82 FR 27504 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

Page Range		27504-27508
FR Document		2017-12443

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

Federal Register, Volume 82 Issue 114 (Thursday, June 15, 2017)

[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27504-27508]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-12443]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1155]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Labeling
Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by July
17, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0381.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726.

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.

[[Page 27505]]

Food Labeling Regulations--21 CFR Parts 101, 102, 104, and 105

OMB Control Number 0910-0381--Extension

Our food labeling regulations require food producers to disclose to
consumers and others specific information about themselves or their
products on the label or labeling of their products. Related
regulations require that food producers retain records establishing the
basis for the information contained in the label or labeling of their
products and provide those records to regulatory officials. Finally,
certain regulations provide for the submission of food labeling
petitions to us. We issued our food labeling regulations under parts
101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) under the
authority of sections 4, 5, and 6 of the Fair Packaging and Labeling
Act (the FPLA) (15 U.S.C. 1453, 1454, and 1455) and sections 201, 301,
402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 321, 331, 342, 343, 348, 350,
371, and 379e). Most of these regulations derive from section 403 of
the FD&C Act, which provides that a food product shall be deemed to be
misbranded if, among other things, its label or labeling fails to bear
certain required information concerning the food product, is false or
misleading in any particular, or bears certain types of unauthorized
claims. The disclosure requirements and other collections of
information in the regulations in parts 101, 102, 104, and 105 are
necessary to ensure that food products produced or sold in the United
States are in compliance with the labeling provisions of the FD&C Act
and the FPLA.
Section 101.3 of our food labeling regulations requires that the
label of a food product in packaged form bear a statement of identity
(i.e., the name of the product), including, as appropriate, the form of
the food or the name of the food imitated. Section 101.4 prescribes
requirements for the declaration of ingredients on the label or
labeling of food products in packaged form. Section 101.5 requires that
the label of a food product in packaged form specify the name and place
of business of the manufacturer, packer, or distributor and, if the
food producer is not the manufacturer of the food product, its
connection with the food product. Section 101.7 specifies requirements
for the declaration of the net quantity of contents on the label of a
food in packaged form and prescribes conditions under which a food
whose label does not accurately reflect the actual quantity of contents
may be sold, with appropriate disclosures, to an institution operated
by a Federal, State, or local government. Section 101.108 provides for
the submission to us of a written proposal requesting a temporary
exemption from certain requirements of Sec. Sec. 101.9 and 105.66 for
the purpose of conducting food labeling experiments with our
authorization. Section 101.9 requires that nutrition information be
provided for all food products intended for human consumption and
offered for sale, unless an exemption in Sec. 101.9(j) applies to the
product. In particular, Sec. 101.9(c)(2)(ii) requires that the amount
of trans fatty acids present in a food must be declared on the
nutrition label on a separate line immediately under the line for the
declaration of saturated fat. Section 101.9(g)(9) provides that
interested parties may submit to us requests for alternative approaches
to nutrition labeling requirements. Finally, Sec. 101.9(j)(18)
provides that firms claiming the small business exemption from
nutrition labeling must submit notice to us supporting their claim
exemption. We developed Form FDA 3570 to assist small businesses in
claiming the small business exemption from nutrition labeling. The form
contains all the elements required by Sec. 101.9(j)(18).
Section 101.10 requires that restaurants provide nutrition
information, upon request, for any food or meal for which a nutrient
content claim or health claim is made. Section 101.12(b) provides the
reference amount that is used for determining the serving sizes for
specific products, including baking powder, baking soda, and pectin.
Section 101.12(e) provides that a manufacturer that adjusts the
reference amount customarily consumed (RACC) of an aerated food for the
difference in density of the aerated food relative to the density of
the appropriate nonaerated reference food must be prepared to show us
detailed protocols and records of all data that were used to determine
the density-adjusted RACC. Section 101.12(g) requires that the label or
labeling of a food product disclose the serving size that is the basis
for a claim made for the product if the serving size on which the claim
is based differs from the RACC. Section 101.12(h) provides for the
submission of petitions requesting that we change the reference amounts
defined by regulation.
Section 101.13 requires that nutrition information be provided in
accordance with Sec. 101.9 for any food product for which a nutrient
content claim is made. Under some circumstances, Sec. 101.13 also
requires the disclosure of other types of information as a condition
for the use of a nutrient content claim. For example, under Sec.
101.13(j), if the claim compares the level of a nutrient in the food
with the level of the same nutrient in another ``reference'' food, the
claim must also disclose the identity of the reference food, the amount
of the nutrient in each food, and the percentage or fractional amount
by which the amount of the nutrient in the labeled food differs from
the amount of the nutrient in the reference food. It also requires that
when this comparison is based on an average of food products, this
information must be provided to consumers or regulatory officials upon
request. Section 101.13(q)(5) requires that restaurants document and
provide to appropriate regulatory officials, upon request, the basis
for any nutrient content claims they have made for the foods they sell.
Section 101.14(d)(2) and (3) provides for the disclosure of
nutrition information in accordance with Sec. 101.9 and, under some
circumstances, certain other information as a condition for making a
health claim for a food product. Section 101.15 provides that, if the
label of a food product contains any representation in a foreign
language, all words, statements, and other information required by or
under authority of the FD&C Act to appear on the label must appear in
both the foreign language and in English. Section 101.22 contains
labeling requirements for the disclosure of spices, flavorings,
colorings, and chemical preservatives in food products. Section
101.22(i)(4) sets forth disclosure and recordkeeping requirements
pertaining to certifications for flavors designated as containing no
artificial flavors. Section 101.30 specifies the conditions under which
a beverage that purports to contain any fruit or vegetable juice must
declare the percentage of juice present in the beverage and the manner
in which the declaration is to be made.
Section 101.36 requires that nutrition information be provided for
dietary supplements offered for sale, unless an exemption in Sec.
101.36(h) applies. In particular, Sec. 101.36(b)(2) requires that the
amount of trans fatty acids present in dietary supplements must be
declared on the nutrition label on a separate line immediately under
the line for the declaration of saturated fat. Section 101.36(e)
permits the voluntary declaration of the quantitative amount and the
percent of Daily Value of a dietary ingredient on a ``per day'' basis
in addition to the required ``per serving'' basis, if a dietary
supplement label recommends that the dietary supplement be consumed
more than once per day. Section 101.36(f)(2) cross-

