81934 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act) 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the award 

of the priority review voucher. FDA has 

determined that ZOKINVY (lonafarnib), 

manufactured by Eiger 

BioPharmaceuticals, Inc., meets the 

criteria for a priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Althea Cuff, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–4061, Fax: 301–796–9856, 

email: althea.cuff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), FDA will 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA has determined 

that ZOKINVY (lonafarnib), 

manufactured by Eiger 

BioPharmaceuticals, Inc., meets the 

criteria for a priority review voucher. 

ZOKINVY (lonafarnib) is indicated in 

patients 12 months of age and older 

with a body surface area of 0.39 m2 and 

above: 

• To reduce the risk of mortality in 

Hutchinson-Gilford progeria 

syndrome 

• For the treatment of processingdeficient progeroid laminopathies 

with either: 

Æ Heterozygous LMNA mutation with 

progerin-like protein accumulation 

or 

Æ Homozygous or compound 

heterozygous ZMPSTE24 mutations 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to http://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about ZOKINVY 

(lonafarnib), go to the ‘‘Drugs@FDA’’ 

website at http://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: December 14, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27778 Filed 12–16–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Presidential Advisory 

Council on Combating AntibioticResistant Bacteria 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that a meeting is scheduled to be held 

for the Presidential Advisory Council on 

Combating Antibiotic-Resistant Bacteria 

(PACCARB). The meeting will be open 

to the public via webex and 

teleconference; a pre-registered public 

comment session will be held during 

the meeting. Pre-registration is required 

for members of the public who wish to 

attend the meeting via webex/ 

teleconference. Individuals who wish to 

send in their pre-recorded or written 

public comments should send an email 

to CARB@hhs.gov. Registration 

information is available on the website 

http://www.hhs.gov/paccarb and must 

be completed by February 8, 2021. 

Additional information about registering 

for the meeting and providing public 

comment can be obtained at http://

www.hhs.gov/paccarb on the Meetings 

page. 

DATES: The meeting is scheduled to be 

held on February 10, 2021, from 10:00 

a.m. to 4:00 p.m. and February 11, 2021, 

from 10:00 a.m. to 3:30 p.m. ET (times 

are tentative and subject to change). The 

confirmed times and agenda items for 

the meeting will be posted on the 

website for the PACCARB at http://

www.hhs.gov/paccarb when this 

information becomes available. Preregistration for attending the meeting is 

required to be completed no later than 

February 8, 2021. 

ADDRESSES: Instructions regarding 

attending this meeting virtually will be 

posted one week prior to the meeting at: 

http://www.hhs.gov/paccarb. 

FOR FURTHER INFORMATION CONTACT: 

Jomana Musmar, M.S., Ph.D., 

Designated Federal Officer, Presidential 

Advisory Council on Combating 

Antibiotic-Resistant Bacteria, Office of 

the Assistant Secretary for Health, U.S. 

Department of Health and Human 

Services, Room L616, Switzer Building, 

330 C St. SW, Washington, DC 20201. 

Phone: 202–746–1512; Email: CARB@

hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Presidential Advisory Council on 

Combating Antibiotic-Resistant Bacteria 

(PACCARB), established by Executive 

Order 13676, is continued by Section 

505 of Public Law 116–22, the 

Pandemic and All-Hazards 

Preparedness and Advancing Innovation 

Act of 2019 (PAHPAIA). Activities and 

duties of the Advisory Council are 

governed by the provisions of the 

Federal Advisory Committee Act 

(FACA), Public Law 92–463, as 

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

forth standards for the formation and 

use of federal advisory committees. 

The PACCARB shall advise and 

provide information and 

recommendations to the Secretary 

regarding programs and policies 

intended to reduce or combat antibioticresistant bacteria that may present a 

public health threat and improve 

capabilities to prevent, diagnose, 

mitigate, or treat such resistance. The 

PACCARB shall function solely for 

advisory purposes. 

Such advice, information, and 

recommendations may be related to 

improving: The effectiveness of 

antibiotics; research and advanced 

research on, and the development of, 

improved and innovative methods for 

combating or reducing antibiotic 

resistance, including new treatments, 

rapid point-of-care diagnostics, 

alternatives to antibiotics, including 

alternatives to animal antibiotics, and 

antimicrobial stewardship activities; 

surveillance of antibiotic-resistant 

bacterial infections, including publicly 

available and up-to-date information on 

resistance to antibiotics; education for 

health care providers and the public 

with respect to up-to-date information 

on antibiotic resistance and ways to 

reduce or combat such resistance to 

antibiotics related to humans and 

animals; methods to prevent or reduce 

the transmission of antibiotic-resistant 

bacterial infections; including 

stewardship programs; and coordination 

with respect to international efforts in 

order to inform and advance the United 

States capabilities to combat antibiotic 

resistance. 

