Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Evidence Based Telehealth Network Program Measures, 83419-83420 [2023-26248]
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Federal Register / Vol. 88, No. 228 / Wednesday, November 29, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, Empaveli
(pegcetacoplan) indicated for the
treatment of adult patients with
paroxysmal nocturnal hemoglobinuria.
Subsequent to this approval, the USPTO
received patent term restoration
applications for Empaveli (U.S. Patent
Nos. 10,035,822; 10,125,171; and
10,875,893) from Apellis
Pharmaceuticals, Inc., and the USPTO
requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
September 21, 2022, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
Empaveli represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
Empaveli is 2,501 days. Of this time,
2,258 days occurred during the testing
phase of the regulatory review period,
while 243 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: July 11, 2014.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on July 11, 2014.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: September 14, 2020.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
Empaveli (NDA 215014) was initially
submitted on September 14, 2020.
3. The date the application was
approved: May 14, 2021. FDA has
verified the applicant’s claim that NDA
215014 was approved on May 14, 2021.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
VerDate Sep<11>2014
17:26 Nov 28, 2023
Jkt 262001
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 137 days, 545 days,
or 579 days of patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26255 Filed 11–28–23; 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; Evidence Based Telehealth
Network Program Measures
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA 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
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
83419
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.
Comments on this ICR should be
received no later than December 29,
2023.
DATES:
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 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
Joella Roland, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Evidence Based Telehealth Network
Program Measures, OMB No. 0906–
0043—Revision.
Abstract: This ICR is for a revision of
a currently approved information
collection of measures for the Office for
the Advancement of Telehealth’s (OAT)
Evidence Based Telehealth Network
Program, under which OAT administers
cooperative agreements in accordance
with section 330I of the Public Health
Service Act (42 U.S.C. 254c–14), as
amended. The purpose of this program
is to fund evidence-based projects that
utilize telehealth technologies through
telehealth networks to expand access to,
and improve access to and the quality
of, health care services. This program
will work to help assess the
effectiveness of evidence-based
practices with the use of telehealth for
patients, providers, and payers.
In the Evidence-Based Telehealth
Network Program Report, the adjusted
data collection instrument includes the
addition, removal, and revision of
measures, with 27 total data elements
addressing patient encounter
information. The current measures focus
on behavioral health and the proposed
adjusted measures allow for the
inclusion of broader health care services
and expanded outcome measures. Five
data elements were updated to specify
data collection that allows for deeper
understanding of outcomes related to
socioeconomic indicators. The
estimated burden for the EvidenceBased Telehealth Network Program
ADDRESSES:
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83420
Federal Register / Vol. 88, No. 228 / Wednesday, November 29, 2023 / Notices
Report has decreased since the data
collection frequency is changing from
monthly to quarterly. In addition, the
information collected from grantees in
the Performance Improvement and
Measurement System more closely
aligns measures with the Notice of
Funding Opportunity and will assist in
clarifying program measures and
impact. These adjustments allow OAT
to gain a more thorough understanding
of how to utilize telehealth technologies
through telehealth to improve access to,
and improve the quality of, health care
services.
A 60-day notice published in the
Federal Register on August 18, 2023, 88
FR 56640–41. There were no public
comments, but OAT made minor
adjustments to the numbering, wording,
and some categories on the Rural
Telehealth Research Center Data
Dictionary and accompanying Direct-toConsumer Telehealth Evidence
Collection tool to increase ease of use.
Need and Proposed Use of the
Information: The measures will enable
HRSA and OAT to capture data that
illustrate the impact and scope of
federal funding along with assessing
these efforts. The measures cover the
principal topic areas of interest to OAT,
including: (1) population demographics,
(2) access to health care, (3) cost savings
and cost-effectiveness, and (4) clinical
outcomes.
Likely Respondents: The likely
respondents are award recipients of the
Evidence Based Telehealth Network
Program.
Total estimated annualized burden hours: instrument
name
Number of
respondents
Number of
responses per
respondent
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.
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Evidence-Based Telehealth Network Program Report ........
Telehealth Performance Measurement Report ...................
11
11
4
1
44
11
31
5
1,364
55
Total ..............................................................................
* 11
........................
55
........................
1,419
* HRSA estimates 11 unique respondents, each completing the two forms.
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.
Comments on this ICR should be
received no later than December 29,
2023.
