Performance Review Board Members, 52226 [2018-22491]
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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This draft guidance refers to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collection of information in the draft
guidance for industry entitled ‘‘Formal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may obtain the draft guidance at either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]
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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]
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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
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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
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[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)]
[Notices]
[Page 52226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22491]
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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 Employee first name
------------------------------------------------------------------------
Alvarez Karl
Bush Laina
Cash Lester
Hoffman Darrell
Kerr Lawrence
Walker 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
