60 Day FRN

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Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices

Matters considered at the meeting will
include current strategies to reduce the
risk of Zika virus (ZIKV) transmission
by blood and blood components, an
update on the Transfusion
Transmissible Infections Monitoring
System (TTIMS), and testing blood
donations for hepatitis B surface
antigen. The meeting will be open to the
public.
DATES: The meeting will be held on
April 2, 2020, from 8:30 a.m. to 3:45
p.m. and April 3, 2020, from 8:30 a.m.
to 12:30 p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For security information,
please refer to https://www.fda.gov/
about-fda/white-oak-campusinformation/public-meetings-fda-whiteoak-campus. Answers to commonly
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm.
For those unable to attend in person,
the meeting will also be webcast and
will be available at the following link:
https://collaboration.fda.gov/
bpacapril20/.
FOR FURTHER INFORMATION CONTACT:
Christina Vert or Joanne Lipkind, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
6268, Silver Spring, MD 20993–0002,
240–402–8054, christina.vert@
fda.hhs.gov, or 240–402–8106,
joanne.lipkind@fda.hhs.gov,
respectively, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
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
Agency’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. For those unable to attend in
person, the meeting will also be
available via webcast. The webcast will

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be available at the following link for
both days: https://collaboration.fda.gov/
bpacapril20/.
SUPPLEMENTARY INFORMATION:
Agenda: On April 2, 2020, in the
morning, the BPAC will meet in open
session to discuss and make
recommendations on strategies to
reduce the risk of ZIKV transmission by
blood and blood components. The
committee will discuss whether
universal testing of blood donations for
ZIKV is an appropriate strategy
considering the decline of ZIKV cases in
the United States and worldwide. In the
afternoon, the committee will meet in
open session to hear an update on the
TTIMS. Sponsored by the FDA, the
National Institutes of Health National
Heart, Lung and Blood Institute, and the
Department of Health and Human
Services Office of the Assistant
Secretary for Health, TTIMS collects
incidence, prevalence and risk factor
data for certain transfusion-transmitted
infections, including human
immunodeficiency virus, in U.S. blood
donations. On April 3, 2020, the
committee will meet in open session to
discuss and make recommendations on
testing for hepatitis B surface antigen
(HBsAg) in blood donations. The
committee will discuss whether testing
for HBsAg can be discontinued
considering the sensitivity of hepatitis B
virus nucleic acid testing and hepatitis
B anti-core testing of blood donations in
the United States.
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. Written
submissions may be made to the contact
person on or before March 25, 2020. On
April 2, 2020, oral presentations from
the public will be scheduled between
approximately 10:50 a.m. to 11:20 a.m.
and 3:15 p.m. to 3:45 p.m. On April 3,
2020, oral presentations from the public
will be scheduled between
approximately 11 a.m. to 11:30 a.m.
Those individuals interested in making

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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 March 16, 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 March 17, 2020.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
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 Christina Vert
(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/Advisory
Committees/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: February 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
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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: Membership
Forms for Organ Procurement and
Transplantation Network OMB No.
0915–0184–Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

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Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices
In compliance with 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 or any
other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than April 13, 2020.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 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:
Membership Forms for Organ
Procurement and Transplantation
Network OMB No. 0915–0184–Revision
Abstract: This is a request for OMB
approval for revisions of the application
documents used to collect information
for determining if the interested party is
compliant with membership
requirements contained in the final rule
Governing the Operation of the Organ
Procurement and Transplantation
Network (OPTN), (42 CFR part 121) ‘‘the
OPTN final rule.’’
Need and Proposed Use of the
Information: Membership in the OPTN
is determined by submission of
application materials to the OPTN (not
to HRSA) demonstrating that the
applicant meets all required criteria for
membership and will agree to comply
with all applicable provisions of the
National Organ Transplant Act, as
amended, 42 U.S.C. 273, et seq., the
OPTN final rule, OPTN Policies, and
OPTN Bylaws. Section 1138 of the
Social Security Act, as amended, 42
U.S.C. 1320b–8 (section 1138) requires
that hospitals in which transplants are
performed be members of, and abide by,
the rules and requirements of the OPTN
(that have been approved by the
Secretary of HHS) as a condition of
participation in Medicare and Medicaid.
Section 1138 contains a similar
provision for the organ procurement
organizations (OPOs) and makes
membership in the OPTN and
compliance with its rules and

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SUMMARY:

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requirements (that have been approved
by the HHS Secretary), including those
relating to data collection, mandatory
for all transplant programs and OPOs.
Proposed Revisions to OPTN
Membership Applications: Changes to
the forms are proposed to make
application requirements more clear and
organized, and thus less cumbersome
for applicants to complete. Proposed
revisions include changes to wording to
make questions more consistent with
the language of the OPTN Bylaws
(Bylaws). In addition, the applications
have been revised so that the sequence
of questions is parallel to that of the
Bylaws. Using the Bylaws as a baseline,
the revamped applications have been
constructed in parallel order of the
Bylaws so that an applicant can have
the application and Bylaws side-by-side
for easy reference. Additional proposed
changes to the application include:
• A few major changes were made to
the application order of documentation
and attachments. The embedded
transplant logs were revised in the form
of a ‘universal’ surgeon and physician
log that will be provided as a separate
attachment to the application. This new
log will provide applicants with all
OPTN Bylaws requirements. We hope
the added technology utilized in the log
will help applicants complete the log
with limited errors.
• Also within the applications,
‘‘checkboxes’’—fillable tables that were
not checkboxes at all—were removed
and working checkboxes were inserted.
The ‘‘narrative’’ section was replaced by
checkbox attestations, which will serve
the same purpose—understanding
relevant and recent surgeon and
physician applicant experience.
• The previous membership
applications had several places for the
applicants to sign. The new application
requests only one signature from each
individual member applicant involved.
• Additional changes to the
application process include
streamlining previous application
attachments for key personnel and
living donor components into one form
for the respective organ application.
• Pediatric Bylaw Requirements,
where applicable, were also given their
own sections within the organ
applications. Conversely, the Certificate
of Assessment (formerly known as
Certificate of Investigation) and the
Primary Coverage Plan Checklist were
pulled out of the previous organ specific
applications and given their own,
separate attachment. These changes will
allow OPTN application reviewers to
give these application components to
applicants in as few attachments as
possible. These changes will also allow

