Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 133.
HOSPITAL LICENSING
Subchapter B. HOSPITAL LICENSE
25 TAC §133.26
The Executive Commissioner of the Health and Human Services
Commission (commission), on behalf of the Department of State Health Services
(department), adopts an amendment to §133.26, concerning hospital licensing
fees with changes to the proposed text as published in the October 21, 2005,
issue of the
Texas Register
(30 TexReg 6905).
BACKGROUND AND PURPOSE
The Texas Legislature passed the General Appropriations Act, Senate Bill
1, 79th Legislature, Regular Session (2005). Article II, Rider 85, makes a
portion of the appropriation contingent upon collection of fees above the
Comptroller of Public Accounts' Biennial Revenue estimate. To meet these requirements,
a cost recovery fee is included in this amendment.
The Hospital Licensing Program was evaluated to determine the level of
increase in fees based on the following criteria: the date of the last fee
increase for the specific program area; the percentage of revenue above costs
for the specific program; the cost of licenses compared to other similar licenses;
and the value added analysis of the license. Additional costs of administration
and enforcement of the program, due to a recent legislative increase in pay,
longevity pay, and travel reimbursement, were also factored in to determine
the direct and indirect costs of the program.
SECTION-BY-SECTION SUMMARY
Amendments to §133.26 contain increases in hospital licensing fees
for initial and renewal applications based on the number of licensed beds,
as well as for certain types of architectural plan reviews, and include clarification
of the language related to application requirements. Specifically, §133.26(b)(1)
increases the fee for initial and renewal license applications by $19 per
bed; §133.26(b)(1)(A) clarifies beds which must be included in the fee
calculation; §133.26(b)(2) requires that the applicant submit the $39
per bed fee when adding a multiple location hospital to the license; §133.26(c)(5)
increases the fee per square foot by $100 for architectural plan reviews when
the applicant is unable to establish an estimated construction cost; and §133.26(f)
adds language authorizing the collection of subscription and convenience fees
to recover costs for application processing through the Texas Online authority.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared
responses to the comments received regarding the proposed rule during the
comment period, which the commission has reviewed and accepts. The commenter
was the Texas Hospital Association. The commenter was not against the rules
in their entirety.
Comment: One commenter had requested and received an explanation for the
increase in fees. The commenter stated that any fee increase should be supported
solely by the costs associated with increased regulatory oversight.
Response: The commission disagrees because the level of the increase in
fees was based on the criteria listed in the Background and Purpose section
of this preamble. No change was made to the rule as a result of this comment.
The department staff on behalf of the commission provided comments and
the commission has reviewed and agrees to the following changes to improve
the accuracy of the section.
Change: Concerning §133.26(b)(1)(A), the words "and surgical suites"
have been deleted as it is not a type of bed and have been replaced with "intermediate
care beds, universal care beds, antepartum beds and postpartum beds".
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the adopted rule has been reviewed by legal counsel and found
to be within the state agencies' authority to adopt.
STATUTORY AUTHORITY
The adopted amendment to §133.26 is authorized by Health and Safety
Code, §§12.0111 and 241.025, which require the department to charge
fees for issuing or renewing a license; and 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.
§133.26.Fees.
(a)
General.
(1)
All fees paid to the Department of State Health Services
(department) are nonrefundable with the exception of inspection fees for inspections
that were not conducted.
(2)
All fees shall be paid by check or money order made payable
to the Department of State Health Services.
(b)
License fees.
(1)
The fee for an initial license or a renewal license is
$39 per bed based upon the design bed capacity of the hospital. The design
bed capacity of a hospital is determined as follows.
(A)
The design bed capacity is the maximum number of patient
beds that a hospital can accommodate in rooms that comply with the requirements
for patient room suites in §133.163 of this title (relating to Spatial
Requirements for New Construction) including beds, bassinets or cribs in critical
care units (including neonatal nurseries), continuing care nursery beds, hospital-based
skilled nursing units, medical nursing units, mental health and chemical dependency
nursing units, pediatric and adolescent nursing units, obstetrical suites
(including labor/delivery/recovery/postpartum (LDRP) beds), intermediate care
beds, universal care beds, antepartum beds and postpartum beds. The design
bed capacity does not include labor/delivery/recovery (LDR) beds, newborn
nursery bassinets, or recovery beds.
(B)
The maximum design bed capacity includes beds that comply
with the requirements in §133.163 of this title even if the beds are
unoccupied or the space is used for other purposes such as offices or storage
rooms, provided such rooms can readily be returned to patient use. All required
support and service areas must be maintained in place. For example, the removal
of a nurse station in an unused patient bedroom wing of 20 beds would effectively
eliminate those 20 beds from the design capacity. Eliminating access to the
medical gas outlets and nurse call would also remove bed(s) from the design
capacity.
(C)
The number of licensed beds in a multiple occupancy room
shall be determined by the design even if the number of beds actually placed
in the room is less than the design capacity.
(2)
hospital shall submit a license fee for each design bed
added as a result of adding a multiple location hospital to its license. The
fee is $39 per bed, regardless of the number of months remaining in the license
period.
(3)
A hospital shall submit an additional license fee with
the Final Construction Approval form for each new design bed resulting from
an approved construction project. The fee is $39 per bed, regardless of the
number of months remaining in the license period. The hospital shall also
submit an additional plan review fee if the construction cost increases to
the next higher fee schedule according to subsection (c)(4) of this section.
(4)
A hospital will not receive a refund of previously submitted
fees should the hospital's design capacity decrease as a result of an approved
construction project.
(c)
Plan review fees. This subsection outlines the fees which
must accompany the application for plan review and all proposed plans and
specifications covering the construction of new buildings or alterations to
existing buildings which must be submitted for review and approval by the
department in accordance with §133.167 of this title (relating to Preparation,
Submittal, Review and Approval of Plans).
(1)
Construction plans will not be reviewed or approved until
the required fee and an application for plan review are received by the department.
(2)
Plan review fees are based upon the estimated construction
project costs which are the total expenditures required for a proposed project
from initiation to completion, including at least the following items.
(A)
Construction project costs shall include expenditures for
physical assets such as:
(i)
site acquisition;
(ii)
soil tests and site preparation;
(iii)
construction and improvements required as a result of
the project;
(iv)
building, structure, or office space acquisition;
(v)
renovation;
(vi)
fixed equipment; and
(vii)
energy provisions and alternatives.
(B)
Construction project costs shall include expenditures for
professional services including:
(i)
planning consultants;
(ii)
architectural fees;
(iii)
fees for cost estimation;
(iv)
legal fees;
(v)
management fees; and
(vi)
feasibility study.
(C)
Construction project costs shall include expenditures or
costs associated with financing, excluding long-term interest, but including:
(i)
financial advisor;
(ii)
fund-raising expenses;
(iii)
lender's or investment banker's fee; and
(iv)
interest on interim financing.
(D)
Construction project costs shall include expenditure allowances
for contingencies including:
(i)
inflation;
(ii)
inaccurate estimates;
(iii)
unforeseen fluctuations in the money market; and
(iv)
other unforeseen expenditures.
(3)
Regarding purchases, donations, gifts, transfers, and other
comparable arrangements whereby the acquisition is to be made for no consideration
or at less than the fair market value, the project cost shall be determined
by the fair market value of the item to be acquired as a result of the purchase,
donation, gift, transfer, or other comparable arrangement.
(4)
The plan review fee schedule based on cost of construction
is:
(A)
$100,000 or less: $300;
(B)
$100,001 to $600,000: $850;
(C)
$600,001 to 2,000,000: $2,000;
(D)
$2,000,001 to 5,000,000: $3,000;
(E)
$5,000,001 to 10,000,000: $4,000; and
(F)
$10,000,001 and over: $5,000.
(5)
If an estimated construction cost cannot be established,
the estimated cost shall be based on $225 per square foot. No construction
project shall be increased in size, scope, or cost unless the appropriate
fees are submitted with the proposed changes.