[[Page 27506]]

references the provisions in Sec. 101.9(g)(9) for the submission to us
of requests for alternative approaches to nutrition labeling
requirements. Also, Sec. 101.36(h)(2) cross-references the provisions
in Sec. 101.9(j)(18) for the submission of small business exemption
notices. As noted previously, we developed Form FDA 3570 to assist
small businesses in claiming the small business exemption from
nutrition labeling. The form contains all the elements required by
Sec. 101.36(h)(2).
Section 101.42 requests that food retailers voluntarily provide
nutrition information for raw fruits, vegetables, and fish at the point
of purchase, and Sec. 101.45 contains guidelines for providing such
information. Also, Sec. 101.45(c) provides for the submission to us of
nutrient databases and proposed nutrition labeling values for raw
fruit, vegetables, and fish for review and approval.
Sections 101.54, 101.56, 101.60, 101.61, and 101.62 specify
information that must be disclosed as a condition for making particular
nutrient content claims. Section 101.67 provides for the use of
nutrient content claims for butter, and cross-references requirements
in other regulations for information declaration (Sec. 101.4) and
disclosure of information concerning performance characteristics (Sec.
101.13(d)). Section 101.69 provides for the submission of a petition
requesting that we authorize a particular nutrient content claim by
regulation. Section 101.70 provides for the submission of a petition
requesting that we authorize a particular health claim by regulation.
Section 101.77(c)(2)(ii)(D) requires the disclosure of soluble fiber
per serving in the nutrition labeling of a food bearing a health claim
about the relationship between soluble fiber and a reduced risk of
coronary heart disease. Section 101.79(c)(2)(iv) requires the
disclosure of the amount of folate in the nutrition label of a food
bearing a health claim about the relationship between folate and a
reduced risk of neural tube defects.
Section 101.100(d) provides that any agreement that forms the basis
for an exemption from the labeling requirements of section 403(c), (e),
(g), (h), (i), (k), and (q) of the FD&C Act be in writing and that a
copy of the agreement be made available to us upon request. Section
101.100 also contains reporting and disclosure requirements as
conditions for claiming certain labeling exemptions (e.g., 101.100(h)).
Regulations in part 102 define the information that must be
included as part of the statement of identity for particular foods and
prescribe related labeling requirements for some of these foods. For
example, Sec. 102.22 requires that the name of a protein hydrolysate
will include the identity of the food source from which the protein was
derived.
Part 104, which pertains to nutritional quality guidelines for
foods, cross references several labeling provisions in part 101 but
contains no separate information collection requirements.
Part 105 contains special labeling requirements for hypoallergenic
foods, infant foods, and certain foods represented as useful in
reducing or maintaining body weight.
The purpose of our food labeling requirements is to allow consumers
to be knowledgeable about the foods they purchase. Nutrition labeling
provides information for use by consumers in selecting a nutritious
diet. Other information enables a consumer to comparison shop.
Ingredient information also enables consumers to avoid substances to
which they may be sensitive. Petitions or other requests submitted to
us provide the basis for us to permit new labeling statements or to
grant exemptions from certain labeling requirements. Recordkeeping
requirements enable us to monitor the basis upon which certain label
statements are made for food products and whether those statements are
in compliance with the requirements of the FD&C Act or the FPLA.
Description of Respondents: Respondents to this information
collection are manufacturers, packers, and distributors of food
products. Because of the existence of exemptions and exceptions, not
all of the requirements apply to all food producers or to all of their
products. Some of the regulations affect food retailers, such as
supermarkets and restaurants.
In the Federal Register of December 30, 2016 (81 FR 96462), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. In this notice, FDA did not accurately
reflect amendments approved in the final rule, technical amendments for
21 CFR parts 1, 100, 101, and 104, ``Food Labeling; Technical
Amendments,'' dated August 29, 2016 (81 FR 59129), which changed
section 101.105 to section 101.7. This has been corrected in this
notice. In addition, FDA received two comments from the 60-day notice.
One comment was not related to the PRA and will not be addressed here,
and one comment was PRA-related and is addressed in this document.
(Comment) One commenter stated that ensuring that food is labeled
accurately and correctly is important because people should know
exactly what is inside of different foods. Labeling food accurately and
correctly ensures no information about the food is hidden because some
people have allergies, and people should be allowed to provide
feedback.
(Response) FDA agrees with this comment, and this collection of
information reinforces that food should be labeled accurately, with no
hidden ingredients, for the public's health and safety. In addition,
the renewal of this collection of information provides the public the
opportunity to comment and provide feedback on this collection.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Third Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual
21 CFR section/part respondents per disclosures Average burden per disclosure Total hours
respondent
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101.3, 101.22, 102, and 104; statement of 25,000 1.03 25,750 .5 (30 minutes)........................ 12,875
identity labeling requirements.
101.4, 101.22, 101.100, 102, 104 and 105; 25,000 1.03 25,750 1...................................... 25,750
ingredient labeling requirements.
101.5; requirement to specify the name and 25,000 1.03 25,750 .25 (15 minutes)....................... 6,438
place of business of the manufacturer, packer,
or distributor and, if the food producer is
not the manufacturer of the food product, its
connection with the food product.
101.9, 101.13(n), 101.14(d)(3), 101.62, and 25,000 1.03 25,750 .40 (24 minutes)....................... 103,000
104; labeling requirements for disclosure of
nutrition information.
101.9(g)(9) and 101.36(f)(2); alternative means 12 1 12 4...................................... 48
of compliance permitted.
101.10; requirements for nutrition labeling of 300,000 1.5 450,000 .25 (15 minutes)....................... 112,500
restaurant foods.
101.12(b); RACC for baking powder, baking soda 29 2.3 67 1...................................... 67
and pectin.

