Attachment B CISA Basic SOW References pre solicitation 3_28_12.docx
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- Clinical Immunization Safety Assessment (CISA) Federal contract opportunity
- Solicitation number
- 2012-N-14296
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ATTACHMENT B
CISA BASIC STATEMENT OF WORK REFERENCES
1. Salmon D, Pavia A, Gellin B. Editor’s Introduction: Vaccine Safety throughout the Product’s Life Cycle. Pediatrics;2011; May;127 Suppl 1:S1-4. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S1.full, accessed on February 29, 2012
2. Marshall V and Baylor N. Food and Drug Administration Regulation and Evaluation of Vaccines, Pediatrics;2011; May;127 Suppl 1:S23-30. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/early/2011/04/18/peds.2010-1722E.full.pdf+html, accessed on February 29, 2012
3. Ball R, Horne D, Izuriet H et al. Statistical, Epidemiologic, and Risk Assessment Approaches to Evaluating Safety of Vaccines throughout the lifecycle at the Food and Drug Administration, Pediatrics;2011; May;127 Suppl 1:S31-8. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S31.full, accessed on February 29, 2012
4. Zhou, W, Pool V, Iskander J et al. Surveillance for Safety After Immunization: Vaccine Adverse Event Reporting System (VAERS) --- United States, 1991--2001. Morbidity and Mortality Weekly Report (MMWR). January 24, 2003 / 52(ss01);1-24, available at http://www.cdc.gov/mmwr/preview/mmwrhtmL/ss5201a1.htm, accessed on February 29, 2012
5. HHS, Vaccine Adverse Event Reporting System, available at http://vaers.hhs.gov/index, accessed on October 16, 2011
6. Baggs J, Gee J, Lewis E et al. The Vaccine Safety Datalink: A Model for Monitoring Immunization Safety, Pediatrics;2011; May;127 Suppl 1:S45-53. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S45.long, accessed on February 29, 2012
7. Food and Drug Administration. Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, March 2005, available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf, accessed on March 5th, 2012
8. Kelly WN, Arellena FM, Barnes J et al. Guidelines for submitting adverse event reports for publication, Pharmacoepidemiology and drug safety 2007; 16: 581–587, available at www.pharmacoepi.org/resources/pds1399.pdf, accessed on February 29, 2012
9. Institute of Medicine (IOM). Adverse Effects of Vaccines: Evidence and Causality, Released August 25, 2011, available at http://www.iom.edu/Reports/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality.aspx, accessed on October 16, 2011.
10. Centers for Disease Control and Prevention’s Immunization Safety Office Scientific Agenda, available at http://www.cdc.gov/vaccinesafety/Activities/agenda.html, accessed on January 15, 2012
11. American Academy of Pediatrics Immunization, available at http://www.aap.org/immunization/, accessed on October 16, 2011.
12. Miller, E, Batten B, Hampton L, Tracking Vaccine Safety Inquiries to Detect Signals and Monitor Public Concerns. Pediatrics;2011;127;S1, originally published April 18, 2011, available at http://pediatrics.aappublications.org/content/early/2011/04/18/peds.2010-1722M.abstract
13. LaRussa P et al. Understanding the Role of Human Variation in Vaccine Adverse Events: The Clinical Immunization Safety Assessment (CISA) Network. Pediatrics. 2011 May;127 Suppl 1:S65-73, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S65.long, accessed on February 29, 2012
14. CDC Executive Summary: External Peer Review of the Clinical Immunization Safety Assessment (CISA) Network, Immunization Safety Office, Division of Healthcare Quality Promotion December 9-10, 2010, Atlanta, Georgia, available at http://www.cdc.gov/vaccinesafety/00_pdf/CISA-exec-summary-peer-review-june2011.pd, accessed on October 16, 2011.
15. US Department of Health and Human Services. 2010 National Vaccine Plan, available at http://www.hhs.gov/nvpo/vacc_plan/2010%20Plan/nationalvaccineplan.pdf, accessed on October 16, 2011.
16. CDC, Advisory Committee on Immunization Practices (ACIP), available at http://www.cdc.gov/vaccines/recs/acip/, accessed on January 27, 2012.
17. Salmon D, Akhtar A, Mergler M et al. Immunization-Safety Monitoring Systems for the 2009 H1N1 Monovalent Influenza Vaccination Program. Pediatrics 2011; 127:S78-S86, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S78.full, accessed on February 29, 2012
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