[Federal Register Volume 88, Number 217 (Monday, November 13, 2023)]
[Notices]
[Pages 77577-77578]
[FR Doc No: 2023-24837]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC23-13-000]

Commission Information Collection Activities (FERC-583); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection, FERC-583, Annual Kilowatt Generating Report
(Annual Charges), which will be submitted to the Office of Management
and Budget (OMB) for a review of the information collection
requirements.

DATES: Comments on the collection of information are due December 13,
2023.

ADDRESSES: Send written comments on FERC-583 to OMB through
www.reginfo.gov/public/do/PRAMain, Attention: Federal Energy Regulatory

Commission Desk Officer. Please identify the OMB control number (1902-
0136) in the subject line. Your comments should be sent within 30 days
of publication of this notice in the Federal Register.
    Please submit copies of your comments (identified by Docket No.
IC23-13-000) to the Commission as noted below. Electronic filing
through https://www.ferc.gov is preferred.
     Electronic Filing: Documents must be filed in acceptable
native applications and print-to-PDF, but not in scanned or picture
format.
     For those unable to file electronically, comments may be
filed by USPS mail or by hand (including courier) delivery.
    [cir] Mail via U.S. Postal Service Only: Addressed to: Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street NE, Washington, DC 20426.
    [cir] Hand (including courier) Delivery: Deliver to: Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
    Instructions:
    OMB submissions must be formatted and filed in accordance with
submission guidelines at www.reginfo.gov/public/do/PRAMain. Using the
search function under the ``Currently Under Review field,'' select
Federal Energy Regulatory Commission; click ``submit'' and select
``comment'' to the right of the subject collection.
    FERC submissions must be formatted and filed in accordance with
submission guidelines at: https://www.ferc.gov. For user assistance,
contact FERC Online Support by email at [email protected], or
by phone at:<PHONE_NUMBER> (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at https://www.ferc.gov.

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

SUPPLEMENTARY INFORMATION:
    Title: FERC-583, Annual Kilowatt Generating Report (Annual
Charges).
    OMB Control No.: 1902-0136.
    Type of Request: Three-year extension of the FERC-583 information
collection requirements with no changes to the existing collection.
    Abstract: Section 10(e) of the Federal Power Act (FPA) \1\ requires
the Federal Energy Commission (FERC or Commission) to collect annual
charges from entities that generate electricity with hydropower in
accordance with Commission authorization. Such charges reimburse the
federal government for the cost of administering Part I of the FPA,\2\
the use of Tribal lands, the use of Federal lands, and the use of
Federal dams.
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 803(e).
    \2\ 16 U.S.C. 791 through 823d.
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    The regulations at 18 CFR 11.1(c)(5) and 11.1(d)(4) require annual
kilowatt generating reports from licensees and exemptees. The
Commission's Financial Services Division uses the reports to determine
the amount of annual charges to be assessed each licensee and exemptee.
    The Commission published a 60-day notice in the Federal Register on
August 9, 2023 under Docket No. IC23-13-000 and received no comments.
    Types of Respondent: (1) Hydropower licensees of projects more than
1.5 megawatts of installed capacity; (2) Holders of exemptions under
section 30 of the FPA; \3\ and (3) exemptees under sections 405 and 408
of the Public Utility Regulatory Policy Act.\4\
---------------------------------------------------------------------------

    \3\ 16 U.S.C. 823a.
    \4\ 16 U.S.C. 2705.
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    Estimate of Annual Burden: \5\ The following table shows the
estimated annual burden and cost:
---------------------------------------------------------------------------

    \5\ ``Burden'' is the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. For further
explanation of what is included in the information collection
burden, refer to 5 CFR 1320.3.

