
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44420-44422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20245]


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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 October 
23, 2017.

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.

[[Page 44421]]


FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
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 (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 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 June 14, 2017 (82 FR 27259), 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  per response           Total hours
                                                respondents     respondent       responses
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80.21; Request for Certification............              38             198           7,524  0.17 (10 minutes).........................           1,279
80.22; Sample to Accompany Request..........              38             198           7,524  0.05 (3 minutes)..........................             376
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  0.22 (13 minutes).........................           1,655
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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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Number of
          21 CFR section/activity               Number of      records per    Total annual         Average burden per recordkeeping         Total hours
                                              recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
80.39; Record of Distribution..............              38             198           7,524  .25 (15 minutes)...........................           1,881
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 44422]]

    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 3,536 hours. The estimated reporting 
burden for this information collection is 1,655 hours and the estimated 
recordkeeping burden for this information collection is 1,881 hours. 
From FY 2014 to FY 2016, we processed an average of 7,524 responses 
(requests for certification of batches of color additives) per year. 
There were 38 different respondents, corresponding to an average of 
approximately 198 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.
    FDA's 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 
hardcopy 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: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20245 Filed 9-21-17; 8:45 am]
 BILLING CODE 4164-01-P


