[Federal Register Volume 85, Number 69 (Thursday, April 9, 2020)]
[Rules and Regulations]
[Pages 19875-19878]
[FR Doc No: 2020-07399]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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Federal Register / Vol. 85, No. 69 / Thursday, April 9, 2020 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0867; Product Identifier 2019-NM-131-AD; Amendment
39-19886; AD 2020-06-17]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

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

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2011-09-
06, which applied to all Airbus SAS Model A330-200 Freighter series
airplanes; Model A330-200 and -300 series airplanes; and Model A340-200
and -300 series airplanes. AD 2011-09-06 required repetitive
inspections and operational checks of the spring function of the
emergency exit door slider mechanism, application of corrosion
inhibitor, and corrective actions. This AD retains those requirements,
with extended repetitive intervals for certain actions, and also
requires those actions on additional airplanes; as specified in a
European Union Aviation Safety Agency (EASA) AD, which is incorporated
by reference. This AD was prompted by report that an escape slide
deployment test found a girt bar that was not in a locked position and
was detached from the airplane. The FAA is issuing this AD to address
the unsafe condition on these products.

DATES: This AD is effective May 14, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 14,
2020.

ADDRESSES: For the material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 89990 1000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available in the AD docket on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2019-0867.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0867; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations is U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0155, dated July 3, 2019
(``EASA AD 2019-0155'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Airbus SAS Model A330-200 Freighter series airplanes;
Model A330-200, -300, and -900 series airplanes; and Model A340-200, -
300, -500, and -600 series airplanes.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2011-09-06, Amendment 39-16668 (76 FR
22005, April 20, 2011) (``AD 2011-09-06''). AD 2011-09-06 applied to
all Airbus SAS Model A330-200 Freighter series airplanes; Model A330-
200, and -300 series airplanes; and Model A340-200, and -300 series
airplanes. The NPRM published in the Federal Register on November 18,
2019 (84 FR 63582). The NPRM was prompted by a report that an escape
slide deployment test found a girt bar that was not in a locked
position and was detached from the airplane. The NPRM was also prompted
by a determination that additional airplanes are affected by the unsafe
condition, and that the repetitive interval times can be extended. The
NPRM proposed to continue to require repetitive inspections and
operational checks, application of corrosion inhibitor, and repair or
replacement if necessary, with extended repetitive intervals for the
functional check and lubrication of the door girt bar slider of each
passenger/crew door and passenger compartment emergency exit. The NPRM
also proposed to revise the applicability to include additional
airplanes. The FAA is issuing this AD to address this condition, which
could result in escape slides detaching from the door after inflation,
and which could, during an emergency, prevent a safe evacuation of the
cabin and possibly result in injuries.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The following presents the comments
received on the NPRM and the FAA's response to each comment.

Request To Clarify Credit for Actions

    Delta Air Lines (Delta) requested clarification on credit for
actions that were accomplished using Airbus Alert Operators
Transmission (AOT) A330-52A3063, dated August 2, 2000, before the
effective date of EASA 2010-0135, dated July 5, 2010 (``EASA AD 2010-
0135''). Delta noted that EASA AD 2019-0155 specifies credit if Airbus
AOT A330-52A3063, dated August 2, 2000, was used before ``July 17,
2010'' (which was incorrectly identified as the effective date of the
superseded EASA AD 2010-0135; the correct effective date is July 19,
2010). AD 2011-09-06, with an effective date of May 5, 2011,
corresponds to EASA AD 2010-0135. Paragraph (h) of the proposed AD did
not provide an exception to use May 5,

2011, as the effective date, and Delta requested confirmation that
credit is still provided for use of Airbus AOT A330-52A3063, dated
August 2, 2000, before the effective date of EASA AD 2010-0135.
    The FAA agrees to clarify when Airbus AOT A330-52A3063, dated
August 2, 2000, is acceptable for credit. Although AD 2011-09-06 did
not provide any credit for Airbus AOT A330-52A3063, dated August 2,
2000, the FAA has determined that use of that AOT is acceptable up to
May 5, 2011. The FAA has added paragraph (h)(4) of this AD to provide
an exception to EASA AD 2019-0155 to allow credit for Airbus AOT A330-
52A3063, dated August 2, 2000, using the FAA AD 2011-09-06 effective
date of May 5, 2011 for the initial inspection only.

Request To Clarify Need for an Alternative Means of Compliance (AMOC)

    Delta requested that the FAA clarify whether an alternative means
of compliance (AMOC) for previous credits would be required for
allowing any repetitive inspections that may have been accomplished
before the effective date of EASA AD 2010-0135 using Airbus AOT A330-
52A3063, dated August 2, 2000. Delta stated that AD 2002-02-07,
Amendment 39-12635 (67 FR 6370, February 12, 2002) (``AD 2002-02-07''),
required using Airbus AOT A330-52A3063, dated August 2, 2000, to
accomplish the inspection requirements, and then AD 2011-09-06 required
Airbus AOT A330-52A3063, Revision 01, dated January 3, 2001. Delta
reasoned that given the time span between the effective dates of AD
2002-02-07 and AD 2011-09-06, and because EASA AD 2019-0155 granted
credit for only initial inspections, it would be possible that an
operator would be doing repetitive inspections using Airbus AOT A330-
52A3063, dated August 2, 2000, and would need an AMOC for the
repetitive inspections.
    The FAA agrees that clarification is needed. ADs 2002-02-07 and
2011-09-06 did not require use of or grant credit for Airbus AOT A330-
52A3063, dated August 2, 2000, for any actions. Unless an AMOC has been
approved, all inspections, initial and repetitive, required by AD 2002-
02-07 and, later, AD 2011-09-06, on U.S.-registered airplanes should
have been accomplished using Airbus AOT A330-52A3063, Revision 01,
dated January 3, 2001, and would be subject to using Revision 01 for
repetitive inspections. However, EASA AD 2019-0155 granted credit for
using Airbus AOT A330-52A3063, dated August 2, 2000, before its
effective date for initial inspections, and as described in the
previous comment, the FAA concurred and is granting credit similar to
EASA AD 2019-0155. However, repetitive inspections were and are still
required to be done in accordance with Airbus AOT A330-52A3063,
Revision 01, dated January 3, 2001. The FAA has not otherwise changed
this AD in that regard.

Additional Change to This Final Rule

    The FAA has revised paragraph (j) of this AD to specify that AMOCs
approved previously for AD 2011-09-06 are approved as AMOCs for the
corresponding provisions of EASA AD 2019-0155 that are required by
paragraph (g) of this AD. This provision was inadvertently left out of
the proposed AD.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this final rule with the changes described previously
and minor editorial changes. The FAA has determined that these minor
changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    The FAA also determined that these changes will not increase the
economic burden on any operator or increase the scope of this final
rule.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2019-0155 describes procedures for repetitive functional
checks and lubrication of the door girt bar slider of each passenger/
crew door and passenger compartment emergency exit, and corrective
actions (repair or replacement). This material is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 111 airplanes of U.S.
registry.
    The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                         Cost per
            Action                  Labor cost         Parts cost         product       Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD 2011-  3 work-hours x     None.............            $255  Up to $28,305.
 09-06.                          $85 per hour =
                                 $255.
New actions...................  2 work-hours x     None.............            $170  $18,870.
                                 $85 per hour =
                                 $170.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition action that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need this on-condition action:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
1 work-hour x $85 per hour = $85 per            $2,160           $2,245
 girt bar replacement.................
------------------------------------------------------------------------

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.
    The FAA is 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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2011-09-06, Amendment 39-16668 (76 FR 22005, April 20, 2011), and
adding the following new AD:

2020-06-17 Airbus SAS: Amendment 39-19886; Docket No. FAA-2019-0867;
Product Identifier 2019-NM-131-AD.

