[Federal Register: December 4, 2007 (Volume 72, Number 232)]
[Proposed Rules]
[Page 68113-68116]
[DOCID:fr04de07-24]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 210 and 211

[Docket No. 2007N-0280]

Amendment to the Current Good Manufacturing Practice Regulations
for Finished Pharmaceuticals; Companion Document to the Direct Final
Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing this
companion proposed rule to the direct final rule, published elsewhere
in this issue of the Federal Register, which is intended to amend
certain sections of the regulations as the first phase of an
incremental approach to modifying the current good manufacturing
practice (CGMP) regulations for finished pharmaceuticals.

DATES: Submit written or electronic comments on or before February 19,
2008.

ADDRESSES: You may submit comments, identified by Docket No. 2007N-
0280, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments.

Follow the instructions for submitting comments on the agency Web site.
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.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm
, 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.fda.gov/ohrms/dockets/default.htm

and insert the docket number(s), 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:
    Mary Malarkey, Center for Biologics Evaluation and Research (HFM-
600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852-1448,<PHONE_NUMBER>, or
    Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-
6956, or
    Frederick Blumenschein, Center for Drug Evaluation and Research
(HFD-326), Food and Drug Administration, 11919 Rockville Pike,
Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Since the development of the CGMP regulations in 1962, FDA has
balanced the need for easily understood minimum standards with the need
to encourage innovation and the development of improved manufacturing
technologies. We strive to give manufacturers latitude to determine how
to achieve the level of control necessary for CGMP compliance,
recognizing that, in some instances, more direction from FDA is
necessary to provide a uniform standard to the entire industry or
because of the potential for harm or the narrow range of acceptable
means to accomplish a particular CGMP objective. FDA periodically
reassesses and revises the CGMP regulations to accommodate advances in
technology that further safeguard the drug manufacturing process and
the public health. As technology and scientific knowledge related to
CGMP evolve, so does understanding of the material, equipment, and
process variables, as well as the operational procedures and oversight
methods that must be defined and controlled to achieve assurance of
drug product quality.
    In 1996, as part of this reassessment process, FDA proposed to
amend certain requirements of the CGMP regulations for finished
pharmaceuticals to clarify certain manufacturing, quality control, and
documentation requirements, and to ensure that the regulations more
accurately encompass current industry practice (61 FR 20103, May 3,
1996) (1996 proposed rule)). Subsequently, as a part of the risk-based
pharmaceutical CGMPs for the 21st century initiative, FDA created a
CGMP Harmonization Analysis Working Group (CGMP Working Group) to
analyze related CGMP requirements in effect in the United States and
internationally, including those related to quality systems. The CGMP
Working Group compared parts 210 amd 211 (21 CFR parts 210 and 211)
with the GMPs of the European Union (EU), as well as other FDA
regulations (e.g., the Quality Systems Regulation, 21 CFR part 820) to
identify the differences and consider the value of supplementing or
changing the current regulations. Based on the CGMP Working Group's
analysis, we decided to take an incremental approach to modifying parts
210 and 211 (see http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm#_Toc84065744
).

    Because of this change in approach, FDA decided not to finalize the
1996

proposed rule. Therefore, elsewhere in this issue of the Federal
Register, we are publishing a notice withdrawing the 1996 proposed
rule.
    The amendments being proposed in this rule are intended to clarify
and modernize the CGMP regulations, as well as harmonize the
regulations with international GMP requirements and other FDA
regulations. This proposed rule represents the first increment of
modifications to parts 210 and 211.

