[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Rules and Regulations]
[Pages 41824-41826]
[FR Doc No: 2023-13714]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2023-0482]

Safety Zone; Northern California and Lake Tahoe Area Annual
Fireworks Events

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce numerous safety zones within the
San Francisco Captain of the Port area of responsibility during the
dates and times specified below. This action is necessary to protect
personnel, vessels, and the marine environment from the hazards
associated with the fireworks displays. During the enforcement period,
unauthorized persons or vessels are prohibited from entering into,
transiting through, or remaining in the regulated areas, unless
authorized by the Patrol Commander (PATCOM) or an Official Patrol
including any Federal, State, or local law enforcement agencies on
scene to assist the Coast Guard in enforcing the regulated area.

DATES: The regulations in 33 CFR 165.1191 will be enforced for the
locations identified in Items 3, 4, 7, 9, 10, 11, 12, 14, 16, 18, and
31 of Table 1 to Sec.  165.1191 during the dates and times identified
in the SUPPLEMENTARY INFORMATION section below.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email Petty Officer First Class
Shannon Curtaz-Milian, Waterways Management, U.S. Coast Guard Sector
San Francisco; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones established in 33 CFR 165.1191, Table 1, Item numbers 3, 4, 7, 9,
10, 11, 12, 14, 16, 18, and 31 during the dates, times, and locations
indicated in the table below. The dates, times, and locations will also
be published in the Local Notice to Mariners at least 10 days prior to
the date of each event.

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

------------------------------------------------------------------------
               3. Fourth of July Fireworks, City of Eureka
------------------------------------------------------------------------
Sponsor...........................  City of Eureka, CA.
Event Description.................  Fireworks Display.
Date..............................  July 3, 2023 and July 4, 2023.
Time..............................  From 8 a.m. on July 3, 2023 to 9:45
                                     p.m. on July 4, 2023, the barge
                                     will load, transit, and stage at
                                     the display location. From 9:45
                                     p.m. until approximately 10:55 p.m.
                                     on July 4, 2023, the safety zone
                                     will encompass all navigable waters
                                     within a 1,000-foot radius of the
                                     fireworks barge.
Location..........................  Humboldt Bay, CA.
Regulated Area....................  100-foot radius around the fireworks
                                     launch barge during the loading of
                                     pyrotechnics aboard the fireworks
                                     barge and during the transit of the
                                     fireworks barge from the loading
                                     location to the display location.
                                     Increases to a 1,000-foot radius
                                     upon commencement of the fireworks
                                     display.
------------------------------------------------------------------------
               4. Fourth of July Fireworks, Crescent City
------------------------------------------------------------------------
Sponsor...........................  Crescent City, CA.
Event Description.................  Fireworks Display.
Date..............................  July 4, 2023.
Time..............................  From 9:30 p.m. until approximately
                                     10:20 p.m. on July 4, 2023.
Location..........................  Crescent City Harbor, Crescent City,
                                     CA.
Regulated Area....................  Crescent City Harbor in the
                                     navigable waters within a 700-foot
                                     radius of the launch platform
                                     located on the West Jetty.
------------------------------------------------------------------------
               7. San Francisco Independence Day Fireworks
------------------------------------------------------------------------
Sponsor...........................  The City of San Francisco.
Event Description.................  Fireworks Display.
Date..............................  July 4, 2023.
Time..............................  From 10 a.m. on July 2, 2023, to
                                     9:25 p.m. on July 4, 2023 the
                                     barges will load, transit, and
                                     stage at the display location. From
                                     9:25 p.m. until approximately 10:30
                                     p.m. on July 4, 2023, the safety
                                     zone will encompass all navigable
                                     waters within a 1000-foot radius of
                                     the fireworks barges.
Location 1........................  A barge located approximately 1,000
                                     feet off San Francisco Pier 39.
Location 2........................  A barge located approximately 700
                                     feet off the San Francisco
                                     Municipal Pier at Aquatic Park.
Regulated Area....................  100-foot radius around each
                                     fireworks barge during the loading,
                                     transit, setup, and until the
                                     commencement of the scheduled
                                     display. Increases to a 1,000-foot
                                     radius upon commencement of the
                                     fireworks display.
------------------------------------------------------------------------
              9. Fourth of July Fireworks, City of Richmond
------------------------------------------------------------------------
Sponsor...........................  Various Sponsors.
Event Description.................  Fireworks Display.
Date..............................  July 3, 2023.
Location..........................  A barge located in the Richmond
                                     Harbor in Richmond, CA.
Time..............................  From 9 a.m. on July 3, 2023 to 9:15
                                     p.m. on July 3, 2023, the barge
                                     will load, transit, and stage at
                                     the display location. From 9:15
                                     p.m. until approximately 10 p.m. on
                                     July 3, 2023, the safety zone will
                                     encompass all navigable waters
                                     within a 560-foot radius of the
                                     fireworks barge.
Regulated Area....................  100-foot radius around the fireworks
                                     barge during the loading, transit,
                                     setup, and until the commencement
                                     of the scheduled display. Increases
                                     to a 560-foot radius upon
                                     commencement of the fireworks
                                     display.
------------------------------------------------------------------------
             10. Fourth of July Fireworks, City of Sausalito
------------------------------------------------------------------------
Sponsor...........................  City of Sausalito.
Event Description.................  Fireworks Display.
Date..............................  July 4, 2023.
Time..............................  From 9 a.m. on July 4, 2023 to 9:15
                                     p.m. on July 4, 2023, the barge
                                     will load, transit, and stage at
                                     the display location. From 9:15
                                     p.m. until approximately 10:20 p.m.
                                     on July 4, 2023, the safety zone
                                     will encompass all navigable waters
                                     within a 1,000-foot radius of the
                                     fireworks barge.
Location..........................  1,000 feet offshore from Sausalito,
                                     CA waterfront, north of Spinnaker
                                     Restaurant.
Regulated Area....................  100-foot radius around the fireworks
                                     launch barge during the loading of
                                     pyrotechnics aboard the fireworks
                                     barge and during the transit of the
                                     fireworks barge from the loading
                                     location to the display location.
                                     Increases to a 1,000-foot radius
                                     upon commencement of the fireworks
                                     display.
------------------------------------------------------------------------
             11. Fourth of July Fireworks, City of Martinez
------------------------------------------------------------------------
Sponsor...........................  City of Martinez.
Event Description.................  Fireworks Display.
Date..............................  July 4, 2023.
Time..............................  From 9:30 p.m. until approximately
                                     9:50 p.m. on July 4, 2023.
Location..........................  Carquinez Strait, CA.
Regulated Area....................  The area of navigable waters within
                                     a 560-foot radius of the launch
                                     platform located near Waterfront
                                     Park.
------------------------------------------------------------------------
              12. Fourth of July Fireworks, City of Antioch
------------------------------------------------------------------------
Sponsor...........................  City of Antioch.
Event Description.................  Fireworks Display.
Date..............................  July 4, 2023.

