83 FR 52226 - Performance Review Board Members
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 83, Issue 200 (October 16, 2018)
Federal Register Volume 83, Issue 200 (October 16, 2018)
| Page Range | 52226-52226 | |
| FR Document | 2018-22491 |
[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)] [Notices] [Page 52226] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22491] ----------------------------------------------------------------------- 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
![52226 Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Notices
on regulatory considerations for use of DEPARTMENT OF HEALTH AND supplemental activities pertaining to
MRD in drug and biological products in HUMAN SERVICES opioids currently undertaken by the
development for hematologic state agency or territory and will
malignancies. It does not establish any Performance Review Board Members support a comprehensive response to
rights for any person and is not binding the opioid epidemic.
Title 5, U.S.C. Section 4314(c)(4) of SAMHSA received approval from
on FDA or the public. You can use an the Civil Service Reform Act of 1978,
alternative approach if it satisfies the OMB in September 2017 to collect
Public Law 95–454, requires that the performance data from Opioid State
requirements of the applicable statutes appointment of Performance Review Targeted Response (STR) grantees (OMB
and regulations. This guidance is not Board Members be published in the No. 0930–0378). However, SAMHSA
subject to Executive Order 12866. Federal Register. The following persons omitted a data collection table (Table E)
II. Paperwork Reduction Act of 1995 may be named to serve on the in the original OMB request. This data
Performance Review Boards or Panels, table is currently in use by Opioid STR
This draft guidance refers to which oversee the evaluation of grantees, who are reporting Table E data
previously approved collections of performance appraisals of Senior to SAMHSA on a semi-annual basis. In
information found in FDA regulations. Executive Service members of the order to correct this violation, SAMHSA
These collections of information are Department of Health and Human is now seeking OMB approval for a new
subject to review by the Office of Services. data collection package that includes
Management and Budget (OMB) under not only the instruments originally
Employee last name Employee first name approved by OMB in September 2017,
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of Alvarez Karl
but also this additional data collection
information in 21 CFR part 312 for Bush Laina table. It is important for SAMHSA to
submitting INDs has been approved Cash Lester continue to collect this information in
under OMB control number 0910–0014. Hoffman Darrell order to assess the impact of funding
The collection of information in 21 CFR Kerr Lawrence from the Opioid STR program on
Walker Edwin increasing access to prevention
part 314 for the submission of new drug
strategies, as well as treatment and
applications has been approved under
Dated: October 10, 2018. recovery services that address the
OMB control number 0910–0001. The opioid crisis. Additionally, this data
collection of information in the draft Charles H. McEnerney III,
will provide SAMHSA with critical
guidance for industry entitled ‘‘Formal Director, Executive and Scientific Resources
Division. information to effectively manage the
Meetings Between the FDA and Opioid STR program, to help states and
Sponsors or Applicants of PDUFA [FR Doc. 2018–22491 Filed 10–15–18; 8:45 am]
territories adopt, or scale-up, effective
Products’’ (available at https:// BILLING CODE 4151–17–P
practices and policies, and to help
www.fda.gov/ucm/groups/fdagov- prepare to implement the new State
public/@fdagov-drugs-gen/documents/ Opioid Response grant program.
DEPARTMENT OF HEALTH AND
document/ucm590547.pdf) has been The primary purpose of the Opioid
HUMAN SERVICES
approved under OMB control number STR program is to address the opioid
0910–0429. The submission of special Substance Abuse and Mental Health crisis by increasing access to treatment,
protocol assessments has been approved Services Administration reducing unmet treatment need, and
under OMB control number 0910–0470. reducing opioid overdose related deaths
Agency Information Collection through the provision of prevention,
The submission of biologics license treatment and recovery activities for
applications has been approved under Activities: Submission for Office of
Management and Budget (OMB) opioid use disorder (OUD) (including
OMB control number 0910–0338. The prescription opioids as well as illicit
Review; Comment Request
submission of investigational device drugs such as heroin).
exemptions has been approved under Periodically, the Substance Abuse and There are 57 (states and jurisdictions)
OMB control number 0910–0078. Mental Health Services Administration award recipients in this program. All
(SAMHSA) will publish a summary of funded states and jurisdictions are
III. Electronic Access information collection requests under asked to report on their implementation
Persons with access to the internet OMB review, in compliance with the and performance through an online data
may obtain the draft guidance at either Paperwork Reduction Act (44 U.S.C. collection system. Award recipients
https://www.fda.gov/Drugs/Guidance Chapter 35). To request a copy of these report performance on the following
ComplianceRegulatoryInformation/ documents, call the SAMHSA Reports measures specific to this program:
Guidances/default.htm, https:// Clearance Officer on (240) 276–1243. Number of people who receive OUD
treatment, number of people who
www.fda.gov/BiologicsBloodVaccines/ Project: State Targeted Response to the
receive OUD recovery services, number
GuidanceComplianceRegulatory Opioid Crisis Grant Program Mid-Year
of providers implementing medication-
Information/Guidances/default.htm, or and End-Year Performance Reports—
assisted treatment, and the number of
https://www.regulations.gov. (OMB No. 0930–0378)—in Use Without OUD prevention and treatment
OMB Approval providers trained, to include nurse
Dated: October 10, 2018.
Leslie Kux, The Substance Abuse and Mental practitioners, physician assistants, as
amozie on DSK3GDR082PROD with NOTICES1
Associate Commissioner for Policy.
Health Services Administration well as physicians, nurses, counselors,
(SAMHSA) is authorized under Section social workers, case managers, etc. This
[FR Doc. 2018–22436 Filed 10–15–18; 8:45 am]
1003 of the 21st Century Cures Act, as information is collected at the mid-point
BILLING CODE 4164–01–P amended, to support a grant program, and conclusion of each grant award
for up to 2 years, that addresses the year. Additionally, each award recipient
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Document Created: 2018-10-15 23:42:19
Document Modified: 2018-10-15 23:42:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 83 FR 52226 |
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