Department of Health and Human Services March 9, 2020 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Application and Other Forms Used by the National Health Service Corps (NHSC) Scholarship Program (SP), the NHSC Students to Service Loan Repayment Program (S2S LRP), and the Native Hawaiian Health Scholarship Program (NHHSP), OMB No. 0915-0146-Revision
Document Number: 2020-04762
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
United States Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting; Request for Comments
Document Number: 2020-04754
Type: Notice
Date: 2020-03-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Vancouver, Canada, scheduled for May 23 through 27, 2020. The topics to be addressed at the public meeting are the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly Meeting in Vancouver.
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment; Draft Guidance for Industry; Availability
Document Number: 2020-04753
Type: Notice
Date: 2020-03-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment.'' This draft guidance provides recommendations for the characterization, during product development, of local safety of topical drug products regarding the risk for contact dermatitis. These recommendations are specifically directed to development of topical new drug products intended for cutaneous application.
Meeting of the Advisory Committee on Organ Transplantation
Document Number: 2020-04744
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Committee on Organ Transplantation (ACOT) has scheduled a public meeting. Information about ACOT and the agenda for this meeting can be found on the ACOT website at https://www.organdonor.gov/about-dot/acot.html.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-04727
Type: Notice
Date: 2020-03-09
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 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 Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. This data collection is designed to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-04726
Type: Notice
Date: 2020-03-09
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 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 Promoting Adolescent Health through School-Based HIV/STD Prevention Reporting Templates. The data collection is designed to obtain detailed, specific, and consistent reporting to ensure that the Division of Adolescent and School Health (DASH) can determine the context, process and effectiveness of program activities.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-04722
Type: Notice
Date: 2020-03-09
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 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 Injection Drug Use Surveillance Project, which proposes to assess (1) the risk behaviors, injection risk networks, receipt of prevention services, and barriers to prevention and care among persons who inject drugs (PWID) and their drug-using peers; and (2) the prevalence of HIV and Hepatitis C infections among PWID and their drug using peers.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-04721
Type: Notice
Date: 2020-03-09
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 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 Community-Based Organizations' Changes in Preparedness and Resources for Support of Biomedical HIV Prevention. The information collection project will be used to assess community-based organizations' (CBOs) awareness of, intentions to provide, and provision of Treatment as Prevention (TasP), non- occupational post-exposure prophylaxis (nPEP), or pre-exposure prophylaxis (PrEP) among clinical and non-clinical CBOs that have received funding from CDC's Division of HIV/AIDS Prevention (DHAP) and those that applied but did not receive funding.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-04720
Type: Notice
Date: 2020-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Clinical Laboratory Improvement Advisory Committee (CLIAC); Notice of Charter Renewal
Document Number: 2020-04713
Type: Notice
Date: 2020-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Clinical Laboratory Improvement Advisory Committee (CLIAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through February 19, 2022.
Solicitation of Nominations for Appointment to the Board of Scientific Counselors (BSC), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2020-04712
Type: Notice
Date: 2020-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the BSC, NIOSH. The BSC consists of 15 experts in fields associated with occupational safety and health. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of occupational medicine, occupational nursing, industrial hygiene, occupational safety and health engineering, toxicology, chemistry, safety and health education, ergonomics, epidemiology, biostatistics, and psychology. Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of the board's objectives https:// www.cdc.gov/niosh/BSC/default.html.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-04706
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-04705
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-04704
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-04703
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Charter Renewal
Document Number: 2020-04702
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-04701
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2020-04699
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting
Document Number: 2020-04698
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2020-04697
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-04696
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-04695
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, National Institutes of Health
Mylan Institutional LLC et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications
Document Number: 2020-04691
Type: Notice
Date: 2020-03-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Nurse Corps Scholarship Program (NCSP), OMB No. 0915-0301-Revision
Document Number: 2020-04679
Type: Notice
Date: 2020-03-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA 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.
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