(d)
Construction inspection fees. A fee of $500 and an application
for construction inspection for each inspection shall be submitted to the
department at least three weeks prior to the anticipated inspection date.
Construction inspections will not be conducted until all required fees are
received by the department. If additional construction inspections of the
proposed project are requested by the hospital, the appropriate additional
fees shall be submitted prior to any inspections conducted by the staff of
the department. When followup construction inspections are performed to verify
plans of correction, the fee shall be submitted upon completion of the inspection.
(e)
Cooperative agreement application fee. The application
fee for a cooperative agreement is $10,000. The application fee shall be submitted
with an application for a cooperative agreement and other documents in accordance
with §133.62 of this title (relating to Cooperative Agreements).
(f)
Subscription and convenience fee. The department is authorized
to collect subscription and convenience fees, in amounts determined by the
Texas Online Authority, to recover costs associated with application and renewal
application processing through Texas Online, in accordance with Texas Government
Code, §2054.111.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on January 10, 2006.
TRD-200600137
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: February 1, 2006
Proposal publication date: October 21, 2005
For further information, please call: (512) 458-7111 x6972
25 TAC §143.4
The Executive Commissioner of the Health and Human Services
Commission (commission), on behalf of the Department of State Health Services
(department), adopts an amendment to §143.4, concerning medical radiologic
technologists fees without changes to the proposed text as published in the
October 21, 2005, issue of the
Texas Register
(30
TexReg 6908), and the section will not be republished.
BACKGROUND AND PURPOSE
The Texas Legislature passed the General Appropriations Act, Senate Bill
1, 79th Legislature, Regular Session (2005). Article II, Rider 85, makes a
portion of the appropriation contingent upon collection of fees above the
Comptroller of Public Accounts' Biennial Revenue estimate. To meet these requirements,
a cost recovery fee is included in this amendment.
The Medical Radiologic Technologists Certification Program was evaluated
to determine the level of increase in fees based on the following criteria:
the date of the last fee increase for the specific program area; and the cost
of licenses compared to other similar licenses. Additional costs of administration
and enforcement of the program, due to a recent legislative increase in pay,
longevity pay, and travel reimbursement, were also factored in to determine
the direct and indirect costs of each program.
SECTION-BY-SECTION SUMMARY
The amendment to §143.4 contains an increase in the fee assessed against
licensed medical radiologic technologists for the biennial certificate renewal.
Specifically, §143.4(b)(2) increases the fee for a two-year renewal by
$20.
COMMENTS
The department, on behalf of the commission, did not receive any comments
regarding the proposed rule during the comment period.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the adopted rule has been reviewed by legal counsel and found
to be within the state agencies' authority to adopt.
STATUTORY AUTHORITY
The adopted amendment to §143.4 is authorized by Health and Safety
Code, §12.0111, which requires the department to charge fees for issuing
or renewing a license; and 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on January 10, 2006.
TRD-200600138
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: February 1, 2006
Proposal publication date: October 21, 2005
For further information, please call: (512) 458-7111 x6972
The Executive Commissioner of the Health and Human Services Commission
(commission), on behalf of the Department of State Health Services (department),
adopts amendments to §205.11, concerning bedding fees, §205.44,
concerning labeling of hazardous substances fees, and §205.57, concerning
inhalant abuse fees. Section 205.11 is adopted with changes to the proposed
text as published in the October 21, 2005, issue of the
Texas Register
(30 TexReg 6909). Sections 205.44 and 205.57 are adopted
without changes, and the sections will not be republished.
BACKGROUND AND PURPOSE
The Texas Legislature passed the General Appropriations Act, Senate Bill
1, 79th Legislature, Regular Session (2005). Article II, Rider 85, makes a
portion of the appropriation contingent upon collection of fees above the
Comptroller of Public Accounts' Biennial Revenue estimate. To meet these requirements,
cost recovery fees are included in these amendments.
Programs with regulatory authority over bedding, labeling of hazardous
substances, and inhalant abuse were evaluated to determine the level of increase
in fees based on the following criteria: the date of the last fee increase
for the specific program area; licensee's ability to pay in comparison to
average salary of professionals; the percentage of revenue above costs for
the specific program; the cost of licenses compared to other similar licenses;
and the value added analysis of the license. Additional costs of administration
and enforcement of the program, due to a recent legislative increase in pay,
longevity pay, and travel reimbursement, were also factored in to determine
the direct and indirect costs of each program.
SECTION-BY-SECTION SUMMARY
Amendments to §205.11(b) contain increases in bedding permit fees
assessed for a two-year term. Specifically, §205.11(b)(1)(A) increases
the mattress manufacturer permit fee for less than 2,000 articles per term
by $20; §205.11(b)(1)(B) increases the mattress manufacturer permit fee
for 2,000 to 9,999 articles per term by $30; §205.11(b)(1)(C) increases
the mattress manufacturer permit fee for 10,000 to 19,999 articles per term
by $40; §205.11(b)(1)(D) increases the mattress manufacturer permit fee
for 20,000 to 29,999 articles per term by $60; §205.11(b)(1)(E) increases
the mattress manufacturer permit fee for 30,000 to 49,999 articles per term
by $80; §205.11(b)(1)(F) increases the mattress manufacturer permit fee
for 50,000 to 100,000 articles per term by $120; §205.11(b)(1)(G) increases
the mattress manufacturer permit fee for over 100,000 articles per term by
$120; §205.11(b)(3)(A) increases the bedding product manufacturer permit
fee for less than 1,000 articles per term by $20; §205.11(b)(3)(B) changes
the 2,000 to 9,999 articles per term to 1,000 to 9,999 articles per term to
correct a typographical error in the current rule and also increases the bedding
product manufacturer permit fee for 1,000 to 9,999 articles per term by $25; §205.11(b)(3)(C)
increases the bedding product manufacturer permit fee for 10,000 to 19,999
articles per term by $30; §205.11(b)(3)(D) increases the bedding product
manufacturer permit fee for 20,000 to 29,999 articles per term by $40; §205.11(b)(3)(E)
increases the bedding product manufacturer permit fee for 30,000 to 49,999
articles per term by $50; §205.11(b)(3)(F) increases the bedding product
manufacturer permit fee for 50,000 to 99,999 articles per term by $70; §205.11(b)(3)(G)
increases the bedding product manufacturer permit fee for 100,000 to 200,000
articles per term by $120; §205.11(b)(3)(H) increases the bedding product
manufacturer permit fee for over 200,000 articles per term by $120; §205.11(b)(6)
increases the processor permit fee by $10; §205.11(b)(7) increases the
germicidal treatment permit fee by $10; and §205.11(b)(8) increases the
arts and crafts permit fee by $5. In addition, amendments to §205.11(c)(1)
change the department name from "Texas Department of Health" to "Department
of State Health Services" to state the new department name; and the program
name from "Product Safety Division" to "Product Safety Program".
Amendments to §205.44 contain an increase in the registration fee
for manufacturers of hazardous substances for a two-year term. Specifically, §205.44(f)(1)
increases the two-year term fee by $60.
Amendments to §205.57 contain an increase in the inhalant abuse permit
fee assessed for a two-year term. Specifically, §205.57(a) increases
the two-year term fee by $5. Amendments to §205.57(b) change the department
name from "Texas Department of Health or its successor" to "Department of
State Health Services" to state the new department name.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared
responses to the comments received regarding the proposed rules during the
comment period, which the commission has reviewed and accepts. The commenter
was an individual. The commenter was not against the rules in their entirety;
however, the commenter suggested recommendations for change as discussed in
the summary of comments.
Comment: Concerning the fees in §205.11, the commenter recommended
that out-of-state mattress manufacturers should pay additional fees above
the requested fees to offset the added risk to Texas residents due to the
inability to inspect for compliance on-site.
