[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28820-28825]
[FR Doc No: 2013-11641]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC13-14-000]

Commission Information Collection Activities (FERC Form 80);
Comment Request; Revision

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of revised information collection and request for
comments.\1\

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

    \1\ This notice supersedes the notice issued on 4/18/2013 in
this same docket, which was subsequently published in the Federal
Register on 4/25/2013 (78 FR 24402).
---------------------------------------------------------------------------

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3506(c)(2)(A), the Federal Energy Regulatory
Commission (Commission or FERC) is soliciting public comment on the
currently approved information collection FERC Form 80, Licensed
Hydropower Development Recreation Report.

DATES: Comments on the collection of information are due July 15, 2013.

ADDRESSES: You may submit comments (identified by Docket No. IC13-14-
000) by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

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

SUPPLEMENTARY INFORMATION:
    Title: FERC Form 80, Licensed Hydropower Development Recreation
Report.
    OMB Control No.: 1902-0106.
    Type of Request: Minor revisions to the FERC Form 80 information
collection. requirements with no change to the current reporting
burden.
    Abstract: FERC uses the information on the FERC Form 80 to
implement the statutory provisions of sections 4(a), 10(a), 301(a), 304
and 309 of the Federal Power Act (FPA), 16 U.S.C. sections 797, 803,
825c & 8254. FERC's authority to collect this information comes from
section 10(a) of the FPA which requires the Commission to be
responsible for ensuring that hydro projects subject to FERC
jurisdiction are consistent with the comprehensive development of the
nation's waterway for recreation and other beneficial public uses. In
the interest of fulfilling these objectives, FERC expects licensees
subject to its jurisdiction to recognize the resources that are
affected by their activities and to play a role in protecting such
resources.
    FERC Form 80 is a report on the use and development of recreational
facilities at hydropower projects licensed by the Commission.
Applications for licenses, amendments to licenses, and/or changes in
land rights frequently involve changes in resources available for
recreation. FERC utilizes the FERC Form 80 data when analyzing the
adequacy of existing public recreational facilities and when processing
and reviewing proposed

amendments to help determine the impact of such changes. In addition,
the FERC regional office staff uses the FERC Form 80 data when
conducting inspections of licensed projects. FERC inspectors use the
data in evaluating compliance with various license conditions and in
identifying recreational facilities at hydropower projects.
    The FERC Form 80 requires data specified by Title 18 of the Code of
Federal Regulations (CFR) under Sec. Sec.  8.11 and 141.14 (and
discussed at http://www.ferc.gov/docs-filing/forms.asp#80).
    FERC collects the FERC Form 80 once every six years. The last
collection was due on April 1, 2009, for data compiled during the 2008
calendar year. The next collection of the FERC Form 80 is due on April
1, 2015, with subsequent collections due every sixth year, for data
compiled during the previous calendar year.
    The Commission made minor revisions throughout the form.
Specifically, FERC clarified and simplified instructions, removed
redundancy in certain questions, clarified questions and terms, and
generally improved the readability of the form.
    FERC has attached the revised form to this notice.
    Type of Respondents: Hydropower project licensees.
    Estimate of Annual Burden: \2\ For each reporting period, FERC
estimates the total Public Reporting Burden for this information
collection as: (a) 1,000 respondents, (b) 0.167 response/respondent,
and (c) 3 hours per response, giving a total of 501 burden hours. The
Commission has increased its total number of respondents to reflect the
actual numbers we received during the last two reporting periods. In
addition, FERC spreads the burden hours and costs over the six-year
collection cycle in the table below to reflect how the information is
collected. The average burden hours per response remains unchanged.
These are the figures FERC will submit to OMB.
---------------------------------------------------------------------------

    \2\ FERC defines burden as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, reference 5 Code of Federal Regulations 1320.3.

                           FERC-80--Licensed Hydropower Development Recreation Report
----------------------------------------------------------------------------------------------------------------
                                                 Number of                      Average  burden
            Number of respondents              responses per   Total number of     hours per     Estimated total
                                               respondent \3\     responses         response      annual burden
(A)                                                      (B)    (A) x (B) = (C)            (D)                (C) x (D)
----------------------------------------------------------------------------------------------------------------
1,000.......................................           0.167              167                3              501
----------------------------------------------------------------------------------------------------------------

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

    \3\ FERC divides the responses per respondent by six because
this collection occurs once every six years.
---------------------------------------------------------------------------

    The total estimated annual cost burden to respondents is $35,070
[501 hours * $70/hour \4\ = $35,070].
---------------------------------------------------------------------------

    \4\ FY2013 Estimated Average Hourly Cost per FTE, including
salary + benefits.
---------------------------------------------------------------------------

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

    Dated: May 8, 2013.
Kimberly D. Bose,
Secretary.
    Revised Form Attached.
BILLING CODE 6717-01-P

[GRAPHIC] [TIFF OMITTED] TN16MY13.006

[GRAPHIC] [TIFF OMITTED] TN16MY13.007

[GRAPHIC] [TIFF OMITTED] TN16MY13.008

[FR Doc. 2013-11641 Filed 5-15-13; 8:45 am]
BILLING CODE 6717-01-C


[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Notices]
[Pages 2449-2451]
[FR Doc No: 2018-00678]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1235]

Determination of Regulatory Review Period for Purposes of Patent
Extension; AVYCAZ

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for AVYCAZ and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by March
19, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by July 16, 2018. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of March 19, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-E-1235 for ``Determination of

