Monday, June 20, 2016

21 CFR 803 displays "plain language" from 2005 to current

Not many realize that in 2005, the FDA made a significant change in the language about Medical Devices. The  plain language was introduced in the Federal Register February 28, 2005. In essence, the language changed from "statutory" to "plain English, by adding the "plain language" below the "statutory." Then, after 2005, the language is all in "plain language" for 21 CFR 803.

It is in the 2005 CFR that you will see both versions, "statutory" and "plain language." Going forward, the language is "plain language" from 2006 to current.

Here is the rationale from the Federal Register, 70 FR 9516.

"SUMMARY: The Food and Drug Administration (FDA or we) is amending its regulation governing reporting of deaths, serious injuries, and certain malfunctions related to medical devices. We are revising the regulation into plain language to make the regulation easier to understand, and we are making technical corrections. Elsewhere in this issue of the Federal Register, we are publishing a
companion proposed rule, under FDA’s usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. DATES: This rule is effective July 13, 2005,"

What is the General Approach?

"In this direct final rule, FDA does not change the existing regulatory requirements described previously in this document. FDA is revising part 803 solely to ensure that despite the many revisions that have been made, part 803 is clear and easy to understand. To achieve this goal, we have rewritten part 803 into plain language, in accordance with the Presidential Memorandum on Plain Language, issued on June 1, 1998. That memorandum directed the agency to ensure that all of its documents are clear and easy to read. Part of achieving that goal involves having readers of a regulation feel that it is speaking directly to them. Therefore, we have attempted to incorporate plain language in this rule as much as possible. We have tried to make each section of the companion proposed rule easy to understand by using clear and simple language rather than jargon, by keeping sentences short, and by using active voice rather than passive voice whenever possible. We have also made changes to improve the consistency of the format and language used throughout parallel regulations governing user facilities, importers, and manufacturers that were added or amended at different times. We do not intend these changes to have any effect on the substantive requirements of part 803."

So if you don't see the statutory language, but a simpler language for 21 CFR 803 after 2006, you will know why.

Monday, June 06, 2016

Before the Revisor harmonizes the Health and Safety Code 81.046

It happens when bills are being passed quickly and the Texas Legislative Council doesn't have time to harmonize things.

Take a look at Texas Health and Safety Code, Section 81.046 - Confidentiality.

There are two sections "C". 

One was passed by Acts 2015, 84th Legislature, Chapter 789 (House Bill 2646) Section 1. This has 7 items. The first 5 items passed by the House are identical to the five items passed by the Senate.

The second "C" was passed by Act 2015, 84th Legislature, chapter 1278 (Senate Bill 1574) Section 6. Items 6 of each bill are different, and there is no item 7.

Obviously, this needs to be looked at and harmonized during the next legislature, but until then, both sections must be followed. Here is the link to 81.046.

Text of subsection as amended by Acts 2015, 84th Leg., R.S., Ch. 789 (H.B. 2646), Sec. 1, eff. September 1, 2015
(c) Medical or epidemiological information, including information linking a person who is exposed to a person with a communicable disease, may be released:
(1) for statistical purposes if released in a manner that prevents the identification of any person;
(2) with the consent of each person identified in the information;
(3) to medical personnel treating the individual, appropriate state agencies in this state or another state, a health authority or local health department in this state or another state, or federal, county, or district courts to comply with this chapter and related rules relating to the control and treatment of communicable diseases and health conditions or under another state or federal law that expressly authorizes the disclosure of this information;
(4) to appropriate federal agencies, such as the Centers for Disease Control and Prevention of the United States Public Health Service, but the information must be limited to the name, address, sex, race, and occupation of the patient, the date of disease onset, the probable source of infection, and other requested information relating to the case or suspected case of a communicable disease or health condition;
(5) to medical personnel to the extent necessary in a medical emergency to protect the health or life of the person identified in the information;
(6) to governmental entities that provide first responders who may respond to a situation involving a potential communicable disease of concern and need the information to properly respond to the situation; or
(7) to a local health department or health authority for a designated monitoring period based on the potential risk for developing symptoms of a communicable disease of concern.

