Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration of Color Additives on Animal Food Labels
The Food and Drug Administration (FDA, Agency, or we) 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 provisions associated with food additive petitions, investigational food additive files exemptions, and declaration of color additives on animal food labels.
Informational Meeting: The Importation of Infectious Biological Agents, Infectious Substances and Vectors; Public Webinar
The HHS/CDC's Division of Select Agents and Toxins (DSAT) is hosting a public webinar to provide information about import permit regulations for infectious biological agents, infectious substances, and vectors. Besides the CDC, presenters will include representatives from the Department of Transportation, Animal and Plant Health Inspection Service, U.S. National Authority for Containment of Poliovirus, Customs and Border Protection, and the Department of Commerce, who will discuss key aspects involved in the importation of infectious biological agents, infectious substances, and vectors.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations
The Food and Drug Administration (FDA, Agency, or we) 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.
Surgical Staplers and Staples for Internal Use-Labeling Recommendations; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance entitled ``Surgical Staplers and Staples for Internal UseLabeling Recommendations.'' FDA is issuing this guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths.
General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify surgical staplers for internal use (formerly regulated under the classification for ``manual surgical instrument for general use'' and assigned the product code GAG) from class I (general controls) into class II (special controls) and subject to premarket review. FDA is identifying the special controls for surgical staplers for internal use that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is issuing this reclassification on its own initiative based on new information. As part of this reclassification, FDA is also amending the existing classification for ``manual surgical instrument for general use'' to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Quarterly Performance Report, OMB No. 0906-0016, Revision
In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this Notice has closed.
Submission for OMB Review; Placement and Transfer of Unaccompanied Children Into ORR Care Provider Facilities (0970-0554)
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on revisions to an approved information collection. The request consists of several forms that allow the Unaccompanied Children (UC) Program to place UC referred to ORR by federal agencies into care provider facilities and to transfer UC within the ORR care provider network.
Termination of Listing of Color Additives Exempt From Certification; Lead Acetate
The Food and Drug Administration (FDA or we) is responding to objections and a public hearing request that we received from Combe Inc., on the final rule entitled ``Termination of Listing of Color Additives Exempt From Certification; Lead Acetate,'' which published on October 31, 2018. The final rule amended the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. Therefore, the stay of the effectiveness for the repeal and delisting of the color additive regulation is now lifted, and we are amending the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp.