[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16310-16312]
[FR Doc No: 2022-05781]

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DEPARTMENT OF TRANSPORTATION

[DOT-OST-2021-0009]

Solicitation for Annual Combating Human Trafficking in
Transportation Impact Award

AGENCY: Office of the Secretary of Transportation, U.S. Department of
Transportation.

ACTION: Notice.

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SUMMARY: The annual Combating Human Trafficking in Transportation
Impact Award (the award) seeks to raise awareness among transportation
stakeholders about human trafficking and increase training and
prevention to combat it. The award is a component of the Department of
Transportation (DOT) Transportation Leaders Against Human Trafficking
initiative. Additional information regarding the Department's counter-
trafficking activities can be found at www.transportation.gov/stophumantrafficking.

DATES: Submissions accepted March 22, 2022 through midnight PST on May
23, 2022.

FOR FURTHER INFORMATION CONTACT: For more information, and to register
your intent to compete individually or as part of a team, visit
www.transportation.gov/stophumantrafficking, email [email protected],
or contact Maha Alkhateeb in the Office of International Transportation
and Trade at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The award serves as a platform for
transportation stakeholders to creatively develop impactful and
innovative counter-trafficking tools, initiatives, campaigns, and
technologies that can help stop these heinous crimes. The award is open
to individuals and entities, including non-governmental organizations,
transportation industry associations, research institutions, and state
and local government organizations. Entrants compete for a cash award
of up to $50,000 to be awarded to the individual(s) or entity selected
for creating the most impactful counter-trafficking initiative or
technology. DOT intends to incentivize individuals and entities to
think creatively in developing innovative solutions to combat human
trafficking in the transportation industry, and to share those
innovations with the broader community.
    Award Approving Official: The Secretary of Transportation
(Secretary).
    Subject of Award Competition: The Combating Human Trafficking in
Transportation Impact Award will recognize impactful and innovative
approaches to combating human trafficking in the transportation
industry.

Problem

    As many as 25 million men, women, and children are held against
their will and trafficked into forced labor and prostitution.
Transportation figures prominently in human trafficking enterprises
when traffickers move victims, which uniquely positions the industry to
combat the crime.

Challenge

    The Combating Human Trafficking in Transportation Impact Award is
looking for the best innovators to develop original, impactful, and
unique human trafficking tools, initiatives, campaigns, and
technologies that can help stop these heinous crimes in the
transportation industry.

Eligibility

    To be eligible to participate in the Combating Human Trafficking in
Transportation Impact Award competition, private entities must be
incorporated in and maintain a primary place of business in the United
States, and individuals must be citizens or permanent residents of the
United States. There is no charge to enter the competition.

Rules, Terms, and Conditions

    The following additional rules apply:
    1. Entrants shall submit a project to the competition under the
rules promulgated by the Department in this Notice;
    2. Entrants must indemnify, defend, and hold harmless the Federal
Government from and against all third-party claims, actions, or
proceedings of any kind and from any and all damages, liabilities,
costs, and expenses relating to or arising from participant's
submission or any breach or alleged breach of any of the
representations, warranties, and covenants of participant hereunder.
Entrants are financially

responsible for claims made by a third party;
    3. Entrants may not be a Federal entity or Federal employee acting
within the scope of employment;
    4. Entrants may not be an employee of the U.S. Department of
Transportation;
    5. Entrants shall not be deemed ineligible because an individual
used Federal facilities or consulted with Federal employees during a
competition if the facilities and employees are made available to all
individuals participating in the competition on an equitable basis;
    6. The entries cannot have been submitted in the same or
substantially similar form in any other previous Federally sponsored
promotion or Federally sponsored competition;
    7. Entrants previously awarded first place are not eligible to
reenter for the same or substantially similar project;
    8. Entries which, in the Department's sole discretion, are
determined to be substantially similar to another entity's entry
submitted to this competition may be disqualified;
    9. The competition is subject to all applicable Federal laws and
regulations. Participation constitutes the entrants' full and
unconditional agreement to these rules and to the Secretary's
decisions, which are final and binding in all matters related to this
competition;
    10. Entries must be original, be the work of the entrant and/or
nominee, and must not violate the rights of other parties. All entries
remain the property of the entrant. Each entrant represents and
warrants that:
     Entrant is the sole author and owner of the submission;
     The entry is not the subject of any actual or threatened
litigation or claim;
     The entry does not and will not violate or infringe upon
the intellectual property rights, privacy rights, publicity rights, or
other legal rights of any third party; and
     The entry does not and will not contain any harmful
computer code (sometimes referred to as ``malware,'' ``viruses,'' or,
``worms'').
    11. By submitting an entry in this competition, entrants agree to
assume any and all risks and waive any claims against the Federal
Government and its related entities (except in the case of willful
misconduct) for any injury, death, damage, or loss of property, revenue
or profits, whether direct, indirect, or consequential, arising from
their participation in this competition, whether the injury, death,
damage, or loss arises through negligence of otherwise. Provided,
however, that by registering or submitting an entry, entrants and/or
nominees do not waive claims against the Department arising out of the
unauthorized use or disclosure by the agency of the intellectual
property, trade secrets, or confidential information of the entrant;
    12. The Secretary or the Secretary's designees have the right to
request additional supporting documentation regarding the application
from the entrants and/or nominees;
    13. Each entrant grants to the Department, as well as other Federal
agencies with which it partners, the right to use names, likeness,
application materials, photographs, voices, opinions, and hometown and
state for the Department's promotional purposes in any media, in
perpetuity, worldwide, without further payment or consideration;
    14. If selected, the entrant and/or nominee must provide written
consent granting the Department and any parties acting on their behalf,
a royalty-free, non-exclusive, irrevocable, worldwide license to
display publicly and use for promotional purposes the entry
(``demonstration license''). This demonstration license includes
posting or linking to the entry on Department websites, including the
Competition website, and partner websites, and inclusion of the entry
in any other media, worldwide;
    15. Applicants which are Federal grant recipients may not use
Federal funds to develop submissions;
    16. Federal contractors may not use Federal funds from a contract
to develop applications or to fund efforts in support of a submission;
and
    17. The submission period begins on March 22, 2022. Submissions
must be sent by 11:59 p.m. Eastern Standard Time on May 23, 2022. The
timeliness of submissions will be determined by the postmark (if sent
in hard copy) or time stamp of the recipient (if emailed). Competition
administrators assume no responsibility for lost or untimely
submissions for any reason.

