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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued

Average Number of Number of Total annual burden per 21 CFR section; activity recordkeepers records per records recordkeeper Total hours recordkeeper (in hours)

Total ...... 584,679 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 The recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12.

The burden for this information variety of drug products, could be identifies you in the body of your collection has changed since the last similarly vulnerable to methanol comments, that information will be OMB approval. The reporting and contamination. As the COVID–19 posted on https://www.regulations.gov. recordkeeping burden has increased pandemic has increased the demand for • If you want to submit a comment mostly due to an increase in the number hand sanitizer products, the demand for with confidential information that you of FAERS reports submitted to FDA and pharmaceutical alcohol as the active do not wish to be made available to the the associated recordkeeping with these ingredient of those products has also public, submit the comment as a reports. increased. The guidance outlines a written/paper submission and in the manner detailed (see ‘‘Written/Paper Dated: February 16, 2021. policy intended to help pharmaceutical Submissions’’ and ‘‘Instructions’’). Lauren K. Roth, manufacturers and pharmacists in State- licensed pharmacies or Federal facilities Acting Principal Associate Commissioner for Written/Paper Submissions Policy. who engage in drug compounding avoid the use of pharmaceutical alcohol that is Submit written/paper submissions as [FR Doc. 2021–03541 Filed 2–22–21; 8:45 am] follows: contaminated with or substituted with • BILLING CODE 4164–01–P methanol in drug products. Given the Mail/Hand Delivery/Courier (for written/paper submissions): Dockets public health emergency presented by Management Staff (HFA–305), Food and coronavirus disease 2019 (COVID–19), DEPARTMENT OF HEALTH AND Drug Administration, 5630 Fishers this guidance document is being HUMAN SERVICES Lane, Rm. 1061, Rockville, MD 20852. implemented without prior public • For written/paper comments Food and Drug Administration comment because FDA has determined submitted to the Dockets Management that prior public participation is not [Docket No. FDA–2020–D–2016] Staff, FDA will post your comment, as feasible or appropriate, but it remains well as any attachments, except for subject to comment in accordance with Policy for Testing of Alcohol (Ethanol) information submitted, marked and the Agency’s good guidance practices. and Isopropyl Alcohol for Methanol, identified, as confidential, if submitted Including During the Public Health DATES: The announcement of the as detailed in ‘‘Instructions.’’ Emergency (COVID–19); Guidance for guidance is published in the Federal Instructions: All submissions received Industry; Availability Register on February 23, 2021. The must include the Docket No. FDA– guidance document is immediately in 2020–D–2016 for ‘‘Policy for Testing of AGENCY: Food and Drug Administration, effect, but it remains subject to comment Alcohol (Ethanol) and Isopropyl HHS. in accordance with the Agency’s good Alcohol for Methanol, Including During ACTION: Notice of availability. guidance practices. the Public Health Emergency (COVID– ADDRESSES: You may submit either 19).’’ Received comments will be placed SUMMARY: The Food and Drug electronic or written comments on in the docket and, except for those Administration (FDA or Agency) is Agency guidances at any time as submitted as ‘‘Confidential announcing the availability of a final follows: Submissions,’’ publicly viewable at guidance for industry entitled ‘‘Policy https://www.regulations.gov or at the for Testing of Alcohol (Ethanol) and Electronic Submissions Dockets Management Staff between 9 Isopropyl Alcohol for Methanol, Submit electronic comments in the a.m. and 4 p.m., Monday through Including During the Public Health following way: Friday, 240–402–7500. Emergency (COVID–19).’’ This guidance • Federal eRulemaking Portal: • Confidential Submissions—To is intended to alert pharmaceutical https://www.regulations.gov. Follow the submit a comment with confidential manufacturers and pharmacists in State- instructions for submitting comments. information that you do not wish to be licensed pharmacies or Federal facilities Comments submitted electronically, made publicly available, submit your who engage in drug compounding to the including attachments, to https:// comments only as a written/paper potential public health hazard of www.regulations.gov will be posted to submission. You should submit two alcohol (ethyl alcohol or ethanol) or the docket unchanged. Because your copies total. One copy will include the isopropyl alcohol contaminated with or comment will be made public, you are information you claim to be confidential substituted with methanol. FDA is solely responsible for ensuring that your with a heading or cover note that states aware of reports of fatal methanol comment does not include any ‘‘THIS DOCUMENT CONTAINS poisoning of consumers who ingested confidential information that you or a CONFIDENTIAL INFORMATION.’’ The alcohol-based hand sanitizers that were third party may not wish to be posted, Agency will review this copy, including manufactured with methanol or such as medical information, your or the claimed confidential information, in methanol-contaminated ethanol and is anyone else’s Social Security number, or its consideration of comments. The concerned that other drug products confidential business information, such second copy, which will have the containing ethanol or isopropyl alcohol as a manufacturing process. Please note claimed confidential information (pharmaceutical alcohol), which are that if you include your name, contact redacted/blacked out, will be available widely used active ingredients in a information, or other information that for public viewing and posted on

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https://www.regulations.gov. Submit I. Background of the importance of proper testing and both copies to the Dockets Management FDA is announcing the availability of the potential hazards if the testing is not Staff. If you do not wish your name and a guidance for industry entitled ‘‘Policy done; and (4) establishing finished contact information to be made publicly for Testing of Alcohol (Ethanol) and product test methods to ensure that available, you can provide this Isopropyl Alcohol for Methanol, when testing for ethanol or isopropyl information on the cover sheet and not Including During the Public Health alcohol content (assay), the method also in the body of your comments and you Emergency (COVID–19).’’ This guidance distinguishes between the active must identify this information as is intended to alert pharmaceutical ingredient and methanol. The policy ‘‘confidential.’’ Any information marked manufacturers 1 and pharmacists in outlined in this guidance applies to as ‘‘confidential’’ will not be disclosed State-licensed pharmacies or Federal pharmaceutical alcohols used as an except in accordance with 21 CFR 10.20 facilities who engage in compounding to active or inactive ingredient in a drug. and other applicable disclosure law. For the potential public health hazard of In light of the public health more information about FDA’s posting alcohol (ethyl alcohol or ethanol) or emergency related to COVID–19 of comments to public dockets, see 80 isopropyl alcohol (collectively declared by the Secretary of the FR 56469, September 18, 2015, or access ‘‘pharmaceutical alcohol’’ 2) Department of Health and Human the information at: https:// contaminated with or substituted with Services (HHS), FDA has determined www.govinfo.gov/content/pkg/FR-2015- methanol. FDA is aware of reports of that prior public participation for this 09-18/pdf/2015-23389.pdf. fatal methanol poisoning of consumers guidance is not feasible or appropriate Docket: For access to the docket to who ingested alcohol-based hand and is issuing this guidance without read background documents or the sanitizers that were manufactured with prior public comment (see section electronic and written/paper comments methanol or methanol-contaminated 701(h)(1)(C)(i) of the FD&C Act (21 received, go to https:// ethanol and is concerned that other drug U.S.C. 371(h)(1)(C)(i)) and 21 CFR www.regulations.gov and insert the products containing pharmaceutical 10.115(g)(2)). This guidance document docket number, found in brackets in the alcohol, which are widely used active is being implemented immediately, but heading of this document, into the ingredients in a variety of drug it remains subject to comment in ‘‘Search’’ box and follow the prompts products, could be similarly vulnerable accordance with the Agency’s good and/or go to the Dockets Management to methanol