Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices 9057 

Estimated Total Annual Burden 

Hours: 317. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 14 days of this publication. 

Authority: 45 CFR 98.64. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–03462 Filed 2–16–22; 8:45 am] 

BILLING CODE 4184–55–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0895] 

Issuance of Priority Review Voucher; 

Material Threat Medical 

Countermeasure 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 material threat medical 

countermeasure (MCM) product 

application. The Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as 

amended by the 21st Century Cures Act 

(Cures Act), authorizes FDA to award 

priority review vouchers to sponsors of 

approved material threat MCM product 

applications that meet certain criteria. 

FDA is required to publish notice of the 

award of the priority review voucher. 

FDA has determined that SPIKEVAX

(COVID–19 Vaccine, mRNA), meets the 

criteria for a material threat priority 

review voucher, which has been issued 

to ModernaTX, Inc., the holder of the 

biologics license application. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a material 

threat MCM priority review voucher to 

the sponsor of an approved material 

threat MCM product application. Under 

section 565A of the FD&C Act (21 U.S.C. 

360bbb–4a), which was added by the 

Cures Act (Pub. L. 114–255), FDA will 

award priority review vouchers to 

sponsors of approved material threat 

MCM product applications that meet 

certain criteria upon approval of those 

applications. FDA has determined that 

SPIKEVAX (COVID–19 Vaccine, 

mRNA), meets the criteria for a material 

threat MCM priority review voucher. 

SPIKEVAX is indicated for active 

immunization to prevent coronavirus 

disease 2019 (COVID–19) caused by 

severe acute respiratory syndrome 

coronavirus 2 (SARS–CoV–2) in 

individuals 18 years of age and older. 

For further information about the 

material threat MCM Priority Review 

Voucher Program and for a link to the 

full text of section 565A of the FD&C 

Act, go to https://www.fda.gov/ 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/mcm-relatedcounterterrorism-legislation. For further 

information about SPIKEVAX, (COVID– 

19 Vaccine, mRNA), go to the Center for 

Biologics Evaluation and Research 

Approved Vaccine Products website at 

https://www.fda.gov/vaccines-bloodbiologics/vaccines/approved-vaccineproducts. 

Dated: February 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03420 Filed 2–16–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0386] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Class II Special 

Controls for Human Immunodeficiency 

Virus Serological Diagnostic and 

Supplemental Tests and Human 

Immunodeficiency Virus Nucleic Acid 

Diagnostic and Supplemental Tests 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 21, 

2022. 

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 0910–0437. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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 Device Reporting—21 CFR Part 

803 

OMB Control Number 0910–0437— 

Revision 

In the Federal Register of February 

21, 2020 (85 FR 10110), we published a 

proposed order to reclassify certain 

human immunodeficiency virus (HIV) 

serological diagnostic and supplemental 

tests and HIV nucleic acid (NAT) 

diagnostic and supplemental tests from 

class III (premarket approval) into class 

II (special controls) (the proposed 

order). In the proposed order, FDA 

proposed special controls that the 

Agency believes are necessary to 

provide a reasonable assurance of safety 

and effectiveness for these devices. The 

proposed special controls would require 

the submission of a log of all complaints 

annually for a period of 5 years 

following FDA clearance of a traditional 

premarket notification (510(k)) 

submission for a device within the 

scope of the proposed order. 

Currently, manufacturers of HIV 

serological diagnostic and supplemental 

tests and HIV NAT diagnostic and 

supplemental tests are subject to FDA 


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