Submission Requirements

    Applicants must submit entries via email or by mail. Electronic
packages may be transmitted by email to: [email protected]. Hard
copies should be forwarded with a cover letter to the attention of:
Combating Human Trafficking in Transportation Impact Award (Room W88-
121), 1200 New Jersey Avenue SE, Washington, DC 20590.
    Expression of Interest: While not required, entrants are strongly
encouraged to send brief expressions of interest to the DOT prior to
submitting entries. The expressions of interest should be sent by April
21, 2022 to [email protected], and include the following elements:
(1) Name of entrant/s; (2) Telephone and email address; and (3) A
synopsis of the concept, limited to no more than two pages.
    Please ensure your submission package includes ALL of the following
elements:

1. Entity

    The (1) name of the submitting individual(s) or organization, (2)
their title, (3) phone, (4) email, (5) website URL, and (6) mailing
address. If the point of contact for the project is different, also
specify their name, title, phone, and email.

2. Background

    Brief background regarding the submitting individual(s) or
organization(s) that includes project-related expertise.

3. Eligibility Statement

    A statement of eligibility by private entities indicating that they
are incorporated in and maintain a primary place of business in the
United States, or a statement of eligibility by individuals indicating
that they citizens or permanent residents of the United States.

4. Mode(s)

    Specify which transportation mode(s) the project will focus on.

5. Title

    The project title.

6. Project Summary and Overview (1-2 Pages)

    A (1) one-paragraph synopsis of the proposed project followed by a
(2) 1-2 page overview of the project. Projects should present a logical
and workable solution and approach to addressing the issue of human
trafficking in the transportation industry. Questions to consider
include: Is the concept unique? Are the anticipated beneficiaries
clearly identified? Were human trafficking survivors consulted in the
development of the project and/or how will survivor input be included
in project implementation? Are the anticipated resources and costs
outlined in detail? Can the project be implemented in a way requiring a
finite amount of resources (e.g., the submission has fixed costs, low
or no marginal costs, and a clear path to implementation and scale
beyond an initial investment)?

7. Impact/Measurability

    A description of how the project will be evaluated, and its
potential impact

on human trafficking in the transportation industry. Questions to
consider include: How will the project's impact be measured? How will
the project contribute to counter-trafficking efforts in the
transportation sector? If not a national project, can the project be
scaled nationally?

8. Partners

    If applicable, list the partners who will be engaged in project
development and/or implementation, including a brief background for
each.

9. Letters of Support

    You may submit supporting letters, which may be from subject matter
experts or industry, and may address the technical merit of the
concept, originality, impact, practicality, measurability and/or
applicability.

10. Supporting Documents (no page limit)

    The paper(s) and/or technologies, programs, video/audio files, and
other related materials, describing the project and addressing the
selection criteria. As applicable, this can include a description of
success of a previous or similar project and/or documentation of
impact. DOT may request additional information, including supporting
documentation, more detailed contact information, releases of
liability, and statements of authenticity to guarantee the originality
of the work. Failure to respond in a timely manner may result in
disqualification.

Initial Screening

    The Office of International Transportation and Trade will initially
review applications to determine that all required submission elements
are included, and to determine compliance with eligibility
requirements.

Evaluation

    After the Initial Screening, the Office of International
Transportation and Trade, with input from the relevant Operating
Administrations, will judge entries based on the factors described
below: Technical merit, originality, impact, practicality,
measurability, and applicability. All factors are important and will be
given consideration.
    The Secretary will make the final selection.
    The Department reserves the right to not award the prize if the
selecting officials believe that no submission demonstrates sufficient
potential for sufficient transformative impact.

Technical Merit

     Presents a clear understanding of the issue of human
trafficking in the transportation industry and utilizes a trauma-
informed, victim-centered approach.
     Presents a logical and workable solution and approach to
addressing human trafficking in the transportation industry.
     Survivors of human trafficking were consulted in the
development of the project concept and survivor input is outlined in
the description of project implementation.
Originality
     The concept is new or a variation of an existing idea.
     The concept possesses and clearly describes its unique
merits.

Impact/Measurability

     The project can make a significant impact and/or
contribution to the fight against human trafficking in the
transportation industry.
     The project clearly describes the breadth of impact.
     The submission clearly outlines how the project will be
measured.
     The project will result in measurable improvements.

Practicality

     The project clearly identifies anticipated beneficiaries
of the project.
     The project clearly outlines anticipated resources and all
costs to be incurred by executing the concept.
     The project can be implemented in a way that requires a
finite amount of resources (specifically, the submission has fixed
costs, low or no marginal costs, and a clear path to implementation and
scale beyond an initial investment).

Applicability

     The project is national and/or can be scaled nationally.

Award

    Up to three winning entries are expected to be announced. The
first-place winner will receive up to a $50,000 cash prize. A plaque
with the first-place winner(s) name and the date of the award will be
on display at the U.S. Department of Transportation, and a display copy
of the plaque(s) will be sent to the first-place award winner's
headquarters. At the discretion of the Secretary, up to two additional
plaques may be awarded to recognize two runners up. At the Department's
discretion, DOT may pay for invitational travel expenses to Washington,
DC for up to two individuals or representatives of the first-place
winning organization and runners up organizations, should selectees be
invited to present their project(s) for DOT officials.

(Authority: 15 U.S.C. 3719 (America COMPETES Act).

