[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35653-35654]
[FR Doc No: 2018-16036]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2456]

Slowly Progressive, Low-Prevalence Rare Diseases With Substrate
Deposition That Results From Single Enzyme Defects: Providing Evidence
of Effectiveness for Replacement or Corrective Therapies; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Slowly
Progressive, Low-Prevalence Rare Diseases with Substrate Deposition
That Results from Single Enzyme Defects: Providing Evidence of
Effectiveness for Replacement or Corrective Therapies.'' This document
is intended to provide guidance to sponsors on the evidence necessary
to demonstrate the effectiveness of new drugs, including biological
drugs, or new drug uses intended for slowly progressive, low-prevalence
rare diseases that are associated with substrate deposition and are
caused by single enzyme defects. This guidance applies only to those
low-prevalence rare diseases with a well-characterized pathophysiology
and in which changes in substrate deposition can be readily measured in
relevant tissue(s).

DATES: Submit either electronic or written comments on the draft
guidance by September 25, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2018-D-2456 for ``Slowly Progressive, Low-Prevalence Rare Diseases
with Substrate Deposition That Results from Single Enzyme Defects:
Providing Evidence of Effectiveness for Replacement or Corrective
Therapies; Draft Guidance for Industry; Availability.'' 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft 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 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. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dragos Roman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5152, Silver Spring, MD 20993-0002, 301-
796-1285; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Slowly Progressive, Low-Prevalence Rare Diseases with
Substrate Deposition That Results from Single Enzyme Defects: Providing
Evidence of Effectiveness for Replacement or Corrective Therapies.''
This document is intended to provide guidance to sponsors on the
evidence necessary to demonstrate the effectiveness of new drugs or new
drug uses intended for slowly progressive, low-prevalence rare diseases
that are associated with substrate deposition and are caused by single
enzyme defects. This guidance applies only to those low-prevalence rare
diseases with a well-characterized pathophysiology and in which changes
in substrate deposition can be readily measured in relevant tissue(s).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on providing
evidence of effectiveness for replacement or corrective therapies
intended for slowly progressive, low-prevalence rare diseases with
substrate deposition that results from single enzyme defects. 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. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 312 have been
approved under OMB control number 0910-0014. The collections of
information in 21 CFR part 50 have been approved under OMB control
number 0910-0755. The collections of information for expedited programs
in the guidance for industry entitled ``Expedited Programs for Serious
Conditions--Drugs and Biologics'' (available at<EMAIL_ADDRESS>have been approved under OMB control number 0910-0765.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: July 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16036 Filed 7-26-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20661-20662]
[FR Doc No: 2013-07892]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1093]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Additive
Petitions and Investigational Food Additive Exemptions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 May 6,
2013.

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 0910-0546.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<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.

Food Additive Petitions and Investigational Food Additive Exemptions--
(OMB Control Number 0910-0546)--Extension

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(a)) provides that a food additive shall be
deemed to be unsafe unless its use is permitted by a regulation which
prescribes the condition(s) under which it may safely be used, or
unless it is exempted by regulation for investigational use. Section
409(b) of the FD&C Act specifies the information that must be submitted
by a petitioner in order to establish the safety of a food additive and
to secure the issuance of a regulation permitting its use.
    To implement the provisions of section 409 of the FD&C Act,
procedural regulations have been issued under part 571 (21 CFR part
571). These procedural regulations are designed to specify more
thoroughly the information that must be submitted to meet the
requirement set down in broader terms by the FD&C Act. The regulations
add no substantive requirements to those indicated in the FD&C Act, but
attempt to explain these requirements and provide a standard format for
submission to speed processing of the petition. Labeling requirements
for food additives intended for animal consumption are also set forth
in various regulations contained in parts 501, 573, and 579 (21 CFR
parts 501, 573, and 579). The labeling regulations are considered by
FDA to be cross-referenced to Sec.  571.1, which is the subject of this
same OMB clearance for food additive petitions.
    With regard to the investigational use of food additives, section
409(j) of the FD&C Act provides that any food additive or any food
bearing or containing such an additive, may be exempted from the
requirements of this section if intended solely for investigational use
by qualified experts. Investigational use of a food additive is
typically to address the safety and/or intended physical or technical
effect of the additive.
    To implement the provisions of section 409(j) of the FD&C Act,
regulations have been issued under Sec.  570.17 (21 CFR 570.17). These
regulations are designed to specify more thoroughly the information
that must be submitted to meet the requirement set down in broad terms
by the FD&C Act. Labeling requirements for investigational food
additives are also set forth in various regulations contained in part
501. The labeling regulations are considered by FDA to be cross-
referenced to Sec.  570.17; which is the subject of this same OMB
clearance for investigational food additive files. In the Federal
Register of November 13, 2012, (75 FR 67655), FDA published a 60-day
notice requesting public comment on the proposed collection of
information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 No. of       No. of  responses     Total annual     Average  burden
                      21 CFR Section                          respondents      per  respondent       responses        per  response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Food Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
571.1(c) moderate category...............................                  1                  1                  1              3,000              3,000
517.1(c) complex category................................                  1                  1                  1             10,000             10,000
517.1(c) complex category................................                  2                  2                  4              1,300              5,200
                                                          ----------------------------------------------------------------------------------------------

    Total................................................  .................  .................  .................  .................             18,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Section 571.1(c) Moderate Category: For a food additive petition
without complex chemistry, manufacturing, efficacy, or safety issues,
the estimated time requirement per petition is approximately 3,000
hours. An average of one petition of this type is received on an annual
basis, resulting in a burden of 3,000 hours.
    Section 571.1(c) Complex Category: For a food additive petition
with complex chemistry, manufacturing, efficacy, and/or safety issues,
the estimated time requirement per petition is approximately 10,000
hours. An average of one petition of this type is received on an annual
basis, resulting in a burden of 10,000 hours.
    Section 571.6: For a food additive petition amendment, the
estimated time requirement per petition is approximately 1,300 hours.
An average of four petitions of this type is received on an annual
basis, resulting in a burden of 5,200 hours.

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 No. of       No. of  responses     Total annual     Average  burden
                      21 CFR Section                          respondents      per  respondent       responses        per  response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Investigation Food Additive Files
--------------------------------------------------------------------------------------------------------------------------------------------------------
570.17 moderate category.................................                  9                  1                  9              1,500             13,500
570.17 complex category..................................                  4                  1                  4              5,000             20,000
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................             33,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Section 570.17 Moderate Category: For an investigational food
additive file without complex chemistry, manufacturing, efficacy, or
safety issues, the estimated time requirement per file is approximately
1,500 hours. An average of nine files of this type is received on an
annual basis, resulting in a burden of 13,500 hours.
    Section 570.17 Complex Category: For an investigational food
additive file with complex chemistry, manufacturing, efficacy, and/or
safety issues, the estimated time requirement per file is approximately
5,000 hours. An average of four files of this type is received on an
annual basis, resulting in a burden of 20,000 hours.

    Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07892 Filed 4-4-13; 8:45 am]
BILLING CODE 4160-01-P


                             SUPPORTING STATEMENT
            ENVIRONMENTAL PROTECTION AGENCY

Approval and Promulgation of Federal Implementation Plan for Oil and Natural Gas Well
Production Facilities; Fort Berthold Indian Reservation (Mandan, Hidatsa, and Arikara Nation), North Dakota (Renewal)

Part A of the Supporting Statement

1. 	Identification of the Information Collection
(a) 	Title and Number of the Information Collection.
      Federal Implementation Plan for Oil and Natural Gas Well Production Facilities; Fort Berthold Indian Reservation (Mandan, Hidatsa, and Arikara Nation), North Dakota (Renewal). This is a renewal of information collection request (ICR), EPA tracking number 2478.03, OMB Control Number 2008-0001.
(b) 	Short Characterization.
      This ICR covers information collection requirements in the final Federal Implementation Plan (FIP) for Oil and Natural Gas Well Production Facilities; Fort Berthold Indian Reservation (Mandan, Hidatsa, and Arikara Nation), North Dakota (40 CFR part 49, subpart K, §§ 49.4161 through 49.4168), herein referred to as the FBIR FIP. The information collected will be used by the EPA and delegated tribal agencies to determine the compliance status of sources subject to the rule.
      On March 22, 2013 (78 FR 17858), the EPA promulgated a final FIP for oil and natural gas well production sources operating on the FBIR, which addressed volatile organic compound (VOC) emissions from well completions, recompletions, and production and storage operations. The standards in the FBIR FIP apply to any person who owns or operates an existing (constructed or modified on or after August 12, 2007), new, or modified oil and natural gas production facility that is located on the FBIR and producing from the Bakken Pool with one or more oil and natural gas wells, any one of which a well completion or recompletion operation is/was initiated on or after August 12, 2007.
      The potential respondents are owners or operators of oil and natural gas production facilities found throughout the FBIR. For the purposes of the FBIR FIP, an oil and natural gas production facility consists of all the air pollution emitting units and activities located on or integrally connected to one or more oil and natural gas wells that are necessary for production operations and storage operations. An oil and natural gas well is a single well that extracts subsurface reservoir fluids containing a mixture of oil, natural gas, and water. A well completion means the process that allows for the flowback of oil and natural gas from newly drilled or re-fractured wells to expel drilling and reservoir fluids and tests the reservoir flow characteristics, which may vent produced hydrocarbons to the atmosphere via an open pit or tank. A well completion operation means any oil and natural gas well completion with hydraulic fracturing occurring at an oil and natural gas production facility. The completion date is considered the date that construction at an oil and natural gas production facility has commenced. The recompletion date is considered the date that a modification has occurred at an oil and natural gas production facility.
      In general, owners or operators are required to maintain records of all oil and natural gas well completions and recompletions, required monitoring, and rule compliance. The FBIR FIP also requires annual reports containing information for each oil and natural gas production facility, including a summary of all required records identifying each oil and natural gas well completion or recompletion conducted during the reporting period, and a summary of all instances where construction or operation was not performed in compliance with the requirements of the FBIR FIP during the reporting period. These reports and records are essential in determining compliance and are required of all sources subject to the FBIR FIP.
--------------------------------------------------------------------------------
      The Office of Management and Budget (OMB) approved the currently active ICR without change. OMB did note with the previous renewal that the EPA should round time and cost burden to significant digits when re-submitting this ICR.
2. 	Need For and Use of the Collection
(a)	 Need/Authority for the Collection.
      The EPA is charged under sections 301(a) and 301(d)(4) of the Clean Air Act (CAA) to
promulgate regulations as necessary to protect tribal air resources. Promulgating the FBIR FIP
addresses an important initial step to fill a regulatory gap between state and federal requirements with regard to controlling volatile organic compound (VOC) emissions from oil and natural gas production operations on the FBIR. There is no other federal rule, including the New Source Performance Standards (NSPS) and National Emissions Standards for Hazardous Air Pollutants (NESHAP) for the Oil and Natural Gas Sector (NSPS OOOO and OOOOa and NESHAP HH), that establishes air pollution control regulations for the particular oil and natural gas production operations that exist on the FBIR. This is in contrast to oil and natural gas operations off the Reservation, which are governed by the North Dakota Department of Health (NDDoH) regulations and North Dakota Industrial Commissions (NDIC) regulations within the State of North Dakota's jurisdiction. Consistent with the regulatory structure that exists off the FBIR, and NSPS OOOO, the FBIR FIP has requirements for VOC emissions control and reductions, monitoring, recordkeeping, and reporting. In addition, section 114(a) states that the Administrator may require any owner or operator subject to any requirement of this Act to:
      :: establish and maintain such records;
      :: make such reports; install, use, and maintain such monitoring equipment;
      :: and use such audit procedures, or methods;
      :: sample such emissions (in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe);
      :: keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical;
      :: submit compliance certifications in accordance with section 114(a)(3); and
      :: provide such other information as the Administrator may reasonably require.
(b) 	Use/Users of the Data.
      These records and reports are necessary for the EPA Administrator (or the tribal agency if
delegated) to: (1) confirm compliance status of stationary sources; (2) identify any stationary sources not subject to the requirements and identify stationary sources subject to the regulations; and (3) ensure that the stationary source control requirements are being achieved. The information would be used by the EPA or tribal enforcement personnel to: (1) identify stationary sources subject to the rules; (2) ensure that appropriate control technology is being properly applied; and (3) ensure that the emission control devices are being properly operated and maintained on a continuous basis. Based on the reported information, the EPA Administrator (or the delegated tribe) can decide which stationary sources, records or processes should be inspected.
3. Nonduplication, Consultations, and Other Collection Criteria
(a) 	Nonduplication.
      The EPA does not anticipate a significant additional burden on the respondents due to potentially duplicative recordkeeping or reporting requirements. Because the FBIR FIP applies to sources located in Indian country, other federal agencies may also have jurisdiction on the FBIR. The EPA reviewed other federal regulations and discussed potentially applicable requirements to the respondents with staff from other federal entities to determine if and when the possible duplication of information collection exists. The EPA has identified potentially minor duplicative recordkeeping and reporting requirements with other federal regulations; however, we have determined that some sources may not be subject to the duplicative requirement or the duplication does not result in a significant burden to the respondents.
      The U.S. Department of Interior (DOI) has established regulations that may apply to the respondents of the FBIR FIP. DOI jurisdiction differs from the EPA's jurisdiction under the CAA in that the applicability of DOI regulations is dependent on the lease status of the land where the facility is located. While DOI regulations do apply to a large majority of the respondents, oil and natural gas production facilities on the FBIR that are not operating on a federal or Indian oil and natural gas lease are not subject to DOI regulations. Therefore, certain requirements of the FBIR FIP are only potentially duplicative as DOI regulations may not apply to all sources subject to the FBIR FIP.
      The FBIR FIP at §49.4166(a) requires owners and operators to measure the barrels of oil
produced according to the methods specified in the Bureau of Land Management (BLM) Onshore Order #4, which also specifies that records of this measurement be kept for 6 years. This information is reported on a monthly basis to the Office of Natural Resources Review (ONRR) through Form OGAR-A.,  The FBIR FIP also requires recordkeeping of the barrels of oil produced (see §49.4167(a)(1)). Additionally, the FIP requires owners and operators to keep records of the volume of produced natural gas sent to the control device (see §49.4167(a)(2)), which is reported to the ONRR on a monthly basis through Form OGAR-B. Although the FBIR FIP requires similar recordkeeping, the information collected is not required to be submitted in the annual report. This information would also be necessary to be kept by the respondents as standard industry practice regardless of the FBIR FIP in order to determine applicability to federal CAA permitting requirements. Therefore, these potentially duplicative recordkeeping requirements do not impose any additional burden on the respondents and are not included as part of this ICR.
      The FBIR FIP requires owners and operators of oil and natural gas production facilities to submit an annual report each year (see §49.4168(b)). As part of the annual report, the respondents are required to provide information about the date, time, duration and location of well completion and recompletion operations performed during the reporting period, as well as the first date of production for each oil and natural gas well. The EPA has determined that the location of well completion and recompletion operations and the first date of production are also required to be reported to the BLM within 30 days following completion operations through Form 3160-4. However, the EPA believes this potentially duplicative information request is extremely minimal and does not pose a significant burden to the respondents. Although the EPA would accept a copy of the submitted Form 3160-4 in lieu of any duplicated information required in the annual report for the FBIR FIP, we anticipate it will be easier for the respondents to separately include the location of the well completion or recompletion and first date of production with the other information submitted in the annual report. The EPA has determined that the FBIR FIP requirements to report the date, time, and duration of flowback and venting during completion and recompletion operations are not duplicative of any other DOI requirements that require similar information during the production phase (i.e., as opposed to the completion phase requirements in the FBIR FIP).
      The EPA asserts that any potentially duplicative recordkeeping or reporting requirements of the FBIR FIP are necessary for the agency to ensure compliance with the rule. We also note that the potential for duplication only exists for facilities subject to DOI requirements, which may not apply to all facilities on the FBIR depending on the land lease status of the facility. The information submitted to BLM and ONRR is not publicly available and it would be extremely resource intensive for the federal agencies to share such a small component of information relative to the total information the EPA is requesting under this ICR. Furthermore, much of the information collected under this ICR is a customary and usual business practice for the respondents. The oil and natural gas industry maintain their own records of production operations as part of routine business operations. The recordkeeping and reporting requirements in the FBIR FIP have been minimized to the greatest extent practicable while
still ensuring compliance with the rule as an effort to reduce the regulatory burden on the respondents. Additionally, the FBIR FIP at §49.4164(f) exempts sources subject to the storage tank control requirements of NSPS OOOO from the requirements of the FBIR FIP for the same affected equipment; therefore, there is no duplication with other EPA regulations.
(b) 	Public Notice Required Prior to ICR Submission to OMB.
      An announcement of a public comment period for the renewal of this ICR was published in the Federal Register (84 FR 26103) on  -  -  - June 5, 2019.
(c) 	Consultations.
      The agency has consulted industry experts and internal data sources in the development and implementation of the FBIR FIP and ICR. The primary source of information for the renewal of this ICR are the annual reports, which are submitted by industry to the EPA in compliance with the recordkeeping and reporting provisions in the FIP. These annual reports contain information on the date, time, duration and location of well completion and recompletion operations and were used to calculate an industry growth rate for the purposes of the ICR. In the development stage, the EPA reviewed existing state and industry standards, and consulted with the Three Affiliated Tribes of the Mandan, Hidatsa, and Arikara Nation, industry, and state and federal agencies. The EPA held numerous workshops to provide industry and other interested parties an opportunity to comment on all aspects of the FBIR FIP and ICR including technical operations, burden and costs, and the permitting process. Specific information concerning industry growth and costs associated with the ICR were obtained from the following companies:

                                 Organization
                                Contact Person
Enerplus Resources Corporation
Tony Lucero
EOG Resources, Inc.
Curtis Rice
QEP Resources, Inc.
Craig Brown
Slawson Exploration Company, Inc.
Ray Gorka
WPX Energy, Inc.
Jodell Mizoue
XTO Energy, Inc.
John McMichael

Additionally, the EPA consulted with its own internal industry experts to verify the accuracy of the burden and costs numbers generated for the renewal of this ICR.
(d) 	Effects of Less Frequent Collection.
      Respondents must monitor all specified criteria at each affected facility and maintain these records for 5 years. The required reporting frequency to the EPA has been established to minimize the burden on owners and operators of affected facilities.
(e) 	General Guidelines.
      This collection of information is consistent with all OMB guidelines established by OMB at 5 CFR part 1320, section 1320.5.
(f) 	Confidentiality.
      All information submitted to the EPA for which a claim of confidentiality is made will be
safeguarded according to the EPA policies set forth in Title 40, Chapter 1, part 2, subpart B--
Confidentiality of Business Information (see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 39999, September 28, 1978; 43 FR 42251, September 28, 1978; 44 FR 17674, March 23, 1979).
(g) 	Sensitive Questions.
      This section is not applicable because this ICR does not involve matters of a sensitive nature.
4. The Respondents and the Information Requested
(a) 	Respondents/NAICS Codes.
      Potential respondents under the FBIR FIP are owners or operators constructing, modifying or operating an oil and natural gas production facility producing from the Bakken Pool with one or more oil and natural gas wells, for any one of which completion or recompletion operations are/were performed on or after August 12, 2007, that is located on the FBIR. The North American Industry Classification System (NAICS) code for the oil and natural gas industry potentially subject to the FBIR FIP is 211111 (Crude Petroleum and Natural Gas Extraction).
(b) 	Information Requested.
      (i) Data Items, Including Recordkeeping Requirements.
                                 Recordkeeping
Maintain records of the measured barrels of oil produced at the oil and natural gas production facility each time the oil is unloaded from the produced oil storage tanks.
                                 49.4167(a)(1)
Maintain records of the volume of produced natural gas sent to each enclosed combustor, utility flare and pit flare.
                                 49.4167(a)(2)
Maintain records of the volume of natural gas emissions from the produced oil storage tanks and produced water storage tanks sent to each enclosed combustor, utility flare and pit flare.
                                 49.4167(a)(3)
Maintain records of each oil and natural gas well completion operation and recompletion operation.
                                 49.4167(a)(4)
Maintain records of the written, site-specific designs, operating instructions, operating procedures and maintenance schedules for each enclosed combustor, utility flare and pit flare.
                               49.4167(a)(5)(i)
Maintain records of all required monitoring of operations for each enclosed combustor, utility flare and pit flare.
                               49.4167(a)(5)(ii)
Maintain records of any deviations from the operating parameters specified by the written site-specific designs, operating instructions, and operating procedures.
                              49.4167(a)(5)(iii)
Maintain records of any instances in which the pilot flame is not present, auto ignition system is not functioning, or the monitoring equipment is not functioning in the enclosed combustor, the utility flare or the pit flare.
                               49.4167(a)(5)(iv)
Maintain records of any instances in which a recording device installed to record data from the enclosed combustor, utility flare, or pit flare is not operational.
                               49.4167(a)(5)(v)
Maintain records of any time periods in which visible smoke emissions are observed emanating from the enclosed combustor, utility flare or pit flare.
                               49.4167(a)(5)(vi)
Maintain records to demonstrate compliance with the use restrictions for pit flares.
                                 49.4167(a)(6)

                                 Recordkeeping
Maintain records of any instances in which any closed-vent system or control device was bypassed or down, the reason for each incident, its duration, and the corrective actions taken and any preventative measures adopted to avoid such bypasses or downtimes.