(a) Effective Date

    This AD is effective May 14, 2020.

(b) Affected ADs

    This AD replaces AD 2011-09-06, Amendment 39-16668 (76 FR 22005,
April 20, 2011) (``AD 2011-09-06'').

(c) Applicability

    This AD applies to the Airbus SAS Model airplanes identified in
paragraphs (c)(1) through (7) of this AD, certificated in any
category, all manufacturer serial numbers.
    (1) Model A330-223F and -243F airplanes.
    (2) Model A330-201, -202, -203, -223, and -243 airplanes.
    (3) Model A330-301, -302, -303, -321, -322, -323, -341, -342,
and -343 airplanes.
    (4) Model A330-941 airplanes.
    (5) Model A340-211, -212, and -213 airplanes.
    (6) Model A340-311, -312, and -313 airplanes.
    (7) Model A340-541 and -642 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

(e) Reason

    This AD was prompted by a report that an escape slide deployment
test found a girt bar that was not in a locked position and was
detached from the airplane. This AD was also prompted by a
determination that additional airplanes not identified in AD 2011-
09-06 are affected by the unsafe condition. The FAA is issuing this
AD to address this condition, which could result in slides detaching
from the door after inflation, and could, during an emergency,
prevent a safe evacuation of the cabin and possibly result in
injuries.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2019-0155, dated July 3, 2019 (``EASA AD 2019-0155'').

(h) Exceptions to EASA AD 2019-0155

    (1) Where EASA AD 2019-0155 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where paragraph (1) of EASA AD 2019-0155 refers to February
17, 2001, as an effective date, this AD requires using March 19,
2002 (the effective date of AD 2002-02-07, Amendment 39-12635 (67 FR
6370, February 12, 2002)), for all airplanes identified in paragraph
(1) of EASA AD 2019-0155, except for Model A330-223F and -243F
airplanes. For Model A330-223F and -243F airplanes, use May 5, 2011
(the effective date of AD 2011-09-06).
    (3) The ``Remarks'' section of EASA AD 2019-0155 does not apply
to this AD.
    (4) Where paragraph (4) of EASA AD 2019-0155 refers to ``July
17, 2010'' as an effective date, this AD requires using May 5, 2011
(the effective date of AD 2011-09-06).
    Note 1 to paragraph (h)(4): A typographical error in EASA AD
2019-0155 incorrectly identified the effective date of EASA AD 2010-
0135 as July 17, 2010; the correct effective date of EASA AD 2010-
0135 is July 19, 2010.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2019-0155
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (k) of this AD. Information may
be emailed to<EMAIL_ADDRESS>    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (ii) AMOCs approved previously for AD 2011-09-06 are approved as
AMOCs for the corresponding provisions of EASA AD 2019-0155 that are
required by paragraph (g) of this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2019-0155 that contains RC procedures and
tests: Except as required by paragraphs (i) and (j)(2) of this AD,
RC procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(k) Related Information

    For more information about this AD, contact Vladimir Ulyanov,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
May 14, 2020.
    (i) European Union Aviation Safety Agency (EASA) AD 2019-0155,
dated July 3, 2019.
    (ii) [Reserved]
    (4) For information about EASA AD 2019-0155, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; email<EMAIL_ADDRESS>internet www.easa.europa.eu.
You may find this EASA AD on the EASA website at https://ad.easa.europa.eu.
    (5) You may view this material at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. This
material may be found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2019-0867.
    (6) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on April 1, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-07399 Filed 4-8-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 128 (Wednesday, July 6, 2022)]
[Notices]
[Page 40250]
[FR Doc No: 2022-14346]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1768]

Advisory Committee; Pharmacy Compounding Advisory Committee;
Renewal

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

ACTION: Notice; renewal of federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Pharmacy Compounding Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the Pharmacy
Compounding Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until the
April 25, 2024, expiration date.

DATES: Authority for the Pharmacy Compounding Advisory Committee will
expire on April 25, 2024, unless the Commissioner formally determines
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Takyiah Stevenson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-2507, [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3, FDA is announcing
the renewal of the Pharmacy Compounding Advisory Committee (the
Committee). The Committee is a non-discretionary Federal advisory
committee established to provide advice to the Commissioner. The
Committee advises the Commissioner or designee in discharging
responsibilities as they relate to compounding drugs for human use and,
as required, any other product for which FDA has regulatory
responsibility.
    The Committee shall provide advice on scientific, technical, and
medical issues concerning drug compounding under sections 503A and 503B
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a and 353b),
and, as required, any other product for which FDA has regulatory
responsibility, and make appropriate recommendations to the
Commissioner of Food and Drugs.
    The Committee shall consist of a core of 12 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of pharmaceutical compounding, pharmaceutical manufacturing,
pharmacy, medicine, and related specialties. These members will include
representatives from the National Association of Boards of Pharmacy,
the U.S. Pharmacopeia, pharmacists with current experience and
expertise in compounding, physicians with background and knowledge in
compounding, and patient and public health advocacy organizations.
Members will be invited to serve for overlapping terms of up to 4
years. Non-Federal members of this committee will serve as Special
Government Employees, representatives, or Ex-Officio members. Federal
members will serve as Regular Government Employees or Ex-Officios. The
core of voting members may include one or more technically qualified
members, selected by the Commissioner or designee, who are identified
with consumer interests and are recommended by either a consortium of
consumer-oriented organizations or other interested persons. In
addition to the voting members, the Committee may include one or more
non-voting representative members who are identified with industry
interests. There may also be an alternate industry representative.
    Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/pharmacy-compounding-advisory-committee-charter or by contacting the Designated Federal Officer (see
FOR FURTHER INFORMATION CONTACT). In light of the fact that no change
has been made to the committee name or description of duties, no
amendment will be made to 21 CFR 14.100.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: June 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14346 Filed 7-5-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 117 (Monday, June 18, 2012)]
[Notices]
[Pages 36331-36332]
[FR Doc No: 2012-14817]

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DEPARTMENT OF TRANSPORTATION

Noise Exposure Maps; Cleveland Hopkins International Airport,
Cleveland, OH

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the noise exposure maps submitted by the City of
Cleveland for Cleveland Hopkins International Airport under the
provisions of 49 U.S.C. 47501 et. seq (Aviation Safety and Noise
Abatement Act, herein after referred to as ``the Act'') and 14 Code of
Federal Regulations (CFR) Part 150 (hereinafter referred to as ``Part
150'') are in compliance with applicable requirements. The FAA also
announces that it is reviewing a proposed noise compatibility program
that was submitted for Cleveland-Hopkins International Airport under
Part 150 in conjunction with the noise exposure map, and that this
program will be approved or disapproved on or before December 2, 2012.

DATES: Effective Date: The effective date of the FAA's determination on
the noise exposure maps and of the start of its review of the
associated noise compatibility program is June 6, 2012. The public
comment period ends August 4, 2012.

FOR FURTHER INFORMATION CONTACT: Katherine S. Delaney, Detroit Airports
District Office, 11677 S. Wayne Road, Romulus, MI 48174,
<EMAIL_ADDRESS>and<PHONE_NUMBER>. Comments on the
proposed noise compatibility program should also be submitted to the
above office.

SUPPLEMENTARY INFORMATION: This notice announces the FAA finds that the
noise exposure maps submitted for Cleveland Hopkins International
Airport are in compliance with applicable requirements of Part 150,
effective June 6, 2012. Further, FAA is reviewing a proposed noise
compatibility program for that airport which will be approved or
disapproved on or before December 2, 2012. This notice also announces
the availability of this program for public review and comment.

