[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)]
[Notices]
[Pages 58811-58815]
[FR Doc No: 2017-26932]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0362]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice Regulations for
Finished Pharmaceuticals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection for the Current
Good Manufacturing Practice Regulations for Finished Pharmaceuticals.

DATES: Submit either electronic or written comments on the collection
of information by February 12, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 12, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-N-0362 for ``Current Good Manufacturing Practice Regulations
for Finished Pharmaceuticals.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
office between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4)

ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.

Current Good Manufacturing Practice Regulations for Finished
Pharmaceuticals (21 CFR Parts 210 and 211)

OMB Control Number 0910-0139--Extension

    This information collection supports FDA regulations. Specifically,
under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the
methods used in or the facilities or controls used for its manufacture,
processing, packing, or holding do not conform to or are not operated
or administered in conformity with Current Good Manufacturing Practice
(CGMP). The CGMP regulations help ensure drug products meet the
statutory requirements for safety and have their purported or
represented identity, strength, quality, and purity characteristics.
The information collection requirements in the CGMP regulations provide
FDA with the necessary information to perform its duty to protect
public health and safety. CGMP requirements establish accountability
for manufacturing and processing drug products, provide for meaningful
FDA inspections, and enable manufacturers to improve the quality of
drug products over time. The CGMP recordkeeping requirements also serve
preventive and remedial purposes and provide crucial information if it
is necessary to recall a drug product.
    The general requirements for recordkeeping under part 211 (21 CFR
part 211) are set forth in Sec.  211.180. Any production, control, or
distribution record associated with a batch and required to be
maintained in compliance with part 211 must be retained for at least 1
year after the expiration date of the batch and, for certain over-the-
counter (OTC) drugs, 3 years after distribution of the batch (Sec.
211.180(a)). Records for all components, drug product containers,
closures, and labeling are required to be maintained for at least 1
year after the expiration date and 3 years for certain OTC products
(Sec.  211.180(b)).
    All part 211 records must be readily available for authorized
inspections during the retention period (Sec.  211.180(c)), and such
records may be retained either as original records or as true copies
(Sec.  211.180(d)). Additionally, Sec.  11.2(a) (21 CFR 11.2(a))
provides that ``for records required to be maintained but not submitted
to the Agency, persons may use electronic records in lieu of paper
records or electronic signatures in lieu of traditional signatures, in
whole or in part, provided that the requirements of this part are
met.'' To the extent this electronic option is used, the burden of
maintaining paper records should be substantially reduced, as should
any review of such records.
    To facilitate improvements and corrective actions, records must be
maintained so data can be used to evaluate the quality standards of
each drug product on at least an annual basis and determine whether to
change any drug product specifications or manufacturing or control
procedures (Sec.  211.180(e)). Written procedures for these evaluations
are to be established and include provisions for a review of a
representative number of batches and, where applicable, records
associated with the batch; provisions for a review of complaints,
recalls, returned or salvaged drug products; and investigations
conducted under Sec.  211.192 for each drug product.
    The specific information collection provisions are as follows:
     Section 211.34--Consultants advising on the manufacture,
processing, packing, or holding of drug products must have sufficient
education, training, and experience to advise on the subject for which
they are retained. Records must be maintained stating the name,
address, and qualifications of any consultants and the type of service
they provide.
     Section 211.67(c)--Records must be kept of maintenance,
cleaning, sanitizing, and inspection as specified in Sec. Sec.  211.180
and 211.182.
     Section 211.68--Appropriate controls must be exercised
over computer or related systems to assure that changes in master
production and control records or other records are instituted only by
authorized personnel.
     Section 211.68(a)--Records must be maintained of
calibration checks, inspections, and computer or related system
programs for automatic, mechanical, and electronic equipment.
     Section 211.68(b)--All appropriate controls must be
exercised over all computers or related systems and control data
systems to assure that changes in master production and control records
or other records are instituted only by authorized persons.
     Section 211.72--Filters for liquid filtration used in the
manufacture, processing, or packing of injectable drug products
intended for human use must not release fibers into such products.
     Section 211.80(d)--Each container or grouping of
containers for components or drug product containers or closures must
be identified with a distinctive code for each lot in each shipment
received. This code must be used in recording the disposition of each
lot. Each lot must be appropriately identified as to its status.
     Section 211.100(b)--Written production and process control
procedures must be followed in the execution of the various production
and process control functions and must be documented at the time of
performance. Any deviation from the written procedures must be recorded
and justified.
     Section 211.105(b)--Major equipment must be identified by
a distinctive identification number or code that must be recorded in
the batch production record to show the specific equipment used in the
manufacture of each batch of a drug product. In cases where only one of
a particular type of equipment exists in a manufacturing facility, the
name of the equipment may be used in lieu of a distinctive
identification number or code.
     Section 211.122(c)--Records must be maintained for each
shipment received of each different labeling and packaging material
indicating receipt, examination, or testing.
     Section 211.130(e)--Inspection of packaging and labeling
facilities must be made immediately before use to assure that all drug
products have been removed from previous operations. Inspection must
also be made to assure that packaging and labeling materials not
suitable for subsequent operations have been removed. Results of
inspection must be documented in the batch production records.
     Section 211.132(c)--Certain retail packages of OTC drug
products must bear a statement that is prominently placed so consumers
are alerted to the specific tamper-evident feature of the package. The
labeling statement is required to be so placed that it will be
unaffected if the tamper-resistant feature of the package is breached
or missing. If the tamper-evident feature chosen is one that uses an
identifying characteristic, that characteristic is required to be
referred to in the labeling statement.
     Section 211.132(d)--A request for an exemption from
packaging and labeling requirements by a manufacturer or packer is
required to be submitted in the form of a citizen petition under 21 CFR
10.30.
     Section 211.137--Requirements regarding product expiration
dating and compliance with 21 CFR 201.17.

