Site Translators for US Federal Law (USC), Code of Federal Regulations (CFR), and New Item Types

kmilgram
edited April 1, 2022

Hello,

I have a need for three new types of items, which I believe are not really handled well by any of the current Zotero item types.

  1. STANDARDS
  2. REGULATIONS
  3. GUIDANCE DOCUMENTS

1/3 - STANDARDS

Searching through the forums, I found this post from March 2016 that also requested STANDARDS . I just mention it to highlight how important this type of item, as well as the other two, are to those of us who work in regulated industries. Although I have been using Zotero for over almost 8 years now, I never really saw the need for this item type until I started working closely with regulatory affairs and legal personnel. I have been using either the report, statute, or book/book section types, but none of them are satisfactory.

Also, having a translator for the ANSI standard search site, NSSN.org , would cover a block of 9 very major standards. All of the categories of items in the list below are searchable from the NSSN.org site. Note that items one - nine are proper standards.

However, item 10 is a regulation, which is different from a law/statute. I run into this issue all of the time. Has anyone else asked for a regulation type?

  1. American National Standards
  2. US Standards
  3. ISO/IEC/ITU Approved Standards
  4. Non-US National and Regional Standards
  5. US DoD Approved Standards
  6. ANS Under Development
  7. ISO/IEC Development Projects
  8. US DoD Development Projects
  9. CFR (Code of Federal Regulations) References

In case it helps, here are some links to some other standards sites that for which having a translator would be extremely useful. I would love to write a translator myself, but after reviewing the documentation for it, I'm not sure that my programming skills are up to snuff.

2/3 - REGULATIONS

Although the NSSN.org site can be used to look up regulations in the USA's CODE OF FEDERAL REGULATIONS (CFR), the official US Government site for the CFR is http://ecfr.gov.

Considering the complexity of the HTML on some of the sites that Zotero can currently decipher, I'm guessing that the clean, highly structured format of the eCFR site would be a breeze to extract.

Is that assumption correct?

On a related note, the US Government maintains a companion site for the CFR that's just in XML. Here's a link to the XML version of 21-CFR-201 and here's a linkto the standard version of 21-CFR-201.

3/3 - GUIDANCE DOCUMENTS

Many organizations can issue GUIDANCE DOCUMENTS, both governmental and non-governmental. However, I'm most familiar with those that are issued by the FDA.

In the case of the FDA, Guidance Documents can be either DRAFT or FINAL. Here are links to examples of both types:

  1. FDA DRAFT BIOANALYTICAL GUIDANCE FOR INDUSTRY (PDF)
  2. FDA FINAL BIOANALYTICAL GUIDANCE FOR INDUSTRY (PDF)

The actual documents themselves are PDFs. I love the Retrieve meta-data for PDF feature in Zotero.

Reading through the documentation, I understand why this feature works for so many journal articles, namely the identification of a DOI. This feature does not work for FDA Guidance Documents because they do not contain a DOI. However, they do contain a Federal Docket number, which is an identifier in the Federal Docket System (FDS).

The FDS appears to use very simple URL mechanism for retrieving the docket. For example, here is the FDA Guidance for Industry: Acrylamide in Foods in PDF. If you click through, you'll see the following text on the cover page:

All comments should be identified with the docket number [FDA–2013–D–0715] listed in the notice of availability that publishes in the Federal Register.

The corresponding docket, which contains all of the information needed to cite this document, is available via http://www.regulations.gov/#!docketDetail;D=FDA-2013-D-0715

Considering the highly structured nature of this information and the importance of the FDA, what's the likelihood of being able to have Zotero auto-retrieve the metadata for FDA Guidance docs in PDF format?

  • LiborA
    I think guidance documents could be saved as type Report. I use this type for all guidance documents which I have in my library.
    Metadata in FDA files are problematic. For example Guidance "Ingredients Declared as Evaporated Cane Juice: Guidance for Industry" has the title "Guidance for Industry" in metadata and topic "Ingredients Declared as Evaporated Cane Juice". Guidance "Guidance for Industry Acrylamide in Foods" has in metadata title "Guidance Outline" and nothing in topics;
    It means that the likelihood of being able to have Zotero auto-retrieve the metadata for FDA Guidance docs in PDF format is zero.
  • fbennett
    If you are working with legal documents, you might (well, you should) take a look at Juris-M, a variant of Zotero that is built to handle legal and multilingual referencing requirements. Some notes on it that are relevant to the issues you raise:
    • Juris-M offers Regulation and Standard item types.
    • Translators for sites of standards organizations could be built. Involving someone with a direct stake in their maintenance in the coding process would probably be a good idea, to help assure that they keep working once built.
    • Same goes for materials in FDsys. I maintain translators for legal resource sites in several countries in Asia, and for a few in the U.S. and Europe, in support of work by postgrad students in our faculty here at Nagoya University. As far as I know, we don't have a call for full FDsys support, so someone with a stronger interest would need to take it on.
    • On guidance documents, Report should indeed work fine. In Juris-M, the Report type has a Jurisdiction field, and with modular legal style support, that gives you pretty complete control over the formatting of government-report citations (which can otherwise be pretty idiosyncratic).
  • fbennett
    (@kmilgram: It looks like a style block or mismatched tag in your post has corrupted formatting for this thread, on my browser at least. If it's broken at your end as well, it might be worth taking a look to see if it can be fixed.)
  • kmilgram
    To everyone who participated in this thread:
    If you are getting notifications for the revival of this zombie thread and they bother you, please accept my apologies. I didn't see your replies at the time when the thread was fresh because I'd mistakenly disabled notifications.

    @LiborA:
    Thank you for the really helpful explanation of the challenges of automatically parsing FDA Guidance docs. I suspected that an issue like the one described might make parsing these docs difficult.

    @fbennett:
    First, please let me know if the thread renders properly now. As you correctly surmised, in my original post, I'd posted HTML directly into the editor here, and it contained some errors.

    I believe there were two problems with my HTML content, both of which have been fixed. For the first problem, I was not aware that the editor here would recognize white space inside HTML element tags.

    For the second problem, in some of my <a> elements, the URLs for their src properties contained & characters for parameter separation. During the cutting and pasting process, they got converted from &amp; to & characters. I didn't see the formatting problem when I previewed my post because I use an extension to automatically disable CSS for web-pages by default, and I guess my browser (i.e., Firefox), rendered the content correctly, despite the invalid URLs.

    Second, thank you for the Juis-M recommendation. I was not familiar with it. Just based on a cursory glance of the website for Juris-M, it appears to be precisely the kind of tool that I've been looking for with regard to managing citations for regulatory affairs documentation.
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