54499 Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Rules and Regulations 
Populations; E.O. 13045, Protection of 
Children from Environmental Health Risks; E.O. 13132, Federalism; E.O. 13175, Consultation and Coordination with Indian Tribal Governments; and E.O. 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, and Use; E.O. 12988, Civil Justice Reform Act. 
This final rule amends TVA’s 
regulations for the protection of archaeological resources by providing for issuance of petty offense citations by TVA’s law enforcement agents for 
violations of ARPA or AA. The rule is not subject to Office of Management and Budget Review under Executive Order 12866. The rule contains no Federal mandates for State, local, or tribal government or for the private sector. TVA has determined that these amendments will not have a significant annual effect of $100 million or more or result in expenditures of $100 million in any one year by State, local, or tribal governments or by the private sector. Nor will the amendments have concerns for environmental health or safety risks that may disproportionately affect children, have significant effect on the supply, distribution, or use of energy, or disproportionally impact low-income or minority populations. Accordingly, this final rule has no implications for any of the referenced authorities. 
B. Regulatory Flexibility Act 
Under the Regulatory Flexibility Act, 
5 U.S.C. 601 et seq., TVA is required to 
prepare a regulatory flexibility analysis 
unless the head of the agency certifies that the proposal will not have a significant economic impact on a substantial number of small entities. TVA’s Chief Executive Officer has certified that the amendments promulgated in this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act. This determination is based on the finding that the amendments are directed toward Federal resource management to help prevent loss or destruction of archaeological resources, with no economic impact on the public. 
C. Paperwork Reduction Act of 1995 (44 
U.S.C. 3501 et seq.) 
This rule does not contain 
information collection requirements that require approval by OMB under the Paperwork Reduction Act. 
List of Subjects in 18 CFR Part 1312 
Administrative practice and 
procedure, Historic Preservation, 
Indians—lands, Penalties, Public Lands, Reporting and recordkeeping requirements. 
For the reasons set out in the 
preamble, 18 CFR part 1312 is amended as follows: 
PART 1312—PROTECTION OF 
ARCHAEOLOGICAL RESOURCES: UNIFORM REGULATIONS 
■1. The authority citation for Part 1312 
is revised to read as follows: 
Authority: Pub. L. 96–95, 93 Stat. 721, as 
amended, 102 Stat. 2983 (16 U.S.C. 470aa– 
mm) (Sec. 10(a) & (b)); 16 U.S.C. 831–831ee (2012). Related Authority: Pub. L. 59–209, 34 Stat. 225 (16 U.S.C. 432, 433); Pub. L. 86– 523, 74 Stat. 220, 221 (16 U.S.C. 469), as amended, 88 Stat. 174 (1974); Pub. L. 89–665, 80 Stat. 915 (16 U.S.C. 470a–t), as amended, 84 Stat. 204 (1970), 87 Stat. 139 (1973), 90 Stat. 1320 (1976), 92 Stat. 3467 (1978), 94 Stat. 2987 (1980); Pub. L. 95–341, 92 Stat. 469 (42 U.S.C. 1996) 
■2. In § 1312.1, a sentence is added at 
the end of paragraph (a) to read as 
follows: 
§ 1312.1 Purpose. 
(a)* * *. The regulations in this part 
also enable TVA’s law enforcement agents to issue petty offense citations for violations of any provision of 16 U.S.C. 470ee or 16 U.S.C. 433. 
* * * * * 
■3. In § 1312.2, paragraph (c) is added 
to read as follows: 
§ 1312.2 Authority. 
* * * * * 
(c) Provisions pertaining to the 
issuance of petty offense citations are 
based on the duties and powers assigned to TVA’s law enforcement agents under 16 U.S.C. 831–831ee. 
■4. In § 1312.3, paragraph (j) is added 
to read as follows: 
§ 1312.3 Definitions. 
* * * * * 
(j) Director means the Director of TVA 
Police and Emergency Management assigned the function and responsibility of supervising TVA employees designated as law enforcement agents under 16 U.S.C. 831c–3(a). 
■5. Section 1312.22 is added to read as 
follows: 
§ 1312.22 Issuance of citations for petty 
offenses. 
Any person who violates any 
provision contained in 16 U.S.C. 470ee 
or 16 U.S.C. 433 in the presence of a TVA law enforcement agent may be tried and sentenced in accordance with the provisions of section 3401 of Title 18, United States Code. Law enforcement agents designated by the Director for that purpose shall have the authority to issue a petty offense citation for any such violation, requiring any person charged with the violation to appear before a United States Magistrate Judge within whose jurisdiction the archaeological resource impacted by the violation is located. The term ‘‘petty offense’’ has the same meaning given that term under section 19 of Title 18, United States Code. 
Dated: August 8, 2016. 
Rebecca C. Tolene, 
Deputy General Counsel and Vice President, 
Natural Resources. 
[FR Doc. 2016–19343 Filed 8–15–16; 8:45 am] 
BILLING CODE 8120–08–P 
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 
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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 (§ 101.8(b)(2) (21 CFR 101.8(b)(2))) and calorie disclosure requirements (§ 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/ 
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GuidanceDocuments
RegulatoryInformation/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 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR part 101 
[Docket No. FDA–2011–F–0171] 
Calorie Labeling of Articles of Food in 
Vending Machines; Draft Guidance for Industry; 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 draft guidance for industry, entitled ‘‘Calorie Labeling of Articles of Food in Vending Machines.’’ The draft guidance, when finalized, will help covered vending machine operators and industry to better understand and comply with the final rule entitled ‘‘Food Labeling: Calorie Labeling of Articles of Food in Vending Machines.’’ 
DATES : Although you can comment on 
any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 30, 2016. 
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 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; Draft Guidance for Industry. 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 Food Labeling and Standards Staff, Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition (HFS– 820), 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 : 
Felicia B. Billingslea, 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 
We are announcing the availability of 
a draft guidance for industry entitled ‘‘Calorie Labeling of Articles of Food in Vending Machines.’’ We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. 
In the Federal Register of December 1, 
2014 (79 FR 71259), we issued a final rule entitled ‘‘Food Labeling: Calorie Labeling of Articles of Food in Vending Machines’’ (‘‘the rule’’). The rule is codified at 21 CFR 101.8. The rule requires vending machine operators who own or operate 20 or more vending 
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