    Issued in Washington, DC, on March 10, 2022.
Carol Annette Petsonk,
Deputy Assistant Secretary, Aviation and International Affairs, U.S.
Department of Transportation.
[FR Doc. 2022-05781 Filed 3-21-22; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: April 21, 2010 (Volume 75, Number 76)]
[Notices]
[Page 20879]
[DOCID:fr21ap10-112]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at the Eagle County Regional Airport, Eagle, CO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Request to Release Airport Property.

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SUMMARY: The FAA proposes to rule and invite public comment on the
release of land at the Eagle County Regional Airport under the
provisions of section 125 of the Wendell H. Ford Aviation Investment
Reform Act for the 21st Century (AIR 21).

DATES: Comments must be received on or before May 21, 2010.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Mr. John P. Bauer, Manager, Federal
Aviation Administration, Northwest Mountain Region, Airports Division,
Denver Airports District Office, 26805 E. 68th Ave., Suite 224, Denver,
Colorado 80249.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Mr. Bryan Treu, Eagle County Attorney, P.O. Box
850, Eagle, Colorado 81631.

FOR FURTHER INFORMATION CONTACT: Mr. Chris Schaffer, Project Manager,
Federal Aviation Administration, Northwest Mountain Region, Airports
Division, Denver Airports District Office, 26805 E. 68th Ave., Suite
224, Denver, Colorado 80249.
    The request to release property may be reviewed in person at this
same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release property at the Eagle County Regional Airport under
the provisions of the AIR 21.
    On March 3, 2010, the FAA determined that the request to release
property at the Eagle County Regional Airport submitted by the County
of Eagle, Colorado met the procedural requirements of the Federal
Aviation Regulations, Part 155. The FAA may approve the request, in
whole or in part, no later than May 21, 2010.
    The following is a brief overview of the request:
    The County of Eagle, Colorado requests the release of 4.91 acres of
non-aeronautical airport property of the Eagle County Regional Airport.
The purpose of this release is to allow non-aviation-related
development of the parcel. The sale of this parcel will provide funds
for airport improvements.
    Any person may inspect the request by appointment at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may inspect the application, notice and
other documents germane to the application in person at the Eagle
County Courthouse, 500 Broadway, Eagle, Colorado 81631.

    Issued in Denver, Colorado on March 30, 2010.
John P. Bauer,
Denver Airports District Office.
[FR Doc. 2010-8841 Filed 4-20-10; 8:45 am]
BILLING CODE 4910-13-M


[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Proposed Rules]
[Page 5346]
[FR Doc No: 2013-00930]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2009-0433; EPA-R01-OAR-2012-0149; A-1-FRL-9754-7]

Approval and Promulgation of Air Quality Implementation Plans;
Massachusetts and New Hampshire; Enhanced Motor Vehicle Inspection and
Maintenance Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve State Implementation Plan (SIP)
revisions submitted by the Commonwealth of Massachusetts and the State
of New Hampshire. These revisions include regulations to update the
enhanced motor vehicle inspection and maintenance (I/M) programs in
Massachusetts and New Hampshire. The revised programs in Massachusetts
and New Hampshire include a test and repair network for an on-board
diagnostic (OBD2) testing program for model year 1996 and newer
vehicles. The intended effect of this action is to propose approval of
the revised programs into the Massachusetts and New Hampshire SIPs.
This action is being taken under the Clean Air Act.

DATES: Written comments must be received on or before February 25,
2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2009-0433 for comments pertaining to our proposed approval action
for Massachusetts or EPA-R01-OAR-2012-0149 for comments pertaining to
our proposed approval action for New Hampshire by one of the following
methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``Docket Identification Number EPA-R01-OAR-2009-0433 or
EPA-R01-OAR-2012-0149,'' Anne Arnold, U.S. Environmental Protection
Agency, EPA New England Regional Office, 5 Post Office Square--Suite
100, (Mail code OEP05-2), Boston, MA 02109-3912.
    5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold,
Manager, Air Quality Planning Unit, Office of Ecosystem Protection,
U.S. Environmental Protection Agency, EPA New England Regional Office,
5 Post Office Square--Suite 100, (Mail code OEP05-2), Boston, MA 02109-
3912. Such deliveries are only accepted during the Regional Office's
normal hours of operation. The Regional Office's official hours of
business are Monday through Friday, 8:30 to 4:30, excluding legal
holidays.
    Please see the direct final rule which is located in the Rules
Section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Ariel Garcia, Air Quality Planning
Unit, U.S. Environmental Protection Agency, EPA New England Regional
Office, 5 Post Office Square, Suite 100 (Mail code: OEP05-2), Boston,
MA 02109-3912., telephone number<PHONE_NUMBER>, fax number (617) 918-
0660, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this action,
no further activity is contemplated. If EPA receives adverse comments,
the direct final rule will be withdrawn and all public comments
received will be addressed in a subsequent final rule based on this
proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.
    For additional information, see the direct final rule which is
located in the Rules Section of this Federal Register.

    Dated: November 15, 2012.
H. Curtis Spalding,
Regional Administrator, EPA New England.
[FR Doc. 2013-00930 Filed 1-24-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 75 (Tuesday, April 19, 2016)]
[Notices]
[Pages 23008-23009]
[FR Doc No: 2016-08915]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2013-0008]

The Benzene Standard; Extension of the Office of Management and
Budget's (OMB) Approval of Information Collection (Paperwork)
Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements specified in the Benzene Standard
(29 CFR 1910.1028).

