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This draft guidance is being issued 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The draft guidance, when finalized, will 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may obtain the draft guidance at either 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 


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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Notices 551 

recommendation to the Secretary. Time 

will be allocated for public comments. 

The agenda and other documents will 

be posted on the PTAC section of the 

ASPE website, https://aspe.hhs.gov/ 

ptac-physician-focused-payment-modeltechnical-advisory-committee, prior to 

the meeting. The agenda is subject to 

change. If the agenda does change, 

registrants will be notified directly via 

email, the website will be updated, and 

notification will be sent out through the 

PTAC email listserv (https://list.nih.gov/ 

cgi-bin/wa.exe?A0=PTAC to subscribe). 

Meeting Attendance. These meetings 

are open to the public and may be 

hosted in-person or virtually. We intend 

that in-person meetings will be held in 

the Great Hall of the Hubert H. 

Humphrey Building. The public may 

attend in person, when feasible, via 

conference call, or view the meeting via 

livestream at www.hhs.gov/live. The 

conference call dial-in information will 

be sent to registrants prior to the 

meeting. Space may be limited, and 

registration is preferred. For meetings 

that are held virtually, the public may 

attend via WebEx link (including a dialin only option) or view the meeting via 

livestream at www.hhs.gov/live. 

Registration may be completed online at 

http://www.cvent.com/d/gbq2tg. Name, 

organization name, and email address 

are submitted when registering. 

Registrants will receive a confirmation 

email shortly after completing the 

registration process. 

Special Accommodations. If sign 

language interpretation or other 

reasonable accommodation for a 

disability is needed, please contact 

ASPE PTAC staff, no later than two 

weeks prior to the scheduled meeting. 

Please submit your requests by email to 

PTAC@hhs.gov. 

Authority. 42 U.S.C 1395(ee); Section 

101(e)(1) of the Medicare Access and 

CHIP Reauthorization Act of 2015; 

Section 51003(b) of the Bipartisan 

Budget Act of 2018. 

PTAC is governed by provisions of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C App.), which sets 

forth standards for the formation and 

use of federal advisory committees. 

Dated: December 30, 2020. 

Brenda Destro, 

Deputy Assistant Secretary for Planning and 

Evaluation (HSP). 

[FR Doc. 2020–29223 Filed 1–5–21; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; A Solicitation of the 

National Institutes of Health (NIH) and the 

Centers for Disease Control and Prevention 

(CDC) for Small Business Innovation 

Research (SBIR) Contract Proposals (N01), 

Topic 098. 

Date: January 27, 2021. 

Time: 2:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3E70A, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Soheyla Saadi, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3E70A, Rockville, MD 

20852, 301–435–0903, saadisoh@

niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: December 30, 2020. 

Tyeshia M. Roberson, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–29267 Filed 1–5–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Integrative, 

Functional and Cognitive Neuroscience 

Integrated Review Group; Behavioral 

Neuroendocrinology, Neuroimmunology, 

Rhythms, and Sleep Study Section. 

Date: February 4–5, 2021. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Michael Selmanoff, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5164, 

MSC 7844, Bethesda, MD 20892, 301–435– 

1119, selmanom@csr.nih.gov. 

Name of Committee: Biological Chemistry 

and Macromolecular Biophysics Integrated 

Review Group; Biochemistry and Biophysics 

of Membranes Study Section. 

Date: February 4–5, 2021. 

Time: 8:30 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Nuria E Assa-Munt, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4164, 

MSC 7806, Bethesda, MD 20892, (301) 451– 

1323, assamunu@csr.nih.gov. 

Name of Committee: Integrative, 

Functional and Cognitive Neuroscience 

Integrated Review Group; Sensory-Motor 

Neuroscience Study Section. 

Date: February 4–5, 2021. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: John Bishop, Ph.D., 

Scientific Review Officer, Center for 


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