     Section 211.160(a)--The establishment of any
specifications, standards, sampling plans, test procedures, or other
laboratory control mechanisms, including any change in such
specifications, standards, sampling plans, test procedures, or other
laboratory control mechanisms, must be drafted by the appropriate
organizational unit and reviewed and approved by the quality control
unit. These requirements must be followed and documented at the time of
performance. Any deviation from the written specifications, standards,
sampling plans, test procedures, or other laboratory control mechanisms
must be recorded and justified.
     Section 211.165(e)--The accuracy, sensitivity,
specificity, and reproducibility of test methods employed by a firm
must be established and documented. Such validation and documentation
may be accomplished in accordance with Sec.  211.194(a)(2).
     Section 211.166--Stability testing program for drug
products.
     Section 211.173--Animals used in testing components, in-
process materials, or drug products for compliance with established
specifications must be maintained and controlled in a manner that
assures their suitability for their intended use. They must be
identified, and adequate records must be maintained showing the history
of their use.
     Section 211.180(e)--Written records required by part 211
must be maintained so that data can be used for evaluating, at least
annually, the quality standards of each drug product to determine the
need for changes in drug product specifications or manufacturing or
control procedures. Written procedures must be established and followed
for such evaluations and must include provisions for a representative
number of batches, whether approved or unapproved or rejected, and a
review of complaints, recalls, returned or salvaged drug products, and
investigations conducted under Sec.  211.192 for each drug product.
     Section 211.180(f)--Procedures must be established to
assure that the responsible officials of the firm, if they are not
personally involved in or immediately aware of such actions, are
notified in writing of any investigations, conducted under Sec.
211.198, Sec.  211.204, or Sec.  211.208, any recalls, reports of
inspectional observations issued, or any regulatory actions relating to
good manufacturing practices brought by FDA.
     Section 211.182--Specifies requirements for equipment
cleaning records and the use log.
     Section 211.184--Specifies requirements for component,
drug product container, closure, and labeling records.
     Section 211.186--Specifies master production and control
records requirements.
     Section 211.188--Specifies batch production and control
records requirement.
     Section 211.192--Specifies the information that must be
maintained on the investigation of discrepancies found in the review of
all drug product production and control records by the quality control
staff.
     Section 211.194--Explains and describes laboratory records
that must be retained.
     Section 211.196--Specifies the information that must be
included in records on the distribution of the drug.
     Section 211.198--Specifies and describes the handling of
all complaint files received by the applicant.
     Section 211.204--Specifies that records be maintained of
returned and salvaged drug products and describes the procedures
involved.
    Written procedures, referred to here as standard operating
procedures (SOPs), are required for many part 211 records. Current SOP
requirements were initially provided in a final rule published in the
Federal Register of September 29, 1978 (43 FR 45014), and are now an
integral and familiar part of the drug manufacturing process. The major
information collection impact of SOPs results from their creation.
Thereafter, SOPs need to be periodically updated. A combined estimate
for routine maintenance of SOPs is provided in table 1. The 25 SOP
provisions under part 211 in the combined maintenance estimate include:
     Section 211.22(d)--Responsibilities and procedures of the
quality control unit;
     Section 211.56(b)--Sanitation procedures;
     Section 211.56(c)--Use of suitable rodenticides,
insecticides, fungicides, fumigating agents, and cleaning and
sanitizing agents;
     Section 211.67(b)--Cleaning and maintenance of equipment;
     Section 211.68(a)--Proper performance of automatic,
mechanical, and electronic equipment;
     Section 211.80(a)--Receipt, identification, storage,
handling, sampling, testing, and approval or rejection of components
and drug product containers or closures;
     Section 211.94(d)--Standards or specifications, methods of
testing, and methods of cleaning, sterilizing, and processing to remove
pyrogenic properties for drug product containers and closures;
     Section 211.100(a)--Production and process control;
     Section 211.110(a)--Sampling and testing of in-process
materials and drug products;
     Section 211.113(a)--Prevention of objectionable
microorganisms in drug products not required to be sterile;
     Section 211.113(b)--Prevention of microbiological
contamination of drug products purporting to be sterile, including
validation of any sterilization process;
     Section 211.115(a)--System for reprocessing batches that
do not conform to standards or specifications to insure that
reprocessed batches conform with all established standards,
specifications, and characteristics;
     Section 211.122(a)--Receipt, identification, storage,
handling, sampling, examination and/or testing of labeling and
packaging materials;
     Section 211.125(f)--Control procedures for the issuance of
labeling;
     Section 211.130--Packaging and label operations,
prevention of mixup and cross contamination, identification and
handling of filed drug product containers that are set aside and held
in unlabeled condition, and identification of the drug product with a
lot or control number that permits determination of the history of the
manufacture and control of the batch;
     Section 211.142--Warehousing;
     Section 211.150--Distribution of drug products;
     Section 211.160--Laboratory controls;
     Section 211.165(c)--Testing and release for distribution;
     Section 211.166(a)--Stability testing;
     Section 211.167--Special testing requirements;
     Section 211.180(f)--Notification of responsible officials
of investigations, recalls, reports of inspectional observations, and
any regulatory actions relating to good manufacturing practice;
     Section 211.198(a)--Written and oral complaint procedures,
including quality control unit review of any complaint involving
specifications failures, and serious and unexpected adverse drug
experiences;
     Section 211.204--Holding, testing, and reprocessing of
returned drug products; and
     Section 211.208--Drug product salvaging.
    In addition, the following regulations in parts 610 and 680 (21 CFR
parts 610 and 680) reference certain CGMP regulations in part 211:
Sec. Sec.  610.12(g),

610.13(a)(2), 610.18(d), 680.2(f), and 680.3(f). In table 1, the burden
associated with the information collection requirements in these
regulations is included in the burden estimates under Sec. Sec.
211.165, 211.167, 211.188, and 211.194, as appropriate.
    Although most CGMP provisions covered in this document were created
many years ago, some existing firms expanding into new manufacturing
areas and startup firms will need to create SOPs. As provided in table
1, FDA assumes approximately 50 firms will have to create up to 25 SOPs
for a total of 1,250 records, estimating 20 hours per recordkeeper to
create 25 new SOPs for a total of 25,000 hours.
    FDA estimates the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                Average
                                     Number of       Number of     Total annual     burden per
     21 CFR section/activity       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                   (in hours) \1\
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SOP Maintenance.................           3,270  ..............           3,270              25          81,750
New Startup SOPs................              50              25           1,250              20          25,000
211.34--Consultants.............           3,270            0.25             818               5            4090
211.67(c)--Equipment cleaning              3,270              50         163,500            0.25          40,875
 and maintenance................
211.68--Changes in master                  3,270               2           6,540               1           6,540
 production and control records
 or other records...............
211.68(a)--Automatic,                      3,270              10          32,700             0.5          16,350
 mechanical, and electronic
 equipment......................
211.68(b)--Computer or related             3,270               5          16,350            0.25           4,088
 systems........................
211.72--Filters.................             416            0.25             104               1             104
211.80(d)--Components and drug             3,270            0.25             818             0.1              82
 product containers or closures.
211.100(b)--Production and                 3,270               3           9,810               2          19,620
 process controls...............
211.105(b)--Equipment                      3,270            0.25             818            0.25             205
 identification.................
211.122(c)--Labeling and                   3,270              50         163,500            0.25          40,875
 packaging material.............
211.130(e)--Labeling and                   3,270              50         163,500            0.25          40,875
 packaging facilities...........
211.132(c)--Tamper-evident                 1,613              20          32,260             0.5          16,130
 packaging......................
211.132(d)--Tamper-evident                 1,613             0.2             323             0.5             162
 packaging......................
211.137--Expiration dating......           3,270               5          16,350             0.5           8,175
211.160(a)--Laboratory controls.           3,270               2           6,540               1           6,540
211.165(e)--Test methodology....           3,270               1           3,270               1           3,270
211.166--Stability testing......           3,270               2           6,540             0.5           3,270
211.173--Laboratory animals.....              33               1              33            0.25               8
211.180(e)--Production, control,           3,270             0.2             654            0.25             164
 and distribution records.......
211.180(f)--Procedures for                 3,270             0.2             654               1             654
 notification of regulatory
 actions........................
211.182--Equipment cleaning and            3,270               2           6,540            0.25           1,635
 use log........................
211.184--Component, drug product           3,270               3           9,810             0.5           4,905
 container, closure, and
 labeling records...............
211.186--Master production and             3,270              10          32,700               2          65,400
 control records................
211.188--Batch production and              3,270              25          81,750               2         163,500
 control records................
211.192--Discrepancies in drug             3,270               2           6,540               1           6,540
 product production and control
 records........................
211.194--Laboratory records.....           3,270              25          81,750             0.5          40,875
211.196--Distribution records...           3,270              25          81,750            0.25          20,438
211.198--Compliant files........           3,270               5          16,350               1          16,350
211.204--Returned drug products.           3,270              10          32,700             0.5          16,350
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    Total.......................  ..............  ..............  ..............  ..............         651,139
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\1\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

