[Federal Register Volume 84, Number 163 (Thursday, August 22, 2019)]
[Notices]
[Pages 43812-43813]
[FR Doc No: 2019-18089]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-0076]

Determination That ZONEGRAN (Zonisamide) Capsules, 50 Milligrams,
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that ZONEGRAN (zonisamide) capsules, 50 milligrams (mg), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6210, Silver Spring, MD 20993-0002, 301-
796-6650<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an

ANDA procedure. ANDA applicants must, with certain exceptions, show
that the drug for which they are seeking approval contains the same
active ingredient in the same strength and dosage form as the ``listed
drug,'' which is a version of the drug that was previously approved.
ANDA applicants do not have to repeat the extensive clinical testing
otherwise necessary to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    ZONEGRAN (zonisamide) capsules, 50 mg, is the subject of NDA
020789, held by Sunovion Pharmaceuticals Inc., and initially approved
on August 22, 2003. ZONEGRAN (zonisamide) is indicated as adjunctive
therapy in the treatment of partial seizures in adults with epilepsy.
ZONEGRAN (zonisamide) capsules, 50 mg, is currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
    Unichem Pharmaceuticals (USA), Inc., submitted a citizen petition
dated December 28, 2018 (Docket No. FDA-2019-P-0076), under 21 CFR
10.30, requesting that the Agency determine whether ZONEGRAN
(zonisamide) capsules, 50 mg, was withdrawn from sale for reasons of
safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that ZONEGRAN (zonisamide) capsules, 50 mg, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that this drug
product was withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
ZONEGRAN (zonisamide) capsules, 50 mg, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information that would
indicate that this drug product was withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list ZONEGRAN (zonisamide)
capsules, 50 mg, in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. FDA will not
begin procedures to withdraw approval of approved ANDAs that refer to
this drug product. Additional ANDAs for this drug product may also be
approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for this drug product should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: August 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18089 Filed 8-21-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Rules and Regulations]
[Pages 71714-71717]
[FR Doc No: 2012-29132]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 567

[Docket No. NHTSA-2012-0093 Notice 2]
RIN 2127-AL18

Final Rule

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Final rule.

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SUMMARY: This document amends regulations that prescribe the format and
contents labels that manufacturers are required to affix to motor
vehicles manufactured for sale in the United States to certify the
compliance of those vehicles with U.S. safety standards. The amendment
will require specified certification language to be included on the
labels affixed to certain types of vehicles.

DATES: This rule is effective January 3, 2013. Petitions for
reconsideration must be received by NHTSA not later than January 18,
2013.

ADDRESSES: Petitions for reconsideration of this final rule should
refer to the docket and notice numbers identified above and be
submitted to: Administrator, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE., West Building, Washington,
DC 20590. It is requested, but not required, that 10 copies of the
petition be submitted. The petition must be received not later than 45
days after publication of this final rule in the Federal Register.
Petitions filed after that time will be considered petitions filed by
interested persons to initiate rulemaking pursuant to 49 U.S.C. Chapter
301.
    The petition must contain a brief statement of the complaint and an
explanation as to why compliance with the final rule is not
practicable, is unreasonable, or is not in the public interest. Unless
otherwise specified in the final rule, the statement and explanation
together may not exceed 15 pages in length, but necessary attachments
may be appended to the submission without regard to the 15-page limit.
If it is requested that additional facts be considered, the petitioner
must state the reason why they were not presented to the Administrator
within the prescribed time. The Administrator does not consider
repetitious petitions and unless the Administrator otherwise provides,
the filing of a petition does not stay the effectiveness of the final
rule.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, 1200 New Jersey Avenue SE., Washington, DC 20590;
(202) 366-3151.

SUPPLEMENTARY INFORMATION: NHTSA published a final rule on February 14,
2005 (70 FR 7414) that amended certain provisions of title 49, Code of
Federal Regulations, that pertain to the certification of motor
vehicles to standards administered by NHTSA. In amending the provisions
that establish the format and content requirements for certification
labels, the agency inadvertently omitted from 49 CFR 576.4(g)(5) the
requirement for manufacturers to include a specific certification
statement in the labels they affix to certain types of motor vehicles.
This rule corrects that inadvertent omission.

