[Federal Register Volume 83, Number 143 (Wednesday, July 25, 2018)]
[Notices]
[Pages 35304-35305]
[FR Doc No: 2018-15853]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 10f-3; SEC File No. 270-237, OMB Control No. 3235-0226

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collections
of information discussed below. The Commission plans to submit these
existing collections of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    Section 10(f) of the Investment Company Act of 1940 (15 U.S.C. 80a)
(the ``Act'') prohibits a registered investment company (``fund'') from
purchasing any security during an underwriting or selling syndicate if
the fund has certain relationships with a principal underwriter for the
security.\1\ Congress enacted this provision in 1940 to protect funds
and their shareholders by preventing underwriters from ``dumping''
unmarketable securities on affiliated funds.
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    \1\ 15 U.S.C. 80a-10(f).
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    Rule 10f-3 permits a fund to engage in a securities transaction
that otherwise would violate section 10(f) if, among other things: (i)
The fund's directors have approved procedures for purchases made in
reliance on the rule, regularly review fund purchases to determine
whether they comply with these procedures, and approve necessary
changes to the procedures; and (ii) a written record of each
transaction effected under the rule is maintained for six years, the
first two of which in an easily accessible place.\2\ The written record
must state: (i) From whom the securities were acquired; (ii) the
identity of the underwriting syndicate's members; (iii) the terms of
the transactions; and (iv) the information or materials on which the
fund's board of directors has determined that the purchases were made
in compliance with procedures established by the board.
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    \2\ 17 CFR 270.10f-3.
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    Rule 10f-3 also conditionally allows managed portions of fund
portfolios to purchase securities offered in otherwise off-limits
primary offerings. To qualify for this exemption, rule 10f-3 requires
that the subadviser that is advising the purchaser be contractually
prohibited from providing investment advice to any other portion of the
fund's portfolio and consulting with any other of the fund's advisers
that is a principal underwriter or affiliated person of a principal
underwriter concerning the fund's securities transactions.
    These requirements provide a mechanism for fund boards to oversee
compliance with the rule. The required recordkeeping facilitates the
Commission staff's review of rule 10f-3 transactions during routine
fund inspections and, when necessary, in connection with enforcement
actions.
    The staff estimates that approximately 236 funds engage in a total
of approximately 2,928 rule 10f-3 transactions each year.\3\ Rule 10f-3
requires that the purchasing fund create a written record of each
transaction that includes, among other things, from whom the securities
were purchased and the terms of the transaction. The staff estimates
\4\ that it takes an average fund approximately 30 minutes per
transaction and approximately 1,464 hours \5\ in the aggregate to
comply with this portion of the rule.
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    \3\ These estimates are based on staff extrapolations from
filings with the Commission.
    \4\ Unless stated otherwise, the information collection burden
estimates are based on conversations between the staff and
representatives of funds.
    \5\ This estimate is based on the following calculation: (0.5
hours x 2,928 = 1,464 hours).
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    The funds also must maintain and preserve these transactional
records in accordance with the rule's recordkeeping requirement, and
the staff estimates that it takes a fund approximately 20 minutes per
transaction and that annually, in the aggregate, funds spend
approximately 976 hours \6\ to comply with this portion of the rule.
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    \6\ This estimate is based on the following calculations: (20
minutes x 2,928 transactions = 58,560 minutes; 58,560 minutes/60 =
976 hours).
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    In addition, fund boards must, no less than quarterly, examine each
of these transactions to ensure that they comply with the fund's
policies and procedures. The information or materials upon which the
board relied to come to this determination also must be maintained and
the staff estimates that it takes a fund 1 hour per quarter and, in the
aggregate, approximately 944 hours \7\ annually to comply with this
rule requirement.
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    \7\ This estimate is based on the following calculation: (1 hour
per quarter x 4 quarters x 236 funds = 944 hours).
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    The staff estimates that reviewing and revising as needed written
procedures for rule 10f-3 transactions takes, on average for each fund,
two hours of a compliance attorney's time per year.\8\ Thus, annually,
in the aggregate, the staff estimates that funds spend a total of
approximately 472 hours \9\ on monitoring and revising rule 10f-3
procedures.
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    \8\ These averages take into account the fact that in most
years, fund attorneys and boards spend little or no time modifying
procedures and in other years, they spend significant time doing so.
    \9\ This estimate is based on the following calculation: (236
funds x 2 hours = 472 hours).
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    Based on an analysis of fund filings, the staff estimates that
approximately 299 fund portfolios enter into