Regulatory Review Period for Purposes of Patent Extension; AVYCAZ.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product AVYCAZ
(ceftazidime pentahydrate and avibactam sodium). AVYCAZ is indicated
for treatment of patients 18 years or older with the following
infections caused by designated susceptible microorganisms:
     Complicated intra-abdominal infections used in combination
with metronidazole and
     Complicated urinary tract infections, including
pyelonephritis.
    Subsequent to this approval, the USPTO received a patent term
restoration application for AVYCAZ (U.S. Patent No. 7,112,592) from
Forest Laboratories Holdings Ltd., and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated July 12, 2016, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of AVYCAZ represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
AVYCAZ is 2,579 days. Of this time, 2,333 days occurred during the
testing phase of the regulatory review period, while 246 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: February 5, 2008. FDA has verified the applicant's claim
that February 5, 2008, is the date the investigational new drug
application (IND) became effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: June 25,
2014. FDA has verified the applicant's claim that the new drug
application (NDA) for AVYCAZ (NDA 206494) was initially submitted on
June 25, 2014.
    3. The date the application was approved: February 25, 2015. FDA
has verified the applicant's claim that NDA 206494 was approved on
February 25, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,411 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.)

Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00678 Filed 1-16-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 135 (Monday, July 15, 2019)]
[Proposed Rules]
[Pages 33715-33721]
[FR Doc No: 2019-14885]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 49

[EPA-HQ-OAR-2014-0606; FRL-9996-50-OAR]
RIN 2060-AU45

Amendments to Federal Implementation Plan for Managing Air
Emissions From True Minor Sources in Indian Country in the Oil and
Natural Gas Production and Natural Gas Processing Segments of the Oil
and Natural Gas Sector

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
amend the Federal Minor New Source Review (NSR) Program in Indian
Country and the Federal Implementation Plan (FIP) for True Minor
Sources in Indian Country in the Oil and Natural Gas Production and
Natural Gas Processing Segments of the Oil and Natural Gas Sector
(National O&NG FIP). The amendment would potentially reduce, by up to
30 days, the time between a source owner/operator's submission of
required Endangered Species Act (ESA)/National Historic Preservation
Act (NHPA) screening documents and beginning construction.
Specifically, the amendment would allow for concurrent, rather than
sequential, submission of two sets of documents: Part 1 Registration
Form (Part 1 Form) to register applicability under the National O&NG
FIP, and documentation supporting completed screening procedures
(screening procedures

documentation) for the evaluation of potential impacts of their
proposed projects on threatened or endangered species and historic
properties (protected resources). The proposal also seeks to further
clarify the 30-day period before construction may begin, and the
potential forms of written notification by the EPA Regional Office to
source owner/operators. Finally, this proposal addresses minor edits to
correct incorrect citations and cross references.

DATES: Comments. Comments must be received on or before September 13,
2019.
    Public Hearing: If anyone contacts us requesting to speak at a
public hearing by July 30, 2019, we will hold a public hearing.
Additional information about the hearing will be published in a
subsequent Federal Register notice.

ADDRESSES: Comments. Submit your comments, identified by Docket ID No.
EPA-HQ-OAR-2014-0606, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (e.g., on the Web, Cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets. Certain other material,
such as copyrighted material, will not be placed on the internet but
may be viewed, with prior arrangement, at the EPA Docket Center.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air and Radiation
Docket and Information Center, EPA/DC, EPA William Jefferson Clinton
West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC.
The 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
Public Reading Room is<PHONE_NUMBER> and the telephone number for the
Air and Radiation Docket and Information Center is<PHONE_NUMBER>. For
additional information about the EPA's public docket, visit the EPA
Docket Center homepage at: http://www.epa.gov/epahome/dockets.htm.
    Public Hearing: For information on the public hearing, contact Ms.
Pamela Long, U.S. EPA, Office of Air Quality Planning and Standards,
Air Quality Policy Division (C504-01), Research Triangle Park, NC
27711; telephone number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: For general questions about this
document, please contact Mr. Ben Garwood, New Source Review Group, Air
Quality Policy Division, Office of Air Quality Planning and Standards
(C504-03), Environmental Protection Agency, Research Triangle Park,
North Carolina 27711; telephone number<PHONE_NUMBER>; fax number (919)
541-4028; email address<EMAIL_ADDRESS>    To request a public hearing or information pertaining to a public
hearing on this document, contact Ms. Pamela Long, Air Quality Policy
Division, Office of Air Quality Planning and Standards (C504-01),
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number<PHONE_NUMBER>; fax number<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>    For questions about the applicability of this action to a
particular source, please contact the appropriate EPA region:
     EPA Region 5 (Illinois, Indiana, Michigan, Minnesota,
Ohio, and Wisconsin)--Ms. Genevieve Damico, Air Permits Section,
Environmental Protection Agency, Region 5, Chicago, Illinois 60604;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>     EPA Region 6 (Arkansas, Louisiana, New Mexico, Oklahoma,
and Texas)--Ms. Bonnie Braganza, Air Permits Section, Multimedia
Permitting and Planning Division, Environmental Protection Agency
Region 6, Dallas, Texas 75202; telephone number<PHONE_NUMBER>; fax
number<PHONE_NUMBER>; email address<EMAIL_ADDRESS>     EPA Region 8 (Colorado, Montana, North Dakota, South
Dakota, Utah, and Wyoming)--Ms. Claudia Smith, Air Program, Mail Code
8P-AR, Environmental Protection Agency Region 8, Denver, Colorado
80202; telephone number<PHONE_NUMBER>; fax number<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>     EPA Region 9 (Arizona, California, Hawaii, Nevada, and
Pacific Islands)--Ms. Lisa Beckham, Permits Office, Air Division, Air-
3, Environmental Protection Agency Region 9, San Francisco, California
94105; telephone number<PHONE_NUMBER>; fax number<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>     All other EPA regions--For further information about minor
sources in Indian country for your EPA region, please use to the Tribal
New Source Review Program at https://www.epa.gov/tribal-air. Scroll
down to the heading, ``Regulatory Resources,'' and click on ``Tribal
Minor New Source Review (NSR)'' and click on ``Tribal and Permitting
Programs in EPA's Regional Offices'' to access the links for tribal
programs in each EPA Regional Office.

