Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 60093-60094 [2019-24263]
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Federal Register / Vol. 84, No. 216 / Thursday, November 7, 2019 / Notices
1. Christian J. Ryan, Byron,
Minnesota; to acquire voting shares of
Olmsted Bancorporation, Inc., and
thereby indirectly acquire voting shares
of First Security Bank, both of Byron,
Minnesota.
Board of Governors of the Federal Reserve
System, November 1, 2019.
Michele Taylor Fennell,
Assistant Secretary of the Board.
[FR Doc. 2019–24241 Filed 11–6–19; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Board on Radiation and
Worker Health (ABRWH or the
Advisory Board), National Institute for
Occupational Safety and Health
(NIOSH)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
CDC, announces the following meeting
of the Advisory Board on Radiation and
Worker Health (ABRWH). This meeting
is open to the public, limited only by
the space available. The meeting space
accommodates approximately 150
people and the audio conference line
has 150 ports for callers. The public is
welcome to submit written comments in
advance of the meeting, to the contact
person below. Written comments
received in advance of the meeting will
be included in the official record of the
meeting. The public is also welcome to
listen to the meeting by joining the
teleconference (information below).
DATES: The meeting will be held on
December 11, 2019 from 8:15 a.m. to
5:30 p.m., PST. A public comment
session will be held on December 11,
2019 at 5:30 p.m., PST and conclude at
6:30 p.m., PST or following the final call
for public comment, whichever comes
first.
SUMMARY:
Hilton Oakland Airport
Hotel, One Hegenberger Road, Oakland,
California 94621; Phone: (510) 635–
5000, Fax: (510) 383–4090. The public
may join the audio conference call via
FTS Conferencing. The USA toll-free
dial-in number is 1–866–659–0537; and
the pass code is 9933701. The meeting
will also be accessible via Web
conference by Skype: meeting
ADDRESSES:
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CONNECTION: https://
webconf.cdc.gov/zab6/yzdq02pl?sl=1.
FOR FURTHER INFORMATION CONTACT:
Theodore Katz, MPA, Designated
Federal Officer, NIOSH, CDC, 1600
Clifton Road, Mailstop E–20, Atlanta,
Georgia 30329–4027, Telephone (513)
533–6800, Toll Free 1 (800) CDC–INFO,
Email ocas@cdc.gov.
SUPPLEMENTARY INFORMATION:
BACKGROUND: The Advisory Board
was established under the
Energy Employees Occupational
Illness Compensation Program Act of
2000 to advise the President on a variety
of policy and technical functions
required to implement and effectively
manage the new compensation program.
Key functions of the Advisory Board
include providing advice on the
development of probability of causation
guidelines which have been
promulgated by the Department of
Health and Human Services (HHS) as a
final rule, advice on methods of dose
reconstruction which have also been
promulgated by HHS as a final rule,
advice on the scientific validity and
quality of dose estimation and
reconstruction efforts being performed
for purposes of the compensation
program, and advice on petitions to add
classes of workers to the Special
Exposure Cohort (SEC). In December
2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS,
which subsequently delegated this
authority to the CDC. NIOSH
implements this responsibility for CDC.
The Advisory Board’s charter was
issued on August 3, 2001, renewed at
appropriate intervals, rechartered on
February 12, 2018, and will terminate
on February 12, 2020.
PURPOSE: This Advisory Board is
charged with (a) providing advice to the
Secretary, HHS, on the development of
guidelines under Executive Order
13179; (b) providing advice to the
Secretary, HHS, on the scientific
validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advising the Secretary
on whether there is a class of employees
at any Department of Energy facility
who were exposed to radiation but for
whom it is not feasible to estimate their
radiation dose, and on whether there is
reasonable likelihood that such
radiation doses may have endangered
the health of members of this class.
MATTERS TO BE CONSIDERED: The
agenda will include discussions on the
following: NIOSH Program Update;
Department of Labor Program Update;
Department of Energy Program Update;
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60093
SEC Petitions Update; Completed Site
Profile Reviews; Draft Report to the
Secretary, HHS on Dose Reconstruction
Reviews, Coworker Modeling
Guidelines Review; SEC Petition Review
Update for Savannah River Site (Aiken,
South Carolina, 1972–2007); Lawrence
Berkeley National Laboratory Site
Profile Review Update; and a Board
Work Session. Agenda items are subject
to change as priorities dictate.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2019–24244 Filed 11–6–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–0375, FDA–
2013–N–0520, FDA–2008–D–0031, FDA–
2012–N–0386, FDA–2013–N–0377, FDA–
2011–D–0147, FDA–2013–N–1588, FDA–
2013–N–0093, and FDA–2016–N–1593]
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
SUPPLEMENTARY INFORMATION:
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60094
Federal Register / Vol. 84, No. 216 / Thursday, November 7, 2019 / Notices
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
Agreement for Shipment of Devices for Sterilization ..............................................................................................
Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed ..........
Clinical Laboratory Improvement Amendments Waiver Applications .....................................................................
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and
Listing of Ingredients in Tobacco Products .........................................................................................................
Tobacco Health Document Submission ..................................................................................................................
Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence Requirements for Tobacco Products ..................................................................................
Exemptions From Substantial Equivalence Requirements for Tobacco Products .................................................
Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity
New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts and
351(k) Biologics License Applications in Biosimilars User Fee Act ....................................................................
Medical Device Accessories ....................................................................................................................................
Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
comment on the draft best practices in
drug and biological product postmarket
safety surveillance.
[FR Doc. 2019–24263 Filed 11–6–19; 8:45 am]
DATES:
Submit either electronic or
written comments on the draft
document by January 6, 2020 to ensure
that the Agency considers your
comment on this draft document before
it begins work on the final version.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ADDRESSES:
Best Practices in Drug and Biological
Product Postmarket Safety
Surveillance for Food and Drug
Administration Staff; Draft Document;
Availability; Establishment of Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability;
establishment of public docket; request
for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
establishing a public docket to collect
comments on a draft document that
details best practices for drug safety
surveillance entitled ‘‘Best Practices in
Drug and Biological Product Postmarket
Safety Surveillance for FDA Staff.’’ The
21st Century Cures Act (Cures Act) was
enacted on December 13, 2016, and
requires that FDA make publicly
available on its internet website best
practices for drug safety surveillance
activities. The draft document sets forth
risk-based principles by which FDA
conducts ongoing postmarketing safety
surveillance for drug and biological
products to address the Cures Act
requirements. FDA is seeking public
SUMMARY:
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You may submit comments
as follows:
[Docket No. FDA–2019–N–3768]
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Date approval
expires
0910–0131
0910–0339
0910–0598
9/30/2022
9/30/2022
9/30/2022
0910–0650
0910–0654
9/30/2022
9/30/2022
0910–0673
0910–0684
9/30/2022
9/30/2022
0910–0746
0910–0823
9/30/2022
9/30/2022
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–3768 for ‘‘Best Practices in
Drug and Biological Product Postmarket
Safety Surveillance for FDA Staff.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
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[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Notices]
[Pages 60093-60094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24263]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-N-0375, FDA-2013-N-0520, FDA-2008-D-0031, FDA-
2012-N-0386, FDA-2013-N-0377, FDA-2011-D-0147, FDA-2013-N-1588, FDA-
2013-N-0093, and FDA-2016-N-1593]
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
[[Page 60094]]
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
------------------------------------------------------------------------
Agreement for Shipment of Devices for 0910-0131 9/30/2022
Sterilization..........................
Substances Prohibited from Use in Animal 0910-0339 9/30/2022
Food or Feed; Animal Proteins
Prohibited in Ruminant Feed............
Clinical Laboratory Improvement 0910-0598 9/30/2022
Amendments Waiver Applications.........
Registration and Product Listing for 0910-0650 9/30/2022
Owners and Operators of Domestic
Tobacco Product Establishments and
Listing of Ingredients in Tobacco
Products...............................
Tobacco Health Document Submission...... 0910-0654 9/30/2022
Guidance for Industry and Food and Drug 0910-0673 9/30/2022
Administration Staff; Section 905(j)
Reports: Demonstrating Substantial
Equivalence Requirements for Tobacco
Products...............................
Exemptions From Substantial Equivalence 0910-0684 9/30/2022
Requirements for Tobacco Products......
Evaluation of the Program for Enhanced 0910-0746 9/30/2022
Review Transparency and Communication
for New Molecular Entity New Drug
Applications and Original Biologics
License Applications in Prescription
Drug User Fee Acts and 351(k) Biologics
License Applications in Biosimilars
User Fee Act...........................
Medical Device Accessories.............. 0910-0823 9/30/2022
------------------------------------------------------------------------
Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24263 Filed 11-6-19; 8:45 am]
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