[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21250-21252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08054]
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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, Agency, 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 (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 June 15, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 15, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 15, 2020. 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): Dockets Management Staff (HFA-305), Food and
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Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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 Dockets Management Staff
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 Dockets Management Staff. 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: https://www.govinfo.gov/content/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 heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
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,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 (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
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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).
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
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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 0.25 (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.
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: April 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08054 Filed 4-15-20; 8:45 am]
BILLING CODE 4164-01-P