Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice, 63500-63501 [2022-22700]

Download as PDF jspears on DSK121TN23PROD with NOTICES 63500 Federal Register / Vol. 87, No. 201 / Wednesday, October 19, 2022 / Notices comments, relevant information, or documents regarding the agreements to the Secretary by email at Secretary@ fmc.gov, or by mail, Federal Maritime Commission, 800 North Capitol Street, Washington, DC 20573. Comments will be most helpful to the Commission if received within 12 days of the date this notice appears in the Federal Register, and the Commission requests that comments be submitted within 7 days on agreements that request expedited review. Copies of agreements are available through the Commission’s website (www.fmc.gov) or by contacting the Office of Agreements at (202)-523– 5793 or tradeanalysis@fmc.gov. Agreement No.: 012355–002. Agreement Name: CMA CGM/SL Gulf Bridge Express Slot Charter Agreement. Parties: CMA CGM S.A.; Maersk A/S dba Sealand. Filing Party: Draughn Arbona, CMA CGM (America) LLC. Synopsis: The Amendment increases the Parties’ allocations to reflect larger capacity vessels being brought into the trade and expands the geographic scope of the Agreement to include Brazil. The Parties have requested expedited review. Proposed Effective Date: 11/27/2022. Location: https://www2.fmc.gov/ FMC.Agreements.Web/Public/ AgreementHistory/49. Agreement No.: 201334–001. Agreement Name: COSCO/ONE/ OOCL/YM EMED–USEC Vessel Sharing Agreement. Parties: CMA CGM S.A.; COSCO SHIPPING Lines Co., Ltd; Ocean Network Express Pte. Ltd.; and Orient Overseas Container Line Limited; OOCL (Europe) Limited. Filing Party: Robert Magovern, Cozen O’Connor. Synopsis: The Amendment renames the agreement to the COSCO/ONE/ OOCL/CMA CGM EMED–USEC Vessel Sharing Agreement. The Amendment deletes Yang Ming Marine Transport Corp., Yang Ming (UK) Ltd., Yang Ming (Singapore) Pte. Ltd. as parties to the agreement and adds CMA CGM S.A. as a party to the agreement. The Amendment also removes Israel from the scope; revises the agreement to update the BSAs for each of the parties; and updates the duration and resignation section of the agreement. Proposed Effective Date: 11/24/2022. Location: https://www2.fmc.gov/ FMC.Agreements.Web/Public/ AgreementHistory/27479. Agreement No.: 201393. Agreement Name: CMA CGM/COSCO Vessel Sharing Agreement Mediterranean—U.S. Gulf & East Coast. VerDate Sep<11>2014 17:58 Oct 18, 2022 Jkt 259001 Parties: CMA CGM S.A.; COSCO SHIPPING Lines Co., Ltd. Filing Party: Draughn Arbona, CMA CGM (America) LLC. Synopsis: The Agreement authorizes CMA CGM and COSCO to share vessels with one another and cooperate on a liner service in the trade between Italy, France, Spain, and Morocco on the one hand and the U.S. Gulf Coast and East Coast on the other hand. Proposed Effective Date: 11/24/2022. Location: https://www2.fmc.gov/ FMC.Agreements.Web/Public/ AgreementHistory/69503. Dated: October 14, 2022. William Cody, Secretary. [FR Doc. 2022–22709 Filed 10–18–22; 8:45 am] BILLING CODE 6730–02–P FEDERAL MARITIME COMMISSION [Docket No. 22–27] Globerunners, Incorporated, Complainant v. Hoyer Global (USA), Inc., Respondent; Notice of Filing of Complaint and Assignment Served: October 14, 2022. Notice is given that a complaint has been filed with the Federal Maritime Commission (Commission) by Globerunners, Incorporated, hereinafter ‘‘Complainant,’’ against Hoyer Global (USA), Inc., hereinafter ‘‘Respondent.’’ Complainant states that it is a nonvessel-operating common carrier that is a corporation organized under the laws of California. Complainant identifies the Respondent as a non-vessel-operating common carrier that is a corporation organized under the laws of Texas. Complainant alleges that Respondent violated 46 U.S.C. 41102(c) and 41104(a)(14) and 46 CFR 532.5(d)(2)(iv) in its practices and pass-through of charges. The full text of the complaint can be found in the Commission’s Electronic Reading Room at https:// www2.fmc.gov/readingroom/ proceeding/22-27/. This proceeding has been assigned to Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by October 14, 2023, and the final decision of the Commission shall be issued by April 29, 2024. William Cody, Secretary. [FR Doc. 2022–22707 Filed 10–18–22; 8:45 am] BILLING CODE 6730–02–P PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–2107] Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pulmonary-Allergy Drugs Advisory Committee. This meeting was announced in the Federal Register of September 8, 2022. The amendment is being made to reflect changes in the DATES, ADDRESSES, and SUPPLEMENTARY INFORMATION portions of the document. The meeting was rescheduled to allow time for FDA to review new information submitted to the application. There are no other changes. FOR FURTHER INFORMATION CONTACT: Takyiah Stevenson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 240– 402–2507, email: PADAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. SUMMARY: In the Federal Register of September 8, 2022, 87 FR 55008, FDA announced that a meeting of the Pulmonary-Allergy Drugs Advisory Committee would be held on October 6, 2022. The following changes are being made. (1) On page 55008, in the third column, the DATES portion of the document is changed to read as follows: DATES: The meeting will be held virtually on November 9, 2022, from 9 a.m. to 5 p.m. Eastern Time. (2) On page 55008, in the third column, the second paragraph and the first sentence of the third paragraph of the ADDRESSES portion of the document are changed to read as follows: FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2022–N–2107. Please note that late, untimely filed comments will not be considered. The docket will close on November 8, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 8, 2022. SUPPLEMENTARY INFORMATION: E:\FR\FM\19OCN1.SGM 19OCN1 Federal Register / Vol. 87, No. 201 / Wednesday, October 19, 2022 / Notices Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. Comments received on or before October 26, 2022, will be provided to the committee. (3) On page 55009, in the third column, the first paragraph of the Procedure section of the SUPPLEMENTARY INFORMATION portion of the document is changed to read as follows: Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before October 26, 2022, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 26, 2022. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 27, 2022. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: October 14, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–22700 Filed 10–18–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration jspears on DSK121TN23PROD with NOTICES [Docket No. FDA–2021–D–1246] Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:58 Oct 18, 2022 Jkt 259001 ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GIF) 258 entitled ‘‘Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds.’’ Tracers are ingredients added to animal food, medicated feed, and Type A medicated articles to identify a particular product. The purpose of this document is to provide guidance on the use of tracers in animal food, medicated feeds, and Type A medicated articles. This final guidance replaces Compliance Policy Guide (CPG) Sec. 680.100 ‘‘Tracers in Animal Feed.’’ DATES: The announcement of the guidance is published in the Federal Register on October 19, 2022. ADDRESSES: You may submit either electronic or written comments on any Agency guidances at any time as follows: SUMMARY: 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 63501 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– 2021–D–1246 for ‘‘Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds.’’ 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-201509-18/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 Policy and E:\FR\FM\19OCN1.SGM 19OCN1

