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patient-related topics. The Committee receiving the highest number of votes DEPARTMENT OF HEALTH AND will provide relevant skills and ordinarily will be selected to serve as HUMAN SERVICES perspectives to improve communication the member representing consumer of benefits, risks, and clinical outcomes interests for that particular advisory Food and Drug Administration and increase integration of patient committee or panel. [Docket No. FDA–2007–D–0369] perspectives into the regulatory process IV. Nomination Procedures for medical devices. The Committee will Product-Specific Guidances; Draft and perform its duties by discussing and Any interested person or organization Revised Draft Guidances for Industry; providing advice and recommendation nominate one or more qualified Availability in ways such as identifying new persons to represent consumer interests AGENCY: Food and Drug Administration, approaches, promoting innovation, on the Agency’s advisory committees or HHS. recognizing unforeseen risks or barriers, panels. Self-nominations are also and identifying unintended accepted. Nominations must include a ACTION: Notice of availability. consequences that could result from current, complete re´sume´ or curriculum SUMMARY: The Food and Drug FDA policy. vitae for each nominee and a signed Administration (FDA or Agency) is II. Criteria for Members copy of the Acknowledgement and announcing the availability of Consent form available at the FDA additional draft and revised draft Persons nominated for membership as Advisory Nomination Portal (see consumer representatives on product-specific guidances. The ADDRESSES section of this document), committees or panels should meet the guidances provide product-specific and a list of consumer or community- recommendations on, among other following criteria: (1) Demonstrate an based organizations for which the affiliation with and/or active things, the design of bioequivalence candidate can demonstrate active participation in consumer or (BE) studies to support abbreviated new participation. community-based organizations, (2) be drug applications (ANDAs). In the able to analyze technical data, (3) Nominations must also specify the Federal Register of 11, 2010, FDA understand research design, (4) discuss advisory committee(s) or panel(s) for announced the availability of a guidance benefits and risks, and (5) evaluate the which the nominee is recommended. In for industry entitled ‘‘Bioequivalence safety and efficacy of products under addition, nominations must also Recommendations for Specific review. The consumer representative acknowledge that the nominee is aware Products’’ that explained the process should be able to represent the of the nomination unless self- that would be used to make product- consumer perspective on issues and nominated. FDA will ask potential specific guidances available to the actions before the advisory committee; candidates to provide detailed public on FDA’s website. The guidances serve as a liaison between the information concerning such matters as identified in this notice were developed committee and interested consumers, financial holdings, employment, and using the process described in that associations, coalitions, and consumer research grants and/or contracts to guidance. organizations; and facilitate dialogue permit evaluation of possible sources of DATES: Submit either electronic or with the advisory committees on conflicts of interest. Members will be written comments on the draft scientific issues that affect consumers. invited to serve for terms of up to 4 guidances by , 2021 to ensure years. that the Agency considers your III. Selection Procedures FDA will review all nominations comment on these draft guidances Selection of members representing received within the specified before it begins work on the final consumer interests is conducted timeframes and prepare a ballot versions of the guidances. through procedures that include the use containing the names of qualified ADDRESSES: You may submit comments of organizations representing the public nominees. Names not selected will on any guidance at any time as follows: interest and public advocacy groups. remain on a list of eligible nominees These organizations recommend and be reviewed periodically by FDA to Electronic Submissions nominees for the Agency’s selection. determine continued interest. Upon Submit electronic comments in the Representatives from the consumer selecting qualified nominees for the following way: health branches of Federal, State, and ballot, FDA will provide those • Federal eRulemaking Portal: local governments also may participate consumer organizations that are https://www.regulations.gov. Follow the in the selection process. Any consumer participating in the selection process instructions for submitting comments. organization interested in participating with the opportunity to vote on the Comments submitted electronically, in the selection of an appropriate voting listed nominees. Only organizations including attachments, to https:// or nonvoting member to represent vote in the selection process. Persons www.regulations.gov will be posted to consumer interests should send a letter who nominate themselves to serve as the docket unchanged. Because your stating that interest to FDA (see voting or nonvoting consumer comment will be made public, you are ADDRESSES) within 30 days of representatives will not participate in solely responsible for ensuring that your publication of this document. the selection process. comment does not include any Within the subsequent 30 days, FDA This notice is issued under the confidential information that you or a will compile a list of consumer Federal Advisory Committee Act (5 third party may not wish to be posted, organizations that will participate in the U.S.C. app. 2) and 21 CFR part 14, such as medical information, your or selection process and will forward to relating to advisory committees. anyone else’s Social Security number, or each such organization a ballot listing at confidential business information, such least two qualified nominees selected by Dated: , 2021. as a manufacturing process. Please note the Agency based on the nominations Lauren K. Roth, that if you include your name, contact received, together with each nominee’s Acting Principal Associate Commissioner for information, or other information that current curriculum vitae or re´sume´. Policy. identifies you in the body of your Ballots are to be filled out and returned [FR Doc. 2021–06206 Filed 3–24–21; 8:45 am] comments, that information will be to FDA within 30 days. The nominee BILLING CODE 4164–01–P 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 19, 2020. 