9514 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

material will be posted on FDA’s 

website after the meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at: https://www.fda.gov/ 

advisory-committees/medical-devicesadvisory-committee/general-and-plasticsurgery-devices-panel. Select the link 

for the 2021 Meeting Materials. The 

meeting will include slide presentations 

with audio components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 9, 2021. Oral 

presentations from the public and 

organizations will be scheduled on 

March 23, 2021, between approximately 

12:40 p.m. Eastern Time to 1:40 p.m. 

Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person (see FOR FURTHER INFORMATION

CONTACT). The notification should 

include a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before March 11, 2021. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing sessions. The contact person 

will notify interested persons regarding 

their request to speak by March 12, 

2021. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Artair Mallet 

at artair.mallett@fda.hhs.gov or 301– 

796–9638 at least 7 days in advance of 

the meeting. FDA is committed to the 

orderly conduct of its advisory 

committee meetings. Please visit our 

website at: https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 9, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03066 Filed 2–12–21; 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), as 

amended by the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), 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 OXLUMO 

(lumasiran) injection, manufactured by 

Alnylam Pharmaceuticals 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, 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), which was 

added by FDASIA, FDA will award 

priority review vouchers to sponsors of 

approved rare pediatric disease product 

applications that meet certain criteria. 

FDA has determined that OXLUMO 

(lumasiran) injection, manufactured by 

Alnylam Pharmaceuticals Inc., meets 

the criteria for a priority review 

voucher. OXLUMO (lumasiran) 

injection is indicated for the treatment 

of primary hyperoxaluria type 1 to 

lower urinary oxalate levels in pediatric 

and adult 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 https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about OXLUMO 

(lumasiran) injection, go to the ‘‘Drugs@

FDA’’ website at https://

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

daf/. 

Dated: February 8, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03012 Filed 2–12–21; 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 March 18, 

2021. 

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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 


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