[Federal Register: September 13, 2007 (Volume 72, Number 177)]
[Proposed Rules]
[Page 52314-52316]
[DOCID:fr13se07-13]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-29174; Directorate Identifier 2007-NM-125-AD]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-100, -200, -200C, -
300, -400, and -500 Series Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Boeing Model 737-100, -200, -200C, -300, -400, and -500
series airplanes. This proposed AD would require repetitive inspections
to detect cracking of the body station 303.9 frame, and corrective
action if necessary. This proposed AD also provides for optional
terminating action for the repetitive inspections. This proposed AD
results from reports of cracks found at the cutout in the web of body
station frame 303.9 inboard of stringer 16L. We are proposing this AD
to detect and correct such cracking, which could prevent the left
forward entry door from sealing correctly, and could cause in-flight
decompression of the airplane.

DATES: We must receive comments on this proposed AD by October 29,
2007.

ADDRESSES: Use one of the following addresses to submit comments on
this proposed AD.
     DOT Docket Web site: Go to http://dms.dot.gov and follow

the instructions for sending your comments electronically.
     Government-wide rulemaking Web site: Go to http://www.regulations.gov
 and follow the instructions for sending your

comments electronically.
     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.
     Fax:<PHONE_NUMBER>.
     Hand Delivery: Room W12-140 on the ground floor of the
West Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle,
Washington 98124-2207, for the service information identified in this
proposed AD.

FOR FURTHER INFORMATION CONTACT: Howard Hall, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6430; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to submit any relevant written data, views, or
arguments regarding this proposed AD. Send your comments to an address
listed in the ADDRESSES section. Include the docket number ``FAA-2007-
29174; Directorate Identifier 2007-NM-125-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of the proposed AD. We will
consider all comments received by the closing date and may amend the
proposed AD in light of those comments.
    We will post all comments we receive, without change, to http://dms.dot.gov
, including any personal information you provide. We will

also post a report summarizing each substantive verbal contact with FAA
personnel concerning this proposed AD. Using the search function of
that web site, anyone can find and read the comments in any of our
dockets, including the name of the individual who sent the comment (or
signed the comment on behalf of an association, business, labor union,
etc.). You may review DOT's complete Privacy Act Statement in the
Federal Register published on April 11, 2000 (65 FR 19477-78), or you
may visit http://dms.dot.gov.

Examining the Docket

    You may examine the AD docket on the Internet at http://dms.dot.gov
, or in person at the Docket Operations office between 9

a.m. and 5 p.m., Monday through Friday, except Federal holidays. The
Docket Operations office (telephone<PHONE_NUMBER>) is located on the
ground floor of the West Building at the DOT street address stated in
the ADDRESSES section. Comments will be available in the AD docket
shortly after the Docket Management System receives them.

Discussion

    We have received reports of cracks found at the cutout in the web
of the body station 303.9 frame inboard of stringer 16L on seven Boeing
Model 737 ``classic'' airplanes. The cracks were found on airplanes
that had accumulated between 37,562 and 64,000 total flight cycles.
Such cracking, if not corrected, could prevent the left forward entry
door from sealing correctly, and could cause in-flight decompression of
the airplane.

Relevant Service Information

    We have reviewed two service bulletins related to this action. The
service bulletins are similar but affect different groups of airplanes.
    Boeing Alert Service Bulletin 737-53A1188, Revision 2, dated May 9,
2007, for certain Model 737-300, -400, and -500 series airplanes,
describes the following actions:
     Repetitive high-frequency eddy current (HFEC) and detailed
inspections to detect cracking in the station 303.9 web and doubler
around the cutouts for door stop straps at stringers 15L and 16L.
     A repair/preventive change, which includes installing a
new web, doubler, and stop fitting assemblies; changing the shape of
the web cutout; and doing an eddy current inspection.
    Service Bulletin 737-53A1188 specifies a threshold for the initial
inspection of 10,000 total flight cycles and a grace period of 2,250
flight cycles.
    Boeing Alert Service Bulletin 737-53A1197, dated August 25, 2006,
for certain Model 737-100, -200, -200C, -300, -400, and -500 series
airplanes, describes the following actions:
     Repetitive ultrasound inspections of the slot-shaped
cutout in the web for the door stop strap at stringer 16L.
     Repetitive HFEC inspections of the web along the upper
edge and lower edge of the doubler around the doorstop strap at
stringer 16L.
     Repetitive detailed inspections of the web around the
doubler for the cutout at stringer 16.
     A repair/preventive change, which involves installing a
new web and doubler.
    Service Bulletin 737-53A1197 specifies a threshold for the initial
inspection of 30,000 total flight cycles and a grace period of 2,250
flight cycles.
    For both service bulletins, a repair/preventive change eliminates
the need

for the repetitive inspections. For airplanes on which the repair/
preventive change was previously done according to the original version
or Revision 1 of Alert Service Bulletin 737-53A1188, replacing the
existing kit with a new kit (in accordance with Revision 2) is
necessary to eliminate the need for the repetitive inspections.
    Accomplishing the actions specified in the service bulletins is
intended to adequately address the unsafe condition.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other airplanes
of this same type design. For this reason, we are proposing this AD,
which would require accomplishing the actions specified in the service
information described previously, except as discussed below.

