83 FR 30741 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certifiable Color Additives

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

Page Range		30741-30742
FR Document		2018-14059

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.

Federal Register, Volume 83 Issue 126 (Friday, June 29, 2018)

[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30741-30742]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-14059]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0025]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Food Labeling; 
Declaration of Certifiable Color Additives

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 July 
30, 2018.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0721.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed

[[Page 30742]]

collection of information to OMB for review and clearance.

Animal Food Labeling; Declaration of Certifiable Color Additives

OMB Control Number 0910-0721--Extension

    This information collection is associated with requirements under 
Sec.  501.22(k) (21 CFR 501.22(k)) in which animal food manufacturers 
must declare the presence of certified and noncertified color additives 
in their animal food products on the product label. We issued this 
regulation in response to the Nutrition Labeling and Education Act of 
1990 (Pub. L. 101-535) to make animal food regulations consistent with 
the regulations regarding the declaration of color additives on human 
food labels and to provide animal owners with information on the color 
additives used in animal food. Animal owners use the information to 
become knowledgeable about the foods they purchase for their animals. 
Color additive information enables a consumer to comparison shop and to 
avoid substances to which their animals may be sensitive.
    Description of Respondents: Respondents to this collection of 
information are manufacturers of pet food products that contain color 
additives. In the Federal Register of February 20, 2018 (83 FR 7198), 
FDA published a 60-day notice requesting public comment on the proposed 
collection of information.
    (Comment) One comment was received that supported FDA's need for 
the information collection and characterized the burden of the 
information collection as low compared to the importance of informative 
food labels. The comment did not suggest revising our estimate of the 
burden. However, it suggested we should provide greater detail about 
how we estimated the number of respondents and the flow of new 
products.
    (Response) We based our estimate of the number of respondents on 
the number of pet food manufacturers subject to this regulation. The 
figure of 3,120 used in table 1 was derived from the number of 
establishments listed under North American Industrial Classification 
System codes 311111 and 311119, including very small establishments. As 
noted in the 60-day notice, we based our estimate of the flow of new 
products on A.C. Nielsen data for the number of animal food product 
units for sale (for which sales of the products are greater than zero) 
in the latest year for which data is available, stated to be 25,874. 
Then, we assumed that the flow of new products would be 10 percent per 
year, for a figure of 2,587 new products per year. That figure was used 
in table 1 as our estimate of the total annual disclosures. FDA 
estimates the burden of this collection of information as follows:

                                                Table 1--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Number of
         21 CFR Section/activity              Number of      disclosures per    Total annual         Average burden per disclosure         Total hours
                                             respondents       respondent        disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
501.22(k); labeling of color additive or             3,120            0.8292             2,587  0.25 (15 minutes).....................               647
 lake of color additive; labeling of
 color additives not subject to
 certification.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The requirement became effective November 18, 2013; thus, we 
estimate that the burden associated with the labeling requirements 
under Sec.  501.22(k) applies only to new product labels. Because the 
vast majority of animal food products that contain certified color 
additives are pet foods, we limit our burden estimate to reviewing 
labels for the use of certified color additives to pet food 
manufacturers subject to this regulation. Based on A.C. Nielsen data, 
we estimate that the number of animal food product units subject to 
Sec.  501.22(k) for which sales of the products are greater than zero 
is 25,874. Assuming that the flow of new products is 10 percent per 
year, then 2,587 new animal food products subject to Sec.  501.22(k) 
will become available on the market each year. We also estimate that 
there are approximately 3,120 manufacturers of pet food subject to 
either Sec.  501.22(k)(1) or (2). Assuming the approximately 2,587 new 
products are split equally among the firms, then each firm would 
prepare labels for approximately 0.8292 new products per year (2,587 
new products--3,120 firms is approximately 0.8292 labels per firm). We 
expect that firms prepare the required labeling for their products in a 
manner that takes into account at one time all information required to 
be disclosed on their product labels. Based on our experience with 
reviewing pet food labeling, we estimate that firms would require less 
than 0.25 hour (15 minutes) per product to comply with the requirement 
to include the color additive information pursuant to Sec.  501.22(k). 
The total burden of this activity is 647 hours (2,587 labels x 0.25 
hour/label is approximately 647 hours). The burden for this information 
collection has not changed since the last OMB approval.

    Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14059 Filed 6-28-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30741

FSMA focuses on ensuring the safety of in cooperation with State, local, (NAFDS), for the purpose of monitoring
the U.S. food supply by shifting the territorial, and tribal governments and progress in food and agricultural
efforts of Federal regulators from private sector partners, protect the defense by government agencies.
response to prevention and recognizes nation’s food supply against intentional A purposive sampling strategy will be
the importance of strengthening existing contamination. Not later than 4 years employed, such that the government
collaboration among all stakeholders to after the initial NAFDS Report to agencies participating in food and
achieve common public health and Congress (2015), and every 4 years agricultural defense cooperative
security goals. FSMA identifies some thereafter (i.e., 2019, 2023, 2017, etc.), agreements with FDA (22 State
key priorities for working with partners HHS, USDA, and DHS are required to Agencies) and USDA (27 State
in areas such as reliance on Federal, revise and submit an updated report to Agencies) will be asked to respond to
State, and local agencies for inspections; the relevant committees of Congress. the voluntary survey. Food defense
improving foodborne illness HHS/FDA is primarily responsible for leaders responsible for conducting food
surveillance; and leveraging and obtaining the information from Federal defense activities during a food
enhancing State and local food safety and State, local, territorial, and tribal emergency for their jurisdiction will be
and defense capacities. Section 108 of partners to complete the NAFDS Report identified and will receive an emailed
FSMA (NAFDS) requires the U.S. to Congress. An interagency working invitation to complete the survey
Department of Health and Human group will conduct the survey and online; they will be provided with a
Services (HHS) and the U.S. Department collect and update the NAFDS as web link to the survey. The survey will
of Agriculture (USDA), in coordination directed by FSMA, including be conducted electronically on the
with the Department of Homeland developing metrics and measuring FDA.gov web portal, and results will be
Security (DHS), to work together with progress for the evaluation process. analyzed by the interagency working
The proposed survey of Federal and
State, local, territorial, and tribal group.
State partners will be used to determine
governments to monitor and measure In the Federal Register of March 28,
what food defense activities, if any,
progress in food defense. 2018 (83 FR 13284), we published a
Federal and/or State Agencies have
In 2015, the initial NAFDS Report to completed (or are planning) from 2015 notice inviting public comment on the
Congress detailed the specific Federal to 2019. Planning for the local, proposed collection of information.
response to food and agriculture defense territorial, and tribal information Although one comment was received, it
goals, objectives, key initiatives, and collections will commence after the was not responsive to the four collection
activities that HHS, USDA, DHS, and collection and reporting of Federal and of information topics solicited and
other stakeholders planned to State Agency level data. therefore will not be discussed in this
accomplish to meet the objectives This survey will be repeated document.
outlined in FSMA. The NAFDS charts a approximately every 2 to 4 years, as FDA estimates the burden of this
direction for how the Federal Agencies, described in section 108 of FSMA collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Activity responses per Total hours
respondents responses response
respondent

State Survey ............................................ 49 1 49 0.33 (20 minutes) ...... 16.17
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The total burden for this collection of DEPARTMENT OF HEALTH AND DATES: Fax written comments on the
information, therefore, is 16.17 hours. HUMAN SERVICES collection of information by July 30,
The FDA Office of Partnerships 2018.
Food and Drug Administration
reviewed the questionnaire and ADDRESSES: To ensure that comments on
provided the amount of time to the information collection are received,
complete the survey. The total burden is [Docket No. FDA–2009–N–0025]
OMB recommends that written
based on our previous experiences Agency Information Collection comments be faxed to the Office of
conducting surveys. Activities; Submission for Office of Information and Regulatory Affairs,
Dated: June 26, 2018. Management and Budget Review; OMB, Attn: FDA Desk Officer, Fax: 202–
Comment Request; Animal Food 395–7285, or emailed to oira_
Leslie Kux,
Labeling; Declaration of Certifiable submission@omb.eop.gov. All
Associate Commissioner for Policy. comments should be identified with the
Color Additives
[FR Doc. 2018–14051 Filed 6–28–18; 8:45 am] OMB control number 0910–0721.
BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT:
HHS. Amber Sanford, Office of Operations,
ACTION: Notice. Food and Drug Administration, Three
sradovich on DSK3GMQ082PROD with NOTICES

White Flint North, 10A–12M, 11601
SUMMARY: The Food and Drug Landsdown St., North Bethesda, MD
Administration (FDA) is announcing 20852, 301–796–8867, PRAStaff@
that a proposed collection of fda.hhs.gov.
information has been submitted to the
Office of Management and Budget SUPPLEMENTARY INFORMATION: In
(OMB) for review and clearance under compliance with 44 U.S.C. 3507, FDA
the Paperwork Reduction Act of 1995. has submitted the following proposed

