[Federal Register Volume 72, Number 231 (Monday, December 3, 2007)]
[Notices]
[Pages 67942-67943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0279]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Color Additive 
Certification Requests and Recordkeeping

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
2, 2008.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0216. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Color Additive Certification Requests and Recordkeeping--OMB Control 
Number 0910-0216)--Extension

    FDA has regulatory oversight for color additives used in foods, 
drugs, cosmetics, and medical devices. Section 721(a) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(a)) provides 
that a color additive shall be deemed to be unsafe unless it meets the 
requirements of a listing regulation, including any requirement for 
batch certification, and is used in accordance with the regulation. FDA 
lists color additives that have been shown to be safe for their 
intended uses in title 21 of the Code of Federal Regulations (CFR). FDA 
requires batch certification for all color additives listed in 21 CFR 
part 74 and for all color additives provisionally listed in 21 CFR part 
82. Color additives listed in 21 CFR part 73 are exempted from 
certification.
    The requirements for color additive certification are described in 
part 80 (21 CFR part 80). In the certification procedure, a 
representative sample of a new batch of color additive, accompanied by 
a ``request for certification'' that provides information about the 
batch, must be submitted to FDA's Office of Cosmetics and Colors. FDA 
personnel perform chemical and other analyses of the representative 
sample and, providing the sample satisfies all certification 
requirements, issue a certification lot number for the batch. FDA 
charges a fee for certification based on the batch weight and requires 
manufacturers to keep records of the batch pending and after 
certification.
    Under Sec.  80.21, a request for certification must include: Name 
of color additive, manufacturer's batch number and weight in pounds, 
name and address of manufacturer, storage conditions, statement of 
use(s), certification fee, and signature of person requesting 
certification. Under Sec.  80.22, a request for certification must 
include a sample of the batch of color additive that is the subject of 
the request. The sample must be labeled to show: Name of color 
additive, manufacturer's batch number and quantity, and name and 
address of person requesting certification. Under Sec.  80.39, the 
person to whom a certificate is issued must keep complete records 
showing the disposal of all the color additive covered by the 
certificate. Such records are to be made available upon request to any 
accredited representative of FDA until at least 2 years after disposal 
of all of the color additive.
    The purpose for collecting this information is to help FDA assure 
that only safe color additives will be used in foods, drugs, cosmetics, 
and medical devices sold in the United States. The required information 
is unique to the batch of color additive that is the subject of a 
request for certification. The manufacturer's batch number is used for 
temporarily identifying a batch of color additive until FDA issues a 
certification lot number and for identifying a certified batch during 
inspections. The manufacturer's batch number also aids

[[Page 67943]]

in tracing the disposal of a certified batch or a batch that has been 
refused certification for noncompliance with the color additive 
regulations. The manufacturer's batch weight is used for assessing the 
certification fee. The batch weight also is used to account for the 
disposal of a batch of certified or certification-rejected color 
additive. The batch weight can be used in a recall to determine whether 
all unused color additive in the batch has been recalled. The 
manufacturer's name and address and the name and address of the person 
requesting certification are used to contact the person responsible 
should a question arise concerning compliance with the color additive 
regulations. Information on storage conditions pending certification is 
used to evaluate whether a batch of certified color additive is 
inadvertently or intentionally altered in a manner that would make the 
sample submitted for certification analysis unrepresentative of the 
batch. FDA checks storage information during inspections. Information 
on intended uses for a batch of color additive is used to assure that a 
batch of certified color additive will be used in accordance with the 
requirements of its listing regulation. The statement of the fee on a 
certification request is used for accounting purposes so that a person 
requesting certification can be notified promptly of any discrepancies.
    In the Federal Register of July 24, 2007 (72 FR 40310), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
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80.21                             32                174              5,568               0.20              1,114
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80.22                             32                174              5,568               0.05                278
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Total              .................  .................  .................               0.25              1,392
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                         No. of        Annual Frequency     Total Annual
  21 CFR Section     Recordkeepers     of Recordkeeping       Records       Hours per  Record     Total Hours
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80.39                             32                174              5,568               0.25              1,392
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Total              .................  .................  .................  .................              1,392
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA bases its estimate on its review of the certification requests 
received over the past 3 fiscal years (FY). The annual burden estimate 
for this information collection is 2,784 hours. The estimated reporting 
burden for this information collection is 1,392 hours and the estimated 
recordkeeping burden for this information collection is 1,392 hours. 
From FY 2004 to FY 2006, FDA processed an average of 5,568 responses 
(requests for certification of batches of color additives) per year. 
There were 32 different respondents, corresponding to an average of 
approximately 174 responses from each respondent per year. Using 
information from industry personnel, FDA estimates that an average of 
0.25 hour per response is required for reporting (preparing 
certification requests and accompanying sample labels) and an average 
of 0.25 hour per response is required for recordkeeping.
    On February 13, 2006, FDA introduced a Web-based Color 
Certification information system. The system was fully operational for 
FY 2007. This system allows certifiers to request color certification 
on-line, follow their submissions through the process, and obtain 
information on account status. The system sends back the certification 
results electronically, allowing certifiers to sell their certified 
color before receiving hard copy certificates. Any delays in the system 
result only from shipment of color additive samples to FDA's Office of 
Cosmetics and Colors for analysis. FDA expects future reductions in the 
hour burdens for reporting and recordkeeping from use of the Web-based 
system.

    Dated: November 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23352 Filed 11-30-07; 8:45 am]
BILLING CODE 4160-01-S