SUPPLEMENTARY INFORMATION: Organization of This Document. The
information presented in this preamble is organized as follows:

I. General Information
    A. What entities are potentially affected by this action?
    B. What should I consider as I prepare my comments for the EPA?
    C. How can I find information about a possible hearing?
    D. Where can I ger a copy of this document and other related
information?
II. Purpose
III. Background
    A. Federal Minor NSR Program in Indian Country
    B. National Oil and Natural Gas FIP
    C. Source Registration Under the Federal Minor NSR Program in
Indian Country
    D. Requirements Under the National O&NG FIP Relating to
Threatened or Endangered Species and Historic Properties
IV. Summary of Proposed Amendments--Revision to the Registration
Process
V. Environmental Justice Considerations
VI. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
    C. Paperwork Reduction Act (PRA)
    D. Regulatory Flexibility Act (RFA)
    E. Unfunded Mandates Reform Act (UMRA)
    F. Executive Order 13132: Federalism
    G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    H. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
    J. National Technology Transfer and Advancement Act (NTTAA)

    K. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. General Information

A. What entities are potentially affected by this action?

    Entities potentially affected by this proposal consist of owners or
operators of facilities included in the following source categories
that are located, or planning to locate, in an Indian reservation or in
another area of Indian country (as defined in 18 U.S.C. 1151) over
which an Indian tribe, or the EPA, has demonstrated that the tribe has
jurisdiction where there is no EPA-approved program in place and that
are subject to the requirements of the Federal Minor NSR Program in
Indian country.

           Table 1--Source Categories Affected by This Action
------------------------------------------------------------------------
                                                  Examples of regulated
       Industry category         NAICS code \a\  entities/description of
                                                    industry category
------------------------------------------------------------------------
Oil and Natural Gas Production/           21111  Exploration for crude
 Operations.                                      petroleum and natural
                                                  gas; drilling,
                                                  completing, and
                                                  equipping wells;
                                                  operation of
                                                  separators, emulsion
                                                  breakers, desilting
                                                  equipment, and field
                                                  gathering lines for
                                                  crude petroleum and
                                                  natural gas; and all
                                                  other activities in
                                                  the preparation of oil
                                                  and natural gas up to
                                                  the point of shipment
                                                  from the producing
                                                  property.
                                                 Production of crude
                                                  petroleum, the mining
                                                  and extraction of oil
                                                  from oil shale and oil
                                                  sands, the production
                                                  of natural gas, sulfur
                                                  recovery from natural
                                                  gas, and the recovery
                                                  of hydrocarbon liquids
                                                  from oil and natural
                                                  gas field gases.
Crude Petroleum and Natural Gas          211111  Exploration,
 Extraction.                                      development and/or the
                                                  production of
                                                  petroleum or natural
                                                  gas from wells in
                                                  which the hydrocarbons
                                                  will initially flow or
                                                  can be produced using
                                                  normal pumping
                                                  techniques or
                                                  production of crude
                                                  petroleum from surface
                                                  shales or tar sands or
                                                  from reservoirs in
                                                  which the hydrocarbons
                                                  are semisolids.
Natural Gas Liquid Extraction..          211112  Recovery of liquid
                                                  hydrocarbons from oil
                                                  and natural gas field
                                                  gases; and sulfur
                                                  recovery from natural
                                                  gas.
Drilling Oil and Natural Gas             213111  Drilling oil and
 Wells.                                           natural gas wells for
                                                  others on a contract
                                                  or fee basis,
                                                  including spudding in,
                                                  drilling in,
                                                  redrilling, and
                                                  directional drilling.
Support Activities for Oil and           213112  Performing support
 Natural Gas Operations.                          activities on a
                                                  contract or fee basis
                                                  for oil and natural
                                                  gas operations (except
                                                  site preparation and
                                                  related construction
                                                  activities) such as
                                                  exploration (except
                                                  geophysical surveying
                                                  and mapping);
                                                  excavating slush pits
                                                  and cellars, well
                                                  surveying; running,
                                                  cutting, and pulling
                                                  casings, tubes, and
                                                  rods; cementing wells,
                                                  shooting wells;
                                                  perforating well
                                                  casings; acidizing and
                                                  chemically treating
                                                  wells; and cleaning
                                                  out, bailing, and
                                                  swabbing wells.
Engines (Spark Ignition and               22111  Provision of electric
 Compression Ignition) for                        power to support oil
 Electric Power Generation.                       and natural gas
                                                  production where
                                                  access to the electric
                                                  grid is unavailable.
------------------------------------------------------------------------
\a\ North American Industry Classification System.

    This list is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be potentially affected
by this action. To determine whether your facility could be affected by
this action, you should examine the applicability criteria in the
Federal Minor NSR Program in Indian country and the National O&NG FIP
(40 CFR 49.153 and 49.101, respectively). If you have any questions
regarding the applicability of this action to a particular entity,
contact the appropriate person listed in the FOR FURTHER INFORMATION
CONTACT section.

