Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 55972-55973 [2019-22803]
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Federal Register / Vol. 84, No. 202 / Friday, October 18, 2019 / Notices
FOR FURTHER INFORMATION CONTACT:
William Lewallen, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6304, Silver Spring,
MD 20993–0002, 301–796–3810,
William.Lewallen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The ICH, formerly known as the
International Conference on
Harmonisation, was established in 1990
as a joint regulatory/industry project to
improve, through harmonization, the
efficiency of the process for developing
and registering new medicinal products
in Europe, Japan, and the United States
without compromising the regulatory
requirements for safety and
effectiveness. One of the goals of
harmonization is to identify and then
reduce regional differences in technical
regulatory requirements for
pharmaceutical products while
preserving a consistently high standard
for drug efficacy, safety, and quality. In
2015, the ICH was reformed to establish
ICH as a true global initiative that
expands beyond the previous ICH
members. More involvement from
regulators around the world is expected,
as they join counterparts from Europe,
Japan, the United States, Canada, and
Switzerland as ICH observers and
regulatory members. Expanded
involvement is also anticipated from
global regulated pharmaceutical
industry parties, joining as ICH
observers and industry members. The
reforms build on a 25-year track record
of successful delivery of harmonized
guidelines for global pharmaceutical
development, and their regulation.
ICH guidelines are developed
following a five-step process. In Step 1,
experts from the different ICH regions
work together to prepare a consensus
draft of the Step 1 Technical Document.
The Step 1 Technical Document is
submitted to the ICH Assembly to
request endorsement under Step 2a of
the process. Step 2b is a ‘‘Regulators
only’’ step in which the ICH regulatory
members review the Step 2a Final
Technical Document and take any
actions, which might include revisions
that they deem necessary, to develop the
draft ‘‘Guideline.’’ Step 3 of the process
begins with the public consultation
process conducted by each of the ICH
regulatory members in their respective
regions, and this step concludes with
completion and acceptance of any
revisions that need to be made to the
Step 2b draft guideline in response to
public comments. Adoption of the new
guideline occurs in Step 4. Following
adoption, the harmonized guideline
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moves to Step 5, the final step of the
process when it is implemented by each
of the regulatory members in their
respective regions. The ICH process has
achieved significant harmonization of
the technical requirements for the
approval of pharmaceuticals for human
use in the ICH regions since 1990. More
information on the current ICH process
and structure can be found at the
following website: https://www.ich.org.
(FDA has verified the website addresses,
as of the date this document publishes
in the Federal Register, but websites are
subject to change over time.)
The topics for discussion at this
public meeting include the current
guidelines under development under
the ICH.
II. Participating in the Public Meeting
Registration: Persons interested in
attending this public meeting must
register online by October 28, 2019. To
register for the public meeting, please
visit the following website: https://
www.eventbrite.ca/e/health-canada-usfda-joint-consultation-on-ich-tickets63004743885. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public meeting must
register by October 28, 2019, midnight
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization.
The agenda for the public meeting
will be made available on the internet
at: https://wcms-internet.fda.gov/drugs/
news-events-human-drugs/healthcanada-and-united-states-food-anddrug-administration-joint-regionalconsultation approximately 2 weeks in
advance of the meeting.
If you need special accommodations
due to a disability, please contact
William Lewallen (see FOR FURTHER
INFORMATION CONTACT) no later than
October 21, 2019.
Requests for Oral Presentations: If you
wish to make a presentation during the
public comment session, please contact
William Lewallen (see FOR FURTHER
INFORMATION CONTACT) no later than
October 28, 2019. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and request time for a
joint presentation. If selected for
presentation, any presentation materials
must be emailed to William Lewallen
(see FOR FURTHER INFORMATION CONTACT)
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no later than October 28, 2019. No
commercial or promotional material
will be permitted to be presented or
distributed at the public meeting.
Streaming Webcast of the Public
Meeting: To register to attend via
webcast, please visit the following
website: https://www.eventbrite.ca/e/
health-canada-us-fda-jointconsultation-on-ich-tickets63004743885.
Dated: October 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22760 Filed 10–17–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–0370,
FDA–2013–N–0065, FDA–2012–N–0427,
FDA–2012–N–0536, FDA–2012–N–0873,
FDA–2015–N–3662, FDA–2012–N–0976,
FDA–2013–N–0297, FDA–2011–D–0893, and
FDA–2019–N–1265]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 84, No. 202 / Friday, October 18, 2019 / Notices
55973
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Export of Medical Devices; Foreign Letters of Approval .........................................................................................
