Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Notices 547 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 6 U.S.C. 279; 8 U.S.C. 

1232; Flores v. Reno Settlement 

Agreement, No. CV85–4544–RJK (C.D. 

Cal. 1996). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–29276 Filed 1–5–21; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–4048] 

Safer Technologies Program for 

Medical Devices; 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 a final 

guidance entitled ‘‘Safer Technologies 

Program for Medical Devices.’’ This 

final guidance describes a new, 

voluntary program for certain medical 

devices and device-led combination 

products that are reasonably expected to 

significantly improve the safety of 

currently available treatments or 

diagnostics that target an underlying 

disease or condition associated with 

morbidities and mortalities less serious 

than those eligible for the Breakthrough 

Devices Program. Devices and deviceled combination products are eligible 

for this program if they are subject to 

review under a premarket approval 

application (PMA), De Novo 

classification request (‘‘De Novo 

request’’), or premarket notification 

(510(k)), taking into account the specific 

eligibility factors described in this 

guidance. Consistent with the Agency’s 

statutory mission to protect and 

promote public health, FDA believes 

that this ‘‘Safer Technologies Program’’ 

or ‘‘STeP’’ will help patients have more 

timely access to these medical devices 

and device-led combination products by 

expediting their development, 

assessment, and review, while 

preserving the statutory standards for 

premarket approval, De Novo marketing 

authorization, and 510(k) clearance. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 6, 2021. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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–4048 for ‘‘Safer Technologies 

Program for 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://

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 guidance 

document entitled ‘‘Safer Technologies 

Program for 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 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: 

Christina Savisaar, Center for Devices 


jbell on DSKJLSW7X2PROD with NOTICES
548 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Notices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G221, Silver Spring, 

MD 20993–0002, 301–796–6404 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 

FDA is introducing a new, voluntary 

program for certain medical devices and 

device-led combination products that 

are reasonably expected to significantly 

improve the safety of currently available 

treatments or diagnostics that target an 

underlying disease or condition 

associated with morbidities and 

mortalities less serious than those 

eligible for the Breakthrough Devices 

Program; for example, this may include 

devices treating or diagnosing non-lifethreatening or reasonably reversible 

conditions. Devices and device-led 

combination products are eligible for 

this program if they are subject to 

review under a premarket approval 

application (PMA), De Novo 

classification request (‘‘De Novo 

request’’), or premarket notification 

(510(k)), taking into account the specific 

eligibility factors described in this 

guidance. Consistent with the Agency’s 

statutory mission to protect and 

promote public health, FDA believes 

that this ‘‘Safer Technologies Program’’ 

or ‘‘STeP’’ will help patients have more 

timely access to these medical devices 

and device-led combination products by 

expediting their development, 

assessment, and review, while 

preserving the statutory standards for 

premarket approval, De Novo marketing 

authorization, and 510(k) clearance. 

FDA has modeled STeP on the key 

principles and features of FDA’s 

Breakthrough Devices Program as 

mandated in section 515B of the Federal 

Food, Drug and Cosmetic Act (21 U.S.C. 

360e-3) and further described in the 

FDA guidance document entitled 

‘‘Breakthrough Devices Program’’ 

(https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/breakthrough-devicesprogram). As resources permit, FDA 

intends for STeP to incorporate similar 

features offered under the Breakthrough 

Devices Program, such as interactive 

and timely communications, early 

engagement on Data Development Plans, 

sprint discussions, and senior 

management engagement. 

FDA recognizes and anticipates that 

the Agency may need up to 60 days to 

perform activities to operationalize 

STeP following issuance of the final 

guidance. FDA does not intend to accept 

requests for inclusion in STeP within 

this time period. 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of September 19, 2019 (84 FR 

49306). FDA considered comments 

received and revised the guidance as 

appropriate in response to the 

comments, including revisions related 

to program scope, such as providing 

additional examples of devices that may 

be eligible for the program, and 

revisions to clarify the review time 

clock. The guidance was also revised to 

further emphasize that participation in 

STeP does not change or impact the 

statutory requirements for marketing 

authorization applicable to a medical 

device nor does it affect the application 

of least burdensome policies and 

approaches. 

This 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 Safer Technologies 

Program for 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 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. This 

guidance document is also available at 

https://www.regulations.gov, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, and https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents. Persons unable to 

download an electronic copy of ‘‘Safer 

Technologies Program for 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 19001 

and complete title to identify the 

guidance you are requesting. 

III. 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 guidance have been 

approved by OMB as listed in the 

following table: 

21 CFR part or guidance Topic OMB Control 

No. 

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

814, subparts A through E .......................................................... Premarket approval .................................................................... 0910–0231 

812 .............................................................................................. Investigational Device Exemption .............................................. 0910–0078 

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

‘‘De Novo Classification Process (Evaluation of Automatic 

Class III Designation)’’.

De Novo classification process .................................................. 0910–0844 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-submissions ........................................................................... 0910–0756 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Notices 549 

Dated: December 29, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29158 Filed 1–5–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2101] 

Human Gene Therapy for 

Neurodegenerative Diseases; Draft 

Guidance for Industry; 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 a draft 

document entitled ‘‘Human Gene 

Therapy for Neurodegenerative 

Diseases; Draft Guidance for Industry.’’ 

Neurodegenerative diseases are a 

heterogeneous group of disorders 

characterized by progressive 

degeneration of the structure and 

function of the central nervous system 

or peripheral nervous system. The draft 

guidance document provides 

recommendations to sponsors 

developing a human gene therapy (GT) 

product for neurodegenerative diseases 

affecting adult and pediatric patients. 

The guidance focuses on considerations 

for product development, preclinical 

testing, and clinical trial design. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 6, 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– 

2020–D–2101 for ‘‘Human Gene 

Therapy for Neurodegenerative 

Diseases; Draft Guidance for Industry.’’ 

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 Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), 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 the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 

1–800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Shruti Modi, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Human Gene 

Therapy for Neurodegenerative 

Diseases; Draft Guidance for Industry.’’ 

Neurodegenerative diseases are a 

heterogeneous group of disorders 

characterized by progressive 

degeneration of the structure and 

function of the central nervous system 

or peripheral nervous system. The draft 

guidance document provides 

recommendations to sponsors 

developing a GT product for 

neurodegenerative diseases affecting 

adult and pediatric patients. This 

guidance focuses on considerations for 

product development, preclinical 

testing, and clinical trial design. 


jbell on DSKJLSW7X2PROD with NOTICES