Document ID: FDA-2004-N-0252-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Color Additive
Certification Requests and Recordkeeping
Posted Date: 2014-04-23T04:00Z

[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22688-22689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09200]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0252]

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 May 23, 
2014.

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 emailed to oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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

    We have 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 
meets the requirements of a listing regulation, including any 
requirement for batch certification, and is used in accordance with the 
regulation. We list color additives that have been shown to be safe for 
their intended uses in Title 21 of the Code of Federal Regulations 
(CFR). We require 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 
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. We charge a fee for 
certification based on the batch weight and require 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 of 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 us 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

[[Page 22689]]

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. We check 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 February 6, 2014 (79 FR 7199), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                        Number of
                    21 CFR section; activity                         Number of        responses  per      Total annual      Average burden   Total hours
                                                                    respondents         respondent         responses         per response
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80.21; Request for Certification...............................                 35                199              6,965               0.17        1,184
80.22; Sample to accompany request.............................                 35                199              6,965               0.05          348
                                                                ----------------------------------------------------------------------------------------
    Total......................................................  .................  .................  .................               0.22        1,532
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                       Table 2--Estimated Recordkeeping Burden \1\
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                                                                 Number of      Number of  records     Total annual       Average burden
                 21 CFR section; activity                      recordkeepers    per  recordkeeping        records        per recordkeeping   Total hours
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80.39; Record of Distribution.............................                 35                 199               6,965                0.25         1,741
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimate on our review of the certification requests 
received over the past 3 fiscal years (FY). The annual burden estimate 
for this information collection is 3,273 hours. The estimated reporting 
burden for this information collection is 1,532 hours and the estimated 
recordkeeping burden for this information collection is 1,741 hours. 
From FY 2011 to FY 2013, we processed an average of 6,954 responses 
(requests for certification of batches of color additives) per year. 
There were 35 different respondents, corresponding to an average of 
approximately 199 responses from each respondent per year. Using 
information from industry personnel, we estimate that an average of 
0.22 hour per response is required for reporting (preparing 
certification requests and accompanying samples) and an average of 0.25 
hour per response is required for recordkeeping.
    Our web-based Color Certification information system allows 
submitters 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 submitters 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.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09200 Filed 4-22-14; 8:45 am]
BILLING CODE 4160-01-P