Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503, 39793-39795 [2017-17703]
Download as PDF
<![CDATA[
39793
Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
naturally occurring cases of diseases or
conditions that are identified in the
Centers for Disease Control and
Prevention’s list of category ‘‘A’’
biological threat agents. The number of
cases that would result from a terrorist
event or other public health emergency
is uncertain. Based on its knowledge of
similar types of submissions, FDA
estimates that it will take about 2 hours
to prepare each certification. We
provider and, where appropriate, to
public health authorities.
In the Federal Register of April 18,
2017 (82 FR 18294), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
estimate the operating and maintenance
cost of $200 for copying and mailing the
information to FDA.
Based on its knowledge of similar
types of submissions, FDA estimates
that it will take about 1 hour to prepare
a report disclosing the investigational
status of the in vitro diagnostic device
and what is known about the
performance characteristics of the
device and submit it to the health care
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
Total
operating and
maintenance
costs
150
21 CFR section
3
450
0.25 (15 minutes) ...............
113
$200
Written certification (sent to
FDA)—50.23(e)(3).
1 There
are no capital costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR Part
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Written certification (sent to IRB)—50.23(e)(1) and (2) ......
Informed consent information—50.23(e)(4) .........................
150
150
3
3
450
450
2
1
900
450
Total ..............................................................................
........................
........................
........................
........................
1,350
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by September
21, 2017.
DATES:
[FR Doc. 2017–17702 Filed 8–21–17; 8:45 am]
BILLING CODE 4164–01–P
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 0910–0016 and
title ‘‘Submission of Petitions: Food
Additive, Color Additive (Including
Labeling), Submission of Information to
a Master File in Support of Petitions;
and Electronic Submission Using Food
and Drug Administration Form 3503.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0258]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Submission of
Petitions: Food Additive, Color
Additive (Including Labeling),
Submission of Information to a Master
File in Support of Petitions; and
Electronic Submission Using Food and
Drug Administration Form 3503
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
VerDate Sep<11>2014
21:20 Aug 21, 2017
Ila
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.
FOR FURTHER INFORMATION CONTACT:
Notice.
Jkt 241001
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Submission of Petitions: Food
Additive, Color Additive (Including
Labeling), Submission of Information to
a Master File in Support of Petitions;
and Electronic Submission Using Food
and Drug Administration Form 3503—
21 CFR 70.25, 71.1, and 171.1, and 21
CFR parts 172, 173, 179, and 180; OMB
Control Number 0910–0016—Extension.
Section 409(a) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 348(a)) provides that a food
additive shall be deemed to be unsafe,
unless: (1) The additive and its use, or
intended use, are in conformity with a
regulation issued under section 409 of
the FD&C Act that describes the
condition(s) under which the additive
may be safely used; (2) the additive and
its use, or intended use, conform to the
terms of an exemption for
investigational use; or (3) a food contact
notification submitted under section
409(h) is effective. Food additive
petitions (FAPs) are submitted by
individuals or companies to obtain
approval of a new food additive or to
amend the conditions of use permitted
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22AUN1.SGM
22AUN1
39794
Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
under an existing food additive
regulation. Section 171.1 of FDA’s
regulations (21 CFR 171.1) specifies the
information that a petitioner must
submit to establish that the proposed
use of a food additive is safe and to
secure the publication of a food additive
regulation describing the conditions
under which the additive may be safely
used. Parts 172, 173, 179, and 180 (21
CFR parts 172, 173, 179, and 180)
contain labeling requirements for
certain food additives to ensure their
safe use.
Section 721(a) of the FD&C Act (21
U.S.C. 379e(a)) provides that a color
additive shall be deemed to be unsafe
unless the additive and its use are in
conformity with a regulation that
describes the condition(s) under which
the additive may safely be used, or the
additive and its use conform to the
terms of an exemption for
investigational use issued under section
721(f). Color additive petitions (CAPs)
are submitted by individuals or
companies to obtain approval of a new
color additive or a change in the
conditions of use permitted for a color
additive that is already approved.
Section 71.1 of the Agency’s regulations
(21 CFR 71.1) specifies the information
that a petitioner must submit to
establish the safety of a color additive
and to secure the issuance of a
regulation permitting its use. FDA’s
color additive labeling requirements in
§ 70.25 (21 CFR 70.25) require that color
additives that are to be used in food,
drugs, medical devices, or cosmetics be
labeled with sufficient information to
ensure their safe use.
FDA scientific personnel review FAPs
to ensure the safety of the intended use
of the additive in or on food, or that may
be present in food as a result of its use
in articles that contact food. Likewise,
FDA personnel review CAPs to ensure
the safety of the color additive prior to
its use in food, drugs, medical devices,
or cosmetics.
