[Federal Register Volume 77, Number 245 (Thursday, December 20, 2012)]
[Notices]
[Pages 75439-75440]
[FR Doc No: 2012-30651]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0482]

Guidances for Industry and Investigators on Safety Reporting
Requirements for Investigational New Drug Applications and
Bioavailability/Bioequivalence Studies, and a Small Entity Compliance
Guide; 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 two guidances for industry and investigators entitled
``Safety Reporting Requirements for INDs and BA/BE Studies'' and
``Safety Reporting Requirements for INDs and BA/BE Studies--Small
Entity Compliance Guide.'' These guidances are intended to help
sponsors and investigators comply with the requirements in the final
rule entitled ``Investigational New Drug Safety Reporting Requirements
for Human Drug and Biological Products and Safety Reporting
Requirements for Bioavailability and Bioequivalence Studies in
Humans,'' published in the Federal Register on September 29, 2010 (75
FR 59935). FDA has prepared the Small Entity Compliance Guide in
accordance with the Small Business Regulatory Enforcement Fairness Act.
It is intended to help small businesses understand and comply with the
regulations issued by FDA concerning safety reporting requirements for
investigational new drug applications (IND) and bioavailability (BA)
and bioequivalence (BE) studies.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidances
to the Office of Communications, 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;
or the Office of Communication, Outreach, and Development (HFM-40),
Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance documents.
    Submit electronic comments on the guidances 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: Stephanie Shapley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6352, Silver Spring, MD 20993-0002, 301-
796-4836; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of two guidances for industry
and investigators entitled ``Safety Reporting Requirements for INDs and
BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE
Studies--Small Entity Compliance Guide.'' These guidances are intended
to help sponsors and investigators comply with the requirements for IND
safety reporting and safety reporting for BA and BE studies. In
addition, the Small Entity Compliance Guide is intended to help small
businesses understand and comply with the regulations issued by FDA
concerning the safety reporting requirements for INDs and BA/BE
studies. FDA has prepared the Small Entity Compliance Guide in
accordance with section 212 of the Small Business Regulatory
Enforcement Fairness Act.
    On September 29, 2010, FDA published a final rule amending the IND
safety reporting requirements under 21 CFR part 312 and adding safety
reporting requirements for persons conducting BA and BE studies under
21 CFR part 320. The requirements in the final rule are intended to
improve the utility and quality of safety reports, expedite and
strengthen FDA's ability to review critical safety information, and
better protect human subjects enrolled in clinical trials. FDA also
published a draft guidance entitled ``Safety Reporting Requirements for
INDs and BA/BE Studies'' on September 29, 2010 (75 FR 60129), and the
public was provided with an opportunity to comment on it until December
28, 2010. FDA carefully considered all of the comments received in
developing the final guidance. The final guidance includes
clarifications and additional detail regarding the draft guidance
topics as well additional information on safety reporting issues raised
in the comments.
    The final guidance entitled ``Safety Reporting Requirements for
INDs and BA/BE Studies'' contains the definitions used for IND safety
reporting, makes recommendations on when and how to submit a safety
report, and provides advice on other safety reporting issues that have
generated questions from sponsors and investigators.
    The Small Entity Compliance Guide provides answers to many
frequently asked questions FDA has received from investigators and
sponsors regarding the safety reporting requirements that are
applicable to small entities.
    In addition, on June 7, 2011, the Agency published a guidance
describing enforcement discretion with the reporting requirements until
September 28, 2011, to allow sponsors additional time to make process
changes to implement the final rule (76 FR 32863; June 7, 2011). At
this time, the Agency is withdrawing this guidance.
    These guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidances represent
the Agency's current thinking on safety reporting requirements for IND
and BA/BE studies. They do not create or confer any rights for or on
any person and do 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.

II. Comments

    Interested persons may submit either written comments regarding
these documents to the Division of Dockets

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

III. Paperwork Reduction Act of 1995

    These guidances refer to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in these guidances have been approved under
OMB control number 0910-0672.

