12901 Federal Register / Vol. 83, No. 58 / Monday, March 26, 2018 / Proposed Rules 
(2) Its one-part rates that include fixed 
costs, by 
(3) The percentage calculated 
consistent with the instructions to FERC 
Form No. 501–G prescribed by § 260.402 of this chapter. 
(d) Timing. Any natural gas company 
filing to reduce its rates pursuant to this section must do so no later than the date that it files its FERC Form No. 501–G pursuant to § 260.402. 
(e) Hearing Issues. (1) The only issues 
that may be raised by Commission staff 
or any intervenor under the procedures established in this section are: 
(i) Whether or not the natural gas 
company may file under this section. 
(ii) Whether or not the percentage 
reduction permitted in § 154.402(c)(iii) has been properly applied, and 
(iii) Whether or not the correct 
information was used in that calculation. 
(2) Any other issue raised will be 
severed from the proceeding and dismissed without prejudice. 
PART 260—STATEMENTS AND 
REPORTS (SCHEDULES) 
■3. The authority citation for part 260 
continues to read as follows: 
Authority: 15 U.S.C. 717–717w, 3301– 
3432; 42 U.S.C. 7101–7352. 
■4. Add § 260.402 to read as follows: 
§ 260.402 FERC Form No. 501–G. One-time 
Report on Rate Effect of the Tax Cuts and Jobs Act. 
(a) Prescription. The form for the One- 
time Report on Rate Effect of the Tax 
Cuts and Jobs Act of 2017, designated herein as FERC Form No. 501–G is prescribed. 
(b) Filing requirement. (1) Who must 
file. (i) Except as provided in paragraph (b)(1)(ii) of this section, every natural gas company that is required under this part to file a Form No. 2 or 2A for 2017 and has cost-based rates for service under any rate schedule that were filed electronically pursuant to part 154 of this chapter, must prepare and file with the Commission a FERC Form No. 501– G pursuant to the definitions and instructions set forth in that form and the Implementation Guide. 
(ii) A natural gas company whose 
rates are being examined in a general rate case under section 4 of the Natural Gas Act or in an investigation under section 5 of the Natural Gas Act need not file FERC Form No. 501–G. In addition, a natural gas company that files an uncontested settlement of its rates pursuant to § 385.207(a)(5) of this chapter after March 26, 2018 need not file FERC Form No. 501–G. 
(2) FERC Form No. 501–G must be 
filed as prescribed in § 385.2011 of this chapter as indicated in the instructions set out in the form and Implementation Guide, and must be properly completed and verified. Each natural gas company must file FERC Form No. 501–G according to the schedule set forth in the Implementation Guide set out in that form. Each report must be prepared in conformance with the Commission’s form and guidance posted and available for downloading from the FERC website (http://www.ferc.gov). One copy of the report must be retained by the respondent in its files. 
PART 284—CERTAIN SALES AND 
TRANSPORTATION OF NATURAL GAS UNDER THE NATURAL GAS POLICY ACT OF 1978 AND RELATED AUTHORITIES 
■5. The authority citation for part 284 
continues to read as follows: 
Authority: 15 U.S.C. 717–717z, 3301–3432; 
42 U.S.C. 7101–7352; 43 U.S.C. 1331–1356. 
■6. In § 284.123, add paragraph (i) to 
read as follows: 
§ 284.123 Rates and charges. 
* * * * * 
(i) If an intrastate pipeline’s rates on 
file with the appropriate state regulatory agency are reduced to reflect the reduced income tax rates adopted in the Tax Cuts and Jobs Act of 2017, the intrastate pipeline must file a new rate election pursuant to paragraph (b) of this section not later than 30 days after the reduced intrastate rate becomes effective. This requirement applies regardless of whether the intrastate pipeline’s existing interstate rates are based on § 284.123(b)(1) or (2). 
[FR Doc. 2018–05669 Filed 3–23–18; 8:45 am] 
BILLING CODE 6717–01–P 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 
Food and Drug Administration 
21 CFR Parts 1100, 1140, and 1143 
[Docket No. FDA–2017–N–6107] 
RIN 0910–AH88 
Regulation of Premium Cigars 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Advance notice of proposed 
rulemaking. 
