Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines, 58425-58428 [2017-26672]

Download as PDF 58425 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices Section 316.24(a) specifies a requirement that sponsors respond to deficiency letters from FDA on designation requests within 1 year of issuance of the deficiency letter, unless within that time frame, the sponsor requests an extension of time to respond. Based on past experience, FDA estimates 20 respondents requiring 40 hours of human resources annually. Section 316.27 specifies content of a change in ownership of orphan-drug designation. Based on past experience, FDA estimates 63 respondents requiring 315 hours of human resources annually. Section 316.30 requires submission of annual reports, including progress reports on studies, a description of the investigational plan, and a discussion of changes that may affect orphan status. Based on number of orphan-drug designations, the number of respondents is estimated as 744 requiring 2,232 hours of human resources annually. Finally, § 316.36 describes information required of sponsor when there is insufficient quantity of approved orphan drug. Based on past experience, FDA estimates two respondents requiring 90 hours of human resources annually. The information requested will provide the basis for an FDA determination that the drug is for a rare disease or condition and satisfies the requirements for obtaining orphan drug status. Secondly, the information will describe the medical and regulatory history of the drug. The respondents to this collection of information are biotechnology firms, drug companies, and academic clinical researchers. In the Federal Register of June 19, 2017 (82 FR 27836), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Content and format when seeking written recommendations; results of studies; and amendments (§§ 316.10, 316.12, and 316.14) ......................................................... Content and format of a request for designation; request for verification of status; amendment to designation ....... Form FDA 3671 or 4035 FDA Orphan Drug Designation Request Form (§§ 316.20, 316.21, and 316.26) .............. Notifications of changes in agents (§ 316.22) ..................... Deficiency letters and granting orphan-drug designation (§ 316.24(a)) ..................................................................... Submissions to change ownership of orphan-drug designation (§ 316.27) ............................................................ Annual reports (§ 316.30) .................................................... Assurance of the availability of sufficient quantities of the orphan drug; holder’s consent for the approval of other marketing applications for the same drug (§ 316.36) ...... Hours per response Total hours 1 1 50 50 496 1.25 620 135 83,700 1.25 70 620 1 32 70 19,840 2 140 20 1 20 2 40 63 744 1 1 63 744 5 3 315 2,232 2 3 6 15 90 ........................ ........................ ........................ ........................ 106,407 are no capital costs or operating and maintenance costs associated with this collection of information. FDA has experienced increases in: (1) The number of submissions to change ownership of orphan-drug designation (§ 316.27), (2) the number of annual reports (§ 316.30), and (3) assurances of the availability of sufficient quantities of the orphan drug and the holder’s consent for the approval of other marketing applications for the same drug (§ 316.36). Dated: December 6, 2017. Leslie Kux, Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–6397] Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines AGENCY: Food and Drug Administration, HHS. Notice. [FR Doc. 2017–26669 Filed 12–11–17; 8:45 am] ACTION: BILLING CODE 4164–01–P ethrower on DSK3G9T082PROD with NOTICES Total annual responses 1 Total .............................................................................. 1 There Annual frequency per response Number of respondents 21 CFR section/Form FDA SUMMARY: VerDate Sep<11>2014 20:03 Dec 11, 2017 The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, Jkt 244001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection provisions for calorie labeling of articles of food in vending machines. Submit either electronic or written comments on the collection of information by February 12, 2018. DATES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 12, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. ADDRESSES: E:\FR\FM\12DEN1.SGM 12DEN1 58426 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). ethrower on DSK3G9T082PROD with NOTICES Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2017–N–6397 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Food Labeling; Calorie Labeling of Articles of Food in Vending Machines OMB Control Number 0910–0782— Extension This information collection supports FDA regulations under § 101.8 (21 CFR 101.8) and Form FDA 3757. Under § 101.8(d) vending machine operators not subject to the requirements of section 403(q)(5)(H)(viii) (21 U.S.C. 343(q)(5)(H)(viii)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may, through an authorized official, voluntarily register with FDA to be subject to those requirements. Those who do voluntarily register must provide FDA with 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 the information is authorized to do so, and that each registered vending machine will be subject to the requirements of § 101.8(c)(2). We have developed Form FDA 3757 entitled, ‘‘DHHS/FDA Menu and Vending Machine Labeling Voluntary Registration,’’ to assist respondents in this regard. 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 E:\FR\FM\12DEN1.SGM 12DEN1 58427 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices FDA. Registration will automatically expire if not renewed. It should be noted that an article of food sold from a vending machine whose operator has voluntarily registered with FDA under the regulations 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 § 101.8(b)(1), or otherwise provides visible nutrition information at the point of purchase as provided in § 101.8(b)(2). FDA estimates the burden of the collection of information as follows: Reporting Burden TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR part 101.8/activity Number of responses per respondent Average burden per response (in hours) Total annual responses Total hours § 101.8(d); initial registration (Form FDA 3757) ...... § 101.8(d); registration renewal (Form FDA 3757) .. 13 19 1 1 13 19 2 ................................ 0.5 (30 minutes) ........ 26 9.5 Total .................................................................. 35.5 ........................ ........................ .................................... ........................ 1 There are no capital costs or operating and maintenance costs associated with this collection of information. As reflected in table 1, we retain the currently approved reporting burden estimate for the information collection. At this time, we lack comprehensive data on the number of vending machine operators with fewer than 20 machines that might voluntarily register to comply with the regulations and, as indicated in our final rule of December 1, 2014 (79 FR 71259) establishing the information collection, no vending machine operators have voluntarily registered with FDA. Therefore, while we expect relatively few submissions, we have provided a conservative estimate of the burden respondents may encounter. 