II. Additional Information

    This proposed rule is a companion to the direct final rule
published in the final rule section of this issue of the Federal
Register. The proposed rule and the direct final rule are substantively
identical. This companion proposed rule provides the procedural
framework to proceed with standard notice-and-comment rulemaking if the
direct final rule receives significant adverse comment and is
withdrawn. A significant adverse comment is one that explains why the
rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without a change. The comment period for the companion proposed rule
runs concurrently with the comment period of the direct final rule. Any
comments received on this companion proposed rule will also be treated
as comments on the direct final rule and vice versa.
    For additional information, see the corresponding direct final rule
published in the final rules section of this issue of the Federal
Register. All persons who may wish to comment should review the
rationale for these amendments set out in the preamble discussion of
the direct final rule. A comment recommending a rule change in addition
to this rule will not be considered a significant adverse comment
unless the comment states why this rule would be ineffective without
the additional change. If no significant adverse comment is received in
response to the direct final rule, no further action will be taken
related to this companion proposed rule. Instead, we will publish a
confirmation notice within 30 days after the comment period ends, and
we intend the direct final rule to become effective 30 days after
publication of the confirmation notice. If we receive significant
adverse comments, we will withdraw the direct final rule. We will
proceed to respond to all of the comments received regarding the direct
final rule, treating those comments as comments to this proposed rule.
The agency will address the comments in a subsequent final rule. We
will not provide additional opportunity for comment.

III. Analysis of Impacts

A. Review Under Executive Order 12866, the Regulatory Flexibility Act,
and the Unfunded Mandates Reform Act of 1995

    FDA has examined the impacts of this proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive order, because the rule, if finalized, would generally
either clarify the agency's longstanding interpretation of, or increase
latitude for manufacturers in complying with, preexisting CGMP
requirements.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this proposed rule, if finalized, would not
impose any new regulatory obligations, the agency tentatively certifies
that it would not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $122 million, using the most current (2005) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    The purpose of this proposed rule is to update the codified
language to reflect current practice and to harmonize requirements in
the CGMP regulations with requirements in other regulations. It would
not impose any additional requirements; therefore, industry would not
incur incremental compliance costs for these proposed changes.

B. Environmental Impact

    It is FDA's tentative conclusion that issuing these clarifying
amendments to the CGMP regulations would not have a significant impact
on the human environment. Therefore, FDA believes that an environmental
impact statement is not required.

C. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the rule does not contain policies that have substantial direct effects
on the States, on the relationship between the National Government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Accordingly, the agency has
tentatively concluded that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

IV. Paperwork Reduction Act of 1995

    The provisions of this proposed rule contain requirements that were
submitted for review and approval to the Director of the Office of
Management and Budget (OMB), as required by section 3507(d) of the
Paperwork Reduction Act of 1995. The requirements were approved and
assigned OMB control number 0910-0139.

V. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
This comment period runs concurrently with the comment period for the
direct final rule. Submit a single copy of electronic comments or two
paper copies of any mailed comments, except that any individuals may
submit one paper copy. Comments are to be identified 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.

List of Subjects

21 CFR Part 210

    Drugs, Packaging and containers

21 CFR Part 211

    Drugs, Labeling, Laboratories, Packaging and containers,
Prescription

drugs, Reporting and recordkeeping requirements, Warehouses.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 210 and 211 be amended as follows:

PART 210--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

    1. The authority citation for 21 CFR part 210 continues to read as
follows:

    Authority:  21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42
U.S.C. 216, 262, 263a, 264.
    2. Section 210.3 is amended by revising paragraph (b)(6) to read as
follows:

Sec.  210.3   Definitions.

    (b) * * *
    (6) Nonfiber releasing filter means any filter, which after
appropriate pretreatment such as washing or flushing, will not release
fibers into the component or drug product that is being filtered.
* * * * *

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED
PHARMACEUTICALS

    3. The authority citation for 21 CFR part 211 continues to read as
follows:

    Authority:  21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42
U.S.C. 216, 262, 263a, 264.
    4. Section 211.48 is amended by revising paragraph (a) to read as
follows:

Sec.  211.48   Plumbing.

    (a) Water supplied by the plumbing system of the facility must be
safe for human consumption. This water shall be supplied under
continuous positive pressure in a plumbing system free of defects that
could contribute contamination to any drug product.
* * * * *
    5. Section 211.67 is amended by revising paragraph (a) to read as
follows:

Sec.  211.67   Equipment cleaning and maintenance.

    (a) Equipment and utensils shall be cleaned, maintained, and
sanitized and/or sterilized at appropriate intervals to prevent
malfunctions or contamination that would alter the safety, identity,
strength, quality, or purity of the drug product beyond the official or
other established requirements.
* * * * *
    6. Section 211.68 is amended by adding paragraph (c) to read as
follows:

Sec.  211.68  Automatic, mechanical, and electronic equipment.

* * * * *
    (c) Such automated equipment used for performance of operations
addressed by Sec. Sec.  211.101(c) or (d), 211.103, 211.182, or
211.188(b)(11) can satisfy the requirements included in those sections
relating to the performance of an operation by one person and checking
by another person if such equipment is used in conformity with this
section and one person verifies that the operations addressed in those
sections are performed accurately by such equipment.
    7. Section 211.72 is revised to read as follows:

Sec.  211.72   Filters.

    Filters for liquid filtration used in the manufacture, processing,
or packing of injectable drug products intended for human use shall not
release fibers into such products. Fiber-releasing filters may not be
used in the manufacture, processing, or packing of these injectable
drug products unless it is not possible to manufacture such drug
products without the use of such filters. If use of a fiber-releasing
filter is necessary, an additional nonfiber-releasing filter of 0.22
micron maximum mean porosity (0.45 micron if the manufacturing
conditions so dictate) shall subsequently be used to reduce the content
of particles in the injectable drug product.
    8. Section 211.82 is amended by revising paragraph (b) to read as
follows:

Sec.  211.82   Receipt and storage of untested components, drug product
containers, and closures.

* * * * *
    (b) Components, drug product containers, and closures shall be
stored under quarantine until they have been tested or examined,
whichever is appropriate, and released. Storage within the area shall
conform to the requirements of Sec.  211.80.
    9. Section 211.84 is amended by revising paragraphs (c)(1), (d)(3),
and (d)(6) to read as follows:

Sec.  211.84   Testing and approval or rejection of components, drug
product containers, and closures.

* * * * *
    (c) * * *
    (1) The containers of components selected shall be cleaned when
necessary in a manner to prevent introduction of contaminants into the
component.
* * * * *
    (d) * * *
    (3) Containers and closures shall be tested for conformity with all
appropriate written specifications. In lieu of such testing by the
manufacturer, a certificate of testing may be accepted from the
supplier, provided that at least a visual identification is conducted
on such containers/closures by the manufacturer and provided that the
manufacturer establishes the reliability of the supplier's test results
through appropriate validation of the supplier's test results at
appropriate intervals.
* * * * *
    (6) Each lot of a component, drug product container, or closure
with potential for microbiological contamination that is objectionable
in view of its intended use shall be subjected to microbiological tests
before use.
* * * * *
    10. Section 211.94 is amended by revising paragraph (c) as follows:

Sec.  211.94  Drug product containers and closures.

* * * * *
    (c) Drug product containers and closures shall be clean and, where
indicated by the nature of the drug, sterilized and processed to remove
pyrogenic properties to assure that they are suitable for their
intended use. Such depyrogenation processes shall be validated.
* * * * *
    11. Section 211.101 is amended by revising paragraphs (c) and (d)
to read as follows:

Sec.  211.101   Charge-in of components.

* * * * *
    (c) Weighing, measuring, or subdividing operations for components
shall be adequately supervised. Each container of component dispensed
to manufacturing shall be examined by a second person to assure that:
    (1) The component was released by the quality control unit;
    (2) The weight or measure is correct as stated in the batch
production records;
    (3) The containers are properly identified. If the weighing,
measuring, or subdividing operations are performed by automated
equipment under Sec.  211.68, only one person is needed to assure
paragraphs (c)(1), (c)(2), and (c)(3) of this section.
    (d) Each component shall either be added to the batch by one person
and verified by a second person or, if the components are added by
automated equipment under Sec.  211.68, only verified by one person.
    12. Section 211.103 is revised to read as follows:

Sec.  211.103   Calculation of yield.

    Actual yields and percentages of theoretical yield shall be
determined at the conclusion of each appropriate phase of
manufacturing, processing, packaging, or holding of the drug product.
Such calculations shall either be performed by one person and
independently verified by a second person, or, if the yield is
calculated by automated equipment under Sec.  211.68, be independently
verified by one person.
    13. Section 211.110 is amended by revising paragraph (a)
introductory text and by adding paragraph (a)(6) to read as follows:

Sec.  211.110   Sampling and testing of in-process materials and drug
products.

    (a) To assure batch uniformity and integrity of drug products,
written procedures shall be established and followed that describe the
in-process controls, and tests, or examinations to be conducted on
appropriate samples of in-process materials of each batch. Such control
procedures shall be established to monitor the output and to validate
the performance of those manufacturing processes that may be
responsible for causing variability in the characteristics of in-
process material and the drug product. Such control procedures shall
include, but are not limited to, the following, where appropriate:
* * * * *
    (6) Bioburden testing.
* * * * *
    14. Section 211.113 is amended by revising paragraph (b) to read as
follows:

Sec.  211.113   Control of microbiological contamination.

* * * * *
    (b) Appropriate written procedures, designed to prevent
microbiological contamination of drug products purporting to be
sterile, shall be established and followed. Such procedures shall
include validation of all aseptic and sterilization processes.
    15. Section 211.160 is amended by revising paragraph (b)(1) to read
as follows:

Sec.  211.160  General requirements.

* * * * *
    (b) * * *
    (1) Determination of conformity to applicable written
specifications for the acceptance of each lot within each shipment of
components, drug product containers, closures, and labeling used in the
manufacture, processing, packing, or holding of drug products. The
specifications shall include a description of the sampling and testing
procedures used. Samples shall be representative and adequately
identified. Such procedures shall also require appropriate retesting of
any component, drug product container, or closure that is subject to
deterioration.
* * * * *
    16. Section 211.182 is revised to read as follows:

Sec.  211.182   Equipment cleaning and use log.

    A written record of major equipment cleaning, maintenance (except
routine maintenance such as lubrication and adjustments), and use shall
be included in individual equipment logs that show the date, time,
product, and lot number of each batch processed. If equipment is
dedicated to manufacture of one product, then individual equipment logs
are not required, provided that lots or batches of such product follow
in numerical order and are manufactured in numerical sequence. In cases
where dedicated equipment is employed, the records of cleaning,
maintenance, and use shall be part of the batch record. The persons
performing and double-checking the cleaning and maintenance (or, if the
cleaning and maintenance is performed using automated equipment under
Sec.  211.68, just the person verifying the cleaning and maintenance
done by the automated equipment) shall date and sign or initial the log
indicating that the work was performed. Entries in the log shall be in
chronological order.
    17. Section 211.188 is amended by revising paragraph (b)(11) to
read as follows:

Sec.  211.188   Batch production and control records.

* * * * *
    (b) * * *
    (11) Identification of the persons performing and directly
supervising or checking each significant step in the operation, or if a
significant step in the operation is performed by automated equipment
under Sec.  211.68, the identification of the person checking the
significant step performed by the automated equipment.
* * * * *

    Dated: November 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23292 Filed 12-3-07; 8:45 am]

BILLING CODE 4160-01-S


8/20/2012

Mr. David K. Paylor Virginia Department of Environmental Quality 629 East Main Street Richmond, Virginia 23219

Dear Director Paylor:

      On March 9, 2012, the U.S. Environmental Protection Agency (EPA) received a revision to the Virginia State Implementation Plan (SIP) from the Virginia Department of Environmental Quality (VADEQ).  The SIP revision addresses the infrastructure elements specified in section 110(a)(2)(A) through (M) of the Clean Air Act (CAA) which are necessary to implement, maintain, and enforce the 2008 lead national ambient air quality standards (NAAQS) in the Commonwealth of Virginia.  EPA has determined that the submittal is administratively and technically complete, and is reviewing it to prepare a Notice of Proposed Rulemaking (NPR).                  If members of your staff have any questions, they may direct them to Ms. Melissa Linden, Office of Air Program Planning, at<PHONE_NUMBER>, or<EMAIL_ADDRESS> She is the principal contact for this rulemaking.