                                 49.4167(a)(7)
Maintain records of the documentation of all produced oil storage tank and produced water storage tank inspections required in § 49.4166(e) and (f).
                                 49.4167(a)(8)
Records retention requirements.
                            49.4167(b), 49.1467 (c)
                          Notifications and Reporting
Each owner and operator must submit an annual report containing the information specified in 49.4168(b)(1) through (4).
                                  49.4168(b)

       (ii) Respondent Activities.

                             Respondent Activities
Read instructions.
Gather relevant information.
Enter information required to be recorded above.
Submit the required reports.
Develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information.
Develop, acquire, install, and utilize technology and systems for the purpose of processing and
maintaining information.
Train personnel to be able to respond to a collection of information.
Completing and reviewing the collection of information.
Transmit, or otherwise disclose the information.

5. 	The Information Collected  -  Agency Activities, Collection Methodology, and Information Management
(a)	 Agency Activities.
      The agency activities associated with the FBIR FIP are to review, analyze, and maintain the annual reports required to be submitted by industry. Section 6(c) provides further detail into the agency activities related with the FBIR FIP.
(b) 	Collection Methodology and Management.
      Data and records maintained by the respondents are tabulated for internal use in compliance and enforcement programs of the EPA or delegated tribal agency. Records may be maintained by the respondents in hard copy or electronic format to allow flexibility and reduce the burden. As a further effort to minimize the reporting burden, the FBIR FIP allows for the electronic submittal of annual reports via email to<EMAIL_ADDRESS>The FBIR FIP also allows owners/operators to submit one report for all of their affected facilities, thus reducing the burden for multiple reports. Additionally, owners/operators are allowed to submit their annual reports required by the FBIR FIP at the same time as any required annual reports under the Title V operating permit program. EPA Region 8 will continue to work with owners/operators to streamline the recordkeeping and reporting process whenever possible.
(c)	 Small Entity Flexibility.
      Minimizing the information collection burden for all sizes of organizations is a continuing effort for the EPA. The impact on small entities (i.e., small businesses) was taken into consideration during the development of the regulation. The EPA has tried to reduce the impact of this rule on small entities by the selection of highly cost-effective controls and specifying monitoring requirements that are the minimum to insure compliance.
(d) 	Collection Schedule.
      The specific frequencies for each information collection activity within this request are shown in Exhibit 1a, Exhibit 1b, and Exhibit 1c: Respondent Burden of Reporting and Recordkeeping Requirements.
6. 	Estimating the Burden and Cost of the Collection
(a) 	Estimating Respondent Burden.
      Exhibit 1a, Exhibit 1b, and Exhibit 1c document the calculation of individual burdens for the recordkeeping and reporting requirements applicable to the respondents for the FBIR FIP included in this ICR for each of the next 3 years. The table below contains a summary of the respondent burden labor hours detailed in Exhibit 1a, Exhibit 1b, and Exhibit 1c.

                                     Year
                           Total Annual Labor Burden
                                    (hours)
                                       1
                                   102,000
                                       2
                                   112,000
                                       3
                                   122,000
                                     Total
                                   336,000
                                3-Year Average
                                   112,000

 (b) 	Estimating Respondent Costs.
      The respondent costs for the information collection activities in the FBIR FIP are presented in Exhibit 1a, Exhibit 1b, and Exhibit 1c. The total cost for each respondent activity includes labor costs, capital/startup costs, and operations and maintenance costs.
      (i) Estimating Labor Costs.
      This ICR uses the following labor rates:
      Managerial 	$59.82
      Technical 	$35.92
      Clerical 	$26.50
      These rates are from the Employer Costs for Employee Compensation published by the
Department of Labor, Bureau of Labor and Statistics, September 2018, "Table 2. Civilian Workers, by occupational and industry group." (Source: http://www.bls.gov/news.release/ecec.toc.htm). The rates are the total compensation rates and include the base rate for wages and salaries, as well as benefits such as paid leave, insurance and retirement savings. The table below contains a summary of the respondent labor costs detailed in Exhibit 1a, Exhibit 1b, and Exhibit 1c.
                                     Year
                            Total Annual Labor Cost
                                      ($)
                                       1
                                  $3,680,000
                                       2
                                 $4,040,000
                                       3
                                 $4,410,000
                                     Total
                                 $12,100,000
                                3-Year Average
                                 $4,050,000

       (ii) Estimating Capital and Operations and Maintenance (O&M) Costs.
      Capital/startup and O&M costs associated with the FBIR FIP result from the requirement to monitor and record proper operation of the control device through the use of an auto igniter or
continuous pilot flame, each equipped with a remote notification system, malfunction alarm and
continuous recording device. These costs were also included in the EPA's preliminary cost analysis, which concluded the FBIR FIP was not a significant regulatory action under Executive Order 12866. The capital/startup costs and O&M costs specific to the auto igniter and continuous pilot flame were provided to the EPA by operators subject to the FBIR FIP. These initial capital/startup costs and O&M costs included the costs for the continuous pilot flame or auto igniter, in addition to the costs for the remote notification system, malfunction alarm and continuous recording device. Since the EPA obtained information that an auto igniter or continuous pilot flame is typically already included with the control device, the EPA believes the estimated capital/startup and O&M costs are conservative overestimates. Furthermore, the annual capital/startup and O&M costs are expected to decline due to group discounts on equipment and increasing familiarity with the system components by the operators. The initial capital/startup costs were annualized over the expected lifetime of the equipment. Since the estimated lifetime of the equipment exceeds the 3-year period covered by this renewal ICR, those initial
annualized capital/startup costs are included for each year of this renewal. The table below shows the expected capital/startup costs and O&M costs for this ICR.
         Capital/Startup vs. Operation and Maintenance (O&M) Costs
                                      (A)
                         Continuous Monitoring Device
                                      (B)
                  Capital/Startup Cost for One Respondent
                                      (C)
                     Average Annual Number of Respondents
                                      (D)
                  Average Annual Capital/Startup Cost, (BxC)
                                      (E)
                   Annual O&M Costs for One Respondent a
                                      (F)
                 Average Number of Respondents with O&M b
                                      (G)
                      Average Annual O&M Cost, (ExF)

Auto igniter or continuous
pilot flame, each equipped
with remote notification,
malfunction alarm, and data recording device
                                    $3,470
                                    2,442
                                 $8,470,000
                                    $5,073
                                    2,442
$12,380,000

      Assumptions:
      [a]O&M costs reflect operation and maintenance of an auto igniter or continuous pilot flame, which is typically included as part of the control device. Therefore, the above costs are a conservative overestimation of actual costs.
      [b] Capital/Startup and O&M costs for continuous control device monitoring were already included in the cost analysis for the FBIR FIP, as detailed in the technical support document for the rule.

