Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: COVID-19 Provider Relief Programs Application and Attestation Portal, and Claims Reimbursement Submission Activities, 47119-47120 [2021-18018]
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Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices
Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) Has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and, with certain exceptions,
labeling as the listed drug, which is a
version of the drug that was previously
approved and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
with Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness, or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ORTHO-CEPT (desogestrel-ethinyl
estradiol) 21- and 28-day oral tablets,
0.15 mg/0.03 mg, is the subject of NDA
020301, held by Janssen
Pharmaceuticals, Inc., and initially
approved on December 14, 1992.
ORTHO-CEPT is indicated for the
prevention of pregnancy in women who
elect to use oral contraceptives as a
method of contraception.
In a letter dated October 7, 2014,
Janssen Pharmaceuticals, Inc., notified
FDA that ORTHO-CEPT (desogestrelethinyl estradiol) 21- and 28-day oral
tablets, 0.15 mg/0.03 mg, were being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Arnall Golden Gregory LLP submitted
a citizen petition dated March 11, 2021
(Docket No. FDA–2021–P–0292), under
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SUPPLEMENTARY INFORMATION:
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21 CFR 10.30, requesting that the
Agency determine whether ORTHOCEPT (desogestrel-ethinyl estradiol) oral
tablets, were withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ORTHO-CEPT
(desogestrel-ethinyl estradiol) 21- and
28-day oral tablets, 0.15 mg/0.03 mg,
were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that ORTHOCEPT (desogestrel-ethinyl estradiol) 21and 28-day oral tablets, 0.15 mg/0.03
mg, were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of ORTHOCEPT (desogestrel-ethinyl estradiol) 21and 28-day oral tablets, 0.15 mg/0.03
mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ORTHO-CEPT
(desogestrel-ethinyl estradiol) 21- and
28-day oral tablets, 0.15 mg/0.03 mg, in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: August 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–17990 Filed 8–20–21; 8:45 am]
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47119
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0906–XXXX]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: COVID–19
Provider Relief Programs Application
and Attestation Portal, and Claims
Reimbursement Submission Activities
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than October 22, 2021.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
COVID–19 Provider Relief Programs
Application and Attestation Portal, and
Claims Reimbursement Submission
Activities, OMB No. 0906–XXXX.
Abstract: HRSA administers the
Provider Relief Programs (which
includes the Provider Relief Fund (PRF),
the American Rescue Plan Act Rural
(ARPA–R) payments, the COVID–19
Coverage Assistance Fund (CAF), and
the COVID–19 Claims Reimbursement
to Health Care Providers and Facilities
for Testing, Treatment, and Vaccine
Administration for the Uninsured
(Uninsured Program or UIP). The
SUMMARY:
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Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices
Provider Relief Programs disbursed, and
are continuing to disburse, funds to
eligible healthcare providers through
two pathways: (1) Direct provider
payments via the PRF and ARPA–R
payments, and (2) claims
reimbursement via the CAF and the UIP.
This information collection includes
four components: (1) The PRF and
ARPA–R application portal; (2) the PRF
and ARPA–R attestation portal; (3) the
CAF application portal; and (4) the UIP
application portal. To date, information
for these programs has been collected
under a Paperwork Reduction Act
waiver executed pursuant to public
health emergency authorities. HRSA is
seeking comments regarding the CAF
and the UIP for the first time. These
information collections support
administration of the Provider Relief
Programs including the PRF, the
Uninsured Program, and the CAF (funds
for these three programs were
appropriated under the Coronavirus
Aid, Relief, and Economic Security Act
(Pub. L. 116–136), Paycheck Protection
Program and Health Care Enhancement
Act (Pub. L. 116–139), Coronavirus
Response and Relief Supplemental
Appropriations Act (Division M of Pub.
L. 116–260)), and the ARPA–R
payments (funds were appropriated
under the American Rescue Plan Act of
2021, Pub. L. 117–2).
Need and Proposed Use of the
Information: Providers who apply for
Provider Relief Programs (i.e., PRF,
ARPA–R, CAF, and UIP payments) must
apply for direct provider payments or
claims reimbursement and attest to a set
of Terms and Conditions to enable
HRSA’s appropriate disbursement and
oversight of recipients’ use of funds.
Information collected will allow for
(1) assessing if recipients have met
statutory and programmatic
requirements; (2) conducting audits; (3)
gathering data required to calculate,
disburse, and report on PRF, ARPA–R,
CAF, and UIP payments; and (4)
program evaluation. HRSA staff may
also use information collected to
identify and report on trends in the
effect of the COVID–19 pandemic on
health care providers and uninsured or
underinsured patients throughout the
United States.
HHS makes publicly available the
names of payment recipients and the
aggregate amounts received, for all
providers who attest to receipt of a
payment and acceptance of the Terms
and Conditions or who retain payments
for more than 90 days and are deemed
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Attestation Portal ..................................................................
Application Portal .................................................................
CAF Application ...................................................................
UIP Application ....................................................................
130,000
130,000
15,000
280,000
1
1
1
1
130,000
130,000
15,000
280,000
0.25
1.00
1.00
5.60
32,500
130,000
15,000
1,568,000
Total ..............................................................................
555,000
........................
555,000
........................
1,745,500
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. 2021–18018 Filed 8–20–21; 8:45 am]
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Number of
responses per
respondent
to have accepted the Terms and
Conditions. By accepting funds, the
recipient consents to HHS publicly
disclosing the payments that recipient
has received.
