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

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer and employee of a small store 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 want to respond to. I want to provide my thoughts and comments on many of these issues, but the time I have to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent countless hours researching and dissecting these issues, but they take a lot of time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all 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 have made my life better. 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.

John D Costa


[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Notices]
[Pages 16485-16486]
[FR Doc No: 2013-06059]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC13-7-000]

Commission Information Collection Activities (FERC-607); Comment
Request

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Comment request.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory
Commission (Commission or FERC) is submitting the information
collection, FERC-607 (Report on Decision or Action on Request for
Federal Authorization.), to the Office of Management and Budget (OMB)
for review of the information collection requirements. Any interested
person may file comments directly with OMB and should address a copy of
those comments to the Commission as explained below. The Commission
issued a Notice in the Federal Register (77 FR 76015, December 26,
2012) requesting public comments. FERC received no comments on the
FERC-607 and is making this notation in its submittal to OMB.

DATES: Comments on the collection of information are due by April 15,
2013.

ADDRESSES: Comments filed with OMB, identified by the OMB Control No.
1902-0240, should be sent via email to the Office of Information and
Regulatory Affairs<EMAIL_ADDRESS>Attention: Federal Energy
Regulatory Commission Desk Officer. The Desk Officer may also be
reached via telephone at<PHONE_NUMBER>.
    A copy of the comments should also be sent to the Federal Energy
Regulatory Commission, identified by the Docket

No. IC13-7-000, by either of the following methods:
     eFiling at Commission's Web Site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>by telephone at<PHONE_NUMBER>, and by fax at
(202) 273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-607: Report on Decision or Action on Request for
Federal Authorization.
    OMB Control No.: 1902-0240.
    Type of Request: Three-year extension of the FERC-607 information
collection requirements with no changes to the reporting requirements.
    Abstract: The FERC-607 information collection requires agencies
(Federal agency or officer, or State agency or officer acting pursuant
to delegated Federal authority, responsible for a Federal
authorization) to submit to the Commission a copy of a decision or
action on a request for Federal authorization and an accompanying index
to the documents and materials relied on in reaching a conclusion. The
Commission authorizes the construction and operation of proposed
natural gas projects under Natural Gas Act Sections 3 and 7; however,
the Commission does not have jurisdiction over every aspect of each
natural gas project. Hence, for a natural gas project to go forward, in
addition to Commission approval, several different agencies must
typically reach favorable findings regarding other aspects of the
project. The Energy Policy Act of 2005 (EPAct 2005) modified FERC's
role in order to better coordinate the activities of the separate
agencies with varying responsibilities over proposed natural gas
projects. Section 313 of EPAct 2005 \1\ directs FERC to compile a
record of each agency's decision along with the record of the
Commission's decision. The Commission compiles this record in order to
serve as a consolidated record for the purpose of appeal or review
(including judicial review).
---------------------------------------------------------------------------

    \1\ Amended 15 U.S.C. 717n (Section 15).
---------------------------------------------------------------------------

    Type of Respondents: Government agencies responsible for issuing
authorizations for proposed natural gas projects.
    Estimate of Annual Burden \2\: The Commission estimates the total
Public Reporting Burden for this information collection as:
---------------------------------------------------------------------------

    \2\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, reference 5 Code of Federal Regulations 1320.3.

                   FERC-607--Report on Decision or Action on Request for Federal Authorization
----------------------------------------------------------------------------------------------------------------
                        Number of responses      Total number of      Average burden hours     Estimated total
Number of respondents      per respondent           responses             per response          annual burden
(A)                                  (B)          (A) x (B) = (C)                  (D)                      (C)
----------------------------------------------------------------------------------------------------------------
                1                      1                      1                      6                      6
----------------------------------------------------------------------------------------------------------------

    The total estimated annual cost burden to respondents is $414 [6
hours / 2080 hours/year \3\ * $143,540/year \4\ = $414]
---------------------------------------------------------------------------

    \3\ 2080 hours = 52 weeks * 40 hours per week (i.e. 1 year of
full-time employment).
    \4\ Average salary plus benefits per full-time equivalent
employee.
---------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: March 11, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-06059 Filed 3-14-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 1, 2006 (Volume 71, Number 170)]
[Notices]
[Page 52202-52204]
[DOCID:fr01se06-98]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54368; File No. SR-NYSE-2005-58]

Self-Regulatory Organizations; New York Stock Exchange, Inc. (n/
k/a New York Stock Exchange LLC); Order Approving Proposed Rule Change
and Amendment No. 1 Thereto Relating to Exchange Rule 312(f) Regarding
Changes Within Member Organizations

 August 25, 2006.