subadvisory agreements each year.\10\ Based on discussions with
industry representatives, the staff estimates that it will require
approximately 3 attorney hours to draft and execute additional clauses
in new subadvisory contracts in order for funds and subadvisers to be
able to rely on the exemptions in rule 10f-3. Because these additional
clauses are identical to the clauses that a fund would need to insert
in their subadvisory contracts to rely on rules 12d3-1, 17a-10, and
17e-1, and because we believe that funds that use one such rule
generally use all of these rules, we apportion this 3 hour time burden
equally to all four rules. Therefore, we estimate that the burden
allocated to rule 10f-3 for this contract change would be 0.75
hours.\11\ Assuming that all 299 funds that enter into new subadvisory
contracts each year make the modification to their contract required by
the rule, we estimate that the rule's contract modification requirement
will result in 224 burden hours annually.\12\
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    \10\ Based on information in Commission filings, we estimate
that 38 percent of funds are advised by subadvisers.
    \11\ This estimate is based on the following calculation (3
hours / 4 rules = .75 hours).
    \12\ These estimates are based on the following calculations:
(0.75 hours x 299 portfolios = 224 burden hours).
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    The staff estimates, therefore, that rule 10f-3 imposes an
information collection burden of 4,080 hours.\13\
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    \13\ This estimate is based on the following calculation: (1,464
hours + 976 hours + 944 hours + 472 + 224 hours = 4,080 total burden
hours).
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    Written comments are invited on: (a) Whether the collections of
information are necessary for the proper performance of the functions
of the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burdens
of the collections of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burdens of the collections of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Candace
Kenner, 100 F Street NE, Washington, DC 20549; or send an email to:
[email protected].

    Dated: July 19, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-15853 Filed 7-24-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 151 (Monday, August 8, 2022)]
[Rules and Regulations]
[Pages 48084-48086]
[FR Doc No: 2022-16904]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2021-0631; Special Conditions No. 25-813-SC]

Special Conditions: Dassault Aviation Model Falcon 6X Airplane;
Flight Envelope Protection: Normal Load-Factor (g) Limiting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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SUMMARY: These special conditions are issued for the Dassault Aviation
(Dassault) Model Falcon 6X airplane. This airplane will have a novel or
unusual design feature when compared to the state of technology
envisioned in the airworthiness standards for transport category
airplanes. This design feature is an electronic flight-control system
(EFCS) that incorporates full-time, normal load-factor limiting,
designed to prevent the pilot from inadvertently or intentionally
exceeding the positive or negative airplane limit load factor. The
applicable airworthiness regulations do not contain adequate or
appropriate safety standards for this design feature. These special
conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES: This action is effective on Dassault on August 8, 2022. Send
comments on or before September 22, 2022.

ADDRESSES: Send comments identified by Docket No. FAA-2021-0631 using
any of the following methods:
     Federal eRegulations Portal: Go to https://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: Except for Confidential Business Information (CBI) as
described in the following paragraph, and other information as
described in title 14, Code of Federal Regulations (14 CFR) 11.35, the
FAA will post all comments received without change to https://www.regulations.gov/, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about these special conditions.
    Confidential Business Information: Confidential Business
Information (CBI) is commercial or financial information that is both
customarily and actually treated as private by its owner. Under the
Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from
public disclosure. If your comments responsive to these special
conditions contain commercial or financial information that is
customarily treated as private, that you actually treat as private, and
that is relevant or responsive to these special conditions, it is
important that you clearly designate the submitted comments as CBI.
Please mark each page of your submission containing CBI as ``PROPIN.''
The FAA will treat such marked submissions as confidential under the
FOIA, and the indicated comments will not be placed in the public
docket of these special conditions. Send submissions containing CBI to
Troy Brown, Performance and Environment Section,

AIR-625, Technical Innovation Policy Branch, Policy and Innovation
Division, Aircraft Certification Service, Federal Aviation
Administration, 1801 S Airport Rd., Wichita, KS 67209-2190; telephone
and fax<PHONE_NUMBER>; email [email protected]. Comments the FAA
receives, which are not specifically designated as CBI, will be placed
in the public docket for these special conditions.
    Docket: Background documents or comments received may be read at
https://www.regulations.gov/ at any time. Follow the online
instructions for accessing the docket or go to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Troy Brown, Performance and
Environment Section, AIR-625, Technical Innovation Policy Branch,
Policy and Innovation Division, Aircraft Certification Service, Federal
Aviation Administration, 1801 S Airport Rd., Wichita, KS 67209-2190;
telephone and fax<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:
    The substance of these special conditions has been published in the
Federal Register for public comment in several prior instances with no
substantive comments received. Therefore, the FAA finds that, pursuant
to Sec.  11.38(b), new comments are unlikely, and notice and comment
prior to this publication are unnecessary.

Comments Invited

    The FAA invites interested people to take part in this rulemaking
by sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    The FAA will consider all comments received by the closing date for
comments. The FAA may change these special conditions based on the
comments received.

Background

    On July 1, 2012, Dassault Aviation applied for a type certificate
for its new Model Falcon 5X airplane. However, Dassault has decided not
to release an airplane under the model designation Falcon 5X, instead
choosing to change that model designation to Falcon 6X.
    In February of 2018, due to engine supplier issues, Dassault
extended the type certificate application date for its Model Falcon 5X
airplane under new Model Falcon 6X. This airplane is a twin-engine
business jet with seating for 19 passengers, and has a maximum takeoff
weight of 77,460 pounds.

Type Certification Basis

    Under the provisions of 14 CFR 21.17, Dassault must show that the
Model Falcon 6X airplane meets the applicable provisions of 14 CFR part
25, as amended by amendments 25-1 through 25-146.
    If the Administrator finds that the applicable airworthiness
regulations (e.g., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Dassault Model Falcon 6X airplane
because of a novel or unusual design feature, special conditions are
prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, these special conditions would also apply to
the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Dassault Model Falcon 6X airplane must comply with the
fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the
noise-certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Dassault Aviation Model Falcon 6X airplane will incorporate the
following novel or unusual design feature:
    An EFCS that incorporates full-time, normal load-factor limiting,
designed to prevent the pilot from inadvertently or intentionally
exceeding the positive or negative airplane limit load factor.

Discussion

    The normal load-factor limit on the Model Falcon 6X is unique in
that traditional airplanes with conventional, mechanical-linkage
flight-control systems are limited, in the pitch axis, only by the
elevator surface area and deflection limit. The elevator control power
is normally derived for adequate controllability and maneuverability at
the most critical longitudinal pitching moment. The result is that for
conventional, mechanical-linkage airplanes, a significant portion of
the flight envelope maneuverability, in excess of limit structural
design values, is possible. With the normal load-factor limit engaged,
the Dassault Model Falcon 6X airplane will not exhibit this excess
maneuverability.
    Part 25 does not specify requirements nor does any FAA policy
require the applicant to demonstrate maneuver control that impose any
handling qualities requirements beyond the design limit structural
loads. Nevertheless, some pilots are accustomed to the availability of
this excess maneuver capacity in case of extreme emergencies, such as
upset recoveries or collision avoidance.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to the
Dassault Model Falcon 6X airplane. Should Dassault apply at a later
date for a change to the type certificate to include another model
incorporating the same novel or unusual design feature, these special
conditions would apply to that model as well.

Conclusion

    This action affects only a certain novel or unusual design feature
on one model of airplane. It is not a rule of general applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

Authority Citation

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40113, 44701, 44702,
44704.

The Special Conditions

0
Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Dassault Model Falcon 6X airplanes.
    In addition to the requirements of Sec.  25.143(a), and in the
absence of other limiting factors, the following apply:
    (a) The positive limiting load factor must not be less than:
    (1) 2.5g for the electronic flight-control system (EFCS) normal
state with the high-lift devices retracted up to VMO/
MMO. The positive limiting load factor may be gradually
reduced down to 2.25g above VMO/MMO.

    (2) 2.0g for the EFCS normal state with the high-lift devices
extended.
    (b) The negative limiting load factor must be equal to or more
negative than:
    (1) Minus 1.0g for the EFCS normal state with the high-lift devices
retracted.
    (2) 0.0g for the EFCS normal state with high-lift devices extended.
    (c) Maximum, reachable, positive load-factor wings level may be
limited by flight-control system characteristics or flight envelope
protections (other than load-factor protection) provided that:
    (1) The required values are readily achievable in turns, and
    (2) Wings level pitch-up responsiveness is satisfactory.
    (d) Maximum achievable negative load factor may be limited by
flight-control system characteristics or flight envelope protections
(other than load-factor protection) provided that:
    (1) Pitch-down responsiveness is satisfactory
    (2) From level flight, 0g is readily achievable or, alternatively,
a satisfactory* trajectory change is readily achievable at operational
speeds.
    * For the FAA to consider a trajectory change as satisfactory, the
applicant should propose and justify a pitch rate that provides
sufficient maneuvering capability in the most critical scenarios.
    (e) Compliance demonstration with the above requirements may be
performed without ice accretion on the airframe.

    Issued in Kansas City, Missouri, on August 2, 2022.
Patrick R. Mullen,
Manager, Technical Innovation Policy Branch, Policy and Innovation
Division, Aircraft Certification Service.
[FR Doc. 2022-16904 Filed 8-5-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 75 (Wednesday, April 19, 2023)]
[Notices]
[Pages 24187-24188]
[FR Doc No: 2023-08271]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-1625-000]

Apex Solar LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Ocotillo Solar LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is May 3, 2023.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. At this

time, the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: April 13, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-08271 Filed 4-18-23; 8:45 am]
BILLING CODE 6717-01-P


52764 Federal Register / Vol. 68, No. 172 / Friday, September 5, 2003 / Notices the period of August 1, 2003 through July 31, 2006. During the period covered by this ICR renewal, respondents will: Complete their 2004 section 305( b) reports and 2004 section 303( d) lists; complete their 2006 section 305( b) reports and 2006 section 303( d) lists; transmit annual electronic updates of their section 305( b) databases in 2003 through 2006; and continue to develop TMDLs according to their established schedules. EPA will prepare two biennial Reports to Congress: one in 2003, one in 2005, and EPA will review TMDL submissions from respondents. The respondent community for section 305( b) reporting consists of 50 States, the District of Columbia, 5 Territories ( Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands), and 3 River Basin Commissions. The Ohio River Valley Sanitation Commission, the Delaware River Basin Commission, and the Interstate Sanitation Commission have jurisdiction over basins that lie in multiple States. Indian Tribes are exempt from the section 305( b) reporting requirement, but some Tribes choose to participate as a way of presenting assessments and water quality issues to the public and Congress. One Tribe or Tribal Group prepared section 305( b) reports in 1996 and 1997. However, since Tribal section 305( b) reporting is a voluntary effort, it is not included in the burden estimates for this ICR. The respondent community for section 303( d) activities consists of 50 States, the District of Columbia, and 5 Territories ( Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands). Although Indian Tribes can be authorized to meet section 303( d) requirements, none are currently authorized nor have applied for authorization. Further, very few Tribes have established water quality standards, and EPA is currently in the process of preparing standards where they are needed. Therefore, we assume that there would be no burden to Indian Tribes over the period covered by this ICR for section 303( d) activities. The burden of specific activities that States undertake as part of their sections 305( b) and 303( d) programs are derived from an ongoing project among EPA, States and other interested stakeholders to develop a tool for estimating the States' resource needs for State water quality management programs. This project has developed the State Water Quality Management Workload Model ( SWQMWM), which estimates and sums the workload involved in more than one hundred activities or tasks comprising a State water quality management program. Over twenty States have contributed information about their activities that became the basis for the model. According to the SWQMWM, the States will carry out the following activities or tasks to meet the sections 305( b) and 303( d) reporting requirements: Watershed characterization; modeling and analysis; development of a TMDL document for public review; public outreach; formal public participation; tracking; planning; legal support; etc. In general, respondents have conducted each of these reporting and record keeping activities for past sections 305( b) and 303( d) reporting cycles and thus have staff and procedures in place to continue their sections 305( b) and 303( d) reporting programs. The burden associated with these tasks is estimated in this ICR to include the total number of TMDLs that may be submitted during the period covered by this ICR. The biennial frequency of the collection is mandated by section 305( b)( 1) of the CWA. Section 305( b) originally required respondents to submit water quality reports on an annual basis. In 1977, the annual requirement was amended to a biennial requirement in the CWA. EPA has determined that abbreviated reporting for hard copy section 305( b) reports, combined with annual electronic reporting using respondent databases, will meet the CWA reporting requirements while reducing burden to respondents. The biennial period with annual electronic reporting ensures that information needed for analysis and water program decisions is reasonably current, yet abbreviated reporting requirements provides respondents with sufficient time to prepare the reports. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9 and are identified on the form and/ or instrument, if applicable. Burden Statement: For the 3 respondents that have section 305( b) responsibility only the annual public reporting and recordkeeping burden for this collection of information is estimated to average 3,659 hours. For the 56 other respondents with both sections 305( b) and 303( d) responsibilities the annual public reporting and recordkeeping burden for this collection of information is estimated to average 66,590 hours. Burden means 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. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: States, District of Columbia, Territories, River Basin commissions, and Indian Tribes. Estimated Number of Respondents: 59. Frequency of Response: Biannually. Estimated Total Annual Hour Burden: 3,740,017. Estimated Total Annual Cost: $ 155,322,906, includes $ 0 annualized capital or O& M costs. Changes in the Estimates: There is a decrease of 749,130 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This decrease is due to: Adjustment Changes in Burden for sections 305( b) and 303( d) reporting. The total annual respondent burden for sections 305( b) and 303( d) reporting has increased from ICR 1560.05 and 1560.06 due to improved estimates of respondent activity.

Dated: August 27, 2003. Doreen Sterling, Acting Director, Collection Strategies Division. [ FR Doc. 03   22641 Filed 9   4   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ RCRA   2002   0024; FRL   7553   7]

Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; The 2003 Hazardous Waste Report, EPA ICR Number 0976.11, OMB Control Number 2050   0024 AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that an Information Collection Request VerDate Jan< 31> 2003 16: 38 Sep 04, 2003 Jkt 200001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05SEN1. SGM 05SEN1 52765 Federal Register / Vol. 68, No. 172 / Friday, September 5, 2003 / Notices ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval. This is a request for a renewal of an existing approved collection. This ICR is scheduled to expire on June 30, 2003. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This ICR describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before October 6, 2003. ADDRESSES: Submit your comments, referencing docket ID number RCRA   2002   0024, to ( 1) EPA online using EDOCKET ( our preferred method), by email to RCRA docket@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, RCRA Docket, Mail Code 5305T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Dave Levy, Office of Solid Waste, Mail Code 5303W, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703   308   8479; fax number: 703   308   8433; e mail address: levy. dave@ epa. gov.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On March 18, 2003 ( 68 FR 12902), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA has addressed the comments received. EPA has established a public docket for this ICR under Docket ID No. RCRA   2002   0024, which is available for public viewing at the RCRA Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and the telephone number for the RCRA Docket is ( 202) 566   0270. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Please use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to www. epa. gov/ edocket. Title: The 2003 Hazardous Waste Report. Abstract: This ICR renews an ongoing information collection from hazardous waste generators and hazardous waste treatment, storage, or disposal facilities. This collection is done on a two year cycle as required by sections 3002 and 3004 of the Resource Conservation and Recovery Act ( RCRA). The information is collected via a mechanism known as the Hazardous Waste Report for the required reporting year ( EPA Form 8700   13 A/ B)( also known as the Biennial Report). Both RCRA sections 3002 and 3004 require EPA to establish standards for recordkeeping and reporting of hazardous waste. Section 3002 applies to hazardous waste generators and section 3004 applies to hazardous waste treatment, storage, and disposal facilities. The implementing regulations are found at 40 CFR 262.40( b) and ( d); 262.41( a)( 1)   ( 5), ( a)( 8), and ( b); 264.75( a)   ( e) and ( j); 265.75( a)   ( e) and ( j); and 270.30( l)( 9). This is mandatory reporting by the respondents. The respondents' submissions ( reports) describe each generated hazardous waste, the activity by which they generated the waste, and the waste quantity; the reports also list the management method by which each waste is treated, recycled, or disposed and the quantity managed. There are a number of uses of Biennial Report data. EPA uses Biennial Report data for planning and developing regulations, compliance monitoring, and enforcement. Also, Biennial Report data allows the Agency to determine whether its regulations are having the desired effect on the generation and management of hazardous waste. For example, Biennial Report data provides information on whether waste management has shifted from one method of disposal to another. Some State uses of Report data include support of planning, fee assessment, compliance monitoring, and enforcement. Some businesses consider some of their hazardous waste information to be Confidential Business Information ( CBI). A business may, if it desires, protect its Biennial Report information from public disclosure by asserting a claim of confidentiality covering all or part of its information. When a claim is made EPA will treat the information in accordance with the confidentiality regulations in 40 CFR part 2, subpart B. EPA also ensures that the information collection procedures comply with the Privacy Act of 1974 and OMB Circular 108. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9 and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average about 19 hours per response. Burden means 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. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Those facilities which generate, treat, store, recycle, or dispose of hazardous waste. Estimated Number of Respondents: 10,178.

VerDate Jan< 31> 2003 16: 38 Sep 04, 2003 Jkt 200001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05SEN1. SGM 05SEN1 52766 Federal Register / Vol. 68, No. 172 / Friday, September 5, 2003 / Notices Frequency of Response: Biennially. Estimated Total Annual Hour Burden: 196,976. Estimated Total Annual Cost: $ 10,311,438, includes $ 0 annualized capital and $ 25,336 O& M costs. Changes in the Estimates: There is an increase of 8,352 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This increase is due to several reasons. Based on reported data for the 2001 Hazardous Waste Report, EPA estimates a slight increase in the number of respondents, an additional 42; we estimate the increase in the number of submitted forms to be 15,218. The completion of the RCRA Subtitle C Site Identification Form will require an estimated additional 20 minutes. This has resulted in a minor increase for those manually filling out the forms ( resulting in an approximately one percent annual burden reduction to the regulated community overall).

Dated: August 12, 2003. Doreen Sterling, Acting Director, Collection Strategies Division. [ FR Doc. 03   22642 Filed 9   4   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OEI   2003   0003; FRL   7553   6]

Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Confidentiality Rules, EPA ICR Number 1665.06, OMB Control Number 2020   0003 AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that an Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval. This is a request to renew an existing approved collection. The current ICR is scheduled to expire on September 30, 2003. Under OMB regulations, EPA may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This renewal notice describes the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before October 6, 2003. ADDRESSES: Submit your comments, referencing docket ID number OEI   2003   0003, to ( 1) EPA online using EDOCKET ( our preferred method), by email to oei. docket@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, OEI Docket, ( 28221T), 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: Jeffrey Kohn, Collection Strategies Division, Office of Information Collection ( 2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 202) 566   1407; fax number: ( 202) 566   1639; e mail address: kohn. jeffrey@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted this renewal ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On April 10, 2003 ( 68 FR 17631), EPA sought comments on this renewal ICR pursuant to 5 CFR 1320.8( d). EPA has received and addressed comments from one organization. EPA has established a public docket for this renewal ICR under Docket ID No. OEI   2003   0003, which is available for public viewing at the OEI Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and the telephone and fax numbers for the OEI Docket are ( 202) 566   1752 and ( 202) 566   1753, respectively. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this renewal ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ edocket. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9 and are identified on the form and/ or instrument, if applicable. Title: Confidentiality Rules ( OMB Control No. 2020   0003; EPA ICR No. 1665.06), expiring September 30, 2003. Abstract: EPA administers a number of environmental protection statutes ( e. g., the Clean Water Act; the Clean Air Act; the Toxic Substances Control Act; the Resource Conservation and Recovery Act; and the Comprehensive Environmental Response, Compensation, and Liability Act), under which the Agency collects information from thousands of facilities in many economic sectors. In addition, businesses submit information to EPA without the Agency requesting it. The information addresses topics such as toxic chemicals, industrial processes, waste streams, and regulatory compliance. In many cases, businesses that submit information claim it to be confidential business information ( CBI). EPA established the procedures described in 40 CFR part 2, subparts A and B to protect the confidentiality of information as well as the rights of the public to obtain access to the information under the Freedom of Information Act ( FOIA). In accordance with these regulations, when EPA finds it necessary to make a final confidentiality determination ( e. g., in response to a FOIA request or in the course of rulemaking or litigation), or an advance confidentiality determination, it notifies the affected business by sending a letter requesting substantiation of the confidentiality claim. This letter provides the affected business with an opportunity to submit VerDate Jan< 31> 2003 16: 38 Sep 04, 2003 Jkt 200001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 05SEN1. SGM 05SEN1


[Federal Register: September 3, 2008 (Volume 73, Number 171)]
[Rules and Regulations]
[Page 51356-51357]
[DOCID:fr03se08-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0550; Airspace Docket 08-AEA-21]

Modification of Class D and Class E Airspace; Rome, NY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Direct final rule, request for comments.

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SUMMARY: This action modifies the Class D and E airspace at Griffiss
Airfield in Rome, NY. After the development of specific Departure
Procedures (DPs) at the airfield, it was determined the Class D and E
Surface airspace should be reduced in size to facilitate a more
efficient operation. This rule increases the safety and management of
the National Airspace System (NAS) around Griffiss Airfield.

DATES: Effective 0901 UTC, November 20, 2008. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.
Comments should be received no later than October 3, 2008.

ADDRESSES: Send comments on this rule to: U. S. Department of
Transportation, Docket Operations, West Building, Ground Floor, Room
W12-140, 1200 New Jersey, SE., Washington, DC 20590-0001; Telephone: 1-
800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket Number
FAA-2008-0550; Airspace Docket No. 08-AEA-21, at the beginning of your
comments. You may also submit and review received comments through the
Internet at http://www.regulations.gov.
    You may review the public docket containing the rule, any comments
received, and any final disposition in person in the Dockets Office
(see ADDRESSES section for address and phone number) between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
    An informal docket may also be examined during normal business
hours at the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Operations Support,
Eastern Service Center, Federal Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

The Direct Final Rule Procedure

    The FAA anticipates that this regulation will not result in adverse
or negative comments, and, therefore, issues it as a direct final rule.
The FAA has determined that this rule only involves an established body
of technical regulations for which frequent and routine amendments are
necessary to keep them operationally current. This rule is effective
and there will be no further action by the FAA unless a written adverse
or negative comment or a written notice of intent to submit an adverse
or negative comment is received within the comment period. If the FAA
receives, within the comment period, an adverse or negative comment, or
written notice of intent to submit such a comment, a document
withdrawing the direct final rule will be published in the Federal
Register, and a notice of proposed rulemaking may be published with a
new comment period.

Comments Invited

    Although this action is in the form of a direct final rule, and was
not preceded by a notice of proposed rulemaking, interested persons are
invited to comment on this rule by submitting such written data, views,
or arguments as they may desire. An electronic copy of this document
may be downloaded from and comments may be submitted and reviewed at
http://www.regulations.gov. Recently published rulemaking documents can
also be accessed through the FAA's Web page at http://www.faa.gov or
the Federal Register's Web page at http://www.gpoaccess.gov/fr/
index.html. Communications should identify both docket numbers and be
submitted in triplicate to the address specified under the caption
ADDRESSES above or through the Web site. All communications received on
or before the closing date for comments will be considered, and this
rule may be amended or withdrawn in light of the comments received.
    Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify the rule. Factual information that supports
the commenter's ideas and suggestions is extremely helpful in
evaluating the effectiveness of this action and determining whether
additional rulemaking action would be needed. All comments submitted
will be available, both before and after the closing date for comments,
in the Rules Docket for examination by interested persons. Those
wishing the FAA to acknowledge receipt of their comments submitted in
response to this rule must submit a self-addressed, stamped postcard on
which the following statement is made: ``Comments to Docket No. FAA-
2008-0550; Airspace Docket No. 08-AEA-21.'' The postcard will be date
stamped and returned to the commenter.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 modifies Class D and E2 airspace at Rome, NY by reducing the
controlled airspace, extending upward from the surface of the Earth to
support IFR operations at Griffiss Airfield to a 5.0-mile radius with
minor extensions for arrivals. Class D and E2 Surface airspace is
usually predicated on departures from an airport with a control tower
climbing at a standard rate of climb in random

directions until reaching 700 feet above the surface of the Earth.
Additionally, the point an aircraft reaches the 1000-foot point Above
Ground Level (AGL) while descending on a Standard Instrument Approach
determines extensions to the Class D and E2 airspace. On September 7,
2007, airspace was developed around the Griffiss Airfield to encompass
this requirement (72 FR 51357). The criteria at that time required the
airspace to be an 8.4-mile radius of the airport because of rising
terrain. Since that date, Departure Procedures (DPs) have been
developed requiring aircraft to climb on specific headings until
reaching that 700-foot AGL altitude prior to turning. This required
procedure allows for the reduction in size of the current Class D and
E2 airspace facilitating a more efficient operation. This Docket
provides for that reduction.
    Class D and E2 airspace designations for airspace areas extending
upwards from the surface of the Earth are published in Paragraph 5000
and 6002 respectively, of FAA Order 7400.9R, dated August 15, 2007, and
effective September 15, 2007, which is incorporated by reference in 14
CFR 71.1. The Class D and E2 airspace designations listed in this
document will be published subsequently in the Order.

