Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling: Nutrition Facts Label and Supplement Facts Label, 16513-16516 [2019-07929]
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Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Notices
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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Bispecific Antibody Development
Programs.’’ This draft guidance provides
recommendations to assist those
involved in the bispecific antibody drug
development process. This draft
guidance discusses general
considerations and recommendations,
as well as regulatory, quality,
nonclinical, and clinical considerations
in the context of bispecific antibody
development programs. This draft
guidance does not discuss development
considerations for other multitarget
therapies that are combinations of
monoclonal antibodies, antibody
cocktails, or polyclonal antibodies.
Since the first therapeutic monoclonal
antibody was commercialized in 1986,
monoclonal antibodies have become a
vital component of therapy for various
diseases and conditions including
cancer, autoimmune and infectious
diseases, and inflammatory conditions.
The regulatory pathway for evaluation
of monoclonal antibodies is well
established, but additional draft
guidance is needed about antibodybased products that target more than
one antigen. Advances in technology
and an interest in novel therapies that
combine targets have led to the
development of bispecific antibodies,
which are genetically engineered,
recombinant antibodies that consist of
two distinct binding domains capable of
binding two different antigens or two
different epitopes of the same antigen.
There are a number of challenges in
developing bispecific antibodies, one of
which may be significant
immunogenicity caused by novel
epitopes. This draft guidance addresses
these considerations and provides
recommendations regarding the type of
data necessary to support the approval
of bispecific antibodies.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Bispecific Antibody Development
Programs.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
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subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 have
been approved under 0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: April 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–07930 Filed 4–18–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1265]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling:
Nutrition Facts Label and Supplement
Facts Label
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 collection of
information for the nutrition facts label
and supplement facts label, which the
Agency believes will serve to promote
and protect public health.
DATES: Submit either electronic or
written comments on the collection of
information by June 18, 2019.
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 18, 2019.
SUMMARY:
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The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 18, 2019. 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
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–
2019–N–1265 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Labeling: Nutrition Facts Label and
Supplement Facts Label.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
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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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), 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
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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.
Food Labeling: The Nutrition Facts
Label and Supplement Facts Label—21
CFR 101.9 OMB Control Number 0910–
0813—Extension
This information collection supports
requirements for the Nutrition Facts and
Supplemental Facts labels. Section
403(q) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
343(q)) specifies certain nutrients to be
declared in nutrition labeling and
authorizes the Secretary of Health and
Human Services (Secretary) to require
other nutrients to be declared if the
Secretary determines that a nutrient will
provide information regarding the
nutritional value of such food that will
assist consumers in maintaining healthy
dietary practices. The Secretary also has
discretion under section 403(q) of the
FD&C Act to remove, by regulation and
under certain circumstances, nutrient
information that is otherwise explicitly
required in food labeling under this
section. Accordingly, we promulgated
regulations in § 101.9 (21 CFR 101.9)
setting forth how nutrition information
is presented to consumers. The
regulations also establish standards to
define serving size and require that
certain products provide additional
information within the Nutrition Facts
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label that conveys that information to
consumers.
Specifically, §§ 101.9 and 101.36 list
nutrients that are required or permitted
to be declared; provide Daily Reference
Values and Reference Daily Intake
values that are based on current dietary
recommendations from consensus
reports; provide requirements for foods
represented or purported to be
specifically for children under the age of
4 years and pregnant and lactating
women and establish nutrient reference
values specifically for these population
subgroups; and provide the format and
appearance of the Nutrition Facts label.
Section 101.12 (21 CFR 101.12) defines
a single-serving container; requires
dual-column labeling for certain
containers; updates, modifies, and
provides several reference amounts
customarily consumed (RACCs);
provides the label serving size for breath
mints; and provides various aspects of
the serving size regulations.
The regulations also require that,
under certain circumstances,
manufacturers make and keep certain
records to verify the amount of added
sugars when a food product contains
both naturally occurring sugars and
added sugars, isolated or synthetic nondigestible carbohydrates that do not
meet the definition of dietary fiber,
different forms of vitamin E, and folate/
folic acid declared on the Nutrition
Facts or Supplement Facts label, which
is the amount in the finished food
product.
Firms make and keep certain records
necessary to verify the amount of the
nutrients in the finished food product.
This collection of information does not
specify what records are to be used to
verify the amounts of these nutrients but
does specify the information that the
records must contain. The collection
requires manufacturers to provide FDA,
upon request during an inspection, with
the records that contain the required
information for each of these nutrients
to verify the amount of the nutrient
declared on the label. These records
may include analyses of nutrient
databases, recipes or formulations,
information from recipes or
formulations, batch records, or any
other records that contain the required
information to verify the nutrient
content in the final product.
Description of Respondents:
Respondents to this collection of
information are manufacturers of food
products sold in the United States.
