Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices 1979 

ANNUAL BURDEN ESTIMATES

Instrument 

Estimated total 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

Semi-Structured Discussions and Focus Groups ............................................ 3,000 1 2 6,000 

Interviews ......................................................................................................... 1,500 1 1 1,500 

Questionnaires/Surveys ................................................................................... 1,125 1 .5 563 

Estimated Total Annual Burden 

Hours: 8,063 

Authority: Social Security Act, Sec. 1110 

[42 U.S.C. 1310]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–00209 Filed 1–8–21; 8:45 am] 

BILLING CODE 4184–79–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2635] 

Potential Approach for Defining 

Durations of Use for Medically 

Important Antimicrobial Drugs 

Intended for Use In or On Feed: A 

Concept Paper; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

requesting comments on a document 

entitled ‘‘Potential Approach for 

Defining Durations of Use for Medically 

Important Antimicrobial Drugs Intended 

for Use In or On Feed: A Concept 

Paper.’’ The concept paper outlines a 

potential framework for how sponsors of 

new animal drug products containing 

medically important antimicrobial drugs 

approved for use in or on animal feed 

might voluntarily establish 

appropriately defined durations of 

therapeutic administration to foodproducing animals where none 

currently exist. Establishing 

appropriately defined durations of use 

to mitigate development of 

antimicrobial resistance would be 

consistent with previous efforts by FDA 

to protect public health by promoting 

the judicious use of these drugs in foodproducing animals. 

DATES: Submit either electronic or 

written comments by April 12, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before April 12, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 12, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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’’). 

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– 

2016–D–2635 for ‘‘Potential Approach 

for Defining Durations of Use for 

Medically Important Antimicrobial 

Drugs Intended for Use In or On Feed: 

A Concept Paper.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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 

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-2015- 

09-18/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 


jbell on DSKJLSW7X2PROD with NOTICES
1980 Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices 

1See GFI #213, ‘‘New Animal Drugs and New 

Animal Drug Combination Products Administered 

in or on Medicated Feed or Drinking Water of FoodProducing Animals: Recommendations for Drug 

Sponsors for Voluntarily Aligning Product Use 

Conditions with GFI #209,’’ December 2013. 

(https://www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/cvm-gfi-213-newanimal-drugs-and-new-animal-drug-combinationproducts-administered-or-medicated-feed) 

2See FDA’s 5-year action plan entitled, 

‘‘Supporting Antimicrobial Stewardship in 

Veterinary Settings: Goals for Fiscal Years 2019– 

2023.’’ (https://www.fda.gov/media/115776/ 

download) 

3See Action item 1.1.2 of the 5-year plan. 

‘‘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. 

Submit written requests for single 

copies of the concept paper 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 concept 

paper. 

FOR FURTHER INFORMATION CONTACT: John 

Mussman, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0589, 

john.mussman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In response to recommendations 

made by FDA in Guidance for Industry 

(GFI) #213,1 as part of a strategy to 

address antimicrobial resistance 

associated with the use of antimicrobial 

drugs in animal agriculture, sponsors of 

all new animal drugs containing 

antimicrobial drugs important to human 

medicine (medically important 

antimicrobial drugs) approved for use in 

or on the feed or in the drinking water 

of food-producing animals worked with 

FDA over a 3-year period from 2013 to 

2016 to voluntarily withdraw approval 

of indications that were not considered 

necessary for assuring animal health 

(production indications) and to 

voluntarily change the marketing status 

of all remaining approved uses of such 

new animal drugs from ‘‘over the 

counter’’ to either by veterinary 

prescription or by veterinary feed 

directive, as applicable. 

In September 2016, FDA announced 

that it intended to enter the next phase 

of its efforts to mitigate antimicrobial 

resistance by focusing on medically 

important antimicrobial drugs used in 

animal feed or water that have at least 

one therapeutic indication without a 

defined duration of use. In a notice 

published in the Federal Register on 

September 14, 2016 (81 FR 63187), the 

Agency requested information from the 

public about how to establish 

appropriately targeted durations of use 

for therapeutic products affected by GFI 

#213 with no defined duration of use. 