SUMMARY : The Food and Drug 
Administration (FDA) is issuing this 
advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of premium cigars under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and regulations regarding the sale and distribution of tobacco products. Specifically, this ANPRM is seeking comments, data, research results, or other information that may inform regulatory actions FDA might take with respect to premium cigars. 
DATES : Submit either electronic or 
written comments by June 25, 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 June 25, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern Time at the end of June 25, 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. 
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. 
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1In the U.S. Code, the tobacco control provisions 
constitute a new Subchapter IX of Chapter 9, which 
constitutes the Federal Food, Drug, and Cosmetic Act. •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–6107 for ‘‘Regulation of Premium Cigars.’’ 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 : 
Nathan Mease or Deirdre Jurand, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1–877– 287–1373, AskCTP@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : 
I. Background 
On July 28, 2017, FDA announced a 
new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect children and significantly reduce tobacco-related disease and death. As part of that announcement, FDA stated that it would solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars and consider the appropriate regulatory status of premium cigars. The goal is to ensure that FDA has a broad scientific and regulatory foundation to efficiently and effectively implement the Tobacco Control Act. Moreover, the regulatory considerations with respect to premium cigars, their use, and related public health issues continue to be of significant interest to some stakeholders, as well as a topic of ongoing and emerging research. Given the ongoing interest from many parties and sectors, such as industry and Members of Congress, in the regulatory status of premium cigars, FDA is issuing this ANPRM to request relevant new and different information, data, and analysis not submitted in response to FDA’s proposed deeming rule (79 FR 23142, discussed below) that could inform FDA’s regulation of premium cigars. 
The Tobacco Control Act was enacted 
on June 22, 2009, amending the FD&C Act and providing FDA with the authority to regulate tobacco products (Pub. L. 111–31). Specifically, section 101(b) of the Tobacco Control Act amends the FD&C Act by adding a new chapter that provides FDA with authority over tobacco products. Section 901 of the FD&C Act (21 U.S.C. 387a), as amended by the Tobacco Control Act, states that the new chapter in the FD&C Act (chapter IX—Tobacco Products) (21 U.S.C. 387 through 387u)
1applies to all 
cigarettes, cigarette tobacco, roll-your- own tobacco, smokeless tobacco, and any other tobacco products that the Secretary of Health and Human Services by regulation deems to be subject to the chapter. 
In the Federal Register of April 25, 
2014 (79 FR 23142), FDA published a proposed rule seeking to deem additional products meeting the 
statutory definition of ‘‘tobacco product’’ in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), except accessories to those products, to be subject to chapter IX of the FD&C Act (the proposed deeming rule). In that proposed rule, FDA proposed two, alternative, options: Option 1 proposed to extend the Agency’s tobacco product authorities to all products that meet the definition of ‘‘tobacco product’’ in the FD&C Act, except accessories of newly deemed tobacco products, while Option 2 proposed to extend the Agency’s tobacco product authorities to all tobacco products set forth in Option 1, except so-called premium cigars (79 FR 23142 at 23150 through 23152). After carefully considering the public comments on the rule, the Agency decided to adopt Option 1, concluding that there was no appropriate public health justification to exclude premium cigars from regulation. Specifically, FDA concluded that: (1) All cigars pose serious negative health risks, (2) the available evidence does not provide a basis for FDA to conclude that the patterns of premium cigar use sufficiently reduce the health risks to warrant exclusion, and (3) premium cigars are used by youth and young adults. FDA noted that, although some premium cigar smokers might smoke these products infrequently or report that they do not inhale, these behaviors do not negate the adverse health effects of tobacco smoke or demonstrate that cigars do not cause secondhand smoke- related disease in others. Consequently, premium cigars were included in the scope of the final deeming rule published on May 10, 2016 (81 FR 28974 at 29020) to more effectively protect the public health. 
We received numerous comments on 
the deeming proposed rule with respect to premium cigars, both in favor of and against regulating these products. However, the comments against regulation provided little data to support the opinions expressed and, where studies were submitted, provided little information about the studies cited. 
FDA is seeking comments, evidence, 
information, data, and analysis that were not submitted in response to the proposed deeming rule, or that may have become available since then, that could further inform FDA’s thinking about the regulation of premium cigars. One example of the type of information that would be responsive to this request is a recent publication that assessed use patterns and related behaviors of 
smokers of ‘‘premium’’ and other cigar types (Ref. 1). This paper, the PATH 
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2While authors of the PATH Study Paper 
included FDA employees, the definition of 
premium cigars reported in the PATH Study Paper was used for research purposes only, and does not necessarily reflect FDA’s current thinking on regulatory policy. Study Paper, analyzed findings from the 
2013–2014 Population Assessment of Tobacco and Health (PATH) Study with a focus on smokers of filtered cigars, cigarillos, and traditional cigars, which were further classified by study authors as either ‘‘premium’’ or ‘‘non- premium.’’
2With respect to this group 
of smokers, the PATH Study Paper described similarities and differences in user characteristics, tobacco use patterns, and purchasing behaviors according to cigar type. Among the findings stated in this PATH Study Paper were that those who smoked ‘‘premium’’ cigars tended to report smoking them on fewer days compared with smokers of the other cigar types and reported consuming fewer cigars per day, on average, compared with smokers of other cigar types. In its conclusion, the PATH Study Paper highlighted the importance of adequately describing the cigar type studied and, where appropriate, differentiating results by cigar type. 
When reviewing the PATH Study 
Paper and any other studies concerning cigars, it should be noted that tobacco research studies have not used a single, consistent definition of ‘‘premium’’ cigars. As demonstrated by FDA’s request for definitional information in this document, FDA considers it important to understand what definitions of premium cigar are used when analyzing and comparing results across studies and papers. 
For the purposes of the questions in 
this ANPRM, ‘‘cigar’’ means a tobacco product that: (1) Is not a cigarette and (2) is a roll of tobacco wrapped in leaf tobacco or any substance containing tobacco (see 21 CFR 1143.1). 
II. Requests for Comments and 
Information 
FDA is seeking comments, data, 
research results, and other information related to the following topics: 
•Definition of premium cigars 
•Use patterns of premium cigars 
•Public health considerations 
associated with premium cigars 
Please provide any evidence or other 
information supporting your comments. 
Also, provide the definition of ‘‘premium cigar,’’ ‘‘youth,’’ and ‘‘young adult’’ used for the studies, information, or views provided in your responses. A. Definition of Premium Cigars 
1. Explain what data may be used to 
assess (a) the universe of cigar products that are currently available to consumers and (b) their relevant characteristics, including ‘‘premium’’ status. How can available sources of information, such as manufacturer registrations and/or product listings with FDA, be used in this assessment? 
2. Explain what you believe to be the 
particular defining characteristics of premium cigars. These characteristics could include, but not be limited to: 
a. Size (e.g., length, ring gauge, total 
weight). 
b. Tobacco filler type and minimum 
required percentages of each filler per cigar. 
c. Fermentation type. 
d. Wrapper and binder composition 
(e.g., whole leaf, reconstituted or 
homogenized tobacco leaf). 
e. Where the tobacco used for 
premium cigar filler or wrappers is 
grown, and whether differences in growing practices for that tobacco, as compared to tobacco used in other cigars, result in different health impacts. 
f. Presence or absence of a filter. 
g. Presence or absence of a 
mouthpiece. 
h. Manufacturing and assembly 
process (e.g., including any production 
by hand or by machine). 
i. Rate of production (e.g., ‘‘produced 
at no more than [insert number] units 
per minute’’). 
j. Presence or absence of flavor 
imparting compounds, flavor additives, or characterizing flavors other than tobacco. 
k. Presence or absence of any 
additives other than cigar glue. 
l. Nicotine content. 
m. Tar delivery amounts (and how 
this should be defined and measured). 
n. Carbon monoxide delivery amounts 
(and how this should be defined and 
measured). 
o. Retail price. 
p. Frequency with which price 
changes are initiated by particular levels 
in the distribution chain (retailers, manufacturers, importers, and/or distributors). 
q. Packaging quantity and size. 
r. Any action directed to consumers, 
by a retailer or manufacturer, such as 
through labeling, advertising, or marketing, which would reasonably be expected to result in consumers believing that the tobacco product is a premium cigar. 
3. If available to you, provide annual 
sales data, including market size and volume, for products that you believe should be categorized as premium cigars, along with the information’s source and the definition of ‘‘premium cigar’’ used in the data provided. 
B. Use Patterns of Premium Cigars 
If available to you, provide the 
following information related to the use 
patterns of premium cigars generally and among youth and young adults specifically: 
1. Studies or information regarding 
the potential role of premium cigars on tobacco initiation and progression to use of other tobacco products, especially compared and contrasted against the potential roles of other cigars. 
2. Studies or information regarding 
behavioral data related to dual use of premium cigars and other tobacco products, especially compared and contrasted against dual use of other cigars. 
3. Studies or information regarding 
the frequency and intensity (e.g., number of cigars smoked per day, depth of smoke inhalation, number of days smoking during a particular time period) of premium cigar use, especially compared and contrasted against other cigars. 
4. Studies or information regarding 
the proportion of premium cigar smokers showing symptoms of dependence, especially compared and contrasted against other cigars. 
5. Studies or information regarding 
the abuse liability of premium cigars compared with other tobacco products, especially compared and contrasted against other cigars. 
6. Studies or information regarding 
the impact of premium cigar labeling, advertising, and marketing efforts on patterns of use, especially compared and contrasted against other cigars. 
7. Information on the extent to which 
users of other tobacco products might switch to premium cigars if FDA were to exempt premium cigars from regulation or to regulate premium cigars differently from other cigars, and the measures that could be taken to prevent this from occurring. Where you discuss the potential effects of FDA regulating premium cigars differently from other cigars, please describe the specific different treatment that you envision. 
C. Public Health Considerations 
If available to you, provide the 
following information related to public 
health considerations: 
1. Studies or information on any 
applicable manufacturing, marketing, sale, distribution, advertising, labeling, and/or packaging requirements and restrictions in the FD&C Act and its implementing regulations, and whether they should be applied differently to 
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premium cigars compared to other 
tobacco products, including other cigars. 
2. Studies or information regarding 
nicotine concentrations for premium cigars compared to other tobacco products, including other cigars. 
3. Studies or information regarding 
the risk of oral cancer, esophageal cancer, laryngeal cancer, lung cancer, or any other form of cancer associated with premium cigars, especially compared and contrasted with risks for other cigars. 
4. Studies or information regarding 
the risk of heart disease associated with premium cigars, especially compared and contrasted with risks for other cigars. 
5. Studies or information regarding 
the risk of aortic aneurysm associated with premium cigars, especially compared and contrasted with risks for other cigars. 
6. Studies or information regarding 
the risk of periodontal disease associated with premium cigars, especially compared and contrasted with risks for other cigars. 
7. Studies or information regarding 
the risk of stroke associated with premium cigars, especially compared and contrasted with risks for other cigars. 
8. Studies or information regarding 
the risk of chronic obstructive pulmonary disease associated with premium cigars, especially compared and contrasted with risks for other cigars. 
9. Studies or information regarding 
risk of cancers of the mouth and throat for premium cigar users who do not inhale or who report that they do not inhale, especially compared and contrasted with risks for other cigars. 
10. Studies or information on the 
impact of premium cigar use on other public health endpoints, including users and non-users, especially compared and contrasted with the impact of other cigars. 
11. Studies or information regarding 
the addictiveness of premium cigars. 
12. Studies or information regarding 
consumer perceptions of the health risks of premium cigars when compared to other tobacco products, including other cigars. 
13. Studies or information regarding 
consumer perceptions of the addictiveness of premium cigars, especially compared and contrasted with perceptions for other cigars. 