Interested persons may transmit FAP
or CAP regulatory submissions in
electronic format or paper format to the
Office of Food Additive Safety in the
Center for Food Safety and Applied
Nutrition using Form FDA 3503. Form
FDA 3503 helps the respondent
organize their submission to focus on
the information needed for FDA’s safety
review. Form FDA 3503 can also be
used to organize information within a
master file submitted in support of
petitions according to the items listed
on the form. Master files can be used as
repositories for information that can be
referenced in multiple submissions to
the Agency, thus minimizing paperwork
burden for food and color additive
approvals. FDA estimates that the
amount of time for respondents to
complete Form FDA 3503 will continue
to be 1 hour.
Description of Respondents:
Respondents are businesses engaged in
the manufacture or sale of food, food
ingredients, color additives, or
substances used in materials that come
into contact with food.
In the Federal Register of May 30,
2017 (82 FR 24718), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section/FDA form
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total
operating and
maintenance
costs
Total hours
Color Additive Petitions
70.25, 71.1 ...............................................
2
1
2
1,337
2,674
$5,600
Food Additive Petitions
171.1 ........................................................
3
1
3
7,093
21,279
0
FDA Form 3503 .......................................
6
1
6
1
6
0
Total ..................................................
........................
........................
........................
........................
23,959
5,600
sradovich on DSK3GMQ082PROD with NOTICES
1 There
are no capital costs associated with this collection of information.
The estimate of burden for food
additive or color additive petitions is
based on FDA’s experience with the
petition process. The burden for this
information collection has changed
since the last OMB approval because the
Generally Recognized as Safe
affirmations have been removed
pursuant to the implementation of
‘‘Substances Generally Recognized as
Safe; Final Rule,’’ August 17, 2016 (81
FR 54960), 21 CFR parts 20, 25, 170,
184, 186, and 570. FDA is retaining its
prior estimate of the number of petitions
received because the average number of
petitions received annually has varied
little over the past 10 years. The figures
for hours per response are based on
estimates from experienced persons in
VerDate Sep<11>2014
18:00 Aug 21, 2017
Jkt 241001
the Agency and in industry. Although
the estimated hour burden varies with
the type of petition submitted, an
average petition involves analytical
work and appropriate toxicological
studies, as well as the work of drafting
the petition itself. The burden varies
depending on the complexity of the
petition, including the amount and
types of data needed for scientific
analysis.
Color additives are subjected to
payment of fees for the petitioning
process. The listing fee for a color
additive petition ranges from $1,600 to
$3,000, depending on the intended use
of the color additive and the scope of
minimum information needed for
labeling in order that food and color
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
manufacturers may comply with all
applicable provisions of the FD&C Act
and other specific labeling acts
administered by FDA. Labeling
information does not require any
additional information gathering beyond
what is already required to assure
conformance with all specifications and
limitations in any given food or color
additive regulation. Labeling
information does not have any specific
recordkeeping requirements unique to
preparing the label. Therefore, because
labeling requirements under § 70.25 for
a particular color additive involve
information required as part of the CAP
safety review process, the estimate for
number of respondents is the same for
§§ 70.25 and 71.1, and the burden hours
E:\FR\FM\22AUN1.SGM
22AUN1
Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
for labeling are included in the estimate
for § 71.1. Also, because labeling
requirements under parts 172, 173, 179,
and 180 for particular food additives
involve information required as part of
the FAP safety review process under
§ 171.1, the burden hours for labeling
are included in the estimate for § 171.1.
Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17703 Filed 8–21–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0623]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary
Cosmetic Registration Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by September
21, 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 0910–0027. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 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.
sradovich on DSK3GMQ082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
18:00 Aug 21, 2017
Jkt 241001
Voluntary Cosmetic Registration
Program—21 CFR Parts 710 and 720
OMB Control Number 0910–0027—
Extension
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) provides us with the
authority to regulate cosmetic products
in the United States. Cosmetic products
that are adulterated under section 601 of
the FD&C Act (21 U.S.C. 361) or
misbranded under section 602 of the
FD&C Act (21 U.S.C. 362) may not be
distributed in interstate commerce. We
have developed the Voluntary Cosmetic
Registration Program (VCRP) to assist us
in carrying out our responsibility to
regulate cosmetics.
FDA is revising forms for the VCRP
(Forms FDA 2511, 2512, 2512a, and
2514) currently approved under OMB
control number 0910–0027, ‘‘Voluntary
Cosmetic Registration Program,’’ for the
following reasons: (1) Modernizing the
forms; (2) Making it easier for filers who
complete the forms; and (3) reducing the
time it will take FDA to review each
submission. In addition, Form FDA
2514 will be eliminated as it duplicates
information that is currently located on
Form FDA 2512. FDA requests PRA
approval for the proposed changes to
these forms, and for the elimination of
Form FDA 2514.
