New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor

by the Food and Drug Administration on 03/08/2021.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2020. FDA is informing the public of the availability of summaries of the basis of approval and of...

Agency Forms Undergoing Paperwork Reduction Act Review

by the Centers for Disease Control and Prevention on 03/08/2021.

Proposed Data Collection Submitted for Public Comment and Recommendations

by the Centers for Disease Control and Prevention on 03/08/2021.

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...

Proposed Data Collection Submitted for Public Comment and Recommendations

by the Centers for Disease Control and Prevention on 03/08/2021.

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...

Proposed Data Collection Submitted for Public Comment and Recommendations

by the Centers for Disease Control and Prevention on 03/08/2021.

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...

Proposed Data Collection Submitted for Public Comment and Recommendations

by the Centers for Disease Control and Prevention on 03/08/2021.

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...

Proposed Data Collection Submitted for Public Comment and Recommendations

by the Centers for Disease Control and Prevention on 03/08/2021.

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...

Submission for OMB Review; Family Violence Prevention and Services Program (OMB #0970-0280)

by the Children and Families Administration on 03/08/2021.

The Administration on Children, Youth and Families, Family and Youth Services Bureau plans to extend data collection for the Family Violence Prevention and Services Program (OMB #0970-0280; Expiration Date: March 31, 2021). No changes are proposed to the existing information collection.

National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting

by the National Institutes of Health on 03/08/2021.

National Institute on Drug Abuse; Notice of Closed Meeting

by the National Institutes of Health on 03/08/2021.

Agency Information Collection Activities: Proposed Collection; Comment Request

by the Agency for Healthcare Research and Quality on 03/05/2021.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve proposed updates to the approved information collection project ``Safety Program in Perinatal Care (SPPC)-II Demonstration Project.''

Supplemental Evidence and Data Request on Management of Infantile Epilepsy

by the Agency for Healthcare Research and Quality on 03/05/2021.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Management of Infantile Epilepsy, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and...

Request for Information on the Use of Clinical Algorithms That Have the Potential To Introduce Racial/Ethnic Bias Into Healthcare Delivery

by the Agency for Healthcare Research and Quality on 03/05/2021.

The Agency for Healthcare Research and Quality (AHRQ) is seeking information from the public on clinical algorithms that are used or recommended in medical practice and any evidence on clinical algorithms that may introduce bias into clinical decision- making and/ or influence access to care, quality of care, or health outcomes for racial and...

Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Diphtheria, Group A Streptococcus, Meningococcal Disease, and Pertussis Sections; Re-Opening of Comment Period

by the Centers for Disease Control and Prevention on 03/05/2021.

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (DHHS), announces the re- opening of a docket to obtain a public comment on the DRAFT Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Diphtheria,...

Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications

by the Food and Drug Administration on 03/05/2021.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of seven 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.

Data Standards; Requirement Begins for the Clinical Data Interchange Standards Consortium Version 1.1 of the Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide and Version 1.6 of the Study Data Tabulation Model; Clarification to Food and Drug Administration Data Standards

by the Food and Drug Administration on 03/05/2021.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing the date that support will begin for version 1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide (SENDIG- DART) and...

Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications

by the Food and Drug Administration on 03/05/2021.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including...

Canned Tuna Deviating From the Standard of Identity; Amendment of Temporary Marketing Permit

by the Food and Drug Administration on 03/05/2021.

The Food and Drug Administration (FDA or we) is amending StarKist Seafood Company's temporary permit to market test canned tuna. The temporary permit is amended to add three additional manufacturing locations and to increase the amount of test product. This amendment will allow the applicant to continue to test market the test product and...

Meeting of the COVID-19 Health Equity Task Force

by the Health and Human Services Department on 03/05/2021.

As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the COVID-19 Health Equity Task Force (Task Force) will hold a virtual meeting on March 26, 2021. The purpose of this meeting is to discuss equitable vaccine access and acceptance. This meeting is open to the...

National Heart, Lung, and Blood Institute; Notice of Closed Meeting

by the National Institutes of Health on 03/05/2021.