MEMORANDUM Eastern Research Group, Inc. 110 Hartwell Avenue Lexington, MA 02421 Date: June 16, 2003 To: James Covington, EPA From: Colleen Campbell and Cal Franz, ERG Re: Meat and Poultry Products Industry Barriers to Entry Analysis INTRODUCTION ERG projected potential barriers to entry for the Meat and Poultry Products ( MPP) industry based on costs received from Tetra Tech on May 27, 2003 and weights received from Westat on April 10, 2003. The barrier to entry analysis compares estimated average incremental facility or company capital costs incurred to meet the effluent guidelines to average total assets. The analysis was performed to evaluate the effect of the proposed rule on the rate on new entrants into the meat and poultry products industry. Increased start up costs resulting from the capital costs of the proposed regulation may prevent entrepreneurs from entering the industry. The calculated ratio of average capital costs to average total assets measures the potential for barriers to entry due to the proposed rule. If the barrier to entry ratio is large, then the possibility exists that the proposed rule will discourage entry into the meat and poultry products market.

The attached tables present the results of these analyses. Table 1 provides the facility level results by subcategory, and Table 2 presents the company level results.

Facility Level Results   The facility level ratio of capital costs to total assets ranges from 0.1 percent in Subcategory A through D under Option 2 to 7.8 percent in Subcategory K under Option 4.

  Option 4 shows the greatest impacts: S Average capital costs of $ 3.0 million per facility in Subcategory A through D result in a 2.1 percent ratio, S Average capital costs of $ 3.1 million per facility in Subcategory K result in a 7.8 percent ratio.

  All other options and subcategories result in ratios below 2 percent.

1 Company Level Results   The company level ratio of capital costs to total assets ranges from 0.02 percent under Option 2 for red meat and mixed meat companies to 1.7 percent under Option 4 for poultry companies.

  Poultry companies show the largest impacts, with ratios ranging from 0.1 percent under Option 2 to 1.7 percent under Option 4.

  Red meat and mixed meat companies have ratios ranging from 0.02 percent under Option 2 to 0.3 percent under Option 4.

2 Table 1 Summary of Projected Facility Level Barrier to Entry by Subcategory and Option Option 2 Option 2+ P Option 2.5 Option 2.5+ P Option 4 Average Ratio of Average Ratio of Average Ratio of Average Ratio of Average Ratio of Total Facilities Capital Costs to Capital Costs to Capital Costs to Capital Costs to Capital Costs to Variable in Class Analyzed* Costs ($ 000) Assets Costs ($ 000) Assets Costs ($ 000) Assets Costs ($ 000) Assets Costs ($ 000) Assets Subcategory A through D Facilities 39 19 $ 75 0.1% $ 1,268 0.9% $ 1,777 1.2% $ 2,375 1.6% $ 3,028 2.1%

Average Facility Assets ($ 000) NA $ 146,686 Subcategory K Facilities 118 24 $ 148 0.4% $ 427 1.1% $ 592 1.5% $ 657 1.7% $ 3,070 7.8%

Average Facility Assets ($ 000) NA $ 39,182 * Facilities with both asset data and compliance costs. Table 2 Summary of Projected Company Level Barrier to Entry by Meat Type and Option Option 2 Option 2+ P Option 2.5 Option 2.5+ P Option 4 Average Ratio of Average Ratio of Average Ratio of Average Ratio of Average Ratio of Total Companies Capital Costs to Capital Costs to Capital Costs to Capital Costs to Capital Costs to Variable in Class Analyzed* Costs ($ 000) Assets Costs ($ 000) Assets Costs ($ 000) Assets Costs ($ 000) Assets Costs ($ 000) Assets Red Meat ( Subcategories A through I)

Companies 9 9 $ 748 0.02% $ 4,321 0.1% $ 7,054 0.2% $ 9,442 0.3% $ 11,901 0.3%

Average Company Assets ($ 000) NA $ 3,600,502 Poultry ( Subcategories K and L)

Companies 13 13 $ 682 0.1% $ 2,383 0.4% $ 2,569 0.4% $ 3,648 0.6% $ 11,061 1.7%

Average Company Assets ($ 000) NA $ 652,136 Mixed Companies 4 4 $ 1,182 0.0% $ 6,351 0.1% $ 9,372 0.2% $ 12,911 0.2% $ 21,132 0.3%

Average Company Assets ($ 000) NA $ 6,215,533 * Companies with both asset data and compliance costs.


[Federal Register: June 6, 2006 (Volume 71, Number 108)]
[Notices]
[Page 32622-32626]
[DOCID:fr06jn06-77]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53878; File No. SR-NYSEArca-2006-02]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Order Granting Accelerated Approval of Proposed Rule Change and
Amendment Nos. 1 and 2 Thereto To Establish a Public Disclosure Program

May 26, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 6, 2006, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange''),
through its subsidiary, NYSE Arca Equities, Inc. (``NYSE Arca
Equities''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. On May 9,
2006, NYSE Arca filed Amendment No. 1 to the proposed rule change. On
May 17, 2006, NYSE Arca filed Amendment No. 2 to the proposed rule
change. The Commission is publishing this notice to solicit comments on
the proposed rule change, as amended, from interested persons and is
approving the proposal on an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NYSE Arca, through its subsidiary, NYSE Arca Equities, proposes to
implement a new rule, NYSE Arca Equities Rule 10.15, that would
institute and govern a program (``Public Disclosure Program'') in which
certain disciplinary actions involving Equity Trading Permit Holders
(``ETP Holders'') and associated persons thereof would be publicized.
The text of the proposed rule change is below. Proposed new language is
in italics.
NYSE Arca Equities Rules
* * * * *

RULE 10 DISCIPLINARY PROCEEDINGS, OTHER HEARINGS, AND APPEALS
* * * * *

Release of Disciplinary Information Through the Public Disclosure
Program

    Rule 10.15(a) The Corporation shall, in response to a request,
release a copy of any identified disciplinary decision issued by the
Corporation or any Committee thereof; provided, however, that each copy
of:
    (1) a decision that is released prior to the expiration of the time
period provided under NYSE Arca Equities Rule 10.8 for appeal or while
such an appeal is pending shall be accompanied by a statement that the
findings and sanctions imposed in the decision may be increased,
decreased, modified, or reversed by the Corporation;
    (2) a final decision of the Corporation that is released prior to
the time period provided under the Securities Exchange Act of 1934 for
appeal to the Securities and Exchange Commission or while such an
appeal is pending shall be accompanied by a statement that the findings
and sanctions of the Corporation are subject to review and modification
by the Securities and Exchange Commission; and
    (3) a final decision of the Corporation that is released after the
decision is appealed to the Securities and Exchange Commission shall be
accompanied by a statement as to whether the effectiveness of the
sanctions has been stayed pending the outcome of proceedings before the
Securities and Exchange Commission.
    (b)(1) The Corporation shall release to the public information with
respect to any disciplinary decision issued pursuant to NYSE Arca
Equities Rule 10 imposing: (i) a suspension, cancellation or expulsion
upon an ETP Holder; or (ii) suspension or revocation of the
registration of an associated person of an ETP Holder; or (iii)
suspension or barring of an ETP Holder or associated person from
association with all ETP Holders; or (iv) imposition of monetary
sanctions of $10,000 or more upon an ETP Holder or associated person;
or (v) containing an allegation of a violation of a Designated Rule;
and may also release to the public such information with respect to any
disciplinary decision or group of decisions that involve a significant
policy or enforcement determination where the release of information is
deemed by the President of the Corporation to be in the public
interest. The Corporation may, in its discretion, determine to waive
the requirement to release information with respect to a disciplinary
decision under those extraordinary circumstances where the release of
such information would violate fundamental notions of fairness or work
as an injustice. The Corporation may release to the public information
on any disciplinary or other decision issued pursuant to NYSE Arca
Equities Rule 10 not specifically enumerated in this paragraph,
regardless of sanctions imposed, so long as the names of the parties
and other identifying information is redacted.
    A ``Designated Rule'' means (i) SEC Rule 10b-5, (ii) NYSE Arca
Equities Rule 6.5, or (iii) NYSE Arca Equities Rule 6.2.
    (A) The Corporation shall release to the public, in unredacted
form, information with respect to any disciplinary decision issued
pursuant to NYSE Arca Equities Rule 10.8 that does not meet one or more
of the criteria in section (b)(1) for the release of information to the
public, provided that the underlying decision issued pursuant to NYSE
Arca Equities Rule 10.7 meets one or more of the criteria in section
(b)(1) for the release of information to the public, and information
regarding such decision has been released to the public in unredacted
form.
    (B) In the event there is more than one respondent in a
disciplinary decision issued pursuant to NYSE Arca Equities Rule 10 and
sanctions imposed on one or more, but not all, of the respondents meets
one or more of the criteria in section (b)(1) for the release of
information to the public, the Corporation shall release to the public,
in unredacted form, information with respect to the respondent(s) who
meet such criteria, and may release to the public, in redacted form,
information with respect to the respondent(s) who do not meet such
criteria. Notwithstanding the foregoing, the Corporation shall release
to the public, in unredacted form, information with respect to any
respondent in a disciplinary decision issued pursuant to NYSE Arca
Equities Rule 10.8 if the sanctions imposed on such respondent in the
underlying decision issued pursuant to NYSE Arca Equities Rule 10.7
meet one or more of the criteria for release of information to the
public, and information with respect to that respondent has been
released in unredacted form.
    (2) Information released to the public pursuant to subparagraph
(b)(1) shall be accompanied by a statement to the extent required for
that type of information under subparagraphs (a)(1)-(3).
    (c) Information regarding any sanctions imposed pursuant to NYSE
Arca Equities Rule 10.6 shall be released to the public pursuant to
paragraph (b) immediately upon such approval.
    (d) If a decision of the Corporation imposing monetary sanctions of
$10,000 or more or a penalty of expulsion, revocation, suspension and/
or barring of an ETP Holder from being associated with all ETP Holders
is appealed to the Securities and Exchange Commission, notice thereof
shall be given to all ETP Holders and to the press as soon as possible
after receipt by the Corporation of notice from the Securities and
Exchange Commission of such appeal and the Corporation's notice shall
state whether the effectiveness of the Corporation's decision has been
stayed pending the outcome of proceedings before the Securities and
Exchange Commission.
    (e) In the event an appeal to the federal courts is filed from a
decision by the Securities and Exchange Commission in a case previously
appealed to it from a decision of the Corporation, involving the
imposition of monetary sanctions of $10,000 or more or a penalty of
expulsion, revocation, suspension and/or barring of an ETP Holder from
being associated with all ETP Holders, notice thereof shall be given to
the ETP Holders as soon as possible after receipt by the Corporation of
a formal notice of appeal. Such notice shall include a statement
whether the order of the Securities and Exchange Commission has been
stayed.
    (f) Any order issued by the Securities and Exchange Commission of
(i) revocation or suspension of an ETP Holder's broker/dealer
registration with the Securities and Exchange Commission; or (ii) the
suspension or expulsion of an ETP Holder from the Corporation; or (iii)
the suspension or barring of an ETP Holder or an associated person from
association with all broker/dealers or ETP Holders; or (iv) the
imposition of monetary sanctions of $10,000 or more shall be released
to the public through a notice containing the effective date thereof
sent as soon as possible after receipt by the Corporation of the order
of the Securities and Exchange Commission.
    (g) Cancellations of Equity Trading Permits or registration
pursuant to the Corporation's Rules and interpretative material shall
be released to the public as soon after the effective date of the
cancellation as possible.
    (h) Releases to the public referred to in paragraph (b) above shall
identify the Corporation's Rule(s) or the SEC Rule(s) violated, and
shall describe the conduct constituting such violation. Releases may
also identify the ETP Holder with which an individual was associated at

the time the violations occurred if such identification is determined
by the Corporation to be in the public interest.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, NYSE Arca included statements
concerning the purpose of, and basis for, the proposed rule change. The
text of these statements may be examined at the places specified in
Item III below, and is set forth in Sections A, B, and C below.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Under the proposed Public Disclosure Program, NYSE Arca Equities
would release to the public certain information concerning the
disciplinary history of ETP Holders and associated persons. NYSE Arca
Equities is instituting such procedures in order to provide investors
with information regarding final disciplinary decisions related to ETP
Holders and associated persons. The primary purpose of the Public
Disclosure Program is to help investors make informed choices about the
individuals and firms with whom they may wish to do business.
Currently, NYSE Arca Equities does not have rules related to the
release of disciplinary decisions to members of the public. Proposed
NYSE Arca Equities Rule 10.15 would allow NYSE Arca Equities to release
such information upon request and when certain other circumstances
exist, as explained in greater detail below.
    Disciplinary Decisions. If a member of the public requests a copy
of an identified disciplinary decision issued by NYSE Arca Equities or
any committee thereof, a copy of the decision will be provided to the
requesting member of the public. NYSE Arca Equities' practice will be
to provide such information on a per-ETP Holder or associated person
basis. NYSE Arca Equities will not charge the public for this service.
    NYSE Arca Equities will also release information to the public with
respect to disciplinary decisions that: (i) Impose a suspension,
cancellation, or expulsion of an ETP Holder; (ii) impose the suspension
or revocation of the registration of an associated person of an ETP
Holder; (iii) impose the suspension or barring of an ETP Holder or
associated person from association with all ETP Holders; (iv) impose
monetary sanctions of $10,000 or more upon an ETP Holder or associated
person; or (v) contain an allegation of a violation of a Designated
Rule.\3\ NYSE Arca Equities will release unredacted information
concerning decisions issued by the Board Appeals Committee that do not
meet one or more of the criteria in proposed NYSE Arca Equities Rule
10.15(b)(1), provided that the underlying decision meets one or more of
the criteria in proposed NYSE Arca Equities Rule 10.15(b)(1), and the
information regarding the underlying decision was released to the
public in unredacted form.
---------------------------------------------------------------------------

    \3\ A ``Designated Rule'' means (i) Commission Rule 10b-5 under
the Act, (ii) NYSE Arca Equities Rule 6.5 (Manipulation), or (iii)
NYSE Arca Equities Rule 6.2 (Prohibited Acts). See proposed NYSE
Arca Equities Rule 10.15(b)(1).
---------------------------------------------------------------------------

    In the event that there is more than one respondent in a
disciplinary decision and sanctions are imposed on one or more of the
respondents, but not all of the respondents meet one or more of the
criteria in proposed NYSE Arca Equities Rule 10.15(b)(1) for the
release of information, NYSE Arca Equities will release to the public
unredacted information with respect to the respondents who meet such
criteria. In addition, NYSE Arca Equities may release redacted
information to the public with respect to the respondents who do not
meet the criteria in proposed NYSE Arca Equities Rule 10.15(b)(1).
    NYSE Arca Equities may release information to the public concerning
disciplinary decisions that involve significant policy or enforcement
determinations where the release of such information is deemed by the
President of NYSE Arca Equities to be in the public interest. In
addition, NYSE Arca Equities may exercise its discretion and waive the
requirement to release information with respect to a disciplinary
decision under extraordinary circumstances where the release of the
information would violate fundamental notions of fairness or work as an
injustice. Finally, NYSE Arca Equities may release public information
concerning any disciplinary or other decision issued pursuant to NYSE
Arca Equities Rule 10 that is not specifically enumerated in proposed
NYSE Arca Equities Rule 10.15(b)(1), regardless of the sanctions
imposed, so long as the names of the parties and other identifying
information are redacted.
    Notices. Decisions that are released to a member of the public must
include certain notices. Decisions that are released prior to the
period in which a respondent may request an appeal pursuant to NYSE
Arca Equities Rule 10.8 (Review) or while an appeal is pending must
include a statement that the findings and sanctions imposed in the
decision may be increased, decreased, modified, or reversed by NYSE
Arca Equities. In addition, a final decision by NYSE Arca Equities that
is released prior to the period in which a respondent may appeal to the
Commission or while such appeal is pending will include a statement
that the findings and sanctions of NYSE Arca Equities are subject to
review and modification by the Commission. Lastly, a final decision of
NYSE Arca Equities that is released after the decision is appealed to
the Commission will include a statement as to whether the effectiveness
of the sanctions has been stayed pending the outcome of proceedings
before the Commission.
    Appeals. In the instance that NYSE Arca Equities' decisions are
appealed to the Commission or the federal courts, NYSE Arca Equities
will notify all ETP Holders and the press. This includes all NYSE Arca
Equities decisions imposing monetary sanctions of $10,000 or more or a
penalty of expulsion, revocation, suspension, and/or barring of an ETP
Holder from being associated with all ETP Holders.
    Commission Orders. NYSE Arca Equities will release through a notice
to the public information with respect to any order issued by the
Commission: (i) Revoking or suspending an ETP Holder's broker-dealer
registration; (ii) suspending or expelling an ETP Holder from NYSE Arca
Equities; (iii) suspending or barring an ETP Holder or an associated
person from associating with all broker-dealers or ETP Holders; or (iv)
imposing monetary sanctions of $10,000 or more.
    Offers of Settlement. NYSE Arca Equities will release information
regarding sanctions imposed pursuant to NYSE Arca Equities Rule 10.6
(Offers of Settlement) upon the approval of offers of settlement.
    Cancellation of Equity Trading Permits. In cases where NYSE Arca
Equities cancels an Equity Trading Permit or registration, NYSE Arca
Equities will notify the public as soon after the effective date of the
cancellation as possible.
    While proposed NYSE Arca Equities Rule 10.15 is based substantially
on NASD Rule 8310 (Sanctions for Violation of the Rules) and IM-8310-2
(Release of Disciplinary and Other Information Through the Public
Disclosure Program), it does not incorporate all aspects of such NASD
Rule. For example, proposed NYSE Arca

