[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)]
[Proposed Rules]
[Pages 45550-45551]
[FR Doc No: 2017-20965]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2017-0267; FRL-9968-60-Region 7]

Approval of Implementation Plans; State of Iowa; Elements of
Infrastructure SIP Requirements for the 2010 Sulfur Dioxide National
Ambient Air Quality Standard (NAAQS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve elements of a State Implementation Plan (SIP) submission from
the State of Iowa for the 2010 Sulfur Dioxide (SO2) National
Ambient Air Quality Standard (NAAQS). Infrastructure SIPs address the
applicable requirements of Clean Air Act (CAA) section 110, which
requires that each state adopt and submit a SIP for the implementation,
maintenance, and enforcement of each new or revised NAAQS promulgated
by the EPA. These SIPs are commonly referred to as ``infrastructure''
SIPs. The infrastructure requirements are designed to ensure that the
structural components of each state's air quality management program
are adequate to meet the state's responsibilities under the CAA.
    In the ``Rules and Regulations'' section of this issue of the
Federal Register, we are approving the state's SIP revisions as a
direct final rule without a prior proposed rule. If we receive no
adverse comment, we will not take further action on this proposed rule.

DATES: Comments must be received on or before October 30, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2017-0267, to https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. 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 (i.e., 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 https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Heather Hamilton, Air Planning and
Development Branch, U.S. Environmental Protection Agency, Region 7,
11201 Renner Boulevard, Lenexa, KS 66219 at<PHONE_NUMBER>, or by email
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document proposes to take direct final
action on Iowa's infrastructure SIP submissions for the 2010
SO2 NAAQS. We have published a direct final rule approving
the State's SIP revision (s) in the ``Rules and Regulations'' section
of this issue of the Federal Register, because we view this as a
noncontroversial action and anticipate no relevant adverse comment. We
have explained our reasons for this action in the preamble to the
direct final rule. A detailed Technical Support Document (TSD) is
included in this rulemaking docket to address the following: A
description of Clean Air Act section 110(a)(1) and (2) infrastructure
SIPs; the applicable elements under sections 110(a)(1) and (2); EPA's
approach to the review of infrastructure SIP submissions, and EPA's
evaluation of how Iowa addressed the relevant elements of sections
110(a)(1) and (2). If we receive no adverse comment, we will not take
further action on this proposed rule. If we receive adverse comment, we
will withdraw the direct final rule and it will not take effect. We
would address all public comments in any subsequent final rule based on
this proposed rule. We do not intend to institute a second comment
period on this action. Any parties interested in commenting must do so
at this time. For further information, please see the information
provided in the ADDRESSES section of this document.

 List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Sulfur dioxide, Reporting and
recordkeeping requirements.

    Dated: September 20, 2017.
 Cathy Stepp,
Acting Regional Administrator, Region 7.
[FR Doc. 2017-20965 Filed 9-28-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 72 (Monday, April 17, 2017)]
[Notices]
[Pages 18148-18150]
[FR Doc No: 2017-07667]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1847]

Pharmacy Compounding Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pharmacy Compounding Advisory
Committee (PCAC). The general function of the committee is to provide
advice on scientific, technical, and medical issues concerning drug
compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), and, as required, any other product for which FDA has regulatory
responsibility, and to make appropriate recommendations to the Agency.
The meeting will be open to the public.

