[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Page 63766]
[FR Doc No: 2015-26728]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP16-32-000.
    Applicants: Trunkline Gas Company, LLC.
    Description: Compliance filing Annual Report of Flow Through filed
10-6-15.
    Filed Date: 10/6/15.
    Accession Number: 20151006-5158.
    Comments Due: 5 p.m. ET 10/19/15.

    Docket Numbers: RP16-33-000.
    Applicants: Gulfstream Natural Gas System, L.L.C.
    Description: Section 4(d) Rate Filing: 1Line Agreement Filing to be
effective 10/30/2015.
    Filed Date: 10/7/15.
    Accession Number: 20151007-5056.
    Comments Due: 5 p.m. ET 10/19/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 7, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-26728 Filed 10-20-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37317-37321]
[FR Doc No: 2019-16260]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2544]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Current Good Manufacturing Practice
Quality System Regulation

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 recordkeeping requirements related to the
medical devices current good manufacturing practice (CGMP) quality
system (QS) regulation (CGMP/QS regulation).

DATES: Submit either electronic or written comments on the collection
of information by September 30, 2019.

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 September 30, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 30, 2019. 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-2016-N-2544 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Devices; Current Good
Manufacturing Practice Quality System Regulation.'' 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 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Medical Devices: Current Good Manufacturing Practice Quality System
Regulation--21 CFR Part 820

OMB Control Number 0910-0073--Extension

    Under section 520(f) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(f)), the Secretary of the Department of
Health and Human Services has the authority to prescribe regulations
requiring that the methods used in, and the facilities and controls
used for, the manufacture, preproduction design validation (including a
process to assess the performance of a device, but not including an
evaluation of the safety and effectiveness of a device), packing,
storage, and installation of a device conform to CGMP, as described in
such regulations, to assure that the device will be safe and effective
and otherwise in compliance with the FD&C Act.
    The CGMP/QS regulation implementing authority provided by this
statutory provision is found under part 820 (21 CFR part 820) and sets
forth basic CGMP requirements governing the design, manufacture,
packing, labeling, storage, installation, and servicing of all finished
medical devices intended for human use. The authority for this
regulation is covered under sections 501, 502, 510, 513, 514, 515, 518,
519, 520, 522, 701, 704, 801, and 803 of the FD&C Act (21 U.S.C. 351,
352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, and
383). The CGMP/QS regulation includes requirements for purchasing and
service controls, clarifies recordkeeping requirements for device
failure and complaint investigations, clarifies requirements for
verifying/validating production processes and process or product
changes, and clarifies requirements for product acceptance activities
quality data evaluations and corrections of nonconforming product/
quality problems.
    Requirements are compatible with specifications in the
international standards ``ISO 9001: Quality Systems Model for Quality
Assurance in Design/Development, Production, Installation, and
Servicing.'' The CGMP/QS information collections will assist FDA
inspections of manufacturers for compliance with QS requirements
encompassing design, production, installation, and servicing processes.
    Section 820.20(a) through (e) requires management with executive
responsibility to establish, maintain, and/or review the following
topics: (1) The quality policy, (2) the organizational structure, (3)
the quality plan, and (4) the quality system procedures of the
organization. Section 820.22 requires the conduct and documentation of
QS audits and reaudits. Section 820.25(b) requires the establishment of
procedures to identify training needs and documentation of such
training.
    Section 820.30(a)(1) and (b) through (j) requires, in respective
order, the establishment, maintenance, and/or documentation of the
following topics: (1) Procedures to control design of class III and
class II devices and certain class I devices as listed therein; (2)
plans for design and development activities and updates; (3) procedures
identifying, documenting, and approving design input requirements; (4)
procedures defining design output, including

