Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices 1981 

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] 

BILLING CODE 4164–01–P 

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, 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] 

BILLING CODE 4140–01–P 

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. 

SUMMARY: 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. 

ADDRESSES: 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 


jbell on DSKJLSW7X2PROD with NOTICES