DATES: The meeting will be held on May 8, 2017, from 8:30 a.m. to 4:30
p.m. and May 9, 2017, from 8:30 a.m. to 12 noon.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-1847. The docket will close on May 5,
2017. Comments received on or before April 24, 2017, will be provided
to the committee. Comments received after that date will be taken into
consideration by the Agency.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions, including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. You may
submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2017-N-1847 for ``Pharmacy Compounding Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments.''
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 Division of Dockets Management 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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:
301-847-8533, email<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes
the conditions that must be satisfied for human drug products
compounded by a licensed pharmacist in a State licensed pharmacy or a
Federal facility, or licensed physician, to be exempt from the
following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21
U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice
(CGMP)); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the
labeling of drugs with adequate directions for use); and (3) section
505 (21 U.S.C. 355) (concerning the approval of human drug products
under new drug applications (NDAs) or abbreviated new drug applications
(ANDAs)).
    The Drug Quality and Security Act added a new section 503B to the
FD&C Act (21 U.S.C. 353b), which created a new category of compounders
termed ``outsourcing facilities.'' Under section 503B of the FD&C Act,
outsourcing facilities are defined, in part, as facilities that meet
certain conditions described in section 503B, including registration
with FDA as an outsourcing facility. If these conditions are satisfied,
a drug product compounded for human use by or under the direct
supervision of a licensed pharmacist in an outsourcing facility is
exempt from three sections of the FD&C Act: (1) Section 502(f)(1)
(concerning the labeling of drugs with adequate directions for use);
(2) section 505 (concerning the approval of human drug products under
NDAs or ANDAs); and (3) section 582 (21 U.S.C. 360eee-1) (concerning
the drug supply chain security requirements). Outsourcing facilities
are not exempt from CGMP requirements in section 501(a)(2)(B) of the
FD&C Act.
    One of the conditions that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that a bulk drug
substance (active pharmaceutical ingredient) used in a compounded drug
product must meet one of the following criteria: (1) Complies with the
standards of an applicable United States Pharmacopoeia (USP) or
National Formulary monograph, if a monograph exists, and the USP
chapter on pharmacy compounding; (2) if an applicable monograph does
not exist, is a component of a drug approved by the Secretary of Health
and Human Services (the Secretary); or (3) if such a monograph does not
exist and the drug substance is not a component of a drug approved by
the Secretary, appears on a list developed by the Secretary through
regulations issued by the Secretary (the ``503A Bulks List'') (see
section 503A(b)(1)(A)(i) of the FD&C Act).
    Another condition that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that the compounded
drug product is not a drug product identified by the Secretary by
regulation as a drug product that presents demonstrable difficulties
for compounding that reasonably demonstrate an adverse effect on the
safety or effectiveness of that drug product (see section 503A(b)(3)(A)
of the FD&C Act).
    A condition that must be satisfied to qualify for the exemptions in
section 503B of the FD&C Act is that the compounded drug is not
identified (directly or as part of a category of drugs) on a list,
published by the Secretary by regulation after consulting with the
PCAC, of drugs or categories of drugs that present demonstrable
difficulties for compounding that are reasonably likely to lead to an
adverse effect on the safety or effectiveness of the drug or category
of drugs, taking into account the risks and benefits to patients, or
the drug is compounded in accordance with all applicable conditions
identified on the list as conditions that are necessary to prevent the
drug or category of drugs from presenting such demonstrable
difficulties (see section 503B(a)(6)(A) and (B) of the FD&C Act).
    FDA intends to discuss with the committee bulk drug substances
nominated for inclusion on the 503A Bulks List and drug products
nominated for inclusion on the list of drug products that present
demonstrable difficulties for compounding under sections 503A and 503B
(``Difficult to Compound List'').
    Agenda: The committee will receive updates on certain issues to
follow up on discussions from previous meetings, including quality
standards and conditions at certain compounding facilities. In
addition, the committee intends to discuss six bulk drug substances
nominated for inclusion on the section 503A Bulks List. FDA will
discuss the following nominated bulk drug substances: Nicotinamide
adenine dinucleotide, nicotinamide adenine dinucleotide disodium
reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl
sulfate, and artemisinin. The chart below describes which use(s) FDA
reviewed for each of the six bulk drug substances being discussed at
this

advisory committee meeting. The nominators of these substances will be
invited to make a short presentation supporting the nomination.

------------------------------------------------------------------------
                  Drug                           Use(s) reviewed
------------------------------------------------------------------------
Nicotinamide adenine dinucleotide......  Reducing fatigue in multiple
                                          sclerosis.
Nicotinamide adenine dinucleotide        Reduce symptoms of fatigue in
 disodium reduced.                        chronic fatigue syndrome.
Nettle (Urtica dioica) whole plant.....  Glycemic control.
Ubiquinol..............................  Glycemic control.
Vanadyl sulfate........................  Diabetes, hypoglycemia,
                                          hyperlipidemia, heart disease,
                                          preventing cancer.
Artemisinin............................  Malaria, protozoal infections
                                          (particularly toxoplasmosis),
                                          helminthic infections, stomach
                                          ulcers, cancer.
------------------------------------------------------------------------

    The committee also intends to discuss oral solid modified release
drug products that employ coated systems, which were nominated for the
Difficult to Compound List. The nominators will be invited to make a
short presentation supporting the nomination.
    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 meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see the
Addresses section) on or before April 24, 2017, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 10:15 a.m. and 10:25 a.m., 11:35 a.m. and 11:45 a.m.,
1:45 p.m. and 1:55 p.m., 2:50 p.m. and 3 p.m., and 4:10 p.m. and 4:20
p.m. on May 8, 2017, and between approximately 10 a.m. and 10:10 a.m.
and 11:35 a.m. and 11:50 a.m. on May 9, 2017. Those individuals
interested in making 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 April 14, 2017. 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 April 17, 2017.
    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
disabilities. If you require accommodations due to a disability, please
contact Cindy Hong 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: April 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07667 Filed 4-14-17; 8:45 am]
 BILLING CODE 4164-01-P