acceptance criteria, and documentation of approved records; (5)
procedures for formal review of design results and documentation of
results in the design history file (DHF); (6) procedures for verifying
device design and documentation of results and approvals in the DHF;
(7) procedures for validating device design, including documentation of
results in the DHF; (8) procedures for translating device design into
production specifications; (9) procedures for documenting, verifying,
and validating approved design changes before implementation of
changes; and (10) the records and references constituting the DHF for
each type of device.
    Section 820.40 requires manufacturers to establish and maintain
procedures controlling approval and distribution of required documents
and document changes. Section 820.40(a) and (b) requires the
establishment and maintenance of procedures for the review, approval,
issuance, and documentation of required records (documents) and changes
to those records.
    Section 820.50(a) and (b) requires the establishment and
maintenance of procedures and requirements to ensure service and
product quality, records of acceptable suppliers, and purchasing data
describing specified requirements for products and services.
    Sections 820.60 and 820.65 require, respectively, the establishment
and maintenance of procedures for identifying all products from receipt
to distribution and for using control numbers to track surgical
implants and life-sustaining or supporting devices and their
components.
    Section 820.70(a) through (e), (g)(1) through (3), (h), and (i)
requires the establishment, maintenance, and/or documentation of the
following topics: (1) Process control procedures; (2) procedures for
verifying or validating changes to specification, method, process, or
procedure; (3) procedures to control environmental conditions and
inspection result records; (4) requirements for personnel hygiene; (5)
procedures for preventing contamination of equipment and products; (6)
equipment adjustment, cleaning, and maintenance schedules; (7)
equipment inspection records; (8) equipment tolerance postings,
procedures for utilizing manufacturing materials expected to have an
adverse effect on product quality; and (9) validation protocols and
validation records for computer software and software changes.
    Sections 820.72(a), (b)(1) and (2), and 820.75(a) through (c)
require, respectively, the establishment, maintenance, and/or
documentation of the following topics: (1) Equipment calibration and
inspection procedures; (2) national, international, or in-house
calibration standards; (3) records that identify calibrated equipment
and next calibration dates; (4) validation procedures and validation
results for processes not verifiable by inspections and tests; (5)
procedures for keeping validated processes within specified limits; (6)
records for monitoring and controlling validated processes; and (7)
records of the results of revalidation where necessitated by process
changes or deviations.
    Sections 820.80(a) through (e) and 820.86, respectively, require
the establishment, maintenance, and/or documentation of the following
topics: (1) Procedures for incoming acceptance by inspection, test, or
other verification; (2) procedures for ensuring that in-process
products meet specified requirements and the control of product until
inspection and tests are completed; (3) procedures for, and records
that show, incoming acceptance or rejection is conducted by
inspections, tests, or other verifications; (4) procedures for, and
records that show, finished devices meet acceptance criteria and are
not distributed until device master record (DMR) activities are
completed; (5) records in the device history record (DHR) showing
acceptance dates, results, and equipment used; and (6) the acceptance/
rejection identification of products from receipt to installation and
servicing.
    Sections 820.90(a), (b)(1) and (2), and 820.100 require,
respectively, the establishment, maintenance and/or documentation of
the following topics: (1) Procedures for identifying, recording,
evaluating, and disposing of nonconforming product; (2) procedures for
reviewing and recording concessions made for, and disposition of,
nonconforming product; (3) procedures for reworking products,
evaluating possible adverse rework effect and recording results in the
DHR; (4) procedures and requirements for corrective and preventive
actions, including analysis, investigation, identification and review
of data, records, causes, and results; and (5) records for all
corrective and preventive action activities.
    Section 820.100(a)(1) through (7) states that procedures and
requirements shall be established and maintained for corrective/
preventive actions, including the following: (1) Analysis of data from
process, work, quality, servicing records, investigation of
nonconformance causes; (2) identification of corrections and their
effectiveness; (3) recording of changes made; and (4) appropriate
distribution and managerial review of corrective and preventive action
information. Section 820.120 states that manufacturers shall establish/
maintain procedures to control labeling storage/application,
examination/release for storage and use, and to document those
procedures.
    Sections 820.120(b) and (d), 820.130, 820.140, 820.150(a) and (b),
820.160(a) and (b), and 820.170(a) and (b), respectively, require the
establishment, maintenance, and/or documentation of the following
topics: (1) Procedures for controlling and recording the storage,
examination, release, and use of labeling; (2) the filing of labels/
labeling used in the DHR; (3) procedures for controlling product
storage areas and receipt/dispatch authorizations; (4) procedures
controlling the release of products for distribution; (5) distribution
records that identify consignee, product, date, and control numbers;
and (6) instructions, inspection and test procedures that are made
available, and the recording of results for devices requiring
installation.
    Sections 820.180(b) and (c), 820.181(a) through (e), 820.184(a)
through (f), and 820.186 require, respectively, the maintenance of
records that are: (1) Retained at prescribed site(s), made readily
available and accessible to FDA, and retained for the device's life
expectancy or for 2 years; (2) contained or referenced in a DMR
consisting of device, process, quality assurance, packaging and
labeling, and installation, maintenance, and servicing specifications
and procedures; (3) contained in a DHR and demonstrate the manufacture
of each unit, lot, or batch of product in conformance with DMR and
regulatory requirements include manufacturing and distribution dates,
quantities, acceptance documents, labels and labeling, and control
numbers; and (4) contained in a quality system record, consisting of
references, documents, procedures, and activities not specific to
particular devices.
    Sections 820.198(a) through (g) and 820.200(a) through (d),
respectively, require the establishment, maintenance, and/or
documentation of the following topics: (1) Complaint files and
procedures for receiving, reviewing, and evaluating complaints; (2)
complaint investigation records identifying the device, complainant,
and relationship of the device to the incident; (3) complaint records
that are reasonably accessible to the manufacturing site or at
prescribed sites; (4) procedures for performing and verifying that
device servicing requirements are met and that service