                                    Sincerely,

							/s/ 							                                       	Diana Esher, Director                                     Air Protection Division

cc:  Michael Dowd, Air Division Director        Virginia Department of Environmental Quality


[Federal Register Volume 84, Number 52 (Monday, March 18, 2019)]
[Notices]
[Pages 9774-9775]
[FR Doc No: 2019-05008]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2014-0084; FRL-9989-98-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Coke Oven Pushing, Quenching, and
Battery Stacks (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NESHAP for Coke Oven Pushing,
Quenching, and Battery Stacks (EPA ICR Number 1995.07, OMB Control
Number 2060-0521), to the Office of Management and Budget (OMB) for
review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through March 31, 2019. Public comments were previously requested, via
the Federal Register, on May 30, 2018 during a 60-day comment period.
This notice allows for an additional 30 days for public comments. A
fuller description of the ICR is given below, including its estimated
burden and cost to the public. An agency may neither conduct nor
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before April 17,
2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2014-0084, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change, including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Coke Oven Pushing, Quenching, and Battery
Stacks (40 CFR part 63, subpart CCCCC) apply to pushing, soaking,
quenching, and battery stacks on both existing and new coke oven
batteries (coke plants) that are major sources of hazardous air
pollutant (HAP) emissions. New facilities include those that commenced
construction or reconstruction after the date of proposal. In general,
all NESHAP standards require initial notifications, performance tests,
and periodic reports by the owners/operators of the affected
facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance with 40 CFR part 63,
subpart CCCCC.
    Form Numbers: None.
    Respondents/affected entities: Owners or operators of coke oven
batteries at coke plants that are a major source of HAP.
    Respondent's obligation to respond: Mandatory (40 CFR 63, Subpart
CCCCC).
    Estimated number of respondents: 16 (total).
    Frequency of response: Initially, occasionally, quarterly and semi-
annual.
    Total estimated burden: 27,200 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $3,240,000 (per year), which includes
$143,000 in annualized capital/startup and/or operation & maintenance
costs.
    Changes in the Estimates: There is an adjustment increase in the
respondent burden as currently identified in the OMB Inventory of
Approved Burdens.

This increase is not due to any program changes. The increase in
estimated respondent burden is due to adjustment to more accurately
reflect the burden associated with rule requirements for observations
of opacity prior to pushing coke from an oven. The previous ICR
included an assumption that the burden for one respondent could not be
attributed to the rule based on voluntary monitoring conducted prior to
the final rule, and included person-hrs for this activity based on the
assumption that each coke plant has 2.8 batteries. This ICR estimates
burden for all respondents and adjusts the person-hrs to reflect one
hour per battery per coke plant per day, assuming 3.1 batteries per
coke plant, based on new data provided by Agency experts and confirmed
by industry representatives.
    The total annual responses have decreased due to a decrease in the
number of respondents, based on the closure of one facility in the past
three years, as identified by Agency experts and confirmed by trade
associations and facility representatives. There is also an adjustment
decrease in operating and maintenance costs, which is due to the
decrease in the number of respondents.
    Finally, there is a decrease in Agency burden from the prior ICR,
due to an adjustment to more accurately reflect the rule requirements
for quarterly reporting, which apply only to coke plants utilizing by-
product recovery ovens. The previous ICR included an assumption that
all coke plants, including those with non-recovery batteries, would
submit the quarterly report. This ICR includes the burden only for
those coke plants using by-product recovery ovens.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-05008 Filed 3-15-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Proposed Rules]
[Pages 44507-44508]
[FR Doc No: 2011-18889]

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

COMMODITY FUTURES TRADING COMMISSION

17 CFR Chapter I

SECURITIES AND EXCHANGE COMMISSION

17 CFR Chapter II

[Release No. 34-64939; File No. 4-636]

Joint Public Roundtable on International Issues Relating to the
Implementation of Title VII of the Dodd-Frank Wall Street Reform and
Consumer Protection Act

AGENCIES: Commodity Futures Trading Commission and Securities and
Exchange Commission.

ACTION: Notice of roundtable discussion; request for comment.

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

SUMMARY: On Monday, August 1, 2011, commencing at 9 a.m. and ending at
4 p.m., staff of Commodity Futures Trading Commission (``CFTC'') and
Securities and Exchange Commission (``SEC'') (each, an ``Agency,'' and
collectively, the ``Agencies'') will hold a public roundtable meeting
at which invited participants will discuss various international issues
related to the implementation of Title VII of the Dodd-Frank Wall
Street Reform and Consumer Protection Act.

DATES: The public roundtable meeting will be held on Monday, August 1,
2011.

ADDRESSES: The roundtable discussion will take place in the Conference
Center at the CFTC's headquarters, Three Lafayette Centre, 1155 21st
Street, NW., Washington, DC. The discussion will be open to the public
with seating made available on a first-come, first-served basis.
Members of the public may also listen to the meeting by telephone.
Call-in participants should be prepared to provide their first name,
last name and affiliation. The information for the conference call is
set forth below.
     U.S. toll-free:<PHONE_NUMBER>.
     International toll:<PHONE_NUMBER>.
     Passcode: 4316057.
    A transcript of the public roundtable discussion will be published
on the CFTC's Web site at http://www.cftc.gov/PressRoom/Events/2011/index.htm and on the SEC's Web site at http://www.sec.gov/news/press/2011/2011-151.htm.

FOR FURTHER INFORMATION CONTACT: The CFTC's Office of Public Affairs at
(202) 418-5080 or the SEC's Office of Public Affairs at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The roundtable discussion will take place on
Monday, August 1, 2011, commencing at 9 a.m. and ending at 4 p.m.
Members of the public who wish to comment on the topics addressed at
the discussion, may do so via:
     Paper submission to David Stawick, Secretary, Commodity
Futures Trading Commission, Three Lafayette Centre, 1155 21st Street,
NW., Washington, DC 20581, or Elizabeth M. Murphy, Secretary,
Securities and Exchange Commission, 100 F Street, NE., Washington, DC
20549-1090; or
     Electronic submission via visiting http://comments.cftc.gov/PublicComments/ReleasesWithComments.aspx and
submitting comments through the CFTC's Web site; and/or by e-mail to
<EMAIL_ADDRESS>(all e-mails must reference the file number 4-636
in the subject field) or through the comment form available at http://www.sec.gov/news/press/2011/2011-151.htm.
    All submissions will be reviewed jointly by the Agencies. All
comments must be in English or be accompanied by an English
translation. All

submissions provided to either Agency in any electronic form or on
paper will be published on the Web site of the respective Agency,
without review and without removal of personally identifying
information. Please submit only information that you wish to make
publicly available.

    By the Commodity Futures Trading Commission.

    Dated: July 21, 2011.
David A. Stawick,
Secretary.
    By the Securities and Exchange Commission.
    Dated: July 21, 2011.
Elizabeth M. Murphy,
 Secretary.
[FR Doc. 2011-18889 Filed 7-25-11; 8:45 am]
BILLING CODE 6351-01-P; 8011-01-P


[Federal Register Volume 84, Number 64 (Wednesday, April 3, 2019)]
[Notices]
[Pages 13037-13038]
[FR Doc No: 2019-06463]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 1984-223; 11162-131]

Wisconsin River Power Company; Wisconsin Power & Light Company;
Notice of Applications Accepted for Filing, Soliciting Comments,
Protests and Motions To Intervene

    Take notice that the following hydroelectric applications have been
filed with the Commission and are available for public inspection:
    a. Type of Proceeding: Extension of License Terms (Southern Basin).
    b. Project Nos.: P-1984-223 and P-11162-131.
    c. Date Filed: March 1, 2019.
    d. Licensees: Wisconsin River Power Company and Wisconsin Power and
Light Company.
    e. Names and Locations of the Projects: Petenwell and Castle Rock
(P-1984-223) and Prairie du Sac (P-11162-131) hydroelectric projects,
located on the Wisconsin River, in Adams, Columbia, Juneau, Sauk, and
Wood counties, Wisconsin.
    f. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    g. Licensees Contact Information: (P-1984-223) Mr. Jamie Nuthals,
Principal Environmental Consultant, WEC Business Services LLC, 700
North Adams Street, Green Bay, WI 54301,<PHONE_NUMBER>,
[email protected]; (P-11162-131) Mr. Brad Kulka,
Director of Operations, Central Region, Wisconsin Power and Light
Company, 4902 North Biltmore Lane, Madison, WI 53718,<PHONE_NUMBER>,
[email protected].
    h. FERC Contact: Mr. Ashish Desai,<PHONE_NUMBER>,
[email protected].
    i. Deadline for filing comments, motions to intervene and protests
is 30 days from the issuance date of this notice by the Commission. The
Commission strongly encourages electronic filing. Please file motions
to intervene, protests, comments, and recommendations, using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. The first page of any filing should include
docket number, for example, ``P-1984-223''.
    Note that you can file comments, motions to intervene, and protects
in response to both of the projects identified in the notice together
(i.e., one response for both projects) or you can respond to each
project individually.
    j. Description of Proceeding: On March 1, 2019, the Wisconsin River
Power Company, licensee for the Petenwell and Castle Rock Project No.
1984, and the Wisconsin Power & Light Company, licensee for the Prairie
du Sac Project No. 11162, filed requests to extend the license terms
for their respective projects located in the southern sub-basin of the
Wisconsin River.
    Currently, the 30-year license for the Petenwell and Castle Rock
Project expires on November 30, 2031 and the 30-year license for the
Prairie du Sac Project expires on May 31, 2032. The licensees seek
Commission approval to extend the license terms for the two projects so
they expire on June 30, 2041. The licensees say the extensions would
assist with the comprehensive study and analysis of the projects'
cumulative environmental impact and would reduce stakeholder burden by
integrating the relicensing consultation process. Additionally, the
licensees say that aligning the license expiration dates would
eliminate redundancies during relicensing for all involved parties as
both projects in the southern sub-basin have similar vegetation, land
cover, hydrology, and resource management concerns.
    The licensees' requests are part of a broader proposal to align the
license expiration dates for 20 projects on the Wisconsin River into
three groupings based on each project's location to facilitate
comprehensive study and analysis and coordinate relicensing as
discussed above. This public notice covers the two projects in the
southern sub-basin of the Wisconsin River. The Commission is issuing
two other public notices--one for eight projects in the northern sub-
basin of the Wisconsin River that would align these expiration dates so
they expire on June 30, 2035 and another public notice for 10 projects
in the central sub-basin of the Wisconsin River that would align the
license expiration dates to expire on June 30, 2038.
    k. This notice is available for review and reproduction at the
Commission in the Public Reference Room, Room 2A, 888 First Street NE,
Washington, DC 20426. The filing may also be viewed on the Commission's
website at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the
Docket number (for example, P-1984-223) excluding the last three digits
in the docket number field to access the notice. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call toll-free 1-866-208-3676
or email [email protected]. For TTY, call<PHONE_NUMBER>.
    l. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    m. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
and .214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    n. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title COMMENTS, PROTEST, or MOTION TO
INTERVENE as applicable; (2) set forth in the heading the name of the
applicant(s) and the project number(s) of the application to which the
filing responds; (3) furnish the name, address, and telephone number of
the person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. All comments, motions
to intervene, or protests must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). All comments,
motions to intervene, or protests should relate to the requests to
extend the license terms. Agencies may obtain copies of the
applications directly from the applicants. A copy of any protest or
motion to intervene must be served upon each representative of the
applicant specified in the particular application. If an intervener
files comments or documents with the Commission relating to the merits
of an issue that may affect the responsibilities of a particular
resource agency, they must also serve a copy of the document on that
resource agency. A copy of all other filings in reference to these
applications must be accompanied by

proof of service on all persons listed in the service list prepared by
the Commission in this proceeding, in accordance with 18 CFR 4.34(b)
and 385.2010.

    Dated: March 28, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-06463 Filed 4-2-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: September 26, 2007 (Volume 72, Number 186)]
[Notices]
[Page 54711-54712]
[DOCID:fr26se07-132]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2007-28416]

Agency Information Collection Activities; Revision of an Approved
Information Collection: Training Certification for Drivers of Longer
Combination Vehicles

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

ACTION: Notice; request for information.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for review
and approval. The ICR is titled, ``Training Certification for Drivers
of Longer Combination Vehicles (LCVs).'' This ICR is necessary because
the training certificate serves as proof that a driver has successfully
completed the training required before he or she may operate an LCV on
the Nation's highways. The hiring motor carrier is required to maintain
a copy of the training certificate in the LCV driver's qualification
file. The document is subject to review by Federal or State enforcement
officials. On June 28, 2007, FMCSA published a Federal Register notice
allowing for a 60-day comment period on the ICR. One comment was
received.

DATES: Please send your comments by October 26, 2007. OMB must receive
your comments by this date in order to act quickly on the ICR.