    The recordkeeping requirement estimates provided in table 2 are
specific to medical gases. In particular, on June 29, 2017, FDA
published a Notice of Availability (NOA) in the Federal Register
regarding revised draft guidance for industry entitled ``Current Good
Manufacturing Practice for Medical Gases'' (82 FR 29565). This guidance
is intended to help medical gas manufacturers comply with applicable
CGMP regulations found in parts 210 and 211. In the NOA for the revised
draft guidance, FDA noted the guidance includes information collection
provisions subject to review by the OMB under the PRA and, in
accordance with the PRA, before publication of the final guidance, FDA
intends to solicit public comment and obtain OMB approval for any
recommended new information collections or material modifications to
previously approved collections of information found in FDA
regulations. This notice is intended to solicit such public comment.
    The regulations addressed in table 2 are the same as those listed
in table 1, but the estimated information collection burden differs and
is specific to medical gas manufacturing. FDA estimates the burden of
this collection of information as follows:

                       Table 2--Estimated Annual Recordkeeping Burden (Medical Gases) \1\
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                                                                                Average
                                     Number of       Number of     Total annual     burden per
     21 CFR section/activity       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                   (in hours) \1\
----------------------------------------------------------------------------------------------------------------
SOP Maintenance.................           2,284            0.65           1,485              25          37,125
New startup SOPs................             100              25           2,500              20          50,000
211.34--Consultants.............           2,284            0.25             571             0.5             286
211.67(c)--Equipment cleaning              2,284            32.5          74,230            0.25          18,558
 and maintenance................
211.68--Changes in master                  2,284               2           4,568               1           4,568
 production and control records
 or other records...............
211.68(a)--Automatic,                      2,284              10          22,840             0.5          11,420
 mechanical, and electronic
 equipment......................
211.68(b)--Computer or related             2,284               5          11,420            0.25           2,855
 systems........................
211.72--Filters.................           2,284            0.25             571               1             571
211.80(d)--Components and drug             2,284            0.25             571             0.1              57
 product containers or closures.
211.100(b)--Production and                 2,284               3           6,382               2          13,704
 process controls...............
211.105(b)--Equipment                      2,284            0.25             571            0.25             143
 identification.................
211.122(c)--Labeling and                   2,284              50         114,200            0.25          28,550
 packaging material.............
211.130(e)--Labeling and                   2,284              50         114,200            0.25          28,550
 packaging facilities...........
211.132(c)--Tamper-evident                 2,284              20          45,680             0.5          22,840
 packaging......................
211.132(d)--Tamper-evident                 2,284             0.2             457             0.5             229
 packaging......................
211.137--Expiration dating......           2,284            3.25           7,423            0.33           2,450
211.160(a)--Laboratory controls.           2,284               2           4,568               1           4,568
211.165(e)--Test methodology....           2,284               1           2,284               1           2,284
211.166--Stability testing......           2,284             1.3           2,969            0.33             980
211.173--Laboratory animals.....           2,284               1           2,284            0.25             571
211.180(e)--Production, control,           2,284             0.2             457            0.25             114
 and distribution records.......
211.180(f)--Procedures for                 2,284             0.2             457               1             457
 notification of regulatory
 actions........................
211.182--Equipment cleaning and            2,284             1.3           2,969            0.16             475
 use log........................
211.184--Component, drug product           2,284            1.95           4,454            0.33           1,470
 container, closure, and
 labeling records...............
211.186--Master production and             2,284              10          22,840               2          45,680
 control records................
211.188--Batch production and              2,284           16.25          37,115             1.3          48,250
 control records................
211.192--Discrepancies in drug             2,284               2           4,568               1           4,568
 product production and control
 records........................
211.194--Laboratory records.....           2,284              25          57,100             0.5          28,550
211.196--Distribution records...           2,284              25          57,100            0.25          14,275
211.198--Complaint files........           2,284               5          11,420               1          11,420
211.204--Returned drug products.           2,284              10          22,840             0.5          11,420
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         396,988
----------------------------------------------------------------------------------------------------------------
\1\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

    Dated: December 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26932 Filed 12-13-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 63 (Friday, April 1, 2022)]
[Notices]
[Page 19152]
[FR Doc No: 2022-07068]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

TIME AND DATE: Notice is hereby given, pursuant to the provisions of
the Government in the Sunshine Act, Public Law 94-409, that the
Securities and Exchange Commission will hold an Open Meeting on
Wednesday, April 6, 2022 at 10:00 a.m.

PLACE: The meeting will be webcast on the Commission's website at
www.sec.gov.

STATUS: The meeting will begin at 10:00 a.m. (ET) and will be open to
the public via webcast on the Commission's website at www.sec.gov.

