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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