Department of Health and Human Services September 22, 2021 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Bureau of Primary Health Care-Program Management Resource Compendium, 0906-XXXX, New
Document Number: 2021-20524
Type: Notice
Date: 2021-09-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-20520
Type: Notice
Date: 2021-09-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-20519
Type: Notice
Date: 2021-09-22
Agency: Department of Health and Human Services, National Institutes of Health
B. Braun Medical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Hydroxyethyl Starch
Document Number: 2021-20511
Type: Notice
Date: 2021-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) BA110013/0032 for 6 Percent Hydroxyethyl Starch 130/0.4 in 0.9 Percent Sodium Chloride Injection in EXCEL[supreg] Plastic Container, held by B. Braun Medical, Inc. B. Braun Medical, Inc., requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.
Advisory Committee on Immunization Practices (ACIP); Correction Notice of Meeting
Document Number: 2021-20478
Type: Notice
Date: 2021-09-22
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 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; for more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/.
Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee on Procedures Reviews (SPR), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2021-20477
Type: Notice
Date: 2021-09-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
Advisory Committee on Immunization Practices (ACIP)
Document Number: 2021-20476
Type: Notice
Date: 2021-09-22
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 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; for more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2021-20468
Type: Notice
Date: 2021-09-22
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of Opportunity To Become an Office on Women's Health (OWH) Self-Measured Blood Pressure (SMBP) Program Partner; Notice by the U.S. Department of Health and Human Services
Document Number: 2021-20456
Type: Notice
Date: 2021-09-22
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services' (HHS) Office on Women's Health (OWH) invites public and private sector organizations to apply to become an OWH Self-Measured Blood Pressure (SMBP) Partner. This ongoing partnership opportunity engages support from partner organizations to promote SMBP and encourages women to maintain healthy blood pressure levels at every age and stage of their lives. Through the OWH SMBP Partnership Program (``SMBP Program''), OWH seeks to increase knowledge and access to SMBP information and resources, as well as encourage organizations to address heart health disparities, prevent hypertension, promote self-measured blood pressure, and improve health equity on a community level. The SMBP Program will launch during the 2nd annual observance of National Women's Blood Pressure Awareness Week (NWBPAW), October 17-23, 2021. The SMBP Program will build on momentum generated by NWBPAW, which emphasizes the importance of blood pressure control and empowers women to improve their heart health through simple, everyday actions. Eligibility: Any organization may apply to be a SMBP Program partner. The selected SMBP Program partners may be recognized for their commitment and their work toward achieving the goals of the program. SMBP Program partners can be public and private organizations such as those at the state, local, county, and tribal levels, non- governmental organizations, non-profit organizations, businesses, academic organizations, organizations that impact health outcomes, philanthropic organizations, and tribal organizations that identify themselves as being aligned with or promoting the goals of the program. Organizations that work in areas such as fitness, nutrition, housing, health education, and those working to improve health outcomes in women may apply. Social organizations that work with, or have access to large populations of women, organizations promoting women in sports, and child-care facilities may apply. Organizations that have a defibrillator accessible onsite and are willing to make a self-measured blood pressure cuff accessible onsite, and organizations that identify themselves as being aligned with, or promoting blood pressure control are encouraged to apply. All organizations may apply. Individuals are not eligible to become an SMBP Program partner. Applicants shall submit a letter of interest and identify how they support or plan to support the SMBP Program goals. Applicants will be considered according to the organization's commitment to support those goals. SMBP Program partners may receive recognition from OWH on womenshealth.gov, girlshealth.gov, or OWH Social Media platforms. They may also receive SMBP information and resources for dissemination. The following activities may be considered as an organization's demonstrated commitment to the SMBP Program's overarching goals and objectives: Working to increase behaviors women can take to improve their heart health; Increasing access to resources and information regarding hypertension, cardiovascular disease, health risks associated with high blood pressure, and factors that increase the risk of high blood pressure; Increasing knowledge and utilization of SMBP activities (also referred to as ``self-monitoring''); Increasing understanding of blood pressure needs and understanding of blood pressure numbers; Increasing number of women collaborating with healthcare providers with a focus on self-monitoring blood pressure control, with special consideration to adapt or modify activities to meet the needs of diverse, minority, underserved, and hard to reach populations; Expanding efforts to reach those disproportionately affected by high blood pressure, including Black or African American women, Latina women, Asian/Pacific Islander women, American Indian/ Alaska Native women, women of reproductive age, women in rural communities, and women across the lifespan, to include those negatively affected by comorbidities and social determinants of health; Developing partnerships to promote SMBP across a variety of sectors, including business, community, academic, education, faith based, government, health care, media, public health, and technology; Partnering with national, state, tribal, or local volunteer organizations to provide education, training, or programs regarding health promotion, disease prevention, hypertension, SMBP, health disparities, health equity, and well-being; and/or Including information in their public facing materials about programs for hypertension, addressing SMBP, eliminating disparities, achieving health equity, and/or promoting well-being in communities. Funds: Neither HHS nor OWH will provide funds to support SMBP Program partners. Applicants, OWH, and SMBP Program partners will not be expected to contribute funds. Application: Organizations may apply to be an SMBP Program partner. Organizations should submit a letter of interest acknowledging their support of the SMBP Program's overarching goals. Organizations interested in being SMBP Program partners shall identify in their letters of interest those activities from the list noted above that demonstrate commitment to the SMBP Program's overarching goals and objectives and indicate how they address or support those goals.
Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
Document Number: 2021-20432
Type: Notice
Date: 2021-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is hosting a virtual public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. The current legislative authority for BsUFA expires in September 2022. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. Following discussions with the regulated industry and consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations, as necessary.
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