MATTERS TO BE CONSIDERED:  1. The Commission will consider whether to
propose rules under the Securities Exchange Act of 1934 for the
registration and regulation of security-based swap execution facilities
(``SBSEFs'') and related matters. The proposed rules would also address
the cross-border application of registration and execution requirements
for security-based swaps. Additionally, the Commission will consider
whether to propose rules designed to mitigate conflicts of interest at
SBSEFs and national securities exchanges that trade security-based
swaps.

CONTACT PERSON FOR MORE INFORMATION: For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact Vanessa A. Countryman from the Office of the Secretary
at<PHONE_NUMBER>.
    Authority: 5 U.S.C. 552b.

    Dated: March 30, 2022.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2022-07068 Filed 3-30-22; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register: November 9, 2007 (Volume 72, Number 217)]
[Notices]
[Page 63574-63575]
[DOCID:fr09no07-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12924-000]

FFP Project 33, LLC; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

November 2, 2007.
    Take notice that the following hydroelectric applications have been
filed with the Commission and are available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: P-12924-000.
    c. Date Filed: August 6, 2007.
    d. Applicant: FFP Project 33, LLC.
    e. Name of the Project: Newton Bend Project.
    f. Location: The project would be located on the Mississippi River
in Warren County, Mississippi and Tensas Parish, Louisiana. The project
uses no dam or impoundment.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicants Contact: Mr. Dan Irvin, FFP Project 33, LLC, 69
Bridge Street, Manchester, MA 01944, phone<PHONE_NUMBER>.
    i. FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-12924-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor 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.
    k. Description of Project: The proposed project would consist of:
(1) 4800 proposed 20-kilowatt Free Flow generating units having a total
installed capacity of 96-megawatts, (2) a proposed transmission line,
and (3) appurtenant facilities. The project would have an average
annual generation of 420.48-gigawatt-hours and be sold to a local
utility.
    l. Location of Application: A copy of the application is available
for inspection and reproduction at the Commission in the Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies Under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work

proposed under the preliminary permit would include economic analysis,
preparation of preliminary engineering plans, and a study of
environmental impacts. Based on the results of these studies, the
Applicant would decide whether to proceed with the preparation of a
development application to construct and operate the project.
    r. 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,
385.211, 385.214. 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.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov

under the ``e-Filing'' link.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the
Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    t. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-22026 Filed 11-8-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 165 (Friday, August 24, 2012)]
[Notices]
[Pages 51592-51593]
[FR Doc No: 2012-20855]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67695; File No. SR-NYSEMKT-2012-38]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Making Certain
Conforming Changes to Its Rules Following the Change in the Exchange's
Name From NYSE Amex LLC (``NYSE Amex'') to NYSE MKT LLC

August 20, 2012.
    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 August 9, 2012, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. 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

    The Exchange proposes to make certain conforming changes to its
rules following the change in the Exchange's name from NYSE Amex LLC
(``NYSE Amex'') to NYSE MKT LLC. The text of the proposed rule change
is available on the Exchange's Web site at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to make certain conforming changes to its
rules following the change in the Exchange's name from NYSE Amex to
NYSE MKT LLC.\3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 67037 (May 21,
2012), 77 FR 31415 (May 25, 2012) (SR-NYSEAmex-2012-32).
---------------------------------------------------------------------------

    As part of the Exchange's name change, the Exchange simplified
cross-references within the Exchange's rules. The Exchange shortened
references to ``NYSE Amex Equities'' to ``Equities'' (e.g., Rule 0--
NYSE Amex Equities became Rule 0--Equities). The Exchange proposes to
change several remaining cross-references to certain NYSE Amex Equities
rules in Rules 17--Equities, 80B--Equities, 107B--Equities, 107C--
Equities, 127--Equities, 128--Equities, 241--Equities, 250--Equities,
273--Equities, 432--Equities, and 502--Equities. Lastly, the Exchange
proposes to replace a reference to ``Amex'' in Rule 193 and references
to ``NYSE Amex Equities'' and ``NYSE Amex'' in Rule 107C--Equities with
references to ``Exchange.''
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Securities Exchange Act of 1934 (the
``Act''),\4\ in general, and Section 6(b)(5) of the Act,\5\ in
particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest. The Exchange is proposing certain conforming changes
that would make the rule text more uniform, which is in the public
interest.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing proposed rule change is concerned solely with the
administration of the Exchange pursuant to Section 19(b)(3)(A)(iii) \6\
of the Act and Rule 19b-4(f)(3) \7\ thereunder. Accordingly, the
proposal will take effect upon filing with the Commission. At any time
within 60 days of the filing of the proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \7\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

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 email to<EMAIL_ADDRESS>Please
include File Number SR-NYSEMKT-2012-38 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2012-38. This
file number should be included on the subject line if email 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 Web site viewing and printing 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 the
filing also will be available for inspection and copying at the
principal office of the Exchange. 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-NYSEMKT-2012-38 and should be submitted on or before
September 14, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-20855 Filed 8-23-12; 8:45 am]
BILLING CODE 8011-01-P


Tribal Governments” (65 FR 67249, November 6, 2000,) requires EPA to
develop an accountable process to ensure “meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.”  “Policies that have tribal implications” is
defined in the Executive Order to include regulations that have
“substantial direct effects on one or more Indian tribes, on the
relationship between the federal government and the Indian tribes, or on
the distribution of power and responsibilities between the federal
government and Indian tribes.”

	Today’s amendments to the conformity rule do not significantly or
uniquely affect the communities of Indian tribal governments, as the
Clean Air Act requires transportation conformity to apply in any area
that is designated nonattainment or maintenance by EPA.  This rule
amends the conformity rule to be consistent with Clean Air Act section
176(c) as amended by SAFETEA-LU.  The Clean Air Act amendments made by
SAFETEA-LU affect nonattainment and maintenance areas subject to
conformity requirements.  This rule does not have tribal implcations, as
specified in Executive Order 13175.  Accordingly, Executive Order 13175
does not apply to this rule.

	Executive Order 13045: Protection of Children from Environmental Health
and Safety Risks

	Executive Order 13045: “Protection of Children from Environmental
Health Risks and Safety Risks” (62 FR 19885, April 23, 1997,) applies
to any rule that: (1) is determined to be “economically significant”
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children.  If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.

	This rule is not subject to Executive Order 13045 because the Agency
does not have reason to believe the environmental health or safety risks
addressed by this action present a disproportionate risk to children.

	Executive Order 13211: Actions That Significantly Affect Energy Supply,
Distribution or Use

	This rule is not subject to Executive Order 13211, “Action Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use” (66 FR 28355; May 22, 2001) because it will not have a
significant adverse effect on the supply, distribution, or use of
energy.  Further, we have determined that this rule is not likely to
have any significant adverse effects on energy supply.

