[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Notices]
[Pages 1170-1173]
[FR Doc No: 2011-94]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0610]

 Draft Guidance for Industry on Postmarketing Adverse Event
Reporting for Medical Products and Dietary Supplements During an
Influenza Pandemic; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Postmarketing
Adverse Event Reporting for Medical Products and Dietary Supplements
During an Influenza Pandemic.'' The draft guidance discusses FDA's
intended approach to enforcement of adverse event reporting
requirements for drugs, biologics, medical devices, and dietary
supplements during an influenza pandemic. The agency makes
recommendations to industry for focusing limited resources on reports

related to products indicated for the prevention and treatment of
influenza and other specific types of reports indicated in the draft
guidance. This draft guidance is a revision of the draft guidance for
industry of the same title published on December 16, 2008.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 8, 2011. Submit written comments on the proposed collection of
information by March 8, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Regarding pandemic influenza: Carmen Maher, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 4146, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.
    Regarding human drug products: Solomon Iyasu, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4447, Silver Spring, MD 20993-0002, 301-
796-2370.
    Regarding human biological products: Stephen Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
    Regarding medical device products: Deborah Moore, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 3230, Silver Spring, MD 20993-0002,
301-796-6106.
    Regarding dietary supplements: John Sheehan, Center for Food Safety
and Applied Nutrition (HFS-315), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Postmarketing Adverse Event Reporting for Medical
Products and Dietary Supplements During an Influenza Pandemic.'' In the
Federal Register of December 16, 2008 (73 FR 76364), FDA published
notice of the availability of a draft guidance of the same title. FDA
anticipates that during an influenza pandemic, industry and FDA
workforces may be reduced while reporting of adverse events related to
widespread use of medical products indicated for the treatment and
prevention of influenza may increase, although the extent of these
possible changes is unknown. The revised draft guidance discusses FDA's
intended approach to enforcement of adverse event reporting
requirements for drugs, biologics, medical devices, and dietary
supplements during an influenza pandemic.

II. Revisions to the 2008 Draft Guidance

    FDA is issuing a revised draft guidance that includes
recommendations for planning, notification, and documentation for firms
that report postmarketing adverse events. The revised draft guidance
recommends that each firm's pandemic influenza continuity of operations
plan (COOP) include instructions for reporting adverse events and a
plan for the submission of stored reports that were not submitted
within regulatory timeframes. The revised draft guidance recommends
that firms that are unable to fulfill normal adverse event reporting
requirements during an influenza pandemic do the following:
     Document the conditions that prevent them from meeting
normal reporting requirements,
     Notify the appropriate FDA organizational unit responsible
for adverse event reporting compliance when these conditions exist and
when the reporting process is restored, and
     Maintain records to identify what reports have been
stored.
    These recommendations represent collections of information under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520)
discussed in section IV of this document. In issuing this revised draft
guidance, FDA considered all comments that were submitted in response
to the December 2008 draft guidance. Most comments requested that
greater clarity be provided in certain sections; FDA has revised these
sections accordingly.
    This draft guidance does not address monitoring and reporting of
adverse events that might be imposed as a condition of authorization
for products authorized for emergency use under section 564 of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360bbb-
3). This draft guidance also does not address monitoring and reporting
of adverse events as required by regulations establishing the
conditions for investigational use of drugs, biologics, and devices.
(See 21 CFR parts 312 and 812.)
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on
postmarketing adverse event reporting for medical products and dietary
supplements during pandemic influenza. 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 to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.

IV. Paperwork Reduction Act of 1995

    Under the PRA, Federal agencies must obtain approval from the
Office of Management and Budget (OMB) for each collection of
information that they conduct or sponsor. ``Collection of information''
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal
agencies to provide a 60-day notice in the Federal Register for each
proposed collection of information before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
this notice of the proposed collection of information set forth in this
document.

