Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Network Development Program, OMB No. 0906-0010-Revision, 17612-17613 [2021-06880]
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17612
Federal Register / Vol. 86, No. 63 / Monday, April 5, 2021 / Notices
21 CFR 810.10(d)—Collections
Specified in the Order—(Reporting)—
FDA may require the person named in
the cease distribution and notification
order to submit certain information to
the Agency, e.g., distribution
information, progress reports.
21 CFR 810.11(a)—Request for
Regulatory Hearing—(Reporting)—A
request for regulatory hearing regarding
the cease distribution and notification
order must be submitted in writing to
FDA.
21 CFR 810.12(a) and (b)—Written
Request for Review—(Reporting)—In
lieu of requesting a regulatory hearing
under § 810.11, the person named in the
cease distribution and notification order
may submit a written request to FDA
asking that the order be modified or
vacated. A written request for review of
a cease distribution and notification
order shall identify each ground upon
which the requestor relies in asking that
the order be modified or vacated,
address an appropriate cease
distribution and notification strategy,
and address whether the order should
be amended to require a recall of the
device that was the subject of the order
and the actions required by such a recall
order.
21 CFR 810.14—Mandatory Recall
Strategy—(Reporting)—The person
named in the cease distribution and
notification order or a mandatory recall
order must develop and submit a
strategy to FDA for complying with the
order that is appropriate for the
individual circumstances.
21 CFR 810.15(a) through (c)—
Notifications to Recipients—(ThirdParty Disclosure)—The person named in
a cease distribution and notification
order or a mandatory recall order must
promptly notify each health
professional, user facility, consignee, or
individual of the order.
21 CFR 810.15(b)—Documentation of
Notifications to Recipients—
(Recordkeeping)—Telephone calls or
other personal contacts may be made in
addition to, but not as a substitute for,
the verified written communication, and
shall be documented in an appropriate
manner.
21 CFR 810.15(d)—Notification to
Recipients; Followup—(Third-Party
Disclosure)—The person named in the
cease distribution and notification order
or mandatory recall order shall ensure
that followup communications are sent
to all who fail to respond to the initial
communication.
21 CFR 810.15(e)—Notification of
Consignees by Recipients—(Third-Party
Disclosure)—Health professionals,
device user facilities, and consignees
VerDate Sep<11>2014
17:23 Apr 02, 2021
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should immediately notify their
consignees of the order.
21 CFR 810.16(a) and (b)—Periodic
Status Reports—(Reporting)—The
person named in a cease distribution
and notification order or a mandatory
recall order must submit periodic status
reports to FDA to enable the Agency to
assess the person’s progress in
complying with the order. The
frequency of such reports and the
Agency official to whom such reports
must be submitted will be specified in
the order.
21 CFR 810.17(a)—Termination
Request—(Reporting)—The person
named in a cease distribution and
notification order or a mandatory recall
order may request termination of the
order by submitting a written request to
FDA. The person submitting a request
must certify that he or she has complied
in full with all the requirements of the
order and shall include a copy of the
most current status report submitted to
the Agency.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
changes to the burden estimate.
Dated: March 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06960 Filed 4–2–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Rural Health Network
Development Program, OMB No. 0906–
0010—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than May 5, 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 Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Rural Health Network Development
Program OMB No. 0906–0010—Revision
Abstract: The Rural Health Network
Development Program (RHND) is
authorized under Section 330A(e) of the
Public Health Service Act (42 U.S.C.
254(e)). The purpose of this program is
to support integrated rural health care
networks that have combined the
functions of the entities participating in
the network to address the health care
needs of the targeted rural community.
Recipients will combine the functions of
the entities participating in the network
to address the following legislative
aims: (i) Achieve efficiencies; (ii)
expand access, coordinate, and improve
the quality of essential health care
services; and (iii) strengthen the rural
health care system as a whole.
RHND-funded programs promote
population health management and the
transition towards value-based care
through diverse network membership
that includes traditional and nontraditional network partners. Evidence
of program impacted demonstrated by
outcome data and program
sustainability are integral components
of the program. This is a 3-year
competitive program for networks
composed of at least three members that
are separate existing health care
providers or entities.
A 60-day Notice published in the
Federal Register on November 19, 2020,
vol. 85, No. 224, pages 73728–73729.
There were no public comments.
Need and Proposed Use of the
Information: This program needs
measures that will enable HRSA to
provide aggregate program data required
by Congress under the Government
Performance and Results Act of 1993.
These measures cover the principal
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05APN1
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Federal Register / Vol. 86, No. 63 / Monday, April 5, 2021 / Notices
topic areas of interest to the Federal
Office of Rural Health Policy, including:
(a) Access to care; (b) population
demographics; (c) staffing; (d)
consortium/network; (e) sustainability;
and (f) project specific domains. All
measures will evaluate HRSA’s progress
toward achieving its goals.
The proposed changes of RHND
measures are a result of the
accumulation of grantee feedback, peerreviewed research, and information
gathered from the previously approved
RHND program measures. The proposed
changes include additional questions
surrounding the network’s components
of sustainability. Questions surrounding
Health Information Technology and
Telehealth have been modified to reflect
updated knowledge on the use of both
and to improve understanding of how
these important technologies are
affecting HRSA grantees. Additional
National Quality Forum measures were
also included in an effort to allow
uniform collection efforts throughout
the Federal Office of Rural Health
Policy.
Likely Respondents: Respondents will
be awardees of the Rural Health
Network Development Program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total
burden hours
Performance Improvement and Measurement System
Database ..........................................................................
44
1
44
6
264
Total ..............................................................................
44
........................
44
........................