      The average annual capital/startup costs for this ICR are $8,470,000. This is the total of column D in the above table. The average annual operation and maintenance (O&M) costs for this ICR are $12,380,000. This is the total of column G. Combined, the average annual cost for capital/startup and operation and maintenance costs to industry during the 3-year period of the ICR is estimated to be $20,850,000.
(c) 	Estimating Agency Burden and Cost.
      Because the information collection requirements were developed as an incidental part of FIP development under section 301 of the CAA, no costs can be attributed to the development of the information collection requirements. Since reporting and recordkeeping requirements on many of the respondents are potentially required under the operating permits rule in 40 CFR part 71, no additional operational costs will be incurred by the federal government for these sources. Examination of records to be maintained by the respondents will occur incidentally as part of the periodic inspection of sources that is part of the EPA's overall compliance and enforcement program and therefore is not attributable to the ICR. The only costs that the federal government will incur are user costs associated with the analysis of the reported information as presented in Exhibit 2a, Exhibit 2b, and Exhibit 2c. This cost is based on the average hourly labor rate as follows:
      Managerial 	$97.42 (GS-14, Step 5, $58.25 + 60%)
      Technical 	$72.75 (GS-13, Step 1, $43.50 + 60%)
      Clerical 	$36.78 (GS-7, Step 3, $22.00 + 60%)

      These rates are from the Office of Personnel Management (OPM), 2018 General Schedule, which includes locality rates of pay for the EPA Region 8 employees in the Denver, Colorado. The rates have been increased by 60 percent to account for the benefit packages available to government employees. The table below contains a summary of the agency labor costs detailed in Exhibit 2a, Exhibit 2b, and Exhibit 2c.

                                     Year
                          Total Annual Labor Cost ($)
                                       1
                                   $181,000
                                       2
                                   $199,000
                                       3
                                   $216,00
                                     Total
                                   $596,000
                                3-Year Average
                                   $199,000

(d) 	Estimating the Respondent Universe and Total Burden and Costs.
      It was estimated that an average of 2,221 facilities will be subject to the FBIR FIP requirements in the first year; 2,442 in the second year; and 2,663 in the third year during the 3-year period of this ICR. These numbers are based on information available at the Drillinginfo website as well as information provided by oil and natural gas operators in the required annual reports for reporting years 2016, 2017 and 2018 and information from consent agreements and final orders (CAFOs) finalized in August 2011. The EPA believes this is an overestimation for future development and that the number of facilities (respondents) will decline as lease spacing limitations for drilling are met. For the FBIR FIP, the components of the total annual responses attributable to this ICR are recordkeeping and reporting of an average of 2,442 entities by 17 owner/operators over the 3-year period.
      The number of total annual responses for the FBIR FIP is estimated as: 7,326 total respondents from 17 operators over the 3-year period. The average number of annual responses is 2,442.
                                     Year
                         Annual Number of Respondents
                                       1
                                2,221 (221 new)
                                       2
                                2,442 (221 new)
                                       3
                                2,663 (221 new)
                                     Total
                                    7,326

(e)	 Bottom Line Burden Hours and Cost Tables.
      (i) Respondent tally.
      The bottom line respondent burden hours and costs, presented in Exhibit 1a, Exhibit 1b, and Exhibit 1c are calculated by adding person-hours per year down each column for technical, managerial, and clerical staff, and by adding down the cost column. The average annual burden for the recordkeeping and reporting requirements for the 17 owners and operators that are subject to the FIP is 112,000 person-hours, with an annual average cost of $24,900,000.
      (ii) The agency tally.
      The average annual EPA cost is $199,000 for an average of 2,800 hours for the FBIR FIP. The bottom line agency burden hours and costs presented in Exhibit 2a, Exhibit 2b, and Exhibit 2c are calculated by adding person-hours per year down each column for technical, managerial, and clerical staff, and by adding down the cost column.
      (iii) Variations in the annual bottom line.
      This section does not apply since no significant variation is anticipated.
(f) 	Reasons for Change in Burden.
      For both the respondent and the EPA, there is an increase in the total estimated labor burden and total estimated annual costs as currently identified in the OMB Inventory of Approved Burdens. There is an increase of 67,539 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase is due to the anticipated industry growth projected to occur over the next 3-year period of this ICR. In the initial creation of this program, the capital/O&M costs were annualized over 10 years. This is the second ICR package and it will cover years 7, 8, and 9 of this 10-year period. The annual estimates over 10 years, along with the anticipated industry growth, explain the increase in cost. The anticipated industry growth comes from an estimated annual increase of 221 facilities each year. Additionally, the EPA updated the respondent and the agency labor costs to reflect current rates referenced from the Bureau of Labor Statistics and the Office of Personnel Management.

(g) 	Burden Statement.
      The burden for this ICR is summarized in the table below.
                                    Burden
                                    Average
                          Annual Number of Responses
                      Average Annual Labor Burden (hours)
                             Average Annual Costs

                                  Labor Costs
                                 Capital Costs
                                 O&M Costs
                              Total Annual Costs
                                  Respondent
                                     2,442
                                    112,000
                                  $4,050,000
                                  $8,470,000
                                  $12,380,000
                                  $24,900,000
                                    Agency
                                      NA
                                     2,800
                                   $199,000
                                      $0
                                      $0
                                   $199,000

      The annual public reporting and recordkeeping burden for this collection of information is estimated to average 48 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. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB Control Number. The OMB Control Numbers for the EPA regulations are listed at 40 CFR part 9 and 48 CFR chapter 15.
      To comment on the agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, the EPA has established a public docket for this ICR under Docket ID Number EPAR08-OAR-2012-0479, which is available for online viewing at www.regulations.gov, or in person viewing at the Office of Environmental Information Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C. 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<PHONE_NUMBER>, and the telephone number for the OEI Docket is<PHONE_NUMBER>. An electronic version of the public docket is available at www.regulations.gov. This site can be used 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. When in the system, select "search," then key in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17[th] Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPA-R08-OAR-2012-0479 and OMB Control Number 2008-0001 in any correspondence.

Part B of the Supporting Statement
This section is not applicable because statistical methods are not used in data collection
associated with the final rule.


[Federal Register Volume 79, Number 169 (Tuesday, September 2, 2014)]
[Proposed Rules]
[Page 51922]
[FR Doc No: 2014-20665]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 172 and 182

[Docket Nos. FDA-2013-F-0700 and FDA-2013-P-0472]

Richard C. Theuer; Withdrawal of Food Additive Petition and
Citizen Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Withdrawal of petitions.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
withdrawal, without prejudice to a future filing, of a food additive
petition (FAP 3A4798) proposing that the food additive regulations be
amended to prohibit the use of carrageenan and salts of carrageenan in
infant formula. In addition, FDA is also announcing the withdrawal of a
citizen petition requesting that the generally recognized as safe
(GRAS) regulations be amended to prohibit the use of Chondrus extract
(carrageenin) in infant formula.

DATES: The food additive petition and the citizen petition were
withdrawn on July 30, 2014.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of July 19, 2013 (78 FR 43093), we announced that we had filed
a food additive petition (FAP 3A4798; Docket No. FDA-2013-F-0700),
submitted by Richard C. Theuer, Ph.D., 7904 Sutterton Ct., Raleigh, NC
27615. The petition proposed to amend the food additive regulations in
Sec.  172.620 and 172.626 (21 CFR172.620 and 172.626) to prohibit the
use of carrageenan and salts of carrageenan in infant formula. In
addition, we also announced in the same document (78 FR 43093), that
Dr. Theuer submitted a citizen petition, under 21 CFR 10.30, requesting
that 21 CFR 182.7255 of the GRAS regulations be amended to prohibit the
use of Chondrus extract (carrageenin) in infant formula (Docket No.
FDA-2013-P-0472). Dr. Theuer has now withdrawn the petitions without
prejudice to future filings (21 CFR 171.7 and 10.30(g)).

    Dated: August 26, 2014.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2014-20665 Filed 8-29-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 28, 2010 (Volume 75, Number 187)]
[Notices]
[Page 59729-59730]
[DOCID:fr28se10-83]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.
    Name of Committee: Vaccines and Related Biological Products
Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 16, 2010, from
9 a.m. to approximately 4 p.m. and on November 17, 2010, from 8:30 a.m.
to approximately 1:15 p.m.
    Location: Hilton Silver Spring Hotel, Maryland Ballroom, 8727
Colesville Rd., Silver Spring, MD 20910.
    Contact Person: Donald W. Jehn or Denise Royster, Food and Drug
Administration, Center for Biologics Evaluation and Research (HFM-71),
Food and Drug Administration, 1401 Rockville, Pike, Rockville, MD
20852,<PHONE_NUMBER>, or FDA Advisory Committee Information Line, 1-800-
741-8138<PHONE_NUMBER> in the Washington, DC area), code<PHONE_NUMBER>.
Please call the Information Line for up-to-date information on this
meeting. A notice in the Federal

Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
agency's Web site and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the
meeting.
    Agenda: On November 16, 2010, the committee will meet in open
session to review and discuss the pathway to licensure for protective
antigen-based anthrax vaccines for a post-exposure prophylaxis
indication using the animal rule. On November 17, 2010, the committee
will meet in open session to review and discuss the effectiveness of
vaccinating males and females with Gardasil manufactured by Merck & Co.
for the prevention of anal dysplasia and anal cancer.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: On November 16, 2010, from 9 a.m. until approximately
11:45 a.m. and from 2 p.m. until approximately 4 p.m. and on November
17, 2010, the meeting is open to the public. Interested persons may
present data, information, or views, orally or in writing, on issues
pending before the committee. Written submissions may be made to the
contact person on or before November 10, 2010. Oral presentations from
the public will be scheduled between approximately 2:15 p.m. and 2:45
p.m. on November 16, 2010, and between approximately 11:45 a.m. and
12:15 p.m. on November 17, 2010. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before November 2, 2010. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by November
3, 2010.
    Closed Committee Deliberations: On November 16, 2010, between 12
p.m. and approximately 2 p.m., the meeting will be closed to permit
discussion and review of trade secret and/or confidential commercial
information (5 U.S.C. 552b(c)(4)). The committee will hear firms
discuss protocols they propose to use for the pathway to licensure for
protective antigen-based anthrax vaccines for a post-exposure
prophylaxis indication using the animal rule.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Donald W. Jehn or
Denise Royster at least 7 days in advance of the meeting. FDA is
committed to the orderly conduct of its advisory committee meetings.
Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct
during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 23, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-24253 Filed 9-27-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73835-73836]
[FR Doc No: 2020-25508]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90429/November 13, 2020]

 Order Setting Aside the Order by Delegated Authority Approving
SR-IEX-2018-06; In the Matter of Investors Exchange LLC, 3 World Trade
Center 58th Floor, New York, NY 10007, File No. SR-IEX-2018-06

    On March 15, 2018, Investors Exchange LLC (the ``Exchange'' or
``IEX'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to establish a new optional
listing category on the Exchange, referred to as the ``LTSE Listings on
IEX'' or ``LTSE Listings.'' The proposed rule change was published for
comment in the Federal Register on April 2, 2018.\3\ On May 11, 2018,
the Division of Trading and Markets, for the Commission pursuant to
delegated authority, extended the time period for Commission action on
the proposed rule change.\4\ On June 27, 2018, the Exchange filed
Amendment No. 1 to the proposed rule change.\5\ On June 29, 2018, the
Division of Trading and Markets, for the Commission pursuant to
delegated authority,\6\ approved the proposed rule change, as modified
by Amendment No. 1.\7\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 82948 (March 27,
2018), 83 FR 14074 (SR-IEX-2018-06).
    \4\ See Securities Exchange Act Release No. 83217, 83 FR 22998
(May 17, 2018).
    \5\ See letter from Claudia Crowley, Chief Regulatory Officer,
Investors Exchange LLC, dated June 27, 2018, available at https://www.sec.gov/comments/sr-iex-2018/06/iex201806/3956434-167066.pdf.
    \6\ 17 CFR 200.30-3(a)(12).
    \7\ See Securities Exchange Act Release No. 83558 (June 29,
2018), 83 FR 31614 (July 6, 2018) (``Delegated Order'').
---------------------------------------------------------------------------

    On June 29, 2018, the Secretary of the Commission notified the
Exchange that pursuant to Rule 431 of the Commission's Rules of
Practice,\8\ the Commission would review the Delegated Order and that
the Delegated Order was stayed until the Commission

ordered otherwise.\9\ On July 20, 2018, the Commission issued a
scheduling order allowing the filing of additional statements.\10\
---------------------------------------------------------------------------

    \8\ 17 CFR 201.431.
    \9\ See Letter from Secretary of the Commission to Sophia Lee,
Associate General Counsel, Investors Exchange LLC, dated June 29,
2018, available athttps://www.sec.gov/rules/sro/iex/2018/34/83558-letter-from-secretary.pdf.
    \10\ See Exchange Act Release No. 83678, 83 FR 35300 (July 25,
2018).
---------------------------------------------------------------------------

    On August 15, 2018, IEX withdrew the proposed rule change (SR-IEX-
2018-06).\11\
---------------------------------------------------------------------------

    \11\ See letter from Claudia Crowley, Chief Regulatory Officer,
IEX, to Brent J. Fields, Secretary, Commission, dated August 15,
2018.
---------------------------------------------------------------------------

    Under Commission Rule of Practice 431(a), the Commission may
``affirm, reverse, modify, set aside or remand for further proceedings,
in whole or in part, any action made pursuant to'' delegated
authority.\12\ We find that, in light of the IEX's withdrawal of the
proposed rule change, it is appropriate to set aside the Delegated
Order.
---------------------------------------------------------------------------

    \12\ 17 CFR 201.431(a).
---------------------------------------------------------------------------

    Accordingly, It is ordered that the June 29, 2018 order approving
by delegated authority IEX's proposed rule change number SR-IEX-2018-
06, be, and it hereby is, set aside.

    By the Commission.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-25508 Filed 11-18-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 48 (Monday, March 15, 2021)]
[Rules and Regulations]
[Pages 14233-14234]
[FR Doc No: 2021-05293]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2020-1207; Special Conditions No. 25-782-SC]

Special Conditions: Rockwell Collins, Bombardier Model BD-100-
1A10 Airplane; Electronic-System Security Protection From Unauthorized
Internal Access

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Bombardier Model
BD-100-1A10 airplane. This airplane, as modified by Rockwell Collins,
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 the installation of a system
that allows connection to airplane electronic systems and networks, and
access from sources internal to the airplane to the previously isolated
internal airplane electronic assets. 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.

DATE: This action is effective on Rockwell Collins on March 15, 2021.
Send comments on or before April 29, 2021.

ADDRESSES: Send comments identified by Docket No. FAA-2020-1207 using
any of the following methods:
     Federal eRegulations Portal: Go to http://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 14 CFR 11.35, the FAA will post all comments received
without change, to http://www.regulations.gov/, including any personal
information you provide. The FAA will also post a report summarizing
each substantive verbal contact received about this proposal.
    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 this Notice contain
commercial or financial information that is customarily treated as
private, that you actually treat as private, and that is relevant or
responsive to this Notice, 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 this Notice. Send
submissions containing CBI to the person indicated in the Contact
section below. Comments the FAA receives, which are not specifically
designated as CBI, will be placed in the public docket for this
rulemaking.
    Docket: Background documents or comments received may be read at
http://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: Varun Khanna, Aircraft Information
Systems Section, AIR-622, Technical Innovation Policy Branch, Policy
and Innovation Division, Aircraft Certification Service, Federal
Aviation Administration, 2200 South 216th Street, Des Moines,
Washington 98198; telephone and fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
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, pursuant to 14 CFR 11.38(b), that new
comments are unlikely, and public 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 May 3, 2019, Rockwell Collins applied for a supplemental type
certificate for installation of the Rockwell Collins Pro Line Fusion
System in the Bombardier Model BD-100-1A10 airplane, requiring security
protection from unauthorized internal access. The Bombardier Model BD-
100-1A10 airplane is a twin-engine, transport-category airplane with a
passenger capacity of 19 and a maximum takeoff weight of 40,600 pounds.

Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14
CFR) 21.101, Rockwell Collins must show that the Bombardier Model BD-
100-1A10 airplane, as changed, continues to meet the applicable
provisions of the regulations listed in Type Certificate No. T00005NY,
or the applicable regulations in effect on the date of application for
the change, except for earlier amendments as agreed upon by the FAA.
    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 Bombardier Model BD-100-1A10
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 applicant apply for a supplemental type
certificate to modify any other model included on the same type
certificate to incorporate 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 Bombardier Model BD-100-1A10 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.  21.101.

Novel or Unusual Design Features

    The Bombardier Model BD-100-1A10 airplane, as modified by Rockwell
Collins, will incorporate the following novel or unusual design
feature:
    Installation of the Rockwell Collins Pro Line Fusion System, which
allows connection to airplane electronic systems and networks, and
access from sources internal to the airplane to the previously isolated
internal airplane electronic assets.

Discussion

    The Bombardier Model BD-100-1A10 airplane architecture is novel or
unusual for commercial transport airplanes because it allows connection
to previously isolated data networks connected to systems that perform
functions required for the safe operation and maintenance of the
airplane. This data network and design integration creates a potential
for unauthorized persons to access the aircraft-control domain and
airline information-services domain, and presents security
vulnerabilities related to the introduction of computer viruses and
worms, user errors, and intentional sabotage of airplane electronic
assets (networks, systems, and databases) critical to the safety and
maintenance of the airplane.
    The existing FAA regulations did not anticipate these networked
airplane system architectures. Furthermore, these regulations and the
current guidance material do not address potential security
vulnerabilities, which could be exploited by unauthorized access to
airplane networks, data buses, and servers. Therefore, these special
conditions ensure that the security (i.e., confidentiality, integrity,
and availability) of airplane systems will not be compromised by
unauthorized wired or wireless connections from within the airplane.
These special conditions also require the applicant to provide
appropriate instructions to the operator to maintain all electronic-
system safeguards that have been implemented as part of the original
network design so that this feature does not allow or reintroduce
security threats.
    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
Bombardier Model BD-100-1A10 airplane. Should Rockwell Collins apply at
a later date for a supplemental type certificate to modify any other
model included on Type Certificate No. T00005NY to incorporate 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, as modified by Rockwell Collins. It is not a
rule of general applicability and affects only the applicant.

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

    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 Bombardier Model BD-100-1A10
airplanes, as modified by Rockwell Collins, for electronic-system
security protection from unauthorized internal access.
    1. The applicant must ensure that the design provides isolation
from, or airplane electronic-system security protection against, access
by unauthorized sources internal to the airplane. The design must
prevent inadvertent and malicious changes to, and all adverse impacts
upon, airplane equipment, systems, networks, or other assets required
for safe flight and operations.
    2. The applicant must establish appropriate procedures to allow the
operator to ensure that continued airworthiness of the airplane is
maintained, including all post-type-certification modifications that
may have an impact on the approved electronic-system security
safeguards.

    Issued in Des Moines, Washington, on February 9, 2021.
Suzanne Masterson,
Manager, Transport Airplane Strategic Policy Section, Policy and
Innovation Division, Aircraft Certification Service.
[FR Doc. 2021-05293 Filed 3-12-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 5, 2009 (Volume 74, Number 2)]
[Notices]
[Page 269]
[DOCID:fr05ja09-40]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13291-000]

Golden Green Energy Storage, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene and Competing Applications

December 24, 2008.
    On November 14, 2008, Golden Green Energy Storage, LLC filed an
application, pursuant to section 4(f) of the Federal Power Act (FPA),
proposing to study the feasibility of the Cliffs Energy Pumped Storage
Project to be located in Klickitat County, Washington partially on
lands owned by the Department of the Army. The proposed project
utilizes water from Lake Umatilla on the Columbia River.
    The proposed project would consist of: (1) An upper earthen dam
with a length of 5,200 feet and height of 260 feet; (2) an upper
reservoir with a surface area of 219 acres, a capacity of 14,000 acre-
feet, and a maximum pool elevation of 2,436 feet msl; (3) a lower
earthen dam with a length of 9,500 feet and a height of 120 feet; (4) a
lower reservoir with a surface area of 209 acres, a capacity of 14,000
acre-feet, and a maximum pool elevation of 624 feet msl; (5) an 8,000
foot long, 25 foot diameter concrete penstock; (6) a powerhouse
containing 4 pump/turbine units with a total installed capacity of
1,050 MW; (7) a 5 mile long, 500 kV transmission line and; (8)
appurtenant facilities. The proposed project would have an annual
production of 21 GWh which would be sold to a local utility.
    Applicant Contact: Scott Tillman, 3313 West Second St, The Dalles,
OR 97058,<PHONE_NUMBER>.
    FERC Contact: Steven Sachs<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
    Comments, motions to intervene, notices of intent and competing
applications may be filed electronically via the internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    For more information on how to submit these types of filings please
go to the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of the Commission's Web site at http:/
/www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13291) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-31310 Filed 1-2-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 107 (Thursday, June 4, 2015)]
[Notices]
[Pages 31945-31946]
[FR Doc No: 2015-13501]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at the Lehigh Valley International Airport (ABE), Allentown,
Pennsylvania

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of request to release airport property for non-
aeronautical purposes.

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

SUMMARY: The FAA proposes to rule and invite public comment on the
release of land for non-aeronautical purposes at the Lehigh Valley
International Airport (ABE), Allentown, Pennsylvania under the
provision 49 U.P.C. 47125(a).

DATES: Comments must be received on or before July 6, 2015.

ADDRESSES: Comments on this application may be mailed or delivered to
the following address:

Ryan Meyer, Senior Aviation Planner, Lehigh Valley International
Airport, 3311 Airport Road, Allentown, Pennsylvania 18109,
and at the FAA Harrisburg Airports District Office:

Lori K. Pagnanelli, Manager, Harrisburg Airports District Office, 3905
Hartzdale Dr., Suite 508, Camp Hill, PA 17011.