Response: The commission acknowledges the comment, but disagrees, as this
comment may involve statutory changes in addition to the rule changes, the
commission will need to study this issue. No change was made as a result of
the comment.
Comment: Concerning the fees in §205.11, the commenter recommended
that out-of-state mattress manufacturers should be required to have an officer
of the company certify by notarized statement the approximate numbers of mattresses
manufactured per reporting period.
Response: The commission acknowledges the comment, but disagrees with the
commenter. The recommendation to require out-of-state mattress manufacturers
to submit a notarized certification statement was considered. However, the
certification statement currently found on the mattress manufacturer license
application form has been reviewed and found to meet the department's requirements.
No change was made as a result of this comment.
The department staff on behalf of the commission provided a comment and
the commission has reviewed and agrees to the following change that will state
the correct program name.
Change: Concerning §205.11(c)(1), the department changed "Product
Safety Division" to "Product Safety Program" to reflect the program's name
change.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the adopted rules have been reviewed by legal counsel and found
to be within the state agencies' authority to adopt.
Subchapter A. BEDDING RULES
25 TAC §205.11
STATUTORY AUTHORITY
The adopted amendment is authorized by Health and Safety Code, §345.043,
which authorizes fees for an annual and renewal permit in amounts reasonable
and necessary to defray the cost of administering the program; Health and
Safety Code, §501.026, which authorizes reasonable registration fees;
Health and Safety Code, §12.0111, which requires the department to charge
fees for issuing or renewing a license designed to recover all direct and
indirect costs; and 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.
§205.11.Permit Requirements; Types; Application; Conditions; Suspension.
(a)
General requirements.
(1)
A person may not manufacture, import, wholesale, distribute,
or engage in the business of renovating or selling bedding in this state or
for delivery in this state unless the person first obtains a permit for that
specific purpose from the department. This requirement does not apply to a
custom upholstery business that does not repair or renovate bedding for resale.
(2)
A processor may not sell filling material in this state
or for delivery in this state unless the person first obtains a permit for
that purpose from the department.
(3)
A person may not apply a germicidal treatment method to
bedding unless the method has been registered with and approved in writing
by the department and the person has been issued a germicidal treatment permit
by the department.
(4)
These permit requirements apply to each separate business
location regardless of business name or ownership.
(5)
Prior to January 1, 2005, the term of all licenses is one-year
and expires on the anniversary of the effective date, unless renewed. Effective
January 1, 2005, the term of all licenses is two years. Some licenses will
be renewed for a one-year term in 2005, in a manner to be determined by the
department and two years thereafter. The department may prorate permit fees
as appropriate to provide for a common expiration date for persons holding
and/or applying for more than one permit.
(6)
Texas Online Fees. The department is authorized to collect
subscription and convenience fees, in amounts determined by the Texas Online
Authority, to recover costs associated with processing license applications
specified under this subchapter through Texas Online, in accordance with the
Texas Government Code, Chapter 2054, §2054.111 (relating to Use of Texas
Online Project).
(b)
Types of permit and permit fees.
(1)
Mattress Manufacturer Permit. Required of all manufacturers
of mattresses or box springs prior to shipping mattresses and/or box springs
into or within this state for the purpose of resale. Permit fees are graduated
based on the number of articles the manufacturer is requesting authorization
to ship during the term of the permit. The fees are set out as follows:
(A)
for less than 2,000 articles per term, a two-year term
is $220;
(B)
2,000 to 9,999 articles per term, a two-year term is $330;
(C)
10,000 to 19,999 articles per term, a two-year term is
$440;
(D)
20,000 to 29,999 articles per term, a two-year term is
$660;
(E)
30,000 to 49,999 articles per term, a two-year term is
$880;
(F)
50,000 to 100,000 articles per term, a two-year term is
$1,320; and
(G)
over 100,000 articles per term, a two-year term is $1,320
plus $.03 for each article.
(2)
Mattress Renovator Permit. Required of all renovators of
mattresses or box springs prior to shipping mattresses and/or box springs
in or within this state for the purpose of resale. Permit fees are graduated
based on the number of mattresses or box springs the renovator is requesting
authorization to ship during the permit period. The fees are set out in subsection
(b)(1) of this section.
(3)
Bedding Product Manufacturer Permit. Required of all manufacturers
of bedding products, other than mattresses and box springs, prior to shipping
such articles in or within this state for the purpose of resale. Permit fees
are graduated based on the number of articles the manufacturer is requesting
authorization to ship during the term of the permit. The fees are set out
as follows:
(A)
for less than 1,000 articles per term, a two-year term
is $220;
(B)
1,000 to 9,999 articles per term, a two-year term is $275;
(C)
10,000 to 19,999 articles per term, a two-year term is
$330;
(D)
20,000 to 29,999 articles per term, a two-year term is
$440;
(E)
30,000 to 49,999 articles per term, a two-year term is
$550;
(F)
50,000 to 99,999 articles per term, a two-year term is
$770;
(G)
100,000 to 200,000 articles per term, a two-year term is
$1,320; and
(H)
over 200,000 articles per term, a two-year term is $1,320
plus $.01 for each article.
(4)
Wholesaler/Distributor Permit. Required of all wholesalers
and distributors of bedding articles or filling materials prior to shipping
such articles or filling materials into this state for the purpose of resale.
Permit fees are graduated based on the number of articles or units of filling
materials the wholesaler/distributor is requesting authorization to ship during
the permit period. The fees are set out in Schedule B, subsection (b)(3) of
this section.
(5)
Importer Permit. Required of all importers of bedding articles
or filling materials prior to shipping such articles or filling materials
into this state for the purpose of resale. Permit fees are graduated based
on the number of imported articles or units of filling materials the importer
is requesting authorization to ship during the permit period. The fees are
set out in Schedule B in subsection (b)(3) of this section.
(6)
Processor Permit. Required of all manufacturers and/or
processors of bulk filling materials prior to selling and shipping such filling
materials into this state. The permit fee is $110 for a two-year term.
(7)
Germicidal Treatment Permit. Required of all persons prior
to the application of a germicidal treatment process, approved by the department,
to articles of bedding and/or filling materials to be shipped into or to be
sold in this state. The permit fee is $110 for a two-year term.
(8)
Arts and Crafts Permit. Required of all persons who manufacture
bedding articles other than mattresses (such as pillows, quilts, comforters),
have no paid employees, and manufacture less than 250 articles per year for
sale in this state. The permit fee is $55 for a two-year term.
(c)
Permit application.
(1)
Application for an initial permit or to renew an expiring
permit must be made through the department on an approved application form
which may be obtained from the Product Safety Program, Department of State
Health Services, 1100 West 49th Street, Austin, Texas 78756.
(2)
A separate application must be completed and submitted
for each specific permit applied for at each specific business location or
plant location.
(3)
The appropriate permit fee, payable to the department,
must accompany each application.
(4)
Additional information that may be required by the department
includes the following:
(A)
copy of current permits or licenses issued by another state,
or states;
(B)
copy of most recent bedding inspection report if the business
or plant is located in a city, county, state or country that has bedding laws
and regulations and conducts inspections;
(C)
copies of bedding article labels proposed for use in this
state;
(D)
samples of products to be shipped into this state;
(E)
confirmation of compliance with applicable federal flammability
standards for mattresses and mattress pads or test results from an independent
testing facility acceptable to the department;
(F)
explanation of the germicidal treatment method to be applied
to second-hand articles of bedding; and
(G)
any other information that the department may determine
is necessary for the protection of the public health and safety.
(d)
Permit conditions.
(1)
Each person required to obtain a permit shall keep accurate
and up-to-date records of all articles of bedding shipped into or within this
state and such records shall be made available to authorized representatives
of the department when requested. The department may require, at the expense
of the person, that an independent audit of the records of the person be conducted
with the results of such audit provided to the department and the person.