I. Introduction

    On August 15, 2005, the New York Stock Exchange, Inc. (n/k/a New
York Stock Exchange LLC) (``NYSE'' or the ``Exchange'') filed with the
Securities and Exchange Commission (``SEC'' or the ``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed
rule change and on May 5, 2006, NYSE filed Amendment No. 1 to the
proposed rule change.\3\ The proposed rule change, as amended, concerns
amendments to Rule 312(f) to, among other changes, permit the
recommendation of purchases and sales of shares of companies controlled
by and under common control with member organizations (other than
MAPs), subject to appropriate customer disclosure of the relationship.
The

proposed rule change, as amended, was published for comment in the
Federal Register on May 26, 2006.\4\ The Commission received two
comment letters on the proposal.\5\ On August 11, 2006, NYSE filed a
response to the S&C Letter.\6\ This order approves the proposed rule
change, as amended.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 replaced the rule text in the original
filing in its entirety and proposed to clarify that Rule 312(f)
applies only to non-investment grade debt and equity securities.
Amendment No. 1 also added Material Associated Persons (``MAPs''),
as that term is used in Rule 17h-1T of the Exchange Act, to the
class of persons for whose securities the solicitation of trades is
prohibited.
    \4\ See Securities Exchange Act Release No. 53840 (May 19,
2006), 71 FR 30458 (May 26, 2006).
    \5\ See letter from John Ramsay, Managing Director, Deputy
General Counsel, Citigroup Global Markets Inc. (``Citigroup''), to
Nancy M. Morris, Secretary, SEC, dated June 16, 2006 (the
``Citigroup Letter'') and letter from Sullivan & Cromwell LLP
(``S&C'') to Nancy M. Morris, Secretary, SEC, dated June 16, 2006
(the ``S&C Letter'').
    \6\ See letter from Mary Yeager, Assistant Secretary, NYSE, to
Catherine McGuire, Chief Counsel, Division of Market Regulation,
SEC, dated August 11, 2006 (the ``NYSE Response'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    NYSE Rule 312(f) (the ``Rule''), in pertinent part, currently
prohibits a member organization from soliciting transactions in its own
publicly traded securities and from making any recommendations with
respect to its publicly traded securities or the securities issued by
any corporation controlling, controlled by or under common control with
such member corporation (i.e., the securities of any parent, sister, or
subsidiary corporation relative to the member organization). The
Exchange's regulatory experience relative to Rule 312(f) has generally
involved determinations as to the existence, or not, of a control
relationship involving a member organization among the complicated
interrelationships of, and equity investments by, financial
organizations.
    The purpose of the proposed rule change is to retain a process for
mitigating conflicts of interest that may arise when recommending the
securities of companies in which a member organization may have an
interest, while also reducing burdens on the industry and the Exchange
with respect to making determinations regarding the existence of a
control relationship by establishing clearer standards and reducing
interpretative questions.

(i) Proposed Codification To Exclude Investment Grade Debt From Rule
312(f)

    NYSE has interpreted Rule 312(f) to apply only to non-investment
grade debt and equity securities.\7\ This proposal would codify that
interpretation.
---------------------------------------------------------------------------

    \7\ Another common interpretive inquiry with respect to Rule
312(f) involves, and NYSE anticipates would continue to involve, a
determination as to whether the security in question has ``debt-like
characteristics.'' The Exchange has generally interpreted Rule
312(f) restrictions to not apply to investment grade debt and
securities that function as investment grade debt. The
interpretation as to whether a security functions as investment
grade debt is based on the totality of the circumstances, e.g., (1)
Whether the shares of stock have fixed dividends; (2) whether the
shares of stock are non-participatory in common dividends; (3)
whether the shares of stock have limited voting rights; and (4)
whether the shares of stock are non-convertible into common stock.
---------------------------------------------------------------------------

(ii) Proposed Expansion To Include All Non-Investment Grade Debt and
Equity Securities

    The proposed rule change would also broaden the application of the
Rule to all non-investment grade debt and equity securities, including
privately placed issues. The current Rule's prohibition applies only to
publicly traded securities.
    In addition, the proposed rule change would extend the prohibition
against solicited transactions to the non-investment grade debt and
equity securities of companies controlling member organizations (e.g.,
parent companies) and MAPs. By their nature, MAPs can substantially
influence a registered broker-dealer, and the inclusion of such
entities along with controlling organizations \8\ acts to limit
inevitable conflicts of interest.
---------------------------------------------------------------------------

    \8\ See NYSE Rule 2.
---------------------------------------------------------------------------

(iii) Proposed Amendment To Permit Certain Recommendations If Disclosed

    Finally, the proposed rule change would permit the recommendation
of purchases and sales of shares of companies controlled by and under
common control with member organizations (other than MAPs), subject to
appropriate customer disclosure of the relationship (e.g., any
recommendation would be subject to a requirement to disclose to the
customer the existence and nature of the control relationship at the
time of recommendation).\9\ The Exchange states that for these types of
relationships disclosure is likely to function as an adequate method
for addressing the conflicts of interest that could arise with respect
to a member's recommendation to buy or sell securities of many
affiliated entities. The Exchange proposes to retain the prohibition on
the recommendation of purchases in the securities of the member
organization, any controlling organization or a MAP given the greater
potential for a conflict of interest inherent in such relationships.
---------------------------------------------------------------------------

