81_FR_54657 81 FR 54499 - Calorie Labeling of Articles of Food in Vending Machines: Guidance for Industry; Small Entity Compliance Guide; Availability

81 FR 54499 - Calorie Labeling of Articles of Food in Vending Machines: Guidance for Industry; Small Entity Compliance Guide; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 158 (August 16, 2016)

Page Range54499-54501
FR Document2016-19492

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Calorie Labeling of Articles of Food in Vending Machines--Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Food Labeling; Calorie Labeling of Articles of Food in Vending Machines.''

Federal Register, Volume 81 Issue 158 (Tuesday, August 16, 2016) 
[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Rules and Regulations]
[Pages 54499-54501]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19492]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0171]


Calorie Labeling of Articles of Food in Vending Machines: 
Guidance for Industry; Small Entity Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Calorie Labeling of 
Articles of Food in Vending Machines--Small Entity Compliance Guide.'' 
The small entity compliance guide (SECG) is intended to help small 
entities comply with the final rule entitled ``Food Labeling; Calorie 
Labeling of Articles of Food in Vending Machines.''

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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

[[Page 54500]]

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 http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-F-0171 for ``Calorie Labeling of Articles of Food in Vending 
Machines--Small Entity Compliance Guide.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Office of Nutrition and Food Labeling, Food Labeling and Standards 
Staff, Center for Food Safety and Applied Nutrition (HFS-305), Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two 
self-addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Ashley N. Rulffes, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of December 1, 2014 (79 FR 71259), we 
issued a final rule requiring vending machine operators who own or 
operate 20 or more vending machines, or who voluntarily register to be 
covered, to provide calorie declarations for those foods sold from 
vending machines for which the Nutrition Facts label cannot be examined 
before purchase or for which visible nutrition information is not 
otherwise provided at the point of purchase (the final rule). Covered 
vending machine operators must comply with the rule by December 1, 
2016. However, in the Federal Register of August 1, 2016 (81 FR 50303), 
we issued a final rule entitled ``Food Labeling; Calorie Labeling of 
Articles of Food in Vending Machines; Extension of Compliance Date.'' 
This rule provides that the compliance date for type size front-of-pack 
labeling requirements (Sec.  101.8(b)(2) (21 CFR 101.8(b)(2))) and 
calorie disclosure requirements (Sec.  101.8(c)(2)) for certain gums, 
mints, and roll candy products in glass-front machines in the final 
rule published December 1, 2014 (79 FR 71259) is extended to July 26, 
2018. The compliance date for all other requirements in the final rule 
(79 FR 71259) remains December 1, 2016.
    We examined the economic implications of the final rule as required 
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined 
that the final rule will have a significant economic impact on a 
substantial number of small entities. In compliance with section 212 of 
the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-
121, as amended by Pub. L. 110-28), we are making available the SECG to 
explain the actions that a small entity must take to comply with the 
rule.
    We are issuing the SECG consistent with our good guidance practices 
regulation (21 CFR 10.115(c)(2)). The SECG represents our current 
thinking on calorie labeling for foods sold in vending machines 
operated by a person engaged in the business of owning or operating 20 
or more vending machines, or a person who voluntarily registers with 
FDA to be covered by the rule. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This SECG refers to collections of information described in FDA's 
final rule that published in the Federal Register of December 1, 2014, 
and that will be effective on December 1, 2016. As stated in the final 
rule, these collections of information are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information 
in the final rule have been approved under OMB control number 0910-
0782. 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.

III. Electronic Access

    Persons with access to the Internet may obtain the SECG at either 
http://www.fda.gov/Food/GuidanceRegulation/

[[Page 54501]]

