the case of bundled items, as we have indicated, we would not object to
additional calorie declarations for each component of a bundled item,
as long as the vending machine operator also provides the total calorie
declaration for the bundled item, as it is vended.
    As discussed in response 21, we have moved what had been proposed
as Sec.  101.8(c)(2)(i)(C) and therefore we are renumbering proposed
Sec.  101.8(c)(2)(i)(D) as Sec.  101.8(c)(2)(i)(C). Also, as discussed
further in section III.C.4.b.v, we have made changes to renumbered
Sec.  101.8(c)(2)(i)(C) to further clarify that a calorie declaration
for a covered vending machine food must include the total number of
calories for the food, whether the food is a single-serving or multiple
serving food. Section 101.8(c)(2)(i)(C) of this final rule provides
that the number of calories for a covered vending machine food must
include the total calories present in the food. As discussed in section
III.D, a vending machine operator may determine the total calories
contained in a covered vending machine food through a variety of
methods, including obtaining the calorie information from the food
package's Nutrition Facts label, the manufacturer or supplier of the
food, nutrient databases, cookbooks or laboratory analyses. Covered
vending operators must ensure that the calorie declarations are
truthful and not misleading, as required by section 403(a)(1) of the
FD&C Act, and otherwise comply with section 403(q)(5)(H)(viii) and (f)
of the FD&C Act and Sec.  101.8.
    v. Calorie declarations for packaged food having multiple servings.
    Proposed Sec.  101.8(c)(2)(i)(E) would require that the calorie
declaration for a covered vending machine food that contains multiple
servings include the total number of calories present in the vending
machine food. Proposed Sec.  101.8(c)(2)(i)(E) would also allow vending
machine operators to voluntarily disclose the calories per serving in
addition to the total calories for the food.
    (Comment 24) Many comments stated that vending machine food,
regardless of its serving size, is typically consumed in one occasion.
The comments agreed with proposed Sec.  101.8(c)(2)(i)(E) and said that
section 403(q)(5)(H)(viii) of the FD&C Act's reference to an ``article
of food sold from a vending machine'' and disclosure of calories
contained in the article indicates that a vending machine operator must
declare the total calories contained in a vending machine food as it is
packaged for sale, or otherwise sold from a vending machine, even if
the food's Nutrition Facts label states that the food contains more
than one serving. Similarly, because vending machine food is typically
consumed in one occasion, a few comments noted that declaring calories
per serving could be potentially confusing to consumers. The comments
stated that it would be deceptive, for example, to label a bag of chips
as 160 calories (per one-ounce serving) on the vending machine, only to
have people discover that the whole bag of chips contained 1.5 servings
and 240 calories.
    Other comments disagreed with proposed Sec.  101.8(c)(2)(i)(E). The
comments would base calorie declarations on the serving size listed on
the Nutrition Facts label and said that doing so would be consistent
with current nutrition labeling requirements. The comments pointed out
that some commonly vended foods contain more than one serving and that,
for those foods, the calories as listed per serving in the Nutrition
Facts label would not be identical to the calorie declaration
disclosing the number of calories contained in the entire article of
food.
    In contrast to the comments asserting that vending machine foods
typically are consumed in their entirety in one occasion, regardless of
listed servings on the package, a few comments stated that labeling
total calories for foods such as gum would be misleading because
typically, people do not chew the entire pack of gum in one occasion
and that calories should be allowed to be displayed per serving.
    Several comments supporting calorie declarations per serving noted
that Congress used the term ``item'' for the nutrition labeling
requirements for standard menu items offered for sale in restaurants
and similar retail food establishments of section 4205 of the ACA, but
used the term ``article'' for the vending machine food labeling
requirements. One comment stated that because Congress used different
words to express the two requirements, the words should have different
meanings. The comment contended that ``article,'' which is used in the
vending machine labeling requirements of section 4205 of the ACA,
suggests that the number of calories per serving, and not the total
number of calories contained in the food, must be declared. The comment
also noted that the nutrition labeling requirements for packaged foods
is per serving. According to the comment, if FDA thinks per serving
calorie declarations are not sufficient, we should address the issue
directly through our serving size regulations and not indirectly
through the vending machine calorie declaration requirements.
    (Response 24) We decline to revise the rule to require the calorie
declarations for covered vending machine food to be based on the
serving size listed on the Nutrition Facts label. We agree with the
comments asserting that many vending machine foods are typically
consumed in one occasion. Further, we note that the requirements of
section 403(q)(5)(H)(viii) of the FD&C Act apply to an ``article of
food sold from a vending machine,'' and section 403(q)(5)(H)(viii) of
the FD&C Act requires a vending machine operator to disclose the
``number of calories contained in the article [of food].'' Thus, we
conclude that section 403(q)(5)(H)(viii) of the FD&C Act requires that
the calorie declaration for an article of food sold from a vending
machine, including foods that contains multiple servings, be equal to
the total ``number of calories contained in the article [of food]'' as
dispensed, rather than the number of calories contained in the serving
size, if applicable, for the food. The total number of calories can be
determined by multiplying the number of calories per serving by the
number of servings in the package. For example, if the Nutrition Facts
for an article of food states 80 calories per serving and 3 servings
per container, the total number of calories in the entire package would
be 240 calories.
    Further, regarding the comments supporting calorie declarations per
serving because Congress used the term ``item'' for the nutrition
labeling requirements for standard menu items offered for sale in
restaurants and similar retail food establishments of section 4205 of
the ACA, but used the term ``article'' for the vending machine food
labeling requirements, we disagree with the comments. First, the
language of section 403(q)(5)(H)(viii) of the FD&C Act generally
provides, in relevant part, that ``[i]n the case of an article of food
sold from a vending machine . . . the vending machine operator shall
provide a sign in close proximity to each article of food or the
selection button that includes . . . the number of calories contained
in the article [of food].'' (Emphasis added.) Therefore, the calorie
declaration must include the number of calories contained in the
article of food, and not the number of calories per serving of the
food.
    Second, the fact that Congress used the term ``menu item'' in
section 403(q)(5)(H)(i)-(vii) of the FD&C Act does not indicate that
``article of food''

should be interpreted to mean ``per serving'' within the meaning of
section 403(q)(5)(H)(viii) of the FD&C Act. If Congress intended to
require calories to be declared in serving size amounts, Congress could
have used specific language to indicate this intent, as demonstrated
elsewhere in section 403(q) of the FD&C Act (``serving size,'' ``number
of servings,'' and ``per serving'' in section 403(q)(1)(A) and
(q)(5)(H)(iii) of the FD&C Act). Such an omission indicates that
declaring calories in serving size amounts was not the intent of
Congress. E.g., Russello v. U.S., 464 U.S. 16, 23 (1983) (``[W]here
Congress includes particular language in one section of a statute but
omits it in another section of the same Act, it is generally presumed
that Congress acts intentionally and purposely in the disparate
inclusion or exclusion'') (citation omitted).
    We reiterate, however, that proposed Sec.  101.8(c)(2)(i)(E) (which
has been consolidated with proposed Sec.  101.8(c)(2)(i)(D) and
renumbered as Sec.  101.8(c)(2)(i)(C) in the final rule, as explained
further in the paragraphs that follow) would allow for the voluntary
declaration of calories per serving for covered vending machine foods.
Regarding the comment suggesting that we revise our serving size
regulations, we clarify that this rule implements the requirements of
section 403(q)(5)(H)(viii) of the FD&C Act for foods sold in vending
machines. For the purposes of this rule, calorie declarations for
covered vending machine foods must be provided for the total number of
calories contained in the article of food.
    As discussed in response 21 of this preamble, we have moved
proposed Sec.  101.8(c)(2)(i)(C) and therefore have renumbered proposed
Sec.  101.8(c)(2)(i)(D) as Sec.  101.8(c)(2)(i)(C). Additionally, for
the reasons noted in the previous paragraphs, and as discussed in
section III.C.4.b.iv, we have made changes to renumbered Sec.
101.8(c)(2)(i)(C) to further clarify that a calorie declaration for a
covered vending machine food must include the total number of calories
for the food, whether the food is a single serving or multiple serving
food. In addition, we have added a sentence to Sec.  101.8(c)(2)(i)(C)
explaining that for a covered vending machine food with multiple
servings a vending machine operator may voluntarily disclose calories
per serving in addition to the total calories for the covered vending
machine food. This sentence was originally included in Sec.
101.8(c)(2)(i)(E). Because we have moved the sentence to Sec.
101.8(c)(2)(i)(C) and Sec.  101.8(c)(2)(i)(C) now applies to both
single- and multiple-serving covered vending machine foods, we have
removed proposed Sec.  101.8(c)(2)(i)(E).
    vi. Calorie declarations on signs in close proximity to the article
of food or selection button.
    Proposed Sec.  101.8(c)(2)(ii) would establish requirements
pertaining to the placement of calorie declarations. Proposed Sec.
101.8(c)(2)(ii)(A) would require the calorie declarations to be placed
on a sign in close proximity to the article of food or selection
button, i.e., in, on, or adjacent to the vending machine, but not
necessarily attached to the vending machine, so long as the sign is
visible at the same time as the food, its name, price, or selection
button or selection number is visible.
    The preamble to the proposed rule explained that ``a sign that is a
poster may be an appropriate medium to convey the required calorie
declarations, so long as the sign is in close proximity to the covered
vending machine food or selection button'' (76 FR 19238 at 19243). We
also tentatively concluded that for certain types of vending machines
with a limited number of selections (e.g., popcorn with or without
added butter), the sign with the statement of calories may appear
anywhere on the front (or face) of the vending machine, and that ``a
sign may consist of a handwritten sticker in permanent marking that is
affixed to the machine'' (76 FR 19238 at 19243).
    (Comment 25) One comment asked that we permit a ``static cling''
type label (e.g., a plastic decal that sticks to a surface because of
static electricity) to be placed on the outside of ``closed-front''
vending machines (i.e., vending machines that do not have transparent
glass fronts).
    (Response 25) Section 403(q)(5)(H)(viii) of the FD&C Act does not
specify how a sign declaring calories is to be affixed to a vending
machine or what materials are to be used for the sign. To give vending
machine operators the greatest flexibility, the final rule also does
not specify the type of material to be used as a sign or the manner in
which the sign must be affixed to a vending machine. However,
regardless of the material used for the sign, compliance with the
calorie labeling requirements is contingent on the sign being in close
proximity to each article of food or selection button and otherwise
satisfying the requirements of section 403(a)(1), (f), and
(q)(5)(H)(viii) of the FD&C Act and Sec.  101.8.
    (Comment 26) Many comments supported proposed Sec.
101.8(c)(2)(ii)(A), which would allow a vending machine operator to
provide a sign in close proximity to each article of food or selection
button that displays calorie declarations for multiple vending machine
foods. These comments stated that allowing vending machine operators to
provide a sign with calorie declarations in this manner would be the
least expensive and least burdensome way for vending machine operators
to comply with section 403(q)(5)(H)(viii) of the FD&C Act. Some
comments stated that a sign or poster could cost as little as $5 per
vending machine and would be the ``least burdensome'' on small
businesses. Other comments stated that allowing a vending machine
operator to provide calorie declarations on a sign adjacent to or on
the vending machine would reduce stocking errors by blind vending
machine operators.
    Conversely, some comments claimed that section 403(q)(5)(H)(viii)
of the FD&C Act requires calorie declarations to be on individual
``signs'' for each article of food and that posting calorie
declarations for multiple foods on a single sign that is not adjacent
to the corresponding article of food would not meet the statute's
requirements. One comment argued that if FDA permits calorie
declarations for multiple vending machine foods on a single sign, we
should at least prohibit such single signs from being placed adjacent
to the vending machine, and ensure the close proximity of the single
sign to each article of food or the selection button by revising the
rule to read as follows: ``This calorie information must be placed on a
sign next to the article of food or its selection button, or on a sign
appended to the front of the vending machine at a similar height as the
machine's selection buttons.''
    (Response 26) Section 403(q)(5)(H)(viii) of the FD&C Act expressly
states, in relevant part, that a vending machine operator must provide
``a sign in close proximity to each article of food or the selection
button that includes the number of calories contained in the article.''
Section 403(q)(5)(H)(viii) of the FD&C Act does not specify whether
vending machine operators must use a single sign with calorie
declarations for multiple articles of food, or multiple signs
corresponding to each article of food or selection button. To give
vending machine operators the greatest amount of flexibility and to
take into consideration different types of vending machines, we
interpret section 403(q)(5)(H)(viii) of the FD&C Act to allow vending
machine operators to use one sign with calorie declarations for all of
the covered vending machine food sold from the vending machine or a
sign for each covered vending machine food sold