reports involving complaints are processed as complaints; and (5)
service reports that record the device, service activity, and test and
inspection data.
    Section 820.250 requires the establishment and maintenance of
procedures to identify valid statistical techniques necessary to verify
process and product acceptability; and sampling plans, when used, which
are written and based on valid statistical rationale; and procedures
for ensuring adequate sampling methods.
    The CGMP/QS regulation added design and purchasing controls,
modified previous critical device requirements, revised previous
validation and other requirements, and harmonized device CGMP
requirements with QS specifications in the international standard ``ISO
9001: Quality Systems Model for Quality Assurance in Design/
Development, Production, Installation, and Servicing.'' The rule does
not apply to manufacturers of components or parts of finished devices,
or to manufacturers of human blood and blood components subject to 21
CFR part 606. With respect to devices classified in class I, design
control requirements apply only to class I devices listed in Sec.
820.30(a)(2) of the regulation. The rule imposes burden upon: (1)
Finished device manufacturer firms, which are subject to all
recordkeeping requirements; (2) finished device contract manufacturers,
specification developers; and (3) re-packer, re-labelers, and contract
sterilizer firms, which are subject only to requirements applicable to
their activities. In addition, remanufacturers of hospital single-use
devices are now considered to have the same requirements as
manufacturers in regard to the regulation.
    The establishment, maintenance, and/or documentation of procedures,
records, and data required by the regulation assists FDA in determining
whether firms are in compliance with CGMP requirements, which are
intended to ensure that devices meet their design, production,
labeling, installation, and servicing specifications and, thus are
safe, effective, and suitable for their intended purpose. In
particular, compliance with CGMP design control requirements should
decrease the number of design-related device failures that have
resulted in deaths and serious injuries.
    The CGMP/QS regulation applies to approximately 27,074 respondents.
This estimate is based on a query of the Agency's registration and
listing database. Respondents to this information collection have no
reporting activities, but must make required records available for
review or copying during FDA inspection. Except for manufacturers, not
every type of firm is subject to every CGMP/QS requirement. For
example, all are subject to Quality Policy (Sec.  820.20(a)), Document
Control (Sec.  820.40), and other requirements, whereas only
manufacturers and specification developers are subject to subpart C,
Design Controls. The PRA burden placed on the 27,074 establishments is
an average burden.
    FDA estimates the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Quality policy--820.20(a).......          27,074               1          27,074               7         189,518
Organization--820.20(b).........          27,074               1          27,074               4         108,296
Management review--820.20(c)....          27,074               1          27,074               6         162,444
Quality planning--820.20(d).....          27,074               1          27,074              10         270,740
Quality system procedures--               27,074               1          27,074              10         270,740
 820.20(e)......................
Quality audit--820.22...........          27,074               1          27,074              33         893,442
Training--820.25(b).............          27,074               1          27,074              13         351,962
Design procedures--820.30(a)(1).          27,074               1          27,074               2          54,148
Design and development planning--         27,074               1          27,074               6         162,444
 820.30(b)......................
Design input--820.30(c).........          27,074               1          27,074               2          54,148
Design output--820.30(d)........          27,074               1          27,074               2          54,148
Design review--820.30(e)........          27,074               1          27,074              23         622,702
Design verification--820.30(f)..          27,074               1          27,074              37       1,001,738
Design validation--820.30(g)....          27,074               1          27,074              37       1,001,738
Design transfer--820.30(h)......          27,074               1          27,074               3          81,222
Design changes--820.30(i).......          27,074               1          27,074              17         460,258
Design history file--820.30(j)..          27,074               1          27,074               3          81,222
Document controls--820.40.......          27,074               1          27,074               9         243,666
Documentation approval and                27,074               1          27,074               2          54,148
 distribution and document
 changes--820.40(a) and (b).....
Purchasing controls--820.50(a)..          27,074               1          27,074              22         595,628
Purchasing data--820.50(b)......          27,074               1          27,074               6         162,444
Identification--820.60..........          27,074               1          27,074               1          27,074
Traceability--820.65............          27,074               1          27,074               1          27,074
Production and process controls--         27,074               1          27,074               2          54,148
 820.70(a)......................
Production and process changes            27,074               1          27,074               2          54,148
 and environmental control--
 820.70(b) and (c)..............
Personnel--820.70(d)............          27,074               1          27,074               3          81,222
Contamination control--820.70(e)          27,074               1          27,074               2          54,148
Equipment maintenance schedule,           27,074               1          27,074               1          27,074
 inspection, and adjustment--
 820.70(g)(1)-(3)...............
Manufacturing material--                  27,074               1          27,074               2          54,148
 820.70(h)......................
Automated processes--820.70(i)..          27,074               1          27,074               8         216,592
Control of inspection,                    27,074               1          27,074               5         135,370
 measuring, and test equipment--
 820.72(a)......................
Calibration procedures,                   27,074               1          27,074               1          27,074
 standards, and records--
 820.72(b)(1)-(2)...............
Process validation--820.75(a)...          27,074               1          27,074               3          81,222

Validated process parameters,             27,074               1          27,074               1          27,074
 monitoring, control methods,
 and data--820.75(b)............
Revalidation--820.75(c).........          27,074               1          27,074               1          27,074
Acceptance activities--820.80(a)-         27,074               1          27,074               5         135,370
 (e)............................
Acceptance status--820.86.......          27,074               1          27,074               1          27,074
Control of nonconforming                  27,074               1          27,074               5         135,370
 product--820.90(a).............
Nonconforming product review/             27,074               1          27,074               5         135,370
 disposition procedures and
 rework procedures--820.90(b)(1)-
 (2)............................
Procedures for corrective/                27,074               1          27,074              12         324,888
 preventive actions--
 820.100(a)(1)-(7)..............
Corrective/preventive                     27,074               1          27,074               1          27,074
 activities--820.100(b).........
Labeling procedures--820.120(b).          27,074               1          27,074               1          27,074
Labeling documentation--                  27,074               1          27,074               1          27,074
 820.120(d).....................
Device packaging--820.130.......          27,074               1          27,074               1          27,074
Handling--820.140...............          27,074               1          27,074               6         162,444
Storage--820.150(a) and (b).....          27,074               1          27,074               6         162,444
Distribution procedures and               27,074               1          27,074               1          27,074
 records--820.160(a) and (b)....
Installation--820.170...........          27,074               1          27,074               2          54,148
Record retention period--                 27,074               1          27,074               2          54,148
 820.180(b) and (c).............
Device master record--820.181...          27,074               1          27,074               1          27,074
Device history record--820.184..          27,074               1          27,074               1          27,074
Quality system record--820.186..          27,074               1          27,074               1          27,074
Complaint files--820.198(a)-(g).          27,074               1          27,074               5         135,370
Servicing procedures and                  27,074               1          27,074               3          81,222
 reports--820.200(a) and (d)....
Statistical techniques                    27,074               1          27,074               1          27,074
 procedures and sampling plans--
 820.250........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       9,421,752
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an
overall increase of 812,928 hours. We attribute this adjustment to an
increase in the number of respondents.