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: and/or go to the Dockets Management • Mail/Hand Delivery/Courier (for industry for drug products containing 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 Drug Administration, 5630 Fishers TABLE 1—NEW DRAFT PRODUCT-SPE- 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 Drug Evaluation and Research, Food information submitted, marked and Bremelanotide acetate. and Drug Administration, 10001 New Calcifediol. identified, as confidential, if submitted Hampshire Ave., Hillandale Building, Cysteamine bitartrate. as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– Degarelix acetate. Instructions: All submissions received Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor. must include the Docket No. FDA– 0002. Send one self-addressed adhesive label to assist that office in processing Entrectinib. 2007–D–0369 for ‘‘Product-Specific Ethinyl estradiol; levonorgestrel (multiple ref- your requests. See the SUPPLEMENTARY Guidances; Draft and Revised Draft erenced listed drugs). Guidances for Industry.’’ Received INFORMATION section for electronic Fedratinib hydrochloride. comments will be placed in the docket access to the draft guidance documents. Ferric maltol. and, except for those submitted as FOR FURTHER INFORMATION CONTACT: Kris Guanfacine hydrochloride. ‘‘Confidential Submissions,’’ publicly Andre, Center for Drug Evaluation and Istradefylline. viewable at https://www.regulations.gov Research, Food and Drug Ledipasvir; Sofosbuvir. or at the Dockets Management Staff Administration, 10903 New Hampshire Monomethyl fumarate. Ave., Bldg. 75, Rm. 4728, Silver Spring, Octreotide acetate (multiple referenced listed between 9 a.m. and 4 p.m., Monday drugs). through Friday, 240–402–7500. MD 20993–0002, 240–402–7959. • Penicillin G benzathine. Confidential Submissions—To SUPPLEMENTARY INFORMATION: Selinexor. submit a comment with confidential I. Background Siponimod fumaric acid. information that you do not wish to be Sofosbuvir. made publicly available, submit your In the Federal Register of , Solriamfetol hydrochloride. comments only as a written/paper 2010 (75 FR 33311), FDA announced the Testosterone undecanoate. submission. You should submit two availability of a guidance for industry copies total. One copy will include the entitled ‘‘Bioequivalence III. Drug Products For Which Revised information you claim to be confidential Recommendations for Specific Draft Product-Specific Guidances Are with a heading or cover note that states Products’’ that explained the process Available ‘‘THIS DOCUMENT CONTAINS that would be used to make product- CONFIDENTIAL INFORMATION.’’ The specific guidances available to the FDA is announcing the availability of Agency will review this copy, including public on FDA’s website at https:// revised draft product-specific guidances the claimed confidential information, in www.fda.gov/Drugs/ for industry for drug products its consideration of comments. The GuidanceCompliance containing the following active second copy, which will have the RegulatoryInformation/Guidances/ ingredients: claimed confidential information default.htm. redacted/blacked out, will be available As described in that guidance, FDA TABLE 2—REVISED DRAFT PRODUCT- for public viewing and posted on adopted this process as a means to SPECIFIC GUIDANCES FOR DRUG https://www.regulations.gov. Submit develop and disseminate product- PRODUCTS both copies to the Dockets Management specific guidances and provide a Staff. If you do not wish your name and meaningful opportunity for the public to Active ingredient(s) contact information to be made publicly consider and comment on those available, you can provide this guidances. Under that process, draft Cannabidiol. Ciclesonide. information on the cover sheet and not guidances are posted on FDA’s website Doxycycline hyclate. in the body of your comments and you and announced periodically in the Fenoprofen calcium. must identify this information as Federal Register. The public is Ipratropium bromide. ‘‘confidential.’’ Any information marked encouraged to submit comments on Ivacaftor; Ivacaftor, Tezacaftor. as ‘‘confidential’’ will not be disclosed those recommendations within 60 days Labetalol hydrochloride. except in accordance with 21 CFR 10.20 of their announcement in the Federal Nitazoxanide (multiple referenced listed and other applicable disclosure law. For Register. FDA considers any comments drugs). more information about FDA’s posting received and either publishes final Pazopanib hydrochloride. of comments to public dockets, see 80 guidances or publishes revised draft Regorafenib. Rucaparib camsylate. FR 56469, 18, 2015, or access guidances for comment. Guidances were Ursodiol (multiple referenced listed drugs). the information at: https:// last announced in the Federal Register

