Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Labeling of Red Blood Cell Units With Historical Antigen Typing Results, 53275-53276 [2018-22959]
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Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
initially submitted on December 20,
2016.
3. The date the application was
approved: August 17, 2017. FDA has
verified the applicant’s claim that BLA
761040 was approved on August 17,
2017.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 654 days, 703 days,
or 1,099 days of patent term extension.
DEPARTMENT OF HEALTH AND
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III. Petitions
SUMMARY:
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submit either electronic or written
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for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22958 Filed 10–19–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2016–D–4308]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry: Labeling of Red Blood Cell
Units With Historical Antigen Typing
Results
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, or Agency) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
21, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Draft Guidance for Industry:
Labeling of Red Blood Cell Units with
Historical Antigen Typing Results.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Labeling of Red Blood Cell Units With
Historical Antigen Typing Results,
OMB Control Number 0910–NEW
The draft guidance document
provides establishments that collect
blood and blood components for
transfusion with recommendations for
labeling RBC units with non-ABO/Rh(D)
antigen typing results obtained from
previous donations (historical antigen
typing results). The draft guidance
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18:12 Oct 19, 2018
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53275
provides recommendations to
transfusion services for managing RBC
units labeled with historical antigen
typing results. The guidance also
provides licensed blood collection
establishments that choose to
implement labeling of RBC units with
historical antigen typing results
instructions regarding how to report the
manufacturing and labeling changes
under 21 CFR 601.12.
Description of Respondents:
Establishments that collect blood and
blood components intended for
transfusion.
Burden Estimate: We believe that the
information collection provisions in the
draft guidance do not create a new
burden for respondents and are part of
usual and customary business practices.
According to the 30th edition of the
AABB Standards for Blood Banks and
Transfusion Services, RBC units may be
labeled as RBC antigen negative without
testing the current donation if two
previous separate donations were tested
by the collection facility and results of
RBC typing were found to be
concordant. The standards indicate that
facilities have the option to put the nonABO/Rh(D) historical antigen typing
results on a tie-tag or directly on the
container label.
The guidance also recommends
establishments that collect blood and
blood components for transfusion
should convey to transfusion services
the practices for repeating historical
RBC typing results on current donations
and for labeling RBC units with
historical RBC antigen typing results.
We believe that collection
establishments have already developed
standard operating procedures for
including the non-ABO/Rh(D) historical
antigen typing results on a tie-tag or
directly on the container label, and for
conveying any change in their antigen
typing or labeling practices to their
consignees, including practices for
repeating historical RBC typing results
on current donations and for labeling
RBC units with historical RBC antigen
typing results.
In the Federal Register of January 3,
2017 (82 FR 130), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received six
comments on the guidance; however, no
comments were related to the collection
of information.
The draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR 601.12 have been approved under
OMB control number 0910–0338; and
the collections of information in 21 CFR
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53276
Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
part 606 have been approved under
OMB control number 0910–116.
Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22959 Filed 10–19–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
daltland on DSKBBV9HB2PROD with NOTICES
National Committee on Vital and Health
Statistics: Hearing
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee hearing.
Name: National Committee on Vital
and Health Statistics (NCVHS),
Subcommittee on Standards.
Date and Times: Wednesday,
December 12, 2018: 9 a.m.–5 p.m. (EST);
Thursday, December 13, 2018: 9 a.m.–1
p.m. (EST).
Place: Omni Shoreham Hotel, 2500
Calvert Street NW, Washington, DC
20008.
Status: Open. There will be a public
comment period during the final 15
minutes of both days of the meeting.
Purpose: Health Insurance Portability
and Accountability Act (HIPAA)
legislation from 1996, as amended,1
directed the Secretary of Health and
Human Services (HHS) to publish
regulations adopting standards, code
sets and identifiers to support the
exchange of electronic health
information between covered entities.
The standards are for retail pharmacy
and medical transactions.
In its capacity to advise the HHS
Secretary on health data, statistics,
privacy, national health information
policy, and HIPAA, NCVHS is in the
final stages of the development of a
standards update and adoption
roadmap, referred to as the
Predictability Roadmap. The
development of the Predictability
Roadmap has been a year and a half
long process, achieved in collaboration
with industry stakeholders and the
standards development organizations
(SDOs). The overall vision for the
Predictability Roadmap is that:
• HIPAA covered entities and their
business associates use the adopted
standards and operating rules in a
consistent way to exchange health
information and conduct business; and
• Standards are reliably updated and
adopted so that covered entities know
1 Along with Section 1104(c) of the Patient
Protection and Affordable Care Act (ACA) of 2010.
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18:12 Oct 19, 2018
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when they will need to, and/or be able
to update systems and business
processes.
To accomplish this goal, NCVHS
conducted several information gathering
activities and stakeholder engagement
meetings and workshops: In June 2017
the Subcommittee on Standards met
with each of the standards development
organizations (SDOs) to learn about
their individual maintenance processes;
in August 2017 the Subcommittee held
a visioning exercise with the SDOs and
Designated Standards Maintenance
Organization (DSMO); and in May 2018,
the Subcommittee conducted a CIO
Forum with 21 health care technology
experts and senior corporate officers
representing a cross-section of
organizations that were end-users of the
HIPAA and ACA administrative
standards. The goal of this Forum was
to elicit input for improving the
standards development, update and
adoption process, and address barriers
to use of those standards. Based on this
work, the Subcommittee on Standards
developed a draft Predictability
Roadmap comprised of 23
recommendations organized under three
major focus areas. The draft
recommendations were presented at the
September 13–14 NCVHS meeting and
are posted on the website at: https://
ncvhs.hhs.gov/wp-content/uploads/
2018/09/Presentation-NCVHS-DraftPredictability-Roadmap-RecsCoussoule-and-Goss.pdf.