ADDRESSES: You may submit comments to the Office of Information and
Regulatory Affairs, Office of Management and Budget, 725 Seventeenth
Street, NW., Washington, DC 20503, Attention: DOT/FMCSA Desk Officer.

FOR FURTHER INFORMATION CONTACT: Robert F. Schultz, Jr., Transportation
Specialist, FMCSA, Telephone:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:
    Title: Training Certification for Drivers of Longer Combination
Vehicles.
    OMB Control Number: 2126-0026.
    Type of Request: Revision of a currently-approved information
collection.
    Respondents: Drivers who have completed the required LCV training
and driver instructors responsible for conducting the required LCV
training.
    Estimated Number of Respondents: 1,200 drivers who complete the
required LCV training each year; 6 driver instructors who must document
their qualifications to train new LCV drivers.
    Estimated Time per Response: 10 minutes for LCV drivers; 10 to 15
minutes for various LCV instructors.
    Expiration Date: September 30, 2007.
    Frequency of Response: Annual.
    Estimated Total Annual Burden: 203 hours. The FMCSA estimates that
10 minutes would be needed for newly certified LCV drivers to fulfill
the information collection requirement, resulting in an annual
information collection burden of 200 hours [1,200 LCV drivers x 10
minutes/60 minutes = 200 hours]. The estimated annual burden associated
with instructor certification would be 3 burden hours [(2 classroom
instructors x 10 minutes = 20 minutes) + (4 skills instructors x 15
minutes = 60 minutes) + (6 new instructors x 15 minutes administrative
burden per instructor certification = 90 minutes) = 170 minutes/60
minutes = 3 burden hours].
    Background: Section 4007(b) of the Motor Carrier Act of 1991 (Title
IV of the Intermodal Surface Transportation Efficiency Act of 1991
(ISTEA), Public Law 102-240, 105 Stat. 1914, 2152; 49 U.S.C. 31307)
required the Secretary of Transportation to establish Federal minimum
training requirements for drivers of LCVs. The responsibility for
implementing the statutory requirement was subsequently delegated to
FMCSA (49 CFR 1.73). On March 30, 2004, the FMCSA, in a final rule
entitled, ``Minimum Training Requirements for Longer Combination
Vehicle (LCV) Operators and LCV Driver-Instructor Requirements,''
adopted implementing regulations for minimum training requirements for
the operators of LCVs (69 FR 16722).
    The 2004 final rule created an information collection burden
concerning the certification of new, current and non-grandfathered LCV
drivers, as well as the certification of LCV driver-instructors. The
implementing regulations define an LCV as any combination of a truck-
tractor and two or more semi-trailers or trailers, which operate on the
National System of Interstate and Defense Highways (as defined in 23
CFR 470.107) with a gross vehicle weight greater than 80,000 pounds (49
CFR 380.105). The purpose of this rule is to enhance the safety of LCV
operations on our nation's highways.
    Drivers are required to present the training certificate to
prospective employers to prove they are certified to drive LCVs. Motor
carriers must not allow drivers to operate LCVs without ensuring the
drivers have been properly trained in accordance with the requirements
of 49 CFR part 380. Motor carriers must maintain a copy of the LCV
training certification form in the driver qualification file (49 CFR
380.401(b)). Motor carriers must be able to show Federal or State
enforcement officials that drivers responsible for operating such LCVs
are certified to do so, based on the training certificate in the driver
qualification file.
    On June 28, 2007 (72 FR 35537), FMCSA published a Federal Register
notice allowing for a 60-day comment period on the ICR. One comment was
received. The commenter was a truck driver who pointed out that the
skills of a truck driver are best learned by experience, not formal
training. He also pointed out that the motor carrier is required to
check the safety history of a new employee, and that such an analysis
will be more helpful in evaluating the skill level of a driver than a
certificate certifying participation in the requisite training. The
commenter did not discuss the information collection aspects of the LCV
rules.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for the FMCSA to enhance
the quality, usefulness, and clarity of the collected information; and
(4) ways that the

burden could be minimized without reducing the quality of the collected
information.

    Issued on: September 21, 2007.
Mary Powers-King,
Acting Associate Administrator for Research and Information Technology.
[FR Doc. E7-19016 Filed 9-25-07; 8:45 am]

BILLING CODE 4910-EX-P