Agency Information Collection Request. 30-Day Public Comment Request, 33317-33318 [2021-13224]
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Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices
CFR 46, followed by an expert panel
discussion on the impact of artificial
intelligence algorithms on Institutional
Review Board considerations for human
subjects protections. The day will
conclude with discussion of a new
SACHRP charge addressing the current
system of engagement and the
interpretation of HHS support in 45 CFR
46. The second day, July 22, will
include discussion of consideration of
risks to third parties in research, and
continue discussion of topics from the
first day’s agenda. Other topics may be
added; for the full and updated meeting
agenda, see https://www.dhhs.gov/ohrp/
sachrp-committee/meetings/.
The meeting will adjourn by 4:30 p.m.
July 22.
The public will have an opportunity
to send comment to SACHRP during the
meeting’s public comment session or to
submit written public comment in
advance. Persons who wish to provide
public comment should review
instructions at https://www.hhs.gov/
ohrp/sachrp-committee/meetings/
index.html and respond by midnight
July 16th, 2021, ET. Individuals
submitting written statements as public
comment should submit their comments
to SACHRP at SACHRP@hhs.gov.
Comments are limited to three minutes
each.
Time will be allotted for public
comment on both days. Note that public
comment must be relevant to topics
currently being addressed by SACHRP.
Dated: June 14, 2021.
Julia G. Gorey,
Executive Director, Secretary’s Advisory
Committee on Human Research Protections,
Office for Human Research Protections.
[FR Doc. 2021–13362 Filed 6–23–21; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Appointment of Administrative Dispute
Resolution Board Members
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
On December 14, 2020, the
Department of Health and Human
Services published in the Federal
Register a final rule (‘‘Rule’’)
establishing the 340B Drug Pricing
Program (340B Program) Administrative
Dispute Resolution (ADR) Board
(hereafter, ‘‘the Board’’). See 85 FR
80632 (Dec. 14, 2020). According to the
Rule, the purpose of the 340B Program’s
ADR process is to resolve (1) claims by
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SUMMARY:
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covered entities that they have been
overcharged for covered outpatient
drugs by manufacturers and (2) claims
by manufacturers, after a manufacturer
has conducted an audit as authorized by
section 340B(a)(5)(C) of the Public
Health Service Act, that a covered entity
has violated the prohibitions on
diversion or duplicate discounts. The
Rule states that Board members from the
Centers for Medicare & Medicaid
Services (CMS) and the Health
Resources and Services Administration
(HRSA) must have relevant expertise
and experience in drug pricing or drug
distribution. The Rule also states that
Board members from the Office of the
General Counsel (OGC) must have
expertise and experience in handling
complex litigation. From the 340B ADR
Board, the HRSA Administrator will
select three voting members, one from
each of the three HHS operating/staff
divisions involved (i.e., CMS, HRSA,
OGC) to form 340B ADR Panels that will
review claims and, pursuant to
delegated authority from the Secretary,
make certain final agency decisions.
All previous appointments to the
Board are revoked. Based on
recommendations from OGC, CMS, and
HRSA, I hereby appoint the following
Board members, who shall serve a term
of two years, to be extended for
additional terms upon agreement by the
member and the head of his or her
operating/staff division.
Sean R. Keveney, Deputy General
Counsel, the Office of the General
Counsel, Department of Health and
Human Services;
Andy J. Miller, National Complex
Litigation and Investigations Division
Attorney, the Office of the General
Counsel, Department of Health and
Human Services;
Glenn Clark, Public Health Advisor,
HIV/AIDS Bureau, Health Resources
and Services Administration,
Department of Health and Human
Services;
CAPT Christina Meade, Area Regional
Pharmacy Consultant, Office of Regional
Operations, Health Resources and
Services Administration, Department of
Health and Human Services;
CDR Timothy Lape, Division of
Medicare Health Plans Operations,
Medicare Branch, Centers for Medicare
& Medicaid Services, Department of
Health and Human Services;
Adele Pietrantoni, Office of Program
Operations and Local Engagement,
Division of Drug and Health Plan
Operations, Centers for Medicare &
Medicaid Services, Department of
Health and Human Services;
Chantelle Britton, Senior Advisor,
Office of Pharmacy Affairs, Health
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33317
Resources and Services Administration,
Department of Health and Human
Services, as ex-officio, non-voting
member; and
Julie Zadecky, Pharmacist, Office of
Pharmacy Affairs, Health Resources and
Services Administration, Department of
Health and Human Services, as exofficio, non-voting member.