IV. Electronic Access

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

    Dated: December 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30651 Filed 12-19-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 47 (Monday, March 11, 2019)]
[Notices]
[Pages 8783-8784]
[FR Doc No: 2019-04381]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2019-0036]

Renewal of Information Collection (OMB No. 2105-0520); Agency
Requests for Reinstatement of a Previously Approved Information
Collection(s): Uniform Administrative Requirements for Grants and
Cooperative Agreements to State and Local Governments and for Grants
and Cooperative Agreements With Institutions of Higher Education, and
Other Nonprofit Organizations

ACTION: Notice and request for comments.

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SUMMARY: The Department of Transportation (DOT) invites public comments
about our intention to request the Office of Management and Budget
(OMB) approval for a previously approved information collection. These
forms include Application for Federal Assistance (SF-424), Federal
Financial Report (SF-425), Request for Advance or Reimbursement (SF-
270), and Outlay Report and Request for Reimbursement for Construction
Programs (SF-271).
    We are required to publish this notice in the Federal Register by
the Paperwork Reduction Act of 1995.

DATES: Written comments should be submitted by May 10, 2019.

ADDRESSES: You may submit comments identified by Docket No. DOT-OST-
2019-0036 through one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail or Hand Delivery: Docket Management Facility, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, West Building,
Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except on Federal holidays.

FOR FURTHER INFORMATION CONTACT: Audrey Clarke, Ph.D., Associate
Director of the Financial Assistance Policy and Oversight Division, M-
65, Office of the Senior Procurement Executive, Office of the
Secretary, U.S. Department of Transportation, 1200 New Jersey Avenue
SE, Washington, DC 20590,<PHONE_NUMBER>. Refer to OMB Control Number
2105-0520.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2105-0520.
    Title: Uniform Administrative Requirements, Cost Principles, and
Audit Requirements for Federal Awards.
    Form Numbers: SF-424, SF-425, SF-270, and SF-271.
    Type of Review: Revision of a previously approved collection.
    Background: This is to request the Office of Management and
Budget's (OMB) renewed three-year approved clearance for the
information collection, entitled, ``Uniform Administrative
Requirements, Cost Principles, and Audit Requirements for Federal
Awards'' OMB Control No 2105-0520, which is currently due to expire on
May 31, 2019. This information collection involves the use of various
forms necessary because of management and oversight responsibilities of
the agency imposed by OMB Circular 2 CFR 200, Uniform Administrative
Requirements, Cost Principles, and Audit Requirements for Federal
Awards. The May 31, 2015 OMB Control Number is titled: Uniform
Administrative Requirements, Cost Principles, and Audit Requirements
for Federal Awards (OMB 2 CFR 200). These guidelines cover the
following data collection standard forms (SF): Application for Federal
Assistance (SF-424); Federal Financial Report (SF-425); Request for
Advance or Reimbursement (SF-270); and Outlay Report & Request for
Reimbursement for Construction Programs (SF-271).
    No adjustments have been made to the burden estimates. In 2015, the

Department estimated a combined total of 1,758 respondents and 123,060
burden hours. Therefore the 2019 burden estimates will remain the same.
    Respondents: Grantees.
    Number of Respondents: 1,758.
    Number of Responses: 7,030.
    Total Annual Burden: 123,060.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for the Department's
performance; (b) the accuracy of the estimated burden; (c) ways for the
Department to enhance the quality, utility and clarity of the
information collection; and (d) ways that the burden could be minimized
without reducing the quality of the collected information.
    The agency will summarize and/or include your comments in the
request for OMB's clearance of this information collection.

    Authority: The Paperwork Reduction Act of 1995, Public Law 104-
13; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1:48.

    Issued in Washington, DC, on March 5, 2019.
Audrey Clarke,
Associate Director, Financial Assistance Policy and Oversight, Office
of the Senior Procurement Executive.
[FR Doc. 2019-04381 Filed 3-8-19; 8:45 am]
 BILLING CODE 4910-9X-P


[Federal Register Volume 82, Number 120 (Friday, June 23, 2017)]
[Notices]
[Pages 28664-28665]
[FR Doc No: 2017-13195]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2697]

Submission of Proposed Recommendations for Industry on Developing
Continuous Manufacturing of Solid Dosage Drug Products in
Pharmaceutical Manufacturing; Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: In connection with promoting the use of innovative
technologies, the Food and Drug Administration (FDA or Agency) is
establishing a public docket to invite discussion of issues related to
the adoption of continuous manufacturing by the pharmaceutical
industry.

