federal_register: 99-33003

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

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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
99-33003 Premarket Notification; Requirement for Redacted Version of Substantially-Equivalent Premarket Notification Proposed Rule The Food and Drug Administration (FDA) is proposing to amend its premarket notification regulations to require applicants to submit a redacted version of each premarket notification submission for which FDA has issued an order declaring a device to be substantially equivalent to a legally marketed predicate device. The purpose of this requirement is to provide applicants improved opportunity to protect nonpublic information contained in their premarket notifications while facilitating the release of information to which the public is entitled under the Federal Food, Drug, and Cosmetic Act (the act); the Freedom of Information Act; and FDA's Public Information regulations. The proposed rule does not require submission of a redacted version of any premarket notification received by FDA prior to the effective date of the regulation. 1999-12-21 1999 12 https://www.federalregister.gov/documents/1999/12/21/99-33003/premarket-notification-requirement-for-redacted-version-of-substantially-equivalent-premarket https://www.govinfo.gov/content/pkg/FR-1999-12-21/pdf/99-33003.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to amend its premarket notification regulations to require applicants to submit a redacted version of each premarket notification submission for which FDA has issued an order declaring a device to be...  

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