Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229.
FOOD AND DRUG
The Executive Commissioner of the Health and Human Services Commission,
on behalf of the Department of State Health Services (department), adopts
amendments to §229.182 concerning licensure of food manufacturers, food
wholesalers, and warehouse operators, and §§229.435, 229.439, 229.441,
229.443, and 229.444, concerning licensing of device distributors and manufacturers
without changes to the proposed text as published in the August 18, 2006,
issue of the
Texas Register
(31 TexReg 6458),
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,
a cost recovery fee is included in these amendments.
Programs with regulatory authority over food manufacturers, food wholesalers,
and warehouse operators; 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; the 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.
Finally, the sections required updating to be consistent with changes resulting
from House Bill 2292, 78th Legislative Session, 2003. The amendments update
and clarify the sections to reflect current licensing procedures and license
term durations as well as identification of the state agencies responsible
for certain licensing, enforcement and advisory committee functions.
SECTION-BY-SECTION SUMMARY
Amendments to §229.182 contain increases in licensing fees for food
wholesalers with combination products for initial and renewal applications
per location, based upon gross annual sales. Specifically, new §229.182(b)(3)(A)
increases the license fee for wholesalers of combination products with gross
annual sales of $0.00 - $199,999.99 by $120 for a two-year term; new §229.182(b)(3)(B)
increases the license fee for wholesalers of combination products with gross
annual sales of $200,000 - $499,999.99 by $180 for a two-year term; new §229.182(b)(3)(C)
increases the license fee for wholesalers of combination products with gross
annual sales of $500,000 - $999,999.99 by $240 for a two-year term; new §229.182(b)(3)(D)
increases the license fee for wholesalers of combination products with gross
annual sales of $1 million - $9,999,999.99 by $300 for a two-year term; and
new §229.182(b)(3)(E) increases the license fee for wholesalers of combination
products with gross annual sales of greater than or equal to $10 million by
$450 for a two-year term.
Amendments to §229.435 remove the reference to one-year license fees
changing the reference to two years, and correctly identify the responsible
licensing agency as the Department of State Health Services.
Amendments to §229.439 contain increases in fees for device distributor
licenses and renewal licenses for distributors with combination products.
Amendments to §229.439(a)(1)(A)-(C) remove references to two-year fees
related to minor changes within the licensure period. Specifically, §229.439(a)(2)(A)
increases the license fee for distributors with gross annual sales of $0 -
$199,999.99 by $120 for a two-year term; §229.439(a)(2)(B) increases
the license fee for distributors with gross annual sales of $200,000 - $499,999.99
by $180 for a two-year term; §229.439(a)(2)(C) increases the license
fee for distributors with gross annual sales of $500,000 - $999,999.99 by
$240 for a two-year term; §229.439(a)(2)(D) increases the license fee
for distributors of combination productions with gross annual sales of $1
million - $9,999,999.99 by $300 for a two-year term; §229.439(a)(2)(E)
increases the license fee for distributors of combination products with gross
annual sales of greater than or equal to $10 million by $450 for a two-year
term. Amendments to §229.439(a)(3) add a statement about late fees and
remove references to two-year fees related to minor changes within the licensure
period.
Amendments to §229.441 correctly reflect that the device-related policies
of the U.S. Food and Drug Administration are also the policies of the Department
of State Health Services. In addition, the amendments recognize that the Executive
Commissioner of the Health and Human Services Commission is responsible for
any modification or rejection of rules relating to device labeling exemptions
adopted under the Federal Food, Drug and Cosmetic Act. References to the "Board
of Health" were removed and replaced with "Executive Commissioner of the Health
and Human Services Commission" due to the abolishment of the board.
Amendments to §229.443 and §229.444 correctly reflect that the
agency responsible for certain enforcement actions with respect to adulterated
and misbranded devices is the Department of State Health Services and that
the Executive Commissioner of the Health and Human Services Commission is
responsible for oversight of the functions and duties of the Device Distributors
and Manufacturers Advisory Committee. Changes were made due to agency name
changes and the abolishment of the Board of Health.
COMMENTS
The department, on behalf of the commission, did not receive any comments
regarding the proposed rules during the comment period.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the rules, as adopted, have been reviewed by legal counsel
and found to be a valid exercise of the agencies' legal authority.
Subchapter L. LICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS