Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) proposes adding a Smallpox Countermeasures Injury Table (Table) for designated covered smallpox countermeasures identified in a declaration. The proposed Smallpox Countermeasures Injury Table includes a list of smallpox countermeasures, proposed time intervals for the first symptom or manifestation of onset of injury, and Qualifications and Aids to Interpretation, which set forth the definitions and requirements necessary to establish the Table injuries.

This Notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Mille Lacs Band of Ojibwe in the State of Minnesota to include the Minnesota counties of Crow Wing and Morrison in the State of Minnesota. The current PRCDA for the Mille Lacs Band of Ojibwe includes the Minnesota counties of Aitkin, Kanebec, Mille Lacs, and Pine. Mille Lacs Band of Ojibwe members residing outside of the PRCDA are eligible for direct care services, however, they are not eligible for Purchased/Referred Care (PRC) services. The sole purpose of this expansion would be to authorize additional Mille Lacs Band of Ojibwe members and beneficiaries to receive PRC services.

The Food and Drug Administration (FDA, the Agency, or we) is hosting a virtual public meeting entitled ``Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.'' The purpose of the meeting is to obtain early input from the public on a potential revised approach for considering the human medical importance of antimicrobial new animal drugs when assessing and managing the antimicrobial resistance risks associated with the use of antimicrobial drugs in animals. The Agency is seeking public input on a potential revised process for ranking antimicrobials according to their relative importance in human medicine, on the potential criteria for their ranking, and on the resulting ranked list of antimicrobial drugs. A concept paper describing this potential revised process will be made available for discussion at the public meeting and can be obtained at the website listed in section II of this notice.

The Administration for Children and Families (ACF) proposes to revise the existing overarching generic clearance for Formative Data Collections for ACF Program Support (OMB #0970-0531) to increase the estimated number of respondents and, therefore, the overall burden estimate.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on a proposed information collection entitled ``Rapid Response Suicide Investigation Data Collection.'' CDC will use the information collected to continue providing rapid responses to urgent requests for CDC assistance in the investigation of an apparent or unexplained potential cluster or increase in suicidal behavior.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Blood Lead Surveillance System (BLSS)'' (OMB Control No. 0920-0931, Exp. Date 05/31/2021). The National Center for Environmental Health (NCEH) is leading a three-year extension information collection request (ICR) for two CDC information collections, one for childhood blood lead surveillance by NCEH and another for adult blood lead surveillance by the National Institute for Occupational Safety and Health (NIOSH).

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Factors Influencing the Transmission of Influenza. This proposed collection is intended to further our understanding of how respiratory viruses like influenza are transmitted from person to person.

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. The listing for FailSafe PSO, PSO number P0196, has expired and AHRQ has delisted the PSO accordingly.

Notice is hereby given of a change in the meeting of the Advisory Committee on Immunization Practices (ACIP); October 28-29, 2020, 10:00 a.m.-5:30 p.m., EDT (times subject to change), in the original Federal Register notice. The meeting, which was published in the Federal Register on September 21, 2020, Volume 85, Number 183, pages 59317-59318, is being amended and should read as follows:

The Food and Drug Administration (FDA or Agency) is withdrawing approval of nine abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on October 1, 2020. That Notice requires a correction in the SUPPLEMENTARY INFORMATION section.

HRSA, an operating division of HHS, is publishing a list of persons who may be named to serve on the Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members within HRSA for the Fiscal Year 2021 and 2022 review period.