Time..............................  From 9 a.m. to 8:45 p.m. on July 4,
                                     2023, the barge will load, transit,
                                     and stage at the display location.
                                     From 8:45 p.m. until approximately
                                     9:50 p.m. on July 4, 2023, the
                                     safety zone will encompass all
                                     navigable waters within a 1,000-
                                     foot radius of the fireworks barge.
Location..........................  San Joaquin River, CA.
Regulated Area....................  100-foot radius around the fireworks
                                     launch barge during the loading of
                                     pyrotechnics aboard the fireworks
                                     barge and during the transit of the
                                     fireworks barge from the loading
                                     location to the display location.
                                     Increases to a 1,000-foot radius
                                     upon commencement of the moving
                                     fireworks display.
------------------------------------------------------------------------
            14. Delta Independence Day Celebration Fireworks
------------------------------------------------------------------------
Sponsor...........................  Various Sponsors.
Event Description.................  Fireworks Display.
Date..............................  July 3, 2023.
Time..............................  From 8 a.m. on July 3, 2023 until
                                     9:15 p.m. on July 3, 2023, the
                                     barge will load, transit, and stage
                                     at the display location. From 9:15
                                     p.m. until approximately 10 p.m. on
                                     July 3, 2023, the safety zone will
                                     encompass all navigable waters
                                     within a 1,000-foot radius of the
                                     fireworks barge.
Location..........................  San Joaquin River, near Mandeville
                                     Island, CA.
Regulated Area....................  100-foot radius around the fireworks
                                     launch barge during the loading of
                                     pyrotechnics aboard the fireworks
                                     barge and during the transit of the
                                     fireworks barge from the loading
                                     location to the display location.
                                     Increases to a 1,000-foot radius
                                     upon commencement of the fireworks
                                     display.
------------------------------------------------------------------------
               16. Fourth of July Fireworks, Glenbrook NV
------------------------------------------------------------------------
Sponsor...........................  Various Sponsors.
Event Description.................  Fireworks Display.
Date..............................  July 4, 2023.
Time..............................  From 9 a.m. to 9:15 p.m. on July 4,
                                     2023, the barge will load, transit,
                                     and stage at the display location.
                                     From 9:15 p.m. until approximately
                                     10:20 p.m. on July 4, 2023, the
                                     safety zone will encompass all
                                     navigable waters within a 1,000-
                                     foot radius of the fireworks barge.
Location..........................  Offshore Glenbrook Beach, NV.
Regulated Area....................  100-foot radius around the fireworks
                                     launch barge during the loading of
                                     pyrotechnics aboard the fireworks
                                     barge and during the transit of the
                                     fireworks barge from the loading
                                     location to the display location.
                                     Increases to a 1,000-foot radius
                                     upon commencement of the fireworks
                                     display.
------------------------------------------------------------------------
  18. Lights on the Lake Fourth of July Fireworks, South Lake Tahoe, CA
------------------------------------------------------------------------
Sponsor...........................  Various Sponsors.
Event Description.................  Fireworks Display.
Date..............................  July 1, 2023 through July 4, 2023.
Time..............................  From 7 a.m. on July 1, 2023 till
                                     9:30 p.m. on July 4, 2023, the
                                     barges will load, transit, and
                                     stage at the display location. From
                                     9:30 p.m. until approximately 10:30
                                     p.m. on July 4, 2023, the safety
                                     zone will encompass all navigable
                                     waters within a 1,000-foot radius
                                     of the fireworks barges.
Location..........................  Off South Lake Tahoe, CA near the NV
                                     Border.
Regulated Area....................  100-foot radius around the fireworks
                                     launch barge during the loading of
                                     pyrotechnics aboard the fireworks
                                     barge and during the transit of the
                                     fireworks barge from the loading
                                     location to the display location.
                                     Increases to a 1,000-foot radius
                                     upon commencement of the fireworks
                                     display.
------------------------------------------------------------------------
                  31. Benicia Fourth of July Fireworks
------------------------------------------------------------------------
Sponsor...........................  City of Benicia, CA.
Event Description.................  Fireworks Display.
Date..............................  July 4, 2023.
Time..............................  From 9:30 p.m. until approximately
                                     9:50 p.m. on July 4, 2023.
Location..........................  Carquinez Strait, Benicia, CA.
Regulated Area....................  1,000-foot radius around the
                                     fireworks launch site located on
                                     the Benicia First Street Pier.
------------------------------------------------------------------------

    Under the provisions of 33 CFR 165.1191, unauthorized persons or
vessels are prohibited from anchoring, blocking, loitering, or impeding
the through transit of participants or official patrol vessels in the
safety zone during all applicable effective dates and times, unless
authorized to do so by the PATCOM or other Official Patrol, defined as
a Federal, State, or local law enforcement agency on scene to assist
the Coast Guard in enforcing the safety zone. During the enforcement
periods, if you are the operator of a vessel in one of the safety
zones, you must comply directions from the Patrol Commander or other
Official Patrol. The PATCOM or Official Patrol may, upon request, allow
the transit of commercial vessels through regulated areas when it is
safe to do so.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard plans to provide notification of this enforcement
period via the Local Notice to Mariners.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

    Dated: June 21, 2023.
Jordan M. Baldueza,
Captain, U.S. Coast Guard, Alternate Captain of the Port, San
Francisco.
[FR Doc. 2023-13714 Filed 6-27-23; 8:45 am]
BILLING CODE P


[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Notices]
[Pages 67325-67326]
[FR Doc No: 2018-28231]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2009-0973]

Random Drug Testing Rate for Covered Crewmembers for 2019

AGENCY: Coast Guard, DHS.

ACTION: Notice of minimum random drug testing rate.

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SUMMARY: The Coast Guard has set the calendar year 2019 minimum random
drug testing rate at 50 percent of covered crewmembers.

DATES: The minimum random drug testing rate is effective January 1,
2019 through December 31, 2019.

FOR FURTHER INFORMATION CONTACT: For questions about this notice,
please contact Mr. Patrick Mannion, Drug and Alcohol Prevention and
Investigation Program Manager, Office of Investigations and Casualty
Analysis (CG-INV), U.S. Coast Guard Headquarters<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard requires marine employers to
establish random drug testing programs for covered crewmembers in
accordance with 46 CFR 16.230. Every marine employer is required by 46
CFR 16.500 to collect and maintain a record of drug testing data for
each calendar year, and submit this data by 15 March of the following
year to the Coast Guard in an annual MIS report.
    Each year, the Coast Guard will publish a notice reporting the
results of random drug testing for the previous calendar year's MIS
data and the minimum annual percentage rate for random drug testing for
the next calendar year. The purpose of setting a minimum random drug
testing rate is to promote maritime safety by establishing an effective
deterrent to drug misuse within the maritime workforce. Intoxicated
operations poses a serious threat to life, property and the environment
in the maritime commons. As such, the minimum random drug testing rate
is intended to deter and detect illegal drug misuse in the maritime
industry.
    The Coast Guard announces that the minimum random drug testing rate
for calendar year 2019 is 50 percent. The Coast Guard has increased the
minimum random drug testing rate for 2019 as a result of MIS data for
the most recent reporting year indicating that the positive rate is
greater than one percent. 46 CFR part 16.230(f)(2) requires the
Commandant to set the minimum random drug testing rate at 50 percent
when the positivity rate for drug use is greater than 1 percent.
    For 2019, the minimum random drug testing rate will be 50 percent
of covered employees for the period of January 1,

2019 through December 31, 2019 in accordance with 46 CFR 16.230(e).

    Dated: December 19, 2018.
Jennifer F. Williams,
Captain, U.S. Coast Guard, Director of Inspections and Compliance.
[FR Doc. 2018-28231 Filed 12-27-18; 8:45 am]
 BILLING CODE 9110-04-P


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

General Comment:?  U.S. DOT/FAA - Regulatory Evaluation Form
?  Foreign Airworthiness Directive - Mandatory Continuing Airworthiness Information (MCAI)
?  U.S. DOT/FAA - Notice of proposed rulemaking
?  U.S. DOT/FAA - Notice of proposed rulemaking grid


[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Rules and Regulations]
[Pages 78500-78507]
[FR Doc No: 2016-26912]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. FDA-2011-N-0697]
RIN 0910-AG26

Amendments to Regulations on Citizen Petitions, Petitions for
Stay of Action, and Submission of Documents to Dockets

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
amending certain regulations relating to citizen petitions, petitions
for stay of action (PSAs), and the submission of documents to the
Agency. In particular, the final rule establishes new regulations to
implement certain provisions of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), which concern certain citizen petitions and PSAs
that involve a request for FDA to take any form of action relating to a
pending abbreviated new drug application (ANDA), 505(b)(2) application,
or certain applications submitted under the Public Health Service Act
(PHS Act). We are making these changes to implement provisions of the
Food and Drug Administration Amendments Act of 2007 (FDAAA) and the
Food and Drug Administration Safety and Innovation Act (FDASIA).

DATES: This rule is effective January 9, 2017.