    \9\ See proposed Rule 312(f)(2). If the disclosure at the time
of the recommendation is not made in writing, then the member must
also provide this disclosure in writing prior to the completion of
the transaction.
---------------------------------------------------------------------------

III. Summary of Comments Received and NYSE Response

    The Commission received two comment letters (the Citigroup Letter
and the S&C Letter) on the proposal and a response to the S&C Letter by
NYSE.\10\ The Citigroup Letter expresses support for the proposed
changes to Rule 312(f).
---------------------------------------------------------------------------

    \10\ S&C Letter. See also NYSE Response. Because the Citigroup
Letter did not express any disagreement with the proposed rule
change, the NYSE Response does not address the Citigroup Letter.
---------------------------------------------------------------------------

    The S&C Letter generally expresses support for the proposed rule
change, but also notes reservations regarding: (1) The expansion of the
Rule 312(f) restrictions to non-public securities, and (2) the
prohibitions contained in Rule 312(f)(1) concerning solicitation of
transactions in the securities of a member organization, its parent or
a MAP.\11\
---------------------------------------------------------------------------

    \11\ S&C Letter.
---------------------------------------------------------------------------

    In responding to S&C's reservation regarding the extension of the
coverage of Rule 312(f) to non-publicly traded securities, NYSE states
that there is a ``need to assure coverage of all post-distribution
transactions by member organizations in affiliated securities, and not
solely those which are sold pursuant to public offerings.'' \12\ NYSE
also expresses the view that the proposed change will not impose a
significant burden on trading in non-publicly traded securities.\13\
---------------------------------------------------------------------------

    \12\ NYSE Response.
    \13\ Id.
---------------------------------------------------------------------------

    In responding to S&C's reservation regarding the prohibitions
contained in Rule 312(f)(1), NYSE states that it ``respectfully
disagree[s] with the suggestion that the prohibition against the
solicitation of transactions in the securities of the member
organization, parent or [MAP] is at present unwarranted [because] [t]he
conflicts which the original rule was written to prevent have not
disappeared.'' \14\ NYSE also clarifies that ``[i]t is not the
transaction which is prohibited, but rather the recommendation of the
transaction; the Rule allows unsolicited transactions.'' \15\
---------------------------------------------------------------------------

    \14\ Id.
    \15\ Id.
---------------------------------------------------------------------------

IV. Discussion and Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Exchange Act, and the
rules and regulations thereunder applicable to a national securities
exchange, and in particular, with the requirements of Section 6(b)(5)
\16\ of the Exchange Act.

Section 6(b)(5) requires, among other things, that the rules of an
exchange be designed to promote just and equitable principles of trade,
to remove impediments to and perfect the mechanism of a free and open
market and national market system, and in general, to protect investors
and the public interest. Section 3(f) of the Exchange Act also
requires, among other things, whenever there is a requirement to
consider or determine whether an action is necessary or appropriate in
the public interest, to also consider, in addition to the protection of
investors, whether the action will promote efficiency, competition, and
capital formation.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the proposed rule change, as amended,
will act to assure adequate and continuing protection for investors
while promoting efficiency, competition, and capital formation by
permitting the recommendation of purchases and sales of shares of
companies controlled by and under common control with member
organizations (other than MAPs), subject to appropriate customer
disclosure of the relationship, by expanding restrictions on effecting
solicited transactions to include non-public securities, and by
codifying NYSE interpretations as described above.

V. Conclusions

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\17\ that the proposed rule change (SR-NYSE-2005-58), as amended,
be, and hereby is, approved.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
[FR Doc. E6-14563 Filed 8-31-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: August 7, 2009 (Volume 74, Number 151)]
[Notices]
[Page 39696-39697]
[DOCID:fr07au09-73]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2008-0278; FRL-8942-2]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Mercury (Renewal), EPA
ICR Number 0113.10, OMB Control Number 2060-0097