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For a complete history of previously patent which claims that medical • Mail/Hand Delivery/Courier (for published Federal Register notices device. written/paper submissions): Dockets related to product-specific guidances, go Management Staff (HFA–305), Food and DATES: Anyone with knowledge that any to https://www.regulations.gov and Drug Administration, 5630 Fishers of the dates as published (see enter Docket No. FDA–2007–D–0369. Lane, Rm. 1061, Rockville, MD 20852. SUPPLEMENTARY INFORMATION) are These draft guidances are being • For written/paper comments incorrect may submit either electronic issued consistent with FDA’s good submitted to the Dockets Management or written comments and ask for a guidance practices regulation (21 CFR Staff, FDA will post your comment, as redetermination by May 24, 2021. 10.115). These draft guidances, when well as any attachments, except for Furthermore, any interested person may finalized, will represent the current information submitted, marked and petition FDA for a determination thinking of FDA on, among other things, identified, as confidential, if submitted regarding whether the applicant for the product-specific design of BE as detailed in ‘‘Instructions.’’ extension acted with due diligence studies to support ANDAs. They do not Instructions: All submissions received during the regulatory review period by establish any rights for any person and must include the Docket Nos. FDA– , 2021. See ‘‘Petitions’’ in are not binding on FDA or the public. 2020–E–1269, FDA–2020–E–1273, and the SUPPLEMENTARY INFORMATION section You can use an alternative approach if FDA–2020–E–1272 for ‘‘Determination for more information. it satisfies the requirements of the of Regulatory Review Period for applicable statutes and regulations. ADDRESSES: You may submit comments Purposes of Patent Extension; as follows. Please note that late, BAROSTIM NEO.’’ Received comments, IV. Paperwork Reduction Act of 1995 untimely filed comments will not be those filed in a timely manner (see FDA tentatively concludes that these considered. Electronic comments must ADDRESSES), will be placed in the docket draft guidances contain no collection of be submitted on or before May 24, 2021. and, except for those submitted as information. Therefore, clearance by the The https://www.regulations.gov ‘‘Confidential Submissions,’’ publicly Office of Management and Budget under electronic filing system will accept viewable at https://www.regulations.gov the Paperwork Reduction Act of 1995 is comments until 11:59 p.m. Eastern Time or at the Dockets Management Staff not required. at the end of May 24, 2021. Comments between 9 a.m. and 4 p.m., Monday received by mail/hand delivery/courier through Friday, 240–402–7500. V. Electronic Access • (for written/paper submissions) will be Confidential Submissions—To Persons with access to the internet considered timely if they are submit a comment with confidential may obtain the draft guidances at either postmarked or the delivery service information that you do not wish to be https://www.fda.gov/drugs/guidance- acceptance receipt is on or before that made publicly available, submit your compliance-regulatory-information/ date. comments only as a written/paper guidances-drugs or https:// submission. You should submit two www.regulations.gov. Electronic Submissions copies total. One copy will include the information you claim to be confidential Submit electronic comments in the Dated: March 22, 2021. with a heading or cover note that states Lauren K. Roth, following way: • ‘‘THIS DOCUMENT CONTAINS Acting Principal Associate Commissioner for Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The Policy. https://www.regulations.gov. Follow the Agency will review this copy, including [FR Doc. 2021–06202 Filed 3–24–21; 8:45 am] instructions for submitting comments. the claimed confidential information, in Comments submitted electronically, BILLING CODE 4164–01–P its consideration of comments. The including attachments, to https:// second copy, which will have the www.regulations.gov will be posted to claimed confidential information DEPARTMENT OF HEALTH AND the docket unchanged. Because your redacted/blacked out, will be available HUMAN SERVICES comment will be made public, you are for public viewing and posted on solely responsible for ensuring that your https://www.regulations.gov. Submit Food and Drug Administration comment does not include any both copies to the Dockets Management confidential information that you or a Staff. If you do not wish your name and [Docket Nos. FDA–2020–E–1269, FDA– third party may not wish to be posted, contact information to be made publicly 2020–E–1273, and FDA–2020–E–1272] such as medical information, your or available, you can provide this anyone else’s Social Security number, or Determination of Regulatory Review information on the cover sheet and not confidential business information, such in the body of your comments and you Period for Purposes of Patent as a manufacturing process. Please note Extension; BAROSTIM NEO must identify this information as that if you include your name, contact ‘‘confidential.’’ Any information marked AGENCY: Food and Drug Administration, information, or other information that as ‘‘confidential’’ will not be disclosed HHS. identifies you in the body of your except in accordance with § 10.20 (21 comments, that information will be ACTION: Notice. CFR 10.20) and other applicable posted on https://www.regulations.gov. disclosure law. For more information SUMMARY: The Food and Drug • If you want to submit a comment about FDA’s posting of comments to Administration (FDA or the Agency) has with confidential information that you public dockets, see 80 FR 56469, determined the regulatory review period do not wish to be made available to the , 2015, or access the for BAROSTIM NEO and is publishing public, submit the comment as a information at: https:// this notice of that determination as written/paper submission and in the www.govinfo.gov/content/pkg/FR-2015- required by law. FDA has made the manner detailed (see ‘‘Written/Paper 09-18/pdf/2015-23389.pdf. determination because of the Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to submission of an application to the read background documents or the Written/Paper Submissions Director of the U.S. Patent and electronic and written/paper comments Trademark Office (USPTO), Department Submit written/paper submissions as received, go to https:// of Commerce, for the extension of a follows: www.regulations.gov and insert the

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