August 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Evaluating Cancer Drugs in Patients with Central Nervous System Metastases.'' This draft guidance document provides recommendations regarding the design of clinical trials of drugs and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS. The draft guidance includes study design recommendations regarding the patient population, available therapy, prior therapies, assessment of CNS disease, study endpoints, and leptomeningeal disease.

This serves as notice of a virtual public meeting for the NOAA Hydrographic Services Review Panel (HSRP) on September 23, 2020, 1-5:30 p.m. EDT, and September 24, 2020, 1-5 p.m. EDT via webinar. The HSRP will be asked for advice and recommendations on the development of the implementation plans for the two ocean and coastal mapping strategies noted below and other HSRP meeting topics. Individuals or groups who also want to comment on these or other NOAA navigation services topics are encouraged to submit advance public comments and letters via email no later than September 15, 2020.

The Federal Communications Commission (FCC or Commission or Agency) has transferred (within the FCC), renamed, and modified an existing system of records, FCC/OMD-31, Private or Civil Injury Claimants (formerly FCC/OGC-6, Private or Civil Injury Claimants), subject to the Privacy Act of 1974, as amended. This action is necessary to meet the requirements of the Privacy Act to publish in the Federal Register notice of the existence and character of records maintained by the Agency. Staff in the Office of the Managing Director (OMD) and the Office of General Counsel (OGC) use the personally identifiable information (PII) in this system for purposes that include, but are not limited to, determining whether a damage claim filed against the FCC should be paid and for reference purposes when similar cases arise. As necessary, the records may be transferred to the appropriate Federal agency charged with the responsibility of disposition.

The Coast Guard is establishing a temporary safety zone for navigable waters within defined points during the launch of SpaceX Falcon 9 SAOCOM1B mission. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by space vehicles being launched in a direction resulting in a polar orbit trajectory. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Jacksonville.

The Department of Justice, Federal Bureau of Investigation, Criminal Justice Information Services Division, will be submitting the following information collection request to the Office of Management and Budget for review and approval in accordance with the Paperwork Reduction Act of 1995.

The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies. Comments are encouraged and must be submitted (no later than September 28, 2020) to be assured of consideration.

Department of Justice (DOJ), Federal Bureau of Investigation, Criminal Justice Information Services Division will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule.

HRSA is seeking additional nominations of qualified tribal officials as candidates for consideration for appointment as voluntary delegate members of the HRSA Tribal Advisory Council (TAC), which is being established. Specifically, HRSA requests submissions of nominations of qualified tribal officials from the Indian Health Service (IHS) geographic areas of: Alaska; Albuquerque; Billings; Navajo; Phoenix; and Tucson. Nominations for membership must be received on or before September 30, 2020. This will allow tribes and tribal serving organizations from the IHS geographic areas noted above, the additional time needed to identify qualified tribal officials as candidates and submit comprehensive nomination packages.

Pursuant to the Privacy Act of 1974, as amended, and the Office of Management and Budget (OMB) Guidelines on the Conduct of Matching Programs, notice is hereby given of the conduct of the Internal Revenue Service (IRS) Disclosure of Information to Federal, State and Local Agencies (DIFSLA) Computer Matching Program.

In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. The Families First Coronavirus Response Act of 2020, enacted March 18, 2020, includes a general provision that allows the Department of Agriculture to issue emergency allotments (EA) based on a public health emergency declaration by the Secretary of Health and Human Services under section 319 of the Public Health Service Act related to an outbreak of COVID-19 when a State has also issued an emergency or disaster declaration. This is a new collection for activities associated with administering emergency allotments.

The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, ``Licenses, Certifications, and Approvals for Nuclear Power Plants.''

In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0106, Unauthorized Entry Into Cuban Territorial Waters; without change. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.

The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.

This is a Notice of the Presidential declaration of a major disaster for the State of Iowa (FEMA-4557-DR), dated 08/20/2020. Incident: Severe Storms. Incident Period: 08/10/2020.

The Maritime Administration (MARAD) invites public comments on our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The information to be collected will be used to assess CVSSA Training Provider Certification applicants against the CVSSA Model Course Standard. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995.

In response to the declaration of a national emergency, announced on March 13, 2020, due to the coronavirus disease of 2019 (COVID-19) pandemic in the United States, the Veterans Benefits Administration (VBA) instituted temporary provisions for determining the acceptable dates for the receipt of correspondence through the United States Postal Service mail and other mail delivery systems. This is an updated notice to VA's April 20, 2020, Federal Register publication.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the revision with changes of the currently approved information collection 0596-0066, Advertised Timber for Sale.