Attachment A - 60 Day FRN

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Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Notices
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: During the morning session,
the committee will discuss new drug
application 212578 for padeliporfin dipotassium powder for solution for
injection, submitted by STEBA Biotech,
S.A. The proposed indication (use) for
this product is for the treatment of
patients with localized prostate cancer,
meeting the following criteria: Stage T1–
T2a and prostate specific antigen less
than or equal to 10 ng/mL and Gleason
Grade Group 1 based on transrectal
ultrasound guided biopsy or unilateral
Gleason Grade Group 2 based on
multiparametric magnetic resonance
imaging-targeted biopsy with less than
50 percent of cores positive.
During the afternoon session, the
committee will discuss supplemental
biologics license application 125477/S–
034, for CYRAMZA (ramucirumab)
injection for intravenous use, submitted
by Eli Lilly and Company. The proposed
indication (use) for this product is in
combination with erlotinib, for first-line
treatment of patients with metastatic
non-small cell lung cancer whose
tumors have epidermal growth factor
receptor exon 19 deletions or exon 21
(L858R) substitution mutations.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see ADDRESSES) on or before
February 19, 2020, will be provided to
the committee. Oral presentations from
the public will be scheduled between

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approximately 11 a.m. to 11:30 a.m. and
3:30 p.m. to 4 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before February
13, 2020. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by February 14, 2020.
Persons attending FDA’s advisory
committee meetings are advised that
FDA is not responsible for providing
access to electrical outlets.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Lauren Tesh
Hotaki (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: January 17, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01150 Filed 1–23–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Bureau of
Health Workforce (BHW) Substance
Use Disorder (SUD) Evaluation, 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 March 24, 2020.
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 ICR title
for reference.
Information Collection Request Title:
Bureau of Health Workforce (BHW)
Substance Use Disorder (SUD)
Evaluation.
OMB No.: 0906–xxxx—New.
Abstract: In September 2017, HRSA
launched a multi-part effort to increase
the workforce capacity of the U.S.
health care system to prevent and treat
the opioid crisis. As a part of this effort,
HRSA developed or expanded activities
under five programs to help combat the
crisis: (1) The National Health Service
Corps (NHSC) Loan Repayment Program
offers loan repayment to providers
focused on Substance Use Disorder
treatment (NHSC SUD Workforce LRP),
(2) the National Health Service Corps
Rural Communities Loan Repayment
SUMMARY:

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Program (NHSC Rural Communities
LRP), (3) the Opioid Workforce
Expansion Program (OWEP), (4) the
Behavioral Health Workforce Education
and Training Program (BHWET), and (5)
the Graduate Psychology Education
(GPE) Program. These programs provide
either loan repayment to providers
(NHSC SUD Workforce LRP, NHSC
Rural Communities LRP) or funding for
training programs for behavioral health
professionals and paraprofessionals to
increase integrated behavioral health
into primary care treatment and
interprofessional team-based care to
high-need areas (OWEP, BHWET, GPE).
The purpose of the planned
evaluation is to assess these five
programs with respect to their stated
goals of increasing access to the number
of clinicians delivering evidence-based
SUD treatment, enhancing education
and training in substance use
prevention and treatment for current
and future health care professionals and
paraprofessionals in rural and
underserved communities, and
integrating behavioral health into
primary care to improve the capacity of
the health care delivery system to
provide SUD prevention and treatment
services.
The evaluation will include data
collection through web-based surveys to
trainees, recipients of loan repayments,
grantee organizations, and training sites
participating in BHW’s SUD prevention
and treatment programs. At the trainee/
participant level, questions will focus
on educational and professional
background, motivation and incentives
to join or leave the program, training
experiences, perceived readiness to
deliver SUD treatment services (where
applicable), capacity to engage in
prevention strategies, and postgraduation employment (where
applicable). At the recipient grantee
organization level (note: This level is not
relevant to the NHSC programs),
questions will focus on recruitment and
retention of students, how their SUD
prevention and treatment training
program curriculum was developed, as
applicable, collaboration with SUD
prevention and treatment training sites,
plans for sustainability of SUD
prevention and treatment activities, as
well as any other benefits that resulted
from the program. At the site level,
questions will focus on SUD prevention
and treatment training such as
addressing motivation for the site to
participate, whether and what type of
integrated care delivery is available, and
other organizational factors of the site.
At all three levels, and for all programs,
we will collect survey SUD prevention
and treatment training data on

