Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices 81933 

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. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

State Enforcement Notifications—21 

CFR 100.2(d) 

OMB Control Number 0910–0275— 

Extension 

This information collection supports 

Agency regulations. Specifically, section 

310(b) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

337(b)) authorizes a State to enforce 

certain sections of the FD&C Act in their 

own name and within their own 

jurisdiction. However, before doing so, 

a State must provide notice to FDA 

according to § 100.2 (21 CFR 100.2). The 

information required in a letter of 

notification under § 100.2(d) enables us 

to identify the food against which a 

State intends to take action and to 

advise that State whether Federal 

enforcement action against the food has 

been taken or is in process. With certain 

narrow exceptions, Federal enforcement 

action precludes State action under the 

FD&C Act. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

100.2(d) ................................................................................ 1 1 1 10 10 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

The estimated reporting burden for 

§ 100.2(d) is minimal because 

enforcement notifications are seldom 

used by States. During the last 3 years, 

we have not received any new 

enforcement notifications; therefore, we 

estimate that one or fewer notifications 

will be submitted annually. Although 

we have not received any new 

enforcement notifications in the last 3 

years, we believe these information 

collection provisions should be 

extended to provide for the potential 

future need of a State government to 

submit enforcement notifications 

informing us when it intends to take 

enforcement action under the FD&C Act 

against a particular food located in the 

State. 

Dated: December 9, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27748 Filed 12–16–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

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://