24172 Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 

certain products that contain NAC and 

are labeled as dietary supplements. The 

enforcement discretion policy would 

apply to products that would be 

lawfully marketed dietary supplements 

if NAC were not excluded from the 

definition of ‘‘dietary supplement’’ and 

that are not otherwise in violation of the 

FD&C Act. Unless we identify safetyrelated concerns during our ongoing 

review, FDA would intend to exercise 

enforcement discretion until either of 

the following occurs: we complete 

notice-and-comment rulemaking to 

allow the use of NAC in or as a dietary 

supplement (if we move forward with 

such proceedings), or we deny the 

citizen petition’s request for rulemaking. 

Should we determine that this 

enforcement discretion policy is no 

longer appropriate, we will notify 

stakeholders by withdrawing or revising 

this guidance in accordance with 21 

CFR 10.115. 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/FoodGuidances, https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. Use the 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: April 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08560 Filed 4–21–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–1137] 

Guidance Documents Related to 

Coronavirus Disease 2019; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of an FDA 

guidance document related to the 

Coronavirus Disease 2019 (COVID–19) 

public health emergency (PHE). This 

notice of availability (NOA) is pursuant 

to the process that FDA announced, in 

the Federal Register of March 25, 2020, 

for making available to the public 

COVID–19-related guidances. The 

guidance identified in this notice 

addresses issues related to the COVID– 

19 PHE and has been issued in 

accordance with the process announced 

in the March 25, 2020, notice. The 

guidance has been implemented 

without prior comment, but it remains 

subject to comment in accordance with 

the Agency’s good guidance practices. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on April 22, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the name of the guidance 

document that the comments address 

and the docket number for the guidance 

(see table 1). Received comments will be 

placed in the docket(s) and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

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. 

You may submit comments on any 

guidance at any time (see § 10.115(g)(5) 

(21 CFR 10.115(g)(5))). 

Submit written requests for single 

copies of this guidance to the address 

noted in table 1. Send two selfaddressed adhesive labels to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 24173 

1Secretary of Health and Human Services, 

‘‘Determination that a Public Health Emergency 

Exists Nationwide as the Result of the 2019 Novel 

Coronavirus’’ (originally issued on January 31, 

2020, and subsequently renewed), available at: 

https://www.phe.gov/emergency/news/ 

healthactions/phe/Pages/default.aspx. 

2 ‘‘Proclamation on Declaring a National 

Emergency Concerning the Novel Coronavirus 

Disease (COVID–19) Outbreak’’ (March 13, 2020), 

available at: https://trumpwhitehouse.archives.gov/ 

presidential-actions/proclamation-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/. On February 24, 2021, 

there was a Presidential Declaration continuing the 

national emergency concerning the COVID–19 

pandemic beyond March 1, 2021. See 

‘‘Continuation of the National Emergency 

Concerning the Coronavirus Disease 2019 (COVID– 

19) Pandemic’’ (February 24, 2021), available at 

https://www.federalregister.gov/documents/2021/ 

02/26/2021-04173/continuation-of-the-nationalemergency-concerning-the-coronavirus-disease2019-covid-19-pandemic. 

FOR FURTHER INFORMATION CONTACT: 

Stephen Ripley, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On January 31, 2020, as a result of 

confirmed cases of COVID–19, and after 

consultation with public health officials 

as necessary, the Secretary of Health 

and Human Services (HHS), pursuant to 

the authority under section 319 of the 

Public Health Service Act (42 U.S.C. 

247d), determined that a PHE exists and 

has existed since January 27, 2020, 

nationwide.1 On March 13, 2020, there 

was a Presidential declaration that the 

COVID–19 outbreak in the United States 

constitutes a national emergency, 

beginning March 1, 2020.2

In the Federal Register of March 25, 

2020 (85 FR 16949) (the March 25, 2020, 

notice) (available at https://

www.govinfo.gov/content/pkg/FR/2020/ 

03/25/pdf/2020/06222.pdf), FDA 

announced procedures for making 

available FDA guidances related to the 

COVID–19 PHE. These procedures, 

which operate within FDA’s established 

good guidance practices regulations, are 

intended to allow FDA to rapidly 

disseminate Agency recommendations 

and policies related to COVID–19 to 

industry, FDA staff, and other 

stakeholders. The March 25, 2020, 

notice stated that due to the need to act 

quickly and efficiently to respond to the 

COVID–19 PHE, FDA believes that prior 

public participation will not be feasible 

or appropriate before FDA implements 

COVID–19-related guidances. Therefore, 

FDA will issue COVID–19-related 

guidances for immediate 

implementation without prior public 

comment (see section 701(h)(1)(C) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 371(h)(1)(C)) and 