                                                           FERC-583--Estimated Annual Burdens
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         C. Annual
                                       B. Number of      number of     D. Total number    E. Average hours &    F. Total annual burden     G. Cost per
         A. Type of response            respondents    responses per    of responses     cost \6\ per response   hours & total annual      respondent
                                                        respondent                                                       cost
                                                                        (Col. B x Col.                          (Col. D x Col. E).....    (Col. F / Col.
                                                                                C)                                                                B)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual kilowatt generating report;               550               1               550  2 hrs.; $192..........  1,100 hrs.; $105,600..              $192
 18 CFR 11.1(c)(5) and 11.1(d)(4).
Application of a State or municipal               50               1                50  2 hrs.; $192..........  100 hrs.; $9,600......               192
 licensee or exemptee for total or
 partial exemption from the
 assessment of annual charges; 18
 CFR 11.6.
Appeals and requests for rehearing                 2               1                 2  40 hrs.; $3,840.......  80 hrs.; $7,680.......             3,840
 of billing for annual charges; 18
 CFR 11.20.
                                     -------------------------------------------------------------------------------------------------------------------
    Totals..........................             602  ..............               602  ......................  1,280 hrs.; $122,880..  ................
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

    \6\ The Commission staff thinks that the average respondent for
this collection is similarly situated to the Commission, in terms of
salary plus benefits. Based upon FERC's 2023 annual average full-
time equivalent of $199,867 per year (for salary plus benefits), the
average hourly cost is $96.00 per hour.

    Dated: November 3, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-24837 Filed 11-9-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 17, 2006 (Volume 71, Number 200)]
[Proposed Rules]
[Page 60934-60937]
[DOCID:fr17oc06-37]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2006-0729; FRL-8231-4]

Revisions to the Arizona State Implementation Plan, Pinal County
Air Quality Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing a limited approval and limited disapproval of
revisions to the Pinal County Air Quality Control District (PCAQCD)
portion of the Arizona State Implementation Plan (SIP). These revisions
concern particulate matter (PM-10) emissions from fugitive dust. We are
proposing action on local rules that regulate these emission sources
under the Clean Air Act as amended in 1990 (CAA or the Act). We are
taking comments on this proposal and plan to follow with a final
action.

DATES: Any comments must arrive by November 16, 2006.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2006-0729, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-

line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available

online at http://www.regulations.gov, including any personal information

provided, unless the comment includes Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through
http://www.regulations.gov or e-mail. www.regulations.gov is an ``anonymous

access'' system, and EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send e-mail directly to EPA, your e-mail address will be automatically
captured and included as part of the public comment. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA Region

IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Francisco Donez, EPA Region IX, (415)
972-3956<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules?
II. EPA's Evaluation and Action.
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. What are the rule deficiencies?
    D. Proposed action and public comment.
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal with the dates
that they were adopted by local air agencies and submitted by the
Arizona Department of Environmental Quality (ADEQ).

                                            Table 1.--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                       Rule < greek-
             Local agency                   i>               Rule title               Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
PCAQCD...............................      4-2-020  General [Fugitive Dust].....         6/29/93       11/27/95.
PCAQCD...............................      4-2-030  Definitions [Fugitive Dust].         6/29/93       11/27/95.
PCAQCD...............................      4-2-040  Standards [Fugitive Dust]...         6/29/93       11/27/95.
PCAQCD...............................      4-2-050  Monitoring and Records               5/14/97       10/07/98.
                                                     [Fugitive Dust].
----------------------------------------------------------------------------------------------------------------

    On June 4, 1996, the submittals of rules 4-2-020, 4-2-030, and 4-2-
040 were found to meet the completeness criteria in 40 CFR part 51,
Appendix V, which must be met before formal EPA review. On April 24,
1999, the submittal of rule 4-2-050 was found to meet the completeness
criteria.

B. Are there other versions of these rules?

    There are no previous versions of Rules 4-2-020, 4-2-030, 4-2-040,
or 4-2-050 in the SIP.