contamination. As the guidance practices. FDA will review Staff, 5630 Fishers Lane, Rm. 1061, COVID–19 pandemic has increased the comments, and the guidance will be Rockville, MD 20852, 240–402–7500. demand for hand sanitizer products, the updated accordingly. You may submit comments on any demand for pharmaceutical alcohol as This guidance is intended to remain guidance at any time (see 21 CFR the active ingredient of those products in effect for the duration of the public 10.115(g)(5)). has also increased. health emergency related to COVID–19 Submit written requests for single The guidance outlines a policy declared by HHS, including any copies of the guidance to the Division of intended to help pharmaceutical renewals made by the Secretary in Drug Information, Center for Drug manufacturers and pharmacists in State- accordance with section 319(a)(2) of the Evaluation and Research, Food and licensed pharmacies or Federal facilities Public Health Service Act (42 U.S.C. Drug Administration, 10001 New who engage in compounding avoid the 247d(a)(2)). However, the Hampshire Ave., Hillandale Building, use of pharmaceutical alcohol that is recommendations and processes 4th Floor, Silver Spring, MD 20993– contaminated with or substituted with described in the guidance are expected 0002; or to the Office of methanol in drug products. The policy to assist the Agency more broadly in its Communication, Outreach and outlined in the guidance includes, but is efforts to ensure that pharmaceutical Development, Center for Biologics not limited to: (1) Performing a specific alcohol that is contaminated with or Evaluation and Research, Food and identity test that includes a limit test for substituted with methanol is not used in Drug Administration, 10903 New methanol on each container within each drug products beyond the termination of Hampshire Ave., Bldg. 71, Rm. 3128, shipment of each lot of pharmaceutical the COVID–19 public health emergency Silver Spring, MD 20993–0002. Send alcohol before the component is used in and reflect the Agency’s current one self-addressed adhesive label to the manufacture or preparation of drug thinking on this issue. Therefore, within assist that office in processing your products; (2) knowing the entities in 60 days following the termination of the requests. See the SUPPLEMENTARY pharmaceutical manufacturers’ supply public health emergency, FDA intends INFORMATION section for electronic chain for pharmaceutical alcohol (i.e., to revise and replace this guidance with access to the guidance document. knowing the identities and any appropriate changes based on FOR FURTHER INFORMATION CONTACT: appropriately qualifying the comments received on this guidance Francis Godwin, Center for Drug manufacturer of the pharmaceutical and the Agency’s experience with Evaluation and Research, Food and alcohol and any subsequent implementation. Drug Administration, 10903 New distributor(s)); (3) ensuring that all This guidance is being issued Hampshire Ave., Bldg. 51, Rm. 4342, personnel in pharmaceutical consistent with FDA’s good guidance Silver Spring, MD 20993–0002, 301– manufacturing facilities (especially practices regulation (21 CFR 10.115). 796–5362; or Stephen Ripley, Center for personnel directly responsible for The guidance represents the current Biologics Evaluation and Research, receipt, testing, and release of thinking of FDA on ‘‘Policy for Testing Food and Drug Administration, 10903 pharmaceutical alcohol) are made aware of Alcohol (Ethanol) and Isopropyl New Hampshire Ave., Bldg. 71, Rm. Alcohol for Methanol, Including During 7301, Silver Spring, MD 20993–0002, 1 References to ‘‘manufacturers’’ includes registered outsourcing facilities, repackers, the Public Health Emergency (COVID– 240–402–7911; or Julie Bailey, Center relabellers, and suppliers of alcohol. 19).’’ It does not establish any rights for for Veterinary Medicine (HFV–140), 2 For the purposes of this guidance, we use the any person and is not binding on FDA Food and Drug Administration, 7500 term pharmaceutical alcohol to mean either ethanol or the public. You can use an alternative Standish Pl., Rockville, MD 20855, 240– (ethyl alcohol) or isopropyl alcohol (2-propanol). Both are used as an active ingredient in alcohol- approach if it satisfies the requirements 402–0700. based hand sanitizers and may be used in other of the applicable statutes and SUPPLEMENTARY INFORMATION: drug products as an active or inactive ingredient. regulations.