DATES: Comments must be submitted (postmarked, sent, or received) by
June 20, 2016.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit your comments and attachments
to the OSHA Docket Office, Docket No. OSHA-2013-0008, Occupational
Safety and Health Administration U.S. Department of Labor, Room N-2625,
200 Constitution Avenue NW., Washington, DC 20210. Deliveries (hand,
express mail, messenger, and courier service) are accepted during the
Department of Labor's and Docket Office's normal business hours, 8:15
a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and the
OSHA docket number (OSHA-2013-0008) for the Information Collection
Request (ICR). All comments, including any personal information you
provide, are placed in the public docket without change, and may be
made available online at http://www.regulations.gov. For further
information on submitting comments see the ``Public Participation''
heading in the section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download from the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You also may contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accord with the Paperwork Reduction Act of
1995 (PRA-95) (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The

Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of efforts in
obtaining information (29 U.S.C. 657).
    The information collection requirements specified in the Benzene
Standard protect workers from the adverse health effects that may
result from occupational exposure to benzene. The major information
collection requirements in the Standard include conducting worker
exposure monitoring, notifying workers of the benzene exposure,
implementing a written compliance program, implementing medical
surveillance for workers, providing examining physicians with specific
information, ensuring that workers receive a copy of their medical
surveillance records, and providing access to these records by OSHA,
the National Institute for Occupational Safety and Health, the worker
who is the subject of the records, the worker's representative, and
other designated parties.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    The Agency is requesting an adjustment increase of 18,726 burden
hours (from 126,183 hours to 144,909 hours). The adjustment increase is
the result of an increase in the number of workers receiving medical
examinations. There was a $1,826,862 increase in the cost under Item 13
from $8,984,612 to $10,811,474 as result of an increase in the number
of workers receiving medical examinations and the cost of a medical
examination.
    Type of Review: Extension of a currently approved collection.
    Title: Benzene Standard (29 CFR 1910.1028).
    OMB Control Number: 1218-0129.
    Affected Public: Business or other for-profits; Not-for-profit
organizations; Federal Government; State, Local, or Tribal Government.
    Number of Respondents: 12,148.
    Frequency of Response: On occasion.
    Total Responses: 297,672.
    Average Time per response: Varies from 5 minutes (.08 hour) for
employers to maintain records to 4 hours for workers to receive
referral medical exams.
    Estimated Total Burden Hours: 144,909.
    Estimated Cost (Operation and Maintenance): $10,811,474.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile; or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for this ICR (Docket No. OSHA-2013-0008).
You may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download from this Web
site. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov Web site to submit comments and
access the docket is available at the Web site's ``User Tips'' link.
Contact the OSHA Docket Office for information about materials not
available from the Web site, and for assistance in using the Internet
to locate docket submissions.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012
(77 FR 3912).

    Signed at Washington, DC, on April 13, 2016.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2016-08915 Filed 4-18-16; 8:45 am]
 BILLING CODE 4510-26-P


TELEPHONE CALL RECORD Project: CWA 316( b) Phase III Rule for Oil and Gas Extraction Facilities Date: 18 May 2004 Name: Mark Briggs, ERG Contact Name: Linda Cook Johnson Screens New Brighton, MN 651 636 3900 Subject: Screen Design for Cooling Water Intake Structures on Oil and Gas Extraction Facilities I spoke with Linda Cook, product specialist in Johnson Screens CWIS group, regarding the CWA 316( b) Phase III Rule for Oil and Gas Extraction facilities. Linda was well aware of the proposed rule and stated that Johnson Screens had developed an informational packet for prospective customers regarding the regulation the application of Johnson Screens to prevent both impingement and entrainment of marine life. Linda stated she would email me the file on the 316( b) rule Johnson Screens has developed.

Linda stated that Johnson Screens manufactures a cylindrical wedge wire screen designed to fit over existing pipes and caissons to prevent both impingement and entrainment. The screens are designed to provide a flow velocity of less than 0.5 feet per second ( fts) and the screen opening is sized to prevent entrainment of the smallest marine organism located within the vicinity of the CWIS opening. Linda stated she would email me product literature on the cylindrical wedge wire screens that Johnson Screens manufactures for CWIS. Linda also stated she would be happy to answer any additional questions we may have regarding their product.

Mark TELEPHONE CALL RECORD Project: CWA 316( b) Phase III Rule for Oil and Gas Extraction Facilities Date: 12 May 2004 Name: Joy Abel, ERG Contact Name: Mark Watson Johnson Screens Wytheville, VA ( 508) 864 4093 Subject: Screen Design for Cooling Water Intake Structures on Oil and Gas Extraction Facilities I spoke with Mark Watson regarding design information on Johnson Screens Products for cooling water intake structures. The following are the questions and answers:

1. Do flat panel wedge wire screens have entrainment reduction properties? Mark's Answer: Entrainment reduction is not inherent with a flat screen. Flat screens do not distribute the flow evenly across the screen. Mark thought that these screens could be designed to distribute the flow evenly with proper baffling.

2. Can cylindrical wedge wire screens be installed onto caissons, sea chests, and submersible pump intakes? Mark's Answer: Mark was not familiar with caissons or sea chests. He said that cylindrical wedge wire screens can be installed as long as there is enough clearance and it can be attached. There must be at leas ½ inch diameter clearance around the screen. There typically needs to be a flange to bolt on this screen. Based on my description of the caisson, he thought this screen would work on a caisson. He did not know if the screen would work on a sea chest because it would create extra drag. He said mechanically, he does not see why it would not work.

Joy


[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11794-11798]
[FR Doc No: 2011-4703]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0100]

Drugs for Human Use; Unapproved and Misbranded Oral Drugs Labeled
for Prescription Use and Offered for Relief of Symptoms of Cold, Cough,
or Allergy; Enforcement Action Dates

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to take enforcement action against unapproved and misbranded
oral drug products that are labeled for prescription use and offered
for relief of symptoms of cold, cough, or allergy and persons who
manufacture or cause the manufacture of such products. These drug
products are marketed without approved applications, and many are
inappropriately labeled for use in infants and young children. These
drug products must obtain FDA approval of a new drug application (NDA)
or an abbreviated new drug application (ANDA), or comply with an FDA
over-the-counter (OTC) drug final monograph, before marketing.

DATES: This notice is effective March 3, 2011. For information about
enforcement dates, see SUPPLEMENTARY INFORMATION, section IV.

