Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 30965 [2020-10977]
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Federal Register / Vol. 85, No. 99 / Thursday, May 21, 2020 / Notices
Food and Drug Administration
[Docket Nos. FDA–2014–N–1533; FDA–
2019–N–2313; FDA–2013–N–0825; FDA–
2013–N–1427; FDA–2013–N–1393; FDA–
2013–N–0719; FDA–2013–N–0796; and
FDA–2018–D–4711]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The
following is a list of FDA information
collections recently approved by OMB
SUPPLEMENTARY INFORMATION:
30965
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.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
National Panel of Tobacco Consumer Studies .......................................................................................................
Study of Oncology Indications in Direct-to-Consumer Television Advertising ........................................................
Premarket Approval of Medical Devices .................................................................................................................
Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing of Juice ...............
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions ................................
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products ......
Testing Communications on Medical Devices and Radiation-Emitting Products ...................................................
Requests for Nonbinding Feedback After Certain FDA Inspections of Device Establishments .............................
Dated: May 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10977 Filed 5–20–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1291]
Stakeholder Engagement on ICH E6:
Guideline for Good Clinical Practice;
Public Web Conference
AGENCY:
Food and Drug Administration,
HHS.
Notice of public web
conference.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a free public web
conference for discussion of the
International Council for
Harmonisation’s (ICH’s) good clinical
practice guidelines, ICH E6. This public
web conference, ‘‘Stakeholder
Engagement on ICH E6: Guideline for
Good Clinical Practice,’’ is being
convened and supported by a
cooperative agreement between the
Clinical Trials Transformation Initiative
(CTTI) and FDA. The purpose of the
web conference is to capture
SUMMARY:
VerDate Sep<11>2014
17:18 May 20, 2020
Jkt 250001
stakeholder experiences with current
ICH E6 guidelines for good clinical
practice (GCP) and to gather stakeholder
input to further inform the development
of an updated guideline, ICH E6(R3).
DATES: The public web conference will
be held on Thursday and Friday, June
4 and 5, 2020, from 10 a.m. to 1 p.m.
Eastern Time. Further details on the
web conference (including times) are
available at the website provided under
ADDRESSES. See the SUPPLEMENTARY
INFORMATION section for details.
ADDRESSES: The web conference will be
held online. Meeting details and
background materials, including the
web conference link, are available at the
following website: https://www.ctticlinicaltrials.org/briefing-room/
meetings/ich-e6-guideline-good-clinicalpractice-stakeholder-engagement.
FOR FURTHER INFORMATION CONTACT:
Suzanne Pattee, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3328,
Silver Spring, MD 20993, 301–796–
1706, Suzanne.Pattee@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
To support GCP renovation, FDA and
ICH are seeking stakeholder input to
develop a new ICH guideline, ‘‘ICH
E6(R3): Guideline for Good Clinical
Practice,’’ to enable flexible application
PO 00000
Frm 00041
Fmt 4703
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0910–0815
0910–0885
0910–0231
0910–0466
0910–0233
0910–0675
0910–0678
0910–0886
Date approval
expires
2/28/2023
2/28/2023
3/31/2023
3/31/2023
4/30/2023
4/30/2023
4/30/2023
4/30/2023
of those guidelines to interventional
clinical trials, including innovative
clinical trial designs and data sources.
ICH E6(R3) materials, including the ICH
Reflection Paper on ‘‘GCP Renovation,’’
concept paper, business plan, work
plan, and an expert list, as well as the
current guideline, ‘‘ICH E6(R2):
Guideline for Good Clinical Practice,’’
are available on the ICH website:
https://www.ich.org/page/efficacyguidelines.
The purpose of the public web
conference announced in this notice is
to obtain input on stakeholder
experiences with the current GCP
guideline (ICH E6(R2)) and suggested
changes to improve the guideline’s
applicability to the changing clinical
trial landscape.
II. Topics for Discussion at the Public
Web Conference
During the public web conference,
speakers and participants will cover a
range of GCP issues to inform revisions
to the current GCP guidelines. Topics
for discussion will include and are not
limited to: (1) Issues with application of
current guidelines to traditional
interventional clinical trials, (2) ways to
modify the guideline to address
innovative trial designs, (3) use of
digital technology tools, (4) new data
sources, and (5) other topics relating to
GCPs.
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[Federal Register Volume 85, Number 99 (Thursday, May 21, 2020)]
[Notices]
[Page 30965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10977]
[[Page 30965]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2014-N-1533; FDA-2019-N-2313; FDA-2013-N-0825; FDA-
2013-N-1427; FDA-2013-N-1393; FDA-2013-N-0719; FDA-2013-N-0796; and
FDA-2018-D-4711]
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.
Table 1--List of Information Collections Approved By OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
National Panel of Tobacco Consumer 0910-0815 2/28/2023
Studies................................
Study of Oncology Indications in Direct- 0910-0885 2/28/2023
to-Consumer Television Advertising.....
Premarket Approval of Medical Devices... 0910-0231 3/31/2023
Hazard Analysis and Critical Control 0910-0466 3/31/2023
Point Procedures for the Safe and
Sanitary Processing of Juice...........
Patent Term Restoration, Due Diligence 0910-0233 4/30/2023
Petitions, Filing, Format, and Content
of Petitions...........................
Planning for the Effects of High 0910-0675 4/30/2023
Absenteeism to Ensure Availability of
Medically Necessary Drug Products......
Testing Communications on Medical 0910-0678 4/30/2023
Devices and Radiation-Emitting Products
Requests for Nonbinding Feedback After 0910-0886 4/30/2023
Certain FDA Inspections of Device
Establishments.........................
------------------------------------------------------------------------
Dated: May 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10977 Filed 5-20-20; 8:45 am]
BILLING CODE 4164-01-P
