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 2012_register executive 2012-08-25 article Notices D09002ee1c7fc8bea D09002ee1c7fc8c67 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United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Self- Identification of Generic Drug Facilities, Sites, and Organizations." On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) (Pub. L. 112-144, Title III) was signed into law by the President. GDUFA, designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. This guidance is intended to assist industry as it prepares to meet the self- identification requirement. It explains who is required to self- identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify. 77 FR 51811 https://www.govinfo.gov/app/details/FR-2012-08-27/2012-20946 2012-20946 fr27au12-81 4160-01-P Docket No. FDA-2010-D-0881 https://www.govinfo.gov/app/details/FR-2012-08-27/2012-20946 https://www.govinfo.gov/content/pkg/FR-2012-08-27/html/2012-20946.htm https://www.govinfo.gov/content/pkg/FR-2012-08-27/pdf/2012-20946.pdf 4 p. 51811 51814 77 FR 51811 Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations; Availability; Federal Register Vol. 77, Issue NOTICE 2012-20946 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2010-D-0881 4160-01-P 2012-20946 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Self- Identification of Generic Drug Facilities, Sites, and Organizations." On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) (Pub. L. 112-144, Title III) was signed into law by the President. GDUFA, designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. This guidance is intended to assist industry as it prepares to meet the self- identification requirement. It explains who is required to self- identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments concerning the proposed collection of information by October 26, 2012. Submit either electronic or written comments on the draft guidance by October 26, 2012. Jaewon Hong, Center for Drug Evaluation and Research (HFD-300), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1-866-405-5367 or 301-796- 6707. Draft Guidances for Industry: Self-Identification of Generic Drug Facilities, Sites, and Organizations , http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 77, no. 166 Office of the Federal Register, National Archives and Records Administration 2012-08-27 continuing daily deposited born digital 195 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-08-27 P0b002ee18345f5bf 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr27au12 https://www.govinfo.gov/app/details/FR-2012-08-27 https://www.govinfo.gov/content/pkg/FR-2012-08-27/pdf/FR-2012-08-27.pdf https://www.govinfo.gov/content/pkg/FR-2012-08-27/xml/FR-2012-08-27.xml fdlp 51681 51865 DGPO 2012-08-25 2024-06-03 FR-2012-08-27 machine generated eng FR FR-2012-08-27 77 166