DATES: Submit electronic or written comments by September 21, 2017.

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 September 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 21, 2017. 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-2017-N-2697 for ``Submission of Proposed Recommendations for
Industry on Developing Continuous Manufacturing of Solid Dosage Drug
Products in Pharmaceutical Manufacturing; Establishment of a Public
Docket.'' 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.

    Submit written requests for single copies of the Engineering
Research Center for Structured Organic Particulate Systems (C-SOPS)
document 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 C-SOPS document.

FOR FURTHER INFORMATION CONTACT: Sau (Larry) Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2128, Silver Spring, MD 20993-0002, 301-
796-2905<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    During a May 7, 2015, workshop on the Future of Pharmaceutical
Manufacturing, FDA agreed that interested parties could submit for
Agency consideration draft guidance or other materials discussing the
science, technology, and best practices related to continuous
manufacturing. On June 13, 2016, C-SOPS submitted to FDA an industry-
coordinated best practices document on continuous manufacturing. FDA is
interested in public comments about the science, technology, and
practices discussed in the C-SOPS document and is opening this docket
for that purpose. In addition, FDA is seeking comments on other
recommendations regarding continuous manufacturing that have already
been published, including ``Regulatory and Quality Considerations for
Continuous Manufacturing: May 20-21, 2014, Continuous Manufacturing
Symposium.'' FDA invites comment on control strategy, facility, and
process validation considerations for continuous manufacturing of solid
oral dosage forms. This request is not limited to comments on the
proposal described in the C-SOPS submission.

II. Electronic Access

    Persons with access to the Internet may obtain the C-SOPS document
at https://www.regulations.gov.

    Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13195 Filed 6-22-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: January 7, 2010 (Volume 75, Number 4)]
[Rules and Regulations]
[Page 904-906]
[DOCID:fr07ja10-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0699 Directorate Identifier 2009-CE-042-AD;
Amendment 39-16169; AD 2009-21-08 R1]
RIN 2120-AA64

Airworthiness Directives; PIAGGIO AERO INDUSTRIES S.p.A Model
PIAGGIO P-180 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are clarifying information contained in Airworthiness
Directive (AD) 2009-21-08, which applies to PIAGGIO AERO INDUSTRIES
S.p.A. (Piaggio) Model PIAGGIO P-180 airplanes. AD 2009-21-08 currently
requires repetitive functional tests of the manifold system and
replacement of any system that does not pass the functional tests
(i.e., movement of the steering system). The language in AD 2009-21-08
incorrectly references not passing the functional tests as ``movement
of the manifold,'' and it should read ``movement of the steering
system'' as specified in the service bulletin. The notice of proposed
rulemaking (NPRM) referenced it as specified in the service bulletin.
This document incorporates the intent of the action as already proposed
in the NPRM. We are issuing this AD to prevent a potentially dangerous
veer along the runway. The steering system must be in the `off'
position during landing and takeoff (in this case when airspeed is
higher than 60 knots) according to the aircraft flight manual
limitations.

DATES: The effective date of this AD is December 14, 2009, which is the
same as AD 2009-21-08.
    As of December 14, 2009 (74 FR 57561, November 9, 2009), the
Director of the Federal Register approved the incorporation by
reference of the following documents listed in this AD:

