[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46070-46071]
[FR Doc No: 2017-21174]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-2530]

Determination That SPECTAZOLE (Econazole Nitrate) Topical Cream,
1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 SPECTAZOLE (econazole nitrate) topical cream, 1%, 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not withdrawn from sale for reasons of safety or effectiveness.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: Nisha Shah, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

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, a drug is 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withdrawn from sale for reasons of safety or effectiveness (21 CFR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.
    SPECTAZOLE (econazole nitrate) topical cream, 1%, is the subject of
NDA 018751, held by Alvogen Malta Operations Ltd., and initially
approved on December 23, 1982. SPECTAZOLE is indicated for topical
application in the treatment of tinea pedis, tinea cruris, and tinea
corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes,
Trichophyton tonsurans, Microsporum canis, Microsporum audouini,
Microsporum gypseum, and Epidermophyton floccosum; in the treatment of
cutaneous candidiasis; and in the treatment of tinea versicolor.
    SPECTAZOLE (econazole nitrate) topical cream, 1%, is currently
listed in

the ``Discontinued Drug Product List'' section of the Orange Book.
    Lachman Consultant Services, Inc. submitted a citizen petition
dated April 21, 2017 (Docket No. FDA-2017-P-2530), under 21 CFR 10.30,
requesting that the Agency determine whether SPECTAZOLE (econazole
nitrate) topical cream, 1%, 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 SPECTAZOLE (econazole nitrate) topical cream,
1%, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
SPECTAZOLE (econazole nitrate) topical cream, 1%, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of SPECTAZOLE (econazole
nitrate) topical cream, 1%, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and determined
that this drug product was not withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list SPECTAZOLE (econazole
nitrate) topical cream, 1%, 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: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21174 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Notices]
[Pages 30213-30223]
[FR Doc No: 2011-12699]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. PA-46; File No. S7-20-11]

Privacy Act of 1974: Systems of Records

AGENCY: Securities and Exchange Commission.

ACTION: Notice.

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SUMMARY: In accordance with the requirements of the Privacy Act of
1974, as amended, 5 U.S.C. 552a, the Securities and Exchange Commission
(``Commission'' or ``SEC'') proposes to establish three new systems of
records and revise two existing systems of records. The three new
systems of records are ``Tips, Complaints, and Referrals (TCR) Records
(SEC-63)'', ``SEC Security in the Workplace Incident Records (SEC-
64)'', and ``Investor Response Information System (IRIS) (SEC-65).'' In
a companion release published elsewhere in this issue of the Federal
Register the Commission is issuing a Proposed Rule concurrent with this
notice. Additionally, two existing systems of records are being
revised: ``Personnel Management Code of Conduct and Employee
Performance Files (SEC-38)'', last published in the Federal Register
Volume 62, Number 176 on Thursday, September 11, 1997; and
``Enforcement Files (SEC-42)'', last published in the Federal Register
Volume 67, Number 142 on Wednesday, July 24, 2002.

DATES: The proposed systems will become effective July 3, 2011, unless
further notice is given. The Commission will publish a new notice if
the effective date is delayed to review comments or if changes are made
based on comments received. To be assured of consideration, comments
should be received on or before June 23, 2011.

ADDRESSES: Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/other.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number S7-20-11 on the subject line.

Paper Comments

    Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, U.S. Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number S7-20-11. This file number
should be included on the subject line if e-mail is used. To help us
process and review your comments more efficiently, please use only one
method. The Commission will post all comments on the Commission's
Internet Web site (http://www.sec.gov/rules/other.shtml). Comments are
also available for Web site viewing and printing in the Commission's
Public Reference Room, 100 F Street, NE., Washington, DC 20549, on
official business days between the hours of 10 a.m. and 3 p.m. All
comments received will be posted without change; we do not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.

FOR FURTHER INFORMATION CONTACT: Cristal Perpignan, Acting Chief
Privacy Officer, Office of Information Technology,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Commission proposes to establish three
new systems of records, ``Tips, Complaints, and Referrals (TCR) Records
(SEC-63)'', ``SEC Security in the Workplace Incident Records (SEC-
64)'', and ``Investor Response Information System (IRIS) (SEC-65).''
The TCR Records (SEC-63) system of records contains records related to
tips, complaints, referrals of misconduct, or related information about
actual or potential violations of the Federal securities laws; investor
harm; conduct of public companies; securities professionals; regulated
entities; and associated persons. The SEC Security in the Workplace
Incident Records (SEC-64) system of records contains records related to
reports involving incidents of assault, harassment, intimidation,
bullying, weapons possession or threats at the SEC workplace. The IRIS
(SEC-65) system of records contains records related to complaints/
inquiries/requests from members of the public and others. In a
companion release published elsewhere in this issue of the Federal
Register the Commission is issuing a Notice of Proposed Rulemaking
concurrent with this notice to exempt these systems from certain
provisions of the Privacy Act to the extent that they contain
investigatory materials for law enforcement purposes.
    Additionally, the Commission proposes to revise two existing
systems of records, ``Personnel Management Code of Conduct and Employee
Performance Files (SEC-38)'', and ``Enforcement Files (SEC-42)''. As
described in the last published notice, the Personnel Management Code
of Conduct and Employee Performance Files (SEC-38) system is used to
verify employee and agency compliance with law, regulation, case
decisions, agency policies, and the Collective Bargaining Agreement.
Minor administrative changes to SEC-38 have been incorporated to
reflect the Commission's current address in the following sections:
System Location; and Notification, Access and Contesting Records
Procedures. Substantive changes to the notice have been made to the
following sections: (1) System Name, reflecting the new title:
``Disciplinary and Adverse Actions, Employee Conduct, and Labor
Relations Files''; (2) Categories of Records, deleting records no
longer maintained in this system; and (3) Routine Uses, adding certain
standard routine uses as applicable to this system of records (those
numbered 1, 2, 4, 5, 6, 7, 8, and 9). On September 8, 2009 (74 FR
46254), the Commission published notice that records related to the
Ethics Conduct Rules applicable to Commission Members and employees,
including reports on securities transactions, holdings, and accounts
required by applicable Federal securities laws and regulations, which
were previously contained in SEC-38, would be maintained in a new
systems of records titled: Ethics Conduct Rules Files (SEC-60). The
Categories of Records Section of SEC-38 has been revised to reflect the
removal of these records.
    As described in the last published notice, the Enforcement Files
(SEC-42) system will be used for purposes of the Commission's
investigations and actions to enforce the Federal securities laws.
Additionally, the information in the system is used in conjunction with
the collection of amounts ordered to be paid in enforcement actions.
Minor administrative changes to SEC-42 have been incorporated to
reflect the Commission's current address in the following sections:
System Location;

and Notification, Access and Contesting Records Procedures. A
substantive change to the notice has been made to the Routine Uses
section to allow disclosure of records in the event of a breach of
records.
    The Commission has submitted a report of the new systems of records
and the amended existing systems of records to the appropriate
Congressional committees and to the Director of the Office of
Management and Budget (``OMB'') as required by 5 U.S.C. 552a(r)
(Privacy Act of 1974) and guidelines issued by OMB on December 12, 2000
(65 FR 77677).
    Accordingly, the Commission is proposing three new systems of
records and amendment of two existing systems of records to read as
follows:
SEC-63

SYSTEM NAME:
    Tips, Complaints, and Referrals (TCR) Records.

SYSTEM LOCATION:
    Securities and Exchange Commission, 100 F Street, NE., Washington,
DC 20549. Files may also be maintained in the Commission's Regional
Offices that conducted an investigation or litigation.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    (1) Individuals that submit tips, complaints, or related
information about actual or potential violations of the Federal
securities laws; investor harm; conduct of public companies, securities
professionals, regulated entities, and associated persons; and internal
and external referrals of misconduct; (2) Individuals that are the
subjects of a tip or complaint related to an actual or potential
securities law violation; (3) Attorneys or other related individuals;
and (4) SEC personnel or contractors assigned to handle such tips,
complaints, and referrals.

CATEGORIES OF RECORDS IN THE SYSTEM:
    Records may include individual names; dates of birth; social
security numbers; addresses; telephone numbers; tip, complaint, and
referral information including allegation descriptions, dates, and
supporting details; supporting documentation; web forms; e-mails;
criminal history; working papers of the staff; and other documents and
records relating to the matter.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    15 U.S.C. 77a et seq., 78a et seq., 80a-1 et seq., 80b-1 et seq.,
and 5 U.S.C. 302.

PURPOSE(S):
    For use by authorized SEC personnel in receiving, recording,
assigning, tracking, and taking action on tips, complaints, and
referrals received from individuals and entities related to actual or
potential violations of the Federal securities laws; investor harm; or
conduct of public companies, securities professionals, regulated
entities and associated persons.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
    In addition to those disclosures generally permitted under 5 U.S.C.
552a(b) of the Privacy Act, these records or information contained
therein may specifically be disclosed outside the Commission as a
routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
    1. To appropriate agencies, entities, and persons when (a) it is
suspected or confirmed that the security or confidentiality of
information in the system of records has been compromised; (b) the SEC
has determined that, as a result of the suspected or confirmed
compromise, there is a risk of harm to economic or property interests,
identity theft or fraud, or harm to the security or integrity of this
system or other systems or programs (whether maintained by the SEC or
another agency or entity) that rely upon the compromised information;
and (c) the disclosure made to such agencies, entities, and persons is
reasonably necessary to assist in connection with the SEC's efforts to
respond to the suspected or confirmed compromise and prevent, minimize,
or remedy such harm.
    2. To other Federal, State, local, or foreign law enforcement
agencies; securities self-regulatory organizations; and foreign
financial regulatory authorities to assist in or coordinate regulatory
or law enforcement activities with the SEC.
    3. To national securities exchanges and national securities
associations that are registered with the SEC, the Municipal Securities
Rulemaking Board; the Securities Investor Protection Corporation; the
Public Company Accounting Oversight Board; the Federal banking
authorities, including, but not limited to, the Board of Governors of
the Federal Reserve System, the Comptroller of the Currency, and the
Federal Deposit Insurance Corporation; state securities regulatory
agencies or organizations; or regulatory authorities of a foreign
government in connection with their regulatory or enforcement
responsibilities.
    4. By SEC personnel for purposes of investigating possible
violations of, or to conduct investigations authorized by, the Federal
securities laws.
    5. In any proceeding where the Federal securities laws are in issue
or in which the Commission, or past or present members of its staff, is
a party or otherwise involved in an official capacity.
    6. In connection with proceedings by the Commission pursuant to
Rule 102(e) of its Rules of Practice, 17 CFR 201.102(e).
    7. To a bar association, state accountancy board, or other Federal,
State, local, or foreign licensing or oversight authority; or
professional association or self-regulatory authority to the extent
that it performs similar functions (including the Public Company
Accounting Oversight Board) for investigations or possible disciplinary
action.
    8. To a Federal, State, local, tribal, foreign, or international
agency, if necessary to obtain information relevant to the SEC's
decision concerning the hiring or retention of an employee; the
issuance of a security clearance; the letting of a contract; or the
issuance of a license, grant, or other benefit.
    9. To a Federal, State, local, tribal, foreign, or international
agency in response to its request for information concerning the hiring
or retention of an employee; the issuance of a security clearance; the
reporting of an investigation of an employee; the letting of a
contract; or the issuance of a license, grant, or other benefit by the
requesting agency, to the extent that the information is relevant and
necessary to the requesting agency's decision on the matter.
    10. To produce summary descriptive statistics and analytical
studies, as a data source for management information, in support of the
function for which the records are collected and maintained or for
related personnel management functions or manpower studies; may also be
used to respond to general requests for statistical information
(without personal identification of individuals) under the Freedom of
Information Act.
    11. To any trustee, receiver, master, special counsel, or other
individual or entity that is appointed by a court of competent
jurisdiction, or as a result of an agreement between the parties in
connection with litigation or administrative proceedings involving
allegations of violations of the Federal securities laws (as defined in
section 3(a)(47) of the Securities Exchange Act of 1934, 15 U.S.C.
78c(a)(47)) or pursuant to the Commission's Rules of

Practice, 17 CFR 201.100-900 or the Commission's Rules of Fair Fund and
Disgorgement Plans, 17 CFR 201.1100-1106, or otherwise, where such
trustee, receiver, master, special counsel, or other individual or
entity is specifically designated to perform particular functions with
respect to, or as a result of, the pending action or proceeding or in
connection with the administration and enforcement by the Commission of
the Federal securities laws or the Commission's Rules of Practice or
the Rules of Fair Fund and Disgorgement Plans.
    12. To any persons during the course of any inquiry, examination,
or investigation conducted by the SEC's staff, or in connection with
civil litigation, if the staff has reason to believe that the person to
whom the record is disclosed may have further information about the
matters related therein, and those matters appeared to be relevant at
the time to the subject matter of the inquiry.
    13. To interns, grantees, experts, contractors, and others who have
been engaged by the Commission to assist in the performance of a
service related to this system of records and who need access to the
records for the purpose of assisting the Commission in the efficient
administration of its programs, including by performing clerical,
stenographic, or data analysis functions, or by reproduction of records
by electronic or other means. Recipients of these records shall be
required to comply with the requirements of the Privacy Act of 1974, as
amended, 5 U.S.C. 552a.
    14. In reports published by the Commission pursuant to authority
granted in the Federal securities laws (as such term is defined in
section 3(a)(47) of the Securities Exchange Act of 1934, 15 U.S.C.
78c(a)(47)), which authority shall include, but not be limited to,
section 21(a) of the Securities Exchange Act of 1934, 15 U.S.C.
78u(a)).
    15. To members of advisory committees that are created by the
Commission or by Congress to render advice and recommendations to the
Commission or to Congress, to be used solely in connection with their
official designated functions.
    16. To any person who is or has agreed to be subject to the
Commission's Rules of Conduct, 17 CFR 200.735-1 to 200.735-18, and who
assists in the investigation by the Commission of possible violations
of the Federal securities laws (as such term is defined in section
3(a)(47) of the Securities Exchange Act of 1934, 15 U.S.C. 78c(a)(47)),
in the preparation or conduct of enforcement actions brought by the
Commission for such violations, or otherwise in connection with the
Commission's enforcement or regulatory functions under the Federal
securities laws.
    17. To a Congressional office from the record of an individual in
response to an inquiry from the Congressional office made at the
request of that individual.
    18. To members of Congress, the press, and the public in response
to inquiries relating to particular Registrants and their activities,
and other matters under the Commission's jurisdiction.
    19. To prepare and publish information relating to violations of
the Federal securities laws as provided in 15 U.S.C. 78c(a)(47)), as
amended.
    20. To respond to subpoenas in any litigation or other proceeding.
    21. To a trustee in bankruptcy.
    22. To members of Congress, the General Accountability Office, or
others charged with monitoring the work of the Commission or conducting
records management inspections.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    Records are maintained in electronic and paper format. Electronic
records are stored in computerized databases and/or on computer disc.
Paper records and records on computer disc are stored in locked file
rooms and/or file cabinets.

RETRIEVABILITY:
    Records may be retrieved by an individual's or entity's name,
receipt date, subject matter, keywords that may include personal
information, and/or other personal identifier. The system will also
enable authorized SEC personnel to search for and retrieve records
using conventional methods including but not limited to the use of
unique record identifiers, keyword searches, geographic data (e.g. zip
code), date and time searches, and sorts and filters.