Agencies

[Federal Register Volume 87, Number 201 (Wednesday, October 19, 2022)]
[Notices]
[Pages 63500-63501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2107]


Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Pulmonary-Allergy Drugs 
Advisory Committee. This meeting was announced in the Federal Register 
of September 8, 2022. The amendment is being made to reflect changes in 
the DATES, ADDRESSES, and SUPPLEMENTARY INFORMATION portions of the 
document. The meeting was rescheduled to allow time for FDA to review 
new information submitted to the application. There are no other 
changes.

FOR FURTHER INFORMATION CONTACT: Takyiah Stevenson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-2507, email: [email protected], or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). Please call the Information Line for up-to-date information on 
this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 8, 
2022, 87 FR 55008, FDA announced that a meeting of the Pulmonary-
Allergy Drugs Advisory Committee would be held on October 6, 2022. The 
following changes are being made.
    (1) On page 55008, in the third column, the DATES portion of the 
document is changed to read as follows:

    DATES: The meeting will be held virtually on November 9, 2022, from 
9 a.m. to 5 p.m. Eastern Time.

    (2) On page 55008, in the third column, the second paragraph and 
the first sentence of the third paragraph of the ADDRESSES portion of 
the document are changed to read as follows:
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2022-N-2107. Please note that late, untimely 
filed comments will not be considered. The docket will close on 
November 8, 2022. The https://www.regulations.gov electronic filing 
system will accept comments until 11:59 p.m. Eastern Time at the end of 
November 8, 2022.

[[Page 63501]]

Comments received by mail/hand delivery/courier (for written/paper 
submissions) will be considered timely if they are received on or 
before that date.
    Comments received on or before October 26, 2022, will be provided 
to the committee.
    (3) On page 55009, in the third column, the first paragraph of the 
Procedure section of the SUPPLEMENTARY INFORMATION portion of the 
document is changed to read as follows:
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
All electronic and written submissions submitted to the Docket (see 
ADDRESSES) on or before October 26, 2022, will be provided to the 
committee. Oral presentations from the public will be scheduled between 
approximately 1:30 p.m. and 2:30 p.m. Eastern Time. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before October 26, 2022. 
Time allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by October 27, 2022.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22700 Filed 10-18-22; 8:45 am]
BILLING CODE 4164-01-P

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