[[Page 27507]]

101.12(e); adjustment to the RACC of an aerated 25 1 25 1...................................... 25
food permitted.
101.12(g); requirement to disclose the serving 5,000 1 5,000 1...................................... 5,000
size that is the basis for a claim made for
the product if the serving size on which the
claim is based differs from the RACC.
101.13(d)(1) and 101.67; requirements to 200 1 200 1...................................... 200
disclose nutrition information for any food
product for which a nutrient content claim is
made.
101.13(j)(2), 101.13(k), 101.54, 101.56, 5,000 1 5,000 1...................................... 5,000
101.60, 101.61, and 101.62; additional
disclosure required if the nutrient content
claim compares the level of a nutrient in one
food with the level of the same nutrient in
another food.
101.13(q)(5); requirement that restaurants 300,000 1.5 450,000 .75 (45 minutes)....................... 337,500
disclose the basis for nutrient content claims
made for their food.
101.14(d)(2); general requirements for 300,000 1.5 450,000 .75 (45 minutes)....................... 337,500
disclosure of nutrition information related to
health claims for food products.
101.15; requirements pertaining to prominence 160 10 1,600 8...................................... 12,800
of required statements and use of foreign
language.
101.22(i)(4); supplier certifications for 25 1 25 1...................................... 25
flavors designated as containing no artificial
flavors.
101.30 and 102.33; labeling requirements for 1,500 5 7,500 1...................................... 7,500
fruit or vegetable juice beverages.
101.36; nutrition labeling of dietary 300 40 12,000 4.025.................................. 48,300
supplements.
101.42 and 101.45; nutrition labeling of raw 1,000 1 1,000 .5 (30 minutes)........................ 500
fruits, vegetables, and fish.
101.45(c); databases of nutrient values for raw 5 4 20 4...................................... 80
fruits, vegetables, and fish.
101.79(c)(2)(i)(D); disclosure requirements for 1,000 1 1,000 .25 (15 minutes)....................... 250
food labels that contain a folate/neural tube
defect health claim.
101.79(c)(2)(iv); disclosure of amount of 100 1 100 .25 (15 minutes)....................... 25
folate for food labels that contain a folate/
neural tube defect health claim.
101.100(d); disclosure of agreements that form 1,000 1 1,000 1...................................... 1,000
the basis for exemption from the labeling
requirements of section 403(c), (e), (g), (h),
(i), (k), and (q) of the FD&C Act.
101.7 and 101.100(h); disclosure requirements 25,000 1.03 25,750 .5 (30 minutes)........................ 12,875
for food not accurately labeled for quantity
of contents and for claiming certain labeling
exemptions.
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Total...................................... .............. .............. .............. ....................................... 1,029,258
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.7(t); recordkeeping pertaining to 100 1 100 1...................................... 100
disclosure requirements for food not
accurately labeled for quantity of contents.
101.12(e); recordkeeping to document the basis 25 1 25 1...................................... 25
for density-adjusted RACC.
101.13(q)(5); recordkeeping to document the 300,000 1.5 450,000 .75 (45 minutes)....................... 337,500
basis for nutrient content claims.
101.14(d)(2); recordkeeping to document 300,000 1.5 450,000 .75 (45 minutes)....................... 337,500
nutrition information related to health claims
for food products.
101.22(i)(4); recordkeeping to document 25 1 25 1...................................... 25
supplier certifications for flavors designated
as containing no artificial flavors.
101.100(d)(2); recordkeeping pertaining to 1,000 1 1,000 1...................................... 1,000
agreements that form the basis for an
exemption from the labeling requirements of
section 403(c), (e), (g), (h), (i), (k), and
(q) of the FD&C Act.
--------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. ....................................... 676,150
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
101.9(j)(18) and 101.36(h)(2); 10,000 1 10,000 8 80,000
procedure for small business
nutrition labeling exemption
notice using Form FDA 3570.....
101.12(h); petitions to 5 1 5 80 400
establish or amend a RACC......
101.69; petitions for nutrient 3 1 3 25 75
content claims.................
101.70; petitions for health 5 1 5 80 400
claims.........................
101.108; written proposal for 1 1 1 40 40
requesting temporary exemptions
from certain regulations for
the purpose of conducting food
labeling experiments...........
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Total....................... .............. .............. .............. .............. 80,915
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

