   EPA  U.S. Environmental Protection Agency NOTICE OF ACTIVITY OF MANUFACTURE, IMPORT, OR PROCESSING  -  FORM B  Submission Date:

 Revised Date:

 Part I  -  Submitter Identification

 Manufacturer, Importer, Processor (in U.S.)           Name of Authorized Official        Mailing Address (street, city, zip code)  CBI*

 (first)  last)

                                        Company Name        Mailing Address (street, city, zip code)

 Technical Contact (in U.S.)                                             Name                                      Telephone Number

 (first) last)

 * CBI refers to the term "Confidential Business Information." Mark (X) in the CBI box(es) if the submitter information is to be held confidential.   Part II  -  Chemical Substance Identity    CASRN           TSCA Inventory Chemical Name (if specific chemical identity is not CBI)

   Accession Number               Generic Chemical Name (if specific chemical identity is CBI)

 Part III  -  Status of Confidential Chemical Substance Identity

 I am seeking to maintain an existing claim of confidentiality for the specific chemical identity, as listed on the TSCA Inventory.

 I am not seeking to maintain an existing claim of confidentiality for the specific chemical identity, as listed on the TSCA Inventory.  Part IV  -  Anticipated Date** of Reintroduction of Chemical Substance in U.S. Commerce***                                            Date:

   ** If the notice is filed prior to the effective date of the chemical substance's inactive designation, the most recent date of manufacture or processing may be provided in lieu of an anticipated date.  *** Mark (X) in the CBI box if the date is to be held confidential.  Part V  -  Certification

 I certify under penalty of law that this document and all attachments were prepared under my direction or supervision and the information contained therein, to the best of my knowledge, is true, accurate, and complete. I also certify that I have intent to manufacture, import, or process the above chemical within 90 days of submission. I am aware it is unlawful to knowingly submit incomplete, false and/or misleading information, and there are significant criminal penalties for such unlawful conduct, including the possibility of fine and imprisonment.  Signature of authorized official

 Date

    Paperwork Reduction Action Notice: The public reporting and record keeping burden for this collection is estimated to average about 11.398 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. This is a mandatory collection pursuant to 40 CFR 710.  An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB Control Number. The OMB Control Number of this collection is 2070-0210. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Director, Collection Strategies Division (Mail Code 2822T), U.S. Environmental Protection Agency, Washington, DC 20460. Include the OMS control number in any correspondence, but do not submit the form or report to this address. The form should be submitted in accordance with the instructions for the form.

                                       (

                                       (

 EPA Form 9600-06

                                         Part VI - CBI SUBSTANTIATION   This substantiation contains CBI:	Yes ☐	No ☐

  Pursuant to TSCA section 14(c)(3), you must substantiate any CBI claims for information elements other than specific chemical identity at the time this notice is submitted. EPA guidance for complying with TSCA section 14(c)(3) may be found at https://www.epa.gov/tsca-cbi/substantiating-cbi-claims-under-tsca-time-initial-submission. You may also substantiate a request to maintain an existing CBI claim for a specific chemical identity at the time this notice is submitted, but this is not required. Rather, you must substantiate the existing CBI claim for the specific chemical identity not later than 30 days after providing this notice.

  If you do not assert a CBI claim at time of submission of this form, or otherwise fail to assert a proper CBI claim (i.e., by failing to substantiate your CBI claim or not providing a certification statement), the information shall be treated as not subject to a CBI claim, and may be made public without further notice. If a single substantiation response applies for all or a class of information claimed as CBI, you should indicate this in your substantiation response. If different substantiation responses are necessary to support CBI claims for different information types, you should provide separate substantiation responses for each information type, clearly identifying the information for which each substantiation applies in the free text boxes (e.g. Question A.1. or 2) or in the additional information box at the end of this form.  Information element(s) that you identified as CBI in previous parts:  Name of Authorized Official/Mailing address (Part I)  Company Name/Mailing address (Part I)  Technical Contact/Telephone Number (in U.S.) (Part I)  Specific Confidential Chemical Identity (as listed on the TSCA Inventory) (Parts II/III)  Anticipated Date of Reintroduction of Chemical Substance in U.S. Commerce (Part IV)  A. APPLICABLE TO ANY CBI CLAIM     1. Do you believe that the information is exempt from substantiation pursuant to TSCA section 14(c)(2)i?     If you answered yes, you must individually identify the specific information claimed as confidential and specify the applicable exemption(s).     If the Agency disagrees with this assertion, you may be asked to provide additional information to support your claim.   Yes   No  Click or tap here to enter text.     2. Will disclosure of the information likely result in substantial harm to your business's competitive position?     If you answered yes, please describe with specificity the substantial harmful effects that would likely result to your competitive position if the information is made available to the public.     If, for example, it is not publicly known that the submitter manufactures, imports or processes the reported chemical, describe with specificity the harmful effects that would result if this information were made available to the public. If you are claiming technical contact name or name of authorized official as CBI, describe with specificity the harmful effects that would result if this information were made available to the public.     If you are claiming multiple information elements as CBI, please provide information for EACH element you identified above.   Yes   No  Click or tap here to enter text.

 To the extent your business has disclosed the information to others (both internally and externally), what precautions has your business taken? Please identify the measures or internal controls your business has taken to protect the information claimed as confidential.  Non-disclosure agreement required prior to access.

2. Access is limited to individuals with a need-to-know                                       Yes    No

3. Information is physically secured (e.g. locked in room or cabinet) or electronically secured (encrypted, password protected, etc.).                                       Yes    No

4. Other internal control measure(s). If yes, please explain     Click or tap here to enter text.                                       Yes   No

    4. Does the information appear in any public documents, including (but not limited to) safety data sheets, advertising or promotional material, professional or trade publication, or any other media or publications available to the general public?     If you answered yes, please explain why the information should be treated as confidential.   Yes   No  Click or tap here to enter text.     5. Is the claim of confidentiality intended to last less than 10 years (see TSCA section 14(e)(1)(B)ii)? If so, please indicate the number of years (between 1-10 years) or the specific date/occurrence after which the claim is withdrawn.  Click or tap here to enter text.     6. Has EPA, another federal agency, or court made any confidentiality determination regarding information associated with this chemical substance?     If you answered yes, please explain the outcome of that determination and provide a copy of the previous confidentiality determination or any other information that will assist in identifying the prior determination.   Yes   No  Click or tap here to enter text.  Additional comments:  Click or tap here to enter text.  B. APPLICABLE ONLY TO A SPECIFIC CHEMICAL IDENTITY CBI CLAIM     1. Are you providing a substantiation at this time to maintain a specific confidential chemical identity as CBI?

    If you answered yes, please respond to questions below and in Section A.

    If you answered no, please leave all questions below blank. You must substantiate not later than 30 days after providing this notice in accordance with TSCA section 8(b)(5)(B)(ii)(II).   Yes   No  Click or tap here to enter text.     2. Is the confidential chemical substance publicly known to have ever been offered for commercial distribution in the United States?

    If you answered yes, explain why the information should be treated as confidential.   Yes   No  Click or tap here to enter text.    3. Does this particular chemical substance leave the site of manufacture (including import) or processing in any form, e.g., as a product, effluent, or emission? If yes, please explain    what measures have been taken, if any, to guard against the discovery of its identity.   Yes    No  Click or tap here to enter text.

    4. If the chemical substance leaves the site in a form that is available to the public or your competitors, can the chemical identity be readily discovered by analysis of the substance (e.g., product, effluent, or emission), in light of existing technologies and any costs, difficulties, or limitations associated with such technologies? Please explain why or why not.

   Yes    No

  Click or tap here to enter text.

 Additional comments:

  Click or tap here to enter text.

 C. CERTIFICATION

    I certify that all claims for confidentiality made or sought to be maintained with this submission are true and correct, and all information submitted herein to substantiate such claims is true and correct. I further certify that it is true and correct that:  My company has taken reasonable measures to protect the confidentiality of the information;  I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;  I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and  I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.

    Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. § 1001.

    Signature of authorized official

    Date

i TSCA section 14(c)(2) states:   Information generally not subject to substantiation requirements     Subject to subsection (f), the following information shall not be subject to substantiation requirements under paragraph (3):  Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article.        Marketing and sales information.        Information identifying a supplier or customer.        In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents.  Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or article.        Specific production or import volumes of the manufacturer or processor.  Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service Registry number, and other information that would identify the specific chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under section 2604 of this title.

 ii TSCA section 14(e)(1)(B) states  in the case of information other than information described in subsection (c)(2) --   for a period of 10 years from the date on which the person asserts the claim with respect to the information submitted to the Administrator; or           if applicable before the expiration of such 10-year period, until such time as --   the person that asserted the claim notifies the Administrator that the person is withdrawing the claim, in which case the information shall not be protected from disclosure under this section; or  the Administrator becomes aware that the information does not qualify for protection from disclosure under this section, in which case the Administrator shall take any actions required under subsections (f) and (g).


[Federal Register Volume 77, Number 95 (Wednesday, May 16, 2012)]
[Rules and Regulations]
[Pages 28782-28785]
[FR Doc No: 2012-11651]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0714; FRL-9670-3]

Approval and Promulgation of Air Quality Implementation Plans;
Delaware, New Jersey, and Pennsylvania; Determinations of Attainment of
the 1997 Annual Fine Particulate Standard for the Philadelphia-
Wilmington Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is making two determinations regarding the Philadelphia-
Wilmington, PA-NJ-DE fine particulate (PM2.5) nonattainment
area (the Philadelphia Area). First, EPA is making a determination that
the Philadelphia Area has attained the 1997 annual PM2.5
national ambient air quality standard (NAAQS) by its attainment date of
April 5, 2010. This determination is based upon quality assured and
certified ambient air monitoring data that show the area monitored
attainment of the 1997 annual PM2.5 NAAQS for the 2007-2009
monitoring period. Second, EPA is making a clean data determination,
finding that the Philadelphia Area has attained the 1997
PM2.5 NAAQS, based on quality assured and certified ambient
air monitoring data for the 2007-2009 and 2008-2010 monitoring periods.
In accordance with EPA's applicable PM2.5 implementation
rule, this determination suspends the requirement for the Philadelphia
Area to submit an attainment demonstration, reasonably available
control measures/reasonably available control technology (RACM/RACT), a
reasonable further progress (RFP) plan, and contingency measures
related to attainment of the 1997 annual PM2.5 NAAQS for so
long as the area continues to attain the 1997 annual PM2.5
NAAQS. These actions are being taken under the Clean Air Act (CAA).

DATES: This rule is effective on June 15, 2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2011-0714. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning EPA's
action related to Delaware or Pennsylvania, please contact Maria A.
Pino,<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>If you have
questions concerning EPA's action related to New Jersey, please contact
Henry Feingersh,<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following outline is provided to aid in
locating information in this action.

I. Background
II. Summary of Actions
III. Summary of Public Comments and EPA Responses
IV. Final Actions
V. Statutory and Executive Order Reviews

I. Background

    On January 23, 2012, EPA published a direct final rulemaking (77 FR
3147) and companion notice of proposed rulemaking (NPR) (77 FR 3223)
for the States of Delaware and New Jersey and the Commonwealth of
Pennsylvania (the States). In the January 23, 2012 rulemaking action,
EPA proposed to determine that the Philadelphia Area attained the 1997
PM2.5 NAAQS by its attainment date, April 5, 2010. EPA also
proposed to make a clean data determination, finding that the
Philadelphia Area has attained the 1997 PM2.5 NAAQS.
    Because EPA received adverse comment, EPA withdrew the direct final
rule on March 13, 2012 (77 FR14697), and the direct final rule was
converted to a proposed rule.

II. Summary of Actions

    These actions do not constitute a redesignation to attainment under
section 107(d)(3) of the CAA. The designation status of the
Philadelphia Area will remain nonattainment for the 1997 annual
PM2.5 NAAQS until such

time as EPA determines that the Philadelphia area meets the CAA
requirements for redesignation to attainment, including an approved
maintenance plan.

A. Determination of Attainment by the Attainment Date

    EPA is making a determination that the Philadelphia Area has
attained the 1997 annual PM2.5 NAAQS by its applicable
attainment date of April 5, 2010. This determination is based upon
quality assured and certified ambient air monitoring data for the 2007-
2009 monitoring period that shows the area has monitored attainment of
the 1997 PM2.5 NAAQS during this monitoring period.
Therefore, EPA has met its requirement pursuant to CAA section 179(c)
to determine, based on the area's air quality as of the attainment
date, whether the area attained the standard by that date. The effect
of a final determination of attainment by the area's attainment date
will be to discharge EPA's obligation under CAA section 179(c).

B. Clean Data Determination

    EPA is making a determination that the Philadelphia Area is
attaining the 1997 annual PM2.5 NAAQS. This determination is
based upon quality assured and certified ambient air monitoring data
that show the area has monitored attainment of the 1997
PM2.5 NAAQS for the 2007-2009 and 2008-2010 monitoring
periods. This determination of attainment suspends the CAA requirements
for the Philadelphia Area to submit an attainment demonstration and the
associated RFP plan, contingency measures, RACM/RACT analysis, and any
other planning requirements related to attainment of the 1997 annual
PM2.5 NAAQS. These requirements remain suspended for so long
as the area continues to attain the 1997 annual PM2.5 NAAQS.
    The clean data determination suspends the requirement for the
Philadelphia Area to submit an attainment demonstration, RACM/RACT, RFP
plan, contingency measures, and any other planning requirements related
to attainment of the 1997 annual PM2.5 NAAQS. This
suspension remains in effect until such time, if any, that EPA (i)
redesignates the area to attainment at which time those requirements no
longer apply, or (ii) subsequently determines that the area has
violated the 1997 annual PM2.5 NAAQS. This determination is
separate from, and does not influence or otherwise affect, any future
designation determination or requirements for the Philadelphia Area
based on any new or revised PM2.5 NAAQS. It remains in
effect regardless of whether EPA designates the Philadelphia Area as a
nonattainment area for purposes of any new or revised PM2.5
NAAQS. Although these requirements are suspended, EPA is not precluded
from acting upon these elements. The States of Delaware and New Jersey,
and the Commonwealth of Pennsylvania have submitted state
implementation plan (SIP) revisions for their portions of the
Philadelphia Area to EPA for review and approval.

C. Ambient Air Quality Monitoring Data

    Consistent with the requirements contained in 40 CFR part 50, EPA
has reviewed the PM2.5 ambient air monitoring data for the
monitoring periods 2007-2009 and 2008-2010 for the Philadelphia Area,
as recorded in the EPA Air Quality System database. On the basis of
that review, EPA has concluded that the Philadelphia Area attained the
1997 annual PM2.5 NAAQS based on data for the 2007-2009 and
2008-2010 monitoring periods. In the Technical Support Document (TSD)
prepared for this action, EPA evaluates the air quality data for the
Philadelphia Area. For details, please refer to EPA's TSD, which can be
viewed at http://www.regulations.gov.

