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Diseases; Draft Guidance for Industry.’’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written comments on the draft guidance 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draft guidance before it begins work on 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
550 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Notices 

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 recommendations for sponsors 

developing human GT products for 

neurodegenerative disorders affecting 

adult and pediatric patients. 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 21 CFR part 50 have been 

approved under OMB control number 

0910–0755; the collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338; and the collections 

of information in the guidance entitled 

‘‘Expedited Programs for Serious 

Conditions—Drugs and Biologics’’ have 

been approved under OMB control 

number 0910–0765. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances or https://

www.regulations.gov. 

Dated: December 22, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29238 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–N–2246] 

Withdrawal of FDA Notice Regarding 

Fee Rates Under the Over-the-Counter 

Monograph Drug User Fee Program for 

Fiscal Year 2021 

AGENCY: Department of Health and 

Human Services (HHS), Food and Drug 

Administration (FDA). 

ACTION: Notice; withdrawal. 

SUMMARY: The Department of Health and 

Human Services is issuing this Notice to 

withdraw FDA’s December 29, 2020 

Federal Register Notice entitled Fee 

Rates Under the Over-the-Counter 

Monograph User Fee Program for Fiscal 

Year 2021 because FDA lacked the 

delegated authority to issue the Notice. 

The Department is further informing the 

public that FDA has been ordered to 

cease further collection efforts related to 

the Over-the-Counter Drug Monograph 

User Fee Program until further action is 

announced in the Federal Register. 

DATES: The Notice, published in the 

Federal Register on December 29, 2020 

(85 FR 85646), is withdrawn as of 

January 6, 2021. 

FOR FURTHER INFORMATION CONTACT: 

David Haas, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 61075, Beltsville, MD 20705–4304, 

240–402 4585. 

SUPPLEMENTARY INFORMATION: On 

December 29, 2020, FDA published a 

Notice in the Federal Register entitled 

Fee Rates Under the Over-the-Counter 

Monograph User Fee Program for Fiscal 

Year 2021. 85 FR 85646. The Notice 

purports to implement certain user fee 

provisions contained in the Coronavirus 

Aid, Relief, and Economic Security Act 

(‘‘CARES Act’’), Public Law 116–136, 

134 Stat. 281 (March 27, 2020). The 

Notice was issued without approval of 

the Secretary. For this reason, the 

Notice, Docket No. FDA–2020–N–2246, 

as published in the Federal Register on 

December 29, 2020, (85 FR 85646), is 

hereby withdrawn. 

FDA has also been ordered to cease 

collections activities related to the Overthe-Counter Monograph User Fee 

Program (‘‘OMUFA’’) until, with the 

approval of the Secretary, the 

Department issues further direction 

concerning FDA’s administration of 

OMUFA which provides the public with 

notice and opportunity for comment. 

Dated: December 31, 2020. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–00030 Filed 1–4–21; 4:15 pm] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Physician-Focused Payment Model 

Technical Advisory Committee; 

Meetings 

ACTION: Notice of meetings. 

SUMMARY: This notice announces the 

2021 meetings of the Physician-Focused 

Payment Model Technical Advisory 

Committee (PTAC). These meetings 

include deliberation and voting on 

proposals for physician-focused 

payment models (PFPMs) submitted by 

individuals and stakeholder entities and 

may include discussions on topics 

related to current or previously 

submitted PFPMs. All meetings are 

open to the public. 

DATES: The 2021 PTAC meetings will 

occur on the following dates: 

• Thursday–Friday, June 10–11, 2021, 

from 9:00 a.m. to 5:00 p.m. ET 

• Monday–Tuesday, September 27–28, 

2021, from 9:00 a.m. to 5:00 p.m. ET 

• Thursday–Friday, December 16–17, 

2021, from 9:00 a.m. to 5:00 p.m. ET 

Please note that times are subject to 

change. If the times change, the ASPE 

PTAC website will be updated (https:// 

aspe.hhs.gov/ptac-physician-focusedpayment-model-technical-advisorycommittee) and registrants will be 

notified directly via email. 

ADDRESSES: All PTAC meetings will be 

held virtually or in the Great Hall of the 

Hubert H. Humphrey Building, 200 

Independence Avenue SW, Washington, 

DC 20201. 

FOR FURTHER INFORMATION CONTACT: 

Stella Mandl, Designated Federal Officer 

at stella.mandl@hhs.gov (202) 690– 

6870. 

SUPPLEMENTARY INFORMATION: 

Agenda and Comments. PTAC will 

hear presentations on proposed PFPMs 

that have been submitted by individuals 

and stakeholder entities and/or 

discussion on topics related to current 

or previously submitted PFPMs. 

Regarding proposed PFPMs, following 

each presentation, PTAC will deliberate 

on the proposed PFPM. If PTAC 

completes its deliberation, PTAC will 

vote on the extent to which the 

proposed PFPM meets criteria 

established by the Secretary of Health 

and Human Services and on an overall 


jbell on DSKJLSW7X2PROD with NOTICES