Difference Between Proposed AD and Service Information

    The service bulletins specify to contact the manufacturer for
instructions on how to repair certain conditions, but this proposed AD
would require repairing those conditions in one of the following ways:
     Using a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by an Authorized Representative
for the Boeing Commercial Airplanes Delegation Option Authorization
Organization whom we have authorized to make those findings.

Costs of Compliance

    There are about 2,765 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs,
depending on airplane configuration, for U.S. operators to comply with
this proposed AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Average
            Action                    Work hours         labor rate           Parts          Cost per airplane      Number of U.S.-        Fleet cost
                                                          per hour                                               registered airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection....................  1 to 4................          $80  None..................  $80 to $320, per   1,154.................  $92,320 to
                                                                                inspection cycle.                          $369,280, per
                                                                                inspection
                                                                                cycle.
Repair/preventive change, if    12 to 30..............           80  $564 to $2,236........  $1,524 to $4,636.  Up to 1,154...........  Up to
 done.                                                                                $5,349,944.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

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 Federal Aviation Administration (FAA) amends Sec.  39.13 by
adding the following new airworthiness directive (AD):

Boeing: Docket No. FAA-2007-29174; Directorate Identifier 2007-NM-
125-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by October
29, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the airplanes, certificated in any
category, identified in Table 1 of this AD.

                         Table 1.--Applicability
------------------------------------------------------------------------
                                          As identified in Boeing Alert
             Boeing model--                     Service Bulletin--
------------------------------------------------------------------------
737-100, -200, and -200C series          737-53A1197, dated August 25,
 airplanes.                               2006.
737-300, -400, and -500 series           737-53A1188, Revision 2, dated
 airplanes.                               May 9, 2007, or 737-53A1197,
                                          dated August 25, 2006.
------------------------------------------------------------------------

Unsafe Condition

    (d) This AD results from reports of cracks found at the cutout
in the web of body station frame 303.9 inboard of stringer 16L. We
are issuing this AD to detect and correct such cracking, which could
prevent the left forward entry door from sealing correctly, and
could cause in-flight decompression of the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Repetitive Inspections: Service Bulletin 737-53A1188

    (f) For airplanes identified in Boeing Alert Service Bulletin
737-53A1188, Revision 2, dated May 9, 2007, including airplanes
modified by the repair/preventive change specified in the original
version, dated April 9, 1998, or Revision 1, dated March 18, 1999,
of the service bulletin: Do detailed and high frequency eddy current
(HFEC) inspections in the web and doubler around the slotted holes
in the frame web at stringers 15L and 16L, in accordance with the
Accomplishment Instructions of the service bulletin. Do the
inspections at the applicable time specified in paragraph 1.E. of
the service bulletin, except as provided by paragraph (h) of this
AD. Do all applicable corrective actions before further flight in
accordance with the service bulletin, except as provided by
paragraph (i) of this AD. Repeat the inspections at intervals not to
exceed 4,500 flight cycles until accomplishment of the repair/
preventive change in accordance with the service bulletin, which
terminates the repetitive inspection requirements. A repair/
preventive change done in accordance with the original version or
Revision 1 of the service bulletin does not terminate the repetitive
inspections, but the repetitive inspections may be terminated after
the existing kit is replaced with a new kit in accordance with
Revision 2 of the service bulletin, paragraph 3.B., Part II, step 3,
or Part III, step 3.

Repetitive Inspections: Service Bulletin 737-53A1197

    (g) For airplanes identified in Boeing Alert Service Bulletin
737-53A1197, dated August 25, 2006: Do an ultrasound inspection of
the slot-shaped cutout in the web for the door stop strap at
stringer 16L, an HFEC inspection of the web along the upper and
lower edges of the doubler around the doorstop strap at stringer
16L, and a detailed inspection of the web around the doubler for the
cutout at stringer 16L, in accordance with the Accomplishment
Instructions of the service bulletin. Do the inspections at the
applicable time specified in paragraph 1.E. of the service bulletin,
except as provided by paragraph (h) of this AD. Do all applicable
corrective actions before further flight in accordance with the
service bulletin, except as provided by paragraph (i) of this AD.
Repeat the inspections at intervals not to exceed 4,500 flight
cycles, until accomplishment of the repair/preventive change in
accordance with the service bulletin, which terminates the
repetitive inspections.

Exceptions to Service Bulletin Specifications

    (h) Where Boeing Alert Service Bulletin 737-53A1188, Revision 2,
dated May 9, 2007; and Boeing Alert Service Bulletin 737-53A1197,
dated August 25, 2006, specify a compliance time after release of
the service bulletin, this AD requires compliance within the
specified time after the effective date of this AD.
    (i) Where Boeing Alert Service Bulletin 737-53A1188, Revision 2,
dated May 9, 2007; and Boeing Alert Service Bulletin 737-53A1197,
dated August 25, 2006, specify to contact Boeing for appropriate
action, including repair of damage outside the scope of the service
bulletin, repair using a method approved in accordance with the
procedures specified in paragraph (j) of this AD.

Alternative Methods of Compliance (AMOCs)

    (j)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested in
accordance with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to be approved, the repair must meet the certification basis
of the airplane, and the approval must specifically refer to this
AD.

    Issued in Renton, Washington, on August 31, 2007.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E7-18049 Filed 9-12-07; 8:45 am]

BILLING CODE 4910-13-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ Office of Solid Waste and Emergency Response / Office of Emergency Prevention, Preparedness and Response 2. OMB control number b. G None a. 2050 0144 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title: Risk Management Program Requirements and Petitions to Modify the List of Regulated Substances under Section 112( r) of the Clean Air Act ( Renewal)

8. Agency form number( s) ( If applicable): ICR No. 1656.12 9. Keywords: Clean Air Act Amendments, Accidental Release Prevention, Registration, Documentation, Risk Management Plans, Risk Management Programs.

10. Abstract: Under Section 112r of the Clean Air Act, as amended, sources must register, document risk management programs, and submit risk management plans ( RMP) to EPA. Sources submitted their first RMPs on June 21, 1999. The plans include information on a source's hazard assessment, prevention program, and emergency response program. The regulations, codified in 40 CFR part 68, also include requirements for a petitioner to submit sufficient information in support of a petition to scientifically support the request to add or delete a chemical from the list of regulated substances. The Agency will use this information in making the decision to grant or deny a petition. The next compliance deadline was June 21, 2004, five years after the first submission. Some of the sources revised and submitted their RMPs between the mandatory deadlines. These sources were then assigned a five year compliance deadline based on the date of their revised plan submission. The next submission of RMPs for all sources is by June 21, 2009. The period covered by this ICR is between the two mandatory deadlines ( 2004 and 2009). Therefore, in this ICR, EPA has accounted for only on going program implementation costs for all sources that are currently covered by part 68 requirements, compliance costs for new sources that may become subject to the regulations, and burden for sources that re submit RMP before the next compliance deadline.

11. Affected public ( Mark primary with" P" and all others that apply with" X")

a. Individuals or households d. Farms b. P Business or other for profit e. X Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 1,397 b. Total annual responses 4,191 1. Percentage of these responses collected electronically 99 % c. Total hours requested 98,599 d. Current OMB inventory 130,803 e. Difference  32,204 f. Explanation of difference 1. Program Change 0 2. Adjustment  32,204 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 0 b. Total annual costs ( O& M) $ 7 c. Total annualized cost requested $ 7 d. Current OMB inventory $ 6 e. Difference $ 1 f. Explanation of difference 1. Program change $ 0 2. Adjustment $ 1 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biennially 8. X Other ( describe) every 5 years 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Sicy Jacob Phone: 202 564 8019 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95


[Federal Register Volume 85, Number 66 (Monday, April 6, 2020)]
[Proposed Rules]
[Page 19116]
[FR Doc No: 2020-06810]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2020-0150; FRL-10007-41-Region 1]

Air Plan Approval; New Hampshire; Negative Declaration for the
Oil and Gas Industry

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
State of New Hampshire. The revision provides the state's
determination, via a negative declaration, that there are no facilities
within its borders subject to EPA's 2016 Control Technique Guideline
(CTG) for the oil and gas industry. The intended effect of this action
is to propose approval of these items into the New Hampshire SIP. This
action is being taken in accordance with the Clean Air Act.

DATES: Written comments must be received on or before May 6, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2020-0150 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets. Publicly
available docket materials are available at https://www.regulations.gov
or at the U.S. Environmental Protection Agency, EPA Region 1 Regional
Office, Air and Radiation Division, 5 Post Office Square--Suite 100,
Boston, MA. EPA requests that if at all possible, you contact the
contact listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
legal holidays.