Public feedback received in response to 

that request for information was taken 

into consideration during development 

of this concept paper. 

On September 14, 2018, FDA released 

a 5-year action plan for supporting 

antimicrobial stewardship in veterinary 

settings.2 This plan includes an action 

item intended to ensure that all 

medically important antimicrobial drugs 

used in or on the feed or drinking water 

of food-producing animals have an 

appropriately targeted duration of use.3

II. Request for Comments 

We are requesting early input and 

comments from the public on a concept 

paper that outlines a potential 

framework for how sponsors of 

approved new animal drug applications 

and abbreviated new animal drug 

applications for products containing 

medically important antimicrobial drugs 

for use in or on the feed of foodproducing animals could voluntarily 

change the approved conditions of use 

of these drugs to establish appropriately 

defined durations of use for those 

indications that currently have an 

undefined duration of use. A copy of the 

concept paper may be obtained as 

described in section III below. 

For the purpose of this potential 

framework, the term ‘‘undefined 

duration of use’’ means that for one or 

more of the indications for which the 

drug is approved, the product’s labeling 

either includes no information regarding 

the duration of administration or 

otherwise does not provide an 

appropriately targeted duration of use. 

Although FDA’s 5-year action plan for 

supporting antimicrobial stewardship 

that issued in September 2018 included 

an action item calling for the Agency to 

develop a strategy for establishing 

appropriately defined durations of use 

for medically important antimicrobial 

drugs used in or on the feed or drinking 

water of food-producing animals, the 

Center for Veterinary Medicine later 

determined that all of the approved uses 

of medically important antimicrobial 

drugs in dosage forms other than feed 

already have appropriately defined 

durations of use. For this reason, the 

scope of the concept paper is limited to 

those drugs that are approved for use in 

or on medicated feed. 

The concept paper is intended to 

outline for sponsors and other 

stakeholders a potential process 

framework for how to make voluntary 

changes to the approved conditions of 

use of their medically important 

antimicrobial drugs administered in or 

on the medicated feed of foodproducing animals to establish 

appropriately defined durations of use 

where none currently exist. Establishing 

appropriately defined durations of use 

to mitigate the development of 

antimicrobial resistance would be 

consistent with previous efforts by FDA 

to protect public health by promoting 

the judicious use of these drugs in foodproducing animals. 

Under the potential framework 

described in the concept paper, the 

process for revising the conditions of 

use would include making changes to 

the approved labeling for the product to 

appropriately define duration of use 

and, when appropriate, providing 

additional information to be included 

on the product’s labeling that would be 

relevant to the veterinarian in 

determining when drug administration 

should be initiated or stopped in 

accordance with the approved labeling 

and consistent with the principles of 

judicious use of antimicrobials. In 

addition, were the potential framework 

later to be adopted through guidance, 

sponsors who choose to voluntarily 

establish appropriately defined 

durations of use for their products 

would be expected to submit data or 

other information supporting 

effectiveness at the shortest duration of 

use proposed for the labeling. 

The potential framework includes a 

possible timeline for sponsors, with two 

phases: Phase 1, reassessing the existing 

data used to support the original 

approval of the affected product 

indications, considering what additional 

data or information might be needed, 

and formulating plans to obtain such 

data or information; and Phase 2, taking 

steps to obtain approval of revisions to 

conditions of use for their affected 

products. The potential framework also 

includes possible timelines for making 

labeling changes to combination 

proprietary free-choice medicated feeds 

and generic products, as well as a 

possible timeline for sponsors who 

intend to voluntarily withdraw the 

approval of an indication or an entire 

application rather than submit data or 

other information to define a duration of 

use. 

We do not intend for the concept 

paper described in this notice to 

produce any decisions or new positions 

on specific regulatory issues or 

processes. Rather, the intent is to gather 


jbell on DSKJLSW7X2PROD with NOTICES
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