from the vending machine, or a combination of the two, as long as the
sign or signs are in close proximity to the covered vending machine
food or selection button, as provided in Sec.  101.8(c)(2), and
otherwise satisfies the requirements of section 403(a)(1), (f), and
(q)(5)(H)(viii) of the FD&C Act and Sec.  101.8.
    (Comment 27) Some comments asked us to clarify whether the rule
would permit a vending machine operator to provide a sign adjacent to
the vending machine that lists calorie declarations for all possible
products that could be sold from the machine. The comments stated that
such signs would be permanent in nature and would reduce the need to
print new signs when different products are added to the vending
machine.
    Other comments suggested that grouping vending machine food items
on a sign by category will allow consumers to better compare products.
    (Response 27) We decline to revise Sec.  101.8(c)(2)(ii)(A) to
allow a vending machine operator to provide a sign adjacent to the
vending machine that lists all possible articles of food that could be
sold from the machine. However, we would not object to a vending
machine operator providing calorie declarations for articles of food
that are typically offered for sale in the specific vending machine but
may not be offered for sale at all times (for example, in cases where
the article sells out, or is temporarily replaced by another item),
provided that the calorie declarations are clear and conspicuous and
placed prominently. The calorie labeling requirements of section
403(q)(5)(H)(viii) of the FD&C Act apply ``[i]n the case of an article
of food sold from a vending machine'' (emphasis added). Accordingly,
whether a vending machine operator provides individual signs for each
article of food or selection button, or a sign with calorie
declarations for multiple articles of food, section 403(q)(5)(H)(viii)
of the FD&C Act requires vending machine operators to provide clear and
conspicuous calorie declarations for those articles of food that are
sold from the machine. Vending machine operators must also ensure that
such calorie declarations are not false or misleading as required by
section 403(a)(1) of the FD&C Act and are prominently placed on signs
with such conspicuousness and in such terms as to render the calorie
declarations likely to be read and understood by the ordinary
individual under customary conditions of purchase and use as required
by section 403(f) of the FD&C Act. A long listing of food items, some
of which are not available for sale in a vending machine, might make it
more difficult for a prospective purchaser to locate the relevant
calorie declarations for articles of food actually sold from the
vending machine. In other words, depending on the number of foods
listed on the sign and other factors, inclusion of calorie declarations
for covered vending machine foods that are not sold from the particular
vending machine, could result in the calorie declarations for covered
vending machine foods actually sold from the vending machine no longer
being clear and conspicuous, non-misleading, prominently placed and
likely to be read and understood by the ordinary individual under
customary conditions of purchase and use.
    Therefore, we have revised Sec.  101.8(c)(2)(ii)(A) to state that
the list of covered vending machine food items on a sign must give
calorie declarations for those articles of food that are sold from that
particular vending machine.
    At the same time, we recognize that calorie declarations could, in
some cases, be displayed for vending machine foods that are not
available for sale in the machine at a given time. For example, the
food may have been offered for sale in the vending machine but the
vending machine may have sold out of that item at some point in time.
As another example, a food that is typically stocked in a vending
machine might be temporarily replaced by another item. Nevertheless,
vending machine operators must continue to ensure that calorie
declarations on such a sign are tailored to articles of food currently
or typically sold from that particular vending machine and otherwise
satisfy the requirements of section 403(a)(1), (f), and (q)(5)(H)(viii)
of the FD&C Act and Sec.  101.8.
    As for the comments suggesting that signs adjacent to the vending
machines should group food items together, the final rule does not
prescribe the manner in which articles of food and their associated
calories are listed on a sign. Therefore, vending machine operators
have the flexibility to organize the information on the signs as they
wish, provided that the sign and the information on the sign comply
with section 403(a)(1), (f), and (q)(5)(H)(viii) of the FD&C Act and
Sec.  101.8.
    (Comment 28) Many comments opposed allowing vending machine
operators to declare calories on a sign adjacent to the vending
machine. Some comments contended that consumers are unlikely to see
calorie declarations on a sign adjacent to a vending machine,
particularly compared to calorie declarations posted directly next to
each vending machine food, but did not provide any data to support this
contention. One comment suggested that we require a statement on the
vending machine directing the consumer to the location of the sign
adjacent to the machine.
    (Response 28) We disagree with those comments stating that we
should not allow signs adjacent to the vending machine. Section
403(q)(5)(H)(viii) of the FD&C Act expressly states that ``a vending
machine operator shall provide a sign in close proximity to each
article of food or the selection button . . . .'' We have determined
that a sign that is adjacent to the vending machine is ``in close
proximity,'' to the covered vending machine food or selection button,
so long as the calorie declaration on the sign is visible at the same
time as the food, its name, or its selection button or selection number
is visible.
    We also note that Sec.  101.8(c)(2)(ii) requires that the sign be
``placed prominently.'' To help ensure that calorie declarations on a
sign placed adjacent to the vending machine are clear and conspicuous,
and placed prominently, Sec.  101.8(c)(2)(ii)(C) requires that the
calorie declaration must be in type that is all black or one color
printed on a white or other neutral background that contrasts with the
type color. Further, Sec.  101.8(c)(2)(ii)(C) also helps to ensure that
such calorie declarations are prominently placed on signs with such
conspicuousness and in such terms as to render them likely to be read
and understood by the prospective purchaser under customary conditions
of purchase and use, consistent with section 403(f) of the FD&C Act.
Considering our interpretation of ``close proximity'' and the
requirement of Sec.  101.8(c)(2)(ii), we conclude that an additional
statement directing the consumer to the sign is not necessary.
Therefore, we decline to amend the rule to require a statement on the
vending machine that directs the consumer to the location of a sign
adjacent to the vending machine. However, to further address the
comments' concern regarding the visibility of the calorie declarations
on a sign adjacent to a vending machine, we have modified Sec.
101.8(c)(2)(ii)(A) to specify that the calorie declaration must be
visible at the same time as the food, its name, price, selection
button, or selection number is visible (emphasis added). In addition,
on our own initiative, we have replaced the reference to ``[t]his
calorie information'' at the beginning of Sec.  101.8(c)(2)(ii)(A) with
``the calorie declarations'' to be consistent with the rest of the
final rule.

    As discussed in response 20, we have also moved the requirement in
the introductory sentence of proposed Sec.  101.8(c)(2)(i) that the
number of calories ``must be clear and conspicuous,'' and placed it
instead in the introductory sentence of Sec.  101.8(c)(2)(ii) for this
final rule. The ``clear and conspicuous'' standard more appropriately
reflects the requirements in Sec.  101.8(c)(2)(ii), which focus on the
placement and appearance of the calorie declarations, rather than the
requirements of Sec.  101.8(c)(2)(i), which focus on the content of the
calorie declarations.
    (Comment 29) One comment, opposed to allowing calorie declarations
on signs adjacent to vending machines, compared such signs to
stanchions at drive-through restaurants. The comment stated that, in
the context of drive-through restaurants, FDA has already taken the
position in its proposed rule for nutrition labeling of standard menu
items in restaurants and similar retail food establishments (76 FR
19192) that requiring consumers to look to one place (i.e., a menu
board) for important food-selection information such as price and then
to another (e.g., a stanchion) for calories, ``is likely to be more
difficult for customers attempting to use the declared calorie
information at the point of selection'' (76 FR 19192 at 19206). The
comment contended that it would be similarly difficult for consumers to
use calorie information if consumers had to look at the food in the
vending machine and at an adjacent sign for calorie declarations.
    (Response 29) We disagree with the comment. Section
403(q)(5)(H)(ii)(II)(aa) of the FD&C Act requires, in relevant part,
that a covered restaurant or similar retail food establishment disclose
the number of calories in a standard menu item ``adjacent to the name
of the standard menu item . . . on the menu board, including a drive-
through menu board . . . .'' (emphasis added). Section
403(q)(5)(H)(viii) of the FD&C Act, in contrast, requires a covered
vending machine operator to ``provide a sign in close proximity to each
article of food or the selection button . . . .'' Thus, the placement
of calorie declarations for covered vending machine food under section
403(q)(5)(H)(viii) of the FD&C Act is not directly analogous to the
placement of calorie information for standard menu items under section
403(q)(5)(H)(ii)(II)(aa) of the FD&C Act.
    Further, we do not consider vending machines to present a situation
that is analogous to menu boards at drive-through restaurants or
similar retail food establishments. A menu board at a drive-through is
distinguishable because, as we discussed in the proposed rule for
nutrition labeling of standard menu items in restaurants and similar
retail food establishments (76 FR 19192 at 19206), customers have a
restricted field of vision from their car windows while in a drive-
through, and they may have a relatively short time to consider and
review the menu board before ordering (76 FR 19192 at 19206). Vending
machine consumers generally are not faced with similar restrictions.
Accordingly, we interpret ``a sign in close proximity to each article
of food or the selection button'' within the context of section
403(q)(5)(H)(viii) of the FD&C Act to mean adjacent to the vending
machine in addition to in or on the vending machine.
    (Comment 30) Another comment noted that some localities prohibit
the use of signs without permits and described certain jurisdictions
that would levy a $25 fine for not obtaining a permit. According to the
comment, such ordinances could be problematic for vending machine
operators who would prefer to use signs adjacent to the vending machine
to meet the calorie declaration requirements of section
403(q)(5)(H)(viii) of the FD&C Act.
    (Response 30) This final rule gives vending machine operators the
flexibility to comply with the calorie labeling requirements for
vending machine foods in a way that minimizes burdens and that does not
conflict with local requirements described by the comment. For example,
where a State or local requirement regulates use of particular types of
signs (e.g., large signs, free-standing signs), a vending machine
operator could still comply with the requirements of section
403(q)(5)(H)(viii) of the FD&C Act by providing a sign in or on the
vending machine (e.g., using small individual signs or stickers).
Alternatively, a vending machine operator could stock foods in a
vending machine that permits a prospective purchaser to view the
calories, serving size, and servings per container listed in the
Nutrition Facts label on the foods, or in a reproduction of the
Nutrition Facts label; or that otherwise provides visible nutrition
information at the point of purchase, as provided in Sec.  101.8(b).
    vii. Color and contrast for calorie declarations in or on the
vending machine.
    Proposed Sec.  101.8(c)(2)(ii)(B) would specify that when the
calorie information is in or on the vending machine, the calorie
declaration must be in the same color or a color at least as
conspicuous as the color of the name or the price of the food or
selection number.
    We received no comments on this provision. However, on our own
initiative, as discussed in response 21, we have moved what was
proposed as Sec.  101.8(c)(2)(i)(C) to Sec.  101.8(c)(2)(ii)(B) of this
final rule to eliminate a duplicate requirement on color and contrast
for calorie declarations in or on the vending machine. Section
101.8(c)(2)(ii)(B) now specifies that when the calorie declaration is
in or on the vending machine, the calorie declaration must be in a type
size no smaller than the name of the food on the machine (not the
label), selection number, or price of the food as displayed on the
vending machine, whichever is smallest, with the same prominence, i.e.,
the same color, or in a color at least as conspicuous, as the color of
the name, if applicable, or price of the food or selection number, and
the same contrasting background, or a background at least as
contrasting as the background used for the item it is in closest
proximity to, i.e., name, selection number, or price of the food item
as displayed on the machine.
    viii. Type size, color, and contrast for calorie declarations
adjacent to the vending machine.
    When the calorie declaration is on a sign adjacent to the vending
machine, proposed Sec.  101.8(c)(2)(ii)(C) would require the calorie
declaration to be in type that is ``all black or one color printed on a
white or other neutral background that contrasts with the type color''
(76 FR 19238 at 19254). The preamble to the proposed rule explained
that we were not proposing a minimum type size for the calorie
declaration when it is on a sign adjacent to the vending machine (76 FR
19238 at 19243), and we invited comment on this issue.
    (Comment 31) One comment asked that we establish additional
requirements for size, type face, and color for the calorie
declarations on the signs adjacent to the vending machine but the
comment did not provide any specific suggestions.
    (Response 31) Unlike calorie declarations in or on the vending
machine, calorie declarations on signs adjacent to a vending machine
are not accompanied, or otherwise surrounded by, pre-existing text or
colors to which we could link the requirements. We note however that
section 403(q)(5)(H)(viii) of the FD&C Act requires that calorie
declarations be clear and conspicuous, and the requirement that the
calorie declarations be clear and conspicuous also is codified in Sec.
101.8(c)(2)(i). Further, section 403(f) of the FD&C Act requires, in
relevant part, that any word,

statement, or other information required by or under the FD&C Act to
appear in the labeling of food be prominently placed thereon with such
conspicuousness and in such terms as to render it likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use. Thus, we conclude that a calorie declaration on a
sign adjacent to a vending machine must be in a type size large enough
to render it likely to be read and understood by the prospective
purchaser under customary conditions of purchase and use, and we have
revised Sec.  101.8(c)(2)(ii)(C) accordingly. In addition, as discussed
in response 28, we have modified Sec.  101.8(c)(2)(ii)(A) to specify
that calorie declarations on signs adjacent to vending machines must be
visible at the same time as the food, its name, price, selection
button, or selection number is visible.
    On our own initiative, we have revised Sec.  101.8(c)(2)(ii)(C) to
replace the reference to calorie ``information'' with calorie
``declaration'' to be consistent with the rest of the final rule.
    ix. Vending machines displaying a picture or other representation
of food.
    Proposed Sec.  101.8(c)(2)(ii)(D) would require that, where the
vending machine only displays a vignette or name of the food item, the
calorie information must be in close proximity to the vignette or name
or in close proximity to the selection button (76 FR 19238 at 19254).
    We received no comments on this provision. However, on our own
initiative, we have revised Sec.  101.8(c)(2)(ii)(D) by inserting the
words ``picture or other representation'' in place of ``vignette'' for
plain language purposes, and by replacing the reference to calorie
``information'' with calorie ``declaration'' to be consistent with the
rest of the final rule.
    x. Electronic vending machines.
    Proposed Sec.  101.8(c)(2)(ii)(E) would require that, for
electronic vending machines (e.g., machines with digital or electronic
or liquid crystal display (LCD) displays), the calorie information may
be displayed when the selection numbers are entered but before the
selection is confirmed.
    (Comment 32) Some comments supported proposed Sec.
101.8(c)(2)(ii)(E) and stated that such electronic or LCD displays meet
the requirements of section 403(q)(5)(H)(viii) of the FD&C Act. One
comment stated that some electronic displays allow the consumer to view
the full Nutrition Facts Panel and rotate a virtual image of the
product, or otherwise allow consumers to compare the Nutrition Facts of
two products side by side.
    Many comments opposed or would delete proposed Sec.
101.8(c)(2)(ii)(E). Several comments noted that electronic displays
would show calorie declarations for just one food item at a time. A few
comments said that calorie declarations for all food items must be
available to consumers at the same time before selection of an item so
that consumers can compare calorie declarations for items
simultaneously. Otherwise, the comments argued, consumers would have to
keep track of the calorie declarations for each item until they made a
final selection.
    One comment said that care should be taken in using the term
``purchaser,'' which the comment considered to be the person paying for
the item. The comment said that the purchaser could be at a different
location from the ``user'' of the vending machine. For example, some
vending machines allow a ``purchaser'' to pay for a vended item in one
location while a ``user'' obtains the vended item in another location.
This comment also suggested adding a new provision for clarity to read
as follows: ``For vending machines retrofitted with digital or
electronic or liquid crystal display (LCD) displays, the calorie
information may be displayed at the user's request before the purchase
is confirmed by entering a selection ID, selecting a product image,
searching by name, or filtering product based on specific criteria.''
The comment did not explain why the new provision would focus on
retrofitted vending machines.
    (Response 32) We disagree with the comments asserting that
electronic vending machines cannot meet the requirements of section
403(q)(5)(H)(viii) of the FD&C Act because electronic vending machines
might be able to display calorie information for only one food item at
a time. First, we note that electronic vending machines that provide
calorie declarations in close proximity to vending machine foods or
their selection buttons would comply with the calorie declaration
requirements in section 403(q)(5)(H)(viii) of the FD&C Act, provided
that such calorie declarations otherwise comply with section 403(a)(1)
and (f) of the FD&C Act and Sec.  101.8. Second, we understand that
electronic vending machines have varying capabilities, and so to
provide flexibility for vending machine operators to satisfy the
requirements of section 403(q)(5)(H)(viii) of the FD&C Act, we are not
requiring calorie declarations for electronic vending machines to be
rendered simultaneously, although some electronic vending machines may
have this capability. An electronic display that provides calorie
declarations for one food at a time, allowing the prospective purchaser
to cancel his or her initial selection, and then select other items in
order to obtain the calorie declaration for each of them would
constitute ``a sign in close proximity to each article of food or the
selection button . . . disclosing the number of calories contained in
the article,'' as required by section 403(q)(5)(H)(viii) of the FD&C
Act. We therefore conclude that electronic vending machines may satisfy
the calorie labeling requirements of section 403(q)(5)(H)(viii) of the
FD&C Act.
    However, to further ensure that the prospective purchaser is able
to view the calorie declaration before making a purchase, we have
revised Sec.  101.8(c)(2)(ii)(E) on our own initiative to replace the
proposed language with language stating that the calorie declaration
must be displayed before the prospective purchaser makes his or her
purchase.
    As discussed in response 13, we also note that an electronic
reproduction of the Nutrition Facts label could be one way that a
vending machine could permit a prospective purchaser to examine the
Nutrition Facts Panel for an article of food to satisfy section
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act. Therefore, we have revised
Sec.  101.8(b)(2) by adding a new paragraph (b)(2)(ii) pertaining to
electronic reproductions of the Nutrition Facts label.
    We decline to adopt the comment's suggestion that we revise the
final rule to distinguish between a vending machine ``user'' and
``purchaser.'' Section 403(q)(5)(H)(viii) of the FD&C Act uses the term
``prospective purchaser'' and does not make a distinction between a
``prospective purchaser'' and a vending machine ``user.'' Accordingly,
we decline to make such a distinction in the final rule.
    We also decline to adopt the comment's suggested language regarding
``retrofitted'' vending machines and the manner in which calorie
information may be displayed. Section 403(q)(5)(H)(viii) of the FD&C
Act does not address retrofitting of vending machines with digital,
electronic, or other displays, and does not distinguish between
retrofitted vending machines with such displays and other vending
machines. We also note that the comment's suggested language, ``may be
displayed at the user's request,'' would make the display of calorie
information discretionary, and such a result would be inconsistent with
the statutory requirement of section 403(q)(5)(H)(viii) of the FD&C Act
that a covered vending machine operator provide a sign

disclosing the number of calories contained in a covered vending
machine food.
    xi. Vending machines with limited choices.
    Proposed Sec.  101.8(c)(2)(ii)(F) would provide that for vending
machines with limited choices, such as vending machines that dispense
only popcorn, the declaration of calories may appear on the face of the
machine so long as the declaration is prominent, not crowded by other
labeling on the machine, and the type size is reasonably related to the
largest print on the vending machine.
    We received no comments on this provision. However, as described in
response 16 of this preamble, we revised Sec.  101.8(b)(2)(i), in
response to comments regarding type size and prominence of the visible
nutrition information on the label of the food, to replace the words
``reasonably related'' with ``at least 50 percent of the size of the
largest print on the label.'' For consistency with our edit to Sec.
101.8(b)(2)(i) and to provide additional clarity, we are revising Sec.
101.8(c)(2)(ii)(F). We considered whether to replace ``reasonably
related to the largest print on the vending machine'' with ``at least
50 percent of the size of the largest print on the vending machine.''
However, we note that unlike Sec.  101.8(b)(2)(i), where we are
establishing a type size requirement based on other printed material on
the label of a package of food, here we are establishing a type size
requirement based on other printed material on the vending machine
itself. Given the comparatively large surface area of vending machines,
we are not requiring that the calorie declaration be 50 percent of the
size of the largest print on the face of the vending machine, as the
largest print could potentially be very large. Instead, Sec.
101.8(c)(2)(ii)(F), as finalized, provides that for vending machines
with limited choices, the declaration of calories may appear on the
face of the machine so long as the declaration is prominent, not
crowded by other labeling on the machine, and the type size is no
smaller than the name of the food on the machine (not the label),
selection number, or price of the food as displayed on the vending
machine, whichever is smallest.
5. Voluntary Registration To Provide Calorie Labeling for Foods Sold
From Vending Machines
    Proposed Sec.  101.8(d) would provide that a vending machine
operator that is not subject to section 403(q)(5)(H)(viii) of the FD&C
Act may voluntarily register with FDA to be subject to the calorie
labeling requirements established in Sec.  101.8(c)(2). Proposed Sec.
101.8(d)(1) and (d)(2) would describe the applicability of the
voluntary registration provision and who may register. Proposed Sec.
101.8(d)(3)(i) through (d)(3)(iv) would list the information that a
vending machine operator would be required to provide to FDA (i.e.,
contact information for the vending machine operator, address of the
location of each vending machine, preferred mailing address,
certification of the information submitted) in order to register
voluntarily. Proposed Sec.  101.8(d)(3)(v) and (d)(3)(vi) also would
describe the mechanism for submission of the information by email, fax,
mail, or online form. Finally, proposed Sec.  101.8(d)(3)(vii) would
require re-registration every other year within 60 days prior to the
expiration of the vending machine operator's current registration with
FDA.
    We received comments asking us to expand the voluntary database to
require registration of all operators of covered vending machines, and
we will address those comments in section III.C.6 of this preamble. We
received no other comments on proposed Sec.  101.8(d). However, on our
own initiative, we have revised Sec.  101.8(d) to clarify that the
vending machine operator, rather than its authorized official, becomes
subject to the requirements of section 403(q)(5)(H)(viii) of the FD&C
Act through voluntary registration, even if the authorized official
voluntarily registered on the vending machine operator's behalf. Also,
for completeness, we have added ``.gov'' to the end of the email
address provided for voluntary registration under Sec.  101.8(d). The
complete email address now reads<EMAIL_ADDRESS>6. Vending Machine Operator Contact Information
    (Comment 33) Some comments said we should develop a database of
covered vending machine operators and those who have elected to comply
voluntarily with section 403(q)(5)(H)(viii) of the FD&C Act. The
comments stated that the database could enable state and local
inspectors to determine which vending machines are subject to the
calorie declaration requirements of section 403(q)(5)(H)(viii) of the
FD&C Act.
    Another comment suggested that, to help with enforcement, we could
expand the voluntary registry in Sec.  101.8(d) to require all
operators of covered vending machines to provide FDA with their names,
contact information, and number and location of vending machines. The
comment stated that we could share this information with States and
localities that enforce local calorie labeling laws. As an alternative,
the comment suggested that we require vending machine operators to post
this information (name, contact information, etc.) on the front of each
vending machine.
    (Response 33) The final rule, at Sec.  101.8(e)(1) and (e)(2), adds
a requirement for vending machine operators to post their contact
information for vending machines selling covered vending machine food.
(We have renumbered proposed Sec.  101.8(e), which dealt with the topic
of signatures, as Sec.  101.8(f) in the final rule). As indicated by a
comment, such a requirement is necessary for efficient enforcement of
section 403(q)(5)(H)(viii) of the FD&C Act because it enables FDA to
contact vending machine operators for enforcement purposes. Without
such a requirement, we would not be able to contact vending machine
operators subject to the requirements of section 403(q)(5)(H)(viii) of
the FD&C Act because such contact information would not always be
readily available to the Agency. Section 101.8(e)(1) specifies that the
contact information must list the vending machine operator's name,
telephone number, and mailing address or email address.
    Section 101.8(e)(2) specifies that the contact information must be
readable and may be placed on the face of the vending machine, or
otherwise must be placed with the calorie declarations described in
Sec.  101.8(c)(2)(ii) (i.e., on the sign in, on, or adjacent to the
vending machine). We are providing flexibility to vending machine
operators regarding where they can display the contact information. We
note that some States have licensing requirements for vending machine
operators, and some of these licensing requirements already require the
vending machine operator's license or contact information to be
displayed on the vending machine. If the contact information displayed
on a vending machine due to State or local requirements includes some
but not all of the contact information required under Sec.
101.8(e)(1), the vending machine operator must display the remaining
contact information required under Sec.  101.8(e)(1) in the manner
specified under Sec.  101.8(e)(2). In other words, rather than
requiring the vending machine operator to display contact information
twice, we are providing flexibility by allowing vending machine
operators to display the remaining contact information in a manner
permitted in Sec.  101.8(e)(2). For example, if a vending machine
operator is required to display its name and address

