Attachment A - 60 Day FRN

54390

Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Notices

became effective: November 17, 2006.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on November 17, 2006.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): January 29, 2018. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
LUMOXITI (BLA 761104) was initially
submitted on January 29, 2018.
3. The date the application was
approved: September 13, 2018. FDA has
verified the applicant’s claim that BLA
761104 was approved on September 13,
2018.
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
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 159 days, 163 days,
and 2 days of patent term extension.

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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: August 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–19214 Filed 8–31–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0906–0053—Extension]

Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Coronavirus
2019 Data Report
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

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 November 2,
2020.

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:
Coronavirus 2019 Data Report OMB No.
0915-0906–0053—Extension.
Abstract: This information collection
request was previously approved by the
Office of Management and Budget
(OMB) on June 11, 2020, as an
emergency clearance (OMB No.: 0906–
0053). HRSA is currently undergoing
the standard Paperwork Reduction Act
process for normal OMB approval.
HRSA’s Ryan White HIV/AIDS
Program (RWHAP) funds and
coordinates with cities, states, and local
clinics/community-based organizations
to deliver efficient and effective HIV
care, treatment, and support to low
ADDRESSES:

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income people with HIV. Nearly twothirds of clients (patients) live at or
below 100 percent of the federal poverty
level and approximately three-quarters
of RWHAP clients are racial/ethnic
minorities. Since 1990, the RWHAP has
developed a comprehensive system of
safety net providers who deliver high
quality direct health care and support
services to over half a million people
with HIV—more than 50 percent of all
people with diagnosed HIV in the
United States.
FY 2020 Coronavirus Aid, Relief, and
Economic Security Act
On March 27, 2020, the President
signed into law the ‘‘Coronavirus Aid,
Relief, and Economic Security Act’’
(CARES Act). The CARES Act
appropriated $90 million to HRSA’s
RWHAP to prevent, prepare for, and
respond to coronavirus disease 2019
(COVID–19). This funding supports 581
RWHAP recipients across the country,
including city/county health
departments, state health departments,
health clinics, community-based
organizations, and AIDS Education and
Training Centers in their efforts to help
prevent or minimize the impact of
COVID–19 on RWHAP clients. The
award provides RWHAP recipients the
flexibility to meet evolving COVID–19
needs in their respective communities,
including extending operational hours,
increasing staffing hours, purchasing
additional equipment, enhancing
workforce training and capacity
development, and providing critical
services to people with HIV during this
pandemic, such as home-delivered
meals, emergency housing, and
transportation.
HRSA identified a new data collection
need to support HRSA’s requirement to
monitor and report quarterly to the
Secretary of HHS the COVID–19
activities conducted with the CARES
Act funding. The COVID–19 Data Report
module will provide monthly reporting
on the types of services provided and
number of people served for the
treatment or prevention of COVID–19
among RWHAP clients (and immediate
household members in limited
circumstances). This module will be
required for all providers (regardless of
whether they are recipients or
subrecipients) who receive CARES Act
RWHAP funding.
Need and Proposed Use of the
Information: HRSA proposes that
service providers who receive CARES
Act RWHAP funding report aggregate
information on the number of clients
and immediate household members
tested for COVID–19, the number of
clients newly diagnosed (or presumed

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Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Notices
positive) with COVID–19, the
cumulative number of clients with
COVID–19, the number of clients who
received services in each RWHAP
service category (identified in Policy
Clarification Notice 16–02 Ryan White
HIV/AIDS Program Services: Eligible
Individuals and Allowable Uses of
Funds), and the types of services
provided using telehealth technology in
the COVID–19 Data Report. The
information obtained in this module
will assist HRSA in understanding how
CARES Act RWHAP funding is being

used to support RWHAP clients and
immediate household members and
ensure that HRSA is compliant with
federal reporting requirements.
Likely Respondents: All RWHAP
providers (regardless of whether they
are recipients or subrecipients) who
receive CARES Act RWHAP funding.
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
Form name

Number of
respondents

Number of
responses per
respondent

Total
responses

Average
burden per
response
(in hours)

Total burden
hours

COVID–19 Data Report .......................................................

2045

12

24,540

2

49,080

2045

........................

24,540

........................

49,080

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. 2020–19247 Filed 8–31–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission on Childhood
Vaccines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice; correction.
AGENCY:

The original Federal Register
Notice announcing the September 2020
Advisory Commission on Childhood
Vaccines (ACCV) meeting indicated that
this meeting would be held on
September 3–4, 2020. This meeting is
not being conducted over 2 days, and
instead will only take place only on
September 4, 2020.
The ACCV will hold a public meeting
on September 4, 2020, at 10:00 a.m. ET.

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SUMMARY:

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The meeting will be held via Adobe
Connect and telephone conference. This
will not be an in-person meeting. The
public can join the meeting by:
1. (Audio Portion) Calling the
conference phone number 888–790–
1734 and providing the following
information:
Leader Name: Ms. Tamara Overby
Passcode: 4177683
2. (Visual Portion) Connecting to the
ACCV Adobe Connect Meeting using the
following URL: https://hrsa.connect
solutions.com/accv/. Participants
should call and connect 15 minutes
prior to the meeting in order for logistics
to be set up. If you have never attended
an Adobe Connect meeting, please test
your connection using the following
URL: https://hrsa.connectsolutions.
com/common/help/en/support/
meeting_test.htm and get a quick
overview by following URL: http://
www.adobe.com/go/connectpro_
overview.
Information about the ACCV and the
agenda for this public meeting can be
obtained by accessing the following
website: https://www.hrsa.gov/advisorycommittees/vaccines/index.html.
FOR FURTHER INFORMATION CONTACT:
Annie Herzog, Program Analyst,
Division of Injury Compensation
Programs (DICP), HRSA, in one of three
ways: (1) Send a request to the following
address: Annie Herzog, Program
Analyst, DICP, HRSA, 5600 Fishers
Lane, 08N146B, Rockville, Maryland
20857; (2) call (301) 443–6593; or (3)
send an email to [email protected].
Meeting times could change. For the
latest information regarding the

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meeting, including start time, please
check the ACCV website: http://
www.hrsa.gov/advisorycommittees/
childhoodvaccines/index.html.
This meeting will only take place on
September 4, 2020, and is not being
conducted over 2 days (September 3–4,
2020) as stated in a previous Federal
Register Notice.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–19257 Filed 8–31–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Exploring the Roles of Biomolecular

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