Results 51 - 100 of 424,769
Notice of Public Meeting of the Connecticut Advisory Committee
Document Number: 2018-22615
Type: Notice
Date: 2018-10-17
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a meeting of the Connecticut Advisory Committee to the Commission will convene by conference call at 12:00 p.m. (EST) on Wednesday, November 14, 2018. The purpose of the meeting is project planning and decision- making on next steps.
Agenda and Notice of Public Meeting of the Colorado Advisory Committee
Document Number: 2018-22614
Type: Notice
Date: 2018-10-17
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA) that a meeting of the Colorado Advisory Committee to the Commission will convene by conference call at 2:00 p.m. (MDT) on Friday, November 2, 2018. The purpose of the meeting is for project planning.
Commission Information Collection Activities (FERC-725G); Comment Request; Extension
Document Number: 2018-22611
Type: Notice
Date: 2018-10-17
Agency: Department of Energy, Federal Energy Regulatory Commission
In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC-725G (Reliability Standards for the Bulk Power System: PRC Reliability Standards, OMB Control No. 1902-0252). As part of this extension request, FERC will transfer the information collection requirements and burden of the FERC-725G1 (OMB Control No. 1902-0284) and FERC-725G4 (OMB Control No. 1902-0282) into FERC-725G. FERC-725G1 and FERC-725G4 information collections will eventually be discontinued.
Request for Public Comment on a Commercial Availability Request Under the U.S.-Korea Free Trade Agreement
Document Number: 2018-22610
Type: Notice
Date: 2018-10-17
Agency: Committee for the Implementation of Textile Agreements, Agencies and Commissions
The Government of the United States received a request from the Government of Korea, submitted on September 24, 2018, to initiate consultations under the KORUS. The Government of Korea is requesting that the United States and Korea (``the Parties'') consider revising the rules of origin for certain yarns, woven fabrics, and knit apparel to address availability of supply of fibers and yarns in the territories of the Parties. The President of the United States may proclaim a modification to the KORUS rules of origin for textile and apparel products after the United States reaches an agreement with the Government of Korea on a modification under the KORUS to address issues of availability of supply of fibers, yarns, or fabrics in the territories of the Parties. CITA hereby solicits public comments on this request, in particular with regard to whether certain fibers, yarns, and knit fabrics can be supplied by the U.S. domestic industry in commercial quantities in a timely manner.
Virginia Electric and Power Company; Notice of Filing
Document Number: 2018-22607
Type: Notice
Date: 2018-10-17
Agency: Department of Energy, Federal Energy Regulatory Commission
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to In-Water Demolition and Construction Activities Associated With a Harbor Improvement Project in Statter Harbor, Alaska
Document Number: 2018-22604
Type: Notice
Date: 2018-10-17
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS has received a request from the City of Juneau for authorization to take marine mammals incidental to harbor improvement projects in Statter Harbor, Alaska. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-year renewal that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorizations and agency responses will be summarized in the final notice of our decision.
Notice of Inventory Completion: Princeton University, Princeton, NJ
Document Number: 2018-22602
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
Princeton University has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and associated funerary objects and any present-day Indian Tribes or Native Hawaiian organizations. Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to Princeton University. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the Indian Tribes or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: University of California, Davis, Davis, CA, and U.S. Bureau of Reclamation, Mid-Pacific Region, Sacramento, CA
Document Number: 2018-22601
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The University of California, Davis (UC Davis) and U.S. Bureau of Reclamation (Reclamation), Mid-Pacific Region, Sacramento, CA, has completed an inventory of human remains and associated funerary objects in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present- day Indian tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to UC Davis and Reclamation. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Arizona State Museum, University of Arizona, Tucson, AZ
Document Number: 2018-22600
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The Arizona State Museum, University of Arizona, has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present- day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Arizona State Museum, University of Arizona. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Intent To Repatriate Cultural Items: Arizona State Parks and Trails, Phoenix, AZ, and Arizona State Museum, University of Arizona, Tucson, AZ
Document Number: 2018-22599
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The Arizona State Parks and Trails and the Arizona State Museum, University of Arizona, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, have determined that the cultural item listed in this notice meets the definition of unassociated funerary object. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request to the Arizona State Museum. If no additional claimants come forward, transfer of control of the cultural item to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Intent To Repatriate Cultural Items: Arizona State Museum, University of Arizona, Tucson, AZ
Document Number: 2018-22598
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The Arizona State Museum, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural items listed in this notice meet the definition of unassociated funerary objects. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request to the Arizona State Museum. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Arizona State Museum, University of Arizona, Tucson, AZ
Document Number: 2018-22597
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The Arizona State Museum, University of Arizona, has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present- day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Arizona State Museum, University of Arizona. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Arizona State Parks and Trails, Phoenix, AZ, and Arizona State Museum, University of Arizona, Tucson, AZ
Document Number: 2018-22596
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The Arizona State Parks and Trails and the Arizona State Museum, University of Arizona, have completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and have determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Arizona State Museum, University of Arizona. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Intent To Repatriate Cultural Items: Arizona State Museum, University of Arizona, Tucson, AZ; Correction