C. What is the purpose of the submitted rules?

    Particulate matter (PM-10) harms human health and the environment.
Section 110(a) of the CAA requires states to submit regulations that
control PM-10 emissions. Rules 4-2-020, 4-2-030, 4-2-040, and 4-2-050
establish requirements that help control PM-10 emissions from fugitive
dust. EPA's technical support document (TSD) has more information about
these rules.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    Generally, SIP rules must be enforceable (see section 110(a) of the
CAA), must require reasonably available control measures (RACM),
including reasonably available control technology (RACT) in moderate
PM-10 nonattaiment areas (see section 189(a)), must require best
available control measures (BACM), including best available control
technology (BACT) in serious PM-10 nonattaiment areas (see section
189(b)), and must not relax existing requirements (see sections 110(l)
and 193). A portion of PCAQCD is designated attainment, a portion is
designated moderate nonattainment, and a portion is designated serious
nonattainment for PM-10.
    The following guidance documents were used for reference:
    1. Requirements for Preparation, Adoption, and Submittal of
Implementation Plans, U.S. EPA, 40 CFR part 51.
    2. PM-10 Guideline Document (EPA-452/R-93-008).

B. Do the rules meet the evaluation criteria?

    These rules improve the SIP by establishing more stringent emission
limits. These rules are largely consistent with the relevant policy and
guidance regarding enforceability, RACT and SIP relaxations. Rule
provisions which do not meet the evaluation criteria are summarized
below and discussed further in the TSD.

C. What are the rule deficiencies?

    These provisions conflict with section 110 and part D of the Act
and prevent full approval of the SIP revision.
    1. Rule 4-2-020, Section B specifies that Article 4 ``shall not be
construed so as to prevent normal farm cultural practices which cause
fugitive dust.'' Normal farm cultural practice is defined in Rule 4-2-
030, Definition 2, as ``all activities * * * conducted on any facility
for the production of crops, livestock, poultry, livestock products or
poultry products.'' As written, Rule 4-2-020, Section B effectively
exempts agricultural activities from the fugitive dust rules without
justification.
    2. Rule 4-2-030, Definition 3, defines ``reasonable precaution'' in
highly general terms. The term ``reasonable precaution'' is then used
in every section of Rule 4-2-040, to define what actions must be taken
to mitigate fugitive dust emissions from relevant activities. This
general requirement is not sufficiently clear or enforceable.
    3. Rule 4-2-050 does not contain recordkeeping provisions. The
absence of these provisions makes the all of the submitted rules
difficult to enforce.

D. Proposed Action and Public Comment

    As authorized in sections 110(k)(3) and 301(a) of the Act, EPA is
proposing a limited approval of the submitted

rules to improve the SIP. If finalized, this action would incorporate
the submitted rules into the SIP, including those provisions identified
as deficient. This approval is limited because EPA is simultaneously
proposing a limited disapproval of the rules under section 110(k)(3).
If this disapproval is finalized, sanctions will be imposed under
section 179 of the Act unless EPA approves subsequent SIP revisions
that correct the rule deficiencies within 18 months. These sanctions
would be imposed according to 40 CFR 52.31. A final disapproval would
also trigger the federal implementation plan (FIP) requirement under
section 110(c). Note that the submitted rules have been adopted by the
PCAQCD, and EPA's final limited disapproval will not prevent the local
agency from enforcing them.
    We will accept comments from the public on the proposed limited
approval and limited disapproval for the next 30 days.

III. Statutory and Executive Order Reviews

A. Executive Order 12866, Regulatory Planning and Review

    The Office of Management and Budget (OMB) has exempted this
regulatory action from Executive Order 12866, entitled ``Regulatory
Planning and Review.''

B. Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.)

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small not-for-profit enterprises, and small governmental
jurisdictions.
    This rule will not have a significant impact on a substantial
number of small entities because SIP approvals under section 110 and
subchapter I, part D of the Clean Air Act do not create any new
requirements but simply approve requirements that the State is already
imposing. Therefore, because the Federal SIP approval does not create
any new requirements, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
    Moreover, due to the nature of the Federal-State relationship under
the Clean Air Act, preparation of flexibility analysis would constitute
Federal inquiry into the economic reasonableness of state action. The
Clean Air Act forbids EPA to base its actions concerning SIPs on such
grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976);
42 U.S.C. 7410(a)(2).