----------------------------------------------------------------------------------------------------------------
    Service information title           Page(s)             Revision                        Date
----------------------------------------------------------------------------------------------------------------
PIAGGIO AERO INDUSTRIES S.p.A.    1 through 9........  Rev. 1............  May 27, 2009.
 Service Bulletin (Mandatory) N.
 80-0249.
PIAGGIO AERO INDUSTRIES S.p.A.    CONFIRMATION SLIP..  Rev. 1............  Not Dated.
 Service Bulletin (Mandatory) N.
 80-0249.
PIAGGIO AERO PIAGGIO P.180        Cover..............  No. D2............  Revised June 16, 2008.
 AVANTI Maintenance Manual,
 Report No. 9066, 32-50-00.
PIAGGIO AERO PIAGGIO P.180        1 through 8........  Not Applicable....  March 1, 2006.
 AVANTI Maintenance Manual,
 Report No. 9066, 32-50-00.
PIAGGIO AERO PIAGGIO P.180        201, 202, 204, and   Not Applicable....  June 16, 2008.
 AVANTI Maintenance Manual,        206 through 216.
 Report No. 9066, 32-50-00.
PIAGGIO AERO PIAGGIO P.180        203 and 205........  Not Applicable....  March 1, 2006.
 AVANTI Maintenance Manual,
 Report No. 9066, 32-50-00.
PIAGGIO AERO PIAGGIO P.180        501 through 506....  Not Applicable....  March 1, 2006.
 AVANTI Maintenance Manual,
 Report No. 9066, 32-50-00.
PIAGGIO AERO PIAGGIO P.180        Cover..............  No. A3............  Revised December 19, 2008.
 AVANTI II Maintenance Manual,
 Report No. 180-MAN-0200-01105,
 32-50-00.
PIAGGIO AERO PIAGGIO P.180        1 through 8........  Not Applicable....  June 30, 2005.
 AVANTI II Maintenance Manual,
 Report No. 180-MAN-0200-01105,
 32-50-00.
PIAGGIO AERO PIAGGIO P.180        201, 202, and 207    Not Applicable....  December 19, 2008.
 AVANTI II Maintenance Manual,     through 209.
 Report No. 180-MAN-0200-01105,
 32-50-00.
PIAGGIO AERO PIAGGIO P.180        203 and 205........  Not Applicable....  June 30, 2005.
 AVANTI II Maintenance Manual,
 Report No. 180-MAN-0200-01105,
 32-50-00.
PIAGGIO AERO PIAGGIO P.180        204, 206, and 210    Not Applicable....  September 14, 2007.
 AVANTI II Maintenance Manual,     through 216.
 Report No. 180-MAN-0200-01105,
 32-50-00.
PIAGGIO AERO PIAGGIO P.180        501 through 506....  Not Applicable....  June 30, 2005.
 AVANTI II Maintenance Manual,
 Report No. 180-MAN-0200-01105,
 32-50-00.
----------------------------------------------------------------------------------------------------------------

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at Document Management Facility, U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590.

FOR FURTHER INFORMATION CONTACT: Sarjapur Nagarajan, Aerospace
Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas
City, Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    On October 7, 2009, we issued AD 2009-21-08, Amendment 39-16047 (74
FR 57561, November 9, 2009), to require repetitive functional tests of
the manifold system and replacement of any system that does not pass
the functional

tests (i.e., movement of the steering system) on Piaggio Model PIAGGIO
P-180 airplanes.
    The language in AD 2009-21-08 incorrectly references not passing
the functional tests as ``movement of the manifold,'' and it should
read ``movement of the steering system'' as specified in the service
bulletin. The NPRM referenced it as specified in the service bulletin.
This document incorporates the intent of the action as already proposed
in the NPRM.
    Consequently, the FAA sees a need to clarify AD 2009-21-08 to
assure that the proper criteria are utilized for the required
functional test and is revising the AD to incorporate the language
discussed above and to add the amendment to section 39.13 of the
Federal Aviation Regulations (14 CFR 39.13).
    Since this action only clarifies the intent of what was originally
proposed in the NPRM, it has no adverse economic impact and imposes no
additional burden on any person than was already proposed. Therefore,
the FAA has determined that prior notice and opportunity for public
comment are unnecessary.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 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 removing Airworthiness Directive (AD)
2009-21-08, Amendment 39-16047 74 FR 57561, November 9, 2009), and
adding the following new AD:

2009-21-08 R1 PIAGGIO AERO INDUSTRIES S.p.A.: Amendment 39-16169;
Docket No. FAA-2009-0699; Directorate Identifier 2009-CE-042-AD.