GuidanceDocumentsRegulatoryInformation/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: August 11, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation and Analysis.
[FR Doc. 2016-19492 Filed 8-15-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Rules and Regulations 54499 Populations; E.O. 13045, Protection of Reporting and recordkeeping Director for that purpose shall have the Children from Environmental Health requirements. authority to issue a petty offense Risks; E.O. 13132, Federalism; E.O. For the reasons set out in the citation for any such violation, requiring 13175, Consultation and Coordination preamble, 18 CFR part 1312 is amended any person charged with the violation to with Indian Tribal Governments; and as follows: appear before a United States Magistrate E.O. 13211, Actions Concerning Judge within whose jurisdiction the Regulations that Significantly Affect PART 1312—PROTECTION OF archaeological resource impacted by the Energy Supply, Distribution, and Use; ARCHAEOLOGICAL RESOURCES: violation is located. The term ‘‘petty E.O. 12988, Civil Justice Reform Act. UNIFORM REGULATIONS offense’’ has the same meaning given This final rule amends TVA’s that term under section 19 of Title 18, regulations for the protection of ■ 1. The authority citation for Part 1312 United States Code. archaeological resources by providing is revised to read as follows: Dated: August 8, 2016. for issuance of petty offense citations by Authority: Pub. L. 96–95, 93 Stat. 721, as TVA’s law enforcement agents for Rebecca C. Tolene, amended, 102 Stat. 2983 (16 U.S.C. 470aa– violations of ARPA or AA. The rule is Deputy General Counsel and Vice President, mm) (Sec. 10(a) & (b)); 16 U.S.C. 831–831ee not subject to Office of Management and Natural Resources. (2012). Related Authority: Pub. L. 59–209, 34 Budget Review under Executive Order Stat. 225 (16 U.S.C. 432, 433); Pub. L. 86– [FR Doc. 2016–19343 Filed 8–15–16; 8:45 am] 12866. The rule contains no Federal 523, 74 Stat. 220, 221 (16 U.S.C. 469), as BILLING CODE 8120–08–P mandates for State, local, or tribal amended, 88 Stat. 174 (1974); Pub. L. 89–665, government or for the private sector. 80 Stat. 915 (16 U.S.C. 470a–t), as amended, 84 Stat. 204 (1970), 87 Stat. 139 (1973), 90 DEPARTMENT OF HEALTH AND TVA has determined that these Stat. 1320 (1976), 92 Stat. 3467 (1978), 94 amendments will not have a significant HUMAN SERVICES Stat. 2987 (1980); Pub. L. 95–341, 92 Stat. annual effect of $100 million or more or 469 (42 U.S.C. 1996) result in expenditures of $100 million in Food and Drug Administration any one year by State, local, or tribal ■ 2. In § 1312.1, a sentence is added at governments or by the private sector. the end of paragraph (a) to read as 21 CFR Parts 11 and 101 Nor will the amendments have concerns follows: [Docket No. FDA–2011–F–0171] for environmental health or safety risks § 1312.1 Purpose. that may disproportionately affect Calorie Labeling of Articles of Food in (a)* * *. The regulations in this part children, have significant effect on the Vending Machines: Guidance for also enable TVA’s law enforcement supply, distribution, or use of energy, or Industry; Small Entity Compliance agents to issue petty offense citations for disproportionally impact low-income or Guide; Availability violations of any provision of 16 U.S.C. minority populations. Accordingly, this 