[[Page 27508]]

The estimated annual third party disclosure, recordkeeping, and
reporting burdens are based on our communications with industry and our
knowledge of and experience with food labeling and the submission of
petitions and requests to us.
We expect that the burden hours for submissions under Sec. 101.108
will be insignificant. Section 101.108 was originally issued to provide
a procedure whereby we could grant exemptions from certain food
labeling requirements. Exemption petitions have infrequently been
submitted in the recent past; none have been submitted since
publication on January 6, 1993, of the final regulations implementing
section 403(q) and (r) of the FD&C Act. Thus, in order to maintain OMB
approval of Sec. 101.108 to accommodate the possibility that a food
producer may propose to conduct a labeling experiment on its own
initiative, we estimate that we will receive one or fewer submissions
under Sec. 101.108 in the next 3 years.

Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12443 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P

27504 Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices

finished products). Therefore, the total www.fda.gov/AdvisoryCommittees/ U.S.C. app. 2) and 21 CFR part 14,
recordkeeping burden for domestic default.htm. relating to advisory committees.
facilities is estimated to be 9,061 hours FOR FURTHER INFORMATION CONTACT: Dated: June 9, 2017.
(13 hours × 697), and the total Shanika Craig, Office of Device
recordkeeping burden for foreign Anna K. Abram,
Evaluation, Center for Devices and
facilities is estimated to be 11,908 hours Deputy Commissioner for Policy, Planning,
Radiological Health, Food and Drug
(13 hours × 916), as shown in table 2. Administration, 10903 New Hampshire
Legislation, and Analysis.
[FR Doc. 2017–12354 Filed 6–14–17; 8:45 am]
Dated: June 12, 2017. Ave., Bldg. 66, Rm. G644, Silver Spring,
MD 20993–0002, 301–796–6639, email: BILLING CODE 4164–01–P
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Shanika.Craig@fda.hhs.gov.
Legislation, and Analysis. SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting DEPARTMENT OF HEALTH AND
[FR Doc. 2017–12448 Filed 6–14–17; 8:45 am]
members on TEPRSSC that include two HUMAN SERVICES
BILLING CODE 4164–01–P
general public representatives and a
Food and Drug Administration
government representative.
DEPARTMENT OF HEALTH AND I. General Description of the
HUMAN SERVICES [Docket No. FDA–2013–N–1155]
Committee’s Duties
Food and Drug Administration The committee provides advice and Agency Information Collection
consultation to the Commissioner of Activities; Submission for Office of
[Docket No. FDA–2017–N–2495] Food and Drugs (Commissioner) on the Management and Budget Review;
technical feasibility, reasonableness, Comment Request; Food Labeling
Request for Nominations for Voting and practicability of performance Regulations
Members on a Public Advisory standards for electronic products to
Committee; Technical Electronic control the emission of radiation from AGENCY: Food and Drug Administration,
Product Radiation Safety Standards such products, and may recommend HHS.
Committee electronic product radiation safety
standards to the Commissioner for ACTION: Notice.
AGENCY: Food and Drug Administration, consideration.
HHS. SUMMARY: The Food and Drug
II. Criteria for Voting Members Administration (FDA or we) is
ACTION: Notice.
The committee consists of a core of 15 announcing that a proposed collection
SUMMARY: The Food and Drug voting members including the Chair. of information has been submitted to the
Administration (FDA) is requesting Members and the Chair are selected by Office of Management and Budget
nominations for members to serve on the Commissioner or designee from (OMB) for review and clearance under
the Technical Electronic Product among authorities knowledgeable in the the Paperwork Reduction Act of 1995
Radiation Safety Standards Committee fields of science or engineering, (PRA).
(TEPRSSC) in the Center for Devices applicable to electronic product
and Radiological Health. radiation safety. Members will be DATES: Fax written comments on the
FDA seeks to include the views of invited to serve for overlapping terms of collection of information by July 17,
women and men, members of all racial up to 4 years. Terms of more than 2 2017.
and ethnic groups, and individuals with years are contingent upon the renewal
and without disabilities on its advisory of the committee by appropriate action ADDRESSES: To ensure that comments on
committees and, therefore, encourages prior to its expiration. the information collection are received,
nominations of appropriately qualified OMB recommends that written
III. Nomination Procedures
candidates from these groups. comments be faxed to the Office of
Any interested person may nominate Information and Regulatory Affairs,
DATES: Nominations received on or
one or more qualified individuals for OMB, Attn: FDA Desk Officer, FAX:
before August 14, 2017 will be given
membership on the committee. Self- 202–395–7285, or emailed to oira_
first consideration for membership on
nominations are also accepted. submission@omb.eop.gov. All
TEPRSSC. Nominations received after
Nominations must include a current and comments should be identified with the
August 14, 2017 will be considered for complete résumé or curriculum vitae for
nomination to the committee as later OMB control number 0910–0381. Also
each nominee, including current
vacancies occur. include the FDA docket number found
business address and/or home address,
ADDRESSES: All nominations for telephone number, and email address if in brackets in the heading of this
membership should be sent available. Nominations must also document.
electronically by accessing FDA’s specify the advisory committee for FOR FURTHER INFORMATION CONTACT: Ila
Advisory Committee Membership which the nominee is recommended.
Nomination Portal at https:// S. Mizrachi, Office of Operations, Food
Nominations must also acknowledge and Drug Administration, Three White
www.accessdata.fda.gov/scripts/ that the nominee is aware of the
FACTRSPortal/FACTRS/index.cfm or by Flint North, 10A63, 11601 Landsdown
nomination unless self-nominated. FDA
St., North Bethesda, MD 20852, 301–
pmangrum on DSK3GDR082PROD with NOTICES

