Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 31317 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–3614] 

Recommendations for Sponsors of 

Medically Important Antimicrobial 

Drugs Approved for Use in Animals to 

Voluntarily Bring Under Veterinary 

Oversight All Products That Continue 

to be Available as Over-the-Counter; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

announcing the availability of a final 

guidance for industry (GFI) #263 

entitled ‘‘Recommendations for 

Sponsors of Medically Important 

Antimicrobial Drugs Approved for Use 

in Animals to Voluntarily Bring Under 

Veterinary Oversight All Products That 

Continue to Be Available as Over-theCounter.’’ This guidance document 

provides information to sponsors of 

medically important antimicrobial new 

animal drug products who are interested 

in changing the approved marketing 

status of these products from over-thecounter (OTC) to by veterinary 

prescription (Rx) consistent with FDA’s 

recommendation that the use of such 

drugs in animals be limited to uses that 

include veterinary oversight to mitigate 

development of antimicrobial 

resistance. It also establishes timelines 

for stakeholders wishing to comply 

voluntarily with this guidance. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 11, 2021. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidance at any time as follows: 

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– 

2019–D–3614 for ‘‘Recommendations 

for Sponsors of Medically Important 

Antimicrobial Drugs Approved for Use 

in Animals to Voluntarily Bring Under 

Veterinary Oversight All Products That 

Continue to Be Available as Over-theCounter.’’ 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 

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 

‘‘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 draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: John 

M. Mussman, Center for Veterinary 

Medicine (HFV–133), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0589, 

email: john.mussman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of September 

25, 2019 (84 FR 50456), FDA published 

a notice of availability of a draft 

guidance entitled ‘‘Recommendations 

for Sponsors of Medically Important 

Antimicrobial Drugs Approved for Use 

in Animals to Voluntarily Bring Under 

Veterinary Oversight All Products That 

Continue to Be Available Over-theCounter’’ giving interested persons until 

December 24, 2019, to comment on the 

draft guidance. FDA received comments 

on the draft guidance, which were 

considered as the guidance was 

finalized. Some comments addressed 

the process outlined in the draft 

guidance, specifically the proposed 

timeframe for sponsors to facilitate 

voluntary changes to the approved 

conditions of use of these drugs to 

prescription marketing status. Further, 

FDA notes that, in general, many of the 

comments received did not address the 


jbell on DSKJLSW7X2PROD with NOTICES
31318 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 

specific process outlined in the draft 

guidance, but rather addressed support 

for, or concerns with, the underlying 

policy of judicious use of medically 

important antimicrobials in animals, 

specifically the principle of limiting 

medically important antimicrobial drugs 

to uses in animals that include 

veterinary oversight or consultation. As 

described in FDA GFI #209, ‘‘The 

Judicious Use of Medically Important 

Antimicrobial Drugs in Food-Producing 

Animals’’ (77 FR 22328, April 13, 2012), 

the development of resistance to this 

important class of drugs, and the 

resulting loss of their effectiveness as 

antimicrobial therapies, poses a serious 

public health threat. Developing 

strategies to reduce antimicrobial 

resistance is critically important for 

protecting both public and animal 

health. This guidance is an extension of 

FDA’s ongoing efforts to promote the 

appropriate or judicious use of 

medically important antimicrobial drugs 

in animals. 

This guidance provides information to 

sponsors of new animal drug products 

containing antimicrobials of human 

medical importance who are interested 

in changing the approved marketing 

status of these products from OTC to Rx 

with specific recommendations on 

submission of revised labeling. Such 

changes are consistent with FDA’s 

recommendation that the use of such 

antimicrobial drugs in animals include 

veterinary oversight in order to mitigate 

development of antimicrobial resistance 

and thereby preserve the effectiveness of 

these drugs for use as therapies to treat 

infections in humans and animals. The 

guidance also identifies timelines for 

stakeholders wishing to comply 

voluntarily with this guidance; these 

timelines remain as outlined in the draft 

guidance. In the final guidance, editorial 

changes were made to improve clarity. 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on recommendations 

for drug sponsors for voluntarily 

bringing under veterinary oversight all 

medically important antimicrobial drugs 

approved for use in animals that 

continue to be available as OTC 

products. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in section 512(n)(1) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(n)(1)) have been 

approved under OMB control number 

0910–0669; the collections of 

information in 21 CFR part 514 have 

been approved under OMB control 

number 0910–0032. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/animal-veterinary/ 

guidance-regulations/guidance-industry 

or https://www.regulations.gov. 

Dated: June 7, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12297 Filed 6–10–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–E–2079] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; BRAVECTO; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

published a notice in the Federal 

Register of February 12, 2018. After 

review of a timely request for 

reconsideration by the applicant of the 

determination of the regulatory review 

period of the animal drug, BRAVECTO, 

in that notice, FDA has determined that 

a revision of the SUPPLEMENTARY

INFORMATION section is warranted. This 

document presents the revised 

regulatory review period. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register of February 

12, 2018 (83 FR 6033), in FR Doc. 2018– 

02761, in the first column, the first two 

paragraphs under the section ‘‘II. 

Determination of Regulatory Review 

Period,’’ the following correction is 

made on page 6034: 

FDA has determined that the 

applicable regulatory review period for 

BRAVECTO is 1,054 days. Of this time, 

1,016 days occurred during the testing 

phase of the regulatory review period, 

while 38 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 512(j) of the FD&C Act (21 

U.S.C. 360b(j)) became effective: June 

28, 2011. The applicant claims February 

19, 2010, as the date the investigational 

new animal drug application (INAD) 

became effective. However, after 

consideration of additional information 

presented by the applicant in response 

to the Federal Register notice (83 FR 

6033), FDA has determined that the start 

of the testing phase was June 28, 2011, 

which was the date the first major 

health or environmental effects test 

began. 

Dated: June 3, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12284 Filed 6–10–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1261] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Study of 

Disclosures to Healthcare Providers 

Regarding Data That Do Not Support 

Unapproved Use of an Approved 

Prescription Drug 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(PRA). 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by July 12, 

2021. 


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