B. What should I consider as I prepare my comments for the EPA?

    When submitting comments, remember to:
    Identify the rulemaking docket by docket number and other
identifying information (subject heading, Federal Register date and
page number).
    Follow directions. The proposed rule may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    Explain why you agree or disagree, suggest alternatives and
substitute language for your requested changes.
    Describe any assumptions and provide any technical information and/
or data that you used to support your comment.
    If you estimate potential costs or burdens, explain how you arrived
at your estimate in sufficient detail to allow for it to be reproduced.
    Provide specific examples to illustrate your concerns wherever
possible, and suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.
    Submitting CBI. Do not submit information containing CBI to the EPA
through https://www.regulations.gov or email. Clearly mark the part or
all of the information that you claim to be CBI. For CBI information on
any digital storage media that you mail to the EPA, mark the outside of
the digital storage media as CBI and then identify electronically
within the digital storage media the specific information that is
claimed as CBI. In addition to one complete version of the comments
that includes information claimed as CBI, you must submit a copy of the
comments that does not contain the information claimed as CBI for
inclusion in the public docket. If you submit any digital storage media
that does not contain CBI, mark the outside of the digital storage
media clearly that it does not contain CBI. Information not marked as
CBI will be included in the public docket and the EPA's electronic
public docket without prior notice. Information marked as CBI will not
be disclosed except in accordance with procedures set forth in 40 Code
of Federal Regulations (CFR) Part 2. Send or deliver information
identified as CBI only to the following address: OAQPS Document Control
Officer (C404-02), OAQPS, U.S. Environmental Protection Agency,
Research Triangle Park, North Carolina 27711, Attention Docket ID No.
EPA-HQ-OAR-2014-0606.

C. How can I find information about a possible hearing?

    To request a public hearing or information pertaining to a public
hearing regarding this document, contact Mrs. Pam Long, OAQPS, U.S.
EPA, at<PHONE_NUMBER> or<EMAIL_ADDRESS>on or before July 30, 2019.
Additional information about the hearing, if one is requested, will be
published in a subsequent Federal Register document.

D. Where can I get a copy of this document and other related
information?

    In addition to being available in the docket, an electronic copy of
this Federal Register document will be posted at https://www.epa.gov/nsr and on the tribal NSR page at https://www.epa.gov/tribal-air/tribal-minor-new-source-review.

II. Purpose

    The EPA proposes to amend the National O&NG FIP \1\ to allow owners
or operators of true minor sources to concurrently submit to the EPA
Regional Office their Part 1 Form together with screening procedures
documentation for the evaluation of potential impacts of their proposed
projects on protected resources. The EPA Regional Office will approve
the screening procedures documentation with the Part 1 Form prior to
construction or modification of the proposed new and/or modified minor
NSR source. We are also proposing to clarify that written notification
by the EPA Regional Office may include email in addition to the
standard letter, and when construction may begin after a Part 1 Form is
submitted. Therefore, the EPA anticipates this proposal to allow
contemporaneous submission of the screening procedures documentation
and the Part I Form, and if finalized, will streamline the
authorization of construction of minor oil and natural gas sources
under the FIP. The EPA is also proposing to make a minor clarification
to the Federal Minor NSR program in Indian country, specifically 40 CFR
49.160(c)(1)(iv), to clarify that the Part 1 Registration Form need not
be submitted exactly 30 days before beginning construction, but rather
at least 30 days before beginning construction. The EPA does not
anticipate the proposed rule changes will result in any increase in
environmental impact(s) or cost increase(s) for reviewing authorities
or the regulated community.
---------------------------------------------------------------------------

    \1\ 40 CFR 49.101-49.105.
---------------------------------------------------------------------------

III. Background

A. Federal Minor NSR Program in Indian Country

    In July 2011, the EPA exercised its authority under the CAA and the
related regulations, including the authority under CAA section
301(d)(4), to promulgate the Federal Minor NSR Program in Indian
country, a type of FIP, which was part of a larger rulemaking referred
to as ``Review of New Sources and Modifications in Indian Country.''
\2\ That action was initiated to address potential adverse impacts to
air quality due to the lack of approved minor NSR permit programs to
regulate construction of new and/or modified minor sources and minor
modifications of major sources in much of Indian country. The EPA
promulgated the Federal Minor NSR Program, in part, to ensure that air
resources are protected by establishing a preconstruction permitting
program to regulate emission increases resulting from construction and
modification activities that were not already regulated by the major
NSR permitting programs.
---------------------------------------------------------------------------

    \2\ ``Review of New Sources and Modifications in Indian
Country,'' U.S. Environmental Protection Agency, 76 FR 38748, July
1, 2011, https://www.gpo.gov/fdsys/pkg/FR-2011-07-01/pdf/2011-14981.pdf.
---------------------------------------------------------------------------

B. National O&NG FIP

    The EPA issued the final National O&NG FIP on June 3, 2016.\3\ The
National O&NG FIP was developed to protect air quality in Indian
country due to the impact of new true minor sources and minor
modifications at existing true minor sources in the oil and natural gas
production and natural gas processing segments of the oil and natural
gas sector that are locating or expanding in an Indian reservation or
in another area of Indian country over which a tribe, or the EPA, has
demonstrated that the tribe has jurisdiction. Accordingly, the FIP
adopted legally and practicably enforceable requirements to control and
reduce air emissions from oil and natural gas production activities.
The FIP applies to new and modified true minor sources in such areas of
Indian country designated as attainment, unclassifiable or attainment/
unclassifiable. (Note, on May 2, 2019, the EPA Administrator signed a
final rule extending the geographic coverage of the National O&NG FIP
to the Indian country portion of the Uinta Basin Ozone Nonattainment
Area (i.e., the Uintah and Ouray Reservation).\4\)
---------------------------------------------------------------------------

    \3\ See 81 FR 35943, 35946, June 3, 2016, https://www.gpo.gov/fdsys/pkg/FR-2016-06-03/pdf/2016-11969.pdf.
    \4\ ``Amendments to Federal Implementation Plan for Managing Air
Emissions From True Minor Sources in Indian Country in the Oil and
Natural Gas Production and Natural Gas Processing Segments of the
Oil and Natural Gas Sector,'' U.S. Environmental Proection Agency,
84 FR 21240, May 14, 2019, https://www.govinfo.gov/content/pkg/FR-2019-05-14/pdf/2019-09829.pdf.
---------------------------------------------------------------------------

    The National O&NG FIP uses a streamlined ``authorization to
construct'' approach for oil and natural gas sources to fulfill the
EPA's obligation under the Federal Minor NSR Program in Indian country
to issue minor source NSR pre-construction permits. True minor sources
in the oil and natural gas production and natural gas processing
segments of the oil and natural gas sector are required to comply with
the FIP, unless they opt out of the FIP to obtain a site-specific
permit or are otherwise required to do so.

