May 2021 – Federal Register Recent Federal Regulation Documents

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for extension of currently approved collections. The ICR describes the nature of the information collection and its expected burden. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on March 15, 2021 (86 FR 14360). No comments were received.

In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for extension of currently approved collections. The ICR describes the nature of the information collection and its expected burden. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on March 11, 2021 (86 FR page 13964). No comments were received.

In accordance with the Federal Advisory Committee Act, this notice announces the June 24, 2021, meeting of the Federal Communications Commission's (Commission) Advisory Committee on Diversity and Digital Empowerment (ACDDE).

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Bispecific Antibody Development Programs.'' This guidance provides recommendations to assist industry and other parties involved in the development of bispecific antibodies. The guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. This guidance finalizes the draft guidance of the same title issued on April 19, 2019.

This Notice of Data Availability is to alert stakeholders of petitions submitted to the Environmental Protection Agency under subsection (i) of the American Innovation and Manufacturing Act of 2020, and to provide notice of a new docket where these petitions and others submitted under subsection (i) will be made publicly available. The docket will provide the public the opportunity to view petitions submitted under this subsection and to submit any supplemental relevant data to the petitions. The Agency may consider relevant information submitted to the docket in its determinations of whether to grant or deny subsection (i) petitions.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs.'' This guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original new drug applications (NDAs) and biologics license applications (BLAs) are expected to be submitted to FDA, in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA). Early pediatric evaluation of certain molecularly targeted oncology drugs as required by the FD&C Act is expected to accelerate the creation of an informed pediatric development plan and ultimately the development of promising drugs for pediatric patients. This guidance finalizes the draft guidance entitled ``FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs'' issued on December 13, 2019, and finalizes certain material related to implementation of FDARA that was included in the draft guidance entitled ``Pediatric Study Plans for Oncology Drugs: Questions and Answers'' issued on January 16, 2020. Accordingly, FDA does not intend to finalize the draft guidance entitled ``Pediatric Study Plans for Oncology Drugs: Questions and Answers,'' which is now withdrawn.

The U.S. Department of Energy (``DOE'') is re-evaluating its prior determination that the Secretary of Energy (``Secretary'') was not required to implement the statutory backstop requirement for general service lamps (``GSLs''). Under the Energy Policy and Conservation Act, as amended, if DOE fails to complete a rulemaking in accordance with certain statutory criteria, or if a final rule for GSLs does not produce savings that are greater than or equal to the savings from a minimum efficacy standard of 45 lumens per watt (``lm/W''), the Secretary must prohibit the sale of any GSL that does not meet a minimum efficacy standard of 45 lm/W. This request for information (``RFI'') solicits information from the public regarding the availability of lamps that would satisfy a minimum efficacy standard of 45 lm/W, as well other information that may be relevant to a possible implementation of the statutory backstop.

The Secretary of the Interior (Secretary) seeks nominations for individuals to be considered for membership on the Sport Fishing and Boating Partnership Council (Council).

This notice amends the notice of a major disaster declaration for the Commonwealth of Kentucky (FEMA-4595-DR), dated April 23, 2021, and related determinations.

This notice amends the notice of a major disaster declaration for the State of Oklahoma (FEMA-4587-DR), dated February 24, 2021, and related determinations.

This notice amends the notice of a major disaster declaration for the territory of American Samoa (FEMA-4537-DR), dated April 17, 2020, and related determinations.

This notice amends the notice of a major disaster declaration for the State of Nevada (FEMA-4523-DR), dated April 4, 2020, and related determinations.

This notice amends the notice of a major disaster declaration for State of Hawaii (FEMA-4510-DR), dated April 1, 2020, and related determinations.

This notice amends the notice of a major disaster declaration for State of California (FEMA-4482-DR), dated March 22, 2020, and related determinations.

On March 15, 2021, U.S. Customs and Border Protection (CBP) published in the Federal Register an Interim Final Rule (IFR), which amends the CBP regulations to provide for mandatory advance electronic data (AED) for international mail shipments. Although the comment period for this IFR closed on May 14, 2021, CBP has decided to reopen the comment period for an additional 30 days.

American Radiolabeled Chem has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), Department of Justice (DOJ), will submit 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 proposed information collection (IC) is also being published to obtain comments from the public and affected agencies.

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.

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.

The Environmental Protection Agency (EPA) is approving a submission by the State of Tennessee, through the Tennessee Department of Environment and Conservation (TDEC), on September 29, 2020, to redesignate the Sumner County, Tennessee, unclassifiable area (hereinafter referred to as the ``Sumner County Area'' or ``Area'') to attainment/unclassifiable for the 2010 1-hour primary sulfur dioxide (SO2) national ambient air quality standard (hereinafter referred to as the 2010 SO2 1-hour NAAQS). EPA now has sufficient information to determine that the Sumner County Area is attaining the 2010 1-hour SO2 NAAQS and is approving the State's request and redesignating the Area to attainment/unclassifiable for the 2010 1-hour SO2 NAAQS.