III. Summary of Public Comments and EPA Responses

    On January 24, 2012, EPA received adverse comments on the direct
final rule from Mr. Robert Ukeiley. A summary of the comments submitted
and EPA's response is provided below.
    Comment: The commenter alleges that the determination of attainment
here (``clean data determination'') violates CAA section 110(l) because
EPA has not completed its review of the PM2.5 NAAQS. The
commenter asserts that the clean data determination should not be
finalized until after EPA promulgates a new PM2.5 NAAQS.
    Response: EPA's rulemaking action here addresses only the 1997
annual PM2.5 NAAQS, and has no bearing on any other NAAQS,
including any future revised NAAQS. Therefore, this comment is not
relevant to this rulemaking action.
    Comment: The commenter states that this clean data determination
violates CAA section 110(l) because all other NAAQS would benefit from
the Philadelphia Area fully implementing the 1997 annual
PM2.5 NAAQS, including implementation of RACT. The commenter
alleged that EPA failed to conduct an analysis of the impacts of the
clean data determination, and this will interfere with other NAAQS
attainment.
    Response: CAA section 110(l) applies explicitly and only to a
``revision to an implementation plan.'' As set forth in the response to
comment above, EPA's rulemaking here is restricted to EPA's
determination, based on ambient air quality, that the Philadelphia Area
is attaining the 1997 annual PM2.5 standard. It is not a SIP
revision, and thus section 110(l) is by its own terms is not applicable
to this rulemaking. It is not this determination of attainment, but
rather EPA's PM2.5 implementation rule, 40 CFR 51.1004(c),
that specifies the consequence of the determination as suspension of
the area's obligations to submit an attainment demonstration, a RFP
plan, contingency measures and other planning requirements related to
attainment as SIP revisions for as long as the area continues to
attain. In any case, the requirements that are suspended by the
regulation are related solely to attainment for the 1997 annual
PM2.5 standard. EPA is determining, and the commenter does
not contest, that the area is attaining the 1997 annual
PM2.5 standard, and that the suspension of attainment
planning SIP submissions lasts only as long as the area is meeting that
standard. No other requirements are suspended and no control measures
in the SIP are being relaxed. This action has no effect on control
measures, or air quality, in the area. In sum, no evaluation under
section 110(l) is required by law, and even if such an evaluation were
required, EPA would conclude that this determination of attainment
would not interfere with attainment, reasonable further progress
towards attainment, or any other applicable requirement of the CAA. EPA
notes that this same individual submitted similar comments on
determinations of attainment (``clean data determinations'') for the
1997 8-hour ozone NAAQS for the Pittsburgh-Beaver Valley nonattainment
area in Pennsylvania (Pittsburgh Area) and the Charlotte-Gastonia-Rock
Hill nonattainment area in North Carolina and South Carolina (Charlotte
Area), and for the 1997 annual PM2.5 NAAQS for the Kentucky
Portion of the Cincinnati-Hamilton nonattainment area (Cincinnati-
Hamilton Area). EPA responded to those comments in final rulemaking
actions for the Pittsburgh, Charlotte, and Cincinnati-Hamilton Areas,
at 76 FR 31237, 76 FR 70656, and 76 FR 77903, respectively.

IV. Final Actions

    EPA is making two determinations regarding the Philadelphia Area.
First, EPA is making a clean data

determination, finding that the Philadelphia Area has attained the 1997
annual PM2.5 NAAQS. This clean data determination is based
upon quality assured, and certified ambient air monitoring data that
show the area has monitored attainment of the 1997 annual
PM2.5 NAAQS for the 2007-2009 and 2008-2010 monitoring
periods. This clean data determination suspends the requirements for
the Philadelphia Area to submit an attainment demonstration and
associated RACM/RACT, RFP plan, contingency measures, and any other
planning requirements related to attainment of the 1997 annual
PM2.5 NAAQS, as provided in 40 CFR 51.1004(c), so long as
the area continues to attain the 1997 annual PM2.5 NAAQS.
Second, pursuant to section 179(c) of the CAA, EPA is making a
determination that the Philadelphia Area has attained the 1997 annual
PM2.5 NAAQS by its attainment date, April 5, 2010. This
determination is based upon quality assured, and certified ambient air
monitoring data for the 2007-2009 monitoring period.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    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. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by July 16, 2012. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This determination that the Philadelphia Area has attained the
1997 annual PM2.5 NAAQS may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: March 28, 2012.
W.C. Early,
Acting Regional Administrator, Region III.
    Dated: April 24, 2012.
Judith A. Enck,
Regional Administrator, Region II.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart I--Delaware

0
2. In Sec.  52.425 the existing paragraph is designated as paragraph
(a), and paragraph (b) is added to read as follows:

Sec.  52.425  Determinations of attainment.

* * * * *
    (b) Based upon EPA's review of the air quality data for the 3-year
period 2007 to 2009, EPA determined that the Philadelphia-Wilmington,
PA-NJ-DE fine particle (PM2.5) nonattainment area attained
the 1997 annual PM2.5 National Ambient Air Quality Standard
(NAAQS) by the applicable attainment date of April 5, 2010. Therefore,
EPA has met the requirement pursuant to CAA section 179(c) to
determine, based on the area's air quality as of the attainment date,
whether the area attained the standard. EPA also determined that the
Philadelphia-Wilmington, PA-NJ-DE PM2.5 nonattainment area
is not subject to the consequences of failing to attain pursuant to
section 179(d).

0
3. Section 52.427 is added to read as follows:

Sec.  52.427  Control strategy: Particulate matter.

    Determination of attainment. EPA has determined, as of May 16,
2012, that based on 2007 to 2009 and 2008 to 2010 ambient air quality
data, the Philadelphia-Wilmington, PA-NJ-DE nonattainment area has
attained the 1997 annual PM2.5 NAAQS. This determination, in
accordance with 40

CFR 51.1004(c), suspends the requirements for this area to submit an
attainment demonstration, associated reasonably available control
measures, a reasonable further progress plan, contingency measures, and
other planning SIPs related to attainment of the standard for as long
as this area continues to meet the 1997 annual PM2.5 NAAQS.

Subpart FF--New Jersey

0
4. In Sec.  52.1576 the existing paragraph is designated as paragraph
(a), and paragraph (b) is added to read as follows:

Sec.  52.1576  Determinations of attainment.

* * * * *
    (b) Based upon EPA's review of the air quality data for the 3-year
period 2007 to 2009, EPA determined that the Philadelphia-Wilmington,
PA-NJ-DE fine particle (PM2.5) nonattainment area attained
the 1997 annual PM2.5 National Ambient Air Quality Standard
(NAAQS) by the applicable attainment date of April 5, 2010. Therefore,
EPA has met the requirement pursuant to CAA section 179(c) to
determine, based on the area's air quality as of the attainment date,
whether the area attained the standard. EPA also determined that the
Philadelphia-Wilmington, PA-NJ-DE PM2.5 nonattainment area
is not subject to the consequences of failing to attain pursuant to
section 179(d).

0
5. Section 52.1602 is amended by adding new paragraph (d) to read as
follows:

Sec.  52.1602  Control strategy and regulations: PM2.5.

* * * * *
    (d) Determination of Attainment. EPA has determined, as of May 16,
2012, that the Philadelphia-Wilmington, PA-NJ-DE fine particle
(PM2.5) nonattainment area has attained the 1997
PM2.5 National Ambient Air Quality Standard. This
determination, in accordance with 40 CFR 51.1004(c), suspends the
requirements for this area to submit an attainment demonstration,
associated reasonably available control measures, a reasonable further
progress plan, contingency measures, and other planning SIPs related to
attainment of the standard for as long as the area continues to attain
the 1997 PM2.5 NAAQS.

Subpart NN--Pennsylvania

0
6. Section 52.2056 is amended by adding paragraph (g) to read as
follows:

Sec.  52.2056  Determinations of attainment.

* * * * *
    (g) Based upon EPA's review of the air quality data for the 3-year
period 2007 to 2009, EPA determined that the Philadelphia-Wilmington,
PA-NJ-DE fine particle (PM2.5) nonattainment area attained
the 1997 annual PM2.5 National Ambient Air Quality Standard
(NAAQS) by the applicable attainment date of April 5, 2010. Therefore,
EPA has met the requirement pursuant to CAA section 179(c) to
determine, based on the area's air quality as of the attainment date,
whether the area attained the standard. EPA also determined that the
Philadelphia-Wilmington, PA-NJ-DE PM2.5 nonattainment area
is not subject to the consequences of failing to attain pursuant to
section 179(d).

