Department of Health and Human Services August 9, 2018 – Federal Register Recent Federal Regulation Documents

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.

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 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. This meeting is open to the public, limited only by the space available. The public is welcome to participate during the public comment period, 12:30 p.m. to 12:45 p.m., EDT, September 27, 2018. Please note that the public comment period ends at the time indicated above. 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 Food and Drug Administration (FDA or Agency) has determined that PROLIXIN (fluphenazine hydrochloride) tablets, 1 milligram (mg), 2.5 mg, 5 mg, and 10 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for fluphenazine hydrochloride tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, if all other legal and regulatory requirements are met.

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 the guidance to assist manufacturers who wish to voluntarily label their foods (human and animal) as being made with or without bioengineering, or the use of bioengineered ingredients, to ensure that labeling is truthful and not misleading.