Background and Amendments

    This rule was preceded by a notice of proposed rulemaking that
NHTSA published on August 6, 2012 (77 FR 46677). There were no comments
in response to the notice of proposed rulemaking.
    Under the National Traffic and Motor Vehicle Safety Act of 1966, as
amended, (49 U.S.C. 30112(a), 30115), a motor vehicle manufactured for
sale in the United States must be manufactured to comply with all
applicable Federal motor vehicle safety standards (FMVSS) and bear a
label certifying such compliance that is permanently affixed by the
vehicle's original manufacturer. The label constitutes the
manufacturer's certification that the vehicle complies with the
applicable standards. Under 49 CFR 567.4, the label, among other
things, must identify the vehicle's manufacturer, its date of
manufacture, its gross vehicle weight rating or GVWR, the gross axle
weight rating or GAWR of each axle, the vehicle type classification
(e.g., passenger car, multipurpose passenger vehicle, truck, bus,
motorcycle, trailer, low-speed vehicle), and the vehicle's Vehicle
Identification Number or ``VIN.'' The certification label must also
contain a variant of the statement: ``This vehicle conforms to all
applicable Federal motor vehicle safety standards in effect on the date
of manufacture shown above.'' For example, passenger cars are subject
to safety, bumper, and theft prevention standards; therefore, a
passenger car certification label must contain the statement: ``This
vehicle conforms to all applicable Federal motor vehicle safety,
bumper, and theft prevention standards in effect on the date of
manufacture shown above.'' The expression ``U.S.'' or ``U.S.A.'' may be
inserted before the word ``Federal'' as it appears in this statement.
    In the final rule published on February 14, 2005 (70 FR 7414), 49
CFR 567.4(g)(5) was amended by replacing the statement ``This vehicle
conforms to all applicable Federal motor vehicle safety standards in
effect on the date of manufacture shown above'' with the language,
``One of the following statements, as appropriate'' followed by
subparagraphs i, ii, and iii, which pertain, respectively, to passenger
cars, multipurpose passenger vehicles (MPVs) and trucks with a GVWR of
6,000 pounds or less, and multipurpose passenger vehicles and trucks
with a GVWR of over 6,000 pounds. Manufacturers of other types of motor
vehicles remained subject to the statutory duty to certify those
vehicles to the applicable FMVSS. And the logical certification
language for these manufacturers to use was: ``This vehicle conforms to
all applicable Federal motor vehicle safety standards in effect on the
date of manufacture shown above.'' But due to an inadvertent omission
in the course of amendments to the regulations, the regulations did not
specifically state that manufacturers of trailers, buses, motorcycles,
and low-speed vehicles (those vehicle types not identified by
subparagraphs i, ii, and iii) were required to use this specific
language. To address this lack of specificity, the agency is amending
section 567.4(g) to add a new subparagraph (iv) that covers these
vehicle types. Subparagraphs i, ii, and iii remain unchanged.

Rulemaking Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

    Executive Order 12866, ``Regulatory Planning and Review'' (58 FR
51735, October 4, 1993), provides for making determinations whether a
regulatory action is ``significant'' and therefore subject to Office of
Management and Budget (OMB) review and to the requirements of the
Executive Order. The Order defines a ``significant regulatory action''
as one that is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or Tribal governments or
communities;
    (2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
    (4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    NHTSA has considered the impact of this rulemaking under Executive
Order 12866 and the Department of Transportation's regulatory policies
and procedures. This rulemaking is not significant. Accordingly, the
Office of Management and Budget has not reviewed this rulemaking under
Executive Order 12886. Further, NHTSA has determined that the
rulemaking is not significant under Department of Transportation's
regulatory policies and procedures. Manufacturers are required by
statute (49 U.S.C. 30115(a)) to permanently affix a tag or label to a
vehicle certifying the vehicle's compliance with applicable safety
standards. The agency is not aware of any manufacturer that has
discontinued inserting the certification language on the certification
labels affixed to trailers, buses, motorcycles, and low-speed vehicles
manufactured since the regulations were revised in 2005. Based on this,
NHTSA currently anticipates that the costs of the final rule would be
so minimal as not to warrant preparation of a regulatory evaluation.
The action does not involve any substantial public interest or
controversy. The rule would have no substantial effect upon State and
local governments. There would be no substantial impact upon a major
transportation safety program.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by
the Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996) provides that no regulatory flexibility analysis is required if
the head of an agency certifies the rule will not have a significant
economic impact on a substantial number of small entities. SBREFA
amended the Regulatory Flexibility Act to require Federal agencies to
provide a statement of the factual basis for certifying that a rule
will not have a significant economic impact on a substantial number of
small entities.
    NHTSA has considered the effects of this rulemaking under the
Regulatory Flexibility Act, and certifies that the rule being adopted
will not have a significant economic impact on a substantial number of
small entities. Accordingly, the agency has not prepared a final
regulatory flexibility analysis for this rulemaking. NHTSA makes these
statements on the basis that covered entities have been and are subject
to a statutory obligation to certify vehicles they manufacture, this
rulemaking merely restores text that was part of the regulation before
it was last amended in 2005, and manufacturers have continued to affix
labels that include the appropriate certification language on trailers,
buses, motorcycles, and low-speed vehicles manufactured since then. As
a consequence, this rulemaking will not impose any significant costs on
anyone. Therefore, it has not been necessary for NHTSA to conduct a
regulatory evaluation or Regulatory Flexibility Analysis for this
rulemaking.
    The costs of the 2005 amendments were analyzed at the time they
were issued as a final rule. At that time, we explained that the rule
did not impose