ADDRESSES: All communications in response to this notice should be
identified with Docket No. FDA-2011-N-0100 and directed to Sakineh
Walther, Division of New Drugs and Labeling Compliance, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5242, Silver Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Sakineh Walther, Division of New Drugs
and Labeling Compliance, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5242,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

A. Cold, Cough, and Allergy Products Covered by This Notice

    This Federal Register notice covers certain unapproved and
misbranded drug products that are available in oral form and labeled
for prescription use. These products are offered for relief of symptoms
relating to cold, cough, or allergy, and include antitussives,
expectorants, antihistamines, and nasal decongestants. This notice
covers extended-release,\1\ tannate, and immediate-release drug
products.
---------------------------------------------------------------------------

    \1\ The term ``extended-release'' is used in this document to
include all timed-release products, including products labeled as
``sustained-release,'' ``controlled-release,'' ``delayed-release,''
or ``long-acting.'' (See 21 CFR 310.502(a)(14).)
---------------------------------------------------------------------------

B. Regulatory History of Products Covered by This Notice

    Many of the drug products covered by this notice contain active
ingredients that were introduced into the marketplace without prior
review for effectiveness. When initially enacted in 1938, the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) required that FDA review
and approve ``new drugs'' for safety, but not effectiveness, before
they could legally be sold in interstate commerce.\2\ The FD&C Act made
it the sponsor's burden to show FDA that its drug was safe through the
submission of an NDA. Between 1938 and 1962, if a drug obtained
approval, FDA considered drugs that were identical, related, or similar
(IRS) \3\ to the approved drug to be ``covered'' by that approval, and
allowed those IRS drugs to be marketed without independent approval.
---------------------------------------------------------------------------

    \2\ A ``new drug'' is defined by the FD&C Act as a drug that is
not generally recognized, by experts qualified by scientific
training and experience to evaluate the safety and effectiveness of
drugs, as safe and effective for use under the conditions
prescribed, recommended, or suggested in its labeling (section 201
of the FD&C Act (21 U.S.C. 321(p)).
    \3\ FDA's regulations at (21 CFR 310.6(b)(1)) provide: ``An
identical, related, or similar drug includes other brands,
potencies, dosage forms, salts, and esters of the same drug moiety
as well as of any drug moiety related in chemical structure or known
pharmacological properties.''
---------------------------------------------------------------------------

    In 1962, Congress amended the FD&C Act to require that new drugs be
proven effective for their labeled indications, as well as safe. This
amendment also required FDA to conduct a retrospective evaluation of
effectiveness for all drugs approved as safe between 1938 and 1962. FDA
contracted with the National Academy of Sciences/National Research
Council (NAS/NRC) to make an initial evaluation of the effectiveness of
over 3,400 products that had been approved only for safety between 1938
and 1962. The NAS/NRC reports for these drug products were submitted to
FDA in the late 1960s and early 1970s. The Agency reviewed and
reevaluated the reports and published its findings in Federal Register
notices. FDA's administrative implementation of the NAS/NRC reports was
called the Drug Efficacy Study Implementation (DESI). DESI covered the
approximately 3,400 products specifically reviewed by the NAS/NRC, as
well as the even larger number of IRS products that entered the market
without FDA approval.\4\ Many of the drug products covered by this
notice contain the same active ingredients as drug products that were
reviewed for effectiveness through the DESI process.
---------------------------------------------------------------------------

    \4\ Section 310.6(b)(2)) provides that when qualified experts
determine that the findings in a DESI notice are applicable to an
IRS drug, that IRS drug is affected by the DESI notice.
---------------------------------------------------------------------------

    All drugs covered by the DESI review are ``new drugs'' under the
FD&C Act. If FDA's final DESI determination classifies a drug product
as ineffective for one or more indications, that drug product and those
IRS to it can no longer be marketed for such indications and are
subject to enforcement action as unapproved new drugs. If FDA's final
DESI determination classifies a drug product as effective for one or
more of its labeled indications, the drug, and those IRS to it, can be
marketed for such indications, provided each product is the subject of
an application approved for safety and effectiveness. Those drug
products with NDAs approved before 1962 for safety therefore require
approved supplements to their original applications if found effective
under DESI; IRS drug products require an approved NDA or ANDA, as
appropriate. Furthermore, labeling for these drug products may contain
only those indications for which the DESI review found the product
effective unless the firm marketing the product has received approval
for additional indication(s).
    In the early 1970s, FDA granted temporary exemptions from the time
limits established for completing certain phases of the DESI program
for certain oral prescription drugs offered for relief of cold, cough,
allergy, and related symptoms (38 FR 34481, December 14, 1973). The
exemptions were granted because of the close relationship between these
prescription drugs and OTC drugs, which were subject to the ongoing OTC
drug review. (See 21 CFR part 330.) Postponement of final evaluations
of these DESI prescription products enabled the Agency to consider the
recommendations of the OTC review panel in addition to any evidence
submitted by NDA holders and other parties in response to various DESI
notices covering relevant products.

II. Safety Concerns With Unapproved New Drugs

    Because marketed unapproved new drug products have not been through

FDA's approval process, there may be safety risks associated with them.
Some unapproved product labeling omits or modifies safety warnings or
other information that is important to ensure safe use, such as drug
interactions or potential adverse experiences. FDA is particularly
concerned about pediatric labeling for these unapproved products. Some
of the unapproved products covered by this notice are labeled and
marketed for use in children as young as 1 month of age. Without
reviewing applications for these products, FDA has no way to assess the
scientific support, if any, for the use of these products in pediatric
populations.
    FDA also has concerns regarding the manufacturing processes for
unapproved new drugs and changes in the formulations of these products.
When new drugs are marketed without FDA approval, FDA does not have an
opportunity, prior to product marketing, to determine whether the
manufacturing process for the drugs is adequate to ensure that they are
of suitable quality. Additionally, there is no opportunity prior to
marketing for FDA to review and approve proprietary names to minimize
potential safety issues caused by product name confusion. In fact, FDA
has received reports of name confusion associated with unapproved
prescription products covered by this notice. Look-alike and sound-
alike similarities between product names may contribute to medication
errors and adverse events.
    Similarly, the new drug approval requirement allows the Agency to
evaluate proposed changes to approved product formulations to ensure
that such modifications meet FDA standards for safety and effectiveness
and to ensure that formulation changes are accompanied, as necessary,
by appropriate changes in product proprietary names or labeling, or
other measures that may be warranted to minimize confusion and risks to
patients. Modifications of product formulations that are not made under
FDA's drug approval process thus pose an increased risk of confusing
healthcare practitioners and causing harm to consumers, such as
underdose or overdose, particularly in pediatric patients.
    Finally, FDA has specific safety concerns about the products
covered by this notice that are marketed as extended-release products.
Many of these products contain amounts of active ingredients that could
pose safety risks if the same amount of active ingredient were
contained in an immediate-release dosage form. Without prior review of
applications for these products, there is no assurance that the firms
that market these products have established appropriate specifications
for release of the active ingredients or that the products are properly
formulated and manufactured to release their active ingredients to an
extent and at a rate that is both safe and effective.