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satisfaction with the program and
recommendations for improving it.
In total, six survey instruments will
be used in this evaluation: (1) NHSC
SUD Workforce Loan Repayment
Program/NHSC Rural Communities
Loan Repayment Program/NHSC Loan
Repayment Program—Participant
Survey, (2) NHSC Loan Repayment
Program—Site Survey, (3) Grantee
Training and Educational Programs—
Trainee Survey, (4) Grantee Training
and Educational Programs—Alumni
Survey, (5) Grantee Training and
Educational Programs—Site Survey, and
(6) Grantee Training and Educational
Programs—Grantee Organization
Survey. As part of a comprehensive
questionnaire design process, questions
will be limited and refined to collect
information not available through
secondary sources. Any data collected
will not be duplicative of that collected
under progress reports or other BHW
grant monitoring. NHSC site and
participant survey questions will be
drawn from prior NHSC Satisfaction
Surveys, which were fielded in 2017
and 2018 but were discontinued. Skip
patterns will allow respondents to
answer only relevant questions for each
of their programs. Participation in all
surveys is voluntary, and all surveys
will be fielded annually for three years
beginning in 2020 and concluding in
2022 to include each annual cohort of
trainees and participants. Each trainee,
participant, or site will complete their
respective surveys one time.
Need and Proposed Use of the
Information: The purpose of this effort
is to evaluate BHW’s SUD prevention
and treatment expansion program
investments with respect to the
following objectives:
• Objective 1: What is the impact of
the NHSC SUD Workforce LRP and the
NHSC Rural Communities LRP on the
provision of SUD, services in
underserved areas compared to those
who participate in the non-SUD NHSC
LRP?
• Objective 2: How are the activities
in the BHWET, GPE, and OWEP
programs contributing to the expansion
of service delivery for SUD prevention
and treatment, at the individual,
educational, and service-delivery
system level?
• Objective 3: To what extent are the
BHW’s programs successful at
increasing access to treatment for SUD,
including opioid treatment services?
The survey data will be critical to
understanding the factors related to the
success of current BHW programs, and
assist in the development of future
programs and ongoing SUD prevention

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and treatment workforce policy
development.
Likely Respondents: Data will be
collected from trainees, grantee
organizations, and sites participating in
BHW’s SUD prevention and treatment
expansion programs as described below.
NHSC SUD Workforce Loan
Repayment Program/NHSC Rural
Communities LRP/NHSC LRP—
Participants Survey: All NHSC SUD
Workforce LRP participants, NHSC
Rural Communities LRP participants,
and NHSC traditional LRP participants
who have served at an NHSC site for at
least nine months will be invited to
respond. Respondents will also include
those whom have exited a program early
to understand reasons for termination.
NHSC Loan Repayment Program—
Site Survey: All sites that were approved
to receive NHSC resources, regardless if
they currently have a participant on
staff will be invited to respond.
Grantee Training and Educational
Programs—Trainee Survey: All
individuals identified by a grantee as
currently receiving training as part of
one of the grantee training and
educational programs will be invited to
respond. Respondents will also include
those who have exited a program early,
to understand reasons for termination.
Grantee Training and Educational
Programs—Alumni Survey: All
individuals who completed the Grantee
Training and Educational Program
Trainee Survey but had not completed
their training at the time of the
participant survey, will be invited to
respond to this short survey which will
ask about employment since graduation.
Grantee Training and Educational
Programs—Site Survey: All sites that
were approved to receive BHWET,
OWEP, or GPE trainees, regardless of
whether they currently have trainees,
will be invited to respond.
Grantee Training and Educational
Programs—Grantee Organization
Survey: All grantee organizations that
received awards in fiscal year 2018 for
the BHWET program, and received
fiscal year 2019 awards for the GPE and
OWEP programs will be invited to
respond.
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

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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

Total
responses

Average
burden per
response
(in hours)

Total burden
hours

NHSC Loan Repayment Programs—Participant Survey ....
NHSC Loan Repayment Programs—Site Survey ...............
Grantee Programs—Trainee Survey ...................................
Grantee Programs—Alumni Survey ....................................
Grantee Programs—Site Survey .........................................
Grantee Programs—Grantee Organization Survey .............

