Charter Renewal of the Advisory Committee on Blood and Tissue Safety and Availability, 58777-58778 [2018-25374]
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Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices
prescribing information entitled ‘‘Full
Prescribing Information: Contents,’’
consisting of a list of each heading and
subheading along with its identifying
number to facilitate health care
practitioners’ use of labeling
information. Section 201.57(c) specifies
the contents of the FPI. Section
201.57(d) mandates the minimum
specifications for the format of
prescription drug labeling and
establishes minimum requirements for
key graphic elements such as bold type,
bullet points, type size, and spacing.
Older drugs not subject to the revised
labeling content and format
requirements in § 201.57 are subject to
labeling requirements at § 201.80.
Section 201.80(f)(2) requires that, within
1 year, any FDA-approved patient
labeling be referenced in the
‘‘Precautions’’ section of the labeling of
older products and either accompany or
be reprinted immediately following the
labeling.
Annual Burden for Prescription Drug
Labeling Design, Testing, and
Submitting to FDA for New Drug
Applications (NDAs) and Biologics
License Applications (BLAs) (§§ 201.56
and 201.57)
New drug product applicants must:
(1) Design and create prescription drug
labeling containing ‘‘Highlights,’’
‘‘Contents,’’ and FPI; (2) test the
designed labeling (e.g., to ensure that
the designed labeling fits into cartonenclosed products); and (3) submit it to
FDA for approval. Based on the
projected data used in the January 24,
2006, final rule, FDA estimates that it
will take applicants approximately
2,327 hours to design, test, and submit
prescription drug labeling to FDA as
part of a NDA or a BLA under the
58777
revised regulations. Currently,
approximately 406 applicants submit
approximately 541 new applications
(NDAs and BLAs) to FDA annually,
totaling 1,258,907 hours.
In the Federal Register of July 20,
2018 (83 FR 34596), we published a 60day notice requesting public comment
on the proposed collection of
information. We received two
comments. One comment encouraged
the use of ‘‘provider-neutral language’’
in specific regulations. The second
comment discussed the distribution of
package inserts for prescription drugs
via paper labeling. Because these
comments do not apply to the
regulations associated with the
information collection, we have not
addressed them here.
Our estimate of the burden for the
information collection is as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR part and activity
Number of
respondents
Number of
responses per
respondent 2
Total annual
responses
Average
burden per
response
Total hours
Labeling Requirements in §§ 201.56 and 201.57 ................
406
1.332
541
2,327
1,258,907
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
may not sum due to rounding.
2 Estimates
Our estimated burden for the
information collection reflects an
overall increase of 602,503 hours and a
corresponding increase of 345 records.
We attribute this adjustment to an
increase in the number of submissions
we received over the last few years.
Dated: November 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–25352 Filed 11–20–18; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Charter Renewal of the Advisory
Committee on Blood and Tissue Safety
and Availability
Office of HIV/AIDS and
Infectious Disease Policy, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
khammond on DSK30JT082PROD with NOTICES
AGENCY:
Notice.
The Department of Health and
Human Services is hereby giving notice
that the charter for the Advisory
Committee on Blood and Tissue Safety
and Availability (ACBTSA) has been
renewed.
SUMMARY:
VerDate Sep<11>2014
16:08 Nov 20, 2018
ACBTSA
is a non-discretionary Federal advisory
committee. ACBTSA is authorized
under 42 U.S.C. 217a, Section 222 of the
Public Health Service (PHS) Act, as
amended. The Committee is governed
by the provisions of the Federal
Advisory Committee Act (FACA), Public
Law 92–463, as amended (5 U.S.C.
App), which sets forth standards for the
formation and use of advisory
committees.
The ACBTSA advises, assists,
consults with, and makes policy
recommendations to the Secretary,
through the Assistant Secretary for
Health, regarding these broad
responsibilities related to the safety of
blood, blood products, tissues, and
organs. For solid organs and blood stem
cells, the Committee’s work is limited to
policy issues related to donor derived
SUPPLEMENTARY INFORMATION:
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ACTION:
Mr.
James Berger, Designated Federal Officer
for the ACBTSA, Senior Advisor for
Blood and Tissue Policy, Office of the
Assistant Secretary for Health,
Department of Health and Human
Services, Mary E. Switzer Building, 330
C Street SW, Suite L100, Washington,
DC 20024. Phone: (202) 795–7697; Fax:
(202) 691–2102; Email: ACBTSA@
hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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infectious disease complications of
transplantation.
To carry out its mission, the ACBTSA
provides advice to the Secretary through
the Assistant Secretary for Health on a
range of policy issues to include: (1)
Identification of public health issues
through surveillance of blood and tissue
safety issues with national biovigilance
data tools; (2) identification of public
health issues that affect availability of
blood, blood products, and tissues; (3)
broad public health, ethical, and legal
issues related to the safety of blood,
blood products, and tissues; (4) the
impact of various economic factors (e.g.,
product cost and supply) on safety and
availability of blood, blood products,
and tissues; (5) risk communications
related to blood transfusion and tissue
transplantation; and (6) identification of
infectious disease transmission issues
for blood, organs, blood stem cells and
tissues.
On September 25, 2018, the Secretary
approved for the ACBTSA charter to be
renewed. The new charter was effected
and filed with the appropriate
Congressional committees and the
Library of Congress on October 9, 2018.
Renewal of the Committee’s charter
gives authorization for the Committee to
continue to operate until October 9,
2020.
