Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 33303 

ANNUAL BURDEN ESTIMATES—Continued 

Instrument Respondents 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Annual 

burden 

(in hours) 

Licensed LifeSet Experts 

Provider Agency Administrators 

LifeSet Developer Administrators 

Site Visit 2 Focus Group 

Guide for Staff.

LifeSet Specialists ..............

LifeSet Team Supervisors 

12 1 1.5 18 6 

Baseline Youth Survey ....... Youth Formerly in Foster 

Care.

600 1 0.6 360 120 

Administrative data file ........ Agency and Program Staff 12 1 5 60 20 

Estimated Total Annual Burden 

Hours: 160. 

Authority: 42 U.S.C. 677. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–13468 Filed 6–23–21; 8:45 am] 

BILLING CODE 4184–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–2462] 

Eligibility for the Index of Legally 

Marketed Unapproved New Animal 

Drugs for Minor Species; Request for 

Comments 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or the 

Agency) is soliciting comments on our 

current policy on eligibility for 

indexing. Indexing is the process of 

adding an unapproved drug for a minor 

species to our index of legally marketed 

unapproved new animal drugs for minor 

species (the Index). Except for in some 

early non-food life stages, members of a 

food-producing minor species are not 

eligible for indexing, even if a subset of 

animals within a food-producing minor 

species is not intended to be consumed 

by humans or food-producing animals. 

Specifically, we are requesting comment 

on this policy. 

DATES: Submit either electronic or 

written comments on the notice by 

September 22, 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 September 22, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 22, 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– 

2017–D–2462 for ‘‘Eligibility for the 

Index of Legally Marketed Unapproved 

New Animal Drugs for Minor Species.’’ 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
33304 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 

1Available at: https://www.fda.gov/media/ 

107583/download. 

‘‘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. 

FOR FURTHER INFORMATION CONTACT: 

Dorothy Bailey, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0565, 

dorothy.bailey@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Minor Use and Minor Species 

Animal Health Act of 2004 (MUMS Act) 

(Pub. L. 108–282) amended the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) to provide incentives to develop 

new animal drugs for minor species and 

minor uses. By enacting the MUMS Act, 

Congress sought to encourage the 

development of animal drugs that are 

unavailable to minor species (species 

other than cattle, horses, swine, 

chickens, turkeys, dogs, and cats) or to 

major species afflicted with uncommon 

diseases or conditions (minor use), 

while still ensuring appropriate 

safeguards for animal and human 

health. Congress recognized that the 

markets for drugs intended to treat these 

species, diseases, or conditions are too 

small to motivate animal drug 

companies to develop data to support 

drug approvals. Further, Congress 

recognized that some minor species 

populations have management systems 

too diverse to make it practical to 

conduct traditional studies to 

demonstrate safety and effectiveness of 

animal drugs for such uses. 

One of the incentives established by 

the MUMS Act is the Index of Legally 

Marketed Unapproved New Animal 

Drugs for Minor Species (section 572 of 

the FD&C Act (21 U.S.C. 360ccc–1)). 

The final rule establishing 

administrative procedures and criteria 

for adding a new animal drug to the 

Index was published in the Federal 

Register on December 6, 2007 (72 FR 

69108). The regulations are codified in 

Title 21, Code of Federal Regulations 

(CFR) part 516, subpart C. 

We refer to the process of adding a 

new animal drug to the Index as 

‘‘indexing.’’ Instead of using the new 

animal drug approval process, indexing 

is a faster and less expensive pathway 

to legal marketing of unapproved new 

animal drugs for use in some minor 

species. Adding a new animal drug to 

the Index uses a combination of FDA 

and qualified expert panel review. It is 

a three-step process with each step 

involving a submission from a requestor 

(the person making a request for 

determination of eligibility) and a 

review and decision by FDA. The three 

steps are as follows: 

1. Requesting determination of 

eligibility for indexing (see 21 CFR 

516.129); 

2. Proposing a qualified expert panel 

to evaluate safety to the animal being 

treated (target animal safety) and 

effectiveness (see 21 CFR 516.141); and 

3. Requesting addition to the Index 

(see 21 CFR 516.145). 

As part of this process, FDA reviews 

information to support environmental 

safety, human user safety, 

manufacturing processes, and human 

food safety considerations. A qualified 

expert panel, once accepted by FDA, 

reviews information to support 

effectiveness and target animal safety of 

the new animal drug. The expert panel 

reviews all available information 

regarding target animal safety and 

effectiveness information, which can 

include study data, literature, and 

anecdotal information, to determine if 

the benefit of using the new animal drug 

outweighs the risk to the target animal. 

The expert panel must be unanimous 

that the benefit outweighs the risk for a 

drug to be added to the Index. FDA 

reviews the findings of the expert panel 

and the labeling for the new animal 

drug as part of the final submission. If 

we agree with the expert panel’s 

conclusions, the drug is added to the 

Index found on our website at https:// 

www.fda.gov/animal-veterinary/minoruseminor-species/index-legallymarketed-unapproved-new-animaldrugs-minor-species. Once a drug is 

listed in the Index, the holder (the 

requestor of an index listing after a 

request is granted) is required to report 

to us any adverse events associated with 

use of the new animal drug. Extra-label 

use of an indexed drug is prohibited. 

This means a veterinarian or animal 

owner using an indexed drug can only 

do so legally by following label 

instructions. 

Section 572(a)(1) of the FD&C Act 

states that the Index is limited to new 

animal drugs intended for use in a 

minor species for which there is a 

reasonable certainty that the animal or 

edible products from the animal will not 

be consumed by humans or foodproducing animals; and new animal 

drugs intended for use only in a 

hatchery, tank, pond, or other similar 

contained man-made structure in an 

early, non-food life stage of a foodproducing minor species, where safety 

for humans is demonstrated in 

accordance with the standard of section 

512(d) of the FD&C Act (including, for 

an antimicrobial new animal drug, with 

respect to antimicrobial resistance). 

For the purposes of indexing, FDA’s 

Guidance for Industry #210 entitled 

‘‘The Index of Legally Marketed 

Unapproved New Animal Drugs for 

Minor Species’’ 1 states that we consider 

a minor species to be a food-producing 

minor species when some members of 

the species are bred, cultured, farmed, 

ranched, hunted, caught, trapped, or 

otherwise harvested for the purpose of 

having the animals or edible products of 

the animals commercially distributed 

for consumption by humans or foodproducing animals in the United States. 

When defining food-producing minor 

species for the indexing process, we 

adhered to current policy for new 

animal drug approvals regarding foodproducing animals. For many years, we 

have considered an animal to be foodproducing if any member of that species 

is raised to be food for humans. For 

example, some rabbits are raised to be 

used as food for humans; under current 

policy, including indexing policy, all 

rabbits, regardless of where they are 

housed, are considered to be foodproducing. This means that a drug for 

use in laboratory rabbits is ineligible for 

indexing even though a rabbit raised for 

use in research is not intended to be 

consumed by humans or other foodproducing animals. 

II. Stakeholder Feedback 

We have received feedback from 

multiple animal stakeholder groups 

regarding the current indexing policy 

for eligibility. These stakeholders have 

asked us to allow indexing of drugs for 

use in certain populations of animals 

that would be considered foodproducing under current indexing 

policy. Instead of considering any 

member of a food-producing minor 

species ineligible for indexing, they 

have requested that we establish criteria 

that, if met, could determine that a 

subset of animals within a foodproducing minor species is eligible for 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 33305 

indexing because they are not consumed 

by humans or by food-producing 

animals. Using the previous example of 

rabbits, this would mean a drug 

intended for use in laboratory rabbits 

could be eligible for indexing because 

this distinct population of rabbits is not 

intended to enter the human food chain. 

The stakeholders assert that because 

there is a reasonable certainty that 

laboratory rabbits will not be eaten, they 

should be considered to be non-foodproducing for the purposes of indexing. 

We want to optimize the incentives 

provided in the MUMS Act and support 

its intended purpose to increase legal 

drug availability for minor species. 

Changing current indexing policy for 

eligibility could help promote legal drug 

availability for underserved populations 

of animals; however, we do not intend 

to implement such a change if it might 

adversely affect human or animal 

health. The purpose of this notice is to 

give stakeholders the opportunity to 

provide feedback about this potential 

change to the current indexing policy 

for eligibility. 

III. Request for Comments 

We request comments, including 

response to the specific questions that 

follow, to assist in evaluating whether 

changing our current indexing policy for 

eligibility can increase the availability 

of safe and effective new animal drugs 

for use in some minor species while 

continuing to protect human and animal 

health. 

Specifically, we request comment on 

the following: 

1. What are the reasons we should or 

should not expand eligibility for 

indexing to certain discrete subsets of 

food-producing minor species? 

2. If you support the expansion of 

indexing, please describe the 

information we should evaluate when 

determining which discrete subsets of 

food-producing minor species should be 

eligible. 

3. Are there any discrete subsets of 

food-producing minor species that you 

believe should be eligible for indexing 

because they are not intended for 

consumption by humans or foodproducing animals? 

Dated: June 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13417 Filed 6–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3741] 

Remanufacturing of Medical Devices; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Remanufacturing of 

Medical Devices.’’ This draft guidance is 

intended to help clarify whether 

activities performed on devices are 

likely ‘‘remanufacturing.’’ This draft 

guidance also includes 

recommendations for information that 

should be included in labeling to help 

assure the continued quality, safety, and 

effectiveness of devices that are 

intended to be serviced over their useful 

life. This draft guidance is not final nor 

is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 23, 2021 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any 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– 

2018–N–3741 for ‘‘Remanufacturing of 

Medical Devices.’’ 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:// 


khammond on DSKJM1Z7X2PROD with NOTICES