81_FR_96713 81 FR 96462 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations

81 FR 96462 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 251 (December 30, 2016)

Page Range96462-96467
FR Document2016-31733

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 information collection provisions of our food labeling regulations and on Form FDA 3570, Model Small Business Nutrition Labeling Exemption Notice, which small businesses may use to claim the small business exemption from nutrition labeling.

Federal Register, Volume 81 Issue 251 (Friday, December 30, 2016)
[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Notices]
[Pages 96462-96467]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31733]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 information collection 
provisions of our food labeling regulations and on Form FDA 3570, Model 
Small Business Nutrition Labeling Exemption Notice, which small 
businesses may use to claim the small business exemption from nutrition 
labeling.

DATES: Submit either electronic or written comments on the collection 
of information by February 28, 2017.

[[Page 96463]]


ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2013-N-1155 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Labeling Regulations.'' 
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 Division of Dockets Management 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 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 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 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.

[[Page 96464]]

    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 101.9 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 (d)(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-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

[[Page 96465]]

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)).
    Section 101.105 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.
    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.
    We estimate the burden of this collection of information as 
follows:

                                               Table 1--Estimated Annual Third Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                21 CFR section                    Number of      disclosures    Total annual         Average burden per disclosure          Total hours
                                                 respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
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  0.25 (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                  12               1              12  4........................................              48
 means of compliance permitted.
101.10; requirements for nutrition labeling           300,000             1.5         450,000  0.25 (15 minutes)........................         112,500
 of restaurant foods.
101.12(b); RACC for baking powder, baking                  29             2.3              67  1........................................              67
 soda and pectin.
101.12(e); adjustment to the RACC of an                    25               1              25  1........................................              25
 aerated food permitted.
101.12(g); requirement to disclose the                  5,000               1           5,000  1........................................           5,000
 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.
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  0.75 (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  0.75 (45 minutes)........................         337,500
 disclosure of nutrition information related
 to health claims for food products.

[[Page 96466]]

 
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  0.5 (30 minutes).........................             500
 fruits, vegetables, and fish.
101.45(c); databases of nutrient values for                 5               4              20  4........................................              80
 raw fruits, vegetables, and fish.
101.79(c)(2)(i)(D); disclosure requirements             1,000               1           1,000  0.25 (15 minutes)........................             250
 for food labels that contain a folate/neural
 tube defect health claim.
101.79(c)(2)(iv); disclosure of amount of                 100               1             100  0.25 (15 minutes)........................              25
 folate for food labels that contain a folate/
 neural tube defect health claim.
101.100(d); disclosure of agreements that               1,000               1           1,000  1........................................           1,000
 form the basis for exemption from the
 labeling requirements of section 403(c),
 (e), (g), (h), (i), (k), and (q) of the FD&C
 Act.
101.105 and 101.100(h); disclosure                     25,000            1.03          25,750  0.5 (30 minutes).........................          12,875
 requirements for food not accurately labeled
 for quantity of contents and for claiming
 certain labeling exemptions.
                                              ----------------------------------------------------------------------------------------------------------
    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
                21 CFR section                    Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.12(e); recordkeeping to document the                   25               1              25  1........................................              25
 basis for density-adjusted RACC.
101.13(q)(5); recordkeeping to document the           300,000             1.5         450,000  0.75 (45 minutes)........................         337,500
 basis for nutrient content claims.
101.14(d)(2); recordkeeping to document               300,000             1.5         450,000  0.75 (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.
101.105(t); recordkeeping pertaining to                   100               1             100  1........................................             100
 disclosure requirements for food not
 accurately labeled for quantity of contents.
                                              ----------------------------------------------------------------------------------------------------------
    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                        Average
     21 CFR section/Form No.         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       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.........................

[[Page 96467]]

 
101.108; written proposal for                  1               1               1              40              40
 requesting temporary exemptions
 from certain regulations for
 the purpose of conducting food
 labeling experiments...........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          80,915
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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: December 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31733 Filed 12-29-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                96462                                Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices

                                                find out if interventions are reaching                                   about vector control activities, and the                                     contraception, mental health/emotional
                                                pregnant women and having the                                            Zika Prevention kit.                                                         support, service/support needs of
                                                intended effects along with getting                                        The following factors will be assessed:                                    families with babies affected by Zika, or
                                                feedback from pregnant women about                                       • Knowledge about Zika virus and                                             vaccine communications (if applicable).
                                                the Zika prevention activities that have                                   related prevention behaviors                                               While pregnant women will be the main
                                                been implemented (e.g., Zika education                                   • Self-efficacy in engaging in Zika                                          focus of most inquiry, other audiences
                                                sessions and prevention kits, vector                                       prevention behaviors                                                       could include community leaders,
                                                control activities, and communication                                    • Engagement in Zika prevention                                              community members, and health care
                                                activities).                                                               behaviors (e.g., protective clothing                                       providers. The goal is to identify
                                                   Findings will be used to improve the                                    use, condom use, and bed net use)                                          specific unmet needs, which can then
                                                                                                                         • Knowledge about, attitudes about, and                                      be shared with the Department of Health
                                                delivery of interventions and to inform
                                                                                                                           use of the Zika Prevention Kit                                             and other human service agencies. The
                                                decisions about future Zika prevention
                                                                                                                           materials                                                                  plan is to hold up to 7 focus groups
                                                activities for pregnant women in Puerto                                  • Knowledge about, attitudes about, and
                                                Rico. The plan is to conduct up to 500                                                                                                                (with up to 10 persons each), or up to
                                                                                                                           use of environmental vector control                                        20 in-depth individual interviews or up
                                                telephone interviews every two months                                      activities
                                                over a 9-month period, (a total of four                                                                                                               to 75 brief intercept interviews. A
                                                                                                                         • Risk perceptions of Zika                                                   maximum of 75 individuals would
                                                rounds), analyze the data, and generate                                  • Exposures to communications along
                                                a report for leaders of the response to                                                                                                               participate in this part.
                                                                                                                           with other factors that may be
                                                offer insights on the delivery of                                          important considerations in their                                            Results of this project will have
                                                interventions to pregnant women. The                                       taking action or not (e.g., does their                                     limited generalizability. However,
                                                information will be used to make                                           house have screens, etc.)                                                  results of this evaluation should provide
                                                recommendations for improving                                              CDC will conduct telephone                                                 information that can be used to enhance
                                                interventions. Information may also be                                   interviews with a mix of closed-ended                                        and revise the existing program as well
                                                used to develop presentations, reports,                                  and open-ended questions with                                                as offer lessons learned to inform
                                                and manuscripts to document the                                          pregnant women. We estimate 2,000                                            infectious disease control programs that
                                                program and lessons learned in order to                                  pregnant women will participate in the                                       use education materials.
                                                inform future programs of this sort.                                     project over a nine month period.                                              Authorizing legislation comes from
                                                   The purpose of this assessment is also                                  Another component of this project is                                       Section 301 of the Public Health Service
                                                to assess core components of CDC’s Zika                                  to conduct qualitative inquiry to explore                                    Act (42 U.S.C. 241). There is no cost to
                                                response in communicating prevention                                     emerging issues related to vector                                            respondents other than their time to
                                                behaviors, risk messages to the public                                   control, sexual transmission,                                                participate.

                                                                                                                        ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                  Average
                                                                                                                                                                                                    Number of
                                                                                                                                                                         Number of                                              burden per              Total burden
                                                                    Type of respondents                                                Form name                                                  responses per
                                                                                                                                                                        respondents                                              response                 (in hrs.)
                                                                                                                                                                                                    respondent                    (in hrs.)

                                                Pregnant WIC participant .....................................               Initial Telephone Inter-                                 2,000                             1                   20/60                667
                                                                                                                                view.
                                                WIC participants, other families affected by Zika                            Focus group .................                                 70                           1                 120/60                 140
                                                WIC participants, other families ............................                In-depth Interviews .......                                   20                           1                  60/60                  20
                                                General population in Zika affected neighbor-                                Brief intercept interview                                     75                           1                  10/60                  13
                                                 hood.

                                                     Total ...............................................................   .......................................   ........................   ........................   ........................            840



                                                Leroy A. Richardson,                                                     DEPARTMENT OF HEALTH AND                                                     1995 (the PRA), Federal Agencies are
                                                Chief, Information Collection Review Office,                             HUMAN SERVICES                                                               required to publish notice in the
                                                Office of Scientific Integrity, Office of the                                                                                                         Federal Register concerning each
                                                Associate Director for Science, Office of the                            Food and Drug Administration                                                 proposed collection of information,
                                                Director, Centers for Disease Control and                                                                                                             including each proposed extension of an
                                                                                                                         [Docket No. FDA–2013–N–1155]
                                                Prevention.                                                                                                                                           existing collection of information, and
                                                [FR Doc. 2016–31737 Filed 12–29–16; 8:45 am]                             Agency Information Collection                                                to allow 60 days for public comment in
                                                BILLING CODE 4163–18–P                                                   Activities; Proposed Collection;                                             response to the notice. This notice
                                                                                                                         Comment Request; Food Labeling                                               solicits comments on the information
                                                                                                                         Regulations                                                                  collection provisions of our food
                                                                                                                         AGENCY:        Food and Drug Administration,                                 labeling regulations and on Form FDA
                                                                                                                         HHS.                                                                         3570, Model Small Business Nutrition
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                                                                                                                         ACTION:       Notice.                                                        Labeling Exemption Notice, which
                                                                                                                                                                                                      small businesses may use to claim the
                                                                                                                         SUMMARY:   The Food and Drug                                                 small business exemption from
                                                                                                                         Administration (FDA or we) is                                                nutrition labeling.
                                                                                                                         announcing an opportunity for public
                                                                                                                         comment on the proposed collection of                                        DATES: Submit either electronic or
                                                                                                                         certain information by the Agency.                                           written comments on the collection of
                                                                                                                         Under the Paperwork Reduction Act of                                         information by February 28, 2017.


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                                                                             Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices                                           96463

                                                ADDRESSES:       You may submit comments                 submission. You should submit two                     before submitting the collection to OMB
                                                as follows:                                              copies total. One copy will include the               for approval. To comply with this
                                                                                                         information you claim to be confidential              requirement, FDA is publishing notice
                                                Electronic Submissions
                                                                                                         with a heading or cover note that states              of the proposed collection of
                                                  Submit electronic comments in the                      ‘‘THIS DOCUMENT CONTAINS                              information set forth in this document.
                                                following way:                                           CONFIDENTIAL INFORMATION.’’ The                          With respect to the following
                                                  • Federal eRulemaking Portal:                          Agency will review this copy, including               collection of information, FDA invites
                                                https://www.regulations.gov. Follow the                  the claimed confidential information, in              comments on these topics: (1) Whether
                                                instructions for submitting comments.                    its consideration of comments. The                    the proposed collection of information
                                                Comments submitted electronically,                       second copy, which will have the                      is necessary for the proper performance
                                                including attachments, to https://                       claimed confidential information                      of FDA’s functions, including whether
                                                www.regulations.gov will be posted to                    redacted/blacked out, will be available               the information will have practical
                                                the docket unchanged. Because your                       for public viewing and posted on                      utility; (2) the accuracy of FDA’s
                                                comment will be made public, you are                     https://www.regulations.gov. Submit                   estimate of the burden of the proposed
                                                solely responsible for ensuring that your                both copies to the Division of Dockets                collection of information, including the
                                                comment does not include any                             Management. If you do not wish your                   validity of the methodology and
                                                confidential information that you or a                   name and contact information to be                    assumptions used; (3) ways to enhance
                                                third party may not wish to be posted,                   made publicly available, you can                      the quality, utility, and clarity of the
                                                such as medical information, your or                     provide this information on the cover                 information to be collected; and (4)
                                                anyone else’s Social Security number, or                 sheet and not in the body of your                     ways to minimize the burden of the
                                                confidential business information, such                  comments and you must identify this                   collection of information on
                                                as a manufacturing process. Please note                  information as ‘‘confidential.’’ Any                  respondents, including through the use
                                                that if you include your name, contact                   information marked as ‘‘confidential’’                of automated collection techniques,
                                                information, or other information that                   will not be disclosed except in                       when appropriate, and other forms of
                                                identifies you in the body of your                       accordance with 21 CFR 10.20 and other                information technology.
                                                comments, that information will be                       applicable disclosure law. For more                   Food Labeling Regulations—21 CFR
                                                posted on https://www.regulations.gov.                   information about FDA’s posting of                    Parts 101, 102, 104, and 105; OMB
                                                  • If you want to submit a comment                      comments to public dockets, see 80 FR                 Control Number 0910–0381—Extension
                                                with confidential information that you                   56469, September 18, 2015, or access
                                                do not wish to be made available to the                                                                          Our food labeling regulations require
                                                                                                         the information at: http://www.fda.gov/
                                                public, submit the comment as a                                                                                food producers to disclose to consumers
                                                                                                         regulatoryinformation/dockets/
                                                written/paper submission and in the                                                                            and others specific information about
                                                                                                         default.htm.                                          themselves or their products on the
                                                manner detailed (see ‘‘Written/Paper                        Docket: For access to the docket to
                                                Submissions’’ and ‘‘Instructions’’).                                                                           label or labeling of their products.
                                                                                                         read background documents or the
                                                                                                                                                               Related regulations require that food
                                                Written/Paper Submissions                                electronic and written/paper comments
                                                                                                                                                               producers retain records establishing
                                                                                                         received, go to https://
                                                   Submit written/paper submissions as                                                                         the basis for the information contained
                                                                                                         www.regulations.gov and insert the
                                                follows:                                                                                                       in the label or labeling of their products
                                                                                                         docket number, found in brackets in the
                                                   • Mail/Hand delivery/Courier (for                                                                           and provide those records to regulatory
                                                                                                         heading of this document, into the                    officials. Finally, certain regulations
                                                written/paper submissions): Division of
                                                                                                         ‘‘Search’’ box and follow the prompts                 provide for the submission of food
                                                Dockets Management (HFA–305), Food
                                                                                                         and/or go to the Division of Dockets                  labeling petitions to us. We issued our
                                                and Drug Administration, 5630 Fishers
                                                                                                         Management, 5630 Fishers Lane, Rm.                    food labeling regulations under parts
                                                Lane, Rm. 1061, Rockville, MD 20852.
                                                   • For written/paper comments                          1061, Rockville, MD 20852.                            101, 102, 104, and 105 (21 CFR parts
                                                submitted to the Division of Dockets                     FOR FURTHER INFORMATION CONTACT: FDA                  101, 102, 104, and 105) under the
                                                Management, FDA will post your                           PRA Staff, Office of Operations, Food                 authority of sections 4, 5, and 6 of the
                                                comment, as well as any attachments,                     and Drug Administration, Three White                  Fair Packaging and Labeling Act (the
                                                except for information submitted,                        Flint North, 10A63, 11601 Landsdown                   FPLA) (15 U.S.C. 1453, 1454, and 1455)
                                                marked and identified, as confidential,                  St., North Bethesda, MD 20852,                        and sections 201, 301, 402, 403, 409,
                                                if submitted as detailed in                              PRAStaff@fda.hhs.gov.                                 411, 701, and 721 of the Federal Food,
                                                ‘‘Instructions.’’                                        SUPPLEMENTARY INFORMATION: Under the                  Drug, and Cosmetic Act (the FD&C Act)
                                                   Instructions: All submissions received                PRA (44 U.S.C. 3501–3520), Federal                    (21 U.S.C. 321, 331, 342, 343, 348, 350,
                                                must include the Docket No. FDA–                         Agencies must obtain approval from the                371, and 379e). Most of these
                                                2013–N–1155 for ‘‘Agency Information                     Office of Management and Budget                       regulations derive from section 403 of
                                                Collection Activities; Proposed                          (OMB) for each collection of                          the FD&C Act, which provides that a
                                                Collection; Comment Request; Food                        information they conduct or sponsor.                  food product shall be deemed to be
                                                Labeling Regulations.’’ Received                         ‘‘Collection of information’’ is defined              misbranded if, among other things, its
                                                comments will be placed in the docket                    in 44 U.S.C. 3502(3) and 5 CFR                        label or labeling fails to bear certain
                                                and, except for those submitted as                       1320.3(c) and includes Agency requests                required information concerning the
                                                ‘‘Confidential Submissions,’’ publicly                   or requirements that members of the                   food product, is false or misleading in
                                                viewable at https://www.regulations.gov                  public submit reports, keep records, or               any particular, or bears certain types of
                                                or at the Division of Dockets                            provide information to a third party.                 unauthorized claims. The disclosure
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                                                Management between 9 a.m. and 4 p.m.,                    Section 3506(c)(2)(A) of the PRA (44                  requirements and other collections of
                                                Monday through Friday.                                   U.S.C. 3506(c)(2)(A)) requires Federal                information in the regulations in parts
                                                   • Confidential Submissions—To                         Agencies to provide a 60-day notice in                101, 102, 104, and 105 are necessary to
                                                submit a comment with confidential                       the Federal Register concerning each                  ensure that food products produced or
                                                information that you do not wish to be                   proposed collection of information,                   sold in the United States are in
                                                made publicly available, submit your                     including each proposed extension of an               compliance with the labeling provisions
                                                comments only as a written/paper                         existing collection of information,                   of the FD&C Act and the FPLA.


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                                                96464                       Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices

                                                   Section 101.3 of our food labeling                   petitions requesting that we change the               for the declaration of saturated fat.
                                                regulations requires that the label of a                reference amounts defined by                          Section 101.36(e) permits the voluntary
                                                food product in packaged form bear a                    regulation.                                           declaration of the quantitative amount
                                                statement of identity (i.e., the name of                  Section 101.13 requires that nutrition              and the percent of Daily Value of a
                                                the product), including, as appropriate,                information be provided in accordance                 dietary ingredient on a ‘‘per day’’ basis
                                                the form of the food or the name of the                 with § 101.9 for any food product for                 in addition to the required ‘‘per serving’’
                                                food imitated. Section 101.4 prescribes                 which a nutrient content claim is made.               basis, if a dietary supplement label
                                                requirements for the declaration of                     Under some circumstances, § 101.13                    recommends that the dietary
                                                ingredients on the label or labeling of                 also requires the disclosure of other                 supplement be consumed more than
                                                food products in packaged form. Section                 types of information as a condition for               once per day. Section 101.36(f)(2) cross-
                                                101.5 requires that the label of a food                 the use of a nutrient content claim. For              references the provisions in § 101.9(g)(9)
                                                product in packaged form specify the                    example, under § 101.13(j), if the claim              for the submission to us of requests for
                                                name and place of business of the                       compares the level of a nutrient in the               alternative approaches to nutrition
                                                manufacturer, packer, or distributor                    food with the level of the same nutrient              labeling requirements. Also,
                                                and, if the food producer is not the                    in another ‘‘reference’’ food, the claim              § 101.36(h)(2) cross-references the
                                                manufacturer of the food product, its                   must also disclose the identity of the                provisions in § 101.9(j)(18) for the
                                                connection with the food product.                       reference food, the amount of the                     submission of small business exemption
                                                Section 101.9 requires that nutrition                   nutrient in each food, and the                        notices. As noted previously, we
                                                information be provided for all food                    percentage or fractional amount by                    developed Form FDA 3570 to assist
                                                products intended for human                             which the amount of the nutrient in the               small businesses in claiming the small
                                                consumption and offered for sale, unless                labeled food differs from the amount of               business exemption from nutrition
                                                an exemption in § 101.9(j) applies to the               the nutrient in the reference food. It also           labeling. The form contains all the
                                                product. In particular, § 101.9(c)(2)(ii)               requires that when this comparison is                 elements required by § 101.36(h)(2).
                                                requires that the amount of trans fatty                 based on an average of food products,                    Section 101.42 requests that food
                                                acids present in a food must be declared                this information must be provided to                  retailers voluntarily provide nutrition
                                                on the nutrition label on a separate line               consumers or regulatory officials upon                information for raw fruits, vegetables,
                                                immediately under the line for the                      request. Section 101.13(q)(5) requires                and fish at the point of purchase, and
                                                declaration of saturated fat. Section                   that restaurants document and provide                 § 101.45 contains guidelines for
                                                101.9(g)(9) provides that interested                    to appropriate regulatory officials, upon             providing such information. Also,
                                                parties may submit to us requests for                   request, the basis for any nutrient                   § 101.45(c) provides for the submission
                                                alternative approaches to nutrition                     content claims they have made for the                 to us of nutrient databases and proposed
                                                labeling requirements. Finally,                         foods they sell.                                      nutrition labeling values for raw fruit,
                                                                                                          Section 101.14(d)(2) and (d)(3)                     vegetables, and fish for review and
                                                § 101.9(j)(18) provides that firms
                                                                                                        provides for the disclosure of nutrition              approval.
                                                claiming the small business exemption
                                                                                                        information in accordance with § 101.9                   Sections 101.54, 101.56, 101.60,
                                                from nutrition labeling must submit
                                                                                                        and, under some circumstances, certain                101.61, and 101.62 specify information
                                                notice to us supporting their claim
                                                                                                        other information as a condition for                  that must be disclosed as a condition for
                                                exemption. We developed Form FDA
                                                                                                        making a health claim for a food                      making particular nutrient content
                                                3570 to assist small businesses in
                                                                                                        product. Section 101.15 provides that, if             claims. Section 101.67 provides for the
                                                claiming the small business exemption
                                                                                                        the label of a food product contains any              use of nutrient content claims for butter,
                                                from nutrition labeling. The form
                                                                                                        representation in a foreign language, all             and cross-references requirements in
                                                contains all the elements required by                   words, statements, and other                          other regulations for information
                                                § 101.9(j)(18).                                         information required by or under                      declaration (§ 101.4) and disclosure of
                                                   Section 101.10 requires that                         authority of the FD&C Act to appear on                information concerning performance
                                                restaurants provide nutrition                           the label must appear in both the foreign             characteristics (§ 101.13(d)). Section
                                                information, upon request, for any food                 language and in English. Section 101.22               101.69 provides for the submission of a
                                                or meal for which a nutrient content                    contains labeling requirements for the                petition requesting that we authorize a
                                                claim or health claim is made. Section                  disclosure of spices, flavorings,                     particular nutrient content claim by
                                                101.12(b) provides the reference amount                 colorings, and chemical preservatives in              regulation. Section 101.70 provides for
                                                that is used for determining the serving                food products. Section 101.22(i)(4) sets              the submission of a petition requesting
                                                sizes for specific products, including                  forth disclosure and recordkeeping                    that we authorize a particular health
                                                baking powder, baking soda, and pectin.                 requirements pertaining to certifications             claim by regulation. Section
                                                Section 101.12(e) provides that a                       for flavors designated as containing no               101.77(c)(2)(ii)(D) requires the
                                                manufacturer that adjusts the reference                 artificial flavors. Section 101.30                    disclosure of soluble fiber per serving in
                                                amount customarily consumed (RACC)                      specifies the conditions under which a                the nutrition labeling of a food bearing
                                                of an aerated food for the difference in                beverage that purports to contain any                 a health claim about the relationship
                                                density of the aerated food relative to                 fruit or vegetable juice must declare the             between soluble fiber and a reduced risk
                                                the density of the appropriate                          percentage of juice present in the                    of coronary heart disease. Section
                                                nonaerated reference food must be                       beverage and the manner in which the                  101.79(c)(2)(iv) requires the disclosure
                                                prepared to show us detailed protocols                  declaration is to be made.                            of the amount of folate in the nutrition
                                                and records of all data that were used                    Section 101.36 requires that nutrition              label of a food bearing a health claim
                                                to determine the density-adjusted                       information be provided for dietary                   about the relationship between folate
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                                                RACC. Section 101.12(g) requires that                   supplements offered for sale, unless an               and a reduced risk of neural tube
                                                the label or labeling of a food product                 exemption in § 101.36(h) applies. In                  defects.
                                                disclose the serving size that is the basis             particular, § 101.36(b)(2) requires that                 Section 101.100(d) provides that any
                                                for a claim made for the product if the                 the amount of trans fatty acids present               agreement that forms the basis for an
                                                serving size on which the claim is based                in dietary supplements must be                        exemption from the labeling
                                                differs from the RACC. Section                          declared on the nutrition label on a                  requirements of section 403(c), (e), (g),
                                                101.12(h) provides for the submission of                separate line immediately under the line              (h), (i), (k), and (q) of the FD&C Act be


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                                                                            Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices                                                              96465

                                                in writing and that a copy of the                       particular foods and prescribe related                   avoid substances to which they may be
                                                agreement be made available to us upon                  labeling requirements for some of these                  sensitive. Petitions or other requests
                                                request. Section 101.100 also contains                  foods. For example, § 102.22 requires                    submitted to us provide the basis for us
                                                reporting and disclosure requirements                   that the name of a protein hydrolysate                   to permit new labeling statements or to
                                                as conditions for claiming certain                      will include the identity of the food                    grant exemptions from certain labeling
                                                labeling exemptions (e.g., 101.100(h)).                 source from which the protein was                        requirements. Recordkeeping
                                                   Section 101.105 specifies                            derived.                                                 requirements enable us to monitor the
                                                requirements for the declaration of the                   Part 104, which pertains to nutritional                basis upon which certain label
                                                net quantity of contents on the label of                quality guidelines for foods, cross                      statements are made for food products
                                                a food in packaged form and prescribes                  references several labeling provisions in                and whether those statements are in
                                                                                                        part 101 but contains no separate                        compliance with the requirements of the
                                                conditions under which a food whose
                                                                                                        information collection requirements.                     FD&C Act or the FPLA.
                                                label does not accurately reflect the
                                                                                                          Part 105 contains special labeling
                                                actual quantity of contents may be sold,                                                                           Description of Respondents:
                                                                                                        requirements for hypoallergenic foods,
                                                with appropriate disclosures, to an                     infant foods, and certain foods                          Respondents to this information
                                                institution operated by a Federal, State,               represented as useful in reducing or                     collection are manufacturers, packers,
                                                or local government. Section 101.108                    maintaining body weight.                                 and distributors of food products.
                                                provides for the submission to us of a                    The purpose of our food labeling                       Because of the existence of exemptions
                                                written proposal requesting a temporary                 requirements is to allow consumers to                    and exceptions, not all of the
                                                exemption from certain requirements of                  be knowledgeable about the foods they                    requirements apply to all food
                                                §§ 101.9 and 105.66 for the purpose of                  purchase. Nutrition labeling provides                    producers or to all of their products.
                                                conducting food labeling experiments                    information for use by consumers in                      Some of the regulations affect food
                                                with our authorization.                                 selecting a nutritious diet. Other                       retailers, such as supermarkets and
                                                   Regulations in part 102 define the                   information enables a consumer to                        restaurants.
                                                information that must be included as                    comparison shop. Ingredient                                We estimate the burden of this
                                                part of the statement of identity for                   information also enables consumers to                    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                                                                                                                              Total hours
                                                                                                               respondents                per            disclosures           per disclosure
                                                                                                                                      respondent

                                                101.3, 101.22, 102 and 104; statement of identity                     25,000                  1.03             25,750     .5 (30 minutes) ..........                 12,875
                                                  labeling requirements.
                                                101.4, 101.22, 101.100, 102, 104 and 105; ingre-                      25,000                  1.03             25,750     1 ................................         25,750
                                                  dient labeling requirements.
                                                101.5; requirement to specify the name and place                      25,000                  1.03             25,750     0.25 (15 minutes) ......                    6,438
                                                  of business of the manufacturer, packer, or dis-
                                                  tributor 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;                      25,000                   1.03            25,750     .40 (24 minutes) ........                103,000
                                                  labeling requirements for disclosure of nutrition
                                                  information.
                                                101.9(g)(9) and 101.36(f)(2); alternative means of                          12                      1              12     4 ................................             48
                                                  compliance permitted.
                                                101.10; requirements for nutrition labeling of res-                 300,000                        1.5        450,000     0.25 (15 minutes) ......                 112,500
                                                  taurant foods.
                                                101.12(b); RACC for baking powder, baking soda                              29                     2.3             67     1 ................................             67
                                                  and pectin.
                                                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 size                       5,000                     1           5,000     1 ................................          5,000
                                                  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 disclose                          200                      1             200     1 ................................            200
                                                  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, 101.60,                          5,000                     1           5,000     1 ................................          5,000
                                                  101.61, and 101.62; additional disclosure re-
                                                  quired if the nutrient content claim compares the
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                                                  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                 300,000                        1.5        450,000     0.75 (45 minutes) ......                 337,500
                                                  the basis for nutrient content claims made for
                                                  their food.
                                                101.14(d)(2); general requirements for disclosure                   300,000                        1.5        450,000     0.75 (45 minutes) ......                 337,500
                                                  of nutrition information related to health claims
                                                  for food products.



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                                                96466                                 Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices

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

                                                101.15; requirements pertaining to prominence of                                                   160                           10                    1,600        8 ................................           12,800
                                                  required statements and use of foreign language.
                                                101.22(i)(4); supplier certifications for flavors des-                                               25                            1                        25      1 ................................               25
                                                  ignated as containing no artificial flavors.
                                                101.30 and 102.33; labeling requirements for fruit                                              1,500                              5                   7,500        1 ................................            7,500
                                                  or vegetable juice beverages.
                                                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,                                            1,000                             1                   1,000         0.5 (30 minutes) ........                       500
                                                  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 food                                            1,000                              1                  1,000         0.25 (15 minutes) ......                        250
                                                  labels that contain a folate/neural tube defect
                                                  health claim.
                                                101.79(c)(2)(iv); disclosure of amount of folate for                                               100                            1                       100       0.25 (15 minutes) ......                         25
                                                  food labels that contain a folate/neural tube de-
                                                  fect health claim.
                                                101.100(d); disclosure of agreements that form the                                              1,000                              1                   1,000        1 ................................            1,000
                                                  basis for exemption from the labeling require-
                                                  ments of section 403(c), (e), (g), (h), (i), (k), and
                                                  (q) of the FD&C Act.
                                                101.105 and 101.100(h); disclosure requirements                                               25,000                         1.03                    25,750         0.5 (30 minutes) ........                    12,875
                                                  for food not accurately labeled for quantity of
                                                  contents and for claiming certain labeling ex-
                                                  emptions.

                                                      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
                                                                                                                                   Number of                                             Total annual                Average burden per
                                                                          21 CFR section                                                                       records per                                                                                 Total hours
                                                                                                                                 recordkeepers                                             records                     recordkeeping
                                                                                                                                                              recordkeeper

                                                101.12(e); recordkeeping to document the basis for                                                   25                            1                        25      1 ................................               25
                                                  density-adjusted RACC.
                                                101.13(q)(5); recordkeeping to document the basis                                          300,000                              1.5                450,000          0.75 (45 minutes) ......                   337,500
                                                  for nutrient content claims.
                                                101.14(d)(2); recordkeeping to document nutrition                                          300,000                              1.5                450,000          0.75 (45 minutes) ......                   337,500
                                                  information related to health claims for food
                                                  products.
                                                101.22(i)(4); recordkeeping to document supplier                                                     25                           1                        25       1 ................................               25
                                                  certifications for flavors designated as containing
                                                  no artificial flavors.
                                                101.100(d)(2); recordkeeping pertaining to agree-                                               1,000                              1                   1,000        1 ................................            1,000
                                                  ments 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.
                                                101.105(t); recordkeeping pertaining to disclosure                                                100                              1                      100       1 ................................              100
                                                  requirements for food not accurately labeled for
                                                  quantity of contents.

                                                      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                                                 Average
                                                                                                                                               Number of                                             Total annual
                                                                        21 CFR section/Form No.                                                                          responses per                                             burden per              Total hours
srobinson on DSK5SPTVN1PROD with NOTICES




                                                                                                                                              respondents                                             responses
                                                                                                                                                                           respondent                                               response

                                                101.9(j)(18) and 101.36(h)(2); procedure for small busi-
                                                  ness nutrition labeling 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



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                                                                                     Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices                                                                                              96467

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

                                                101.108; written proposal for requesting temporary exemp-
                                                  tions from certain regulations for the purpose of con-
                                                  ducting 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.


                                                   The estimated annual third party                                       Classification Pathways for New                                             public, submit the comment as a
                                                disclosure, recordkeeping, and reporting                                  Accessory Types.’’ This document                                            written/paper submission and in the
                                                burdens are based on our                                                  provides guidance to industry and FDA                                       manner detailed (see ‘‘Written/Paper
                                                communications with industry and our                                      staff about the regulation of accessories                                   Submissions’’ and ‘‘Instructions’’).
                                                knowledge of and experience with food                                     to medical devices. The guidance                                            Written/Paper Submissions
                                                labeling and the submission of petitions                                  explains what devices FDA generally
                                                and requests to us.                                                       considers an ‘‘accessory’’ and                                                 Submit written/paper submissions as
                                                   We expect that the burden hours for                                    encourages use of the de novo                                               follows:
                                                submissions under § 101.108 will be                                       classification process under the Federal                                       • Mail/Hand delivery/Courier (for
                                                insignificant. Section 101.108 was                                        Food, Drug, and Cosmetic Act (the                                           written/paper submissions): Division of
                                                originally issued to provide a procedure                                  FD&C Act) to allow manufacturers and                                        Dockets Management (HFA–305), Food
                                                whereby we could grant exemptions                                         other parties to request risk- and                                          and Drug Administration, 5630 Fishers
                                                from certain food labeling requirements.                                  regulatory control-based classification of                                  Lane, Rm. 1061, Rockville, MD 20852.
                                                Exemption petitions have infrequently                                     accessories of a new type (i.e.,                                               • For written/paper comments
                                                                                                                                                                                                      submitted to the Division of Dockets
                                                been submitted in the recent past; none                                   accessories of a type that has not been
                                                                                                                                                                                                      Management, FDA will post your
                                                have been submitted since publication                                     previously classified under the FD&C
                                                                                                                                                                                                      comment, as well as any attachments,
                                                on January 6, 1993, of the final                                          Act, cleared for marketing under a
                                                                                                                                                                                                      except for information submitted,
                                                regulations implementing section 403(q)                                   510(k) submission, or approved in an
                                                                                                                                                                                                      marked and identified, as confidential,
                                                and (r) of the FD&C Act. Thus, in order                                   application for premarket approval
                                                                                                                                                                                                      if submitted as detailed in
                                                to maintain OMB approval of § 101.108                                     (PMA)).
                                                                                                                                                                                                      ‘‘Instructions.’’
                                                to accommodate the possibility that a                                     DATES: Submit either electronic or                                             Instructions: All submissions received
                                                food producer may propose to conduct                                      written comments on this guidance at                                        must include the Docket No. FDA–
                                                a labeling experiment on its own                                          any time. General comments on Agency                                        2015–D–0025 for ‘‘Medical Device
                                                initiative, we estimate that we will                                      guidance documents are welcome at any                                       Accessories—Describing Accessories
                                                receive one or fewer submissions under                                    time.                                                                       and Classification Pathway for New
                                                § 101.108 in the next 3 years.                                            ADDRESSES: You may submit comments                                          Accessory Types.’’ Received comments
                                                  Dated: December 27, 2016.                                               as follows:                                                                 will be placed in the docket and, except
                                                Leslie Kux,                                                                                                                                           for those submitted as ‘‘Confidential
                                                                                                                          Electronic Submissions                                                      Submissions,’’ publicly viewable at
                                                Associate Commissioner for Policy.
                                                [FR Doc. 2016–31733 Filed 12–29–16; 8:45 am]                                Submit electronic comments in the                                         https://www.regulations.gov or at the
                                                BILLING CODE 4164–01–P
                                                                                                                          following way:                                                              Division of Dockets Management
                                                                                                                            • Federal eRulemaking Portal:                                             between 9 a.m. and 4 p.m., Monday
                                                                                                                          https://www.regulations.gov. Follow the                                     through Friday.
                                                DEPARTMENT OF HEALTH AND                                                  instructions for submitting comments.                                          • Confidential Submissions—To
                                                HUMAN SERVICES                                                            Comments submitted electronically,                                          submit a comment with confidential
                                                                                                                          including attachments, to https://                                          information that you do not wish to be
                                                Food and Drug Administration                                              www.regulations.gov will be posted to                                       made publicly available, submit your
                                                                                                                          the docket unchanged. Because your                                          comments only as a written/paper
                                                [Docket No. FDA–2015–D–0025]                                              comment will be made public, you are                                        submission. You should submit two
                                                Medical Device Accessories—                                               solely responsible for ensuring that your                                   copies total. One copy will include the
                                                                                                                          comment does not include any                                                information you claim to be confidential
                                                Describing Accessories and
                                                                                                                          confidential information that you or a                                      with a heading or cover note that states
                                                Classification Pathway for New
                                                                                                                          third party may not wish to be posted,                                      ‘‘THIS DOCUMENT CONTAINS
                                                Accessory Types; Guidance for
                                                                                                                          such as medical information, your or                                        CONFIDENTIAL INFORMATION.’’ The
                                                Industry and Food and Drug
                                                                                                                          anyone else’s Social Security number, or                                    Agency will review this copy, including
                                                Administration Staff; Availability
                                                                                                                          confidential business information, such                                     the claimed confidential information, in
                                                AGENCY:      Food and Drug Administration,                                as a manufacturing process. Please note                                     its consideration of comments. The
                                                HHS.                                                                      that if you include your name, contact                                      second copy, which will have the
srobinson on DSK5SPTVN1PROD with NOTICES




                                                ACTION:     Notice of availability.                                       information, or other information that                                      claimed confidential information
                                                                                                                          identifies you in the body of your                                          redacted/blacked out, will be available
                                                SUMMARY:   The Food and Drug                                              comments, that information will be                                          for public viewing and posted on
                                                Administration (FDA) is announcing the                                    posted on https://www.regulations.gov.                                      https://www.regulations.gov. Submit
                                                availability of the guidance entitled                                       • If you want to submit a comment                                         both copies to the Division of Dockets
                                                ‘‘Medical Device Accessories—                                             with confidential information that you                                      Management. If you do not wish your
                                                Describing Accessories and                                                do not wish to be made available to the                                     name and contact information to be


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Document Created: 2016-12-30 05:16:16
Document Modified: 2016-12-30 05:16:16
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by February 28, 2017.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation81 FR 96462 

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