Registration of Food Facilities .................................................................................................................................
Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of
2002 .....................................................................................................................................................................
Medical Device User Fee Cover Sheet—Form FDA 3601 .....................................................................................
Bar Code Label Requirement for Human Drug Products and Biological Products ................................................
Guidance on Reagents for Detection of Specific Novel Influenza A Viruses .........................................................
Guidance: Emergency Use Authorization of Medical Products and Related Authorities .......................................
Production, Storage, and Transportation of Shell Eggs (preventing Salmonella Enteritidis (SE)) .........................
Center for Devices and Radiological Health Appeals Processes ...........................................................................
Food Labeling: Nutrition Facts Label and Supplement Facts Labels .....................................................................
Dated: October 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22803 Filed 10–17–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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
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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Brain Tumors, Neuro-sequalae of
Cancer Treatments and Neurodegeneration.
Date: November 5, 2019.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Wei-Qin Zhao, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5181,
MSC 7846, Bethesda, MD 20892, 301–827–
7238 zhaow@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
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Fellowships: Brain Disorders and Related
Neurosciences.
Date: November 7–8, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marriott-Residence Inn Bethesda,
7355 Wisconsin Avenue, Bethesda, MD
20814.
Contact Person: Vilen A. Movsesyan,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040M,
MSC 7806, Bethesda, MD 20892, 301–402–
7278, movsesyanv@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR17–094:
Maximizing Investigators’ Research Award
(R35).
Date: November 12, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Methode Bacanamwo,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2200,
Bethesda, MD 20892, 301–827–7088,
methode.bacanamwo@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: October 11, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–22709 Filed 10–17–19; 8:45 am]
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Date
approval
expires
0910–0264
0910–0502
8/31/2022
8/31/2022
0910–0510
0910–0511
0910–0537
0910–0584
0910–0595
0910–0660
0910–0738
0910–0813
8/31/2022
8/31/2022
8/31/2022
8/31/2022
8/31/2022
8/31/2022
8/31/2022
8/31/2022
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
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 of
Allergy and Infectious Diseases Special
Emphasis Panel PAR–16–412: NIAID
Resource-Related Research Projects (R24).
Date: November 13, 2019.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute for Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Rockville, MD
20892 (Telephone Conference Call).
Contact Person: Ann Marie M. Brighenti,
Ph.D., Scientific Review Officer, Program
Management and Operations Branch,
Scientific Review Program, National Institute
for Allergy and Infectious Diseases, National
Institutes of Health, 5601 Fishers Lane, RM
3E71, Rockville, MD 20852, 301–761–3100,
cruza@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)
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]]>Agencies
[Federal Register Volume 84, Number 202 (Friday, October 18, 2019)]
[Notices]
[Pages 55972-55973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22803]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-N-0370, FDA-2013-N-0065, FDA-2012-N-0427, FDA-
2012-N-0536, FDA-2012-N-0873, FDA-2015-N-3662, FDA-2012-N-0976, FDA-
2013-N-0297, FDA-2011-D-0893, and FDA-2019-N-1265]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
[[Page 55973]]
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Export of Medical Devices; Foreign 0910-0264 8/31/2022
Letters of Approval....................
Registration of Food Facilities......... 0910-0502 8/31/2022
Inspection by Accredited Persons Program 0910-0510 8/31/2022
Under the Medical Device User Fee and
Modernization Act of 2002..............
Medical Device User Fee Cover Sheet-- 0910-0511 8/31/2022
Form FDA 3601..........................
Bar Code Label Requirement for Human 0910-0537 8/31/2022
Drug Products and Biological Products..
Guidance on Reagents for Detection of 0910-0584 8/31/2022
Specific Novel Influenza A Viruses.....
Guidance: Emergency Use Authorization of 0910-0595 8/31/2022
Medical Products and Related
Authorities............................
Production, Storage, and Transportation 0910-0660 8/31/2022
of Shell Eggs (preventing Salmonella
Enteritidis (SE))......................
Center for Devices and Radiological 0910-0738 8/31/2022
Health Appeals Processes...............
Food Labeling: Nutrition Facts Label and 0910-0813 8/31/2022
Supplement Facts Labels................
------------------------------------------------------------------------
Dated: October 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22803 Filed 10-17-19; 8:45 am]
BILLING CODE 4164-01-P