III. Legal Status of Products Identified in This Notice

A. Extended-Release Products

    Some of the products covered by this notice are sold as extended-
release products. Since 1959, FDA has concluded that all products in
extended-release dosage forms are new drugs requiring approved NDAs or
ANDAs before being marketed (24 FR 3756, May 9, 1959). Agency review of
individual applications for extended-release products is needed to
ensure that the finished product releases its active ingredient to an
extent and at a rate that is both safe, with a predictable and
controlled release of the dose, and effective, sustaining the intended
effect over the entire dosing interval. Firms submitting applications
are required to establish appropriate release specifications supported
by clinical evidence, along with data showing that the finished product
as manufactured by the firm releases its active ingredient according to
those specifications.
    The Agency's determination that all products in timed-release
dosage form are new drugs requiring approved applications is codified
at 21 CFR 310.502(a)(14). Approval of an NDA under section 505(b) of
the FD&C Act (21 U.S.C. 355(b)) or an ANDA under section 505(j) of the
FD&C Act is required as a condition for marketing all such products.
    The unapproved extended-release drug products subject to this
notice are all labeled for prescription use. Prescription drugs are
defined under section 503(b)(1)(A) of the FD&C Act (21 U.S.C.
353(b)(1)(A)) as drugs that, because of toxicity or other potentially
harmful effect, are not safe to use except under the supervision of a
practitioner licensed by law to administer such drugs.\5\ A drug that
is labeled as a prescription drug but does not meet the definition of
``prescription drug'' under section 503(b)(1)(A) of the FD&C Act is
misbranded under section 503(b)(4)(B) of the FD&C Act (21 U.S.C.
353(b)(4)(B)). Thus, if an extended-release drug covered by this notice
is labeled as a prescription product, but does not meet the definition
in section 503(b)(1)(A) of the FD&C Act, it is misbranded under section
503(b)(4)(B) of the FD&C Act. If an extended-release drug subject to
this notice actually meets the definition of ``prescription drug''
under 503(b)(1)(A), it is misbranded under section 502(f)(1) of the
FD&C Act (21 U.S.C. 352(f)(1)), in that it fails to bear adequate
directions for use. An approved prescription drug can satisfy the
``adequate directions for use'' requirement if it bears the NDA-
approved labeling (Sec. Sec.  201.100(c)(2) and 201.115 (21 CFR
201.100(c)(2) and 201.115)). Because the unapproved prescription
extended-release drug products covered by this notice do not have
approved applications with approved labeling, they fail to bear
``adequate directions for use,'' and are misbranded under section
502(f)(1) of the FD&C Act.
---------------------------------------------------------------------------

    \5\ The definition of ``prescription drug'' also includes a drug
that is limited by an approved application to use under the
professional supervision of a licensed practitioner (21 U.S.C.
353(b)(1)(B)). This prong of the definition obviously does not apply
to the unapproved extended-release drug products covered by this
notice.
---------------------------------------------------------------------------

B. Tannates

    Some of the products covered by this notice contain active
ingredients that are in tannate salt form (tannate drugs). FDA has
reviewed the publicly available scientific literature on these
ingredients, and has determined that unapproved oral drugs labeled for
prescription use and offered for relief of symptoms of cold, cough, or
allergy that contain the following ingredients are not generally
recognized as safe and effective (GRASE): Brompheniramine tannate;
carbetapentane tannate; carbinoxamine tannate; chlorpheniramine
tannate; dexbrompheniramine tannate; dexchlorpheniramine tannate;
dextromethorphan tannate; diphenhydramine tannate; ephedrine tannate;
phenylephrine tannate; pseudoephedrine tannate; pyrilamine tannate; and
triprolidine tannate. Therefore, products containing these ingredients
are new drugs within the meaning of section 201(p) of the FD&C Act, and
require approved NDAs or ANDAs before marketing.
    The unapproved tannate drug products subject to this notice are all
labeled for prescription use. Prescription drugs are defined under
section 503(b)(1)(A) of the FD&C Act as drugs that, because of toxicity
or other potentially harmful effect, are not safe to use except under
the supervision of a practitioner licensed by law to administer such
drugs.\6\ A drug that is

labeled as a prescription drug but does not meet the definition of
``prescription drug'' under section 503(b)(1)(A) of the FD&C Act is
misbranded under section 503(b)(4)(B) of the FD&C Act. Thus, if a
tannate drug covered by this notice is labeled as a prescription
product, but does not meet the definition in section 503(b)(1)(A) of
the FD&C Act, it is misbranded under section 503(b)(4)(B) of the FD&C
Act. If a tannate drug covered by this notice actually meets the
definition of ``prescription drug,'' it is misbranded under section
502(f)(1) of the FD&C Act, in that it fails to bear adequate directions
for use. An approved prescription drug can satisfy the ``adequate
directions for use'' requirement if it bears the NDA-approved labeling
(21 CFR 201.100(c)(2) and 201.115). Because the unapproved prescription
tannate drug products covered by this notice do not have approved
applications with approved labeling, they fail to bear ``adequate
directions for use,'' and are misbranded under section 502(f)(1) of the
FD&C Act.
---------------------------------------------------------------------------