mail to Advisory Committee Oversight will ask potential candidates to provide
and Management Staff, Food and Drug detailed information concerning such 796–7726.
Administration, 10903 New Hampshire matters related to financial holdings, SUPPLEMENTARY INFORMATION: In
Ave., Bldg. 32, Rm. 5103, Silver Spring, employment, and research grants and/or compliance with 44 U.S.C. 3507, FDA
MD 20993–0002. Information about contracts to permit evaluation of has submitted the following proposed
becoming a member on an FDA advisory possible sources of conflicts of interest. collection of information to OMB for
committee can also be obtained by This notice is issued under the review and clearance.
visiting FDA’s Web site at https:// Federal Advisory Committee Act (5

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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27505

Food Labeling Regulations—21 CFR with appropriate disclosures, to an the use of a nutrient content claim. For
Parts 101, 102, 104, and 105 institution operated by a Federal, State, example, under § 101.13(j), if the claim
or local government. Section 101.108 compares the level of a nutrient in the
OMB Control Number 0910–0381—
provides for the submission to us of a food with the level of the same nutrient
Extension
written proposal requesting a temporary in another ‘‘reference’’ food, the claim
Our food labeling regulations require exemption from certain requirements of must also disclose the identity of the
food producers to disclose to consumers §§ 101.9 and 105.66 for the purpose of reference food, the amount of the
and others specific information about conducting food labeling experiments nutrient in each food, and the
themselves or their products on the with our authorization. Section 101.9 percentage or fractional amount by
label or labeling of their products. requires that nutrition information be which the amount of the nutrient in the
Related regulations require that food provided for all food products intended labeled food differs from the amount of
producers retain records establishing for human consumption and offered for the nutrient in the reference food. It also
the basis for the information contained sale, unless an exemption in § 101.9(j) requires that when this comparison is
in the label or labeling of their products applies to the product. In particular, based on an average of food products,
and provide those records to regulatory § 101.9(c)(2)(ii) requires that the amount this information must be provided to
officials. Finally, certain regulations of trans fatty acids present in a food consumers or regulatory officials upon
provide for the submission of food must be declared on the nutrition label request. Section 101.13(q)(5) requires
labeling petitions to us. We issued our on a separate line immediately under that restaurants document and provide
food labeling regulations under parts the line for the declaration of saturated to appropriate regulatory officials, upon
101, 102, 104, and 105 (21 CFR parts fat. Section 101.9(g)(9) provides that request, the basis for any nutrient
101, 102, 104, and 105) under the interested parties may submit to us content claims they have made for the
authority of sections 4, 5, and 6 of the requests for alternative approaches to foods they sell.
Fair Packaging and Labeling Act (the nutrition labeling requirements. Finally, Section 101.14(d)(2) and (3) provides
FPLA) (15 U.S.C. 1453, 1454, and 1455) § 101.9(j)(18) provides that firms for the disclosure of nutrition
and sections 201, 301, 402, 403, 409, claiming the small business exemption information in accordance with § 101.9
411, 701, and 721 of the Federal Food, from nutrition labeling must submit and, under some circumstances, certain
Drug, and Cosmetic Act (the FD&C Act) notice to us supporting their claim other information as a condition for
(21 U.S.C. 321, 331, 342, 343, 348, 350, exemption. We developed Form FDA making a health claim for a food
371, and 379e). Most of these 3570 to assist small businesses in product. Section 101.15 provides that, if
regulations derive from section 403 of claiming the small business exemption the label of a food product contains any
the FD&C Act, which provides that a from nutrition labeling. The form representation in a foreign language, all