470ee or 16 U.S.C. 433. AGENCY: Food and Drug Administration, final rule has no implications for any of * * * * * HHS. the referenced authorities. ■ 3. In § 1312.2, paragraph (c) is added ACTION: Notification of availability. B. Regulatory Flexibility Act to read as follows: SUMMARY: The Food and Drug Under the Regulatory Flexibility Act, § 1312.2 Authority. Administration (FDA or we) is 5 U.S.C. 601 et seq., TVA is required to * * * * * announcing the availability of a prepare a regulatory flexibility analysis (c) Provisions pertaining to the guidance for industry entitled ‘‘Calorie unless the head of the agency certifies issuance of petty offense citations are Labeling of Articles of Food in Vending that the proposal will not have a based on the duties and powers Machines—Small Entity Compliance significant economic impact on a assigned to TVA’s law enforcement Guide.’’ The small entity compliance substantial number of small entities. agents under 16 U.S.C. 831–831ee. guide (SECG) is intended to help small TVA’s Chief Executive Officer has entities comply with the final rule certified that the amendments ■ 4. In § 1312.3, paragraph (j) is added entitled ‘‘Food Labeling; Calorie promulgated in this final rule will not to read as follows: Labeling of Articles of Food in Vending have a significant economic impact on § 1312.3 Definitions. Machines.’’ a substantial number of small entities within the meaning of the Regulatory * * * * * DATES: Submit either electronic or Flexibility Act. This determination is (j) Director means the Director of TVA written comments on FDA guidances at based on the finding that the Police and Emergency Management any time. amendments are directed toward assigned the function and responsibility ADDRESSES: You may submit comments Federal resource management to help of supervising TVA employees as follows: prevent loss or destruction of designated as law enforcement agents under 16 U.S.C. 831c–3(a). Electronic Submissions archaeological resources, with no economic impact on the public. ■ 5. Section 1312.22 is added to read as Submit electronic comments in the follows: following way: C. Paperwork Reduction Act of 1995 (44 • Federal eRulemaking Portal: http:// U.S.C. 3501 et seq.) § 1312.22 Issuance of citations for petty www.regulations.gov. Follow the This rule does not contain offenses. instructions for submitting comments. asabaliauskas on DSK3SPTVN1PROD with RULES information collection requirements that Any person who violates any Comments submitted electronically, require approval by OMB under the provision contained in 16 U.S.C. 470ee including attachments, to http:// Paperwork Reduction Act. or 16 U.S.C. 433 in the presence of a www.regulations.gov will be posted to TVA law enforcement agent may be the docket unchanged. Because your List of Subjects in 18 CFR Part 1312 tried and sentenced in accordance with comment will be made public, you are Administrative practice and the provisions of section 3401 of Title solely responsible for ensuring that your procedure, Historic Preservation, 18, United States Code. Law comment does not include any Indians—lands, Penalties, Public Lands, enforcement agents designated by the confidential information that you or a VerDate Sep<11>2014 18:12 Aug 15, 2016 Jkt 238001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\16AUR1.SGM 16AUR1

