Department of Health and Human Services August 19, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
State-Based Occupational Health Surveillance; Request for Information and Meeting Notice
The National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), announces a public teleconference meeting and an opportunity to comment on funding mechanisms and other considerations for state-based occupational health surveillance.
Submission for OMB Review; Evaluation of the Child Welfare Capacity Building Collaborative
The Administration for Children and Families (ACF) is requesting a three-year extension of 20 previously approved forms that include satisfaction surveys; a leadership interview protocol; a web- based collaboration survey; assessment tools; and service-specific feedback forms (OMB #0970-0484, expiration 8/31/2019). There are no changes to these forms. An extension is not being sought for four instruments originally included (Tribal Organizational Assessment Interviews: Caseworker Interview; Community Provider Interview; Community Member/Elder Interview; Family Interview).
Request for Public Comment: 30-Day Information Collection: Indian Health Service Forms To Implement the Privacy Rule
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``IHS Forms to Implement the Privacy Rule'' Office of Management and Budget (OMB) Control Number 0917-0030. This previously approved information collection project was last published in the Federal Register (84 FR 19088) on May 3, 2019, and allowed 60 days for public comment. One public comment was received in response to the notice. The comment was not pertinent to the collection itself. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).
Notice of Meeting
Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA) and the Preventing Sex Trafficking and Strengthening Families Act, that a meeting of the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (Committee) will be held on October 4, 2019. The purpose of the meeting is for the Committee to discuss its work on its interim report on recommended best practices for states to follow to combat the sex trafficking of children and youth based on multidisciplinary research and promising, evidence-based models, and programs. The members of the Committee request any examples and comments from the public to inform their work and have also requested input on the following specific topics pertaining to combating the sex trafficking of children and youth in the United States: Screening and Identification: Intersections with interpersonal violence; screening or universal approaches. Service Provision: Models for multi-agency response protocols; evaluated training curricula for service providers; case management and specialized service models. Housing: Prevention efforts of public housing authorities. Prevention: Initiatives of city, county, and state public health departments. Data: Strategies for state Medicaid offices to collect quality measures regarding violence or exploitation; collection and protection of exploitation data in health records. Child Welfare: Evidence-informed or -based curricula for child welfare providers, child and youth service providers, and foster parents; child welfare policies and procedures for identifying and responding to trafficking; interagency data sharing agreements that pertain to child sex trafficking cases; specialized foster care models including residential treatment; screening tools used in child welfare agencies and whether or not they've been validated. State funding sources for prevention, training, and/or services in addition to federal non-IV-E funding. Please submit your examples and/or comments to adonald@nhttac.org with the subject ``NAC Comments'' as soon as possible and before August 30.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Nonprescription Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Nonprescription Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies To Establish Product Withdrawal Periods in Aquatic Species; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #257 entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species'' (VICH GL57). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements. This guidance document provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Dear Health Care Provider Letters: Improving Communication of Important Safety Information
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 each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with Agency guidance entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' The guidance offers specific recommendations to industry on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. This guidance provides recommendations on when to use a DHCP letter, the types of information to include in the DHCP letter, how to organize the information so that it is communicated effectively to health care providers, and formatting techniques to make the information more accessible.
Food and Drug Administration Science Forum 2019; Public Workshop
The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled ``FDA Science Forum 2019.'' The purpose of the public workshop is to share with the public the unique scientific research and collaborative efforts of FDA's 11,000 scientists and researchers, who use novel science and technologies to inform FDA's regulatory decision-makingand drive innovation.
Solicitation of Nominations for Appointment to the Advisory Council for the Elimination of Tuberculosis (ACET)
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACET. The ACET consists of 10 experts in fields associated with public health, epidemiology, immunology, infectious disease, pulmonary disease, pediatrics, tuberculosis, microbiology, or preventive health care delivery. They are selected by the Secretary of the U.S. Department of Health and Human Services (HHS). ACET provides advice and recommendations regarding eliminating tuberculosis (TB) to the Secretary, HHS; the Assistant Secretary for Health, HHS; and the CDC Director. ACET (a) makes recommendations regarding TB prevention and control policies, strategies, objectives, and priorities; (b) addresses development and application of new technologies; (c) provides guidance and review of CDC's TB prevention research portfolio and program priorities; and (d) reviews the extent to which progress has been made toward eliminating TB. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of ACET's objectives. Nominees will be selected on the basis of their expertise in public health, epidemiology, immunology, infectious diseases, pulmonary disease, pediatrics, tuberculosis, microbiology, or preventive health care delivery. Federal employees are ineligible 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 ACET's objectives.
National Institute for Occupational Safety and Health (NIOSH); World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC)
In accordance with the Federal Advisory Committee Act, the CDC National Institute for Occupational Safety and Health (NIOSH), announces the following meeting for the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC). This meeting is open to the public, limited only by the number of telephone lines. The room will accommodate approximately 100 persons. The public is also welcome to listen to the meeting by dial-in 1 (800) 988-0212, the passcode 1440561, and will accommodate up to 50 callers. To view the web conference, enter the following web address in your web browser: https://odniosh.adobeconnect.com/wtchpstac19-1/.
Agency Information Collection Activities: Proposed Collection; Comment Request
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
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