FOR FURTHER INFORMATION CONTACT: Bob McConnell, Environmental Engineer,
Air and Radiation Division (Mail Code 05-2), U.S. Environmental
Protection Agency, Region 1, 5 Post Office Square, Suite 100, Boston,
Massachusetts 02109-3912;<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this action
rule, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.
    For additional information, see the direct final rule which is
located in the Rules Section of this Federal Register.

    Dated: March 27, 2020.
Dennis Deziel,
Regional Administrator, EPA Region 1.
[FR Doc. 2020-06810 Filed 4-3-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Pages 16472-16473]
[FR Doc No: 2022-06108]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2018-0767; FRL-9356-01-OLEM]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Recordkeeping and Reporting--Solid Waste Disposal
Facilities and Practices; EPA ICR No. 1381.13, OMB Control No. 2050-
0122

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit the information collection request (ICR), Recordkeeping and
Reporting--Solid Waste Disposal Facilities and Practices; ``(EPA ICR
No. 1381.13, OMB Control No. 2050-0122) to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act (PRA). Before doing so, the EPA is soliciting public
comments on specific aspects of the proposed information collection as
described in Supplementary Information. This is a proposed extension of
the ICR, which is currently approved through November 30, 2022. An
Agency may not conduct or sponsor and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.

DATES: Comments must be submitted on or before May 23, 2022.

ADDRESSES: Submit your comments, referencing by Docket ID No. EPA-HQ-
OLEM-2018-0767, at https://www.regulations.gov (our preferred method),
or the other methods identified in the ADDRESSES section. Once
submitted, comments cannot be edited or removed from the docket. The
EPA may publish any comment received to its public docket. Do not
submit to EPA's docket at https://www.regulations.gov any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    Due to public health concerns related to COVID-19, the EPA Docket
Center and Reading Room are open to the public by appointment only. Our
Docket Center staff also continues to provide remote customer service
via email, phone, and webform. Hand deliveries or couriers will be
received by scheduled appointment only. For further information and
updates on EPA Docket Center services, please visit us online at
https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID-19.

FOR FURTHER INFORMATION CONTACT: Craig Dufficy, Materials Recovery and
Waste Management Division, Office of Resource Conservation and
Recovery, Mail Code 3204A, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202)
566-0537; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov. Out of an abundance of caution for members of the
public and our staff, the EPA Docket Center and Reading Room is closed
to the public, with limited exceptions, to reduce the risk of
transmitting COVID-19. Our Docket Center staff will continue to provide
remote customer service via email, phone and webform. For further
information about the EPA's public docket, Docket Center services and
the current status, please visit us online at https://www.epa.gov/dockets. The telephone number for the Docket Center is<PHONE_NUMBER>.
    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and

clarity of the information to be collected; and (iv) minimize the
burden of the collection of information on those who are to respond,
including through the use of appropriate automated electronic,
mechanical, or other technological collection techniques or other forms
of information technology, e.g., permitting electronic submission of
responses. The EPA will consider the comments received and amend the
ICR as appropriate. The final ICR package will then be submitted to OMB
for review and approval. At that time, the EPA will issue another
Federal Register notice to announce the submission of the ICR to OMB
and the opportunity to submit additional comments to OMB.
    Abstract: In order to effectively implement and enforce final
changes to 40 CFR part 258 on a State level, owners/operators of
municipal solid waste landfills have to comply with the final reporting
and recordkeeping requirements. Respondents include owners or operators
of new municipal solid waste landfills (MSWLFs), existing MSWLFs, and
lateral expansions of existing MSWLFs. The respondents, in complying
with 40 CFR part 258, are required to record information in the
facility operating record, pursuant to Sec.  258.29, as it becomes
available. The operating record must be supplied to the State as
requested until the end of the post-closure care period of the MSWLF.
The information collected will be used by the State Director to confirm
owner or operator compliance with the regulations under 40 CFR part
258.
    Form Numbers: None.
    Respondents/affected entities: Recordkeeping and Reporting--Solid
Waste Disposal Facilities and Practices.
    Respondent's obligation to respond: The respondents, in complying
with 40 CFR part 258, are required to record information in the
facility operating record, pursuant to Sec.  258.29, as it becomes
available.
    Estimated number of respondents: 3,800.
    Frequency of response: On occasion.
    Total estimated burden: 204,868 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $2,211,000 (per year), includes $1,831,000
annualized capital or operation & maintenance costs capital or
operation & maintenance costs.
    Changes in Estimates: There is increase of 60 hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB. This increase is due to the increased number of states adopting
the RD&D section (258.4) since the last ICR update.

