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  • 1.  Tracking CFR

    Posted 29-Mar-2013 10:13
    Hello All

    Can someone please help? Does anyone know a way to request auto notification of specific updates to the CFR?  Is there some easy way to find if 312 has changed?

    Your input is much appreciated. In fact any suggestions of clever ways you have of following regulation changes would be interesting to hear.

    Thank you and kind regards
    -carol

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    Carol Bailey RAC
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  • 2.  RE:Tracking CFR

    Posted 29-Mar-2013 10:15

    Original Message


  • 3.  RE:Tracking CFR

    Posted 01-Apr-2013 09:12
    I use Thomson Reuter Cortellis for regulatory intelligence.  For example, I searched for 21 CFR 312, found the document in their database, and can put an alert on it to know when it changes.  However, you need to subscribe. 

    Regards,

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    Rachel Thornton
    Associate Director
    UCB
    Smyrna GA
    United States
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    Original Message


  • 4.  RE:Tracking CFR

    Posted 04-Apr-2013 16:38


    I'm a little surprised nobody has responded to this question, but maybe I missed responses.

    One way to know of changes is to check the Federal Register each day--notifications of proposed (and final) rule changes are all published there.  See:

    http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR

    FDA also offers several e-mail notification services:

    http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/GetEmailUpdates/default.htm

    In addition, the CFR itself includes information on the latest revision date in the locations designated as "SOURCE".  For part 312 the source is given as, "52 FR 8831, Mar. 19, 1987, unless otherwise noted."  Admittedly, you will have to look at each subpart to see the latest revision date, but it's quite complete. You can find the CFR online at:

    http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR

    Hope that helps.

    -------------------------------------------
    Theodore Heise PhD RAC
    VP Regulatory Scientific Affairs
    Cook Incorporated
    Bloomington IN
    United States
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    Original Message


  • 5.  RE:Tracking CFR

    Posted 05-Apr-2013 00:04
    Dr. Heise shares some excellent resources that those who work in this field regularly should take advantage of.

    However, I would add one caveat to his last point.  While a Federal Register cite usually can be found at the end of each CFR section, they are not always substantive citations, especially if they are from the 1970's or early 1980's.  The reason is -- and I have been reminded of this several times in recent months -- is that the CFR citation to the FR sometimes is not to a substantive Federal Register notice, but to a recodification of the regulations, which FDA did periodically during those times.  Thus, you may end up finding that the cite provided at the end of the CFR section is just the beginning of a journey through a series of other FR publications until you get to a FR notice that is substantive.

    And to make the search difficult, the free publicly available FR database only goes back, to the best of my knowledge, to 1994.  Thus, if you are trying to find an earlier FR notice, you may have to rely on a proprietary database such as HeinOnline (the one my law firm uses). 

    Happy hunting!


    ______________________________________________
    Michael A. Swit, Esq.
    Special Counsel, FDA Law Practice
    Duane Morris LLP
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    Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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    Original Message


  • 6.  RE:Tracking CFR

    Posted 06-Apr-2013 08:38


    Michael, that's a good point about the citations in the CFR--and also about the scope of the online FR from GPO.  For those who may not have access to a proprietary database for pre-1994 issues of the FR, there is free (albeit more tedious) option in the Federal Depository Library Program:

    http://catalog.gpo.gov/fdlpdir/FDLPdir.jsp

    Traveling to a library (and using microfiche) can be a pain, but it's an avenue folks may wish to be aware of.

    Thanks for clarifying.

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    Theodore Heise PhD RAC
    VP Regulatory Scientific Affairs
    Cook Incorporated
    Bloomington IN
    United States
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    Original Message


  • 7.  RE:Tracking CFR

    Posted 06-Apr-2013 08:47

    Apologies for following up my own post, but I needed to add two points.

    First, apologies to Rachel--I did not see (in the e-mail digest I look at) her message as the first reply to this topic.

    Second, you can sign up to receive the daily Federal Register Table of Contents via e-mail at this location:
     
    http://listserv.access.gpo.gov/archives/fedregtoc-l.html

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    Theodore Heise PhD RAC
    VP Regulatory Scientific Affairs
    Cook Incorporated
    Bloomington IN
    United States
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    Original Message