Effective Date

    (a) The effective date of this AD is December 14, 2009, which is
the same as AD 2009-21-08.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Model PIAGGIO P-180 airplanes, all serial
numbers (S/N), certificated in any category.

Subject

    (d) Air Transport Association of America (ATA) Code 32: Landing
Gear.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Some cases of uncommanded steering action were observed, while
the steering system was switched off.
    A leakage in the Steering Select/Bypass Valve, installed in the
Steering Manifold, when closed, is suspected to have caused the
uncommanded steering.
    If left uncorrected, this condition could lead to a potentially
dangerous veer along the runway; in fact, according to the Aircraft
Flight Manual limitations, the steering system must be in `off'
position during landing and takeoff (in this case when airspeed is
higher than 60 knots). For the reasons stated above, this new AD
mandates repetitive inspections for leakage of the Nose Landing Gear
steering manifold.
    The MCAI requires, if any inspection finds internal leakage of
the steering manifold, the replacement of the steering manifold.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Within the next 6 months after December 14, 2009 (the
effective date of this AD and AD 2009-21-08) or within the next 100
hours time-in-service (TIS) after December 14, 2009 (the effective
date of this AD and AD 2009-21-08), whichever occurs first, and
repetitively thereafter at intervals not to exceed every 165 hours
TIS, do a functional test of the nose landing gear (NLG) steering
manifold. Follow the accomplishment instructions of PIAGGIO AERO
INDUSTRIES S.p.A. Service Bulletin (Mandatory) N. 80-0249 (includes
CONFIRMATION SLIP), Rev. 1, dated May 27, 2009.
    (2) Upon installation of a NLG steering manifold on any
airplane, do a functional test of the NLG steering manifold.
Repetitively thereafter at intervals not to exceed every 165 hours
TIS, do a functional test of the NLG steering manifold. Follow the
accomplishment instructions of PIAGGIO AERO INDUSTRIES S.p.A.
Service Bulletin (Mandatory) N. 80-0249 (includes CONFIRMATION
SLIP), Rev. 1, dated May 27, 2009.
    (3) If during any inspection required in paragraphs (f)(1) and
(f)(2) of this AD, any manifold system does not pass the functional
tests (i.e., movement of the steering system), using the compliance
times in the accomplishment instructions of PIAGGIO AERO INDUSTRIES
S.p.A. Service Bulletin (Mandatory) N. 80-0249 (includes
CONFIRMATION SLIP), Rev. 1, dated May 27, 2009, replace the NLG
steering manifold following (for S/N 1004 through 1104) pages 1
through 8 dated March 1, 2006; 201, 202, 204, and 206 through 216,
dated June 16, 2008; 203 and 205, dated March 1, 2006; and 501
through 506, dated March 1, 2006, of PIAGGIO AERO PIAGGIO P.180
AVANTI Maintenance Manual, Report No. 9066, 32-50-00, Revision No.
D2, revised June 16, 2008; or (for S/N 1105 and greater) pages 1
through 8, dated June 30, 2005; 201, 202, and 207 through 209, dated
December 19, 2008; 203 and 205, dated June 30, 2005; 204, 206, and
210 through 216, dated September 14, 2007; and 501 through 506,
dated June 30, 2005, of PIAGGIO AERO PIAGGIO P.180 AVANTI II
Maintenance Manual, Report No. 180-MAN-0200-01105, 32-50-00,
Revision No. A3, revised December 19, 2008.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Sarjapur Nagarajan, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI EASA AD 2009-0129, dated June 19, 2009;
PIAGGIO AERO INDUSTRIES S.p.A. Service Bulletin (Mandatory) N. 80-
0249 (includes CONFIRMATION SLIP), Rev. 1, dated May 27, 2009;
PIAGGIO AERO PIAGGIO P. 180 AVANTI Maintenance Manual, Report No.
9066, 32-50-00, revised June 16, 2008, pages 1 through 8, 201
through 216, and 501 through 506; and PIAGGIO AERO PIAGGIO P. 180
AVANTI II Maintenance Manual, Report No. 180-MAN-0200-01105, 32-50-
00, revised December 19, 2008, pages 1 through 8, 201 through 216,
and 501 through 506, for related information.

Material Incorporated by Reference

    (i) You must use the service information specified in Table 1 of
this AD to do the

actions required by this AD, unless the AD specifies otherwise.
    (1) On December 14, 2009 (74 FR 57561, November 9, 2009), the
Director of the Federal Register previously approved the
incorporation by reference of the service information listed in
Table 1 of this AD.
    (2) For service information identified in this AD, contact
Piaggio Aero Industries S.p.a., Via Cibrario, 4--16154 Genoa, Italy;
telephone +39 010 06481 741; fax: +39 010 6481 309; Internet: http:/
/www.piaggioaero.com, or e-mail<EMAIL_ADDRESS>    (3) You may review copies of the service information
incorporated by reference for this AD at the FAA, Central Region,
Office of the Regional Counsel, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the
Central Region, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information
incorporated by reference for this AD at the National Archives and
Records Administration (NARA). For information on the availability
of this material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

                                   Table 1--Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
    Service information title           Page(s)             Revision                        Date
----------------------------------------------------------------------------------------------------------------
PIAGGIO AERO INDUSTRIES S.p.A.    1 through 9........  Rev. 1............  May 27, 2009.
 Service Bulletin (Mandatory) N.
 80-0249.
PIAGGIO AERO INDUSTRIES S.p.A.    CONFIRMATION SLIP..  Rev. 1............  Not Dated.
 Service Bulletin (Mandatory) N.
 80-0249.
PIAGGIO AERO PIAGGIO P. 180       Cover..............  No. D2............  Revised June 16, 2008.
 AVANTI Maintenance Manual,
 Report No. 9066, 32-50-00.
PIAGGIO AERO PIAGGIO P. 180       1 through 8........  Not Applicable....  March 1, 2006.
 AVANTI Maintenance Manual,
 Report No. 9066, 32-50-00.
PIAGGIO AERO PIAGGIO P. 180       201, 202, 204, and   Not Applicable....  June 16, 2008.
 AVANTI Maintenance Manual,        206 through 216.
 Report No. 9066, 32-50-00.
PIAGGIO AERO PIAGGIO P. 180       203 and 205........  Not Applicable....  March 1, 2006.
 AVANTI Maintenance Manual,
 Report No. 9066, 32-50-00.
PIAGGIO AERO PIAGGIO P. 180       501 through 506....  Not Applicable....  March 1, 2006.
 AVANTI Maintenance Manual,
 Report No. 9066, 32-50-00.
PIAGGIO AERO PIAGGIO P. 180       Cover..............  No. A3............  Revised December 19, 2008.
 AVANTI II Maintenance Manual,
 Report No. 180-MAN-0200-01105,
 32-50-00.
PIAGGIO AERO PIAGGIO P. 180       1 through 8........  Not Applicable....  June 30, 2005.
 AVANTI II Maintenance Manual,
 Report No. 180-MAN-0200-01105,
 32-50-00.
PIAGGIO AERO PIAGGIO P. 180       201, 202, and 207    Not Applicable....  December 19, 2008.
 AVANTI II Maintenance Manual,     through 209.
 Report No. 180-MAN-0200-01105,
 32-50-00.
PIAGGIO AERO PIAGGIO P. 180       203 and 205........  Not Applicable....  June 30, 2005.
 AVANTI II Maintenance Manual,
 Report No. 180-MAN-0200-01105,
 32-50-00.
PIAGGIO AERO PIAGGIO P. 180       204, 206, and 210    Not Applicable....  September 14, 2007.
 AVANTI II Maintenance Manual,     through 216.
 Report No. 180-MAN-0200-01105,
 32-50-00.
PIAGGIO AERO PIAGGIO P. 180       501 through 506....  Not Applicable....  June 30, 2005.
 AVANTI II Maintenance Manual,
 Report No. 180-MAN-0200-01105,
 32-50-00.
----------------------------------------------------------------------------------------------------------------

    Issued in Kansas City, Missouri, on December 30, 2009.
Kim Smith,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. E9-31364 Filed 1-6-10; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44699-44700]
[FR Doc No: 2017-20356]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2017-0109; Notice No. 2017-08]

Hazardous Materials: Emergency Waiver No. 2

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of emergency waiver order.

