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redacted/blacked out, will be available 505(j) of the FD&C Act (21 U.S.C. 355(j)) DEPARTMENT OF HEALTH AND for public viewing and posted on rather than as an NDA under section HUMAN SERVICES https://www.regulations.gov. Submit 505(b) of the FD&C Act. Food and Drug Administration both copies to the Dockets Management This guidance finalizes the draft Staff. If you do not wish your name and guidance entitled ‘‘ANDAs for Certain [Docket No. FDA–2007–D–0369] contact information to be made publicly Highly Purified Synthetic Peptide Drug available, you can provide this Product-Specific Guidances; Draft and Products That Refer to Listed Drugs of information on the cover sheet and not Revised Draft Guidances for Industry; rDNA Origin’’ issued on October 3, 2017 in the body of your comments and you Availability must identify this information as (82 FR 46075). FDA considered ‘‘confidential.’’ Any information marked comments received on the draft AGENCY: Food and Drug Administration, as ‘‘confidential’’ will not be disclosed guidance as the guidance was finalized. HHS. except in accordance with 21 CFR 10.20 In addition, editorial changes were ACTION: Notice of availability. made to improve clarity. and other applicable disclosure law. For SUMMARY: The Food and Drug more information about FDA’s posting This guidance is being issued Administration (FDA or Agency) is of comments to public dockets, see 80 consistent with FDA’s good guidance announcing the availability of FR 56469, September 18, 2015, or access practices regulation (21 CFR 10.115). additional draft and revised draft the information at: https:// The guidance represents the current product-specific guidances. The www.govinfo.gov/content/pkg/FR-2015- thinking of FDA on ‘‘ANDAs for Certain guidances provide product-specific 09-18/pdf/2015-23389.pdf. Highly Purified Synthetic Peptide Drug recommendations on, among other Docket: For access to the docket to Products That Refer to Listed Drugs of things, the design of bioequivalence read background documents or the rDNA Origin.’’ It does not establish any (BE) studies to support abbreviated new electronic and written/paper comments rights for any person and is not binding drug applications (ANDAs). In the received, go to https:// on FDA or the public. You can use an Federal Register of June 11, 2010, FDA www.regulations.gov and insert the alternative approach if it satisfies the announced the availability of a guidance docket number, found in brackets in the for industry entitled ‘‘Bioequivalence heading of this document, into the requirements of the applicable statutes and regulations. Recommendations for Specific ‘‘Search’’ box and follow the prompts Products’’ that explained the process and/or go to the Dockets Management II. Paperwork Reduction Act of 1995 that would be used to make product- Staff, 5630 Fishers Lane, Rm. 1061, specific guidances available to the Rockville, MD 20852, 240–402–7500. While this guidance contains no public on FDA’s website. The guidances You may submit comments on any collection of information, it does refer to identified in this notice were developed guidance at any time (see 21 CFR previously approved FDA collections of using the process described in that 10.115(g)(5)). information. Therefore, clearance by the guidance. Submit written requests for single Office of Management and Budget DATES: Submit either electronic or copies of this guidance to the Division (OMB) under the Paperwork Reduction written comments on the draft of Drug Information, Center for Drug Act of 1995 (44 U.S.C. 3501–3521) is not guidances by July 19, 2021 to ensure Evaluation and Research, Food and required for this guidance. The that the Agency considers your Drug Administration, 10001 New previously approved collection of comment on these draft guidances Hampshire Ave., Hillandale Building, information required under 21 CFR part before it begins work on the final 4th Floor, Silver Spring, MD 20993– 314 for the submission of NDAs and versions of the guidances. 0002. Send one self-addressed adhesive ANDAs is approved under OMB control ADDRESSES: label to assist that office in processing You may submit comments number 0910–0001, and the submission on any guidance at any time as follows: your requests. See the SUPPLEMENTARY of controlled correspondence pertaining INFORMATION section for electronic Electronic Submissions to ANDAs is approved under OMB access to the guidance document. control number 0910–0797. Submit electronic comments in the FOR FURTHER INFORMATION CONTACT: following way: James Hanratty, Center for Drug III. Electronic Access • Federal eRulemaking Portal: Evaluation and Research, Food and https://www.regulations.gov. Follow the Drug Administration, 10903 New Persons with access to the internet instructions for submitting comments. Hampshire Ave., Bldg. 75, Rm. 1672, may obtain the