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(A) Descriptive information. (1 ) A narrative summary and analysis of the information in the report;

(2 ) An analysis of the 15-day Alert reports submitted during the reporting interval (all 15-day Alert reports being appropriately referenced by the applicant's patient identification code for nonvaccine biological product reports or by the unique case identification number for vaccine reports, adverse reaction term(s), and date of submission to FDA); CFR - Code of Federal Regulations Title 21

Could you please help me with this structure? I can't figure out which elements are combined by "or" and "and".

I assume it means:

by 1) the applicant's patient identification code for nonvaccine biological product reports OR by 2) the unique case identification number

and the unique case identification number for 1) vaccine reports, 2) adverse reaction term(s), and 3) date of submission to FDA

Am I correct?

(3 ) A history of actions taken since the last report because of adverse experiences (for example, labeling changes or studies initiated);

(4 ) An index consisting of a line listing of the applicant's patient identification code for nonvaccine biological product reports or by the unique case identification number for vaccine reports and adverse reaction term(s) for ICSRs submitted under paragraph (c)(2)(ii)(B) of this section; and

And here again, why is there "by" after or? Is this "an index by"?

And lastly, is "adverse reaction term(s)" paralleled with vaccine reports?

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Here's what it looks like to me:

(ii)(A)(2) says that each 15-day alert report has to be labeled with three things: first, the appropriate patient ID code (or the appropriate vaccine report ID code); second, the adverse reaction term(s); and third, the date of submission to the FDA.

(ii)(A)(4) says that when you send a batch of 15-day alert reports, you have to include sort of a table of contents (TOC), or index, of everything in your submission. For each item in the TOC, there must be two things: first, a patient ID code (or vaccine report ID code); and second, the relevant adverse reaction term(s).

I think that your interpretation is correct (if I understood it right).

The last "by" is an accident.

Tangential remark: when I am wading through regulations I find it helpful to copy the whole text, paste it into MS Word, and indent paragraphs, multiple times if necessary, to make the structure of the outline clearer to myself as I'm reading it. I visited the link you provided and did the copy-paste-indent-indent, and this made the text a tiny bit easier for me to read. Example:

outline with indenting to show outline structure

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  • You saved me. Thank you very much. Sep 16, 2019 at 5:01
  • @MangoGummy - Glad to help. Sep 16, 2019 at 5:02
  • Oh btw, I was wrong since I thought in A (2), the unique case identification number for 1) vaccine reports, 2) adverse reaction term(s), and 3) date of submission to FDA. (I thought the id number was about those three.) Sep 16, 2019 at 5:06

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