§ 10.115(g)(2)). The guidances are 

available on FDA’s web pages entitled 

‘‘COVID–19-Related Guidance 

Documents for Industry, FDA Staff, and 

Other Stakeholders’’ (available at 

https://www.fda.gov/emergencypreparedness-and-response/mcmissues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders) and ‘‘Search for FDA 

Guidance Documents’’ (available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments). 

The March 25, 2020, notice further 

stated that, in general, rather than 

publishing a separate NOA for each 

COVID–19-related guidance, FDA 

intends to publish periodically a 

consolidated NOA announcing the 

availability of certain COVID–19-related 

guidances that FDA issued during the 

relevant period, as included in table 1. 

This notice announces COVID–19- 

related guidances that are posted on 

FDA’s website. 

II. Availability of COVID–19-Related 

Guidance Documents 

Pursuant to the process described in 

the March 25, 2020, notice, FDA is 

announcing the availability of the 

following COVID–19-related guidance: 

TABLE 1—GUIDANCE RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY

Docket No. Center Title of guidance Contact information to request single copies 

FDA–2020–D–1137 CBER ....... Emergency Use Authorization for Vaccines to Prevent COVID–19 (Updated March 31, 2022).Office of Communication, Outreach and Development, 10903 New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002, 1–800–835– 

4709 or 240–402–8010; email ocod@fda.hhs.gov. 

Although this guidance has been 

implemented immediately without prior 

comment, FDA will consider all 

comments received and revise the 

guidance as appropriate (see 

§ 10.115(g)(3)). 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The 

guidance represents the current thinking 

of FDA. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

III. Paperwork Reduction Act of 1995 

While this CBER guidance contains 

no collection of information, it does 

refer to previously approved FDA 

collections of information (listed in 

table 2). Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in the following FDA 

regulations and guidance have been 

approved by OMB as listed in the 

following table: 

TABLE 2—CBER GUIDANCES AND COLLECTIONS

COVID–19 guidance title CFR cite referenced in 

COVID–19 guidance 

Another guidance title referenced in 

COVID–19 guidance 

OMB control 

No(s). 

Emergency Use Authorization for Vaccines to Prevent COVID–19 (Updated 

March 31, 2022).

21 CFR 314.420 ......................................

21 CFR part 312 .....................................

21 CFR parts 210, 211, and 610 ............

..................................................................

..................................................................

0910–0001.

0910–0014 ...............................................

0910–0139.


lotter on DSK11XQN23PROD with NOTICES1
24174 Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 

1See https://www.fda.gov/radiation-emittingproducts/home-business-and-entertainmentproducts/laser-light-shows. 

2See https://www.fda.gov/about-fda/cdrhtransparency/515-program-initiative and https://

www.fda.gov/about-fda/cdrh-transparency/515- 

project-status. 

TABLE 2—CBER GUIDANCES AND COLLECTIONS—Continued 

COVID–19 guidance title CFR cite referenced in 

COVID–19 guidance 

Another guidance title referenced in 

COVID–19 guidance 

OMB control 

No(s). 

21 CFR part 600 ..................................... .................................................................. 0910–0308

21 CFR part 601 ..................................... 0910–0338.

Emergency Use Authorization of Medical 

Products and Related Authorities.

0910–0595 

IV. Electronic Access 

Persons with access to the internet 

may obtain COVID–19-related guidances 

at: 

• FDA web page entitled ‘‘COVID–19- 

Related Guidance Documents for 

Industry, FDA Staff, and Other 

Stakeholders,’’ available at https://

www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19- 

related-guidance-documents-industryfda-staff-and-other-stakeholders; 

• FDA web page entitled ‘‘Search for 

FDA Guidance Documents’’ available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or https://

www.regulations.gov. 

Dated: April 18, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08564 Filed 4–21–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–0957] 

Compliance Policy Guides Sec. 

