Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certifiable Color Additives, 30741-30742 [2018-14059]
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Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
FSMA focuses on ensuring the safety of
the U.S. food supply by shifting the
efforts of Federal regulators from
response to prevention and recognizes
the importance of strengthening existing
collaboration among all stakeholders to
achieve common public health and
security goals. FSMA identifies some
key priorities for working with partners
in areas such as reliance on Federal,
State, and local agencies for inspections;
improving foodborne illness
surveillance; and leveraging and
enhancing State and local food safety
and defense capacities. Section 108 of
FSMA (NAFDS) requires the U.S.
Department of Health and Human
Services (HHS) and the U.S. Department
of Agriculture (USDA), in coordination
with the Department of Homeland
Security (DHS), to work together with
State, local, territorial, and tribal
governments to monitor and measure
progress in food defense.
In 2015, the initial NAFDS Report to
Congress detailed the specific Federal
response to food and agriculture defense
goals, objectives, key initiatives, and
activities that HHS, USDA, DHS, and
other stakeholders planned to
accomplish to meet the objectives
outlined in FSMA. The NAFDS charts a
direction for how the Federal Agencies,
in cooperation with State, local,
territorial, and tribal governments and
private sector partners, protect the
nation’s food supply against intentional
contamination. Not later than 4 years
after the initial NAFDS Report to
Congress (2015), and every 4 years
thereafter (i.e., 2019, 2023, 2017, etc.),
HHS, USDA, and DHS are required to
revise and submit an updated report to
the relevant committees of Congress.
HHS/FDA is primarily responsible for
obtaining the information from Federal
and State, local, territorial, and tribal
partners to complete the NAFDS Report
to Congress. An interagency working
group will conduct the survey and
collect and update the NAFDS as
directed by FSMA, including
developing metrics and measuring
progress for the evaluation process.
The proposed survey of Federal and
State partners will be used to determine
what food defense activities, if any,
Federal and/or State Agencies have
completed (or are planning) from 2015
to 2019. Planning for the local,
territorial, and tribal information
collections will commence after the
collection and reporting of Federal and
State Agency level data.
This survey will be repeated
approximately every 2 to 4 years, as
described in section 108 of FSMA
(NAFDS), for the purpose of monitoring
progress in food and agricultural
defense by government agencies.
A purposive sampling strategy will be
employed, such that the government
agencies participating in food and
agricultural defense cooperative
agreements with FDA (22 State
Agencies) and USDA (27 State
Agencies) will be asked to respond to
the voluntary survey. Food defense
leaders responsible for conducting food
defense activities during a food
emergency for their jurisdiction will be
identified and will receive an emailed
invitation to complete the survey
online; they will be provided with a
web link to the survey. The survey will
be conducted electronically on the
FDA.gov web portal, and results will be
analyzed by the interagency working
group.
In the Federal Register of March 28,
2018 (83 FR 13284), we published a
notice inviting public comment on the
proposed collection of information.
Although one comment was received, it
was not responsive to the four collection
of information topics solicited and
therefore will not be discussed in this
document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
State Survey ............................................
1 There
Number of
responses per
respondent
Number of
respondents
Activity
49
Total annual
responses
1
49
Total hours
0.33 (20 minutes) ......
16.17
are no capital costs or operating and maintenance costs associated with this collection of information.
The total burden for this collection of
information, therefore, is 16.17 hours.
The FDA Office of Partnerships
reviewed the questionnaire and
provided the amount of time to
complete the survey. The total burden is
based on our previous experiences
conducting surveys.
Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14051 Filed 6–28–18; 8:45 am]
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:
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
sradovich on DSK3GMQ082PROD with NOTICES
Average burden per
response
ACTION:
Notice.
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.
SUMMARY:
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Fax written comments on the
collection of information by July 30,
2018.
DATES:
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 0910–0721.
ADDRESSES:
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
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
§ 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
(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:
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.
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR Section/activity
501.22(k); labeling of color additive or
lake of color additive; labeling of color
additives not subject to certification.
sradovich on DSK3GMQ082PROD with NOTICES
1 There
Number of
disclosures per
respondent
3,120
Total annual
disclosures
0.8292
Average burden per
disclosure
2,587
Total hours
0.25 (15 minutes) ......
647
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 § 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 § 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 § 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 § 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
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17:58 Jun 28, 2018
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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 § 501.22(k). The total
burden of this activity is 647 hours
(2,587 labels × 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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2398]
Development of Non-Traditional
Therapies for Bacterial Infections;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Development of
Non-Traditional Therapies for Bacterial
Infections.’’ The purpose of the public
workshop is to discuss the general
development considerations of nontraditional therapies, including preclinical development, early clinical
studies, and phase 3 clinical trial
designs to evaluate safety and efficacy.
DATES: The public workshop will be
held on August 21, 2018, from 8:30 a.m.
to 4:30 p.m. and August 22, 2018, from
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30741-30742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14059]
-----------------------------------------------------------------------
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
