[Federal Register Volume 71, Number 235 (Thursday, December 7, 2006)]
[Rules and Regulations]
[Pages 70873-70875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20800]


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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.

[[Page 70874]]


ACTION: Interim final rule; technical amendment; reopening of comment 
period.

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SUMMARY: The Food and Drug Administration (FDA) is amending an interim 
final rule (IFR) that was published in the Federal Register of March 
29, 2005 (70 FR 15755). The IFR amended the color additive regulations 
by increasing the fees for certification services. The IFR was 
published with one typographical error regarding fees for repacks of 
certified color additives and color additive mixtures. FDA also 
inadvertently omitted the color certification fee study referenced in 
the IFR from the docket at the time of publication. This document 
corrects the typographical error in the fees for repacks of certified 
color additives and color additive mixtures, announces the availability 
of the referenced color certification fee study, and provides for 
additional time to submit comments.

DATES: This amendment is effective January 8, 2007. Submit written or 
electronic comments by February 5, 2007.

ADDRESSES: You may submit comments, identified by Docket No. 2005N-
0077, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     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.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For 
additional information on submitting comments, see the ``Comments'' 
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://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: Kathleen Klausing, Division of Budget 
Execution (HFA-140), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7021; 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

    In the Federal Register of March 29, 2005 (70 FR 15755), FDA issued 
an IFR to amend the color additive regulations by increasing the fees 
for certification services in 21 CFR 80.10. The change in fees was 
necessary so that FDA could continue to provide, maintain, and equip an 
adequate color certification program as required by section 721(e) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379(e)). 
The fees are intended to recover the full costs of operation of FDA's 
color certification program. The IFR went into effect on April 28, 
2005. FDA requested written or electronic comments by May 31, 2005.
    FDA subsequently discovered: (1) That the referenced 2003 color 
certification fee study had inadvertently been omitted from the docket 
and (2) that there was a typographical error regarding the fees for 
repacks of certified color additives and color additive mixtures in the 
codified portion of the IFR.

II. 2003 Color Certification Fee Study

    The agency has made available the color certification fee study 
that describes the cost estimates reflected in the March 29, 2005, IFR. 
FDA stated in the IFR that the document entitled ``2003 Color 
Certification Fee Study'' is on file at the Division of Dockets 
Management. FDA subsequently discovered that we had inadvertently 
omitted the document from the docket at the time of publication. The 
agency made the document available at the Division of Dockets 
Management (see ADDRESSES) on May 16, 2005.

III. Fee Listing Typographical Error

    The agency is also amending the March 29, 2005, IFR (70 FR 15755 at 
15756) regarding fees for repacks of certified color additives and 
color additive mixtures. Before issuance of the IFR, Sec.  80.10(b) 
provided, in relevant part, ``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 * * * shall be: * * * (2) Over 100 pounds but not 
over 1,000 pounds--$30 plus six cents for each pound over 100 pounds'' 
(emphasis added). In revising that portion of the codified, we intended 
to increase the fees for repacks of certified color additives and color 
additive mixtures for the first 100 pounds, i.e., from $30 to $35, but 
maintain the fee of 6 cents for each pound over 100 pounds. However, we 
inadvertently specified ``$0.05'' rather than specifying ``$0.06.'' 
This provision should read, in relevant part, ``(2) Over 100 pounds but 
not over 1,000 pounds--$35 plus $0.06 for each pound over 100 pounds.'' 
FDA is correcting this typographical error in the codified language by 
way of this technical amendment.

IV. Analysis of Impacts

    FDA has examined the impacts of the March 29, 2005, IFR 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) (70 FR 15755 at 15756). Based on this analysis of the impact of the 
IFR, the technical amendment to the IFR described in section III would 
generate a cost of $0 to $2,000 per year. Therefore, this technical 
amendment is not a significant regulatory action as defined by the 
Executive Order.
    The technical amendment does not necessitate a change in our 
certification, under the Regulatory Flexibility Act. The IFR, as 
amended, will not have a significant economic impact on a substantial 
number of small entities. In addition, the IFR, as amended, does not 
change our expectation that this rule will not result in any 1-year 
expenditure that would meet or exceed the threshold amount triggering a 
written statement under the Unfunded Mandates Reform Act.

V. Environmental Impact

    The agency has determined under 21 CFR 25.22(a) that, as amended in 
this

[[Page 70875]]

document, the March 29, 2005, IFR 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.

VI. Opportunity for Public Comment

    Under 5 U.S.C. 553(b)(B) and 21 CFR 10.40(e), FDA found in the 
March 29, 2005, IFR 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 (70 FR 
15755 at 15756). FDA continues to find it necessary to implement the 
amended fee increase as soon as possible to preserve adequate funds for 
the program. The agency believes, however, that it is appropriate to 
invite and consider additional public comments on these requirements. 
Any comments already received by FDA on the March 29, 2005, IFR do not 
need to be resubmitted to the agency. The agency is considering them at 
this time and will address them at a later date.
    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 comments 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 paragraph (b) (2) to read as 
follows:


Sec.  80.10  Fees for certification services.

* * * * *
    (b) * * *
    (2) Over 100 pounds but not over 1,000 pounds--$35 plus $0.06 for 
each pound over 100 pounds.
* * * * *

    Dated: November 29, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-20800 Filed 12-6-06; 8:45 am]
BILLING CODE 4160-01-S