    With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following topics: (1)
Whether the proposed information collected is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimated burden of
the proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    The draft guidance explains FDA's approach to enforcement of
adverse event reporting requirements for drugs, biologics, medical
devices, and dietary supplements during an influenza pandemic,
including an intent not to object to changes in the timing of
submission of certain reports during some stages of the pandemic
response. The Agency recommends that each firm's pandemic influenza
COOP include instructions for reporting adverse events, including a
plan for the submission of stored reports that were not submitted
within regulatory timeframes. The draft guidance explains that firms
that are unable to fulfill normal adverse event reporting requirements
during an influenza pandemic should: (1) Maintain documentation of the
conditions that prevent them from meeting normal reporting
requirements, (2) notify the appropriate FDA organizational unit
responsible for adverse event reporting compliance when the conditions
exist and when the reporting process is restored, and (3) maintain
records to identify what reports have been stored.
    Based on the number of manufacturers that would be covered by the
draft guidance, we estimate that approximately 5,000 firms will add to
their COOP: (1) Instructions for reporting adverse events and (2) a
plan for submitting stored reports that were not submitted within
regulatory timeframes. We estimate that each firm will take
approximately 50 hours to prepare the adverse event reporting plan for
its COOP.
    We estimate that approximately 500 firms will be unable to fulfill
normal adverse event reporting requirements because of conditions
caused by an influenza pandemic and that these firms will notify the
appropriate FDA organizational unit responsible for adverse event
reporting compliance when the conditions exist. Although we do not
anticipate such pandemic influenza conditions to occur every year, for
purposes of the PRA, we estimate that each of these firms will notify
FDA approximately once each year, and that each notification will take
approximately 8 hours to prepare and submit.
    Concerning the recommendation in the draft guidance that firms
unable to fulfill normal adverse event reporting requirements maintain
documentation of the conditions that prevent them from meeting these
requirements and also maintain records to identify what adverse event
reports have been stored and when the reporting process is restored, we
estimate that approximately 500 firms will each need approximately 8
hours to maintain the documentation and that approximately 500 firms
will each need approximately 8 hours to maintain the records.
Therefore, the total recordkeeping burden that would result from the
draft guidance would be 258,000 hours.
    The draft guidance also refers to previously approved collections
of information found in FDA's adverse event reporting requirements in
21 CFR 310.305, 314.80, 314.98, 600.80, 606.170, 640.73, 1271.350, and
part 803. These regulations contain collections of information 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) and are
approved under OMB control numbers 0910-0116, 0910-0291, 0910-0230,
0910-0308, 0910-0437, and 0910-0543. In addition, the draft guidance
also refers to adverse event reports for nonprescription human drug
products marketed without an approved application and dietary
supplements required under sections 760 and 761 of the FD&C Act (21
U.S.C. 379aa and 379aa-1), which include collections of information
approved under OMB control numbers 0910-0636 and 0910-0635.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of     responses per       Total         Hours per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Notify FDA when normal reporting             500               1             500               8           4,000
 is not feasible................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           4,000
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this information collection.

                                    Table 2--Estimated Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      records per    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
----------------------------------------------------------------------------------------------------------------
Add adverse event reporting plan           5,000               1           5,000              50         250,000
 to COOP........................
Maintain documentation of                    500               1             500               8           4,000
 influenza pandemic conditions
 and resultant high absenteeism.
Maintain records to identify                 500               1             500               8           4,000
 what reports have been stored
 and when the reporting process
 was restored...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         258,000
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this information collection.

V. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm,
or http://www.regulations.gov.

    Dated: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-94 Filed 1-6-11; 8:45 am]
BILLING CODE 4110-01-P


[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Rules and Regulations]
[Pages 34085-34087]
[FR Doc No: 2023-11294]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0229]
RIN 1625-AA00

Safety Zone; Illinois River Mile Markers 163.3 to 162.7, Peoria,
IL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters in the Illinois Waterway at Mile Marker (MM) 162.7
through 163.3. The safety zone is needed to protect personnel, vessels,
and the marine environment from all potential hazards associated with
an aerial drone display. Entry of vessels or persons into this zone is
prohibited unless specifically authorized by the Captain of the Port
Sector Upper Mississippi River (COTP) or a designated representative.

DATES: This rule is effective from 8:45 p.m. through 10:15 p.m. on June
10, 2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0229 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Richard Cherkauer, Sector Upper
Mississippi River Waterways Management Division, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
MM Mile marker
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On February 3, 2023, the Peoria Parks District notified the Coast
Guard that from 9 to 10 p.m. on June 10, 2023, it will be conducting an
aerial drone entertainment display launched landside from Peoria
Riverfront Park and flown over the Illinois River north of the Illinois
River Bridge at MM 162.9. In response, on April 20, 2023, the Coast
Guard published a notice of proposed rulemaking (NPRM) titled Safety
Zone; Illinois River Mile Markers 163.3 to 162.7, Peoria, IL (88 FR
24375). There we stated why we issued the NPRM and invited comments on
our proposed regulatory action related to aerial drone display. During
the comment period that ended April 30, 2023, we received no comments.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because the event takes place on June
10, 2023 and immediate action is needed to protect personnel, vessels,
and the marine environment from all potential hazards associated with
the aerial drone display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Sector Upper