ADDRESSES: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number (FDA-2011-N-0697) 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: Darren Eicken, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD, 20993-0002, 240-
402-0978.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
I. Background
II. Overview of the Final Rule, Including Significant Changes to the
Proposed Rule
    A. Overview
    B. Significant Changes to the Proposed Rule
III. Comments on the Proposed Rule and FDA Responses
    A. Introduction
    B. Scope of the Proposed Rule (Sec.  10.31)
    C. Certification and Verification Requirements
    D. Nonretroactivity of the Rule
    E. Additional Comments
IV. Legal Authority
V. Analysis of Environmental Impact
VI. Economic Analysis of Impacts
    A. Introduction and Summary
    B. Summary of Final Regulatory Impacts Analysis
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. References

Executive Summary

Purpose of the Rule

    This rule establishes new regulations implementing section 505(q)
of the FD&C Act (21 U.S.C. 355(q)) as enacted by FDAAA (Pub. L. 110-85)
and amended by FDASIA (Pub. L. 112-144). Section 505(q) of the FD&C Act
governs the manner in which FDA handles certain citizen petitions and
PSAs that ask the Agency to take any form of action related to an ANDA,
a 505(b)(2) application, or an application submitted under section
351(k) of the PHS Act (351(k) application) (42 U.S.C. 262(k)). Section
505(q) of the FD&C Act specifies that FDA must not delay approval of a
pending application because of any request to take any form of action
relating to the application, unless the request is in writing and in a
citizen petition or a PSA, and the Agency determines, upon reviewing
the petition, that a delay is necessary to protect the public health.
Section 505(q) of the FD&C Act also requires that all submitters of a
petition (or PSA) include with their submission a verbatim
certification statement specifying the date on which the information
relied on in the petition first became known. Similarly, section 505(q)
of the FD&C Act requires that the submitters of a supplement or a
comment to a petition include with their submission a verbatim
verification statement specifying the date on which the information
relied on in their submission first became known. By enacting section
505(q) of the FD&C Act, Congress indicated a desire to ensure that
petitions not be used to improperly delay approval of ANDAs, 505(b)(2)
applications, or 351(k) applications. This rule clarifies the
requirements of section 505(q) of the FD&C Act.

Summary of the Major Provisions of the Rule

    This rule amends FDA's regulations on general administrative
procedures in part 10 (21 CFR part 10).

    In Sec.  10.31, paragraph (a) states that Sec.  10.31 applies to
all citizen petitions and PSAs that request that the Agency take any
action that could, if taken, delay approval of an ANDA, a 505(b)(2)
application, or a 351(k) application (i.e., petitions and PSAs that are
or may be subject to section 505(q) of the FD&C Act). Section 10.31(b)
clarifies that the date of submission for petitions submitted under
Sec.  10.31 is the date on which the petition is received by FDA's
Division of Dockets Management.
    The rule also codifies the certification and verification
requirements of section 505(q) of the FD&C Act. Section 10.31(c)
clarifies that the Agency will consider a certification deficient if
every word in the petitioner's certification does not match every word
of the certification provided in section 505(q)(1)(H) of the FD&C Act.
Likewise, Sec.  10.31(d) clarifies that the Agency will consider the
verification deficient if every word in the petitioner's or commenter's
verification does not match every word of the verification provided in
section 505(q)(1)(I) of the FD&C Act. However, because we believe
section 505(q)(1)(I) of the FD&C Act contains a technical error when it
specifies the word ``petition'' in the last sentence of the
verification, we will accept either the word ``petition'' or
``document'' in the last sentence of the petitioner's or commenter's
verification.
    The rule also amends Sec. Sec.  10.30 and 10.35. Section
10.30(e)(5) states that FDA intends to respond to a petition subject to
section 505(q) of the FD&C Act within 150 days after the date on which
the petition is received. This amendment incorporates a statutory
change enacted by FDASIA. In addition, Sec.  10.35(i) clarifies that a
petitioner requesting a stay of action may supplement, amend, or
withdraw a PSA, similar to the provision for citizen petitions in
current Sec.  10.30(g). Finally, Sec. Sec.  10.30(e)(3) and 10.35(e)
are amended to reflect that the Commissioner of Food and Drugs (the
Commissioner) may dismiss a petition if changes in law, facts, or
circumstances since the date on which the petition was submitted render
the petition moot.

Costs and Benefits

    We estimate one-time costs to industry from this rule at about
$613,800. We estimate annual costs at about $1,700. These costs equate
to an estimated total annualized cost of about $89,100 at a 7 percent
discount rate over 10 years and about $73,700 at a 3 percent discount
rate over 10 years. The total annualized costs include the
administrative cost to review the rule ($87,400) plus the cost for the
additional effort preparing certifications for petitions and
verifications for both responses to petitions and supplements to
petitions ($1,700).
    By providing additional clarity on the statutory requirements, we
expect the rule will slightly reduce the number of deficient 505(q)
petitions, leading to lower administrative costs for both industry and
FDA.

I. Background

    In the Federal Register of January 3, 2012 (77 FR 25), FDA issued a
proposed rule to amend certain regulations relating to citizen
petitions, PSAs, and the submission of documents to the Agency, to
implement provisions of section 505(q) of the FD&C Act. Section 505(q)
of the FD&C Act governs certain citizen petitions and PSAs
(collectively referred to as petitions) that ask FDA to take any form
of action that could, if taken, delay approval of a pending application
submitted under section 505(b)(2) or (j) of the FD&C Act or a pending
application for licensure of a biological product as a biosimilar or
interchangeable product that is submitted under section 351(k) of the
PHS Act. An application submitted under section 505(b)(2) of the FD&C
Act is a type of new drug application (NDA) described in that
subsection and is referred to in this document as a ``505(b)(2)
application.'' An application submitted under section 505(j) of the
FD&C Act is an ANDA seeking approval for a generic drug product. An
application submitted under section 351(k) of the PHS Act is referred
to in this document as a ``351(k) application.''
    Over the years, FDA has received numerous petitions asking the
Agency not to approve a particular ANDA or 505(b)(2) application (or
classes of these applications concerning a particular drug product or
active ingredient) unless certain criteria set forth in the petition
are met. In many cases, the petitions have raised scientific and/or
legal issues relating to the standards for approval of an application.
Examples include petitions suggesting a particular method for
demonstrating the bioequivalence of a proposed generic product to the
reference listed drug (RLD) and petitions maintaining that a proposed
generic product does not contain the same active ingredient as the RLD.
When submitted early, such as when we are making decisions about the
bioequivalence requirements for a generic drug product or before we
have received the first ANDA, 505(b)(2) application, or 351(k)
application for a drug or biological product, a petition may contain
information that can contribute towards our evaluation of an
application. However, when petitions are submitted late in the review
process for challenged applications and do not raise valid scientific
and/or legal issues, they may have the effect of improperly delaying
the approval of an application. By enacting section 505(q) of the FD&C
Act, Congress indicated a desire to ensure that petitions not be used
to improperly delay approval of ANDAs, 505(b)(2) applications, or
351(k) applications.
    Scope of section 505(q) of the FD&C Act: FDAAA was enacted on
September 27, 2007. Section 914 of Title IX of FDAAA added section
505(q) to the FD&C Act. Section 505(q) of the FD&C Act was subsequently
amended by FDASIA on July 9, 2012.
    Section 505(q)(1)(A) of the FD&C Act specifies that FDA must not
delay approval of a pending ANDA, a 505(b)(2) application, or a 351(k)
application because of any request to take any form of action relating
to the application, unless the request is in writing and in a citizen
petition submitted under Sec.  10.30 or a PSA submitted under Sec.
10.35, and the Agency determines, upon reviewing the petition, that a
delay is necessary to protect the public health. In section 505(q)(5)
of the FD&C Act the term application is defined as an application
submitted under section 505(b)(2) or 505(j) of the FD&C Act or 351(k)
of the PHS Act and the term petition is defined as a request defined in
section 505(q)(1)(A)(i).
    Section 505(q)(1)(B) of the FD&C Act states in this context that if
FDA determines that a delay of approval of an ANDA, a 505(b)(2)
application, or a 351(k) application is necessary to protect the public
health, FDA is required to provide to the applicant not later than 30
days after making the determination (1) notification that the
determination has been made; (2) if applicable, any clarification or
additional data that the applicant should submit to the petition docket
to allow FDA to review the petition promptly; and (3) a brief summary
of the specific substantive issues raised in the petition that form the
basis of FDA's determination. At FDA's discretion, the information is
to be conveyed either in writing or in a meeting with the applicant.
The information conveyed in the notification is to be considered part
of the application and is subject to the disclosure requirements
applicable to information in the application.
    Section 505(q)(1)(F) of the FD&C Act governs the timeframe for
final Agency action on a petition. Under this provision, FDA must take
final Agency action on a petition not later than 150

