[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Notices]
[Pages 10371-10373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4155]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0622]


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 March 
28, 2011.

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: 202-395-7285, 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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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--21 CFR part 80 (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 FD&C Act) (21 U.S.C. 379e(a)) 
provides that a color additive shall be deemed to be unsafe unless it

[[Page 10372]]

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 in tracing the 
disposal of a certified batch or a batch that has been denied 
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-denied 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 December 13, 2010 (75 FR 77645), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. 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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                                                                    Number of     Annual frequency    Total annual        Hours per
                        21 CFR Section                             respondents      per response        responses         response         Total hours
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80.21.........................................................                32               185             5,920              0.17             1,006
80.22.........................................................                32               185             5,920              0.05               296
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    Total.....................................................  ................  ................  ................              0.22             1,302
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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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                                                                                  Annual frequency
                        21 CFR Section                              Number of            per          Total annual    Hours per record     Total hours
                                                                  recordkeepers     recordkeeping        records
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80.39.........................................................                32               185             5,920              0.25             1,480
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................             1,480
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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 2,782 hours. The estimated reporting 
burden for this information collection is 1,302 hours and the estimated 
recordkeeping burden for this information collection is 1,480 hours. 
From FY 2008 to FY 2010, FDA processed an average of 5,932 responses 
(requests for certification of batches of color additives) per year. 
There were 32 different respondents, corresponding to an average of 
approximately 185 responses from each respondent per year. Using 
information from industry personnel, FDA estimates that an average of 
0.22 hour per response is required for reporting (preparing 
certification requests and accompanying

[[Page 10373]]

samples) and an average of 0.25 hour per response is required for 
recordkeeping.
    FDA's Web-based color certification information system allows 
certifiers to request color certification online, 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 has estimated a reduction in the hour burden for 
reporting from use of the Web-based system.

    Dated: February 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4155 Filed 2-23-11; 8:45 am]
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