Dated: June 21, 2021.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–13461 Filed 6–23–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0955–0003]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before July 26, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0955–0003–30D and project title for
reference.
SUMMARY:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
SUPPLEMENTARY INFORMATION:
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33318
Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery.
Type of Collection: Father Generic ICR
revision.
OMB No. 0955–0003—Office of the
National Coordinator for Health
Information Technology.
Abstract: The Office of the National
Coordinator for Health Information
Technology is seeking a three-year
revision of OMB control number 0955–
0003 to continue collecting routine
customer feedback on agency service
delivery. The proposed information
collection activity provides a means to
garner qualitative customer and
stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. Qualitative
service delivery, and resolution of
issues with service delivery. Responses
will be assessed to plan and inform
efforts to improve or maintain the
quality of service offered to the public.
If this information is not collected, vital
feedback from customers and
stakeholders on the Agency’s services
will be unavailable.
Affected Public: Individuals,
households, professionals, and/or the
public/private sector.
Average estimates for the next three
years:
Estimated Total Number of
Respondents: 10,000.
Expected Annual Number of
Activities: 6.
Average Number of Respondents per
Activity: 1667.
Frequency of Response: Once per
activity.
Average Minutes per Response: 7.
Total Burden Hours: 1167.
feedback means information that
provides useful insights on perceptions
and opinions, and is not statistical
surveys that yield quantitative results
that can be generalized to the
population of study. This feedback will
provide insights into customer or
stakeholder perceptions, experiences,
and expectations; provide an early
warning of issues with the service; or
focus attention on areas where
communication, training, or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative,
and actionable communications
between the Agency and its customers
and stakeholders. It will also allow
feedback to contribute directly to the
improvement of program management.
The solicitation of feedback will target
areas such as timeliness,
appropriateness, accuracy of
information, courtesy, efficiency of
ESTIMATED ANNUALIZED BURDEN TABLE
Type of respondent
Number of
respondents
Number
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Individuals, households, professionals, and/or the public/private sector ........
10,000
1
7/60
1167
Total ..........................................................................................................
10,000
1
7/60
1167
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2021–13224 Filed 6–23–21; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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National Committee on Vital and Health
Statistics: Notice of Meeting and
Request for Public Comment
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting and request for
public comment.
Name: National Committee on Vital
and Health Statistics (NCVHS),
Listening Session to be held by the
Subcommittee on Standards.
Dates and Times: Wednesday, August
25, 2021: 10:00 a.m.–5:30 p.m. EST.
Place: Virtual.
Status: Open.
Purpose: The purpose of this listening
session is to obtain input from
representatives of standards
development organizations, invited
industry stakeholders, and
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representatives from federal agencies on
a variety of topics pertaining to data
standards, harmonization of standards
and code sets, new Fast Healthcare
Interoperability Resources (FHIR)
application programming interfaces
(APIs) to enhance the exchange of
clinical and administrative data, the
state of readiness for certain
administrative and clinical standards to
be considered for adoption or use as
standards under the Health Insurance
Portability and Accountability Act
(HIPAA),1 for interoperability, and other
subjects beyond HIPAA transactions.
This Notice also includes a Request
for Public Comment to solicit input
from interested individuals and
stakeholders who would like to provide
input to the Subcommittee in advance
of the August 25, 2021, listening
session.
The Subcommittee seeks to
understand the extent to which current
and emerging standards for exchanging
electronic health-related data under
HIPAA and other applicable federal
legislation and regulatory processes are
1 Public Law 104–191, 110 Stat. 1936 (Aug 21,
1996), available at https://www.congress.gov/104/
plaws/publ191/PLAW-104publ191.pdf.
