Agency Information Collection Activities: Submission for Office of Management and Budget (OMB) Review; Comment Request, 52226-52227 [2018-22446]
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52226
Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Notices
on regulatory considerations for use of
MRD in drug and biological products in
development for hematologic
malignancies. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information in 21 CFR part 312 for
submitting INDs has been approved
under OMB control number 0910–0014.
The collection of information in 21 CFR
part 314 for the submission of new drug
applications has been approved under
OMB control number 0910–0001. The
collection of information in the draft
guidance for industry entitled ‘‘Formal
Meetings Between the FDA and
Sponsors or Applicants of PDUFA
Products’’ (available at https://
www.fda.gov/ucm/groups/fdagovpublic/@fdagov-drugs-gen/documents/
document/ucm590547.pdf) has been
approved under OMB control number
0910–0429. The submission of special
protocol assessments has been approved
under OMB control number 0910–0470.
The submission of biologics license
applications has been approved under
OMB control number 0910–0338. The
submission of investigational device
exemptions has been approved under
OMB control number 0910–0078.
III. Electronic Access
amozie on DSK3GDR082PROD with NOTICES1
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: October 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22436 Filed 10–15–18; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Performance Review Board Members
Title 5, U.S.C. Section 4314(c)(4) of
the Civil Service Reform Act of 1978,
Public Law 95–454, requires that the
appointment of Performance Review
Board Members be published in the
Federal Register. The following persons
may be named to serve on the
Performance Review Boards or Panels,
which oversee the evaluation of
performance appraisals of Senior
Executive Service members of the
Department of Health and Human
Services.
Employee last name
Alvarez
Bush
Cash
Hoffman
Kerr
Walker
Employee first name
Karl
Laina
Lester
Darrell
Lawrence
Edwin
Dated: October 10, 2018.
Charles H. McEnerney III,
Director, Executive and Scientific Resources
Division.
[FR Doc. 2018–22491 Filed 10–15–18; 8:45 am]
BILLING CODE 4151–17–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for Office of
Management and Budget (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: State Targeted Response to the
Opioid Crisis Grant Program Mid-Year
and End-Year Performance Reports—
(OMB No. 0930–0378)—in Use Without
OMB Approval
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) is authorized under Section
1003 of the 21st Century Cures Act, as
amended, to support a grant program,
for up to 2 years, that addresses the
PO 00000
Frm 00039
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supplemental activities pertaining to
opioids currently undertaken by the
state agency or territory and will
support a comprehensive response to
the opioid epidemic.
SAMHSA received approval from
OMB in September 2017 to collect
performance data from Opioid State
Targeted Response (STR) grantees (OMB
No. 0930–0378). However, SAMHSA
omitted a data collection table (Table E)
in the original OMB request. This data
table is currently in use by Opioid STR
grantees, who are reporting Table E data
to SAMHSA on a semi-annual basis. In
order to correct this violation, SAMHSA
is now seeking OMB approval for a new
data collection package that includes
not only the instruments originally
approved by OMB in September 2017,
but also this additional data collection
table. It is important for SAMHSA to
continue to collect this information in
order to assess the impact of funding
from the Opioid STR program on
increasing access to prevention
strategies, as well as treatment and
recovery services that address the
opioid crisis. Additionally, this data
will provide SAMHSA with critical
information to effectively manage the
Opioid STR program, to help states and
territories adopt, or scale-up, effective
practices and policies, and to help
prepare to implement the new State
Opioid Response grant program.
The primary purpose of the Opioid
STR program is to address the opioid
crisis by increasing access to treatment,
reducing unmet treatment need, and
reducing opioid overdose related deaths
through the provision of prevention,
treatment and recovery activities for
opioid use disorder (OUD) (including
prescription opioids as well as illicit
drugs such as heroin).
There are 57 (states and jurisdictions)
award recipients in this program. All
funded states and jurisdictions are
asked to report on their implementation
and performance through an online data
collection system. Award recipients
report performance on the following
measures specific to this program:
Number of people who receive OUD
treatment, number of people who
receive OUD recovery services, number
of providers implementing medicationassisted treatment, and the number of
OUD prevention and treatment
providers trained, to include nurse
practitioners, physician assistants, as
well as physicians, nurses, counselors,
social workers, case managers, etc. This
information is collected at the mid-point
and conclusion of each grant award
year. Additionally, each award recipient
E:\FR\FM\16OCN1.SGM
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Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Notices
describes the purposes for which the
grant funds received were expended and
the activities implemented under this
program.
ANNUALIZED ESTIMATED BURDEN HOURS FOR THE PROGRESS REPORT
Respondent
Number of
respondents
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
State and Jurisdictions .........................................................
57
2
114
8.5
969
Written comments and
recommendations concerning the
proposed information collection should
be sent by November 15, 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
Affairs, New Executive Office Building,
Room 10102, Washington, DC 20503.
Summer King,
Statistician.
[FR Doc. 2018–22446 Filed 10–15–18; 8:45 am]
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BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Accreditation and Approval of Intertek
USA Inc. (Yorktown, VA) as a
Commercial Gauger and Laboratory
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of accreditation and
approval of Intertek USA Inc.
(Yorktown, VA), as a commercial gauger
and laboratory.
AGENCY:
Notice is hereby given,
pursuant to CBP regulations, that
Intertek USA Inc. (Yorktown, VA), 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
August 23, 2017.
DATES: Intertek USA Inc. (Yorktown,
VA) was approved and accredited as a
commercial gauger and laboratory as of
August 23, 2017. The next triennial
inspection date will be scheduled for
August 2020.