    \6\ The definition of ``prescription drug'' also includes a drug
that is limited by an approved application to use under the
professional supervision of a licensed practitioner (21 U.S.C.
353(b)(1)(B)). This prong of the definition obviously does not apply
to the unapproved tannate drug products covered by this notice.
---------------------------------------------------------------------------

C. Immediate-Release Products

    The remaining unapproved oral products covered by this notice are
immediate-release products labeled for prescription use and offered for
relief of symptoms associated with cold, cough, or allergy. The
immediate-release products fall into the following three categories:
1. Drugs Inappropriately Labeled for Prescription Use
    A small number of the immediate-release products covered by this
notice conform to the requirements of the final OTC monograph at 21 CFR
part 341, ``Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic
Drug Products for Over-the-Counter Human Use'' (the final OTC Cold
Cough monograph), except that they are labeled for prescription use
only. Section 503(b)(1) of the FD&C Act establishes the definition of a
``prescription drug.'' Drug products that do not meet the definition of
a prescription drug but are labeled for prescription use are misbranded
under section 503(b)(4)(B) of the FD&C Act. If these drugs conform to
the requirements of the final OTC Cold Cough monograph, they are not
new drugs and they do not require an approved NDA or ANDA in order to
be legally marketed OTC.\7\
---------------------------------------------------------------------------

    \7\ In addition to any other applicable requirements, firms that
manufacture OTC drugs must comply with the labeling requirements at
21 CFR 201.66.
---------------------------------------------------------------------------

2. Drugs Containing Ingredients Included in the Final OTC Cold Cough
Monograph But Labeled With Nonconforming Indications or Dosing Regimens
    The majority of the immediate-release products covered by this
notice are labeled for prescription use and contain ingredients that
are included in the final OTC Cold Cough monograph, but have
indications, dosing regimens, or both, that are inconsistent with that
monograph. FDA has reviewed the indications and dosing regimens (dosing
intervals and dosage amounts) in the labeling of over 300 such
products, and has reviewed the publicly available scientific literature
for studies of these products.\8\ In no case did FDA find literature
sufficient to support a determination that one of these products was
GRASE for relief of symptoms of cold, cough, or allergy. Therefore,
these products are all ``new drugs'' within the meaning of section
201(p) of the FD&C Act, that require approved NDAs or ANDAs before
marketing.
---------------------------------------------------------------------------

    \8\ The over 300 products reviewed by FDA represent all products
in this category that FDA was able to identify.
---------------------------------------------------------------------------

    The unapproved immediate-release drug products subject to this
notice that contain ingredients that are included in the final OTC Cold
Cough monograph, but with indications, dosing regimens, or both, that
are inconsistent with that monograph, are all labeled for prescription
use. Prescription drugs are defined under section 503(b)(1)(A) of the
FD&C Act as drugs that, because of toxicity or other potentially
harmful effect, are not safe to use except under the supervision of a
practitioner licensed by law to administer such drugs.\9\ A drug that
is labeled as a prescription drug but does not meet the definition of
``prescription drug'' under section 503(b)(1)(A) of the FD&C Act is
misbranded under section 503(b)(4)(B) of the FD&C Act. Thus, if an
immediate-release drug covered by this notice is labeled as a
prescription product, but does not meet the definition in section
503(b)(1)(A), it is misbranded under section 503(b)(4)(B). If an
immediate-release drug covered by this notice does meet the definition
of ``prescription drug'' in 503(b)(1)(A), it is misbranded under
section 502(f)(1) of the FD&C Act, in that it fails to bear adequate
directions for use. An approved prescription drug can satisfy the
``adequate directions for use'' requirement if it bears the NDA-
approved labeling (Sec. Sec.  201.100(c)(2) and 201.115). Because the
unapproved prescription immediate-release drug products subject to this
notice that contain ingredients that are included in the final OTC Cold
Cough monograph, but with indications, dosing regimens, or both, that
are inconsistent with that monograph, do not have approved applications
with approved labeling, they fail to bear ``adequate directions for
use,'' and are misbranded under section 502(f)(1).
---------------------------------------------------------------------------

    \9\ The definition of ``prescription drug'' also includes a drug
that is limited by an approved application to use under the
professional supervision of a licensed practitioner (21 U.S.C.
353(b)(1)(B)). This prong of the definition obviously does not apply
to the unapproved immediate-release drug products subject to this
notice and containing ingredients that are included in the final OTC
Cold Cough monograph, but with indications, dosing regimens, or
both, that are inconsistent with that monograph.
---------------------------------------------------------------------------

3. Drugs Containing Ingredients Not Included in the Final OTC Cold
Cough Monograph
    The remaining immediate-release products covered by this notice are
labeled for prescription use and contain active ingredients that are
not included in the final OTC Cold Cough monograph. FDA has reviewed
the publicly available scientific literature on these ingredients, and
has determined that the products covered by this notice and offered for
relief of symptoms of cold, cough, or allergy that contain the
following ingredients are not GRASE: Atropine; carbetapentane;
cyproheptadine; dyphylline; hyoscyamine; methscopolamine nitrate;
phenyltoloxamine; potassium guaiacosulfonate; promethazine; and
scopolamine. Therefore, products covered by this notice containing
these ingredients and marketed for relief of symptoms of cold, cough,
or allergy are new drugs within the meaning of section 201(p) of the
FD&C Act, and require approved NDAs or ANDAs prior to marketing.
    The unapproved immediate-release drug products that are subject to
this notice and that contain active ingredients not included in the
final OTC Cold Cough monograph are all labeled for prescription use.
Prescription drugs are defined under section 503(b)(1)(A) of the FD&C
Act as drugs that, because of toxicity or other potentially harmful
effect, are not safe to use except under the supervision of a
practitioner licensed by law to administer such drugs.\10\ A drug that
is