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before September 8,
2009.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2008-0278, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
28221T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2)
OMB at: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment
and Media Programs Division, Office of Compliance, Mail Code 2223A,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 30, 2008 (73 FR 31088), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2008-0278, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: NESHAP for Mercury (Renewal).
    ICR Numbers: EPA ICR Number 0113.10, OMB Control Number 2060-0097.
    ICR Status: This ICR is scheduled to expire on August 31, 2009.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
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. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Mercury, published at 40 CFR part 61, subpart
E, were proposed on December 7, 1971, promulgated on April 6, 1973, and
amended on October 14, 1975, March 19, 1987, and October 17, 2000.
    These standards apply to stationary sources, which process mercury
ore to recover mercury, use mercury chlor-alkali cells to produce
chlorine gas and alkali metal hydroxide, and either incinerate or dry
wastewater treatment plant sludge. Approximately 107 sources (100
sludge incineration and drying plants and 7 mercury-cell chlor-alkali
plants) are currently subject to the standard; and no additional
sources are expected to become subject to the standard in the next
three years. Mercury is the pollutant regulated under this standard.
This information is being collected to ensure compliance with 40 CFR
part 61, subpart E.
    Owners or operators of affected facilities must make the following
one-time only notification; date of construction or reconstruction,
anticipated and actual dates of startup; physical or operational change
to an existing facility; date of initial performance test; and results
of initial performance test. These facilities must also maintain
records of performance test results, and startup, shutdowns, and
malfunctions. In order to ensure compliance with the standards,
adequate recordkeeping and reporting is necessary. This information
enables the Agency to identify the sources subject to the standard,
ensure initial compliance with emission limits, and verify continuous
compliance with the standard and all other information needed to
determine compliance with the applicable standards.
    Any owner or operator subject to the provisions of this subpart
must maintain a file of these measurements, and retain the file for at
least two years following the collection of such measurements,
maintenance reports, and records. All reports are sent to the delegated
state or local authority. In the event that there

is no such delegated authority, the reports are sent directly to the
EPA regional office.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 160
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose and provide information to or for a Federal agency. This
includes the time needed to review instructions, develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information. All
existing ways will have to adjust to comply with any previously
applicable instructions and requirements that have subsequently
changed; train personnel to be able to respond to a collection of
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose the information.
    Respondents/Affected Entities: Mercury.
    Estimated Number of Respondents: 107.
    Frequency of Response: Initially, annually and semiannually.
    Estimated Total Annual Hour Burden: 20,490.
    Estimated Total Annual Cost: $1,735,421 in labor costs exclusively.
There are no capital/startup or O&M costs associated with this ICR.
    Changes in the Estimates: There is no change in the labor cost in
this ICR compared to the previous ICR. This is due to two
considerations: (1) The regulations have not changed over the past
three years and are not anticipated to change over the next three
years; and (2) the growth rate for the industry is very low, negative
or nonexistent, so there is no significant change in the overall
burden.
    Since there are no changes in the regulatory requirements and there
is no significant industry growth, the labor hours and cost figures in
the previous ICR are used in this ICR, and there is no change in burden
to industry.

    Dated: July 31, 2009.
John Moses,
Director, Collection Strategies Division.
[FR Doc. E9-18965 Filed 8-6-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Proposed Rules]
[Pages 3531-3533]
[FR Doc No: 2015-00956]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0077; Directorate Identifier 2013-NM-254-AD]
RIN 2120-AA64

Airworthiness Directives; ATR-GIE Avions de Transport
R[eacute]gional Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain ATR-GIE Avions de Transport R[eacute]gional Model ATR42-500 and
Model ATR72-212A airplanes. This proposed AD was prompted by a report
indicating interference between a Type III Emergency Exit door and the
surrounding passenger cabin furnishing during a production check. This
proposed AD would require measuring the gap between the Type III
Emergency Exit doors and certain overhead stowage compartment fittings;
removing certain fittings from the overhead stowage compartments and
measuring the gap between the Type III Emergency Exit doors and the
overhead stowage compartment hooks, if necessary; and re-installing or
repairing, as applicable, the Type III Emergency Exit doors. We are
proposing this AD to detect and correct interference between a Type III
Emergency Exit door and the overhead stowage compartment fitting
installed on the rail; which could result in obstructed opening of a
Type III Emergency Exit door during an emergency evacuation.

DATES: We must receive comments on this proposed AD by March 9, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Transport R[eacute]gional, 1, All[eacute]e Pierre Nadot, 31712 Blagnac
Cedex, France; telephone +33 (0) 5 62 21 62 21; fax +33 (0) 5 62 21 67
18; email<EMAIL_ADDRESS>Internet http://www.aerochain.com. You may view this referenced service information at
the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0077; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-0077;
Directorate Identifier 2013-NM-254-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2013-0280, dated November 26, 2013 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for ATR-GIE Avions de
Transport R[eacute]gional Model ATR42-500 and Model ATR72-212A
airplanes. The MCAI states:

    Interference between a Type III Emergency Exit door opening and
the surrounding passenger cabin furnishing was detected during a
production check.
    Subsequent investigation identified an insufficient gap between
the Emergency Exit door internal skin structure and the overhead
stowage compartment fitting, installed on the rail, as a cause of
the interference.
    This condition, if not detected and corrected, could prevent an
unobstructed opening of both Type III Emergency Exit doors in case
of emergency evacuation.
    For the reasons described above, this [EASA] AD requires a one-
time check [measurement] of the gap between the Type III Emergency
Exit door internal skin and a relevant [overhead stowage
compartment] fitting and, depending on findings, the accomplishment
of applicable corrective action(s). This [EASA] AD is considered to
be a temporary measure and further actions may follow.