FOR FURTHER INFORMATION CONTACT:
Melanie Glass, Laboratories and
Scientific Services, U.S. Customs and
Border Protection, 1300 Pennsylvania
Avenue NW, Suite 1500N, Washington,
DC 20229, tel. 202–344–1060.
SUMMARY:
Notice is
hereby given pursuant to 19 CFR 151.12
and 19 CFR 151.13, that Intertek USA,
Inc., 109–B Freedom Blvd., Yorktown,
VA 23692, 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.
Intertek USA Inc. (Yorktown, VA) is
approved for the following gauging
procedures for petroleum and certain
petroleum products from the American
Petroleum Institute (API):
SUPPLEMENTARY INFORMATION:
API chapters
1 ..................
3 ..................
5 ..................
7 ..................
8 ..................
12 ................
17 ................
Title
Vocabulary.
Tank Gauging.
Metering.
Temperature Determination.
Sampling.
Calculations.
Maritime Measurement.
Intertek USA Inc. (Yorktown, VA) is
accredited for the following laboratory
analysis procedures and methods for
petroleum and certain petroleum
products set forth by the U.S. Customs
and Border Protection Laboratory
Methods (CBPL) and American Society
for Testing and Materials (ASTM):
CBPL No.
ASTM
Title
27–01 ............
27–02 ............
D287
D1298
27–04
27–05
27–06
27–07
27–08
27–09
27–11
27–13
............
............
............
............
............
............
............
............
D95
D4928
D473
D4807
D86
D4953
D445
D4294
27–46
27–48
27–50
27–54
............
............
............
............
D5002
D4052
D93
D1796
Standard Test Method for API Gravity of Crude Petroleum and Petroleum Products (Hydrometer Method).
Standard Test Method for Density, Relative Density (Specific Gravity), or API Gravity of Crude Petroleum and Liquid
Petroleum Products by Hydrometer Method.
Standard Test Method for Water in Petroleum Products and Bituminous Materials by Distillation.
Standard Test Method for Water in Crude Oils by Coulometric Karl Fischer Titration.
Standard Test Method for Sediment in Crude Oils and Fuel Oils by the Extraction Method.
Standard Test Method for Sediment in Crude Oil by Membrane Filtration.
Standard Test Method for Distillation of Petroleum Products.
Standard Test Method for Vapor Pressure of Gasoline and Gasoline-Oxgenate Blends (Dry Method).
Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids.
Standard Test Method for Sulfur in Petroleum and Petroleum Products by Energy-Dispersive X-ray Fluorescence Spectrometry.
Standard Test Method for Density and Relative Density of Crude Oils by Digital Density Analyzer.
Standard Test Method for Density and Relative Density of Liquids by Digital Density Meter.
Standard Test Methods for Flash-Point by Pensky-Martens Closed Cup Tester.
Standard Test Method for Water and Sediment in Fuel Oils by the Centrifuge Method.
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]]>Agencies
[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)]
[Notices]
[Pages 52226-52227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22446]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for Office
of Management and Budget (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: State Targeted Response to the Opioid Crisis Grant Program
Mid-Year and End-Year Performance Reports--(OMB No. 0930-0378)--in Use
Without OMB Approval
The Substance Abuse and Mental Health Services Administration
(SAMHSA) is authorized under Section 1003 of the 21st Century Cures
Act, as amended, to support a grant program, for up to 2 years, that
addresses the supplemental activities pertaining to opioids currently
undertaken by the state agency or territory and will support a
comprehensive response to the opioid epidemic.
SAMHSA received approval from OMB in September 2017 to collect
performance data from Opioid State Targeted Response (STR) grantees
(OMB No. 0930-0378). However, SAMHSA omitted a data collection table
(Table E) in the original OMB request. This data table is currently in
use by Opioid STR grantees, who are reporting Table E data to SAMHSA on
a semi-annual basis. In order to correct this violation, SAMHSA is now
seeking OMB approval for a new data collection package that includes
not only the instruments originally approved by OMB in September 2017,
but also this additional data collection table. It is important for
SAMHSA to continue to collect this information in order to assess the
impact of funding from the Opioid STR program on increasing access to
prevention strategies, as well as treatment and recovery services that
address the opioid crisis. Additionally, this data will provide SAMHSA
with critical information to effectively manage the Opioid STR program,
to help states and territories adopt, or scale-up, effective practices
and policies, and to help prepare to implement the new State Opioid
Response grant program.
The primary purpose of the Opioid STR program is to address the
opioid crisis by increasing access to treatment, reducing unmet
treatment need, and reducing opioid overdose related deaths through the
provision of prevention, treatment and recovery activities for opioid
use disorder (OUD) (including prescription opioids as well as illicit
drugs such as heroin).
There are 57 (states and jurisdictions) award recipients in this
program. All funded states and jurisdictions are asked to report on
their implementation and performance through an online data collection
system. Award recipients report performance on the following measures
specific to this program: Number of people who receive OUD treatment,
number of people who receive OUD recovery services, number of providers
implementing medication-assisted treatment, and the number of OUD
prevention and treatment providers trained, to include nurse
practitioners, physician assistants, as well as physicians, nurses,
counselors, social workers, case managers, etc. This information is
collected at the mid-point and conclusion of each grant award year.
Additionally, each award recipient
[[Page 52227]]
describes the purposes for which the grant funds received were expended
and the activities implemented under this program.
Annualized Estimated Burden Hours for the Progress Report
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondent Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
State and Jurisdictions............................................ 57 2 114 8.5 969
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent by November 15, 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. 2018-22446 Filed 10-15-18; 8:45 am]
BILLING CODE 4162-20-P