264
HRSA specifically requests comments
on: (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 techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–06880 Filed 4–2–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Heritable Disorders in Newborns and
Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
In accordance with section
1111(g) of the Public Health Service Act
and the Federal Advisory Committee
Act, this notice announces that the
Advisory Committee on Heritable
Disorders in Newborns and Children
SUMMARY:
VerDate Sep<11>2014
17:23 Apr 02, 2021
Jkt 253001
(ACHDNC or Committee) has scheduled
a public meeting to be held on
Thursday, May 13, 2021, and Friday,
May 14, 2021. Information about the
ACHDNC and the agenda for this
meeting can be found on the ACHDNC
website at https://www.hrsa.gov/
advisory-committees/heritabledisorders/.
DATES: Thursday, May 13, 2021, from
10:00 a.m. to 3:00 p.m. Eastern Time
(ET) and Friday, May 14, 2021, from
10:00 a.m. to 3:00 p.m. ET.
ADDRESSES: This meeting will be held
via webinar. While this meeting is open
to the public, advance registration is
required.
Please register online at https://
www.achdncmeetings.org/registration/
by 12:00 p.m. ET on May 12, 2021.
Instructions on how to access the
meeting via webcast will be provided
upon registration.
FOR FURTHER INFORMATION CONTACT:
Alaina Harris, Maternal and Child
Health Bureau, HRSA, 5600 Fishers
Lane, Rockville, Maryland 20857; 301–
443–0721; or ACHDNC@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACHDNC
provides advice and recommendations
to the Secretary of HHS (Secretary) on
the development of newborn screening
activities, technologies, policies,
guidelines, and programs for effectively
reducing morbidity and mortality in
newborns and children having, or at risk
for, heritable disorders. The ACHDNC
reviews and reports regularly on
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Fmt 4703
Sfmt 4703
newborn and childhood screening
practices, recommends improvements in
the national newborn and childhood
screening programs, and fulfills
requirements stated in the authorizing
legislation. In addition, ACHDNC’s
recommendations regarding inclusion of
additional conditions for screening,
following adoption by the Secretary, are
evidence-informed preventive health
services provided for in the
comprehensive guidelines supported by
HRSA through the Recommended
Uniform Screening Panel (RUSP)
pursuant to section 2713 of the Public
Health Service Act (42 U.S.C. 300gg–
13). Under this provision, nongrandfathered group health plans and
health insurance issuers offering group
or individual health insurance are
required to provide insurance coverage
without cost-sharing (a co-payment, coinsurance, or deductible) for preventive
services for plan years (i.e., policy years)
beginning on or after the date that is 1
year from the Secretary’s adoption of the
condition for screening.
During the May 13–14, 2021, meeting,
ACHDNC will hear from experts in the
fields of public health, medicine,
heritable disorders, rare disorders, and
newborn screening. Agenda items
include the following:
(1) Mucopolysaccharidosis type II
(MPS II) nomination summary;
(2) Possible Committee vote on
whether to move MPS II forward to a
full evidence review;
E:\FR\FM\05APN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Notices]
[Pages 17612-17613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06880]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Rural Health Network
Development Program, OMB No. 0906-0010--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period. OMB may act on HRSA's ICR only after the 30
day comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than May 5,
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 Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Rural Health Network
Development Program OMB No. 0906-0010--Revision
Abstract: The Rural Health Network Development Program (RHND) is
authorized under Section 330A(e) of the Public Health Service Act (42
U.S.C. 254(e)). The purpose of this program is to support integrated
rural health care networks that have combined the functions of the
entities participating in the network to address the health care needs
of the targeted rural community. Recipients will combine the functions
of the entities participating in the network to address the following
legislative aims: (i) Achieve efficiencies; (ii) expand access,
coordinate, and improve the quality of essential health care services;
and (iii) strengthen the rural health care system as a whole.
RHND-funded programs promote population health management and the
transition towards value-based care through diverse network membership
that includes traditional and non-traditional network partners.
Evidence of program impacted demonstrated by outcome data and program
sustainability are integral components of the program. This is a 3-year
competitive program for networks composed of at least three members
that are separate existing health care providers or entities.
A 60-day Notice published in the Federal Register on November 19,
2020, vol. 85, No. 224, pages 73728-73729. There were no public
comments.
Need and Proposed Use of the Information: This program needs
measures that will enable HRSA to provide aggregate program data
required by Congress under the Government Performance and Results Act
of 1993. These measures cover the principal
[[Page 17613]]
topic areas of interest to the Federal Office of Rural Health Policy,
including: (a) Access to care; (b) population demographics; (c)
staffing; (d) consortium/network; (e) sustainability; and (f) project
specific domains. All measures will evaluate HRSA's progress toward
achieving its goals.
The proposed changes of RHND measures are a result of the
accumulation of grantee feedback, peer-reviewed research, and
information gathered from the previously approved RHND program
measures. The proposed changes include additional questions surrounding
the network's components of sustainability. Questions surrounding
Health Information Technology and Telehealth have been modified to
reflect updated knowledge on the use of both and to improve
understanding of how these important technologies are affecting HRSA
grantees. Additional National Quality Forum measures were also included
in an effort to allow uniform collection efforts throughout the Federal
Office of Rural Health Policy.
Likely Respondents: Respondents will be awardees of the Rural
Health Network Development Program.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Performance Improvement and 44 1 44 6 264
Measurement System Database....
-------------------------------------------------------------------------------
Total....................... 44 .............. 44 .............. 264
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on: (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 techniques or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-06880 Filed 4-2-21; 8:45 am]
BILLING CODE 4165-15-P