C. Source Registration Under the Federal Minor NSR Program in Indian
Country

    The source registration requirements for true minor sources in
Indian country are set out at 40 CFR 49.151 and 49.160.\5\ Sources
complying with the National O&NG FIP must submit the Part 1 Form,
containing specified information, at least 30 days prior to beginning
construction. 40 CFR 49.160(c)(1)(iv). Such sources must also submit
the Part 2 Registration Form within 60 days after the startup of
production, and both parts of the Registration Form, in combination,
satisfy the registration requirement. Id.
---------------------------------------------------------------------------

    \5\ See also 40 CFR 49.151(c).
---------------------------------------------------------------------------

D. Requirements Under the National O&NG FIP Relating to Threatened or
Endangered Species and Historic Properties

    In addition to the registration requirements, sources complying
with the National O&NG FIP must fulfill requirements concerning
potential impacts to protected resources. Under 40 CFR 49.104, these
requirements generally may be satisfied in one of two ways, which,
presently, may have different consequences relating to the submission
of the Part 1 Form and beginning construction:
    (1) Where an agency other than the EPA (e.g., the Bureau of Land
Management) has already evaluated the potential impacts of the specific
oil and gas activity on protected resources, the source may submit
appropriate documentation of the other federal agency's protected
resources review. In that case, the appropriate

documentation of protected resources review should be submitted with
the Part 1 Form, and the source may begin construction no sooner than
thirty days later.
    (2) Where an assessment related to protected resources has not
already been conducted by another agency, the owner or operator must
follow a set of screening procedures to assess potential impacts on
protected resources and receive approval of that assessment by the EPA
Regional Office. In that instance, the EPA's confirmation that the
source has satisfactorily completed the procedures must occur prior to
the source's submittal of its Part 1 Form pursuant to 40 CFR
49.160(c)(1)(iv) and 40 CFR 49.104(a)(2). The EPA Regional Office has
up to 30 days before it must either approve the screening procedures
documentation or notify the owner/operator by letter that additional
information is required. 40 CFR 49.104(a)(2)(i). As a practical matter,
this means that, after submitting screening procedure documentation,
the source must wait at least 30 days before being able to submit its
Part 1 Form, and then wait an additional 30 days before it can begin
construction.\6\
---------------------------------------------------------------------------

    \6\ On August 2, 2016, after the EPA issued the National O&NG
FIP, the American Petroleum Institute (API) petitioned the
Administrator to revise the FIP. Letter from Howard J. Feldman, API,
to Gina McCarthy, EPA Administrator, August 2, 2016. Docket ID EPA-
HQ-OAR-2014-0606. On August 2, 2016, API also petitioned for
judicial review of the National O&NG FIP, No. 16-1271 (D.C.
Circuit). More recently, on September 24, 2018, API sent EPA another
inquiry and request relating to the National O&NG FIP. Letter from
Matt Todd, API to Peter Tsirigotis, Director, EPA Office of Air
Quality Planning and Standards, September 24, 2018. Docket ID EPA-
HQ-OAR-2014-0606. Among the concerns raised by API were concerns
relating to possible construction delays associated with the process
under the National O&NG FIP for submission of the Part 1 Form. On
November 27, 2018, the EPA responded to some of the issues raised by
API and indicated, in part, that it was open to consideration of
possible changes to the process relating to submission of the Part 1
Form. Letter from Jenny Edmonds, Acting Director, Outreach and
Information Division, the EPA Office of Air Quality Planning and
Standards, to Matt Todd, American Petroleum Institute, November 27,
2018. Docket ID EPA-HQ-OAR-2014-0606. This proposal, in part,
responds to API's concerns and seeks comment on possible limited
changes to the existing Part 1 Form submission process.
---------------------------------------------------------------------------