D. Unfunded Mandates Reform Act

    Under sections 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
the private sector, of $100 million or more. Under section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
    EPA has determined that the approval action proposed does not
include a Federal mandate that may result in estimated costs of $100
million or more to either State, local, or tribal governments in the
aggregate, or to the private sector. This Federal action proposes to
approve pre-existing requirements under State or local law, and imposes
no new requirements. Accordingly, no additional costs to State, local,
or tribal governments, or to the private sector, result from this
action.

E. Executive Order 13132, Federalism

    Federalism (64 FR 43255, August 10, 1999) revokes and replaces
Executive Orders 12612 (Federalism) and 12875 (Enhancing the
Intergovernmental Partnership). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' Under Executive Order 13132, EPA may not issue a
regulation that has federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless
the Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, or EPA
consults with State and local officials early in the process of
developing the proposed regulation. EPA also may not issue a regulation
that has federalism implications and that preempts State law unless the
Agency consults with State and local officials early in the process of
developing the proposed regulation.
    This rule 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 the various
levels of government, as specified in Executive Order 13132, because it
merely approves a state rule implementing a federal standard, and does
not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. Thus, the
requirements of section 6 of the Executive Order do not apply to this
rule.

F. Executive Order 13175, Coordination With Indian Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This proposed rule does not
have tribal implications, as specified in Executive Order 13175. It
will not have substantial direct effects on tribal governments, on the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes. Thus, Executive Order 13175 does not
apply to this rule.
    EPA specifically solicits additional comment on this proposed rule
from tribal officials.

G. Executive Order 13045, Protection of Children from Environmental
Health Risks and Safety Risks

    Protection of Children from Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is
determined to be ``economically significant'' as defined under
Executive Order 12866, and (2) concerns an

environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
    This rule is not subject to Executive Order 13045 because it does
not involve decisions intended to mitigate environmental health or
safety risks.

H. Executive Order 13211, Actions that Significantly Affect Energy
Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12 of the National Technology Transfer and Advancement Act
(NTTAA) of 1995 requires Federal agencies to evaluate existing
technical standards when developing a new regulation. To comply with
NTTAA, EPA must consider and use ``voluntary consensus standards''
(VCS) if available and applicable when developing programs and policies
unless doing so would be inconsistent with applicable law or otherwise
impractical.
    The EPA believes that VCS are inapplicable to this action. Today's
action does not require the public to perform activities conducive to
the use of VCS.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Particulate matter, Reporting and recordkeeping
requirements.

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

    Dated: September 14, 2006.
Wayne Nastri,
Regional Administrator, Region IX.
 [FR Doc. E6-17233 Filed 10-16-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: November 30, 2005 (Volume 70, Number 229)]
[Notices]
[Page 71821]
[DOCID:fr30no05-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP02-132-009]

Viking Gas Transmission Company; Notice of Compliance Filing

November 22, 2005.
    Take notice that on November 17, 2005, Viking Gas Transmission
Company (Viking) tendered for filing to become part of its FERC Gas
Tariff, First Revised Volume No. 1, the tariff sheets attached to the
filing, to become effective on January 1, 2006.
    Viking states that the purpose of this filing is to comply with
Article XIII of the Stipulation and Agreement (Settlement) in Docket
No. RP02-132-002 approved by Letter Order dated November 8, 2002.
Article XIII of the Settlement provides that Viking would file to
cancel Rate Schedule FT-D and remove all references to service under
this rate schedule upon completion of Stage 4 of the rolled-in rate
treatment of its expansion facilities approved by the Commission in
Docket No. RP98-761-000. Accordingly, Viking is proposing herein to
implement rates reflecting Stage 4 of the rolled-in rate treatment to
be effective on January 1, 2006 and to delete all references to Rate
Schedule FT-D.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

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

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

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6685 Filed 11-29-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 182 (Tuesday, September 20, 2016)]
[Notices]
[Pages 64574-64575]
[FR Doc No: 2016-22556]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twenty Fourth Meeting of SC-217 Aeronautical Databases

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Twenty Seventh Meeting of the SC-217 Aeronautical Databases.

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of Twenty Seventh Meeting of SC-217 Aeronautical Databases.