    Dated: July 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16260 Filed 7-30-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 42 (Friday, March 2, 2012)]
[Notices]
[Page 12835]
[FR Doc No: 2012-5003]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM01-5-000]

Electronic Tariff Filings; Notice of Procedures for Public
Utilities Seeking To Extend the Date for Commission Action on Statutory
Filings

    This is to provide notice that Commission staff has posted (at
http://www.ferc.gov/docs-filing/etariff/comm-order/extend-date.pdf)
procedures that public utilities filing under Part 35 must follow if
they seek to extend the date by which the Commission must act on a rate
case or other statutory filing.

    Dated: February 23, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-5003 Filed 3-1-12; 8:45 am]
BILLING CODE 6717-01-P


entity that uses credit ratings for regulatory purposes; and whether
the credit rating agency, its affiliates, or its employees have any
other business relationship or affiliation with a rated obligor, issuer
of rated securities or money market instruments, underwriter of rated
securities or money market instruments, or entity that uses credit
ratings for regulatory purposes. In addition, identify each entity that
is an underwriter of rated securities or money market instruments or
that uses credit ratings for regulatory purposes that is also a person
associated with the credit rating agency.
    Exhibit 7. This exhibit must include the written policies and
procedures established, maintained, and enforced by the credit rating
agency pursuant to Section 15E(h) of the Exchange Act to address and
manage conflicts of interest.
    Exhibit 8. This exhibit must include the following information
regarding each of the credit rating agency's credit analysts and each
officer and employee of the credit rating agency responsible for
supervising the credit rating agency's credit analysts:
     Name.
     Title and brief description of responsibilities, including
whether a supervisor.
     Employment history.
     Post-secondary education.
     Whether employed by the credit rating agency full-time (at
least 35 hours per week) or part-time.
    For purposes of this exhibit: Credit analyst means an individual
associated with the credit rating agency who is responsible for
determining a credit rating using either a quantitative model, a
qualitative model and analysis, or a combination of these methods.
    Exhibit 9. This exhibit must include the following information
about the credit rating agency's designated compliance officer
(identified in Item 4) and any other persons that assist the designated
compliance officer in carrying out the responsibilities set forth in
Section 15E(j) of the Exchange Act:
     Name.
     Title and brief description of responsibilities.
     Employment history.
     Post secondary education.
     Whether employed by the credit rating agency full-time (at
least 35 hours per week) or part-time.
    Exhibit 10. This exhibit must include a list of the largest
customers that used credit rating services provided by the credit
rating agency by the amount of net revenue received by the credit
rating agency and its affiliates from the customer during the fiscal
year ending immediately before the date the credit rating agency
submits an INITIAL APPLICATION. In making this list, the credit rating
agency should first determine the 20 largest issuer and subscriber
customers in terms of net revenue received by the credit rating agency
and its affiliates from the issuer or subscriber. Next, the credit
rating agency should add to the list any obligor or underwriter that
used credit rating services provided by the credit rating agency if the
net revenue received by the credit rating agency and its affiliates
from the obligor or underwriter during the fiscal year equaled or
exceeded the net revenue received from the 20th largest issuer or
subscriber. In making the list, rank the customers from largest to
smallest and include the net revenue amount for each customer.
    For purposes of this exhibit:
    Net revenue means all fees, sales proceeds, commissions, and other
revenue received by the credit rating agency and its affiliates for any
type of service or product, regardless of whether related to credit
rating services, and net of any fees, sales proceeds, rebates, and
other monies paid to the customer by the credit rating agency and its
affiliates; and
    Credit rating services means any of the following: rating an
obligor (regardless of whether the obligor or any other person paid for
the credit rating); rating an issuer's securities or money market
instruments (regardless of whether the issuer, underwriter, or any
other person paid for the credit rating); and providing credit ratings
to a subscriber.
    Exhibit 11. This exhibit must include financial statements of the
credit rating agency, which must include a balance sheet, an income
statement and statement of cash flows, and a statement of changes in
owners' equity, audited by an independent public accountant, for each
of the three fiscal or calendar years ending immediately before the
date it submits an INITIAL APPLICATION to the Commission, subject to
the following:
    If the credit rating agency is a division, unit, or subsidiary of a
parent company, the credit rating agency can provide audited
consolidated and consolidating financial statements of the parent
company.
    If the credit rating agency does not have audited financial
statements for one or more of the three fiscal or calendar years ending
immediately before the date it submits an INITIAL APPLICATION to the
Commission, it can provide unaudited financial statements for the
applicable year or years, but the credit rating agency must provide
audited financial statements for the fiscal or calendar year ending
immediately before the date it submits an INITIAL APPLICATION to the
Commission. The credit rating agency must attach to the unaudited
financial statements a certification by a person duly authorized by the
credit rating agency to make the certification that the person has
responsibility for the financial statements and that to the best
knowledge of the person making the certification the financial
statements fairly present, in all material respects, the financial
condition, results of operations, and cash flows of the rating
organization for the period presented.
    Exhibit 12. This exhibit must include the following information, as
applicable, regarding the credit rating agency's aggregate revenues for
the fiscal or calendar year ending immediately before the date it
furnishes an INITIAL APPLICATION to the Commission:
     Revenue from determining and maintaining credit ratings;
     Revenue from subscribers;
     Revenue from granting licenses or rights to publish credit
ratings;
     Revenue from determining credit ratings that are not made
readily accessible (private ratings); and
     Revenue from all other services and products offered by
the rating