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58778
Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices
A copy of the ACBTSA charter is
available on the Committee’s website at
https://www.hhs.gov/ohaidp/initiatives/
blood-tissue-safety/advisory-committee/
charter/. A copy of the
charter can also be obtained by
accessing the FACA database that is
maintained by the Committee
Management Secretariat under the
General Services Administration. The
website address for the FACA database
is www.facadatabase.gov.
Dated: October 19, 2018.
James J. Berger,
Senior Advisor for Blood and Tissue Policy,
Designated Federal Officer, Advisory
Committee on Blood and Tissue Safety and
Availability.
BILLING CODE 4150–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
khammond on DSK30JT082PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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
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: Heart, Lung, and
Blood Initial Review Group; NHLBI
Institutional Training Mechanism Review
Committee.
Date: December 14, 2018.
Time: 9:30 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Lindsay M. Garvin, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive; Suite
7189, Bethesda, MD 20892, 301–827–7911,
lindsay.garvin@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
16:08 Nov 20, 2018
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–25354 Filed 11–20–18; 8:45 am]
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
[FR Doc. 2018–25374 Filed 11–20–18; 8:45 am]
VerDate Sep<11>2014
Dated: November 15, 2018.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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
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 on
Aging Special Emphasis Panel; Health and
Aging Trends.
Date: December 3, 2018.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Room 2W200, 7201
Wisconsin Avenue, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Kimberly Firth, Ph.D.,
National Institutes of Health, National
Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892, 301–402–7702, firthkm@
mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: November 15, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–25351 Filed 11–20–18; 8:45 am]
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PO 00000
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National Institutes of Health
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
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
Neurological Disorders and Stroke Special
Emphasis Panel; Review of R35 Research
Program Award.
Date: December 3–4, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Alexandria Old
Town, Virginia Ballroom A & B, 1900
Diagonal Rd, Alexandria, VA 22314.
Contact Person: Jimok Kim, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS/NIH/DHHS, NSC, 6001 Executive
Blvd., Suite 3226, MSC 9529, Bethesda, MD
20892–9529, (301) 496–9223, Jimok.kim@
nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Biomarkers Discovery in
Parkinsonism.
Date: December 3, 2018.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Joel A. Saydoff, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS/NIH/DHHS, NSC, 6001 Executive
Blvd., Suite 3205, MSC 9529, Bethesda, MD
20892–9529, (301) 496–9223, Joel.saydoff@
nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
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]]>Agencies
[Federal Register Volume 83, Number 225 (Wednesday, November 21, 2018)]
[Notices]
[Pages 58777-58778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25374]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Charter Renewal of the Advisory Committee on Blood and Tissue
Safety and Availability
AGENCY: Office of HIV/AIDS and Infectious Disease Policy, Office of the
Assistant Secretary for Health, Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services is hereby giving
notice that the charter for the Advisory Committee on Blood and Tissue
Safety and Availability (ACBTSA) has been renewed.
FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Designated Federal
Officer for the ACBTSA, Senior Advisor for Blood and Tissue Policy,
Office of the Assistant Secretary for Health, Department of Health and
Human Services, Mary E. Switzer Building, 330 C Street SW, Suite L100,
Washington, DC 20024. Phone: (202) 795-7697; Fax: (202) 691-2102;
Email: [email protected].
SUPPLEMENTARY INFORMATION: ACBTSA is a non-discretionary Federal
advisory committee. ACBTSA is authorized under 42 U.S.C. 217a, Section
222 of the Public Health Service (PHS) Act, as amended. The Committee
is governed by the provisions of the Federal Advisory Committee Act
(FACA), Public Law 92-463, as amended (5 U.S.C. App), which sets forth
standards for the formation and use of advisory committees.
The ACBTSA advises, assists, consults with, and makes policy
recommendations to the Secretary, through the Assistant Secretary for
Health, regarding these broad responsibilities related to the safety of
blood, blood products, tissues, and organs. For solid organs and blood
stem cells, the Committee's work is limited to policy issues related to
donor derived infectious disease complications of transplantation.
To carry out its mission, the ACBTSA provides advice to the
Secretary through the Assistant Secretary for Health on a range of
policy issues to include: (1) Identification of public health issues
through surveillance of blood and tissue safety issues with national
biovigilance data tools; (2) identification of public health issues
that affect availability of blood, blood products, and tissues; (3)
broad public health, ethical, and legal issues related to the safety of
blood, blood products, and tissues; (4) the impact of various economic
factors (e.g., product cost and supply) on safety and availability of
blood, blood products, and tissues; (5) risk communications related to
blood transfusion and tissue transplantation; and (6) identification of
infectious disease transmission issues for blood, organs, blood stem
cells and tissues.
On September 25, 2018, the Secretary approved for the ACBTSA
charter to be renewed. The new charter was effected and filed with the
appropriate Congressional committees and the Library of Congress on
October 9, 2018. Renewal of the Committee's charter gives authorization
for the Committee to continue to operate until October 9, 2020.
[[Page 58778]]
A copy of the ACBTSA charter is available on the Committee's
website at https://www.hhs.gov/ohaidp/initiatives/blood-tissue-safety/advisory-committee/charter/. A copy of the charter can also
be obtained by accessing the FACA database that is maintained by the
Committee Management Secretariat under the General Services
Administration. The website address for the FACA database is
www.facadatabase.gov.
Dated: October 19, 2018.
James J. Berger,
Senior Advisor for Blood and Tissue Policy, Designated Federal Officer,
Advisory Committee on Blood and Tissue Safety and Availability.
[FR Doc. 2018-25374 Filed 11-20-18; 8:45 am]
BILLING CODE 4150-41-P
