United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2007_register executive 2014-05-29 article Rules and Regulations D09002ee1c8098b73 D09002ee1c8098c61 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is issuing regulations to permit FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). Under this rule, the appropriate FDA Center Director may grant an exception or alternative to such labeling requirements if he or she determines that compliance with the requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of human drugs, biological products, or medical devices that are or will be included in the SNS, including not only those that are approved, licensed, or cleared for marketing, but also those that are investigational. A grant of an exception or alternative under these regulations will include any safeguards or conditions deemed appropriate by the FDA Center Director to ensure that the labeling of such products includes information for the safe and effective use of the products given their anticipated circumstances of use. This rule will facilitate the safety, effectiveness, and availability of appropriate medical countermeasures in the event of a public health emergency. 72 FR 73589 https://www.govinfo.gov/app/details/FR-2007-12-28/E7-25165 E7-25165 fr28de07-9 4160-01-S Docket No. 2006N-0466 https://www.govinfo.gov/app/details/FR-2007-12-28/E7-25165 https://www.govinfo.gov/content/pkg/FR-2007-12-28/html/E7-25165.htm https://www.govinfo.gov/content/pkg/FR-2007-12-28/pdf/E7-25165.pdf Drugs Labeling Reporting and Recordkeeping Requirements Exports Imports Investigations Medical Research Safety Administrative Practice and Procedure Confidential Business Information Biologics Medical Devices Health Records 14 p. 73589 73602 72 FR 73589 Title 21 Part 201 21 CFR Part 201 Title 21 Part 312 21 CFR Part 312 Title 21 Part 314 21 CFR Part 314 Title 21 Part 601 21 CFR Part 601 Title 21 Part 610 21 CFR Part 610 Title 21 Part 801 21 CFR Part 801 Title 21 Part 807 21 CFR Part 807 Title 21 Part 809 21 CFR Part 809 Title 21 Part 812 21 CFR Part 812 Title 21 Part 814 21 CFR Part 814 Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile; Federal Register Vol. 72, Issue RULE E7-25165 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2007-12-28 2008-03-27 Docket No. 2006N-0466 4160-01-S E7-25165 Interim final rule; request for comments.

The Food and Drug Administration (FDA) is issuing regulations to permit FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). Under this rule, the appropriate FDA Center Director may grant an exception or alternative to such labeling requirements if he or she determines that compliance with the requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of human drugs, biological products, or medical devices that are or will be included in the SNS, including not only those that are approved, licensed, or cleared for marketing, but also those that are investigational. A grant of an exception or alternative under these regulations will include any safeguards or conditions deemed appropriate by the FDA Center Director to ensure that the labeling of such products includes information for the safe and effective use of the products given their anticipated circumstances of use. This rule will facilitate the safety, effectiveness, and availability of appropriate medical countermeasures in the event of a public health emergency.

The interim final rule is effective on December 28, 2007. Submit written or electronic comments on the interim final rule by March 27, 2008. Submit written or electronic comments regarding the information collection by January 28, 2008 to the Office of Management and Budget (OMB) (see ADDRESSES). For information concerning human biological products: Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. Drugs Labeling Reporting and Recordkeeping Requirements Exports Imports Investigations Medical Research Safety Administrative Practice and Procedure Confidential Business Information Biologics Medical Devices Health Records Human drugs, biological products, or medical devices: Strategic National Stockpile; product labeling requirements; exceptions or alternatives, http://www.fda.gov/dockets/ecomments http://www.fda.gov/ohrms/dockets/default.htm http://www.regulations.gov Vol. 72, no. 248 Office of the Federal Register, National Archives and Records Administration 2007-12-28 continuing daily deposited born digital 594 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2007-12-28 P0b002ee1892c77c3 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28de07 https://www.govinfo.gov/app/details/FR-2007-12-28 https://www.govinfo.gov/content/pkg/FR-2007-12-28/pdf/FR-2007-12-28.pdf https://www.govinfo.gov/content/pkg/FR-2007-12-28/xml/FR-2007-12-28.xml fdlp 73573 74152 DGPO 2014-05-29 2024-06-05 FR-2007-12-28 machine generated eng FR FR-2007-12-28 72 248