days after the date on which the petition is submitted. The 150-day
period is not to be extended for any reason, including any
determination made under section 505(q)(1)(A) of the FD&C Act regarding
delay of approval of an application (i.e., that delay is necessary to
protect the public health), the submission of comments or supplemental
information, or the consent of the petitioner. In addition, FDA may
deny a petition at any point if it determines that a petition or a
supplement to the petition was submitted with the primary purpose of
delaying the approval of an application and the petition does not on
its face raise valid scientific or regulatory issues (section
505(q)(1)(E) of the FD&C Act).
    Section 505(q) of the FD&C Act also includes certification and
verification requirements for certain documents. Under section
505(q)(1)(H) of the FD&C Act, FDA may not consider a petition for
review unless the petition is in writing and is signed and contains a
certification that is specified in that section. Section 505(q)(1)(H)
of the FD&C Act sets forth the exact words to be used in the
certification. In addition, FDA may not accept for review any
supplemental information or comments on a petition unless the
submission is in writing and is signed and contains a specific
verification. Section 505(q)(1)(I) of the FD&C Act sets forth the exact
words to be used in the verification.
    Section 505(q)(2) of the FD&C Act governs judicial review of final
Agency action on a petition subject to section 505(q). Under section
505(q)(2)(A) of the FD&C Act, FDA will be considered to have taken
final Agency action on a petition if FDA makes a final decision within
the meaning of Sec.  10.45(d) during the 150-day period, or the 150-day
period expires without FDA having made a final decision. Under section
505(q)(2)(B) of the FD&C Act, if a civil action is filed against the
Secretary with respect to any issues raised in the petition before
final Agency action, a court shall dismiss the action without prejudice
for failure to exhaust administrative remedies. Section 505(q)(2) of
the FD&C Act, however, does not apply to a petition containing requests
relating to a 351(k) application.

II. Overview of the Final Rule, Including Significant Changes to the
Proposed Rule

A. Overview

    In this rulemaking, the Agency finalizes the provisions outlined in
the January 2012 proposed rule. In addition, the final rule
incorporates changes enacted by FDASIA and responds to comments made to
the proposed rule. FDA also is making editorial and organizational
changes to clarify provisions. The final rule amends part 10 of FDA
regulations on general administrative procedures. The amendment adds
Sec.  10.31, which includes the following provisions:
     Section10.31(a) states that Sec.  10.31 will encompass all
citizen petitions and PSAs that request that the Agency take any action
that could, if taken, delay approval of an ANDA, a 505(b)(2)
application, or a 351(k) application (i.e., petitions and PSAs that are
or may be subject to section 505(q) of the FD&C Act).
     Section 10.31(b) clarifies the date of submission for
petitions submitted under Sec.  10.31.
     Section 10.31(c) and (d) codify the certification and
verification requirements of section 505(q)(1)(H) and (I) of the FD&C
Act. Section 10.31(c) clarifies that the Agency will consider a
certification deficient if every word in the petitioner's certification
does not match every word of the certification provided in section
505(q)(1)(H) of the FD&C Act. Likewise, Sec.  10.31(d) clarifies that
the Agency will consider the verification deficient if every word in
the petitioner's or commenter's verification does not match every word
of the verification provided in section 505(q)(1)(I) of the FD&C Act.
As discussed in section II.B.4 of the preamble to the proposed rule, we
are making one minor editorial change to the language of the
verification set out in the statute. We are changing ``I verify under
penalty of perjury that the foregoing is true and correct as of the
date of this petition'' to ``I verify under penalty of perjury that the
foregoing is true and correct as of the date of this document''
(emphasis added). Because the statute specifies the word ``petition'',
we will accept either ``petition'' or ``document'' in the last sentence
of the verification. In addition, section 505(q) of the FD&C Act
requires both the certification and verification to be signed and
executed under penalty of perjury. FDA interprets the signature
provision to require a handwritten or electronic signature by the
person whose name appears as the signatory to the petition, supplement,
or comment. If the certification or verification is signed by another
person with the notation ``for,'' signature/[initials], ``on behalf
of,'' or with similar notation that indicates one person signed for
another, we will consider the certification or verification to be
deficient and will not consider the petition for review.
    The final rule amends Sec. Sec.  10.20, 10.30, and 10.35 as
follows:
     Adds Sec.  10.30(e)(5) to incorporate a statutory change
enacted by FDASIA. New Sec.  10.30(e)(5) states that FDA intends to
respond to a petition subject to section 505(q) of the FD&C Act within
150 days after the date on which the petition is received.
     Revises Sec.  10.30(e)(2) to conform with the addition of
Sec.  10.30(e)(5).
     Makes minor revisions to Sec. Sec.  10.20 and 10.30 to
conform to the addition of Sec.  10.31.
     With respect to Sec.  10.35, administrative stay of
action, makes revisions to conform with the implementation of section
505(q) of the FD&C Act. The final rule also adds new Sec.  10.35(i) to
clarify that a petitioner requesting a stay of action may supplement,
amend, or withdraw a PSA, similar to the provision for citizen
petitions in current Sec.  10.30(g).
    In addition to implementing the provisions in section 505(q) of the
FD&C Act, the final rule makes minor technical changes by revising
Sec. Sec.  10.30(e)(3) and 10.35(e) to allow the Commissioner to
dismiss a petition if changes in law, facts, or circumstances since the
date on which the petition was submitted render the petition moot.

B. Significant Changes to the Proposed Rule

    The final rule reflects revisions to the proposed rule in response
to the enactment of FDASIA. Section 1135 of FDASIA amended section
505(q) of the FD&C Act in several ways. First, it shortened from 180
days to 150 days FDA's deadline for responding to petitions subject to
section 505(q) of the FD&C Act. Second, it expanded the scope of
section 505(q) of the FD&C Act to include certain petitions related to
351(k) applications. Lastly, FDASIA also added section 505(q)(4)(B) of
the FD&C Act, which excludes such petitions from section 505(q)(2).
    Accordingly, the final rule includes the following changes to the
proposed rule:
     Adds Sec.  10.30(e)(5) and revises Sec.  10.30(e)(2) to
reflect FDA's 150-day deadline for responding to petitions subject to
section 505(q) of the FD&C Act.
     Revises Sec.  10.31(a)(1) to reflect the applicability of
section 505(q) of the FD&C Act to 351(k) applications.
    These changes conform the final rule to reflect amendments to
section 505(q) of the FD&C Act enacted by FDASIA that became law after
publication of the proposed rule.

III. Comments on the Proposed Rule and FDA Responses

A. Introduction

    We received one submission containing several comments from the
Pharmaceutical Research and Manufacturers of America (PhRMA). These
comments primarily focused on the scope of proposed Sec.  10.31 and the
certification and verification requirements. PhRMA also raised several
issues we deemed outside the scope of the proposed rule. In the
discussion that follows, we address the comments.
    We describe and respond to the comments in sections III.B through
III.E. We have numbered each comment to help distinguish between
different comments. The number assigned to each comment is purely for
organizational purposes and does not signify the comment's value or
importance or the order in which comments were received.