Tribal NSR Rules Conference Call

January 9, 2007 at 9:00 – 11:00 AM Alaska Time

Call-in number:  1-866-299-3188 ~  Access Code<PHONE_NUMBER>

Agenda

January 9, 2007

9:00 AM  [AK Time]	Welcome & Introductions

9: 15 AM		Purpose of this Rulemaking

9:15 AM		Applicability to Indian country in Alaska

9:30 AM		Overview of Proposal - Highlights

9: 50 AM		Process for submitting comments

10:00AM		Q & A

10:30 AM		Wrap-up and Adjourn

Participants:

Raj Rao, EPA Office of Air Quality Standards and Planning (OAQPS),

Laura McClintock, EPA OAQPS

Rich McAllister, Assistant Regional Counsel, EPA Region 10

Dave Bray, Senior Advisor to Director , Office of Air Waste and Toxics, EPA Region 10

Debra Suzuki, Environmental Engineer, NSR Lead, EPA Region 10

Mary Manous, Team Lead: Tribal Air Program, EPA Region 10


[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30815-30816]
[FR Doc No: 2018-14029]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-26367]

Motor Carrier Safety Advisory Committee (MCSAC); Public Meeting

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of advisory committee meeting.

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SUMMARY: FMCSA announces that its MCSAC will meet on Monday and
Tuesday, July 30-31, 2018.

DATES: The meeting will be held Monday-Tuesday, July 30-31, 2018, from
9:15 a.m. to 4:30 p.m., Eastern Daylight Time (EDT).

ADDRESSES: This meeting will be held at the U.S. Department of
Transportation, Oklahoma City Rooms A, B, and C, 1200 New Jersey Avenue
SE, Washington, DC 20590. Copies of the MCSAC Task Statements and an
agenda for the entire meeting will be made available in advance of the
meeting at https://www.fmcsa.dot.gov/mcsac.

FOR FURTHER INFORMATION CONTACT: Ms. Shannon L. Watson, Senior Advisor
to the Associate Administrator for Policy, Federal Motor Carrier Safety
Administration, U.S. Department of Transportation, at<PHONE_NUMBER>,
or via email at [email protected].
    Services for Individuals with Disabilities: For information on
facilities or services for individuals with disabilities or to request
special assistance at the meeting, contact Ms. Watson by Wednesday,
July 18, 2018.

SUPPLEMENTARY INFORMATION:

I. Background

Purpose of the Committee

    MCSAC was established to provide FMCSA with advice and
recommendations on motor carrier safety programs and motor carrier
safety regulations. MCSAC is composed of up to 20 voting
representatives from safety advocacy, safety enforcement, labor, and
industry stakeholders of motor carrier safety. The diversity of the
Committee ensures the requisite range of views and expertise necessary
to discharge its responsibilities. The Committee operates as a
discretionary committee under the authority of the U.S. Department of
Transportation (DOT), established in accordance with the provisions of
the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. App. 2.
See FMCSA's MCSAC website for additional information about the
committee's activities at https://www.fmcsa.dot.gov/mcsac.

Meeting Agenda

    The MCSAC will complete its deliberations from June 2017 and
provide recommendations to the Agency concerning automated driving
systems (ADS)-equipped commercial motor vehicles (CMVs), the
development of the Agency's fiscal year (FY) 2018-2022 strategic plan,
and the review of the Federal Motor Carrier Safety Regulations (FMCSRs)
to identify potential opportunities to reduce regulatory burdens while
ensuring that Federal safety programs continue to achieve safety
outcomes.

Task 17-1: Automated Driving Systems Equipped CMVs

    On September 12, 2017, the Department published the Automated
Driving Systems (ADS): A Vision for Safety 2.0. (Publication No. DOT HS
812-442, https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/13069a-ads2.0_090617_v9a_tag.pdf) (the Voluntary Guidance). On March 1,
2018, the Secretary convened an Automated Vehicle summit, which
included a Public Listening Summit on Automated Vehicles Policy to seek
input on Automated Vehicles 3.0 (https://www.transportation.gov/AV/avsummit). Automated driving systems (ADS) equipped CMVs are those in
which the vehicle can take full control of the

driving tasks in at least some circumstances. ADS hold enormous
potential benefits for safety, mobility, and the efficiency of our
transportation system.
    The Voluntary Guidance adopts the SAE International (SAE) published
Standard J3016, ``Taxonomy and Definitions for Terms Related to On-Road
Motor Vehicle Automated Driving Systems'' definitions for levels of
automation. The SAE definitions divide vehicles into levels based on
``who does what, when.'' Generally:
     SAE Level 0, No Driving Automation; the driver performs
all driving tasks.
     SAE Level 1, Driver Assistance; the vehicle is controlled
by the driver but some driving assist features may be included in the
vehicle design. SAE Level 2, Partial Driving Automation; the vehicle
has combined automated functions, like acceleration and steering, but
the driver must remain engaged with the driving task and monitor the
environment at all times.
     SAE Level 3, Conditional Driving Automation; the driver is
a necessity but is not required to monitor the environment. The driver
must be ready to take control of the vehicle at all times with notice.
SAE Level 4, High Driving Automation; the vehicle can perform all
driving functions under certain conditions. The driver may have the
option to control the vehicle. SAE Level 5, Full Driving Automation;
the vehicle can perform all driving functions under all conditions.
    Using the SAE levels described above, the Department draws a
distinction between Levels 0-2 and 3-5 based on whether the human
driver or the automated system is primarily responsible for monitoring
the driving environment. The term ``automated vehicle systems''
represents SAE Levels 3-5 vehicles that are responsible for monitoring
the driving environment. For this task, the Agency's primary focus is
SAE Levels 3-5 ADS, as delineated in its Federal Register notice of
March 26, 2018, Request for Comments Concerning FMCSRs Which May Be a
Barrier to the Safe Testing and Deployment of ADS-Equipped CMVs on
Public Roads (https://federalregister.gov/d/2018-05788). The comment
period closed on May 10, 2018.
    Public discussions regarding ADS have become more prominent in
recent months as developers continue efforts to demonstrate and test
the viability of advanced driver assistance systems on large commercial
vehicles. FMCSA encourages the development of these advanced safety
technologies for use on commercial vehicles, while recognizing the need
to work with the States to ensure that, from an operations standpoint,
all testing and use of these advanced safety systems is conducted in a
manner that ensures the safe operation of ADS-equipped CMVs.
    FMCSA tasked the MCSAC in June 2017 with providing recommendations
regarding the framework for considering temporary exemptions that
entities may seek to operate an ADS-equipped CMV on a public roadway.

Task 17-2: FY 2018-2022 Strategic Plan

    FMCSA is drafting a new strategic plan for release in 2018. The new
strategic plan will provide a high-level overview of our mission,
vision, strategic goals and outlook for FY2018-2022 based on
Department's goals for the next several years. The Department released
its Strategic Plan for FY 2018-2022 in February 2018 (https://www.transportation.gov/dot-strategic-plan). The MCSAC has been tasked
with providing feedback on the current FMCSA strategic goals and
objectives and recommendations for additional goals, objectives,
programs, and initiatives that the members believe should be
highlighted in the next strategic plan to align with DOT's plan.

Task 17-3: Regulatory Review

    In June 2017, FMCSA tasked the MCSAC with providing recommendations
to the Agency concerning implementation of Executive Orders 13771,
``Reducing Regulation and Controlling Regulatory Costs'' (82 FR 9339,
February 3, 2017) and 13777, ``Enforcing the Regulatory Reform Agenda''
(82 FR 12285, March 1, 2017). The Agency requests that the MCSAC
identify regulations that it believes to be (1) outdated, unnecessary,
or ineffective or (2) impose costs that exceed benefits. The MCSAC's
recommendations would be based on the members' understanding of the
regulatory requirements, how the rules have been implemented by the
industry and enforcement officials, and crash, injury, and fatality
data. FMCSA will provide technical assistance to the MCSAC members, as
needed.

II. Meeting Participation

    The meeting will be open to the public for its entirety. Oral
comments from the public will be heard throughout the meeting, at the
discretion of the MCSAC chairman and designated federal officer.
Members of the public may submit written comments on the topics to be
considered during the meeting by Wednesday, July 18, 2018, to Federal
Docket Management System (FDMC) Docket Number FMCSA-2006-26367 using
any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, Room W12-140, Washington, DC
20590.
     Hand Delivery: U.S. Department of Transportation, 1200 New
Jersey Avenue SE, West Building, Room W12-140, Washington, DC, between
9 a.m. and 5 p.m., ET Monday through Friday, except Federal holidays.

    Issued on: June 21, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-14029 Filed 6-28-18; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 88, Number 164 (Friday, August 25, 2023)]
[Notices]
[Pages 58282-58284]
[FR Doc No: 2023-18320]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3167]

Notice of Opportunity for Public Comment on Proposal To Withdraw
Approval of New Drug Application for PEPAXTO, Equivalent to 20
Milligrams Base per Vial

AGENCY: Center for Drug Evaluation and Research, Food and Drug
Administration, HHS.

ACTION: Notice of opportunity for public comment.

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

SUMMARY: The Center for Drug Evaluation and Research (CDER) of the Food
and Drug Administration (FDA, the Agency) is proposing to withdraw
approval of PEPAXTO (melphalan flufenamide) for injection, equivalent
to (EQ) 20 milligrams (mg) BASE/VIAL, once every 28 days, new drug
application (NDA) 214383, held by Oncopeptides AB (Oncopeptides). This
notice is intended to provide an opportunity for public comment on
CDER's proposed withdrawal of PEPAXTO, in accordance with the expedited
withdrawal of approval procedures described in the Federal Food, Drug
and Cosmetic Act (FD&C Act).

DATES: Either electronic or written comments on this proposal to
withdraw PEPAXTO must be submitted by September 25, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 25, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2023-N-3167 for ``Notice of Opportunity for Public Comment on
Proposal To Withdraw Approval of New Drug Application for PEPAXTO,
Equivalent to 20 Milligrams Base per Vial.'' 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Anuj Shah, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA approved NDA 214383 for PEPAXTO on February 26, 2021, under the
accelerated approval pathway (section 506(c) of the FD&C Act (21 U.S.C.
356(c)) and 21 CFR part 314, subpart H) for use in combination with
dexamethasone for the treatment of adult patients with relapsed or
refractory multiple myeloma who have received at least four prior lines
of therapy and whose disease is refractory to at least one proteasome
inhibitor, one immunomodulatory drug, and one CD38-directed monoclonal
antibody (triple class refractory).\1\
---------------------------------------------------------------------------

    \1\ Most patients in the United States with relapsed disease
will have been exposed to lenalidomide (an immunomodulatory agent),
a proteasome inhibitor, corticosteroids, and an anti-CD38 monoclonal
antibody after one or two lines of treatment, and retreatment with
previously used agents or agents in the same class of drug can be
effective.
---------------------------------------------------------------------------

    NDA 214383 relied on evidence from Trial OP-106 (ClinicalTrials.gov
NCT number, NCT02963493), also known as HORIZON, a single-arm, open-
label, phase 2 multicenter clinical trial that enrolled patients with
relapsed or refractory multiple myeloma and who received at least two
lines of prior therapy including an immunomodulatory drug and a
proteasome inhibitor. The primary endpoint was overall response rate
(ORR),\2\ as assessed by the investigator.
---------------------------------------------------------------------------

    \2\ ORR was defined as the proportion of patients with a best
confirmed response of stringent complete response, complete
response, very good partial response, or partial response according
to the International Myeloma Working Group Uniform Response
Criteria.
---------------------------------------------------------------------------

    At the time of approval under the accelerated approval pathway, the
applicant was required to conduct an appropriate post-approval study to
verify and describe the clinical benefit of PEPAXTO.\3\ CDER has
determined

withdrawal of approval is warranted because the required post-approval
confirmatory trial failed to verify clinical benefit and because
available evidence demonstrates PEPAXTO is not shown to be safe or
effective under its conditions of use. The Oncologic Drugs Advisory
Committee (ODAC) convened on September 22, 2022, to discuss issues
related to this proposed withdrawal. The ODAC voted 14 to 2 that the
benefit-risk profile of melphalan flufenamide was not favorable for the
currently indicated patient population. For additional background,
please refer to CDER's letter to Oncopeptides Re: Section 506(c)(3)(B)
Notice of Proposed Withdrawal of Approval; PEPAXTO (melphalan
flufenamide) for injection; NDA 214383 (``Notice to Oncopeptides of
Proposed Withdrawal of PEPAXTO'') and CDER's Proposed Withdrawal of
PEPAXTO Decisional Memorandum, available at Docket No. FDA-2023-N-3167,
https://www.regulations.gov.
---------------------------------------------------------------------------

    \3\ Section 506(c)(2)(A)(i) of the FD&C Act (as renumbered by
the Consolidated Appropriations Act of 2023 (Pub. L. 117-328); see
also 21 CFR 314.510.
---------------------------------------------------------------------------

II. Legal Standard for Withdrawal of Approval

    Section 506(c) of the FD&C Act, as amended most recently by the
Consolidated Appropriations Act of 2023 (Pub. L. 117-328), describes
the accelerated approval of new drug applications and the procedures
and authority governing expedited withdrawal of approval. FDA has the
legal authority to use the expedited procedures to withdraw approval of
a product that has received accelerated approval if, among other
reasons, ``a study required to verify and describe the predicted effect
on irreversible morbidity or mortality or other clinical benefit of the
product fails to verify and describe such effect or benefit'' (section
506(c)(3)(A)(ii) of the FD&C Act) or ``other evidence demonstrates that
the product is not shown to be safe or effective under the conditions
of use.'' (section 506(c)(3)(A)(iii) of the FD&C Act.)