Participation in the VCRP is voluntary
under provisions found in sections parts
710 and 720 (21 CFR parts 710 and 720).
Participants have the option of
submitting information via paper forms
or via the online interface. The term
‘‘form’’ refers to both the paper form and
the online system.
Currently, in part 710, we request that
establishments that manufacture or
package cosmetic products voluntarily
register with us using Form FDA 2511
entitled ‘‘Registration of Cosmetic
Product Establishment.’’ The online
version of Form FDA 2511 is available
on our VCRP Web site at https://
www.fda.gov/Cosmetics/Registration
Program/default.htm. We strongly
encourage online registration with Form
FDA 2511 because it is faster and more
efficient for the filer and the Agency. A
registering facility will receive
confirmation of online registration,
including a registration number by
email. The online system also allows for
amendments to past submissions.
Because registration of cosmetic
product establishments is not
mandatory, voluntary registration
provides FDA with the best information
available about the locations, business
trade names, and types of activity
(manufacturing or packaging) of
cosmetic product establishments. We
place the registration information in a
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
39795
computer database and use the
information to generate lists for
distributing regulatory information and
for inviting firms to participate in
workshops on topics in which they may
be interested. Registration is permanent,
although we request that respondents
submit an amended Form FDA 2511 if
any of the originally submitted
information changes.
FDA’s proposed changes to the forms
through the use of an electronic
submission system have been designed
to make it easier for participants to
provide information to FDA about their
products. The system also assists
participants, through interactive
question and response scenarios, to
identify submissions that will be
ineligible to be accepted in VCRP
because they do not meet parts 710 and
720 requirements. The electronic
submission system is expected to reduce
burden currently associated with the
manual identification process for filers
and FDA. The rejection rate for
ineligible submissions when using the
current forms is high: 51 percent for
new accounts, 43 percent for Form FDA
2511 registrations, and 7 percent for
Form FDA 2512 filings (2010–2016).
The revised forms include the
addition of links between Forms FDA
2511 and 2512, clarification of what
information should be entered onto the
forms, additional self-identifying fields,
removal of certain duplicative fields,
and the deletion of Form FDA 2514.
These changes are needed because both
VCRP voluntary filer participation and
FDA resources required to administer
VCRP have increased significantly since
2014 (i.e., increases in new accounts
(156 percent), Form FDA 2511
registrations (405 percent), Form FDA
2512 filings (67 percent), and FDA
review hours (59 percent) in 2016.)
FDA’s current process confirms that
each submission meets the requirements
established in parts 710 and 720 by
using a manual process for both filers
and FDA reviewers that may result in a
long waiting period where filers must
wait and respond to questions generated
by FDA, which may result in a high
rejection rate. FDA projects a significant
reduction in rejection rates when using
the revised forms. Examples of possible
burden savings for participants and FDA
include:
(1) Form FDA 2511 asks filers if they
are a manufacturer or packer; however,
in the past, distributors and retailers
have checked these boxes in error when
neither applies to them because there
are no distributor or retailer checkboxes
on Form FDA 2511. Retailers have also
filed Form FDA 2512 in error even
though only manufacturers, packers,
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39793-39795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17703]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0258]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Submission of
Petitions: Food Additive, Color Additive (Including Labeling),
Submission of Information to a Master File in Support of Petitions; and
Electronic Submission Using Food and Drug Administration Form 3503
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
September 21, 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 0910-0016 and
title ``Submission of Petitions: Food Additive, Color Additive
(Including Labeling), Submission of Information to a Master File in
Support of Petitions; and Electronic Submission Using Food and Drug
Administration Form 3503.'' Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila 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.
Submission of Petitions: Food Additive, Color Additive (Including
Labeling), Submission of Information to a Master File in Support of
Petitions; and Electronic Submission Using Food and Drug Administration
Form 3503--21 CFR 70.25, 71.1, and 171.1, and 21 CFR parts 172, 173,
179, and 180; OMB Control Number 0910-0016--Extension.
Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(a)) provides that a food additive shall be
deemed to be unsafe, unless: (1) The additive and its use, or intended
use, are in conformity with a regulation issued under section 409 of
the FD&C Act that describes the condition(s) under which the additive
may be safely used; (2) the additive and its use, or intended use,
conform to the terms of an exemption for investigational use; or (3) a
food contact notification submitted under section 409(h) is effective.
