Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID), 72670-72671 [2020-25063]
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Federal Register / Vol. 85, No. 220 / Friday, November 13, 2020 / Notices
sensitive, classified, or crypto-logic
materials or devices throughout CDC;
(24) ensures proper destruction of
classified documents that are no longer
required; (25) conducts security
inspections and audits of all national
security information storage and
processing areas; and (26) provides
deployable unclassified and classified
communication platforms to support
high-level deploying staff to natural or
manmade disaster areas in support of
COOP plans.
Occupational Health Clinic (CAJSJ).
(1) Provides occupational health
services to maintain a healthy domestic
and global CDC workforce through
occupational health clinics and
contracted health services; (2) manages
CDC occupational health services to
ensure CDC compliance with
Occupational Health and Safety
Standards and to support the
occupational requirements of CDC; (3)
serves as the CDC resource for routine
and emergency response occupational
health services; (4) prepares CDC staff to
work in hazardous conditions in
response to domestic and international
public health threats or concerns; (5)
provides medical evaluations and
consultation for personal protective
equipment; (6) assures the safety and
health of the CDC workforce for during
deployments; (7) supports deployment
processes through health screenings and
physical examinations, administration
of vaccinations and medications, and
respiratory clearance; (8) conducts and
documents ongoing medical
surveillance, as needed, for postexposures or deployed staff; (9) ensures
a prepared and resilient workforce; and
(10) develops and maintains procedures
that support the occupational health of
the CDC workforce.
Robert R. Redfield,
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2020–25115 Filed 11–12–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Notice and reopening of
comment period.
Centers for Disease Control and
Prevention
On July 28, 2018 the Center
for State, Tribal, Local, and Territorial
Support (CSTLTS), Centers for Disease
Control and Prevention (CDC),
published a notice in the Federal
Register announcing the Public Health
Associate Program (PHAP) Alumni and
Host Site Assessment. Written
comments were to be received by
September 28, 2020. The Docket
Number that was included in the initial
publication of this 60 Day Federal
Register Notice was incorrect. CDC is
announcing the reopening of the
comment period.
Board of Scientific Counselors, Deputy
Director for Infectious Diseases (BSC,
DDID)
SUMMARY:
Electronic or written comments
must be received by January 12, 2021.
DATES:
You may submit comments,
identified by Docket No. CDC–2020–
0082, by any of the following methods:
Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta,
Georgia 30329.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; Email:
omb@cdc.gov.
SUPPLEMENTARY INFORMATION:
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
Dated: November 4, 2020.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
Centers for Disease Control and
Prevention
[CDC–2020–0082]
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Prevention (CDC), Department of Health
and Human Services (HHS).
Public Health Associate Program
(PHAP) Alumni and Host Site
Assessment; Reopening of the
Comment Period
[FR Doc. 2020–25146 Filed 11–12–20; 8:45 am]
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Center for State, Tribal, Local,
and Territorial Support (CSTLTS),
Centers for Disease Control and
AGENCY:
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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
for the Board of Scientific Counselors,
Deputy Director for Infectious Diseases
(BSC, DDID). This virtual meeting is
open to the public via Zoom, limited
only by the space available, which is
500 seats. Pre-registration is required by
accessing the link below in the address
section.
DATES: The meeting will be held on
December 9, 2020, 1:00 p.m. to 5 p.m.,
EST.
ADDRESSES: Zoom virtual meeting. Preregistration is required by accessing the
link at https://cdc.zoomgov.com/
webinar/register/WN_6_
Kuhs0ERBSX73CRak7gRQ. Instructions
to access the meeting will be provided
following registration.
FOR FURTHER INFORMATION CONTACT:
Hilary Eiring, MPH, Designated Federal
Officer, CDC, 1600 Clifton Road NE,
Mailstop H24–12, Atlanta, Georgia
30329–4027, Telephone (770) 488–3901;
HEiring@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The BSC, DDID, provides
advice and guidance to the Secretary,
Department of Health and Human
Services; the Director and the Deputy
Director for Infectious Diseases (DDID),
CDC; and the Directors of the National
Center for Emerging and Zoonotic
Infectious Diseases, the National Center
for HIV/AIDS, Viral Hepatitis, STD, and
TB Prevention, and the National Center
for Immunization and Respiratory
Diseases, CDC, in the following areas:
Strategies, goals, and priorities for
programs and research within the
national centers and monitor the overall
strategic direction and focus of DDID
and the national centers.
