[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Proposed Rules]
[Pages 50054-50056]
[FR Doc No: 2012-20371]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 77, No. 161 / Monday, August 20, 2012 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0846; Directorate Identifier 2012-CE-021-AD]
RIN 2120-AA64

Airworthiness Directives; Cessna Aircraft Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Cessna Aircraft Company Models 172R and 172S airplanes. This
proposed AD was prompted by reports of chafed fuel return line
assemblies, which were caused by the fuel return line assembly rubbing
against the right steering tube assembly during full rudder pedal
actuation. This proposed AD would require you to inspect the fuel
return line assembly for chafing; replace the fuel return line assembly
if chafing is found; inspect the clearance between the fuel return line
assembly and both the right steering tube assembly and the airplane
structure; and adjustment as necessary. We are proposing this AD to
correct the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by October 4, 2012.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Cessna Aircraft Company, Customer service, P.O. Box 7706, Wichita, KS
67277; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; Internet: http://www.cessnasupport.com. You may review copies of the referenced service
information at the FAA, Small Airplane Directorate, 901 Locust, Kansas
City, MO 64106. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Jeff Janusz, Aerospace Engineer,
Wichita Aircraft Certification Office, FAA, 1801 S. Airport Road, Room
100, Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2012-0846;
Directorate Identifier 2012-CE-021-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    In January 2012, we issued AD 2012-02-02 (77 FR 6003, February 7,
2012) for certain Cessna Aircraft Company (Cessna) Models 172R and 172S
airplanes. That AD required inspection of the fuel return line assembly
for chafing; replacement of the fuel return line assembly if chafing is
found; inspection of the clearance between the fuel return line
assembly and both the right steering tube assembly and the airplane
structure; and adjustment as necessary. That AD resulted from reports
of chafed fuel return line assemblies, which were caused by the fuel
return line assembly rubbing against the right steering tube assembly
during full rudder pedal actuation. We issued that AD to detect and
correct chafing of the fuel return line assembly, which could result in
fuel leaking under the floor and fuel vapors entering the cabin. This
condition could lead to fire under the floor or in the cabin area.
    We were recently notified that the unsafe condition also applies to
airplanes with an installed engine fuel return system modification kit.

Relevant Service Information

    We reviewed Cessna Service Bulletin SB07-28-01, Revision 1, dated
September 22, 2011. The service information describes the following
procedures:
     Inspecting the fuel return line assembly;
     Replacing the fuel return line assembly if chafing is
found; and
     Inspecting the clearance between the fuel return line
assembly and both the right steering tube assembly and the airplane
structure, adjusting as necessary.

FAA's Determination

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

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under

``Differences Between the Proposed AD and the Service Information.''
    This proposed AD will apply to only the Cessna Models 172R and 172S
airplanes that have installed an engine fuel return system modification
kit.
    AD 2012-02-02 (77 FR 6003, February 7, 2012) will remain in effect
for the airplanes without the modification kit.

Differences Between the Proposed AD and the Service Information

    The service information permits tube damage up to a depth of 0.0035
inch. There is no known method to accurately measure the thickness
damage on a tube. We propose to require replacement of the fuel return
line assembly if any damage is found.
    If no chafing is found in the inspection of the fuel return line
assembly, the service information does not require inspection for
clearance around the fuel return line assembly. We propose to require
you to inspect the clearance between the fuel return line assembly and
both the right steering tube assembly and airplane structure if no
chafing is found and if the fuel return line assembly requires
replacing.
    The service information does not specify a minimum clearance
requirement between the fuel return line assembly and the right
steering tube assembly, only that the fuel return line assembly does
not touch either the right steering tube assembly or the airplane
structure. We propose to require a minimum of 0.5 inch of clearance
between the fuel return line assembly and the right steering tube
assembly and require visible positive clearance between the fuel return
line assembly and the airplane structure, during full rudder pedal
actuation.
    The serial numbers this proposed AD apply to are not included in
the Effectivity of the service information. However, the procedures in
the service information for inspection and replacement of the fuel
return line assembly are still accurate for the serial numbers this
proposed AD applies to.
    The requirements of this proposed AD, if adopted as a final rule,
would take precedence over the provisions in the service information.

Costs of Compliance

    We estimate that this proposed AD affects 55 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
            Action                  Labor cost              Parts cost              product         operators
----------------------------------------------------------------------------------------------------------------
Inspection of the fuel return   1 work-hour x $85  Not applicable.............             $85           $4,675
 line assembly for chafing and   per hour = $85.
 clearance.
----------------------------------------------------------------------------------------------------------------

     We estimate the following costs to do any necessary replacements
and adjustments that would be required based on the results of the
inspection. We have no way of determining the number of aircraft that
might need these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement of the fuel return line assembly   1 work-hour x $85 per hour =               $123             $208
 and adjustment of the clearance between the    $85.
 fuel return line assembly and both the
 steering tube assembly and the airplane
 structure.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Cessna Aircraft Company: Docket No. FAA-2012-0846; Directorate
Identifier 2012-CE-021-AD.

(a) Comments Due Date

    We must receive comments by October 4, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the following Cessna Aircraft Company
(Cessna) airplanes, certificated in any category:
    (1) Model 172R, serial numbers (S/N) 17280001 through 17281187,
that have incorporated Cessna Aircraft Company Service Bulletin
SB04-28-03, dated August 30, 2004, and Engine Fuel Return System,
Modification Kit MK172-28-01, dated August 30, 2004; and
    (2) Model 172S, S/N 172S8001 through 172S9490, that have
incorporated Cessna Aircraft Company Service Bulletin SB04-28-03,
dated August 30, 2004, and Engine Fuel Return System, Modification
Kit MK172-28-01; dated August 30, 2004.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 2820, Aircraft Fuel Distribution System.

(e) Unsafe Condition

    This AD was prompted by reports of chafed fuel return line
assemblies caused by the fuel return line assembly rubbing against
the right steering tube assembly during full rudder pedal actuation.
We are issuing this AD to correct the unsafe condition on these
products.

(f) Compliance

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

(g) Inspect the Fuel Return Line Assembly

    At whichever of the following that occurs later, inspect the
fuel return line assembly (Cessna part number (P/N) 0500118-49) for
chafing following Cessna Service Bulletin SB07-28-01, Revision 1,
dated September 22, 2011.
    (1) At the next annual inspection after the effective date of
this AD; or
    (2) Within the next 100 hours time-in-service (TIS) after the
effective date of this AD; or
    (3) Within the next 12 calendar months after the effective date
of this AD.

(h) Replace the Fuel Line Assembly

    If you find evidence of chafing of the fuel return line assembly
(Cessna P/N 0500118-49) as a result of the inspection required by
paragraph (g) of this AD, then before further flight, replace the
fuel return line assembly (Cessna P/N 0500118-49) following Cessna
Service Bulletin SB07-28-01, Revision 1, dated September 22, 2011.

(i) Inspect for a Minimum Clearance Between Certain Parts

    After any inspection required by paragraph (g) of this AD and no
chafing of the fuel return line assembly (Cessna P/N 0500118-49) is
found or after replacement of the fuel return line assembly (Cessna
P/N 0500118-49) required by paragraph (h) of this AD, before further
flight, inspect for a minimum clearance between the following parts
throughout the range of copilot pedal travel:
    (1) A minimum clearance of 0.5 inch between the fuel return line
assembly (Cessna P/N 0500118-49) and the right steering tube
assembly (Cessna P/N MC0543022-2C); and
    (2) Visible positive clearance between the fuel return line
assembly (Cessna P/N 0500118-49) and the airplane structure.

(j) Adjust Clearance for Fuel Return Line Assembly

    If the clearance between the fuel return line assembly and the
right steering tube assembly and the clearance between the fuel
return line assembly and the aircraft structure do not meet the
minimums as specified in paragraphs (i)(l) and (i)(2) of this AD,
before further flight, adjust the clearances to meet the required
minimums following the Instructions paragraph of Cessna Service
Bulletin SB07-28-01, Revision 1, dated September 22, 2011.

(k) Engine Fuel Return System Modification

    Do not install Cessna Aircraft Company Service Bulletin SB 04-
28-03 and Engine Fuel Return System Modification Kit MK 172-28-01,
both dated August 30, 2004, without performing the actions in this
AD.

(l) Alternative Methods of Compliance (AMOCs)

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

(m) Related Information

    (1) For more information about this AD, contact Jeff Janusz,
Aerospace Engineer, Wichita ACO, FAA, 1801 S. Airport Road, Room
100, Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax: (316) 946-
4107; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Cessna Aircraft Company, Customer Service, P.O. Box 7706, Wichita,
KS 67277; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; Internet:
http://www.cessnasupport.com. You may review copies of the
referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, MO 64106. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Kansas City, Missouri, on August 14, 2012.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2012-20371 Filed 8-17-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: December 15, 2006 (Volume 71, Number 241)]
[Notices]
[Page 75525]
[DOCID:fr15de06-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP97-287-060]

El Paso Natural Gas Company; Notice of Filing

December 8, 2006.
    Take notice that on November 21, 2006, El Paso Natural Gas Company
(El Paso) tendered for filing as part of its FERC Gas Tariff, Second
Revised volume No. 1-A, Fortieth Revised sheet No. 30, with an
effective date of December 22, 2006.
    El Paso states that the filing is being made to remove a terminated
contract from the statement of rates sheets.
    Any person desiring to protest this filing must file in accordance
with rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

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

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

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-21381 Filed 12-14-06; 8:45 am]

BILLING CODE 6717-01-P


BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

Joint Applications of		)

		)

DELTA AIR LINES, INC.,		)

ATLANTIC SOUTHEAST AIRLINES, INC. and	)

COMAIR, INC.		)

		)

and		)	Docket OST-2000-6939

		)

SOCIETÉ AIR FRANCE		)

for statements of authorization		)

pursuant to 14 C.F.R. Part 212		)

(United States-France blanket codesharing)		)

NOTICE

Communications with respect to this document should be sent to:

Michael F. Goldman			D. Scott Yohe

SILVERBERG, GOLDMAN		Senior Vice President - Government Affairs

  & BIKOFF, L.L.P.			DELTA AIR LINES, INC.

1101 30th Street, N.W., Suite 120	1275 K Street, N.W.

Washington, D.C. 20007			Washington, D.C. 20005

(202) 944-3305<PHONE_NUMBER>

Counsel for 					John Varley, Assistant General Counsel

SOCIETÉ AIR FRANCE			James Coblin, Attorney

						DELTA AIR LINES, INC.

						Law Department #981

						1030 Delta Boulevard

						Atlanta, GA 30320

<PHONE_NUMBER>

						Robert E. Cohn

						Alexander Van der Bellen

						SHAW PITTMAN LLP

						2300 N. Street, N.W.

						Washington, D.C. 20037-1128

<PHONE_NUMBER>

						Counsel for

						DELTA AIR LINES, INC.

				ATLANTIC SOUTHEAST AIRLINES, INC.