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the United Network for Organ Sharing
Membership Team to give these
important application components to
applicants in as few attachments as
possible, but are inclusive of all possible
changes within a program.
• Further changes have been made to
the Vascularized Composite Allograft
(VCA) Transplant program applications,
which were previously submitted as
separate applications for OMB approval
based on body part transplanted. These
forms have been revised into one single
application with sections for each VCA
organ type.
• Personnel changes for Organ
Procurement Organizations (OPOs) and
Histocompatibility Laboratories have
also been consolidated into organization
applications. OPO and Lab applicants
will be able to use one respective
application for new and/or personnel
changes.
• Given these changes, the overall
burden has decreased significantly from
an estimated 7,016 total burden hours to
4,755 hours in this current proposed
revision package, although some forms
have been combined into one more
comprehensive form resulting in
increased burden hours for a particular
form.
Likely Respondents: Parties seeking
initial OPTN membership approval and
then maintenance of existing OPTN
approval. Applicants include the
following: hospitals seeking to perform
organ transplants, non-profit
organizations seeking to become an
organ procurement organization, and
medical laboratories seeking to become
an OPTN-approved histocompatibility
laboratory. In addition, there are other
OPTN membership categories for
organizations and individuals who want
to participate in the organ transplant
system, and they are also required to fill
out an appropriate application.
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.

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Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Number of
respondents

Form name

OPTN Membership Application for
Transplant Hospitals
OPTN Certificate of Assessment and
Program Coverage Plan Membership
Application
OPTN Membership Application for Kidney Transplant Programs
OPTN Membership Application for
Liver Transplant Programs
OPTN Membership Application for
Pancreas Transplant Programs
OPTN Membership Application for
Heart Transplant Programs
OPTN Membership Application for
Lung Transplant Programs
OPTN Membership Application for Islet
Transplant Programs
OPTN Membership Application for
Vascularized Composite Allograft
(VCA) Transplant Programs
OPTN Membership Application for Intestine Transplant Programs
OPTN Membership Application for
Organ Procurement Organizations
(OPOs)
OPTN Membership Application for
Histocompatibility Laboratories
OPTN Representative Form
OPTN Medical/Scientific Membership
Application
OPTN Public Organization Membership
Application
OPTN Business Membership Application
OPTN Individual Membership Application
OPTN Membership Application Surgeon or Physician Log*
Total = 18 forms

Average
burden per
response
(in hours)

Total
responses

Total burden
hours

2

1

2

3

6

2

1

2

3

6

189

2

378

3

1,134

110

2

220

3

660

120

2

240

3

720

142

2

284

3

852

60

2

120

3

360

4

2

8

2

16

53

2

106

2

212

90

2

180

3

540

10

1

10

3

30

27

2

54

3

162

20
7

2
1

40
7

1
1

40
7

4

1

4

1

4

2

1

2

1

2

4

1

4

1

4

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

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

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

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

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

846

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

1,661

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

4,755

* The OPTN Membership Application Surgeon or Physician Log accompanies every individual organ application. The burden to complete is
built into the organ application data.

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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Office of the Assistant Secretary for
Preparedness and Response;
Statement of Organization, Functions
and Delegations of Authority
Part A, Office of the Secretary,
Statement of Organization, Functions,
and Delegations of Authority of the
Department of Health and Human
Services (HHS) is being amended at
Chapter AN, Office of the Assistant
Secretary for Preparedness and
Response (ASPR), as last amended at 83
FR 33941 (July 2018), 79 FR 70.535
(Nov. 26, 2014), 78 FR 25277 (April 30,
2013), 78 FR 7784 (Feb. 4, 2013), 75 FR
35.035 (June 21, 2010) to add the
Strategic National Stockpile (SNS). This

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notice transfers the Office of the
Director, Strategic National Stockpile, to
the Office of the Principal Deputy
Assistant Secretary (ANC), Division of
Resource Management (ANC3) pursuant
to 5 U.S.C. Appendix (the
Reorganization Plan No. 1 of 1953 and
the Reorganization Plan No. 3 of 1966)
and 31 U.S.C. 1531, and effective
October 1, 2018 the functions,
personnel, assets, and liabilities of the
SNS to the Office of the Secretary,
Office of the Assistant Secretary for
Preparedness and Response (ASPR).
The changes are as follows.
I. Delete AR.20 Functions in its
entirety and replace with the following:
Section AN.20 Functions.
A. Immediate Office of the Assistant
Secretary for Preparedness and
Response: The Immediate Office of the
Assistant Secretary for Preparedness
and Response (IO/ASPR) is headed by

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