FOR FURTHER INFORMATION CONTACT: Rick Harner, Civil Engineer,
Harrisburg Airports District Office, location listed above.
    The request to release property may be reviewed in person at this
same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release airport property for non-aeronautical purposes at
the Lehigh Valley International Airport under the provisions of Section
47125(a) of Title 49 U.S.C. On May 27, 2015, the FAA determined that
the request to release airport property for non-aeronautical purposes
at the Lehigh Valley International Airport (ABE), Pennsylvania,
submitted by the Lehigh Northampton Airport Authority (Authority), met
the procedural requirements. Final release of the

property is subject to FAA's NEPA determination.
    The following is a brief overview of the request:
    The Authority requests the release of a portion of airport property
totaling 260 acres, which is no longer needed for aeronautical
purposes. Of the total 260 acres, 248 acres are part of Parcel H-1, and
12 acres are part of Parcel X-2. These parcels are located in Allen
Township, and were originally included as part of larger property
purchased with federal funds over multiple AIP grants.
    The 260 acres requested for non-aeronautical use, are to be
released to the Rockefeller Group Development Corporation (Rockefeller
Group), 500 International Drive North, Suite 345, Mt. Olive, NJ 07828.
The property is located in the northwest corner of existing airport
property. Rockefeller Group is proposing to sell the 260 acre property
to FedEx Ground for the construction of a ground transportation
facility. The undeveloped property is located in Allen Township at the
intersection of Willowbrook Road and Race Street. As shown on the
Airport Layout Plan, the airport property does not serve an
aeronautical purpose and is not needed for current or future airport
development. The property was part of an inverse condemnation judgment
against the Authority. The proceeds from the Fair Market Value (FMV)
sale of the 260 acres of property will be used to pay off the judgment
and the remaining balance will be placed into an identifiable interest
bearing account to be used for eligible airport development purposes,
as outlined in FAA Order 5190.6B, Airport Compliance Manual.
    Any person may inspect the request by appointment at the FAA office
address listed above. Interested persons are invited to comment on the
proposed release. All comments will be considered by the FAA to the
extent practicable.

    Issued in Camp Hill, Pennsylvania, May 28, 2015.
Lori K. Pagnanelli,
Manager, Harrisburg Airports District Office.
[FR Doc. 2015-13501 Filed 6-3-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 175 (Tuesday, September 12, 2023)]
[Notices]
[Pages 62566-62567]
[FR Doc No: 2023-19608]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OEJECR-2023-0099; FRL-11361-01-OEJECR]

White House Environmental Justice Advisory Council; Notification
of Virtual Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of a public meeting.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act (FACA), the
U.S. Environmental Protection Agency (EPA) hereby provides notice that
the White House Environmental Justice Advisory Council (WHEJAC) will
meet on the date and time described below. Due to unforeseen
administrative circumstances, EPA is announcing this meeting with less
than 15 calendar days public notice. The meeting is open to the public.
The meeting is open to the public. For additional information about
registering to attend the meeting or to provide a public comment,
please see REGISTRATION under SUPPLEMENTARY INFORMATION. Pre-
registration is required.

DATES: The WHEJAC will convene a virtual public meeting on Tuesday,
September 26, 2023, from approximately 3 to 8 p.m. EDT. Meeting
discussions will focus on several topics including, but not limited to,
workgroup activities, proposed recommendations for the Council on
Environmental Quality (CEQ) and the White House Environmental Justice
Interagency Council (IAC), CEQ briefings, and a new formal charge for
the WHEJAC. A public comment period relevant to current WHEJAC charges
will be considered by the WHEJAC at the meeting on Tuesday, September
26, 2023, (see SUPPLEMENTARY INFORMATION). Members of the public who
wish to participate during the public comment period must register by
11:59 p.m., EDT, Thursday, September 21, 2023.

FOR FURTHER INFORMATION CONTACT: Audrie Washington, WHEJAC Designated
Federal Officer, U.S. EPA; email: [email protected]; telephone: (202) 441-
7295. Additional information about the WHEJAC is available at https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council.

SUPPLEMENTARY INFORMATION: The Charter of the WHEJAC (available at
https://www.epa.gov/system/files/documents/2023-03/2023%20White%20House%20Environmental%20Justice%20Advisory%20Council%20Charter.pdf) states that the advisory committee will provide independent
advice and recommendations to the Chair of CEQ and to the IAC. The
WHEJAC provides advice and recommendations about broad cross-cutting
issues related, but not limited, to issues of environmental justice and
pollution reduction, energy, climate change mitigation and resiliency,
environmental health, and racial inequity. The WHEJAC's efforts include
a broad range of strategic, scientific, technological, regulatory,
community engagement, and economic issues related to environmental
justice.

I. Registration

    Individual registration is required for the public meeting.
Information on how to register is located at https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council. Registration for the meeting is available until the scheduled
end time of the meeting. Registration to speak during the public
comment period will close at 11:59 p.m., EDT, on Thursday, September
21, 2023. When registering, please provide your name, organization,
city and state, and email address for follow up. Please also indicate
whether you would like to provide public comment during the meeting, or
if you are submitting written comments.

A. Public Comment

    The WHEJAC is interested in receiving public comments relevant to
the following charges, topics, and questions currently under
consideration: (1) the Climate and Economic Justice Screening Tool; (2)
the Environmental Justice Scorecard; (3) carbon management; (4) ways
that the WHEJAC could recommend advancing environmental justice through
a whole-of-government approach; and (5) environmental justice issues
affecting Indigenous Peoples and Tribal Nations. With respect to
environmental justice issues affecting indigenous peoples and tribal
nations, the WHEJAC Indigenous Peoples and Tribal Nations Workgroup is
particularly interested in receiving comments on: Examples of
environmental hazards of particular concern for indigenous peoples and
tribal nations (for example, environmental hazards related to Federal
activities that may affect sacred sites and areas of cultural
significance, cultural or other traditions or practices, subsistence,
and ways of life); ways in which the Federal Government can address
community impacts on, and concerns of, indigenous peoples and tribal
nations; and ways in which the incorporation of indigenous knowledge
into Federal decision-making could help address environmental hazards
and environmental justice concerns. More information on WHEJAC
workgroup charges is located online at: https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council, under WHEJAC Membership and Workgroups.
    Priority to speak during the meeting will be given to public
commenters with comments relevant to the topics and questions listed
above. Every effort will be made to hear from as many registered public
commenters during the time specified on the agenda. Individuals or
groups making remarks during the public comment period will be limited
to three (3) minutes. Please be prepared to briefly describe your issue
and your recommendation relevant to the current charges, topics, and
questions under consideration by the WHEJAC. Submitting written
comments for the record is strongly encouraged. You can submit your
written comments in three different ways: (1) by creating comments in
the Docket ID No. EPA-HQ-OEJECR-2023-0099 at https://www.regulations.gov, (2) by using the webform at https://www.epa.gov/environmentaljustice/forms/white-house-environmental-justice-advisory-council-whejac-public-comment, and (3) by sending comments via email to
[email protected]. Written comments can be submitted through October 10,
2023.

B. Information About Services for Individuals With Disabilities or
Requiring English Language Translation Assistance

    To request special accommodations for a disability or other
assistance, please submit your request at least five (5) working days
prior to the meeting to give EPA sufficient time to process your
request. All requests should be sent to the email listed in the FOR
FURTHER INFORMATION CONTACT section.

Matthew Tejada,
Deputy Assistant Administrator for Environmental Justice, Office of
Environmental Justice and External Civil Rights.
[FR Doc. 2023-19608 Filed 9-11-23; 8:45 am]
BILLING CODE 6560-50-P