National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings, 1981 [2021-00219]
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Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices
information and obtain early input from
the public on a potential framework for
how sponsors may voluntarily change
the approved conditions of use of
medically important antimicrobial drugs
used in or on the medicated feed of
food-producing animals to establish an
appropriately defined duration of use
for those indications that currently have
an undefined duration of use. The
concept paper does not contain
recommendations and does not
constitute draft or final guidance by
FDA. It should not be used for any
purpose other than to facilitate public
comment. FDA intends to consider all
information and comments received on
the concept paper before issuing draft
guidance for additional comment.
We are specifically interested in
receiving public comments on the
following questions:
1. Are the potential timeframes
outlined in the concept paper
reasonable to achieve the goals
described in the concept paper? If not,
are there specific scientific or
administrative barriers that would
prevent sponsors from meeting these
timeframes?
2. Are the potential processes for
revising the applications described in
the concept paper reasonable? If not,
what specific adjustments could be
made to improve these processes?
3. Are there other factors we should
consider regarding this potential
framework? If so, what are they?
III. Electronic Access
Persons with access to the internet
may obtain the concept paper at either
https://www.fda.gov/animal-veterinary/
guidance-regulations/guidance-industry
or https://www.regulations.gov.
Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–00189 Filed 1–8–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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National Institute of Allergy and
Infectious Diseases; 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
VerDate Sep<11>2014
22:36 Jan 08, 2021
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552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, 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 HHS–NIH–CDC–SBIR PHS
2021–1 Phase I: Reagents for Immunologic
Analysis of Non-Mammalian and
Underrepresented Mammalian Models (Topic
094) (For SBIRs Phase I)
Date: January 28, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G41,
Rockville, MD 20892 (Virtual Meeting),
Contact Person: Kelly L. Hudspeth, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G41, Rockville, MD
20852, 240–669–5067, kelly.hudspeth@
nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel HHS–NIH–CDC–SBIR PHS
2021–1 Phase II: Reagents for Immunologic
Analysis of Non-Mammalian and
Underrepresented Mammalian Models (Topic
094) (For SBIRs Phase II).
Date: January 29, 2021.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G41,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Kelly L. Hudspeth, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G41, Rockville, MD
20852, 240–669–5067, kelly.hudspeth@
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)
Dated: January 5, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–00219 Filed 1–8–21; 8:45 am]
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1981
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee
on the Validation of Alternative
Methods Communities of Practice
Webinar on Non-Animal Approaches
for Mixtures Assessment; Notice of
Public Webinar; Registration
Information
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM)
announces a public webinar ‘‘Nonanimal Approaches for Mixtures
Assessment.’’ The webinar is organized
on behalf of ICCVAM by the National
Toxicology Program Interagency Center
for the Evaluation of Alternative
Toxicological Methods (NICEATM).
Interested persons may participate via
WebEx. Time will be allotted for
questions from the audience.
Information about the webinar and
registration are available at https://
ntp.niehs.nih.gov/go/commprac-2021.
DATES:
Webinar: January 26, 2021, 9:00 a.m.
to approximately 11:00 a.m. EST.
Registration for Webinar: January 4,
2021, until 11:00 a.m. EST January 26,
2021.
Registration to view the webinar is
required.
SUMMARY:
Webinar web page https://
ntp.niehs.nih.gov/go/commprac-2021.
FOR FURTHER INFORMATION CONTACT: Dr.
Nicole Kleinstreuer, Acting Director,
NICEATM, Division of NTP, NIEHS,
P.O. Box 12233, K2–16 Research
Triangle Park, NC 27709. Phone: 984–
287–3150, Email: Nicole.kleinstreuer@
nih.gov. Hand Deliver/Courier address:
530 Davis Drive, Room K2032,
Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background: ICCVAM promotes the
development and validation of toxicity
testing methods that protect human
health and the environment while
replacing, reducing, or refining animal
use. ICCVAM also provides guidance to
test method developers and facilitates
collaborations that promote the
development of new test methods. To
address these goals, ICCVAM will hold
a Communities of Practice webinar on
‘‘Non-animal Approaches for Mixtures
Assessment.’’
While most available toxicity data are
for single chemicals, humans are often
ADDRESSES:
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Agencies
[Federal Register Volume 86, Number 6 (Monday, January 11, 2021)]
[Notices]
[Page 1981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00219]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; 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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the contract proposals, 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 HHS-NIH-CDC-SBIR PHS 2021-1 Phase I:
Reagents for Immunologic Analysis of Non-Mammalian and
Underrepresented Mammalian Models (Topic 094) (For SBIRs Phase I)
Date: January 28, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G41,
Rockville, MD 20892 (Virtual Meeting),
Contact Person: Kelly L. Hudspeth, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G41,
Rockville, MD 20852, 240-669-5067, [email protected].
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel HHS-NIH-CDC-SBIR PHS 2021-1 Phase
II: Reagents for Immunologic Analysis of Non-Mammalian and
Underrepresented Mammalian Models (Topic 094) (For SBIRs Phase II).
Date: January 29, 2021.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G41,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Kelly L. Hudspeth, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G41,
Rockville, MD 20852, 240-669-5067, [email protected].
(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)
Dated: January 5, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-00219 Filed 1-8-21; 8:45 am]
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