DATES:
[FR Doc. 2023–26248 Filed 11–28–23; 8:45 am]
BILLING CODE 4165–15–P
ddrumheller on DSK120RN23PROD with NOTICES1
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Rural Health Network
Development Program Performance
Improvement Measurement System,
OMB No. 0906–0010–Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
VerDate Sep<11>2014
17:26 Nov 28, 2023
Jkt 262001
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 information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA 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.
SUMMARY:
To
request a copy of the clearance requests
submitted to OMB for review, email
Joella Roland, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Information Collection Request Title:
Rural Health Network Development
Program Performance Improvement
Measurement System, OMB No. 0906–
0010–Revision.
Abstract: The Rural Health Network
Development (RHND) program is
authorized under section 330A(f) of the
Public Health Service Act (42 U.S.C.
254c(f)). The purpose of this program is
to support integrated health care
networks that collaborate to achieve
efficiencies; expand access to,
coordinate, and improve the quality of
basic health care services and associated
health outcomes; and strengthen the
rural health care system as a whole. The
program supports networks as they
address gaps in service, enhance
systems of care, and expand capacity of
the local health care system.
RHND-funded programs promote
population health management and the
transition towards value-based care
through diverse network participants
that include traditional and
nontraditional network partners.
Evidence of program impact
demonstrated by outcome data and
program sustainability are integral
components of the program. This is a 4year competitive program for networks
composed of at least three participants
that are existing health care providers.
At least 66 percent of network
E:\FR\FM\29NON1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 228 (Wednesday, November 29, 2023)]
[Notices]
[Pages 83419-83420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26248]
-----------------------------------------------------------------------
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; Evidence Based Telehealth
Network Program Measures
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
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 December
29, 2023.
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 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 Joella Roland, the HRSA
Information Collection Clearance Officer, at [email protected] or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Evidence Based Telehealth
Network Program Measures, OMB No. 0906-0043--Revision.
Abstract: This ICR is for a revision of a currently approved
information collection of measures for the Office for the Advancement
of Telehealth's (OAT) Evidence Based Telehealth Network Program, under
which OAT administers cooperative agreements in accordance with section
330I of the Public Health Service Act (42 U.S.C. 254c-14), as amended.
The purpose of this program is to fund evidence-based projects that
utilize telehealth technologies through telehealth networks to expand
access to, and improve access to and the quality of, health care
services. This program will work to help assess the effectiveness of
evidence-based practices with the use of telehealth for patients,
providers, and payers.
In the Evidence-Based Telehealth Network Program Report, the
adjusted data collection instrument includes the addition, removal, and
revision of measures, with 27 total data elements addressing patient
encounter information. The current measures focus on behavioral health
and the proposed adjusted measures allow for the inclusion of broader
health care services and expanded outcome measures. Five data elements
were updated to specify data collection that allows for deeper
understanding of outcomes related to socioeconomic indicators. The
estimated burden for the Evidence-Based Telehealth Network Program
[[Page 83420]]
Report has decreased since the data collection frequency is changing
from monthly to quarterly. In addition, the information collected from
grantees in the Performance Improvement and Measurement System more
closely aligns measures with the Notice of Funding Opportunity and will
assist in clarifying program measures and impact. These adjustments
allow OAT to gain a more thorough understanding of how to utilize
telehealth technologies through telehealth to improve access to, and
improve the quality of, health care services.
A 60-day notice published in the Federal Register on August 18,
2023, 88 FR 56640-41. There were no public comments, but OAT made minor
adjustments to the numbering, wording, and some categories on the Rural
Telehealth Research Center Data Dictionary and accompanying Direct-to-
Consumer Telehealth Evidence Collection tool to increase ease of use.
Need and Proposed Use of the Information: The measures will enable
HRSA and OAT to capture data that illustrate the impact and scope of
federal funding along with assessing these efforts. The measures cover
the principal topic areas of interest to OAT, including: (1) population
demographics, (2) access to health care, (3) cost savings and cost-
effectiveness, and (4) clinical outcomes.
Likely Respondents: The likely respondents are award recipients of
the Evidence Based Telehealth Network 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.
----------------------------------------------------------------------------------------------------------------
Average
Total estimated annualized Number of Number of Total burden per Total burden
burden hours: instrument name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Evidence-Based Telehealth 11 4 44 31 1,364
Network Program Report.........
Telehealth Performance 11 1 11 5 55
Measurement Report.............
-------------------------------------------------------------------------------
Total....................... * 11 .............. 55 .............. 1,419
----------------------------------------------------------------------------------------------------------------
* HRSA estimates 11 unique respondents, each completing the two forms.
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. 2023-26248 Filed 11-28-23; 8:45 am]
BILLING CODE 4165-15-P
