Table of
Content of Background Package
TAB 1 Federal Register Notice: Tentative Final Monograph for OTC Healthcare
Antiseptic Drug Products -
TAB 2 “National Nosocomial Infections Surveillance (NNIS) System Report, data
summary from January 1992 through June 2004, issued October 2004”
TAB 3 John M. Boyce, M.D. and Didier Pittet, M.D. “Guideline for Hand Hygiene in Health-Care
Settings”
TAB 4 21 CFR (Subparts E and H) “Approval based on a surrogate
endpoint or on an effect on a clinical endpoint other than survival or
irreversible morbidity.”
TAB 5 Comments from CTFA/SDA in regards to benefit from use of topical
antiseptics (75N-183H – C80)
TAB 6 Excerpt of comments from CTFA/SDA in regards to the relationship of
benefit to efficacy (75N-183H – CP7, section 3)
TAB 7 Excerpt of comments from CTFA/SDA in regards to the log reduction
performance criteria (75N-183H – CP7, section 4)
TAB 8 Excerpt of comments from CTFA/SDA in regards to the log reduction
performance criteria (75N-183H – CP7, Appendix C)
TAB 9A FDA Reviewer’s Evaluation of CTFA/SDA Submission (CP7 & C80)
TAB 9B Regarding Clinical
Benefit:
·
Healthcare Personnel
Handwashes – Steven Osborne, M.D.
·
Patient Preoperative Skin
Preparations -Steven Osborne, M.D.
·
Surgical Hand Scrubs –
Michelle M. Jackson, Ph.D.
TAB 10A FDA Reviewer’s Literature
Survey to Determine Correlation of Infection
TAB 10B Rates to Microbiological
Endpoints:
·
Healthcare Personnel
Handwashes – Colleen Rogers, Ph.D.
·
Surgical Hand Scrubs –
Michelle M. Jackson, Ph.D.
·
Patient Preoperative Skin Preparations
– Peter Kim, M.D.
TAB 11A FDA Reviewer’s Evaluation of
CTFA/SDA Submission Regarding Log
TAB 11B Reduction Performance Criteria
(CP7 & C80):
·
Healthcare Personnel
Handwashes – Colleen Rogers, Ph.D.
·
Surgical Hand Scrubs - Xin
Zhou, Ph.D.
·
Patient Preoperative Skin
Preparations -Xin Zhou, Ph.D.
TAB 12 Statistics Background Information