SAFEGUARDS:
    Records are safeguarded in a secured environment. Buildings where
records are stored have security cameras and 24 hour security guard
service. The records are kept in limited access areas during duty hours
and in locked file cabinets and/or locked offices or file rooms at all
other times. Access is limited to those personnel whose official duties
require access. Computerized records are safeguarded through use of
access codes and information technology security. Contractors and other
recipients providing services to the Commission are contractually
obligated to maintain equivalent safeguards.

RETENTION AND DISPOSAL:
    These records will be maintained until they become inactive, at
which time they will be retired or destroyed in accordance with records
schedules of the United States Securities and Exchange Commission and
as approved by the National Archives and Records Administration.

SYSTEM MANAGER(S) AND ADDRESS:
    Deputy Director, Division of Risk, Strategy, and Financial
Innovation, U.S. Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549

NOTIFICATION PROCEDURE:
    All requests to determine whether this system of records contains a
record pertaining to the requesting individual may be directed to the
FOIA/PA Officer, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-5100.

RECORD ACCESS PROCEDURES:
    Persons wishing to obtain information on the procedures for gaining
access to or contesting the contents of these records may contact the
FOIA/PA Officer, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-5100.

CONTESTING RECORD PROCEDURES:
    See Record Access Procedures above.

RECORD SOURCE CATEGORIES:
    Information in these records may be supplied by investors and the
general public, Commission-regulated entities including broker-dealers,
investment advisers, self-regulatory organizations, other government
agencies, and foreign regulators.

EXEMPTIONS CLAIMED FOR THE SYSTEM:
    Under 5 U.S.C. 552a(k)(2), this system of records is exempted from
the following provisions of the Privacy Act, 5 U.S.C. 552a(c)(3), (d),
(e)(1), (e)(4)(G), (H), and (I), and (f) and 17 CFR 200.303, 200.304,
and 200.306, insofar as it contains investigatory materials compiled
for law enforcement purposes. This exemption is contained in 17 CFR
200.312(a)(1).
SEC-64

SYSTEM NAME:
    SEC Security in the Workplace Incident Records.

SYSTEM LOCATION:
    Securities and Exchange Commission, 100 F Street, NE., Washington,
DC 20549.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Past and present employees, interns, and volunteers of the
Securities and Exchange Commission (employees), contractors, visitors,
and others who have access to SEC facilities who report potential or
actual workplace violence; persons accused of threatening to commit, or
committing workplace violence, and persons interviewed or investigated
in connection with reports or allegations of potential or actual
workplace violence.

CATEGORIES OF RECORDS IN THE SYSTEM:
    These records include, but are not limited to: Case number,
victim's name, office telephone number, room number, office/division,
duty station, position, supervisor, supervisor's telephone number,
location of incident, activity at time of incident, circumstances
surrounding the incident, perpetrator, name(s) and telephone number(s)
of witness(es), injured party(s), medical treatment(s), medical report,
property damages, report(s) to police, and related information needed
to investigate violence, threats, harassment, intimidation, or other
inappropriate behavior causing SEC employees, contractors, or other
individuals to fear for their personal safety in the SEC workplace.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    5 U.S.C. 7902(d) and (e).

PURPOSE(S):
    The records are used by SEC personnel to take action on, or to
respond to a complaint about a threat, harassment, intimidation,
violence, or other inappropriate behavior involving one or more SEC
employees, contractors, interns, or other individuals against an SEC
employee; and to make assessments of violent or potentially violent
situations and then make recommendations regarding interventions for
those persons involved with the situations.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
    In addition to those disclosures generally permitted under 5 U.S.C.
552a(b) of the Privacy Act, these records or information contained
therein may specifically be disclosed as follows:
    1. To appropriate agencies, entities, and persons when (a) It is
suspected or confirmed that the security or confidentiality of
information in the system of records has been compromised; (b) the SEC
has determined that, as a result of the suspected or confirmed
compromise, there is a risk of harm to economic or property interests,
identity theft or fraud, or harm to the security or integrity of this
system or other systems or programs (whether maintained by the SEC or
another agency or entity) that rely upon the compromised information;
and (c) the disclosure made to such agencies, entities, and persons is
reasonably necessary to assist in connection with the SEC's efforts to
respond to the suspected or confirmed compromise and prevent, minimize,
or remedy such harm.
    2. When a person or property is harmed, or when threats of harm to
a person or property are reported, disclosure will be made, as
appropriate, to law enforcement authorities, medical treatment
authorities, and those persons being threatened or harmed.
    3. To other Federal, State, local, or foreign law enforcement
agencies; securities self-regulatory organizations; and foreign
securities authorities to assist in or coordinate regulatory or law
enforcement activities with the SEC.
    4. To a bar association, a state accountancy board, the Public
Company Accounting Oversight Board, or any similar Federal, State, or
local licensing authority for possible disciplinary action.
    5. To a Federal, State, local, tribal, foreign, or international
agency, if necessary to obtain information relevant to the SEC's
decision concerning the hiring or retention of an employee; the
issuance of a security clearance; the letting of a contract; or the
issuance of a license, grant, or other benefit.
    6. To a Federal, State, local, tribal, foreign, or international
agency in response to its request for information concerning the hiring
or retention of an employee; the issuance of a security clearance; the
reporting of an investigation of an employee; the letting of a
contract; or the issuance of a license, grant, or other benefit by the
requesting agency, to the extent that the information is relevant and
necessary to the requesting agency's decision on the matter.
    7. To produce summary descriptive statistics and analytical
studies, as a data source for management information, in support of the
function for which the records are collected and maintained or for
related personnel management functions or manpower studies; may also be
used to respond to general requests for statistical information
(without personal identification of individuals) under the Freedom of
Information Act.
    8. To any persons during the course of any inquiry, examination, or
investigation conducted by the SEC's staff, or in connection with civil
litigation, if the staff has reason to believe that the person to whom
the record is disclosed may have further information about the matters
related therein, and those matters appeared to be relevant at the time
to the subject matter of the inquiry.
    9. To interns, grantees, experts, contractors, and others who have
been engaged by the Commission to assist in the performance of a
service related to this system of records and who need access to the
records for the purpose of assisting the Commission in the efficient
administration of its programs, including by performing clerical,
stenographic, or data analysis functions, or by reproduction of records
by electronic or other means. Recipients of these records shall be
required to comply with the requirements of the Privacy Act of 1974, as
amended, 5 U.S.C. 552a.
    10. To members of advisory committees that are created by the
Commission or by Congress to render advice and recommendations to the
Commission or to Congress, to be used solely in connection with their
official designated functions.
    11. To any person who is or has agreed to be subject to the
Commission's Rules of Conduct, 17 CFR 200.735-1 to 200.735-18, and who
assists in the investigation by the Commission of possible violations
of the Federal securities laws (as such term is defined in section
3(a)(47) of the Securities Exchange Act of 1934, 15 U.S.C. 78c(a)(47)),
in the preparation or conduct of enforcement actions brought by the
Commission for such violations, or otherwise in connection with the
Commission's enforcement or regulatory functions under the Federal
securities laws.
    12. To a Congressional office in response to an inquiry from that
Congressional office made at the request of the individual to whom the
record pertains.
    13. To respond to subpoenas in any litigation or other proceeding.
    14. To members of Congress, the Government Accountability Office,
or others charged with monitoring the work of the Commission or
conducting records management inspections.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    Records are maintained in electronic and paper format. Electronic
records are stored in computerized databases and/or on computer disc in
accordance with all appropriate laws. Paper records are

stored in locked file rooms and/or file cabinets.