    Dated: March 11, 2022.
Carolyn Hoskinson,
Director, Office of Resource Conservation and Recovery.
[FR Doc. 2022-06108 Filed 3-22-22; 8:45 am]
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[Federal Register Volume 88, Number 111 (Friday, June 9, 2023)]
[Proposed Rules]
[Pages 37843-37845]
[FR Doc No: 2023-12296]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 571

[Docket No. NHTSA-2023-0012]
RIN 2127-AM54

Side Underride Guards; Extension of Comment Period

AGENCY: National Highway Traffic Safety Administration (NHTSA);
Department of Transportation (DOT).

ACTION: Advance notice of proposed rulemaking; extension of comment
period.

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SUMMARY: NHTSA received two requests to extend the comment period for
the Advance Notice of Proposed Rulemaking (ANPRM) regarding side
underride guards that NHTSA published on April 21, 2023. The comment
period for the ANPRM was scheduled to end on June 20, 2023. NHTSA is
extending the comment period for the ANPRM by 30 days.

DATES: The comment period for the ANPRM published on April 21, 2023, at
88 FR 24535, is extended to July 20, 2023.

ADDRESSES: You may submit comments to the docket number identified in
the heading of this document by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: All submissions must include the agency name and
docket number. Note that all comments received will be posted without
change to https://www.regulations.gov, including any personal
information provided. Please see the Privacy Act discussion below. We
will consider all comments received before the close of business on the
comment closing date indicated above. To the extent possible, we will
also consider comments filed after the closing date.
    Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov at any time or to
1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays. Telephone:<PHONE_NUMBER>.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its decision-making process.
DOT posts these comments, without edit, including any personal
information the commenter provides, to www.regulations.gov, as
described in

the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at www.transportation.gov/privacy. In order to facilitate comment
tracking and response, we encourage commenters to provide their name,
or the name of their organization; however, submission of names is
completely optional. Whether or not commenters identify themselves, all
timely comments will be fully considered.
    Confidential Business Information: If you wish to submit any
information under a claim of confidentiality, you must submit your
request directly to NHTSA's Office of the Chief Counsel. Requests for
confidentiality are governed by 49 CFR part 512. NHTSA is currently
treating electronic submission as an acceptable method for submitting
confidential business information to the agency under part 512. If you
would like to submit a request for confidential treatment, you may
email your submission to Dan Rabinovitz in the Office of the Chief
Counsel at [email protected] or you may contact him for a
secure file transfer link. At this time, you should not send a
duplicate hardcopy of your electronic CBI submissions to DOT
headquarters. If you claim that any of the information or documents
provided to the agency constitute confidential business information
within the meaning of 5 U.S.C. 552(b)(4), or are protected from
disclosure pursuant to 18 U.S.C. 1905, you must submit supporting
information together with the materials that are the subject of the
confidentiality request, in accordance with part 512, to the Office of
the Chief Counsel. Your request must include a cover letter setting
forth the information specified in our confidential business
information regulation (49 CFR 512.8) and a certificate, pursuant to
Sec.  512.4(b) and part 512, appendix A. In addition, you should submit
a copy, from which you have deleted the claimed confidential business
information, to the Docket at the address given above.

FOR FURTHER INFORMATION CONTACT:
    For technical issues: Ms. Lina Valivullah, National Highway Traffic
Safety Administration, 1200 New Jersey Avenue SE, West Building,
Washington, DC 20590 (telephone)<PHONE_NUMBER>, (email)
[email protected].
    For legal issues: Ms. Callie Roach, Office of the Chief Counsel,
National Highway Traffic Safety Administration, 1200 New Jersey Avenue
SE, West Building, Washington, DC 20590, (telephone)<PHONE_NUMBER>,
(email) [email protected].

SUPPLEMENTARY INFORMATION: On April 21, 2023, NHTSA published an ANPRM
responding to section 23011(c) of the November 2021 Infrastructure
Investment and Jobs Act (IIJA), commonly referred to as the Bipartisan
Infrastructure Law (BIL), which directs the Secretary to conduct
research on side underride guards to better understand their overall
effectiveness, and assess the feasibility, benefits, costs, and other
impacts of installing side underride guards on trailers and
semitrailers. The BIL further directs the Secretary to report the
findings of the research in a Federal Register notice to seek public
comment. The ANPRM also responds to a petition for rulemaking from Ms.
Marianne Karth and the Truck Safety Coalition (TSC). The comment period
for the ANPRM was scheduled to end on June 20, 2023.

