Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping, 21250-21252 [2020-08054]
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21250
Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
We therefore estimate the burden of
the information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR part 14; subpart e—members of
advisory committees
Total
annual
responses
Average
burden per
response
Total hours
Advisory Committee Membership Nominations ........................................................
391
1
391
0.25
(15 minutes)
98
Representative Member Submission of
Updated Information ...............................
54
1
54
0.25
(15 minutes)
14
Total ....................................................
........................
........................
445
..................................................
112
1 There
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Number of
responses per
respondent
Number of
respondents
are no capital costs or operating and maintenance costs associated with this information collection.
Based on a review of data, we
received 354 nominations for
membership to FDA advisory
committees in fiscal year (FY) 2015; we
received 510 nominations in FY 2016;
we received 500 nominations in FY
2017; we received 258 nominations in
FY 2018; and we received 333
nominations in FY 2019. By averaging
the number of nominations received
annually over the past 5 years, we
estimate there are approximately 391
respondents to the information
collection. We estimate it takes
respondents 15 minutes to complete an
initial nomination, where
accompanying documentation is already
available or has been prepared in
advance by respondents. Multiplying 15
minutes (0.25) by the number of
respondents to the information
collection (391) equals 97.75 (98
rounded) annual burden hours.
We have also included a burden
estimate for members who currently
serve on FDA advisory committees who
are not Special Government and Regular
Government Employees and who must
submit an updated CV and an executed/
completed consent form annually.
Currently there are 54 authorized
positions for these Representative
members, mostly Industry
Representatives. While some positions
are vacant, we anticipate the positions
will be filled during the year. The
request for the updated CV and consent
form will be made through email
communications by the Designated
Federal Officer of the committee. We
anticipate that the burden to the
respondent will be the same as that for
new nominations. We estimate each
response will require 15 minutes (0.25)
for a total of 13.5 (14 rounded) annual
hours.
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18:20 Apr 15, 2020
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Dated: April 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Food and Drug Administration
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.
[Docket No. FDA–2010–N–0622]
Electronic Submissions
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Color Additive
Certification Requests and
Recordkeeping
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’’).
[FR Doc. 2020–08008 Filed 4–15–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
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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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Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
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-201509-18/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
VerDate Sep<11>2014
18:20 Apr 15, 2020
Jkt 250001
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, PRAStaff@
fda.hhs.gov.
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
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21251
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 § 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 § 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
§ 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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Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
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
Number of
respondents
21 CFR section; activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
80.21; Request for certification ...................................
80.22; Sample to accompany request ........................
38
38
198
198
7,524
7,524
0.17 (10 minutes) ..
0.05 (3 minutes) .....
1,279
376
Total ......................................................................
........................
........................
........................
0.22 (13 minutes) ...
1,655
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
recordkeepers
21 CFR section; activity
80.39; Record of distribution .......................................
1 There
38
Total annual
records
198
7,524
Average
burden per
recordkeeping
0.25 (15 minutes) ...
Total hours
1,881
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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Number of
records per
recordkeeper
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
Section 2112(b)(2) of the Public Health
Service (PHS) Act, as amended. While
the Secretary of HHS is named as the
SUMMARY:
VerDate Sep<11>2014
18:20 Apr 15, 2020
Jkt 250001
respondent in all proceedings brought
by the filing of petitions for
compensation under the Program, the
United States Court of Federal Claims is
charged by statute with responsibility
for considering and acting upon the
petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, Maryland 20857; (301) 443–
6593, or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the United States Court of Federal
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Claims and to serve a copy of the
petition to the Secretary of HHS, who is
named as the respondent in each
proceeding. The Secretary has delegated
this responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
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[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 21251]]
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
[[Page 21252]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
