; individuals may preregister the day of the meeting.
Individuals who would like to submit
written statements should email or fax
their comments to SACHRP at
SACHRP@hhs.gov at least five business
days prior to the meeting.
Dated: September 18, 2015.
Jerry Menikoff,
Executive Secretary, Secretary’s Advisory
Committee on Human Research Protections,
Director, Office for Human Research
Protections.
[FR Doc. 2015–24264 Filed 9–23–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: 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.
E:\FR\FM\24SEN1.SGM
24SEN1
57628
Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices
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 deidentified. 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 threeyear clearance period is presented
below:
TOTAL AND ANNUALIZED AVERAGES: RESPONDENTS, RESPONSES, AND HOURS
Instrument
Number of
respondents
Responses
per
respondent *
Total number
of responses
Burden per
response
Annual burden *
Hospital Data Abstraction Form ...........................................
30
334
10,020
.04
401
* Rounded to the nearest whole number
tkelley on DSK3SPTVN1PROD with NOTICES
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:
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. 2015–24290 Filed 9–23–15; 8:45 am]
BILLING CODE 4162–20–P
VerDate Sep<11>2014
16:45 Sep 23, 2015
Jkt 235001
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Accreditation and Approval of Amspec
Services, LLC, as a Commercial
Gauger and Laboratory
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of accreditation and
approval of AmSpec Services, LLC, as a
commercial gauger and laboratory.
AGENCY:
Notice is hereby given,
pursuant to CBP regulations, that
AmSpec Services, LLC, has been
approved to gauge petroleum and
certain petroleum products and
accredited to test petroleum and certain
petroleum products for customs
purposes for the next three years as of
April 29, 2015.
DATES: Effective Dates: The
accreditation and approval of AmSpec
Services, LLC, as commercial gauger
and laboratory became effective on
April 29, 2015. The next triennial
inspection date will be scheduled for
April 2018.
SUMMARY:
PO 00000
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Fmt 4703
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FOR FURTHER INFORMATION CONTACT:
Approved Gauger and Accredited
Laboratories Manager, Laboratories and
Scientific Services Directorate, U.S.
Customs and Border Protection, 1300
Pennsylvania Avenue NW., Suite
1500N, Washington, DC 20229, tel. 202–
344–1060.
SUPPLEMENTARY INFORMATION: Notice is
hereby given pursuant to 19 CFR 151.12
and 19 CFR 151.13, that AmSpec
Services, LLC, 100 Wheeler St., Unit G,
New Haven, CT 06512, has been
approved to gauge petroleum and
certain petroleum products and
accredited to test petroleum and certain
petroleum products for customs
purposes, in accordance with the
provisions of 19 CFR 151.12 and 19 CFR
151.13. AmSpec Services, LLC is
approved for the following gauging
procedures for petroleum and certain
petroleum products from the American
Petroleum Institute (API):
API chapters
1 ...................
3 ...................
7 ...................
8 ...................
12 .................
E:\FR\FM\24SEN1.SGM
24SEN1
Title
Vocabulary.
Tank Gauging.
Temperature Determination.
Sampling.
Calculations.
Agencies
[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Pages 57627-57628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
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. 2015-24290 Filed 9-23-15; 8:45 am]
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