B. Scope of the Proposed Rule (Sec.  10.31)

    (Comment 1) We received a comment from PhRMA concerning the scope
of the rule. PhRMA stated that, in some instances, the rule would
require unnecessary certifications for petitions outside the scope of
section 505(q) of the FD&C Act that could cause confusion among
petitioners, commentators, and the courts regarding which rules to
apply to any given petition. PhRMA claimed the proposed rule could
compromise a petitioner's fundamental right to know which statutory
requirements and timelines FDA will apply to the petition. Accordingly,
PhRMA requested that FDA revise the proposed rule to limit the rule's
application to cases in which there is evidence that a relevant ANDA or
505(b)(2) application is pending before FDA.
    (Response 1) We decline to make this revision. Normally, the
existence of a pending application is not made public by FDA. (See
e.g., 21 CFR 314.430.) To prevent uncertainty as to when a
certification or verification is required and to protect against the
unintended release of information acknowledging the existence of an
ANDA, a 505(b)(2) application, or a 351(k) application, we are making
Sec.  10.31 apply to all petitions that request an action that could
delay the approval of an ANDA, a 505(b)(2) application, or a 351(k)
application, regardless of whether an application subject to the
petition's requested action is pending at the time the petition is
submitted. Otherwise, if petitioners were to omit the certification
statement and wait for FDA to inform them that the certification is
required (because of the existence of a pending application), the
filing of petitions could become a way for individuals to uncover the
existence of certain pending applications. Neither FDAAA nor FDASIA
suggest such an outcome. Moreover, rather than causing confusion, as
PhRMA suggests, we believe that requiring certifications and
verifications for all applicable petitions would remove any uncertainty
as to whether a petitioner should submit or not submit a certification
or verification. If there is no related ANDA, 505(b)(2) application, or
351(k) application pending at the time the petition is submitted, then
the requirements of Sec.  10.31 will apply to the petition, but we will
not consider the provisions of section 505(q) of the FD&C Act to apply
to the petition.

C. Certification and Verification Requirements

    (Comment 2) PhRMA expressed specific concerns regarding the
certification and verification requirements of the rule. First, PhRMA
requested that the discretionary language found in the preamble to the
proposed rule, i.e., ``[t]he failure to provide any information relied
upon (and the date) in the certification or verification may result in
the failure of FDA to consider that information . . . .'', be clarified
to prevent confusion over how FDA intends to interpret and implement
the certification and verification requirements. Second, PhRMA
questioned FDA's assertion that a failure to certify or verify a
``became known'' date would foreclose a petitioner from relying on that
information when seeking judicial review. Accordingly, PhRMA requested
that FDA: (1) Revise the proposed rule and provide additional
explanation and examples to clarify what types of information
petitioners must provide ``became known'' dates for and (2) ``provide
support for, modify, or expressly withdraw'' the preamble statement
concerning judicial review.
    (Response 2) We recognize that a petition, supplement, or comment
could be based on more than one type of information or multiple pieces
of information. Section 505(q) of the FD&C Act requires that the
petitioner provide in the certification the date on or about which
information first became known to the petitioner. We interpret section
505(q) of the FD&C Act to require an on or about date for each piece of
information that is relied upon in the petition. Section II.B.7 of the
preamble to the proposed rule provides an example illustrating how a
petition may list different types of information. A petition,
supplement, or comment will meet the certification/verification
requirement if it contains a date followed by a short description of
the information. This requirement is essential to carrying out the
legislative intent of Congress and does not impose an unreasonable
burden on petitioners. Because of the fact-based nature of a petition,
it is impracticable for FDA to specifically define or categorize all
types of information that may be relied upon by a petitioner. A
petitioner or commenter can, however, reasonably be expected to
identify the main categories of information on which the petition,
supplement, or comment relies and to provide dates for such categories.
Indeed, this interpretation of the certification has worked well to
date. The failure to certify or verify a ``became known'' date for any
item of information contained in a petition would preclude the
petitioner from relying on that information when seeking judicial
review since section 505(q)(1)(H) and (I) of the FD&C Act requires that
FDA not consider and/or accept for review any petition or information
that fails to meet the certification and verification requirements.

D. Nonretroactivity of the Rule

    (Comment 3) PhRMA expressed concern that the rule could be read as
retroactively imposing requirements on petitions filed after September
26, 2007, but before the effective date of the final rule. Based on its
concern, PhRMA requested that FDA revise the rule to clarify that Sec.
10.31 will not apply to any petition that was pending at FDA before the
final rule's effective date, to any supplement to such a petition, or
to any comments on such a petition.
    (Response 3) FDA's guidance for industry ``Citizen Petitions and
Petitions for Stay of Action Subject to Section 505(q) of the Federal
Food, Drug, and Cosmetic Act'' (Ref. 1), describes FDA's current
thinking on the applicability of section 505(q) to petitions submitted
after September 27, 2007. As that guidance notes, section 505(q) of the
FD&C Act applies to all petitions that are submitted on or after
September 27, 2007 (or July 9, 2012, if the subject matter of the
petition relates to the approval of a 351(k) application). To the
extent the final rule imposes any additional requirements, those
requirements will apply only to those petitions submitted on or after
the effective date of the final rule.

E. Additional Comments

    (Comment 4) PhRMA requested that FDA include or otherwise establish
a

mechanism for notifying a petitioner if the Agency determines that a
delay of approval of an ANDA or 505(b)(2) application is not necessary
to protect the public health.
    (Response 4) We decline to implement such a mechanism for notifying
petitioners. As PhRMA pointed out, section 505(q) of the FD&C Act does
not require such a notification. The only notification provision in
section 505(q) of the FD&C Act is found in section 505(q)(1)(B), which
requires FDA to inform an ANDA applicant, a section 505(b)(2)
applicant, or a 351(k) applicant that a delay in approval is necessary
to protect the public health. Moreover, such a notification mechanism
would be burdensome for the Agency and could inadvertently inform the
public of pending ANDAs, 505(b)(2) applications, or 351(k)
applications.
    (Comment 5) PhRMA requested that FDA issue a regulation
establishing (or clarifying) the administrative consequence of a
decision to approve an ANDA or a 505(b)(2) application prior to making
a final decision on a related 505(q) petition (i.e., whether such an
approval would be considered a denial of the petition under section
505(q)(2)(A)(i) of the FD&C Act).
    (Response 5) We believe the statute clearly defines what
constitutes an exhaustion of administrative remedies with regard to
section 505(q) petitions. Section 505(q)(2) of the FD&C Act governs
judicial review of final Agency action on certain petitions filed under
section 505(q). Under section 505(q)(2)(A) of the FD&C Act, FDA is
considered to have taken final Agency action on a petition if either:
(1) FDA makes a final decision within the meaning of Sec.  10.45(d)
during the 150-day period or (2) the 150-day period expires without FDA
making a final decision. Section 505(q)(2) of the FD&C Act is silent as
to the effect of approving an ANDA or a 505(b)(2) application prior to
FDA's action on a petition. In our view, the language of section
505(q)(2) of the FD&C Act is clear and decouples a final action on a
petition from a decision on an underlying ANDA or 505(b)(2)
application. (We note that petitions addressing issues concerning
351(k) applications are excluded from the scope of section 505(q)(2) of
the FD&C Act). Therefore, a decision on an ANDA or a 505(b)(2)
application that occurs prior to the issuance of a petition response
will not constitute final Agency action on the petition.
    (Comment 6) PhRMA requested that FDA issue a regulation
establishing (or clarifying) that a delay in approval of an ANDA or a
505(b)(2) application can extend beyond the 180-day (now 150-day)
review period for a petition.
    (Response 6) We decline to issue a regulation establishing or
clarifying that a delay in approval of an ANDA or a 505(b)(2)
application can exceed the 150-day review period for petitions. Because
of the uncertainty in predicting the time it will take to resolve a
particular issue, establishing an expectation on the possible length of
a delay would be neither practical nor feasible. We believe that based
on the language of section 505(q) of the FD&C Act, no clarification is
necessary.
    (Comment 7) Finally, PhRMA requested that FDA abandon its practice
of not providing a substantive response to every section 505(q)
petition regardless of the review status of a pending ANDA or 505(b)(2)
application.
    (Response 7) This issue is outside the scope of this rulemaking.
FDA's current thinking on this issue is outlined in section III.E of
its guidance for industry ``Citizen Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the Federal Food, Drug, and
Cosmetic Act'' (Ref. 1), and we do not believe further elaboration is
necessary.