(2)
Each person required to obtain a Germicidal Treatment Permit
shall:
(A)
conspicuously post the permit on the premises of the person's
business near the treatment device; and
(B)
keep accurate records in a bound log book describing all
bedding articles or materials treated, date of treatment, method of treatment,
and the name and address of the owner of each item.
(3)
Each person required to obtain a permit shall provide product
samples in sufficient numbers to determine compliance with these regulations
when requested by the department and shall reimburse retail business establishments
for samples of bedding or materials taken by authorized representatives of
the department.
(4)
Each person required to obtain a permit shall provide test
results acceptable to the department confirming compliance with federal flammability
standards for mattresses and mattress pads when requested by the department.
(5)
Each person required to obtain a permit shall maintain
each business location in a sanitary condition that complies with §205.9
of this title.
(6)
Each person required to obtain a permit shall allow, during
normal business hours, an authorized representative or representatives of
the department to conduct an announced or unannounced inspection of their
place of business for purposes of determining compliance with the Act and
regulations and to take samples of bedding articles or materials for inspection
and analysis or to be held as evidence of a violation of these regulations.
(7)
Each person required to obtain a permit shall allow an
authorized representative or representatives of the department to copy records
and take photographs of articles of bedding or materials during inspections.
(e)
Permit denial, suspension, revocation.
(1)
An application for permit issuance or renewal will be denied
by the department if the applicant fails or refuses to provide a complete
application, pay the appropriate permit fee, provide requested information
or product samples or test results, or if the business location or plant location
is not in a sanitary condition in violation of the Act and regulations.
(2)
An application for permit issuance or renewal may be denied
by the department if the applicant has failed to make acceptable progress
implementing corrective actions agreed upon by the applicant and the department
to remedy previous violations of the Act or these regulations.
(3)
A permit may be suspended or revoked by the department
if the permit holder fails to maintain the permitted business location or
plant location in a sanitary condition, manufactures or renovates and sells
mattresses or mattress pads that do not comply with federal flammability standards,
fails to germicidally treat articles of used bedding prior to resale, or commits
any other or repeated violations of the Act or these regulations.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of
the Secretary of State on January 10, 2006.
TRD-200600141
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: February 1, 2006
Proposal publication date: October 21, 2005
For further information, please call: (512) 458-7111 x6972
25 TAC §205.44
STATUTORY AUTHORITY
The adopted amendment is authorized by Health and Safety Code, §345.043,
which authorizes fees for an annual and renewal permit in amounts reasonable
and necessary to defray the cost of administering the program; Health and
Safety Code, §501.026, which authorizes reasonable registration fees;
Health and Safety Code, §12.0111, which requires the department to charge
fees for issuing or renewing a license designed to recover all direct and
indirect costs; and 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on January 10, 2006.
TRD-200600142
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: February 1, 2006
Proposal publication date: October 21, 2005
For further information, please call: (512) 458-7111 x6972
25 TAC §205.57
STATUTORY AUTHORITY
The adopted amendment is authorized by Health and Safety Code, §345.043,
which authorizes fees for an annual and renewal permit in amounts reasonable
and necessary to defray the cost of administering the program; Health and
Safety Code, §501.026, which authorizes reasonable registration fees;
Health and Safety Code, §12.0111, which requires the department to charge
fees for issuing or renewing a license designed to recover all direct and
indirect costs; and 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on January 10, 2006.
TRD-200600143
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: February 1, 2006
Proposal publication date: October 21, 2005
For further information, please call: (512) 458-7111 x6972
The Executive Commissioner of the Health and Human Services Commission
(commission), on behalf of the Department of State Health Services (department),
adopts amendments to §229.145 concerning the narcotic treatment program
fees, §229.182 concerning food manufacturers, food wholesalers, and warehouse
operators fees, §229.372 concerning permitting of retail food establishments
fees, and §229.439 concerning the device distributors and device manufacturers
fees. Sections 229.182 and 229.439 are adopted with changes to the proposed
text as published in the October 21, 2005, issue of the
Texas Register
(30 TexReg 6912). Amendments to §229.145 and §229.372
are adopted without changes and the sections will not be republished.
BACKGROUND AND PURPOSE
The Texas Legislature passed the General Appropriations Act, Senate Bill
1, 79th Legislature, Regular Session (2005). Article II, Rider 85, makes a
portion of the appropriation contingent upon collection of fees above the
Comptroller of Public Accounts' Biennial Revenue estimate. To meet these requirements,
cost recovery fees are included in these amendments.
Programs with regulatory authority over narcotic treatment, food manufacturers,
food wholesalers, warehouse operators, retail food establishments, and device
distributors and manufacturers, were evaluated to determine the level of increase
in fees based on the following criteria: the date of the last fee increase
for the specific program area; licensee's ability to pay in comparison to
average salary of professionals; the percentage of revenue above costs for
the specific program; the cost of licenses compared to other similar licenses;
and the value added analysis of the license. Additional costs of administration
and enforcement of the program, due to a recent legislative increase in pay,
longevity pay, and travel reimbursement, were also factored in to determine
the direct and indirect costs of each program.
SECTION-BY-SECTION SUMMARY
Amendments to §229.145 contain increases in fees for permits, patient
certificates, renewal certificates and delinquency charges for renewing expired
permits or submission of late status reports, for narcotic treatment licensees.
References to one-year permits have been deleted because the program no longer
issues one-year permits. Specifically, §229.145 increases the fees by
40%, including a $300 increase in the initial application fee stated in §229.145(b)(1); §229.145(b)(2)
increases the initial patient fee by $50 and increases the patient fee certificate
by $20; §229.145(b)(4)(A) increases the delinquency fee for an expired
patient certificate by $2; §229.145(b)(4)(B) increases a delinquency
fee for submission of a status report after expiration of a patient certificate
by $100; §229.145(b)(4)(C) increases the renewal fee of a patient certificate
by $20; and §229.145(b)(4)(D) increases the fee for each additional patient
requiring a certificate by $20.
Amendments to §229.182(a)(7) change the department name from "Texas
Department of Health or its successor" to "Department of State Health Services"
to state the new department name. Amendments to §229.182 contain increases
in licensing fees for food manufacturers, food wholesalers, and wholesalers
with combination products for initial and renewal applications per location,
based upon gross annual sales. References to one-year permits have been deleted
because the program no longer issues one-year permits. Specifically, new §229.182(b)(1)(A)
increases the license fee for food manufacturers with gross annual sales of
$0.00 - $9,999.99 by $50; new §229.182(b)(1)(B) increases the license
fee for food manufacturers with gross annual sales of $10,000.00 - $24,999.99
by $50; new §229.182(b)(1)(C) increases the license fee for food manufacturers
with gross annual sales of $25,000.00 - $99,999.99 by $50; new §229.182(b)(1)(D)
increases the license fee for food manufacturers with gross annual sales of
$100,000.00 - $199,999.99 by $60; new §229.182(b)(1)(E) increases the
license fee for food manufacturers with gross annual sales of $200,000.00
- $999,999.99 by $100; new §229.182(b)(1)(F) increases the license fee
for food manufacturers with gross annual sales of $1 million - $9,999,999.99
by $120; new §229.182(b)(1)(G) increases the license fee for food manufacturers
with gross annual sales of greater than or equal to $10 million by $180; new §229.182(b)(2)(A)
increases the license fee for food wholesalers with gross annual sales of
$0.00 - $199,999.99 by $50; new §229.182(b)(2)(B) increases the license
fee for food wholesalers with gross annual sales of $200,000.00 - $499,999.99
by $50; new §229.182(b)(2)(C) increases the license fee for food wholesalers
with gross annual sales of $500,000.00 - $999,999.99 by $80; new §229.182(b)(2)(D)
increases the license fee for food wholesalers with gross annual sales of
$1 million - $9,999,999.99 by $100; and new §229.182(b)(2)(E) increases
the license fee for food wholesalers with gross annual sales of greater than
or equal to $10 million by $150.