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SUMMARY: The Pipeline and Hazardous Materials Safety Administration is
issuing an emergency waiver order to persons conducting operations
under the direction of Environmental Protection Agency Regions 2 or 4
or United States Coast Guard 7th District within the Hurricane Irma
emergency and disaster areas of Florida, Puerto Rico, South Carolina,
and the United States Virgin Islands. This Waiver Order is effective
September 8, 2017, and shall remain in effect for 30 days from the date
of issuance.

FOR FURTHER INFORMATION CONTACT: Adam Horsley, Deputy Assistant Chief
Counsel for Hazardous Materials Safety, Pipeline and Hazardous
Materials Safety Administration, telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    In accordance with the provisions of 49 U.S.C. 5103(c), the Acting
Administrator for the Pipeline and Hazardous Materials Safety
Administration (PHMSA), hereby declares that an emergency exists that
warrants issuance of a Waiver of the Hazardous Materials Regulations
(HMR, 49 CFR parts 171-180) to persons conducting operations under the
direction of Environmental Protection Agency (EPA) Region 2 (290
Broadway, New York, NY 10007-1866) or Region 4 (61 Forsyth Street SW.,
Atlanta, GA 30303) or United States Coast Guard (USCG) 7th District
(Brickell Plaza Federal Building, 909 SE 1st Avenue, Miami, FL 33131-
3050) within the Hurricane Irma emergency and disaster areas of
Florida, Puerto Rico, South Carolina, and the United States Virgin
Islands. The Waiver is granted to support EPA and USCG in taking
appropriate actions to prepare for, respond to, and recover from a
threat to public health, welfare, or the environment caused by actual
or potential oil and hazardous materials incidents resulting from
Hurricane Irma.
    On September 5, 2017, the President issued an Emergency Declaration
for Hurricane Irma for all 67 Florida counties (EM-3385), and all 78
municipalities in the Commonwealth of Puerto Rico (EM-3384). On
September 7, 2017, the President issued an Emergency Declaration for
Hurricane Irma for all 46 South Carolina counties and the Catawba
Indian Nation (EM-3386), and a Major Disaster Declaration for all of
the United States Virgin Islands (DR-4335).
    This Waiver Order covers all areas identified in the declarations,
as amended. Pursuant to 49 U.S.C. 5103(c), PHMSA has authority
delegated by the Secretary (49 CFR 1.97(b)(3)) to waive compliance with
any part of the HMR provided that the grant of the waiver is: (1) In
the public interest; (2) not inconsistent with the safety of
transporting hazardous materials; and (3) necessary to facilitate the
safe movement of hazardous materials into, from, and within an area of
a major disaster or emergency that has been declared under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C.
5121 et seq.).
    Given the continuing impacts caused by Hurricane Irma, PHMSA's
Acting Administrator has determined that regulatory relief is in the
public interest and necessary to ensure the safe transportation in
commerce of hazardous materials while EPA and USCG execute their
recovery and cleanup efforts in Florida, Puerto Rico, South Carolina,
and the United States Virgin Islands. Specifically, PHMSA's Acting
Administrator finds that issuing this Waiver Order will allow EPA and
USCG to conduct their emergency support function under the National
Response Framework to safely remove, transport, and dispose of
hazardous materials. By execution of this Waiver Order, persons
conducting operations under the direction of EPA Regions 2 or 4 or USCG
7th District within the Hurricane Irma emergency and disaster areas of
Florida, Puerto Rico, South Carolina, and the United States Virgin
Islands are authorized to offer and transport non-radioactive hazardous
materials under alternative safety requirements imposed by EPA Regions
2 or 4 or USCG 7th District when compliance with the HMR is not
practicable. Under this Waiver Order, non-radioactive hazardous
materials may be transported to staging areas within 50 miles of the
point of origin. Further transportation of the hazardous materials from
staging areas must be in full compliance with the HMR.
    This Waiver Order is effective September 8, 2017, and shall remain
in

effect for 30 days from the date of issuance.