Comment Period Extension Requests

    On May 9, 2023, NHTSA received a joint request from Eric Hein,
Stephen Bingham, Aaron Kiefer, Jerry Karth, and Lois Durso asking NHTSA
to extend the comment period for the ANPRM. The requestors state that
60 days does not provide adequate time to prepare robust and
substantive comments on such an important issue, and that they are
preparing to conduct additional crash tests of side underride guards
that will involve considerable stakeholder involvement, planning, and
subsequent analysis. The requestors indicate that extending the comment
period by no less than 30 days would provide the opportunity to develop
comprehensive, well informed, and data-based input for NHTSA's
consideration.
    The requestors also noted their concern that there were two
additional reports missing from the docket that were referenced in the
report titled, ``Side Impact Guards for Combination Truck-Trailers:
Cost-Benefit Analysis,'' referred to hereafter as the Cost-Benefit
Analysis Report (CBAR). The requestors request immediate posting of
this information to the docket and state that a full and proper
analysis cannot be conducted until this additional information is
released for review.
    As to the first report, a sentence on page 1 of CBAR states that
``[t]he effects of speed limit, vehicle age, occupant age, belt use,
and road surface conditions on occupant fatalities are also discussed
in this study'' (emphasis added). The ``study'' refers to a NHTSA
analysis conducted for the CBAR. As mentioned in the report, the code
NHTSA used for compiling data for the analysis is found in Appendix A
of the CBAR. The relevant data from the analysis is available in
Section II.A of the CBAR. While the CBAR included NHTSA's analysis of
speed limit and restraint use, the data and analysis regarding vehicle
age, occupant age, and road surface conditions were removed from the
CBAR because they did not add any new information on crash outcomes
with respect to underride. Inadvertently, the introductory statement on
page 1 and language used elsewhere in the document were not modified
accordingly. For completeness, we have now submitted the supplementary
information and analysis to the docket, NHTSA-2023-0012. Since these
factors do not affect crash outcomes with respect to underride, the
additional information does not change the analysis or results of the
CBAR.
    As to the second report, a sentence on page B-2 of the CBAR refers,
in part, to an ``Evaluation of Vehicle Underride and Associated
Fatalities in Light Vehicle Crashes into the Side of Truck Trailers
Report.'' This refers to a draft NHTSA report the agency prepared and
later decided to incorporate into the CBAR. The methodology, data, and
analysis for the referenced study may be found in Section II.B of the
CBAR. Inadvertently, the reference in Appendix B was not updated
accordingly.
    NHTSA received a second request to extend the comment period on May
23, 2023, from the American Trucking Associations (ATA). ATA requests a
30-day extension to the comment period to ensure ATA has sufficient
time to coordinate with its members to develop comments on the complex
issues presented in the notice. ATA notes that the ANPRM requested
specific feedback on side underride guard interactions with road
features, loading docks, port operations, and other types of
operations, and ATA seeks additional time to work with its members to
gather examples of these interactions.

Agency Decision

    Pursuant to 49 CFR 553.19 and after thorough consideration of these
requests, NHTSA has determined that the requestors have provided
sufficient justification for an extension, and that the extension is
consistent with the public interest. NHTSA agrees that allowing
additional time for the public and its stakeholders to provide robust
and substantive comments on this complex issue will better inform
NHTSA. A 30-day extension appropriately balances NHTSA's interest in
providing the public with sufficient time to review the docket and
comment on the complex questions raised in the ANPRM with its interest
in obtaining specific feedback from stakeholders in a timely manner.
The

extension will also provide sufficient time for commenters to review
the supplementary information that we have submitted to the docket.
Accordingly, NHTSA is granting the aforementioned request and extending
the comment period by 30 days.

    Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30166;
delegation of authority at 49 CFR 1.95.

Sophie Shulman,
Deputy Administrator.
[FR Doc. 2023-12296 Filed 6-8-23; 8:45 am]
BILLING CODE 4910-59-P


the proposed amendments to Exchange Act Rule 12h-1.

G. Significant Alternatives

    The Regulatory Flexibility Act directs us to consider significant
alternatives that would accomplish the stated objective, while
minimizing any significant adverse impact on small entities. Insofar as
the amendments only apply to entities that are subject to Section 12(g)
registration with regard to a class of equity security and, therefore,
do not apply to small entities, we did not consider any alternatives to
the proposed amendments specifically with respect to small entities. In
connection with the proposed exemptions, we considered alternatives
related to the scope of issuers eligible for the exemption, the
information required to be provided, and transfer restrictions on the
options and shares issuable on exercise of the options.

H. Request for Comment

    We encourage the submission of comments with respect to any aspect
of this Initial Regulatory Flexibility Analysis. Commenters are asked
to describe the nature of any impact and provide empirical data
supporting the extent of any impact on small entities. Such comments
will be considered in the preparation of the Final Regulatory
Flexibility Analysis, if the proposed amendments are adopted, and will
be placed in the same public file as comments on the proposed
amendments.

VII. Small Business Regulatory Enforcement Fairness Act

    For purposes of the Small Business Regulatory Enforcement Fairness
Act of 1996 \88\ (``SBREFA''), a rule is ``major'' if it has resulted,
or is likely to result in:
---------------------------------------------------------------------------

    \88\ Pub. L. 104-121, Title II, 110 Stat. 857 (1996).
---------------------------------------------------------------------------

     An annual effect on the economy of $100 million or more;
     A major increase in costs or prices for consumers or
individual industries; or
     Significant adverse effects on competition, investment or
innovation.

We request comment on whether our proposed exemptions would be a
``major rule'' for purposes of SBREFA. We solicit comment and empirical
data on:
     The potential effect on the U.S. economy on an annual
basis;
     Any potential increase in costs or prices for consumers or
individual industries; and
     Any potential effect on competition, investment or
innovation.

VIII. Statutory Basis and Text of Proposed Rule Amendments

    We are proposing to amend Exchange Act Rule 12h-1 under the
authority in Sections 12, 23, and 36 of the Securities Exchange Act of
1934, as amended.

List of Subjects in 17 CFR Part 240

    Reporting and recordkeeping requirements, Securities.

Text of Proposed Rule

    For the reasons set out in the preamble, we propose to amend Title
17, Chapter II of the Code of Federal Regulations as follows:

PART 240--GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF
1934

    1. The authority citation for Part 240 continues to read in part as
follows:

    Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3,
77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i,
78j, 78j-1, 78k, 78k-1, 78l, 78m, 78n, 78o, 78p, 78q, 78s, 78u-5,
78w, 78x, 78ll, 78mm, 80a-20, 80a-23, 80a-29, 80a-37, 80b-3, 80b-4,
80b-11, and 7201 et seq.; and 18 U.S.C. 1350, unless otherwise
noted.
* * * * *
    2. Amend Sec.  240.12h-1 to add paragraphs (f) and (g) to read as
follows:

Sec.  240.12h-1  Exemptions from registration under section 12(g) of
the Act.

* * * * *
    (f)(1) Stock options issued under written compensatory stock option
plans of an issuer under the following conditions:
    (i) The issuer of the stock options does not have a class of
security registered under section 12 of the Act and is not required to
file reports pursuant to section 15(d) of the Act;
    (ii) The stock options have been issued by the issuer pursuant to
one or more written compensatory stock option plans established by the
issuer, its parents, its majority-owned subsidiaries or majority-owned
subsidiaries of the issuer's parents;

    Note to paragraph (f)(1)(ii): All stock options issued under all
of the issuer's written compensatory stock option plans on the same
class of equity security will be considered part of the same class
of equity security for purposes of the provisions of this section.

    (iii) The stock options are held only by those persons described in
Rule 701(c) under the Securities Act (17 CFR 230.701(c));
    (iv) The stock options and the shares issuable upon exercise of
such stock options are restricted as to transfer by the optionholder or
holder of the shares received on exercise of the option other than to
persons who are family members (as defined in Rule 701(c)(3) under the
Securities Act (17 CFR 230.701(c)(3)) through gifts or domestic
relations orders, or to an executor or guardian of the optionholder or
holder of shares received on exercise of such stock option upon the
death or disability of the optionholder or holder of shares, until the
issuer becomes subject to the reporting requirements of section 13 or
15(d) of the Act; provided that the optionholder or holder of shares
may transfer the options or shares to the issuer (or its designated
affiliate if the issuer is unable to repurchase the options or shares)
if applicable law prohibits a restriction on transfer;

    Note to paragraph (f)(1)(iv): For purposes of this section,
optionholders and holders of shares received on exercise of an
option may include any permitted transferee under paragraph
(f)(1)(iv) of this section; provided that such permitted transferees
may not further transfer the stock options or shares issuable upon
exercise of such stock options;

    (v) The stock options, the shares issuable upon exercise of such
stock options, and shares of the same class of equity security as those
underlying the options are restricted as to any pledge, hypothecation,
or other transfer, including any short position, any ``put equivalent
position'' (as defined in Sec.  240.16a-1(h) of this chapter), or any
``call equivalent position'' (as defined in Sec.  240.16a-1(b) of this
chapter) by the optionholder or holder of shares received on exercise
of an option, except as permitted in paragraph (f)(1)(iv) of this
section, until the issuer becomes subject to the reporting requirements
of section 13 or 15(d) of the Act;
    (vi) There can be no market or available process or methodology
that permits an optionholder or holder of shares received on exercise
of an option to receive any consideration or compensation for the
options, the shares issuable on exercise of the options, or shares of
the same class of equity security as those underlying the options,

except as permitted in paragraph (f)(1)(iv) of this section, until the
issuer becomes subject to the reporting requirements of section 13 or
15(d) of the Act;

    Note to paragraphs (f)(1)(iv), (f)(1)(v), and (f)(1)(vi): The
transferability restrictions in paragraphs (f)(1)(iv), (f)(1)(v),
and (f)(1)(vi) of this section must be contained in either the
written compensatory stock option plan, individual written
compensatory stock option agreement, or other stock purchase or
stockholder agreement to which the issuer and the optionholder or
holder of shares are a signatory or party, or in the issuer's by-
laws, certificate of incorporation; and

    (vii) The issuer has agreed in the written compensatory stock
option plan or the individual written compensatory stock option
agreement to provide the following information to optionholders and
holders of shares received on exercise of an option until the issuer
becomes subject to the reporting requirements of section 13 or 15(d) of
the Act:
    (A) The information described in Rules 701(e)(3), (4), and (5)
under the Securities Act (17 CFR 230.701(e)(3), (4), and (5)), with
such information provided either by physical or electronic delivery to
the optionholders and holders of shares received on exercise of an
option or by written notice to the optionholders and holders of shares
received on exercise of an option of the availability of the
information on a password-protected Internet site and of any password
needed to access the information; and
    (B) Access to the issuer's books and records, including corporate
governance documents, to the same extent that they are available to
other shareholders of the issuer.

    Note to paragraph (f)(1)(vii): The issuer may request that the
optionholder or holder of shares received on exercise of an option
agree to keep the information to be provided pursuant to this
section confidential. If an optionholder or holder of shares
received on exercise of an option does not agree to keep the
information to be provided pursuant to this section confidential,
then the issuer is not required to provide the information;
provided, that the issuer must then allow the optionholder or holder
of shares received on exercise of an option to inspect the
information and documents at one of the issuer's offices that is at
or near where the optionholder or holder of shares received on
exercise of an option is or was employed or retained by the issuer.

    (2) If the exemption provided by paragraph (f)(1) of this section
ceases to be available, the issuer of the compensatory stock options
that is relying on the exemption provided by this section must file a
registration statement to register the class of options under section
12 of the Act within 60 calendar days after the conditions in paragraph
(f)(1) of this section are no longer satisfied.
    (g)(1) Stock options issued under written compensatory stock option
plans of an issuer under the following conditions:
    (i) The issuer of the stock options has registered the class of
equity security issuable on exercise of the options under section 12 of
the Act;
    (ii) The stock options have been issued by the issuer pursuant to
one or more written compensatory stock option plans established by the
issuer, its parents, its majority-owned subsidiaries or majority-owned
subsidiaries of the issuer's parents;

    Note to paragraph (g)(1)(ii): All stock options issued under all
of the issuer's written compensatory stock option plans on the same
class of equity security will be considered part of the same class
of equity security for purposes of the provisions of this section;
and

    (iii) The stock options are held only by those persons described in
Rule 701(c) under the Securities Act (17 CFR 230.701(c)).
    (2) If the exemption provided by paragraph (g)(1) of this section
ceases to be available, the issuer of the compensatory stock options
that is relying on the exemption provided by this section must file a
registration statement to register the class of options or the class of
equity security issuable on exercise of the options under section 12 of
the Act within 60 calendar days after the conditions in paragraph
(g)(1) of this section are no longer satisfied.

    Dated: July 5, 2007.

    By the Commission.
Nancy M. Morris,
Secretary.
[FR Doc. E7-13324 Filed 7-9-07; 8:45 am]

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[Federal Register Volume 77, Number 187 (Wednesday, September 26, 2012)]
[Notices]
[Pages 59196-59197]
[FR Doc No: 2012-23573]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Anti-Infective Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Anti-Infective Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 28, 2012, from
8 a.m. to 5 p.m.
    Location: DoubleTree by Hilton Hotel Washington DC--Silver Spring,
The Ballroom, 8727 Colesville Rd., Silver Spring, MD. The hotel's phone
number is<PHONE_NUMBER>.
    Contact Person: Diane Goyette, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss the safety and efficacy of new
drug application (NDA) 204384, bedaquiline tablets, submitted by
Janssen Therapeutics, Division of Janssen Products, LP. The proposed
indication (use) for this product is for the treatment of patients with
multi-drug resistant pulmonary tuberculosis.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 13, 2012. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before November 2, 2012. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by November 5, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Diane Goyette at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 18, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-23573 Filed 9-25-12; 8:45 am]
BILLING CODE 4160-01-P