on the face of a vending machine under an applicable State or local
requirement and the operator complied with such requirement, the
operator could display the remaining contact information required under
Sec.  101.8(e)(1) (i.e., its phone number) on the face of the vending
machine or on the sign listing calorie declarations in, on, or adjacent
to the vending machine in order to comply with Sec.  101.8(e).
Regardless of the method that vending machine operators select to
satisfy the requirements of Sec.  101.8(e), they should ensure that the
information being provided is their contact information.
    As for the comments requesting that all vending machine operators
(including those who are subject to section 403(q)(5)(H)(viii) of the
FD&C Act and those who voluntarily register to be subject to section
403(q)(5)(H)(viii) of the FD&C Act) register with FDA, we decline to
establish such a database at this time. We believe it would be more
practical to wait until we and vending machine operators have been able
to implement the vending machine labeling requirements and see what
issues arise as part of that implementation.
7. Signatures
    Proposed Sec.  101.8(e) would provide that signatures obtained
under the voluntary registration provisions that meet the definition of
electronic signatures in Sec.  11.3(b)(7) are exempt from the
requirements of part 11.
    The preamble to the proposed rule indicated that we expect this
exemption for signatures to facilitate the voluntary registration
process (76 FR 19238 at 19245).
    We received no comments on this provision, however because we have
added a new Sec.  101.8(e) (contact information of vending machine
operators for vending machines selling covered vending machine food),
we have renumbered this provision as Sec.  101.8(f).

D. Determination of Calorie Content

    Section 403(q)(5)(H)(viii) of the FD&C Act does not prescribe where
or how covered vending machine operators must obtain the necessary
calorie information to meet the calorie declaration requirements for
covered vending machine foods. If a covered vending machine food does
not bear Nutrition Facts, we anticipated in the preamble to the
proposed rule, that the vending machine operator could obtain the
calorie information from food manufacturers or suppliers (76 FR 19238
at 19242). We invited comment on whether ``a vending machine operator
may use nutrient databases, cookbooks, laboratory analyses, and other
reasonable means'' if calorie information is not available from the
food manufacturer or supplier (Id.). We also invited comment on
``whether vending machine operators should be required to provide FDA
the information on which they relied to determine the total calories
posted for the vending machine food'' (76 FR 19238 at 19242).
    (Comment 34) One comment supported allowing covered vending machine
operators to use nutrient databases and cookbooks as tools for
determining calorie information if calorie information is not available
from the food manufacturer or supplier. The comment also suggested
allowing menus as a tool for determining calorie information. Further,
the comment said that we should not require vending machine operators
to give FDA the method or information on which the vending machine
operators relied to determine the total calories posted for the vending
machine food. The comment said that such a requirement would be an
economic burden both for the vending machine operator to provide such
information and for FDA to collect, record, and store such information.
Another comment suggested that FDA require covered vending machine
operators to have a reasonable basis for calorie declarations for
vending machine foods, in accordance with the reasonable basis
provision for nutrition labeling for standard menu items offered for
sale in restaurants and similar retail food establishments in section
403(q)(5)(H)(iv) of the FD&C Act.
    (Response 34) We agree with the comments supporting the use of
nutrient databases and cookbooks to determine the total calories
contained in a covered vending machine food. A vending machine operator
may obtain the necessary calorie information from the food package's
Nutrition Facts label, the manufacturer or supplier of the food,
nutrient databases, cookbooks, or laboratory analyses. We anticipate
that, for most packaged foods, the vending machine operator will use
the food package's Nutrition Facts label to determine calorie
information for the food.
    Menus likely would not be a reliable means of determining the
calorie information for a vending machine food, because the
ingredients, portion size, and method of preparing a food listed on a
menu may differ from those used for a food sold from a vending machine.
Such differences may result in a calorie declaration for a food listed
on a menu that does not accurately reflect the calorie content of the
same food sold from a vending machine. We recognize, however, that
compliance ultimately is based on the accuracy of the declaration
rather than just the method used to determine the calorie information.
    We anticipate that vending machine operators are likely to generate
and maintain a record of the information on which they relied to
determine the total calories posted for the vending machine food. We
encourage vending machine operators to be prepared to share it with FDA
upon our request during an inspection if we need to determine whether
the calories declarations, posted by a vending machine operator under
Sec.  101.8(c), are truthful and not misleading.
    We disagree with the comment suggesting that we apply the
reasonable basis provision in section 403(q)(5)(H)(vi) of the FD&C Act
to covered vending machine food. The reasonable basis requirement in
section 403(q)(5)(H)(vi) of the FD&C Act applies only to restaurants
and similar retail food establishments covered by the requirements of
section 403(q)(5)(H) of the FD&C Act, and does not apply to covered
vending machine food. We note that covered vending machine operators
must ensure that calorie declarations are truthful and not misleading
under section 403(a)(1) of the FD&C Act, and otherwise comply with
section 403(q)(5)(H)(viii) and (f) of the FD&C Act and Sec.  101.8.

E. Effective Date

    The preamble to the proposed rule indicated that a final rule would
become effective 1 year from the date of publication of the final rule
in the Federal Register (76 FR 19238 at 19245).
    (Comment 35) Many comments suggested that FDA make the final rule
effective 6 months after its publication. Noting that we proposed a 6-
month effective date in the proposed rule pertaining to nutrition
labeling of standard menu items in restaurants and similar retail food
establishments, the comments argued that labeling foods sold in vending
machines with calorie information would be even less burdensome than
restaurant menu labeling because a vending machine operator could
simply post stickers listing calories to meet the requirements. The
comments asserted that vending machine operators should be able to
comply with the calorie labeling requirements within the same timeframe
that we proposed in the proposed rule for nutrition labeling of
standard menu items in restaurants and

similar retail food establishments (76 FR 19192).
    Other comments--many from vending machine trade associations--
requested a minimum of 2 years to come into compliance. The comments
claimed that 1 year was not sufficient time to come into compliance
because more than 70 percent of vending machine operators have three or
fewer employees. Some comments said that because vending machine
operators may have few employees, placing calorie declarations for all
of their vending machines would be costly and time-consuming.
    A few comments asserted that a 2-year effective date is needed due
to a lengthy design and test process for new vending machines, and to
establish a relationship between vending machine operators and food
manufacturers in order to develop ``verification procedures'' which
typically do not exist at the present time. The comments did not
explain what they meant by ``verification procedures.''
    Another comment suggested a phased-in implementation period to give
vending machine operators a longer time to meet the calorie declaration
requirements. The comment did not state how long the phased-in
implementation period should be.
    A few comments said we should follow the same approach that we have
taken historically for other food labeling changes and cited FDA's
uniform compliance date policy for food labeling regulations. The
comments stated that the uniform compliance date for food labeling
regulations issued between January 1, 2011, and December 31, 2012, is
January 1, 2014 (75 FR 78155 (December 15, 2010)), and we should,
therefore, impose an effective date of January 1, 2014, assuming the
final rule publishes before December 31, 2012.
    (Response 35) We recognize that vending machine operators may have
few employees and resources. We also understand that vending machine
manufacturers and food manufacturers are continuing to design new
products, and that vending machine operators may wish to work with
vending machine manufacturers and food manufacturers to develop ways to
comply with section 403(q)(5)(H)(viii) of the FD&C Act. We are also
taking into consideration FDA's 2012 final rule (77 FR 70885, November
28, 2012), which establishes January 1, 2016, as the next uniform
compliance date for food labeling changes required by food labeling
regulations that are issued between January 1, 2013, and December 31,
2014. Because vending machine operators may display the Nutrition Facts
label or other visible nutrition information in order to satisfy Sec.
101.8(b), it would be helpful for vending machine operators to see any
changes that manufacturers may make to the labels of packaged foods
which may be timed in accordance with the next uniform compliance date.
For these reasons, we are revising the effective date of the final rule
to 2 years from the date of its publication in the Federal Register,
which will be after the January 1, 2016 uniform compliance date. All
covered vending machine operators must come into compliance with the
requirements of this rule no later than 2 years after the date of its
publication.

F. Enforcement

    (Comment 36) Some comments said we should devise a reporting
mechanism for individuals to report possible violations of section
403(q)(5)(H)(viii) of the FD&C Act and a regime of penalties for
confirmed violations. These comments also suggested that we develop a
protocol for checking the accuracy of the calorie information provided
by covered vending machine operators.
    (Response 36) We decline to establish a reporting mechanism for
individuals to report possible violations of section 403(q)(5)(H)(viii)
of the FD&C Act or the final rule. FDA's regulations already provide
individuals with mechanisms to communicate with the Agency. If an
individual finds that the calorie declaration for an article of food
sold from a vending machine is incorrect, he or she can contact FDA by
calling the FDA complaint coordinator for their region (http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm).
    As for the comments' suggestion regarding penalties, penalties are
already set forth in the FD&C Act. We are establishing these
regulations under sections 201(n), 403(a)(1), (f), (q)(5)(H), and
701(a) of the FD&C Act. Therefore, we note that failure to comply with
the regulations will render the covered vending machine food misbranded
under section 403(a), (f), or (q) of the FD&C Act. Violations of Sec.
101.8 may result in enforcement action. For example, introducing,
delivering for introduction, or receiving a misbranded food in or into
interstate commerce, or misbranding a food while it is in interstate
commerce or being held for sale after shipment in interstate commerce,
are prohibited acts under section 301 of the FD&C Act (21 U.S.C. 331),
carrying criminal penalties under section 303 of the FD&C Act (21
U.S.C. 333). In addition, under section 302 of the FD&C Act (21 U.S.C.
332), the United States can bring a civil action in Federal court to
enjoin a person who commits a prohibited act. Under section 304(a)(1)
of the FD&C Act (21 U.S.C. 334(a)(1)), food that is misbranded when
introduced into or while in interstate commerce or while held for sale
after shipment in interstate commerce may be seized by order of a
Federal court.
    With respect to the comments suggesting that we develop a protocol
to check the accuracy of calorie information, we intend to develop an
enforcement strategy as we gain more experience with the final rule.
For example, we could first check to ensure that the calorie
declaration provided by a covered vending machine operator matches the
calorie information on the article of food from the food manufacturer
or supplier, such as on the Nutrition Facts label. We could also use
lab analyses to determine whether the calorie declaration for a given
vending machine food is accurate.
    (Comment 37) Another comment asked us to provide training,
guidance, and funding to State and local inspectors to facilitate
enforcement.
    (Response 37) The final rule does not become effective until
December 1, 2016. During that period we will assess resources and
consider conducting training or further outreach as necessary.

