Meeting of the Advisory Council on Blood Stem Cell Transplantation, 37323-37324 [2019-16306]
Download as PDF
<![CDATA[
37323
Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices
services, who had control over a
distributed product when the deviation
occurred, to report to CBER as soon as
possible but at a date not to exceed 45
calendar days after acquiring
information reasonably suggesting that a
reportable event has occurred.
Similarly, § 1271.350(b), in brief,
requires HCT/P establishments that
manufacture non-reproductive HCT/Ps
described in § 1271.10 to investigate and
report to CBER all HCT/P deviations
relating to a distributed HCT/P that
relates to the core CGTP requirements,
if the deviation occurred in the
establishment’s facility or in a facility
that performed a manufacturing step for
the establishment under contract,
agreement or other arrangement. Form
FDA 3486 is used to submit BPD reports
and HCT/P deviation reports.
Respondents to this collection of
information are: (1) Licensed
manufacturers of biological products
other than human blood and blood
components, (2) licensed manufacturers
of blood and blood components
including Source Plasma, (3) unlicensed
registered blood establishments, (4)
transfusion services, and (5)
establishments that manufacture nonreproductive HCT/Ps regulated solely
under section 361 of the PHS Act as
described in § 1271.10. The number of
respondents and total annual responses
are based on the BPD reports and HCT/
P deviation reports FDA received in
fiscal year 2018. The number of licensed
manufacturers and total annual
responses under § 600.14 include the
estimates for BPD reports submitted to
both CBER and CDER. Based on the
information from industry, the
estimated average time to complete a
deviation report is 2 hours, which
includes a minimal one-time burden to
create a user account for those reports
submitted electronically. The
availability of the standardized report
form, Form FDA 3486, and the ability to
submit this report electronically to
CBER (CDER does not currently accept
electronic filings) further streamlines
the report submission process.
CBER has developed a Web-based
addendum to Form FDA 3486 (Form
FDA 3486A) to provide additional
information when a BPD report has been
reviewed by FDA and evaluated as a
possible recall. The additional
information requested includes
information not contained in the Form
FDA 3486 such as: (1) Distribution
pattern; (2) method of consignee
notification; (3) consignee(s) of products
for further manufacture; (4) additional
product information; (5) updated
product disposition; and (6) industry
recall contacts. This information is
requested by CBER through email
notification to the submitter of the BPD
report. This information is used by
CBER for recall classification purposes.
CBER estimates that 5 percent of the
total BPD reports submitted to CBER
would need additional information
submitted in the addendum. CBER
further estimates that it would take
between 10 to 20 minutes to complete
the addendum. For calculation
purposes, CBER is using 15 minutes.
Activities such as investigating,
changing standard operating procedures
or processes, and followup are currently
required under 21 CFR parts 211
(approved under OMB control number
0910–0139), 606 (approved under OMB
control number 0910–0116), 820
(approved under OMB control number
0910–0073). and 1271 (approved under
OMB control number 0910–0543) and,
therefore, are not included in the
burden calculation for the separate
requirement of submitting a deviation
report to FDA.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA
form No.
21 CFR section
600.14; Reporting of product deviations by licensed manufacturers.
606.171; Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.
1271.350(b); Reporting requirements (human cells, tissues, and
cellular and tissue-based products).
1271.350(b) (CBER addendum report) ..........................................
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average
burden per
response
Total hours
3486
93
6.14
571
2.0
1,142
3486
1,937
23.847
46,192
2.0
92,384
3486
93
2.61
243
2.0
486
102
22.76
2,322
0.25
580.5
........................
........................
49,328
........................
94,592.5
3486A 2
Total .........................................................................................
1 There
jbell on DSK3GLQ082PROD with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Five percent of the number of respondents ((1,937 + 93) × 0.05 = 102) and total annual responses to CBER ((46,192 + 243) × 0.05 = 2,322).
Our estimated burden for the
information collection reflects an
overall increase of 739 hours and a
corresponding increase of 398
responses. We attribute this adjustment
to an increase in the number of
submissions we received over the last
few years.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
AGENCY:
[FR Doc. 2019–16243 Filed 7–30–19; 8:45 am]
20:09 Jul 30, 2019
Meeting of the Advisory Council on
Blood Stem Cell Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Council on Blood Stem Cell
Transplantation (ACBSCT) has
SUMMARY:
BILLING CODE 4164–01–P
VerDate Sep<11>2014
Health Resources and Services
Administration
Jkt 247001
PO 00000
Frm 00094
Fmt 4703
Sfmt 4703
scheduled a public meeting. Information
about ACBSCT and the agenda for this
meeting will be available on the
ACBSCT website at https://
bloodcell.transplant.hrsa.gov/about/
advisory_council/meetings/.
DATES: September 10, 2019, 10:00 a.m.–
4:00 p.m. Eastern Time (ET).
ADDRESSES: This meeting will be held
by webinar. Members of the public can
access the webinar link and conference
call-in number at https://
bloodcell.transplant.hrsa.gov/about/
advisory_council/meetings/.
FOR FURTHER INFORMATION CONTACT:
Robert Walsh, Designated Federal
Official, (DFO), at Division of
Transplantation, Healthcare Systems
E:\FR\FM\31JYN1.SGM
31JYN1
37324
Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices
Bureau, HRSA, 5600 Fishers Lane,
8W60, Rockville, Maryland 20857; 301–
443–6839; or RWalsh@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACBSCT
provides advice and recommendations
to the Secretary of HHS (Secretary) and
the HRSA Administrator on the
activities of the C.W. Bill Young Cell
Transplantation Program and the
National Cord Blood Inventory Program.