Agency Findings

    The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among various levels of government. Therefore, it is
determined that this final rule does not have federalism implications
under Executive Order 13132.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies the Class D and E2 airspace at Griffiss Airfield in
Rome, NY.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9R, Airspace Designations and Reporting
Points, dated August 15, 2007, and effective September 15, 2007, is
amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AEA NY D Rome, NY [Revised]

Griffiss Airfield, NY
    (Lat. 43[deg]14'02'' N, Long. 75[deg]24'25'' W)

    That airspace extending upward from the surface of the Earth to
and including 3,000 feet MSL within a 5.0-mile radius of the
Griffiss Airfield and within 1.2 miles each side of the 331[deg]
bearing from the airport to 5.6 miles northwest of the airfield and
within 1.3 miles each side of the 152[deg] bearing from the Griffiss
Airfield to 5.1 miles southeast of the Airfield. This Class D
airspace area is effective during the specific days and times
established in advance by a Notice to Airmen. The effective days and
times will thereafter be continuously published in the Airport/
Facility Directory.
* * * * *

Paragraph 6002 Class E Airspace Designated as Surface Areas.

* * * * *

AEA NY E2 Rome, NY [Revised]

Griffiss Airfield, NY
    (Lat. 43[deg]14'02'' N, Long. 75[deg]24'25'' W)

    That airspace extending upward from the surface of the Earth
within a 5.0-mile radius of the Griffiss Airfield and within 1.2
miles each side of the 331[deg] bearing from the airport to 5.6
miles northwest of the airfield and within 1.3 miles each side of
the 152[deg] bearing from the Griffiss Airfield to 5.1 miles
southeast of the Airfield. This Class E Surface airspace area is
effective during the specific days and times established in advance
by a Notice to Airmen. The effective days and times will thereafter
be continuously published in the Airport/Facility Directory.
* * * * *

    Issued in College Park, Georgia, on August 4, 2008.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. E8-19568 Filed 9-2-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 88, Number 86 (Thursday, May 4, 2023)]
[Notices]
[Pages 28565-28566]
[FR Doc No: 2023-09517]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0705]

Q9(R1) Quality Risk Management; International Council for
Harmonisation; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Q9(R1)
Quality Risk Management.'' The guidance was prepared under the auspices
of the International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH). The guidance is a
targeted revision of the 2006 guidance for industry ``Q9 Quality Risk
Management'' and addresses product availability risks due to
manufacturing quality issues, lack of understanding as to what
constitutes formality in Quality Risk Management (QRM) work, lack of
clarity on risk-based decision-making, and high levels of subjectivity
in risk assessments and QRM outputs. The revision is intended to
provide guidance on quality risk management principles and tools that
can be applied to different aspects of pharmaceutical quality. The
guidance replaces the draft guidance ``Q9(R1) Quality Risk Management''
issued on June 15, 2022.

DATES: The announcement of the guidance is published in the Federal
Register on May 4, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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-2022-D-0705 for ``Q9(R1) Quality Risk Management.'' Received
comments 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.govinfo.gov/content/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling the
Center for Biologics Evaluation and Research at 1-800-835-4709 or 240-
402-8010. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Rick Friedman, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 4348, Silver Spring, MD 20993-0002,<PHONE_NUMBER> or Diane
Maloney, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10906 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0005,<PHONE_NUMBER>.
    Regarding ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Q9(R1) Quality Risk Management.'' The guidance was prepared
under the

auspices of ICH. ICH seeks to achieve greater regulatory harmonization
worldwide to ensure that safe, effective, high-quality medicines are
developed, registered, and maintained in the most resource-efficient
manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines enhance global drug development, improve
manufacturing standards, and increase the availability of medications.
For example, ICH guidelines have substantially reduced duplicative
clinical studies, prevented unnecessary animal studies, standardized
the reporting of important safety information, and standardized
marketing application submissions.
    The six Founding Members of the ICH are the FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. ICH membership
continues to expand to include other regulatory authorities and
industry associations from around the world (refer to https://www.ich.org/).
    ICH works by engaging global regulatory and industry experts in a
detailed, science-based, and consensus-driven process that results in
the development of ICH guidelines. The regulators around the world are
committed to consistently adopting these consensus-based guidelines,
realizing the benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In the Federal Register of June 15, 2022 (87 FR 36135), FDA
published a notice announcing the availability of a draft guidance
entitled ``Q9(R1) Quality Risk Management.'' The notice gave interested
persons an opportunity to submit comments by July 15, 2022.
    After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agencies on January 18, 2023.
    This guidance finalizes the draft guidance of the same title issued
on June 15, 2022. The final guidance includes: (1) updated references,
(2) a dedicated section to the subjectivity of QRM, (3) clarification
on the application of risk management in the use of digitalization and
emerging technologies, (4) an emphasis on root cause analysis, (5) a
clearer definition of ``risk-based decision-making,'' and (6) an
improved distinction between hazards, harms, and associated risks. The
final guidance further addresses detection controls' link to reducing
the probability of the occurrence of harm, situations which call for
higher levels of QRM formality, and the importance of QRM regarding
distribution practices.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Q9(R1) Quality Risk Management.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR parts 210 and 211 relating to current good
manufacturing practice requirements have been approved under OMB
control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: May 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09517 Filed 5-3-23; 8:45 am]
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[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Page 32949]
[FR Doc No: 2015-14226]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9929-04-OA]