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II. Paperwork Reduction Act of 1995 SUMMARY: The Food and Drug Written/Paper Submissions Administration (FDA, we, or Agency) is While this guidance contains no Submit written/paper submissions as extending the comment period for the collection of information, it does refer to follows: notice that appeared in the Federal previously approved FDA collections of • Mail/Hand Delivery/Courier (for Register of January 11, 2021. In that information. Therefore, clearance by the written/paper submissions): Dockets notice, FDA requested comments Office of Management and Budget Management Staff (HFA–305), Food and regarding a document entitled (OMB) under the Paperwork Reduction Drug Administration, 5630 Fishers ‘‘Potential Approach for Defining Act of 1995 (PRA) (44 U.S.C. 3501– Lane, Rm. 1061, Rockville, MD 20852. Durations of Use for Medically 3521) is not required for this guidance. • For written/paper comments Important Antimicrobial Drugs Intended The previously approved collections of submitted to the Dockets Management for Use In or On Feed: A Concept information are subject to review by Staff, FDA will post your comment, as Paper.’’ The Agency is taking this action OMB under the PRA. The collections of well as any attachments, except for in response to requests for an extension information in 21 CFR part 314 have information submitted, marked and to allow interested persons additional been approved under OMB control identified, as confidential, if submitted time to submit comments. number 0910–0001; the collections of as detailed in ‘‘Instructions.’’ information in 21 CFR part 312 have DATES: FDA is extending the comment Instructions: All submissions received been approved under OMB control period announced in the notice must include the Docket No. FDA– number 0910–0014; the collections of published January 11, 2021 (86 FR 2016–D–2635 for ‘‘Potential Approach information in 21 CFR part 601 have 1979). Submit either electronic or for Defining Durations of Use for been approved under OMB control written comments by June 11, 2021. Medically Important Antimicrobial Drugs Intended for Use In or On Feed: number 0910–0338; and the collections ADDRESSES: You may submit comments A Concept Paper.’’ Received comments of information in 21 CFR parts 210 and as follows. Please note that late, will be placed in the docket and, except 211 have been approved under OMB untimely filed comments will not be for those submitted as ‘‘Confidential control number 0910–0139. considered. Electronic comments must Submissions,’’ publicly viewable at be submitted on or before June 11, 2021. III. Electronic Access https://www.regulations.gov or at the The https://www.regulations.gov Dockets Management Staff between 9 Persons with access to the internet electronic filing system will accept a.m. and 4 p.m., Monday through may obtain the guidance at https:// comments until 11:59 p.m. Eastern Time Friday, 240–402–7500. www.fda.gov/drugs/guidance- at the end of June 11, 2021. Comments • Confidential Submissions—To compliance-regulatory-information/ received by mail/hand delivery/courier submit a comment with confidential guidances-drugs, https://www.fda.gov/ (for written/paper submissions) will be information that you do not wish to be vaccines-blood-biologics/guidance- considered timely if they are made publicly available, submit your compliance-regulatory-information- postmarked or the delivery service comments only as a written/paper biologics, https://www.fda.gov/ acceptance receipt is on or before that submission. You should submit two emergency-preparedness-and-response/ date. coronavirus-disease-2019-covid-19/ copies total. One copy will include the covid-19-related-guidance-documents- Electronic Submissions information you claim to be confidential industry-fda-staff-and-other- with a heading or cover note that states Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS stakeholders, or https:// following way: www.regulations.gov. CONFIDENTIAL INFORMATION.’’ The • Federal eRulemaking Portal: Agency will review this copy, including Dated: February 16, 2021. https://www.regulations.gov. Follow the the claimed confidential information, in Lauren K. Roth, instructions for submitting comments. its consideration of comments. The Acting Principal Associate Commissioner for Comments submitted electronically, second copy, which will have the Policy. including attachments, to https:// claimed confidential information [FR Doc. 2021–03548 Filed 2–22–21; 8:45 am] www.regulations.gov will be posted to redacted/blacked out, will be available BILLING CODE 4164–01–P the docket unchanged. Because your for public viewing and posted on comment will be made public, you are https://www.regulations.gov. Submit solely responsible for ensuring that your both copies to the Dockets Management DEPARTMENT OF HEALTH AND comment does not include any Staff. If you do not wish your name and HUMAN SERVICES confidential information that you or a contact information to be made publicly third party may not wish to be posted, Food and Drug Administration available, you can provide this such as medical information, your or information on the cover sheet and not anyone else’s Social Security number, or in the body of your comments and you [Docket No. FDA–2016–D–2635] confidential business information, such must identify this information as as a manufacturing process. Please note ‘‘confidential.’’ Any information marked Potential Approach for Defining that if you include your name, contact as ‘‘confidential’’ will not be disclosed Durations of Use for Medically information, or other information that except in accordance with 21 CFR 10.20 Important Antimicrobial Drugs identifies you in the body of your and other applicable disclosure law. For Intended for Use In or On Feed: A comments, that information will be more information about FDA’s posting Concept Paper; Request for posted on https://www.regulations.gov. of comments to public dockets, see 80 Comments; Extension of Comment • If you want to submit a comment FR 56469, September 18, 2015, or access Period with confidential information that you the information at: https:// AGENCY: Food and Drug Administration, do not wish to be made available to the www.govinfo.gov/content/pkg/FR-2015- HHS. public, submit the comment as a 09-18/pdf/2015-23389.pdf. written/paper submission and in the Docket: For access to the docket to ACTION: Notice; request for comments; manner detailed (see ‘‘Written/Paper read background documents or the extension of comment period. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments

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