DATES: The meeting will be held November 29 to December 2, 2016, 9:00
a.m. to 5:00 p.m.

ADDRESSES: The meeting will be held at: 202 Burlington Road, Bedford,
MA 01730-1420.

FOR FURTHER INFORMATION CONTACT: Karan Hofmann at<EMAIL_ADDRESS>or
(202) 330-0680, or The RTCA Secretariat, 1150 18th Street NW., Suite
910, Washington, DC, 20036, or by telephone at<PHONE_NUMBER>, fax at
(202) 833-9434, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of the Twenty

Seventh Meeting of SC-217 Aeronautical Databases. The agenda will
include the following:

Monday, November 28th

Working Session

    For those able to attend, a working group session will be held to
progress on action items ahead of the plenary.

Tuesday, November 29th (9:00 a.m.-11:00 a.m.)

Opening Plenary Session

1. Co-Chairmen's remarks and introductions
2. Housekeeping
3. Approve minutes from 26th meeting
4. Review and approve meeting agenda for 27th meeting
5. Action item list review
6. Presentations (TBD)
    a. Status of EASA PBN IR

Tuesday, November 29th (11:00 a.m.) through Thursday, December 1st
(5:00 p.m.)

Working Group Sessions

1. Sub-team report-outs
     Document structure
     Background/PBN principles
     Data preparation rules
     Data quality
     Procedure encoding
     Aeronautical information basics
2. Draft of requirements tables based on data catalog
3. Review of action item inputs
    a. Working Papers
    b. Discussion Papers
    c. Information Papers
4. New business

Friday December 2nd (9:00 a.m.-12:00 p.m.)

Closing Plenary session

Meeting wrap-up: main conclusions and way forward
Review of action items
Next meetings
Any other business
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC on September 15, 2016.
Mohannad Dawoud,
Management & Program Analyst, Partnership Contracts Branch, ANG-A17,
NextGen, Procurement Services Division, Federal Aviation
Administration.
[FR Doc. 2016-22556 Filed 9-19-16; 8:45 am]
 BILLING CODE 4910-13-P


Comment Info: =================

General Comment:Unexpected effects of methylphenidate in Attention-Deficit/Hyperactivity Disorder reflect decreases in core/secondary symptoms and physical complaints common to all children.


[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Pages 38992-38993]
[FR Doc No: 2019-17026]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0560]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance on Informed
Consent for In Vitro Diagnostic Device Studies Using Leftover Human
Specimens That Are Not Individually Identifiable

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by
September 9, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0582.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance on Informed Consent for In Vitro Diagnostic Device Studies
Using Leftover Human Specimens That Are Not Individually Identifiable