IV. Analysis of Impacts--Final Regulatory Impact Analysis

    FDA has examined the impacts of this final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4). Executive Orders 12866 and 13563 direct Agencies to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). We have developed a detailed Regulatory Impact Analysis (RIA)
that presents the benefits and costs of this final rule (Ref. 1) which
is available at http://www.regulations.gov (enter Docket No. FDA-2011-
F-0171). The full economic impact analyses of FDA regulations are no
longer (as of April 2012) published in the Federal Register but are
submitted to the docket and are available at http://www.regulations.gov. We also post the full economic impact analyses of
FDA regulations at the following Web site: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

We believe that the final rule is an economically significant
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. According to our analysis, we believe that the final
rule will have a significant economic impact on a substantial number of
small entities, and we have accordingly analyzed regulatory options
that would minimize the economic impact of the rule on small entities
consistent with statutory objectives. We have crafted the final rule to
provide flexibility for compliance.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
    The analyses that we have performed to examine the impacts of this
final rule under Executive Order 12866, Executive Order 13563, the
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of
1995 are included in the RIA (Ref. 1).
    We had prepared a ``Preliminary Regulatory Impact Analysis'' (Ref.
2) in connection with the proposed rule. We also included sections
titled ``Summary Preliminary Regulatory Impact Analysis'' and ``Initial
Regulatory Flexibility Analysis'' in the preamble to the proposed rule
(76 FR 19238 at 19245-19249). We received comments on our analysis of
the impacts presented in those sections, and the RIA (Ref. 1) contains
our responses to those comments.

V. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by OMB under the Paperwork Reduction Act of 1995 (the
PRA) (44 U.S.C. 3501-3520). A description of these provisions is given
in this section of the document with estimates of the annual reporting
and third-party disclosure burden. Included in each burden estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
    We had included a section entitled ``Paperwork Reduction Act'' in
the preamble to the proposed rule (76 FR 19238 at 19249-19251). We
received the following comments on our analysis of the burdens
presented in the proposed rule.
    (Comment 38) One comment stated that we did not calculate the
burdens to the suppliers of vending machine food. The comment stated
that these suppliers will bear the larger burden from the requirements
of the final rule.
    (Response 38) Neither section 403(q)(5)(H)(viii) of the FD&C Act
nor the final rule applies to suppliers of vending machine food;
instead, section 403(q)(5)(H)(viii) of the FD&C Act and the final rule
establish requirements for certain vending machine operators. We
recognize that a supplier of covered vending machine food may provide
calorie information on front-of-package labeling and such calorie
information may constitute visible nutrition information in accordance
with section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act provided that
the applicable requirements of Sec.  101.8(b) are satisfied. However,
neither section 403(q)(5)(H)(viii) of the FD&C Act nor the final rule
requires suppliers to provide such information. As such, the final rule
does not impose burdens on suppliers of vending machine food.
    (Comment 39) One comment stated that posting calories would not be
burdensome, as most foods sold in vending machines already provide
calorie information on their Nutrition Facts labels, and for foods that
do not already have calorie information, labeling to disclose calories
can be accomplished easily by using stickers. Another comment stated
that, in light of the major beverage companies' prior commitment to
putting calorie information on selection buttons, we should reduce our
burden estimate.
    (Response 39) To the extent that foods sold from covered vending
machines permit a prospective purchaser to examine the Nutrition Facts
label before purchasing the food or otherwise provide visible nutrition
information at the point of purchase in accordance with section
403(q)(5)(H)(viii) of the FD&C Act and Sec.  101.8(b), the vending
machine operator would not be required to provide calorie declarations
for such foods. In addition, we recognize that the ``Clear on
Calories'' commitment by the American Beverage Association, which
includes a pledge that calories will be displayed on selection buttons
of ``company-controlled vending machines,'' may be consistent with the
calorie declaration requirements of section 403(q)(5)(H)(viii) of the
FD&C Act. Our estimates of the burdens already account for the fact
that many vending machine foods will not require additional nutrition
analysis under this final rule. For example, we estimate in the RIA
that only 723 to 963 covered vending machine operators will need to
acquire nutrition information for at least some of their vending
machine food (Ref. 1).
    Our estimate of the burdens and cost of nutrition analysis also
takes into consideration that vending machine operators can comply with
the requirements of the final rule by providing calorie declarations
through less burdensome and less expensive means (e.g., a poster
affixed to the front of the machine could cost, on average, $20 per
machine per year) (Ref. 1). The final rule does not prescribe the types
of materials through which calories must be declared, and a sticker,
for example, could be an appropriate medium to convey a required
calorie declaration.
    (Comment 40) One comment stated that our estimate on how frequently
labeling would need to change is too low. The comment stated that in
almost all cases, machines are restocked and serviced every 5 weeks,
with busier locations stocked once or more per week. The comment stated
that the restocking will require labeling changes because restocking
may result in the substitution of certain products for other products
or the addition of new products. The comment stated that relabeling
would need to occur between 10 and 17 times per year for each machine,
with some machines requiring partial relabeling at least 50 times per
year.
    (Response 40) In the preliminary RIA, we estimated an average
recurring burden of between 5 and 15 minutes per vending machine per
year to install or refresh the calorie displays. We said that signs
would not always need to be updated every time a machine's product mix
(i.e., the assortment of vending machine foods offered for sale in a
vending machine at a particular time) changed.
    We recognize that the product mix in a particular vending machine
may change with each restocking. For each machine, the rule requires
operators to declare the calorie information for those articles of food
that are sold from that particular vending machine. However, we would
not object to a vending machine operator providing calorie

declarations for articles of food that are typically offered for sale
in a vending machine but may not be offered for sale at all times (for
example, in cases where the article sells out, or is temporarily
replaced by another item), provided that the calorie declarations are
clear and conspicuous and placed prominently. Thus, signs would not
always need to be updated every time a machine's product mix changed,
so long as the sign declares the calories for each article of food sold
from the covered vending machine. For example, if a particular article
of food is sold out, the vending machine operator would not need to
design and print a new sign to remove the calorie declaration for such
food. In addition, to the extent that foods sold from covered vending
machines permit a prospective purchaser to examine the Nutrition Facts
label before purchasing the food or otherwise provide visible nutrition
information at the point of purchase in accordance with section
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act and Sec.  101.8(b), the
vending machine operator would not be required to provide calorie
declarations for such foods. Therefore, restocking of covered vending
machines that sell such foods would not require the vending machine
operator to update signs. Furthermore, in order to accommodate the
occasional trial or experimental product, the sign template could, for
example, be designed with blank space, on which the operator could
handwrite the experimental product's name and caloric value, or place a
declarative sticker next to the new product within the machine (should
it have a glass/plexiglass front). The comment provided an estimate of
the number of times a vending machine's sign would likely need to be
replaced, or 10 to 17 times. We estimate that in accordance to the
factors described in the earlier paragraphs of this response, calorie
declaration signs would only need to be replaced between 1 and 4 times
per year (or even zero for some products). This estimate also takes
into consideration that vending machine operators have the flexibility
to choose a medium (e.g., stickers, posters) and a format (e.g.,
individual signs per covered vending machine food; sign(s) in, on, or
adjacent to the vending machine) for the calorie declaration that will
make the most sense for a particular vending machine operator depending
on the variability of products that the operator carries and the
frequency of restocking.
    We invite 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.

Title: Information Collection Provisions of the Final Rule on Food
Labeling; Calorie Labeling of Articles of Food in Vending Machines

A. Reporting Requirements

Description of Respondents
    The likely respondents to this information collection are vending
machine operators that voluntarily elect to be subject to the Federal
requirements of this rule by registering with FDA.
Description
    Vending machine operators not subject to the requirements of the
ACA may elect to be subject to the Federal requirements by registering
with FDA. Vending machine operators that voluntarily register must
provide FDA with their contact information, the address of the location
of each vending machine owned or operated by the vending machine
operator that is being registered, the preferred mailing address (if
different from the vending machine operator address) for purposes of
receiving correspondence, and certification that the information
submitted is true and accurate, that the person or firm submitting it
is authorized to do so, and that each registered vending machine will
be subject to the requirements of Sec.  101.8. In the proposed rule,
the total reporting burden included both the reporting burden for menu
labeling and vending machine operator voluntary registration (see 76 FR
19238 and 19251). For the final rule, these burdens are estimated
separately for each rule. To keep the establishment's registration
active, the authorized official of the vending machine operator must
register every other year within 60 days prior to the expiration of the
vending machine operator's current registration with FDA. Registration
will automatically expire if not renewed.
    Vending machine operators that have voluntarily registered to
become subject to the Federal requirements must satisfy the calorie
labeling requirements of section 403(q)(5)(H)(viii) of the FD&C Act and
Sec.  101.8(c). We further note that an article of food sold from a
vending machine operator who has voluntarily registered with FDA to be
subject to the requirements of section 403(q)(5)(H)(viii) of the FD&C
Act is not required to provide calorie declarations for articles of
food sold from a vending machine that permits the prospective purchaser
to examine the Nutrition Facts label before purchasing the article as
provided in Sec.  101.8(b)(1), or otherwise provides visible nutrition
information at the point of purchase as provided in Sec.  101.8(b)(2).

                     Table 1--Estimated Annual Reporting Burden: Voluntary Registration \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
        21 CFR part 101            Number of     responses per   Total annual     per response     Total hours
                                  respondents     respondent       responses       (in hours)
----------------------------------------------------------------------------------------------------------------
Initial Burden (annualized
 over 3 years):
    Sec.   101.8(d) Initial                 13               1              13              2               26
     Registration.............
Annual Burden:
    Sec.   101.8(d)                         19               1              19          \2\ 0.5              9.5
     Registration Renewal.....
                               ---------------------------------------------------------------------------------
        Total Burden Hours....  ..............  ..............  ..............  ...............             35.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ 30 minutes.

    We lack data on the number of vending machine operators with fewer
than 20 machines that might voluntarily register to comply with this
final rule. We do not expect the net benefit for voluntary registration
by any non-covered vending machine operators to be positive and in the
RIA (Ref. 1) we indicate that as of the conducting of this analysis, no
vending machine operators have voluntarily registered with FDA.
Therefore we did not estimate a significant burden in the RIA (Ref. 1).
However, in the event that a few will register anyway, or find some
positive incentive to do so, for the purposes of this PRA analysis, we
estimate the burden such operators will face. We estimate there are
approximately 757 vending machine operators with fewer than 20
machines; this number is based on the mean estimate of the low and high
counts of firms with less than $50,000 in annual revenue from the RIA
(Ref. 1). We estimate that 5 percent of vending machine operators with
fewer than 20 machines may voluntarily register to become subject to
the final requirements, or 38 operators. We estimate a burden of
approximately 2 hours per initial registration, which yields a total
burden of 76 hours (38 total operators x 2 hours per response).
Annualizing this number over 3 years yields a rounded 13 respondents
per year (5 percent x 757 operators/3 years). With an annualized
estimate of 13 vending machine operators and one registration per
vending machine operator at 2 hours per registration, we estimate the
initial hourly burden for these operators is 26 hours.
    We expect that renewal registrations after the first year will
require substantially less time because operators are expected to be
able to affirm or update the existing information in an online account
in a way similar to other FDA firm registration systems. Therefore, we
estimate that re-registration will take 0.5 hours for each registrant.
This would indicate that biennial registration would impose a burden of
19 hours (38 operators x 0.5 hours) every 2 years, or 9.5 hours every
year (18 operators every year x 0.5 hours).

B. Recordkeeping Requirements

    The preamble to the proposed rule (76 FR 19238 at 19249-19251)
provided an estimate of the recordkeeping burden, which consisted of
the burden associated with calorie analysis and the burden associated
with generating, providing, or maintaining records. Upon further
consideration, we have omitted the burden estimate associated with
generating, providing, or maintaining records previously provided in
table 3 of the proposed rule because the rule does not require vending
machine operators to generate, provide, or maintain records. Further,
as discussed in section C of this analysis, we have included a burden
estimate for calorie analysis as part of the third party disclosure
burden, since the ``total time, effort, or financial resources expended
by [covered vending machine operators]'' (5 CFR 1320.3(b)) to declare
calories for covered vending machine food likely includes time, effort,
or financial resources to determine the calorie content of such food.

