Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Notices 10977 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeper 

(in hours) 

Total hours 

Total .............................................................................. ........................ ........................ ........................ ........................ 584,679 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2The recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12. 

The burden for this information 

collection has changed since the last 

OMB approval. The reporting and 

recordkeeping burden has increased 

mostly due to an increase in the number 

of FAERS reports submitted to FDA and 

the associated recordkeeping with these 

reports. 

Dated: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03541 Filed 2–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2016] 

Policy for Testing of Alcohol (Ethanol) 

and Isopropyl Alcohol for Methanol, 

Including During the Public Health 

Emergency (COVID–19); Guidance for 

Industry; 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 a final 

guidance for industry entitled ‘‘Policy 

for Testing of Alcohol (Ethanol) and 

Isopropyl Alcohol for Methanol, 

Including During the Public Health 

Emergency (COVID–19).’’ This guidance 

is intended to alert pharmaceutical 

manufacturers and pharmacists in Statelicensed pharmacies or Federal facilities 

who engage in drug compounding to the 

potential public health hazard of 

alcohol (ethyl alcohol or ethanol) or 

isopropyl alcohol contaminated with or 

substituted with methanol. FDA is 

aware of reports of fatal methanol 

poisoning of consumers who ingested 

alcohol-based hand sanitizers that were 

manufactured with methanol or 

methanol-contaminated ethanol and is 

concerned that other drug products 

containing ethanol or isopropyl alcohol 

(pharmaceutical alcohol), which are 

widely used active ingredients in a 

variety of drug products, could be 

similarly vulnerable to methanol 

contamination. As the COVID–19 

pandemic has increased the demand for 

hand sanitizer products, the demand for 

pharmaceutical alcohol as the active 

ingredient of those products has also 

increased. The guidance outlines a 

policy intended to help pharmaceutical 

manufacturers and pharmacists in Statelicensed pharmacies or Federal facilities 

who engage in drug compounding avoid 

the use of pharmaceutical alcohol that is 

contaminated with or substituted with 

methanol in drug products. Given the 

public health emergency presented by 

coronavirus disease 2019 (COVID–19), 

this guidance document is being 

implemented without prior public 

comment because FDA has determined 

that prior public participation is not 

feasible or appropriate, 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 February 23, 2021. The 

guidance document is immediately in 

effect, but it remains subject to comment 

in accordance with the Agency’s good 

guidance practices. 

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 Docket No. FDA– 

2020–D–2016 for ‘‘Policy for Testing of 

Alcohol (Ethanol) and Isopropyl 

Alcohol for Methanol, Including During 

the Public Health Emergency (COVID– 

19).’’ 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.’’ 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 

10978 Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Notices 

1References to ‘‘manufacturers’’ includes 

registered outsourcing facilities, repackers, 

relabellers, and suppliers of alcohol. 

2For the purposes of this guidance, we use the 

term pharmaceutical alcohol to mean either ethanol 

(ethyl alcohol) or isopropyl alcohol (2-propanol). 

Both are used as an active ingredient in alcoholbased hand sanitizers and may be used in other 

drug products as an active or inactive ingredient. 

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 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; or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

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: 

Francis Godwin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4342, 

Silver Spring, MD 20993–0002, 301– 

796–5362; or Stephen Ripley, 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; or Julie Bailey, Center 

for Veterinary Medicine (HFV–140), 

Food and Drug Administration, 7500 

Standish Pl., Rockville, MD 20855, 240– 

402–0700. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Policy 

for Testing of Alcohol (Ethanol) and 

Isopropyl Alcohol for Methanol, 

Including During the Public Health 

Emergency (COVID–19).’’ This guidance 

is intended to alert pharmaceutical 

manufacturers 1 and pharmacists in 

State-licensed pharmacies or Federal 

facilities who engage in compounding to 

the potential public health hazard of 

alcohol (ethyl alcohol or ethanol) or 

isopropyl alcohol (collectively 

‘‘pharmaceutical alcohol’’ 2) 

contaminated with or substituted with 

methanol. FDA is aware of reports of 

fatal methanol poisoning of consumers 

who ingested alcohol-based hand 

sanitizers that were manufactured with 

methanol or methanol-contaminated 

ethanol and is concerned that other drug 

products containing pharmaceutical 

alcohol, which are widely used active 

ingredients in a variety of drug 

products, could be similarly vulnerable 

to methanol contamination. As the 

COVID–19 pandemic has increased the 

demand for hand sanitizer products, the 

demand for pharmaceutical alcohol as 

the active ingredient of those products 

has also increased. 

