Department of Health and Human Services November 21, 2022 – Federal Register Recent Federal Regulation Documents

Requirements for Additional Traceability Records for Certain Foods
Document Number: 2022-24417
Type: Rule
Date: 2022-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule establishing additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL). The final rule adopts provisions requiring these entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this regulation in accordance with the FDA Food Safety Modernization Act (FSMA).
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2022-25244
Type: Notice
Date: 2022-11-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2022-25243
Type: Notice
Date: 2022-11-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2022-25242
Type: Notice
Date: 2022-11-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Input on the National Public Health Strategy for the Prevention and Control of Vector-Borne Diseases in Humans: Request for Information
Document Number: 2022-25241
Type: Notice
Date: 2022-11-21
Agency: Department of Health and Human Services
This Request for information (RFI) invites comments and suggestions on the National Strategy for the Prevention and Control of Vector-Borne Diseases. The Strategy represents the Federal Government's priorities for addressing vector-borne disease (VBD) threats.
Proposed Information Collection Activity: Administration for Children and Families Program Instruction-Children's Justice Act (OMB #0970-0425)
Document Number: 2022-25223
Type: Notice
Date: 2022-11-21
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACF Program Instruction Children's Justice Act (Office of Management and Budget (OMB) #0970- 0425, expiration 6/30/2023). There are no changes proposed to the Program Instruction.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2022-25245
Type: Notice
Date: 2022-11-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed revision of the information collection project titled National Health and Nutrition Examination Survey (NHANES). NHANES produces descriptive statistics, which measure the health and nutrition status of the general population.
CDC Clinical Practice Guideline for Prescribing Opioids for Pain-United States, 2022
Document Number: 2022-25264
Type: Notice
Date: 2022-11-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), announces the availability of the CDC Clinical Practice Guideline for Prescribing Opioids for PainUnited States, 2022 (2022 Clinical Practice Guideline). The 2022 Clinical Practice Guideline updates and expands the CDC Guideline for Prescribing Opioids for Chronic PainUnited States, 2016 (2016 Guideline) and provides evidence-based recommendations for clinicians who provide pain care, including those prescribing opioids, for outpatients age 18 years and older with: acute pain (duration less than 1 month), subacute pain (duration of 1-3 months), or chronic pain (duration of more than 3 months). The recommendations in the 2022 Clinical Practice Guideline do not apply to pain management related to sickle cell disease, cancer-related pain treatment, palliative care, or end-of-life care. The 2022 Clinical Practice Guideline finalizes the draft clinical practice guideline issued on February 10, 2022.
Office of the Assistant Secretary for Health; Opportunity To Co-Sponsor OASH-Supported Grantee Workshops
Document Number: 2022-25259
Type: Notice
Date: 2022-11-21
Agency: Department of Health and Human Services
The Grants and Acquisitions Management Division (GAM) in the Office of the Assistant Secretary for Health (OASH), in conjunction with the grant making program offices it supports, announces the opportunity for non-federal public and private sector entities to co- sponsor OASH-supported grants workshops (OASH Grants Workshops). Potential co-sponsors must have a demonstrated interest and experience in building capacity among potential grant applicants and grant recipients. Potential co-sponsors must be willing to participate substantively in the co-sponsored activity. Expressions of interest for co-sponsorships of OASH Grants Workshops are received throughout the year at the email address below. OASH intends to co-sponsor a limited number of workshops with other entities each year. Expressions of interest are being received for OASH Grants Workshops that will take place in the next fiscal year (October 2022 through September 2023) or beyond. Expressions of interest for co-sponsorships should be sent by email to OASH_Grants@HHS.GOV with ``Co-sponsorship for OASH-supported Grants Workshops'' in the subject field or by mail to Duane Barlow, Grants Branch Chief, OASH, Grants and Acquisitions Management Division, at 1101 Wootton Parkway, Plaza Level, Rockville, MD 20852.
Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID)
Document Number: 2022-25276
Type: Notice
Date: 2022-11-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID). This virtual meeting is open to the public via Zoom, limited only by the number of web conference lines available (500 lines). Pre-registration is required by accessing the link below in the addresses section.
Animal Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2022-25274
Type: Notice
Date: 2022-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Animal Drug User Fee Act.'' The purpose of the public meeting is to discuss the proposed recommendations for the reauthorization of the Animal Drug User Fee Act (ADUFA V) for fiscal years 2024 through 2028.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2022-25318
Type: Notice
Date: 2022-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Cancellation of Meeting
Document Number: 2022-25317
Type: Notice
Date: 2022-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Allergan Sales, LLC, et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications
Document Number: 2022-25315
Type: Notice
Date: 2022-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 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.
Cargill, Inc.; Filing of Food Additive Petition
Document Number: 2022-25310
Type: Proposed Rule
Date: 2022-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Cargill, Inc., proposing that the food additive regulations be amended to provide for the safe use of hydrogen peroxide (CAS Reg. No. 7722-84-1) as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide.
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