National Environmental Education Advisory Council

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meetings.

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SUMMARY: Under the Federal Advisory Committee Act, EPA gives notice of
a series of teleconference meetings of the National Environmental
Education Advisory Council (NEEAC). The NEEAC was created by Congress
to advise, consult with, and make recommendations to the Administrator
of the Environmental Protection Agency (EPA) on matters related to
activities, functions and policies of EPA under the National
Environmental Education Act (the Act). 20 U.S.C. 5508(b).
    The purpose of this teleconference(s) is to discuss specific topics
of relevance for consideration by the council in order to provide
advice and insights to the Agency on environmental education.

DATES: The National Environmental Education Advisory Council will hold
a public teleconference on Thursday, June 18th, 2015, from 1:00 p.m.
until 2:00 p.m. Eastern Daylight Time.

FOR FURTHER INFORMATION CONTACT: Javier Araujo, Designated Federal
Officer<EMAIL_ADDRESS>202-564-2642, U.S. EPA, Office of
Environmental Education, William Jefferson Clinton North Room, 1426,
1200 Pennsylvania Avenue NW., Washington, DC 20460.

SUPPLEMENTARY INFORMATION: Members of the public wishing to gain access
to the teleconference, make brief oral comments, or provide a written
statement to the NEEAC must contact Javier Araujo, Designated Federal
Officer, at<EMAIL_ADDRESS>or<PHONE_NUMBER> by 10 business days
prior to each regularly scheduled meeting.
    Meeting Access: For information on access or services for
individuals with disabilities or to request accommodations, please
contact Javier Araujo at<EMAIL_ADDRESS>or<PHONE_NUMBER>,
preferably at least 10 days prior to the meeting, to give EPA as much
time as possible to process your request.

    Dated: June 2, 2015.
Sarah Sowell,
Deputy Director, Office of Environmental Education.
    Dated: June 2, 2015.
Javier Araujo,
(NEEAC) Designated Federal Officer.
[FR Doc. 2015-14226 Filed 6-9-15; 8:45 am]
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 . Signature: Project No.: 0<IP_ADDRESS>   DISTRIBUTION Page __ 1_ of _ 1_

Project Name: 304m Industry Investigations: Timber Products TELEPHONE CALL RECORD Outgoing Call Date: January 13, 2004 Time: 2  3 PM Company Name: US EPA, Office of Env. Information OIAA, TRI Prorgram Division Contact Name: Velu Senthil Phone No.: ( 202) 566 0749 Name: Betsy Bicknell & Arash Hooshangi Eastern Research Group, Inc.

GENERAL SUBJECT : Wood Treating FacilitiesTRI reporting of dioxins and PACS TOPICS DISCUSSED AND ACTION TAKEN Arash and I called Velu Senthil, TRI Program Division, to learn more about the TRI Quality Program contacts with wood treating facilities. Velu had previously informed us that the TRI program had contacted the following wood treating facilities:

Koppers, Montgomery, AL, for dioxin and dioxin like compounds; Koppers, IL, for dioxin and dioxin like compounds; Koppers, PA, for dioxin and dioxin like compounds; Koppers, VA, for mercury compounds; and Taylor Lumber, OR for lead compounds; We did not call Koppers, MS for dioxin and dioxin like compounds; and Wheeler, SD, for dioxin and dioxin like compounds.

Velu explained that either he or a regional TRI coordinator will call the 5 to 10 facilities that have the highest releases of each chemical in an SIC code. They don't focus on wastewater releases, but look at the total releases. Depending on the experience of the person making the call, they don't usually ask how the release was estimated, but just give the reporter a chance to check their estimate and revise it if necessary. In addition, Velu said he called all facilities that reported releasing more than 100 lb/ yr of mercury to water.

In our category review, ERG found some discrepancies between TRI loads in OTIS and our RSEIReleases2000 database. Our database is based on the public release version of the data. Velu said that the public release version is " frozen" at the release date. It is that version to which TRI explorer refers. OTIS looks at Envirofacts, and Envirofacts will be updated as facilities correct their reported releases. So there may very well be some numbers in OTIS/ Envirofacts that don't match the TRI Explorer/ public release.