Department of Health and Human Services January 31, 2022 – Federal Register Recent Federal Regulation Documents
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Regulatory Agenda
The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.
Meeting of the Advisory Committee on Childhood Vaccines
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Commission on Childhood Vaccines (ACCV) will hold public meetings for the 2022 calendar year (CY). Information about the ACCV, agendas, and materials for these meetings can be found on the ACCV website at https://www.hrsa.gov/advisory- committees/vaccines/.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Emerging Infections Program (EIP). EIP is a population-based surveillance system designed to collect information via active, laboratory case finding that is used for detecting, identifying, and monitoring emerging pathogens.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Fire Fighter Fatality Investigation and Prevention Program Survey which will evaluate fire department implementation of the National Institute for Occupational Safety and Health (NIOSH) Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) recommendations. The evaluation will assess whether NIOSH FFFIPP recommendations are utilized by fire departments, identify barriers to implementation of recommendations, and identify areas for potential intervention projects.
Advisory Committee on Immunization Practices (ACIP)
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.
Advisory Committee; Vaccines and Related Biological Products Advisory Committee; Renewal
The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Vaccines and Related Biological Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Vaccines and Related Biological Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the December 31, 2023, expiration date.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Assessment for the Be Antibiotics Aware Consumer and Healthcare Professional (HCP) Campaign. Individuals who have opted to be contacted for surveys will be screened for eligibility and given access to an online survey to assess the Be Antibiotics Aware campaign, which is designed to optimize antibiotic prescribing and use.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Assessment for the Get Ahead of Sepsis (GAOS) Consumer Campaign. This assessment collects on-line survey data from target consumer groups and healthcare professionals (HCP) before and after the campaign.
Principles of Premarket Pathways for Combination Products; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ``Principles of Premarket Pathways for Combination Products.'' This guidance presents FDA's current thinking on principles for premarket review of combination products. This guidance includes general, high-level information regarding what combination products are, coordination within FDA and interaction between FDA and sponsors regarding combination product regulation, and how combination products are reviewed by FDA before they are marketed. The guidance also includes recommendations on how to determine which type of premarket submissions may be appropriate for combination products. FDA is publishing this guidance as part of its efforts to implement the 21st Century Cures Act (Cures Act) and in keeping with the Agency's long-standing commitment to transparency, efficiency, and regulatory consistency to facilitate development of safe and effective combination products. This guidance finalizes the draft guidance of the same title that published on February 6, 2019.
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