IV. Legal Authority

    This rule amends Sec. Sec.  10.20, 10.30, and 10.35, and adds Sec.
10.31 in a manner consistent with the Agency's current understanding
and application of these provisions. FDA is implementing certain
provisions of FDAAA and FDASIA that govern petitions subject to section
505(q) of the FD&C Act. FDA has authority to issue regulations for the
efficient administration of these provisions under section 701(a) of
the FD&C Act (21 U.S.C. 371(a)).

V. Analysis of Environmental Impact

    FDA has determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Economic Analysis of Impacts

A. Introduction and Summary

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule (Ref. 2). We believe that this
final rule is not a significant regulatory action as defined by
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the annualized compliance costs to industry members,
including small entities, is estimated to be slightly above $100, we
certify that the final rule will not have a significant economic impact
on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $146
million, using the most current (2015) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.

B. Summary of Final Regulatory Impacts Analysis

1. Industry Costs
    We estimate one-time costs to industry from this final rule at
about $626,300. We estimate annual costs at about $1,800. These costs
equate to an estimated total annualized cost of about $91,000 at a 7
percent discount rate over 10 years and about $75,200 at a 3 percent
discount rate over 10 years. The total annualized costs include the
administrative cost to review the rule ($89,200) plus the cost for the
additional effort preparing certifications for petitions and
verifications for both responses to petitions and supplements to
petitions ($1,800).
2. Benefits
    The final rule contains several clarifications to the language
provided in FDAAA and small additions to the statute's provisions. It
reinforces the need for exact wording of both the certification and
verification statements for petitions, supplements to petitions, and
responses to petitions. Furthermore,

the rule clarifies the exact dating procedures for these documents. By
providing additional clarity on the statutory requirements, we expect
the final rule will slightly reduce the number of deficient 505(q)
petitions. We do not have enough information to estimate this reduction
in deficient 505(q) petitions, but the reduction should result in lower
administrative costs for both industry and FDA.
    The Economic Analysis of Impacts of the final rule, performed in
accordance with Executive Order 12866, Executive Order 13563, the
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act, is
available at http://www.regulations.gov under the docket number for
this final rule (FDA-2011-N-0697) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Paperwork Reduction Act of 1995

    This final rule contains no new information collection provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the
PRA). The final rule refers to previously approved collections of
information found in FDA regulations. The collections of information in
Sec. Sec.  10.30 and 10.35 have been approved under OMB control number
0910-0191. The collections of information in Sec.  10.31 have been
approved under OMB control number 0910-0679. The collections of
information in 21 CFR part 314 have been approved under OMB control
number 0910-0001. The certification and verification statements
required under Sec.  10.31(c) and (d) are ``public disclosure[s] of
information originally supplied by the Federal government to the
recipient for the purpose of disclosure to the public . . . ,'' (5 CFR
1320.3(c)(2)) and therefore not subject to OMB review.

VIII. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

IX. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. FDA Guidance for Industry, ``Citizen Petitions and Petitions for
Stay of Action Subject to Section 505(q) of the Federal Food, Drug,
and Cosmetic Act,'' November 2014, available at<EMAIL_ADDRESS>2. Final Regulatory Impact Analysis, ``Amendments to Regulations on
Citizen Petitions, Petitions for Stay of Action, and Submission of
Documents to Dockets,'' Docket No. FDA-2011-N-0697, available at
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 10

    Administrative practice and procedure, News media.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
10 is amended as follows:

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

0
1. The authority citation for part 10 continues to read as follows:

    Authority:  5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.

0
2. In Sec.  10.20, revise paragraph (e) to read as follows:

Sec.  10.20   Submission of documents to Division of Dockets
Management; computation of time; availability for public disclosure.

* * * * *
    (e) Except as provided in Sec.  10.31(b), all submissions to the
Division of Dockets Management will be considered as submitted on the
date they are postmarked or, if delivered in person during regular
business hours, on the date on which they are delivered, unless a
provision in this part, an applicable Federal Register notice, or an
order issued by an administrative law judge specifically states that
the documents must be received by a specified date, e.g., Sec.
10.33(g) relating to a petition for reconsideration, in which case they
will be submitted on the date received.
* * * * *

0
3. Section 10.30 is amended as follows:
0
a. Revise paragraph (b) introductory text;
0
b. Revise the first sentence of paragraph (c);
0
c. Revise the second sentence of paragraph (d);
0
d. Revise the first sentence of paragraph (e)(2);
0
e. Remove from paragraph (e)(2)(ii) the word ``or'';
0
f. Redesignate paragraph (e)(2)(iii) as paragraph (e)(2)(iv);
0
g. Add new paragraph (e)(2)(iii);
0
h. Add to paragraph (e)(3) a new sentence after the first sentence; and
0
i. Add new paragraph (e)(5).
    The additions and revisions read as follows:

Sec.  10.30   Citizen petition.

* * * * *
    (b) A petition (including any attachments) must be submitted in
accordance with Sec.  10.20 and, if applicable, Sec.  10.31. The
certification requirement in this section does not apply to petitions
subject to the certification requirement of Sec.  10.31. The petition
must also be submitted in accordance with the following paragraphs, as
applicable:
* * * * *
    (c) A petition that appears to meet the requirements of paragraph
(b)(3) of this section, Sec.  10.20, and, if applicable, Sec.  10.31,
will be filed by the Division of Dockets Management, stamped with the
date of filing, and assigned a unique docket number. * * *
    (d) * * * The comments are to specify the docket number of the
petition and include, if applicable, the verification under Sec.
10.31, and may support or oppose the petition in whole or in part. * *
*
    (e) * * *
    (2) Except as provided in paragraphs (e)(4) and (5) of this
section, the Commissioner shall furnish a response to each petitioner
within 180 days of receipt of the petition. * * *
    (iii) Dismiss the petition if at any time the Commissioner
determines that changes in law, facts, or circumstances since the date
on which the petition was submitted have rendered the petition moot; or
* * * * *
    (3) * * * If, at any time, the Commissioner determines that changes
in law, facts, or circumstances since the date on which the petition
was submitted have rendered the petition

moot, the Commissioner may dismiss the petition. * * *
* * * * *
    (5) The Commissioner intends to furnish a response to each
petitioner within 150 days of receipt of a petition subject to section
505(q) of the Federal Food, Drug, and Cosmetic Act.
* * * * *

0
4. Add Sec.  10.31 to subpart B to read as follows:

Sec.  10.31   Citizen petitions and petitions for stay of action
related to abbreviated new drug applications, certain new drug
applications, or certain biologics license applications.

    (a) Applicability. This section applies to a citizen petition or
petition for stay of action that meets all of the following criteria:
    (1) The petition requests that the Commissioner take any form of
action that could, if taken, delay approval of an abbreviated new drug
application submitted under section 505(j) of the Federal Food, Drug,
and Cosmetic Act, a new drug application submitted through the pathway
described by section 505(b)(2) of the Federal, Food, Drug and Cosmetic
Act, or a biologics license application submitted under section 351(k)
of the Public Health Service Act.
    (2) The petition is submitted on or after September 27, 2007.
    (3) The petition is submitted in writing and under Sec.  10.30 (for
citizen petitions) or Sec.  10.35 (for petitions for stay of action).
    (b) Date of submission. A petition subject to this section and
submitted in accordance with Sec.  10.20, Sec.  10.30, Sec.  10.31, or
Sec.  10.35 is regarded as submitted on the date on which the petition
is received by the Division of Dockets Management.
    (c) Certification. (1) FDA will not consider for review a petition
that is subject to this section unless the petition is in writing and
contains the following certification:
[GRAPHIC] [TIFF OMITTED] TR08NO16.000

    (2) The certification in paragraph (c)(1) of this section must
contain one or more specific dates (month, day, and year) in the first
blank space provided. If different categories of information become
known at different times, the certification must contain each estimated
relevant date. The information associated with a particular date must
be identified.
    (d) Verification. (1) FDA will not accept for review any
supplemental information or comments on a petition that is subject to
this section unless the supplemental information or comments are in
writing and contain the following verification:
[GRAPHIC] [TIFF OMITTED] TR08NO16.001

    (2) The verification in paragraph (d)(1) of this section must
contain one or more specific dates (month, day, and year) in the first
blank space provided. If different categories of information become
known at different times, the verification must contain each estimated
relevant date. The information associated with a particular date must
be identified.

