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Federal Register / Vol. 84, No. 45 / Thursday, March 7, 2019 / Notices

a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies, total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments, and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For

more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://www.regulations
.gov and insert the docket number,
found in brackets in the heading of this
document, into the ‘‘Search’’ box and
follow the prompts and/or go to the
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Gretchen Opper, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will

continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act. The 30-day period for requesting
administrative reconsideration of an
FDA action under § 10.33(b) (21 CFR
10.33(b)) for notices announcing
approval of a PMA begins on the day the
notice is placed on the internet. Section
10.33(b) provides that FDA may, for
good cause, extend this 30-day period.
Reconsideration of a denial or
withdrawal of approval of a PMA may
be sought only by the applicant; in these
cases, the 30-day period will begin
when the applicant is notified by FDA
in writing of its decision.
The regulations (21 CFR 814.44(d)
and 814.45(d)) provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of PMAs approved by
CBER for which safety and effectiveness
summaries were placed on the internet
from October 1, 2017, through December
31, 2018. There were no denial actions
during this period. The list provides the
manufacturer’s name, the product’s
generic name or the trade name, and the
approval date.

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1,
2017, THROUGH DECEMBER 31, 2018
PMA No./Docket No.

Applicant

Trade name

BP160122, FDA–2017–M–
6870.

Ortho-Clinical Diagnostics, Inc .................

BP170122, FDA–2018–M–
3584.
BP170154, FDA–2018–M–
3870.

Avita Medical Americas, LLC ...................

VITROS Immunodiagnostic Products HIV
Combo Reagent Pack & VITROS
Immunodiagnostic
Products
HIV
Combo Calibrator.
RECELL Autologous Cell Harvesting Device.
ID CORE XT (Reagents and Analysis
Software).

Progenika Biopharma, S.A .......................

II. Electronic Access
Persons with access to the internet
may obtain the documents at https://
www.fda.gov/BiologicsBloodVaccines/
BloodBloodProducts/Approved
Products/PremarketApprovalsPMAs/
default.htm.
Dated: March 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.

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[FR Doc. 2019–04114 Filed 3–6–19; 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: The Stem Cell
Therapeutic Outcomes Database OMB
No. 0915–0310—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

In compliance with the
requirement for an opportunity for
public comment on proposed data
collection projects of the Paperwork

SUMMARY:

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Approval date
December 13, 2017.

September 20, 2018.
October 11, 2018.

Reduction Act of 1995, HRSA
announces plans to submit an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB). Before
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 May 6, 2019.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 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

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8335

Federal Register / Vol. 84, No. 45 / Thursday, March 7, 2019 / Notices
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:
The Stem Cell Therapeutic Outcomes
Database OMB No. 0915–0310,
Revision.
Abstract: The Stem Cell Therapeutic
and Research Act of 2005, Public Law
(Pub. L.) 109–129, as amended by the
Stem Cell Therapeutic and Research
Reauthorization Act of 2015, Public Law
114–104 (the Act), provides for the
collection and maintenance of human
blood stem cells for the treatment of
patients and research. The Act requires
the Secretary to contract for the
establishment and maintenance of
information related to patients who
have received stem cell therapeutic
products and to do so using a
standardized, electronic format. HRSA’s
Healthcare Systems Bureau has

established the Stem Cell Therapeutic
Outcomes Database, which necessitates
certain electronic record keeping and
reporting requirements to perform the
functions related to hematopoietic stem
cell transplantation under contract to
HHS. Data is collected from transplant
centers by the Center for International
Blood and Marrow Transplant Research
and is used for ongoing analysis of
transplant outcomes. Over time, there is
an expected increase in the number of
recipients for whom data are reported as
the increasing number of transplants are
performed annually and survivorship
after transplantation improves.
Need and Proposed Use of the
Information: Per statutory
responsibilities, information collected
on the forms outlined in the ‘‘Total
Estimated Annualized Burden Hours’’
section below is needed to monitor the
clinical status of transplantation and
provide the Secretary with an annual
report of transplant center-specific
survival data. The proposed revisions of
these data collection forms fall into
several categories: Consolidating
questions and removing duplicate

questions across the forms,
implementing ‘‘check all that apply’’
formatting to reduce data entry time,
and removing items no longer clinically
significant (e.g., drugs). These proposed
revisions are not anticipated to affect
total burden hours.
Likely Respondents: Transplant
Centers.
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 1

Form name

Average
burden per
response
(in hours)

Total
responses

Total
burden
hours

Baseline Pre-Transplant Essential Data (TED) ...................
Disease Classification ..........................................................
Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) ........................................................
100-Day Post-TED ...............................................................
6-Month Post-TED ...............................................................
12-Month Post-TED .............................................................
Annual Post-TED .................................................................

200
200

44
44

8,800
8,800

1.00
0.15

8,800
1,320

200
200
200
200
200

33
44
36
32
110

6,600
8,800
7,200
6,400
22,000

1.00
1.25
1.15
1.15
1.15

6,600
11,000
8,280
7,360
25,300

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

200

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

68,600

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

68,660

1 The

total of 200 is the number of centers completing the form; the same group will complete all of the forms.

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.
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Number of
responses per
respondent

Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2019–04117 Filed 3–6–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Council on Nurse Education and
Practice
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

In accordance with the
Federal Advisory Committee Act, this
notice announces that the National
Advisory Council on Nurse Education
and Practice (NACNEP) has scheduled
public meetings for the 2019 calendar

SUMMARY:

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year (CY). Information about NACNEP,
agendas, and materials for these
meetings can be found on the NACNEP
website at https://www.hrsa.gov/
advisory-committees/nursing/
index.html.
All CY 2019 NACNEP meetings
will be held by teleconference and
webinar:
• April 1, 2019, 8:30 a.m.–2:30 p.m.
Eastern Time (ET)
• May 21, 2019, 8:30 a.m.–5:00 p.m.
ET; and
• September 24, 2019, 8:30 a.m.–5:00
p.m. ET.
ADDRESSES: Meetings will be held by
teleconference and/or Adobe Connect
webinar. Instructions for joining the
meetings remotely will be posted on the
DATES:

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