    Under 49 U.S.C., section 47503 of the Act, an airport operator may
submit to the FAA noise exposure maps which meet applicable regulations
and which depict non-compatible land uses as of the date of submission
of such maps, a description of projected aircraft operations, and the
ways in which such operations will affect such maps. The Act requires
such maps to be developed in consultation with interested and affected
parties in the local community, government agencies, and persons using
the airport.
    An airport operator who submits noise exposure maps (NEMs) in
compliance with the requirements of Part 150, may also submit a noise
compatibility program (NCP) for FAA review and approval. The NCP sets
forth the measures the operator has taken or proposes to take to reduce
existing non-compatible uses, prevent the introduction of additional
non-compatible uses, and/or mitigate to reduce impacts on non-
compatible uses.
    The City of Cleveland submitted to the FAA on April 19, 2011 noise
exposure maps, descriptions and other documentation that were produced
during Cleveland Hopkins International Airport 14 CFR part 150 Noise
Exposure Map Update, April 2011 and the Cleveland Hopkins International
Airport 14 CFR part 150 Noise Compatibility Program Update, May 2011.
It was requested that the FAA review this material as the noise
exposure maps, as described in section 47503 of the Act, and that the
noise mitigation measures, to be implemented jointly by the airport and
surrounding communities, be approved as a noise compatibility program
under section 47504 of the Act.
    The FAA has completed its review of the noise exposure maps and
related descriptions submitted by the City of Cleveland. The specific
documentation determined to constitute the noise exposure maps
includes: Figure ES-1, 2011 Noise Exposure Map; Figure ES-2, 2017 Noise
Exposure Map. Additional NEM graphics for flight tracks are presented
in Figure 2, Jet Aircraft Radar and Model Tracks for Arrivals and
Departures (North Flow); Figure 3, Propeller Aircraft Radar and Model
Tracks for Arrivals and Departures (North Flow); Figure 4, Jet Aircraft
Radar and Model Tracks for Arrivals and Departures (South Flow); Figure
5, Propeller Aircraft Radar and Model Tracks for Arrivals and
Departures (South Flow). Narrative discussion of the flight tracks is
in Chapter 2, Development of Noise Contours, inclusive of airport
operations, existing and forecasted fleet mix, and nighttime
operations. Appendix B, Master Plan Update: Chapter 2, Aviation
Activity Forecasts, provides additional detail on aircraft operations
and fleet mix. Noise measurements are detailed in Section 3.3, Noise
Measurement Site Selection, Table 9, Summary of Portable Noise
Measurement Sites, and Figure 6, Locations of Permanent and Portable
Noise Monitoring Sites and Recommendations for New Sites. Existing Land
Use in the vicinity of the Cleveland Hopkins International Airport is
detailed in Chapter 4, Land Use supported by Figure 7, Preliminary Land
Use Area Map of Surrounding Areas and Figure 8 Zoning Map of
Surrounding Areas. The FAA has determined that these maps for Cleveland
Hopkins International Airport are in compliance with applicable
requirements. This determination is effective on June 6, 2012. FAA's
determination on an airport operator's noise exposure maps is limited
to a finding that the maps were developed in accordance with the
procedures contained in appendix A of FAR Part 150. Such determination
does not constitute approval of the applicant's data, information or
plans, or constitute a commitment to approve a noise compatibility
program or to fund the implementation of that program.
    If questions arise concerning the precise relationship of specific
properties to noise exposure contours depicted on a noise exposure map
submitted under section 47503 of the Act, it should be noted that the
FAA is not involved in any way in determining the relative locations of
specific properties with regard to the depicted noise contours, or in
interpreting the noise exposure maps to resolve questions concerning,
for example, which properties should be covered by the provisions of
section 47506 of the Act. These functions are inseparable from the
ultimate land use control and planning responsibilities of local
government. These local responsibilities are not changed in any way
under Part 150 or through FAA's review of noise exposure maps.
Therefore, the responsibility for the detailed overlaying of noise
exposure contours onto the map depicting properties on the surface
rests exclusively with the airport operator that submitted those maps,
or with those public agencies and planning agencies with which
consultation is required under section 47503 of the Act. The FAA has
relied on the certification by the airport operator, under section
150.21 of Part 150, that the statutorily required consultation has been
accomplished.
    The FAA has formally received the noise compatibility program for
Cleveland Hopkins International Airport, also effective on June 6,
2012. Preliminary review of the submitted material indicates that it
conforms to the requirements for the submittal of noise compatibility
programs, but that further review will be necessary prior to approval
or disapproval of the program. The formal review period, limited by law
to a maximum of 180 days, will be completed on or before December 2,
2012.
    The FAA's detailed evaluation will be conducted under the
provisions of section 150.33 of Part 150. The primary considerations in
the evaluation process are whether the proposed measures may reduce the
level of aviation safety, create an undue burden on interstate or
foreign commerce, or be reasonably consistent with obtaining the goal
of reducing existing non-compatible land uses and preventing the
introduction of additional non-compatible land uses.
    Interested persons are invited to comment on the proposed program
with specific reference to these factors. All relevant comments, other
than those properly addressed to local land use authorities, will be
considered by the FAA to the extent practicable. Copies of the noise
exposure maps, the FAA's evaluation of the maps, and the proposed noise
compatibility program are available for examination at the following
locations:

Federal Aviation Administration, Detroit Airports District Office,
11677 South Wayne Road, Suite 107, Romulus, MI 48174, 8:00 a.m.-4:30
p.m.
Traci Clark, Deputy Chief Planning and Engineering, Department of Port
Control, Cleveland Hopkins International Airport, 19501 Five Points
Drive, Building 206, Cleveland, OH 44135, 8:00 a.m.-5:00 p.m.

    Questions may be directed to the individual named above under the
heading, FOR FURTHER INFORMATION CONTACT.

    Issued in Romulus, MI, June 6, 2012.
John L. Mayfield, Jr.,
Manager, Detroit Airports District Office.
[FR Doc. 2012-14817 Filed 6-15-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 130 (Friday, July 6, 2012)]
[Notices]
[Pages 40088-40090]
[FR Doc No: 2012-16513]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2012-0024]

Rollins College; T.A. Loving Co.; US Ecology Idaho, Inc.; and
West Pharmaceutical Services, Inc.: Technical Amendment to, and
Revocation of, Permanent Variances

AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.

ACTION: Notice of technical amendment to, and revocation of, permanent
variances.

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

SUMMARY: With this notice, the Occupational Safety and Health
Administration (``OSHA'' or ``the Agency'') is making a technical
amendment to an existing permanent variance, and revoking several
others. The technical amendment and revocations result from an OSHA
review

to identify variances that are outdated, unnecessary, or otherwise
defective.

DATES: The effective date of the technical correction and revocation of
the permanent variances is July 6, 2012.

FOR FURTHER INFORMATION CONTACT:
    General information and press inquiries. Contact Frank Meilinger,
Director, OSHA Office of Communications, Room N-3647, U.S. Department
of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone:
(202) 693-1999. Email<EMAIL_ADDRESS>    Technical information. Contact Stefan Weisz, Office of Technical
Programs and Coordination Activities, Room N-3655, OSHA, U.S.
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Email:
<EMAIL_ADDRESS>    Copies of this Federal Register notice. Electronic copies of this
notice are available at http://www.regulations.gov. Electronic copies
of this notice, as well as news releases and other relevant
information, are available on OSHA's Web site at http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    OSHA reviewed variances currently in effect to identify variances
that are outdated, unnecessary, or otherwise defective; as part of this
review, OSHA contacted by telephone every employer having a variance to
ask them if they still needed the variance. Based on this review, OSHA
identified four defective variances. The first of these variances
requires a technical correction because OSHA, after granting the
variance, renumbered the standard from which it granted the variance.
The Agency also determined that the remaining three variances are no
longer necessary because the employers that received the variances
indicated that the requirement for the variances no longer exists, and
that they now can comply with the standard from which OSHA granted the
variance. With this notice, the Agency is correcting these problems.
OSHA believes this notice will ensure that the first variance is
consistent with the standard's existing enumeration and, for the
revoked variances, this notice will notify employers and employees that
the variances no longer cover the employers, and that the employers
must comply with the appropriate OSHA standard.
    The technical amendment implemented by this notice does not alter
the substantive requirements of the first variance, which still remains
in effect, so this corrected variance will continue to provide
employees with the safety and health protection afforded to them by the
original variance. For the variances revoked by this notice, existing
OSHA standards will provide employees with the necessary protection.
    With this notice, the Agency is making only a technical correction
to an existing variance, and revoking variances that employers no
longer need for employee protection. Accordingly, this notice will not
have a substantive effect on employers or employees; OSHA, therefore,
finds that public notice-and-comment procedures specified under Section
6(d) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655),
and by 29 CFR 1905.11 or 1905.13, are unnecessary.
    The following table provides details about the variances addressed
by this notice:

----------------------------------------------------------------------------------------------------------------
                                                                            Federal
 Name of employer  (company) affected    Variance No.    Date granted    Register cite       OSHA standards
----------------------------------------------------------------------------------------------------------------
Rollins College.......................         V-74-16      03/28/1974     39 FR 11481  1910.37(i).
T.A. Loving Co........................         V-74-43      04/13/1976     41 FR 15483  1918.66(f)(1)(i).
US Ecology Idaho, Inc. (formerly                V-93-1      06/07/1994     59 FR 29440  1910.106(b)(2)(viii)(f).
 Envirosafe Services, Inc.).
West Pharmaceutical Services, Inc.              V-77-9      01/20/1978      43 FR 2945  1910.217(c)(3)(i)(e) and
 (formerly The West Co.).                                                                1910.217(c)(3)(ii).
----------------------------------------------------------------------------------------------------------------

II. Technical Amendment to, and Revocation of, Permanent Variances

A. Technical Amendment of the Permanent Variance Granted to Rollins
College

    OSHA granted Rollins College a variance from 29 CFR 1910.37(i),
which governed ceiling height for means of egress (see table above for
details). The Agency renumbered this provision (to 29 CFR
1910.36(g)(1)) in a subsequent rulemaking that revised its means-of-
egress standards to improve the clarity and comprehensibility of these
standards (see 67 FR 67962, November 7, 2002). While this rulemaking
renumbered 29 CFR 1910.37(i) as 29 CFR 1910.36(g)(1), it did not revise
the substantive requirements of the provision.

B. Revoking Permanent Variances

    1. T. A. Loving Co. The Agency granted T. A. Loving Co. a variance
permitting it to use dynamometers instead of load-indicating devices on
mobile cranes (see the table above for details). In response to OSHA's
telephone call, T. A. Loving's representative indicated that the
variance is no longer needed. T. A. Loving requested in a subsequent
letter that OSHA revoke the variance (Ex. 1--OSHA-2012-0024).
    2. US Ecology Idaho, Inc. The Agency granted Envirosafe Services,
Inc. (now US Ecology Idaho, Inc.), a variance to make and break filling
and emptying connections inside, instead of outside, a building during
the transfer of flammable/combustible liquids as required by the OSHA
standard (see the table above for details). In response to OSHA's
telephone call, US Ecology Idaho's representative indicated that the
variance is no longer necessary. Later, US Ecology Idaho requested in a
letter that OSHA revoke the variance (Ex. 2--OSHA-2012-0024).
    3. West Pharmaceutical Services, Inc. The Agency granted The West
Co. (now West Pharmaceutical Services, Inc.) a variance to use power
presses with safety blocks and a sliding barrier that did not conform
to OSHA's distance and guarding requirements (see the table above for
details). In response to OSHA's telephone call, West Pharmaceutical
Services' representative indicated that the company no longer needed
the variance. West Pharmaceutical Services then requested in a letter
that OSHA revoke the variance (Ex. 3--OSHA-2012-0024).

III. Decision

    Based on the information described herein, including the finding
that this notice will not alter the substantive requirements of the
variance and will maintain the protection afforded to employees by the
variances, the Agency is taking the following actions:
    A. Correcting the Rollins College variance by updating the
designation of

the provision from which OSHA granted the variance from 29 CFR
1910.37(i) to 29 CFR 1910.36(g)(1).
    B. Revoking the variances granted to T. A. Loving Co., US Ecology
Idaho, Inc., and West Pharmaceutical Services. The variances granted to
T. A. Loving Co. and West Pharmaceutical Services included facilities
in North Carolina, a state with an OSHA-approved State Plan under
Section 18 of the Occupational Safety and Health Act (29 U.S.C. 667).
OSHA will notify North Carolina of the revocation of these variances.

IV. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, 200
Constitution Ave. NW., Washington, DC, authorized the preparation of
this notice. OSHA is issuing this notice under the authority specified
by Section 6(d) of the Occupational Safety and Health Act of 1970 (29
U.S.C. 655), Secretary of Labor's Order No. 1-2012 (76 FR 3912), and 29
CFR part 1905.

    Signed at Washington, DC, on June 29, 2012.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2012-16513 Filed 7-5-12; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45258-45259]
[FR Doc No: 2018-19354]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3207]

Request for Nominations of Voting Members on a Public Advisory
Committee; National Mammography Quality Assurance Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the National Mammography
Quality Assurance Advisory Committee in the Center for Devices and
Radiological Health. Nominations will be accepted for upcoming
vacancies effective with this notice.
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.

DATES: Nominations received on or before November 5, 2018, will be
given first consideration for membership on the National Mammography
Quality

Assurance Advisory Committee. Nominations received after November 5,
2018, will be considered for nomination to the committee as later
vacancies occur.

ADDRESSES: All nominations for membership should be submitted
electronically by logging into the FDA Advisory Nomination Portal:
http://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member on an
FDA advisory committee can also be obtained by visiting FDA's website
at http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT:
    Regarding all nomination questions for membership: Sara Anderson,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G616, Silver
Spring, MD 20993,<PHONE_NUMBER>, email: [email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members to fill upcoming vacancies on the National Mammography Quality
Assurance Advisory Committee.

I. General Description of the Committee Duties

    The National Mammography Quality Assurance Advisory Committee
advises the Commissioner of Food and Drugs (the Commissioner) or
designee on: (1) Developing appropriate quality standards and
regulations for mammography facilities; (2) developing appropriate
standards and regulations for bodies accrediting mammography facilities
under this program; (3) developing regulations with respect to
sanctions; (4) developing procedures for monitoring compliance with
standards; (5) establishing a mechanism to investigate consumer
complaints; (6) reporting new developments concerning breast imaging
that should be considered in the oversight of mammography facilities;
(7) determining whether there exists a shortage of mammography
facilities in rural and health professional shortage areas and
determining the effects of personnel on access to the services of such
facilities in such areas; (8) determining whether there will exist a
sufficient number of medical physicists after October 1, 1999; and (9)
determining the costs and benefits of compliance with these
requirements.

II. Criteria for Voting Members

    The committee consists of a core of 15 members, including the
Chair. Members and the Chair are selected by the Commissioner or
designee from among physicians, practitioners, and other health
professionals, whose clinical practice, research specialization, or
professional expertise includes a significant focus on mammography.
Almost all non-Federal members of this committee serve as Special
Government Employees. Members will be invited to serve for terms of up
to 4 years.

III. Nomination Procedures

    Any interested person may nominate one or more qualified persons
for membership on the advisory committee. Self-nominations are also
accepted. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address, telephone number, and email address if
available and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Nomination Portal (see ADDRESSES).
Nominations must specify the advisory committee for which the nominee
is recommended. Nominations must also acknowledge that the nominee is
aware of the nomination unless self-nominated. FDA will ask potential
candidates to provide detailed information concerning such matters
related to financial holdings, employment, and research grants and/or
contracts to permit evaluation of possible sources of conflict of
interest.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: August 31, 2018.
 Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19354 Filed 9-5-18; 8:45 am]
 BILLING CODE 4164-01-P


Last Revised 7/ 13/ 2006 PAPERWORK REDUCTION ACT SUBMISSION WORKSHEET PART I: Information Collection Request This worksheet replaces the previous OMB 83 I form for Information Collection Requests ( ICRs). This worksheet is intended to help ICR preparers transition between the paper 83 I system and use of the RISC/ OIRA Consolidated Information System ( ROCIS) ICR Module for submitting ICRs to OMB/ OIRA. This form is not intended for submission to OMB. For additional guidance on completing this worksheet please consult the two OMB guidance documents: ROCIS How To Guide for Agency Users of the ICR Module and ROCIS IC Q& A, located at: http:// intranet. epa. gov/ icrintra/ download. html , or visit EPA's ICR webpage http:// intranet. epa. gov/ icrintra/ and contact your appropriate ICR desk officer.

1. Agency/ Subagency originating request: EPA/ OAQPS/ AQPD/ NSRG 2. Title:

I nformation Collection Request for Proposed Rule for Review of New Sources and Modifications in Indian Country ( 40 CFR Parts 49 and 51)

3. Type of information collection ( check one) ( See instructions)

  New collection   Extension of a currently approved collection x   Revision of a currently approved collection   Nonmaterial or non substantive change to a currently approved collection 4. OMB Control Number:

2060 0003 5. EPA ICR Number: EPA ICR # 1230.13 6. Type of review requested ( check one) a. x Regular b. Emergency  Approval requested by: / / c. Delegated If Emergency, please attach justification.( 4000 characters maximum) 7. Requested expiration date ( check one) a. Three years from approval date b. Six Months from approval date ( Maximum for Emergency reviews) c. x Other Specify: 01/ 2008 ( mm/ yyyy) or Number of Months from Approval Date 8. Does this ICR contain surveys, censuses, or employ statistical methods?

Yes x No 9. Is a Privacy Impact Assessment required by the E Government Act of 2002 for this ICR? ( A PIA is needed for a new, electronic collection of information.) Yes x No 10. Abstract ( 4000 characters maximum, attach additional sheets as necessary)

The information will be used by EPA or Tribal enforcement personnel to: ( 1) identify major and minor sources, new or modified, subject to the NSR rules, ( 2) ensure that control technology, if required, is being properly applied, and ( 3) ensure that the emission control devices are being properly operated and maintained on a continuous basis. Based on the reported information, the EPA or Tribal agency can decide which plants, records, or processes should be inspected. Potential respondents are owners or operators of all new minor stationary sources and minor modifications ( to both minor and major sources) in Indian Country, and those new major stationary sources and major modifications located in portions of Indian Country that are in nonattainment areas.

11. Citations for Authorizing Statute( s) ( Required if any change in burden is a Program Change Due to New Statute) a. Public Law Pub. L.  Sec  Name of law  b. US Code US Code  USC  Name of Law  c. Executive Order EO  Name/ Subject of EO  d. Statute Statute at large  Last Revised 7/ 13/ 2006 USC  Name of Statute  Last Revised 7/ 13/ 2006 12. Associated Rulemaking Information ( For Rule Related ICRs Only)

Stage of Rulemaking ( check one) Federal Register Citation RIN: 2 0 6 0  A H 3 7 a. x Proposed Rule Volume Page number ____________

Publication Date / /____ SAN: 3 9 7 5 b. Interim Final or Final Rule For a Proposed Rule, OMB will not consider an ICR complete until the Notice of Proposed Rulemaking has been published. For a Final Rule, please put the ICR reference number for the ICR reviewed at the proposed rule stage in Box 4. For ICRs associated with Interim Final or Final rules that are not significant under EO.

11. Federal Register Notices & Comments ( For Non Rule Related and Renewal ICRs Only)

Federal Register Citation 60 day Notice: Volume Page number Publication Date / /

30 day Notice: Volume Page number Publication Date / /

Did the Agency receive public comments on this ICR? Yes _ No Unless submitted as an Emergency or Associated with Rulemaking, OMB will not consider an ICR complete until the 30 day notice has been published. 12866, please attach a draft of the Federal Register document.

13. Annual Cost to Federal Gov ( in real dollars):

$ 4,220 16. Agency contact: Name: Raj Rao Phone: 919 541 5344 E mail: rao. raj@ epa. gov If a change in burden is due to a Program Change Due to New Statute, identify the Citations for New Statutory Requirements: Add New Citation: a. Public Law Pub. L.  Sec  Name of law  b. US Code US Code  USC  Name of Law  c. Executive Order EO  Name/ Subject of EO  d. Statute Statute at large  USC  Name of Statute

If Program Change is due to Agency Discretion, please categorize the reduction. Burden reduction from ( select one):

a. Cutting Redundancy b. Using Information Technology c. Changing Regulations d. Changing Forms e. Miscellaneous Actions If Program Change is due to Agency Discretion, please categorize the increase in burden. Burden increase caused by ( select one): x a. Changing Regulations b. Miscellaneous Actions Explain the reasons for any program changes or adjustments reported; that is, provide a short statement how the reduction in burden was achieved or why the increase in burden occurred. ( If you need more space, please provide a short summary here and elaborate in the Supporting Statement.) Last Revised 7/ 13/ 2006 Since the proposed rules would require affected sources to obtain permits from EPA regions or Tribal agencies if they accept delegation of the program, we anticipate some increase in burden for both industry and Federal/ Tribal Government.

PAPERWORK REDUCTION ACT SUBMISSION WORKSHEET Part II: Information Collection Detail ( IMPORTANT: Part II must be completed for each Information Collection ( IC) activity associated with the ICR. Please be sure that you copy this portion of the template as many times as necessary so that each IC has its own Part II submission. For more information on how to break your ICR into ICs, please see OMB's ROCIS IC Q& A, located at: http:// intranet. epa. gov/ icrintra/ download. html 1. Title : Proposed Rule for Review of New Sources and Modifications in Indian Country ( 40 CFR Parts 49 and 51): Industry 3. Is this a Common Form? 4. Obligation to respond ( check one) 5. Frequency of reporting ( check all that apply)

Yes x No ( A common form is defined as a form set up by one Agency , which can be used by other Federal Agencies and Departments.) a. Voluntary b. Required to obtain or retain benefits c. x Mandatory a. Hourly ( 24  7) b. __ Hourly Bus ( 40 per week) c. Daily ( 7 per week) d. Daily Bus ( 5 per week) e. Weekly ( 52 per year) f. Monthly g. x Yearly h. Every Decade i. Quarterly j. Semi annually k. Biennially l. Other ( Describe )

6. CFR Citation( s) for the information collection under review ( if applicable). Title: 40 CFR Part 49 Section____________ Title: 40 CFR Part 51 Section____________ Title: Part Section____________ Title: Part Section____________

7. Information Collection Instruments ( attach additional rows as necessary)

Form Name EPA Form # URL ( required unless Not Electronic) Is this collection available electronically ? ( Yes/ No) If yes, can this collection be submitted electronically? ( Yes/ No)

8. Federal Enterprise Architecture Business Reference Model ( Required for any Reporting Requirements) ( Please note: most EPA ICRs will be aligned with the Environmental Management FEA Line of Business. Included below is this and other likely categories. For a full listing of the FEA Business Reference Model, categories and definitions, see: http:// www. whitehouse. gov/ omb/ egov/ documents/ FY07_ Ref_ Model_ Mapping_ QuickGuide. pdf Please check one. Please check one.

None Environmental Management Environmental Monitoring and Forecasting Environmental Remediation Pollution Prevention and Control None Health Illness Prevention Immunization Management Public Health Monitoring Health Care Services Consumer Health and Safety None Last Revised 7/ 13/ 2006 Natural Resources Water Resource Management Conservation, Marine and Land Management Recreational Resource Management and Tourism Agricultural Innovation and Services None 9. Privacy Act System of Records ( if applicable)

Title:

Federal Register Citation: Volume ________ Page number ____________ Publication date / /____ Last Revised 7/ 13/ 2006 10. Respondents a. Total # 58 b. Small Entity # 54________ c. Percent Electronic 10____________ Affected public ( choose one) a. Individuals or households b. x Private Sector ( If Private Sector check all that apply) 1. x Business or other for profits 2. Not for profit institutions 3. Farms c. State, Local, or Tribal Governments d. Federal Government 11. Frequency: How often on average will each respondent respond to the Information Collection? Number of Responses per Respondent ______ one______ Per ( select the most appropriate time period for this collection) a. Hour ( 24 7)  8736 per year b. Business Hour ( 40 per week)  2080 per year c. Day ( 7 per week)  364 per year d. Business Day ( 5 per week)  260 per year e. Week  52 per year f. Month  12 per year g. x Year h. Decade i. Quarter  4 per year j. Half Year  2 per year k. Biennial  0.5 per year l. Other ( Describe )

Calculated: Annual Frequency =_____ one____________ times a year ( per respondent)

Calculated: Annual Number Of Responses = ___________ 58______ a year 14. Hour and Cost Burden Enter the hours and cost ( per response) broken out by reporting, record keeping, and third party disclosure.

Time per Response Hour per response Annual Hour Burden Cost per Response Annual cost Burden Reporting 170 170 9,860 $ 11,539 $ 669,262 Record keeping 126 126 7,308 $ 7,283 $ 422,414 Third party disclosure 0 0 0 $ 0 $ 0 Total 296 296 17,168 $ 18,822 $ 1,091,676 15. Allocate the change in burden.

Total Requested Change Due to New Statute Change Due to Agency Discretion Due to Agency Estimate Change Due Violation Currently Approved a. Annual Responses b. Annual Hour Burden 5,851,127 hours hours hours hours hours 5,851,126 hours c. Annual Cost Burden $ 8,613,001 $ $ $ $ $ 8,613,000 PAPERWORK REDUCTION ACT SUBMISSION WORKSHEET Part II: Information Collection Detail ( IMPORTANT: Part II must be completed for each Information Collection ( IC) activity associated with the ICR. Please be sure that you copy this portion of the template as many times as necessary so that each IC has its own Part II submission. For more information on how to break your ICR into ICs, please see OMB's ROCIS IC Q& A, located at: http:// intranet. epa. gov/ icrintra/ download. html Last Revised 7/ 13/ 2006 1. Title : Proposed Rule for Review of New Sources and Modifications in Indian Country ( 40 CFR Parts 49 and 51): State/ Local/ Tribal Government 3. Is this a Common Form? 4. Obligation to respond ( check one) 5. Frequency of reporting ( check all that apply)

Yes x No ( A common form is defined as a form set up by one Agency , which can be used by other Federal Agencies and Departments.) a. Voluntary b. Required to obtain or retain benefits c. x Mandatory a. Hourly ( 24  7) b. __ Hourly Bus ( 40 per week) c. Daily ( 7 per week) d. Daily Bus ( 5 per week) e. Weekly ( 52 per year) f. Monthly g. x Yearly h. Every Decade i. Quarterly j. Semi annually k. Biennially l. Other ( Describe )

6. CFR Citation( s) for the information collection under review ( if applicable). Title: 40 CFR Part 49 Section____________ Title: 40 CFR Part 51 Section____________ Title: Part Section____________ Title: Part Section____________

7. Information Collection Instruments ( attach additional rows as necessary)

Form Name EPA Form # URL ( required unless Not Electronic) Is this collection available electronically ? ( Yes/ No) If yes, can this collection be submitted electronically? ( Yes/ No)

8. Federal Enterprise Architecture Business Reference Model ( Required for any Reporting Requirements) ( Please note: most EPA ICRs will be aligned with the Environmental Management FEA Line of Business. Included below is this and other likely categories. For a full listing of the FEA Business Reference Model, categories and definitions, see: http:// www. whitehouse. gov/ omb/ egov/ documents/ FY07_ Ref_ Model_ Mapping_ QuickGuide. pdf Please check one. Please check one.

None Environmental Management Environmental Monitoring and Forecasting Environmental Remediation Pollution Prevention and Control None Health Illness Prevention Immunization Management Public Health Monitoring Health Care Services Consumer Health and Safety None Natural Resources Water Resource Management Conservation, Marine and Land Management Recreational Resource Management and Tourism Agricultural Innovation and Services None 9. Privacy Act System of Records ( if applicable)

Title:

Federal Register Citation: Volume ________ Page number ____________ Publication date / /____ Last Revised 7/ 13/ 2006 10. Respondents a. Total # 58 b. Small Entity # _ 58________ c. Percent Electronic 10____________ Affected public ( choose one) a. Individuals or households b. Private Sector ( If Private Sector check all that apply) 4. Business or other for profits 5. Not for profit institutions 6. Farms c. x State, Local, or Tribal Governments d. Federal Government 11. Frequency: How often on average will each respondent respond to the Information Collection? Number of Responses per Respondent ______ one______ Per ( select the most appropriate time period for this collection) a. Hour ( 24 7)  8736 per year b. Business Hour ( 40 per week)  2080 per year c. Day ( 7 per week)  364 per year d. Business Day ( 5 per week)  260 per year e. Week  52 per year f. Month  12 per year g. x Year h. Decade i. Quarter  4 per year j. Half Year  2 per year k. Biennial  0.5 per year l. Other ( Describe )

Calculated: Annual Frequency =_____ one____________ times a year ( per respondent)

Calculated: Annual Number Of Responses = _______ 58 __________ a year 14. Hour and Cost Burden Enter the hours and cost ( per response) broken out by reporting, record keeping, and third party disclosure.

Time per Response Hour per response Annual Hour Burden Cost per Response Annual cost Burden Reporting 42 42 2,436 $ 2,754 $ 159,732 Record keeping 79 79 4,582 $ 5,240 $ 303,920 Third party disclosure 0 0 0 $ 0 $ 0 Total 121 121 7,018 $ 7,994 $ 463,652 15. Allocate the change in burden.

Total Requested Change Due to New Statute Change Due to Agency Discretion Due to Agency Estimate Change Due Violation Currently Approved a. Annual Responses b. Annual Hour Burden 5,851,127 hours hours hours hours hours 5,851,126 hours c. Annual Cost Burden $ 8,613,001 $ $ $ $ $ 8,613,000 Last Revised 7/ 13/ 2006 PAPERWORK REDUCTION ACT SUBMISSION WORKSHEET Part III: Information Collection Request Completeness Check Complete this checklist prior to submitting the information collection package to the Clearance Officer. The Clearance Officer will use the information contained in this checklist, along with other information, to certify the information collection prior to submission to OMB.

The supporting statement:

a. x

Identifies the statute or regulation authorizing the collection of the information b. x

Describes efforts taken to avoid the collection of similar information already available, or collected under a different information collection c. x

Describes, if applicable, methods to minimize the burden on small businesses or other small entities d. x

Is written using plain English, and all terminology used is unambiguous and understandable to those required to respond to the collection e. x

Indicates how long records specified in the collection are to be maintained by persons required to maintain the records f. x

Has dedicated resources to ensure the proper use and processing of the information being collected to enhance ( as appropriate) the value of the information to agencies and the public.

g. x

Indicates the use of a statistical survey method ( if applicable) that produces valid and reliable results while minimizing undue burden.

h. x

Describes the intended use of information technology to reduce burden and where possible avoid unnecessary system and technology costs. Last Revised 7/ 13/ 2006 PAPERWORK REDUCTION ACT SUBMISSION WORKSHEET Part IV: Certification 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 Last Revised 7/ 13/ 2006 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any 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."


MEMORANDUM

Date:	October 20, 2011

Subject:	Energy and Environmental Impacts for Mineral Wool Production
Industry to Comply with Proposed Residual Risk and Technology Review
Amendments

Mineral Wool Production  RTR

RTI Project No. 0213199.000.010

From:	Dave Reeves, RTI International

To:	Susan Fairchild

OAQPS/SPPD/NRG (D243-02)

U.S. Environmental Protection Agency

The purpose of this memorandum is to present the estimated energy and
environmental impacts related to the mineral wool production source
category for their processes and facilities to comply with the proposed
RTR amendments and associated emission limits.

BACKGROUND

Based on the information provided by the mineral wool production
industry and their primary trade association, North American Insulation
Manufacturers Association (NAIMA), there are currently 7 facilities in
the U.S. producing mineral wool.

ENERGY AND ENVIRONMENTAL IMPACTS

We estimate that none of 7 facilities subject to the NESHAP will have to
install additional add-on control equipment to demonstrate compliance
with the new (proposed) emission limits or other requirements.
Therefore, there are no energy or environmental impacts associated with
the proposed requirements.

  PAGE  2

  PAGE   \* MERGEFORMAT  1


[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69693-69694]
[FR Doc No: 2013-27774]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1358]

Draft Guidance for Industry: Recommendations for Premarket
Notification (510(k)) Submissions for Nucleic Acid-Based Human
Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients
in Transfusion and Transplantation; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry:
Recommendations for Premarket Notification (510(k)) Submissions for
Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for
Matching of Donors and Recipients in Transfusion and Transplantation''
dated November 2013. The draft guidance document provides
recommendations to submitters and FDA reviewers in preparing and
reviewing 510(k) submissions for nucleic acid-based HLA test kits used
for matching of donors and recipients in transfusion and
transplantation. The guidance provides detailed information on the
types of studies FDA recommends for validation of HLA test kits
submitted as 510(k)s.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 18, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John Reilly, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Recommendations for Premarket Notification
(510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen
(HLA) Test Kits Used for Matching of Donors and Recipients in
Transfusion and Transplantation'' dated November 2013.
    The draft guidance provides recommendations to submitters and FDA
reviewers in preparing and reviewing 510(k) submissions for nucleic
acid-based HLA test kits used for the matching of donors and recipients
in transfusion and transplantation, whether testing is for a single
locus or for multiple loci simultaneously. This includes detailed
information on the types of studies FDA recommends for validation of
HLA test kits submitted as 510(k)s. The guidance document addresses the
types of studies and other information that FDA recommends be used in
designing and conducting studies for validation of nucleic acid-based
HLA test kits and preparing a 510(k) submission.
    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirement of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 809 have been approved under OMB control
number 0910-0485; the collections of information in 21 CFR part 812
have been approved under OMB control numbers 0910-0078 and 0910-0582;
the collections of information in 21 CFR part 820 have been approved
under OMB control number 0910-0073; the collections of information in
21 CFR part 56 have been approved under OMB control number 0910-0130;
and the collections of information in 21 CFR part 50 have been approved
under OMB control number 0910-0586.

III. Comments

    The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

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

    Dated: November 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27774 Filed 11-19-13; 8:45 am]
BILLING CODE 4160-01-P


``Dry ice'', is marked with the name of the contents being cooled, and
is marked with the net weight of the dry ice or an indication that the
net weight is 2.5 kg (5.5 pounds) or less.
    (d) Carbon dioxide, solid (dry ice), when used to refrigerate
materials being shipped for diagnostic or treatment purposes (e.g.,
frozen medical specimens), is excepted from the shipping paper and
certification requirements of this subchapter if the requirements of
paragraphs (a) and (c)(2) of this section are met and the package is
marked ``Carbon dioxide, solid'' or ``Dry ice'' and is marked with an
indication that the material being refrigerated is being transported
for diagnostic or treatment purposes.

0
28. In Sec.  173.301, paragraphs (c), (f)(1) and (g)(1) are revised to
read as follows:

Sec.  173.301  General requirements for shipment of compressed gases in
cylinders and spherical pressure vessels.

* * * * *
    (c) Toxic gases and mixtures. Cylinders containing toxic gases and
toxic gas mixtures meeting the criteria of Division 2.3 Hazard Zone A
or B must conform to the requirements of Sec.  173.40 and CGA S-1.1
(compliance with paragraph <IP_ADDRESS> is not required) (IBR; see Sec.
171.7 of this subchapter) and CGA S-7 (IBR; see Sec.  171.7 of this
subchapter). A DOT 39 cylinder, UN non-refillable cylinder, or a UN
composite cylinder certified to ISO-11119-3 may not be used for a toxic
gas or toxic gas mixture meeting the criteria for Division 2.3, Hazard
Zone A or B.
* * * * *
    (f) * * *
    (1) Except as provided in paragraphs (f)(5), (f)(6), and (l)(2) of
this section, a cylinder filled with a gas and offered for
transportation must be equipped with one or more pressure relief
devices sized and selected as to type, location, and quantity, and
tested in accordance with CGA S-1.1 (compliance with paragraph <IP_ADDRESS>
is not required) and CGA S-7. The pressure relief device must be
capable of preventing rupture of the normally filled cylinder when
subjected to a fire test conducted in accordance with CGA C-14 (IBR,
see Sec.  171.7 of this subchapter), or, in the case of an acetylene
cylinder, CGA C-12 (IBR, see Sec.  171.7 of this subchapter).
* * * * *
    (g) * * *
    (1) Cylinder manifolding is authorized only under conditions
prescribed in this paragraph (g). Manifolded cylinders must be
supported and held together as a unit by structurally adequate means.
Except for Division 2.2 materials, each cylinder must be equipped with
an individual shutoff valve that must be tightly closed while in
transit. Manifold branch lines must be sufficiently flexible to prevent
damage to the valves that otherwise might result from the use of rigid
branch lines. Each cylinder must be individually equipped with a
pressure relief device as required in paragraph (f) of this section,
except that pressure relief devices on manifolded horizontal cylinders
that are mounted on a motor vehicle or framework may be selected as to
type, location, and quantity according to the lowest marked pressure
limit of an individual cylinder in the manifolded unit. The pressure
relief devices selected for the manifolded unit must have been tested
in accordance with CGA S-1.1 and CGA S-7. Pressure relief devices on
manifolded horizontal cylinders filled with a compressed gas must be
arranged to discharge unobstructed to the open air. In addition, for
Division 2.1 (flammable gas) material, the pressure

relief devices (PRDs) must be arranged to discharge upward to prevent
any escaping gas from contacting personnel or any adjacent cylinders.
Valves and pressure relief devices on manifolded cylinders filled with
a compressed gas must be protected from damage by framing, a cabinet or
other method. Manifolding is authorized for cylinders containing the
following gases:
    (i) Nonliquefied (permanent) compressed gases authorized by Sec.
173.302.
    (ii) Liquefied compressed gases authorized by Sec.  173.304. Each
manifolded cylinder containing a liquefied compressed gas must be
separately filled and means must be provided to ensure no interchange
of cylinder contents can occur during transportation.
    (iii) Acetylene as authorized by Sec.  173.303.
* * * * *

0
29. In Sec.  173.304a, paragraph (e)(1)(ii) is revised to read as
follows:

Sec.  173.304a  Additional requirements for shipment of liquefied
compressed gases in specification cylinders.

* * * * *
    (e) * * *
    (1) * * *
    (ii) Each cylinder must be protected with at least one pressure
relief device and at least one frangible disc conforming to Sec.
173.301(f) and paragraph (a)(2) of this section. The relieving capacity
of the pressure relief device system must be equal to or greater than
that calculated by the applicable formula in paragraph 5.8.3 of CGA S-
1.1 (IBR, see Sec.  171.7 of this subchapter).
* * * * *

0
30. In Sec.  173.306, paragraphs (i) and (j) are revised and a new
paragraph (k) is added to read as follows:

Sec.  173.306  Limited quantities of compressed gases.

* * * * *
    (i) A limited quantity which conforms to the provisions of
paragraph (a)(1), (a)(3), or (b) of this section and is a ``consumer
commodity'' as defined in Sec.  171.8 of this subchapter, may be
renamed ``consumer commodity'' and reclassed as ORM-D material. Each
package may not exceed 30 kg (66 pounds) gross weight. In addition to
the exceptions provided by paragraphs (a) and (b) of this section--
    (1) Outside packagings are not required to be marked ``INSIDE
CONTAINERS COMPLY WITH PRESCRIBED REGULATIONS'';
    (2) Shipments of ORM-D materials are not subject to the shipping
paper requirements of subpart C of part 172 of this subchapter, unless
the material meets the definition of a hazardous substance, a hazardous
waste, or a marine pollutant or unless offered for transportation or
transported by aircraft; and
    (3) Shipments of ORM-D materials are eligible for the exceptions
provided in Sec.  173.156.
    (j) Aerosols and receptacles small, containing gas with a capacity
of less than 50 mL. Aerosols, as defined in Sec.  171.8 of this
subchapter, and receptacles small, containing gas, with a capacity not
exceeding 50 mL (1.7 oz.) and with a pressure not exceeding 970 kPa
(141 psig) at 55 [deg]C (131 [deg]F), containing no hazardous materials
other than a Division 2.2 gas, are not subject to the requirements of
this subchapter. The pressure limit may be increased to 2000 kPa (290
psig) at 55 [deg]C (131 [deg]F) provided the aerosols are transported
in outer packages that conform to the packaging requirements of Subpart
B of this part. This paragraph does not apply to a self-defense spray
(e.g., pepper spray).
    (k) For additional exceptions, also see Sec.  173.307.

Sec.  173.335  [Removed]

0
31. Section 173.335 is removed and reserved.

PART 175--CARRIAGE BY AIRCRAFT

0
32. The authority citation for part 175 continues to read as follows:

    Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.45 and 1.53.

0
33. In Sec.  175.10, paragraph (a)(10) is revised to read as follows:

Sec.  175.10  Exceptions for passengers, crewmembers, and air
operators.

* * * * *
    (a) * * *
    (10) Dry ice (carbon dioxide, solid):
    (i) in quantities not exceeding 2.5 kg (5.5 pounds) per person in
carry-on baggage, when used to pack perishables not subject to the HMR.
The package must permit the release of carbon dioxide gas; and/or
    (ii) in checked baggage, with the approval of the operator(s), when
each package is marked ``DRY ICE'' or ``CARBON DIOXIDE, SOLID'', and
marked with the net mass of dry ice or an indication the net weight is
2.5 kg (5.5 pounds) or less.
* * * * *

0
34. A new Sec.  175.900 is added to read as follows:

Sec.  175.900  Handling requirements for carbon dioxide, solid (dry
ice).

    Carbon dioxide, solid (dry ice) when shipped by itself or when used
as a refrigerant for other commodities, may be carried only if the
operator has made suitable arrangements based on the aircraft type, the
aircraft ventilation rates, the method of packing and stowing, whether
animals will be carried on the same flight and other factors. The
operator must ensure that the ground staff is informed that the dry ice
is being loaded or is on board the aircraft. For arrangements between
the shipper and operator, see Sec.  173.217 of this subchapter. Where
dry ice is contained in a unit load device (ULD) or other type of
pallet prepared by a single shipper in accordance with Sec.  173.217
and the operator after the acceptance adds additional dry ice, the
operator must ensure that the information provided to the Pilot-in-
Command and the marking on the ULD when used as a packaging reflects
that revised quantity of dry ice.

PART 177--CARRIAGE BY PUBLIC HIGHWAY

0
35. The authority citation for part 177 continues to read as follows:

    Authority: 49 U.S.C. 5101-5128; 49 CFR 1.53.

0
36. In Sec.  177.848, paragraph (a)(1) is revised to read as follows:

Sec.  177.848  Segregation of hazardous materials.

    (a) * * *
    (1) In packages that must be labeled or placarded in accordance
with part 172 of this subchapter;
* * * * *

PART 178--SPECIFICATIONS FOR PACKAGINGS

0
37. The authority citation for part 178 continues to read as follows:

    Authority: 49 U.S.C. 5101-5128; 49 CFR 1.53.

0
38. In Sec.  178.75, paragraph (f)(1) is revised to read as follows:

Sec.  178.75  Specifications for MEGCs.

* * * * *
    (f) * * *
    (1) The size of the pressure relief devices: CGA S-1.1 (IBR, see
Sec.  171.7 of this subchapter) must be used to determine the relief
capacity of individual pressure receptacles.
* * * * *
0
39. In Sec.  178.274, in paragraph (b)(1), the first sentence is
revised to read as follows:

Sec.  178.274  Specifications for UN portable tanks.

* * * * *
    (b) * * *
    (1) The design temperature range for the shell must be -40 [deg]C
to 50 [deg]C (-40 [deg]F to 122 [deg]F) for hazardous materials
transported under normal conditions of transportation, except for
portable tanks used for refrigerated liquefied gases where the minimum
design temperature must not be higher than the lowest (coldest)
temperature (for example, service temperature) of the contents during
filling, discharge or transportation. * * *
* * * * *

0
40. In Sec.  178.337-9, paragraph (b)(8) is revised to read as follows:

Sec.  178.337-9  Pressure relief devices, piping, valves, hoses, and
fittings.

* * * * *
    (b) * * *
    (8) Chlorine cargo tanks. Angle valves on cargo tanks intended for
chlorine service must conform to the standards of the Chlorine
Institute, Inc., Dwg. 104-8 or ``Section 3, Pamphlet 166, Angle Valve
Guidelines for Chlorine Bulk Transportation.'' (IBR, see Sec.  171.7 of
this subchapter). Before installation, each angle valve must be tested
for leakage at not less than 225 psig using dry air or inert gas.
* * * * *

0
41. In Sec.  178.337-10, paragraph (d) is revised to read as follows:

Sec.  178.337-10  Accident damage protection.

* * * * *
    (d) Chlorine tanks. A chlorine tank must be equipped with a
protective housing and a manway cover to permit the use of standard
emergency kits for controlling leaks in fittings on the dome cover
plate. For tanks manufactured on or after October 1, 2009, the housing
and manway cover must conform to the Chlorine Institute, Inc., Dwg.
137-5 (IBR, see Sec.  171.7 of this subchapter).
* * * * *

PART 180--CONTINUING QUALIFICATION AND MAINTENANCE OF PACKAGINGS

0
42. The authority citation for part 180 continues to read as follows:

    Authority: 49 U.S.C. 5101-5128; 49 CFR 1.53.

0
43. In Sec.  180.205, a new paragraph (g)(6) added to read as follows:

Sec.  180.205  General requirements for requalification of
specification cylinders.

* * * * *
    (g) * * *
    (6) Training materials (e.g., CGA publication C-1.1) may be used
for training persons who requalify cylinders using the volumetric
expansion test method.
* * * * *

    Issued in Washington, DC, on January 16, 2008 under authority
delegated in 49 CFR part 1.
Krista L. Edwards,
Deputy Administrator.
 [FR Doc. E8-1211 Filed 1-25-08; 8:45 am]

BILLING CODE 4910-60-P