Amendments to §229.372 contain increases in retail food establishment
permit fees based on gross annual volume of food sales or establishment type.
References to one-year permits have been deleted because the program no longer
issues one-year permits. Specifically, §229.372(a)(1)(A) increases the
fee for an establishment with a gross annual volume of food sales of $0 -
$49,999.99 by 25% or $50; §229.372(a)(1)(B) increases the fee for an
establishment with a gross annual volume of sales of $50,000 - $149,999.99
by 25% or $100; §229.372(a)(1)(C) increases the fee for an establishment
with a gross annual volume of sales of $150,000 or more by 17% or $100; §229.372(a)(2)
increases the fee for a for-profit school contractor by 25% or $50; §229.372(a)(3)(B)
increases the fee for mobile food unit by 25% or $50; §229.372(a)(4)
increases the fee for a roadside food vendor by 25% or $50; and §229.372(a)(5)
increases the fee for a child care center by 25% or $50.
Amendments to §229.439 contain increases in fees for licenses and
renewal licenses for device distributors or manufacturers. References to one-year
permits have been deleted because the program no longer issues one-year permits.
Specifically, §229.439 increases the fees by 20%, §229.439(a)(1)(A)
increases the license fee for distributors with gross annual sales of $0 -
$499,999.99 by $80; §229.439(a)(1)(B) increases the license fee for distributors
with gross annual sales of $500,000 - $9,999,999.99 by $180; §229.439(a)(1)(C)
increases the license fee for distributors with gross annual sales greater
than or equal to $10 million by $280; §229.439(a)(3)(A) increases the
license fee for manufacturers with gross annual sales of $0 - 499,999.99 by
$80; §229.439(a)(3)(B) increases the license fee for manufacturers with
gross annual sales of $500,000 - $9,999,999.99 by $360; and §229.439(a)(3)(C)
increases the license fee for manufacturers with gross annual sales of greater
than or equal to $10 million by $600.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared
responses to the comments received regarding the proposed rules during the
comment period, which the commission has reviewed and accepts. The department's
responses to the comments are discussed in the summary of comments.
The comment on the proposed rule §229.145 was submitted by Texas Clinic
Fulton. The commenter was generally not in favor of the amendment to the rule
requiring increased patient fees for operating narcotic treatment programs.
Comment: Concerning the patient fee increases in §229.145(b), the
commenter objected to the increased patient fees and requested that the proposed
fee increases be withdrawn altogether or, at a minimum, delayed until 2007
to provide an adjustment period and to eliminate the cost advantage to programs
that paid for 2006 fees in 2005, at 2005 fee rates. The commenter also sought
an annual, rather than biennial, payment schedule for patient fees.
Response: The commission disagrees with this comment. Fees based upon the
number of patients link a program's increased costs to the ability to generate
revenue. At the same time, the department has been directed to recover 100%
of its regulatory costs, including indirect costs. The increased fees recover
regulatory costs associated with increases in employee pay, travel reimbursement,
and allows for recovery of appropriations. No change was made to the rule
as a result of the comment.
The comments on the proposed rule §229.182 were submitted by Glacier
Water and National Automatic Merchandising Association. The commenters were
not against the rule in its entirety; however, the commenters suggested recommendations
for change as discussed in the comments.
Comment: Concerning the fee increase in §229.182(b)(1)(A), both commenters
stated that the fees were being significantly increased for water vending
machines. The commenters also felt that this increase is disproportionate
to the increases for food manufacturers in other fee categories.
Response: The commission disagrees with the comments, because the department
has been directed to recover 100% of its regulatory costs, including indirect
costs. The increased fees recover regulatory costs associated with increases
in employee pay, travel reimbursement, and allows for recovery of appropriations.
With regard to the comment concerning the disproportionate increase, the lowest
fee category was recovering, at a minimum, the cost of printing the license.
This does not even include the cost of conducting an inspection. This fee
schedule was raised to cover at least the cost to print the license. No change
was made to the rule as a result of the comments.
Comment: Concerning the fee increase in §229.182(b)(1)(A), one commenter
proposed that a separate category for water vending machines be created under
the heading of Food Manufacturers.
Response: The commission disagrees with the comment, because this comment
may involve statutory changes in addition to rule changes. The commission
will study this issue and propose changes at a later date, if warranted. No
change was made as a result of this comment.
The department staff on behalf of the commission provided a comment and
the commission has reviewed and agrees to the following changes that will
clarify the fee structure.
Change: Concerning §229.182(b)(1)(A)-(G), 229.182(b)(2)(A)-(E), 229.182(b)(3)(A)-(E),
and 229.182(b)(5)(A)-(E), language was added to clarify the fees for a two-year
license, a two-year license that is amended due to ownership, and a two-year
license that is amended during the current licensure period due to minor changes.
The comment on the proposed rule §229.372 was submitted by the Gulf
Coast Retailers Association. The commenter was against the fee increases;
however, the commenter suggested recommendations for changes as discussed
in the comments.
Comment: Concerning the retail food establishment fee increases in general,
the commenter expressed opposition to the fee increases at the present time.
The commenter stated that members of his organization have experienced increases
in fuel costs and have supported the relief efforts of Hurricane Katrina.
The commenter suggested that the fee increases be postponed until January
2007.
Response: The commission disagrees with the comments, because the department
has been directed by the legislature to recover 100% of its regulatory costs,
including indirect costs, and must do so at this time. The increased fees
recover regulatory costs associated with increase in employee pay, travel,
reimbursement, and allows for recovery of appropriations. In addition, the
department has not raised the fees since March 2000. No change was made to
the rule as a result of this comment.
The department staff on behalf of the commission provided a comment and
the commission has reviewed and agrees to the following changes that will
clarify license fees associated with amending a license.
Change: Concerning §§229.439(a)(1)(A)-(C), 229.439(a)(2)(A)-(E),
and 229.439(a)(3)(A)-(C), the section was clarified to distinguish between
license fees that apply to a two-year license, a two-year license that is
amended due to a change in ownership, and a two-year license that is amended
during the current licensure period due to minor changes.
No other comments were received regarding the amended sections as proposed.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the adopted rules have been reviewed by legal counsel and found
to be within the state agencies' authority to adopt.
Subchapter J. MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS
25 TAC §229.145
STATUTORY AUTHORITY
The adopted amendment is authorized by Health and Safety Code, §§12.0111,
431.204, 431.222, 431.276, 432.009, 437.0125, 441.003, and 466.023, which
require the department to charge fees for issuing or renewing a license or
permit; and 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on January 11, 2006.
TRD-200600179
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: February 1, 2006
Proposal publication date: October 21, 2005
For further information, please call: (512) 458-7111 x6972
25 TAC §229.182
STATUTORY AUTHORITY
The adopted amendment is authorized by Health and Safety Code, §§12.0111,
431.204, 431.222, 431.276, 432.009, 437.0125, 441.003, and 466.023, which
require the department to charge fees for issuing or renewing a license or
permit; and 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.
§229.182.Licensing/Registration Fee and Procedures.
(a)
License/registration required.
(1)
A person who manufactures food must obtain a food manufacturer's
license for each place of business as described in subsection (b)(1) or (2)
of this section; also, a food manufacturer who distributes its own food, and/or
food from another manufacturer must only obtain a food manufacturer's license.
When calculating the amount of the licensing fee, the manufacturer must include
the total for all food manufactured and wholesaled from the place of business.
(2)
A person who distributes food, but who does not manufacture
food, must obtain a food wholesaler's license for each place of business as
described in subsection (b)(3) or (4) of this section.
(3)
A person who distributes food, but who does not manufacture
food, and who chooses to store that food with a warehouse operator licensed
under subsection (b)(8) or (9) of this section, must register as a food wholesaler
under subsection (b)(7) of this section.