June 6, 2002					COMAIR, INC.BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

June 6, 2002

Joint Applications of		)

		)

DELTA AIR LINES, INC.,		)

ATLANTIC SOUTHEAST AIRLINES, INC. and	)

COMAIR, INC.		)

		)

and		)	Docket OST-2000-6939

		)

SOCIETÉ AIR FRANCE		)

for statements of authorization		)

pursuant to 14 C.F.R. Part 212		)

(United States-France blanket codesharing)		)

NOTICE

Air France and Delta hold a blanket statement of authorization and have previously notified the Department of Delta codeshare service on Air France operated flights between Paris and N’djamena, Chad.  The carriers wish to notify the Department that Air France is now operating this flight with an intermediate stop in Bangui, Central African Republic (BGF) on the return leg of the flight between N’djamena and Paris.  Delta is not marketing or holding out services in the U.S.-BGF market; no U.S. origin or destined Delta passengers are offloaded or boarded at BGF.

Respectfully submitted,

/s/						/s/

Michael F. Goldman	Robert E. Cohn

SILVERBERG, GOLDMAN	Alexander Van der Bellen

  & BIKOFF, L.L.P.	SHAW PITTMAN LLP

1101 30th Street, N.W., Suite 120	2300 N Street, N.W.

Washington, D.C. 20007	Washington, D.C. 20037-1128

(202) 944-3305<PHONE_NUMBER>

Counsel for	Counsel for

SOCIETÉ AIR FRANCE	DELTA AIR LINES, INC.

	ATLANTIC SOUTHEAST AIRLINES, INC.

	COMAIR, INC.

Footnote continued from previous page

Footnote continued on next page

Notice

Page   PAGE  2


[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45268-45269]
[FR Doc No: 2011-19098]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0294]

Reprocessing of Reusable Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is considering factors
affecting the reprocessing of reusable medical devices, including
reprocessing quality, device design as it relates to the reprocessing
of reusable medical devices, reprocessing methodologies, validation
methodologies, and health care facility best practices. This is part of
an ongoing effort to address patient exposure to inadequately
reprocessed reusable medical devices. FDA would like to provide another
opportunity for public comment by establishing a docket to receive
information and comments from the public on factors affecting the
reprocessing of reusable medical devices.

DATES: Submit either electronic or written comments by September 26,
2011.

ADDRESSES: You may submit comments, identified with the FDA docket
number found in brackets in the heading of this document, by any of the
following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and

docket number for this notice. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Carol Krueger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5437, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA has launched an effort focused on the reprocessing of reusable
medical devices, including reprocessing quality, device design as it
relates to the reprocessing of reusable medical devices, reprocessing
methodologies, validation methodologies, and health care facility best
practices. As part of this effort, FDA held a 2-day public workshop on
June 8 and 9, 2011, at FDA's White Oak Conference Center in Silver
Spring, MD. In the Federal Register of May 2, 2011 (76 FR 24495), FDA
announced the workshop and provided background information. The
workshop focused on medical devices that are intended for reuse after
reprocessing, rather than third-party reprocessing of single-use-only
medical devices. FDA has a Web cast of the workshop available for
viewing at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm252205.htm. The workshop included a public
comment session.
    On the workshop Web site (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm252205.htm), FDA stated that
electronic comments regarding the public workshop could be submitted to
http://www.regulations.gov until June 29, 2011. FDA inadvertently
failed to state this in the May 2, 2011, workshop notice. Hence, http://www.regulations.gov was not open for submission of electronic
comments. FDA is publishing this notice to provide another opportunity
for public comment on reprocessing of reusable medical devices issues.
    Various types of medical devices used in health care settings, from
surgical suction tips to complex endoscopes, are designed and labeled
for use on multiple patients. Thousands of reusable medical devices
requiring reprocessing are used every day in diagnosing and treating
patients. FDA has received a number of reports of patient exposure to
inadequately reprocessed medical devices and subsequent health care-
associated infections (HAIs).
    A definitive causal relationship between reusable device
reprocessing and any patient infection is difficult to establish
because inadequate reprocessing is not often investigated as a cause
when an HAI is diagnosed. Several reports, however, contained evidence
suggesting that inadequate reprocessing may have been a contributing
factor in microbial transmission and subsequent infection. Ensuring
adequate reprocessing of reusable medical devices could reduce the
incidence of HAIs associated with the use of a reprocessed medical
device. This will decrease the public health burden of HAIs in terms of
morbidity, mortality, and cost.
    The adequate reprocessing of reusable medical devices is a
critically important factor in protecting patient safety. Inadequate
reprocessing between patients can result in the retention of blood,
tissue, and other biological debris (soil) in reusable medical devices.
This soil can allow microbes to survive the high level disinfection or
sterilization process, potentially resulting in HAIs or other adverse
patient outcomes. FDA receives reports of problems in all steps of
medical device reprocessing,\1\ including cleaning, disinfecting, and
sterilizing. Manufacturers, health care facilities, health care
professionals, and FDA all have a role in reducing the risk of
inadequately reprocessed medical devices. To help address these issues,
FDA has engaged partners at the Centers for Disease Control and
Prevention, the Centers for Medicaid and Medicare Services, the
Veterans Health Administration, and The Joint Commission, who bring
valuable expertise in disease control and health care practices to this
effort.
---------------------------------------------------------------------------

    \1\ A more comprehensive description of reprocessing steps is
available in FDA's draft guidance ``Processing/Reprocessing Medical
Devices in Health Care Settings: Validation Methods and Labeling''
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/default.htm.
---------------------------------------------------------------------------

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
    To assist interested parties, we are asking for public comment on
the following issues:
    1. What are the nature, scope, and impact of reusable medical
device reprocessing problems that have been observed? What are the
causes of these problems?
    2. What factors or criteria to facilitate reprocessing should be
considered when designing reusable medical devices? How can the design
process be improved to better incorporate cleanability as a design
endpoint?
    3. What factors or criteria should be considered when developing
reprocessing instructions and validation protocols for devices to be
used in various health care environments (e.g., hospital, ambulatory
surgical center, physician's office), based on the draft guidance
document, ``Processing/Reprocessing Medical Devices in Health Care
Settings: Validation Methods and Labeling,'' available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/default.htm?
    4. What factors or criteria should be considered by a health care
facility when developing reusable device reprocessing procedures and
quality assurance processes?
    5. How should problems with reusable medical device reprocessing be
identified, reported, and acted upon by industry and users?