	National Technology Transfer and Advancement Act

	Section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (“NTTAA”), Public Law No. 104-113, section 12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical.  Voluntary consensus standards
are technical standards (e.g., material specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies.  The NTTAA directs EPA
to provide

Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.

	This action does not involve technical standards.  Therefore, EPA did
not consider the use of any voluntary consensus standards.

J.  Congressional Review Act

	The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.  EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.  A major rule cannot
take effect until 60 days after it is published in the Federal Register.
This action is not a “major rule” as defined by 5 U.S.C. 804(2).
This rule will be effective 30 days after it is published in the Federal
Register.

List of Subjects in 40 CFR Parts 51 and 93

Administrative practice and procedure, Air pollution control, Carbon
monoxide, Clean Air Act, Environmental protection, Highways and roads,
Intergovernmental relations, Mass transportation, Nitrogen Dioxide,
Ozone, Particulate matter, Transportation, Volatile organic compounds.

DATE: _________________________________

_____________________________________________

Stephen L. Johnson,

Administrator.

For the reasons set out in the preamble, 40 CFR parts 51 and 93 are
amended as follows:

PART 51 – [AMENDED]

1.  An authority citation for Subpart T of part 51 is added to read as
follows:

Authority:  42 U.S.C. 7401-7671q.

Subpart T – [Amended]

2.  Section 51.390 is revised to read as follows:

§51.390	Implementation plan revision.

(a) Purpose and applicability. The federal conformity rules under part
93, subpart A, of this chapter, in addition to any existing applicable
state requirements, establish the conformity criteria and procedures
necessary to meet the requirements of Clean Air Act section 176(c) until
such time as EPA approves the conformity implementation plan revision
required by this subpart.  A state with an area subject to this subpart
and part 93, subpart A, of this chapter must submit to EPA a revision to
its implementation plan which contains criteria and procedures for DOT,
MPOs and other state or local agencies to assess the conformity of
transportation plans, programs, and projects, consistent with this
subpart and part 93, subpart A, of this chapter.  The federal conformity
regulations contained in part 93, subpart A, of this chapter would
continue to apply for the portion of the requirements that the state did
not include in its conformity implementation plan and the portion, if
any, of the state's conformity provisions that is not approved by EPA.
In addition, any previously applicable implementation plan conformity
requirements remain enforceable until the state submits a revision to
its applicable implementation plan to specifically remove them and that
revision is approved by EPA.

(b) Conformity implementation plan content. To satisfy the requirements
of Clean Air Act section 176(c)(4)(E), the implementation plan revision
required by this section must include the following three requirements
of part 93, subpart A, of this chapter: §§93.105, 93.122(a)(4)(ii),
and 93.125(c).  A state may elect to include any other provisions of
part 93, subpart A.  If the provisions of the following sections of part
93, subpart A, of this chapter are included, such provisions must be
included in verbatim form, except insofar as needed to clarify or to
give effect to a stated intent in the revision to establish criteria and
procedures more stringent than the requirements stated in this chapter:
§§93.101, 93.102, 93.103, 93.104, 93.106, 93.109, 93.110, 93.111,
93.112, 93.113, 93.114, 93.115, 93.116, 93.117, 93.118, 93.119, 93.120,
93.121, 93.126, and 93.127.  A state's conformity provisions may contain
criteria and procedures more stringent than the requirements described
in this subpart and part 93, subpart A, of this chapter only if the
state's conformity provisions apply equally to non-federal as well as
federal entities.

(c) Timing and approval. A state must submit this revision to EPA by
November 25, 1994 or within 12 months of an area's redesignation from
attainment to nonattainment, if the state has not previously submitted
such a revision.  The state must also revise its conformity
implementation plan within 12 months of the date of publication of any
final amendments to §§93.105, 93.122(a)(4)(ii), and 93.125(c), as
appropriate.  Any other portions of part 93, subpart A, of this chapter
that the state has included in its conformity implementation plan and
EPA has approved must be revised in the state’s implementation plan
and submitted to EPA within 12 months of the date of publication of any
final amendments to such sections.  EPA will provide DOT with a 30-day
comment period before taking action to approve or disapprove the
submission.  In order for EPA to approve the implementation plan
revision submitted to EPA under this subpart, the plan revision must
address and give full legal effect to the following three requirements
of part 93, subpart A: §§93.105, 93.122(a)(4)(ii), and 93.125(c). Any
other provisions that are incorporated into the conformity
implementation plan must also be done in a manner that gives them full
legal effect.  Following EPA approval of the state conformity provisions
(or a portion thereof) in a revision to the state’s conformity
implementation plan, conformity determinations will be governed by the
approved (or approved portion of the) state criteria and procedures as
well as any applicable portions of the federal conformity rules that are
not addressed by the approved conformity SIP.

PART 93 – [AMENDED]

3.  The authority citation for part 93 continues to read as follows:

Authority:  42 U.S.C. 7401-7671q.

4.  Section 93.101 is amended by:

a.  Revising the definitions for “Metropolitan planning organization
(MPO)” and “Transportation improvement program (TIP)”; and

b.  Revising the first sentence of the definition for “Transportation
control measure (TCM)”.

The revisions read as follows:

  SEQ CHAPTER \h \r 1 §93.101 Definitions.

* * * * *

	Metropolitan planning organization (MPO) means the policy board of an
organization created as a result of the designation process in 23 U.S.C.
134(d).

* * * * *

Transportation control measure (TCM) is any measure that is specifically
identified and committed to in the applicable implementation plan,
including a substitute or additional TCM that is incorporated into the
applicable SIP through the process established in CAA section 176(c)(8),
that is either one of the types listed in CAA section 108, or any other
measure for the purpose of reducing emissions or concentrations of air
pollutants from transportation sources by reducing vehicle use or
changing traffic flow or congestion conditions. * * *

	Transportation improvement program (TIP) means a transportation
improvement program developed by a metropolitan planning organization
under 23 U.S.C. 134(j).

* * * * *

§93.102	[Amended]

5.  Section 93.102 is amended as follows:

a.  In paragraph (b)(2)(v), revising “sulfur oxides (SOx)” to read
“sulfur dioxide (SO2)”; and

b.  In paragraph (b)(4), revising “for 20 years from the date EPA
approves the area’s request under section 107(d) of the CAA for
redesignation to attainment” to read “through the last year of a
maintenance area’s approved CAA section 175A(b) maintenance plan”.

6.  Section 93.104 is amended as follows:

	a.  By revising paragraphs (b)(2), (b)(3), and (c)(3);

b.  By revising paragraph (e) introductory text; and

c.  By adding paragraph (f).