0
7. Section 52.2059 is amended by adding paragraph (f) to read as
follows:

Sec.  52.2059  Control strategy: Particulate matter.

* * * * *
    (f) Determination of Attainment. EPA has determined, as of May 16,
2012, that based on 2007 to 2009 and 2008 to 2010 ambient air quality
data, the Philadelphia-Wilmington, PA-NJ-DE nonattainment area has
attained the 1997 annual PM2.5 NAAQS. This determination, in
accordance with 40 CFR 51.1004(c), suspends the requirements for this
area to submit an attainment demonstration, associated reasonably
available control measures, a reasonable further progress plan,
contingency measures, and other planning SIPs related to attainment of
the standard for as long as this area continues to meet the 1997 annual
PM2.5 NAAQS.

[FR Doc. 2012-11651 Filed 5-15-12; 8:45 am]
BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 November 17, 2005 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM SUBJECT: Usage Report Package in Support of Reregistration for the Herbicide/ desiccant Sodium Chlorate ( 073301)

FROM: Jenna Carter, Botanist Science Information & Analysis Branch Biological and Economic Analysis Division ( 7503C)

THRU: Steve Jarboe/ Rafael A. Prieto, Team Leaders Science Information & Analysis Branch Biological and Economic Analysis Division ( 7503C)

TO: Jacqueline Guerry, CRM Reregistration Review Branch III Special Review and Reregistration Division ( 7509C)

Reviewer: Jihad Alsadek Attached is a usage report for the chemical sodium chlorate. The report included in this package is electronically transmitted to Reviewers or Team Members in the Office of Pesticide Programs ( OPP) in support of the Reregistration and/ or Registration process and designed to help in the scientific assessments of this chemical. This report is written in MS Word, so it is advised to open or save it, to view or print from the appropriate program. For questions, comments and other usage or label use information requests, please contact the name( s) listed on the memorandum header, the OPP Usage and Label Use Team ( our group e mail address in Lotus Notes), or some of its members: Jihad Alsadek ( 308 8140), Jenna Carter ( 308 8370), Steve Jarboe ( 308 8105), Sharlita Harris ( 308 8147), or Rafael Prieto ( 308 8152). You can also complete the feedback form at your convenience. The Usage and Label Use Team ( ULUT) looks forward to hearing from you. The Usage report( s) electronically transmitted through Lotus Notes links include:

9 Updated SLUA Sodium Chlorate ( 073301) Screening level Usage Analysis ( SLUA)

Date: November 15, 2005 What is a Screening Level Usage Analysis ( SLUA)?

  Available estimates of pesticide usage data for a particular active ingredient that is used on agricultural crops in the United States.

What does it contain?

  Pesticide usage data for a single active ingredient only.   Agricultural use sites ( crops) that the pesticide is reported to be used on.   Available pesticide usage information ( i. e., does not include all of the United States).   Annual percent of crop treated ( average & maximum) for each agricultural crop.   Average annual pounds of the pesticide applied for each agricultural crop ( i. e., for the states surveyed, not for the entire United States).

What assumptions can I make about the reported data?

  Average pounds of active ingredient applied  Values are calculated by merging pesticide usage data sources together; averaging by year, averaging across all years, & then rounding. Note: If the estimated value is less than 500, then that value is labeled < 500. Estimated values between 500 & < 1,000,000 are rounded to 1 significant digit. Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)

  Average percent of crop treated  Values are calculated by merging data sources together; averaging by year, averaging across all years, & rounding to the nearest multiple of 5. Note: If the estimated value is less than 1, then the value is labeled < 1.

  Maximum percent of crop treated  Value is the single maximum value reported across all data sources, across all years, & rounded up to the nearest multiple of 5. Note: If the estimated value is less than 2.5, then the value is labeled < 2.5.

What are the data sources used?

  USDA NASS ( United States Department of Agriculture's National Agricultural Statistics Service)   pesticide usage data from 1999 to 2004.   NCFAP ( National Center for Food and Agricultural Policy)   pesticide usage data from 1997 and used only if data are not available from the other sources.   Private Pesticide Market Research   pesticide usage data from 1999 to 2004.   California DPR data can be requested separately.

What are the data limitations?

  Additional registered uses may exist but are not included because the available surveys do not report usage ( e. g., small acreage crops).   Lack of reported usage data for the pesticide on a crop does not imply zero usage.   Usage data on a particular site may be noted in data sources, but not quantified. In these instances, the site would not be reported in the SLUA.   Non agricultural use sites ( e. g., turf, post harvest, mosquito control, etc.) are not reported in the SLUA. A separate request must be made to receive these estimates.   Some sites show some use, even though they are not on the label. This usage could be due to Section 18 requests, existing stocks of the chemical, data collection errors, experimental use permit ( EUP), and/ or because of an illegal use.

Who do I contact for further information and/ or questions on this SLUA?

  Jenna Carter ( 703 308 8370)   Jihad Alsadek ( 703 308 8140) Monday, November 14, 2005 6: 04 Screening Level Estimates of Agricultural Uses of Sodium Chlorate ( 073301) Sorted Alphabetically Crop Lbs. A. I. Percent Crop Ttd. Avg. Max.

1 Beans, Dry ( NCFAP ' 97) 90,000 5 2 Cotton 1,900,000 5 10 3 Peppers 3,000 < 1 < 2.5 4 Potatoes < 500 < 1 < 2.5 5 Rice 70,000 < 1 < 2.5 6 Safflower ( NCFAP ' 97) 6,000 < 1 ______________________________________

All numbers rounded. '< 500' indicates less than 500 pounds of active ingredient. '< 2.5' indicates less than 2.5 percent of crop is treated.


[Federal Register Volume 80, Number 44 (Friday, March 6, 2015)]
[Notices]
[Page 12228]
[FR Doc No: 2015-05161]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74407; File No. SR-NYSEArca-2014-89]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proceedings To
Determine Whether To Approve or Disapprove a Proposed Rule Change, as
Modified by Amendment No. 1, To List and Trade Shares of Eight PIMCO
Exchange-Traded Funds

March 2, 2015.
    On August 15, 2014, NYSE Arca, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
shares of the following eight PIMCO exchange-traded funds, pursuant to
NYSE Arca Equities Rule 8.600: PIMCO StocksPLUS[supreg] Absolute Return
Exchange-Traded Fund, PIMCO Small Cap StocksPLUS[supreg] AR Strategy
Exchange-Traded Fund, PIMCO Fundamental IndexPLUS[supreg] AR Exchange-
Traded Fund, PIMCO Small Company Fundamental IndexPLUS[supreg] AR
Strategy Exchange-Traded Fund, PIMCO EM Fundamental IndexPLUS[supreg]
AR Strategy Exchange-Traded Fund, PIMCO International Fundamental
IndexPLUS[supreg] AR Strategy Exchange-Traded Fund, PIMCO EM
StocksPLUS[supreg] AR Strategy Exchange-Traded Fund, and PIMCO
International StocksPLUS[supreg] AR Strategy Exchange-Traded Fund
(Unhedged) (each a ``Fund'' and collectively, the ``Funds''). The
proposed rule change was published for comment in the Federal Register
on September 3, 2014.\3\ On October 15, 2014, pursuant to section
19(b)(2) of the Act,\4\ the Commission designated a longer period
within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\5\ On December 1, 2014, the
Commission instituted proceedings under section 19(b)(2)(B) of the Act
\6\ to determine whether to approve or disapprove the proposed rule
change.\7\ On December 23, 2014, the Exchange filed Amendment No. 1 to
the proposed rule change, which entirely replaced and superseded its
proposal as originally filed.\8\ The Commission has not received any
comments on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 72937 (Aug. 27,
2014), 79 FR 52385.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 73364, 79 FR 62988
(Oct. 21, 2014). The Commission designated a longer period within
which to take action on the proposed rule change and designated
December 2, 2014 as the date by which it should approve, disapprove,
or institute proceedings to determine whether to disapprove the
proposed rule change.
    \6\ 16 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 73706, 79 FR 72223
(December 5, 2014) (``Order Instituting Proceedings''). In the Order
Instituting Proceedings, the Commission noted that it was
instituting proceedings to allow for additional analysis of the
proposed rule change's consistency with the requirement of Section
(6)(b)(5) of the Act, which requires, among other things, that the
rules of a national securities exchange be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, and to protect investors and the
public interest.
    \8\ In Amendment No. 1, the Exchange: (1) Clarified the
definition of Fixed Income Instruments; (2) clarified that the types
of securities and instruments specified as permitted investments may
be economically tied to foreign countries; (3) clarified that the
types of securities specified as permitted investments may be
denominated in foreign currencies; (4) clarified that the Funds may
invest in OTC foreign currency options contracts; (5) eliminated the
ability of the Funds to enter into any series of purchase and sale
contracts; (6) modified the proposal to exclude from the Funds'
permitted investments variable and floating rate securities and
floaters and inverse floaters that are not Fixed Income Instruments;
(7) modified the proposal to provide that a Fund may invest up to
20% of its total assets in (a) trade claims, (b) junior bank loans,
(c) exchange-traded and OTC-traded structured products, and (d)
privately placed and unregistered securities (except that no limit
will apply to privately placed and unregistered securities that
satisfy the listing requirements in the Exchange's Rule 5.2(j)(3),
Commentary .02(a)(6)); and (8) clarified that each Fund may invest
up to 20% of its total assets in senior bank loans.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \9\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of the filing of the proposed rule
change. The Commission may, however, extend the period for issuing an
order approving or disapproving the proposed rule change by not more
than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule change was published for notice and comment in the
Federal Register on September 3, 2014,\10\ and the 180th day after
publication of the notice of the filing of the proposed rule change in
the Federal Register is March 2, 2015.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2).
    \10\ See supra note 3.
---------------------------------------------------------------------------

    The Commission finds that it is appropriate to designate a longer
period within which to issue an order approving or disapproving the
proposed rule change so that it has sufficient time to consider the
proposed rule change, as modified by Amendment No. 1. Accordingly, the
Commission, pursuant to section 19(b)(2) of the Act,\11\ designates May
1, 2015 as the date by which the Commission shall either approve or
disapprove the proposed rule change (File No. SR-NYSEArca-2014-89).
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-05161 Filed 3-5-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Page 27644]
[FR Doc No: 2022-09889]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0728]

Celgene Corporation and Teva Pharmaceutical Industries Ltd.;
Withdrawal of Approval of Peripheral T-Cell Lymphoma Indication for
ISTODAX (Romidepsin) for Injection and Romidepsin Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that it is withdrawing approval of the peripheral T-cell lymphoma
(PTCL) indication for ISTODAX (romidepsin) for injection, approved
under new drug application (NDA) 022393, held by Celgene Corporation,
86 Morris Ave., Summit, NJ 07901 (Celgene). We are also announcing the
withdrawal of approval of the same indication for Romidepsin injection,
approved under NDA 208574, held by Teva Pharmaceuticals USA, Inc., 400
Interpace Parkway, Building A, Parsippany, NJ 07054 (Teva). Celgene and
Teva have voluntarily requested that FDA withdraw approval of this
indication and have waived their opportunity for a hearing.

DATES: Approval was withdrawn as of May 9, 2022.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].

SUPPLEMENTARY INFORMATION: On June 16, 2011, FDA approved an additional
indication for Celgene's new drug application (NDA) 22393 for ISTODAX
(romidepsin) for injection, 10 mg, specifically for treatment of
peripheral T-cell lymphoma (PTCL) in adult patients who have received
at least one prior therapy, under the Agency's accelerated approval
regulations, 21 CFR part 314, subpart H. The accelerated approval of
Celgene's ISTODAX (romidepsin) for injection for PTCL included a
required postmarketing clinical trial intended to verify the clinical
benefit of romidepsin (the Ro-CHOP study) for PTCL.
    On March 13, 2020, FDA approved Teva's NDA 208574 for Romidepsin
injection, 10 mg/2 milliliter, for treatment of peripheral T-cell
lymphoma (PTCL) in adult patients who have received at least one prior
therapy, under the Agency's accelerated approval regulations, 21 CFR
part 314, subpart H. The accelerated approval of Teva's Romidepsin
injection for PTCL also included a required postmarketing clinical
trial intended to verify the clinical benefit of romidepsin for PTCL.
Teva's Romidepsin injection product was approved under the 505(b)(2)
approval pathway, and the listed drug relied upon is Celgene's NDA
22393, ISTODAX (romidepsin) for injection.
    On August 6, 2020, Celgene submitted high level results from the
Ro-CHOP study to FDA, which indicated the study failed to meet its
primary endpoint of progression free survival. On May 14, 2021, Celgene
informed FDA that after careful consideration, Celgene decided to
voluntarily withdraw the PTCL indication from ISTODAX (romidepsin) for
injection.
    On June 17, 2021, Celgene submitted a supplemental NDA proposing to
remove the PTCL indication. On July 14, 2021, Celgene submitted a
letter asking FDA to withdraw approval of the PTCL indication pursuant
to Sec.  314.150(d) (21 CFR 314.150(d)) and waiving its opportunity for
a hearing.
    On August 27, 2021, Teva submitted a labeling supplement proposing
to remove the PTCL indication. On September 12, 2021, the Agency
requested Teva voluntarily request withdraw of the PTCL indication
pursuant to Sec.  314.150(d) and waive its opportunity for a hearing.
On September 14, 2021, Teva amended its supplement by submitting a
cover letter requesting withdrawal of approval of the PTCL indication
pursuant to Sec.  314.150(d) and waiving its opportunity for a hearing.
    Therefore, under Sec.  314.150(d), approval of the PTCL indications
for ISTODAX (romidepsin) for injection, and Romidepsin injection, is
withdrawn effective May 9, 2022. Withdrawal of approval of the PTCL
indication does not affect any other approved indication(s) for ISTODAX
(romidepsin) for injection or Romidepsin injection.

    Dated: May 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09889 Filed 5-6-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Pages 13401-13403]
[FR Doc No: 2015-05418]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2015-0145]

Cooperative Research and Development Agreement--Coast Guard
Response Boat-Medium Data Recorder

AGENCY: Coast Guard, DHS.

ACTION: Notice of intent; request for comments.

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

SUMMARY: The Coast Guard announces its intent to enter into a
Cooperative Research and Development Agreement (CRADA) with Vector
Controls, Inc. (Vector) to develop changes to the response boat-medium
(RB-M) onboard engine data bus that will convert Society of Automotive
Engineers (SAE) J1939 format to the National Marine Electronics
Association (NMEA) 0183/2000 data format. A test schedule has been
proposed in which Vector will develop and install the required RB-M
control system software upgrades and relevant additional equipment; a
Coast Guard field unit will operate the RB-M in normal operations; and
the Coast

Guard Research and Development Center (R&DC) will install a dedicated
data recorder system and conduct periodic data downloads for
demonstration purposes. While the Coast Guard is currently considering
partnering with Vector, the Coast Guard solicits public comment on the
possible nature of and participation of other parties in the proposed
CRADA. In addition, the Coast Guard also invites other potential non-
Federal participants, who have the interest and capability to bring
similar contributions to this type of research, to consider submitting
proposals for consideration in similar CRADAs.

DATES: Comments must be submitted to the online docket via http://www.regulations.gov, or reach the Docket Management Facility, on or
before April 13, 2015.
    Synopses of proposals regarding future CRADAs must reach the Coast
Guard (see FOR FURTHER INFORMATION CONTACT) on or before April 13,
2015.