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30742 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices

collection of information to OMB for about the foods they purchase for their (Response) We based our estimate of
review and clearance. animals. Color additive information the number of respondents on the
enables a consumer to comparison shop number of pet food manufacturers
Animal Food Labeling; Declaration of
and to avoid substances to which their subject to this regulation. The figure of
Certifiable Color Additives
animals may be sensitive. 3,120 used in table 1 was derived from
OMB Control Number 0910–0721— Description of Respondents: the number of establishments listed
Extension Respondents to this collection of under North American Industrial
information are manufacturers of pet Classification System codes 311111 and
This information collection is food products that contain color
associated with requirements under 311119, including very small
additives. In the Federal Register of
§ 501.22(k) (21 CFR 501.22(k)) in which establishments. As noted in the 60-day
February 20, 2018 (83 FR 7198), FDA
animal food manufacturers must declare published a 60-day notice requesting notice, we based our estimate of the
the presence of certified and public comment on the proposed flow of new products on A.C. Nielsen
noncertified color additives in their collection of information. data for the number of animal food
animal food products on the product (Comment) One comment was product units for sale (for which sales
label. We issued this regulation in received that supported FDA’s need for of the products are greater than zero) in
response to the Nutrition Labeling and the information collection and the latest year for which data is
Education Act of 1990 (Pub. L. 101–535) characterized the burden of the available, stated to be 25,874. Then, we
to make animal food regulations information collection as low compared assumed that the flow of new products
consistent with the regulations to the importance of informative food would be 10 percent per year, for a
regarding the declaration of color labels. The comment did not suggest figure of 2,587 new products per year.
additives on human food labels and to revising our estimate of the burden. That figure was used in table 1 as our
provide animal owners with However, it suggested we should estimate of the total annual disclosures.
information on the color additives used provide greater detail about how we FDA estimates the burden of this
in animal food. Animal owners use the estimated the number of respondents collection of information as follows:
information to become knowledgeable and the flow of new products.

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
Number of Total annual Average burden per
21 CFR Section/activity disclosures per Total hours
respondents disclosures disclosure
respondent

501.22(k); labeling of color additive or 3,120 0.8292 2,587 0.25 (15 minutes) ...... 647
lake of color additive; labeling of color
additives not subject to certification.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The requirement became effective firms prepare the required labeling for DEPARTMENT OF HEALTH AND
November 18, 2013; thus, we estimate their products in a manner that takes HUMAN SERVICES
that the burden associated with the into account at one time all information
labeling requirements under § 501.22(k) required to be disclosed on their Food and Drug Administration
applies only to new product labels. product labels. Based on our experience [Docket No. FDA–2018–N–2398]
Because the vast majority of animal food with reviewing pet food labeling, we
products that contain certified color estimate that firms would require less Development of Non-Traditional
additives are pet foods, we limit our than 0.25 hour (15 minutes) per product Therapies for Bacterial Infections;
burden estimate to reviewing labels for to comply with the requirement to Public Workshop; Request for
the use of certified color additives to pet include the color additive information Comments
food manufacturers subject to this pursuant to § 501.22(k). The total AGENCY: Food and Drug Administration,
regulation. Based on A.C. Nielsen data, burden of this activity is 647 hours HHS.
we estimate that the number of animal (2,587 labels × 0.25 hour/label is ACTION: Notice of public workshop;
food product units subject to § 501.22(k) approximately 647 hours). The burden request for comments.
for which sales of the products are for this information collection has not
greater than zero is 25,874. Assuming changed since the last OMB approval. SUMMARY: The Food and Drug
that the flow of new products is 10 Administration (FDA, the Agency, or
percent per year, then 2,587 new animal Dated: June 26, 2018. we) is announcing the following public
food products subject to § 501.22(k) will Leslie Kux, workshop entitled ‘‘Development of
become available on the market each Associate Commissioner for Policy. Non-Traditional Therapies for Bacterial
year. We also estimate that there are [FR Doc. 2018–14059 Filed 6–28–18; 8:45 am] Infections.’’ The purpose of the public
approximately 3,120 manufacturers of BILLING CODE 4164–01–P workshop is to discuss the general
pet food subject to either § 501.22(k)(1) development considerations of non-
sradovich on DSK3GMQ082PROD with NOTICES

or (2). Assuming the approximately traditional therapies, including pre-
2,587 new products are split equally clinical development, early clinical
among the firms, then each firm would studies, and phase 3 clinical trial
prepare labels for approximately 0.8292 designs to evaluate safety and efficacy.
new products per year (2,587 new DATES: The public workshop will be
products—3,120 firms is approximately held on August 21, 2018, from 8:30 a.m.
0.8292 labels per firm). We expect that to 4:30 p.m. and August 22, 2018, from

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Document Created: 2018-06-29 01:13:50
Document Modified: 2018-06-29 01:13:50

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by July 30, 2018.
Contact		Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation		83 FR 30741

83 FR 30741 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certifiable Color Additives

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration