    FRN for the Pilot Fragrance Notification Program:  Response to Comments                               September 14, 2011

Submitter Comments/Recommendations OPP Response

IFRA  1. Clarify that submission of fragrance composition data is not necessary if certification requirements are met.

2. Require the resubmission of certifications only when there are changes to an individual fragrance formulation.

3. Edit  Attachments  I & II as suggested above.

Done.

4. Establish the requirements for submission of information regarding an ingredient proposed for addition to the Fragrance Ingredient List (FIL).

Should be submitted to the Inert Ingredient Assessment Branch of the Registration Division.

5. Add all ingredients on the existing inert lists (food & nonfood) to the FIL.

There are many ingredients on the inert list and most are not appropriate for inclusion on the FIL.  Those for consideration are done on a case by case basis.

6. Remove an ingredient from the FIL upon notification that IFRA has instituted a Standard banning that ingredient.

This should be submitted to the Inert Ingredient Assessment Branch.  Once notification is received that concurs about the ingredient, it will be promptly removed.

7. Give registrants and fragrance suppliers adequate time to reformulate a fragrance after an ingredient has been removed from the FIL.

Registrants and fragrance companies

8. Clarify the frequency and timing of publication of future revisions to the FIL.

  It has not been determined.  However, it might be quarterly or twice a year depending whether or not there are new fragrances to add to the list.

IRG (ACC, Clorox, P&G and Reckett Benckiser support the comments of IRG) 1. An annual submission of composition data makes sense for an annual EPA audit.

OPP agrees.

2.  Requirement for "annual self-certification" of a supplier's "fragrances" should be deleted.

OPP agrees that annual certification is not needed since the fragrance supplier is certifying with each notification that all components in the fragrance are listed in the FIL.

3.#9 every 6 months to provide "fragrance composition" seems at odds with an annual "self certification"     OPP agrees with once a year submissions. However, each fragrance supplier must e-submit (once a year) full composition of each fragrance that the company has submitted through notification.

4. #10 talks about the OPP audit (requests for composition data for a portion of the new fragrances" - IRG thinks they understand the intent, but wouldn't the composition data already be required by #9?

EPA should clarify that no additional "requirements for composition data" beyond those normally required, are intended.

The process calls for a yearly audit.  Thus, the information is needed only when we perform our audit.  A yearly submission will require fewer resources.  We have never had to disclose the identity of a fragrance due to health concerns.

Recket Benckiser (IRG also supports this) Eligibility of fragrance actions involving aerosol antimicrobial products. It has been long standing policy that any change to an antimicrobial aerosol formulation could affect the efficacy.  If companies have data to prove otherwise, the data needs to be submitted to EPA for evaluation.  If the data support the claim that fragrance changes do not affect the efficacy of an aerosol product, then the Agency will revise this process and allow aerosol products to make fragrance changes via notification.

P&G 1.Deletion of eligibility item #8 (self-certification requirement every year) OPP agrees to deletion of item #8.

2. Twice a year requirement to contact the fragrance supplier to ensure that the fragrance composition is submitted in the Agency.

OPP agrees that the identity of the components in a given fragrance needs to be provided only once a year.

3.#10 Auditing of the program would be done yearly by OPP.  It's not clear how this audit program will differ from the submission of the fragrance disclosures to EPA cited from item 9.  Please clarify. The process calls for a yearly audit.  Thus, the information is needed only when we perform our audit.  A yearly submission will require fewer resources.  We have never had to disclose the identity of a fragrance due to health concerns.


[Federal Register: November 21, 2007 (Volume 72, Number 224)]
[Notices]
[Page 65582]
[DOCID:fr21no07-68]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. COTP Houston-Galveston 07-022]

Area Maritime Security Committee, Houston-Galveston, TX;
Vacancies

AGENCY: Coast Guard, DHS.

ACTION: Request for applications.

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

SUMMARY: The Coast Guard seeks applications for membership in the Area
Maritime Security Committee, Houston-Galveston, Texas. The Committee
assists the Captain of the Port, Houston-Galveston, Texas in
developing, reviewing, and updating the Area Maritime Security Plan for
their area of responsibility.

DATES: Requests for membership should reach the Captain of the Port,
Houston-Galveston on or before December 21, 2007.

ADDRESSES: Submit applications for membership to the Captain of the
Port, Houston-Galveston, AMSC Executive Administrator, 9640 Clinton
Drive, Houston TX 77029 or by e-mail to<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: For questions about the Houston-
Galveston AMS Committee or its charter, contact Mr. John Walker, AMSC
Executive Administrator, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

The Committee

    The Area Maritime Security Committee, Houston-Galveston, Texas (the
Committee), is established under, and governed by, 33 CFR part 103,
subpart C. The functions of the Committee include, but are not limited
to, the following:
    (1) Identifying critical port infrastructure and operations.
    (2) Identifying risks (i.e., threats, vulnerabilities, and
consequences).
    (3) Determining strategies and implementation methods for
mitigation.
    (4) Developing and describing the process for continuously
evaluating overall port security by considering consequences and
vulnerabilities, how they may change over time, and what additional
mitigation strategies can be applied.
    (5) Advising and assisting the Captain of the Port in developing,
reviewing, and updating the Area Maritime Security Plan under 33 CFR
part 103, subpart E.
    The Houston-Galveston AMS Committee meets quarterly. Subcommittees,
work groups and task forces convene between meetings of the parent
committee. AMS Committee meeting location is currently at the Port of
Houston Authority, 111 East Loop North, Houston, TX at 9 a.m.

Positions Available on the Committee

    There are twenty (27) vacancies on the Committee. Members may be
selected from:
    (1) The Federal, Territorial, or Tribal government;
    (2) The State government and political subdivisions of the State;
    (3) Local public safety, crisis management, and emergency response
agencies;
    (4) Law enforcement and security organizations;
    (5) Maritime industry, including labor;
    (6) Other port stakeholders having a special competence in maritime
security; and
    (7) Port stakeholders affected by security practices and policies.
    In support of the Coast Guard's policy on gender and ethnic
diversity, we encourage qualified women and members of minority groups
to apply.

Qualification of Members

    Members should possess at least five (5) years of experience
related to maritime or port security operations. Applicants may be
required to pass an appropriate security background check before
appointment to the Committee.
    The terms of office for each vacancy is five (5) years. However, a
member may serve one additional term of office. Members are not
salaried or otherwise compensated for their service on the Committee.
    The Houston-Galveston AMS Committee is currently requesting
applications to fill the following vacancies:
    (1) Channel Industries Mutual Aid--Primary and Alternate;
    (2) Cruise Lines--Primary and Alternate;
    (3) Educational Institutions--Alternate;
    (4) Fleets--Alternate;
    (5) Freeport Pilots Assoc--Alternate;
    (6) Freeport Port Security--Primary and Alternate;
    (7) Galveston County--Alternate;
    (8) Galveston/Texas City Pilots Assoc--Primary and Alternate;
    (9) Greater Houston Port Bureau--Primary;
    (10) Gulf Intracoastal Canal Assoc--Alternate;
    (11) Harbor Tugs--Alternate;
    (12) Houston Port Police--Primary and Alternate;
    (13) Offshore Carriers/Area--Alternate;
    (14) Offshore Suppliers--Alternate;
    (15) Port Rail--Alternate;
    (16) Recreational Boaters--Alternate;
    (17) Shipping Agents--Primary and Alternate;
    (18) Texas City Port Police--Primary and Alternate;
    (19) Trucking Industry--Alternate; and
    (20) Waterborne Venders--Alternate.

Format of Applications

    Applications for membership may be in any format. However, because
members must demonstrate an interest in the security of the area
covered by the Committee, we particularly encourage the submission of
information highlighting experience in maritime or security matters.

    Authority: Section 102 of the Maritime Transportation Security
Act of 2002 (Pub. L. 107-295)(the Act) authorizes the Secretary of
the Department in which the Coast Guard is operating to establish
Area Maritime Security Committees for any port area of the United
States. See 33 U.S.C. 1226; 46 U.S.C. 70112(a)(2); 33 CFR 103.205;
Department of Homeland Security Delegation No. 0170.1. The Act
exempts Area Maritime Security Committees from the Federal Advisory
Committee Act (FACA), 5 U.S.C. App. (Pub. L. 92-463).

    Dated: November 6, 2007.
William J. Diehl,
Captain, U.S. Coast Guard, Federal Maritime Security Coordinator/
Captain of the Port, Houston-Galveston.
 [FR Doc. E7-22787 Filed 11-20-07; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: June 16, 2006 (Volume 71, Number 116)]
[Notices]
[Page 34905-34906]
[DOCID:fr16jn06-74]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-822-001; EL06-48-001]

Fore River Development, LLC; Braintree Electric Light Department;
Notice of Filing

June 9, 2006.
    Take notice that on May 30, 2006, ISO New England Inc. submitted
for filing the above-referenced generating units are no longer deemed
to be needed for reliability must agreements.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy

of that document on the Applicant and all the parties in this
proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on June 20, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-9389 Filed 6-15-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)]
[Proposed Rules]
[Pages 1311-1313]
[FR Doc No: 2018-00178]

========================================================================
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. 83, No. 8 / Thursday, January 11, 2018 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0003; Directorate Identifier 2017-CE-033-AD]
RIN 2120-AA64

Airworthiness Directives; American Champion Aircraft Corp.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 2017-07-
10, which applies to certain American Champion Aircraft Corp. (ACAC)
Model 8KCAB airplanes. AD 2017-07-10 requires fabrication and
installation of a placard to prohibit aerobatic flight, inspection of
the aileron hinge rib and support, and a reporting requirement of the
inspection results to the FAA. This AD was prompted by a report of a
cracked hinge support and cracked hinge ribs, which resulted in partial
loss of control with the aileron binding against the cove. Since we
issued AD 2017-07-10, ACAC redesigned the aileron hinge supports with a
reinforcement kit to strengthen the supports and prevent future damage
from developing. This proposed AD would require repetitive inspections
of the aileron hinge support, installation of the aileron hinge support
reinforcement kit, and incorporation of revised pages into the service
manual. We are proposing this AD to address the unsafe condition on
these products.

DATES: We must receive comments on this proposed AD by February 26,
2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact American
Champion Aircraft Corp., P.O. Box 37, 32032 Washington Ave., Rochester,
Wisconsin 53167; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected]; internet: http://www.americanchampionaircraft.com/service-letters.html. You may review
copies of the referenced service information at the FAA, Policy and
Innovation Division, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call (816)
329-4148.

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-2018-
0003; or in person at the Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations (phone: 800-
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Wess Rouse, Small Airplane Program
Manager, 2300 East Devon Avenue, Room 107, Des Plaines, Illinois 60018;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

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-2018-0003;
Directorate Identifier 2017-CE-033-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. We will
consider all comments received by the closing date and may amend this
NPRM because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We issued AD 2017-07-10, Amendment 39-18849 (82 FR 17542, April 12,
2017), (``AD 2017-07-10''), for certain American Champion Aircraft
Corp. (ACAC) Model 8KCAB airplanes. AD 2017-07-10 requires fabrication
and installation of a placard to prohibit aerobatic flight, inspection
of the aileron hinge rib and support, and a reporting requirement of
the inspection results to the FAA. AD 2017-07-10 resulted from a report
of a cracked hinge support and cracked hinge ribs, which resulted in
partial loss of control with the aileron binding against the cove. We
issued AD 2017-07-10 to prevent failure of the aileron support
structure, which may lead to excessive deflection, binding of the
control surface, and potential loss of control.

Actions Since AD 2017-07-10 Was Issued

    Since we issued AD 2017-10, ACAC redesigned the aileron hinge
supports with a reinforcement kit. This kit, when incorporated,
strengthens the supports and prevents future damage from developing.

Related Service Information Under 1 CFR Part 51

    We reviewed American Champion Aircraft Corp. Service Letter (SL)
442, Revision A, dated August 18, 2017 (ACAC SL No. 442); American
Champion Aircraft Corp. Service Letter 444 Initial Revision, dated
August 18, 2017 (ACAC SL No. 444); and page 4-1 of the Airworthiness
Limitations section and page 5-9 of the Time and Maintenance Checks,
both dated October 3, 2017, and included in American Champion Aircraft
Corporation SM-601 8KCAB Service Manual, Reissue B, dated October 3,
2017. ACAC SL No. 442 describes procedures and inspection intervals for
inspection of the aileron hinge rib and hinge support. ACAC SL No. 444
provides instructions for the installation of the aileron hinge
reinforcement kit.

Page 4-1 and page 5-9 are revised pages that add a repetitive
inspection to the 8KCAB Service Manual, SM-601, Reissue B, dated
October 3, 2017. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would retain the placarding requirement of AD
2017-07-10 to prohibit aerobatic flight until completion of the initial
10-hour inspection. This proposed AD would also require repetitive 100-
hour inspections until a maximum of 400 hours is reached, installation
of the aileron hinge reinforcement kit, and incorporation of pages into
the Airworthiness Limitations and Time and Maintenance Checks sections
of the service manual. The existing AD contained a reporting
requirement for the inspection results. This proposed NPRM will not
include a reporting requirement.
    Provided no damage is found during the inspections, an airplane
could have up to five inspections before incorporating the
reinforcement kit (initially at 10 hours TIS with the retained
inspection from AD 2017-07-10, and then four 100-hour inspections up to
a maximum of 400 hours TIS).

Differences Between This Proposed AD and the Service Information

    ACAC SL No. 442 and ACAC SL No. 444 both require installation of
the aileron hinge support reinforcement kit within 100 hours TIS for
airplanes used for competitive aerobatics. Since the FAA has no way of
tracking airplanes used for competitive aerobatics, we require
installation of the reinforcement kit within 400 hours TIS. ACAC SL No.
444 requires 100-hour repetitive inspections after installation of the
reinforcement kit. This proposed AD does not write those actions into
the AD requirements; however, the revised pages of the Airworthiness
Limitations section in the service manual include that inspection
requirement. Both ACAC SL No. 442 and ACAC SL No. 444 have reporting
requirements, but this AD does not include a reporting requirement. The
actions of this AD take precedence over the service information.

Costs of Compliance

    We estimate that this proposed AD affects 64 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Fabrication of placard, inspection of   2 work-hours x $85 per              $100         $270.00         $17,280
 aileron hinge rib and support.          hour = $170.00.
Repetitive 100-hour TIS inspections...  1.5 work-hours x $85 per             N/A          127.50           8,160
                                         hour = $127.50.
Installation of aileron hinge support   50 work-hours x $85 per            2,200           6,450         412,800
 reinforcement kit.                      hour = $4,250.
----------------------------------------------------------------------------------------------------------------

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to small airplanes, gliders, domestic
business jet transport airplanes, and associated appliances to the
Director of the Policy and Innovation Division.

Regulatory Findings

    We have 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 that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2017-07-10, Amendment 39-18849 (82 FR 17542, April 12, 2017), and
adding the following new AD:

American Champion Aircraft Corp.: Docket No. FAA-2018-0003; Product
Identifier 2017-CE-033-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by February 26,
2018.

(b) Affected ADs

    This AD replaces AD 2017-07-10, Amendment 39-18849 (82 FR 17542,
April 12, 2017) (``AD 2017-07-10'').

(c) Applicability

    This AD applies to any American Champion Aircraft Corp. Model
8KCAB airplane, certificated in any category, that either has:
    (i) A serial number in the range of 1116-2012 through 1120-2012
or 1122-2012 through 1170-2017; or
    (ii) is equipped with part number 4-2142 exposed balance
ailerons.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 57, Wings.

(e) Unsafe Condition

    AD 2017-07-10 was prompted by a report of a cracked hinge
support and cracked hinge ribs, which resulted in partial loss of
control with the aileron binding against the cove. This AD
incorporates a newly designed aileron hinge support reinforcement
kit. We are issuing this AD to prevent failure of the aileron
support structure, which may lead to excessive deflection, binding
of the control surface, and potential loss of control.

(f) Compliance

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

(g) Restrict Airplane Operation

    (1) As of April 12, 2017 (the effective date retained from AD
2017-07-10), the airplane is restricted to non-aerobatic flight
until the actions required in paragraphs (g)(2) through (3) of this
AD are done.
    (2) Before further flight after April 12, 2017 (the effective
date retained from AD 2017-07-10), fabricate a placard using at
least \1/8\ inch letters with the words ``AEROBATIC FLIGHT
PROHIBITED'' on it and install the placard on the instrument panel
within the pilot's clear view.
    (3) This action may be performed by the owner/operator (pilot)
holding at least a private pilot certificate and must be entered
into the aircraft records showing compliance with this AD in
accordance with 14 CFR 43.9 (a)(1)-(4) and 14 CFR 91.417(a)(2)(v).
The record must be maintained as required by 14 CFR 91.417, 121.380,
or 135.439.

(h) Inspection and Reinforcement

    (1) Within the next 10 hours time-in-service (TIS) after April
12, 2017 (the effective date retained from AD 2017-07-10), inspect
the aileron hinge rib and support for cracks or other damage
following American Champion Aircraft Corporation Service Letter (SL)
442, dated February 16, 2017, or American Champion Aircraft Corp.
Service Letter (SL) 442, Revision A, dated August 18, 2017 (ACAC SL
No. 442).
    (2) If no cracks or other damage is found during the initial
inspection required in paragraph (h)(1) of this AD, the placard
prohibiting aerobatic flight required in paragraph (g)(2) of this AD
can be removed.
    (3) Within 100 hours TIS from the initial inspection required in
paragraph (h)(1) of this AD or within 10 hours TIS after the
effective date of this AD, whichever occurs later, and repetitively
thereafter at intervals not the exceed 100 hours TIS, inspect the
aileron hinge rib and support for cracks or other damage following
ACAC SL No. 442.
    (4) If cracks or other damage is found during any inspection
required in paragraph (h)(1) or (3) of this AD, before further
flight, replace any retained parts or structure that are cracked or
damaged, and install the aileron hinge reinforcement kit following
American Champion Aircraft Corp. Service Letter 444, dated August
18, 2017 (ACAC SL No. 444).
    (5) Within 400 hours after the initial inspection required in
paragraph (h)(1) of this AD, if not already done as required in
paragraph (h)(4) of this AD, install the aileron hinge reinforcement
kit following the procedures in ACAC SL No. 444.
    (6) After installation of the aileron hinge reinforcement kit
required in paragraph (h)(4) or (5) of this AD, as applicable,
insert page 4-1 of the Airworthiness Limitations section and page 5-
9 of the Time and Maintenance Checks section, both dated October 3,
2017, from the American Champion Aircraft Corporation SM-601 8KCAB
Service Manual, Reissue B, dated October 3, 2017, into the
maintenance program (service manual).
    (7) Installing the aileron hinge reinforcement kit as required
in paragraph (h)(4) or (h)(5) of this AD and the insertion of page
4-1 of the Airworthiness Limitations section and page 5-9 of the
Time and Maintenance Checks section, both dated October 3, 2017, of
the American Champion Aircraft Corporation SM-601 8KCAB Service
Manual, Reissue B, dated October 3, 2017, into the maintenance
program (service manual), as required in paragraph (h)(6) of this AD
is terminating action to this AD. The revised Airworthiness
Limitations section includes a 100-hour/annual inspection
requirement for the aileron hinge supports.

(i) Reporting Requirement

    Although ACAC SL No. 442 and ACAC SL No. 444 specify submitting
certain information to the manufacturer, this AD does not require
that action.

(j) Special Flight Permit

    No aerobatic flight permitted with a special flight permit.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Chicago ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the ACO, send it to the attention of the person
identified in paragraph (l) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(l) Related Information

    (1) For more information about this AD, contact Wess Rouse,
Small Airplane Program Manager, 2300 East Devon Avenue, Room 107,
Des Plaines, Illinois 60018; telephone:<PHONE_NUMBER>; fax: (847)
294-7834; email: [email protected].
    (2) For service information identified in this AD, contact
American Champion Aircraft Corp., P.O. Box 37, 32032 Washington
Ave., Rochester, Wisconsin 53167; telephone:<PHONE_NUMBER>; fax:
(262) 534-2395; email: [email protected]; internet: http://www.americanchampionaircraft.com/service-letters.html. You may view
this referenced service information at the FAA, Policy and
Innovation Division, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.

    Issued in Kansas City, Missouri, on January 3, 2018.
Melvin J. Johnson,
Deputy Director, Policy & Innovation Division, Aircraft Certification
Service.
[FR Doc. 2018-00178 Filed 1-10-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: February 3, 2009 (Volume 74, Number 21)]
[Rules and Regulations]
[Page 5900-5903]
[DOCID:fr03fe09-3]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 112

[EPA-HQ-OPA-2007-0584; FRL-8770-7]
RIN 2050-AG16

Oil Pollution Prevention; Non-Transportation Related Onshore
Facilities; Spill Prevention, Control, and Countermeasure Rule--Final
Amendments

AGENCY: Environmental Protection Agency.

ACTION: Final rule: Delay of effective date and request for comment.

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

SUMMARY: The Environmental Protection Agency (EPA) is delaying by sixty
days the effective date of the final rule that amends the Spill
Prevention, Control, and Countermeasure (SPCC) regulations published in
the Federal Register on December 5, 2008. Thus, the amendments will
become effective on April 4, 2009. EPA additionally is requesting
public comment on the extension of the effective date and its duration,
and on the regulatory amendments contained in the final rule.

DATES: This document is effective February 3, 2009. The effective date
of FR Doc. E8-28159, published in the Federal Register on December 5,
2008 (73 FR 74236), is delayed to April 4, 2009.
    Comments must be received on or before March 5, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OPA-2007-0584, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Mail: EPA Docket, Environmental Protection Agency, Mail
code: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery: EPA/DC, EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OPA-
2007-0584. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information

whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
www.regulations.gov or e-mail. The www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the EPA Docket, EPA/DC EPA
West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the EPA
Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For general information, contact the
Superfund, TRI, EPCRA, RMP, and Oil Information Center at<PHONE_NUMBER>
or TDD at<PHONE_NUMBER> (hearing impaired). In the Washington, DC
metropolitan area, contact the Superfund, TRI, EPCRA, RMP, and Oil
Information Center at<PHONE_NUMBER> or TDD<PHONE_NUMBER>. For more
detailed information on specific aspects of this final rule, contact
either Vanessa E. Principe at<PHONE_NUMBER> (principe.vanessa@epa.gov),
or Mark W. Howard at<PHONE_NUMBER> (howard.markw@epa.gov), U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC, 20460-0002, Mail Code 5104A.

SUPPLEMENTARY INFORMATION: In accordance with the January 20, 2009,
White House memorandum entitled, ``Regulatory Review,'' and the
memorandum from the Office of Management and Budget entitled,
``Implementation of Memorandum Concerning Regulatory Review'' (M-09-08,
January 21, 2009) (OMB memorandum), EPA is delaying the effective date
of the final rule that amends the Spill Prevention, Control, and
Countermeasure (SPCC) regulations promulgated in the Federal Register
on December 5, 2008 (73 FR 74236) under section 311 of the Clean Water
Act and seeking public comment on the extension and its duration. The
effective date of the final rule would have been February 3, 2009. With
the 60-day extension, the amendments will become effective on April 4,
2009. The SPCC rule amendments clarify, tailor, and streamline certain
existing requirements for those facility owners or operators who are
required to prepare and implement an SPCC Plan (or ``Plan'') to prevent
the discharge of oil into or upon navigable waters of the United States
or adjoining shorelines.
    Section 553 of the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(B), provides that, when an Agency for good cause finds that
notice and public procedure are impracticable, unnecessary, or contrary
to the public interest, the Agency may issue a rule without providing
notice and an opportunity for public comment. We have determined that
there is good cause for delaying the effective date of the final rule
amending the SPCC regulations without prior proposal and opportunity
for comment because notice and comment would be impracticable and
unnecessary. Consistent with the January 21, 2009 OMB memorandum
``Implementation of Memorandum Concerning Regulatory Review,'' the EPA
Administrator has chosen this rule for additional assessment of policy
and legal issues. Notice and comment is impracticable because the rule
currently has an effective date of February 3, 2009, and the Agency can
not adequately comply with the presidential directive without delaying
the effective date of the rule. We have also determined that notice and
comment is unnecessary because there are no applicable compliance dates
for the final rule until well after the April 4, 2009 effective date.
    The Agency is taking this action to ensure that the rule reflects
proper consideration of all relevant facts. While the Agency is
requesting public comment on the entire final rule, the Agency is
specifically interested in receiving comments on the optional
approaches for produced water containers and the criteria for qualified
oil production facilities. The preamble and regulatory text for the
optional approaches for exempting or providing containment for produced
water containers can be found at Sec. Sec.  112.2, 112.3(d)(vi),
112.3(d)(vii), 112.5(b), 112.5(c), 112.9(c)(6), and Section V.M.7 of
the December 5, 2008 document, 73 FR 74285 through 74290. The preamble
and regulatory text on the criteria for the identification of oil
production facilities that are qualified and eligible to prepare self-
certified Plans can be found at Sec.  112.3(g)(2)(ii) and Section V.M.6
of the December 5, 2008 document, 73 FR 74280 through 74285. The Agency
requests that comments include an appropriate rationale and supporting
data for Agency review and consideration. Following the comment period,
EPA will take appropriate steps to ensure careful evaluation of the
comments received and will consider whether further amendment of the
final rule is necessary.
    Finally, the Agency is also reviewing the dates by which owners or
operators of facilities must prepare or amend their SPCC Plans, and
implement those Plans. EPA intends to address these dates in a separate
notice.

Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is,
therefore, not subject to review under the Executive Order.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
This action results in no changes to the information collection
requirements of the SPCC rule and will have no impact on the
information collection estimate of project cost and hour burden
previously submitted to OMB.

C. Regulatory Flexibility Act

    Today's final rule is not subject to the Regulatory Flexibility Act
(RFA), which generally requires an agency to prepare a regulatory
flexibility analysis for any

rule that will have a significant economic impact on a substantial
number of small entities. The RFA applies only to rules subject to
notice and comment rulemaking requirements under the APA or any other
statute. This rule is not subject to notice and comment requirements
under the APA or any other statute because, although the rule is
subject to the APA, the Agency has invoked the ``good cause'' exemption
under 5 U.S.C. 553(b), therefore, it is not subject to the notice and
comment requirement.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for state, local, or tribal governments or the private
sector. This action imposes no enforceable duty on any state, local, or
tribal governments or the private sector. Therefore, this action is not
subject to the requirements of sections 202 and 205 of the UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. This action only
delays the effective date of the December 5, 2008 rule and does not
impose any additional enforceable duty.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by state and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects 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.''
    This action does not have federalism implications. It will not have
substantial direct effects 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, as
specified in Executive Order 13132. This action will not impose direct
compliance costs on state or local governments, and will not preempt
state law. Thus, Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (59 FR 22951, November 9, 2000). It will not have
substantial direct effects on tribal governments, 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, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying to those regulatory actions that concern health or safety
risks, such that the analysis required under section 5-501 of the
Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because the NSPS for
petroleum refineries are based on technology performance. This action
is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997)
because it is not economically significant as defined in EO 12866, and
because the Agency does not believe the environmental health or safety
risks addressed by this action presents a disproportionate risk to
children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (Pub. L. 104-113; 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards (VCS) in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. VCS are technical standards
(e.g., materials specifications, test methods, sampling procedures, and
business practices) that are developed or adopted by VCS bodies. NTTAA
directs EPA to provide Congress, through OMB, explanations when EPA
decides not to use available and applicable VCS.
    This action does not involve technical standards. Therefore, EPA
did not consider the use of any VCS.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801, et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. Section 808 allows the issuing agency to
make a rule effective sooner than otherwise provided by the CRA if the
agency makes a good cause finding that notice and public procedure is
impracticable, unnecessary, or contrary to the public interest. This
determination must be supported by a brief statement. 5 U.S.C. 808(2).
As stated previously, EPA has made such a good cause finding, including
the reasons therefor. EPA will submit a report containing this rule and
other required information to the United States Senate, the United
States House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 112

    Environmental protection, Animal fats and vegetable oils, Hot-mix
asphalt, Farms, Flammable and combustible materials, Integrity testing,
Loading

racks, Materials handling and storage, Natural gas, Oil pollution, Oil
and gas exploration and production, Oil spill response, Penalties,
Petroleum, Reporting and recordkeeping requirements, Secondary
containment, Security, Tanks, Unloading racks, Water pollution control,
Water resources.

    Dated: January 29, 2009.
Lisa P. Jackson,
Administrator.
[FR Doc. E9-2335 Filed 2-2-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: June 11, 2008 (Volume 73, Number 113)]
[Notices]
[Page 33154]
[DOCID:fr11jn08-123]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Mid-Continent Railway Historical Society, Inc.

[Docket Number FRA-2006-26300]

    On March 15, 2007, FRA granted a waiver of compliance from certain
provisions of the safety glazing standards, as prescribed by 49 CFR
Section 223.11, Requirements for existing locomotives, to the Mid-
Continent Railway Historical Society, Inc. (MCRY) for diesel-electric
Locomotive Number 1256. Condition Number 1 of the above-referenced
approval letter states: ``This approval of the requirements of 49 CFR
Section 223.11(c) shall apply to MCRY 1256 while operating on MCRY
property at speeds not exceeding 10 mph.'' On December 31, 2007, MCRY
asked FRA for reconsideration of Condition Number 1 to allow an
increase in operating speed of the locomotive from 10 mph to 15 mph.
    MCRY is a tourist railroad operating over 4.2 miles of private
rights-of-way in rural Wisconsin, with a track speed of 15 mph. In
addition, FRA previously granted safety glazing waivers to MCRY for two
of their diesel locomotives with maximum operating speeds of 15 mph.
The petitioner states that when more than one train is operated at a
time, it places an undue hardship on them by restricting the speed of
Locomotive Number 1256 to 10 mph. There have been no reported
accidents/injuries at MCRY related to safety glazing, and the change
would make the conditions of this waiver consistent with those of the
two previously granted. Pursuant to the receipt of the waiver request,
FRA is hereby providing the public an opportunity to comment on this
waiver.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. All communications
concerning these proceedings should identify the appropriate docket
number (FRA-2006-26300) and may be submitted by one of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    FRA does not anticipate scheduling a public hearing in connection
with these proceedings since the facts do not appear to warrant a
hearing. If any interested party desires an opportunity for oral
comment, they should notify FRA, in writing, before the end of the
comment period and specify the basis for their request.
    Communications received within 30 days of the date of this notice
or within 30 days following the filing of supporting safety data,
whichever is later, will be considered by FRA before final action is
taken. Comments received after that date will be considered as far as
practicable.
    All written communications concerning these proceedings are
available for examination during regular business hours (9 a.m.-5 p.m.)
at the above facility. All documents in the public docket are also
available for inspection and copying on the Internet at the docket
facility's Web site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment
on behalf of an association, business, labor union, etc.). You may
review DOT's complete Privacy Act Statement in the Federal Register
published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78).

    Issued in Washington, DC on June 5, 2008.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
 [FR Doc. E8-13113 Filed 6-10-08; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54622-54624]
[FR Doc No: 2023-17261]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1922]

Formal Meetings Between the Food and Drug Administration and
Sponsors or Applicants of Biosimilar User Fee Act Products; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Formal
Meetings Between the FDA and Sponsors or Applicants of BsUFA
Products.'' This draft guidance provides recommendations to industry on
formal meetings between FDA and sponsors or applicants relating to the
development and review of biosimilar or interchangeable biosimilar
products regulated by the Center for Drug Evaluation and Research
(CDER) or the Center for Biologics Evaluation and Research (CBER). This
draft guidance for industry revises and replaces the draft guidance of
the same name issued in June 2018.

DATES: Submit either electronic or written comments on the draft
guidance by October 10, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1922 for ``Formal Meetings Between the Food and Drug
Administration and Sponsors or Applicants of Biosimilar User Fee Act
Products.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    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, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993, 301-796-
1042, [email protected]; or Anne Taylor, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants
of BsUFA Products.'' This draft guidance provides recommendations to
industry on formal meetings between FDA and sponsors or applicants
relating to the development and review of biosimilar or interchangeable
biosimilar products regulated by CDER or CBER. This draft guidance does
not apply to meetings associated with the development of products
intended for submission in, or review of, new drug applications or
abbreviated new drug applications under section 505 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355), biologics
license applications (BLAs) under section 351(a) of the Public Health
Service Act (PHS Act) (42 U.S.C. 262(a)), or submissions for devices
under the FD&C Act. For the purposes of this draft guidance, a formal
meeting includes any meeting that is requested by a sponsor or
applicant following the procedures provided in this draft guidance and
includes meetings conducted in any

format (i.e., in-person, virtual (video conference), teleconference, or
written response only). This guidance discusses the principles of good
meeting management practices and describes standardized procedures for
requesting, preparing, scheduling, conducting, and documenting such
formal meetings.
    This draft guidance for industry revises and replaces the draft
guidance of the same name issued on June 5, 2018 (83 FR 26060). This
revision includes:

 Changes to the data expectations in Biosimilar Initial
Advisory meeting requests
 Addition of Biological Product Development (BPD) Type 2a
meeting
 Changes to when the meeting background package is submitted
for BPD Type 4 meeting
 Changes to the description of the available meeting formats
 Addition of an option for a request for clarification

    FDA also made certain clarifying and editorial changes. Editorial
changes were made primarily for clarification.
    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 current thinking of FDA on ``Formal
Meetings Between the FDA and Sponsors or Applicants of BsUFA
Products.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 regarding sponsor requests to FDA
related to the submission of an investigational new drug application
have been approved under OMB control number 0910-0014. The collections
of information in section 351(a) of the PHS Act and part 601 (21 CFR
part 601) relating to the submission of a BLA have been approved under
OMB control number 0910-0338. The collections of information in section
351(k) of the PHS Act and part 601 relating to the submission of
biosimilar applications and biosimilar user fee applications have been
approved under OMB control number 0910-0718.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17261 Filed 8-10-23; 8:45 am]
BILLING CODE 4164-01-P


% Perimeter carpet 14 days exposure, daily shower, 10% dissipation daily
% February 2, 2016
% Cecilia Tan

% Setting model parameters
use human_parameters_MRP
QPC = 29; 	% to get QALV = 8.3 L/min @BW = 75 kg
use preg_female_parameters
BWSW=1;		% Set BW to a fixed value
BWST=75;		% Set BW to 75kg
PREG=0;			% Not pregnant
DZONE = 1;		% Turn on dermal exposure
KDIS = 0.1;		% 10% daily dissipation
TSTOP=1000;	%Simulation time in hours

% Dermal exposure
SAF= 0.5;	 	% Fraction of skin in contact with chlorpyrifos.
FAD=1;     	% Fraction of dose available to be absorbed. Values of <1 could be used if pesticide is encapsulated.
DERM = 65.28;	% dose in ug/kg
D3=7;  %DAYS/WEEK
%P2=16; %HRS/DAY
P2 = 8;	%hours/day
S2=0 ;%OFFSET FROM 0 START TIME (EG IF YOU WANT TO MODEL FROM MIDNIGHT, BUT DOSE AT 8 AM)
%W2=14; %14 day exposure
W2=30;	%30 day exposure

% Inhalation exposure
CONCMGM=0.00089; % Inhalation concentration mg/m3. Value is largest value reported in monitoring data.
D3IN=5;  %DAYS/WEEK
P2IN=2; %HRS/DAY
S2IN=0 ;%OFFSET FROM 0 START TIME (EG IF YOU WANT TO MODEL FROM MIDNIGHT, BUT DOSE AT 8 AM)
%W2IN=28; %28 day exposure
W2IN=1; %1 day exposure

prepare @clear@all
start @NoCallback
simall = [_time _rbcce _urinetcpy _cv*350.6*1000 _cvo*334.5*1000]; 	%conc unit = pg/g

%save simall @file='perimeter_carpet_02022016_8h' @format=ascii
save simall @file='perimeter_carpet_02032016_30day' @format=ascii


[Federal Register: December 4, 2009 (Volume 74, Number 232)]
[Notices]
[Page 63750-63751]
[DOCID:fr04de09-76]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0264; FRL-9088-7]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Notice of Supplemental
Distribution of a Registered Pesticide Product; EPA ICR No. 0278.10,
OMB Control No. 2070-0044

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

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

DATES: Additional comments may be submitted on or before January 4,
2010.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OPP-
2009-0264, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by mail to: EPA Docket Center, Environmental
Protection Agency, Office of Pesticide Programs (OPP), Regulatory
Public Docket (7502P), 1200 Pennsylvania Ave., NW., Washington, DC
20460-0001, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Lily Negash, Field and External
Affairs Division, (7506P), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703-
347-8515; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On June 24, 2009 (74 FR 30073), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2009-0264, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the OPP Regulatory
Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The Docket Facility telephone number is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, confidential business information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: Notice of Supplemental Distribution of a Registered
Pesticide Product.
    ICR numbers: EPA ICR No. 0278.10, OMB Control No. 2070-0044.
    ICR Status: This ICR is scheduled to expire on March 31, 2010.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable.
    Abstract: This information collection activity provides the
Environmental Protection Agency (EPA) with notification of supplemental
registration of distributors of pesticide products. EPA is responsible
for the regulation of pesticides as mandated by the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended. Section
3(e) of FIFRA (see 7 U.S.C. 136a(e)), allows pesticide registrants to
distribute or sell a registered pesticide product under a different
name instead of or in addition to his own. Such distribution and sale
is termed ``supplemental distribution'' and the product is termed a
``distributor product.'' EPA requires the pesticide registrant to
submit a supplemental statement (EPA Form 8570-5, Notice of
Supplemental Distribution of a Registered Pesticide Product) when the
registrant has entered into an agreement with a second company that
will distribute the registrant's product under the second company's
name and product name. Responses to this collection of information are
mandatory.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average about
15 minutes per response. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Individuals or firms engaged in
activities related to the registration and supplemental distribution of
a pesticide product.
    Estimated Number of Respondents: 1,895.
    Frequency of Response: On occasion.
    Estimated Total Annual Hour Burden: 455.

    Estimated Total Annual Cost: $36,952, includes $0 annualized
capital or O&M costs.
    Changes in the Estimates: There is a decrease of 140 hours in the
total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This decrease is an adjustment due to the
decrease in the number of applications the Agency expects to receive in
the next 3 years. EPA expects to receive a projected 584 fewer annual
responses, based on a year-over-year decrease in the number of
responses received in the 2006-2008 fiscal years. The Agency estimates
that it will receive an average of 1,895 supplemental registrations
annually for the next three years.

    Dated: November 23, 2009.
John Moses, Director,
Collection Strategies Division.
[FR Doc. E9-28973 Filed 12-3-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: October 25, 2011 (Volume 76, Number 206)]
[Notices]
[Page 66119-66120]
[DOCID:fr25oc11-124]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0270]

Agency Information Collection Activities; Revision of a
Currently-Approved Information Collection Request: Application for
Certificate of Registration for Foreign Motor Carriers and Foreign
Motor Private Carriers

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

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for review
and approval. The FMCSA requests approval to revise an ICR entitled,
``Application for Certificate of Registration for Foreign Motor
Carriers and Foreign Motor Private Carriers,'' that requires Mexico-
domiciled for-hire and private motor carriers to file an application
Form OP-2 if they wish to register to transport property only

within municipalities in the United States on the U.S.-Mexico
international border or within the commercial zones of such
municipalities. On July 22, 2011, FMCSA published a Federal Register
notice allowing for a 60-day comment period on the ICR. No comments
were received.

DATES: Please send your comments by November 25, 2011. OMB must receive
your comments by this date in order to act quickly on the ICR.

ADDRESSES: All comments should reference Federal Docket Management
System (FDMS) Docket Number FMCSA-2011-0270. Interested persons are
invited to submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the attention
of the Desk Officer, Department of Transportation/Federal Motor Carrier
Safety Administration, and sent via electronic mail to oira_
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street, NW., Washington,
DC 20503.

FOR FURTHER INFORMATION CONTACT: Ms. Vivian Oliver, Transportation
Specialist, Office of Information Technology, IT Operations Division,
Department of Transportation, Federal Motor Carrier Safety
Administration, 6th Floor, West Building, 1200 New Jersey Ave., SE.,
Washington DC 20590. Telephone Number:<PHONE_NUMBER>; E-mail Address:
<EMAIL_ADDRESS>Office hours are from 9 a.m. to 5 p.m., Monday
through Friday, except Federal Holidays.

SUPPLEMENTARY INFORMATION: Title: Application for Certificate of
Registration for Foreign Motor Carriers and Foreign Motor Private
Carriers.
    OMB Control Number: 2126-0019.
    Type of Request: Revision of a currently-approved information
collection.
    Respondents: Foreign motor carriers and commercial motor vehicle
drivers.
    Estimated Number of Respondents: 400.
    Estimated Time per Response: 4 hours to complete Form OP-2.
    Expiration Date: February 29, 2012.
    Frequency of Response: Other (Once).
    Estimated Total Annual Burden: 1,600 hours [400 responses x 4 hours
to complete Form OP-2 = 1,600].
    Background: Title 49 U.S.C. 13902(c) contains basic licensing
procedures for registering foreign motor carriers to operate across the
U.S.-Mexico border into the United States. Part 368 of title 49, CFR,
contains the regulations that require Mexico-domiciled motor carriers
to apply to the FMCSA for a Certificate of Registration to provide
interstate transportation in municipalities in the United States on the
U.S.-Mexico international border or within the commercial zones of such
municipalities as defined in 49 U.S.C. 13902(c)(4)(A). The FMCSA
carries out this registration program under authority delegated by the
Secretary of Transportation.
    Foreign (Mexico-based) motor carriers use Form OP-2 to apply for
Certificate of Registration authority at the FMCSA. The form requests
information on the foreign motor carrier's name, address, U.S. DOT
Number, form of business (e.g., corporation, sole proprietorship,
partnership), locations where the applicant plans to operate, types of
registration requested (e.g., for-hire motor carrier, motor private
carrier), insurance, safety certifications, household goods arbitration
certifications, and compliance certifications.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the FMCSA to perform its functions; (2) the
accuracy of the estimated burden; (3) ways for FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information.

    Issued on: October 12, 2011.
Kelly Leone,
Associate Administrator, Research and Information Technology.
[FR Doc. 2011-27475 Filed 10-24-11; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: March 31, 2011 (Volume 76, Number 62)]
[Notices]
[Page 17971-17972]
[DOCID:fr31mr11-104]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-29618]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

March 25, 2011.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
March 2011. A copy of each application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>. An order granting each application will be
issued unless the SEC orders a hearing. Interested persons may request
a hearing on any application by writing to the SEC's Secretary at the
address below and serving the relevant applicant with a copy of the
request, personally or by mail. Hearing requests should be received by
the SEC by 5:30 p.m. on April 19, 2011, and should be accompanied by
proof of service on the applicant, in the form of an affidavit or, for
lawyers, a certificate of service. Hearing requests should state the
nature of the writer's interest, the reason for the request, and the
issues contested. Persons who wish to be notified of a hearing may
request notification by writing to the Secretary, U.S. Securities and
Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

FOR FURTHER INFORMATION CONTACT: Diane L. Titus at<PHONE_NUMBER>, SEC,
Division of Investment Management, Office of Investment Company
Regulation, 100 F Street, NE., Washington, DC 20549-4041.

Morgan Stanley Dividend Growth Securities Inc. [File No. 811-3128];
Morgan Stanley California Tax-Free Income Fund [File No. 811-4020];
Morgan Stanley New York Tax-Free Income Fund [File No. 811-4222];
Morgan Stanley Equally-Weighted S&P 500 Fund [File No. 811-5181];
Morgan Stanley Balanced Fund [File No. 811-7245]; Morgan Stanley S&P
500 Index Fund [File No. 811-8265]; Morgan Stanley Fundamental Value
Fund [File No. 811-21160]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On June 1, 2010, each applicant
transferred its assets to a corresponding series of AIM Counselor
Series Trust, based on net asset value. Expenses of approximately
$1,244,560, $93,704, $73,457, $566,552, $151,484, $434,071, and
$92,108, respectively, incurred in connection with the reorganizations
were paid by Morgan Stanley Investment Advisors Inc., applicants'
investment adviser, and Invesco Advisers, Inc.
    Filing Date: The applications were filed on March 4, 2011.
    Applicants' Address: c/o Morgan Stanley Investment Advisors Inc.,
522 Fifth Ave., New York, NY 10036.

Morgan Stanley Pacific Growth Fund Inc. [File No. 811-6121]; Morgan
Stanley Health Sciences Trust [File No. 811-6683]; Morgan Stanley
Global Dividend Growth Securities [File No. 811-7548]; Morgan Stanley
Global Advantage Fund [File No. 811-8455]; Morgan Stanley FX Series
Funds [File No. 811-22020]; Morgan Stanley Series Funds [File No. 811-
22075]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On June 1, 2010, each applicant
transferred its assets to a corresponding series of AIM Investment
Funds, based on net asset value. Expenses of approximately $183,371,
$191,468, $410,968, $186,821, $151,617, and $203,843, respectively,
incurred in connection with the reorganizations were paid by Morgan
Stanley Investment Advisors Inc., applicants' investment adviser, and
Invesco Advisers, Inc.
    Filing Date: The applications were filed on March 4, 2011.
    Applicants' Address: c/o Morgan Stanley Investment Advisors Inc.,
522 Fifth Ave., New York, NY 10036.

Morgan Stanley Special Value Fund [File No. 811-7683]; Morgan Stanley
Value Fund [File No. 811-8861]; Morgan Stanley Technology Fund [File
No. 811-8916]; Morgan Stanley Mid-Cap Value Fund [File No. 811-10359];
Morgan Stanley Small-Mid Special Value Fund [File No. 811-21042]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On June 1, 2010, each applicant
transferred its assets to a corresponding series of AIM Sector Funds,
based on net asset value. Expenses of approximately $232,421, $154,029,
$396,121, $182,975, and $153,105, respectively, incurred in connection
with the reorganizations were paid by Morgan Stanley Investment
Advisors Inc., applicants' investment adviser, and Invesco Advisers,
Inc.
    Filing Date: The applications were filed on March 4, 2011.
    Applicants' Address: c/o Morgan Stanley Investment Advisors Inc.,
522 Fifth Ave., New York, NY 10036.