14. Studies or information on the 
required warning statements, shown below and which will be required to appear on cigar packaging and advertising in the near future (21 CFR 1143.5(a)(1)). Comment on whether any additional or alternative warning statements would be appropriate and provide your suggested language and any relevant studies or information. 
a. WARNING: Cigar smoking can 
cause cancers of the mouth and throat, even if you do not inhale. 
b. WARNING: Cigar smoking can 
cause lung cancer and heart disease. 
c. WARNING: Cigars are not a safe 
alternative to cigarettes. 
d. WARNING: Tobacco smoke 
increases the risk of lung cancer and heart disease, even in nonsmokers. 
e. WARNING: Cigar use while 
pregnant can harm you and your baby; or SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight. 
f. WARNING: This product contains 
nicotine. Nicotine is an addictive chemical. 
III. Reference 
The following reference is on display 
in the Dockets Management Staff (see 
ADDRESSES ) and is available for viewing 
by interested persons between 9 a.m. 
and 4 p.m., Monday through Friday; it is also available electronically at https:// 
www.regulations.gov. FDA has verified 
the website address, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 
1. Corey, C.G., E. Holder-Hayes, A.B. Nguyen, 
et al. ‘‘U.S. Adult Cigar Smoking 
Patterns, Purchasing Behaviors, and Reasons for Use According to Cigar Type: Findings From the Population Assessment of Tobacco and Health (PATH) Study, 2013–2014’’, Nicotine & Tobacco Research, September 15, 2017, available at https://academic.oup.com/ ntr/article/4159211/U-S-adult-cigar- smoking-patterns-purchasing. 
Dated: March 21, 2018. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2018–06047 Filed 3–23–18; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF LABOR 
Mine Safety and Health Administration 
30 CFR Parts 57, 70, 72, and 75 
[Docket No. MSHA–2014–0031] 
RIN 1219–AB86 
Exposure of Underground Miners to 
Diesel Exhaust 
AGENCY : Mine Safety and Health 
Administration, Labor. ACTION : Request for information; 
reopening of the rulemaking record for 
public comments. 
SUMMARY : In response to requests from 
the public, the Mine Safety and Health 
Administration (MSHA) is reopening the rulemaking record for public comments on the Agency’s request for information on Exposure of Underground Miners to Diesel Exhaust. 
DATES : The comment period for the 
request for information, published on June 8, 2016 (81 FR 36826), which closed on January 9, 2018 (82 FR 2284), is reopened. Comments must be received on or before midnight Eastern Standard Time on March 26, 2019. 
ADDRESSES : Submit comments and 
informational materials for the rulemaking record, identified by RIN 1219–AB86 or Docket No. MSHA–2014– 0031, by one of the following methods: 
•Federal E-Rulemaking Portal: 
http://www.regulations.gov. Follow the on-line instructions for submitting comments. 
•Email: zzMSHA-comments@
dol.gov. 
•Mail: MSHA, Office of Standards, 
Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, Virginia 22202–5452. 
•Hand Delivery or Courier: 201 12th 
Street South, Suite 4E401, Arlington, Virginia, between 9:00 a.m. and 5:00 p.m. Monday through Friday, except Federal holidays. Sign in at the receptionist’s desk on the 4th floor East, Suite 4E401. 
•Fax: 202–693–9441. 
Instructions: All submissions must 
include ‘‘RIN 1219–AB86’’ or ‘‘Docket No. MSHA–2014–0031.’’ Do not include personal information that you do not want publicly disclosed; MSHA will post all comments without change to http://www.regulations.gov and http://
arlweb.msha.gov/currentcomments.asp, including any personal information provided. 
Docket: For access to the docket to 
read comments received, go to http://www.regulations.gov or http://
arlweb.msha.gov/currentcomments.asp . 
To read background documents, go to http://www.regulations.gov. Review the docket in person at MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Arlington, Virginia, between 9:00 a.m. and 5:00 p.m. Monday through Friday, except Federal Holidays. Sign in at the receptionist’s desk in Suite 4E401. 
Email Notification: To subscribe to 
receive an email notification when MSHA publishes rules in the Federal Register, go to http://www.msha.gov/ subscriptions. 
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