0
5. In Sec.  10.35 revise the third sentence of paragraph (b); in
paragraph (e)

introductory text add a new sentence after the second sentence; and add
paragraph (i) to read as follows:

Sec.  10.35  Administrative stay of action.

* * * * *
    (b) * * * A request for stay must be submitted in accordance with
Sec.  10.20 and in the following form (except that a request for stay
subject to Sec.  10.31 must also include the certification provided in
Sec.  10.31(c)) no later than 30 days after the date of the decision
involved. * * *
* * * * *
    (e) * * * If, at any time, the Commissioner determines that changes
in law, facts, or circumstances since the date on which the petition
was submitted have rendered the petition moot, the Commissioner may
dismiss the petition. * * *
* * * * *
    (i) A petitioner may supplement, amend, or withdraw a petition for
stay of action in writing without Agency approval and without prejudice
to resubmission at any time until the Commissioner rules on the
petition, provided the resubmission is made in accordance with
paragraph (b) of this section, unless the petition for stay of action
has been referred for a hearing under parts 12, 13, 14, or 15 of this
chapter. After a ruling or referral, a petition for stay of action may
be supplemented, amended, or withdrawn only with the approval of the
Commissioner. The Commissioner may approve withdrawal with or without
prejudice against resubmission of the petition for stay of action.

    Dated: November 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26912 Filed 11-7-16; 8:45 am]
 BILLING CODE 4164-01-P


  SEQ CHAPTER \h \r 1 ICF Consulting Review of the TERA Report

Introduction

ICF reviewed the report, “Scientific Review of 1-Bromopropane
Occupational Exposure Limit Derivations – Preliminary Thoughts and
Areas for Further Analysis” by Toxicology Excellence for Risk
Assessment (TERA 2004).  Details regarding the methods, results, and
discussion associated with the occupational exposure limit (OEL) derived
in this report are detailed in the following text.  Further, the
relevance of TERA’s report to the determination of an Acceptable
Exposure Limit for n-propyl bromide (nPB) is discussed.

Summary of Findings

TERA carefully examined five studies on nPB toxicity and their analysis
is thorough.  ICF generally agrees with TERA’s discussion for the
different health endpoints analyzed. TERA’s analysis agrees with the
basis of the most recent ICF analysis in that the reproductive effects
are the critical effects.  TERA used the WIL study approach in their
analysis of estrous cycle data, and they analyzed acyclic and cyclic
females separately.  TERA excluded the acyclic females and analyzed
them separately in the endpoint titled "No Estrous Cycle Incidence."
This endpoint presents only the dose where a 10% increase in acyclic
females was observed and disregards the acyclic animal impact on the
overall estrous cycle effect.  ICF's statistical analysis revealed
statistically significant changes in estrous cycle length, due to an
increase in the diestrus phase.  This effect was considered an early
biomarker of an increase in the nature and magnitude of reproductively
toxic outcomes that occurred with increasing dose. Therefore, ICF
considers this endpoint in the F0 females to be the critical effect
because it is the first effect occurring along a continuum of adverse
reproductive outcomes that increase in frequency and severity at higher
doses.  The BMDL [HEC] calculated by ICF for this endpoint is 122 ppm,
a value smaller than the BMDL [HEC] of 190 ppm calculated for decreased
litter size in WIL (2001).  Thus ICF's most recent AEL, although
different from the TERA results is nonetheless consistent with the
reasoning in the TERA report.

			Methods

The authors of the TERA report critically evaluated the basis of
existing OELs for nPB, which differ by approximately 16 fold (Table 1).
The authors also used the concepts of critical effect, benchmark dose,
and uncertainty factors, published by Haber et al. (2001), to derive
their own OEL.

Table 1.  OELs Derived for Various Groups and Their Basis

Group	OEL (ppm)	Critical Effect	Uncertainty	Reference

ACGIH TLV (2004)

	10	LOAEL of 100 ppm for decreased fetal weight	An apparent factor of 10
was used, no specific factor or rationale was provided	Huntingdon, 2001

Stelljes and Wood (2004)	156	BMDL of 156 ppm for decreased sperm
motility in F1 generation	1-fold, no uncertainty remains	WIL Research,
2001

Rozman and Doull (2002)	60 - 90	NOAEL of 170 ppm for mild CNS effects
(headache) in workers	2-3-fold for within human variability	NIOSH, 2000

U.S. EPA (2002)	20	BMDL  (adjusted) of 177 ppm for decreased sperm
motility in F1 generation	10-fold for within human and animal to human
variability	WIL Research, 2001

ICF (1998)

	100	NOAEL (adjusted) of 300 ppm for mild liver histopathology and NOAEL
of 280 ppm for decreased sperm motility	3-fold for animal to human
variability	ClinTrials BioResearch, 1997

TERA used the benchmark dose (BMD) approach in conjunction with the more
standard NOAEL/LOAEL technique to analyze the data for nPB.  U.S.
EPA’s BMD software, version 1.3.2 (U.S. EPA, 2001) was used to
reproduce each critical benchmark dose (BMD) and lower bound estimate of
the benchmark dose (BMDL) for nPB calculated by Stelljes and Wood (2004)
and to expand the analysis to additional endpoints of interest for the
2-generation study (WIL Research, 2001).  Benchmark responses (BMRs) of
1.0 control standard deviation were used by TERA for all continuous data
and BMRs of 10% were used for all dichotomous data.  These choices
reflected standard operating procedure.  All the available models in the
BMDS software were run for each data set, and BMDs and BMDLs from the
best fitting model were selected.

Results and Discussion

The results of Benchmark Dose (BMD) modeling are summarized in Table 2.
TERA’s calculations were generally consistent with those reported by
Stelljes and Wood (2004).  Additional reproductive and developmental
effects not considered by Stelljes and Wood (2004) were also evaluated
by TERA.

Table 2. BMD and BMDL Estimates

	Endpoint	Stelljes and Wood	TERA

 	BMD (ppm)	BMDL (ppm)	BMR	BMD (ppm)	BMDL (ppm)	Model	Variance

Hindlimb strength	286	214	1 sd	290	210	Linear	Homogeneous

Minimal centrilobular vacuolization males	345	226	10%	290	200
Multistage-2

	Fetal body weight

1 sd	510	310	Poly-2	Non-homogeneous

F0 sperm motility	343	263	1 sd	380	270	Linear	Homogeneous

F1 sperm motility	261	156	1 sd	260	150	Power	Non-homogeneous

F0 prostate weight

1 sd	740	190	Power	Homogeneous

F0 Estrous Cycle Length

1 sd	290	210	Power	Non-homogeneous

F1 Estrous Cycle Length

1 sd	810	400	Linear	Non-homogeneous

F0 No Estrous Cycle Incidence

10%	670	480	Multistage-2

	F1 No Estrous Cycle Incidence

10%	360	180	Quantal Linear

	Maternal GD20 body weight

1 sd	1000	690	Linear	Homogeneous

F1 litter viability index

 No dose-response

F1 pup weight gain PND 21 to 28

1 sd	240	180	Linear	Homogeneous

F1 decreased live litter size	280	188	1 sd	280	190	Linear
Non-homogeneous

F2 decreased live litter size	238	169	1 sd	240	170	Linear
Non-homogeneous

Through evaluation of the derivation of existing OELs and the results of
the Benchmark Dose Analysis, TERA came to the following conclusions
about each of the previously considered endpoints:

Neurotoxicity:

Neurotoxicity is a common effect from exposure to nPB.  However, while
some animal and human studies suggest effects in the range of 100 to 200
ppm or higher, results across the overall database are not consistent.
Furthermore, definitive effect levels in these studies generally fall in
the same range as for reproductive toxicity endpoints (which are of
greater severity).  The human data are limited by co-exposure to other
solvents, small populations examined, and limitations in the exposure
estimates.  Due to these uncertainties, the human data appear inadequate
to serve as the primary basis for the critical effect as suggested by
Rozman and Doull (2002), although they are quite useful in serving as a
comparison to any derived OEL.

