Department of Health and Human Services March 25, 2019 – Federal Register Recent Federal Regulation Documents

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-05658
Type: Notice
Date: 2019-03-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pulmonary-Allergy 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.
Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease; Public Workshop; Request for Comments
Document Number: 2019-05657
Type: Notice
Date: 2019-03-25
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 workshop entitled ``Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease.'' The purpose of the public workshop is to discuss the clinical trial design considerations, including endpoints, related to the development of antibacterial drug products for treatment of nontuberculous mycobacterial (NTM) disease.
Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops; Guidance for Industry; Availability
Document Number: 2019-05656
Type: Notice
Date: 2019-03-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.'' This guidance provides FDA's interpretation of, and a compliance policy for, the requirement that the label of tobacco products contain an accurate statement of the percentage of foreign and domestic grown tobacco under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance document is also intended to assist retailers who sell deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements of the FD&C Act and the limited circumstances under which FDA does not intend to enforce compliance.
Rare Diseases: Natural History Studies for Drug Development; Draft Guidance for Industry; Availability
Document Number: 2019-05655
Type: Notice
Date: 2019-03-25
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 ``Rare Diseases: Natural History Studies for Drug Development.'' FDA is publishing this draft guidance to help inform the design and implementation of natural history studies that can be used to support the development of safe and effective drugs and biological products for rare diseases. A natural history study collects information about the natural history of a disease in the absence of an intervention, from the disease's onset until either its resolution or the individual's death. Although knowledge of a disease's natural history can benefit drug development for many disorders and conditions, natural history information is usually not available or is incomplete for most rare diseases; therefore, natural history information is particularly needed for these diseases.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-05654
Type: Notice
Date: 2019-03-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial 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 meeting.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-05652
Type: Notice
Date: 2019-03-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial 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.
Agency Information Collection Activities; Submission for OMB Review; the State Plan for Independent Living (SPIL) (0985-0044)
Document Number: 2019-05619
Type: Notice
Date: 2019-03-25
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to State Plan for Independent Living (SPIL) (Information Collection Request Ext (ICR Ext)).
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2019-05595
Type: Notice
Date: 2019-03-25
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Advisory Council for the Elimination of Tuberculosis (ACET); Notice of Charter Renewal
Document Number: 2019-05592
Type: Notice
Date: 2019-03-25
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 Advisory Council for the Elimination of Tuberculosis Meeting (ACET), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through March 15, 2021.
Notice of Closed Meeting
Document Number: 2019-05591
Type: Notice
Date: 2019-03-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
Document Number: 2019-05590
Type: Notice
Date: 2019-03-25
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 of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 33 people. The public is welcome to participate during the public comment period, 12:30 p.m. to 12:40 p.m. EDT May 30, 2019. Please note that the public comment period ends at the time indicated above or following the last call for comments, whichever is earlier. Members of the public who wish to address the NIOSH BSC are requested to contact the Executive Secretary for scheduling purposes (see contact information below). Alternatively, written comments to the BSC may be submitted via an on-line form at the following website: https://www.cdc.gov/niosh/bsc/contact.html. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come-first served basis. Written comments will also be accepted from those unable to attend the public session via an on-line form at the following website: https:// www.cdc.gov/niosh/bsc/contact.html. The meeting is also open to the public via webcast. If you wish to attend in person or by webcast, please see the NIOSH website to register (https://www.cdc.gov/niosh/bsc/ ) or call (404-498-2539) at least five business days in advance of the meeting. Teleconference is available toll-free; please dial (888) 397- 9578, Participant Pass Code 63257516. Adobe Connect webcast will be available at https://odniosh.adobeconnect.com/nioshbsc/ for participants wanting to connect remotely.
Decision To Evaluate a Petition To Designate a Class of Employees From the Y-12 Plant in Oak Ridge, Tennessee, To Be Included in the Special Exposure Cohort
Document Number: 2019-05586
Type: Notice
Date: 2019-03-25
Agency: Department of Health and Human Services
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the Y-12 Plant in Oak Ridge, Tennessee, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Final National Occupational Research Agenda for Immune, Infectious, and Dermal Disease Prevention (IID)
Document Number: 2019-05561
Type: Notice
Date: 2019-03-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH announces the availability of the final National Occupational Research Agenda for Immune, Infectious, and Dermal Disease Prevention.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-05556
Type: Notice
Date: 2019-03-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-05555
Type: Notice
Date: 2019-03-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-05554
Type: Notice
Date: 2019-03-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-05553
Type: Notice
Date: 2019-03-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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