    Required actions include an additional measurement of the gap
between the internal skin and overhead stowage compartment hooks of
both Type III Emergency Exits, if necessary. Corrective actions include
re-installing the Type III Emergency Exit doors or contacting the
manufacturer for repair instructions and doing the repair, as
applicable. You may examine the MCAI in the AD docket on the Internet
at http://www.regulations.gov by searching for and locating Docket No.
FAA-2015-0077.

Related Service Information

    ATR-GIE Avions de Transport R[eacute]gional has issued the
following service information, which, among other things, describes
procedures for removing certain fittings from the overhead stowage
compartments, measuring the gap between the Type III Emergency Exit
doors and the overhead stowage compartment hooks, re-installing the
Type III Emergency Exit doors, and contacting the manufacturer for
repair information.
     ATR Service Bulletin ATR42-25-0180, dated August 19, 2013.
     ATR Service Bulletin ATR72-25-1141, dated August 19, 2013.
    The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 1 airplane of U.S.
registry.
    We also estimate that it would take about 1 work-hour per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be or $85 per
product.
    In addition, we estimate that any necessary follow-on actions would
take about 1 work-hour and require parts costing $0, for a cost of $85
per product. We have no way of determining the number of aircraft that
might need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

ATR--GIE Avions de Transport R[eacute]gional: Docket No. FAA-2015-
0077; Directorate Identifier 2013-NM-254-AD.

(a) Comments Due Date

    We must receive comments by March 9, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes identified in paragraphs (c)(1)
and (c)(2) of this AD.
    (1) ATR--GIE Avions de Transport R[eacute]gional Model ATR42-500
airplanes, certificated in any category, all manufacturer serial
numbers (MSNs) on which ATR Modification 6518 has been embodied in
production, except MSN 1002 and 1005, and except those airplanes on
which ATR Modification 7152 has been embodied in production.
    (2) ATR--GIE Avions de Transport R[eacute]gional Model ATR72-
212A airplanes, certificated in any category, on which ATR
Modification 6517 has been embodied in production, except MSNs 1089,
1094, 1095, 1097, 1098, 1099, 1100, 1101, and 1102; and except those
airplanes on which ATR Modification 7152 has been embodied in
production.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Reason

    This AD was prompted by a report indicating interference between
a Type III Emergency Exit door and the surrounding passenger cabin
furnishing during a production check. We are issuing this AD to
detect and correct interference between a Type III Emergency Exit
door and the overhead stowage compartment fitting installed on the
rail, which could result in obstructed opening of a Type III
Emergency Exit door during an emergency evacuation.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Measurement of Gap Between Type III Emergency Exit Doors and
Certain Overhead Stowage Compartment Fittings

    Within 2 months after the effective date of this AD: Measure the
gap between each Type III Emergency Exit door, left hand (LH) and
right hand (RH), and the overhead stowage compartment fitting
installed on the rail, by unlocking and slightly rotating the LH and
RH Type III Emergency Exit doors with the doors remaining on the
lower fittings. Use a shim gauge 6 millimeters (mm) (0.236 inch)
thick, to measure the gap between the internal skin of the doors and
the relevant fittings, part number (P/N) S2522924620000 (LH fitting)
and P/N S2522924620100 (RH fitting).

    Note 1 to paragraph (g) of this AD:  Illustrations may be found
in the applicable ATR Illustrated Parts Catalog (IPC) 25-23-02,
figure 87, item 90/100.

    Note 2 to paragraph (g) of this AD:  It might be necessary to
pull on the door blanket to correctly see the door internal skin.

(h) Re-Installation of Type III Emergency Exit Doors

    During the measurement required by paragraph (g) of this AD, if
it is determined that there is a gap equal to or greater than 6 mm
(0.236 inch), before further flight, re-install the LH and RH Type
III Emergency Exit Doors, in accordance with paragraph 3.C.(1)(d) of
the Accomplishment Instructions of ATR Service Bulletin ATR42-25-
0180, dated August 19, 2013; or ATR72-25-1141, dated August 19,
2013; as applicable.

(i) Removal of Fitting and Measurement of Gap Between Door Internal
Skin and Overhead Stowage Compartment Hooks

    During the measurement required by paragraph (g) of this AD, if
it is determined that there is a gap less than 6 mm (0.236 inch):
Before further flight, remove the fitting P/N S2522924620000 (LH
fitting) or P/N S2522924620100 (RH fitting), and measure the gap
between the internal skin of the LH and RH Type III Emergency Exit
Doors and the overhead stowage compartment hooks, in accordance with
the Accomplishment Instructions of ATR Service Bulletin ATR42-25-
0180, dated August 19, 2013; or ATR72-

25-1141, dated August 19, 2013; as applicable.
    (1) If, during the measurement required by paragraph (i) of this
AD, it is determined that there is a gap equal to or greater than 6
mm (0.236 inch): Before further flight, re-install the LH and RH
Type III Emergency Exit Doors, in accordance with the Accomplishment
Instructions of ATR Service Bulletin ATR42-25-0180, dated August 19,
2013; or ATR72-25-1141, dated August 19, 2013; as applicable.
    (2) If, during the measurement required by paragraph (i) of this
AD, it is determined that there is a gap less than 6 mm (0.236
inch): Before further flight, repair using a method approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA; or the European Aviation Safety Agency (EASA); or
ATR--GIE Avions de Transport R[eacute]gional's EASA Design
Organization Approval (DOA).