organization (include descriptions of any major sources of revenue).
    Exhibit 13. This exhibit must include the total and median annual
compensation of the credit rating agency's credit analysts.
    F. Explanation of Terms. For purposes of Form NRSRO, the following
definitions and descriptions apply:
    1. COMMISSION--The U. S. Securities and Exchange Commission.
    2. CREDIT RATING--An assessment of the creditworthiness of an
obligor as an entity or with respect to specific securities or money
market instruments [Section 3(a)(60) of the Exchange Act].
    3. CREDIT RATING AGENCY [Section 3(a)(61) of the Exchange Act]--Any
person:
     Engaged in the business of issuing credit ratings on the
Internet or through another readily accessible means, for free or for a
reasonable fee, but does not include a commercial credit reporting
company;
     Employing either a quantitative or qualitative model, or
both to determine credit ratings; and
     Receiving fees from either issuers, investors, and/or
other market participants.
    4. NATIONALLY RECOGNIZED STATISTICAL RATING ORGANIZATION [Section
3(a)(62) of the Exchange Act]--A credit rating agency that:
     Has been in business as a credit rating agency for at
least the 3 consecutive years immediately preceding the date of its
application for registration as an NRSRO;
     Issues credit ratings certified by qualified institutional
buyers with respect to:
    [cir] Financial institutions, brokers, or dealers;
    [cir] Insurance companies;
    [cir] Corporate issuers;
    [cir] Issuers of asset-backed securities;
    [cir] Issuers of government securities, municipal securities, or
securities issued by a foreign government; or
    [cir] A combination of one or more of the above; and
     Is registered as an NRSRO.
    5. NON-RESIDENT RATING ORGANIZATION [Exchange Act Rule 17g-4(a)]--A
nationally recognized statistical rating organization that:
     If a corporation, is incorporated in or has its principal
office in, a location outside the United States, its territories, or
possessions;
     If a partnership or other unincorporated organization or
association, has its principal office in a location outside the United
States, its territories, or possessions.
    6. PERSON--An individual, partnership, corporation, trust, limited
liability company, or other organization.
    7. PERSON ASSOCIATED WITH THE CREDIT RATING AGENCY--Any partner,
officer, director, or branch manager of the credit rating agency (or
any person occupying a similar status or performing similar functions),
any person directly or indirectly controlling, controlled by, or under
common control with a credit rating agency, or any employee of a credit
rating agency [Section 3(a)(63) of the Exchange Act].
    8. QUALIFIED INSTITUTIONAL BUYER--An entity listed in 17 CFR
230.144A(a) that is not affiliated with the credit rating agency
[Section 3(a)(64) of the Exchange Act].

Disclosure Reporting Page (NRSRO)

    This Disclosure Reporting Page (DRP) is to be used to report
information related to affirmative responses to Item 8 of Form NRSRO.
    Use a separate DRP for each event or proceeding. Attach additional
pages as necessary.