Text of subsection as amended by Acts 2015, 84th Leg., R.S., Ch. 1278 (S.B. 1574), Sec. 6, eff. September 1, 2015
(c) Medical or epidemiological information may be released:
(1) for statistical purposes if released in a manner that prevents the identification of any person;
(2) with the consent of each person identified in the information;
(3) to medical personnel treating the individual, appropriate state agencies in this state or another state, a health authority or local health department in this state or another state, or federal, county, or district courts to comply with this chapter and related rules relating to the control and treatment of communicable diseases and health conditions or under another state or federal law that expressly authorizes the disclosure of this information;
(4) to appropriate federal agencies, such as the Centers for Disease Control and Prevention of the Unites States Public Health Service, but the information must be limited to the name, address, sex, race, and occupation of the patient, the date of disease onset, the probable source of infection, and other requested information relating to the case or suspected case of a communicable disease or health condition;
(5) to medical personnel to the extent necessary in a medical emergency to protect the health or life of the person identified in the information; or
(6) to a designated infection control officer.
(c-1) A local health department or health authority shall provide to first responders the physical address of a person who is being monitored by the local department or authority for a communicable disease for the duration of the disease's incubation period. The local health department, health authority, or other governmental entity, as applicable, shall remove the person's physical address from any computer-aided dispatch system after the monitoring period expires.
(c-2) Only the minimum necessary information may be released under Subsections (c)(6) and (7) and (c-1), as determined by a health authority, local health department, governmental entity, or department.

Wednesday, June 01, 2016

Dodd-Frank Act Information

If you have ever had to research the Dodd-Frank Act, you know that it can take some time determining where to begin your journey.

Here are four useful resources that are not behind a paywall, so you don't need credentials to access the information.

Law Librarians' Society of Washington, D.C.
http://www.llsdc.org/dodd-frank-legislative-history
This resource was last updated July 29, 2015 and provides links to bill versions and hearings.

U.S. Commodities Futures Trading Commission
http://www.cftc.gov/LawRegulation/DoddFrankAct/index.htm
This resource is organized within a drop down menu from the Dodd-Frank Act, and a page with topics such as Rule-Writing Process and External Meetings, to name just two. For current and historic documents organized in one place.

Federal Reserve Bank of St. Louis
https://www.stlouisfed.org/federal-banking-regulations/
Search 'Dodd-Frank' in the search window for all banking regulations that relate to Dodd-Frank.

Securities and Exchange Commission
https://www.sec.gov/spotlight/dodd-frank.shtml
'Implementing the Dodd-Frank Wall Street Reform and Consumer Protection Act' is organized into four categories: Mandatory Rule Making Provisions; Public Comments; New Offices; and Reports & Studies.

Thursday, April 28, 2016

DALL Formally Endorses UELMA's Enactment in Texas

DALL's executive board formally adopted a resolution to support UELMA's adoption in Texas on March 8, 2016.

What is UELMA?
The Uniform Electronic Legal Materials Act ("UELMA") seeks to ensure that online official state legal material -- namely constitutions, session laws, codified laws, and regulations are unaltered, preserved, and permanently available to the public. UELMA offers an outcomes-based approach leaving it to the individual state enacting UELMA to decide how best to ensure the requirements of the statute are met.

This concept may already be familiar to some as the federal government has taken steps to ensure that federal government documents are authenticated. When accessing documents provided by the GPO, such as those available on FDsys, the words "Authenticated U.S. Government Information" appear on the first page and the certification provided by the Superintendent of Documents can be examined.

UELMA was drafted by the Uniform Law Commission and has wide support from the law community, including support by the American Association of Law Libraries, the American Bar Association, and many other regional and local law library associations. Specifically in Texas, the Houston Area Law Librarians and the Texas Library Association have also adopted resolutions in support of UELMA.

For more information concerning UELMA visit AALL's website:
http://www.aallnet.org/documents/government-relations/uelma

You may also wish to visit the Uniform Law Commission's website concerning UELMA. It also features a helpful enactment status map so you can identify where other states are in their process of having UELMA enacted:
http://www.uniformlaws.org/Act.aspx?title=Electronic+Legal+Material+Act

To assist UELMA's passage contact your Texas State Senator and State Representative and urge their support of UELMA in the next legislative session visit (or if you live in another state get in touch with your senator and representative):
http://www.fyi.legis.state.tx.us/Address.aspx

Wednesday, April 06, 2016

Visit the Texas State Law Library's New Resource Site!

Checkout the Texas State Law Library's Web Portal: http://www.sll.texas.gov/

Here are just a few of the many resources available:

  • Historical Texas Statutes (1879-1960) -- not available electronically elsewhere
  • HeinOnline*
  • Nutshell e-books* 
  • Texas Court Rules

*Texas residents who are not currently registered patrons can register to become library patrons and access these resources. For more information see the TSLL Library Use Policy.

Registered Texas users can also ask questions of the reference librarians!

For more detailed information on this great resource, read the article in the April issue of the Texas Bar Journal, available here.

Tuesday, March 29, 2016

Join us for the DALL Institute on Thursday, April 14th

Join us for the DALL Institute at UNT Dallas College of Law, prior to the SEAALL / SWALL Joint Annual Meeting.

