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

General Comment:Dear Mr. Zeller:

I am an individual consumer who is writing 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 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 I will be able to live a longer and fuller life because these products have helped me quit combustible cigarettes. I would like 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.


[Federal Register Volume 79, Number 167 (Thursday, August 28, 2014)]
[Notices]
[Pages 51343-51344]
[FR Doc No: 2014-20481]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Risk Communications Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Risk Communications Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 3 and 4, 2014,
from 9 a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Luis G. Bravo, Office of Planning, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3274, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>or FDA Advisory Committee Information Line, 1-800-
741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    If you are unable to join us in person, we encourage you to watch
the free Webcast. Visit the Risk Communication Advisory Committee Web
site at http://

www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
RiskCommunicationAdvisoryCommittee/default.htm. The link will become
active shortly before the open session begins at 9 a.m.
    Interested persons can also log on to https://collaboration.fda.gov/rcac/ to see and hear the proceedings.
    Agenda: On November 3 and 4, 2014, the Risk Communication Advisory
Committee will discuss methods for effective risk communication with a
focus on messages about the importance of eating adequate amounts of
fish, while avoiding certain fish with higher amounts of methyl-
mercury. These messages are especially important for women who are
pregnant or nursing, or for anyone who prepares food for young
children.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 20, 2014. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on November 3 and 4, 2014.
Those individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
October 10, 2014. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by October 14,
2014.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Luis G. Bravo at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-20481 Filed 8-27-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Pages 61709-61710]
[FR Doc No: 2011-25708]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0708]

Agency Information Collection Activities; Proposed Collection;
Comment Request; FDA Form 3728, Animal Generic Drug User Fee Act Cover
Sheet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish a 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 the information collection
burden of the Animal Generic Drug User Fee Cover Sheet Form FDA 3728
that further implements certain provisions of the Animal Generic Drug
User Fee Act of 2008 (AGDUFA).

DATES: Submit either electronic or written comments on the collection
of information by December 5, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

FDA Form 3728, Animal Generic Drug User Fee Act Cover Sheet--21 U.S.C.
379j-21 (OMB Control Number 0910-0632)--Extension

    Section 741 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 379j-21) establishes three different kinds of user fees: (1)
Fees for certain types of abbreviated applications for generic new
animal drugs, (2) annual fees for certain generic new animal drug
products, and (3) annual fees for certain sponsors of abbreviated
applications for generic new animal drugs and/or investigational
submissions for generic new animal drugs (21 U.S.C. 379j-21(a)).
Because the submission of user fees concurrent with applications is
required, the review of an application cannot begin until the fee is
submitted. FDA Form 3728 is the AGDUFA Cover Sheet, which is designed
to provide the minimum necessary information to determine whether a fee
is required for review of an application, to determine the amount of
the fee required, and to account for and track user fees. FDA estimates
the burden of this collection of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                            FDA Form No.                                Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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FDA Form 3728......................................................              20                2               40              .08              3.2
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents to this collection of information are generic animal
drug applicants. Based on FDA's data base system, there are an
estimated 20 sponsors of new animal drugs potentially subject to
AGDUFA.

    Dated: September 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25708 Filed 10-4-11; 8:45 am]
BILLING CODE 4160-01-P


January 15, 2014
Monthly generator capacity factor data now available by fuel and technology

Source: U.S. Energy Information Administration, Electric Power Monthly, Tables 6.7a and 6.7b

Capacity factors are an important measure of electric generator usage. In December 2013, EIA began publishing tables of monthly capacity factors for 16 different fossil and non-fossil fuel and technology combinations in the Electric Power Monthly.
What is a capacity factor?
Capacity factors describe how intensively a fleet of generators is run. A capacity factor near 100% means a fleet is operating nearly all of the time. It is the ratio of a fleet's actual generation to its maximum potential generation.
In the past, EIA published annual capacity factors for only a few fuel types, and several renewable fuel types were aggregated. With an updated methodology and more detailed technology breakout, these new tables allow readers to distinguish between generators having different roles within the electric power system. Baseload generators, like nuclear units, typically have high capacity factors, while peaking generators like natural gas-fired combustion turbines have low capacity factors.
Monthly data allow users to see seasonal patterns, such as periods of nuclear refueling outages in the shoulder seasons (spring and fall) and increased operation of peaking generators during the periods of highest electricity demand in the summer months (driven primarily by air conditioning use).
EIA's new tables include capacity factors for individual renewable generating technologies (see chart below). Geothermal and waste technologies operate fairly steadily and at high capacity factors. Intermittent renewable sources like solar and wind tend to have lower capacity factors, as their output varies with the availability of the sun and wind on both a daily and seasonal basis. Solar generators -- particularly solar thermal -- operate at a minimum during winter months, while the U.S. wind fleet on average has a period of low production during the late summer. Hydroelectric generators show both seasonal and annual variations reflecting changing levels of precipitation, river flow, and snowmelt.

Source: U.S. Energy Information Administration, Electric Power Monthly, Tables 6.7a and 6.7b

Principal contributor: EIA Staff
Tags: capacity factor , electricity , generation , renewable