Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling: Nutrition Facts Label and Supplement Facts Label, 35119-35121 [2019-15523]
Download as PDF
<![CDATA[
35119
Federal Register / Vol. 84, No. 140 / Monday, July 22, 2019 / Notices
comments should be identified with the
OMB control number 0910–0537. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Bar Code Label Requirement for
Human Drug and Biological Products
OMB Control Number 0910–0537—
Extension
In the Federal Register of February
26, 2004 (69 FR 9120), FDA issued a
final rule that requires human drug
product and biological product labels to
have bar codes. Specifically, the final
rule requires bar codes on most human
prescription drug products and on overthe-counter (OTC) drug products that
are dispensed under an order and
commonly used in healthcare facilities.
It also requires machine-readable
information on blood and blood
components. For human prescription
drug products and OTC drug products
that are dispensed under an order and
commonly used in healthcare facilities,
the bar code must contain the national
drug code number for the product. For
blood and blood components, the final
rule specifies the minimum contents of
the label in a format that is machine
readable and approved for use by the
Director, Center for Biologics Evaluation
and Research. We believe that the final
rule helps reduce the number of
medication errors in hospitals and other
healthcare settings by allowing
healthcare professionals to use bar code
scanning equipment to verify that the
right drug (in the right dose and right
route of administration) is being given
to the right patient at the right time.
Although most of the information
collections created by the final rule have
now been incorporated in OMB
approved information collections
supporting the applicable regulations,
respondents to the collection may
continue to seek an exemption from the
bar code label requirement under
§ 201.25(d) (21 CFR 201.25(d)). Section
201.25(d) requires submission of a
written request for an exemption and
describes the information that must be
included in such a request. Based on the
number of exemption requests we have
received previously, we estimate that
approximately two exemption requests
will be submitted annually and each
exemption request will require 24 hours
to complete. This results in an annual
reporting burden of 48 hours, as
reflected in table 1.
In the Federal Register of November
1, 2018 (83 FR 54930), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
21 CFR 201.25(d) ................................................................
2
1
2
24
48
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Fax written comments on the
collection of information by August 21,
2019.
DATES:
[FR Doc. 2019–15488 Filed 7–19–19; 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 0910–0813. 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–2019–N–1265]
jbell on DSK3GLQ082PROD with NOTICES
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:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Labeling:
Nutrition Facts Label and Supplement
Facts Label
FOR FURTHER INFORMATION CONTACT:
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
19:11 Jul 19, 2019
Jkt 247001
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
E:\FR\FM\22JYN1.SGM
22JYN1
35120
Federal Register / Vol. 84, No. 140 / Monday, July 22, 2019 / Notices
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 issued
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
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).
In the Federal Register of April 19,
2019 (84 FR 16513), we published a 60day notice requesting public comment
on the proposed collection of
information. One anonymous comment
was received that made specific
suggestions on how labeling might be
improved, but that supported the overall
goals of food labeling and making
information available to consumers. The
comment made no comments regarding
our burden estimate.
We estimate the burden of this
collection of information as follows:
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
jbell on DSK3GLQ082PROD with NOTICES
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
VerDate Sep<11>2014
19:11 Jul 19, 2019
Jkt 247001
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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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
E:\FR\FM\22JYN1.SGM
22JYN1
35121
Federal Register / Vol. 84, No. 140 / Monday, July 22, 2019 / Notices
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
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
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 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.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
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
jbell on DSK3GLQ082PROD with NOTICES
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. This information collection
reflects adjustments resulting from
regulations that have become effective
since last OMB review (RIN 0910–
AF22). Accordingly, we have lowered
our third-party disclosure estimate to
reflect that burden associated with
changes in labeling resulting from the
new requirements has since been
realized by respondents. This results in
a decrease of 1,149,158 annual
disclosures and 2,299,816 burden hours
attributable to those labeling changes.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Pain and Opioid use
in Hemodialysis Patients.
Date: August 6, 2019.
Time: 8:00 a.m. to 6:00 p.m.
[FR Doc. 2019–15523 Filed 7–19–19; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:11 Jul 19, 2019
Jkt 247001
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
PO 00000
Frm 00054
Fmt 4703
Sfmt 9990
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites—Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Ryan G. Morris, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7015, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, 301–594–4721,
ryan.morris@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: July 16, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–15463 Filed 7–19–19; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\22JYN1.SGM
22JYN1
]]>Agencies
[Federal Register Volume 84, Number 140 (Monday, July 22, 2019)]
[Notices]
[Pages 35119-35121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15523]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1265]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 August
21, 2019.
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 0910-0813.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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
[[Page 35120]]
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 issued 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).
In the Federal Register of April 19, 2019 (84 FR 16513), we
published a 60-day notice requesting public comment on the proposed
collection of information. One anonymous comment was received that made
specific suggestions on how labeling might be improved, but that
supported the overall goals of food labeling and making information
available to consumers. The comment made no comments regarding our
burden estimate.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of declaration; 21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
[[Page 35121]]
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.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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. This information collection reflects adjustments
resulting from regulations that have become effective since last OMB
review (RIN 0910-AF22). Accordingly, we have lowered our third-party
disclosure estimate to reflect that burden associated with changes in
labeling resulting from the new requirements has since been realized by
respondents. This results in a decrease of 1,149,158 annual disclosures
and 2,299,816 burden hours attributable to those labeling changes.
Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15523 Filed 7-19-19; 8:45 am]
BILLING CODE 4164-01-P