guidance at either Comments submitted electronically, Silver Spring, MD 20993–0002, 240– https://www.fda.gov/drugs/guidance- including attachments, to https:// 402–4718, [email protected]. compliance-regulatory-information/ www.regulations.gov will be posted to SUPPLEMENTARY INFORMATION: guidances-drugs or https:// the docket unchanged. Because your www.regulations.gov. comment will be made public, you are I. Background Dated: May 14, 2021. solely responsible for ensuring that your FDA is announcing the availability of Lauren K. Roth, comment does not include any a guidance for industry entitled confidential information that you or a Acting Principal Associate Commissioner for ‘‘ANDAs for Certain Highly Purified third party may not wish to be posted, Policy. Synthetic Peptide Drug Products That such as medical information, your or Refer to Listed Drugs of rDNA Origin.’’ [FR Doc. 2021–10603 Filed 5–19–21; 8:45 am] anyone else’s Social Security number, or This guidance is intended to assist BILLING CODE 4164–01–P confidential business information, such potential applicants in determining as a manufacturing process. Please note when an application for a synthetic that if you include your name, contact peptide drug product that refers to a information, or other information that previously approved peptide drug identifies you in the body of your product of rDNA origin should be comments, that information will be submitted as an ANDA under section posted on https://www.regulations.gov.

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• If you want to submit a comment www.govinfo.gov/content/pkg/FR-2015- on March 24, 2021. This notice with confidential information that you 09-18/pdf/2015-23389.pdf. announces draft product-specific do not wish to be made available to the Docket: For access to the docket to guidances, either new or revised, that public, submit the comment as a read background documents or the are posted on FDA’s website. written/paper submission and in the electronic and written/paper comments II. Drug Products for Which New Draft manner detailed (see ‘‘Written/Paper received, go to https:// Product-Specific Guidances Are Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the Available Written/Paper Submissions docket number, found in brackets in the heading of this document, into the FDA is announcing the availability of Submit written/paper submissions as ‘‘Search’’ box and follow the prompts new draft product-specific guidances for follows: industry for drug products containing • and/or go to the Dockets Management Mail/Hand Delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, the following active ingredients: written/paper submissions): Dockets Rockville, MD 20852, 240–402–7500. Management Staff (HFA–305), Food and You may submit comments on any TABLE 1—NEW DRAFT PRODUCT-SPE- Drug Administration, 5630 Fishers guidance at any time (see 21 CFR CIFIC GUIDANCES FOR DRUG PROD- Lane, Rm. 1061, Rockville, MD 20852. • 10.115(g)(5)). UCTS For written/paper comments Submit written requests for single submitted to the Dockets Management copies of the draft guidances to the Active ingredient(s) Staff, FDA will post your comment, as Division of Drug Information, Center for well as any attachments, except for Amlodipine Besylate; Celecoxib. Drug Evaluation and Research, Food Fluticasone Furoate; Umeclidinium Bromide; information submitted, marked and and Drug Administration, 10001 New Vilanterol Trifenatate. identified, as confidential, if submitted Lumateperone Tosylate. Hampshire Ave., Hillandale Building, as detailed in ‘‘Instructions.’’ Meloxicam. 4th Floor, Silver Spring, MD 20993– Instructions: All submissions received Metoclopramide Hydrochloride. Midazolam. must include the Docket No. FDA– 0002. Send one self-addressed adhesive label to assist that office in processing Pexidartinib Hydrochloride. 2007–D–0369 for ‘‘Product-Specific Pitolisant Hydrochloride. SUPPLEMENTARY Guidances; Draft and Revised Draft your requests. See the Quinidine Gluconate. Guidances for Industry.’’ Received INFORMATION section for electronic Trifarotene. access to the draft guidance documents. Ubrogepant. comments will be placed in the docket Voxelotor. and, except for those submitted as FOR FURTHER INFORMATION CONTACT: Kris Zanubrutinib. ‘‘Confidential Submissions,’’ publicly Andre, Center for Drug Evaluation and viewable at https://www.regulations.gov Research, Food and Drug III. Drug Products for Which Revised or at the Dockets Management Staff Administration, 10903 New Hampshire Draft Product-Specific Guidances Are between 9 a.m. and 4 p.m., Monday Ave., Bldg. 75, Rm. 4728, Silver Spring, Available through Friday, 240–402–7500. MD 20993–0002, 240–402–7959. • FDA is announcing the availability of Confidential Submissions—To SUPPLEMENTARY INFORMATION: revised draft product-specific guidances submit a comment with confidential I. Background for industry for drug products information that you do not wish to be containing the following active made publicly available, submit your In the Federal Register of June 11, ingredients: comments only as a written/paper 2010 (75 FR 33311), FDA announced the submission. You should submit two availability of a guidance for industry TABLE 2—REVISED DRAFT PRODUCT- copies total. One copy will include the entitled ‘‘Bioequivalence SPECIFIC GUIDANCES FOR DRUG information you claim to be confidential Recommendations for Specific PRODUCTS with a heading or cover note that states Products’’ that explained the process ‘‘THIS DOCUMENT CONTAINS that would be used to make product- Active ingredient(s) CONFIDENTIAL INFORMATION.’’ The specific guidances available to the Agency will review this copy, including public on FDA’s website at https:// Azacitidine. Dasatinib. the claimed confidential information, in www.fda.gov/Drugs/ Fluticasone Propionate. its consideration of comments. The GuidanceCompliance Ledipasvir; Sofosbuvir. second copy, which will have the RegulatoryInformation/Guidances/ Nitrofurantoin. Pentosan Polysulfate Sodium. claimed confidential information default.htm. Sofosbuvir. redacted/blacked out, will be available As described in that guidance, FDA Tofacitinib. for public viewing and posted on adopted this process as a means to https://www.regulations.gov. Submit develop and disseminate product- For a complete history of previously both copies to the Dockets Management specific guidances and provide a published Federal Register notices Staff. If you do not wish your name and meaningful opportunity for the public to related to product-specific guidances, go contact information to be made publicly consider and comment on those to https://www.regulations.gov and available, you can provide this guidances. Under that process, draft enter Docket No. FDA–2007–D–0369. information on the cover sheet and not guidances are posted on FDA’s website These draft guidances are being in the body of your comments and you and announced periodically in the issued consistent with FDA’s good must identify this information as Federal Register. The public is guidance practices regulation (21 CFR ‘‘confidential.’’ Any information marked encouraged to submit comments on 10.115). These draft guidances, when as ‘‘confidential’’ will not be disclosed those recommendations within 60 days finalized, will represent the current except in accordance with 21 CFR 10.20 of their announcement in the Federal thinking of FDA on, among other things, and other applicable disclosure law. For Register. FDA considers any comments the product-specific design of BE more information about FDA’s posting received and either publishes final studies to support ANDAs. They do not of comments to public dockets, see 80 guidances or publishes revised draft establish any rights for any person and FR 56469, September 18, 2015, or access guidances for comment. Guidances were are not binding on FDA or the public. the information at: https:// last announced in the Federal Register You can use an alternative approach if

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it satisfies the requirements of the DATES: Submit either electronic or • Confidential Submissions—To applicable statutes and regulations. written comments on the draft guidance submit a comment with confidential by July 19, 2021 to ensure that the information that you do not wish to be IV. Paperwork Reduction Act of 1995 Agency considers your comment on this made publicly available, submit your FDA tentatively concludes that these draft guidance before it begins work on comments only as a written/paper draft guidances contain no collection of the final version of the guidance. submission. You should submit two information. Therefore, clearance by the ADDRESSES: You may submit comments copies total. One copy will include the Office of Management and Budget under on any guidance at any time as follows: information you claim to be confidential the Paperwork Reduction Act of 1995 is with a heading or cover note that states Electronic Submissions not required. ‘‘THIS DOCUMENT CONTAINS V. Electronic Access Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The following way: Agency will review this copy, including Persons with access to the internet • Federal eRulemaking Portal: the claimed confidential information, in may obtain the draft guidances at either https://www.regulations.gov. Follow the its consideration of comments. The https://www.fda.gov/drugs/guidance- instructions for submitting comments. second copy, which will have the compliance-regulatory-information/ Comments submitted electronically, claimed confidential information guidances-drugs or https:// including attachments, to https:// redacted/blacked out, will be available www.regulations.gov. www.regulations.gov will be posted to for public viewing and posted on Dated: May 14, 2021. the