RETRIEVABILITY:
    Records are retrieved by name or case designation (those who
reported a violent or potentially violent event and those who were
reported), event date, and event location.

SAFEGUARDS:
    Records are safeguarded in a secured environment. Buildings where
records are stored have security cameras and 24 hour security guard
service. Access is limited to those personnel whose official duties
require access. Paper records are maintained in limited access areas
during duty hours and in locked file cabinets and/or locked offices or
file rooms at all other times. Computerized records are safeguarded
through use of access codes and information technology security.

RETENTION AND DISPOSAL:
    These records will be maintained until they become inactive, at
which time they will be retired or destroyed in accordance with records
schedules of the United States Securities and Exchange Commission and
as approved by the National Archives and Records Administration.

SYSTEM MANAGER(S) AND ADDRESS:
    Chief, SEC Security Branch, 100 F Street, NE., Washington, DC
20549-5100

NOTIFICATION PROCEDURE:
    All requests to determine whether this system of records contains a
record pertaining to the requesting individual may be directed to the
FOIA/PA Officer, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-5100.

RECORD ACCESS PROCEDURE:
    Persons wishing to obtain information on the procedures for gaining
access to or contesting the contents of these records may contact the
FOIA/Privacy Act Officer, Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-5100.

CONTESTING RECORD PROCEDURES:
    See Record Access Procedures above.

RECORD SOURCE CATEGORIES:
    Records source is from individuals who report potential or actual
workplace security incidents, and reports made on individuals
interviewed or investigated in connection with allegations of potential
or actual workplace security incidents.

EXEMPTIONS CLAIMED FOR THE SYSTEM:
    Under 5 U.S.C. 552a(k)(2), this system of records is exempted from
the following provisions of the Privacy Act, 5 U.S.C. 552a(c)(3), (d),
(e)(1), (e)(4)(G), (H), and (I), and (f) and 17 CFR 200.303, 200.304,
and 200.306, insofar as it contains investigatory materials compiled
for law enforcement purposes. This exemption is contained in 17 CFR
200.312(a)(1).
SEC-65

SYSTEM NAME:
    Investor Response Information System (IRIS).

SYSTEM LOCATION:
    Securities and Exchange Commission, 100 F Street, NE., Washington,
DC 20549. Also, records covered by Subsystem A are received by and
maintained in the Commission's Regional Offices, whose addresses are
listed below under System Manager(s) and Address.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Subsystem A: Records are maintained on members of the public and
others who submit inquiries or make complaints to the Commission,
generally, or to Divisions and Offices of the Commission or who contact
the Office of Investor Education and Advocacy (OIEA) or the
Commission's Regional Offices.
    Subsystem B: Records are maintained on members of the public,
members of Congress or their staff, and others who address their
inquiries or complaints to the Commission's Chairman or the Office of
Legislative and Intergovernmental Affairs.
    Subsystem C: Records are maintained on members of the public who
submit requests for copies of, or review of records accessible through
the Commission's Public Reference Room.
    Subsystem D: Computerized records are comprised of data collected
in all of the above subsystems.

CATEGORIES OF RECORDS IN THE SYSTEM:
    Both electronic and paper records in this system/subsystems may
contain the name of the complainant/inquirer/requester or their
representative, the name of the entity and/or subject of the complaint/
inquiry/request, the date relating to the receipt and disposition of
the complaint/inquiry/request and, where applicable, the type of
complaint/inquiry/request and other information derived from or
relating to the complaint/inquiry/request. Paper records may include,
but are not limited to, letters of complaint/inquiry/request,
responses, and related documentation.

 AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    15 U.S.C. 77s, 77sss, 78d, 78d-1, 78d-2, 78w, 78ll(d), 79t, 80a-37,
and 80b-11.

PURPOSE(S):
    The records will be used by the staff to track and process
complaints/inquiries/requests from members of the public and others.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
    In addition to those disclosures generally permitted under 5 U.S.C.
552a(b) of the Privacy Act, these records or information contained
therein may specifically be disclosed outside the Commission as a
routine use pursuant to 5 U.S.C. 552 a(b)(3) as follows:
    1. To appropriate agencies, entities, and persons when (a) it is
suspected or confirmed that the security or confidentiality of
information in the system of records has been compromised; (b) the SEC
has determined that, as a result of the suspected or confirmed
compromise, there is a risk of harm to economic or property interests,
identity theft or fraud, or harm to the security or integrity of this
system or other systems or programs (whether maintained by the SEC or
another agency or entity) that rely upon the compromised information;
and (c) the disclosure made to such agencies, entities, and persons is
reasonably necessary to assist in connection with the SEC's efforts to
respond to the suspected or confirmed compromise and prevent, minimize,
or remedy such harm.
    2. To other Federal, State, local, or foreign law enforcement
agencies; securities self-regulatory organizations; and foreign
financial regulatory authorities to assist in or coordinate regulatory
or law enforcement activities with the SEC.
    3. To national securities exchanges and national securities
associations that are registered with the SEC, the Municipal Securities
Rulemaking Board; the Securities Investor Protection Corporation; the
Public Company Accounting Oversight Board; the Federal banking
authorities, including, but not limited to, the Board of Governors of
the Federal Reserve System, the Comptroller of the Currency, and the
Federal Deposit Insurance Corporation; state securities regulatory
agencies or organizations; or regulatory authorities of a foreign
government in connection with their regulatory or enforcement
responsibilities.

    4. By SEC personnel for purposes of investigating possible
violations of, or to conduct investigations authorized by, the Federal
securities laws.
    5. In any proceeding where the Federal securities laws are in issue
or in which the Commission, or past or present members of its staff, is
a party or otherwise involved in an official capacity.
    6. In connection with proceedings by the Commission pursuant to
Rule 102(e) of its Rules of Practice, 17 CFR 201.102(e).
    7. To a bar association, state accountancy board, or other Federal,
State, local, or foreign licensing or oversight authority; or
professional association or self-regulatory authority to the extent
that it performs similar functions (including the Public Company
Accounting Oversight Board) for investigations or possible disciplinary
action.
    8. To a Federal, State, local, tribal, foreign, or international
agency, if necessary to obtain information relevant to the SEC's
decision concerning the hiring or retention of an employee; the
issuance of a security clearance; the letting of a contract; or the
issuance of a license, grant, or other benefit.
    9. To a Federal, State, local, tribal, foreign, or international
agency in response to its request for information concerning the hiring
or retention of an employee; the issuance of a security clearance; the
reporting of an investigation of an employee; the letting of a
contract; or the issuance of a license, grant, or other benefit by the
requesting agency, to the extent that the information is relevant and
necessary to the requesting agency's decision on the matter.
    10. To produce summary descriptive statistics and analytical
studies, as a data source for management information, in support of the
function for which the records are collected and maintained or for
related personnel management functions or manpower studies; may also be
used to respond to general requests for statistical information
(without personal identification of individuals) under the Freedom of
Information Act.
    11. To any trustee, receiver, master, special counsel, or other
individual or entity that is appointed by a court of competent
jurisdiction, or as a result of an agreement between the parties in
connection with litigation or administrative proceedings involving
allegations of violations of the Federal securities laws (as defined in
section 3(a)(47) of the Securities Exchange Act of 1934, 15 U.S.C.
78c(a)(47)) or pursuant to the Commission's Rules of Practice, 17 CFR
201.100-900 or the Commission's Rules of Fair Fund and Disgorgement
Plans, 17 CFR 201.1100-1106, or otherwise, where such trustee,
receiver, master, special counsel, or other individual or entity is
specifically designated to perform particular functions with respect
to, or as a result of, the pending action or proceeding or in
connection with the administration and enforcement by the Commission of
the Federal securities laws or the Commission's Rules of Practice or
the Rules of Fair Fund and Disgorgement Plans.
    12. To any persons during the course of any inquiry, examination,
or investigation conducted by the SEC's staff, or in connection with
civil litigation, if the staff has reason to believe that the person to
whom the record is disclosed may have further information about the
matters related therein, and those matters appeared to be relevant at
the time to the subject matter of the inquiry.
    13. To interns, grantees, experts, contractors, and others who have
been engaged by the Commission to assist in the performance of a
service related to this system of records and who need access to the
records for the purpose of assisting the Commission in the efficient
administration of its programs, including by performing clerical,
stenographic, or data analysis functions, or by reproduction of records
by electronic or other means. Recipients of these records shall be
required to comply with the requirements of the Privacy Act of 1974, as
amended, 5 U.S.C. 552a.
    14. In reports published by the Commission pursuant to authority
granted in the Federal securities laws (as such term is defined in
section 3(a)(47) of the Securities Exchange Act of 1934, 15 U.S.C.
78c(a)(47)), which authority shall include, but not be limited to,
section 21(a) of the Securities Exchange Act of 1934, 15 U.S.C.
78u(a)).
    15. To members of advisory committees that are created by the
Commission or by Congress to render advice and recommendations to the
Commission or to Congress, to be used solely in connection with their
official designated functions.
    16. To any person who is or has agreed to be subject to the
Commission's Rules of Conduct, 17 CFR 200.735-1 to 200.735-18, and who
assists in the investigation by the Commission of possible violations
of the Federal securities laws (as such term is defined in section
3(a)(47) of the Securities Exchange Act of 1934, 15 U.S.C. 78c(a)(47)),
in the preparation or conduct of enforcement actions brought by the
Commission for such violations, or otherwise in connection with the
Commission's enforcement or regulatory functions under the Federal
securities laws.
    17. To a Congressional office from the record of an individual in
response to an inquiry from the Congressional office made at the
request of that individual.
    18. To members of Congress, the press, and the public in response
to inquiries relating to particular Registrants and their activities,
and other matters under the Commission's jurisdiction.
    19. To prepare and publish information relating to violations of
the Federal securities laws as provided in 15 U.S.C. 78c(a)(47)), as
amended.
    20. To respond to subpoenas in any litigation or other proceeding.
    21. To a trustee in bankruptcy.
    22. To members of Congress, the General Accountability Office, or
others charged with monitoring the work of the Commission or conducting
records management inspections.
    23. To respond to inquiries from individuals who have submitted
complaints/inquiries/request, or from their representatives.
    24. To entities against which complaints/inquiries/requests are
directed when Commission staff requests them to research the issues
raised and report back to the staff.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    Records are maintained in electronic and paper format. Electronic
records are stored in computerized databases and/or on computer disc.
Paper records and records on computer disc are stored in file rooms
and/or file cabinets, as well as off-site locations including the
Federal Records Center, pursuant to applicable record retention
guidelines.

RETRIEVABILITY:
    By use of the computerized records in Subsystem D, the files (both
paper and electronic) in Subsystems A, B, and C are retrievable by the
name, receipt date, name of the registered representative or associated
person named in the complaint/inquiry/request, or the name of the
entity/issuer that is the subject of the complaint/inquiry/request.

SAFEGUARDS:
    Records are safeguarded in a secured environment. Buildings where
records are stored have security cameras and 24 hour security guard
service. The records are kept in limited access areas during duty hours
and in file cabinets and/or

offices or file rooms at all other times. Computerized records are
safeguarded through use of access codes and information technology
security. Contractors and other recipients providing services to the
Commission are contractually obligated to maintain equivalent
safeguards.

RETENTION AND DISPOSAL:
    These records will be maintained until they become inactive, at
which time they will be retired or destroyed in accordance with records
schedules of the United States Securities and Exchange Commission and
as approved by the National Archives and Records Administration.

SYSTEM MANAGER(S) AND ADDRESS:
    Subsystem A: Chief Counsel, Office of Investor Education and
Advocacy, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549; New York Regional Office, Regional Director, 3
World Financial Center, Suite 400, New York, NY 10281-1022; Boston
Regional Office, Regional Director, 33 Arch Street, 23rd Floor, Boston,
MA 02110-1424; Philadelphia Regional Office, Regional Director, The
Mellon Independence Center, 701 Market Street, Suite 2000,
Philadelphia, PA 19106-1532; Miami Regional Office, Regional Director,
801 Brickell Avenue, Suite 1800, Miami, FL 33131-4901, Atlanta Regional
Office, Regional Director, 3475 Lenox Road, NE., Suite 1000, Atlanta,
GA 30326-1232; Chicago Regional Office, Regional Director, 175 West
Jackson Boulevard, Suite 900, Chicago, IL 60604-2908; Denver Regional
Office, Regional Director, 1801 California Street, Suite 1500, Denver,
CO 80202-2656; Fort Worth Regional Office, Regional Director, Burnett
Plaza, Suite 1900, 801 Cherry Street, Unit 18, Fort Worth, TX
76102-6882; Salt Lake Regional Office, Regional Director, 15 West South
Temple Street, Suite 1800, Salt Lake City, UT 84101-1573; Los Angeles
Regional Office, Regional Director, 5670 Wilshire Boulevard, 11th
Floor, Los Angeles, CA 90036-3648; San Francisco Regional Office,
Regional Director, 44 Montgomery Street, Suite 2600, San Francisco, CA
94104-4716.
    Subsystem B: Office of the Chairman, Securities and Exchange
Commission, 100 F Street, NE., Washington, DC 20549.
    Subsystem C: Records Officer, Office of Records Management
Services, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549.
    Subsystem D: Chief Information Officer, Office of Information
Technology, Securities and Exchange Commission, Operations Center, Mail
Stop 0-4, 6432 General Green Way, Alexandria, VA 22312.

NOTIFICATION PROCEDURE:
    All requests to determine whether this system of records contains a
record pertaining to the requesting individual may be directed to the
FOIA/PA Officer, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-5100.

RECORD ACCESS PROCEDURES:
    Persons wishing to obtain information on the procedures for gaining
access to or contesting the contents of these records may contact the
FOIA/PA Officer, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-5100.

CONTESTING RECORD PROCEDURES:
    See Record access procedures above.

RECORD SOURCE CATEGORIES:
    Information collected in all subsystems is received from
individuals primarily through letters, telephone calls, or personal
visits to the Commission's offices.

EXEMPTIONS CLAIMED FOR THE SYSTEM:
    Under 5 U.S.C. 552a(k)(2), this system of records is exempted from
the following provisions of the Privacy Act, 5 U.S.C. 552a(c)(3), (d),
(e)(1), (e)(4)(G), (H), and (I), and (f) and 17 CFR 200.303, 200.304,
and 200.306, insofar as it contains investigatory materials compiled
for law enforcement purposes. This exemption is contained in 17 CFR
200.312(a)(1).
SEC-38

SYSTEM NAME:
    Disciplinary and Adverse Actions, Employee Conduct, and Labor
Relations Files.

SYSTEM LOCATION:
    Securities and Exchange Commission, Office of Human Resources, 100
F Street NE., Washington, DC 20549-3990.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Present and former SEC employees.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The system of records includes information in the following
categories of records: (a) Disciplinary and adverse action cases,
regulatory appeal files, grievances and complaints relating to an
employee, union issues (including collective bargaining documents and
dues withholding forms), leave bank/transfer date, and third party
complaints; (b) Investigatory materials gathered in connection with the
individual's initial appointment to the agency as well as materials
gathered in connection with investigations into allegations of employee
misconduct.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    5 U.S.C. 1302 & 2951 and 17 CFR 200.735-13.

PURPOSE(S):
    Assigned staff uses records to verify employee and agency
compliance with law, regulation, case decisions, agency policies, and
the Collective Bargaining Agreement.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
    In addition to those disclosures generally permitted under 5 U.S.C.
552a(b) of the Privacy Act, these records or information contained
therein may specifically be disclosed outside the Commission as a
routine use pursuant to 5 U.S.C. 552 a(b)(3) as follows:
    1. To appropriate agencies, entities, and persons when (a) it is
suspected or confirmed that the security or confidentiality of
information in the system of records has been compromised; (b) the SEC
has determined that, as a result of the suspected or confirmed
compromise, there is a risk of harm to economic or property interests,
identity theft or fraud, or harm to the security or integrity of this
system or other systems or programs (whether maintained by the SEC or
another agency or entity) that rely upon the compromised information;
and (c) the disclosure made to such agencies, entities, and persons is
reasonably necessary to assist in connection with the SEC's efforts to
respond to the suspected or confirmed compromise and prevent, minimize,
or remedy such harm.
    2. To other Federal, State, local, or foreign law enforcement
agencies; securities self-regulatory organizations; and foreign
financial regulatory authorities to assist in or coordinate regulatory
or law enforcement activities with the SEC.
    3. In any proceeding where the human resources law or regulations
are in issue or in which the Commission, or past or present members of
its staff, is a party or otherwise involved in an official capacity.
    4. To a Federal, State, local, tribal, foreign, or international
agency, if necessary to obtain information relevant to the SEC's
decision concerning the hiring or retention of an employee; the
issuance of a security clearance; the

letting of a contract; or the issuance of a license, grant, or other
benefit.
    5. To produce summary descriptive statistics and analytical
studies, as a data source for management information, in support of the
function for which the records are collected and maintained or for
related personnel management functions or manpower studies; may also be
used to respond to general requests for statistical information
(without personal identification of individuals) under the Freedom of
Information Act.
    6. To any persons during the course of any inquiry, examination, or
investigation conducted by the SEC's staff, or in connection with civil
litigation, if the staff has reason to believe that the person to whom
the record is disclosed may have further information about the matters
related therein, and those matters appeared to be relevant at the time
to the subject matter of the inquiry.
    7. To interns, grantees, experts, contractors, and others who have
been engaged by the Commission to assist in the performance of a
service related to this system of records and who need access to the
records for the purpose of assisting the Commission in the efficient
administration of its programs, including by performing clerical,
stenographic, or data analysis functions, or by reproduction of records
by electronic or other means. Recipients of these records shall be
required to comply with the requirements of the Privacy Act of 1974, as
amended, 5 U.S.C. 552a.
    8. To a Congressional office from the record of an individual in
response to an inquiry from the Congressional office made at the
request of that individual.
    9. To members of Congress, the Government Accountability Office, or
others charged with monitoring the work of the Commission or conducting
records management inspections.
    10. To a commercial contractor in connection with benefit programs
administered by the contractor on the Commission's behalf, including,
but not limited to, supplemental health, dental, disability, life and
other benefit programs.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
 STORAGE:
    Records are maintained in electronic and paper format. Electronic
records are stored in computerized databases and/or on computer disc.
Paper records and records on computer disc are stored in locked file
rooms and/or file cabinets.

 RETRIEVABILITY:
    Records are indexed and retrieved by employee name or assigned ID.

 SAFEGUARDS:
    Records are safeguarded in a secured environment. Buildings where
records are stored have security cameras and 24 hour security guard
service. The records are kept in limited access areas during duty hours
and in locked file cabinets and/or locked offices or file rooms at all
other times. Access is limited to those personnel whose official duties
require access. Computerized records are safeguarded through use of
access codes and information technology security. Contractors and other
recipients providing services to the Commission are contractually
obligated to maintain equivalent safeguards.

RETENTION AND DISPOSAL:
    These records will be maintained until they become inactive, at
which time they will be retired or destroyed in accordance with records
schedules of the United States Securities and Exchange Commission and
as approved by the National Archives and Records Administration.

 SYSTEM MANAGER(S) AND ADDRESS:
    Associate Executive Director, Office of Human Resources, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549-3990.

 NOTIFICATION PROCEDURE:
    All requests to determine whether this system of records contains a
record pertaining to the requesting individual may be directed to the
FOIA/PA Officer, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-5100.

RECORD ACCESS PROCEDURES:
    Persons wishing to obtain information on the procedures for gaining
access to or contesting the contents of these records may contact the
FOIA/PA Officer, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-5100.

CONTESTING RECORD PROCEDURES:
    See Record access procedures above.

RECORD SOURCE CATEGORIES:
    Employees, managers, union officials.

EXEMPTIONS CLAIMED FOR THE SYSTEM:
    Under 5 U.S.C. 552a(k)(2), this system of records is exempted from
the following provisions of the Privacy Act, 5 U.S.C. 552a(c)(3), (d),
(e)(1), (e)(4)(G), (H), and (I), and (f) and 17 CFR 200.303, 200.304,
and 200.306, insofar as it contains investigatory materials compiled to
determine an individual's suitability, eligibility, and qualifications
for Federal civilian employment or access to classified information,
but only to the extent that the disclosure of such material would
reveal the identity of a source who furnished information to the
Government under an express promise that the identity of the source
would be held in confidence, or, prior to September 27, 1975, under an
implied promise that the identity of the source would be held in
confidence. This exemption is contained in 17 CFR 200.312(b)(1).
SEC-42

SYSTEM NAME:
    Enforcement Files.

SYSTEM LOCATION:
    Securities and Exchange Commission, 100 F Street, NE., Washington,
DC 20549. Files may also be maintained in the Commission's Regional
Offices that conducted an investigation or litigation, or at a records
management company under contract with the Commission. Closed
investigatory files are stored at a Federal records center.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Records are maintained on persons who have been involved in
Commission investigations or litigation, or in activities which
violated or may have violated Federal, State or foreign laws relating
to transactions in securities, the conduct of securities business or
investment advisory activities, and banking or other financial
activities.

CATEGORIES OF RECORDS IN THE SYSTEM:
    Records contain names and addresses of persons involved in
Commission investigations or litigation. Also, correspondence relevant
to the matter, internal staff memoranda, Commission Minutes and
Commission Orders, copies of subpoenas issued in the course of the
matter, affidavits, transcripts of testimony and exhibits thereto,
copies of pleadings and exhibits in related private or governmental
actions, documents and other evidence obtained in the course of the
matter, computerized records, working papers of the staff and other
documents and records relating to the matter, opening reports, progress
reports and closing reports, and miscellaneous records relating to
investigations or litigation.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    15 U.S.C. 77s, 77t, 78u, 77uuu, 80a-41, and 80b-9. 17 CFR 202.5.

PURPOSE(S):
    The records are maintained for purposes of the Commission's
investigations and actions to enforce the Federal securities laws.
Additionally, the information in the system is used in conjunction with
the collection of amounts ordered to be paid in enforcement actions, a
function that is a necessary component of litigation.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
    In addition to those disclosures generally permitted under 5 U.S.C.
552a(b) of the Privacy Act, these records or information contained
therein may specifically be disclosed outside the Commission as a
routine use pursuant to 5 U.S.C. 552 a(b)(3) as follows:
    1. To appropriate agencies, entities, and persons when (a) it is
suspected or confirmed that the security or confidentiality of
information in the system of records has been compromised; (b) the SEC
has determined that, as a result of the suspected or confirmed
compromise, there is a risk of harm to economic or property interests,
identity theft or fraud, or harm to the security or integrity of this
system or other systems or programs (whether maintained by the SEC or
another agency or entity) that rely upon the compromised information;
and (c) the disclosure made to such agencies, entities, and persons is
reasonably necessary to assist in connection with the SEC's efforts to
respond to the suspected or confirmed compromise and prevent, minimize,
or remedy such harm.
    2. To other Federal, State, local, or foreign law enforcement
agencies; securities self-regulatory organizations; and foreign
financial regulatory authorities to assist in or coordinate regulatory
or law enforcement activities with the SEC.
    3. To national securities exchanges and national securities
associations that are registered with the SEC, the Municipal Securities
Rulemaking Board; the Securities Investor Protection Corporation; the
Public Company Accounting Oversight Board; the Federal banking
authorities, including, but not limited to, the Board of Governors of
the Federal Reserve System, the Comptroller of the Currency, and the
Federal Deposit Insurance Corporation; state securities regulatory
agencies or organizations; or regulatory authorities of a foreign
government in connection with their regulatory or enforcement
responsibilities.
    4. By SEC personnel for purposes of investigating possible
violations of, or to conduct investigations authorized by, the Federal
securities laws.
    5. In any proceeding where the Federal securities laws are in issue
or in which the Commission, or past or present members of its staff, is
a party or otherwise involved in an official capacity.
    6. In connection with proceedings by the Commission pursuant to
Rule 102(e) of its Rules of Practice, 17 CFR 201.102(e).
    7. To a bar association, state accountancy board, or other Federal,
State, local, or foreign licensing or oversight authority; or
professional association or self-regulatory authority to the extent
that it performs similar functions (including the Public Company
Accounting Oversight Board) for investigations or possible disciplinary
action.
    8. To a Federal, State, local, tribal, foreign, or international
agency, if necessary to obtain information relevant to the SEC's
decision concerning the hiring or retention of an employee; the
issuance of a security clearance; the letting of a contract; or the
issuance of a license, grant, or other benefit.
    9. To a Federal, State, local, tribal, foreign, or international
agency in response to its request for information concerning the hiring
or retention of an employee; the issuance of a security clearance; the
reporting of an investigation of an employee; the letting of a
contract; or the issuance of a license, grant, or other benefit by the
requesting agency, to the extent that the information is relevant and
necessary to the requesting agency's decision on the matter.
    10. To produce summary descriptive statistics and analytical
studies, as a data source for management information, in support of the
function for which the records are collected and maintained or for
related personnel management functions or manpower studies; may also be
used to respond to general requests for statistical information
(without personal identification of individuals) under the Freedom of
Information Act.
    11. To any trustee, receiver, master, special counsel, or other
individual or entity that is appointed by a court of competent
jurisdiction, or as a result of an agreement between the parties in
connection with litigation or administrative proceedings involving
allegations of violations of the Federal securities laws (as defined in
section 3(a)(47) of the Securities Exchange Act of 1934, 15 U.S.C.
78c(a)(47)) or pursuant to the Commission's Rules of Practice, 17 CFR
201.100-900 or the Commission's Rules of Fair Fund and Disgorgement
Plans, 17 CFR 201.1100-1106, or otherwise, where such trustee,
receiver, master, special counsel, or other individual or entity is
specifically designated to perform particular functions with respect
to, or as a result of, the pending action or proceeding or in
connection with the administration and enforcement by the Commission of
the Federal securities laws or the Commission's Rules of Practice or
the Rules of Fair Fund and Disgorgement Plans.
    12. To any persons during the course of any inquiry, examination,
or investigation conducted by the SEC's staff, or in connection with
civil litigation, if the staff has reason to believe that the person to
whom the record is disclosed may have further information about the
matters related therein, and those matters appeared to be relevant at
the time to the subject matter of the inquiry.
    13. To interns, grantees, experts, contractors, and others who have
been engaged by the Commission to assist in the performance of a
service related to this system of records and who need access to the
records for the purpose of assisting the Commission in the efficient
administration of its programs, including by performing clerical,
stenographic, or data analysis functions, or by reproduction of records
by electronic or other means. Recipients of these records shall be
required to comply with the requirements of the Privacy Act of 1974, as
amended, 5 U.S.C. 552a.
    14. In reports published by the Commission pursuant to authority
granted in the Federal securities laws (as such term is defined in
section 3(a)(47) of the Securities Exchange Act of 1934, 15 U.S.C.
78c(a)(47)), which authority shall include, but not be limited to,
section 21(a) of the Securities Exchange Act of 1934, 15 U.S.C.
78u(a)).
    15. To members of advisory committees that are created by the
Commission or by Congress to render advice and recommendations to the
Commission or to Congress, to be used solely in connection with their
official designated functions.
    16. To any person who is or has agreed to be subject to the
Commission's Rules of Conduct, 17 CFR 200.735-1 to 200.735-18, and who
assists in the investigation by the Commission of possible violations
of the Federal securities laws (as such term is defined in section
3(a)(47) of the Securities Exchange Act of 1934, 15 U.S.C. 78c(a)(47)),
in the preparation or conduct of enforcement actions brought

by the Commission for such violations, or otherwise in connection with
the Commission's enforcement or regulatory functions under the Federal
securities laws.
    17. To a Congressional office from the record of an individual in
response to an inquiry from the Congressional office made at the
request of that individual.
    18. To members of Congress, the press, and the public in response
to inquiries relating to particular Registrants and their activities,
and other matters under the Commission's jurisdiction.
    19. To prepare and publish information relating to violations of
the Federal securities laws as provided in 15 U.S.C. 78c(a)(47), as
amended.
    20. To respond to subpoenas in any litigation or other proceeding.
    21. To a trustee in bankruptcy.
    22. To any governmental agency, governmental or private collection
agent, consumer reporting agency or commercial reporting agency,
governmental or private employer of a debtor, or any other person, for
collection, including collection by administrative offset, Federal
salary offset, tax refund offset, or administrative wage garnishment,
of amounts owed as a result of Commission civil or administrative
proceedings.

DISCLOSURE TO CONSUMER REPORTING AGENCIES:
    When the Commission seeks to collect a debt arising from a civil
action or administrative proceeding, it may disclose the following
information to a consumer reporting agency: (i) information necessary
to establish the identity of the debtor, including name, address and
taxpayer identification number or social security number; (ii) the
amount, status, and history of the debt; and (iii) the fact that the
debt arose from a Commission action or proceeding to enforce the
Federal securities laws.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
 STORAGE:
    Records are maintained in electronic and paper format. Electronic
records are stored in computerized databases and/or on computer disc.
Paper records and records on computer disc are stored in locked file
rooms and/or file cabinets.

RETRIEVABILITY:
    The records are retrieved by the name under which the investigation
is conducted or administrative or judicial litigation is filed. Access
to information about an individual may be obtained through the
Commission's Name-Relationship Search Index system by the name of the
individual. Information concerning an individual may also be obtained
by reference to computer-based indices maintained by the Division of
Enforcement.

SAFEGUARDS:
    Records are safeguarded in a secured environment. Buildings where
records are stored have security cameras and 24 hour security guard
service. The records are kept in limited access areas during duty hours
and in locked file cabinets and/or locked offices or file rooms at all
other times. Access is limited to those personnel whose official duties
require access. Computerized records are safeguarded through use of
access codes and information technology security. Contractors and other
recipients providing services to the Commission are contractually
obligated to maintain equivalent safeguards.

RETENTION AND DISPOSAL:
    These records will be maintained until they become inactive, at
which time they will be retired or destroyed in accordance with records
schedules of the United States Securities and Exchange Commission and
as approved by the National Archives and Records Administration.

SYSTEM MANAGER(S) AND ADDRESS:
    Director, Division of Enforcement, Securities and Exchange
Commission, 100 F Street, NE., Washington, DC 20549-0801; Records
Officer, Office of Records Management Services, Securities and Exchange
Commission, 100 F Street, NE., Washington, DC 20549; New York Regional
Office, Regional Director, 3 World Financial Center, Suite 400, New
York, NY 10281-1022; Boston Regional Office, Regional Director, 33 Arch
Street, 23rd Floor, Boston, MA 02110-1424; Philadelphia Regional
Office, Regional Director, The Mellon Independence Center, 701 Market
Street, Philadelphia, PA 19106-1532; Miami Regional Office, Regional
Director, 801 Brickell Ave., Suite 1800, Miami, FL 33131, Atlanta
Regional Office, Regional Director, 3475 Lenox Road, NE., Suite 1000,
Atlanta, GA 30326-1232; Chicago Regional Office, Regional Director, 175
W. Jackson Boulevard, Suite 900, Chicago, IL 60604; Denver Regional
Office, Regional Director, 1801 California Street, Suite 1500, Denver,
CO 80202-2656; Fort Worth Regional Office, Regional Director, Burnett
Plaza, Suite 1900, 801 Cherry Street, Unit 18, Fort Worth, TX 76102;
Salt Lake Regional Office, Regional Director, 15 W. South Temple
Street, Suite 1800, Salt Lake City, UT 84101; Los Angeles Regional
Office, Regional Director, 5670 Wilshire Boulevard, 11th Floor, Los
Angeles, CA 90036-3648; San Francisco Regional Office, Regional
Director, 44 Montgomery Street, Suite 2600, San Francisco, CA 94104.

NOTIFICATION PROCEDURE:
    All requests to determine whether this system of records contains a
record pertaining to the requesting individual may be directed to the
FOIA/PA Officer, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-5100.

RECORD ACCESS PROCEDURES:
    Persons wishing to obtain information on the procedures for gaining
access to or contesting the contents of these records may contact the
FOIA/PA Officer, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-5100.

CONTESTING RECORD PROCEDURES:
    See Record Access Procedures above.

 RECORD SOURCE CATEGORIES:
    Information in these records is supplied by: Individuals including,
where practicable, those to whom the information relates; witnesses,
banks, corporations, or other entities; self-regulatory organizations;
the Postal Inspection Service, the Department of Justice, state
securities commissions, other Federal, state, or local bodies and law
enforcement agencies or foreign governmental authorities; public
sources, i.e., libraries, newspapers, television, radio, court records,
filings with Federal, state, and local bodies; filings made with the
SEC pursuant to law; electronic information sources; other offices
within the Commission; documents, litigation, transcripts of testimony,
evidence introduced into court, orders entered by a court and
correspondence relating to litigation; pleadings in administrative
proceedings, transcripts of testimony, documents, including evidence
entered in such proceedings, and miscellaneous other sources.

EXEMPTIONS CLAIMED FOR THE SYSTEM:
    Under 5 U.S.C. 552a(k)(2), this system of records is exempted from
the following provisions of the Privacy Act, 5 U.S.C. 552a(c)(3), (d),
(e)(1), (e)(4)(G), (H), and (I), and (f) and 17 CFR 200.303, 200.304,
and 200.306, insofar as it contains investigatory materials compiled
for law enforcement purposes. This exemption is contained in 17 CFR
200.312(a)(1).

    By the Commission.

    Dated: May 18, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-12699 Filed 5-23-11; 8:45 am]
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greater than those of VIP Growth Portfolio except for the Service Class
shares of VIP Growth Portfolio.

                                                                        [Percent]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                T. Rowe Price Large   T. Rowe Price Large
                                            VIP Growth Portfolio  VIP Growth Portfolio  VIP Growth Portfolio  Cap Growth Portfolio  Cap Growth Portfolio
                                               (Initial Class)      (Service Class 2)      (Service Class)          (Class A)             (Class B)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Management Fee............................                  0.57                  0.57                  0.57                  0.60                  0.60
12b-1 Fee.................................  ....................                  0.25                  0.10  ....................                  0.25
Other Expenses............................                  0.10                  0.10                  0.10                  0.12                  0.12
Total Expenses............................                  0.67                  0.92                  0.77                  0.72                  0.97
Waivers...................................               \+\0.04               \+\0.04               \+\0.04               \+\0.01               \+\0.01
Net Expenses..............................                  0.63                  0.88                  0.73                  0.71                 0.96
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Voluntary waiver which can be discontinued at any time.

30. Lazard Retirement Small Cap Portfolio--Third Avenue Small Cap Value
Portfolio

    The aggregate amount of assets in the Lazard Retirement Small Cap
Portfolio as of December 31, 2005 was approximately $137 million. As of
December 31, 2005, Third Avenue Small Cap Value Portfolio's total
assets were approximately $912 million. As set forth below, the
historical performance of Third Avenue Small Cap Value Portfolio for
the one-year period ended December 31, 2005 exceeded that of Lazard
Retirement Small Cap Value Portfolio. Third Avenue Small Cap Portfolio
commenced operation on May 1, 2002.

                                [Percent]
------------------------------------------------------------------------
                                                     Third Avenue Small
                                Lazard Retirement    Cap Value Portfolio
                               Small Cap Portfolio        (Class B)
------------------------------------------------------------------------
One Year....................                  3.99                 15.48
------------------------------------------------------------------------

    In addition, as set forth below, the management fee of Third Avenue
Small Cap Value Portfolio is the same as that of Lazard Retirement
Small Cap Portfolio and the total operating expenses of Third Avenue
Small Cap Value Portfolio are less than those of Lazard Retirement
Small Cap Portfolio.

                                [Percent]
------------------------------------------------------------------------
                                                     Third Avenue Small
                                Lazard Retirement    Cap Value Portfolio
                               Small Cap Portfolio        (Class B)
------------------------------------------------------------------------
Management Fee..............                  0.75                  0.75
12b-1 Fee...................                  0.25                  0.25
Other Expenses..............                  0.22                  0.05
Total Expenses..............                  1.22                  1.05
Waivers.....................  ....................  ....................
Net Expenses................                  1.22                  1.05
------------------------------------------------------------------------

[FR Doc. 06-3318 Filed 4-10-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 193 (Thursday, October 6, 2022)]
[Notices]
[Page 60680]
[FR Doc No: 2022-21781]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-2963-000]

Yellowbud Solar, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Yellowbud Solar, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 20, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: September 30, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-21781 Filed 10-5-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85629-85630]
[FR Doc No: 2023-27004]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2022-E-2102 and FDA-2022-E-2103]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by February 6, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by June 5, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 6, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2022-E-2102 and FDA-2022-E-2103 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; EXKIVITY.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.

    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product EXKIVITY
(mobocertinib). EXKIVITY is indicated for the treatment of adult
patients with locally advanced or metastatic non-small cell lung cancer
with epidermal growth factor receptor exon 20 insertion mutations, as
detected by an FDA-approved test, whose disease has progressed on or
after platinum-based chemotherapy. Subsequent to this approval, the
USPTO received a patent term restoration application for EXKIVITY (U.S.
Patent Nos. 9,796,712; 10,227,342) from Takeda Pharmaceutical Company
Limited and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
September 28, 2022, FDA advised the USPTO that this human drug product
had undergone a regulatory review period and that the approval of
EXKIVITY represented the first permitted commercial marketing or use of
the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
EXKIVITY is 2,059 days. Of this time, 1,857 days occurred during the
testing phase of the regulatory review period, while 202 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
January 28, 2016. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
January 28, 2016.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: February 26,
2021. FDA has verified the applicant's claim that the new drug
application (NDA) for EXKIVITY (NDA 215310) was initially submitted on
February 26, 2021.
    3. The date the application was approved: September 15, 2021. FDA
has verified the applicant's claim that NDA 215310 was approved on
September 15, 2021.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 126 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27004 Filed 12-7-23; 8:45 am]
BILLING CODE 4164-01-P