(4)
A person who distributes food and drugs, food and medical
devices, or food and drugs and medical devices, must obtain a wholesaler with
combination products license, as described in subsection (b)(5) or (6) of
this section, for each place of business; this license is required even if
the products are stored in a separate warehouse or with a warehouse operator
licensed under subsection (b)(8) or (9) of this section.
(5)
A warehouse operator storing food for a registered food
wholesaler must obtain a warehouse operator license as described in subsection
(b)(8) or (9) of this section for each such warehouse. A warehouse operator
who distributes only food is required to obtain only a warehouse operator
license. A warehouse operator who distributes combination products (food and
drugs, food and medical devices, or food, drugs, and medical devices) and
is also required to obtain a wholesaler's license under subsection (b)(5)
or (6) of this section will be issued only one license. The license fee to
be paid will be the higher of the two applicable fees.
(6)
A warehouse operated by a food manufacturer which is totally
separate from any manufacturing location, including locations from which foods
are held for limited periods of time for distribution, must obtain a warehouse
operator license as described in subsection (b)(8) or (9) of this section
for each such warehouse.
(7)
A retail food store that also manufactures food and is
required to be permitted by the Department of State Health Services (department)
pursuant to Health and Safety Code, Chapter 437, and the Texas Food Establishment
Regulations, §229.370 and §229.371 of this title (relating to Permitting
Retail Food Establishments), will be issued only one license or permit. The
license or permit fee to be paid will be the higher of the two applicable
fees.
(8)
A wholesaler who distributes combination products and who
is also required to be licensed as a warehouse operator under this section
will be issued only one license. The license fee to be paid will be the higher
of the two applicable fees.
(9)
A food manufacturer required to be licensed exclusively
pursuant to Health and Safety Code, Chapter 432, relating to Food, Drug, Device
and Cosmetic Salvage, Chapter 433, relating to Meat and Poultry Inspection,
Chapter 435, relating to Dairy Products, Chapter 436, relating to Aquatic
Life, or Chapter 440, relating to Frozen Desserts, is not required to license
pursuant to this chapter.
(b)
Licensing and registration fees.
(1)
Food manufacturer. No person may operate or conduct business
as a food manufacturer in this state without first obtaining a license from
the department. Licenses issued under this subsection expire two years from
the start date of the regulated activity. All applicants for a new or renewal
food manufacturer's license shall pay a license fee.
(A)
For each place of business having gross annual manufactured
food sales of $0.00 - $9,999.99, the fees are:
(i)
$100 for a two-year license;
(ii)
$100 for a two-year license that is amended due to a change
of ownership; and
(iii)
$50 for a two-year license that is amended during the
current licensure period due to minor changes.
(B)
For each place of business having gross annual manufactured
food sales of $10,000 - $24,999.99, the fees are:
(i)
$150 for a two-year license;
(ii)
$150 for a two-year license that is amended due to a change
of ownership; and
(iii)
$75 for a two-year license that is amended during the
current licensure period due to minor changes.
(C)
For each place of business having gross annual manufactured
food sales of $25,000 - $99,999.99, the fees are:
(i)
$250 for a two-year license;
(ii)
$250 for a two-year license that is amended due to a change
of ownership; and
(iii)
$125 for a two-year license that is amended during the
current licensure period due to minor changes.
(D)
For each place of business having gross annual manufactured
food sales of $100,000 - $199,999.99, the fees are:
(i)
$560 for a two-year license;
(ii)
$560 for a two-year license that is amended due to a change
of ownership; and
(iii)
$280 for a two-year license that is amended during the
current licensure period due to minor changes.
(E)
For each place of business having gross annual manufactured
food sales of $200,000 - $999,999.99, the fees are:
(i)
$900 for a two-year license;
(ii)
$900 for a two-year license that is amended due to a change
of ownership; and
(iii)
$450 for a two-year license that is amended during the
current licensure period due to minor changes.
(F)
For each place of business having gross annual manufactured
food sales of $1 million - $9,999,999.99, the fees are:
(i)
$1,120 for a two-year license;
(ii)
$1,120 for a two-year license that is amended due to a
change of ownership; and
(iii)
$560 for a two-year license that is amended during the
current licensure period due to minor changes.
(G)
For each place of business having gross annual manufactured
food sales greater than or equal to $10 million, the fees are:
(i)
$1,680 for a two-year license;
(ii)
$1,680 for a two-year license that is amended due to a
change of ownership; and
(iii)
$840 for a two-year license that is amended during the
current licensure period due to minor changes.
(2)
Food wholesaler. No person may operate or conduct business
as a food wholesaler in this state without first obtaining a food wholesaler's
license from the department. Licenses issued under this subsection expire
two years from the start date of the regulated activity. Except as provided
for in paragraph (4) of this subsection, all food wholesalers shall pay a
license fee.
(A)
For each place of business having gross annual food sales
of $0.00 - $199,999.99, the fees are:
(i)
$250 for a two-year license;
(ii)
$250 for a two-year license that is amended due to a change
of ownership; and
(iii)
$125 for a two-year license that is amended during the
current licensure period due to minor changes.
(B)
For each place of business having gross annual food sales
of $200,000 - $499,999.99, the fees are:
(i)
$450 for a two-year license;
(ii)
$450 for a two-year license that is amended due to a change
of ownership; and
(iii)
$225 for a two-year license that is amended during the
current licensure period due to minor changes.
(C)
For each place of business having gross annual food sales
of $500,000 - $999,999.99, the fees are:
(i)
$680 for a two-year license;
(ii)
$680 for a two-year license that is amended due to a change
of ownership; and
(iii)
$340 for a two-year license that is amended during the
current licensure period due to minor changes.
(D)
For each place of business having gross annual food sales
of $1 million - $9,999,999.99, the fees are:
(i)
$900 for a two-year license;
(ii)
$900 for a two-year license that is amended due to a change
of ownership; and
(iii)
$450 for a two-year license that is amended during the
current licensure period due to minor changes.
(E)
For each place of business having gross annual food sales
of greater than or equal to $10 million, the fees are:
(i)
$1,350 for a two-year license;
(ii)
$1,350 for a two-year license that is amended due to a
change of ownership; and
(iii)
$675 for a two-year license that is amended during the
current licensure period due to minor changes.
(3)
Wholesaler with combination products. A person who is required
to be licensed as a food wholesaler under this section and who is also required
to be licensed as a wholesale distributor of drugs under §229.252(a)(1)
of this title or as a device distributor under §229.439(a)(1) of this
title shall pay a combined licensure fee for each place of business. The licensure
fee shall be based on the combined gross annual sales of these regulated products
(foods, drugs, and/or devices).
(A)
For each place of business having combined gross annual
sales of $0.00 - $199,999.99, the fees are:
(i)
$400 for a two-year license;
(ii)
$400 for a two-year license that is amended due to a change
of ownership; and
(iii)
$200 for a two-year license that is amended during the
current licensure period due to minor changes.
(B)
For each place of business having combined gross annual
sales of $200,000 - $499,999.99, the fees are:
(i)
$600 for a two-year license;
(ii)
$600 for a two-year license that is amended due to a change
of ownership; and
(iii)
$300 for a two-year license that is amended during the
current licensure period due to minor changes.
(C)
For each place of business having combined gross annual
sales of $500,000 - $999,999.99, the fees are:
(i)
$800 for a two-year license;
(ii)
$800 for a two-year license that is amended due to a change
of ownership; and
(iii)
$400 for a two-year license that is amended during the
current licensure period due to minor changes.
(D)
For each place of business having combined gross annual
sales of $1 million - $9,999,999.99, the fees are:
(i)
$1,000 for a two-year license;
(ii)
$1,000 for a two-year license that is amended due to a
change of ownership; and
(iii)
$500 for a two-year license that is amended during the
current licensure period due to minor changes.
(E)
For each place of business having combined gross annual
sales greater than or equal to $10 million, the fees are:
(i)
$1,500 for a two-year license;
(ii)
$1,500 for a two-year license that is amended due to a
change of ownership; and
(iii)
$750 for two-year license that is amended during the
current licensure period due to minor changes.
