Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p7
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 17108–20476

and journal editors. These resources are all available online. A list of links to useful resources is provided below:

    (i) Equator Network: overview of reporting guidelines
    http://www.equator-network.org/index.aspx?o=1032
    (ii) GRADE: Grades of Recommendation, Assessment, Development, and Evaluation
    http://www.jclinepi.com/content/jce-GRADE-Series

    (iii) CONSORT Statement: Consolidated Standards Of Reporting Trials
    http://www.consort-statement.org/

    (iv) PRISMA Statement (formerly QUOROM): Preferred Reporting Items for Systematic Reviews and Meta-Analyses
    http://www.prisma-statement.org/

    (v) STARD Statement: Standards for Reporting Studies of Diagnostic Accuracy
    http://www.consort-statement.org/resources/downloads/other-instruments/

    (vi) MOOSE Statement: proposal for reporting meta analyses of observational studies in epidemiology
    http://www.consort-statement.org/index.aspx?o=1347

    (vii) STARLITE Statement: Standards for Reporting Literature searches
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1629442/pdf/i1536-5050-094-04-0421.pdf

    (viii) STROBE Statement (& STREGA): STrengthening the Reporting of OBservational studies in Epidemiology.
    http://www.strobe-statement.org/

     F Assessment procedure

If related to a variation to the Code, the application must provide details as to what an applicant considers. is the appropriate procedure to be adopted in assessing the application i.e. general, minor, major or high level health claim variation. This is a requirement under paragraph 22(2)(e) of the FSANZ Act. As a matter of practice, FSANZ has regard to the applicant's suggestion, but makes its own determination on the process to be adopted. The process to be adopted by FSANZ will be communicated to FSANZ in accordance with section 27(c) of the FSANZ Act.

Note:

FSANZ makes the final determination on the appropriate procedure and cost recovery level (based on the number of hours. estimated for the assessment) during the administrative assessment, taking account of the purpose and complexity of the application.

     G Confidential commercial information (CCI)

Any information that the applicant considers. to be CCI must be identified as CCI. This information must be separated from the other parts of the application (both electronically and in hard copy).

The application must be accompanied by a written explanation of why and how that identified information is CCI. That is, how that information satisfies the definition of CCI in section 4 of the FSANZ Act.

The application must be accompanied by provide a non-confidential general summary of any information that they consider to CCI. That summary must be sufficiently detailed for it to be useful for assessment. This allows FSANZ to address the information in general terms as part of the assessment.

Note:

FSANZ may not accept an applicant's claim that information is CCI. In such a case, if FSANZ is satisfied that the information is not CCI, FSANZ will advise the applicant that it does not consider that the material is protected by section 114 of the FSANZ Act.

FSANZ will deal with CCI in accordance with section 114 of the FSANZ Act. Applicants should note that section 114 allows CCI to be disclosed to third parties in certain circumstances.

FSANZ will provide CCI to advisory committees or