Morgan Stanley Tax-Exempt Securities Trust [File No. 811-2979]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On June 1, 2010, applicant transferred its
assets to Invesco Tax-Exempt Securities Fund, a series of AIM Tax-
Exempt Funds, based on net asset value. Expenses of approximately
$274,002 incurred in connection with the reorganization were paid by
Morgan Stanley Investment Advisors Inc., applicant's investment
adviser, and Invesco Advisers, Inc.
    Filing Date: The application was filed on March 4, 2011.
    Applicant's Address: c/o Morgan Stanley Investment Advisors Inc.,
522 Fifth Ave., New York, NY 10036.

Morgan Stanley Convertible Securities Trust [File No. 811-4310]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On June 1, 2010, applicant transferred its
assets to Invesco Convertible Securities Fund, a series of AIM Growth
Series, based on net asset value. Expenses of approximately $150,888
incurred in connection with the reorganization were paid by Morgan
Stanley Investment Advisors Inc., applicant's investment adviser, and
Invesco Advisers, Inc.
    Filing Date: The application was filed on March 4, 2011.
    Applicant's Address: c/o Morgan Stanley Investment Advisors Inc.,
522 Fifth Ave., New York, NY 10036.

Morgan Stanley Natural Resource Development Securities Inc. [File No.
811-3129]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On February 5, 2010, applicant transferred
its assets to Morgan Stanley Commodities Alpha Fund, a series of Morgan
Stanley Series Funds, based on net asset value. Expenses of
approximately $248,780 incurred in connection with the reorganization
were paid by applicant and Morgan Stanley Investment Advisors Inc.,
applicant's investment adviser.
    Filing Date: The application was filed on March 7, 2011.
    Applicant's Address: c/o Morgan Stanley Investment Advisors Inc.,
522 Fifth Ave., New York, NY 10036.

Man-Glenwood Lexington, LLC [File No. 811-21173]; Man-Glenwood
Lexington TEI, LLC [File No. 811-21458]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants made a public offering of their securities from January 2003
until September 2010 and from April 2004 until September 2010,
respectively, at which time each applicant's board of managers
determined to cease such offer. Each applicant conducted final investor
repurchases and presently has fewer than one hundred investors.
Applicants are not presently making an offering of securities and do
not propose to make any offering of securities. Each applicant will
continue to operate as a private investment fund in reliance on section
3(c)(1) of the Act until final liquidation.
    Filing Date: The applications were filed on February 28, 2011.
    Applicants' Address: 1 Rockefeller Plaza, 16th Floor, New York, NY
10020.

Man-Glenwood Lexington Associates Portfolio, LLC [File No. 811-21285]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant
made a private offering of its securities to its feeder funds from
January 2003 until September 2010, at which time applicant's board of
managers determined to cease such offer. Applicant conducted final
investor repurchases and presently has fewer than one hundred
investors. Applicant is not presently making an offering of securities
and does not propose to make any offering of securities. Applicant will
continue to operate as a private investment fund in reliance on section
3(c)(1) of the Act until final liquidation.
    Filing Date: The application was filed on February 28, 2011.
    Applicant's Address: 1 Rockefeller Plaza, 16th Floor, New York, NY
10020.

Aetos Capital Opportunities Fund, LLC [File No. 811-21728]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On December
31, 2010, applicant transferred its assets to Aetos Capital Long/Short
Strategies Fund, LLC, based on net asset value. Expenses of
approximately $150,000 incurred in connection with the reorganization
were paid by applicant.
    Filing Dates: The application was filed on February 4, 2011, and
amended on March 23, 2011.
    Applicant's Address: c/o Aetos Capital, LLC, 875 Third Ave., New
York, NY 10022.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
 Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-7516 Filed 3-30-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: February 17, 2009 (Volume 74, Number 30)]
[Notices]
[Page 7450]
[DOCID:fr17fe09-90]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-S-0002]

Phonetic Orthographic Computer Analysis Software Program for
Review of Proprietary Drug and Biologic Names; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the source code and supporting technical documentation
for the Phonetic Orthographic Computer Analysis (POCA) software
program. POCA is an analytic tool designed to help identify drug and
biologic names and medical terminology that are phonetically and
orthographically similar to one another. POCA is one analytic tool that
FDA uses to review proposed proprietary drug and biologic names.

ADDRESSES: Requests for single copies of the POCA software should be
submitted to the following e-mail address:
<EMAIL_ADDRESS>Communications other than requests
for POCA software should be directed to the Division of Medication
Error Prevention and Analysis, Center for Drug Evaluation and Research,
10903 New Hampshire Ave. Bldg. 22, Mail Stop 4447, Silver Spring, MD
20993-0002,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Carol Holquist, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4416, Silver Spring, MD 20993-0002, 301-
796-2360.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of the
source code and supporting technical documentation for the POCA
software program, an analytic tool designed to help identify drug and
biologic names and medical terminology that are phonetically and
orthographically\1\ similar to one another. POCA is one analytic tool
that FDA uses in its review of proposed proprietary drug and biologic
names to help FDA identify proprietary names that look alike or sound
alike. FDA is not providing technical support for the software program.
---------------------------------------------------------------------------

    \1\ Merriam-Webster Online defines the term ``orthography'' in
part as: (1) The representation of the sounds of a language by
written or printed symbols or (2) a part of language study that
deals with letters and spelling. Complete definitions of
``orthography'' and ``orthographic'' are available at http://
www.merriam-webster.com/dictionary.htm.
---------------------------------------------------------------------------

    In title I of the Food and Drug Administration Amendments Act of
2007 (Public Law 110-85), Congress reauthorized and expanded the
Prescription Drug User Fee Act (PDUFA IV). As part of the PDUFA IV
performance goals, FDA agreed to provide the full source code and
supporting technical documentation for the POCA tool and make it
available on disk for use by industry and others from the general
public (see section IX.C.2. at http://www.fda.gov/oc/pdufa4/
pdufa4goals.html).
    The POCA software was produced under a U.S. Government contract,
and the United States has unlimited rights in the software. The United
States has determined that it is in its best interest to provide it
royalty-free to the public to use or modify the software for any
purpose. Thus, the software is hereby provided free of any restriction
on use or distribution. The software is furthermore provided ``as is''
without warranty of any kind or any guarantee that the software will
work for any purpose. Project Performance Corp. developed the software
under a U.S. Government contract.
    Single copies of the POCA software are available from FDA upon
request (see ADDRESSES).

    Dated: February 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3170 Filed 2-13-09; 8:45 am]

BILLING CODE 4160-01-S