C. Third-Party Disclosure Requirements

Description of Respondents
    The likely respondents to this information collection are vending
machine operators that are subject to the ACA's requirements and those
that choose to voluntarily register to comply with the disclosure
requirements.
Description
    We calculate two types of third party disclosure burdens under the
rule. The first burden is the time and effort expended by vending
machine operators to determine the calorie content of covered vending
machine food for the required calorie declarations, which we refer to
as ``Calorie Analysis.''
    Vending machine operators must also provide calorie declarations
for covered vending machine foods on signs in, on, or adjacent to
vending machines. The second burden is the cost of materials and the
time expended by vending machine operators to physically produce and
install the signs for the calorie declarations, which we refer to as
``Calorie Declaration Signs.'' We estimate the burden of signage for
non-bulk and bulk vending machines separately. We provide our estimates
of the third party disclosure burdens in table 2.

                                                         Table 2--Third Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Number of
            21 CFR part 101                Number of      disclosures    Total annual    Average burden per  disclosure     Total hours    Capital costs
                                          respondents   per respondent    disclosures              (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i), Calorie                     282              11           3,102  1...............................           3,102  ..............
 Analysis.
Sec.   101.8(c)(2)(ii), Template                 3,279               5          16,395  2...............................          32,790  ..............
 Design.
Sec.   101.8(c)(2)(ii), Sign Creation.           3,279             125         409,875  0.475 (28.5 min.)...............         194,710      $4,671,047
Sec.   101.8(e)(1), Contact                      3,279             125         409,875  0.025 (1.5 min.)................          10,248  ..............
 Information.
Sec.   101.8(c)(2)(ii), Sign                 1,868,419               1       1,868,419  0.083 (5 min.)..................         155,079  ..............
 Installation.
Sec.   101.8(c)(2)(ii), Sign                   511,576               2       1,023,152  0.5 (30 min.)...................         511,576  ..............
 Information Update.
Sec.   101.8(c)(2)(ii), Sign                 1,755,986               2       3,511,972  0.17 (10 min.)..................         597,035  ..............
 Replacement.
Sec.   101.8(c)(2)(ii), Bulk Machine           128,533               1         128,533  0.025 (1.5 min.)................           3,213  ..............
 Signage.
                                       ------------------------------------------------                                  -------------------------------
    Total Burden......................  ..............  ..............  ..............  ................................       1,507,753       4,671,047
--------------------------------------------------------------------------------------------------------------------------------------------------------

Third-Party Disclosure Requirements: Calorie Analysis
    A calorie analysis entails the burden of determining calorie
content for covered vending machine food. Most foods sold from vending
machines provide the nutrition labeling required by section 403(q) of
the FD&C Act and Sec.  101.9, including calorie content information,
which means that calorie content for many covered vending machine foods
is already available on the Nutrition Facts labels for such foods. In
that case, vending machine operators will not need to determine the
calorie content of such foods because they can simply declare the
calorie information they find on the Nutrition Facts label.
Nevertheless, some operators may need to determine calorie information
for those vending machine foods that may not bear Nutrition Facts
labels or otherwise provide visible nutrition information at the point
of purchase in

accordance with section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act and
Sec.  101.8(b). An operator may obtain the necessary calorie
information from nutrient databases, cookbooks, or laboratory analyses.
Calorie analysis will most likely only be needed for vended food items
such as refrigerated, frozen, can/bowl, or other shelf-stable main meal
items, hot cup beverages, and cold cup beverages. We anticipate that
vending machine operators are likely to generate and maintain a record
of the information on which they relied to determine the total calories
posted for the vending machine food.
    As stated in the RIA (Ref. 1), we estimate the mean number of
vending machine operators that need calorie analysis to be 847.
Annualizing this estimate over 3 years yields 282 operators. We also
estimate the range of products available in a typical machine for each
of the three most commonly sold product categories that are likely to
require a calorie analysis, or 3 percent of food items, 5 percent of
hot beverages, and 1 percent of cold cup beverages. We estimate that
food machines typically offer between 10 and 25 different items, and
both hot beverage and cold cup beverage machines typically offer
between 5 and 10 items. From this, we estimate each vending machine
operator will require a calorie analysis for 11 items, on average.
These estimates were based upon conversations with vending machine
operators (Ref. 3) and our survey of various vending machine models
that vend these types of food and beverage (Ref. 4). Based on data from
FDA's Recordkeeping Cost Model (Ref. 5), we estimate the time needed to
determine the calorie content of each covered vending machine food to
be approximately 1 hour. Our estimate for the burden hours that would
be required for new calorie analysis is then 9,317 hours (847 operators
x 11 products needing analysis x 1 hour per analysis). Annualizing this
value over 3 years yields 3,102 hours (847 operators/3 years x 11
products needing analysis x 4 hours per analysis). (847 operators/3
years = 282 operators per year.) There will not be capital costs
associated with a calorie analysis.
Third-Party Disclosure Requirements: Calorie Declaration Signs
    Under this rule, covered vending machine operators with 20 or more
vending machines and vending machine operators that voluntarily
register to become subject to the Federal requirements, must disclose
calorie information by providing calorie declaration signs in, on, or
adjacent to their vending machines to a third party who will most often
be the prospective purchaser or consumer. Our burden estimate for the
calorie declaration signs is based on the total time it takes for
vending machine operators to produce and install the calorie
declaration signs. We separately estimate the burden for two kinds of
vending machines, non-bulk and bulk machines. For non-bulk vending
machines, we estimate the burden to operators as the initial time it
takes them to develop the calorie disclosure signage, which includes
the time for the sign template design (i.e. the creation of generalized
sign templates), sign creation (i.e. using templates to design machine-
specific signs), and installation; and then the time for the recurring
burden, which includes the time to update or change calorie information
and the physical replacement of the disclosure signage when the product
mix of the machine changes. For bulk machines, we estimate the burden
to operators for the cost of individual calorie labels. (We assume that
individual calorie declaration stickers will be placed on the face of
each individual bulk vending machine, since each machine only vends a
single product.) Recurring updates to signage will only likely be
required for non-bulk, non-beverage machines since the product mixes of
these machines are changed regularly, while the product mix for bulk
machines is unlikely to change.
    We estimate there is an average of 9,838 (9,800 covered non-bulk +
38 voluntary) vending machine operators subject to the rule. (9,838/3 =
3,279 annualized). Our estimate for the average number of non-bulk
vending machines that will require declaration signage is based upon
data obtained from the Vending Times Survey and National Automatic
Merchandising Association (NAMA) and the Economic Census, and as
summarized in table 8 of the final RIA (Refs. 1, 6 to 8). We estimate
there is an average of 5.61 million non-bulk vending machines. Digital
signage is an emerging technology, and according to NAMA approximately
0.1 percent of all vending machines in operation currently have
electronic video displays capable of providing calorie information, or
approximately 4,014 to 5,670 vending machines (Ref. 3). Subtracting the
number of vending machines with the electronic video from the total
machine count yields an average of 5.611 million vending machines that
will need signage. We expect the number of vending machines that will
require signage to decline over time as manufacturers continue to add
the required calorie information to the principal display panel of the
package as part of ``front of package labeling,'' and because we
anticipate greater use of electronic video displays on vending
machines. In addition, to the extent that covered vending machines sell
foods that permit prospective purchasers to examine the Nutrition Facts
label before purchase or otherwise provide visible nutrition
information at the point of purchase in accordance with section
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act and Sec.  101.8(b), this
analysis may overestimate the burden estimate for calorie declaration
signs.
    We estimate the time it takes for the one-time design of a calorie
disclosure sign template to be 2 hours. The number of templates a given
firm would need to design to produce signs that comply with the rule
may vary based upon the number of different types of products the firm
purveys. We estimate a range of one to ten templates would be
necessary. We base this range on the eight general food and beverage
vending categories monitored by the Vending Times Census, plus two
additional templates to account for the existence of combination
machines, which vend more than one general product type (e.g. snacks
and cold canned beverages)--see table 4 of the final RIA (Refs. 1, 6).
Since not all firms will sell items from each of the general food
categories, we estimate that on average, firms will sell items from
approximately four general food categories and operate one set of
combination machines, requiring the need to develop (on average) five
templates. At 2 hours per template, the total initial burden for
designing templates comes to an estimated 98,380 hours (9,838 operators
x 5 templates x 2 hours per template). Annualizing this value over 3
years yields a burden of 32,790 hours (9,838 operators/3 years x 5
templates x 2 hours per template). There are no capital costs
associated with template design.
    We estimate the time it takes to enter calorie information into a
single sign template and prepare it for printing to be 0.475 hours.
Again, we estimate the number of machine configurations to be 125. The
count of machine configurations is a general estimate of the number of
different types of machines an operator uses to sell its products, and
takes into account that fact that a machine's specific product mix will
depend on locational characteristics (e.g. office vs. hotel) and the
type of machine (e.g. beverage vs. snack). We estimate the total
initial burden for sign creation using the predesigned templates to be
584,131

hours (9,838 operators x 125 sign formats x 0.475 hours per sign).
Annualized over 3 years, this burden becomes 194,710 hours (9,838
operators/3 years x 125 signs x 0.475 hours per sign). Capital costs
associated with sign creation correspond to the cost of paper and ink
for printing the signs. As estimated in the RIA (Ref. 1), the capital
costs are $2.50 per sign, which results in a total capital cost of
$14,013,143 [(5,604,914 covered non-bulk machines + 343 voluntarily
registered machines) x $2.50 per machine]. Annualized over 3 years,
this value becomes $4,671,048 (5,605,257 machines/3 years x $2.50 per
machine).
    Vending machine operators must also provide their contact
information on each vending machine selling covered vending machine
food as required under Sec.  101.8(e)(1). We assume that venders that
do not already have a sign or label with their contact information will
add their contact information into the initial sign design. We estimate
the time it takes to include contact information is 1.5 minutes (0.025
hours) for each sign. We estimate the total initial burden for
including contact information on the predesigned templates to be 30,744
hours (9,838 operators x 125 sign formats x 0.025 hours per sign).
Annualized over 3 years, this burden becomes 10,248 hours (9,838
operators/3 years x 125 signs x 0.025 hours per sign). There are no
capital costs associated with adding contact information. (Some States
have licensing requirements for vending machine operators, and some of
these licensing requirements already require the vending machine
operator's license or contact information to be displayed on the
vending machine. If the contact information displayed on a vending
machine due to State or local requirements includes some but not all of
the contact information required under Sec.  101.8(e)(1), the vending
machine operator is required to display the remaining contact
information required under Sec.  101.8(e)(1) in a manner specified
under Sec.  101.8(e)(1). We do not have an estimate of the number of
machines already in compliance; to the extent that some operators are
already in compliance, we overestimate the burden of third-party
disclosure.)
    We estimate the time it takes to install a sign onto a single
machine to be 5 minutes (0.083 hours) for each sign. With 5,605,257
machines (5,604,914 covered machines + 343 voluntarily registered
machines), we estimate the annual burden for initial sign installation
to be 465,236 hours (5,605,257 machines x 1 sign per machine x 0.083
hours installation). Annualized over 3 years, this burden becomes
155,079 hours (5,605,257 machines/3 years x 1 sign per machine x 0.083
hours installation). (5,605,257 machines/3 years = 1,868,419 machines
per year.) There are no capital costs associated with sign
installation.
    We divide the estimates for the recurring burden of non-bulk third-
party disclosure into two parts: Updating calorie sign information for
changes in the product mix (which involves updating the digital format)
and physical sign replacement (which involves printing and
installation). We estimate the average number of product configurations
for machines that will experience regular changes to their product mix
to be 52. This value is lower than the overall average of 125 since
some machines (such as beverage machines) do not experience regular
changes to the product mix. We estimate the average number of times
that calorie signs will need to be updated to be twice per year.
Finally, we estimate the time it takes to update a single sign using
the predesigned template to be 0.5 hours. Thus, the total burden for
updating sign information is 511,576 hours [511,576 records (made up of
9,838 operators x 52 product configurations) x 2 updates per year x 0.5
hours per update].
    We estimate the annual number of covered machines that will need
regular sign replacement to be 1,755,986 machines (1,755,879 covered
machines + 107 voluntarily registered machines). We estimate the time
it takes to remove and replace old signs with new signs to be 0.17
hours (10 minutes). Thus, the total annual burden for replacing signs
is 597,035 hours (1,755,986 machines x 2 replacements per year x 0.17
hours per replacement). There are no capital costs associated with
updating sign information or physical sign replacement.
    We estimate there is an average of 385,600 covered bulk vending
machines, based on data obtained from the Vending Times Census and NAMA
(Refs. 6, 8). We assume each bulk machine vends a single bulk product,
and we further assume they will choose the most economical signage,
which means they are likely to use a small sticker on the face of each
machine. We estimate the time to print and apply each sticker is 1.5
minutes (0.025 hours). Thus, the total burden for bulk machine signage
is 9,640 hours (385,600 bulk machines x 0.025 hours per machine).
Annualized over 3 years, this value becomes 3,213 hours (385,600/3
years x 0.025 hours per machine). (385,600/3 years) = 128,533 machines
per year.)
    To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>,
or emailed to<EMAIL_ADDRESS>All comments should be
identified with the title ``Information Collection Provisions of the
Final Rule on Food Labeling; Calorie Labeling of Articles of Food in
Vending Machines.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have resubmitted the information collection provisions of
this final rule to OMB for review, because the final rule provides an
additional modification to Sec.  101.8. These requirements will not be
effective until we obtain OMB approval. Interested persons are
requested to submit comments regarding information collection to OMB
(see DATES and ADDRESSES).
    Prior to the effective and compliance date of this final rule, we
will publish a notice in the Federal Register announcing OMB's decision
to approve, modify, or disapprove the information collection provisions
in this final rule. An Agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number.