Document Number: 2018-22595
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The Arizona State Museum, University of Arizona has corrected a Notice of Intent To Repatriate published in the Federal Register on September 10, 2014. This notice corrects the number of unassociated funerary objects. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request to the Arizona State Museum, University of Arizona. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Arizona State Museum, University of Arizona, Tucson, AZ; Correction
Document Number: 2018-22594
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The Arizona State Museum, University of Arizona has corrected an inventory of human remains and associated funerary objects, published in a Notice of Inventory Completion in the Federal Register on September 10, 2014. This notice corrects the number of associated funerary objects. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Arizona State Museum, University of Arizona. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: History Colorado, Formerly Colorado Historical Society, Denver, CO
Document Number: 2018-22593
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
History Colorado, formerly Colorado Historical Society, has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and any present-day Indian Tribes or Native Hawaiian organizations. Representatives of any Indian Tribe Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to History Colorado. If no additional requestors come forward, transfer of control of the human remains to the Indian Tribes or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Sam Noble Oklahoma Museum of Natural History, Norman, OK
Document Number: 2018-22592
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The Sam Noble Oklahoma Museum of Natural History at the University of Oklahoma has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Sam Noble Oklahoma Museum of Natural History. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: California Department of Parks and Recreation, Sacramento, CA
Document Number: 2018-22591
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The California Department of Parks and Recreation has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the California Department of Parks and Recreation. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: California Department of Parks and Recreation, Sacramento, CA
Document Number: 2018-22590
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The California Department of Parks and Recreation has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the California Department of Parks and Recreation. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Carter County Museum, Ekalaka, MT
Document Number: 2018-22589
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The Carter County Museum has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Carter County Museum. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Intent To Repatriate Cultural Items: Sternberg Museum of Natural History, Hays, KS
Document Number: 2018-22588
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The Sternberg Museum of Natural History, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural item listed in this notice meets the definition of an unassociated funerary object. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request to the Sternberg Museum of Natural History. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Sternberg Museum of Natural History, Hays, KS
Document Number: 2018-22587
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The Sternberg Museum of Natural History has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present- day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Sternberg Museum of Natural History. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: U.S. Department of Defense, Army Corps of Engineers, Nashville District, Nashville, TN; Correction
Document Number: 2018-22586
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The U.S. Army Corps of Engineers, Nashville District (USACE), has corrected an inventory of human remains and associated funerary objects, published in a Notice of Inventory Completion in the Federal Register on August 8, 2017. This notice corrects the minimum number of individuals and the number of associated funerary objects.
Notice of Inventory Completion: The University of Oregon Museum of Natural and Cultural History, Eugene, OR
Document Number: 2018-22585
Type: Notice
Date: 2018-10-17
Agency: Department of the Interior, National Park Service
The University of Oregon Museum of Natural and Cultural History has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the University of Oregon Museum of Natural and Cultural History. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Isachi Gil; Denial of Hearing; Final Debarment Order
Document Number: 2018-22581
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is denying Isachi Gil's (Gil's) request for a hearing and issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Gil for 6 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Gil was convicted of 12 felonies under Federal Law involving fraud or falsification and that Gil has demonstrated a pattern of conduct sufficient to find that there is reason to believe she may violate requirements under the FD&C Act relating to drug products. In determining the appropriateness and period of Gil's debarment, FDA considered the relevant factors listed in the FD&C Act. Gil failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Corporation for Travel Promotion Board of Directors
Document Number: 2018-22580
Type: Notice
Date: 2018-10-17
Agency: Department of Commerce, International Trade Administration
The Department of Commerce is again seeking applications from travel and tourism leaders from specific industries for membership on the Board of Directors (Board) of the Corporation for Travel Promotion (doing business as Brand USA). The purpose of the Board is to guide the Corporation for Travel Promotion on matters relating to the promotion of the United States as a travel destination and communication of travel facilitation issues, among other tasks. On July 19, 2018, the Department published in the Federal Register a ``Notice of an opportunity for travel and tourism industry leaders to apply for membership on the Board of Directors of the Corporation for Travel Promotion'' (83 FR 34112), announcing membership opportunities on the Board of Directors of the Corporation for Travel Promotion. The application period closed on August 17, 2018. The Department is now reopening the application period to solicit additional applications. This notice supplements the notice of July 19, 2018. Interested parties who have already applied in response to that Federal Register notice do not need to re-apply.
Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Continuation of the Antidumping Duty Order
Document Number: 2018-22579
Type: Notice
Date: 2018-10-17
Agency: Department of Commerce, International Trade Administration
As a result of the determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC) that revocation of the antidumping duty order on tapered roller bearings and parts thereof, finished and unfinished (TRBs), from the People's Republic of China (China) would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, Commerce is publishing a notice of continuation of the antidumping duty order.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007
Document Number: 2018-22578
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the guidance for industry entitled ``Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.''
Mattresses From the People's Republic of China: Initiation of Less-Than-Fair-Value Investigation
Document Number: 2018-22577
Type: Notice
Date: 2018-10-17
Agency: Department of Commerce, International Trade Administration
Proposed Information Collection; Comment Request; Estimating Economic Burden of Vibrio parahaemolyticus in Washington State Aquaculture
Document Number: 2018-22574
Type: Notice
Date: 2018-10-17
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Submission for OMB Review; Comment Request
Document Number: 2018-22573
Type: Notice
Date: 2018-10-17
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; TREMFYA
Document Number: 2018-22571
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TREMFYA 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 biological product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of an Accelerated Approval Disclosure
Document Number: 2018-22570
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Experimental Study of an Accelerated Approval Disclosure.'' This study will examine the presence, wording, and prominence of a disclosure communicating information related to the drug's accelerated approval in direct-to- consumer (DTC) promotional materials.
Agency Information Collection Activities; Proposed Collection; Comment Request; Physician Interpretation of Information About Prescription Drugs in Scientific Publications Versus Promotional Pieces
Document Number: 2018-22569
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces.'' This study will examine important public health issues in professionally directed prescription drug print promotion.
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements; Draft Guidance for Industry; Availability
Document Number: 2018-22568
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.'' This draft guidance provides recommendations for presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements for prescription human drugs and biological products and prescription animal drugs and in DTC promotional labeling for over-the- counter (OTC) animal drugs (collectively promotional materials). FDA is issuing this draft guidance to describe the Agency's recommendations for how manufacturers, distributers, and packers (collectively firms) that include quantitative efficacy or risk information about their drugs in DTC promotional materials can make the language and presentation more consumer-friendly.
Agency Information Collection Activities; Proposed Collection; Comment Request; Disease Awareness and Prescription Drug Promotion on Television
Document Number: 2018-22567
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Disease Awareness and Prescription Drug Promotion on Television.''
Determination of Regulatory Review Period for Purposes of Patent Extension; DUPIXENT
Document Number: 2018-22566
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DUPIXENT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 biological product.
Oncology Center of Excellence: Pediatric Oncology Program; Establishment of a Public Docket; Request for Comments
Document Number: 2018-22565
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Oncology Center of Excellence (OCE) Pediatric Oncology Program of the Food and Drug Administration (FDA or the Agency) announces the creation of a list of molecular targets that have been determined to be substantially relevant to the growth or progression of a pediatric cancer (Candidate Pediatric Molecular Target List) and a list of molecular targets of new cancer drugs and biological products in development for which requirements for studies in pediatric cancers would be automatically waived. The former list includes molecular targets for which prevailing evidence and/or a scientific rationale exists to determine their potential relevance to the growth or progression of one or more pediatric cancers. The latter list details those targets that are unlikely to be associated with the growth or progression of pediatric cancers such that statutory requirements for early pediatric evaluation would be waived. These lists fulfill one of FDA's obligations under the FDA Reauthorization Act of 2017 (FDARA) and provide information to industry in planning for initial pediatric study plan submissions for certain oncology drugs or biological products in accordance with the amended provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is establishing this docket for public comment on possible additions to or deletions from the list on the lists described above. The lists can be found on the Oncology Center of Excellence: Pediatric Oncology website at the following link: https://www.fda.gov/ AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE / ucm544641.htm.
Net Worth, Asset Transfers, and Income Exclusions for Needs-Based Benefits
Document Number: 2018-22564
Type: Rule
Date: 2018-10-17
Agency: Department of Veterans Affairs
On September 18, 2018, the Department of Veterans Affairs (VA) published a final rule amending its regulations governing veterans' eligibility for VA pensions and other needs-based benefit programs. The final rule contained some errors in its preamble and in one amendment to the CFR. This document corrects those errors.
Petition for Waiver of Compliance; Docket Number FRA-2018-0076
Document Number: 2018-22563
Type: Notice
Date: 2018-10-17
Agency: Federal Railroad Administration, Department of Transportation
Petition for Waiver of Compliance; Docket Number FRA-2018-0072
Document Number: 2018-22562
Type: Notice
Date: 2018-10-17
Agency: Federal Railroad Administration, Department of Transportation
Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC); Notice of Charter Renewal
Document Number: 2018-22561
Type: Notice
Date: 2018-10-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through September 12, 2020.