food product shall be deemed to be contains all the elements required by words, statements, and other
misbranded if, among other things, its § 101.9(j)(18). information required by or under
label or labeling fails to bear certain Section 101.10 requires that authority of the FD&C Act to appear on
required information concerning the restaurants provide nutrition the label must appear in both the foreign
food product, is false or misleading in information, upon request, for any food language and in English. Section 101.22
any particular, or bears certain types of or meal for which a nutrient content contains labeling requirements for the
unauthorized claims. The disclosure claim or health claim is made. Section disclosure of spices, flavorings,
requirements and other collections of 101.12(b) provides the reference amount colorings, and chemical preservatives in
information in the regulations in parts that is used for determining the serving food products. Section 101.22(i)(4) sets
101, 102, 104, and 105 are necessary to sizes for specific products, including forth disclosure and recordkeeping
ensure that food products produced or baking powder, baking soda, and pectin. requirements pertaining to certifications
sold in the United States are in Section 101.12(e) provides that a for flavors designated as containing no
compliance with the labeling provisions manufacturer that adjusts the reference artificial flavors. Section 101.30
of the FD&C Act and the FPLA. amount customarily consumed (RACC) specifies the conditions under which a
Section 101.3 of our food labeling of an aerated food for the difference in beverage that purports to contain any
regulations requires that the label of a density of the aerated food relative to fruit or vegetable juice must declare the
food product in packaged form bear a the density of the appropriate percentage of juice present in the
statement of identity (i.e., the name of nonaerated reference food must be beverage and the manner in which the
the product), including, as appropriate, prepared to show us detailed protocols declaration is to be made.
the form of the food or the name of the and records of all data that were used Section 101.36 requires that nutrition
food imitated. Section 101.4 prescribes to determine the density-adjusted information be provided for dietary
requirements for the declaration of RACC. Section 101.12(g) requires that supplements offered for sale, unless an
ingredients on the label or labeling of the label or labeling of a food product exemption in § 101.36(h) applies. In
food products in packaged form. Section disclose the serving size that is the basis particular, § 101.36(b)(2) requires that
101.5 requires that the label of a food for a claim made for the product if the the amount of trans fatty acids present
product in packaged form specify the serving size on which the claim is based in dietary supplements must be
name and place of business of the differs from the RACC. Section declared on the nutrition label on a
manufacturer, packer, or distributor 101.12(h) provides for the submission of separate line immediately under the line
and, if the food producer is not the petitions requesting that we change the for the declaration of saturated fat.
manufacturer of the food product, its reference amounts defined by Section 101.36(e) permits the voluntary
pmangrum on DSK3GDR082PROD with NOTICES

connection with the food product. regulation. declaration of the quantitative amount
Section 101.7 specifies requirements for Section 101.13 requires that nutrition and the percent of Daily Value of a
the declaration of the net quantity of information be provided in accordance dietary ingredient on a ‘‘per day’’ basis
contents on the label of a food in with § 101.9 for any food product for in addition to the required ‘‘per serving’’
packaged form and prescribes which a nutrient content claim is made. basis, if a dietary supplement label
conditions under which a food whose Under some circumstances, § 101.13 recommends that the dietary
label does not accurately reflect the also requires the disclosure of other supplement be consumed more than
actual quantity of contents may be sold, types of information as a condition for once per day. Section 101.36(f)(2) cross-

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27506 Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices

references the provisions in § 101.9(g)(9) and a reduced risk of neural tube compliance with the requirements of the
for the submission to us of requests for defects. FD&C Act or the FPLA.
alternative approaches to nutrition Section 101.100(d) provides that any Description of Respondents:
labeling requirements. Also, agreement that forms the basis for an Respondents to this information
§ 101.36(h)(2) cross-references the exemption from the labeling collection are manufacturers, packers,
provisions in § 101.9(j)(18) for the requirements of section 403(c), (e), (g), and distributors of food products.
submission of small business exemption (h), (i), (k), and (q) of the FD&C Act be Because of the existence of exemptions
notices. As noted previously, we in writing and that a copy of the and exceptions, not all of the
developed Form FDA 3570 to assist agreement be made available to us upon requirements apply to all food
small businesses in claiming the small request. Section 101.100 also contains producers or to all of their products.
business exemption from nutrition reporting and disclosure requirements Some of the regulations affect food
labeling. The form contains all the as conditions for claiming certain retailers, such as supermarkets and
elements required by § 101.36(h)(2). labeling exemptions (e.g., 101.100(h)). restaurants.
Regulations in part 102 define the In the Federal Register of December
Section 101.42 requests that food
information that must be included as 30, 2016 (81 FR 96462), FDA published
retailers voluntarily provide nutrition
part of the statement of identity for a 60-day notice requesting public
information for raw fruits, vegetables,
particular foods and prescribe related comment on the proposed collection of
and fish at the point of purchase, and
labeling requirements for some of these information. In this notice, FDA did not
§ 101.45 contains guidelines for
foods. For example, § 102.22 requires accurately reflect amendments approved
providing such information. Also,
that the name of a protein hydrolysate in the final rule, technical amendments
§ 101.45(c) provides for the submission
will include the identity of the food for 21 CFR parts 1, 100, 101, and 104,
to us of nutrient databases and proposed
source from which the protein was ‘‘Food Labeling; Technical
nutrition labeling values for raw fruit,
derived. Amendments,’’ dated August 29, 2016
vegetables, and fish for review and
(81 FR 59129), which changed section
approval. Part 104, which pertains to nutritional 101.105 to section 101.7. This has been
Sections 101.54, 101.56, 101.60, quality guidelines for foods, cross corrected in this notice. In addition,
101.61, and 101.62 specify information references several labeling provisions in FDA received two comments from the
that must be disclosed as a condition for part 101 but contains no separate 60-day notice. One comment was not
making particular nutrient content information collection requirements. related to the PRA and will not be
claims. Section 101.67 provides for the Part 105 contains special labeling addressed here, and one comment was
use of nutrient content claims for butter, requirements for hypoallergenic foods, PRA-related and is addressed in this
and cross-references requirements in infant foods, and certain foods document.
other regulations for information represented as useful in reducing or (Comment) One commenter stated
declaration (§ 101.4) and disclosure of maintaining body weight. that ensuring that food is labeled
information concerning performance The purpose of our food labeling accurately and correctly is important
characteristics (§ 101.13(d)). Section requirements is to allow consumers to because people should know exactly
101.69 provides for the submission of a be knowledgeable about the foods they what is inside of different foods.
petition requesting that we authorize a purchase. Nutrition labeling provides Labeling food accurately and correctly
particular nutrient content claim by information for use by consumers in ensures no information about the food is
regulation. Section 101.70 provides for selecting a nutritious diet. Other hidden because some people have
the submission of a petition requesting information enables a consumer to allergies, and people should be allowed
that we authorize a particular health comparison shop. Ingredient to provide feedback.
claim by regulation. Section information also enables consumers to (Response) FDA agrees with this
101.77(c)(2)(ii)(D) requires the avoid substances to which they may be comment, and this collection of
disclosure of soluble fiber per serving in sensitive. Petitions or other requests information reinforces that food should
the nutrition labeling of a food bearing submitted to us provide the basis for us be labeled accurately, with no hidden
a health claim about the relationship to permit new labeling statements or to ingredients, for the public’s health and
between soluble fiber and a reduced risk grant exemptions from certain labeling safety. In addition, the renewal of this
of coronary heart disease. Section requirements. Recordkeeping collection of information provides the
101.79(c)(2)(iv) requires the disclosure requirements enable us to monitor the public the opportunity to comment and
of the amount of folate in the nutrition basis upon which certain label provide feedback on this collection.
label of a food bearing a health claim statements are made for food products FDA estimates the burden of this
about the relationship between folate and whether those statements are in collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Number of
Number of disclosures Total annual Average burden
21 CFR section/part Total hours
respondents per disclosures per disclosure
respondent

101.3, 101.22, 102, and 104; statement of identity labeling requirements ... 25,000 1.03 25,750 .5 (30 minutes) ..... 12,875
101.4, 101.22, 101.100, 102, 104 and 105; ingredient labeling require- 25,000 1.03 25,750 1 ........................... 25,750
pmangrum on DSK3GDR082PROD with NOTICES

ments.
101.5; requirement to specify the name and place of business of the man- 25,000 1.03 25,750 .25 (15 minutes) ... 6,438
ufacturer, packer, or distributor and, if the food producer is not the man-
ufacturer of the food product, its connection with the food product.
101.9, 101.13(n), 101.14(d)(3), 101.62, and 104; labeling requirements for 25,000 1.03 25,750 .40 (24 minutes) ... 103,000
disclosure of nutrition information.
101.9(g)(9) and 101.36(f)(2); alternative means of compliance permitted .... 12 1 12 4 ........................... 48
101.10; requirements for nutrition labeling of restaurant foods ..................... 300,000 1.5 450,000 .25 (15 minutes) ... 112,500
101.12(b); RACC for baking powder, baking soda and pectin ...................... 29 2.3 67 1 ........................... 67