    Dated: July 25, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-19098 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P


     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

                             OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
MEMORANDUM FOR THE RECORD

RE:  	Meeting with Daikin on the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h)
List of Contents
 Meeting Summary
 Attendees
Meeting Summary

On July 18, 2022, representatives from EPA met with Daikin to discuss comments submitted in docket EPA-HQ-OPPT-2021-0598 on the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1); Compliance Date Extension, published March 8, 2022. During the meeting, Daikin presented an overview of their use of PIP (3:1) in specialized engine filters for locomotive and marine applications, including current worker protection measures, expected market demands, and estimated timelines for finding alternative chemistries. EPA gave an overview of the TSCA section 6(h) rulemaking activities to date. Daikin indicated they would continue engaging with the EPA rulemaking process, in particular with respect specialized engine filters for locomotive and marine applications.

Attendees
EPA:
Niva Kramek
Cindy Wheeler
Gabriela Rossner

Daikin:
Charlie McCrudden
Manish Vyas
Nathaniel Nance
Chris Chmielewski
William Barrows


[Federal Register: May 17, 2010 (Volume 75, Number 94)]
[Notices]
[Page 27547-27548]
[DOCID:fr17my10-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13693-000]

South Dakota Energy, L.L.C.; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

May 10, 2010.
    On March 29, 2010, and revised May 5, 2010, the South Dakota
Energy, L.L.C. filed an application for a preliminary permit, pursuant
to section 4(f) of the Federal Power Act, proposing to study the
feasibility of the South Dakota Energy Hydroelectric Project located on
the Missouri River in Gregory County, South Dakota. The proposed
project's existing lower reservoir is owned and operated by the U.S.
Army Corps of Engineers (Corps). The sole purpose of a preliminary
permit, if issued, is to grant the permit holder priority to file a
license application during the permit term. A preliminary permit does
not authorize the permit holder to perform any land-disturbing
activities or otherwise enter upon lands or waters owned by others
without the owners' express permission. The proposed project boundary
is partially located on Federal lands managed by the Corps.
    The proposed project would consist of the following: (1) A new 60-
foot-high, 15,700-foot long earth embankment dam, impounding a 450-acre
upper reservoir, with 25,250 acre-feet of storage capacity at a normal
elevation of 2,090 mean sea level; (2) a 30-foot-diameter, 700-foot-
long vertical shaft concrete or steel power tunnel; (3) a 30-foot-
diameter, 7,100-foot-long concrete or steel conduit; (4) an underground
powerhouse containing four 300-megawatt reversible pump-turbine/
generator units, discharging into Lake Francis Case through a 40-foot-
diameter, 2,200-foot-long discharge tunnel; (5) the existing Lake
Francis Case lower reservoir; (6) a new 20-mile-long, 345-kilovolt
transmission line to interconnect with an existing transmission line at
the Fort Randall generation facility; and (7) appurtenant facilities.
    Applicant Contact: Brent Smith, Chief Operating Officer, South
Dakota Energy, L.L.C., 975 South State Highway, Logan, UT 84321; phone:
(435) 752-2580.
    FERC Contact: Joseph C. Adamson,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site (http://www.ferc.gov/docs-filing/ferconline.asp) under the
``eFiling'' link. For a simpler method of submitting text only
comments, click on ``Quick Comment.'' For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>call toll-free at
(866) 208-3676; or, for TTY, contact<PHONE_NUMBER>. Although the
Commission strongly encourages electronic filing, documents may also be
paper-filed. To paper-file, mail an original and eight copies to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/

elibrary.asp. Enter the docket number (P-13693-000) in the docket
number field to access the document. For assistance, contact FERC
Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-11629 Filed 5-14-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 7, 2008 (Volume 73, Number 153)]
[Notices]
[Page 46108-46111]
[DOCID:fr07au08-114]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58283; File No. SR-FINRA-2008-040]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change To Eliminate
the Requirement To Report Yield to TRACE and for FINRA To Calculate
Yield That Will Be Disseminated by TRACE

August 1, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 17, 2008, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') (f/k/a National Association of Securities Dealers, Inc.
(``NASD'')) filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to: (a) Amend NASD Rule 6230(c) \3\ to eliminate
the requirement to report yield to the Trade Reporting and Compliance
Engine (``TRACE'') system (``TRACE System'') when a member reports a
transaction in a TRACE-eligible security \4\ and (b) implement a policy
to disseminate yield

as calculated by the TRACE system (``Standard yield'') in TRACE data.
Below is the text of the proposed rule change. Proposed new language is
in italics; proposed deletions are in brackets.
---------------------------------------------------------------------------

    \3\ On May 23, 2008, FINRA filed with the Commission a proposed
rule change (SR-FINRA-2008-021) in which FINRA proposed, among other
things, to adopt without material change NASD Rule 6200 Series and
NASD Rule 6230 as, respectively, FINRA Rule 6700 Series and FINRA
Rule 6730. If the Commission approves this proposed rule change
prior to approving SR-FINRA-2008-021, FINRA will amend SR-FINRA-
2008-021 as necessary to reflect such approval. If the Commission
approves SR-FINRA-2008-021 prior to approving this proposed rule
change, FINRA will amend this proposed rule change as necessary to
reflect such approval.
    \4\ The term ``TRACE-eligible security'' is defined in NASD Rule
6210(a).
---------------------------------------------------------------------------

* * * * *

6200. TRADE REPORTING AND COMPLIANCE ENGINE (TRACE)

* * * * *

6230. Transaction Reporting

    (a) through (b) No Change.
    (c) Transaction Information to Be Reported
    Each TRACE trade report shall contain the following information:
    (1) Through (10) No Change.
    (11) Stated commissions; and
    (12) Such trade modifiers as required by either the TRACE rules or
the TRACE users guide.[; and]
    [(13) The lower of yield to call or yield to maturity. A member is
not required to report yield when the TRACE-eligible security is a
security that is in default; a security for which the interest rate is
floating; a security for which the interest rate will be or may be
increased (e.g., certain ``step-up bonds'') or decreased (e.g., certain
``step-down bonds'') and the amount of increase or decrease is an
unknown variable; a pay-in-kind security (``PIK''); any other security
where the principal or interest to be paid is an unknown variable or is
an amount that is not currently ascertainable, or any other security
that the Association designates if the Association determines that
reporting yield would provide inaccurate or misleading information
concerning the price of, or trading in, the security.]
    (d) through (f) No Change.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    FINRA proposes to eliminate the requirement to report yield when a
member reports a transaction in a TRACE-eligible security. In addition,
FINRA proposes to include a yield (``Standard yield'') calculated based
on the disseminated price in disseminated real-time TRACE data, with
certain exceptions that would be identified clearly.
    Currently, NASD Rule 6230(c) requires that a member report to TRACE
price, yield and other information for every transaction in a TRACE-
eligible security. NASD Rule 6230(c)(13) specifically requires that a
member report, for most transactions, the lower of yield to call or
yield to maturity. Yield is not reported if the TRACE-eligible security
is in default, if the interest rate floats and the adjusted amount is
unknown and in several other circumstances where an unknown variable
prevents yield calculation or where the reported yield would provide
inaccurate or misleading information.\5\
---------------------------------------------------------------------------

    \5\ Yield is not reported when the TRACE-eligible security is in
default; a security for which the interest rate floats; a security
for which the interest rate will or may be ``stepped-up'' or
``stepped-down'' and the amount of increase or decrease is an
unknown variable; a pay-in-kind (``PIK'') security; a security where
the principal or interest to be paid is an unknown variable or is an
amount that is not currently ascertainable; or any other security
that FINRA designates if FINRA determines that reporting yield would
provide inaccurate or misleading information concerning the price
of, or trading in, the security. See NASD Rule 6230(c)(13).
---------------------------------------------------------------------------

    Information, including member-reported yield, on all transactions
(except Rule 144A transactions) is disseminated currently by TRACE upon
receipt of the report.\6\ The TRACE System also calculates the Standard
yield. However, generally this Standard yield currently is not
disseminated in TRACE data.\7\
---------------------------------------------------------------------------

    \6\ The disseminated TRACE data includes all transactions
reported to TRACE except certain transactions executed pursuant to
Rule 144A under the Securities Act of 1933. 17 CFR 230.144A.
    \7\ Standard yield is included in the disseminated TRACE data
when yield is required to be reported and the member fails to submit
it.
---------------------------------------------------------------------------

    FINRA proposes to eliminate the requirement to report yield to
TRACE and to disseminate a Standard yield in disseminated TRACE data.
The Standard yield for each transaction would be calculated based on
the same assumptions, using a method adopted by many professional
market participants.\8\ The price upon which Standard yield would be
calculated would be the price as disseminated by TRACE. Generally, this
means that, for principal transactions, it would be the reported price
inclusive of markup, and, for agency trades, it would be the reported
price plus any reported commission.
---------------------------------------------------------------------------

    \8\ The Standard yield in TRACE is calculated as the internal
rate of return according to a discounted cash flow model. Currently,
Standard yield is calculated, in a principal trade, on the reported
price, which includes the mark-up/mark-down, and in an agency trade,
on the reported price and reported commission. Standard yield does
not include any fees or charges that are not included, in a
principal trade, as part of the reported price, and in an agency
trade, in the reported commission. Standard yield is calculated as
the lower of yield to call (if the bond is callable) and yield to
maturity, or so-called ``yield-to-worst.'' All results are
calculated using standards, rules or practices generally accepted in
the industry (e.g., Standard yield is calculated using a day count
of 30/360, which is standard for corporate bonds). Currently,
Standard yield is calculated utilizing a calculation library that is
widely used by professionals in the securities industry. See e-mail
from Sharon Zackula, Associate Vice President and Associate General
Counsel, FINRA, to Michael Gaw, Assistant Director, and Geoffrey
Pemble, Special Counsel, Division of Trading and Markets,
Commission, dated July 25, 2008.
---------------------------------------------------------------------------

    Disseminated TRACE data would not include Standard yield for those
transactions with respect to which a member currently is not required
to report yield under NASD Rule 6230(c)(13). Thus, Standard yield would
not be disseminated when the TRACE-eligible security is in default; a
security for which the interest rate floats; a security for which the
interest rate will or may be ``stepped-up'' or ``stepped-down'' and the
amount of increase or decrease is an unknown variable; a pay-in-kind
(``PIK'') security; a security where the principal or interest to be
paid is an unknown variable or is an amount that is not currently
ascertainable; or when FINRA determines that disseminating a yield
would provide inaccurate or misleading information concerning the price
of, or trading in, the security.
    FINRA does not believe that transparency will be affected adversely
if member-reported yields are no longer reported nor disseminated and,
instead, Standard yields are disseminated. Currently, there is no
uniformity in the manner by which members calculate yield, as members
use several different methods (and assumptions). For example, some
firms begin the calculation based on Trade date, while others begin on
T + 1. In addition, some firms include all miscellaneous fees and
charges in their yield calculations, while others only include such
fees and charges if they exceed a specified amount. Thus, it is
possible for two firms to report contemporaneous transactions in the
same bond at the

same price, charging the same miscellaneous fees, but report different
yields because they use different methods or assumptions or include or
omit certain charges or fees. The possible variance in member-reported
yields in the same security executed at the same price makes such
yields less valuable as a tool to improve corporate bond market
transparency for market participants, especially individual investors.
    In addition, the consistency achieved by FINRA's proposal to
disseminate a Standard yield will enhance the usefulness of TRACE data
to market participants. Disseminating Standard yields in TRACE data,
which are calculated according to a single formula and a uniform set of
assumptions, will provide more useful information, especially for
customers other than market professionals, and will permit retail
customers to compare yields of contemporaneous transactions in the same
and similar securities more meaningfully.
    Moreover, deleting member-reported yields from disseminated TRACE
data and replacing them with Standard yields will not limit a
customer's access to relevant yield information. Under SEC Rule 10b-10,
a customer currently receives yield information in the customer's
confirmation.\9\ That yield is specifically calculated, reflecting the
price and various fees the customer was charged by the member, as
required in SEC Rule 10b-10.\10\ The value of seeing both the Standard
yield and the member-calculated yield may provide additional
transparency to retail customers. For example, a customer could compare
the yield calculated by the member in the SEC Rule 10b-10 \11\
confirmation with the Standard yield in the TRACE data and more readily
determine the impact that fees specific to a corporate bond transaction
or a member have on the customer's yield.
---------------------------------------------------------------------------

    \9\ 17 CFR 240.10b-10.
    \10\ Id.
    \11\ Id.
---------------------------------------------------------------------------

    Finally, FINRA's assessment of a member's compliance with various
provisions of the TRACE rules and the federal securities laws will
continue to be achieved using the Standard yield calculated by TRACE.
For example, FINRA currently uses member-reported yields to validate
member-reported prices. However, by comparing member-reported prices to
the Standard yield, FINRA will be able to continue performing basic
price validation without requiring firms to provide yield as part of
their trade reports.
    Vendors. As part of FINRA's yield dissemination policy, FINRA will
require that data vendors providing TRACE data to the market and to
redistributors of such data display yield in real-time TRACE data.
However, certain vendors desire to disseminate a yield calculated by
the vendor, rather than use the Standard yield. FINRA proposes to
permit this flexibility, provided that vendors that display a yield
other than the Standard yield disclose that they are disseminating a
yield other than the Standard yield provided by FINRA.
    FINRA will announce the effective date of the proposed rule change
in a Regulatory Notice to be published no later than 60 days following
Commission approval. The effective date will be no later than 90 days
following publication of the Regulatory Notice announcing Commission
approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\12\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that amending the TRACE reporting
provisions to reduce a reporting burden and to implement a
dissemination policy to provide more standardized yield information to
investors will increase transparency in the corporate bond markets,
protect investors and is in the public interest.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change would impose
any burden on competition that is not necessary or appropriate in
furtherance of purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2008-040 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2008-040. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You

should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-FINRA-2008-040
and should be submitted on or before August 28, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-18160 Filed 8-6-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47147-47149]
[FR Doc No: 2023-15487]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0601]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice Regulations for Medicated Feeds

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by August 21, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0152. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Current Good Manufacturing Practice Regulations for Medicated Feeds--21
CFR Part 225

OMB Control Number 0910-0152--Extension

    Under section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351), FDA has the statutory authority to issue current
good manufacturing practice (CGMP) regulations for drugs, including
medicated feeds. Medicated feeds are

administered to animals for the prevention, cure, mitigation, or
treatment of disease, or growth promotion and feed efficiency.
Statutory requirements for CGMPs have been codified under part 225 (21
CFR part 225). Medicated feeds that are not manufactured in accordance
with these regulations are considered adulterated under section
501(a)(2)(B) of the FD&C Act. Under part 225, a manufacturer is
required to establish, maintain, and retain records for a medicated
feed, including records to document procedures required during the
manufacturing process to assure that proper quality control is
maintained. Such records would, for example, contain information
concerning receipt and inventory of drug components, batch production,
laboratory assay results (i.e., batch and stability testing), labels,
and product distribution.
    This information is needed so that FDA can monitor drug usage and
possible misformulation of medicated feeds to investigate violative
drug residues in products from treated animals and to investigate
product defects when a drug is recalled. In addition, FDA will use the
CGMP criteria in part 225 to determine whether the systems and
procedures used by manufacturers of medicated feeds are adequate to
ensure that their feeds meet the requirements of the FD&C Act as to
safety, and also that they meet their claimed identity, strength,
quality, and purity, as required by section 501(a)(2)(B) of the FD&C
Act.
    A license is required when the manufacturer of a medicated feed
involves the use of a drug or drugs that FDA has determined requires
more control because of the need for a withdrawal period before
slaughter or because of carcinogenic concerns. Conversely, a license is
not required, and the recordkeeping requirements are less demanding,
for those medicated feeds for which FDA has determined that the drugs
used in their manufacture need less control. Respondents to this
collection of information are commercial feed mills and mixers/feeders.
    In the Federal Register of February 6, 2023 (88 FR 7741), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Recordkeeping Burden
                                 [Registered licensed commercial feed mills] \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of        Total
   21 CFR section; activity       Number of      responses per      annual       Average burden per       Total
                                 respondents       respondent     responses           response            hours
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (8)                   791              260      205,660  1.......................   205,660
 requires records of receipt,
 storage, and inventory
 control of medicated feeds.
225.58(c) and (d) requires                 791               45       35,595  0.5 (30 minutes)........    17,798
 records of the results of
 periodic assays for
 medicated feeds that are in
 accord with label
 specifications and also
 those medicated feeds not
 within documented
 permissible assay limits.
225.80(b)(2) requires that                 791            1,600    1,265,600  0.12 (7 minutes)........   151,872
 verified medicated feed
 label(s) be kept for 1 year.
225.102(b)(1) through (5),                 791            7,800    6,169,800  0.08 (5 minutes)........   493,584
 requires records of master
 record files and production
 records for medicated feeds.
225.110(b)(1) and (2)                      791            7,800    6,169,800  0.02 (1 minute).........   123,396
 requires maintenance of
 distribution records for
 medicated feeds.
225.115(b)(1) and (2)                      791                5        3,955  0.12 (7 minutes)........       475
 requires maintenance of
 complaint files by the
 medicated feed manufacturer.
                              ----------------------------------------------------------------------------------
    Total....................  ...............  ...............  ...........  ........................   992,785
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                 Table 2--Estimated Annual Recordkeeping Burden
                                     [Registered licensed mixer/feeders] \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of        Total
   21 CFR section; activity       Number of       records per       annual       Average burden per       Total
                                recordkeepers     recordkeeper     records          recordkeeping         hours
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (8)                   100              260       26,000  0.15 (9 minutes)........     3,900
 requires records of receipt,
 storage, and inventory
 control of medicated feeds.
225.58(c) and (d) requires                 100               36        3,600  0.5 (30 minutes)........     1,800
 records of the results of
 periodic assays for
 medicated feeds that are in
 accord with label
 specifications and also
 those medicated feeds not
 within documented
 permissible assay limits.
225.80(b)(2) requires that                 100               48        4,800  0.12 (7 minutes)........       576
 verified medicated feed
 label(s) be kept for 1 year.
225.102(b)(1) through (5)                  100              260       26,000  0.4 (24 minutes)........    10,400
 requires records of master
 record files and production
 records for medicated feeds.
                              ----------------------------------------------------------------------------------
    Total....................  ...............  ...............  ...........  ........................    16,676
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                 Table 3--Estimated Annual Recordkeeping Burden
                             [Nonregistered non-licensed commercial feed mills] \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of        Total
   21 CFR section; activity       Number of       records per       annual       Average burden per       Total
                                recordkeepers     recordkeeper     records          recordkeeping         hours
----------------------------------------------------------------------------------------------------------------
225.142 requires procedures              4,357                4       17,428  1.......................    17,428
 for identification, storage,
 and inventory control
 (receipt and use) of Type A
 medicated articles and Type
 B medicated feeds.

225.158 requires records of              4,357                1        4,357  4.......................    17,428
 investigation and corrective
 action when the results of
 laboratory assays of drug
 components indicate that the
 medicated feed is not in
 accord with the permissible
 assay limits.
225.180 requires                         4,357               96      418,272  0.12 (7 minutes)........    50,193
 identification, storage, and
 inventory control of
 labeling in a manner that
 prevents label mix-ups and
 assures that correct labels
 are used for medicated feeds.
225.202 requires records of              4,357              260    1,132,820  0.65 (39 minutes).......   736,333
 formulation, production, and
 distribution of medicated
 feeds.
                              ----------------------------------------------------------------------------------
    Total....................  ...............  ...............  ...........  ........................   821,382
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                 Table 4--Estimated Annual Recordkeeping Burden
                                 [Nonregistered non-licensed mixer/feeders] \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of        Total
   21 CFR section; activity       Number of       records per       annual       Average burden per       Total
                                recordkeepers     recordkeeper     records          recordkeeper          hours
----------------------------------------------------------------------------------------------------------------
225.142 requires procedures              3,400                4       13,600  1.......................    13,600
 for identification, storage,
 and inventory control
 (receipt and use) of Type A
 medicated articles and Type
 B medicated feeds.
225.158 requires records of              3,400                1        3,400  4.......................    13,600
 investigation and corrective
 action when the results of
 laboratory assays of drug
 components indicate that the
 medicated feed is not in
 accord with the permissible
 assay limits.
225.180 requires                         3,400               32      108,800  0.12 (7 minutes)........    13,056
 identification, storage, and
 inventory control of
 labeling in a manner that
 prevents label mix-ups and
 assures that correct labels
 are used for medicated feeds.
225.202 requires records of              3,400              260      884,000  0.33 (20 minutes).......   291,720
 formulation, production, and
 distribution of medicated
 feeds.
                              ----------------------------------------------------------------------------------
    Total....................  ...............  ...............  ...........  ........................   331,976
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an
overall decrease of 10,435 hours and an increase of 831,545 records
since the last OMB approval. We attribute this adjustment due to an
increase in the number of non-registered, non-licensed commercial
medicated feed mills and decrease in non-licensed medicated feed mill
recordkeeping the last few years.

    Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15487 Filed 7-20-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)]
[Proposed Rules]
[Pages 57418-57419]
[FR Doc No: 2017-26183]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2017-0555; FRL-9971-57-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; Removal of Source-Specific Requirements for Permanently
Shutdown Facilities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state implementation plan (SIP) revision submitted by the
State of West Virginia. This revision pertains to the removal of
source-specific SIP requirements for the following five facilities in
West Virginia that have permanently shutdown: Mountaineer Carbon
Company; Standard Lafarge; Follansbee Steel Corporation; International
Mill Service, Inc.; and Columbian Chemicals Company. These sources have
permanently ceased operation; therefore, SIP requirements for these
sources are obsolete and no longer necessary for attaining and
maintaining the national ambient air quality standards (NAAQS). This
action is being taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before January 4, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2017-0555 at http://www.regulations.gov, or via email to
[email protected]. 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, 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. 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 http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Irene Shandruk,<PHONE_NUMBER>, or by
email at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The West Virginia SIP at 40 Code of Federal Regulations (CFR) part
52, subpart XX, Sec.  52.2520(d) contains source-specific requirements,
which were incorporated into the West Virginia SIP over the course of
many years to allow the State to demonstrate attainment with various
NAAQS. Subsequently, several of these sources have permanently ceased
operation rendering source-specific requirements for these facilities
obsolete.
    SIP revisions pertaining to the removal of obsolete SIP
requirements for sources that have permanently shutdown are considered
administrative, non-substantive changes. If a source has permanently
shutdown, the emissions are permanently reduced to zero, so removing
source-specific SIP requirements for that source will not interfere
with attainment and maintenance of any NAAQS, reasonable further
progress or any other applicable CAA requirement. See CAA section
110(l).

II. Summary of SIP Revision and EPA Analysis

    On August 25, 2017, West Virginia submitted a SIP revision
requesting that the consent orders for the sources listed in Table 1 be
removed from the West Virginia SIP located at 40 CFR part 52, subpart
XX, Sec.  52.2520(d).

              Table 1--Source-Specific Requirements Proposed for Removal From the West Virginia SIP
----------------------------------------------------------------------------------------------------------------
                                                                                EPA Approval date/
               Source name                             Order                  State       Federal Register (FR)
                                                                         effective date          citation
----------------------------------------------------------------------------------------------------------------
Mountaineer Carbon Company...............  Consent Order...............          7/2/82                  9/1/82,
                                                                                47 FR 38532
Standard Lafarge.........................  Consent Order...............        11/14/91                 7/25/94,
                                           CO-SIP-91-30................                              59 FR 37696
Follansbee Steel Corporation.............  Consent Order...............        11/14/91                 7/25/94,
                                           CO-SIP-91-31................                              59 FR 37696
International Mill Service, Inc..........  Consent Order...............        11/14/91                 7/25/94,
                                           CO-SIP-91-33................                              59 FR 37696
Columbian Chemicals Company..............  Consent Order...............         1/31/00                  8/2/00,
                                           CO-SIP-2000-3...............                              65 FR 47339
----------------------------------------------------------------------------------------------------------------

    According to West Virginia, the five facilities listed in Table 1
have permanently shutdown and ceased operation. West Virginia's August
25, 2017 submittal lists the dates of facility closures and closure
inspections, and provides relevant documentation verifying the
permanent closure of these sources (see Table 2). EPA has confirmed
that all permits, where applicable, have been surrendered and are
inactive (see Table 2). Because these five sources have permanently
ceased operation and their emissions have been permanently reduced to
zero, their source-specific SIP requirements have been rendered
obsolete.

                              Table 2--Closure Dates and Closure Inspection Dates for Five Permanently Shutdown Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Verification
                                                                                of closure
              Source name                      Source location           Title V        Permanent      inspection             Permit surrendered
                                                                        facility      closure date    conducted by
                                                                                West Virginia
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mountaineer Carbon Company.............  Marshall County...........             Yes       10/9/2015        6/2/2017  Yes.
Standard Lafarge.......................  Hancock County............              No       7/20/2011        6/2/2017  Yes.
Follansbee Steel Corporation...........  Brooke County.............              No       7/12/2012       5/31/2017  Not applicable.\1\
International Mill Service, Inc........  Brooke County.............              No       6/27/2000       5/31/2017  Not applicable.\2\
Columbian Chemicals Company............  Marshall County...........             Yes       10/9/2015        6/2/2017  Yes.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Follansbee Steel Corporation was grandfathered into the West Virginia Department of Environmental Protection--Division of Air Quality's (WVDEP--DAQ)
  permitting program. Therefore, no permits were ever issued for this facility.
\2\ International Mill Service, Inc. was grandfathered into the WVDEP--DAQ permitting program. Therefore, no permits were ever issued for this facility.

III. Proposed Action

    EPA has reviewed West Virginia's SIP revision seeking removal of
obsolete source-specific SIP requirements from the West Virginia SIP.
These five sources have permanently ceased operation, rendering source-
specific SIP requirements for these sources obsolete. EPA has confirmed
that all permits have been surrendered and are inactive. Therefore, EPA
is proposing to approve the West Virginia August 25, 2017 SIP revision,
which sought removal of source-specific revisions related to five now
closed facilities in accordance with section 110 of the CAA. EPA is
soliciting public comments on the issues discussed in this document.
These comments will be considered before taking final action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule, pertaining to removal of source-
specific requirements from the West Virginia SIP, does not have tribal
implications as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

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

    Dated: November 22, 2017.
Cosmo Servidio,
Regional Administrator, Region III.
[FR Doc. 2017-26183 Filed 12-4-17; 8:45 am]
 BILLING CODE 6560-50-P