Mississippi River (COTP) has determined that potential hazards
associated with the aerial drone event to be used in this June 10,
2023, display will be a safety concern for anyone within a half mile
radius of the display. The purpose of this rule is to ensure safety of
vessels and the navigable waters in the safety zone before, during, and
after the scheduled event.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published April
20, 2023. There are no changes in the regulatory text of this rule from
the proposed rule in the NPRM.
    This rule establishes a safety zone from 8:45 to 10:15 p.m. on June
10, 2023. The safety zone will cover all navigable waters from MM 162.7
through 163.3 in the Illinois River. The duration of the zone is
intended to ensure the safety of vessels and these navigable waters
before, during, and after the scheduled 9 to 10 p.m. aerial drone
display. No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on safety concerns
associated with an aerial drone display at MM 162.9 and the
consequential safety zone located on the Illinois Waterway from MM
162.7 through 163.3 near Peoria, IL.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received 00 comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone encompassing the width of the Illinois River from MM 162.7
through 163.3. It is categorically excluded from further review under
paragraph L60 of Appendix A, Table 1 of DHS Instruction Manual 023-01-
001-01, Rev. 1. A Record of Environmental Consideration supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  Authority: 46 U.S.C. 70034, 70051, 70124; 33 CFR
1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security
Delegation No. 00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T08-0229 to read as follows:

Sec.  165.T08-0229  Safety Zone; Illinois River from MM 162.7 through
163.3, Peoria, IL

    (a) Location. The following area is a safety zone: all navigable
waters within the Illinois River from MM 162.7 through 163.3.
    (b) Enforcement period. This section will be subject to enforcement
on June 10, 2023, from 8:45 p.m. to 10:15 p.m.
    (c) Regulations. (1) In accordance with the general safety zone
regulations in Sec.  165.23, entry of persons or vessels into this
safety zone described in paragraph (a) of this section is prohibited
unless authorized by the COTP or a designated representative. A
designated representative is a commissioned, warrant, or petty officer
of the U.S. Coast Guard (USCG) assigned to units under the operational
control of USCG Sector Upper Mississippi River.
    (2) To seek permission to enter, contact the COTP or a designated
representative via VHF-FM channel 16, or through USCG Sector Upper
Mississippi River at<PHONE_NUMBER>. Persons and vessels permitted to
enter the safety zone must comply with all lawful orders or directions
issued by the COTP or designated representative.
    (d) Informational broadcasts. The COTP or a designated
representative will inform the public of the effective period for the
safety zone as well as any changes in the dates and times of
enforcement, as well as reductions in size or scope of the safety zone,
through Local Notice to Mariners (LNMs), Broadcast Notices to Mariners
(BNMs), and/or Safety Marine Information Broadcast (SMIB) as
appropriate.

    Dated: May 20, 2023.
A.R. Bender,
Captain, U.S. Coast Guard, Captain of the Port, Sector Upper
Mississippi River.
[FR Doc. 2023-11294 Filed 5-25-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52488-52490]
[FR Doc No: 2018-22578]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0125]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Establishing That a Tobacco
Product Was Commercially Marketed in the United States as of February
15, 2007

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of

certain information by the Agency. Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the guidance for industry
entitled ``Establishing That a Tobacco Product Was Commercially
Marketed in the United States as of February 15, 2007.''

DATES: Submit either electronic or written comments on the collection
of information by December 17, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 17, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2011-D-0125 for the guidance for industry entitled ``Establishing
That a Tobacco Product Was Commercially Marketed in the United States
as of February 15, 2007.'' Received comments, those filed in a timely
manner (see ADDRESSES), 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance for Industry on Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007
OMB Control Number 0910-0775--Extension
    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law.

The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic
Act (FD&C Act) by adding, among other things, a chapter granting FDA
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect the public health generally and to reduce
tobacco use by minors.
    Section 201(rr) of the FD&C Act (21 U.S.C.321(rr)), as amended,
defines a tobacco product as any product made or derived from tobacco
that is intended for human consumption, including any component, part,
or accessory of a tobacco product (except for raw materials other than
tobacco used in manufacturing a component, part, or accessory of a
tobacco product). Section 910 of the FD&C Act (21 U.S.C. 387j) sets out
premarket requirements for new tobacco products. The term new tobacco
product is defined as any tobacco product (including those products in
test markets) that was not commercially marketed in the United States
as of February 15, 2007, or any modification (including a change in
design, any component, any part, or any constituent, including a smoke
constituent, or in the content, delivery, or form of nicotine, or any
other additive or ingredient) of a tobacco product where the modified
product was commercially marketed in the United States after February
15, 2007 (section 910(a)(1) of the FD&C Act).
    The Tobacco Control Act also gave FDA the authority to issue a
regulation deeming all other products that meet the statutory
definition of a tobacco product to be subject to chapter IX of the FD&C
Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10,
2016, FDA issued that rule, extending FDA's tobacco product authority
to all products that meet the definition of tobacco product in the law
(except for accessories of newly regulated tobacco products), including
electronic nicotine delivery systems, cigars, hookah, pipe tobacco,
nicotine gels, dissolvables that were not already subject to the FD&C
Act, and other tobacco products that may be developed in the future (81
FR 28974 at 28976).
    FDA refers to tobacco products that were commercially marketed
(other than exclusively in test markets) in the United States as of
February 15, 2007, as grandfathered tobacco products. Grandfathered
tobacco products are not considered new tobacco products and are not
subject to the premarket requirements of section 910 of the FD&C Act.
The guidance document provides information on how a manufacturer may
establish that a tobacco product was commercially marketed in the
United States as of February 15, 2007. A grandfathered tobacco product
may also serve as the predicate tobacco product in a section 905(j)
report (intended to be used toward demonstrating substantial
equivalence) for a new tobacco product (section 905(j)(1)A)(i) of the
FD&C Act (21 U.S.C. 387e(j)(1)(A)(i))).
    The guidance recommends that the manufacturer submit information
adequate to demonstrate that the tobacco product was commercially
marketed in the United States as of February 15, 2007. Examples of such
information may include, but are not limited to, the following: Dated
copies of advertisements, dated catalog pages, dated promotional
material, and dated bills of lading.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
   FD&C Act sections or action       Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
Submit evidence of commercial              1,000               1           1,000               5           5,000
 marketing in the United States
 as of February 15, 2007........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's estimate of the number of respondents is based on the fact
that requesting an Agency determination of the grandfathered status of
a tobacco product under the guidance is not required and also on the
number of grandfathered submissions received from 2011 to June 2018. We
estimate submissions have increased due to the effective date of the
deeming rule. FDA has stated that, for deemed combustible products that
were on the market as of August 8, 2016, it does not intend to initiate
enforcement for failure to have premarket authorization until August 8,
2021. FDA has also stated that, for deemed noncombustible products that
were on the market as of August 2, 2016, it does not intend to initiate
enforcement for failure to have premarket authorization until August 8,
2022. When these compliance periods end, FDA expects a drop in the
number of grandfathered submissions. The number of hours to gather the
evidence is FDA's estimate of how long it might take one to review,
gather, and submit dated information if making a request for Agency
determination.
    FDA further estimates it would take a manufacturer approximately 5
hours to put together this collection of evidence and to submit the
package to FDA for review. FDA estimates that it should take
approximately 5,000 hours annually to respond to this collection of
information.
    Our estimated burden for the information collection reflects an
overall increase of 4,235 hours. We attribute this adjustment to an
updated number of submissions received through this approval and the
number of submissions expected in the next 3 years.

    Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22578 Filed 10-16-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 4, 2006 (Volume 71, Number 192)]
[Notices]
[Page 58649-58650]
[DOCID:fr04oc06-101]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54531; File No. SR-ISE-2006-52]

 Self-Regulatory Organizations; International Securities
Exchange, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change Relating to the Block Order Mechanism

September 28, 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 September 6, 2006, the International Securities Exchange, Inc.
(``ISE'' or ``Exchange'') 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 ISE. The
ISE filed the proposed rule change pursuant to Section 19(b)(3)(A) of
the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\ which renders the
proposal effective upon filing with the Commission. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange is proposing to reduce the exposure period for orders
entered into the Block Order Mechanism under Rule 716 to three seconds.
The text of the proposed rule change is available on the ISE's Web site
(http://www.iseoptions.com), at the ISE's Office of the Secretary, and

at the Commission's Public Reference Room.