The guidance outlines a policy 

intended to help pharmaceutical 

manufacturers and pharmacists in Statelicensed pharmacies or Federal facilities 

who engage in compounding avoid the 

use of pharmaceutical alcohol that is 

contaminated with or substituted with 

methanol in drug products. The policy 

outlined in the guidance includes, but is 

not limited to: (1) Performing a specific 

identity test that includes a limit test for 

methanol on each container within each 

shipment of each lot of pharmaceutical 

alcohol before the component is used in 

the manufacture or preparation of drug 

products; (2) knowing the entities in 

pharmaceutical manufacturers’ supply 

chain for pharmaceutical alcohol (i.e., 

knowing the identities and 

appropriately qualifying the 

manufacturer of the pharmaceutical 

alcohol and any subsequent 

distributor(s)); (3) ensuring that all 

personnel in pharmaceutical 

manufacturing facilities (especially 

personnel directly responsible for 

receipt, testing, and release of 

pharmaceutical alcohol) are made aware 

of the importance of proper testing and 

the potential hazards if the testing is not 

done; and (4) establishing finished 

product test methods to ensure that 

when testing for ethanol or isopropyl 

alcohol content (assay), the method also 

distinguishes between the active 

ingredient and methanol. The policy 

outlined in this guidance applies to 

pharmaceutical alcohols used as an 

active or inactive ingredient in a drug. 

In light of the public health 

emergency related to COVID–19 

declared by the Secretary of the 

Department of Health and Human 

Services (HHS), FDA has determined 

that prior public participation for this 

guidance is not feasible or appropriate 

and is issuing this guidance without 

prior public comment (see section 

701(h)(1)(C)(i) of the FD&C Act (21 

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

10.115(g)(2)). This guidance document 

is being implemented immediately, but 

it remains subject to comment in 

accordance with the Agency’s good 

guidance practices. FDA will review 

comments, and the guidance will be 

updated accordingly. 

This guidance is intended to remain 

in effect for the duration of the public 

health emergency related to COVID–19 

declared by HHS, including any 

renewals made by the Secretary in 

accordance with section 319(a)(2) of the 

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

247d(a)(2)). However, the 

recommendations and processes 

described in the guidance are expected 

to assist the Agency more broadly in its 

efforts to ensure that pharmaceutical 

alcohol that is contaminated with or 

substituted with methanol is not used in 

drug products beyond the termination of 

the COVID–19 public health emergency 

and reflect the Agency’s current 

thinking on this issue. Therefore, within 

60 days following the termination of the 

public health emergency, FDA intends 

to revise and replace this guidance with 

any appropriate changes based on 

comments received on this guidance 

and the Agency’s experience with 

implementation. 

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 ‘‘Policy for Testing 

of Alcohol (Ethanol) and Isopropyl 

Alcohol for Methanol, Including During 

the Public Health Emergency (COVID– 

19).’’ 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. 

Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Notices 10979 

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 in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338; and the collections 

of information in 21 CFR parts 210 and 

211 have been approved under OMB 

control number 0910–0139. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

emergency-preparedness-and-response/ 

coronavirus-disease-2019-covid-19/ 

covid-19-related-guidance-documentsindustry-fda-staff-and-otherstakeholders, or https://

www.regulations.gov. 

Dated: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03548 Filed 2–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2635] 

Potential Approach for Defining 

Durations of Use for Medically 

Important Antimicrobial Drugs 

Intended for Use In or On Feed: A 

Concept Paper; Request for 

Comments; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments; 

extension of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

extending the comment period for the 

notice that appeared in the Federal 

Register of January 11, 2021. In that 

notice, FDA requested comments 

regarding a document entitled 

‘‘Potential Approach for Defining 

Durations of Use for Medically 

Important Antimicrobial Drugs Intended 

for Use In or On Feed: A Concept 

Paper.’’ The Agency is taking this action 

in response to requests for an extension 

to allow interested persons additional 

time to submit comments. 

DATES: FDA is extending the comment 

period announced in the notice 

published January 11, 2021 (86 FR 

1979). Submit either electronic or 

written comments by June 11, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before June 11, 2021. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 11, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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– 

2016–D–2635 for ‘‘Potential Approach 

for Defining Durations of Use for 

Medically Important Antimicrobial 

Drugs Intended for Use In or On Feed: 

A Concept Paper.’’ 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.’’ 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