2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry.'' The guidance document provides blood establishments that collect or process blood and blood components with recommendations for implementing a pathogen reduction device for the manufacture of pathogen-reduced blood components. The guidance, in a question-and-answer format, addresses the most frequently asked questions concerning implementation of the INTERCEPT[supreg] Blood System for Platelets and Plasma. The guidance also provides recommendations to licensed manufacturers on reporting the manufacturing changes associated with implementation of a pathogen reduction device. The guidance announced in this notice finalizes the draft document entitled ``Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry,'' dated December 2017.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADAKVEO 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.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RECARBRIO 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 drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SEVENFACT 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.

Notice is hereby given that the Office for Coastal Management, National Ocean Service, National Oceanic and Atmospheric Administration, U.S. Department of Commerce approves the revised management plans for the Lake Superior National Estuarine Research Reserve in Wisconsin and the Mission-Aransas National Estuarine Research Reserve in Texas. In accordance with applicable Federal regulations, the University of Wisconsin-Madison Division of Extension revised the Lake Superior Reserve's management plan, which replaces the plan previously approved in 2010, and the University of Texas at Austin revised the Mission-Aransas Reserve's management plan, which replaces the plan previously approved in 2015.

In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the OCC, the Board, and the FDIC (the agencies) may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. On July 22, 2021, the agencies, under the auspices of the Federal Financial Institutions Examination Council (FFIEC), requested public comment for 60 days on proposals to revise and extend for three years the Consolidated Reports of Condition and Income (Call Reports) (FFIEC 031, FFIEC 041, and FFIEC 051), which is currently an approved collection of information. The agencies requested comment on proposed changes to the instructions for reporting of deferred tax assets (DTAs) and to add a new item related to the standardized approach for counterparty credit risk (SA-CCR). The comment period for the notice has closed. The agencies are adding the new item related to SA-CCR as proposed. The agencies are deferring the proposed changes to the instructions for reporting of DTAs until a future notice, which will also provide an opportunity for additional comment on the instructions. The agencies hereby give notice of their plan to submit to OMB a request to approve the revision and extension of these information collections and again invite comment on the renewal.

The Tennessee Valley Authority (TVA) has completed an inventory of associated funerary objects in consultation with the appropriate Indian Tribes and Native Hawaiian organizations, and has determined that there is no cultural affiliation between the 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 associated funerary objects should submit a written request to the TVA. If no additional requestors come forward, transfer of control of the associated funerary objects to the Indian Tribes or Native Hawaiian organizations stated in this notice may proceed.

The McClure Archives and University Museum, University of Central Missouri, 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 object of cultural patrimony. 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 McClure Archives and University 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.

The Denver Museum of Nature & Science, 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 a sacred object and object of cultural patrimony. 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 Denver Museum of Nature & Science. 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.

The Department of Labor (DOL) is submitting this Employment and Training Administration (ETA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

The Department of Veterans Affairs (VA) is requesting information from the public to inform VA's review of access standards for furnishing hospital care, medical services and extended care services to covered veterans, for purposes of the Veterans Community Care Program (VCCP). Specifically, VA requests information regarding access standards, including but not limited to, information regarding health plans on the use of access standards for the design of health plan provider networks; referrals from network providers to out-of- network providers; the appeals process for exemptions from benefit limits to out-of-network providers; and the measurement of performance against Federal or State regulatory standards. Further, VA is requesting input on Veterans' experience with the access standards established in 2019.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 29, 2021, under section 337 of the Tariff Act of 1930, as amended, on behalf of Honeywell International Inc. of Charlotte, North Carolina; Hand Held Products, Inc. of Charlotte, North Carolina; and Metrologic Instruments, Inc. of Charlotte, North Carolina. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain barcode scanners, mobile computers with barcode scanning capabilities, scan engines, and components thereof by reason of infringement of certain claims of U.S. Patent Nos. 7,568,628 (``the '628 patent''); 7,770,799 (``the '799 patent''); 8,794,520 (``the '520 patent''); 9,576,169 (``the '169 patent''); and 10,721,429 (``the '429 patent''). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

In compliance with the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense for Personnel and Readiness announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

Pursuant to the provisions of the Privacy Act of 1974, as amended, the Department of the Interior (DOI) is issuing a public notice of its intent to create a new Privacy Act system of records titled, ``INTERIOR/DOI-92, Public Health Emergency Response Records.'' This system of records notice (SORN) describes DOI's collection, maintenance, and use of records on individuals associated with DOI efforts to respond to the Coronavirus Disease 2019 (COVID-19), a declared public health emergency, and protect the health and safety of its workforce and members of the public. This newly established system will be included in DOI's inventory of record systems.