
[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27259-27261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 August 14, 2017.

ADDRESSES: You may submit comments as follows. Late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before August 14, 2017. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of August 14, 2017. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0622 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Color Additive Certification 
Requests and Recordkeeping.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov/ and insert the docket number, found in brackets in 
the

[[Page 27260]]

heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, FDA PRA Staff, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794.

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 (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.
    We estimate the burden of this collection of information as 
follows:

[[Page 27261]]



                                                     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
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    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\
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                                                                 Number of
           21 CFR section/activity               Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
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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.

    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.
    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 
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: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12328 Filed 6-13-17; 8:45 am]
 BILLING CODE 4164-01-P