III. Explanation for the Proposed Withdrawal

    CDER proposes to withdraw approval of PEPAXTO because the required
confirmatory study, Trial OP-103, also known as OCEAN, failed to verify
clinical benefit and because available evidence demonstrates PEPAXTO is
not shown to be safe or effective under its conditions of use. More
specifically, the results failed to show that PEPAXTO had a significant
effect on the primary endpoint of progression-free survival.
Furthermore, the observed median overall survival was 5.3 months
shorter in the PEPAXTO arm compared to the control arm. After
considering all the available data and the discussion at the ODAC held
in September 2022, CDER recommends withdrawing the accelerated approval
for PEPAXTO. Please refer to CDER's ``Notice to Oncopeptides of
Proposed Withdrawal of PEPAXTO'' and ``Proposed Withdrawal of PEPAXTO
Decisional Memorandum'' for additional explanation.

IV. Opportunity for Public Comment on CDER's Proposal To Withdraw
Approval of PEPAXTO

    In accordance with the expedited withdrawal of approval procedures
described in section 506(c)(3)(B)(ii) and (iii) of the FD&C Act, CDER
is providing an opportunity for public comment on its proposal to
withdraw approval of NDA 214383 (PEPAXTO) through the issuance of a
Federal Register Notice. FDA will consider any such public comments it
receives in making its decision on CDER's proposal to withdraw approval
of NDA 214383 (PEPAXTO) and make available on its website and in the
public docket a summary of such comments and FDA's response to them.

    Dated: August 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18320 Filed 8-24-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Notices]
[Pages 10172-10175]
[FR Doc No: 2020-03464]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0017]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Voluntary National Retail Food Regulatory Program
Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the Voluntary National Retail Food Regulatory Program
Standards.

DATES: Submit either electronic or written comments on the collection
of information by April 21, 2020.

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 April 21, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 21, 2020. 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-2011-N-0017 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Voluntary National Retail Food
Regulatory Program Standards.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice

of the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Voluntary National Retail Food Regulatory Program Standards

OMB Control Number 0910-0621--Extension

    This information collection request supports implementation of
FDA's Voluntary National Retail Food Regulatory Program Standards (the
Program Standards). The Program Standards define nine essential
elements of an effective regulatory program for retail food
establishments, establish basic quality control criteria for each
element, and provide a means of recognition for the State, local,
territorial, tribal and Federal regulatory programs that meet the
Program Standards. The program elements addressed by the Program
Standards are: (1) Regulatory foundation; (2) trained regulatory staff;
(3) inspection program based on Hazard Analysis and Critical Control
Point (HACCP) principles; (4) uniform inspection program, (5) foodborne
illness and food defense preparedness and response; (6) compliance and
enforcement; (7) industry and community relations; (8) program support
and resources; and (9) program assessment. Each standard includes a
list of records needed to document conformance with the standard
(referred to in the Program Standards document as ``quality records'')
and has one or more corresponding forms and worksheets to facilitate
the collection of information needed to assess the retail food
regulatory program against that standard. The respondents are State,
local, territorial, tribal, and potentially other Federal regulatory
agencies. Regulatory agencies may use existing available records or may
choose to develop and use alternate forms and worksheets that capture
the same information.
    In the course of their normal activities, State, local,
territorial, tribal, and Federal regulatory agencies already collect
and keep on file many of the records needed as quality records to
document compliance with each of the Program Standards. Although the
detail and format in which this information is collected and recorded
may vary by jurisdiction, records that are kept as a usual and
customary part of normal Agency activities include inspection records,
written quality assurance procedures, records of quality assurance
checks, staff training certificates and other training records, a log
or database of food-related illness or injury complaints, records of
investigations resulting from such complaints, an inventory of
inspection equipment, records of outside audits, and records of
outreach efforts (e.g., meeting agendas and minutes, documentation of
food safety education activities). No new recordkeeping burden is
associated with these existing records, which are already a part of
usual and customary program recordkeeping activities by State, local,
territorial, tribal and Federal regulatory agencies, and which can
serve as quality records under the Program Standards.
    State, local, territorial, tribal and Federal regulatory agencies
that enroll in the Program Standards and seek listing in the FDA
National Registry are required to report to FDA on the completion of
the following three management tasks outlined in the Program Standards:
(1) Conducting a program self-assessment; (2) conducting a risk factor
study of the regulated industry; and (3) obtaining an independent
outside audit (verification audit). The results are reported on FDA's
website at: https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-november-2019. If a regulatory agency follows all the
recordkeeping recommendations in the individual standards and their
sample worksheets, it will have all the information needed to complete
the reports.
Recordkeeping
    FDA's recordkeeping burden estimate includes time required for a
state, local, territorial, tribal, or Federal agency to review the
instructions in the Program Standards, compile information from
existing sources, and create any records recommended in the Program
Standards that are not already kept in the normal course of the
agency's usual and customary activities. Sample worksheets are provided
to assist in this compilation. In estimating the time needed for the
program self-assessment (Program Standards 1 through 8, shown in table
1), FDA considered responses from four State and three local
jurisdictions that participated in an FDA Program Standards Pilot
study. Table 2 shows the estimated recordkeeping burden for the
completion of the baseline data collection, and table 3 shows the
estimated recordkeeping burden for the verification audit.
    FDA estimates the burden of this collection of information as
follows:

                        Table 1--Self Assessment
------------------------------------------------------------------------
                                                             Hours per
            Standard              Recordkeeping activity      record
------------------------------------------------------------------------
No. 1: Regulatory Foundation...  Self-Assessment:                     16
                                  Completion of
                                  worksheet recording
                                  results of evaluations
                                  and comparison on
                                  worksheets \1\.
No. 2: Trained Regulatory Staff  Self-Assessment:                   19.3
                                  Completion of CFP
                                  Field Training Manual
                                  and Documentation of
                                  Successful Completion--
                                  Field Training
                                  Process; completion of
                                  summary worksheet of
                                  each employee training
                                  records 1 2.
No. 3: HACCP Principles........  Self-Assessment:                      4
                                  Completion of
                                  worksheet
                                  documentation \1\.
No. 4: Uniform Inspection        Self-Assessment:                     19
 Program.                         Completion of
                                  worksheet
                                  documentation of
                                  jurisdiction's quality
                                  assurance procedures 1
                                  2.
No. 5: Foodborne Illness         Self-Assessment:                      5
 Investigation.                   Completion of
                                  worksheet
                                  documentation \1\.
No. 6: Compliance Enforcement..  Self-Assessment:                     19
                                  Selection and review
                                  of 20 to 70
                                  establishment files at
                                  25 minutes per file.
                                  Estimate is based on a
                                  mean number of 45.
                                  Completion of
                                  worksheet \1\.
No. 7: Industry & Community      Self-Assessment:                      2
 Relations.                       Completion of
                                  worksheet \1\.

No. 8: Program Support and       Self-Assessment:                      8
 Resources.                       Selection and review
                                  of establishment files
                                  \1\.
                                                         ---------------
    Total......................  .......................            92.3
------------------------------------------------------------------------
\1\ Or comparable documentation.
\2\ Estimates will vary depending on number of regulated food
  establishments and the number of inspectors employed by the
  jurisdiction.

               Table 2--Risk Factor Study Data Collection
------------------------------------------------------------------------
                                                             Hours per
            Standard              Recordkeeping activity      record
------------------------------------------------------------------------
No. 9: Program Assessment......  Risk Factor Study and               333
                                  Intervention Strategy
                                  \1\.
------------------------------------------------------------------------
\1\ Calculation based on mean sample size of 39 and average FDA
  inspection time for each establishment type. Estimates will vary
  depending on number of regulated food establishments within a
  jurisdiction and the number of inspectors employed by the
  jurisdiction.

                       Table 3--Verification Audit
------------------------------------------------------------------------
                                                             Hours per
            Standard              Recordkeeping activity      record
------------------------------------------------------------------------
Administrative Procedures......  Verification Audit \1\.           46.15
------------------------------------------------------------------------
\1\ We estimate that no more than 50 percent of time spent to complete
  self-assessment of all nine standards is spent completing verification
  audit worksheets. Time will be considerably less if less than nine
  standards require verification audits.

                                                   Table 4--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping for FDA Worksheets \2\...............................             500                1              500            94.29           47,145
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Or comparable documentation.