Liver Toxicity:

Most risk assessors would consider the increased incidence of mild liver
cytoplasmic vacuolization, such as that seen by ClinTrials BioResearch
(1997), as a minimal adverse effect, even though other measures of liver
damage were not affected in this study.  In fact, the lack of additional
liver effects further supports the mild cytoplasmic vacuolization as an
effect of minimal severity.  The BMDL of 226 ppm determined by Stelljes
and Wood (2004) for this endpoint corresponds well with the effect level
for other endpoints, although the severity is minimal (Table 2).
Furthermore, no severe treatment related liver findings were reported in
preliminary data from the 13-week NTP study (NTP, 2003).  These data
suggest that liver toxicity is not the critical target for nPB toxicity.

Reproductive and Fetal Effects:

Decreased fetal weight - The ACGIH (2004) use of a LOAEL of 100 ppm for
decreased fetal weight in the Huntingdon Study (2001) as the critical
basis for its OEL derivation is difficult to justify.  Firstly, BMDL
estimates for this endpoint are greater than for other effects.
Secondly, questions about the conduct of the Huntingdon (2001) study
decrease the selection of this endpoint as the most relevant for
deriving the OEL.

Sperm Parameters – Based on the research of WIL Research (2001) and
Ichihara et. al. (2000b) as well as the BMDLs calculated by both
Stelljes and Wood (2004) and TERA (2004), the effects of nPB on male
sperm parameters suggests that the male reproductive effect in parental
animals occur in the same general range, but are not more sensitive than
other relevant effects.  Furthermore, as the study authors summarize,
Stelljes and Wood argue that the effect level for sperm parameters in
the WIL Research (2001) study should be based on the F0 generation
results and not those for F1 or F2 animals, because the goal of an OEL
is to develop a safe exposure level for workers and the exposure
patterns for the parental F0 animals more closely resemble occupational
exposure scenarios.

Litter size - Benchmark dose modeling for several measures of male and
female reproductive parameters from the two-generation study correspond
well with each other and provide a consistent story indicating that 1-BP
can affect reproductive parameters in males (decreased sperm motility
and prostate weight), females (increased estrous cycle length, no
estrous cycle incidence, and maternal body weight at gestation day 20),
and functional reproductive performance (litter viability index, pup
weight gain at post natal days 21 to 29, and live litter size).  The
BMDL values for these latter effects are in the same range, but slightly
lower, than for the liver effects, and represent a more serious outcome
(Table 2).  The BMDL value of 188 ppm from Stelljes and Wood (2004) or
of 190 ppm from TERA for decreased live F1 litter size is the most
appropriate basis for deriving the OEL, since this is the lowest measure
related to exposure to F0 animals that is clearly adverse.

TERA decided that a decrease in live litter size, was of sufficient
severity to warrant its choice as the critical effect.  Although other
effects might have occured at the same, or slightly lower exposures,
they were not considered as toxicologically significant.  The choice of
the BMD and BMDL values of 280 and 190 for the F1 generation, rather
than lower values from the F2 generation reflected the desire to
replicate the likely exposure in a worker population.  Specifically, it
was not anticipated that any human would have the exposure pattern of an
F2 animal.  In contrast, the effects on offspring (F1 pups) as a result
of occupational exposure to the parent (F0 dams) might occur in humans.

After selecting live litter size as the critical effect, TERA divided
the BMDL of 190 ppm with an uncertainty factor of 10-fold, which is
composed of 3-fold for extrapolation from an experimental animal study
to humans for expected toxicodynamic differences and 3-fold for expected
human variability in toxicokinetics and toxicodynamics within the worker
population.  The application of uncertainty factors resulted in an OEL
of 20 ppm.

References

TERA 2004.  Scientific Review of 1-Bromopropane Occupational Exposure
Limit Derivations – Preliminary Thoughts and Areas for Further
Analysis.  Toxicology Excellence for Risk Assessment.  Accessed on the
World Wide Web at <    HYPERLINK
"http://www.tera.org/OEL/1-bromopropane-7-29-04.pdf"
http://www.tera.org/OEL/1-bromopropane-7-29-04.pdf >

 TERA identified a BMDL of 200 ppm for this endpoint.

***DRAFT – December 13, 2004 – DO NOT CITE OR QUOTE***


[Federal Register Volume 85, Number 20 (Thursday, January 30, 2020)]
[Notices]
[Pages 5535-5536]
[FR Doc No: 2020-01670]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2020-0009]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
provides the public notice that on January 13, 2020, the Metropolitan
Council's Metro Transit Division (Metro Transit), petitioned the
Federal Railroad Administration (FRA) for a waiver of compliance from
certain provisions of the Federal railroad safety regulations contained
at 49 CFR parts 214, 219, 220, 229, 235, and 236. FRA assigned the
petition Docket Number FRA-2020-0009.
    Metro Transit operates two rail fixed guideway transit systems in
Minnesota--the METRO Blue and Green light rail transit (LRT) Lines.
Currently, the Green Line is 11 miles in length with 18 stations
between Target Field Station in downtown Minneapolis, and Union Depot
Station in downtown St. Paul, sharing 5 stations in downtown
Minneapolis with the Blue Line. The Green Line LRT Extension Project,
also known as Southwest Light Rail Transit Line (SWLRT), will add
approximately 14.5 miles of standard-gage light rail double-track with
16 new passenger stations within Hennepin County, Minnesota, to the
existing Green Line LRT operations. The SWLRT project will extend the
existing Green Line from the Target Field/Interchange Station near the
central business district of downtown Minneapolis through the
communities of St. Louis Park, Hopkins, Minnetonka, and Eden Prairie,
passing near Edina. The SWLRT line will terminate at the Southwest
Station in Eden Prairie. Construction of the SWLRT Project began in
2019 with the projected opening for revenue service operations in 2023.
    SWLRT will be constructed adjacent to freight rail service operated
by Twin Cities & Western Railroad (TCWR) in the Kenilworth Corridor and
a portion of the Bass Lake Spur, and adjacent to freight rail service
operated by BNSF Railway (BNSF) in the Wayzata Subdivision. Typical
track center spacing averages 25 feet or more throughout this shared
corridor. SWLRT and TCWR will share use of five highway-rail grade
crossings (HRGC) on the Kenilworth Corridor and Bass Lake Spur located
at 21st Street South in Minneapolis, Beltline Boulevard and Wooddale
Avenue in St. Louis Park, and 5th Avenue South and Blake Road North in
Hopkins. There are no shared HRGCs on the BNSF Wayzata Subdivision. An
intrusion detection system will be installed wherever typical spacing
for track centers between SWLRT and freight tracks is less than 50
feet.
    On the Bass Lake Spur (Milepost (MP) 16.3/428.38 to MP 435.06), the
Metropolitan Council has, on Hennepin County Regional Railroad
Authority's behalf, contracted with third parties to perform freight
rail operations maintenance, dispatching, and flagging services. The
SWLRT track and signal system is wholly separate and distinct from any
adjacent freight tracks and related equipment. Metro Transit will
maintain its own track and signals in the SWLRT, and only Metro Transit
Signal and Train Control employees will be working on signal and train
control equipment at the five shared HRGCs.
    Specifically, Metro Transit seeks a waiver of compliance from
certain provisions of FRA regulations applicable to the limited
connections of the SWLRT to the general railroad system at five shared
HRGCs, stating it has alternative procedures in place on its existing
Green Line operations which are comparable from a substantive
perspective to FRA safety regulations. Moreover, Metro Transit states
the waivers would promote consistency in the standard operating
procedures followed by Metro Transit in its Green Line LRT operations
and provide an equivalent level of safety to the corresponding FRA
regulations.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey Ave.
SE, W12-140, Washington, DC 20590. The Docket Operations Facility is
open from 9 a.m. to 5 p.m., Monday through Friday, except Federal
Holidays.

    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Ave. SE, W12-140, Washington, DC 20590.
     Hand Delivery: 1200 New Jersey Ave. SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received by March 16, 2020 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2020-01670 Filed 1-29-20; 8:45 am]
 BILLING CODE 4910-06-P