Food additive petitions (FAPs) are submitted by individuals or
companies to obtain approval of a new food additive or to amend the
conditions of use permitted
[[Page 39794]]
under an existing food additive regulation. Section 171.1 of FDA's
regulations (21 CFR 171.1) specifies the information that a petitioner
must submit to establish that the proposed use of a food additive is
safe and to secure the publication of a food additive regulation
describing the conditions under which the additive may be safely used.
Parts 172, 173, 179, and 180 (21 CFR parts 172, 173, 179, and 180)
contain labeling requirements for certain food additives to ensure
their safe use.
Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a
color additive shall be deemed to be unsafe unless the additive and its
use are in conformity with a regulation that describes the condition(s)
under which the additive may safely be used, or the additive and its
use conform to the terms of an exemption for investigational use issued
under section 721(f). Color additive petitions (CAPs) are submitted by
individuals or companies to obtain approval of a new color additive or
a change in the conditions of use permitted for a color additive that
is already approved. Section 71.1 of the Agency's regulations (21 CFR
71.1) specifies the information that a petitioner must submit to
establish the safety of a color additive and to secure the issuance of
a regulation permitting its use. FDA's color additive labeling
requirements in Sec. 70.25 (21 CFR 70.25) require that color additives
that are to be used in food, drugs, medical devices, or cosmetics be
labeled with sufficient information to ensure their safe use.
FDA scientific personnel review FAPs to ensure the safety of the
intended use of the additive in or on food, or that may be present in
food as a result of its use in articles that contact food. Likewise,
FDA personnel review CAPs to ensure the safety of the color additive
prior to its use in food, drugs, medical devices, or cosmetics.
Interested persons may transmit FAP or CAP regulatory submissions
in electronic format or paper format to the Office of Food Additive
Safety in the Center for Food Safety and Applied Nutrition using Form
FDA 3503. Form FDA 3503 helps the respondent organize their submission
to focus on the information needed for FDA's safety review. Form FDA
3503 can also be used to organize information within a master file
submitted in support of petitions according to the items listed on the
form. Master files can be used as repositories for information that can
be referenced in multiple submissions to the Agency, thus minimizing
paperwork burden for food and color additive approvals. FDA estimates
that the amount of time for respondents to complete Form FDA 3503 will
continue to be 1 hour.
Description of Respondents: Respondents are businesses engaged in
the manufacture or sale of food, food ingredients, color additives, or
substances used in materials that come into contact with food.
In the Federal Register of May 30, 2017 (82 FR 24718), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Average operating and
21 CFR section/FDA form respondents responses per responses burden per Total hours maintenance
respondent response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
70.25, 71.1............................................. 2 1 2 1,337 2,674 $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.1................................................... 3 1 3 7,093 21,279 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Form 3503........................................... 6 1 6 1 6 0
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. 23,959 5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
The estimate of burden for food additive or color additive
petitions is based on FDA's experience with the petition process. The
burden for this information collection has changed since the last OMB
approval because the Generally Recognized as Safe affirmations have
been removed pursuant to the implementation of ``Substances Generally
Recognized as Safe; Final Rule,'' August 17, 2016 (81 FR 54960), 21 CFR
parts 20, 25, 170, 184, 186, and 570. FDA is retaining its prior
estimate of the number of petitions received because the average number
of petitions received annually has varied little over the past 10
years. The figures for hours per response are based on estimates from
experienced persons in the Agency and in industry. Although the
estimated hour burden varies with the type of petition submitted, an
average petition involves analytical work and appropriate toxicological
studies, as well as the work of drafting the petition itself. The
burden varies depending on the complexity of the petition, including
the amount and types of data needed for scientific analysis.
Color additives are subjected to payment of fees for the
petitioning process. The listing fee for a color additive petition
ranges from $1,600 to $3,000, depending on the intended use of the
color additive and the scope of minimum information needed for labeling
in order that food and color manufacturers may comply with all
applicable provisions of the FD&C Act and other specific labeling acts
administered by FDA. Labeling information does not require any
additional information gathering beyond what is already required to
assure conformance with all specifications and limitations in any given
food or color additive regulation. Labeling information does not have
any specific recordkeeping requirements unique to preparing the label.
Therefore, because labeling requirements under Sec. 70.25 for a
particular color additive involve information required as part of the
CAP safety review process, the estimate for number of respondents is
the same for Sec. Sec. 70.25 and 71.1, and the burden hours
[[Page 39795]]
for labeling are included in the estimate for Sec. 71.1. Also, because
labeling requirements under parts 172, 173, 179, and 180 for particular
food additives involve information required as part of the FAP safety
review process under Sec. 171.1, the burden hours for labeling are
included in the estimate for Sec. 171.1.
Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17703 Filed 8-21-17; 8:45 am]
BILLING CODE 4164-01-P