    FDA bases its estimates of the number of recordkeepers and the
hours per record on its experience with the Program Standards over the
past 16 years. Based upon the level of ongoing support provided by FDA
to enrolled jurisdictions and the number of forms submitted annually,
FDA estimates that no more than 500 jurisdictions actively participate
in the Program Standards during any given year. There are approximately
3,000 jurisdictions in the United States and its territories that have
retail food regulatory programs. Enrollment in the Program Standards is
voluntary and, therefore, FDA does not expect all jurisdictions to
participate.
    FDA bases its estimate of the hours per record on the recordkeeping
estimates for the management tasks of self-assessment, risk factor
study, and verification audit (tables 1, 2, and 3 of this document)
that enrolled jurisdictions must perform a total of 471.45 hours (92.3
+ 333 + 46.15 = 471.45). Enrolled jurisdictions must conduct the work
described in tables 1, 2, and 3 over a 5-year period. Therefore, FDA
estimates that, annually, 500 recordkeepers will spend 94.29 hours
(471.45 / 5 = 94.29) performing the required recordkeeping for a total
of 47,145 hours as shown in table 4.
Reporting
    Form FDA 3958, ``Voluntary National Retail Food Regulatory Program
Standards FDA National Registry Report,'' used for reporting to FDA,
consists of four parts. Part 1 requires the name and address of the
jurisdiction; name and contact information for the contact person for
this jurisdiction; the jurisdiction's website address and if the
jurisdiction is willing to serve as an auditor for another
jurisdiction. Part 2 requires information about enrollment, whether
this jurisdiction is a new enrollee and the date of enrollment;
indication whether this jurisdiction would like to be removed from the
jurisdiction listing; indication of updated findings to the self-
assessment or verification audit. Part 3 requires information about
self-assessment findings and verification audit findings; dates when
self-assessment was completed; which standards have been met as
determined by the self- assessment; which standards have been met as
verified by a verification audit including the completion dates. Part 4
requires permission to publish information on FDA's website by checking
the appropriate box(es) to indicate what information FDA may publish on
the website.
    The reporting burden in table 5 includes only the time necessary to
complete a report, as compiling the underlying information (including
self- assessment reports, Risk Factor Study data collection, outside
audits, and supporting documentation) is accounted for under the
recordkeeping estimates in table 4.
    FDA estimates the reporting burden for this collection of
information as follows:

                                  Table 5--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Submission of ``Voluntary                  500               1             500  0.1 (6 minutes).              50
 National Retail Food
 Regulatory Program Standards
 FDA National Registry
 Report''.
Request for documentation of               500               3           1,500  0.1 (6 minutes).             150
 successful completion of
 staff training.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             200
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA bases its estimates of the number of respondents and the hours
per response on its experience with the Program Standards. As explained
previously in this document, FDA estimates that no more than 500
regulatory jurisdictions will participate in the Program Standards in
any given year. FDA estimates a total of 6 minutes annually for each
enrolled jurisdiction to complete the form. FDA bases its estimate on
the small number of data elements on the form and the ease of
availability of the information. FDA estimates that, annually, 500
regulatory jurisdictions will submit one Form FDA 3598 for a total of
500 annual responses. Each submission is estimated to take 0.1 hour (or
6 minutes) per response for a total of 50 hours. In addition, FDA
estimates that, annually, 500 regulatory jurisdictions will submit
three requests for documentation of successful completion of staff
training using the CFP Training Plan and Log for a total of 1,500
annual responses. Each submission is estimated to take 0.1 hour (or 6
minutes) per response for a total of 150 hours. Thus, the total
reporting burden for this information collection is 200 hours.
    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: February 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03464 Filed 2-20-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: January 20, 2006 (Volume 71, Number 13)]
[Notices]
[Page 3281]
[DOCID:fr20ja06-37]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12481-002]

AMG Energy, LLC; Notice of Surrender of Preliminary Permit

January 12, 2006.
    Take notice that AMG Energy, LLC, permittee for the proposed Selden
Dam Project, has requested that its preliminary permit be terminated.
The permit was issued on April 20, 2004, and would have expired on
March 31, 2007.\1\ The project would have been located on the Black
Warrior River in Greene and Hale Counties, Alabama.
---------------------------------------------------------------------------

    \1\ 107 FERC ] 62,053.
---------------------------------------------------------------------------

    The permittee filed the request on December 7, 2005, and the
preliminary permit for Project No. 12481 shall remain in effect through
the thirtieth day after issuance of this notice unless that day is a
Saturday, Sunday, part-day holiday that affects the Commission, or
legal holiday as described in section 18 CFR 385.2007, in which case
the effective date is the first business day following that day. New
applications involving this project site, to the extent provided for
under 18 CFR Part 4, may be filed on the next business day.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-598 Filed 1-19-06; 8:45 am]

BILLING CODE 6717-01-P