54500 Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Rules and Regulations third party may not wish to be posted, made publicly available, you can that the compliance date for type size such as medical information, your or provide this information on the cover front-of-pack labeling requirements anyone else’s Social Security number, or sheet and not in the body of your (§ 101.8(b)(2) (21 CFR 101.8(b)(2))) and confidential business information, such comments and you must identify this calorie disclosure requirements as a manufacturing process. Please note information as ‘‘confidential.’’ Any (§ 101.8(c)(2)) for certain gums, mints, that if you include your name, contact information marked as ‘‘confidential’’ and roll candy products in glass-front information, or other information that will not be disclosed except in machines in the final rule published identifies you in the body of your accordance with 21 CFR 10.20 and other December 1, 2014 (79 FR 71259) is comments, that information will be applicable disclosure law. For more extended to July 26, 2018. The posted on http://www.regulations.gov. information about FDA’s posting of compliance date for all other • If you want to submit a comment comments to public dockets, see 80 FR requirements in the final rule (79 FR with confidential information that you 56469, September 18, 2015, or access 71259) remains December 1, 2016. do not wish to be made available to the the information at: http://www.fda.gov/ We examined the economic public, submit the comment as a regulatoryinformation/dockets/ implications of the final rule as required written/paper submission and in the default.htm. by the Regulatory Flexibility Act (5 manner detailed (see ‘‘Written/Paper Docket: For access to the docket to U.S.C. 601–612) and determined that Submissions’’ and ‘‘Instructions’’). read background documents or the the final rule will have a significant electronic and written/paper comments economic impact on a substantial Written/Paper Submissions received, go to http:// number of small entities. In compliance Submit written/paper submissions as www.regulations.gov and insert the with section 212 of the Small Business follows: docket number, found in brackets in the Regulatory Enforcement Fairness Act • Mail/Hand delivery/Courier (for (Pub. L. 104–121, as amended by Pub. heading of this document, into the written/paper submissions): Division of L. 110–28), we are making available the ‘‘Search’’ box and follow the prompts Dockets Management (HFA–305), Food SECG to explain the actions that a small and/or go to the Division of Dockets and Drug Administration, 5630 Fishers entity must take to comply with the Management, 5630 Fishers Lane, Rm. Lane, Rm. 1061, Rockville, MD 20852. rule. • For written/paper comments 1061, Rockville, MD 20852. Submit written requests for single We are issuing the SECG consistent submitted to the Division of Dockets with our good guidance practices Management, FDA will post your copies of the guidance to the Office of Nutrition and Food Labeling, Food regulation (21 CFR 10.115(c)(2)). The comment, as well as any attachments, SECG represents our current thinking on except for information submitted, Labeling and Standards Staff, Center for Food Safety and Applied Nutrition calorie labeling for foods sold in marked and identified, as confidential, vending machines operated by a person if submitted as detailed in (HFS–305), Food and Drug Administration, 5001 Campus Dr., engaged in the business of owning or ‘‘Instructions.’’ operating 20 or more vending machines, Instructions: All submissions received College Park, MD 20740. Send two self- addressed adhesive labels to assist that or a person who voluntarily registers must include the Docket No. FDA– with FDA to be covered by the rule. It 2011–F–0171 for ‘‘Calorie Labeling of office in processing your request. See the SUPPLEMENTARY INFORMATION section does not create or confer any rights for Articles of Food in Vending Machines— or on any person and does not operate Small Entity Compliance Guide.’’ for electronic access to the guidance. to bind FDA or the public. An Received comments will be placed in FOR FURTHER INFORMATION CONTACT: alternative approach may be used if the docket and, except for those Ashley N. Rulffes, Center for Food such approach satisfies the submitted as ‘‘Confidential Safety and Applied Nutrition (HFS– requirements of the applicable statutes Submissions,’’ publicly viewable at 820), Food and Drug Administration, and regulations. http://www.regulations.gov or at the 5001 Campus Dr., College Park, MD Division of Dockets Management 20740, 240–402–2371. II. Paperwork Reduction Act of 1995 between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION: This SECG refers to collections of through Friday. information described in FDA’s final • Confidential Submissions—To I. Background rule that published in the Federal submit a comment with confidential In the Federal Register of December 1, Register of December 1, 2014, and that information that you do not wish to be 2014 (79 FR 71259), we issued a final will be effective on December 1, 2016. made publicly available, submit your rule requiring vending machine As stated in the final rule, these comments only as a written/paper operators who own or operate 20 or collections of information are subject to submission. You should submit two more vending machines, or who review by the Office of Management and copies total. One copy will include the voluntarily register to be covered, to Budget (OMB) under the Paperwork information you claim to be confidential provide calorie declarations for those Reduction Act of 1995 (the PRA) (44 with a heading or cover note that states foods sold from vending machines for U.S.C. 3501–3520). The collections of ‘‘THIS DOCUMENT CONTAINS which the Nutrition Facts label cannot information in the final rule have been CONFIDENTIAL INFORMATION.’’ The be examined before purchase or for approved under OMB control number Agency will review this copy, including which visible nutrition information is 0910–0782. An Agency may not conduct the claimed confidential information, in not otherwise provided at the point of or sponsor, and a person is not required its consideration of comments. The purchase (the final rule). Covered to respond to, a collection of asabaliauskas on DSK3SPTVN1PROD with RULES second copy, which will have the vending machine operators must information unless it displays a claimed confidential information comply with the rule by December 1, currently valid OMB control number. redacted/blacked out, will be available 2016. However, in the Federal Register for public viewing and posted on http:// of August 1, 2016 (81 FR 50303), we III. Electronic Access www.regulations.gov. Submit both issued a final rule entitled ‘‘Food Persons with access to the Internet copies to the Division of Dockets Labeling; Calorie Labeling of Articles of may obtain the SECG at either http:// Management. If you do not wish your Food in Vending Machines; Extension www.fda.gov/Food/ name and contact information to be of Compliance Date.’’ This rule provides GuidanceRegulation/ VerDate Sep<11>2014 18:12 Aug 15, 2016 Jkt 238001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\FR\FM\16AUR1.SGM 16AUR1

Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Rules and Regulations 54501 GuidanceDocuments such as medical information, your or sheet and not in the body of your RegulatoryInformation/default.htm or anyone else’s Social Security number, or comments and you must identify this http://www.regulations.gov. Use the confidential business information, such information as ‘‘confidential.’’ Any FDA Web site listed in the previous as a manufacturing process. Please note information marked as ‘‘confidential’’ sentence to find the most current that if you include your name, contact will not be disclosed except in version of the guidance. information, or other information that accordance with 21 CFR 10.20 and other Dated: August 11, 2016. identifies you in the body of your applicable disclosure law. For more comments, that information will be information about FDA’s posting of Jeremy Sharp, posted on http://www.regulations.gov. comments to public dockets, see 80 FR Deputy Commissioner for Policy, Planning, • If you want to submit a comment Legislation and Analysis. 56469, September 18, 2015, or access with confidential information that you the information at: http://www.fda.gov/ [FR Doc. 2016–19492 Filed 8–15–16; 8:45 am] do not wish to be made available to the regulatoryinformation/dockets/ BILLING CODE 4164–01–P public, submit the comment as a default.htm. written/paper submission and in the Docket: For access to the docket to manner detailed (see ‘‘Written/Paper read background documents or the DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments HUMAN SERVICES Written/Paper Submissions received, go to http:// Food and Drug Administration www.regulations.gov and insert the Submit written/paper submissions as docket number, found in brackets in the follows: heading of this document, into the 21 CFR part 101 • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts [Docket No. FDA–2011–F–0171] written/paper submissions): Division of and/or go to the Division of Dockets Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm. Calorie Labeling of Articles of Food in and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852. Vending Machines; Draft Guidance for Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments Submit written requests for single Industry; Availability submitted to the Division of Dockets copies of the guidance to Food Labeling AGENCY: Food and Drug Administration, Management, FDA will post your and Standards Staff, Office of Nutrition HHS. comment, as well as any attachments, and Food Labeling, Center for Food ACTION: Notification of availability. except for information submitted, Safety and Applied Nutrition (HFS– marked and identified, as confidential, 820), Food and Drug Administration, SUMMARY: The Food and Drug 5001 Campus Dr., College Park, MD if submitted as detailed in Administration (FDA or we) is 20740. Send two self-addressed ‘‘Instructions.’’ announcing the availability of a draft Instructions: All submissions received adhesive labels to assist that office in guidance for industry, entitled ‘‘Calorie must include the Docket No. FDA– processing your request. See the Labeling of Articles of Food in Vending 2011–F–0171 for Calorie Labeling of SUPPLEMENTARY INFORMATION section for Machines.’’ The draft guidance, when Articles of Food in Vending Machines; electronic access to the guidance. finalized, will help covered vending Draft Guidance for Industry. Received FOR FURTHER INFORMATION CONTACT: machine operators and industry to comments will be placed in the docket Felicia B. Billingslea, Center for Food better understand and comply with the and, except for those submitted as Safety and Applied Nutrition (HFS– final rule entitled ‘‘Food Labeling: ‘‘Confidential Submissions,’’ publicly 820), Food and Drug Administration, Calorie Labeling of Articles of Food in viewable at http://www.regulations.gov 5001 Campus Dr., College Park, MD Vending Machines.’’ or at the Division of Dockets 20740, 240–402–2371. DATES: Although you can comment on Management between 9 a.m. and 4 p.m., SUPPLEMENTARY INFORMATION: any guidance at any time (see 21 CFR Monday through Friday. 10.115(g)(5)), to ensure that we consider • Confidential Submissions—To I. Background your comment on the draft guidance submit a comment with confidential We are announcing the availability of before we begin work on the final information that you do not wish to be a draft guidance for industry entitled version of the guidance, submit either made publicly available, submit your ‘‘Calorie Labeling of Articles of Food in electronic or written comments on the comments only as a written/paper Vending Machines.’’ We are issuing the draft guidance by September 30, 2016. submission. You should submit two draft guidance consistent with our good ADDRESSES: You may submit comments copies total. One copy will include the guidance practices regulation (21 CFR as follows: information you claim to be confidential 10.115). The draft guidance, when with a heading or cover note that states finalized, will represent the current Electronic Submissions ‘‘THIS DOCUMENT CONTAINS thinking of the FDA on this topic. It Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The does not establish any rights for any following way: Agency will review this copy, including person and is not binding on FDA or the • Federal eRulemaking Portal: http:// the claimed confidential information, in public. You can use an alternate www.regulations.gov. Follow the its consideration of comments. The approach if it satisfies the requirements instructions for submitting comments. second copy, which will have the of the applicable statutes and Comments submitted electronically, claimed confidential information regulations. asabaliauskas on DSK3SPTVN1PROD with RULES including attachments, to http:// redacted/blacked out, will be available In the Federal Register of December 1, www.regulations.gov will be posted to for public viewing and posted on http:// 2014 (79 FR 71259), we issued a final the docket unchanged. Because your www.regulations.gov. Submit both rule entitled ‘‘Food Labeling: Calorie comment will be made public, you are copies to the Division of Dockets Labeling of Articles of Food in Vending solely responsible for ensuring that your Management. If you do not wish your Machines’’ (‘‘the rule’’). The rule is comment does not include any name and contact information to be codified at 21 CFR 101.8. The rule confidential information that you or a made publicly available, you can requires vending machine operators third party may not wish to be posted, provide this information on the cover who own or operate 20 or more vending VerDate Sep<11>2014 18:12 Aug 15, 2016 Jkt 238001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\16AUR1.SGM 16AUR1


Document Created: 2016-08-16 03:20:41
Document Modified: 2016-08-16 03:20:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionNotification of availability.
DatesSubmit either electronic or written comments on FDA guidances at any time.
ContactAshley N. Rulffes, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371.
FR Citation81 FR 54499 
CFR Citation21 CFR 101
21 CFR 11
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR