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Federal Register/Vol. 85, No. 161/Wednesday, August 19, 2020

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Federal Register/Vol. 85, No. 161/Wednesday, August 19, 2020 Federal Register / Vol. 85, No. 161 / Wednesday, August 19, 2020 / Rules and Regulations 50951 Docket No. FDA–2020–P–1181). This petitions, the parties have had adequate to https://www.regulations.gov will be petition (Parent petition) was routed for time and reasonable opportunity to posted for public review and are part of review and response after FDA’s March obtain a ruling from the D.C. Circuit the official docket record. However, 27, 2020, letter granting JRC’s request regarding a stay of FDA’s response to should you wish to submit written for a stay in part. Although filed by the petitions. comments through regular or express different parties, the Parent petition FDA’s partial stay is limited to those mail, they should be sent to: Robert requested the same action as the JRC devices currently in use on specific Hinchman, Senior Counsel, Office of petition and did not necessitate a individuals who have or would need to Legal Policy, U.S. Department of Justice, different response or change in the stay obtain a physician-directed transition Room 4252 RFK Building, 950 FDA granted in response to the JRC plan to cease use of such devices in Pennsylvania Avenue NW, Washington, petition. Both petitions request a stay order to comply with the final DC 20530. Comments received by mail based on all four criteria for a regulation banning ESDs. For all other will be considered timely if they are mandatory stay or, alternatively, based devices, the ban became effective on, postmarked on or before September 18, on being ‘‘in the public interest and in and required compliance by, April 6, 2020. The electronic Federal the interest of justice’’ for a 2020. eRulemaking portal will accept discretionary stay (§ 10.35 (21 CFR Dated: July 27, 2020. comments until midnight Eastern Time 10.35(e))). Because the petitions request Lowell J. Schiller, at the end of that day. the same action for substantially similar FOR FURTHER INFORMATION CONTACT: reasons, FDA has determined that its Principal Associate Commissioner for Policy. [FR Doc. 2020–16595 Filed 8–17–20; 4:15 pm] Robert Hinchman, Senior Counsel, March 27, 2020, response to the JRC Office of Legal Policy, U.S. Department BILLING CODE 4164–01–P petition is equally applicable to the of Justice, Room 4252 RFK Building, Parent petition. FDA notes that both sets 950 Pennsylvania Avenue NW, of petitioners filed legal challenges to Washington, DC 20530, telephone (202) DEPARTMENT OF JUSTICE the ban in the U.S. Court of Appeals for 514–8059 (not a toll-free number). the D.C. Circuit, which challenges have now been consolidated before that Office of the Attorney General SUPPLEMENTARY INFORMATION: court. I. Posting of Public Comments By a letter dated March 27, 2020, FDA 28 CFR Part 50 responded to the JRC petition granting Please note that all comments [Docket No. OAG 165; AG Order No. 4769– received are considered part of the in part a discretionary temporary stay. 2020] As the letter states, it is in the public public record and made available for health interest and interest of justice to Prohibition on the Issuance of public inspection online at https:// stay the compliance date for devices Improper Guidance Documents Within www.regulations.gov. Information made subject to the ban that are currently in the Justice Department available for public inspection includes use on specific individuals who would personal identifying information (such AGENCY: need to obtain a physician-directed Office of the Attorney General, as your name, address, etc.) voluntarily transition plan to cease use of such Department of Justice. submitted by the commenter. devices. The stay is in the public ACTION: Interim final rule; request for If you wish to submit personal interest and interest of justice because of comments. identifying information (such as your the ongoing national emergency caused name, address, etc.) as part of your SUMMARY: This rule codifies in the comment, but do not wish it to be by ‘‘severe acute respiratory syndrome regulations of the Department of Justice coronavirus 2’’ (SARS–CoV–2) and the posted online, you must include the (‘‘Department’’) the Memorandum for phrase ‘‘PERSONAL IDENTIFYING disease it causes ‘‘Coronavirus Disease All Components from Attorney General 2019 (COVID–19).’’ Specifically, the INFORMATION’’ in the first paragraph Jefferson B. Sessions III titled, of your comment. You must also locate creation or implementation of a ‘‘Prohibition on Improper Guidance physician-directed transition plan has all the personal identifying information Documents’’ (Nov. 16, 2017), consistent the potential to increase the risk of that you do not want posted online in with Executive Order 13891, transmission or exposure to COVID–19, the first paragraph of your comment and ‘‘Promoting the Rule of Law Through and it may divert healthcare delivery identify what information you want the Improved Agency Guidance resources from other uses during the agency to redact. Personal identifying Documents’’ (Oct. 9, 2019). pandemic. information identified and located as set The stay is intended to remain in DATES: Effective date: This rule is forth above will be placed in the effect for the duration of the public effective August 19, 2020. Comments: agency’s public docket file, but not health emergency related to COVID–19 Comments are due on or before posted online. declared by HHS, including any September 18, 2020. If you wish to submit confidential renewals made by the Secretary in ADDRESSES: To ensure proper handling business information as part of your accordance with section 319(a)(2) of the of comments, please reference Docket comment but do not wish it to be posted PHS Act (42 U.S.C. 247d(a)(2)). Once No. OAG 165 on all electronic and online, you must include the phrase the public health emergency ends, FDA written correspondence. The ‘‘CONFIDENTIAL BUSINESS will substantively respond to the Department encourages the electronic INFORMATION’’ in the first paragraph petitions, and issue another notification submission of all comments through of your comment. You must also in the Federal Register, if necessary, in https://www.regulations.gov using the prominently identify confidential accordance with § 10.35. If the public electronic comment form provided on business information to be redacted health emergency ends while the that site. For easy reference, an within the comment. If a comment has consolidated legal challenge in the D.C. electronic copy of this document is also so much confidential business Circuit is still pending, the stay will available at that website. It is not information that it cannot be effectively continue in effect until: (1) FDA necessary to submit paper comments redacted, the agency may choose not to substantively responds to the petitions that duplicate the electronic post that comment (or to post that and (2) if FDA does not grant the submission, as all comments submitted comment only partially) on https:// VerDate Sep<11>2014 15:52 Aug 18, 2020 Jkt 250001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\19AUR1.SGM 19AUR1 jbell on DSKJLSW7X2PROD with RULES 50952 Federal Register / Vol. 85, No. 161 / Wednesday, August 19, 2020 / Rules and Regulations www.regulations.gov. Confidential and regulations. But guidance may not with Executive Order 13891. The scope business information identified and be used as a substitute for rulemaking of this rulemaking is limited. The located as set forth above will not be and may not be used to impose new Department anticipates publishing a placed in the public docket file, nor will requirements on entities outside the rulemaking in the future to implement it be posted online. Executive Branch. Nor should guidance the requirements and provisions of If you wish to inspect the agency’s create binding standards by which the Executive Order 13891 that are not public docket file in person by Department will determine compliance covered by this rulemaking. appointment, please see the FOR with existing regulatory or statutory III. Regulatory Certifications FURTHER INFORMATION CONTACT requirements.’’ Id. paragraph. The Attorney General’s memorandum A. Administrative Procedure Act acknowledged that ‘‘the Department has II. Discussion This rule relates to a matter of agency in the past published guidance management or personnel and is a rule A. Attorney General Memorandum of documents—or similar instruments of of agency organization, procedure, or November 16, 2017 future effect by other names, such as practice. As such, this rule is exempt letters to regulated entities—that In a memorandum to all components from the usual requirements of prior effectively bind private parties without of the Department dated November 16, notice and comment and a 30-day delay undergoing the rulemaking process.’’ Id. 2017, then-Attorney General Jefferson B. in effective date. See 5 U.S.C. 553(a)(2), However, it stated that, going forward, Sessions III reiterated the duty of the (b)(A), (d). However, the Department is, ‘‘[t]he Department will no longer engage Department ‘‘to uphold the laws of the in its discretion, seeking public in this practice.’’ Id. Effective United States and to ensure the fair and comment on this rulemaking. immediately, the Attorney General impartial administration of justice.’’ directed Department components not to B. Regulatory Flexibility Act Memorandum for All Components, ‘‘issue guidance documents that purport ‘‘Prohibition on Improper Guidance This rule will not have an impact on to create rights or obligations binding on Documents,’’
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