The principal purpose of these programs
is to make blood stem cells from adult
donors and cord blood units available
for patients who need a transplant to
treat life-threatening conditions such as
leukemia, and who lack a suitably
matched relative who can be the donor.
During the September 10, 2019,
meeting, ACBSCT will discuss issues
related to utilization of cord blood for
transplant and utilization of blood stem
cells in cellular therapies. Agenda items
are subject to change as priorities
dictate. Refer to the ACBSCT website for
any updated information concerning the
meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to ACBSCT
must be sent to Robert Walsh, DFO,
using the contact information above at
least three business days before the
meeting.
Individuals who plan to participate in
the webinar and need special assistance
or other reasonable accommodations
should notify Robert Walsh at the
address and phone number listed above
at least 10 business days before the
meeting.
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 of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Resource-Related
Research Projects (R24).
Date: August 20, 2019.
Time: 10:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: David C. Chang, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, 5601
Fishers Lane, MSC 9823, Rockville, MD
20852 david.chang3@nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Implementation Cooperative Agreement (U01
Clinical Trial Required).
Date: August 22, 2019.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Roberta Binder, Ph.D.
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G21A, National Institutes of Health/
NIAID, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20892–9823, (240) 669–5050,
rbinder@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
[FR Doc. 2019–16306 Filed 7–30–19; 8:45 am]
Dated: July 25, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4165–15–P
[FR Doc. 2019–16245 Filed 7–30–19; 8:45 am]
Maria G. Button,
Director, Division of the Executive Secretariat.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSK3GLQ082PROD with NOTICES
National Institute of Allergy and
Infectious Diseases; 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.,
VerDate Sep<11>2014
20:09 Jul 30, 2019
Jkt 247001
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Proposed
Collection; 60-Day Comment Request;
NIH Information Collection Forms To
Support Genomic Data Sharing for
Research Purposes (Office of Director)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
PO 00000
Notice.
Frm 00095
Fmt 4703
Sfmt 4703
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:
Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dr. Lyric A. Jorgenson, Acting
Director, Division of Scientific Data
Sharing Policy, Office of Science Policy,
NIH, 6705 Rockledge Dr., Suite 750,
Bethesda, MD 20892, or call non-tollfree
number (301) 496–9838 or email your
request including your address to:
SciencePolicy@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on May 1, 2019, page 18555 (84
FR 18555) and allowed 60 days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment.
The Office of the Director (OD),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: NIH Information
Collection Forms to Support Genomic
Data Sharing for Research Purposes—
0925–0670—Expiration Date 07/31/
2019—Revision—Office of the Director
(OD), National Institutes of Health
(NIH).
ADDRESSES:
E:\FR\FM\31JYN1.SGM
31JYN1
]]>Agencies
[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37323-37324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16306]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the Advisory Council on Blood Stem Cell
Transplantation
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, this
notice announces that the Advisory Council on Blood Stem Cell
Transplantation (ACBSCT) has scheduled a public meeting. Information
about ACBSCT and the agenda for this meeting will be available on the
ACBSCT website at https://bloodcell.transplant.hrsa.gov/about/advisory_council/meetings/.
DATES: September 10, 2019, 10:00 a.m.-4:00 p.m. Eastern Time (ET).
ADDRESSES: This meeting will be held by webinar. Members of the public
can access the webinar link and conference call-in number at https://bloodcell.transplant.hrsa.gov/about/advisory_council/meetings/.
FOR FURTHER INFORMATION CONTACT: Robert Walsh, Designated Federal
Official, (DFO), at Division of Transplantation, Healthcare Systems
[[Page 37324]]
Bureau, HRSA, 5600 Fishers Lane, 8W60, Rockville, Maryland 20857; 301-
443-6839; or [email protected].
SUPPLEMENTARY INFORMATION: ACBSCT provides advice and recommendations
to the Secretary of HHS (Secretary) and the HRSA Administrator on the
activities of the C.W. Bill Young Cell Transplantation Program and the
National Cord Blood Inventory Program. The principal purpose of these
programs is to make blood stem cells from adult donors and cord blood
units available for patients who need a transplant to treat life-
threatening conditions such as leukemia, and who lack a suitably
matched relative who can be the donor.
During the September 10, 2019, meeting, ACBSCT will discuss issues
related to utilization of cord blood for transplant and utilization of
blood stem cells in cellular therapies. Agenda items are subject to
change as priorities dictate. Refer to the ACBSCT website for any
updated information concerning the meeting.
Members of the public will have the opportunity to provide
comments. Public participants may submit written statements in advance
of the scheduled meeting. Oral comments will be honored in the order
they are requested and may be limited as time allows. Requests to
submit a written statement or make oral comments to ACBSCT must be sent
to Robert Walsh, DFO, using the contact information above at least
three business days before the meeting.
Individuals who plan to participate in the webinar and need special
assistance or other reasonable accommodations should notify Robert
Walsh at the address and phone number listed above at least 10 business
days before the meeting.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-16306 Filed 7-30-19; 8:45 am]
BILLING CODE 4165-15-P
