federal_register: 2011-32548

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-32548 Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements Notice The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 regulations requiring the distribution of patient labeling, called Medications Guides, for certain products that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication. 2011-12-21 2011 12 https://www.federalregister.gov/documents/2011/12/21/2011-32548/agency-information-collection-activities-proposed-collection-comment-request-prescription-drug https://www.govinfo.gov/content/pkg/FR-2011-12-21/pdf/2011-32548.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice...

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