VI. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive Order
requires Agencies to ``construe . . . a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts ``any requirement for nutrition labeling of food that is
not identical to the requirement of section 403(q) [of the FD&C Act [21
U.S.C. 343(q)]]'', except that this provision does not apply ``to food
that is offered for sale in a restaurant or similar retail food
establishment that is not part of a chain with 20 or more locations
doing business under the same name (regardless of the type of ownership
of the locations) and offering for sale substantially the same menu
items unless such restaurant or similar retail food establishment
complies with the

voluntary provision of nutrition information requirements under section
403(q)(5)(H)(ix) [of the FD&C Act]'' (21 U.S.C. 343(q)(5)(H)(ix)). The
final rule creates requirements for nutrition labeling of food under
section 403(q) of the FD&C Act that would preempt certain non-identical
State and local nutrition labeling requirements.
    Section 4205 of the ACA also included a Rule of Construction
providing that nothing in the amendments made by [section 4205] shall
be construed--(1) to preempt any provision of State or local law,
unless such provision establishes or continues into effect nutrient
content disclosures of the type required under section 403(q)(5)(H) of
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)] (as
added by subsection(b)) and is expressly preempted under subsection
(a)(4) of such section; (2) to apply to any State or local requirement
respecting a statement in the labeling of food that provides for a
warning concerning the safety of the food or component of the food; or
(3) except as provided in section 403(q)(5)(H)(ix) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)(ix)] (as added by
subsection (b)), to apply to any restaurant or similar retail food
establishment other than a restaurant or similar retail food
establishment described in section 403(q)(5)(H)(i) of such Act [21
U.S.C. 343(q)(5)(H)(i)]. (See Public Law 111-148, Sec. 4205(d), 124
Stat. 119, 576 (2010).)
    We interpret the provisions of section 4205 of the ACA related to
preemption to mean that States and local governments may not impose
nutrition labeling requirements for food sold from vending machines
that must comply with the Federal requirements of section 403(q)(5)(H)
of the FD&C Act, unless the State or local requirements are identical
to the Federal requirements. In other words, States and localities
cannot have additional or different nutrition labeling requirements for
food sold either: (1) From vending machines that are operated by a
person engaged in the business of owning or operating 20 or more
vending machines subject to the requirements of section
403(q)(5)(H)(viii) of the FD&C Act or (2) from vending machines
operated by a person not subject to the requirements of section
403(q)(5)(H)(viii) of the FD&C Act who voluntarily elects to be subject
to those requirements by registering biannually under section
403(q)(5)(H)(ix) of the FD&C Act.
    Otherwise, for food sold from vending machines not subject to the
nutrition labeling requirements of section 403(q)(5)(H)(viii) of the
FD&C Act, States and localities may impose nutrition labeling
requirements. Under our interpretation of the Rule of Construction in
section 4205(d)(1) of the ACA, nutrition labeling for food sold from
these vending machines would not be ``nutrient content disclosures of
the type required under section 403(q)(5)(H)(viii) [of the FD&C Act]''
and, therefore, would not be preempted. Under this interpretation,
States and localities would be able to continue to require nutrition
labeling for food sold from vending machines which are exempt from
nutrition labeling under section 403(q)(5) of the FD&C Act. This
interpretation is consistent with the fact that Congress included
vending machine operators in the voluntary registration provision of
section 403(q)(5)(H)(ix) of the FD&C Act. There would have been no need
to include vending machine operators in the provision that allows
opting into the Federal requirements if States and localities could not
otherwise require non-identical nutrition labeling for food sold from
any vending machines.
    The preamble to the proposed rule (76 FR 19238 at 19252) described
an alternative interpretation of section 4205 of the ACA that could
leave less room for States and localities to require nutrition labeling
for food sold from vending machines. Under this alternative
interpretation, State or local nutrition labeling requirements for food
sold from vending machines would be preempted because such nutrition
labeling requirements would be ``nutrition content disclosures of the
type required under section 403(q)(5)(H) [of the FD&C Act ]'' and would
not fall within the exception to preemption in section 403A(a)(4) of
the FD&C Act (``except that this paragraph does not apply to food that
is offered for sale in a restaurant or similar retail food
establishment that is not part of a chain with 20 or more locations . .
.'').
    Under this alternative interpretation, States and localities could
not have nutrition labeling requirements for food sold in vending
machines that were not identical to the Federal requirements, unless
they successfully petitioned FDA. The position that no State or
locality may have a vending machine food nutrition labeling requirement
not identical to the Federal requirements, regardless of how many
vending machines the operator owns or operates, was the position in the
guidance we issued (entitled ``Guidance for Industry: Questions and
Answers Regarding the Effect of Section 4205 of the Patient Protection
and Affordable Care Act of 2010 on State and Local Menu and Vending
Machine Labeling Laws'' (75 FR 52427, August 25, 2010)). Federal law
provides that, upon petition, we may exempt State or local requirements
from the express preemption provisions of section 403A(a) of the FD&C
Act under certain conditions (21 U.S.C. 343-1(b)). We have issued
regulations at Sec.  100.1 (21 CFR 100.1) describing the petition
process that is available to State and local governments to request
such exemptions from preemption. Under our proposed interpretation, for
food sold from vending machines that is not subject to the nutrition
labeling requirements of section 403(q)(5)(H) of the FD&C Act, States
and localities may establish or continue to impose nutrition labeling
requirements. Under the alternative interpretation, there would be food
sold in vending machines for which the Federal Government has not
required nutrition labeling and for which States and localities would
be precluded from establishing such labeling requirements unless they
successfully petitioned FDA and a rulemaking was completed. This
approach would risk creating a regulatory gap that would be
inconsistent with the purposes of section 4205 of the ACA. It would
also impose a restriction and burden on the States and localities that
is inconsistent with the Federalism principles expressed in Executive
Order 13132, as well as a substantial administrative burden on FDA if
States petition for exemption.
    We invited comments on our interpretation of section 4205 of the
ACA related to preemption, as well as on the alternative interpretation
described in the Federalism section. We also requested comments on the
use of the petition process in this context and on other potential
interpretations that interested persons identify as appropriate given
both the preemption-related language of section 4205 of the ACA and the
statutory goals.
    (Comment 41) Several comments supported the preemptive scope being
limited to State and local requirements imposing additional or
different nutritional labeling requirements for food sold from covered
vending machines, including food sold from machines operated by a
person who has elected to be subject to the requirements of section
403(q)(5)(H) of the FD&C Act (76 FR 19238 at 19251-19252). Some
comments stated that the alternative interpretation, that no State or
locality may have a vending machine food nutrition labeling requirement
that is not identical to the Federal requirements regardless of how
many vending machines the operator owns or operates, would restrict
State and local

authorities and create a ``regulatory vacuum'' because the Federal
system exempts vending machine operators with fewer than 20 machines. A
few comments stated that the alternative interpretation, which would
create a gap in coverage of vending machines, would be inconsistent
with the purposes and language of section 4205 of the ACA. These
comments also stated that imposing a restriction on States and
localities is inconsistent with Federalism principles expressed in
Executive Order 13132. Another comment stated that section 4205 of the
ACA intends that States and localities have authority to regulate
nutritional information for machines that do not come under the purview
of the Federal law.
    Several comments would have us revise the rule to clarify that
``identical'' does not mean verbatim in wording rather in effect. One
comment suggested the following language: ``The specific words of the
State or local requirements need not be the same. State or local
requirements that are worded differently from the Federal requirements
and/or provide for different enforcement schemes may still be
`identical' under [section 4205 of the ACA].''
    Other comments noted that the savings clause for warnings about the
safety of food is included in the Rule of Construction in section
4205(d) of the ACA. A few comments suggested that we codify the Rule of
Construction because its omission from the rule may lead to confusion
over how the statute should be interpreted. The comments noted that the
lack of a codified statement for a similar rule of construction in the
NLEA has led to confusion and to court decisions that did not take that
rule of construction into account. One comment stated that we should
include a savings clause that expressly identifies that nutrition
labeling for less than 20 machines is not preempted in the absence of
voluntary compliance by non-covered vending machine operators.
    (Response 41) We agree with the comments asserting that the
preemptive effect of the Federal nutrition labeling requirements of
section 4205 of the ACA for food sold from vending machines is limited
to State and local requirements that impose additional or different
nutrition labeling requirements for food sold from vending machines
that are covered by the Federal requirements of section 403(q)(5)(H) of
the FD&C Act and Sec.  101.8. We also agree that the alternative
interpretation described in the proposed rule (76 FR 19238 at 19251
through 19252), that no State or locality may have a nutrition labeling
requirement for food sold from vending machines that is not identical
to the Federal requirements regardless of how many vending machines the
operator owns or operates, would restrict State and local authorities
and create a regulatory gap that would be inconsistent with the
purposes and language of section 4205 of the ACA and the Federalism
principles expressed in Executive Order 13132. In addition, as we noted
in the preamble to the proposed rule (76 FR 19238 at 19251 through
19252), there would be no reason for Congress to include vending
machine operators in the voluntary registration provision of section
403(q)(5)(H)(ix) of the FD&C Act, which allows vending machine
operators not subject to the requirements of section 403(q)(5)(H) of
the FD&C Act to opt into the Federal requirements if State and local
governments could not otherwise require non-identical nutrition
labeling for food sold from any vending machines.
    For these reasons, we interpret the provisions of section 4205 of
the ACA related to preemption to mean that States and local governments
may not establish or continue into effect nutrition labeling
requirements for food sold from vending machines covered by the Federal
requirements of section 403(q)(5)(H) of the FD&C Act and Sec.  101.8,
unless the State or local requirements are identical to the Federal
requirements of section 403(q)(5)(H) of the FD&C Act and Sec.  101.8.
In other words, States and localities cannot have additional or
different nutrition labeling requirements for food sold either from:
(1) Vending machines that are operated by a person engaged in the
business of owning or operating 20 or more vending machines subject to
the requirements of section 403(q)(5)(H)(viii) of the FD&C Act and
Sec.  101.8; or (2) vending machines operated by a person not otherwise
subject to the requirements of section 403(q)(5)(H)(viii) of the FD&C
Act and Sec.  101.8 who voluntarily elects to be subject to those
requirements by registering biannually with FDA in accordance with
section 403(q)(5)(H)(ix) of the FD&C Act and Sec.  101.8(d). For food
sold from vending machines not subject to the nutrition labeling
requirements of section 403(q)(5)(H)(viii) of the FD&C Act, States and
localities may impose nutrition labeling requirements.
    In response to the comments asserting that we revise the rule to
clarify the meaning of ``identical'' within the context of section
403A(a)(4) of the FD&C Act, we note that we have already issued a
regulation at Sec.  100.1 that explains the meaning of ``not identical
to'' in the context of section 403A of the FD&C Act in describing the
petition process available to State and local governments to request an
exemption from the express preemption provisions of section 403A of the
FD&C Act under section 403A(b) of the FD&C Act. FDA regulations, at
Sec.  100.1(c)(4), provide, in relevant part, that, within the context
of section 403A of FD&C Act, ``not identical to'' does not refer to the
specific words in the State or local requirement but instead means that
the State or local requirement directly or indirectly imposes
obligations or contains provisions concerning the labeling of food
that: (1) Are not imposed by or contained in the applicable provision
(including any implementing regulation) of section 403 of the FD&C Act
or (2) differ from those specifically imposed by or contained in the
applicable provision (including any implementing regulation) of section
403 of the FD&C Act. Accordingly, a State or local nutrition labeling
requirement for food sold from vending machines covered by the
requirements of section 403(q)(5)(H)(viii) of the FD&C Act and Sec.
101.8 that directly or indirectly imposes obligations or contains
labeling provisions that: (1) Are not imposed by or contained in
section 403(q) of the FD&C Act and Sec.  101.8; or (2) differ from
those specifically imposed by or contained in section 403(q) of the
FD&C Act and Sec.  101.8 would be ``not identical to'' the Federal
requirements and therefore would be preempted under section 403A(a)(4)
of the FD&C Act. Because the meaning of the phrase ``not identical
to,'' within the context of section 403A of the FD&C Act, is already
described in Sec.  100.1 and is further clarified here in the context
of vending machines, we decline to revise the rule to clarify the
meaning of ``identical'' as suggested by the comments.
    We decline to amend Sec.  101.8 to restate the Rule of Construction
at section 4205(d) of the ACA or to add a savings clause that expressly
provides that nutrition labeling for fewer than 20 vending machines is
not preempted in the absence of voluntary compliance. As discussed in
section III.C.4.a of this preamble, and specified in Sec.  101.8(c)(1),
Sec.  101.8 only applies to food sold from a vending machine that: (1)
Is operated by a person engaged in the business of owning or operating
20 or more machines; or (2) is operated by a vending machine operator
that has voluntarily elected to be subject to Sec.  101.8 by
registering with FDA in accordance with Sec.  101.8(d). In addition, we
explain our interpretation of the provisions of section 4205 of the ACA

