Federal Register / Vol. 88, No. 232 / Tuesday, December 5, 2023 / Notices 84337 

(DCBFD2) Regulatory Review 

Branch 3 (DCBFD3) 

Review Management Support Branch 

(DCBFD4) 

Division of Clinical and Toxicology 

Review (DCBFE) 

Clinical Review Branch 1 (DCBFE1) 

Clinical Review Branch 2 (DCBFE2) 

Clinical Review Branch 3 (DCBFE3) 

Toxicology Staff (DCBFE4) 

II. Delegations of Authority 

Pending further delegation, directives, 

or orders by the Commissioner of Food 

and Drugs, all delegations and 

redelegations of authority made to 

officials and employees of affected 

organizational components will 

continue in them or their successors 

pending further redelegations, provided 

they are consistent with this 

reorganization. 

III. Electronic Access 

After completion of the necessary 

requirements for implementation, this 

reorganization will be reflected in FDA’s 

Staff Manual Guide (SMG) at: https://

www.fda.gov/AboutFDA/

ReportsManualsForms/

StaffManualGuides/default.htm. 

Authority: 44 U.S.C. 3101. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2023–26512 Filed 12–4–23; 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 

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 priority review voucher. FDA has 

determined that XENPOZYME 

(olipudase alfa-rpcp), manufactured by 

Genzyme Corporation, meets the criteria 

for a priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394. 

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 XENPOZYME (olipudase alfa-rpcp), 

manufactured by Genzyme Corporation, 

meets the criteria for a priority review 

voucher. XENPOZYME (olipudase alfarpcp) is indicated for treatment of noncentral nervous system manifestations 

of acid sphingomyelinase deficiency 

(ASMD) in adult and pediatric patients. 

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/RarePediatricDisease

PriorityVoucherProgram/default.htm. 

For further information about 

XENPOZYME (olipudase alfa-rpcp), go 

to the ‘‘Drugs@FDA’’ website at http:// 

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

daf/. 

Dated: November 30, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26652 Filed 12–4–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5569] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Device Tracking 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 4, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0442. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10 a.m.–12 p.m., 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–3794, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Devices; Device Tracking—21 

CFR Part 821 

OMB Control Number 0910–0442— 

Extension 

Section 519(e)(1) of the Federal Food, 

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

360i(e)(1)) provides that FDA may 

require by order that a manufacturer 

adopt a method for tracking a class II or 

III medical device, if the device meets 

one of the three following criteria: (1) 

the failure of the device would be 

reasonably likely to have serious 

adverse health consequences, (2) the 

device is intended to be implanted in 

the human body for more than 1 year 

(referred to as a ‘‘tracked implant’’), or 

(3) the device is life-sustaining or lifesupporting (referred to as a ‘‘tracked l/ 

s-l/s device’’) and is used outside a 

device user facility. Tracked device 

information is collected to facilitate 

identifying the current location of 

medical devices and patients possessing 

those devices, to the extent that patients 

permit the collection of identifying 

information. Manufacturers and FDA 

(where necessary) use the data to: (1) 

expedite the recall of distributed 

medical devices that are dangerous or 

defective and (2) facilitate the timely 

notification of patients or licensed 

practitioners of the risks associated with 

the medical device. 


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