Respondents are from the private sector
(for-profit businesses).
We estimate the burden of this
collection of information as follows:
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TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Type of declaration; 21 CFR section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
Added Sugars; 101.9(c)(6)(iii) 2 .............
Dietary Fiber; 101.9(c)(6)(i) 2 .................
Soluble Fiber; 101.9(c)(6)(i)(A) 2 ............
Insoluble Fiber; 101.9(c)(6)(i)(B) 2 .........
Vitamin E; 101.9(c)(8) 3 ..........................
Folate/Folic Acid; 101.9(c)(8) 3 ..............
New Products .........................................
31,283
31,283
31,283
31,283
31,283
31,283
216
1
1
1
1
1
1
1
31,283
31,283
31,283
31,283
31,283
31,283
216
1
1
1
1
1
1
1
31,283
31,283
31,283
31,283
31,283
31,283
216
Total ................................................
..............................
..............................
..............................
..............................
187,914
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates are likely to be large overestimates, as not all manufacturers will need to keep records for added sugars, dietary fiber, and
soluble and insoluble fiber. Manufacturers will only need to keep records for products with both added and naturally occurring sugars, added sugars that undergo fermentation in certain fermented foods, and products with non-digestible carbohydrates (soluble or insoluble) that do and do
not meet the definition of dietary fiber.
3 These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for vitamin E and folate/folic acid.
The declaration of vitamin E and folate/folic acid is not mandatory unless a health or nutrient content claim is being made or these nutrients are
directly added to the food for enrichment purposes.
2 These
Based on our experience with food
labeling regulations, records that are
required to be retained are records that
a prudent and responsible manufacturer
uses and retains as a normal part of
doing business, e.g., analyses of nutrient
databases, recipes or formulations, batch
records, or other records. Thus, the
recordkeeping burden of this collection
of information consists of the time
required to identify and assemble the
records for copying and retention. Based
on our previous experience with similar
information collections, we estimate the
recordkeeping burden to be 1 hour per
product as estimated in table 1.
The declarations for added sugars,
dietary fiber, soluble fiber, and
insoluble fiber are mandatory, and we
conservatively estimate all of the
roughly 31,283 food manufacturers
would incur this recordkeeping burden
and the required recordkeeping would
be 1 hour per manufacturer. These
calculations are reflected in table 1,
rows 1 to 4. The declaration of vitamin
E and folate/folic acid is not mandatory
unless a health or nutrient content claim
is being made or these nutrients are
directly added to the food for
enrichment purposes. However, we
conservatively estimate that all 31,283
respondents would incur this
recordkeeping burden and that the
required recordkeeping would be 1 hour
per manufacturer. These calculations
are reflected in table 1, rows 5 and 6.
We estimate that the number of newly
introduced products that are covered
under this collection of information is
216. We assume the required
recordkeeping is 1 hour per product, for
an annual recurring recordkeeping
burden of 216 hours, as reflected in
table 1, row 7. Adding the burden from
new products to the burden for existing
products results in a total of 187,914
annual recordkeeping burden hours.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Filing of citizen petition regarding a particular isolated or
synthetic non-digestible carbohydrate
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Dietary Fiber; 101.9(c)(6)(i) .................................................
28
1
28
1
28
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Manufacturers of food products that
contain an isolated or synthetic nondigestible carbohydrate that is not listed
in the definition of dietary fiber have
the option of submitting a citizen
petition to FDA requesting us to amend
the definition of ‘‘dietary fiber’’ to
include the carbohydrate as a listed
dietary fiber, by demonstrating the
physiological benefits of the isolated or
synthetic non-digestible carbohydrate to
human health.
We estimate that there are
approximately 28 isolated or synthetic
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non-digestible carbohydrates that do not
meet the definition of dietary fiber.
Once a citizen petition filed by a
manufacturer related to a particular
isolated or synthetic non-digestible
carbohydrate is granted or denied, or the
carbohydrate is the subject of an
authorized health claim, and the dietary
fiber is listed in the definition of dietary
fiber, the use of the dietary fiber as an
ingredient in any food product must be
included in the total amount of dietary
fiber declared in nutrition labeling for
such product.
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Thus, we estimate that 28
manufacturers would incur burden
associated with filing a citizen petition
to amend the listing of dietary fiber
related to an isolated and synthetic nondigestible carbohydrate that is not
currently listed in the definition of
dietary fiber and that the required
recordkeeping would be 1 hour per
manufacturer. This calculation is shown
in table 2.
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Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
21 CFR 101.9
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total
hours
Nutritional labeling for new products ...................................