related to preemption mentioned previously, including our
interpretation that State and local governments may impose nutrition
labeling requirements for food sold from vending machines not subject
to the requirements of section 403(q)(5)(H) of the FD&C Act, which
would include vending machines operated by a person engaged in the
business of owning or operating fewer than 20 vending machines. Because
Sec.  101.8(c)(1) specifies what foods and vending machines are covered
by the requirements of section 403(q)(5)(H) and Sec.  101.8, and we
have described the Rule of Construction at section 4205(d) of the ACA
and explained our interpretation of the provisions of section 4205 of
the ACA related to preemption mentioned previously, we decline to
revise Sec.  101.8 as suggested by the comments.

VII. Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.

1. FDA/CFSAN, ``Food Labeling: Calorie Labeling of Articles of Food
in Vending Machines, Regulatory Impact Analysis,'' 2014.
2. FDA/CFSAN, ``Food Labeling: Calorie Labeling of Articles of Food
in Vending Machines NPRM, Preliminary Regulatory Impact Analysis,''
2011.
3. Memo to File. Correspondence with Eric Dell of the National
Automatic Merchandising Association. April 10, 2013.
4. Memo to File. Correspondence with Eric Dell of the National
Automatic Merchandising Association. April 13, 2013.
5. Eastern Research Group I. ``Evaluation of Recordkeeping Costs for
Food Manufacturers, Final Report,'' A. Sertkaya, A. Berlind, and S.
Erdem, Eds. Contract No. 223-01-2461, Task Order Number 5. 2007.
6. ``2012 Census of the Industry,'' Vending Times, 2012; 52(12).
7. 2012 State of the Vending Industry Report, 2013,'' Automatic
Merchandiser.
8. National Automatic Merchandising Association. Comments of: The
National Automatic Merchandising Association. Docket No. FDA-2010-N-
0298. 2010.

List of Subjects

21 CFR Part 11

    Administrative practice and procedure, Computer technology,
Reporting and recordkeeping requirements.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
11 and 101 are amended as follows:

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
1. The authority citation for 21 CFR part 11 continues to read as
follows:

    Authority:  21 U.S.C. 321-393; 42 U.S.C. 262.

0
2. Section 11.1 is amended by adding paragraph (h) to read as follows:

Sec.  11.1  Scope.

* * * * *
    (h) This part does not apply to electronic signatures obtained
under Sec.  101.8(d) of this chapter.

PART 101--FOOD LABELING

0
3. The authority citation for 21 CFR part 101 continues to read as
follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
4. Section 101.8 is added to subpart A to read as follows:

Sec.  101.8  Vending machines.

    (a) Definitions. The definitions of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act apply to such terms when used in
this section. In addition, for the purposes of this section:
    Authorized official of a vending machine operator means an owner,
operator, agent in charge, or any other person authorized by a vending
machine operator who is not otherwise subject to section
403(q)(5)(H)(viii) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343(q)(5)(H)(viii)), to register the vending machine operator
with the Food and Drug Administration (``FDA'') for purposes of
paragraph (d) of this section.
    Vending machine means a self-service machine that, upon insertion
of a coin, paper currency, token, card, or key, or by optional manual
operation, dispenses servings of food in bulk or in packages, or
prepared by the machine, without the necessity of replenishing the
machine between each vending operation.
    Vending machine operator means a person(s) or entity that controls
or directs the function of the vending machine, including deciding
which articles of food are sold from the machine or the placement of
the articles of food within the vending machine, and is compensated for
the control or direction of the function of the vending machine.
    (b) Articles of food not covered. Articles of food sold from a
vending machine are not covered vending machine food if:
    (1) The prospective purchaser can view:
    (i) The calories, serving size, and servings per container listed
in the Nutrition Facts label on the vending machine food without any
obstruction. The Nutrition Facts label must be in the format required
in Sec.  101.9(c) and (d). The Nutrition Facts label must be in a size
that permits the prospective purchaser to be able to easily read the
nutrition information contained in the Nutrition Facts label on the
article of food in the vending machine. Smaller formats allowed for
Nutrition Facts for certain food labeling under FDA regulation at Sec.
101.9 are not considered to be a size that a prospective purchaser is
able to easily read; or
    (ii) The calories, serving size, and servings per container listed
in a reproduction of the Nutrition Facts label on the vending machine
food, provided that the reproduction is a reproduction of an actual
Nutrition Facts label that complies with Sec.  101.9 for a vending
machine food, is presented in a size that permits the prospective
purchaser to be able to easily read the nutrition information, and the
calories, serving size, and servings per container are displayed by the
vending machine before the prospective purchaser makes his or her
purchase; or
    (2) The prospective purchaser can otherwise view visible nutrition
information, including, at a minimum the total number of calories for
the article of food as sold at the point of purchase. This visible
nutrition information must appear on the food label itself. The visible
nutrition information must be clear and conspicuous and able to be
easily read on the article of food while in the vending machine, in a
type size at least 50 percent of the size of the largest printed matter
on the label and with sufficient color and contrasting background to
other print on the label

to permit the perspective purchaser to clearly distinguish the
information.
    (c) Requirements for calorie labeling for certain food sold from
vending machines--(1) Applicability; covered vending machine food. For
the purposes of this section, the term ``covered vending machine food''
means an article of food that is:
    (i) Sold from a vending machine that does not permit the
prospective purchaser to examine the Nutrition Facts label prior to
purchase as provided in paragraph (b)(1) of this section or otherwise
provide visible nutrition information at the point of purchase as
provided in paragraph (b)(2) of this section; and
    (ii) Sold from a vending machine that:
    (A) Is operated by a person engaged in the business of owning or
operating 20 or more vending machines; or
    (B) Is operated by a vending machine operator that has voluntarily
elected to be subject to the requirements of this section by
registering with FDA under paragraph (d) of this section.
    (2) Calorie declaration. (i) The number of calories for a covered
vending machine food must be declared in the following manner:
    (A) To the nearest 5-calorie increment up to and including 50
calories and 10-calorie increment above 50 calories, except that
amounts less than 5 calories may be expressed as zero.
    (B) The term ``Calories'' or ``Cal'' must appear adjacent to the
caloric content value for each food in the vending machine.
    (C) The calorie declaration for a packaged food must include the
total calories present in the packaged food, regardless of whether the
packaged food contains a single serving or multiple servings. The
vending machine operator may voluntarily disclose calories per serving
in addition to the total calories for the food.
    (D) If a covered vending machine food is one where the prospective
purchaser selects among options to produce a final vended product
(e.g., vended coffee, hot chocolate or tea with options for added
sugar, sugar substitute, milk, and cream), calories must be declared
per option or for the final vended products.
    (ii) Calorie declarations for covered vending machine food must be
clear and conspicuous and placed prominently in the following manner:
    (A) The calorie declarations may be placed on a sign in close
proximity to the article of food or selection button, i.e., in, on, or
adjacent to the vending machine, but not necessarily attached to the
vending machine, so long as the calorie declaration is visible at the
same time as the food, its name, price, selection button, or selection
number is visible. The sign must give calorie declarations for those
articles of food that are sold from that particular vending machine.
    (B) When the calorie declaration is in or on the vending machine,
the calorie declaration must be in a type size no smaller than the name
of the food on the machine (not the label), selection number, or price
of the food as displayed on the vending machine, whichever is smallest,
with the same prominence, i.e., the same color, or in a color at least
as conspicuous, as the color of the name, if applicable, or price of
the food or selection number, and the same contrasting background, or a
background at least as contrasting as the background used for the item
it is in closest proximity to, i.e., name, selection number, or price
of the food item as displayed on the machine.
    (C) When the calorie declaration is on a sign adjacent to the
vending machine, the calorie declaration must be in a type size large
enough to render it likely to be read and understood by the prospective
purchaser under customary conditions of purchase and use, and in a type
that is all black or one color on a white or other neutral background
that contrasts with the type color.
    (D) Where the vending machine only displays a picture or other
representation or name of the food item, the calorie declaration must
be in close proximity to the picture or other representation or name,
or in close proximity to the selection button.
    (E) For electronic vending machines (e.g., machines with digital or
electronic or liquid crystal display (LCD) displays), the calorie
declaration must be displayed before the prospective purchaser makes
his or her purchase.
    (F) For vending machines with few choices, e.g., popcorn, the
calorie declaration may appear on the face of the machine so long as
the declaration is prominent, not crowded by other labeling on the
machine, and the type size is no smaller than the name of the food on
the machine (not the label), selection number, or price of the food as
displayed on the vending machine, whichever is smallest.
    (d) Voluntary provision of calorie labeling for foods sold from
vending machines--(1) Applicability. A vending machine operator that is
not subject to the requirements of section 403(q)(5)(H)(viii) of the
Federal Food, Drug, and Cosmetic Act may, through its authorized
official, voluntarily register with FDA to be subject to the
requirements established in paragraph (c)(2) of this section. An
authorized official of a vending machine operator that voluntarily
registers cannot be subject to any State or local nutrition labeling
requirements that are not identical to the requirements in 403(q)(5)(H)
of the Federal Food, Drug, and Cosmetic Act.
    (2) Who may register? A vending machine operator that is not
otherwise subject to the requirements of section 403(q)(5)(H) of the
Federal Food, Drug, and Cosmetic Act may register with FDA.
    (3) What information is required? The vending machine operator must
provide FDA with the following information:
    (i) The contact information (including name, address, phone number,
email address), for the vending machine operator;
    (ii) The address of the location of each vending machine owned or
operated by the vending machine operator that is being registered;
    (iii) Preferred mailing address (if different from the vending
machine operator address), for purposes of receiving correspondence;
and
    (iv) Certification that the information submitted is true and
accurate, that the person or firm submitting it is authorized to do so,
and that each registered vending machine will be subject to the
requirements of this section.
    (v) Information should be submitted by email by typing complete
information into the portable document format (PDF) form, saving it on
the registrant's computer, and sending it by email to
<EMAIL_ADDRESS>If email is not available, the