Name of credit rating agency

[fxsp0]----------------------------------------------------------------
Date

[fxsp0]----------------------------------------------------------------
    Check Item being responded to:

[ballot] Item 8A
[ballot] Item 8B
[ballot] Item 8C

    The individual(s) or entity(ies) for whom this DRP is being filed
is (are):

[ballot] The credit rating agency
[ballot] The credit rating agency and one or more associated persons
[ballot] One or more associated persons

    If this DRP is being filed for one or more associated persons,
provide the full name of the associated person(s):

[fxsp0]----------------------------------------------------------------

    If this DRP provides information relating to a ``Yes'' answer to
Item 8A, describe the act(s) that was (were) committed or omitted; or
the order(s) or finding(s); or the injunction(s) (provide the relevant
statute(s) or regulation(s)) and provide jurisdiction(s) and date(s):

[fxsp0]----------------------------------------------------------------

    If this DRP provides information relating to a ``Yes'' answer to
Item 8B, describe the crime(s) and provide jurisdiction(s) and date(s):

[fxsp0]----------------------------------------------------------------

    If this DRP provides information relating to a ``Yes'' answer to
Item 8C, attach the relevant Commission order(s) and provide date(s):

[fxsp0]----------------------------------------------------------------

[ballot] This DRP should be removed from Form NRSRO because the
person(s) is (are) no longer associated with the credit rating agency.

    By the Commission.

    Dated: February 2, 2007.
Nancy M. Morris,
Secretary.
[FR Doc. 07-548 Filed 2-8-07; 8:45 am]

BILLING CODE 8010-01-P


72170 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices The sum of these adjustments is a decrease of 57,855 responses and 7,134,152 burden hours from the current approved total. According to the procedures prescribed in 5 CFR 1320.12, EPA has submitted this ICR to OMB for review and approval. Any comments related to the renewal of this ICR should be submitted within 30 days of this notice, as described above.

Dated: November 22, 2002. Oscar Morales, Director, Collection Strategies Division, Office of Environmental Information. [ FR Doc. 02   30762 Filed 12   3   02; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OPP   2002   0250; FRL   7274   7]

Fenarimol; Availability of the Risk Assessments on FQPA Tolerance Reassessment Progress and Tolerance Reassessment Decision ( TRED)

AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the availability of EPA's tolerance reassessment decision and related documents for fenarimol including the Fenarimol Overview, Fenarimol Summary, Fenarimol Decision Document ( TRED), and supporting risk assessment documents. EPA has reassessed the 42 tolerances, or legal limits, for residues of fenarimol in or on raw agricultural commodities. These tolerances are now considered safe under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act ( FQPA) of 1996. DATES: Comments on the tolerance reassessment decision or on the human health effects risk assessment for fenarimol, identified by docket ID number OPP   2002   0250, must be received by EPA on or before January 3, 2003. In the absence of substantive comments, the tolerance reassessment decision will be considered final. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP   2002   0250 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: Tom Myers, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308   8589; email address: myers. tom@ epa. gov. SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

This action is directed to the public in general, but will be of interest to a wide range of stakeholders, including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the use of pesticides. The Agency has not attempted to describe all the persons or entities who may be interested in or affected by this action. If you have questions in this regard, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules,'' and then look up the entry for this document under the `` Federal Register   Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. You can obtain copies of the TRED and related documents discussed in this notice on EPA's website at http:// www. epa. gov/ pesticides/ reregistration/ status. htm. Information on pesticide reregistration and tolerance reassessment, including the purpose and status of Agency programs to complete Reregistration Eligibility Decisions ( REDs), Interim REDs, and tolerance reassessment decisions ( TREDs), is available at http:// www. epa. gov/ pesticides/ reregistration. General information is available on the Office of Pesticide Programs' home page, http:// www. epa. gov/ pesticides/. 2. In person. The Agency has established an official record for this action under docket ID numbers OPP   2002   0250. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305   5805.

C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP   2002   0250 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305   5805. 3. Electronically. You may submit your comments electronically by e mail to: opp docket@ epa. gov, or you can submit a computer disk as described in this unit. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0/ 9.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPP   2002   0250. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1 72171 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has reassessed the risks associated with current food uses of the pesticide fenarimol, reassessed 42 existing tolerances, and reached a tolerance reassessment and risk management decision. The Agency is issuing for comment the resulting report on FQPA tolerance reassessment progress, including the Fenarimol Overview, Fenarimol Summary, Fenarimol Decision Document ( TRED), and supporting risk assessment documents. EPA must review tolerances and tolerance exemptions that were in effect when FQPA was enacted in August 1996, to ensure that these existing pesticide residue limits for food and feed commodities meet the safety standard established by the new law. Tolerances are considered reassessed once the safety finding has been made or a revocation occurs. EPA has reviewed and made the requisite safety finding for the tolerances and exemptions included in this notice. EPA approved registration of products containing fenarimol as an active ingredient prior to the 1996 enactment of the Food and Quality Protection Act; therefore, while no reregistration decision is required at present, risks from non occupational exposure to fenarimol through food, drinking water, and residential uses must be reassessed. The Agency has evaluated the dietary risk associated with fenarimol and has determined that there is a reasonable certainty, with appropriate mitigation, that no harm to any population subgroup will result from aggregate exposure to fenarimol when considering dietary exposure and all other nonoccupational sources of pesticide exposure for which there is reliable information. Residential postapplication exposure was of concern for children and infants from fenarimol products applied in residential settings. To mitigate this risk, the registrant has agreed to remove the residential uses from their labels until they conduct a special developmental toxicity study that will assess possible effects of fenarimol on the adult and juvenile rat hormonal systems. Once these data are submitted and reviewed, the Agency will make a determination regarding the reinstatement of the residential uses. For chronic drinking water risk from surface water, potential ( average) estimated environmental concentrations ( EECs) of fenarimol ( 84 parts per billion ( ppb)) exceeds the chronic drinking water level of comparison ( DWLOC) for all populations. The 84 ppb value includes all residential uses and the golf course use of fenarimol. However, with the residential uses removed from the label, a correction factor of 0.31 can be applied to the 84 ppb surface water number to account for the use of fenarimol only on tees, greens, and fairways on golf courses. This would reduce the chronic EEC to 26 ppb. Infants and children, the most sensitive population subgroups would still exceed the chronic DWLOC of 20. However, the chronic EECs were estimated using Tier I modeling and only slightly exceed the DWLOC. Additional data are being required that will provide important information on the mobility of fenarimol and its degradates. These studies will help to refine the chronic surface water, ground water, and drinking water risk assessments. The Agency has reassessed all 42 tolerances for fenarimol and can make a FQPA safety determination. In addition, available residue chemistry data support the establishment of a 0.02 part per million ( ppm) permanent tolerance for fenarimol residues in filberts under 40 CFR 180.421 ( a). The Agency has sufficient residue data for reassessing the tolerances for fenarimol. The chronic dietary exposure assessment for fenarimol is highly refined using anticipated residues based on 1996   1999 Food and Drug Administration ( FDA) monitoring data for apples, bananas, cherries, grapes, and pears. Field trial residue data were used for pecans and filberts. Percent crop treated information and processing factors, where available, were used in the assessment. There were no U. S. Department of Agriculture Pesticide Data Program monitoring data available for fenarimol. Residues of fenarimol per se were non detectable ( below the method limit of detection ( LOD)) in all 1996   1999 FDA monitoring samples of apples, bananas, grapes, and pears ( a total of more than 3,000 samples). Out of 214 cherry samples, three had detectable residues. Residues of fenarimol per se were non detectable < LOD in/ on all but one pecan nut meat sample from seven trials. There were no detectable residues in filbert samples from four field trials. Chronic dietary risks from exposure do not exceed the Agency's level of concern. EPA works with affected parties to reach the tolerance reassessment decisions. The Agency therefore is issuing the fenarimol decision as a final decision with a public comment period. All comments received during the public comment period will be carefully considered by the Agency. If any comment significantly affects the Agency's decision, EPA will publish an amendment to the decision in the Federal Register. In the absence of substantive comments, the tolerance reassessment decisions reflected here will be considered final.

List of Subjects Environmental protection, Chemicals, Pesticides and pests.

Dated: November 15, 2002.

Betty Shackleford,

Acting Director, Special Review and Reregistration Division, Office of Pesticide Programs. [ FR Doc. 02   30471 Filed 12   3   02 8: 45 am]

BILLING CODE 6560   50   S VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1