Texas Register, Volume 34, Number 33, Pages 5445-5614, August 14, 2009 Page: 5,467
5445-5614 p. ; 28 cm.View a full description of this periodical.
Extracted Text
The following text was automatically extracted from the image on this page using optical character recognition software:
five-year period the sections are in effect, there will be no fiscal
implications to state or local government as a result of enforcing
or administering the sections as proposed, because there is no
cost impact to state or local government.
ECONOMIC IMPACT STATEMENT AND REGULATORY FLEX-
IBILITY ANALYSIS FOR SMALL AND MICRO-BUSINESSES
Dr. Suarez has also determined that there will be no adverse
economic impact on small businesses or micro-businesses re-
quired to comply with the sections as proposed. This was de-
termined by interpretation of the rules that small businesses and
micro-businesses will not be required to alter their business prac-
tices in order to comply with the sections. An economic impact
statement and regulatory flexibility analysis are not required.
ECONOMIC IMPACT TO PERSONS AND IMPACT ON LOCAL
EMPLOYMENT
There are no anticipated economic costs to persons who are
required to comply with the sections as proposed. There is no
anticipated impact on local employment.
PUBLIC BENEFIT
In addition, Dr. Suarez has also determined that for each year of
the first five years the sections are in effect, the public will benefit
by added clarity to the definitions. The amendments allow the
department to collect data in a more efficient and convenient
manner. The amendments clarify the department's policies and
procedures regarding access to data and the allowed research
use of the data.
In adopting the rules which cover this program, the department
has considered the known incidence and prevalence rates of
birth defects in the state; the known incidence and prevalence
rates of particular birth defects in specific population groups who
live in the state or portions of the state; the morbidity and mor-
tality resulting from these birth defects; and the existence, cost,
and availability of a strategy to prevent and treat these birth de-
fects.
REGULATORY ANALYSIS
The department has determined that this proposal is not a
"major environmental rule" as defined by Government Code,
2001.0225. "Major environmental rule" is defined to mean a
rule the specific intent of which is to protect the environment
or reduce risk to human health from environment exposure
and that may adversely affect, in a material way, the economy,
a sector of the economy, productivity, competition, jobs, the
environment or the public health and safety of a state or a
sector of the state. This proposal is not specifically intended to
protect the environment or reduce risks to human health from
environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed amendments
do not restrict or limit an owner's right to his or her property that
would otherwise exist in the absence of government action and,
therefore, do not constitute a taking under Government Code,
2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Mark Canfield,
Ph.D., Department of State Health Services, MC 1964, P.O. Box
149347,1100 West 49th Street, Austin, Texas 78714-9347, tele-
phone (512) 458-7232, fax (512) 458-7330. Comments will beaccepted for 30 days following publication of the proposal in the
Texas Register.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa
Hernandez, certifies that the proposed rules have been reviewed
by legal counsel and found to be within the state agencies' au-
thority to adopt.
STATUTORY AUTHORITY
The amendments are authorized by Health and Safety Code,
87.001, which allows the department to specify which health
facilities are required to report information on birth defects;
87.021 (d), which requires the department to adopt rules to
govern the operation of the program and carry out the intent of
the statute; 87.022(b) and (c), which requires the department
to adopt rules on how information is made available to the
department; 87.063(a), which requires the department to adopt
rules to establish criteria to be used in deciding if research which
proposes to use birth defect data should be approved; and the
Government Code, 531.0055, and Health and Safety Code,
1001.075, which authorize the Executive Commissioner of the
Health and Human Services Commission to adopt rules and
policies necessary for the operation and provision of health and
human services by the department and for the administration
of Health and Safety Code, Chapter 1001. Review of the rules
implements Government Code, 2001.039.
The amendments affect Health and Safety Code, Chapters 87
and 1001; and Government Code, Chapter 531.
37.301. Purpose.
These sections implement the provisions of Health and Safety Code,
Chapter 87, [to the Health and Safety Code. Chapter 87] that provides
[the Texas Board of Health with] the authority to adopt rules relating
to the surveillance and control of birth defects. The legislation directs
the Texas Department of Health to develop a statewide surveillance
program. The Texas Department of Health and the Texas Board of
Health were abolished by Chapter 198, 1.18 and 1.26, 78th Legisla-
ture, Regular Session, 2003. Health and Safety Code, Chapter 1001, es-
tablishes the Department of State Health Services (department), which
now administers these programs. Government Code, 531.0055, pro-
vides authority to the Executive Commissioner of the Health and Hu-
man Services Commission to adopt rules for the department.
37.302. Policy.
(a) The department, recognizing the sensitive and confidential
nature of information collected regarding birth defects and their pos-
sible causes, expects [shalt expect] all staff to carry out all duties in a
professional, compassionate, and culturally sensitive manner.
(b) The department shall [it i the policy of the program to]
limit medical researcher contact with individuals and families identi-
fied by the central registry to only those studies with high scientific
merit with no feasible alternate means of conducting the study.
(c) The department shall [It i also the policy of the program
to] protect patient information from disclosure through the legal
process and Government Code, Chapter 552.
37.303. Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1) - (9) (No change.)
(10) Health facility--Any of the following types of facility:PROPOSED RULES August 14, 2009
34 TexReg 5467
Upcoming Pages
Here’s what’s next.
Search Inside
This issue can be searched. Note: Results may vary based on the legibility of text within the document.
Tools / Downloads
Get a copy of this page or view the extracted text.
Citing and Sharing
Basic information for referencing this web page. We also provide extended guidance on usage rights, references, copying or embedding.
Reference the current page of this Periodical.
Texas. Secretary of State. Texas Register, Volume 34, Number 33, Pages 5445-5614, August 14, 2009, periodical, August 14, 2009; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth90865/m1/22/: accessed July 16, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.