24170 Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 

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 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Kavita Vyas, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 4154, Silver Spring, 

MD, 20993–0002, 301–796–4787; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, 10903 New 

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

Silver Spring, MD, 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Drug 

Products, Including Biological Products, 

That Contain Nanomaterials.’’ This 

guidance applies to human drug 

products, including those that are 

biological products, in which a 

nanomaterial is present in the finished 

dosage form. This guidance discusses 

both general principles and specific 

considerations for developing drug 

products containing nanomaterials 

through abbreviated pathways. 

Considerations for quality, nonclinical, 

and clinical studies are discussed as 

they relate to drug products containing 

nanomaterials throughout product 

development and production. 

This guidance finalizes the draft 

guidance issued December 18, 2017 (82 

FR 60019). There were two noteworthy 

changes made from the draft version to 

final guidance in response to 

stakeholder comments. First, the final 

guidance provides a glossary of 

terminology to assist in understanding 

how important terms are used in the 

document. Second, several revisions 

were made to reflect FDA’s current 

thinking with respect to abbreviated 

applications, including abbreviated new 

drug applications (ANDAs), for products 

containing nanomaterials. In addition to 

changes in response to comments, the 

final guidance document’s discussion 

regarding over-the-counter (OTC) 

monograph drugs has been updated for 

consistency with the enactment of OTC 

reform provisions of the Coronavirus 

Aid, Relief, and Economic Security Act 

(Pub. L. 116–136). 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Drug Products, 

Including Biological Products, That 

Contain Nanomaterials.’’ 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. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. 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, related to investigational 

new drug applications, in 21 CFR part 

312 have been approved under OMB 

control number 0910–0014. The 

collections of information, related to 

new drug applications and ANDAs, 

including supplemental applications, in 

21 CFR part 314 have been approved 

under OMB control number 0910–0001. 

The collections of information in 

section 351(k) of the Public Health 

Service Act (42 U.S.C. 262(k)), regarding 

biosimilar applications, have been 

approved under OMB control number 

0910–0718. The collections of 

information, related to biologics license 

applications, in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. The collections of 

information, related current good 

manufacturing process requirements, in 

21 CFR part 211 have been approved 

under OMB control number 0910–0139. 

The collections of information, related 

to environmental impact requirements, 

in 21 CFR part 25 have been approved 

under OMB control number 0910–0322. 

The collections of information related to 

controlled correspondence regarding 

generic drug development have been 

approved under OMB control number 

0910–0797. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: April 18, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08572 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–2022–D–0490] 

Policy Regarding N-acetyl-L-cysteine: 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Policy 

Regarding N-acetyl-L-cysteine: Draft 

Guidance for Industry.’’ The draft 

guidance, when finalized, will explain 

our intent to exercise enforcement 

discretion with respect to the sale and 

distribution of certain products that 

contain N-acetyl-L-cysteine (NAC) and 

are labeled as dietary supplements. This 

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 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). 

DATES: Submit either electronic or 

written comments on the draft guidance 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 24171 

by May 23, 2022 to ensure that we 

consider your comment on the draft 

guidance before we begin work on the 

final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 Docket No. FDA– 

2022–D–0490for ‘‘Policy Regarding Nacetyl-L-cysteine: Draft Guidance for 

Industry.’’ Received comments will be 

placed in the docket 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the Office 

of Dietary Supplement Programs, Center 

for Food Safety and Applied Nutrition, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740. 

Send two self-addressed adhesive labels 

to assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: 

Gerie Voss, Center for Food Safety and 

Applied Nutrition (HFS–810), Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–620–9744; 

or Lauren Ferguson Baham, Center for 

Food Safety and Applied Nutrition, 

Office of Regulations and Policy (HFS– 

024), Food and Drug Administration, 

5001 Campus Dr., College Park, MD 

20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a draft guidance for industry entitled 

‘‘Policy Regarding N-acetyl-L-cysteine: 

Draft Guidance for Industry.’’ We are 

issuing the draft guidance consistent 

with our good guidance practices 

regulation (21 CFR 10.115). The draft 

guidance, when finalized, will represent 

the current thinking of FDA on this 

topic. It does not establish any rights for 

any person and is not binding on FDA 

or the public. You can use an alternate 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

FDA has determined that, under 

section 201(ff)(3)(B)(i) of the FD&C Act 

(21 U.S.C. 321(ff)(3)(B)(i)), NAC is 

excluded from the dietary supplement 

definition because NAC was approved 

as a new drug before it was marketed as 

a dietary supplement or as a food. FDA 

received two citizen petitions requesting 

that we conclude that NAC is not 

excluded from the definition of dietary 

supplement under section 201(ff)(3)(B) 

of the FD&C Act. On March 31, 2022, we 

denied this request. 

In addition, one of the citizen 

petitions asked FDA ‘‘to recommend 

and support to the Secretary of HHS’’ 

that he issue a regulation that would 

determine NAC to be lawful under the 

FD&C Act. As we stated in our response 

to the citizen petitions, we have not yet 

reached a final decision on this request, 

but we are considering initiating 

rulemaking under section 201(ff)(3)(B) 

of the FD&C Act to permit the use of 

NAC in or as a dietary supplement (i.e., 

to provide by regulation that NAC is not 

excluded from the definition of dietary 

supplement), and, if, among other 

considerations, FDA does not identify 

safety-related concerns as we continue 

our review of the available data and 

information, we are likely to propose a 

rule providing that NAC is not excluded 

from the definition of dietary 

supplement. While our full safety 

review of NAC remains ongoing, our 

initial review has not revealed safety 

concerns with respect to the use of this 

ingredient in or as a dietary supplement. 

In addition, NAC-containing products 

represented as dietary supplements 

have been sold in the United States for 

more than 30 years, and consumers 

continue to seek access to such 

products. 

Accordingly, the draft guidance, if 

finalized, would state our intent to 

exercise enforcement discretion with 

respect to the sale and distribution of 


lotter on DSK11XQN23PROD with NOTICES1
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