[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Notices]
[Pages 60477-60478]
[FR Doc No: 2014-23844]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1208]

Laboratory Site Tours Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration's (FDA's) Center for Tobacco
Products' (CTP) Office of Science is announcing an invitation for
participation in its Laboratory Site Tours Program. This program is
intended to give CTP staff an opportunity to visit facilities involved
in the testing and analysis of tobacco products and tobacco smoke.
These visits are intended to provide CTP staff with the opportunity to
gain a better understanding of tobacco science and laboratory
operations and are not intended as regulatory inspections or facility
visits for the purposes of developing Tobacco Product Manufacturing
Practice regulations. The purpose of this notice is to invite parties
interested in participating in the Laboratory Site Tours Program to
submit their requests to CTP.

DATES: Submit either an electronic or written request for participation
in this program by December 8, 2014. The request should include a
description of your facility, including, as applicable, a list of the
types of testing and analyses of tobacco products and tobacco smoke
performed. Please specify the physical address(es) of the site(s) for
which you are submitting a request, along with a proposed 1-day tour
agenda.

ADDRESSES: If your facility is interested in offering a site visit,
submit either an electronic request to http://www.regulations.gov or a
written request to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.

FOR FURTHER INFORMATION CONTACT: Carolyn Dresler, Center for Tobacco
Products, Food and Drug Administration, 10903 New Hampshire Ave.,
Document Control Center, Bldg. 71, rm. G335, Silver Spring, MD 20993-
0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Pub. L. 111-31) was signed into law, amending the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) and giving FDA authority to
regulate tobacco product manufacturing, distribution, and marketing.
    CTP's Office of Science is conducting the Laboratory Site Tours
Program to provide its scientific and regulatory staff the opportunity
to gain a better understanding of tobacco science and laboratory
operations, to include tobacco product testing and analysis. CTP's goal
for the Laboratory Site Tours Program is for its staff to gain: (1)
Firsthand exposure to laboratories that perform tobacco product testing
and (2)

knowledge of product analyses used by tobacco product manufacturers to
ensure product consistency.

II. Description of Site Tours Program

    In the Laboratory Site Tours Program, small groups of CTP staff
plan to observe the operations of laboratories that perform testing and
analyses of tobacco products and tobacco smoke relative to analytical
chemistry, microbiology, toxicology, biomarkers of exposure or risk,
and analytical method development. Please note that the Laboratory Site
Tours Program is not intended to include official FDA inspections of
facilities to determine compliance with the FD&C Act or for the
purposes of developing Tobacco Product Manufacturing Practice
regulations; rather, the program is meant to educate CTP staff and
improve their understanding of laboratory testing and analyses used by
the tobacco industry.

III. Site Selection

    CTP plans to select a wide variety of laboratories that include
academic, private, and those affiliated with tobacco manufacturers. All
travel expenses associated with the site tours will be the
responsibility of CTP. Final site selections will be based on the
availability of CTP funds and resources for the relevant fiscal year,
as well as the following factors, if applicable: (1) Compliance status
of the requesting facility and affiliated firm, (2) whether the
requesting facility is in arrears for user fees, and (3) whether the
requesting facility or affiliated firm has a significant request or
marketing application or submission pending with FDA.

IV. Requests for Participation

    Identify requests for participation with the docket number found in
brackets in the heading of this document. Received requests are
available for public examination in the Division of Dockets Management
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23844 Filed 10-6-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 228 (Wednesday, November 26, 2014)]
[Notices]
[Page 70516]
[FR Doc No: 2014-27944]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL15-21-000]

New England Power Generators Association, Inc. (Complainant) v.
ISO New England Inc. (Respondent); Notice of Complaint

    Take notice that on November 14, 2014, pursuant to Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.206 and sections 206 and 306 of the Federal
Power Act, the New England Power Generators Association, Inc (NEPGA or
Complainant) filed a formal complaint against the ISO New England Inc
(ISO-NE or Respondent), requesting that the Commission issue an order
directing ISO-NE to (1) disqualify all Demand Response Capacity
Resources from the ninth Forward Capacity Auction and (2) file
revisions to its Transmission, Markets & Services Tariff, as more fully
explained in the Complaint.
    The Complainant certifies that copies of the complaint were served
on the contacts for ISO-NE as listed on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on December 4, 2014.

     Dated: November 14, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-27944 Filed 11-25-14; 8:45 am]
BILLING CODE 6717-01-P