The February 10–11, 2021, public 

meeting will be dedicated to 

presentations from two new working 

groups of the PACCARB, one on InterProfessional Education and another on 

Antibiotics Access and Use, which were 

formed in response to a task letter from 

the Assistant Secretary for Health. The 

two-day virtual public meeting will also 

include an update on the impact of 

COVID–19 on antimicrobial resistance. 

The meeting agenda will be posted on 

the PACCARB website at http:// 

Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices 81935 

www.hhs.gov/paccarb when it has been 

finalized. All agenda items are tentative 

and subject to change. 

Instructions regarding attending this 

meeting virtually will be posted one 

week prior to the meeting at: http://

www.hhs.gov/paccarb. 

Members of the public will have the 

opportunity to provide comments prior 

to the public meeting by emailing 

CARB@hhs.gov. Public comments 

should be sent in by midnight February 

7, 2021 and should be limited to no 

more than one page. All public 

comments received prior to February 7, 

2021, will be provided to Advisory 

Council members and will be 

acknowledged during the public 

teleconference. 

Dated: December 4, 2020. 

Jomana F. Musmar, 

Designated Federal Officer, Presidential 

Advisory Council on Combating AntibioticResistant Bacteria, Office of the Assistant 

Secretary for Health. 

[FR Doc. 2020–27769 Filed 12–16–20; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Office of the Assistant 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) is updating the 

organizational structure of the Office of 

Grants in the Office of the Assistant 

Secretary for Financial Resources 

(ASFR), which is located within the 

Office of the Secretary. ASFR is 

modifying the Office of Grants 

organizational structure to further 

improve and streamline its operation 

and to assume responsibility for 

maintaining and operating the 

GrantSolutions System currently 

aligned to the National Grant Center of 

Excellence (COE) in the Administration 

for Children and Families (ACF). The 

changes proposed affect HHS 

organizational Chapter AM Section 

AMU1 and AMU2 and Chapter KP 

Section KPA. 

ADDRESSES: 200 Independence Ave. SW, 

Washington, DC 20201, (202) 619–0142. 

FOR FURTHER INFORMATION CONTACT: 

Alice Bettencourt, Deputy Assistant 

Secretary for Grants, Alice.Bettencourt@

hhs.gov or (202) 619–0142. 

SUPPLEMENTARY INFORMATION: 

Chapter AMU, the Office of Grants 

Section AMU1 and AMU2 

The Office of Grants (AMU) 

organizational structure and 

responsibilities remain as described in 

Federal Register Document 2019– 

09459, with two divisional 

modifications. 

1. The Division of Systems (AMU2) is 

renamed the Division of Information 

and Solutions. The Division of 

Information and Solutions is headed by 

a Director and develops, manages, and 

operates major, grant-shared services 

and solution offerings for HHS, as 

directed by the Secretary of HHS or 

delegated authority. Organizational 

units within AMU2 may be adjusted 

from time to time and as necessary to 

accommodate new, changing, or 

discontinued shared services or solution 

offerings. The Division of Information 

and Solutions assumes responsibility for 

operating and maintaining the 

GrantSolutions system in its current 

form as well as for future 

GrantSolutions development efforts. 

The Division of Information and 

Solutions will also manage 

GrantSolutions-related customer 

relationships and agreements, formerly 

managed by the National Grant COE in 

ACF. 

2. The Division of Grant Policy, 

Oversight, and Evaluation (AMU1) is 

renamed the Division of Policy, 

Oversight, and Evaluation. 

Chapter KP, the Office of the Deputy 

Associate Secretary for Administration 

(ODASA) in ACF, Section KPA, 

National Grants Center of Excellence 

ODASA dissolves the National Grant 

COE, in compliance with OMB Memo 

Memorandum M–18–24, Strategies to 

Reduce Grant Recipient Reporting 

Burden, which rescinded all Center of 

Excellence designations. Responsibility 

for operating and managing the 

GrantSolutions system moves to The 

Office of Grants, Division of Information 

and Solutions (AMU2). 

Dated: December 10, 2020. 

Alex M. Azar II, 

Secretary, Department of Health & Human 

Services. 

[FR Doc. 2020–27814 Filed 12–16–20; 8:45 am] 

BILLING CODE 4150–24–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 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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Emergency Awards: Rapid 

Investigation of Severe Acute Respiratory 

Syndrome Coronavirus 2 (SARS–CoV–2) and 

Coronavirus Disease 2019 (COVID–19). 

Date: January 14–15, 2021. 

Time: 10:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3E61, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Ann Marie M. Brighenti, 

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 3E61, 

Rockville, MD 20852, 301–761–3100, annmarie.brighenti@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 11, 2020. 

Tyeshia M. Roberson, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–27780 Filed 12–16–20; 8:45 am] 

BILLING CODE 4140–01–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