federal_register: 03-31412

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
03-31412 Agency Information Collection Activities; Comment Request; Guidance for Industry-Changes to an Approved New Drug Application or Abbreviated New Drug Application 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 the collection of information contained in a guidance for industry entitled "Changes to an Approved NDA or ANDA." 2003-12-19 2003 12 https://www.federalregister.gov/documents/2003/12/19/03-31412/agency-information-collection-activities-comment-request-guidance-for-industry-changes-to-an https://www.govinfo.gov/content/pkg/FR-2003-12-19/pdf/03-31412.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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