[Federal Register: March 29, 2005 (Volume 70, Number 59)]
[Rules and Regulations]               
[Page 15755-15756]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr05-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 80

[Docket No. 2005N-0077]

 
Color Additive Certification; Increase in Fees for Certification 
Services

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; opportunity for public comment.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an interim 
final rule to amend the color additive regulations by increasing the 
fees for certification services. The change in fees will allow FDA to 
continue to maintain an adequate color certification program as 
required by the Federal Food, Drug, and Cosmetic Act (the act). The 
fees are intended to recover the full costs of operation of FDA's color 
certification program.

DATES: The interim final rule is effective April 28, 2005. Submit 
written or electronic comments by May 31, 2005.

ADDRESSES: You may submit comments, identified by Docket No. 2005N-0077 
by any of the following methods:
     Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting comments on the agency Web site.
     E-mail: fdadockets@oc.fda.gov. Include Docket No. 2005N-
0077 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and Docket No(s). or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted without change to 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, including any personal 

information provided. For detailed instructions on submitting comments 
and additional information on the rulemaking process, see the 
``Opportunity for Public Comment'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm 

and insert the docket number(s), found in brackets in the heading of 
this document, into the ``Search'' box and follow the prompts and/or go 
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert MacLeod, Division of Budget 
Execution (HFA-140), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-887-3923; and Theodor J. Dougherty, Division 
of Accounting (HFA-120), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-5032.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is increasing the fees provided for in the agency's regulations 
for certifying color additives. This modification is necessary because 
of a general increase in all costs of operating the certification 
program.
    The fee schedule for color additive certification is designed to 
cover all the costs involved in certifying batches of color additives. 
This includes both the cost of specific tests required by the 
regulations and the general costs associated with the certification 
program, such as costs of accounting, reviewing data, issuing 
certificates, and conducting research and establishment inspections.
    Section 721(e) of the act (21 U.S.C. 379(e)) requires that fees 
necessary to provide, maintain, and equip an adequate color additive 
certification program be specified in agency regulations. The current 
fee schedule specified in the regulations became effective in 1994. 
Since 1994, the costs of the certification program significantly 
increased as a result of escalating staff payroll, rent and facility 
charges, as well as general operational expenses including equipment.
    As is evidenced by the increased costs incurred since 1994, the 
current fee schedule is insufficient to provide, equip, and maintain an 
adequate certification service. Therefore, an immediate increase is 
necessary. All cost estimates are described in the ``2003 Color 
Certification Fee Study.'' A copy of this document is on file at the 
Division of Dockets Management (see ADDRESSES).

II. Effective Date

    The agency is issuing this amendment as an interim final rule 
effective (see DATES). The establishment of fees necessary to provide, 
equip, and maintain an adequate certification service for colors has 
been mandated by Congress under section 721(e) of the act. As 
certification services are provided to industry directly by FDA, the 
setting of a fee schedule to pay for these services is a matter 
particularly within the purview and expertise of the agency. The fees 
established by this regulation have been based on cost accounting 
methods using data compiled by the agency. Increasing the fees by $0.05 
per pound will ensure the viability of the certification program and 
offset the increased costs of maintaining this program. The fee for 
straight colors including lakes will be $0.35 per pound (a $0.05 per 
pound increase) with a minimum fee of $224. There are similar increases 
in fees for repacks of certified

[[Page 15756]]

color additives and color additive mixtures.

III. Analysis of Impacts

    FDA has examined the impacts of the interim final rule under 
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandate Reforms Flexibility Act (Public Law 104-
4). Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). The agency 
believes that this interim final rule is consistent with the regulatory 
philosophy and principles identified in the Executive order. In 
addition, the interim final rule is not a significant regulatory action 
as defined by the Executive order and so is not subject to review under 
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The entire cost of this fee increase would be 
approximately $849,626 per year and would be distributed amongst 
approximately 23 companies who would pay an increased fee that is 
proportional to the number of pounds of color that they certify. The 
great majority of these costs will be borne by a few firms that have a 
dominate share of the color certification market. These firms that have 
the largest shares of the market would pay most of these fees. In 
addition, by the Small Business Administration (SBA) standards, all of 
the affected manufacturers of color additives are considered large. 
Thus, the agency certifies that the interim final rule will not have a 
significant economic impact on a substantial number of small entities. 
Therefore, under the Regulatory Flexibility Act, no further analysis is 
required.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $115 million, using the most current (2003) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.22(a) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Opportunity for Public Comment

    Under 5 U.S.C. 553(b)(B) and 21 CFR 10.40(e), FDA finds that 
providing for notice and public comment before the establishment of 
these fees, and for revising the basis on which these fees are 
calculated, is contrary to the public interest. It is necessary to 
implement the fee increase as soon as possible to preserve adequate 
funds for the program. A delay could result in the fund being exhausted 
before the end of the fiscal year. The agency believes, however, that 
it is appropriate to invite and consider public comments on these 
requirements.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic copies or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects in 21 CFR Part 80

    Color additives, Cosmetics, Drugs, Reporting and recordkeeping 
requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
80 is amended as follows:

PART 80--COLOR ADDITIVE CERTIFICATION

0
1. The authority citation for 21 CFR part 80 continues to read as 
follows:

    Authority: 21 U.S.C. 371, 379e.

0
2. Section 80.10 is amended by revising paragraphs (a) and (b) to read 
as follows:


Sec.  80.10  Fees for certification services.

    (a) Fees for straight colors including lakes. The fee for the 
services provided by the regulations in this part in the case of each 
request for certification submitted in accordance with Sec.  
80.21(j)(1) and (j)(2) shall be $0.35 per pound of the batch covered by 
such requests, but no such fee shall be less than $224.
    (b) Fees for repacks of certified color additives and color 
additive mixtures. The fees for the services provided under the 
regulations in this part in the case of each request for certification 
submitted in accordance with Sec.  80.21(j)(3) and (j)(4) shall be:
    (1) 100 pounds or less--$35.
    (2) Over 100 pounds but not over 1,000 pounds--$35 plus $0.05 for 
each pound over 100 pounds.
    (3) Over 1,000 pounds--$89 plus $0.02 for each pound over 1,000 
pounds.
* * * * *

    Dated: March 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6155 Filed 3-28-05; 8:45 am]

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