2024 – Federal Register Recent Federal Regulation Documents

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $5,000,000, with an expected total funding of approximately $25,000,000 over a 5-year period, to Ponce Health Sciences Foundation, Inc. The award will support surveillance and research studies for endemic and emerging arboviruses in Puerto Rico.

The Bureau of Land Management (BLM) is publishing this notice of the reasons for the BLM Director's determination to reject the Governor of Wyoming's recommendations regarding the Buffalo Field Office Proposed Resource Management Plan Amendment (RMPA) and Final Supplemental Environmental Impact Statement (SEIS).

The Coast Guard is amending the current temporary safety zone in the vicinity of the Kernwood Avenue Bridge between Salem, MA and Beverly, MA. We are extending the effective period by 11 months to November 30, 2025, and are updating the enforcement schedule of the safety zone. The temporary safety zone is necessary to protect personnel, vessels, and the marine environment from potential hazards created during emergency bridge repairs. When enforced, entry of vessels or persons into this zone will be prohibited unless specifically authorized by the Captain of the Port Boston or a designated representative.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Coast Guard will enforce a safety zone for the Crescent City Countdown Club/New Year's Celebration fireworks display, from 11:30 p.m. on December 31, 2024, through 12:30 a.m. on January 1, 2025, to provide for the safety of life on the navigable waterways during this event. Our regulation for annual fireworks displays and other events in the Eighth Coast Guard District identifies this safety zone for this event on the Mississippi River in New Orleans, LA. During the enforcement period, entry into this zone is prohibited unless authorized by the Captain of the Port or a designated representative.

The Food and Drug Administration (FDA or the Agency) is requesting that any industry organizations interested in participating in the selection of a pool of nonvoting industry representatives to serve as temporary nonvoting members on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the Committee. Nominees recommended to serve as a temporary nonvoting industry representative may either be self- nominated or nominated by an industry organization. This position may be filled by representatives from different medical device areas based on expertise relevant to the topics being considered by the Committee. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VEOZAH and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

FMCSA announces that the State of Hawaii has applied for an exemption from specified portions of the commercial driver's license (CDL) skills test and entry-level driver training (EDLT) curriculum requirements. The State of Hawaii currently has a two-year exemption that expires on February 20, 2026, under which it may waive portions of the CDL skills test for CDL applicants who take the skills test on the islands of Lanai and Molokai and grant restricted CDLs to successful applicants. The State of Hawaii now requests a five-year exemption of these provisions, with the addition of an exemption from certain portions of the ELDT curriculum requirements for providers of behind- the-wheel (BTW) public road training on the islands of Lanai and Molokai. FMCSA requests public comment on the applicant's request for an exemption and whether the Agency should withdraw Hawaii's current exemption that expires on February 20, 2026, and grant a new five-year exemption from both the CDL skills test and the ELDT requirements.

Kidney and liver transplants from donors with HIV no longer require institutional review board (IRB)-approved research protocols or compliance with HHS research criteria per a November 27, 2024, final rule. Through this notice, the U.S. Department of Health and Human Services (HHS) announces the publication of this accompanying Final Revised Safeguards and Research Criteria for Transplantation of Organs from Donors with HIV to apply to non-kidney and non-liver organs from donors with HIV for transplantation in recipients with HIV. Under the HOPE Act, these transplants must still occur under an IRB-approved research protocol that is compliant with federal regulations governing human subjects' research. The goal of this research is to increase knowledge about the safety, efficacy, and effectiveness of transplants other than liver and kidney, from donors with HIV, thereby expanding access to organs for patients with HIV in need of transplants. HHS published Draft Revised Safeguards and Research Criteria on December 12, 2024. A summary of the public comments and HHS' responses follows. As explained below, NIH adopts revised research criteria as proposed except that NIH removed residual stigmatizing language from the title of the Research Criteria.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on July 29, 2024. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of August 28, 2024. The document indicated that FDA was withdrawing approval of the ANDAs 073462 for tolmetin sodium capsules, equivalent to (EQ) 400 milligrams (mg) base; 073588 for tolmetin sodium tablets, EQ 200 mg base; 074002 for tolmetin sodium tablets, EQ 600 mg base; 077040 for citalopram hydrobromide tablets, EQ 10 mg base, EQ 20 mg base; EQ 40 mg base; 085787 for trifluoperazine hydrochloride (HCl) concentrate, EQ 10 mg base/milliliters (mL); 086808 for cyproheptadine HCl tablets, 4 mg; 087774 for phenylbutazone capsules, 100 mg; and 088602 for pseudoephedrine HCl; triprolidine HCl tablets, 60 mg/2.5.mg, held by Fosun Pharma USA Inc., 104 Carnegie Center, Suite 204, Princeton, NJ 08540. Additionally, ANDAS 075631 for ketorolac tromethamine injectable, 15 mg/mL and 30 mg/mL; 076427 for milrinone lactate injectable, EQ 1 mg base/mL; 076791 for haloperidol lactate injectable, EQ 5 mg base/mL; 076828 haloperidol lactate injectable, EQ 5 mg base/ mL; 077947 for fluconazole injectable, 200 mg/100 mL (2 mg/mL) and 400 mg/200 mL (2 mg/mL); 078197 for granisetron HCl injectable, EQ 0.1 mg base/mL (EQ 0.1 mg base/mL); 091436 for levofloxacin injectable, EQ 500 mg/20 mL (EQ 25 mg/mL); 207101 for sumatriptan succinate injectable, EQ 6 mg base/0.5 mL (EQ12 mg base/mL); and 215065 for methocarbamol solution, 1gram/10 mL (100 mg/mL), held by Baxter Healthcare Corp., One Baxter Parkway, Deerfield, IL 60015; and the ANDAs 090367 for levofloxacin tablets, 250 mg, 500 mg, 750 mg; and 211959 for clobazam tablets, 10 mg and 20 mg, held by Celltrion USA, Inc., U.S. Agent for Celltrion, Inc., One Evertrust Plaza, Suite 1207, Jersey City, NJ 07302; and the ANDA 212053 for chlorzoxazone tablet, 375 mg and 750 mg, held by i3 Pharmaceuticals LLC, 200 Park Ave., Warminster, PA 18974. Before FDA withdrew the approval of these ANDAs, Fosun Pharma USA Inc.; Baxter Healthcare Corp.; Celltrion USA, Inc., U.S. Agent for Celltrion, Inc.; and i3 Pharmaceuticals LLC, 200 Park Ave., Warminster, PA 18974, informed FDA that they did not want the approval of the ANDAs withdrawn. Because Fosun Pharma USA Inc.; Baxter Healthcare Corp.; Celltrion USA, Inc., U.S. Agent for Celltrion, Inc.; and i3 Pharmaceuticals, LLC, timely requested that approval of their respective ANDAs not be withdrawn, the approvals are still in effect. This notice corrects these errors.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing Document." This draft guidance provides recommendations to sponsors regarding use and development of a combined version of the ODAC briefing document, as part of the Oncology Center of Excellence's (OCE) Project Point/Counterpoint initiative. This single document includes information that customarily would be contained in separate briefing documents prepared individually by the Sponsor and FDA. Project Point/ Counterpoint is an option for advisory committee meetings for oncology products. Sponsors in non-oncology therapeutic areas who want to discuss whether a combined advisory committee briefing document may be appropriate for their applications should contact the relevant review division. This briefing document format may provide efficiencies by allowing Sponsors and FDA to choose to use a single document that provides the views of the Sponsor and FDA on key issues.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of California, Riverside has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.

Siegfried USA, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Georgia, Laboratory of Archaeology intends to repatriate certain cultural items that meet the definition of objects of cultural patrimony and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Department of Agriculture, Forest Service, Carson National Forest (CAF), intends to carry out the disposition of objects of cultural patrimony removed from Federal or Tribal lands to the lineal descendants, Indian Tribe, or Native Hawaiian organization with priority for disposition in this notice.

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Oregon Museum of Natural and Cultural History intends to repatriate a certain cultural item that meets the definition of an object of cultural patrimony and that has a cultural affiliation with the Indian Tribes in this notice.