(4)
Food wholesaler registration. Except as provided in paragraph
(3) of this subsection, a food wholesaler is not required to obtain a license
under this section for a place of business if all of the food distributed
from that place of business will be stored in a warehouse licensed under this
section. A food wholesaler that is not required to obtain a license for a
place of business under this section shall register each place of business
with the department pursuant to subsection (d)(2) of this section, but only
one registration fee must be paid by each such food wholesaler. A food wholesaler
who meets this subsection's requirements shall pay a registration fee of $100.
A registration issued under this subsection expires two years from the start
date of the regulated activity.
(5)
Warehouse operator. No person may operate or conduct business
as a warehouse operator in this state without first obtaining a license from
the department. Licenses issued under this subsection expire two years from
the start date of the regulated activity. License fees are based on the maximum
amount of square feet dedicated to food storage during the licensing period.
A warehouse operator shall pay a license fee.
(A)
For each place of business having food storage of 0 - 6,000
square feet, the fees are:
(i)
$350 for a two-year license;
(ii)
$350 for a two-year license that is amended due to a change
of ownership; and
(iii)
$175 for a two-year license that is amended during the
current licensure period due to minor changes.
(B)
For each place of business having food storage of 6,001
- 24,000 square feet, the fees are:
(i)
$700 for a two-year license;
(ii)
$700 for a two-year license that is amended due to a change
of ownership; and
(iii)
$350 for a two-year license that is amended during the
current licensure period due to minor changes.
(C)
For each place of business having food storage of 24,001
- 75,000 square feet, the fees are:
(i)
$1,050 for a two-year license;
(ii)
$1,050 for a two-year license that is amended due to a
change of ownership; and
(iii)
$525 for a two-year license that is amended during the
current licensure period due to minor changes.
(D)
For each place of business having food storage of 75,001
- 250,000 square feet, the fees are:
(i)
$1,400 for a two-year license;
(ii)
$1,400 for a two-year license that is amended due to a
change of ownership; and
(iii)
$700 for a two-year license that is amended during the
current licensure period due to minor changes.
(E)
For each place of business having food storage of 250,001
or more square feet, the fees are:
(i)
$2,000 for a two-year license;
(ii)
$2,000 for a two-year license that is amended due to a
change of ownership; and
(iii)
$1,000 for a two-year license that is amended during
the current licensure period due to minor changes.
(6)
A firm that has more than one business location may request
a one-time proration of fees when applying for a license for each new location.
Upon approval by the department, the expiration date of the license for the
new location will be established the same as the firm's previously licensed
locations.
(7)
For all applications and renewal applications, the department
is authorized to collect subscription and convenience fees, in amounts determined
by the Texas Online Authority, to recover costs associated with application
and renewal application processing through Texas Online.
(8)
All license/registration fees paid under this section are
non-refundable.
(9)
If the license/registration category changes during the
license period, the license shall be renewed in the proper category at the
time of renewal.
(c)
License/registration forms. License/registration forms
may be obtained from the department, located at 1100 West 49th Street, Austin,
Texas 78756-3182, or from the website at www.tdh.state.tx.us/bfds/lic/apps.html.
(d)
License/registration application. All food manufacturers,
food wholesalers, and warehouse operators shall file a license application
on a form authorized by the department.
(1)
The application form shall be signed and verified, and
shall contain the following information:
(A)
the name of the legal entity to be licensed, including
the name under which the business is conducted;
(B)
the physical address of the place of business;
(C)
the mailing address of the place of business;
(D)
if a sole proprietorship, the name of the proprietor; if
a partnership, the names of all partners; if a corporation, the name of the
corporation, the date and place of incorporation and name and address of its
registered agent in the state; or if any other type of association, the names
of the principals of such association;
(E)
the names of those individuals in an actual administrative
capacity which, in the case of a sole proprietorship shall be the managing
proprietor; in a partnership, the managing partner; in a corporation, the
officers and directors; in any other association, those in a managerial capacity;
and
(F)
a list of categories of gross annual sales or square footage
as applicable, which must be marked and adhered to by the licensee in the
determination and paying of the license fee.
(2)
Food wholesalers who meet the requirements to register
under subsection (b)(7) of this section, must submit a registration form authorized
by the department which shall be signed and verified, and contain the following
information:
(A)
the name of the legal entity to be registered, including
the name under which the business is conducted;
(B)
the name, telephone number, and physical addresses of the
licensed warehouses where the food wholesaler's food products are or will
be stored;
(C)
the physical address where the food wholesaler's distribution
records are located and available for review upon inspection;
(D)
the mailing address and telephone number where the food
wholesaler may be contacted; and
(E)
a description of the type of food products being distributed
by the food wholesaler.
(e)
Two or more establishments. If the food manufacturer, food
wholesaler, or warehouse operator operates more than one place of business,
each place of business shall be licensed separately by listing the name and
address of each place of business on the license application.
(f)
Issuance of license/registration. The department may license/register
a manufacturer, food wholesaler, or warehouse operator who meets the requirements
of this section and §229.183 of this title (relating to Minimum Standards
for Licensure/Registration).
(1)
The initial license/registration shall be valid for two
years from the date the license/registration was issued.
(2)
The renewal license/registration shall be valid for two
years from the date the license/registration was issued.
(3)
A current license/registration shall only be issued when
all past due fees and late fees are paid.
(g)
Renewal of license/registration.
(1)
For each licensing/registration period, the food manufacturer,
food wholesaler, or warehouse operator shall renew its license/registration
as applicable following the requirements of this section and §229.183
of this title.
(2)
A person who holds a license/registration issued by the
department under the Health and Safety Code shall renew the license/registration
by filing an application for renewal on a form authorized by the department
accompanied by the appropriate licensing/registration fee. A licensee/registrant
must file for renewal before the expiration date of the current license. A
person who files a renewal application after the expiration date must pay
an additional $100 as a delinquency fee.
(3)
Failure to submit the renewal during the licensing/registration
period may subject the food manufacturer, food wholesaler, or warehouse operator
to the offense provisions under the Health and Safety Code, Chapter 431, to
the provision of §229.184 of this title (relating to the Refusal, Revocation,
or Suspension of License/Registration), and to the provisions of §229.222
of this title (relating to Penalties).
(h)
Amendment of license/registration.
(1)
Fees. A license or registration that is amended during
the licensing or registration period, including a change of name, ownership
(change in legal entity), or a notification of a change in the location of
a licensed or registered place of business required under the Health and Safety
Code, §431.2251, will require a new application and submission of license
or registration fees as outlined in subsection (b) of this section.
(2)
Change in name, ownership, status, or location of business.
(A)
Not later than the 31st day before the date of the change
in the name, status, or location of a licensed/registered place of business,
the license/registration holder shall provide written notice to the department
of the intended change. The notice shall include, as applicable:
(i)
The new name of the legal entity to be licensed or registered,
including the name under which the business is conducted;
(ii)
The physical and mailing address of the new location;
(iii)
The name and physical address of the licensed warehouse
where the food wholesaler's food products will be stored;
(iv)
The physical address where the food wholesaler's distribution
records are located and available for review upon inspection; and
(v)
The mailing address and telephone number where the food
wholesaler may be contacted.
(B)
Not later than the 10th day after completion of the change
of location, the licensee or registrant shall forward to the department the
name and residence address of the individual in charge of the new place of
business.
(C)
Notice is considered adequate if the licensee or registrant
provides the intent and verification notices to the department by certified
mail, return receipt requested, mailed to the department at 1100 West 49th
Street, Austin, Texas 78756-3182.