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. 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 × 2 hours per response). Annualizing this number over 3 years yields a rounded 13 respondents per year (5 percent × 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 reregistration will take 0.5 hours for each registrant. This indicates that biennial registration would impose a burden of 19 hours (38 operators × 0.5 hours) every 2 years, or 9.5 hours every year (19 operators every year × 0.5 hours). Recordkeeping Requirements We have omitted providing a burden estimate associated with generating, providing, or maintaining records associated with calorie analysis and recording because the regulations do not require vending machine operators to maintain such records. However, we have considered the ‘‘time, effort, or financial resources’’ expended by covered vending machine operators to declare calories for covered vending machine food and have included the burden in table 2 as part of the thirdparty disclosure burden. We are particularly interested in hearing from respondents to the information collection regarding calorie declaration signage. Third-Party Disclosure Requirements TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of disclosures per respondent Number of respondents 21 CFR Part 101 Average burden per disclosure (in hours) Total annual disclosures Total hours § 101.8(c)(2)(i); calorie analysis ............................... § 101.8(c)(2)(ii); calorie declaration signage ............ § 101.8(e)(1); vending operator contact information 282 3,279 3,279 11 2,122 125 3,102 6,958,346 409,875 1 ................................ 0.21 (12.5 minutes) ... .025 (1.5 minutes) ..... 3,102 1,494,403 10,248 Total .................................................................. ........................ ........................ ........................ .................................... 1,507,753 ethrower on DSK3G9T082PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with the information collection. As reflected in table 2, we have retained the currently approved thirdparty burden estimate for the information collection. Under the regulations, we calculate three types of third party disclosure burden. The first burden estimate reflects the time and effort we believe VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 necessary for vending machine operators to determine the calorie content of covered vending machine food for the required calorie declarations as described in § 101.8(c)(2)(i). We refer to this as a ‘‘calorie analysis.’’ A calorie analysis entails the burden of determining PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 21 CFR 101.9, including calorie content information, which means that calorie content for many covered vending machine foods is E:\FR\FM\12DEN1.SGM 12DEN1 ethrower on DSK3G9T082PROD with NOTICES 58428 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 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 § 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 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 are based upon conversations with vending machine operators and our survey of various vending machine models that vend these types of food and beverage, as discussed in our final rule. Based on available data, 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 required for new calorie analysis is then 9,317 hours (847 operators × 11 products needing analysis × 1 hour per analysis). Annualizing this value over 3 years yields 3,102 hours (847 operators/3 years × 11 products needing analysis × 4 hours per analysis). (847 operators/3 years = 282 operators per year.) This is reflected in table 2, row 1. The second burden estimate reflects burden associated with calorie declaration signage as described in § 101.8(c)(2)(ii). Covered vending machine operators with 20 or more vending machines and vending machine VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 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. We estimate there is an average of 9,838 (9,800 covered non-bulk + 38 voluntary) vending machine operators subject to the regulations (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 relied upon in our final rule (see references 1, 6 to 8 under Docket No. FDA–2011–F–0171). We estimate there is an average of 5.61 million non-bulk vending machines. Digital signage is an emerging technology, and according to available sources, 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. Subtracting the number of vending machines with the electronic video from the total machine count yields an average of 5.61 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 § 101.8(b), this analysis may overestimate the burden estimate for calorie declaration signs. Vending machine operators can create one sign that contains all of the information for the products offered in the vending machine, and do not have to create individual signs for each item. The number of templates a given firm would need to design to produce signs that comply with the regulations may vary based upon the number of different types of products the firm purveys. In our estimate, we have considered the time it takes for template design, sign creation, sign installation, updates, replacement, and bulk machine signage. Cumulatively we estimate that those 3,279 (annualized) vending machine operators subject to the regulations will PO 00000 Frm 00051 Fmt 4703 Sfmt 9990 expend a total 1,494,403 hours to fulfill the requirements under § 101.8(c)(2)(ii) regarding signage for calorie declarations. This is reflected in table 2 row 2. We note that while we previously provided burden estimates for individual disclosure activities found under § 101.8(c)(2)(ii) in our final rule of December 1, 2014 (79 FR 71259 at 71286), we have consolidated them here into one entry. Because this is the first extension request for this information collection and we have limited available data, we are specifically interested in respondents’ experience with the thirdparty burden associated with the requirements under § 101.8(c)(2)(ii). Finally, we have provided a burden estimate associated with § 101.8(e)(1) requiring a vending machine operator subject to section 403(q)(5)(H)(viii) of the FD&C Act or a vending machine operator that voluntarily registers to provide contact information. 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 × 125 sign formats × 0.025 hours per sign). Annualized over 3 years, this burden becomes 10,248 hours (9,838 operators/3 years × 125 signs × 0.025 hours per sign). (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 § 101.8(e)(1), the vending machine operator is required to display the remaining contact information required under § 101.8(e)(1) in a manner specified under § 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 associated burden for third-party disclosure.) This is reflected in table 2, row 3. Dated: December 5, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26672 Filed 12–11–17; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\12DEN1.SGM 12DEN1

Agencies

[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58425-58428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26672]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6397]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Labeling; Calorie Labeling of Articles of Food in 
Vending Machines

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection provisions for 
calorie labeling of articles of food in vending machines.

DATES: Submit either electronic or written comments on the collection 
of information by February 12, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 12, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

[[Page 58426]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-6397 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Labeling; Calorie Labeling 
of Articles of Food in Vending Machines.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Food Labeling; Calorie Labeling of Articles of Food in Vending Machines

OMB Control Number 0910-0782--Extension

    This information collection supports FDA regulations under Sec.  
101.8 (21 CFR 101.8) and Form FDA 3757. Under Sec.  101.8(d) vending 
machine operators not subject to the requirements of section 
403(q)(5)(H)(viii) (21 U.S.C. 343(q)(5)(H)(viii)) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) may, through an authorized official, 
voluntarily register with FDA to be subject to those requirements. 
Those who do voluntarily register must provide FDA with 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 the information is authorized to do so, 
and that each registered vending machine will be subject to the 
requirements of Sec.  101.8(c)(2). We have developed Form FDA 3757 
entitled, ``DHHS/FDA Menu and Vending Machine Labeling Voluntary 
Registration,'' to assist respondents in this regard. 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

[[Page 58427]]

FDA. Registration will automatically expire if not renewed.
    It should be noted that an article of food sold from a vending 
machine whose operator has voluntarily registered with FDA under the 
regulations 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).
    FDA estimates the burden of the collection of information as 
follows:
Reporting Burden