Equities Rule 10.15 excludes public disclosure of disciplinary
complaints and arbitrations. NYSE Arca Equities's intention is for
public disclosure not to apply to disciplinary complaints that involve
undecided issues or arbitrations between parties. NYSE Arca Equities
plans to notify ETP Holders and associated persons of the effectiveness
of this proposed rule change through NYSE Arca Equities' Internet Web
site and a regulatory bulletin.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \4\ in general, and furthers the
objectives of Section 6(b)(5) \5\ in particular, in that it is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b).
    \5\ 15 U.S.C. 78s(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, is consistent with the Act. Comments may be
submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSEArca-2006-02 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2006-02. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEArca-2006-02 and should be submitted on or before
June 27, 2006.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    The Commission finds that the proposed rule change, as amended, is
consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange.\6\
In particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\7\ which requires that an
exchange have rules designed, among other things, to promote just and
equitable principles of trade, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and
in general to protect investors and the public interest.
---------------------------------------------------------------------------

    \6\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the proposal to institute the Public
Disclosure Program, which is substantially based on NASD Rule 8310 and
IM-8310-2,\8\ serves the interest of investor protection because it
allows NYSE Arca Equities members and the general public to promptly
learn of final disciplinary decisions involving its broker-dealer
members or associated persons of such members. By notifying the public
of a final decision issued by the Exchange or any committee of the
Exchange that results in the suspension, cancellation, expulsion, and/
or barring of an ETP Holder or the imposition of monetary sanctions of
$10,000 or more, for example, the Commission believes that the Public
Disclosure Program should provide important information to the public,
create additional incentives for members of the Exchange to comply with
its rules, and help investors make informed choices and decisions about
the individuals and firms with whom they may wish to conduct business.
As such, the Commission finds that the proposed program promotes just
and equitable principles of trade, encourages the prevention of
fraudulent and manipulative acts and practices, and seeks to perfect
the mechanism of a free and open market.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 35138 (December 22,
1994), 59 FR 67362 (December 29, 1994) (approving the NASD program
to publish final disciplinary decisions involving its members).
---------------------------------------------------------------------------

    The Commission finds good cause for approving this proposed rule
change, as amended, before the thirtieth day after the publication of
notice thereof in the Federal Register. As noted earlier, prompt
disclosure of final disciplinary decisions serves the interest of
protecting investors and the general public.\9\ Therefore, accelerating
approval of the proposed rule change should benefit investors because
they will have access to the NYSE Arca Equities disciplinary
information sooner. The Public Disclosure Program should foster
compliance with NYSE Arca Equities rules, heighten awareness of the
public investor with respect to the conduct of business on the
Exchange, and, in general, improve the overall integrity of the market
center.
---------------------------------------------------------------------------

    \9\ See id.
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-NYSEArca-

2006-02), as amended, is hereby approved on an accelerated basis.\10\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
 [FR Doc. E6-8716 Filed 6-5-06; 8:45 am]

BILLING CODE 8010-01-P


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

General Comment:Dear Mr. Zeller:

I am an individual consumer. I would like 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 Rules request input to FDA, many of which questions I would like to respond to in a meaningful and informed way. I have already spent hours just in reading the Proposed Rules and at FDA's request I have even more research to do in order to provide answers to FDA's questions, which takes time. FDA took years to write these Proposed Rules. I think it only appropriate that FDA then provide consumers, for whom this is the only opportunity to provide input into this process, sufficient time to do the research and provide feedback.

As a consumer of e-cigarettes, the Proposed Rules contain regulations that are extremely important, not just to my continued use of electronic cigarettes, but to my future health -- health that will be gravely impacted should FDA's regulations be enacted as proposed. I wish to tell you how e-cigarettes have positively impacted my own health, as well as provide you with researched, evidence-based answers to your requests for input with regards to electronic cigarettes. FDA has authority under 21 CFR 10.40 to extend the public comment period, an authority which FDA has used in the past. Due to the potential negative impact of these regulations as proposed, I request that FDA do so in this case so that all interested parties, consumers and vendors, are able to provide comment on these Proposed Rules.

Thank you for your consideration of my request. If you have any questions, please do not hesitate to contact me for further discussion.


e. Total annualized cost of FRMS paperwork is about $14,950
($1,253.50 x 20) for the estimated 20 carriers.
    f. The nominal cost for 10-year is $149,500 or $99,186 present
value at 7%.

(2) PRA analysis for fatigue training Sec.  117.9 provision

    The fatigue training requirement in the final rule will also result
in an annual recordkeeping and reporting burden. Total fatigue training
annualized paperwork burden costs are determined by the numbers of
responders and fatigue training reporting cost per responders. FAA

estimated that the fatigue training will incur the paperwork burden
approximately 2,345 hours, $152,425 for the first year, $1.5 million
nominal cost for 10 years or $1 million present value at 7%. FAA took
steps to arrive the estimate as follows.
    a. Number of responders (dispatchers and managers): 67 operators;
    b. Estimated time needed for each responder: 35 hours, or 2,345
hours incurred by 67 responders;
    c. Average hourly wage rate of trainee: $65 per hour;
    d. Fatigue training paperwork cost: $152,425 per annum ($65 hourly
wage rate x 2,345 hours);

(3) PRA analysis for Sec.  117.11, Sec.  117.19 and Sec.  117.29
provisions

    The FAA combined the cost estimates in one PRA analysis for three
provisions of the final rule (Sec.  117.11, Sec.  117.19 and Sec.
117.29), since paperwork burdens for carriers to report activities that
were not otherwise permitted by Sec.  117.11, Sec.  117.19 and Sec.
117.29 are the same. Reporting and recordkeeping by carriers can be
done electronically by addressing the facts of events. Under the above
provisions, carriers do not need to conduct complicated analyses, so
that there will be no paperwork burden of analyses. In this analysis,
the estimate of paperwork burden will be determined by the numbers of
respondents, the frequencies of their reporting, hours required and the
reporter's wage rate. The FAA estimated the final annual paperwork
burden for three provisions is $92,250, and $0.9 million for the 10-
years nominal cost, or the present value of $0.6 million at 7%, by
taking steps to arrive the estimate as follows.
    a. Number of respondents (air carriers): there are 67 carriers or
respondents;
    b. Estimated frequencies for reporting requirements under each
provision: Although a definitive frequency is unknown and will decrease
as certificate holders adapt the changes, the FAA assumes an average of
6 times per year for each provision;
    c. Estimated total frequencies of annual responses: 18 times (6 x
3) per carrier and 1,206 times (67 x 18) by 67 carriers for these three
provisions of the final rule;
    d. Estimated time needed for each report for each occurrence: 30
minutes, one hundred percent of these responses will be collected
electronically. The time needed for each carrier to report is about 9
hours (18 x 30 minutes), and 603 hours in total by 67 carriers for
these three provisions of the final rule;
    e. Estimated hourly wage rate of reporting staff: $65 per hour;
    f. The estimated total annual cost of reporting is about $39,195
(603 hours x $65);
    g. The nominal cost for 10-years is about $0.4 million or the
present value of $0.24 million at 7%.
    Summarizing the above, the annualized cost is approximately
$194,950 and the total nominal cost for 10-years about $2.1 million
($0.15 million + $1.5 million + $0.4 million) or the present value of
approximately $1.3 million at 7% ($0.1 + $1 million + $0.2 million).
The public reporting burden is estimated to be an average of 47 hours
for each Part 121 certificate holder and 3,178 hours, including the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the collection of information. The total annual cost burden is
approximately $204,950 in total for 67 carriers. There will be no
additional annualized cost to the Federal Government, because FAA will
not add additional staff or pay additional contractors for collecting,
viewing and keeping electronic report-emails.

F. International Compatibility

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to conform to
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
determined that there are no ICAO Standards and Recommended Practices
that directly correspond to these regulations.\106\
---------------------------------------------------------------------------

    \106\ Chapter 4 of ICAO 6, Amendment 33, section <IP_ADDRESS> states
the following:
    Fatigue management. An operator shall establish flight time and
duty period limitations and a rest scheme that enable it to manage
the fatigue of all its flight and cabin crew members. This scheme
shall comply with the regulations established by the State of the
Operator, or approved by that State and shall be included in the
operations manual.
    This provision of ICAO is not inconsistent with this rule.
Moreover, because the ICAO provision defers to the regulations
promulgated by the State of the Operator, it does not even directly
correspond to this rule.
---------------------------------------------------------------------------

G. Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in paragraph 312f and involves no extraordinary
circumstances.

V. Executive Order Determinations

A. Executive Order 12866 and 13563

    See the ``Regulatory Evaluation'' discussion in the ``Regulatory
Notices and Analyses'' section elsewhere in this preamble.

B. Executive Order 13132, Federalism

    The FAA has analyzed this final rule under the principles and
criteria of Executive Order 13132, Federalism. The agency determined
that this action will not have a substantial direct effect on the
States, or the relationship between the Federal Government and the
States, or on the distribution of power and responsibilities among the
various levels of government, and, therefore, does not have Federalism
implications.

C. Executive Order 13211, Regulations That Significantly Affect Energy
Supply, Distribution, or Use

    The FAA analyzed this final rule under Executive Order 13211,
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). The agency has determined that it
is not a ``significant energy action'' under the executive order and it
is not likely to have a significant adverse effect on the supply,
distribution, or use of energy.

VI. How To Obtain Additional Information

A. Rulemaking Documents

    An electronic copy of a rulemaking document may be obtained by
using the Internet--
    1. Search the Federal eRulemaking Portal (http://www.regulations.gov);
    2. Visit the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/ or
    3. Access the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html.
    Copies may also be obtained by sending a request (identified by
notice, amendment, or docket number of this rulemaking) to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.

B. Comments Submitted to the Docket

    Comments received may be viewed by going to http://www.regulations.gov and following the online instructions to search the
docket number for this action. Anyone is able to search the electronic
form of all comments received into any of the FAA's dockets by the name
of the individual submitting the comment (or signing the

comment, if submitted on behalf of an association, business, labor
union, etc.).

C. Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with small entity requests for information
or advice about compliance with statutes and regulations within its
jurisdiction. A small entity with questions regarding this document,
may contact its local FAA official, or the person listed under the FOR
FURTHER INFORMATION CONTACT heading at the beginning of the preamble.
To find out more about SBREFA on the Internet, visit http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

List of Subjects

14 CFR Part 117

    Airmen, Aviation safety, Reporting and recordkeeping requirements,
Safety.

14 CFR Part 119

    Air carriers, Aircraft, Aviation safety, Reporting and
recordkeeping requirements.

14 CFR Part 121

    Air carriers, Aircraft, Airmen, Aviation safety, Reporting and
recordkeeping requirements, Safety.

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends chapter I of title 14, Code of Federal
Regulations as follows:

0
1. Part 117 is added to read as follows:

PART 117--FLIGHT AND DUTY LIMITATIONS AND REST REQUIREMENTS:
FLIGHTCREW MEMBERS

Sec.
117.1 Applicability.
117.3 Definitions.
117.5 Fitness for duty.
117.7 Fatigue risk management system.
117.9 Fatigue education and awareness training program.
117.11 Flight time limitation.
117.13 Flight duty period: Unaugmented operations.
117.15 Flight duty period: Split duty.
117.17 Flight duty period: Augmented flightcrew.
117.19 Flight duty period extensions.
117.21 Reserve status.
117.23 Cumulative limitations.
117.25 Rest period.
117.27 Consecutive nighttime operations.
117.29 Emergency and government sponsored operations.
Table A to Part 117--Maximum Flight Time Limits for Unaugmented
Operations Table B to Part 117--Flight Duty Period: Unaugmented
Operations
Table C to Part 117--Flight Duty Period: Augmented Operations

    Authority: 49 U.S.C. 106(g), 40113, 40119, 44101, 44701-44702,
44705, 44709-44711, 44713, 44716-44717, 44722, 46901, 44903-44904,
44912, 46105.

Sec.  117.1  Applicability.

    (a) This part prescribes flight and duty limitations and rest
requirements for all flightcrew members and certificate holders
conducting passenger operations under part 121 of this chapter.
    (b) This part applies to all operations directed by part 121
certificate holders under part 91, other than subpart K, of this
chapter if any segment is conducted as a domestic passenger, flag
passenger, or supplemental passenger operation.
    (c) This part applies to all flightcrew members when participating
in an operation under part 91, other than subpart K of this chapter, on
behalf of the part 121 certificate holder if any flight segment is
conducted as a domestic passenger, flag passenger, or supplemental
passenger operation
    (d) Notwithstanding paragraphs (a), (b) and (c) of this section, a
certificate holder may conduct under part 117 its part 121 operations
pursuant to 121.470, 121.480, or 121.500.

Sec.  117.3  Definitions.

    In addition to the definitions in Sec. Sec.  1.1 and 110.2 of this
chapter, the following definitions apply to this part. In the event
there is a conflict in definitions, the definitions in this part
control.
    Acclimated means a condition in which a flightcrew member has been
in a theater for 72 hours or has been given at least 36 consecutive
hours free from duty.
    Airport/standby reserve means a defined duty period during which a
flightcrew member is required by a certificate holder to be at an
airport for a possible assignment.
    Augmented flightcrew means a flightcrew that has more than the
minimum number of flightcrew members required by the airplane type
certificate to operate the aircraft to allow a flightcrew member to be
replaced by another qualified flightcrew member for in-flight rest.
    Calendar day means a 24-hour period from 0000 through 2359 using
Coordinated Universal Time or local time.
    Certificate holder means a person who holds or is required to hold
an air carrier certificate or operating certificate issued under part
119 of this chapter.
    Deadhead transportation means transportation of a flightcrew member
as a passenger or non-operating flightcrew member, by any mode of
transportation, as required by a certificate holder, excluding
transportation to or from a suitable accommodation. All time spent in
deadhead transportation is duty and is not rest. For purposes of
determining the maximum flight duty period in Table B of this part,
deadhead transportation is not considered a flight segment.
    Duty means any task that a flightcrew member performs as required
by the certificate holder, including but not limited to flight duty
period, flight duty, pre- and post-flight duties, administrative work,
training, deadhead transportation, aircraft positioning on the ground,
aircraft loading, and aircraft servicing.
    Fatigue means a physiological state of reduced mental or physical
performance capability resulting from lack of sleep or increased
physical activity that can reduce a flightcrew member's alertness and
ability to safely operate an aircraft or perform safety-related duties.
    Fatigue risk management system (FRMS) means a management system for
a certificate holder to use to mitigate the effects of fatigue in its
particular operations. It is a data-driven process and a systematic
method used to continuously monitor and manage safety risks associated
with fatigue-related error.
    Fit for duty means physiologically and mentally prepared and
capable of performing assigned duties at the highest degree of safety.
    Flight duty period (FDP) means a period that begins when a
flightcrew member is required to report for duty with the intention of
conducting a flight, a series of flights, or positioning or ferrying
flights, and ends when the aircraft is parked after the last flight and
there is no intention for further aircraft movement by the same
flightcrew member. A flight duty period includes the duties performed
by the flightcrew member on behalf of the certificate holder that occur
before a flight segment or between flight segments without a required
intervening rest period. Examples of tasks that are part of the flight
duty period include deadhead transportation, training conducted in an
aircraft or flight simulator, and airport/standby reserve, if the above
tasks occur before a flight segment or between flight segments without
an intervening required rest period:
    Home base means the location designated by a certificate holder
where a flightcrew member normally begins and ends his or her duty
periods.
    Lineholder means a flightcrew member who has an assigned flight
duty

period and is not acting as a reserve flightcrew member.
    Long-call reserve means that, prior to beginning the rest period
required by Sec.  117.25, the flightcrew member is notified by the
certificate holder to report for a flight duty period following the
completion of the rest period.
    Physiological night's rest means 10 hours of rest that encompasses
the hours of 0100 and 0700 at the flightcrew member's home base, unless
the individual has acclimated to a different theater. If the flightcrew
member has acclimated to a different theater, the rest must encompass
the hours of 0100 and 0700 at the acclimated location.
    Report time means the time that the certificate holder requires a
flightcrew member to report for an assignment.
    Reserve availability period means a duty period during which a
certificate holder requires a flightcrew member on short call reserve
to be available to receive an assignment for a flight duty period.
    Reserve flightcrew member means a flightcrew member who a
certificate holder requires to be available to receive an assignment
for duty.
    Rest facility means a bunk or seat accommodation installed in an
aircraft that provides a flightcrew member with a sleep opportunity.
    (1) Class 1 rest facility means a bunk or other surface that allows
for a flat sleeping position and is located separate from both the
flight deck and passenger cabin in an area that is temperature-
controlled, allows the flightcrew member to control light, and provides
isolation from noise and disturbance.
    (2) Class 2 rest facility means a seat in an aircraft cabin that
allows for a flat or near flat sleeping position; is separated from
passengers by a minimum of a curtain to provide darkness and some sound
mitigation; and is reasonably free from disturbance by passengers or
flightcrew members.
    (3) Class 3 rest facility means a seat in an aircraft cabin or
flight deck that reclines at least 40 degrees and provides leg and foot
support.
    Rest period means a continuous period determined prospectively
during which the flightcrew member is free from all restraint by the
certificate holder, including freedom from present responsibility for
work should the occasion arise.
    Scheduled means to appoint, assign, or designate for a fixed time.
    Short-call reserve means a period of time in which a flightcrew
member is assigned to a reserve availability period.
    Split duty means a flight duty period that has a scheduled break in
duty that is less than a required rest period.
    Suitable accommodation means a temperature-controlled facility with
sound mitigation and the ability to control light that provides a
flightcrew member with the ability to sleep either in a bed, bunk or in
a chair that allows for flat or near flat sleeping position. Suitable
accommodation only applies to ground facilities and does not apply to
aircraft onboard rest facilities.
    Theater means a geographical area where local time at the
flightcrew member's flight duty period departure point and arrival
point differ by more than 60 degrees longitude.
    Unforeseen operational circumstance means an unplanned event of
insufficient duration to allow for adjustments to schedules, including
unforecast weather, equipment malfunction, or air traffic delay that is
not reasonably expected.
    Window of circadian low means a period of maximum sleepiness that
occurs between 0200 and 0559 during a physiological night.

Sec.  117.5  Fitness for duty.

    (a) Each flightcrew member must report for any flight duty period
rested and prepared to perform his or her assigned duties.
    (b) No certificate holder may assign and no flightcrew member may
accept assignment to a flight duty period if the flightcrew member has
reported for a flight duty period too fatigued to safely perform his or
her assigned duties.
    (c) No certificate holder may permit a flightcrew member to
continue a flight duty period if the flightcrew member has reported him
or herself too fatigued to continue the assigned flight duty period.
    (d) As part of the dispatch or flight release, as applicable, each
flightcrew member must affirmatively state he or she is fit for duty
prior to commencing flight.

Sec.  117.7  Fatigue risk management system.

    (a) No certificate holder may exceed any provision of this part
unless approved by the FAA under a Fatigue Risk Management System that
provides at least an equivalent level of safety against fatigue-related
accidents or incidents as the other provisions of this part.
    (b) The Fatigue Risk Management System must include:
    (1) A fatigue risk management policy.
    (2) An education and awareness training program.
    (3) A fatigue reporting system.
    (4) A system for monitoring flightcrew fatigue.
    (5) An incident reporting process.
    (6) A performance evaluation.

Sec.  117.9  Fatigue education and awareness training program.

    (a) Each certificate holder must develop and implement an education
and awareness training program, approved by the Administrator. This
program must provide annual education and awareness training to all
employees of the certificate holder responsible for administering the
provisions of this rule including flightcrew members, dispatchers,
individuals directly involved in the scheduling of flightcrew members,
individuals directly involved in operational control, and any employee
providing direct management oversight of those areas.
    (b) The fatigue education and awareness training program must be
designed to increase awareness of:
    (1) Fatigue;
    (2) The effects of fatigue on pilots; and
    (3) Fatigue countermeasures
    (c) (1) Each certificate holder must update its fatigue education
and awareness training program every two years and submit the update to
the Administrator for review and acceptance.
    (2) Not later than 12 months after the date of submission of the
fatigue education and awareness training program required by (c)(1) of
this section, the Administrator shall review and accept or reject the
update. If the Administrator rejects an update, the Administrator shall
provide suggested modifications for resubmission of the update.

Sec.  117.11  Flight time limitation.

    (a) No certificate holder may schedule and no flightcrew member may
accept an assignment or continue an assigned flight duty period if the
total flight time:
    (1) Will exceed the limits specified in Table A of this part if the
operation is conducted with the minimum required flightcrew.
    (2) Will exceed 13 hours if the operation is conducted with a 3-
pilot flightcrew.
    (3) Will exceed 17 hours if the operation is conducted with a 4-
pilot flightcrew.
    (b) If unforeseen operational circumstances arise after takeoff
that are beyond the certificate holder's control, a flightcrew member
may exceed the maximum flight time specified in paragraph (a) of this
section and the cumulative flight time limits in 117.23(b) to the
extent necessary to safely land the aircraft at the next destination
airport or alternate, as appropriate.
    (c) Each certificate holder must report to the Administrator within
10 days any flight time that exceeded the maximum

flight time limits permitted by this section. The report must contain
the following:
    (1) A description of the extended flight time limitation and the
circumstances surrounding the need for the extension; and
    (2) If the circumstances giving rise to the extension were within
the certificate holder's control, the corrective action(s) that the
certificate holder intends to take to minimize the need for future
extensions.
    (d) Each certificate holder must implement the corrective action(s)
reported in paragraph (c)(2) of this section within 30 days from the
date of the extended flight time limitation.

Sec.  117.13  Flight duty period: Unaugmented operations.

    (a) Except as provided for in Sec.  117.15, no certificate holder
may assign and no flightcrew member may accept an assignment for an
unaugmented flight operation if the scheduled flight duty period will
exceed the limits in Table B of this part.
    (b) If the flightcrew member is not acclimated:
    (1) The maximum flight duty period in Table B of this part is
reduced by 30 minutes.
    (2) The applicable flight duty period is based on the local time at
the theater in which the flightcrew member was last acclimated.

Sec.  117.15  Flight duty period: Split duty.

    For an unaugmented operation only, if a flightcrew member is
provided with a rest opportunity (an opportunity to sleep) in a
suitable accommodation during his or her flight duty period, the time
that the flightcrew member spends in the suitable accommodation is not
part of that flightcrew member's flight duty period if all of the
following conditions are met:
    (a) The rest opportunity is provided between the hours of 22:00 and
05:00 local time.
    (b) The time spent in the suitable accommodation is at least 3
hours, measured from the time that the flightcrew member reaches the
suitable accommodation.
    (c) The rest opportunity is scheduled before the beginning of the
flight duty period in which that rest opportunity is taken.
    (d) The rest opportunity that the flightcrew member is actually
provided may not be less than the rest opportunity that was scheduled.
    (e) The rest opportunity is not provided until the first segment of
the flight duty period has been completed.
    (f) The combined time of the flight duty period and the rest
opportunity provided in this section does not exceed 14 hours.

Sec.  117.17  Flight duty period: Augmented flightcrew.

    (a) For flight operations conducted with an acclimated augmented
flightcrew, no certificate holder may assign and no flightcrew member
may accept an assignment if the scheduled flight duty period will
exceed the limits specified in Table C of this part.
    (b) If the flightcrew member is not acclimated:
    (1) The maximum flight duty period in Table C of this part is
reduced by 30 minutes.
    (2) The applicable flight duty period is based on the local time at
the theater in which the flightcrew member was last acclimated.
    (c) No certificate holder may assign and no flightcrew member may
accept an assignment under this section unless during the flight duty
period:
    (1) Two consecutive hours in the second half of the flight duty
period are available for in-flight rest for the pilot flying the
aircraft during landing.
    (2) Ninety consecutive minutes are available for in-flight rest for
the pilot performing monitoring duties during landing.
    (d) No certificate holder may assign and no flightcrew member may
accept an assignment involving more than three flight segments under
this section.
    (e) At all times during flight, at least one flightcrew member
qualified in accordance with Sec.  121.543(b)(3)(i) of this chapter
must be at the flight controls.

Sec.  117.19  Flight duty period extensions.

    (a) For augmented and unaugmented operations, if unforeseen
operational circumstances arise prior to takeoff:
    (1) The pilot in command and the certificate holder may extend the
maximum flight duty period permitted in Tables B or C of this part up
to 2 hours.
    (2) An extension in the flight duty period under paragraph (a)(1)
of this section of more than 30 minutes may occur only once prior to
receiving a rest period described in Sec.  117.25(b).
    (3) A flight duty period cannot be extended under paragraph (a)(1)
of this section if it causes a flightcrew member to exceed the
cumulative flight duty period limits specified in 117.23(c).
    (4) Each certificate holder must report to the Administrator within
10 days any flight duty period that exceeded the maximum flight duty
period permitted in Tables B or C of this part by more than 30 minutes.
The report must contain the following:
    (i) A description of the extended flight duty period and the
circumstances surrounding the need for the extension; and
    (ii) If the circumstances giving rise to the extension were within
the certificate holder's control, the corrective action(s) that the
certificate holder intends to take to minimize the need for future
extensions.
    (5) Each certificate holder must implement the corrective action(s)
reported in paragraph (a)(4) of this section within 30 days from the
date of the extended flight duty period.
    (b) For augmented and unaugmented operations, if unforeseen
operational circumstances arise after takeoff:
    (1) The pilot in command and the certificate holder may extend
maximum flight duty periods specified in Tables B or C of this part to
the extent necessary to safely land the aircraft at the next
destination airport or alternate airport, as appropriate.
    (2) An extension of the flight duty period under paragraph (b)(1)
of this section of more than 30 minutes may occur only once prior to
receiving a rest period described in Sec.  117.25(b).
    (3) An extension taken under paragraph (b) of this section may
exceed the cumulative flight duty period limits specified in 117.23(c).
    (4) Each certificate holder must report to the Administrator within
10 days any flight duty period that exceeded the maximum flight duty
period limits permitted by Tables B or C of this part. The report must
contain a description of the circumstances surrounding the affected
flight duty period.

Sec.  117.21  Reserve status.

    (a) Unless specifically designated as airport/standby or short-call
reserve by the certificate holder, all reserve is considered long-call
reserve.
    (b) Any reserve that meets the definition of airport/standby
reserve must be designated as airport/standby reserve. For airport/
standby reserve, all time spent in a reserve status is part of the
flightcrew member's flight duty period.
    (c) For short call reserve,
    (1) The reserve availability period may not exceed 14 hours.
    (2) For a flightcrew member who has completed a reserve
availability period, no certificate holder may schedule and no
flightcrew member may accept an assignment of a reserve availability
period unless the flightcrew member receives the required rest in Sec.
117.25(e).
    (3) For an unaugmented operation, the total number of hours a
flightcrew member may spend in a flight duty period and a reserve
availability period

may not exceed the lesser of the maximum applicable flight duty period
in Table B of this part plus 4 hours, or 16 hours, as measured from the
beginning of the reserve availability period.
    (4) For an augmented operation, the total number of hours a
flightcrew member may spend in a flight duty period and a reserve
availability period may not exceed the flight duty period in Table C of
this part plus 4 hours, as measured from the beginning of the reserve
availability period.
    (d) For long call reserve, if a certificate holder contacts a
flightcrew member to assign him or her to a flight duty period that
will begin before and operate into the flightcrew member's window of
circadian low, the flightcrew member must receive a 12 hour notice of
report time from the certificate holder.
    (e) A certificate holder may shift a reserve flightcrew member's
reserve status from long-call to short-call only if the flightcrew
member receives a rest period as provided in Sec.  117.25(e).

Sec.  117.23  Cumulative limitations.

    (a) The limitations of this section include all flying by
flightcrew members on behalf of any certificate holder or 91K Program
Manager during the applicable periods.
    (b) No certificate holder may schedule and no flightcrew member may
accept an assignment if the flightcrew member's total flight time will
exceed the following:
    (1) 100 hours in any 672 consecutive hours and
    (2) 1,000 hours in any 365 consecutive calendar day period.
    (c) No certificate holder may schedule and no flightcrew member may
accept an assignment if the flightcrew member's total Flight Duty
Period will exceed:
    (1) 60 flight duty period hours in any 168 consecutive hours and
    (2) 190 flight duty period hours in any 672 consecutive hours.

Sec.  117.25  Rest period.

    (a) No certificate holder may assign and no flightcrew member may
accept assignment to any reserve or duty with the certificate holder
during any required rest period.
    (b) Before beginning any reserve or flight duty period a flightcrew
member must be given at least 30 consecutive hours free from all duty
in any 168 consecutive hour period.
    (c) If a flightcrew member operating in a new theater has received
36 consecutive hours of rest, that flightcrew member is acclimated and
the rest period meets the requirements of paragraph (b) of this
section.
    (d) If a flightcrew member travels more than 60[deg] longitude
during a flight duty period or a series of flight duty periods that
require him or her to be away from home base for more than 168
consecutive hours, the flightcrew member must be given a minimum of 56
consecutive hours rest upon return to home base. This rest must
encompass three physiological nights' rest based on local time.
    (e) No certificate holder may schedule and no flightcrew member may
accept an assignment for any reserve or flight duty period unless the
flightcrew member is given a rest period of at least 10 consecutive
hours immediately before beginning the reserve or flight duty period
measured from the time the flightcrew member is released from duty. The
10 hour rest period must provide the flightcrew member with a minimum
of 8 uninterrupted hours of sleep opportunity.
    (f) If a flightcrew member determines that a rest period under
paragraph (e) of this section will not provide eight uninterrupted
hours of sleep opportunity, the flightcrew member must notify the
certificate holder. The flightcrew member cannot report for the
assigned flight duty period until he or she receives a rest period
specified in paragraph (e) of this section.
    (g) If a flightcrew member engaged in deadhead transportation
exceeds the applicable flight duty period in Table B of this part, the
flightcrew member must be given a rest period equal to the length of
the deadhead transportation but not less than the required rest in
paragraph (e) of this section before beginning a flight duty period.

Sec.  117.27  Consecutive nighttime operations.

    A certificate holder may schedule and a flightcrew member may
accept up to five consecutive flight duty periods that infringe on the
window of circadian low if the certificate holder provides the
flightcrew member with an opportunity to rest in a suitable
accommodation during each of the consecutive nighttime flight duty
periods. The rest opportunity must be at least 2 hours, measured from
the time that the flightcrew member reaches the suitable accommodation,
and must comply with the conditions specified in Sec.  117.15(a), (c),
(d), and (e). Otherwise, no certificate holder may schedule and no
flightcrew member may accept more than three consecutive flight duty
periods that infringe on the window of circadian low. For purposes of
this section, any split duty rest that is provided in accordance with
Sec.  117.15 counts as part of a flight duty period.

Sec.  117.29  Emergency and government sponsored operations.

    (a) This section applies to operations conducted pursuant to
contracts with the U.S. Government and operations conducted pursuant to
a deviation under Sec.  119.57 of this chapter that cannot otherwise be
conducted under this part because of circumstances that could prevent
flightcrew members from being relieved by another crew or safely
provided with the rest required under Sec.  117.25 at the end of the
applicable flight duty period.
    (b) The pilot-in-command may determine that maximum applicable
flight duty periods must be exceeded to the extent necessary to allow
the flightcrew to fly to the closest destination where they can safely
be relieved from duty by another flightcrew or can receive the
requisite amount of rest prior to commencing their next flight duty
period.
    (c) A flight duty period may not be extended for an operation
conducted pursuant to a contract with the U.S. Government if it causes
a flightcrew member to exceed the cumulative flight time limits in
Sec.  117.23(b) and the cumulative flight duty period limits in Sec.
117.23(c).
    (d) The flightcrew shall be given a rest period immediately after
reaching the destination described in paragraph (b) of this section
equal to the length of the actual flight duty period or 24 hours,
whichever is less.
    (e) Each certificate holder must report within 10 days:
    (1) Any flight duty period that exceeded the maximum flight duty
period permitted in Tables B or C of this part, as applicable, by more
than 30 minutes; and
    (2) Any flight time that exceeded the maximum flight time limits
permitted in Table A of this part and Sec.  117.11, as applicable.
    (f) The report must contain the following:
    (1) A description of the extended flight duty period and flight
time limitation, and the circumstances surrounding the need for the
extension; and
    (2) If the circumstances giving rise to the extension(s) were
within the certificate holder's control, the corrective action(s) that
the certificate holder intends to take to minimize the need for future
extensions.
    (g) Each certificate holder must implement the corrective action(s)
reported pursuant to paragraph (e)(2) of

this section within 30 days from the date of the extended flight duty
period.

     Table A to Part 117--Maximum Flight Time Limits for Unaugmented
                            Operations Table
------------------------------------------------------------------------
                                                               Maximum
                Time of report (acclimated)                  flight time
                                                               (hours)
------------------------------------------------------------------------
0000-0459.................................................             8
0500-1959.................................................             9
2000-2359.................................................             8
------------------------------------------------------------------------

                         Table B to Part 117--Flight Duty Period: Unaugmented Operations
----------------------------------------------------------------------------------------------------------------
                                                    Maximum flight duty period (hours) for lineholders based on
                                                                     number of flight segments
    Scheduled time of start (acclimated time)     --------------------------------------------------------------
                                                      1        2        3        4        5        6        7+
----------------------------------------------------------------------------------------------------------------
0000-0359........................................        9        9        9        9        9        9        9
0400-0459........................................       10       10       10       10        9        9        9
0500-0559........................................       12       12       12       12     11.5       11     10.5
0600-0659........................................       13       13       12       12     11.5       11     10.5
0700-1159........................................       14       14       13       13     12.5       12     11.5
1200-1259........................................       13       13       13       13     12.5       12     11.5
1300-1659........................................       12       12       12       12     11.5       11     10.5
1700-2159........................................       12       12       11       11       10        9        9
2200-2259........................................       11       11       10       10        9        9        9
2300-2359........................................       10       10       10        9        9        9        9
----------------------------------------------------------------------------------------------------------------

                          Table C to Part 117--Flight Duty Period: Augmented Operations
----------------------------------------------------------------------------------------------------------------
                                                  Maximum flight duty period (hours) based on rest facility and
                                                                        number of pilots
                                               -----------------------------------------------------------------
   Scheduled time of start (acclimated time)        Class 1  rest         Class 2  rest         Class 3  rest
                                                      facility              facility              facility
                                               -----------------------------------------------------------------
                                                 3 pilots   4 pilots   3 pilots   4 pilots   3 pilots   4 pilots
----------------------------------------------------------------------------------------------------------------
0000-0559.....................................         15         17         14       15.5         13       13.5
0600-0659.....................................         16       18.5         15       16.5         14       14.5
0700-1259.....................................         17         19       16.5         18         15       15.5
1300-1659.....................................         16       18.5         15       16.5         14       14.5
1700-2359.....................................         15         17         14       15.5         13       13.5
----------------------------------------------------------------------------------------------------------------

PART 119--CERTIFICATION: AIR CARRIERS AND COMMERCIAL OPERATORS

0
2. The authority citation for part 119 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 1153, 40101, 40102, 40103, 40113,
44105, 44106, 44111, 44701-44717, 44722, 44901, 44903, 44904, 44906,
44912, 44914, 44936, 44938, 46103, 46105.

0
3. In Sec.  119.55, revise paragraph (a) to read as follows:

Sec.  119.55  Obtaining deviation authority to perform operations under
a U.S. military contract.

    (a) The Administrator may authorize a certificate holder that is
authorized to conduct supplemental or on-demand operations to deviate
from the applicable requirements of this part, part 117, part 121, or
part 135 of this chapter in order to perform operations under a U.S.
military contract.
* * * * *

PART 121--OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL
OPERATIONS

0
4. The authority section for part 121 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 40119, 44101, 44701-44702,
44705, 44709-44711, 44713, 44716-44717, 44722, 46901, 44903-44904,
44912, 46105.

0
5. In Sec.  121.467, revise paragraphs (c) introductory text and (c)
(1) to read as follows:

Sec.  121.467  Flight attendant duty period limitations and rest
requirements: Domestic, flag, and supplemental operations.

* * * * *
    (c) Notwithstanding paragraph (b) of this section, a certificate
holder conducting domestic, flag, or supplemental operations may apply
the flightcrew member flight time and duty limitations and requirements
of part 117 of this chapter to flight attendants for all operations
conducted under this part provided that--
    (1) The flightcrew is subject to part 117;
* * * * *

Subpart Q [Amended]

0
6. Revise Sec.  121.470 to read as follows:

Sec.  121.470  Applicability.

    This subpart prescribes flight time limitations and rest
requirements for domestic all-cargo operations, except that:
    (a) Certificate holders conducting operations with airplanes having
a passenger seat configuration of 30 seats or fewer, excluding each
crewmember seat, and a payload capacity of 7,500 pounds or less, may
comply with the

applicable requirements of Sec. Sec.  135.261 through 135.273 of this
chapter.
    (b) Certificate holders conducting scheduled operations entirely
within the States of Alaska or Hawaii with airplanes having a passenger
seat configuration of 30 seats or fewer, excluding each crewmember
seat, and a payload capacity of 7,500 pounds or less, may comply with
the applicable requirements of subpart R of this part for those
operations.
    (c) A certificate holder may apply the flightcrew member flight
time and duty limitations and requirements of part 117 of this chapter.
A certificate holder may choose to apply part 117 to its--
    (1) Cargo operations conducted under contract to a U.S. government
agency.
    (2) All-cargo operations not conducted under contract to a U.S.
Government agency,
    (3) A certificate holder may elect to treat operations in
paragraphs (c)(1) and (c)(2) of this section differently but, once
having decided to conduct those operations under part 117, may not
segregate those operations between this subpart and part 117.

0
7. Add Sec.  121.473 to read as follows:

Sec.  121.473  Fatigue risk management system.

    (a) No certificate holder may exceed any provision of this subpart
unless approved by the FAA under a Fatigue Risk Management System.
    (b) The Fatigue Risk Management System must include:
    (1) A fatigue risk management policy.
    (2) An education and awareness training program.
    (3) A fatigue reporting system.
    (4) A system for monitoring flightcrew fatigue.
    (5) An incident reporting process.
    (6) A performance evaluation.

Subpart R--[Amended]

0
8. Revise Sec.  121.480 to read as follows:

Sec.  121.480  Applicability.

    This subpart prescribes flight time limitations and rest
requirements for flag all-cargo operations, except that:
    (a) Certificate holders conducting operations with airplanes having
a passenger seat configuration of 30 seats or fewer, excluding each
crewmember seat, and a payload capacity of 7,500 pounds or less, may
comply with the applicable requirements of Sec. Sec.  135.261 through
135.273 of this chapter.
    (b) A certificate holder may apply the flightcrew member flight
time and duty limitations and requirements of part 117 of this chapter.
A certificate holder may choose to apply part 117 to its--
    (1) All-cargo operations conducted under contract to a U.S.
government agency.
    (2) All-cargo operations not conducted under contract to a U.S.
Government agency,
    (3) A certificate holder may elect to treat operations in
paragraphs (b)(1) and (b) (2) of this section differently but, once
having decided to conduct those operations under part 117, may not
segregate those operations between this subpart and part 117.

0
9. Add Sec.  121.495 to read as follows:

Sec.  121.495  Fatigue risk management system.

    (a) No certificate holder may exceed any provision of this subpart
unless approved by the FAA under a Fatigue Risk Management System.
    (b) The Fatigue Risk Management System must include:
    (1) A fatigue risk management policy.
    (2) An education and awareness training program.
    (3) A fatigue reporting system.
    (4) A system for monitoring flightcrew fatigue.
    (5) An incident reporting process.
    (6) A performance evaluation.

Subpart S--[Amended]

0
10. Revise Sec.  121.500, to read as follows:

Sec.  121.500  Applicability.

    This subpart prescribes flight time limitations and rest
requirements for supplemental all-cargo operations, except that:
    (a) Certificate holders conducting operations with airplanes having
a passenger seat configuration of 30 seats or fewer, excluding each
crewmember seat, and a payload capacity of 7,500 pound or less, may
comply with the applicable requirements of Sec. Sec.  135.261 through
135.273 of this chapter.
    (b) A certificate holder may apply the flightcrew member flight
time and duty limitations and requirements of part 117 of this chapter.
A certificate holder may choose to apply part 117 to its--
    (1) All-cargo operations conducted under contract to a U.S.
Government agency.
    (2) All-cargo operations not conducted under contract to a U.S.
Government agency,
    (3) A certificate holder may elect to treat operations in
paragraphs (b)(1) and (b)(2) of this section differently but, once
having decided to conduct those operations under part 117, may not
segregate those operations between this subpart and part 117.

0
11. Add Sec.  121.527 to read as follows:

Sec.  121.527  Fatigue risk management system.

    (a) No certificate holder may exceed any provision of this subpart
unless approved by the FAA under a Fatigue Risk Management System.
    (b) The Fatigue Risk Management System must include:
    (1) A fatigue risk management policy.
    (2) An education and awareness training program.
    (3) A fatigue reporting system.
    (4) A system for monitoring flightcrew fatigue.
    (5) An incident reporting process.
    (6) A performance evaluation.
    12. In Sec.  121.583, revise paragraph (a) introductory text to
read as follows:

Sec.  121.583--Carriage  of persons without compliance with the
passenger-carrying requirements of this part and part 117.

    (a) When authorized by the certificate holder, the following
persons, but no others, may be carried aboard an airplane without
complying with the passenger-carrying airplane requirements in
Sec. Sec.  121.309(f), 121.310, 121.391, 121.571, and 121.587; the
passenger-carrying operation requirements in part 117 and Sec. Sec.
121.157(c) and 121.291; and the requirements pertaining to passengers
in Sec. Sec.  121.285, 121.313(f), 121.317, 121.547, and 121.573:
* * * * *

    Issued in Washington, DC, on December 21, 2011.
 Michael P. Huerta,
Acting Administrator.
[FR Doc. 2011-33078 Filed 12-23-11; 4:15 pm]
BILLING CODE P


[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Notices]
[Pages 66848-66849]
[FR Doc No: 2012-27147]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1075]

Minimum Clinically Important Difference: An Outcome Metric in
Orthopaedic Device Science and Regulation; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Minimum Clinically Important
Difference: An Outcome Metric in Orthopaedic Device Science and
Regulation.'' FDA is co-sponsoring this public workshop together with
the Board of Regents of the University System of Georgia by and on
behalf of the Georgia Institute of Technology's Translational Research
Institute for Biomedical Engineering and Science

(TRIBES). The purpose of this public workshop is to bring together a
wide variety of stakeholders to discuss key topics relating to minimum
clinically important difference (MCID) for patient-reported outcome
(PRO) instruments used in orthopaedic extremity device-related
procedures in order to streamline evidence-based scientific rationales
for regulatory guidance of clinical trials and device study design.
    Date and Time: The public workshop will be held on November 27,
2012, from 7:45 a.m. to 5:30 p.m., and on November 28, 2012, from 7:45
a.m. to 1 p.m.
    Location: The public workshop will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (Rm. 1503), Silver Spring, MD 20993, on November 27, 2012
(Day 1), and Building 66, Atrium, on November 28, 2012 (Day 2).
Entrance for the public workshop participants (non-FDA employees) is
through Building 1 on Day 1 and Building 66 on Day 2, where routine
security check procedures will be performed. For parking and security
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Faisal Mirza, Center for Devices and Radiological
Health, Food and Drug Administration, Bldg. 66, Rm. 1558, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER> or 6311, FAX:
301-847-8117, email<EMAIL_ADDRESS>    Registration: TRIBES will charge a registration fee for non-federal
employees to cover its share of the expenses associated with the
workshop. The registration fee is $230 for non-federal employees.
Registration is available on a first-come, first-served basis. Persons
interested in attending this public workshop must register online by
November 13, 2012. Early registration is recommended because facilities
are limited and, therefore, FDA may limit the number of participants
from each organization. If time and space permits, onsite registration
on Day 1 of the public workshop will be provided beginning at 6:45 a.m.
The onsite registration fee is $275.
    If you need special accommodations due to a disability, please
contact Joyce Raines at<PHONE_NUMBER>, email<EMAIL_ADDRESS>no later than November 13, 2012.
    To register for the public workshop, please visit the Georgia
Institute of Technology's TRIBES Web site at http://www.tribes.gatech.edu/mcid-conf-2012. Registrants will receive
confirmation after they have been accepted. You will be notified if you
are on a waiting list.
    For more information on the public workshop, please see FDA's
Medical Devices News & Events--Workshops and Conferences calendar at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
    Streaming Webcast of the Public Workshop: This public workshop will
also be available as a Webcast for registrants only. Persons interested
in viewing the Webcast must register online by November 13, 2012. Early
registration is recommended because Webcast connections are limited.
Organizations are requested to register all participants, but to view
using one connection per location. Webcast participants will be sent
technical system requirements after registration and will be sent
connection access information after November 13, 2012. If you have
never attended a Connect Pro event before, test your connection at
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.
To get a quick overview of the Connect Pro program, please visit:
http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web
site addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management, Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

SUPPLEMENTARY INFORMATION:

I. Background

    Evidence-based medicine guidelines advise the use of PRO
instruments for assessing the successes of clinical treatment in
practice and clinical investigations. However, the selection of a valid
instrument and accurate estimation of its respective clinically
meaningful differences remain challenging particularly with orthopaedic
device-related procedures. The MCID approach has been proposed to
overcome this problem for PRO instruments. There have been various
methodological approaches to determine MCID for particular PRO
instruments but consistency in the literature remains elusive in
orthopaedics and, thus, is the focus of this workshop.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the public workshop include, but are not
limited to:
    1. Current high-quality validated PRO instruments used in
orthopaedic extremity device-related procedures and published MCID
values, if any, for the various PRO instruments.
    2. The impact of variables such as gender, racial/ethnic diversity,
age, body mass index, timeliness, patient expectations, and patient
satisfaction on PRO response and how this affects MCID calculation
within these diverse populations and particular target subgroups of
interest.
    3. Methodology for determining the MCID for validated PRO
instruments in a consistent, reliable, and reproducible manner that is
least cumbersome.
    4. Current evidence on how the MCID, pertaining to a particular PRO
instrument that is used in device-related orthopaedic extremity
surgery, may affect patient outcomes and device regulation.
    5. Potential standard metric by which to gauge patient outcomes
across the spectrum of devices, target populations, and variables of
interest, in order to streamline evidence-based scientific rationales
for regulatory guidance of clinical trials and device study design.
    Approximately 45 days after the workshop, presentation slides will
be available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the
posted events list.)

    Dated: November 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27147 Filed 11-6-12; 8:45 am]
BILLING CODE 4160-01-P