IV. Summary of Proposed Amendments--Revisions to the Registration
Process

    As noted in Section III.D. of this document, in certain cases,
submission of documentation of completion of the screening procedures,
and the EPA's confirmation of satisfactory completion of the
procedures, must occur prior to the source's submittal of its Part 1
Form. And, upon submittal of the Part 1 Form, the source must wait an
additional 30 days before beginning construction. We believe it is
reasonable, instead, to allow the owner or operator to submit the Part
1 Form together with the screening procedures documentation, rather
than after the EPA Regional Office approval of the screening procedures
documentation, possibly expediting the preconstruction permitting
process. This approach would still afford at least a 30-day
notification period before construction begins (similar to the process
for sources relying on documentation of another federal agency's
completion of protected resources evaluation under 40 CFR
49.104(a)(1)). In addition, the EPA Regional Office still has the
responsibility to determine the adequacy of the screening procedures
documentation, and if not adequate, the source may not begin
construction.
    Accordingly, we propose to amend the National O&NG FIP to authorize
sources to submit Part 1 Forms concurrent with screening procedures
documentation. We also propose to clarify that sources may begin
construction under this FIP if two conditions have been met: (1) At
least 30 days have passed from the date the Part 1 Form was submitted,
and (2) the EPA Regional Office has provided notification that the
screening procedures have been satisfactorily completed. So, a
hypothetical timeline under this proposal would be:
     On day 1, a source would submit its Part 1 Form and
screening procedures documentation;
     On day 15, the EPA could notify the source that it has
satisfactorily completed the screening procedures;
     On day 31, the source could begin construction.
    In another hypothetical timeline illustration under this proposal:
     On day 1, a source would submit its Part 1 Form and
screening procedures documentation;
     On day 29, the EPA could notify the source that additional
documentation is required and specify that it must be submitted within
15 days.
     If the owner or operator timely submits sufficient
documentation, the date that construction may begin must shift to the
date when the EPA subsequently notifies the owner or operator that the
screening procedures have been satisfactorily completed, which would
extend more than 30 days after submitting the Part 1 Form.
    We also propose to make three additional, minor changes to related
regulatory text. First, the rule currently specifically provides that
the EPA Regional Office will provide notice of satisfactory completion
of the screening procedures (or a determination that the documentation
is not adequate) by letter to the owner or operator, as noted in 40 CFR
49.104(a)(2)(i). The EPA did not and does not intend that the notice be
in the form of a letter sent via the United States Postal Service. The
EPA proposes to clarify that the EPA Regional Office give written
notification approving screening procedure documentation, which need
not necessarily be in the form or manner of a traditional ``letter,''
but could, for example, be in an electronic format and transmitted via
email (e.g. a signed .pdf document).
    Second, to address potential confusion, we also propose to amend 40
CFR 49.160(c)(1)(iv) to clarify that the Part I Form need not be
submitted exactly 30 days before beginning construction, but must be
submitted at least 30 days before beginning construction.
    Lastly, we take this opportunity to propose to make a technical
correction to 40 CFR 49.104(a) to resolve a typographical or
scrivener's error and correct a reference to non-existent subsection
(c)(1) or (2) of 40 CFR 49.

V. Environmental Justice Considerations

    This action seeks to revise existing rules to further streamline
the pre-construction process for true minor sources in the oil and
natural gas sector in areas covered by the Federal Minor NSR Program in
Indian country. It does not remove any of the prior rules'
environmental or procedural protections. Therefore, the EPA believes
that this action will not have potential disproportionately high and
adverse human health or environmental effects on minority, low-income,
or indigenous populations.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was,
therefore, not submitted to the Office of Management and Budget (OMB)
for review.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is expected to be an Executive Order 13771 deregulatory
action. This proposed rule is expected to provide burden reduction by
reducing the waiting time before certain true minor new and modified
oil and

natural gas sources can begin construction. This streamlined
authorization reduces the resource burden on the permitting authority
and regulated community associated with submitting and reviewing permit
applications for these sources in attainment and unclassifiable areas.

C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the Federal Minor NSR Program in Indian country
rule and has assigned OMB control number 2060-0003.\7\ This action
amends the National O&NG FIP which provides a mechanism for authorizing
construction for true minor sources in the oil and natural gas
production and natural gas processing segments of the oil and natural
gas sector locating or located in areas covered by the Federal Minor
NSR Program in Indian country to satisfy the requirements of that rule
other than by obtaining a site-specific minor source permit. Because it
substitutes for a site-specific permit, which would contain information
collection activities covered by the Information Collection Request for
Federal Minor NSR Program in Indian country rule issued in July 2011,
neither the proposed amendments nor the National O&NG FIP impose any
new obligations or new enforceable duties on any state, local or tribal
government or the private sector.
---------------------------------------------------------------------------

    \7\ Since the Federal Minor NSR Program in Indian country rule
was promulgated, the Information Collection Request (ICR) has been
renewed and approved by OMB twice. The most recent approval extended
the ICR until October 31, 2020. The ICR covers the activities of the
National O&NG FIP. For more information, go to: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201702-2060-005.
---------------------------------------------------------------------------

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, has no
net burden or otherwise has a positive economic effect on the small
entities subject to the rule. The EPA analyzed the impact on small
entities of streamlined permitting under the National O&G FIP and the
Federal Minor NSR Program in Indian country rule \8\ and determined
that it would not have a significant economic impact on a substantial
number of small entities. This action merely modifies the timing to
allow a submission of required documentation at an earlier point in the
regulatory process. We have, therefore, concluded that this action will
have no net regulatory burden for all directly regulated small
entities.
---------------------------------------------------------------------------

    \8\ ``Review of New Sources and Modifications in Indian
Country,'' U.S. Environmental Protection Agency, 76 FR 38748, July
1, 2011, https://www.federalregister.gov/articles/2011/07/01/2011-14981/review-of-new-sources-and-modifications-in-indian-country.
---------------------------------------------------------------------------

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandates, as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal government or the private sector. In material part, it
simply modifies the permissible time-frame for submission of otherwise
required forms to streamline the National O&NG FIP and Federal Minor
NSR Program in Indian country.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It would not
have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action has tribal implications. However, it will neither
impose substantial direct compliance costs on federally recognized
tribal governments, nor preempt tribal law. Consistent with the EPA
Policy on Consultation and Coordination with Indian Tribes (May 4,
2011),\9\ the EPA offered consultation on this proposed action. The EPA
conducted outreach on issues related to the Federal Minor NSR Program
in Indian country and the National O&NG FIP via ongoing monthly
meetings with tribal environmental professionals.\10\
---------------------------------------------------------------------------

    \9\ For more information, go to: https://www.epa.gov/tribal/epa-policy-consultation-and-coordination-indian-tribes.
    \10\ These monthly meetings are general in nature, dealing with
many air-related topics, and are not specific to this proposed
action.
---------------------------------------------------------------------------

    As this amendment, if finalized, is implemented, we will continue
to provide regular outreach to tribes to ensure we address issues
concerning the FIP if and when they arise. The EPA is available for
consultation with any interested tribe.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because the EPA does not believe the environmental health or safety
risks addressed by this action present a disproportionate risk to
children.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes this action does not have potential
disproportionately high and adverse human health or environmental
effects on minority, low-income or indigenous populations. Through this
amendment, we seek to further streamline the process for true minor
sources in the oil and natural gas sector in areas covered by the
Federal Minor NSR Program in Indian country. This action does not
remove any of the prior rules' environmental or procedural protections.

List of Subjects in 40 CFR Part 49

    Environmental protection, Administrative practices and procedures,
Air pollution control, Indians, Indians-law, Indians-tribal government,
Intergovernmental relations, Reporting and recordkeeping requirements.

    Dated: July 3, 2019.
Andrew R. Wheeler,
Administrator.
    For the reasons set forth in the preamble, 40 CFR part 49 is
proposed to be amended as follows:

PART 49--INDIAN COUNTRY: AIR QUALITY PLANNING AND MANAGEMENT

0
1. The authority citation for part 49 continues to read as follows:

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

Subpart C--General Federal Implementation Plan Provisions

0
2. Amend Sec.  49.104 by:
0
a. Revising paragraph (a) introductory text;
0
b. Revising paragraph (a)(2) introductory text;
0
c. Revising paragraph (a)(2)(i) introductory text;
0
d. Revising paragraph (a)(2)(i)(B); and
0
e. Revising paragraph (a)(2)(ii).
    The revisions read as follows:

Sec.  49.104  Requirements regarding threatened or endangered species
and historic properties.

    (a) What are sources required to do to address threatened or
endangered species and historic properties? An owner/operator subject
to the requirements contained in Sec. Sec.  49.101 through 49.105 to
satisfy its obligation under Sec.  49.151(c)(1)(iii)(B) to obtain a
minor NSR permit shall meet either paragraph (a)(1) or (2) of this
section, as appropriate.
    (1) * * *
    (2) Screening procedures completed by the owner/operator. The
owner/operator shall submit to the EPA Regional Office (and to the
relevant tribe for the area where the source is located/locating)
documentation demonstrating that it has completed the required
screening procedures specified for consideration of threatened or
endangered species and historic properties and received written
confirmation from the EPA stating that the owner/operator has
satisfactorily completed these procedures prior to beginning
construction of a new true minor source or minor modification of a true
minor source. The completed screening procedures may be submitted
together with the source's Part 1 Registration Form pursuant to Sec.
49.160(c)(1)(iv). (The procedures are contained in the following
document: ``Procedures to Address Threatened and Endangered Species and
Historic Properties for the Federal Implementation Plan for Managing
Air Emissions from True Minor Sources in Indian Country in the Oil and
Natural Gas Production and Natural Gas Processing Segments of the Oil
and Natural Gas Sector,'' https://www.epa.gov/tribal-air/tribal-minor-new-source-review). Review of your submittal will be conducted by the
EPA Regional Office in accordance with the procedure in paragraphs
(a)(2)(i) and (ii) of this section:
    (i) Within 30 days of receipt of your documentation, by written
notification to you, the EPA Regional Office must provide one of the
following determinations:
    (A) * * *
    (B) The documentation is not adequate, and additional information
is needed. If the initial submittal is deficient, the EPA Regional
Office will note any such deficiencies and may offer further direction
on completing the screening procedures. Once you have addressed the
noted deficiencies, you must resubmit your revised screening procedure
documentation for review. An additional 15-day review notification
period will be used for the EPA Regional Office to determine whether
the listed species and/or historic property screening procedures have
been satisfied. If the EPA Regional Office makes such a determination,
they will send you written notification stating that conclusion.
    (ii) You must obtain written notification from the EPA Regional
Office indicating that the source has adequately completed the
screening procedures. The EPA Regional Office may send written
notification by mail, email, or any other written means of
notification. You may not begin construction under this FIP until the
following two conditions are met: (1) At least 30 days has passed from
the date the Part 1 Registration Form was submitted, and (2) the EPA
Regional Office has provided this notification.
* * * * *
0
3. Amend Sec.  49.160 by revising paragraph (c)(1)(iv) to read as
follows:

Sec.  49.160  Federal Minor New Source Review in Indian Country.

* * * * *
    (c) * * *
    (1) * * *
    (iv) Minor sources complying with Sec. Sec.  49.101 through 49.105
for the oil and natural gas production and natural gas processing
segments of the oil and natural gas sector, as defined in Sec.  49.102,
must submit the Part 1 Registration Form, at least 30 days prior to
beginning construction, that contains the information in paragraph
(c)(2) of this section. The Part 2 Registration Form, including
emissions information, must be submitted within 60 days after the
startup of production as defined in Sec.  49.152(d). The source must
determine the potential for emissions within 30 days after startup of
production. The combination of the Part 1 and Part 2 Registration Forms
submittals satisfies the requirements in paragraph (c)(2) of this
section. The forms are submitted to the EPA instead of the application
form required in paragraph (c)(1)(iii) of this section. The forms are
available at: https://www.epa.gov/tribal-air/tribal-minor-new-source-review or from the EPA Regional Offices.
* * * * *

[FR Doc. 2019-14885 Filed 7-12-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3438-3439]
[FR Doc No: 2016-01103]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0372]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adverse Event
Reporting and Recordkeeping for Dietary Supplements as Required by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act

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
February 22, 2016.

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 0910-0635.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<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.