500
1
500
2
1,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Under §§ 101.9 and 101.12, some
manufacturers of retail food products
make labeling changes to modify the
serving sizes and other nutrition
information based on changes to what
products may be or are required to be
labeled as a single serving, or based on
updated, modified, or established
RACCs. We estimate that about 500 new
products will be affected by these
requirements each year and that the
associated disclosure burden is 2 hours
per product, for an annual burden of
1,000 hours.
Dated: April 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–07929 Filed 4–18–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–1261]
Technical Considerations for NonClinical Assessment of Medical
Devices Containing Nitinol; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Technical
Considerations for Non-Clinical
Assessment of Medical Devices
containing Nitinol.’’ Due to the unique
properties of nitinol, the Agency has
developed this draft guidance to provide
FDA’s current thinking on technical
considerations specific to devices using
nitinol. This draft guidance document is
intended to provide clarity and
consistency in recommended nonclinical assessments across a variety of
medical devices that contain nitinol.
This draft guidance is not final nor is it
in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by June 18, 2019 to ensure that the
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SUMMARY:
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Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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
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–
2019–D–1261 for ‘‘Technical
Considerations for Non-Clinical
Assessment of Medical Devices
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containing Nitinol.’’ Received
comments 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
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[Federal Register Volume 84, Number 76 (Friday, April 19, 2019)]
[Notices]
[Pages 16513-16516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07929]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1265]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Labeling: Nutrition Facts Label and Supplement
Facts Label
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 collection of information for the
nutrition facts label and supplement facts label, which the Agency
believes will serve to promote and protect public health.
DATES: Submit either electronic or written comments on the collection
of information by June 18, 2019.
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 18, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 18, 2019. 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 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-2019-N-1265 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Labeling: Nutrition Facts
Label and Supplement Facts Label.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential
[[Page 16514]]
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.gpo.gov/fdsys/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. 3501-3520), 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.
Food Labeling: The Nutrition Facts Label and Supplement Facts Label--21
CFR 101.9 OMB Control Number 0910-0813--Extension
This information collection supports requirements for the Nutrition
Facts and Supplemental Facts labels. Section 403(q) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(q)) specifies
certain nutrients to be declared in nutrition labeling and authorizes
the Secretary of Health and Human Services (Secretary) to require other
nutrients to be declared if the Secretary determines that a nutrient
will provide information regarding the nutritional value of such food
that will assist consumers in maintaining healthy dietary practices.
The Secretary also has discretion under section 403(q) of the FD&C Act
to remove, by regulation and under certain circumstances, nutrient
information that is otherwise explicitly required in food labeling
under this section. Accordingly, we promulgated regulations in Sec.
101.9 (21 CFR 101.9) setting forth how nutrition information is
presented to consumers. The regulations also establish standards to
define serving size and require that certain products provide
additional information within the Nutrition Facts label that conveys
that information to consumers.
Specifically, Sec. Sec. 101.9 and 101.36 list nutrients that are
required or permitted to be declared; provide Daily Reference Values
and Reference Daily Intake values that are based on current dietary
recommendations from consensus reports; provide requirements for foods
represented or purported to be specifically for children under the age
of 4 years and pregnant and lactating women and establish nutrient
reference values specifically for these population subgroups; and
provide the format and appearance of the Nutrition Facts label. Section
101.12 (21 CFR 101.12) defines a single-serving container; requires
dual-column labeling for certain containers; updates, modifies, and
provides several reference amounts customarily consumed (RACCs);
provides the label serving size for breath mints; and provides various
aspects of the serving size regulations.
The regulations also require that, under certain circumstances,
manufacturers make and keep certain records to verify the amount of
added sugars when a food product contains both naturally occurring
sugars and added sugars, isolated or synthetic non-digestible
carbohydrates that do not meet the definition of dietary fiber,
different forms of vitamin E, and folate/folic acid declared on the
Nutrition Facts or Supplement Facts label, which is the amount in the
finished food product.
Firms make and keep certain records necessary to verify the amount
of the nutrients in the finished food product. This collection of
information does not specify what records are to be used to verify the
amounts of these nutrients but does specify the information that the
records must contain. The collection requires manufacturers to provide
FDA, upon request during an inspection, with the records that contain
the required information for each of these nutrients to verify the
amount of the nutrient declared on the label. These records may include
analyses of nutrient databases, recipes or formulations, information
from recipes or formulations, batch records, or any other records that
contain the required information to verify the nutrient content in the
final product.
Description of Respondents: Respondents to this collection of
information are manufacturers of food products sold in the United
States. Respondents are from the private sector (for-profit
businesses).