The revisions read as follows:

§93.104 Frequency of conformity determinations.

* * * * *

(b) * * *

(1) * * *

(2) All transportation plan amendments must be found to conform before
the transportation plan amendments are approved by the MPO or accepted
by DOT, unless the amendment merely adds or deletes exempt projects
listed in §93.126 or §93.127.  The conformity determination must be
based on the transportation plan and the amendment taken as a whole.

	(3) The MPO and DOT must determine the conformity of the transportation
plan (including a new regional emissions analysis) no less frequently
than every four years.  If more than four years elapse after DOT’s
conformity determination without the MPO and DOT determining conformity
of the transportation plan, a 12-month grace period will be implemented
as described in paragraph (f) of this section.  At the end of this
12-month grace period, the existing conformity determination will lapse.

	(c) * * *

	(3) The MPO and DOT must determine the conformity of the TIP (including
a new regional emissions analysis) no less frequently than every four
years. If more than four years elapse after DOT’s conformity
determination without the MPO and DOT determining conformity of the TIP,
a 12-month grace period will be implemented as described in paragraph
(f) of this section.  At the end of this 12-month grace period, the
existing conformity determination will lapse.

* * * * *

	(e) Triggers for transportation plan and TIP conformity determinations.
Conformity of existing transportation plans and TIPs must be
redetermined within two years of the following, or after a 12-month
grace period (as described in paragraph (f) of this section) the
existing conformity determination will lapse, and no new project-level
conformity determinations may be made until conformity of the
transportation plan and TIP has been determined by the MPO and DOT:

* * * * *

	(f) Lapse grace period.  During the 12-month grace period referenced in
paragraphs (b)(3), (c)(3), and (e) of this section, a project may be
found to conform according to the requirements of this part if:

(1) the project is included in the currently conforming transportation
plan and TIP (or regional emissions analysis); or

(2) the project is included in the most recent conforming transportation
plan and TIP (or regional emissions analysis).

§93.105	[Amended]

7.	Section 93.105 is amended by removing “revisions or” in paragraph
(c)(1)(v), and by revising the reference “23 CFR 450.316(b)” in
paragraph (e) to read as “23 CFR 450.316(a)”.

8.  Section 93.106 is amended as follows:

a.  By revising the section heading;

b.  By revising paragraphs (a)(1)(iii) and (iv);

c.  By adding new paragraph (a)(v);

d.  By redesignating paragraph (d) as paragraph (e); and

e.  By adding new paragraph (d).

The revisions read as follows:

§93.106 Content of transportation plans and timeframe of conformity
determinations.

(a) * * *

(1) * * *

	(iii) The attainment year must be a horizon year if it is in the
timeframe of the transportation plan and conformity determination;

	(iv) The last year of the transportation plan’s forecast period must
be a horizon year; and

	(v) If the timeframe of the conformity determination has been shortened
under paragraph (d) of this section, the last year of the timeframe of
the conformity determination must be a horizon year.

* * * * *

	(d) Timeframe of conformity determination.

(1) Unless an election is made under paragraph (d)(2) or (d)(3) of this
section, the timeframe of the conformity determination must be through
the last year of the transportation plan’s forecast period.

(2) For areas that do not have an adequate or approved CAA section
175A(b) maintenance plan, the MPO may elect to shorten the timeframe of
the transportation plan and TIP conformity determination, after
consultation with state and local air quality agencies, solicitation of
public comments, and consideration of such comments.

(i) The shortened timeframe of the conformity determination must extend
at least to the latest of the following years:

(A)  The tenth year of the transportation plan;

(B)  The latest year for which an adequate or approved motor vehicle
emissions budget(s) is established in the submitted or applicable
implementation plan; or

(C)	The year after the completion date of a regionally significant
project if the project is included in the TIP or the project requires
approval before the subsequent conformity determination.

(ii)  The conformity determination must be accompanied by a regional
emissions analysis (for informational purposes only) for the last year
of the transportation plan and for any year shown to exceed motor
vehicle emissions budgets in a prior regional emissions analysis, if
such a year extends beyond the timeframe of the conformity
determination.

(3)  For areas that have an adequate or approved CAA section 175A(b)
maintenance plan, the MPO may elect to shorten the timeframe of the
conformity determination to extend through the last year of such
maintenance plan after consultation with state and local air quality
agencies, solicitation of public comments, and consideration of such
comments.

(4)  Any election made by an MPO under paragraphs (d)(2) or (d)(3) of
this section shall continue in effect until the MPO elects otherwise,
after consultation with state and local air quality agencies,
solicitation of public comments, and consideration of such comments.

* * * * *

§93.109	[Amended]

9.  Section 93.109 is amended as follows:

a.  By removing “, subject to the exception in paragraph (e)(2)(v)”
in the introductory text of paragraph (e)(2);

b.  By removing paragraph (e)(2)(v); and

c.  By revising in paragraph (l)(2)(i) “§§93.118 and 93.119” to
read “§§93.106(d), 93.116, 93.118, and 93.119” and by adding to
the end of this same paragraph, “When the requirements of §93.106(d)
apply to isolated rural nonattainment and maintenance areas, references
to “MPO” should be taken to mean the state department of
transportation.”

10.  Section 93.114 is amended by revising the introductory text to read
as follows:

§ 93.114   Criteria and procedures: Currently conforming transportation
plan and TIP.

	There must be a currently conforming transportation plan and currently
conforming TIP at the time of project approval, or a project must meet
the requirements in §93.104(f) during the 12-month lapse grace period.

* * * * *

11.  Section 93.115 is amended by revising the section heading and
adding a new paragraph (e) to read as follows:

§ 93.115   Criteria and procedures: Projects from a transportation plan
and TIP.

* * * * *

	(e) Notwithstanding the requirements of paragraphs (a), (b), and (c) of
this section, a project must meet the requirements of §93.104(f) during
the 12-month lapse grace period.

12.  Section 93.116 is amended by removing in paragraph (a) “(or
regional emissions analysis)”.

13.  Section 93.118 is amended as follows:

a.  By revising paragraph (b) introductory text;

b.  By revising the first sentence in paragraph (d)(2); and

c.  By adding new paragraph (d)(3).

The revisions read as follows:

§93.118 Criteria and procedures: Motor vehicle emissions budget.

* * * * *

	(b) Consistency with the motor vehicle emissions budget(s) must be
demonstrated for each year for which the applicable (and/or submitted)
implementation plan specifically establishes motor vehicle emissions
budget(s), for the attainment year (if it is within the timeframe of the
transportation plan and conformity determination), for the last year of
the timeframe of the conformity determination (as described under
§93.106(d)), and for any intermediate years within the timeframe of the
conformity determination as necessary so that the years for which
consistency is demonstrated are no more than ten years apart, as
follows:

* * * * *

	(d) * * *

	(2) The regional emissions analysis may be performed for any years in
the timeframe of the conformity determination (as described under
§93.106(d)) provided they are not more than ten years apart and
provided the analysis is performed for the attainment year (if it is in
the timeframe of the transportation plan and conformity determination)
and the last year of the timeframe of the conformity determination. * *
*

(3) When the timeframe of the conformity determination is shortened
under §93.106(d)(2), the conformity determination must be accompanied
by a regional emissions analysis (for informational purposes only) for
the last year of the transportation plan, and for any year shown to
exceed motor vehicle emissions budgets in a prior regional emissions
analysis (if such a year extends beyond the timeframe of the conformity
determination).

* * * * *

14.  Section 93.119 is amended to read as follows:

	a. In paragraph (f)(10), by revising “SOx” to read “SO2”;

	b. By revising the last sentence in paragraph (g)(1); and

	c. By adding new paragraph (g)(3).

	The revisions read as follows:

§93.119  Criteria and procedures: Interim emissions in areas without
motor vehicle emissions budgets.

* * * * *

	(g) * * *

	(1) * * * The last year of the timeframe of the conformity
determination (as described under §93.106(d)) must also be an analysis
year.

* * * * *

(3) When the timeframe of the conformity determination is shortened
under §93.106(d)(2), the conformity determination must be accompanied
by a regional emissions analysis (for informational purposes only) for
the last year of the transportation plan.

* * * * *

15.  Section 93.120 is amended by revising paragraph (a)(2) to read as
follows:

§93.120	Consequences of control strategy implementation plan failures.

	(a) * * *

	(1) * * *

	(2)  If EPA disapproves a submitted control strategy implementation
plan revision without making a protective finding, only projects in the
first four years of the currently conforming transportation plan and TIP
or that meet the requirements of §93.104(f) during the 12-month lapse
grace period may be found to conform.  This means that beginning on the
effective date of a disapproval without a protective finding, no
transportation plan, TIP, or project not in the first four years of the
currently conforming transportation plan and TIP or that meets the
requirements of §93.104(f) during the 12-month lapse grace period may
be found to conform until another control strategy implementation plan
revision fulfilling the same CAA requirements is submitted, EPA finds
its motor vehicle emissions budget(s) adequate pursuant to §93.118 or
approves the submission, and conformity to the implementation plan
revision is determined.

16.  Section 93.121 is amended by revising paragraphs (a)(1) and (2) to
read as follows:

§ 93.121   Requirements for adoption or approval of projects by other
recipients of funds designated under title 23 U.S.C. or the Federal
Transit Laws.

	(a) * * *

	(1) The project comes from the currently conforming transportation plan
and TIP (or meets the requirements of §93.104(f) during the 12-month
lapse grace period), and the project's design concept and scope have not
changed significantly from those that were included in the regional
emissions analysis for that transportation plan and TIP;

	(2) The project is included in the regional emissions analysis for the
currently conforming transportation plan and TIP conformity
determination (or meets the requirements of §93.104(f) during the
12-month lapse grace period), even if the project is not strictly
included in the transportation plan or TIP for the purpose of MPO
project selection or endorsement, and the project's design concept and
scope have not changed significantly from those that were included in
the regional emissions analysis; or

* * * * *

17.  Section 93.123 is amended by adding paragraph (a)(3) and revising
paragraph (b)(1)(i) to read as follows:

§93.123	Procedures for determining localized CO, PM10, and PM2.5
concentrations (hot-spot analysis).

	(a) * * *

(3) DOT, in consultation with EPA, may also choose to make a categorical
hot-spot finding that (93.116(a) is met without further hot-spot
analysis for any project described in paragraphs (a)(1) and (a)(2) of
this section based on appropriate modeling.  DOT, in consultation with
EPA, may also consider the current air quality circumstances of a given
CO nonattainment or maintenance area in categorical hot-spot findings
for applicable FHWA or FTA projects.

	(b) * * *

(1) * * *

(i) New highway projects that have a significant number of diesel
vehicles, and expanded highway projects that have a significant increase
in the number of diesel vehicles;

* * * * *

§93.126	[Amended]

18.  Section 93.126, Table 2 is amended by revising “Hazard
elimination program” to read “Projects that correct, improve, or
eliminate a hazardous location or feature”, “Safety improvement
program” to read “Highway Safety Improvement Program
implementation”, and “Pavement marking demonstration” to read
“Pavement marking”.

	40 CFR 93.102(b)(1) defines PM2.5 and PM10 as particles with an
aerodynamic diameter less than or equal to a nominal 2.5 and 10
micrometers, respectively.

 	Note that the TCM portion of the February 14, 2006, guidance is not
covered in today’s final rule, but in an updated guidance document
that will be available on EPA’s Website at   HYPERLINK
"http://www.epa.gov/otaq/stateresources/transconf/policy.htm"
http://www.epa.gov/otaq/stateresources/transconf/policy.htm  .

 By the phrase “meet conformity requirements,” EPA means that
FHWA/FTA projects can be found to conform, and non-federal projects can
be approved.

 	These scenarios are consistent with those highlighted in EPA and
DOT’s joint February 14, 2006, interim guidance, which is superceded
by today’s final rule.

   For example, an MPO may want to amend its TIP before the
transportation plan expires to allow projects from the fifth year of the
transportation plan to proceed during the lapse grace period.  The
conformity determination for such an amended TIP would have to be made
before the lapse grace period begins, but the determination could rely
on the previous regional emissions analysis as long as the requirements
of 40 CFR 93.122(g) are met.

	This one-year grace period for newly designated areas most recently
applied to the areas designated for the 8-hour ozone and PM2.5
standards.  All of these metropolitan areas have at this point
determined transportation plan/TIP conformity.

 	Such disapprovals occur infrequently; EPA has only disapproved SIPs
without a protective finding in three instances since the 1997
conformity rule was promulgated.

 	The amendment to the Clean Air Act that allows areas to shorten the
timeframe of conformity determinations, Clean Air Act section 176(c)(7),
requires the MPO to consult with “the air pollution control agency.”
 For the reasons explained in the May 2, 2007, proposed rule (72 FR
24479 and 27780), EPA is using the equivalent term “state and local
air quality agencies” in this preamble and final rule.

 Donut areas are defined as “geographic areas outside a metropolitan
planning area boundary, but inside the boundary of a nonattainment or
maintenance area that contains any part of a metropolitan area(s)…”
(40 CFR 93.101).

 Joint Explanatory Statement of the Committee of Conference, “Section
6011, Transportation Conformity,” p. 1059.

 As discussed further below, categorical hot-spot findings under the
proposal could not be used to meet 40 CFR 93.116(b) requirements in the
limited number of CO areas without approved attainment demonstrations or
maintenance plans.

 	For additional information about PM2.5 and PM10 hot-spot analysis
requirements, including regulations, guidance, and Q and As, see
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[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)]
[Notices]
[Pages 48299-48300]
[FR Doc No: 2018-20684]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC18-16-000]

Commission Information Collection Activities (FERC-567); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection, FERC-567 [Gas Pipeline Certificates: Annual
Reports of System Flow Diagrams and System Capacity], which will be
submitted to the Office of Management and Budget (OMB) for a review of
the information collection requirements.

DATES: Comments on the collection of information are due October 24,
2018.

ADDRESSES: Comments filed with OMB, identified by OMB Control No. 1902-
0005, should be sent via email to the Office of Information and
Regulatory Affairs: [email protected]. Attention: Federal Energy
Regulatory Commission Desk Officer. The Desk Officer may also be
reached via telephone at<PHONE_NUMBER>.
    A copy of the comments should also be sent to the Commission, in
Docket No. IC18-16-000 by either of the following methods:
     eFiling at Commission's website: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at [email protected], or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
[email protected], telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-567, Gas Pipeline Certificates: Annual Reports of
System Flow Diagrams and System Capacity.
    OMB Control No.: 1902-0005.
    Type of Request: Three-year extension of the FERC-567 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: The Commission uses the information from the FERC-567 to
obtain accurate data on pipeline facilities and the peak capacity of
these facilities. Additionally, the Commission validates the need for
new facilities proposed by pipelines in certificate applications. By
modeling an applicant's pipeline system, Commission staff utilizes the
FERC-567 data to determine configuration and location of installed
pipeline facilities; verify and determine the receipt and delivery
points between shippers, producers and pipeline companies; determine
the location of receipt and delivery points and emergency
interconnections on a pipeline system; determine the location of
pipeline segments, laterals and compressor stations on a pipeline
system; verify pipeline segment lengths and pipeline diameters; justify
the maximum allowable operating pressures and suction and discharge
pressures at compressor stations; verify the installed horsepower and
volumes compressed at each compressor station; determine the existing
shippers and producers currently using each pipeline company; verify
peak capacity on the system; and develop and evaluate alternatives to
the proposed facilities as a means to mitigate environmental impact of
new pipeline construction.
    18 Code of Federal Regulations (CFR) 260.8(a) requires each major
natural gas pipeline with a system delivery capacity exceeding 100,000
Mcf \1\ per day to submit by June 1 of each year, diagrams reflecting
operating conditions on the pipeline's main transmission system during
the previous 12 months ended December 31. These physical/engineering
data are not included as part of any other data collection requirement.
---------------------------------------------------------------------------

    \1\ Mcf = Thousand cubic feet.
---------------------------------------------------------------------------

    Type of Respondents: Applicants with a system delivery capacity in
excess of 100,000 Mcf per day.
    Estimate of Annual Burden:\2\ The Commission estimates the annual
public reporting burden for the information collection as:
---------------------------------------------------------------------------

    \2\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, reference 5 Code of Federal Regulations 1320.3.
    \3\ The estimates for cost per response are derived using the
following formula: 2018 Average Burden Hours per Response * $79 per
Hour = Average Cost per Response. The hourly cost figure of $79 is
the 2018 average FERC hourly cost for wages plus benefits. We assume
for FERC-567 that respondents earn at a similar rate.

                             FERC-567--Gas Pipeline Certificates: Annual Reports of System Flow Diagrams and System Capacity
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total annual
                                                         Number of     Annual number   Total number of  Average burden  burden hours and     Cost per
                                                        respondents    of responses       responses      and cost per     total annual    respondent ($)
                                                                      per respondent                     response \3\         cost
                                                                 (1)             (2)   (1) * (2) = (3)             (4)   (3) * (4) = (5)       (5) / (1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Natural Gas.........................................             121               1               121               3               363            $237
Pipelines...........................................  ..............  ..............  ................            $237           $28,677  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: September 12, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-20684 Filed 9-21-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: April 1, 2008 (Volume 73, Number 63)]
[Rules and Regulations]
[Page 17249]
[DOCID:fr01ap08-5]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2008-0111]

Drawbridge Operation Regulations; Piscataqua River, Portsmouth,
NH, and Kittery, ME

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Memorial (US 1) Bridge across the Piscataqua River at mile 3.5, between
Portsmouth, New Hampshire and Kittery, Maine. Under this temporary
deviation, the bridge may remain in the closed position. This deviation
is necessary to facilitate scheduled bridge maintenance.

DATES: This deviation is effective from 7 a.m. on April 21, 2008
through 7 a.m. on April 26, 2008.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-0111 and are available online
at http://www.regulations.gov. They are also available for inspection
or copying at two locations: The Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays, and
the First Coast Guard District, Bridge Branch Office, 408 Atlantic
Avenue, Boston, Massachusetts 02110, between 7 a.m. and 2 p.m., Monday
through Friday, except Federal holidays. The telephone number is (617)
223-8364.

FOR FURTHER INFORMATION CONTACT: John McDonald, Project Officer, First
Coast Guard District, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Memorial (US 1) Bridge, across the
Piscataqua River at mile 3.5, between Portsmouth, New Hampshire and
Kittery, Maine, has a vertical clearance in the closed position of 11
feet at mean high water and 19 feet at mean low water. The existing
drawbridge operation regulations are listed at 33 CFR 117.531.
    The owner of the bridge, New Hampshire Department of
Transportation, requested a temporary deviation to facilitate scheduled
bridge maintenance, counterweight rope replacement.
    Under this temporary deviation, in effect from 7 a.m. on April 21,
2008 through 7 a.m. on April 26, 2008, the Memorial (US 1) Bridge may
remain in the closed position. Vessels that can pass under the bridge
without a bridge opening may do so at all times.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.
    Should the bridge maintenance authorized by this temporary
deviation be completed before the end of the effective period published
in this notice, the Coast Guard will rescind the remainder of this
temporary deviation, and the bridge shall be returned to its normal
operating schedule. Notice of the above action shall be provided to the
public in the Local Notice to Mariners and the Federal Register, where
practicable.

    Dated: March 20, 2008.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
 [FR Doc. E8-6616 Filed 3-31-08; 8:45 am]

BILLING CODE 4910-15-P