Agency Information Collection Activities: Submission for OMB Review; Comment Request, 27435-27436 [2021-10680]
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Federal Register / Vol. 86, No. 96 / Thursday, May 20, 2021 / Notices
number: 0938–1148); Frequency: Once,
quarterly, and on occasion; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 616; Total
Annual Hours: 1,344. (For policy
questions regarding this collection
contact Ryan Shannahan at 410–786–
0295.)
Dated: May 14, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–10574 Filed 5–19–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10536, CSM–
10225 and CMS–10764]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by June 21, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
DATES:
VerDate Sep<11>2014
17:36 May 19, 2021
Jkt 253001
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.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at: https://
www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid
Eligibility and Enrollment (EE)
Implementation Advanced Planning
Document (IAPD) Template; Use: To
assess the appropriateness of states’
requests for enhanced federal financial
participation for expenditures related to
Medicaid eligibility determination
systems, we will review the submitted
information and documentation to make
an approval determination for the
advanced planning document. Form
Number: CMS–10536 (OMB control
number: 0938–1268); Frequency: Yearly,
once, and occasionally; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 56; Total
Annual Responses: 168; Total Annual
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
27435
Hours: 2,688. (For policy questions
regarding this collection contact Edward
Dolly at 410–786–8554.)
2. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title of
Information Collection: Disclosures
Required of Certain Hospitals and
Critical Access Hospitals Regarding
Physician Ownership; Use: This
information collection relates to the
required third party disclosures by
certain Medicare-participating hospitals
and Critical Access Hospitals (CAHs)
and physicians to their patients. There
are 5 types of disclosures required. The
intent of the disclosure notice is to
assist the patient in making an informed
decision regarding their care. The first
disclosure requires physician owned
hospitals and CAHs to disclose to its
patients whether the hospitals/CAHs are
physician-owned and, if so, the names
of the physician-owners. The second
disclosure requires the physician owner
or investor in the hospital, as part of his
or her continued medical staff
membership or admitting privileges, to
disclose to the patient being referred to
the hospital any ownership or
investment interest held by the
physician or an immediate family
member of the physician. The third
disclosure requires physician owned
hospitals to disclose on all public
websites for and in any public
advertising for the hospital that the
hospital is owned or invested in by
physicians. The fourth and fifth
disclosures apply to all hospitals and
CAHs that do not have a Doctor of
Medicine (MD) or a Doctor of
Osteopathic Medicine (DO) on the
premises at all times to disclose this to
patients upon admission or registration
for both inpatient and specified
outpatient services. These hospitals and
CAHs must provide a written disclosure
to the patients admitted to the hospital
and must also post a conspicuous notice
in the Emergency Departments (ED)
which states that the hospital does not
have a physician present 24 hours per
day, 7 days per week. Form Number:
CMS–10225 (OMB control number:
0938–1034); Frequency: Occasionally;
Affected Public: Private sector—
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 210; Total Annual
Responses: 1,193,890; Total Annual
Hours: 78,935. (For policy questions
regarding this collection contact
Caroline Gallaher at 410–786–8705).
3. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Evaluation of
Risk Adjustment Data Validation
E:\FR\FM\20MYN1.SGM
20MYN1
27436
Federal Register / Vol. 86, No. 96 / Thursday, May 20, 2021 / Notices
(RADV) Appeals and Health Insurance
Exchange Outreach Training Sessions;
Use: CMS recognizes that the success of
accurately identifying risk-adjustment
payments and payment errors is
dependent upon the data submitted by
Medicare Advantage Organizations
(MAOs), and is strongly committed to
providing appropriate education and
technical outreach to MAOs and thirdparty administrators (TPAs). In
addition, CMS is strongly committed to
providing appropriate education and
technical outreach to States, issuers,
self-insured group health plans and
TPAs participating in the Marketplace
and/or market stabilization programs
mandated by the Affordable Care Act
(ACA).
CMS will strengthen outreach and
engagement with MAOs and
stakeholders in the Marketplace through
satisfaction surveys following contractlevel (CON) RADV audit and Health
Insurance Exchange training events. The
survey results will help to determine
stakeholders’ level of satisfaction with
trainings, identify any issues with
training and technical assistance
delivery, clarify stakeholders’ needs and
preferences, and define best practices
for training and technical assistance.
Form Number: CMS–10764 (OMB
control number: 0938–NEW);
Frequency: Occasionally; Affected
Public: Private Sector; Number of
Respondents: 4,270; Total Annual
Responses: 4,270; Total Annual Hours:
1,068. (For questions regarding this
collection contact Melissa Barkai at
410–786–4305.)
Dated: May 17, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–10680 Filed 5–19–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–P–0226]
Determination That AVACLYR
(Acyclovir Ophthalmic Ointment), 3
Percent, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that AVACLYR (acyclovir
SUMMARY:
VerDate Sep<11>2014
17:36 May 19, 2021
Jkt 253001
ophthalmic ointment), 3 percent, was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for acyclovir
ophthalmic ointment, 3 percent, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Nisha Shah, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6222, Silver Spring,
MD 20993–0002, 301–796–4455,
Nisha.Shah@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which 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.