Matters To Be Considered: The agenda
will include updates and discussions on
recent outbreaks and affected
populations, as well as a brief report
back from the Board’s Food Safety
Modernization Act Surveillance
Working Group. Agenda items are
subject to change as priorities dictate.
SUMMARY:
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Federal Register / Vol. 85, No. 220 / Friday, November 13, 2020 / Notices
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 Disease 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. 2020–25063 Filed 11–12–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0052]
Documenting Electronic Data Files and
Statistical Analysis Programs;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry (GFI) #197
entitled ‘‘Documenting Electronic Data
Files and Statistical Analysis
Programs.’’ This guidance is intended to
inform sponsors of recommendations for
documenting electronic data files and
statistical analyses submitted to the
Center for Veterinary Medicine (CVM)
to support new animal drug
applications.
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on November 13, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
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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
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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’’).
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–
2009–D–0052 for ‘‘Documenting
Electronic Data Files and Statistical
Analysis Programs.’’ 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, 240–402–7500.
• 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
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
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in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Virginia Recta, Center for Veterinary
Medicine (HFV–160), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0840,
virginia.recta@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
GFI #197 entitled ‘‘Documenting
Electronic Data Files and Statistical
Analysis Programs.’’ In the Federal
Register of May 21, 2018 (83 FR 23468),
FDA published the notice of availability
for a draft guidance entitled
‘‘Documenting Electronic Data Files and
Statistical Analysis Programs,’’ giving
interested persons until July 20, 2018, to
comment on the draft guidance. On July
20, 2018, FDA published a notice of
availability announcing the extension of
the comment period to October 18, 2018
(83 FR 34595). FDA received numerous
comments on the draft guidance and
these comments were considered as the
guidance was finalized. The guidance
announced in this notice finalizes the
draft guidance dated May 2018.
This guidance is intended to inform
sponsors of recommendations for
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]]>Agencies
[Federal Register Volume 85, Number 220 (Friday, November 13, 2020)]
[Notices]
[Pages 72670-72671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25063]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Board of Scientific Counselors, Deputy Director for Infectious
Diseases (BSC, DDID)
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, the CDC
announces the following meeting for the Board of Scientific Counselors,
Deputy Director for Infectious Diseases (BSC, DDID). This virtual
meeting is open to the public via Zoom, limited only by the space
available, which is 500 seats. Pre-registration is required by
accessing the link below in the address section.
DATES: The meeting will be held on December 9, 2020, 1:00 p.m. to 5
p.m., EST.
ADDRESSES: Zoom virtual meeting. Pre-registration is required by
accessing the link at https://cdc.zoomgov.com/webinar/register/WN_6_Kuhs0ERBSX73CRak7gRQ. Instructions to access the meeting will be
provided following registration.
FOR FURTHER INFORMATION CONTACT: Hilary Eiring, MPH, Designated Federal
Officer, CDC, 1600 Clifton Road NE, Mailstop H24-12, Atlanta, Georgia
30329-4027, Telephone (770) 488-3901; [email protected].
SUPPLEMENTARY INFORMATION:
Purpose: The BSC, DDID, provides advice and guidance to the
Secretary, Department of Health and Human Services; the Director and
the Deputy Director for Infectious Diseases (DDID), CDC; and the
Directors of the National Center for Emerging and Zoonotic Infectious
Diseases, the National Center for HIV/AIDS, Viral Hepatitis, STD, and
TB Prevention, and the National Center for Immunization and Respiratory
Diseases, CDC, in the following areas: Strategies, goals, and
priorities for programs and research within the national centers and
monitor the overall strategic direction and focus of DDID and the
national centers.
Matters To Be Considered: The agenda will include updates and
discussions on recent outbreaks and affected populations, as well as a
brief report back from the Board's Food Safety Modernization Act
Surveillance Working Group. Agenda items are subject to change as
priorities dictate.
[[Page 72671]]
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 Disease 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. 2020-25063 Filed 11-12-20; 8:45 am]
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