docket unchanged. Because your https://www.regulations.gov. Submit Lauren K. Roth, comment will be made public, you are both copies to the Dockets Management Acting Principal Associate Commissioner for solely responsible for ensuring that your Staff. If you do not wish your name and Policy. comment does not include any contact information to be made publicly [FR Doc. 2021–10589 Filed 5–19–21; 8:45 am] confidential information that you or a available, you can provide this BILLING CODE 4164–01–P third party may not wish to be posted, information on the cover sheet and not such as medical information, your or in the body of your comments and you anyone else’s Social Security number, or must identify this information as DEPARTMENT OF HEALTH AND confidential business information, such ‘‘confidential.’’ Any information marked HUMAN SERVICES as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed that if you include your name, contact except in accordance with 21 CFR 10.20 Food and Drug Administration information, or other information that and other applicable disclosure law. For [Docket No. FDA–2008–D–0406] identifies you in the body of your more information about FDA’s posting comments, that information will be of comments to public dockets, see 80 Frequently Asked Questions— posted on https://www.regulations.gov. • FR 56469, September 18, 2015, or access Statement of Investigator (Form FDA If you want to submit a comment the information at: https:// 1572) (Revision 1); Draft Information with confidential information that you www.govinfo.gov/content/pkg/FR-2015- Sheet Guidance for Sponsors, Clinical do not wish to be made available to the 09-18/pdf/2015-23389.pdf. Investigators, and Institutional Review public, submit the comment as a Docket: For access to the docket to Boards; Availability written/paper submission and in the read background documents or the manner detailed (see ‘‘Written/Paper electronic and written/paper comments AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). HHS. received, go to https:// Written/Paper Submissions www.regulations.gov and insert the ACTION: Notice of availability. Submit written/paper submissions as docket number, found in brackets in the SUMMARY: The Food and Drug follows: heading of this document, into the Administration (FDA, Agency, or we) is • Mail/Hand Delivery/Courier (for ‘‘Search’’ box and follow the prompts announcing the availability of a draft written/paper submissions): Dockets and/or go to the Dockets Management information sheet guidance for Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, sponsors, clinical investigators, and Drug Administration, 5630 Fishers Rockville, MD 20852, 240–402–7500. institutional review boards (IRBs) Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any entitled ‘‘Frequently Asked Questions— • For written/paper comments guidance at any time (see 21 CFR Statement of Investigator (Form FDA submitted to the Dockets Management 10.115(g)(5)). 1572) (Revision 1).’’ This draft guidance Staff, FDA will post your comment, as Submit written requests for single partially revises the final information well as any attachments, except for copies of the draft guidance to the sheet guidance for sponsors, clinical information submitted, marked and Division of Drug Information, Center for investigators, and IRBs entitled identified, as confidential, if submitted Drug Evaluation and Research, Food ‘‘Frequently Asked Questions— as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New Statement of Investigator (Form FDA Instructions: All submissions received Hampshire Ave., Hillandale Building, 1572)’’ (May 2010) (the Form FDA 1572 must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– FAQ Guidance) to explain FDA’s 2008–D–0406 for ‘‘Frequently Asked 0002; or the Office of Communication, current thinking regarding waivers of Questions—Statement of Investigator Outreach and Development, Center for the signature requirement for Form FDA (Form FDA 1572) (Revision 1).’’ Biologics Evaluation and Research, 1572. This draft guidance proposes to Received comments will be placed in Food and Drug Administration, 10903 revise responses to frequently asked the docket and, except for those New Hampshire Ave., Bldg. 71, Rm. questions 10, 11, and 13 from the Form submitted as ‘‘Confidential 3128, Silver Spring, MD 20993–0002. FDA 1572 FAQ Guidance by including Submissions,’’ publicly viewable at Send one self-addressed adhesive label information regarding the waiver of the https://www.regulations.gov or at the to assist that office in processing your Form FDA 1572 signature requirement Dockets Management Staff between 9 requests. See the SUPPLEMENTARY and proposes a new section regarding a.m. and 4 p.m., Monday through INFORMATION section for electronic signature waivers. Friday, 240–402–7500. access to the draft guidance document.

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