Search Results for citation:"86 FR 10108"

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Search Results: citation:"86 FR 10108"

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  • 2021-03258 — Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
    Type:Notice
    Citation:86 FR 10108
    Reading Time:about 8 minutes

    The Food and Drug Administration (FDA) is seeking public comments on a proposed information collection concerning class II special controls for automated blood cell separator devices. This notice, published under the Paperwork Reduction Act of 1995, requires federal agencies to notify the public about proposed information collections and give them 60 days to respond. The FDA is inviting feedback on the utility of the information collection, its accuracy, and suggestions for enhancing its clarity and minimizing the burden on respondents. Comments can be submitted electronically or in writing until April 19, 2021.

    Simple Explanation

    The FDA wants to know what people think about some new rules for machines that separate blood using spinning or filters. They are asking folks to share their thoughts by April 19, 2021, which can help make sure the rules are clear and not too tricky for everyone involved.

  • 2021-03239 — Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee; Renewal
    Type:Notice
    Citation:86 FR 10108
    Reading Time:about 2 minutes

    The Food and Drug Administration (FDA) is renewing the Technical Electronic Product Radiation Safety Standards Committee for another two years, with the new charter effective until December 24, 2022. This committee provides advice to the FDA on setting standards for radiation emissions from electronic products. The committee includes 15 voting members, selected for their expertise in science or engineering related to radiation safety. The renewal is in the public interest to ensure the safeguarding of health and safety through proper regulatory standards.

    Simple Explanation

    The FDA is keeping a special team of experts for two more years to help make rules about how much radiation electronic gadgets can safely give off. This is done to make sure people are healthy and safe.