We estimate the burden of this collection of information as
follows:
[[Page 16515]]
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Average burden
Type of declaration; 21 CFR section recordkeepers per recordkeeper records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Added Sugars; 101.9(c)(6)(iii) \2\....................... 31,283 1 31,283 1 31,283
Dietary Fiber; 101.9(c)(6)(i) \2\........................ 31,283 1 31,283 1 31,283
Soluble Fiber; 101.9(c)(6)(i)(A) \2\..................... 31,283 1 31,283 1 31,283
Insoluble Fiber; 101.9(c)(6)(i)(B) \2\................... 31,283 1 31,283 1 31,283
Vitamin E; 101.9(c)(8) \3\............................... 31,283 1 31,283 1 31,283
Folate/Folic Acid; 101.9(c)(8) \3\....................... 31,283 1 31,283 1 31,283
New Products............................................. 216 1 216 1 216
----------------------------------------------------------------------------------------------
Total................................................ ................. ................. ................. ................. 187,914
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for added sugars, dietary fiber, and
soluble and insoluble fiber. Manufacturers will only need to keep records for products with both added and naturally occurring sugars, added sugars
that undergo fermentation in certain fermented foods, and products with non-digestible carbohydrates (soluble or insoluble) that do and do not meet
the definition of dietary fiber.
\3\ These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for vitamin E and folate/folic acid. The
declaration of vitamin E and folate/folic acid is not mandatory unless a health or nutrient content claim is being made or these nutrients are
directly added to the food for enrichment purposes.
Based on our experience with food labeling regulations, records
that are required to be retained are records that a prudent and
responsible manufacturer uses and retains as a normal part of doing
business, e.g., analyses of nutrient databases, recipes or
formulations, batch records, or other records. Thus, the recordkeeping
burden of this collection of information consists of the time required
to identify and assemble the records for copying and retention. Based
on our previous experience with similar information collections, we
estimate the recordkeeping burden to be 1 hour per product as estimated
in table 1.
The declarations for added sugars, dietary fiber, soluble fiber,
and insoluble fiber are mandatory, and we conservatively estimate all
of the roughly 31,283 food manufacturers would incur this recordkeeping
burden and the required recordkeeping would be 1 hour per manufacturer.
These calculations are reflected in table 1, rows 1 to 4. The
declaration of vitamin E and folate/folic acid is not mandatory unless
a health or nutrient content claim is being made or these nutrients are
directly added to the food for enrichment purposes. However, we
conservatively estimate that all 31,283 respondents would incur this
recordkeeping burden and that the required recordkeeping would be 1
hour per manufacturer. These calculations are reflected in table 1,
rows 5 and 6.
We estimate that the number of newly introduced products that are
covered under this collection of information is 216. We assume the
required recordkeeping is 1 hour per product, for an annual recurring
recordkeeping burden of 216 hours, as reflected in table 1, row 7.
Adding the burden from new products to the burden for existing products
results in a total of 187,914 annual recordkeeping burden hours.
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Filing of citizen petition regarding a particular isolated or Number of responses per Total annual Average burden Total hours
synthetic non-digestible carbohydrate respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dietary Fiber; 101.9(c)(6)(i)...................................... 28 1 28 1 28
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Manufacturers of food products that contain an isolated or
synthetic non-digestible carbohydrate that is not listed in the
definition of dietary fiber have the option of submitting a citizen
petition to FDA requesting us to amend the definition of ``dietary
fiber'' to include the carbohydrate as a listed dietary fiber, by
demonstrating the physiological benefits of the isolated or synthetic
non-digestible carbohydrate to human health.
We estimate that there are approximately 28 isolated or synthetic
non-digestible carbohydrates that do not meet the definition of dietary
fiber. Once a citizen petition filed by a manufacturer related to a
particular isolated or synthetic non-digestible carbohydrate is granted
or denied, or the carbohydrate is the subject of an authorized health
claim, and the dietary fiber is listed in the definition of dietary
fiber, the use of the dietary fiber as an ingredient in any food
product must be included in the total amount of dietary fiber declared
in nutrition labeling for such product.
Thus, we estimate that 28 manufacturers would incur burden
associated with filing a citizen petition to amend the listing of
dietary fiber related to an isolated and synthetic non-digestible
carbohydrate that is not currently listed in the definition of dietary
fiber and that the required recordkeeping would be 1 hour per
manufacturer. This calculation is shown in table 2.
[[Page 16516]]
Table 3--Estimated Annual Third-Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR 101.9 Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nutritional labeling for new products.............................. 500 1 500 2 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Under Sec. Sec. 101.9 and 101.12, some manufacturers of retail
food products make labeling changes to modify the serving sizes and
other nutrition information based on changes to what products may be or
are required to be labeled as a single serving, or based on updated,
modified, or established RACCs. We estimate that about 500 new products
will be affected by these requirements each year and that the
associated disclosure burden is 2 hours per product, for an annual
burden of 1,000 hours.
Dated: April 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07929 Filed 4-18-19; 8:45 am]
BILLING CODE 4164-01-P
