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Draft Guidance for Industry and Food 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:// 


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33306 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 

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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Remanufacturing of 

Medical Devices’’ to the Office of Policy, 

Guidance and Policy Development, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002 or to the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Katelyn Bittleman, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4250, Silver Spring, 

MD 20993–0002, 240–402–1478; Joshua 

Silverstein, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1615, Silver Spring, 

MD 20993–0002, 301–796–5155; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Many devices are reusable and need 

preventive maintenance and repair 

during their useful life. For these 

devices, proper servicing is critical to 

their continued safe and effective use. 

However, there is a lack of clarity 

regarding the distinction between 

‘‘servicing’’ and ‘‘remanufacturing.’’ 

FDA has been working to gain 

additional perspectives on the 

distinction between ‘‘servicing’’ and 

‘‘remanufacturing’’ and has undertaken 

several efforts to help promote clarity. 

FDA opened a docket for public 

comment (81 FR 11477) and held a 

public workshop (81 FR 46694) in 2016. 

Public comments submitted to this 

docket are searchable under FDA–2016– 

N–0436 (https://www.regulations.gov/ 

docket?D=FDA-2016-N-0436).In 2018, 

FDA issued a white paper, opened a 

public docket, and held a public 

workshop to facilitate public discussion 

on the distinction between servicing 

and remanufacturing. Public comments 

submitted to this docket are searchable 

under FDA–2018–N–3741 (https://

www.regulations.gov/docket?D=FDA2018-N-3741). The white paper 

described FDA’s initial thoughts about 

guiding principles, provided a flowchart 

with accompanying text for 

understanding the distinctions, and 

contained a complementary approach 

for software, as well as considerations 

for labeling, and examples utilizing the 

flowchart. FDA also included targeted 

questions throughout the white paper 

for which the Agency sought feedback. 

FDA concurrently opened a docket 

under FDA–2018–N–3741 and held a 

public workshop to discuss the white 

paper and obtain public comment before 

issuing draft guidance. FDA considered 

the comments from the public docket 

and discussions during the public 

workshop in developing this draft 

guidance. 

Because of the apparent confusion 

between servicing and remanufacturing 

among entities performing these 

activities, FDA committed in the ‘‘FDA 

Report on the Quality, Safety, and 

Effectiveness of Servicing of Medical 

Devices’’ (https://www.fda.gov/media/ 

113431/download) to issue guidance 

that clarifies the difference between 

servicing and remanufacturing 

activities. To assist with this 

clarification, FDA focuses this draft 

guidance on those activities that are 

likely remanufacturing. The 

determination of whether the activities 

an entity performs are remanufacturing 

affects the applicability and 

enforcement of regulatory requirements 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) and its 

implementing regulations. FDA has 

consistently enforced requirements 

under the FD&C Act and its 

implementing regulations on entities 

engaged in remanufacturing, including 

but not limited to registration and 

listing, adverse event reporting, the 

Quality System regulation, and 

marketing submissions. 

For activities involving components/ 

parts/materials, FDA recommends the 

use of the flowchart in the draft 

guidance to help entities determine if 

their activities are likely 

remanufacturing. Although the servicing 

and remanufacturing definitions and 

guiding principles in this draft 

document apply to software, the 

flowchart should not be applied to 

changes involving software. FDA has 

instead identified several activities 

performed on software that are likely 

not 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 intended 

to adopt significant policy changes, but 

to clarify FDA’s current thinking on 

applicable definitions, and clarify, not 

change, the regulatory requirements 

applicable to remanufacturers. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Remanufacturing of Medical 

Devices.’’ 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. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products or from the 

Center for Biologics Evaluation and 

Research at https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances. This 

guidance document is also available at 

https://www.regulations.gov and at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download 

an electronic copy of ‘‘Remanufacturing 

of Medical Devices’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 17048 and complete title to 

identify the guidance you are 

requesting. 

III. Other Issues for Consideration 

FDA’s white paper introduced a 

flowchart that the Agency was 

considering proposing in draft guidance. 

FDA requested public comment on this 

flowchart during our December 2018 


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Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 33307 

workshop and through the Docket No. 

FDA–2018–N–3741. While FDA has 

considered all comments and made 

changes as appropriate, FDA received 

opposing comments that suggested 

either no flowchart or more detail than 

FDA provided in the white paper. FDA 

encourages all interested stakeholders to 

comment on their preferred approach to 

help determine whether activities are 

remanufacturing and their rationale for 

such, using the following options: (1) 

No flowchart; (2) a flowchart similar to 

that proposed by FDA in this draft 

guidance; and (3) a more detailed 

flowchart, such as that proposed in 

comment FDA–2018–N–3741–0036. 

IV. 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 the following FDA 

regulations and forms have been 

approved by OMB as listed in the 

following table: 

21 CFR part; or FDA form Topic OMB control 

No. 

800, 801, and 809 .................................... Medical Device Labeling Regulations .......................................................................... 0910–0485 

803 ............................................................ Medical Devices; Medical Device Reporting; Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting.0910–0437 

820 ............................................................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..... 0910–0073 

807, subparts A through D ....................... Electronic Submission of Medical Device Registration and Listing ............................. 0910–0625 

807, subpart E .......................................... Premarket Notification .................................................................................................. 0910–0120 

Form FDA 3670 ........................................ Adverse Event Reports/MedSun program ................................................................... 0910–0471 

Dated: June 15, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13360 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–2020–E–1281] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ZOLGENSMA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for ZOLGENSMA and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human 

biological product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by August 23, 2021. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

December 21, 2021. See ‘‘Petitions’’ in 

the SUPPLEMENTARY INFORMATION section 

for more information. 

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 August 23, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 23, 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– 

2020–E–1281 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; ZOLGENSMA.’’ 

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 


khammond on DSKJM1Z7X2PROD with NOTICES