any significant economic impact on a substantial number of small
businesses. The agency explained that the rule would, in fact, reduce
burdens on final-stage manufacturers, many of which are small
businesses.
    The agency is not aware that any vehicle manufacturers have stopped
including the certification language that is the subject of this rule
on the labels they affix to trailers, buses, motorcycles, or low-speed
vehicles. For this reason, we view this rulemaking as merely restoring
to the regulation text that was inadvertently omitted in the 2005
amendment and find that there is no change in the meaning or
application of the rule as explained in the preamble at 70 FR 7414.

C. Executive Order 13132 (Federalism)

    Executive Order 13132 on ``Federalism'' requires NHTSA to develop
an accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
Federalism implications.'' Executive Order 13132 defines the term
``policies that have federalism implications'' to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' Under Executive Order 13132, NHTSA may not issue a
regulation that has federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless
the Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, or NHTSA
consults with State and local officials early in the process of
developing the proposed regulation.
    This rule will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government as specified in Executive Order 13132. Thus, the
requirements of section 6 of the Executive Order do not apply to this
rulemaking action.

D. Executive Order 12988 (Civil Justice Reform)

    Executive Order 12988 requires that agencies review proposed
regulations and legislation and adhere to the following general
requirements: (1) The agency's proposed legislation and regulations
shall be reviewed by the agency to eliminate drafting errors and
ambiguity; (2) The agency's proposed legislation and regulations shall
be written to minimize litigation; and (3) The agency's proposed
legislation and regulations shall provide a clear legal standard for
affected conduct rather than a general standard, and shall promote
simplification and burden reduction.
    When promulgating a regulation, Executive Order 12988 specifically
requires the agency to make every reasonable effort to ensure that the
regulation, as appropriate: (1) Specifies in clear language the
preemptive effect; (2) specifies in clear language the effect on
existing Federal law or regulation, including all provisions repealed,
circumscribed, displaced, impaired, or modified; (3) provides a clear
legal standard for affected conduct rather than a general standard,
while promoting simplification and burden reduction; (4) specifies in
clear language the retroactive effect; (5) specifies whether
administrative proceedings are to be required before parties may file
suit in court; (6) explicitly or implicitly defines key terms; and (7)
addresses other important issues affecting clarity and general
draftsmanship of regulations.
    NHTSA has reviewed this rulemaking according to the general
requirements and the specific requirements for regulations set forth in
Executive Order 12988. This rulemaking simply restores text that
existed before the regulation was amended in 2005 and makes clear the
requirement that manufacturers include language in the certification
labels that they must affix to vehicles under 49 U.S.C. 30115 and the
regulations at 49 CFR part 567. This change does not result in any
preemptive effect and does not have a retroactive effect. A petition
for reconsideration or other administrative proceeding is not required
before parties may file suit in court.

F. Unfunded Mandates Reform Act of 1995

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
requires agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
tribal governments, in the aggregate, or by the private sector, of more
than $100 million annually (adjusted for inflation with the base year
of 1995). Before promulgating a rule for which a written assessment is
needed, Section 205 of the UMRA generally requires NHTSA to identify
and consider a reasonable number of regulatory alternatives and to
adopt the least costly, most cost-effective, or least burdensome
alternative that achieves the objectives of the rule. The provisions of
Section 205 do not apply when they are inconsistent with applicable
law. Moreover, Section 205 allows NHTSA to adopt an alternative other
than the least costly, most cost-effective or least burdensome
alternative if the agency publishes with the final rule an explanation
why that alternative was not adopted. Because this final rule will not
require the expenditure of resources beyond $100 million annually, this
action is not subject to the requirements of Sections 202 and 205 of
the UMRA.

G. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995, a person is not required
to respond to a collection of information by a Federal agency unless
the collection displays a valid OMB control number. This final rule
includes a ``collection of information,'' as that term is defined in 5
CFR part 1320 Controlling Paperwork Burdens on the Public, because it
requires manufactures to insert text in the certification labels they
affix to trailers, buses, motorcycles, and low-speed vehicles that is
not specified in the regulations as they currently exist. There is no
burden on the general public.
    OMB has approved NHTSA's collection of information associated with
motor vehicle labeling requirements under OMB clearance no. 2127-0512,
Consolidated Labeling Requirements for Motor Vehicles (Except the
Vehicle Identification Number). NHTSA's request for the extension of
this approval was granted on June 6, 2011, and remains in effect until
June 30, 2014. For the following reasons, NHTSA believes that the
requirements imposed by this rule will not increase the information
collection burden on the public. Manufacturers of all motor vehicles
manufactured for sale in the United States are required by statute to
certify their vehicles' compliance with all applicable Federal motor
vehicle safety standards. See 49 U.S.C. 30115(a). The statute provides
that ``[c]ertification of a vehicle must be shown by a label or tag
permanently fixed to the vehicle.'' Ibid. To satisfy this requirement,
manufacturers of all motor vehicles, including trailers, buses,
motorcycles, and low-speed vehicles, have been affixing certification
labels to those vehicles containing the required certification language
even though there has been no certification language specified in the
regulations since they

were amended in 2005. Reinstating the specific language in the
regulations will therefore not increase the paperwork burden on those
manufacturers.

H. Executive Order 13045

    Executive Order 13045 applies to any rule that (1) is determined to
be ``economically significant'' as defined under E.O. 12866, and (2)
concerns an environmental, health, or safety risk that NHTSA has reason
to believe may have a disproportionate effect on children. If the
regulatory action meets both criteria, we must evaluate the
environmental health or safety effects of the planned rule on children,
and explain why the planned rule is preferable to other potentially
effective and reasonably feasible alternatives considered by us. This
rulemaking is not economically significant and does not concern an
environmental, health, or safety risk.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272)
directs NHTSA to use voluntary consensus standards in its regulatory
activities unless doing so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies, such as the Society of Automotive
Engineers (SAE). The NTTAA directs the agency to provide Congress,
through the OMB, with explanations when we decide not to use available
and applicable voluntary consensus standards.
    In this final rule, we are adding to 49 CFR 576.4(g)(5) the
requirement that manufacturers include in the certification labels that
they affix to certain types of motor vehicles a statement certifying
that the vehicle conforms to all applicable FMVSS. This language was
inadvertently omitted from the regulation in 2005 and we are adopting
no substantive changes to the regulation nor do we propose any
technical standards. For these reasons, Section 12(d) of the NTTAA
would not apply.

J. Regulation Identifier Number (RIN)

    The Department of Transportation assigns a regulation identifier
number (RIN) to each regulatory action listed in the Unified Agenda of
Federal Regulations. The Regulatory Information Service Center
publishes the Unified Agenda in April and October of each year. You may
use the RIN contained in the heading at the beginning of this document
to find this action in the Unified Agenda.

List of Subjects in 49 CFR Part 567

    Labeling, Motor vehicle safety, Motor vehicles.
    In consideration of the foregoing, Part 567, Certification, in
Title 49 of the Code of Federal Regulations is amended as follows:

PART 567--CERTIFICATION

0
1. The authority citation for part 567 is revised to read as follows:

    Authority: 49 U.S.C. 322, 30111, 30115, 30117, 30166, 32502,
32504, 33101-33104, 33108, and 33109; delegation of authority at 49
CFR 1.95.

0
2. Amend Sec.  567.4 by adding paragraph (g)(5)(iv) to read as follows:

Sec.  567.4  Requirements for manufacturers of motor vehicles.

* * * * *
    (g) * * *
    (5) * * *
    (iv) For all other vehicles, the statement: ``This vehicle conforms
to all applicable Federal motor vehicle safety standards in effect on
the date of manufacture shown above.'' The expression ``U.S.'' or
``U.S.A.'' may be inserted before the word ``Federal''.
* * * * *

    Issued on: November 28, 2012.
Daniel C. Smith,
Senior Associate Administrator for Vehicle Safety.
[FR Doc. 2012-29132 Filed 12-3-12; 8:45 am]
BILLING CODE 4910-59-P