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
         21 CFR part 101.8/activity              Number of     responses per   Total annual     Average burden per response  (in hours)     Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(d); initial registration (Form               13               1              13  2.........................................              26
 FDA 3757).
Sec.   101.8(d); registration renewal (Form               19               1              19  0.5 (30 minutes)..........................             9.5
 FDA 3757).
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................            35.5  ..............  ..............  ..........................................  ..............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    As reflected in table 1, we retain the currently approved reporting 
burden estimate for the information collection. At this time, we lack 
comprehensive data on the number of vending machine operators with 
fewer than 20 machines that might voluntarily register to comply with 
the regulations and, as indicated in our final rule of December 1, 2014 
(79 FR 71259) establishing the information collection, no vending 
machine operators have voluntarily registered with FDA. Therefore, 
while we expect relatively few submissions, we have provided a 
conservative estimate of the burden respondents may encounter.
    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. 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 indicates 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 
(19 operators every year x 0.5 hours).
Recordkeeping Requirements
    We have omitted providing a burden estimate associated with 
generating, providing, or maintaining records associated with calorie 
analysis and recording because the regulations do not require vending 
machine operators to maintain such records. However, we have considered 
the ``time, effort, or financial resources'' expended by covered 
vending machine operators to declare calories for covered vending 
machine food and have included the burden in table 2 as part of the 
third-party disclosure burden. We are particularly interested in 
hearing from respondents to the information collection regarding 
calorie declaration signage.
Third-Party Disclosure Requirements

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                                                 Number of      disclosures    Total annual
               21 CFR Part 101                  respondents         per         disclosures   Average burden  per disclosure  (in hours)    Total hours
                                                                respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i); calorie analysis.....             282              11           3,102  1.........................................           3,102
Sec.   101.8(c)(2)(ii); calorie declaration            3,279           2,122       6,958,346  0.21 (12.5 minutes).......................       1,494,403
 signage.
Sec.   101.8(e)(1); vending operator contact           3,279             125         409,875  .025 (1.5 minutes)........................          10,248
 information.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................       1,507,753
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.

    As reflected in table 2, we have retained the currently approved 
third-party burden estimate for the information collection.
    Under the regulations, we calculate three types of third party 
disclosure burden. The first burden estimate reflects the time and 
effort we believe necessary for vending machine operators to determine 
the calorie content of covered vending machine food for the required 
calorie declarations as described in Sec.  101.8(c)(2)(i). We refer to 
this as a ``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 21 CFR 101.9, including 
calorie content information, which means that calorie content for many 
covered vending machine foods is

[[Page 58428]]

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 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 are based upon conversations with 
vending machine operators and our survey of various vending machine 
models that vend these types of food and beverage, as discussed in our 
final rule. Based on available data, 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 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.) This is reflected in table 2, row 1.
    The second burden estimate reflects burden associated with calorie 
declaration signage as described in Sec.  101.8(c)(2)(ii). 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.
    We estimate there is an average of 9,838 (9,800 covered non-bulk + 
38 voluntary) vending machine operators subject to the regulations 
(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 relied upon in our final rule (see references 1, 6 to 8 
under Docket No. FDA-2011-F-0171). We estimate there is an average of 
5.61 million non-bulk vending machines. Digital signage is an emerging 
technology, and according to available sources, 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. Subtracting the number 
of vending machines with the electronic video from the total machine 
count yields an average of 5.61 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.
    Vending machine operators can create one sign that contains all of 
the information for the products offered in the vending machine, and do 
not have to create individual signs for each item. The number of 
templates a given firm would need to design to produce signs that 
comply with the regulations may vary based upon the number of different 
types of products the firm purveys. In our estimate, we have considered 
the time it takes for template design, sign creation, sign 
installation, updates, replacement, and bulk machine signage. 
Cumulatively we estimate that those 3,279 (annualized) vending machine 
operators subject to the regulations will expend a total 1,494,403 
hours to fulfill the requirements under Sec.  101.8(c)(2)(ii) regarding 
signage for calorie declarations. This is reflected in table 2 row 2. 
We note that while we previously provided burden estimates for 
individual disclosure activities found under Sec.  101.8(c)(2)(ii) in 
our final rule of December 1, 2014 (79 FR 71259 at 71286), we have 
consolidated them here into one entry. Because this is the first 
extension request for this information collection and we have limited 
available data, we are specifically interested in respondents' 
experience with the third-party burden associated with the requirements 
under Sec.  101.8(c)(2)(ii).
    Finally, we have provided a burden estimate associated with Sec.  
101.8(e)(1) requiring a vending machine operator subject to section 
403(q)(5)(H)(viii) of the FD&C Act or a vending machine operator that 
voluntarily registers to provide contact information. 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). (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 associated burden for third-
party disclosure.) This is reflected in table 2, row 3.

    Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26672 Filed 12-11-17; 8:45 am]
 BILLING CODE 4164-01-P