60 Day FRN

Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Notices
early consultation on the use of new
surrogate endpoints, and exploring the
use of real world evidence for use in
regulatory decision-making, among
other enhancements. This iteration
includes commitments to enhance the
use of regulatory tools to support drug
development and review through
incorporation of the patient’s voice in
drug development, expanded use of a
benefit-risk framework in drug reviews,
and advancing the use of complex
innovative trial designs and model
informed drug development. More
information on these commitments can
be found in the PDUFA VI commitment
letter at: https://www.fda.gov/media/
99140/download.
As part of the current authorization,
FDA also modernized the user fee
structure to improve program funding
predictability, stability, and
administrative efficiency. The new
structure eliminated the supplement
fees, replaced the establishment and
product fees with a program fee, and
shifted a greater proportion of the target
revenue to the new more predictable
and stable annual program fee. The
agreement also included commitments
to enhance management of user fee
resources through the development of a
resource capacity planning capability
and third-party evaluation of program
resource management, along with the
publication and annual update of a 5year financial plan.
Recognizing the challenges with
hiring in PDUFA V, the current
authorization also includes several
commitments to improve the hiring and
retention of critical review staff through
modernization of FDA’s hiring system,
augmentation of hiring staff capacity
and capabilities, creation of a dedicated
function focused on staffing the
program, reporting on hiring metrics,
and a comprehensive and continuous
assessment of hiring and retention. A
list of the deliverables developed to
meet PDUFA VI commitments is
available on the FDA web page at:
https://www.fda.gov/industry/
prescription-drug-user-fee-amendments/
completed-pdufa-vi-deliverables.

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III. Public Meeting Information
A. Purpose and Scope of the Meeting
In general, the meeting format will
include presentations by FDA and a
series of panels representing different
stakeholder groups. We will also
provide an opportunity for other
stakeholders to provide public comment
at the meeting. FDA policy issues are
beyond the scope of these
reauthorization discussions.
Accordingly, the presentations should

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focus on process enhancements and
funding issues, and not focus on policy
issues.

Dated: June 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.

B. Participating in the Public Meeting

[FR Doc. 2020–12317 Filed 6–5–20; 8:45 am]

Registration: Persons interested in
attending this virtual public meeting
should register online by 11:59 p.m.
Eastern Time on June 23, 2020, at http://
pdufavii-publicmeeting.eventbrite.com.
Please provide complete contact
information for each attendee, including
name, title, affiliation, email, and
telephone.
Opportunity for Public Comment:
Those who register online by June 23,
2020, will receive a notification about
an opportunity to participate in the
public comment session of the meeting.
If you wish to speak during the public
comment session, follow the
instructions in the notification and
identify which topic(s) you wish to
address. We will do our best to
accommodate requests to make public
comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
comments and request time jointly. All
requests to make a public comment
during the meeting must be received by
July 9, 2020, 11:59 p.m. Eastern Time.
We will determine the amount of time
allotted to each commenter, the
approximate time each comment is to
begin, and will select and notify
participants by July 16, 2020. No
commercial or promotional material
will be permitted to be presented at the
public meeting.
Streaming Webcast of the Public
Meeting: The webcast for this public
meeting is available at https://
collaboration.fda.gov/pdufajuly2020/.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/
industry/fda-user-fee-programs/
prescription-drug-user-fee-amendments.

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BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Maternal
Health Portfolio Evaluation Design,
OMB No. 0906–xxxx—NEW
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
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 August 7, 2020.
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:
Maternal Health Portfolio Evaluation
Design OMB No. 0906–xxxx—NEW.
Abstract: HRSA programs provide
health care to people who are
geographically isolated, economically,
or medically vulnerable. HRSA
programs help those in need of high
quality primary health care, such as
pregnant women and mothers.
Improving maternal health outcomes
and access to quality maternity care
SUMMARY:

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Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Notices

services is a key component of the
HRSA mission. HRSA’s Maternal and
Child Health Bureau (MCHB) provides
funding to address some of the most
urgent issues influencing the high rates
of maternal mortality. Recent efforts to
address persistent disparities in
maternal, infant, and child health have
employed a ‘‘life course’’ perspective
and health equity lens focused on health
promotion and disease prevention. The
life course approach can be defined as
analyzing people’s lives within
structural, social, and cultural contexts
through a defined sequence of age
categories that people are normally
expected to pass through as they
progress from birth to death. Health
equity is defined as the attainment of
the highest level of health for all people.
Achieving health equity for pregnant
and postpartum women will require
attention to barriers in access to quality
health services and promotion of equal
opportunities to seek the highest
possible level of health and well-being.
Achieving health equity also requires a
focus on social determinants of health.
With this emphasis on improving
maternal health across the life course
and promoting optimal health for all
mothers, HRSA is employing a
multipronged strategy to address
maternal mortality and severe maternal
morbidity through the following suite of
programs:
1. The State Maternal Health
Innovation Program,

2. The Alliance for Innovation on
Maternal Health Program,
3. The Alliance for Innovation on
Maternal Health—Community Care
Initiative,
4. The Rural Maternity and Obstetrics
Management Strategies Program, and
5. The Supporting Maternal Health
Innovation Program.
MCHB is conducting a portfolio-wide
evaluation of HRSA-supported Maternal
Health Programs with a primary focus
on reducing maternal mortality.
Through this evaluation, HRSA seeks to
identify individual and/or collective
strategies, interrelated activities, and
common themes within and across the
Maternal Health Programs that may be
contributing to or driving improvements
in key maternal health outcomes. HRSA
seeks to ascertain which components
should be elevated and replicated to the
national level, as well as inform future
investments to reduce rates of maternal
mortality and severe maternal
morbidity.
Need and Proposed Use of the
Information: HRSA seeks to understand
the impact of HRSA’s investments into
maternal health programs. These five
HRSA maternal health programs
represent a total of 12 state-based
grantees and three grantees with the
potential for national reach. In
understanding the strategies that are
most effective in reducing maternal
morbidity and mortality, HRSA will be
able to determine which program

elements could be replicated and/or
scaled up nationally.
Likely Respondents: Likely
respondents are recipients of the
cooperative agreements mentioned
above (State Maternal Health Innovation
Program, Alliance for Innovation on
Maternal Health Program, Alliance for
Innovation on Maternal Health—
Community Care Initiative, Rural
Maternity and Obstetrics Management
Strategies Program, and Supporting
Maternal Health Innovation Program)
which include 11 state health agencies,
2 national organizations, and 2
academic organizations.
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

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Instrument
Instrument
Instrument
Instrument

1:
2:
3:
4:

Number of
responses
per
respondent

Total
responses

Average
burden per
response
(in hours)

Total burden
hours

Interview guide for grantee staff ....................
Interview guide for HRSA POs ......................
Partnership Survey ........................................
Web-based data collection tool .....................

75
7
290
15

1
1
1
1

75
7
290
15

1.00
1.50
0.25
0.50

75.0
10.5
72.5
7.5

Total ..............................................................................

387

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

387

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

165.5

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.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Maria G. Button,
Director, Executive Secretariat.

Office of the Secretary

[FR Doc. 2020–12308 Filed 6–5–20; 8:45 am]

Second Amendment to Declaration
Under the Public Readiness and
Emergency Preparedness Act for
Medical Countermeasures Against
COVID–19

BILLING CODE 4165–15–P

ACTION:

Notice of amendment.

The Secretary issues this
amendment pursuant to section 319F–3
of the Public Health Service Act to
clarify that Covered Countermeasures

SUMMARY:

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