ADDRESSES: Submit comments using one of the listed methods, and see
SUPPLEMENTARY INFORMATION for more information on public comments.
     Online--http://www.regulations.gov following Web site
instructions.
     Fax--202-493-2251.
     Mail or hand deliver--Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Hours
for hand delivery are 9 a.m. to 5 p.m., Monday through Friday, except
Federal holidays (telephone<PHONE_NUMBER>).

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice
or wish to submit proposals for future CRADAs, contact Jay Carey,
Project Official, Surface Branch, U.S. Coast Guard Research and
Development Center, 1 Chelsea Street, New London, CT 06320, telephone
860-271-2702, email<EMAIL_ADDRESS>If you have questions on
viewing or submitting material to the docket, call Cheryl Collins,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>, toll free
1-800-647-5527.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to submit comments and related material on this
notice. All comments received will be posted, without change, to http://www.regulations.gov and will include any personal information you have
provided.
    Do not submit detailed proposals for future CRADAs to the Docket
Management Facility. Instead, submit them directly to the Coast Guard
(see FOR FURTHER INFORMATION CONTACT) .
    Comments should be marked with docket number USCG-2015-0145 and
should provide a reason for each suggestion or recommendation. You
should provide personal contact information so that we can contact you
if we have questions regarding your comments; but please note that all
comments will be posted to the online docket without change and that
any personal information you include can be searchable online (see the
Federal Register Privacy Act notice regarding our public dockets, 73 FR
3316, Jan. 17, 2008).
    Mailed or hand-delivered comments should be in an unbound 8\1/2\ x
11 inch format suitable for reproduction. The Docket Management
Facility will acknowledge receipt of mailed comments if you enclose a
stamped, self-addressed postcard or envelope with your submission.
    Documents mentioned in this notice, and all public comments, are in
our online docket at http://www.regulations.gov and can be viewed by
following the Web site's instructions. You can also view the docket at
the Docket Management Facility (see the mailing address under
ADDRESSES) between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays.

Discussion

    CRADAs are authorized under 15 U.S.C. 3710(a).\1\ A CRADA promotes
the transfer of technology to the private sector for commercial use, as
well as specified research or development efforts that are consistent
with the mission of the Federal parties to the CRADA. The Federal party
or parties agree with one or more non-Federal parties to share research
resources, but the Federal party does not contribute funding.
---------------------------------------------------------------------------

    \1\ The statute confers this authority on the head of each
Federal agency. The Secretary of DHS's authority is delegated to the
Coast Guard and other DHS organizational elements by DHS Delegation
No. 0160.1, para. II.B.34.
---------------------------------------------------------------------------

    CRADAs are not procurement contracts. Care is taken to ensure that
CRADAs are not used to circumvent the contracting process. CRADAs have
a specific purpose and should not be confused with other types of
agreements such as procurement contracts, grants, and cooperative
agreements.
    Under the proposed CRADA, the R&DC will collaborate with one non-
Federal participant. Together, the R&DC and the non-Federal participant
would develop the changes required to convert the current engine data
format used on the USCG RB-M (Society of Automotive Engineers (SAE)
J1939) to a widely used format in marine electronics (NMEA 0183/2000).
The RDC will provide Vector access to an operational RB-M at a Coast
Guard field unit on or about May 1, 2015. The Coast Guard plans to
operate a dedicated data recorder system on the RB-M for 90 days then
return the vessel to its standard operational configuration.
    We anticipate that the Coast Guard's contributions under the
proposed CRADA will include the following:
    (1) Develop the demonstration test plan to be executed under the
CRADA;
    (2) Provide the test vessel, test vessel support, facilities, and
all required approvals as required for a 90-day demonstration under the
CRADA;
    (3) Conduct a Privacy Threshold Analysis (PTA) as required for the
demonstration to be conducted under this CRADA;
    (4) Conduct a Privacy Impact Assessment as required for the
demonstration to be conducted under this CRADA;
    (5) Collect and analyze demonstration test plan data in accordance
with the CRADA demonstration test plan; and
    (6) Develop the Demonstration Final Report, which will document the
methodologies, findings, conclusions, and recommendations of this CRADA
work.
    We anticipate that the non-Federal participants' contributions
under the proposed CRADA will include the following:
    (1) Provide any equipment and software upgrades required to conduct
the demonstration as described in the demonstration test plan developed
under this CRADA;
    (2) Provide technical oversight as required to conduct the
demonstration as described in the demonstration test plan developed
under this CRADA;
    (3) Provide the technical data package for all equipment, including
dimensions, weight, power requirements, interface specifications, and
other technical considerations for the additional components to be
utilized under this CRADA;
    (4) Provide shipment and delivery of all equipment required for the
demonstration to be conducted under this CRADA; and
    (5) Provide travel and other associated personnel and other
expenses as required.
    The Coast Guard reserves the right to select for CRADA participants
all, some, or no proposals submitted for this CRADA. The Coast Guard
will provide

no funding for reimbursement of proposal development costs. Proposals
and any other material submitted in response to this notice will not be
returned. Proposals submitted are expected to be unclassified and have
no more than five single-sided pages (excluding cover page, DD 1494,
JF-12, etc.). The Coast Guard will select proposals at its sole
discretion on the basis of:
    (1) How well they communicate an understanding of, and ability to
meet, the proposed CRADA's goal; and
    (2) How well they address the following criteria:
    (a) Technical capability to support the non-Federal party
contributions described; and
    (b) Resources available for supporting the non-Federal party
contributions described.
    Currently, the Coast Guard is considering Vector for participation
in this CRADA. This consideration is based on the fact that Vector has
demonstrated its technical ability as the developer and manufacturer of
the current RB-M propulsion control system. However, we do not wish to
exclude other viable participants from this or future similar CRADAs.
    This is a technology demonstration effort. The goal of this CRADA
is to develop the changes required to convert the current data format
used on the USCG RB-M (J1939) to a widely used format in marine
electronics (NMEA 0183/2000). Special consideration will be given to
small business firms/consortia, and preference will be given to
business units located in the U.S. This notice is issued under the
authority of 5 U.S.C. 552(a).

    Dated: February 24, 2015.
B.N. Macesker,
Executive Director, U.S. Coast Guard Research and Development Center.
[FR Doc. 2015-05418 Filed 3-12-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 156 (Friday, August 12, 2011)]
[Proposed Rules]
[Page 50164]
[FR Doc No: 2011-20450]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 72 and 75

[EPA-HQ-OAR-2009-0837; FRL-9450-6]
RIN 2060-AQ06

Protocol Gas Verification Program and Minimum Competency
Requirements for Air Emission Testing; Corrections

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to correct certain portions of the Protocol
Gas Verification Program and Minimum Competency Requirements for Air
Emission Testing rule. EPA published in the Federal Register of March
28, 2011 (76 FR 17288), a final rule that amends the Agency's Protocol
Gas Verification Program (PGVP) and the minimum competency requirements
for Air Emission Testing Bodies (AETBs), and makes a number of other
changes to the regulation. After the final rule was published, it was
brought to our attention that there are some incorrect and incomplete
statements in the preamble, some potentially confusing statements in a
paragraph of the rule text, and the title of Appendix D to Part 75 was
inadvertently changed and is incorrect.

DATES: Written comments must be received by September 12, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2009-0837, by mail to: Air and Radiation Docket and Information
Center, U.S. Environmental Protection Agency, Mailcode: 2822T, 1200
Pennsylvania Avenue, NW., Washington, DC 20460. Comments may also be
submitted electronically or through hand delivery/courier by following
the detailed instructions in the ADDRESSES section of the direct final
rule located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: John Schakenbach, U.S. Environmental
Protection Agency, Clean Air Markets Division, MC 6204J, Ariel Rios
Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, telephone
(202) 343-9158, e-mail at<EMAIL_ADDRESS>Electronic copies
of this document can be accessed through the EPA Web site at: http://epa.gov/airmarkets.

SUPPLEMENTARY INFORMATION: This document proposes to take action on
certain portions of the Protocol Gas Verification Program and Minimum
Competency Requirements for Air Emission Testing rule. We have
published a direct final rule to amend the March 28, 2011 final
regulation (76 FR 17288) by removing two inaccurate preamble
statements, correcting one incomplete preamble statement, clarifying
the text of Sec.  75.4(e), and correcting the title of Appendix D to
Part 75 in the ``Rules and Regulations'' section of this Federal
Register because we view this as a non-controversial action and
anticipate no adverse comment.
    We have explained our reasons for this action in the preamble to
the direct final rule. If we receive no adverse comment, we will not
take further action on this proposed rule. If we receive adverse
comment, we will withdraw the direct final rule and it will not take
effect. We would address all public comments in any subsequent final
rule based on this proposed rule.
    We do not intend to institute a second comment period on this
action. Any parties interested in commenting must do so at this time.
For further information, please see the information provided in the
ADDRESSES section of this document.

    Dated: August 3, 2011.
Lisa P. Jackson,
Administrator.
[FR Doc. 2011-20450 Filed 8-11-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 195 (Wednesday, October 7, 2020)]
[Notices]
[Pages 63282-63284]
[FR Doc No: 2020-22192]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1987]

Fee Rate for Using a Material Threat Medical Countermeasure
Priority Review Voucher in Fiscal Year 2021

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

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rate for using a material threat medical
countermeasure (MCM) priority review voucher for fiscal year (FY) 2021.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the
21st Century Cures Act (Cures Act), authorizes FDA to determine and
collect material threat MCM priority review user fees for certain
applications for review of human drug products when those applications
use a material threat MCM priority review voucher. These vouchers are
awarded to the sponsors of material threat MCM applications that meet
all the requirements of this program and upon FDA approval of such
applications. The amount of the fee for using a material threat MCM
priority review voucher is determined each FY based on the difference
between the average cost incurred by FDA to review a human drug
application designated as priority review in the previous FY, and the
average cost incurred in the review of an application that is not
subject to priority review in the previous FY. This notice establishes
the material threat MCM priority review fee rate for FY 2021 and
outlines the payment procedures for such fees.

FOR FURTHER INFORMATION CONTACT: Lola Olajide, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61077B, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 3086 of the Cures Act (Pub. L. 114-255) added section 565A
to the FD&C Act (21 U.S.C. 360bbb-4a). In section 565A of the FD&C Act,
Congress encouraged development of material threat MCMs by offering
additional incentives for obtaining FDA approval of such products.
Under section 565A of the FD&C Act, the sponsor of an eligible material
threat MCM application (as defined in section 565A(a)(4)) shall receive
a priority review voucher upon approval of the material threat MCM
application. The recipient of a material threat MCM priority review
voucher may either use the voucher for a future human drug application
submitted to FDA under section 505(b)(1) of the FD&C Act (21 U.S.C.
355(b)(1)) or section 351(a) of the Public Health Service Act (42
U.S.C. 262(a)), or transfer (including by sale) the voucher to another
party. The voucher may be transferred repeatedly until it ultimately is
used for a human drug application submitted to FDA under section
505(b)(1) of the FD&C Act or section 351(a) of the Public Health
Service Act. A priority review is a review conducted with a
Prescription Drug User Fee Act (PDUFA) goal date of 6 months after the
receipt or filing date, depending on the type of application.
Information regarding PDUFA goals is available at

https://www.fda.gov/media/99140/download.
    The sponsor that uses a material threat MCM priority review voucher
is entitled to a priority review of its eligible human drug
application, but must pay FDA a material threat MCM priority review
user fee in addition to any user fee required by PDUFA for the
application. Information regarding the material threat MCM priority
review voucher program is available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions.
    This notice establishes the material threat MCM priority review fee
rate for FY 2021 at $1,360,879 and outlines FDA's payment procedures
for material threat MCM priority review user fees. This rate is
effective on October 1, 2020, and will remain in effect through
September 30, 2021.

II. Material Threat Medical Countermeasure Priority Review User Fee
Rate for FY 2021

    FDA interprets section 565A(c)(2) of the FD&C Act as requiring that
FDA determine the amount of the material threat MCM priority review
user fee each fiscal year based on the difference between the average
cost incurred by FDA in the review of a human drug application subject
to priority review in the previous fiscal year, and the average cost
incurred by FDA in the review of a human drug application that is not
subject to priority review in the previous fiscal year.
    A priority review is a review conducted with a PDUFA goal date of 6
months after the receipt or filing date, depending on the type of
application. As described in the PDUFA goals letter, FDA has committed
to reviewing and acting on 90 percent of the applications granted
priority review status within this expedited timeframe. Normally, an
application for a human drug product will qualify for priority review
if the product is intended to treat a serious condition and, if
approved, would provide a significant improvement in safety or
effectiveness. An application that does not receive a priority
designation receives a standard review. As described in the PDUFA goals
letter, FDA has committed to reviewing and acting on 90 percent of
standard applications within 10 months of the receipt or filing date,
depending on the type of application. A priority review involves a more
intensive level of effort and a higher level of resources than a
standard review.
    FDA is setting a fee for FY 2021, which is to be based on standard
cost data from the previous fiscal year, FY 2020. However, the FY 2020
submission cohort has not been closed out yet, thus the cost data for
FY 2020 are not complete. The latest year for which FDA has complete
cost data is FY 2019. Furthermore, because FDA has never tracked the
cost of reviewing applications that get priority review as a separate
cost subset, FDA estimated this cost based on other data that the
Agency has tracked. The Agency expects all applications that received
priority review would contain clinical data. The application categories
with clinical data that for which FDA tracks the cost of review are:
(1) New drug applications (NDAs) for a new molecular entity (NME) with
clinical data and (2) biologics license applications (BLAs).
    The total cost for FDA to review NME NDAs with clinical data and
BLAs in FY 2019 was $199,369,923. There was a total of 70 applications
in these two categories (49 NME NDAs with clinical data and 21 BLAs).
(Note: These numbers exclude the President's Emergency Plan for AIDS
Relief NDAs; no investigational new drug review costs are included in
this amount.) Of these applications 44 (32 NDAs and 12 BLAs) received
priority review and the remaining 26 (17 NDAs and 9 BLAs) received
standard reviews. Because a priority review compresses a review
schedule that ordinarily takes 10 months into 6 months, FDA estimates
that a multiplier of 1.67 (10 months / 6 months) should be applied to
non-priority review costs in estimating the effort and cost of a
priority review as compared to a standard review. This multiplier is
consistent with published research on this subject, which supports a
priority review multiplier in the range of 1.48 to 2.35 (Ref. 1). Using
FY 2019 figures, the costs of a priority and standard review are
estimated using the following formula:
(44 [alpha] x 1.67) + (26 [alpha]) = $199,369,923

where ``[alpha]'' is the cost of a standard review and ``[alpha]
times 1.67'' is the cost of a priority review. Using this formula,
the cost of a standard review for NME NDAs and BLAs is calculated to
be $2,004,121 (rounded to the nearest dollar) and the cost of a
priority review for NME NDAs and BLAs is 1.67 times that amount, or
$3,346,882 (rounded to the nearest dollar). The difference between
these two cost estimates, or $1,342,761, represents the incremental
cost of conducting a priority review rather than a standard review.

    For the FY 2021 fee, FDA will need to adjust the FY 2019
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2020, to adjust the FY 2019 amount
for cost increases in FY 2020. That adjustment, published in the
Federal Register on August 3, 2020 (see 85 FR 46651), setting FY 2021
PDUFA fees, is 1.3493 percent for the most recent year, not compounded.
Increasing the FY 2019 incremental priority review cost of $1,342,761
by 1.3493 percent (or 0.013493) results in an estimated cost of
$1,360,879 (rounded to the nearest dollar). This is the material threat
MCM priority review user fee amount for FY 2021 that must be submitted
with a priority review voucher for a human drug application in FY 2021,
in addition to any PDUFA fee that is required for such an application.

