Department of Health and Human Services April 2, 2019 – Federal Register Recent Federal Regulation Documents

The meeting of the Pulmonary-Allergy Drugs Advisory Committee scheduled for March 27, 2019, has been cancelled. This meeting was announced in the Federal Register of January 31, 2019. This meeting has been cancelled due to new information regarding the application. The Agency intends to continue evaluating the application and, as needed, will announce future meeting dates in the Federal Register.

The Food and Drug Administration (FDA or Agency) has determined that CHLOR-TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate) extended release tablets, 8 milligrams (mg) and 12 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a new collection of information entitled ``Generic Clearance for Quick Turnaround Testing of Communication Effectiveness.''

The HHS Assistant Secretary for Preparedness and Response (ASPR) in the Department of Health and Human Services (HHS) is announcing a public meeting, Biodefense Summit: Implementing the National Biodefense Strategy (Strategy). Implementing the Strategy involves partners among multiple sectors, including medical; public, animal, and plant health; emergency response; scientific and technical; law enforcement; industrial; academic; diplomatic; defense and security; intelligence; and nonproliferation and counterproliferation stakeholders. This meeting is being held to introduce the Strategy to these groups and to solicit feedback from them. The meeting will be open to representatives from invited organizations and the public.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Pain Management Best Practices Inter-Agency Task Force (Task Force). The meeting will be open to the public; public comment sessions will be held during the meeting.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace.

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 The Childcare Survey of Activity and Wellness (C-SAW) Pilot Study. The pilot study will determine the current practices and policies of early care and education (ECE) providers in four states around nutrition, physical activity, and wellness and will inform the development of a potential national surveillance system.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on 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 Information Collection on Soil- transmitted Helminth Infections in Alabama and Mississippi. CDC requests OMB approval to collect information on prevalence and distribution of soil-transmitted helminth infections and potential risk factors.

The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the biologics regulations by removing the specified test for the presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. FDA is proposing this action because the existing test for Mycoplasma is restrictive in that it identifies only one test method in detail to be used even though other methods also may be appropriate. More sensitive and specific methods exist and are currently being practiced, and removal of the specific method to test for Mycoplasma provides flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections. This action is part of FDA's implementation of Executive Orders 13771 and 13777. Under these Executive orders, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.

The Food and Drug Administration (FDA, the Agency, or we) is correcting with technical amendments two final rules that published in the Federal Register of September 17, 2015, and one final rule that published in the Federal Register of November 27, 2015. The final rules published with editorial and inadvertent errors. This document corrects those errors.

The Food and Drug Administration (FDA) is issuing a proposed rule to establish requirements for the content and format of reports intended to establish the substantial equivalence of a tobacco product (SE Reports). The proposed rule would establish the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the proposed rule would establish the general procedures FDA intends to follow when evaluating SE Reports, including procedures that would address communications with the applicant and the confidentiality of data in an SE Report. The proposed rule is intended to provide more clarity to applicants and support efficient and predictable reviews of SE Reports.