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meeting the business needs of the health
care system. Applicable legislation and
regulation include, but are not limited
to HIPAA, the final Interoperability and
Patient Access Rule promulgated by the
Centers for Medicare and Medicaid
Services (CMS),2 the 21st Century Cures
Act,3 the Affordable Care Act of 2010,4
the Health Information Technology for
Economic and Clinical Health Act
(HITECH),5 and Medicare Access and
2 Centers for Medicare and Medicaid Services,
Final Rule: Medicare and Medicaid Programs;
Patient Protection and Affordable Care Act;
Interoperability and Patient Access for Medicare
Advantage Organization and Medicaid Managed
Care Plans, State Medicaid Agencies, CHIP
Agencies and CHIP Managed Care Entities, Issuers
of Qualified Health Plans on the FederallyFacilitated Exchanges, and Health Care Providers,’’
85 FR 25510, May 1, 2020, available at https://
www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/
2020-05050.pdf.
3 Public Law 114–255, 130 STAT. 1033 (Dec. 13,
2016), available at https://www.congress.gov/114/
plaws/publ255/PLAW-114publ255.pdf.
4 Public Law 111–148, 124 Stat. 119 (Mar 13.
2010), available at https://www.congress.gov/111/
plaws/publ148/PLAW-111publ148.pdf.
5 Public Law 111–5, Title XIII, 123 Stat. 115, 226
(Feb. 17, 2009), available at https://
www.govinfo.gov/content/pkg/PLAW-111publ5/pdf/
PLAW-111publ5.pdf.
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]]>Agencies
[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33317-33318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13224]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0955-0003]
Agency Information Collection Request. 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before July 26, 2021.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0955-0003-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection
[[Page 33318]]
techniques or other forms of information technology to minimize the
information collection burden.
Title of the Collection: Generic Clearance for the Collection of
Qualitative Feedback on Agency Service Delivery.
Type of Collection: Father Generic ICR revision.
OMB No. 0955-0003--Office of the National Coordinator for Health
Information Technology.
Abstract: The Office of the National Coordinator for Health
Information Technology is seeking a three-year revision of OMB control
number 0955-0003 to continue collecting routine customer feedback on
agency service delivery. The proposed information collection activity
provides a means to garner qualitative customer and stakeholder
feedback in an efficient, timely manner, in accordance with the
Administration's commitment to improving service delivery. Qualitative
feedback means information that provides useful insights on perceptions
and opinions, and is not statistical surveys that yield quantitative
results that can be generalized to the population of study. This
feedback will provide insights into customer or stakeholder
perceptions, experiences, and expectations; provide an early warning of
issues with the service; or focus attention on areas where
communication, training, or changes in operations might improve
delivery of products or services. These collections will allow for
ongoing, collaborative, and actionable communications between the
Agency and its customers and stakeholders. It will also allow feedback
to contribute directly to the improvement of program management.
The solicitation of feedback will target areas such as timeliness,
appropriateness, accuracy of information, courtesy, efficiency of
service delivery, and resolution of issues with service delivery.
Responses will be assessed to plan and inform efforts to improve or
maintain the quality of service offered to the public. If this
information is not collected, vital feedback from customers and
stakeholders on the Agency's services will be unavailable.
Affected Public: Individuals, households, professionals, and/or the
public/private sector.
Average estimates for the next three years:
Estimated Total Number of Respondents: 10,000.
Expected Annual Number of Activities: 6.
Average Number of Respondents per Activity: 1667.
Frequency of Response: Once per activity.
Average Minutes per Response: 7.
Total Burden Hours: 1167.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number Average burden
Type of respondent Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Individuals, households, professionals, and/ 10,000 1 7/60 1167
or the public/private sector...............
-------------------------------------------------------------------
Total................................... 10,000 1 7/60 1167
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2021-13224 Filed 6-23-21; 8:45 am]
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