III. Fee Rate Schedule for FY 2021

    The fee rate for FY 2021 is set out in table 1:

Table 1--Material Threat Medical Countermeasure Priority Review Schedule
                               for FY 2021
------------------------------------------------------------------------
                                                         Priority review
                      Fee category                       fee rate for FY
                                                               2021
------------------------------------------------------------------------
Application submitted with a material threat MCM             $1,360,879
 priority review voucher in addition to the normal
 PDUFA fee.............................................
------------------------------------------------------------------------

IV. Implementation of Material Threat Medical Countermeasure Priority
Review User Fee

    Under section 565A(c)(4)(A) of the FD&C Act, the priority review
user fee is due upon submission of a human drug application for which
the priority review voucher is used. Section 565A(c)(4)(B) of the FD&C
Act specifies that the application will be considered incomplete if the
priority review user fee and all other applicable user fees are not
paid in accordance with FDA payment procedures. In addition, section
565A(c)(4)(C) specifies that FDA may not grant a waiver, exemption,
reduction, or refund of any fees due and

payable under this section of the FD&C Act.
    The material threat MCM priority review fee established in the new
fee schedule must be paid for any application with a priority review
voucher that is received on or after October 1, 2020. This fee must be
paid in addition to any other fee due under PDUFA. Payment must be made
in U.S. currency by electronic check, check, bank draft, wire transfer,
credit card, or U.S. postal money order payable to the order of the
Food and Drug Administration. The preferred payment method is online
using electronic check (Automated Clearing House (ACH) also known as
eCheck). Secure electronic payments can be submitted using the User
Fees Payment Portal at https://userfees.fda.gov/pay. (Note: Only full
payments are accepted. No partial payments can be made online.) Once
you search for your invoice, select ``Pay Now'' to be redirected to
Pay.gov. Note that electronic payment options are based on the balance
due. Payment by credit card is available for balances that are less
than $25,000. If the balance exceeds this amount, only the ACH option
is available. Payments must be made using U.S. bank accounts as well as
U.S. credit cards.
    FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after the
user fee ID number is generated.
    If paying by paper check, the user fee identification (ID) number
should be included on the check, followed by the words ``Material
Threat Medical Countermeasure Priority Review.'' All paper checks must
be in U.S. currency from a U.S. bank made payable and mailed to: Food
and Drug Administration, P.O. Box 979107, St. Louis, MO 63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery, contact the U.S. Bank at 314-
418-4013. This telephone number is only for questions about courier
delivery). The FDA post office box number (P.O. Box 979107) must be
written on the check. If needed, FDA's tax identification number is 53-
0196965.
    If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. The originating financial
institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required to add that
amount to the payment to ensure that the invoice is paid in full. The
account information is as follows: U.S. Dept. of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY 10045, Account Number: 75060099,
Routing Number: 021030004, SWIFT: FRNYUS33.

V. Reference

    The following reference is on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852,<PHONE_NUMBER>, and is available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
it is not available electronically at https://www.regulations.gov as
this reference is copyright protected. FDA has verified the website
address, as of the date this document publishes in the Federal
Register, but websites are subject to change over time.

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006, available at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.25.2.313.

    Dated: October 2, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22192 Filed 10-2-20; 4:15 pm]
BILLING CODE 4164-01-P


[Federal Register: January 24, 2008 (Volume 73, Number 16)]
[Proposed Rules]
[Page 4123-4125]
[DOCID:fr24ja08-35]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0057; Directorate Identifier 2007-CE-102-AD]
RIN 2120-AA64

Airworthiness Directives; APEX Aircraft Model CAP 10 B Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    A case of loose bond (ungluing) of one mounting wooden block of
the control stick base cover, found during the cover reinstallation,
was reported to the Type Certificate Holder (TCH) and led to the
issuance of the ``recommended'' Service Bulletin (SB) No. 031004 in
February 2004. Since that date, other similar occurrences have been
reported. This SB in its revision 1, has therefore been reclassified
``mandatory'' by the TCH.

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by February 25,
2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Management Facility

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

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

SUPPLEMENTARY INFORMATION:

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-2008-0057;
Directorate Identifier 2007-CE-102-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD 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

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD No.: 2007-0296, dated December 7, 2007 (referred to after this as
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    A case of loose bond (ungluing) of one mounting wooden block of
the control stick base cover, found during the cover reinstallation,
was reported to the Type Certificate Holder (TCH) and led to the
issuance of the ``recommended'' Service Bulletin (SB) No. 031004 in
February 2004. Since that date, other similar occurrences have been
reported. This SB in its revision 1, has therefore been reclassified
``mandatory'' by the TCH.
    This Airworthiness Directive (AD) mandates inspection of the
mounting blocks of the control stick base cover for loose bonds and
repair, as necessary.
    These actions are intended to address the identified unsafe
condition so as to prevent separation of the mounting blocks from
the wing spar which could result in restricted movement of the
ailerons and elevators with possible partial or complete loss of
controls.

The MCAI requires an inspection of the four mounting wooden blocks of
the control stick base cover. You are to take corrective action by
repairing any loose blocks where inspection indicates necessary.
    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    APEX Aircraft has issued service bulletin No. 031004 R1, Revision
1, dated November 12, 2007. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this

AD because we evaluated all information and determined the unsafe
condition exists and is likely to exist or develop on other products of
the same type design.

Differences Between This Proposed AD and the MCAI or Service
Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 52 products of U.S. registry. We also estimate that
it would take about .5 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Required parts would cost about $135 per product.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $9,100, or $175 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

APEX Aircraft: Docket No. FAA-2008-0057; Directorate Identifier
2007-CE-102-AD.

Comments Due Date

    (a) We must receive comments by February 25, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the following CAP 10 B airplanes that are
certificated in any category:
    (i) serial numbers 300 through 310; and
    (ii) serial numbers 1 through 40 that have been retrofitted with
carbon/wood wing reference 5702-0104048*

    (*with or without a variable letter or number at the reference
end).

Subject

    (d) Air Transport Association of America (ATA) Code 57: Wings.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    A case of loose bond (ungluing) of one mounting wooden block of
the control stick base cover, found during the cover reinstallation,
was reported to the Type Certificate Holder (TCH) and led to the
issuance of the ``recommended'' Service Bulletin (SB) No. 031004 in
February 2004. Since that date, other similar occurrences have been
reported. This SB in its revision 1, has therefore been reclassified
``mandatory'' by the TCH.
    This Airworthiness Directive (AD) mandates inspection of the
mounting blocks of the control stick base cover for loose bonds and
repair, as necessary.
    These actions are intended to address the identified unsafe
condition so as to prevent separation of the mounting blocks from
the wing spar which could result in restricted movement of the
ailerons and elevators with possible partial or complete loss of
controls.

The MCAI requires an inspection of the four mounting wooden blocks
of the control stick base cover. You are to take corrective action
by repairing any loose blocks where inspection indicates necessary.

Actions and Compliance

    (f) Unless already done, do the following actions within the
next 6 months after the effective date of this AD, following APEX
Aircraft Service Bulletin No. 031004 R1, Revision 1, dated November
12, 2007:
    (1) Inspect the four mounting wooden blocks of the control stick
base cover for loose bonding (gluing); and
    (2) If any wooden block is found to be loose, take corrective
action.

FAA AD Differences

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

Other FAA AD Provisions

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

provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et. seq.),
the Office of Management and Budget (OMB) has approved the
information collection requirements and has assigned OMB Control
Number 2120-0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency AD No.: 2007-
0296, dated December 7, 2007; and APEX Aircraft Service Bulletin
(SB) No. 031004 R1, Revision 1, dated November 12, 2007, for related
information.

    Issued in Kansas City, Missouri, on January 16, 2008.
James E. Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-1164 Filed 1-23-08; 8:45 am]

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