We have pulled together a remarkable program about competency of legal technology and the practice of law. While not directly related to the duties most of us perform in our institutions, this is an evolving area that has ethical implications. Everyone connected to legal practice should be aware of these issues, especially in how we support our users in the most technologically sound and proficient way!

To register or for additional information visit http://libguides.lawschool.untsystem.edu/c.php?g=221407&p=2334624


Thursday, February 11, 2016

AALL Members Vote Down the Proposed Name Change

Members of the American Association of Law Libraries voted overwhelmingly to keep its name; a name that goes back to its formation in 1906. 80.11% of those voting, voted to keep the name, while 19.89% were in favor of the name change to the Association for Legal Information. 59.51% of AALL's membership voted in this election that has fueled much ongoing discussion.

For more information on the vote including a breakdown statistically of many of those voting, see http://www.aallnet.org/hc/NewsCallout/AALL-ebriefing-feb11.html

Information on the rebranding itself can be found here: http://www.aallnet.org/rebrand. This includes access to member discussions in the My Communities Discussion page (accessible to AALL members).

Monday, January 11, 2016

NYPL Labs Remix Residency

New York Public Library offers its first Virtual $2,000 residency to do transformative things with its digital collection!

http://www.nypl.org/help/about-nypl/fellowships-institutes/remix

Timeline: February 19, 2016 -> March 11, 2016 -> June 30, 2016

Complete the the application form by 11:59 pm February 19, 2016.
https://docs.google.com/forms/d/1PfXtiXQJVTSlVaAHjGz8DDdkCHhHxGISUsj13mGafI4/viewform?c=0&w=1 


March 11, 2016
A panel of experts will review submissions and two winners will be chosen by Friday, March 11, 2016. 

June 30, 2016
The project will be due at the end of June 2016.
Individuals or teams may submit proposals.

Recipients will receive:
  • A $2,000 stipend
  • An opportunity to meet and consult with NYPL curators and NYPL Labs staff
  • A work space in one of our research study rooms at NYPL's historic Stephen A. Schwarzman Building for the duration of the residency
  • Promotion of finished work by NYPL Labs
The NYPL is seeking submissions for projects that provide new ways of looking at or presenting public domain materials—or allow access to the information or beauty currently locked within the static images it has digitized. Submissions may include:
  • Mappings
  • Visualizations
  • Generative Art
  • Games
  • Bots
  • Interactives

Evaluation of your proposal:
  • Creativity and engagement: Is the project re-using NYPL public domain materials in an engaging way that we haven't seen before?
  • New perspective and usability: Will this project help users see the collections in new ways, by recontextualizing, remixing, or recombining the collection?
  • Feasibility: Is the project scaled and scoped so that it can be completed during the duration of the residency?
More about the NYPL Labs
http://www.nypl.org/collections/labs

Wednesday, December 16, 2015

Access to Court Opinions Expands - UELMA is Model

Richard Leiter, Director of the Library, at University of Nebraska College of Law commented that the change adopted by the Nebraska Supreme Court was rolled out after two years of planning with the goal of being UELMA compliant.  


In February, our chapter program will be by Barbara Bintliff to provide us her guidance of needs to be done to move forward with UELMA legislation here in Texas in 2017.

For an update on the progress of UELMA being enacted check out this link to see AALL's progress chart.


Below is the original post about Nebraska's change:


Access to Court Opinions Expands

Text-searchable opinions dating back to 1871 will be available for the Nebraska Supreme Court. The full collection of opinions of the Nebraska Court of Appeals, beginning with its establishment in 1992, will also be offered.

Previously, appellate court opinions were printed or were available online through various for-profit subscription services. All published opinions will be provided via the Nebraska Appellate Courts Online Library at ne.gov/go/opinions. Once printing of judicial opinions in the Nebraska Advance Sheets and the Decisions of the Nebraska Court of Appeals ceases in June 2016, opinions will be available exclusively online.

Newly released opinions of both courts will continue to be available for 90 days on the Nebraska Judicial Branch Web site at https://supremecourt.nebraska.gov/ and from the Clerk of the Supreme Court and Court of Appeals upon request, and from any electronic provider of legal information choosing to provide them.

Official opinions in the online library will be accessible 24/7 using smart phones, tablets or computers from anywhere with Internet access. Access via the online library allows the appellate courts to make their judicial opinions more easily available to the public.
Monday, December 14, 2015


Free online access to the official published judicial opinions of the Nebraska Supreme Court and Nebraska Court of Appeals will be available to the public beginning January 1, 2016.