[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7199-7200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02513]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
provisions of FDA's regulations governing batch certification of color 
additives manufactured for use in foods, drugs, cosmetics, or medical 
devices in the United States.

DATES: Submit either electronic or written comments on the collection 
of information by April 7, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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 the color additive.
    The purpose for collecting this information is to help us assure 
that

[[Page 7200]]

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. 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.
    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
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    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                       Average burden
                      21 CFR section; activity                          Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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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: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02513 Filed 2-5-14; 8:45 am]
BILLING CODE 4160-01-P