(i)
This section does not apply to:
(1)
a person, firm, or corporation that harvests, packages,
washes, or ships raw fruits or vegetables;
(2)
a direct seller who is not otherwise engaged in manufacturing;
(3)
a person engaged solely in the distribution of alcoholic
beverages in sealed containers by holders of licenses or permits issued under
the Alcoholic Beverage Code, Chapters 19, 20, 21, 23, 64, or 65;
(4)
a food service establishment or a commissary which distributes
food primarily intended for immediate consumption on the premises of a retail
outlet under common ownership unless the business regularly engages in the
labeling, combining, and purifying of food which is either sold for resale
or packaged for sale in other than individual portions; or
(5)
a restaurant that provides food for immediate human consumption
to a political subdivision or to a licensed nonprofit organization if the
restaurant would not otherwise be considered a food wholesaler.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on January 11, 2006.
TRD-200600180
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: February 1, 2006
Proposal publication date: October 21, 2005
For further information, please call: (512) 458-7111 x6972
25 TAC §229.372
STATUTORY AUTHORITY
The adopted amendment is authorized by Health and Safety Code, §§12.0111,
431.204, 431.222, 431.276, 432.009, 437.0125, 441.003, and 466.023, which
require the department to charge fees for issuing or renewing a license or
permit; and 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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on January 11, 2006.
TRD-200600181
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: February 1, 2006
Proposal publication date: October 21, 2005
For further information, please call: (512) 458-7111 x6972
25 TAC §229.439
STATUTORY AUTHORITY
The adopted amendment is authorized by Health and Safety Code, §§12.0111,
431.204, 431.222, 431.276, 432.009, 437.0125, 441.003, and 466.023, which
require the department to charge fees for issuing or renewing a license or
permit; and 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.
§229.439.Licensure Fees.
(a)
License fee.
(1)
No person may operate or conduct business as a device distributor
without first obtaining a license from the department. All applicants for
a device distributor license or a renewal license shall pay a licensing fee.
All fees are nonrefundable. Licenses are issued for two-year terms. A license
shall only be issued when all past due fees and delinquency fees are paid.
License fees are based on gross annual device sales.
(A)
For a distributor with gross annual device sales of $0
- $499,999.99, the fees are:
(i)
$480 for a two-year license;
(ii)
$480 for a two-year license that is amended due to a change
of ownership; and
(iii)
$240 for a two-year license that is amended during the
current licensure period due to minor changes.
(B)
For a distributor with gross annual device sales of $500,000
- $9,999,999.99, the fees are:
(i)
$1,080 for a two-year license;
(ii)
$1,080 for a two-year license that is amended due to a
change of ownership; and
(iii)
$540 for a two-year license that is amended during the
current licensure period due to minor changes.
(C)
For a distributor with gross annual device sales greater
than or equal to $10 million, the fees are:
(i)
$1,680 for a two-year license;
(ii)
$1,680 for a two-year license that is amended due to a
change of ownership; and
(iii)
$840 for a two-year license that is amended during the
current licensure period due to minor changes.
(2)
A person who is required to be licensed as a device distributor
under this section and who is also required to be licensed as a wholesale
drug distributor under §229.252(a)(1) of this title (relating to Licensing
Fee and Procedures) or as a wholesale food distributor under §229.182(a)(3)
of this title (relating to Licensing Fee and Procedures) shall pay a combined
licensure fee for each place of business. All fees are nonrefundable. Licenses
are issued for two-year terms. License fees are based on the combined gross
annual sales of these regulated products (foods, drugs, and/or devices).
(A)
For each place of business having combined gross annual
sales of $0 - $199,999.99, the fees are:
(i)
$400 for a two-year license;
(ii)
$400 for a two-year license that is amended due to a change
of ownership; and
(iii)
$200 for a two-year license that is amended during the
current licensure period due to minor changes.
(B)
For each place of business having combined gross annual
sales of $200,000 - $499,999.99, the fees are:
(i)
$600 for a two-year license;
(ii)
$600 for a two-year license that is amended due to a change
of ownership; and
(iii)
$300 for a two-year license that is amended during the
current licensure period due to minor changes.
(C)
For each place of business having combined gross annual
sales of $500,000 - $999,999.99, the fees are:
(i)
$800 for a two-year license;
(ii)
$800 for a two-year license that is amended due to a change
of ownership; and
(iii)
$400 for a two-year license that is amended during the
current licensure period due to minor changes.
(D)
For each place of business having combined gross annual
sales of $1 million - $9,999,999.99, the fees are:
(i)
$1,000 for a two-year license;
(ii)
$1,000 for a two-year license that is amended due to a
change of ownership; and
(iii)
$500 for a two-year license that is amended during the
current licensure period due to minor changes.
(E)
For each place of business having combined gross annual
sales greater than or equal to $10 million, the fees are:
(i)
$1,500 for a two-year license;
(ii)
$1,500 for a two-year license that is amended due to a
change of ownership; and
(iii)
$750 for a two-year license that is amended during the
current licensure period due to minor changes.
(3)
No person may operate or conduct business as a device manufacturer
in this state without first obtaining a license from the department. All applicants
for a device manufacturer license or renewal license shall pay a licensing
fee. All fees are nonrefundable. Licenses are issued for two-year terms. License
fees are based on gross annual device sales.
(A)
For a manufacturer with gross annual device sales of $0
- $499,999.99, the fees are:
(i)
$480 for a two-year license;
(ii)
$480 for a two-year license that is amended due to a change
of ownership; and
(iii)
$240 for a two-year license that is amended during the
current licensure period due to minor changes.
(B)
For a manufacturer with gross annual device sales of $500,000
- $9,999,999.99, the fees are:
(i)
$2,160 for a two-year license;
(ii)
$2,160 for a two-year license that is amended due to a
change of ownership; and
(iii)
$1,080 for a two-year license that is amended during
the current licensure period due to minor changes.
(C)
For a manufacturer with gross annual device sales greater
than or equal to $10 million, the fees are:
(i)
$3,600 for a two-year license;
(ii)
$3,600 for a two-year license that is amended due to a
change of ownership; and
(iii)
$1,800 for a two-year license that is amended during
the current licensure period due to minor changes.
(b)
Texas Online. Applicants may submit applications and renewal
applications for a license under these sections electronically by the Internet
through Texas Online at www.texasonline.state.tx.us. The department is authorized
to collect fees, in amounts determined by the Texas Online Authority, to recover
costs associated with application and renewal application processing through
Texas Online.
(c)
Exemption from licensing fees. A person is exempt from
the licensing fees required by this section if the person is:
(1)
licensed under §289.252 of this title (relating to
Licensing of Radioactive Material) or registered under §289.226 of this
title (relating to Registration of Radiation Machine Use and Services) and
engages only in the following types of device distribution or manufacturing:
(A)
the manufacture or distribution of radiation machines which
are devices; or
(B)
the manufacture or distribution of devices which contain
radioactive materials; or
(2)
a charitable organization, as described in the Internal
Revenue Code of 1986, §501(c)(3), or a nonprofit affiliate of the organization,
to the extent otherwise permitted by law.
(d)
Sale of food, drugs, or devices. This section includes
the manufacture, production, processing, packaging, exposure, offer, possession,
and holding of any of the regulated articles for sale; the sale, dispensing,
and giving of any regulated article; and supplying or applying of any regulated
articles in the operation of any food, drug, or device place of business.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed
with the Office of the Secretary of State on January 11, 2006.
TRD-200600182
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: February 1, 2006
Proposal publication date: October 21, 2005
For further information, please call: (512) 458-7111 x6972
Subchapter D. GENERAL
Chapter 143.
MEDICAL RADIOLOGIC TECHNOLOGISTS
Chapter 205.
PRODUCT SAFETY
Subchapter C. LABELING OF HAZARDOUS SUBSTANCES
Subchapter D. INHALANT ABUSE
Chapter 229.
FOOD AND DRUG
Subchapter L. LICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS
Subchapter U. PERMITTING RETAIL FOOD ESTABLISHMENTS
Subchapter X. LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS
Chapter 289.
RADIATION CONTROL