Adverse Event Reporting and Recordkeeping for Dietary Supplements as
Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act--21 U.S.C. 379aa-1(b)(1) OMB Control Number 0910-0635--
Extension

    The Dietary Supplement and Nonprescription Drug Consumer Protection
Act (the DSNDCPA) (Pub. L. 109-462, 120 Stat. 3469) amends the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) with respect to serious
adverse event reporting and recordkeeping for dietary supplements and
non-prescription drugs marketed without an approved application.
Section 761(b)(1) of the FD&C Act (21 U.S.C. 379aa-1(b)(1)) requires
the manufacturer, packer, or distributor whose name under section
403(e)(1) of the FD&C Act (21 U.S.C. 343(e)(1))) appears on the label
of a dietary supplement marketed in the United States to submit to us
all serious adverse event reports associated with the use of a dietary
supplement, accompanied by a copy of the product label. The
manufacturer, packer, or distributor of a dietary supplement is
required by the DSNDCPA to use the MedWatch Form FDA 3500A when
submitting a serious adverse event report to FDA. In addition, under
section 761(c)(2) of the FD&C Act, the submitter of the serious adverse
event report (referred to in the statute as the ``responsible person'')
is required to submit to FDA a follow-up report of any related new
medical information the responsible person receives within 1 year of
the initial report.
    Section 761(e)(1) of the FD&C Act (21 U.S.C. 379aa-1(e)(1))
requires that responsible persons maintain records related to the
dietary supplement adverse event reports they receive, whether or not
the adverse event is serious. Under the statute, the records must be
retained for a period of 6 years.
    As required by section 3(d)(3) of the DSNDCPA, we issued guidance
to describe the minimum data elements for serious adverse event reports
for dietary supplements. In the Federal Register of July 14, 2009 (74
FR 34024), we announced the availability of guidance entitled
``Guidance for Industry: Questions and Answers Regarding Adverse Event
Reporting and Recordkeeping for Dietary Supplements as Required by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act''.
The guidance discusses how, when, and where to submit serious adverse
event reports for dietary supplements and follow-up reports. The
guidance also provides our recommendation on records maintenance and
access for serious and non-serious adverse event reports, and related
documents.
    The guidance recommends that the responsible person document their
attempts to obtain the minimum data elements for a serious adverse
event report. Along with these records, the guidance recommends that
the responsible person keep the following other records: (1)
Communications between the responsible person and the initial reporter
of the adverse event and

between the responsible person and any other person(s) who provided
information about the adverse event; (2) the responsible person's
serious adverse event report to us with attachments; (3) any new
information about the adverse event received by the responsible person;
(4) any reports to us of new information related to the serious adverse
event report.
    In the Federal Register of October 21, 2015 (80 FR 63797), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
        21 U.S.C. Section           Number  of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 379aa-1(b)(1)--serious             170              17           2,860               2           5,720
 adverse event reports for
 dietary supplements............
21 U.S.C. 379aa-1(c)(2)-- follow-             42              17             715               1             715
 up reports of new medical
 information....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           6,435
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This estimate is based on our experience with similar adverse event
reporting programs and the number of serious adverse event reports and
follow-up reports received in the past 3 years. All dietary supplement
manufacturers, packers, or distributors are subject to serious adverse
event mandatory reporting.
    We received 2,435 initial serious adverse event reports in Fiscal
Year (FY) 2012, 3,414 in FY2013, and 2,745 in FY2014. We averaged these
figures (2,860 rounded to the nearest ten) as a basis for our estimated
number of annual reports. We also used an average of the number of
firms filing reports (170 rounded to the nearest ten). Finally, we
estimate that it will take respondents an average of 2 hours per report
to collect information about a serious adverse event associated with a
dietary supplement and report the information to us on Form FDA 3500A.
Thus, the estimated burden associated with submitting initial dietary
supplement serious adverse event reports is 5,720 hours (2,860
responses x 2 hours) as shown in row 1 of table 1.
    If a respondent that has submitted a serious adverse event report
receives new information related to the serious adverse event within 1
year of submitting the initial report, the respondent must provide the
new information to us in a follow-up report. We estimate that 25
percent of serious adverse event reports related to dietary supplements
will have a follow-up report submitted, resulting in approximately 715
follow-up reports submitted annually (2,860 x 0.25 = 715). Dividing the
annual number of reports among the 170 firms reporting results in
approximately 17 reports for 42 respondents. We estimate that each
follow-up report will require an hour to assemble and submit, including
the time needed to copy and attach the initial serious adverse event
report as recommended in the guidance. Thus the estimated burden for
follow-up reports of new information is 715 hours (715 responses x 1
hour) as shown in row 2 of table 1.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
        21 U.S.C. Section            Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Dietary supplement adverse event           1,700              74         125,800             0.5          62,900
 records (21 U.S.C. 379aa-
 1(e)(1)).......................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    All dietary supplement manufacturers, packers, or distributors are
subject to serious adverse event recordkeeping. We estimate that there
are 1,700 such respondents, based on the figure 1,460 as provided in
our final rule of June 25, 2007 (72 FR 34751), on the Current Good
Manufacturing Practice in Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary Supplements, and factoring a two percent
annual growth rate. Estimating that each recordkeeper will keep
approximately 74 records per year results in an annual burden of
125,800 records. Estimating that assembling and filing these records,
including any necessary photocopying, will take approximately 30
minutes, or 0.5 hours, per record, results in an annual burden of
62,900 hours (125,800 records x 0.50 hours = 62,900 total hours.
    Once the documents pertaining to an adverse event report have been
assembled and filed pursuant to the Safety Reporting Portal, we expect
the records retention burden to be minimal, as we believe most
establishments would normally keep this kind of record for at least
several years after receiving the report, as a matter of usual and
customary business practice.

    Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01103 Filed 1-20-16; 8:45 am]
 BILLING CODE 4164-01-P