Department of Health and Human Services May 14, 2018 – Federal Register Recent Federal Regulation Documents

Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC)
Document Number: 2018-10224
Type: Notice
Date: 2018-05-14
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 Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This meeting is open to the public limited only by the space and ports available. The meeting room accommodates 70 participants and there will be 125 ports available. Due to the limited accommodations by phone ports and room size, we are encouraging the public to please register using the link provided: Register Here. There will be public comment periods from 11:10 a.m.-11:40 a.m., on June 19, 2018, and from 11:30 a.m.-11:45 a.m., on June 20, 2018. All public comments will be limited to two-minutes per speaker.
National Advisory Committee on Children and Disasters and National Preparedness and Response Science Board Public Meetings
Document Number: 2018-10212
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) and National Preparedness and Response Science Board (NPRSB) will hold public meetings on June 26-28, 2018.
Availability of Draft Interaction Profile for Mixtures of Insecticides: Pyrethroids, Organophosphorus Compounds, and Carbamates
Document Number: 2018-10204
Type: Notice
Date: 2018-05-14
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS) announces the availability of the Draft Interaction Profile for Mixtures of Insecticides: Pyrethroids, Organophosphorus Compounds, and Carbamates for review and comment. This interaction profile evaluates a mixture of chemicals often found in human blood, adipose tissue, and breast milk. The purpose of this interaction profile is to investigate the possible joint actions of these chemicals on endocrine, developmental, and neurobehavioral endpoints in humans. This interaction profile has undergone external peer-review and review by ATSDR's Interagency Workgroup on Mixtures. ATSDR remains committed to providing a public comment period for these documents as a means to best serve public health and the public.
Partial Withdrawal of Proposed Amendment to the Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use
Document Number: 2018-10194
Type: Proposed Rule
Date: 2018-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a partial withdrawal of a proposed rule published in the Federal Register of August 21, 2002 (2002 proposed rule). The proposed rule, if finalized, would have amended FDA's tentative final monograph (TFM) for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized as safe and effective (GRASE) analgesic/antipyretic active ingredient for OTC use. FDA is withdrawing this proposed rule due to changes in our understanding of ibuprofen since FDA issued the proposed rule. FDA is not withdrawing those portions of the 2002 proposed rule to amend its regulations to include consistent pregnancy and allergy warnings for OTC IAAA drug products containing nonsteroidal anti- inflammatory active ingredients.
Pediatric HIV Infection: Drug Development for Treatment; Draft Guidance for Industry; Availability
Document Number: 2018-10187
Type: Notice
Date: 2018-05-14
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 ``Pediatric HIV Infection: Drug Development for Treatment.'' This guidance provides general recommendations on the development of drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients (birth to younger than 17 years of age).
Health Resources and Services Administration
Document Number: 2018-10182
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services
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.
Submission for OMB Review; Comment Request
Document Number: 2018-10178
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2018-10169
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services, Administration for Children and Families
Occupational Robotics Research Prioritization
Document Number: 2018-10165
Type: Notice
Date: 2018-05-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention has recently established the Center for Occupational Robotics Research. NIOSH is requesting information to guide the prioritization of research to be undertaken by the Center. NIOSH is seeking input on priority gaps in knowledge on the safety and health of humans working with robotics technology, with an emphasis on worker safety and health research which is unlikely to be completed by other federal agencies, academia, and the private sector.
The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
Document Number: 2018-10148
Type: Rule
Date: 2018-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the Food and Drug Administration RegulationSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification for Certain Provisions of Four Implementing Rules.''
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2018-10139
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2018-10138
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-10137
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-day Comment Request; Collection of Customer Service, Demographic, and Smoking/Tobacco Use Information From the National Cancer Institute's Contact Center (CC) Clients (National Cancer Institute)
Document Number: 2018-10136
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-10135
Type: Notice
Date: 2018-05-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-10130
Type: Notice
Date: 2018-05-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Solicitation of Nominations for Membership To Serve on the Council on Graduate Medical Education
Document Number: 2018-10129
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Council on Graduate Medical Education (COGME). COGME provides advice and recommendations to the Secretary of HHS; the Senate Committee on Health, Education, Labor and Pensions; and the U.S. House of Representatives Committee on Energy and Commerce on matters concerning the supply and distribution of physicians in the United States, physician workforce trends, training issues, financing policies, and other matters of significance related to physician workforce and graduate medical education.
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