335.500; Sec. 310.200; Sec. 393.100; 

Sec. 398.425; Sec. 394.500; Sec. 

300.750; Withdrawal of Guidance 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the withdrawal of six 

compliance policy guides (CPG). The 

Agency is taking this action because the 

CPGs identified in this notice contain 

information that is either duplicative of 

other information the Agency has 

published or no longer reflects the 

Agency’s current thinking. 

DATES: The withdrawal is effective April 

22, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Erica Takai, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5456, Silver Spring, 

MD 20993–0002, 301–796–6353. 

SUPPLEMENTARY INFORMATION: 

After careful review of CPGs related to 

device products, FDA has identified the 

following six CPGs, that contain 

information that is either duplicative or 

no longer reflects the Agency’s current 

thinking. 

FDA originally issued CPG Sec. 

335.500, ‘‘Razor Blades, Manicuring 

Instruments—Not Considered Devices 

Under 201(h)’’ (CPG Sec. 335.500) in 

April 1976. The CPG was revised 

periodically but has not been revised 

since March 1995. Given the time that 

has passed since the last revision of CPG 

Sec. 335.500, upon further review, FDA 

has determined that while the CPG still 

reflects the Agency’s current thinking, it 

is no longer needed because it appears 

to be seldomly accessed. 

CPG Sec. 310.200, 

‘‘Sphygmomanometers—Rx Legend’’ 

(CPG Sec. 310.200) was originally 

issued in January 1973. The CPG was 

revised periodically but has not been 

revised since September 1987. Since 

CPG Sec. 310.200 was last updated, 

many of these products have been 

cleared to be sold over the counter and 

therefore, the policy contained in this 

CPG is obsolete and no longer needed. 

CPG Sec. 393.100, ‘‘Enforcement 

Policy for Certain Laser Light Shows, 

Displays, and/or Devices. (21 CFR 

1040.10 and 1040.11)’’ (CPG Sec 

393.100) was originally issued in 

October 1980. The CPG was revised 

periodically but has not been revised 

since March 2005. Since CPG Sec. 

393.100 was last revised, the policies 

regarding these products have been 

updated and additional resources have 

been made available to the public 

regarding these products, including in 

four laser notice guidance documents.1

The change in policies and the 

availability of additional resources has 

resulted in the information contained 

within CPG Sec. 393.100 to be 

duplicative and outdated. 

CPG Sec. 398.425, ‘‘Override of 

Positive Beam Limitation—21 CFR 

1020.31(g)(5)’’ (CPG Sec. 398.425) was 

originally issued in October 1980. The 

CPG was revised periodically but has 

not been revised since March 2005. 

Given the time that has passed since the 

last revision of CPG Sec. 398.425, upon 

further review, FDA has determined that 

the CPG provides duplicative 

information to what is provided in 21 

CFR 1020.31(g)(5). 

CPG Sec. 394.500, ‘‘Importation of 

Television Products, Microwave Ovens, 

and Inherent Class I Laser Products for 

Investigation and Evaluation during 

Design Development’’ (CPG Sec. 

394.500) was originally issued in March 

1984. The CPG was revised periodically 

but has not been revised since July 

2004. Given the time that has passed 

since the last revision of CPG Sec. 

394.500, upon further review, FDA has 

determined that the CPG contains 

outdated information and references. 

Finally, CPG Sec. 300.750, ‘‘Class III 

Devices Subject to 515(b) 

Requirements’’ (CPG Sec. 300.750) was 

originally issued in October 1990. The 

CPG was revised periodically but has 

not been revised since July 2005. Since 

CPG Sec. 300.750 was last revised, FDA 

has completed the actions for the 

preamendment class III devices 

discussed in the CPG to either reclassify 

them into class I, or II, or, if retaining 

the device in class III, calling for 

PMAs; 2 as such, the CPG is obsolete. 

Therefore, after careful review, FDA is 

withdrawing CPG Sec. 335.500, CPG 

Sec. 310.200, 393.100, CPG Sec. 

398.425, CPG Sec. 394.500, and CPG 

Sec. 300.750 in their entirety because 

the CPGs are either obsolete or contain 

duplicative information. 

Dated: April 18, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08587 Filed 4–21–22; 8:45 am] 

BILLING CODE 4164–01–P 


lotter on DSK11XQN23PROD with NOTICES1