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

    In its filing with the Commission, the ISE included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The ISE has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    Under ISE Rule 716, members can seek liquidity for a single-sided
order of at least fifty contracts (a ``block order'') by entering such
order into the Block Order Mechanism. Currently, upon entry of an
order, the Block Order Mechanism gives market participants thirty
seconds to respond with contra-side trading interest.\5\ The ISE has
reduced the exposure period for the other special order mechanisms
contained in Rule 716, the Facilitation Mechanism and the Solicited
Order Mechanism, to three seconds and has found that this is more than
enough time for market participants to respond.

Because the longer exposure period introduces unnecessary market risk
to orders entered into the Block Order Mechanism, the Exchange proposes
to reduce the Block Order Mechanism exposure period to three seconds.
---------------------------------------------------------------------------

    \5\ At the conclusion of this time period, either an execution
occurs automatically, or the order is cancelled. Bids (offers) on
the Exchange at the time the block order is executed that are priced
higher (lower) than the block execution price, as well as responses
that are priced higher (lower) than the block execution price, are
executed at the block execution price. Responses, quotes and non-
customer orders at the block execution price participate in the
execution of the block order according to the allocation method set
forth in ISE Rule 713(e). See ISE Rule 716(c).
---------------------------------------------------------------------------

2. Statutory Basis
    The basis under the Act for this proposed rule change is found in
Section 6(b)(5),\6\ in that the proposed rule change is designed to
promote just and equitable principles of trade, 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. In particular, the proposed rule change will reduce
unnecessary market risk for orders entered into the Block Order
Mechanism.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \7\ and Rule 19b-
4(f)(6) thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.\9\
However, Rule 19b-4(f)(6)(iii) \10\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The ISE provided the Commission with
written notice of its intent to file this proposed rule change at least
five business days prior to the date of filing of the proposed rule
change. In addition, the ISE has requested that the Commission waive
the 30-day operative delay. The Commission has previously stated its
belief that in an electronic environment--such as that of the ISE
options market--reducing the exposure period for orders to three
seconds could facilitate the prompt execution of such orders, while
providing market participants with an adequate opportunity to compete
for them.\11\ Thus, the Commission believes that waiving the 30-day
operative delay for the instant proposed rule change is consistent with
the protection of investors and the public interest. For this reason,
the Commission designates the proposal to be effective and operative
immediately.\12\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6)(iii).
    \10\ Id.
    \11\ See, e.g., Securities Exchange Act Release Nos. 52711
(November 1, 2005), 70 FR 67508 (November 7, 2005) (SR-ISE-2004-04);
53384 (February 27, 2006), 71 FR 11280 (March 6, 2006) (SR-PCX-2005-
135); and 53567 (March 29, 2006), 71 FR 17529 (April 6, 2006) (SR-
CBOE-2006-09).
    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change 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-ISE-2006-52 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2006-52. 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 ISE. 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-ISE-2006-52 and should be submitted on or before October
25, 2006.
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
Nancy M. Morris,
Secretary.
[FR Doc. E6-16363 Filed 10-3-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Proposed Rules]
[Pages 40018-40019]
[FR Doc No: 2014-16257]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0328; Directorate Identifier 2014-NE-07-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Rolls-Royce plc (RR) RB211 Trent 875-17, 877-17, 884-17, 884B-17, 892-
17, 892B-17, and 895-17 turbofan engines. This proposed AD was prompted
by failure of the intermediate pressure (IP) turbine disk drive arm on
an RR RB211 Trent turbofan engine. This proposed AD would require
modification of the engine by removing any electronic engine control
(EEC) that incorporates EEC software standard prior to version B7.2 and
installing an EEC eligible for installation. We are proposing this AD
to prevent overspeed failure of the turbine blades or the IP turbine
disk, which could lead to uncontained blade or disk release, damage to
the engine, and damage to the airplane.

DATES: We must receive comments on this proposed AD by September 9,
2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    For service information identified in this proposed AD, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby, England,
DE248BJ; phone: 011-44-1332-242424; fax: 011-44-1332-249936; email:
http://www.rolls-royce.com/contact/civil_team.jsp; or Web site:
https://www.aeromanager.com. You may view this service information at
the FAA, Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA. 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-2014-
0328; or in person at the Docket Operations office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the mandatory continuing airworthiness
information (MCAI), the regulatory evaluation, any comments received,
and other information. The address for the Docket Office (phone: 800-
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Wego Wang, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:
781-238-7199; email<EMAIL_ADDRESS>
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-2014-0328;
Directorate Identifier 2014-NE-07-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
with FAA personnel concerning this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2014-0051, dated March 6, 2014 (referred to hereinafter as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    A Trent engine experienced an engine internal fire, caused by
combustion of carbon deposits inside the high/intermediate (HP/IP)
oil vent tubes. The consequent chain of events resulted in the
failure of the IP turbine disk drive arm. Similar engine
architecture exists on Trent 800 series engines.
    This condition, if not corrected, could lead to uncontained
multiple turbine blade failures or an IP turbine disk burst,
possibly resulting in damage to, and reduced control of, the
aeroplane.

    This AD requires incorporating a revised EEC software standard that
can prevent an unsafe chain of events that occur subsequent to an
internal engine fire. The revised EEC software standard can properly
adjust fuel flow, shut down the engine, prevent an overspeed condition,
and indirectly extinguish the fire.
    You may obtain further information by examining the MCAI in the AD
docket on the Internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2014-0328.

Relevant Service Information

    RR has issued Alert Service Bulletin No. RB.211-73-AH001, dated
July 17, 2013. The ASB provides guidance for removal and replacement of
the affected EEC.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of the
United Kingdom, and is approved for operation in the United States.
Pursuant to our bilateral agreement with the European Community, EASA
has notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information provided by EASA and determined the unsafe
condition exists

and is likely to exist or develop on other products of the same type
design. This proposed AD would require modification of the engine by
removing any EEC that incorporates EEC software standard prior to
version B7.2 and installing an EEC eligible for installation.

Costs of Compliance

    We estimate that this proposed AD would affect about 140 engines
installed on airplanes of U.S. registry. We also estimate that it would
take about 2 hours per product to comply with this proposed AD. The
average labor rate is $85 per hour. Required parts cost about $170.
Based on these figures, we estimate the cost of this proposed AD on
U.S. operators to be $23,800.

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 to the extent
that it justifies making a regulatory distinction, 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):

Rolls-Royce plc: Docket No. FAA-2014-0328; Directorate Identifier
2014-NE-07-AD.

(a) Comments Due Date

    We must receive comments by September 9, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Rolls-Royce plc (RR) RB211 Trent 875-17,
877-17, 884-17, 884B-17, 892-17, 892B-17, and 895-17 turbofan
engines.

(d) Reason

    This AD was prompted by failure of the intermediate pressure
(IP) turbine disk drive arm on an RR RB211 Trent turbofan engine. We
are issuing this AD to prevent overspeed failure of the turbine
blades or the IP turbine disk, which could lead to uncontained blade
or disk release, damage to the engine, and damage to the airplane.

(e) Actions and Compliance

    Unless already done, within 12 months after the effective date
of this AD, remove any electronic engine control (EEC) that
incorporates EEC software standard prior to version B7.2 and install
an EEC eligible for installation.

(f) Installation Prohibition

    After modification of an engine as required by paragraph (e) of
this AD, do not install an EEC that incorporates a software standard
prior to version B7.2 onto any engine.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
to this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(h) Related Information

    (1) For more information about this AD, contact Wego Wang,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency AD 2014-0051,
dated March 6, 2014, for more information. You may examine the MCAI
in the AD docket on the Internet at http://www.regulations.gov by
searching for and locating it in Docket No. FAA-2014-0328.
    (3) RR Alert Service Bulletin No. RB.211-73-AH001, dated July
17, 2013, pertains to the subject of this AD and can be obtained
from Rolls-Royce plc using the contact information in paragraph
(h)(4) of this AD.
    (4) For service information identified in this AD, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby,
England, DE248BJ; phone: 011-44-1332-242424; fax: 011-44-1332-
249936; email: http://www.rolls-royce.com/contact/civil_team.jsp;
or Web site: https://www.aeromanager.com.
    (5) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on July 2, 2014.
Carlos A. Pestana,
Acting Assistant Directorate Manager, Engine & Propeller Directorate,
Aircraft Certification Service.
[FR Doc. 2014-16257 Filed 7-10-14; 8:45 am]
BILLING CODE 4910-13-P