Document ID: FDA-2010-N-0622-0009
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: 2020-07-30T04:00Z

[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45890-45892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16534]

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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.

[[Page 45891]]

DATES: Submit written comments (including recommendations) on the 
collection of information by August 31, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0216. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
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 (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 (21 CFR 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 (21 CFR 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 
(21 CFR 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.
    Description of Respondents: The respondents include businesses 
engaged in the manufacture of color additives used in FDA-regulated 
foods, drugs, cosmetics, and medical devices. Respondents are from the 
private sector (for-profit businesses).
    In the Federal Register of April 16, 2020 (85 FR 21250), we 
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
----------------------------------------------------------------------------------------------------------------
80.21; Request for                          38             198           7,524  0.17 (10                   1,279
 certification.                                                                  minutes).
80.22; Sample to accompany                  38             198           7,524  0.05 (3 minutes)             376
 request.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  0.22 (13                   1,655
                                                                                 minutes).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 45892]]

                               Table 2--Estimated Annual 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
----------------------------------------------------------------------------------------------------------------
80.39; Record of distribution.              38             198           7,524  0.25 (15                   1,881
                                                                                 minutes).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: July 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16534 Filed 7-29-20; 8:45 am]
BILLING CODE 4164-01-P