AVACLYR (acyclovir ophthalmic
ointment), 3 percent, is the subject of
NDA 202408, held by Fera
Pharmaceuticals, LLC, and initially
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
approved on March 29, 2019. AVACLYR
is indicated for the treatment of acute
herpetic keratitis (dendritic ulcers) in
patients with herpes simplex (HSV–1
and HSV–2) virus.
In a letter dated August 21, 2019, Fera
Pharmaceuticals, LLC notified FDA that
AVACLYR (acyclovir ophthalmic
ointment), 3 percent, was being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Cumulus Pharmaceutical LLC
submitted a citizen petition dated
February 23, 2021, (Docket No. FDA–
2021–P–0226), under 21 CFR 10.30,
requesting that the Agency determine
whether AVACLYR (acyclovir
ophthalmic ointment), 3 percent, was
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 AVACLYR (acyclovir
ophthalmic ointment), 3 percent, was
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that AVACLYR (acyclovir
ophthalmic ointment), 3 percent, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
AVACLYR (acyclovir ophthalmic
ointment), 3 percent, from sale. We have
also independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list AVACLYR (acyclovir
ophthalmic ointment), 3 percent, 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. Any ANDAs
referencing AVACLYR (acyclovir
ophthalmic ointment), 3 percent, may
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.
E:\FR\FM\20MYN1.SGM
20MYN1
]]>Agencies
[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Pages 27435-27436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10680]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier CMS-10536, CSM-10225 and CMS-10764]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by June 21, 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.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' website address at website address at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicaid
Eligibility and Enrollment (EE) Implementation Advanced Planning
Document (IAPD) Template; Use: To assess the appropriateness of states'
requests for enhanced federal financial participation for expenditures
related to Medicaid eligibility determination systems, we will review
the submitted information and documentation to make an approval
determination for the advanced planning document. Form Number: CMS-
10536 (OMB control number: 0938-1268); Frequency: Yearly, once, and
occasionally; Affected Public: State, Local, or Tribal Governments;
Number of Respondents: 56; Total Annual Responses: 168; Total Annual
Hours: 2,688. (For policy questions regarding this collection contact
Edward Dolly at 410-786-8554.)
2. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title of Information Collection:
Disclosures Required of Certain Hospitals and Critical Access Hospitals
Regarding Physician Ownership; Use: This information collection relates
to the required third party disclosures by certain Medicare-
participating hospitals and Critical Access Hospitals (CAHs) and
physicians to their patients. There are 5 types of disclosures
required. The intent of the disclosure notice is to assist the patient
in making an informed decision regarding their care. The first
disclosure requires physician owned hospitals and CAHs to disclose to
its patients whether the hospitals/CAHs are physician-owned and, if so,
the names of the physician-owners. The second disclosure requires the
physician owner or investor in the hospital, as part of his or her
continued medical staff membership or admitting privileges, to disclose
to the patient being referred to the hospital any ownership or
investment interest held by the physician or an immediate family member
of the physician. The third disclosure requires physician owned
hospitals to disclose on all public websites for and in any public
advertising for the hospital that the hospital is owned or invested in
by physicians. The fourth and fifth disclosures apply to all hospitals
and CAHs that do not have a Doctor of Medicine (MD) or a Doctor of
Osteopathic Medicine (DO) on the premises at all times to disclose this
to patients upon admission or registration for both inpatient and
specified outpatient services. These hospitals and CAHs must provide a
written disclosure to the patients admitted to the hospital and must
also post a conspicuous notice in the Emergency Departments (ED) which
states that the hospital does not have a physician present 24 hours per
day, 7 days per week. Form Number: CMS-10225 (OMB control number: 0938-
1034); Frequency: Occasionally; Affected Public: Private sector--
Business or other for-profits and Not-for-profit institutions; Number
of Respondents: 210; Total Annual Responses: 1,193,890; Total Annual
Hours: 78,935. (For policy questions regarding this collection contact
Caroline Gallaher at 410-786-8705).
3. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Evaluation of Risk Adjustment Data Validation
[[Page 27436]]
(RADV) Appeals and Health Insurance Exchange Outreach Training
Sessions; Use: CMS recognizes that the success of accurately
identifying risk-adjustment payments and payment errors is dependent
upon the data submitted by Medicare Advantage Organizations (MAOs), and
is strongly committed to providing appropriate education and technical
outreach to MAOs and third-party administrators (TPAs). In addition,
CMS is strongly committed to providing appropriate education and
technical outreach to States, issuers, self-insured group health plans
and TPAs participating in the Marketplace and/or market stabilization
programs mandated by the Affordable Care Act (ACA).
CMS will strengthen outreach and engagement with MAOs and
stakeholders in the Marketplace through satisfaction surveys following
contract-level (CON) RADV audit and Health Insurance Exchange training
events. The survey results will help to determine stakeholders' level
of satisfaction with trainings, identify any issues with training and
technical assistance delivery, clarify stakeholders' needs and
preferences, and define best practices for training and technical
assistance. Form Number: CMS-10764 (OMB control number: 0938-NEW);
Frequency: Occasionally; Affected Public: Private Sector; Number of
Respondents: 4,270; Total Annual Responses: 4,270; Total Annual Hours:
1,068. (For questions regarding this collection contact Melissa Barkai
at 410-786-4305.)
Dated: May 17, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2021-10680 Filed 5-19-21; 8:45 am]
BILLING CODE 4120-01-P