Likely Respondents: Health care
providers that apply to receive, or have
applied to receive, PRF, ARPA–R, CAF,
or UIP payments, and attested to the
associated Terms and Conditions.
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:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Information Technology
Advisory Committee 2021 Schedule of
Meetings
Office of the National
Coordinator for Health Information
Technology (ONC), HHS.
AGENCY:
ACTION:
Notice of meetings.
The Health Information
Technology Advisory Committee
(HITAC) was established in accordance
with the 21st Century Cures Act and the
Federal Advisory Committee Act. The
HITAC, among other things, identifies
priorities for standards adoption and
makes recommendations to the National
Coordinator for Health Information
Technology (National Coordinator). The
HITAC will hold public meetings
SUMMARY:
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throughout 2021. See list of public
meetings below.
FOR FURTHER INFORMATION CONTACT:
Michael Berry, Designated Federal
Officer, at Michael.Berry@hhs.gov, (202)
701–0795.
Section
4003(e) of the 21st Century Cures Act
(Pub. L. 114–255) establishes the Health
Information Technology Advisory
Committee (referred to as the ‘‘HITAC’’).
The HITAC will be governed by the
provisions of the Federal Advisory
Committee Act (FACA) (Pub. L. 92–
463), as amended, (5 U.S.C. App.),
which sets forth standards for the
formation and use of federal advisory
committees.
SUPPLEMENTARY INFORMATION:
Composition
The HITAC is comprised of at least 25
members, of which:
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[Federal Register Volume 86, Number 160 (Monday, August 23, 2021)]
[Notices]
[Pages 47119-47120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18018]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
[OMB No. 0906-XXXX]
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title: COVID-19
Provider Relief Programs Application and Attestation Portal, and Claims
Reimbursement Submission Activities
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than October
22, 2021.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: COVID-19 Provider Relief
Programs Application and Attestation Portal, and Claims Reimbursement
Submission Activities, OMB No. 0906-XXXX.
Abstract: HRSA administers the Provider Relief Programs (which
includes the Provider Relief Fund (PRF), the American Rescue Plan Act
Rural (ARPA-R) payments, the COVID-19 Coverage Assistance Fund (CAF),
and the COVID-19 Claims Reimbursement to Health Care Providers and
Facilities for Testing, Treatment, and Vaccine Administration for the
Uninsured (Uninsured Program or UIP). The
[[Page 47120]]
Provider Relief Programs disbursed, and are continuing to disburse,
funds to eligible healthcare providers through two pathways: (1) Direct
provider payments via the PRF and ARPA-R payments, and (2) claims
reimbursement via the CAF and the UIP. This information collection
includes four components: (1) The PRF and ARPA-R application portal;
(2) the PRF and ARPA-R attestation portal; (3) the CAF application
portal; and (4) the UIP application portal. To date, information for
these programs has been collected under a Paperwork Reduction Act
waiver executed pursuant to public health emergency authorities. HRSA
is seeking comments regarding the CAF and the UIP for the first time.
These information collections support administration of the Provider
Relief Programs including the PRF, the Uninsured Program, and the CAF
(funds for these three programs were appropriated under the Coronavirus
Aid, Relief, and Economic Security Act (Pub. L. 116-136), Paycheck
Protection Program and Health Care Enhancement Act (Pub. L. 116-139),
Coronavirus Response and Relief Supplemental Appropriations Act
(Division M of Pub. L. 116-260)), and the ARPA-R payments (funds were
appropriated under the American Rescue Plan Act of 2021, Pub. L. 117-
2).
Need and Proposed Use of the Information: Providers who apply for
Provider Relief Programs (i.e., PRF, ARPA-R, CAF, and UIP payments)
must apply for direct provider payments or claims reimbursement and
attest to a set of Terms and Conditions to enable HRSA's appropriate
disbursement and oversight of recipients' use of funds.
Information collected will allow for (1) assessing if recipients
have met statutory and programmatic requirements; (2) conducting
audits; (3) gathering data required to calculate, disburse, and report
on PRF, ARPA-R, CAF, and UIP payments; and (4) program evaluation. HRSA
staff may also use information collected to identify and report on
trends in the effect of the COVID-19 pandemic on health care providers
and uninsured or underinsured patients throughout the United States.
HHS makes publicly available the names of payment recipients and
the aggregate amounts received, for all providers who attest to receipt
of a payment and acceptance of the Terms and Conditions or who retain
payments for more than 90 days and are deemed to have accepted the
Terms and Conditions. By accepting funds, the recipient consents to HHS
publicly disclosing the payments that recipient has received.
Likely Respondents: Health care providers that apply to receive, or
have applied to receive, PRF, ARPA-R, CAF, or UIP payments, and
attested to the associated Terms and Conditions.
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 Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Attestation Portal.............. 130,000 1 130,000 0.25 32,500
Application Portal.............. 130,000 1 130,000 1.00 130,000
CAF Application................. 15,000 1 15,000 1.00 15,000
UIP Application................. 280,000 1 280,000 5.60 1,568,000
-------------------------------------------------------------------------------
Total....................... 555,000 .............. 555,000 .............. 1,745,500
----------------------------------------------------------------------------------------------------------------
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. 2021-18018 Filed 8-20-21; 8:45 am]
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