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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27507

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

101.12(e); adjustment to the RACC of an aerated food permitted ............... 25 1 25 1 ........................... 25
101.12(g); requirement to disclose the serving size that is the basis for a 5,000 1 5,000 1 ........................... 5,000
claim made for the product if the serving size on which the claim is
based differs from the RACC.
101.13(d)(1) and 101.67; requirements to disclose nutrition information for 200 1 200 1 ........................... 200
any food product for which a nutrient content claim is made.
101.13(j)(2), 101.13(k), 101.54, 101.56, 101.60, 101.61, and 101.62; addi- 5,000 1 5,000 1 ........................... 5,000
tional disclosure required if the nutrient content claim compares the level
of a nutrient in one food with the level of the same nutrient in another
food.
101.13(q)(5); requirement that restaurants disclose the basis for nutrient 300,000 1.5 450,000 .75 (45 minutes) ... 337,500
content claims made for their food.
101.14(d)(2); general requirements for disclosure of nutrition information 300,000 1.5 450,000 .75 (45 minutes) ... 337,500
related to health claims for food products.
101.15; requirements pertaining to prominence of required statements and 160 10 1,600 8 ........................... 12,800
use of foreign language.
101.22(i)(4); supplier certifications for flavors designated as containing no 25 1 25 1 ........................... 25
artificial flavors.
101.30 and 102.33; labeling requirements for fruit or vegetable juice bev- 1,500 5 7,500 1 ........................... 7,500
erages.
101.36; nutrition labeling of dietary supplements .......................................... 300 40 12,000 4.025 .................... 48,300
101.42 and 101.45; nutrition labeling of raw fruits, vegetables, and fish ...... 1,000 1 1,000 .5 (30 minutes) ..... 500
101.45(c); databases of nutrient values for raw fruits, vegetables, and fish 5 4 20 4 ........................... 80
101.79(c)(2)(i)(D); disclosure requirements for food labels that contain a 1,000 1 1,000 .25 (15 minutes) ... 250
folate/neural tube defect health claim.
101.79(c)(2)(iv); disclosure of amount of folate for food labels that contain 100 1 100 .25 (15 minutes) ... 25
a folate/neural tube defect health claim.
101.100(d); disclosure of agreements that form the basis for exemption 1,000 1 1,000 1 ........................... 1,000
from the labeling requirements of section 403(c), (e), (g), (h), (i), (k), and
(q) of the FD&C Act.
101.7 and 101.100(h); disclosure requirements for food not accurately la- 25,000 1.03 25,750 .5 (30 minutes) ..... 12,875
beled for quantity of contents and for claiming certain labeling exemp-
tions.

Total ........................................................................................................ ........................ ........................ ........................ ............................... 1,029,258
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Total Average
Number of
21 CFR section records per annual burden per Total hours
recordkeepers recordkeeper records recordkeeping

101.7(t); recordkeeping pertaining to disclosure requirements for food not 100 1 100 1 ........................... 100
accurately labeled for quantity of contents.
101.12(e); recordkeeping to document the basis for density-adjusted 25 1 25 1 ........................... 25
RACC.
101.13(q)(5); recordkeeping to document the basis for nutrient content 300,000 1.5 450,000 .75 (45 minutes) ... 337,500
claims.
101.14(d)(2); recordkeeping to document nutrition information related to 300,000 1.5 450,000 .75 (45 minutes) ... 337,500
health claims for food products.
101.22(i)(4); recordkeeping to document supplier certifications for flavors 25 1 25 1 ........................... 25
designated as containing no artificial flavors.
101.100(d)(2); recordkeeping pertaining to agreements that form the basis 1,000 1 1,000 1 ........................... 1,000
for an exemption from the labeling requirements of section 403(c), (e),
(g), (h), (i), (k), and (q) of the FD&C Act.

Total ........................................................................................................ ........................ ........................ ........................ ............................... 676,150
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
21 CFR section/form No. responses per annual burden per Total hours
respondents respondent responses response

101.9(j)(18) and 101.36(h)(2); procedure for small business nutrition labeling
pmangrum on DSK3GDR082PROD with NOTICES

exemption notice using Form FDA 3570 .......................................................... 10,000 1 10,000 8 80,000
101.12(h); petitions to establish or amend a RACC ............................................. 5 1 5 80 400
101.69; petitions for nutrient content claims ......................................................... 3 1 3 25 75
101.70; petitions for health claims ........................................................................ 5 1 5 80 400
101.108; written proposal for requesting temporary exemptions from certain
regulations for the purpose of conducting food labeling experiments .............. 1 1 1 40 40

Total ............................................................................................................... ........................ ........................ ........................ ........................ 80,915
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

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Document Created: 2017-06-15 01:03:39
Document Modified: 2017-06-15 01:03:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by July 17, 2017.
Contact		Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726.
FR Citation		82 FR 27504

82 FR 27504 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration