PPT-1 Instructions / Guidance

This template is a reporting template for product updates or enhancements being promoted into operations The OSPO SPSD Division Chief or his representative will use this information to decide whether to promote a product enhancement into operations These slides do not have to be briefed to the SPSRB. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the not ice announcing the availa bility of the draft guidance Submit electronic comments to httpwwwregulationsgov S Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit written comments to the Di vision of Dockets Mana Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic com ments to httpwwwregulationsgov Su Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 60 calendar days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Mana Federal Register Federal Register US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER March 2014 ClinicalMedical 16617dftdoc 030614 brPage 2br Guidance for Industry Chronic Fatigue Sy Federal Register Federal Register US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER January 2010 Clinical Medical brPage 2br Guidance for Industry Assessment of Abuse Potential of Dr Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management HF Com ents and suggestio ns regar ing this draft do cu ent should be sub itted wit in 9 0 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Subm it comments to the D ivision of Dockets Manage e 3 1 Research ethics committee approval3 2 Grounds for objection 4 3 Labelling of medical devices Guidance Identification Page 2 Legislative Compliance 3 Introduction Procedures Commendations Comments and suggestions regarding this draft docu ment should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management H Career guidance. Associated with initial career choice and young people. Influenced by Frank Parson’s 1909 work ‘Choosing a vocation’ and a ‘talent matching’ process. Led onto, and developed in tandem with, trait-factor or ‘matching’ theories of occupational choice.