The purpose of this Subcommittee
hearing is to obtain input from
stakeholders on the draft
recommendations designed to improve
the processes for updating, adopting and
using standards and operating rules, and
developing a formal Predictability
Roadmap. The Subcommittee will use
the feedback received at this hearing to
finalize recommendations to the
Secretary of HHS.
Individuals and representatives of
organizations interested in submitting
written testimony are invited to respond
to the following questions:
In general,
1. Would these recommendations as a
whole improve the predictability of the
adoption of administrative standards
and operating rules?
2. What additional recommendations
are critical to achieve predictability?
And specifically,
3. What is the value proposition of
each recommendation and what
improvements to the current state do
you believe will arise from each
recommendation/group of similar
recommendations?
4. Are there potential unintended
consequences? What are those and how
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can they be mitigated with
modifications to the recommendations?
The questions outlined above can be
used to guide written submissions to the
Subcommittee. Written submissions
should be sent electronically to
NCVHSmail@cdc.gov with
‘‘Predictability Roadmap’’ in the subject
line no later than November 20, 2018.
The times and topics for this meeting
are subject to change. Please refer to the
posted agenda at www.ncvhs.hhs.gov for
any updates.
Contact Persons for More Information:
Substantive program information may
be obtained from Rebecca Hines, MHS,
Executive Secretary, NCVHS, National
Center for Health Statistics, Centers for
Disease Control and Prevention, 3311
Toledo Road, Hyattsville, Maryland
20782, telephone (301) 458–4715.
Information pertaining to meeting
content may be obtained from Lorraine
Doo, MSW, MPH, (410) 786–6597; and/
or Geanelle G. Herring, MSW, (410)
786–4466; Centers for Medicare &
Medicaid Services, Office of Information
Technology, Division of National
Standards, 7500 Security Boulevard,
Baltimore, Maryland, 21244. Summaries
of meetings and a roster of Committee
members are available on the NCVHS
website: www.ncvhs.hhs.gov where
further information including an agenda
and instructions to access the live audio
broadcast of the meeting will be posted.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment
Opportunity on (770) 488–3210 as soon
as possible.
Sharon Arnold,
Associate Deputy Assistant Secretary for
Planning and Evaluation, Science and Data
Policy, Office of the Assistant Secretary for
Planning and Evaluation.
[FR Doc. 2018–22952 Filed 10–19–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; 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.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
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]]>Agencies
[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53275-53276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22959]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-4308]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry: Labeling of Red Blood Cell Units With Historical Antigen
Typing Results
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, or Agency) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 21, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Draft Guidance for Industry: Labeling of Red Blood Cell Units
with Historical Antigen Typing Results.'' Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Labeling of Red Blood Cell Units With Historical Antigen Typing
Results, OMB Control Number 0910-NEW
The draft guidance document provides establishments that collect
blood and blood components for transfusion with recommendations for
labeling RBC units with non-ABO/Rh(D) antigen typing results obtained
from previous donations (historical antigen typing results). The draft
guidance provides recommendations to transfusion services for managing
RBC units labeled with historical antigen typing results. The guidance
also provides licensed blood collection establishments that choose to
implement labeling of RBC units with historical antigen typing results
instructions regarding how to report the manufacturing and labeling
changes under 21 CFR 601.12.
Description of Respondents: Establishments that collect blood and
blood components intended for transfusion.
Burden Estimate: We believe that the information collection
provisions in the draft guidance do not create a new burden for
respondents and are part of usual and customary business practices.
According to the 30th edition of the AABB Standards for Blood Banks and
Transfusion Services, RBC units may be labeled as RBC antigen negative
without testing the current donation if two previous separate donations
were tested by the collection facility and results of RBC typing were
found to be concordant. The standards indicate that facilities have the
option to put the non-ABO/Rh(D) historical antigen typing results on a
tie-tag or directly on the container label.
The guidance also recommends establishments that collect blood and
blood components for transfusion should convey to transfusion services
the practices for repeating historical RBC typing results on current
donations and for labeling RBC units with historical RBC antigen typing
results.
We believe that collection establishments have already developed
standard operating procedures for including the non-ABO/Rh(D)
historical antigen typing results on a tie-tag or directly on the
container label, and for conveying any change in their antigen typing
or labeling practices to their consignees, including practices for
repeating historical RBC typing results on current donations and for
labeling RBC units with historical RBC antigen typing results.
In the Federal Register of January 3, 2017 (82 FR 130), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received six comments on the guidance;
however, no comments were related to the collection of information.
The draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR 601.12 have been approved under OMB control number 0910-0338;
and the collections of information in 21 CFR
[[Page 53276]]
part 606 have been approved under OMB control number 0910-116.
Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22959 Filed 10-19-18; 8:45 am]
BILLING CODE 4164-01-P