8,000
18,000
8,000
2,000
5,000
300

1
1
1
1
1
1

8,000
18,000
8,000
2,000
5,000
300

0.33
0.33
0.33
0.16
0.33
0.33

2,640
5,940
2,640
320
1,650
99

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

41,300

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

41,300

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

13,289

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. 2020–01119 Filed 1–23–20; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Solicitation of Nominations for
Membership To Serve on the Advisory
Committee on Infant Mortality
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).

AGENCY:

ACTION:

Request for nominations.

HRSA is seeking nominations
of qualified candidates for consideration
for appointment as members of the
Advisory Committee on Infant Mortality
(ACIM). The ACIM provides advice to
the Secretary of HHS on Department
activities and programs directed at
reducing infant mortality and improving
the health status of pregnant women
and infants. With a focus on life course,
ACIM addresses disparities in maternal
health to improve maternal health
outcomes, including preventing and
reducing maternal mortality and severe
maternal morbidity. HRSA is seeking

SUMMARY:

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Number of
responses per
respondent

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nominations of qualified candidates to
fill positions on the ACIM.
DATES: Written nominations for
membership on the ACIM must be
received on or before February 24, 2020.
ADDRESSES: Nomination packages must
be submitted electronically as email
attachments to David de la Cruz, the
ACIM’s Designated Federal Official, at:
dcruz@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
David de la Cruz, Ph.D., MPH. Address:
Maternal and Child Health Bureau,
HRSA 5600 Fishers Lane, Room 18N25,
Rockville, MD 20857; phone number:
301–443–0543; email: dcruz@hrsa.gov.
A copy of the ACIM charter and list of
the current membership can be obtained
by accessing the ACIM website at
https://www.hrsa.gov/advisorycommittees/Infant-Mortality/index.html.
SUPPLEMENTARY INFORMATION: The ACIM
was established in 1991 and advises the
Secretary of HHS on Department
activities and programs directed at
reducing infant mortality and improving
the health status of pregnant women
and infants. The ACIM represents a
public-private partnership at the highest
level to provide guidance and focus
attention on the policies and resources
required to address the reduction of
infant mortality and the improvement of
the health status of pregnant women
and infants. Women who experience
conditions such as hypertension,
malnutrition, substance use disorder,
and/or diabetes during pregnancy are at
an elevated risk of delivering a baby
who is low birth weight or premature.
These are two of the leading causes of
infant mortality. The ACIM provides
advice on how best to coordinate a
myriad of federal, state, local, and
private programs and efforts that are
designed to deal with the health and
social problems affecting infant
mortality and maternal health including

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implementation of the Healthy Start
program and the maternal and infant
health objectives from the National
Health Promotion and Disease
Prevention Objectives.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
(SGEs) on the ACIM. The Secretary
appoints up to 21 members for a term
of up to 4 years. Nominees should
include medical, technical, or scientific
professionals with special expertise in
the field of maternal and child health,
in particular infant mortality and related
health disparities; members of the
public having special expertise about or
concern with infant mortality; and/or
representatives from such public health
constituencies, consumers, and medical
professional societies. Interested
applicants may self-nominate or be
nominated by another individual or
organization.
Members appointed as SGEs receive a
stipend and reimbursement for per diem
and travel expenses incurred for
attending the ACIM meetings and/or
conducting other business on behalf of
the ACIM, as authorized by 5 U.S.C.
5703 for persons employed
intermittently in government service.
The ACIM meets approximately twice
per year.
The following information must be
included in the package of materials
submitted for each individual being
nominated for consideration: (1) A
statement that includes the name and
affiliation of the nominee and a clear
statement regarding the basis for the
nomination, including the area(s) of
expertise that may qualify a nominee for
service on the ACIM, as described
above; (2) confirmation the nominee is
willing to serve as a member of the
ACIM; (3) the nominee’s contact
information (please include home
address, work address, daytime

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