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or
ATR--GIE Avions de Transport R[eacute]gional's EASA DOA. If approved
by the DOA, the approval must include the DOA-authorized signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2013-0280, dated November 26,
2013, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2015-0077.
    (2) For service information identified in this AD, contact ATR--
GIE Avions de Transport R[eacute]gional, 1, All[eacute]e Pierre
Nadot, 31712 Blagnac Cedex, France; telephone +33 (0) 5 62 21 62 21;
fax +33 (0) 5 62 21 67 18; email<EMAIL_ADDRESS>
Internet http://www.aerochain.com. You may view this service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on January 15, 2015.
John P. Piccola, Jr.,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-00956 Filed 1-22-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61004-61006]
[FR Doc No: 2020-21463]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1445]

Blood Glucose Monitoring Test Systems for Prescription Point-of-
Care Use; Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Blood Glucose
Monitoring Test Systems for Prescription Point-of-Care Use.'' This
guidance describes studies and information that FDA recommends be used
when submitting premarket notifications (510(k)s) for blood glucose
monitoring systems (BGMSs) that are for prescription point-of-care use.

DATES: The announcement of the guidance is published in the Federal
Register on September 29, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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.
     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-2013-D-1445 for ``Blood Glucose Monitoring Test Systems for
Prescription Point-of-Care Use.'' Received comments 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care
Use'' to the Office of Policy, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Leslie Landree, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3566, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 11, 2016 (81 FR 70122), FDA published a final guidance
entitled ``Blood Glucose Monitoring Test Systems for Prescription
Point-of-Care Use.'' That guidance document described studies and
information that FDA recommends be used when submitting 510(k)s for
BGMSs that are for prescription point-of-care use.
    On November 30, 2018, FDA published a notice of availability in the
Federal Register (83 FR 61648) of a draft guidance that proposed
revisions to the guidance. FDA proposed modifications based on feedback
received from stakeholders and to better align with the evolving
understanding and development of these types of devices.
    FDA considered comments received on the draft guidance and made
revisions as appropriate in response to the comments, including a minor
edit encouraging manufacturers to consider design features that will
aid in user accessibility and a technical edit in hemoglobin testing
concentration. This revised guidance replaces the existing final
guidance of the same title issued on October 11, 2016.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
current thinking of FDA on ``Blood Glucose Monitoring Test Systems for
Prescription Point-of-Care Use.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance is also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Blood Glucose Monitoring
Test Systems for Prescription Point-of-Care Use'' may send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of
the document. Please use the document number 1755 and title to identify
the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required
for this guidance. The collections of information in the following FDA
guidances and regulations have been approved by OMB as listed in the
following table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket Notification.       0910-0120
``Requests for Feedback on       Q-Submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff``.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
Recommendations for Clinical     CLIA Waiver                   0910-0598
 Laboratory Improvement           Applications.
 Amendments of 1988 (CLIA)
 Waiver Applications for
 Manufacturers of In Vitro
 Diagnostic Devices--Guidance
 for Industry and Food and Drug
 Administration Staff.
Administrative Procedures for    Administrative                0910-0607
 CLIA Categorization--Guidance    Procedures for
 for Industry and Food and Drug   Clinical Laboratory
 Administration Staff.            Improvement Amendments
                                  of 1988 Categorization
                                  (42 CFR 493.17).
------------------------------------------------------------------------

    Dated: September 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21463 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 114 (Thursday, June 13, 2019)]
[Notices]
[Pages 27690-27691]
[FR Doc No: 2019-12491]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2010-0203; FMCSA-2016-0011; FMCSA-2016-0313]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to renew exemptions for nine
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on February 3, 2019. The
exemptions expire on February 3, 2021.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2010-0203; FMCSA-2016-0011; FMCSA-2016-
0313, in the keyword box, and click ``Search.'' Next, click the ``Open
Docket Folder'' button and choose the document to review. If you do not
have access to the internet, you may view the docket online by visiting
the Docket Management Facility in Room W12-140 on the ground floor of
the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590,
between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal
holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On April 1, 2019, FMCSA published a notice announcing its decision
to renew exemptions for nine individuals from the epilepsy and seizure
disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV in
interstate commerce and requested comments from the public (84 FR
12320). The public comment period ended on May 1, 2019, and no comments
were received.
    As stated in the previous notice, FMCSA has evaluated the
eligibility of these applicants and determined that renewing these
exemptions would achieve a level of safety equivalent to, or greater
than, the level that would be achieved by complying with the current
regulation 49 CFR 391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based on its evaluation of the nine renewal exemption applications,
FMCSA announces its decision to exempt the following drivers from the
epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8).
    In accordance with 49 U.S.C. 31136(e) and 31315, the following
groups of drivers received renewed exemptions in the month of February
and are discussed below. As of February 2019, and in accordance with 49
U.S.C. 31136(e) and 31315, the following nine individuals have
satisfied the renewal conditions for obtaining an exemption from the
epilepsy and seizure disorders prohibition in the FMCSRs for interstate
CMV drivers (84 FR 12320):

Ryan Babler (WI)
James Connelly (NJ)
Ricky Conway, Jr. (MO)
Bradley Hollister (PA)
Henrietta Ketcham (NY)
Michael Merical (NY)
Elvin P. Morgan (CA)
Larry Nicholson (NC)
Daniel Zielinski (OR)

    The drivers were included in docket numbers FMCSA-2010-0203; FMCSA-
2016-0011; FMCSA-2016-0313. Their exemptions are applicable as of
February 3, 2019, and will expire on February 3, 2021.
    In accordance with 49 U.S.C. 31315, each exemption will be valid
for two years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136 and
31315.

     Issued on: June 7, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-12491 Filed 6-12-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Pages 54657-54658]
[FR Doc No: 2013-21547]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0350]

Guidance for Tobacco Retailers on Tobacco Retailer Training
Programs; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for tobacco retailers entitled ``Tobacco
Retailer Training Programs.'' The Family Smoking Prevention and Tobacco
Control Act (Tobacco Control Act) does not require retailers to
implement retailer training programs. However, the Tobacco Control Act
does provide for lower civil money penalties for violations of sale and
distribution, including youth access, advertising, and promotion
restrictions issued under the Federal Food, Drug, and Cosmetic Act

(the FD&C Act), as amended by the Tobacco Control Act, for retailers
who have implemented a training program that complies with standards
developed by FDA for such programs. FDA intends to issue regulations
establishing standards for approved retailer training programs. In the
interim, this guidance document is intended to assist tobacco retailers
who wish to implement training programs for employees.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Center for Tobacco Products, Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850-3229. Send one self-addressed
adhesive label to assist that office in processing your request or
include a fax number to which the guidance document may be sent. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beth Buckler, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229, 1-877-287-1373<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for tobacco
retailers entitled ``Tobacco Retailer Training Programs.'' This
guidance document is intended to assist tobacco retailers who wish to
implement training programs for employees.
    On June 22, 2009, the President signed the Tobacco Control Act
(Pub. L. 111-31; 123 Stat. 1776) into law. The Tobacco Control Act
grants FDA important authority to regulate the manufacture, marketing,
and distribution of tobacco products to protect the public health
generally and to reduce tobacco use by minors.
    Among its many provisions, section 906(d) of the FD&C Act (21
U.S.C. 387f(d)), as amended by the Tobacco Control Act, states that
``[t]he Secretary may by regulation require restrictions on the sale
and distribution of a tobacco product, including restrictions on the
access to, and the advertising and promotion of, the tobacco product,
if the Secretary determines that such regulation would be appropriate
for the protection of the public health.''
    In accordance with section 102 of the Tobacco Control Act (21
U.S.C. 387a-1), FDA re-issued its 1996 final regulation restricting the
sale and distribution of cigarettes and smokeless tobacco products (75
FR 13225, March 19, 2010). The regulation is deemed to be issued under
chapter 9 of the FD&C Act, as amended by the Tobacco Control Act
(section 102(a)(1)(A) of the Tobacco Control Act). The regulation
contains provisions designed to limit young people's access to
cigarettes and smokeless tobacco products, as well as restrictions on
advertising and promotion of such products, to curb the appeal of these
products to minors (part 1140 (21 CFR part 1140)).
    Section 103(q)(2) of the Tobacco Control Act (21 U.S.C. 333 note)
includes two schedules for assessing the maximum civil money penalties
against retailers for violations of restrictions issued under section
906(d) of the FD&C Act, as amended by the Tobacco Control Act,
pertaining to the sale and distribution, including youth access, and
advertising and promotion of tobacco products. Under each schedule,
violators are subject to increasing penalties for multiple violations
within prescribed time periods. For the first three violations in a 24-
month period, retailers with an approved training program are subject
to lower penalties than retailers without such programs. Section
103(q)(2)(B) defines ``approved training program'' as a training
program that complies with standards developed by FDA for such
programs.
    FDA intends to issue regulations establishing standards for
approved retailer training programs. In the interim, however, FDA is
issuing this guidance to provide recommendations on elements the Agency
believes should be included in a retailer training program. Until FDA
issues these regulations, the Agency intends to use the lower maximum
civil money penalties schedule for all retailers who violate the
regulations restricting the sale and distribution of cigarettes and
smokeless tobacco products (part 1140), whether or not they have
implemented a training program. However, FDA may consider further
reducing the civil money penalty for retailers who have implemented a
training program.
    In the Federal Register of July 16, 2010 (75 FR 41498), FDA
announced the availability of a draft guidance entitled ``Tobacco
Retailer Training Programs.'' The Agency considered received comments
as it finalized this guidance. In addition, editorial changes were made
to improve clarity.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the Agency's current thinking on tobacco retailer training programs. 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.

III. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in this guidance was approved under OMB
control number 0910-0745.

V. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: August 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21547 Filed 9-4-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Page 44399]
[FR Doc No: 2017-20255]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP17-1048-000.
    Applicants: Guardian Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: Sales and Purchases of Gas for
Operational Purposes to be effective 10/16/2017.
    Filed Date: 9/14/17.
    Accession Number: 20170914-5030.
    Comments Due: 5 p.m. ET 9/26/17.

    Docket Numbers: RP17-1049-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Compliance filing: Annual Cash-Out Report Period
Ending July 31, 2017.
    Filed Date: 9/14/17.
    Accession Number: 20170914-5049.
    Comments Due: 5 p.m. ET 9/26/17.

    Docket Numbers: RP17-1051-000.
    Applicants: Tallgrass Interstate Gas Transmission, L.
    Description: Sec.  4(d) Rate Filing: Administrative Updates to
Tariff to be effective 10/15/2017.
    Filed Date: 9/15/17.
    Accession Number: 20170915-5106.
    Comments Due: 5 p.m. ET 9/27/17.

    Docket Numbers: RP17-1052-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: Fuel Tracker--2017 November to
be effective 11/1/2017.
    Filed Date: 9/15/17.
    Accession Number: 20170915-5127.
    Comments Due: 5 p.m. ET 9/27/17.

    Docket Numbers: RP17-1053-000.
    Applicants: Dominion Energy Carolina Gas Transmission.
    Description: Sec.  4(d) Rate Filing: DECG--2017 FRQ and TDA Report
to be effective 11/1/2017.
    Filed Date: 9/15/17.
    Accession Number: 20170915-5133.
    Comments Due: 5 p.m. ET 9/27/17.

    Docket Numbers: RP17-884-001.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Compliance filing: Correction to previously filed NRA
to be effective 7/1/2017.
    Filed Date: 9/15/17.
    Accession Number: 20170915-5100.
    Comments Due: 5 p.m. ET 9/27/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 18, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-20255 Filed 9-21-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: October 22, 2007 (Volume 72, Number 203)]
[Notices]
[Page 59527-59528]
[DOCID:fr22oc07-47]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12889-000]

BPUS Generation Development, LLC; Notice of Application Accepted
for Filing and Soliciting Motions To Intervene, Protests, and Comments

October 12, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12889-000.
    c. Date filed: July 30, 2007.
    d. Applicant: BPUS Generation Development, LLC.
    e. Name of Project: Mississippi Lock & Dam No. 18 Hydroelectric
Project.
    f. Location: Mississippi River in Des Moines County, Iowa, and
Henderson County, Illinois. It would use the U.S. Army Corps of
Engineers' Mississippi Lock & Dam No. 18.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Jeffrey M. Auser, P.E., BPUS Generation
Development, LLC, 225 Greenfield Parkway, Suite 201, Liverpool, NY
13088,<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Comments, protests, and interventions may be
filed electronically via the Internet in lieu of paper; see 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings. Please include the project number (P-12889-000) on
any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project using the U.S. Army
Corps of Engineers' Mississippi Lock & Dam No. 18 and operated in a
run-of-river mode would consist of: (1) A new 200-foot long, 250-foot
wide, 50-foot high concrete powerhouse; (2) a new intake channel and
tailrace channel excavated on the left side of the river between the
existing lock and Henderson Creek; (3) five turbine/generator units
with a combined installed capacity of 23.5 megawatts; (4) a new 7,100-
foot above ground transmission line extending from the switchyard near
the powerhouse to an interconnection point with the 161-kilovolt
Denmark-Newport transmission line on the Illinois side of the river;
and (5) appurtenant facilities. The proposed Mississippi Lock & Dam No.
18 Project would have an average annual generation of 102.4 gigawatt-
hours.
    l. This filing is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3676 or
e-mail<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy
is also available for inspection and reproduction at the address in
item h above.
    m. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    n. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    o. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    p. Proposed Scope of Studies Under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    q. Comments, Protests, or Motions to Intervene--Anyone may submit

comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210,
385.211, 385.214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    r. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the
Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    s. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
 Secretary.
[FR Doc. E7-20713 Filed 10-19-07; 8:45 am]

BILLING CODE 6717-01-P