OMB Control Number 0910-0582--Extension

    FDA's investigational device regulations are intended to encourage
the development of new, useful devices in a manner that is consistent
with public health, safety, and compliant with ethical standards.
Investigators should have freedom to pursue the least burdensome means
of accomplishing this goal. However, to ensure that the balance is
maintained between product development and the protection of public
health, safety, and ethical standards, FDA has established human
subject protection regulations addressing requirements for informed
consent and institutional review board (IRB) review that apply to all
FDA-regulated clinical investigations involving human subjects. In
particular, informed consent requirements further both safety and
ethical considerations by allowing potential subjects to consider both
the physical and privacy risks they face if they agree to participate
in a trial.
    Under FDA regulations, clinical investigations using human
specimens conducted in support of premarket submissions to FDA are
considered human subject investigations (see 21 CFR 812.3(p)). Many
investigational device studies are exempt from most provisions of part
812, Investigational Device Exemptions, under 21 CFR 812.2(c)(3), but
FDA's regulations for the protection of human subjects (21 CFR parts 50
and 56) apply to all clinical investigations that are regulated by FDA
(see 21 CFR 50.1, 21 CFR 56.101, and 21 U.S.C. 360j(g)(3)(A) and (D)).
    FDA regulations do not contain exceptions from the requirements of
informed consent on the grounds that the specimens are not identifiable
or that they are remnants of human specimens collected for routine
clinical care or analysis that would otherwise have been discarded. Nor
do FDA regulations allow IRBs to decide whether or not to waive
informed consent for research involving leftover or unidentifiable
specimens.
    In the document entitled ``Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are
Not Individually Identifiable,'' issued under the Good Guidances
Practices regulation (21 CFR 10.115), FDA outlines the circumstances in
which it intends to exercise enforcement discretion as to the informed
consent regulations for clinical investigators, sponsors, and IRBs.
    The recommendations of the guidance impose a minimal burden on
industry. FDA estimates that 700 studies will be affected annually.
Each study will result in one annual record, estimated to take 4 hours
to complete. This results in a total recordkeeping burden of 2,800
hours (700 x 4 = 2,800).
    In the Federal Register of March 5, 2019 (84 FR 7906), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received the following comments:
    (Comment 1) Some comments strongly support further harmonization
between the updated Common Rule and FDA regulations. Although the
comments support FDA's 2006 Guidance and discretionary enforcement, the
comments suggested that scientists would welcome expanded efforts to
remove investigations using de-identified human tissues from FDA's
human subject regulations, consistent with the Common Rule. The
comments suggest there is little practical utility in FDA maintaining
de-identified specimens as part of human subject investigations. The
comments suggest that removing de-identified specimens from these
requirements would allow for safety and ethical considerations while
reducing administrative burden for investigators, ensuring consistency
with the Common Rule and streamlining effectiveness. The comments
suggest there is a longstanding tradition of research using de-
identified human tissue in a way that demonstrates adherence to the
Belmont principles of justice, beneficence, and respect for persons.
Further the comments express the belief that requiring consent for
tissue routinely archived would render a very large and crucial
resource essentially off limits for research because most institutions/
hospitals, particularly outside academia, do not include consent for
surplus tissue use prior to surgery or tissue biopsy. The comments
suggested that asking for consent retrospectively is very cumbersome,
costly, and may be perceived as intrusive by patients.
    (Response) These comments are not related to the information
collection or burden estimate. However, we have forwarded the comment
to the appropriate program office for consideration.
    (Comment 2) A comment suggested that 4 hours per recordkeeper may
be a significant underestimation of the burden of the information
collection. The comment referenced Section V of the 2006 Guidance and
stated that the two-step process in that section amounts to both a
general review of policies and procedures and a study-by-study IRB
review to ensure compliance. The comment suggested that requiring
reviews at the level of individual FDA investigations will lead to an
aggregate of more than 4 hours per year per recordkeeper.
    (Response) The comment was considered but FDA does not believe that
the 4-hour estimate is a significant

underestimation given that these actions should not be a burdensome
process for the recordkeeper.
    (Comment 3) The commenter opposed changing the default from ``opt-
in'' to ``opt-out'' for patients to consent to their tissue being used
for research. Although simple malformations, such as warts and tumors,
may be useful to labs to fine-tune their tests, and although many (even
most) patients might be willing to share this tissue, a significant
minority of Americans hold beliefs about the human body that would
prevent them from consenting, and all Americans likely assume that
their tissue is destroyed (burned as medical waste) after procedures
have been performed. The commenter believes that changing what happens
without changing the public understanding of what happens is
fundamentally dishonest. The commenter recognizes that obtaining
consent is time-consuming, particularly when the patient does not speak
English as a first language, or has other comprehension issues;
however, the commenter believes no lab has a right to the tissue of an
American citizen for its private, profit-making use.
    (Response) The subject of the comment deals with sample
acquisition, a step that happens in advance of the information
communicated in this guidance. Therefore, patient ``opt-in'' versus
``opt-out'' is out of scope. This guidance describes the enforcement
discretion policy FDA uses when sponsors choose to use de-identified
samples for IVD medical device clinical trials.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Average  burden
                              Activity                                  Number of       records per     Total  annual         per          Total  hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping regarding leftover human specimens that are not                   700                1              700                4            2,800
 individually identifiable that are used in certain IVD studies....
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: August 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17026 Filed 8-7-19; 8:45 am]
BILLING CODE 4164-01-P