Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it Would be unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I Smoked Cigarettes for 39+ years. Tried Every thing on the market to quit. Nothing worked until I found E cigs. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 83, Number 211 (Wednesday, October 31, 2018)]
[Notices]
[Pages 54741-54742]
[FR Doc No: 2018-23757]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2014-0096; FRL-9984-04-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Iron and Steel Foundries Area
Sources (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NESHAP for Iron and Steel
Foundries Area Sources (EPA ICR Number 2267.05, OMB Control number
2060-0605), to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. This is a
proposed extension of the ICR, which is currently approved through
November 30, 2018. Public comments were previously requested via the
Federal Register on June 29, 2017 during a 60-day comment period. This
notice allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may neither conduct nor sponsor, and
a

person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before November 30,
2018.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2014-0096 to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to [email protected], or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to [email protected]. Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change, including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed either
online at www.regulations.gov or in person at the EPA Docket Center,
WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The
telephone number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Iron and Steel Foundries Area Sources (40 CFR
part 63, subpart ZZZZZ) apply to both new and existing iron and/or
steel foundries that are an area source of hazardous air pollutants
(HAP) emissions. There are different requirements for foundries based
on size. Existing foundries with an annual metal melt production
greater that 20,000 tons and new foundries with an annual melt capacity
of 10,000 tons are classified as large foundries. Existing foundries
with an annual metal melt capacity of 10,000 tons or less are
classified as small foundries. Research and development facilities are
not covered by the rule. New facilities include those that commenced
construction, modification or reconstruction after the date of
proposal. In general, all NESHAP standards require initial
notifications, performance tests, and periodic reports by the owners/
operators of the affected facilities. They are also required to
maintain records of the occurrence and duration of any startup,
shutdown, or malfunction in the operation of an affected facility, or
any period during which the monitoring system is inoperative. These
notifications, reports, and records are essential in determining
compliance with 40 CFR part 63, subpart ZZZZZ.
    Form Numbers: None.
    Respondents/affected entities: Iron and steel foundries.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart ZZZZZ).
    Estimated number of respondents: 392 (total).
    Frequency of response: Initially, occasionally, quarterly,
semiannually, and annually.
    Total estimated burden: 9,140 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $1,000,000 (rounded) (per year). No
annualized capital and/or operation & maintenance costs are included.
    Changes in the estimates: There is an adjustment increase in the
total estimated respondent burden compared with the ICR currently
approved by OMB. While the overall number of respondents has decreased
from 427 to 392 since the previous ICR renewal to account for shutdown
facilities, this renewal includes a burden estimate for each existing
respondent to familiarize themselves with regulatory requirements each
year. As a result, there is a net increase in the burden hours as
compared to the previous ICR renewal.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018-23757 Filed 10-30-18; 8:45 am]
 BILLING CODE 6560-50-P