Drue Pearce,
Acting Administrator, Pipeline and Hazardous Materials Safety
Administration.
[FR Doc. 2017-20356 Filed 9-22-17; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Page 63660]
[FR Doc No: 2019-24922]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4693]

Mayne Pharma Group Limited and Actavis Laboratories UT, Inc.;
Withdrawal of Approval of Abbreviated New Drug Applications for
Fentanyl Transdermal Systems

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing the approval of abbreviated new drug application (ANDA)
077062 for the fentanyl transdermal system held by Mayne Pharma Group
Ltd. (Mayne) and ANDA 076709 for the fentanyl transdermal system held
by Actavis Laboratories UT, Inc. (Actavis), an indirect wholly owned
subsidiary of Teva Pharmaceuticals USA, Inc. (Teva). These drug
products are both transdermal systems designed with a liquid reservoir.
Mayne and Actavis have both requested withdrawal of their respective
applications and have waived their opportunity for a hearing.

DATES: Approval is withdrawn as of November 18, 2019.

FOR FURTHER INFORMATION CONTACT: Bronwen Blass, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On August 20, 2007, FDA approved Actavis
South Atlantic LLC Inc.'s (Actavis South) ANDA 077062, and Watson
Pharmaceuticals' (Watson) ANDA 076709 for fentanyl transdermal systems
with liquid reservoirs. Both ANDAs 077062 and 076709 are indicated for
use in the management of pain in opioid-tolerant patients, severe
enough to require daily, around-the-clock, long-term opioid treatment
and for which alternative treatment options are inadequate. Both ANDAs
077062 and 076709 fentanyl transdermal systems were approved for the
following strengths: 25 micrograms (mcg)/hour (hr), 50 mcg/hr, 75 mcg/
hr, and 100 mcg/hr.
    ANDA 077062, previously held by Actavis South, is now held by Mayne
\1\ and ANDA 076709 is now held by Actavis as an indirect wholly owned
subsidiary of Teva.\2\ However, after ANDAs 077062 and 076709 were
approved, FDA became aware of new information related to problems with
the manufacturing, design, and quality control of fentanyl transdermal
systems with a liquid reservoir design, leading to potential leakage,
unintended opioid exposure, and potentially life-threatening adverse
events.
---------------------------------------------------------------------------

    \1\ At the time of original approval, ANDA 077062 was held by
Actavis South. In 2012, Actavis South divested ANDA 077062 to Par
Pharmaceutical, Inc. In 2017, Par Pharmaceutical, Inc., divested
ANDA 077062 to Mayne.
    \2\ At the time of original approval, ANDA 076709 was held by
Watson. In 2015, Watson became a wholly owned subsidiary of Actavis,
and thus, the application transferred to Actavis. In 2017, Actavis
became an indirect wholly owned subsidiary of Teva. Thus, ANDA
076709 is currently held by Actavis as a subsidiary of Teva.
---------------------------------------------------------------------------

    In June 2019, Mayne requested withdrawal of ANDA 077062 under Sec.
314.150(d) (21 CFR 314.150(d)) and waived its opportunity for a
hearing, and in July 2019, Actavis requested withdrawal of ANDA 076709
under Sec.  314.150(d) and waived its opportunity for a hearing. In its
letter requesting withdrawal of approval, Actavis stated that it
voluntarily discontinued manufacture and sale of products under ANDA
076709 in 2018 for commercial reasons and has agreed to withdrawal of
the application for those reasons only.
    For the reasons discussed above, and pursuant to Mayne's and
Actavis' requests, approval of ANDAs 077062 and 076709, and all
amendments and supplements thereto, is withdrawn under Sec.
[thinsp]314.150(d).
    Distribution of Mayne's fentanyl transdermal system (25 mcg/hr, 50
mcg/hr, 75 mcg/hr, and 100 mcg/hr) or Actavis's fentanyl transdermal
system (25 mcg/hr, 50 mcg/hr, 75 mcg/hr, and 100 mcg/hr) into
interstate commerce without an approved application is illegal and
subject to regulatory action (see sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).

    Dated: November 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24922 Filed 11-15-19; 8:45 am]
 BILLING CODE 4164-01-P