labeled as a prescription drug but does not meet the definition of
``prescription drug'' under section 503(b)(1)(A) is misbranded under
section 503(b)(4)(B) of the FD&C Act. Thus, if an immediate-release
drug covered by this notice is labeled as a prescription product, but
does not meet the definition in section 503(b)(1)(A), it is misbranded
under section 503(b)(4)(B). If a drug covered by this notice meets the
definition of ``prescription drug'' in 503(b)(1)(A), it is misbranded
under section 502(f)(1) of the FD&C Act, in that it fails to bear
adequate directions for use. An approved prescription drug can satisfy
the ``adequate directions for use'' requirement if it bears the NDA-
approved labeling (Sec. Sec.  201.100(c)(2) and 201.115). Because the
unapproved prescription immediate-release drug products covered by this
notice that contain active ingredients not included in the final OTC
Cold Cough monograph do not have approved applications with approved
labeling, they fail to bear ``adequate directions for use,'' and are
misbranded under section 502(f)(1) of the FD&C Act.
---------------------------------------------------------------------------

    \10\ The definition of ``prescription drug'' also includes a
drug that is limited by an approved application to use under the
professional supervision of a licensed practitioner (21 U.S.C.
353(b)(1)(B)). This prong of the definition obviously does not apply
to the unapproved immediate-release drug products covered by this
notice that contain active ingredients not included in the final OTC
Cold Cough monograph.
---------------------------------------------------------------------------

IV. Notice of Enforcement Action

    Although not required to do so by the Administrative Procedure Act,
the FD&C Act, or any rules issued under its authority, or for any other
legal reason, FDA is providing this notice to persons \11\ who are
marketing unapproved and misbranded oral drug products labeled for
prescription use and offered for relief of symptoms relating to cold,
cough, or allergy that the Agency intends to take enforcement action
against such products and those who manufacture them or cause them to
be manufactured or shipped in interstate commerce.
---------------------------------------------------------------------------

    \11\ A ``person'' includes individuals, partnerships,
corporations, and associations (21 U.S.C. 321(e)).
---------------------------------------------------------------------------

    Manufacturing or shipping the drug products covered by this notice
can result in enforcement action, including seizure, injunction, or
other judicial or administrative proceeding. Consistent with policies
described in the Agency's guidance entitled ``Marketed Unapproved
Drugs--Compliance Policy Guide'' (the Marketed Unapproved Drugs CPG)
(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf), the
Agency does not expect to issue a warning letter or any other further
warning to firms marketing drug products covered by this notice prior
to taking enforcement action. The Agency also reminds firms that, as
stated in the Marketed Unapproved Drugs CPG, any unapproved drug
marketed without a required approved application is subject to Agency
enforcement action at any time. The issuance of this notice does not in
any way obligate the Agency to issue similar notices or any notice in
the future regarding marketed unapproved drugs.\12\
---------------------------------------------------------------------------

    \12\ The Agency's general approach for dealing with these
products in an orderly manner is spelled out in the Marketed
Unapproved Drugs CPG. That CPG, however, provides notice that any
product that is being marketed illegally, and the persons
responsible for causing the illegal marketing of the product, are
subject to FDA enforcement action at any time.
---------------------------------------------------------------------------

    As described in the Marketed Unapproved Drugs CPG, the Agency may,
at its discretion, identify a period of time during which the Agency
does not intend to initiate an enforcement action against a currently
marketed unapproved drug solely on the ground that it lacks an approved
application under section 505 of the FD&C Act. With respect to drug
products covered by this notice, the Agency intends to exercise its
enforcement discretion for only a limited period of time because there
are safety issues with respect to the products covered by this notice
and numerous marketed products that have approved applications or
comply with the applicable OTC drug final monograph are offered to
treat symptoms relating to cold, cough, and allergy. Therefore, the
Agency intends to implement this notice as follows.
    For the effective date of this notice, see the DATES section of
this document. FDA intends to take enforcement action against any drug
product covered by this notice that is not listed with the Agency in
full compliance with section 510 of the FD&C Act (21 U.S.C. 360) before
March 2, 2011, and is manufactured, shipped, or otherwise introduced or
delivered for introduction into interstate commerce by any person on or
after March 3, 2011. FDA also intends to take enforcement action
against any drug product covered by this notice that is listed with FDA
in full compliance with section 510 of the FD&C Act but is not being
commercially used or sold \13\ in the United States on March 2, 2011
and that is manufactured, shipped, or otherwise introduced or delivered
for introduction into interstate commerce by any person on or after
March 3, 2011.
---------------------------------------------------------------------------

    \13\ For purposes of this notice, the term ``commercially used
or sold'' means that the product has been used in a business or
activity involving retail or wholesale marketing and/or sale.
---------------------------------------------------------------------------

    However, for drug products covered by this notice that are
commercially used or sold in the United States, have a National Drug
Code (NDC) number listed with FDA, and are in full compliance with
section 510 of the FD&C Act before March 2, 2011 (``currently marketed
and listed''), the Agency intends to exercise its enforcement
discretion as follows. FDA intends to initiate enforcement action
against any currently marketed and listed product covered by this
notice that is manufactured on or after June 1, 2011 or that is shipped
on or after August 30, 2011.\14\ Further, FDA intends to take
enforcement action against any person who manufactures or ships such
products after these dates. Any person who has submitted or submits an
application for a drug product covered by this notice but has not
received approval must comply with this notice.
---------------------------------------------------------------------------

    \14\ If FDA finds it necessary to take enforcement action
against a product covered by this notice, the agency may take action
relating to all of the defendant's other violations of the FD&C Act
at the same time. For example, if a firm continues to manufacture or
market a product covered by this notice after the applicable
enforcement date has passed, to preserve limited agency resources,
FDA may take enforcement action relating to all of the firm's
unapproved drugs that require applications at the same time. (See,
e.g., United States v. Sage Pharmaceuticals, 210 F.3d 475, 479-480
(5th Cir. 2000) (permitting the Agency to combine all violations of
the act in one proceeding, rather than taking action against
multiple violations of the act in ``piecemeal fashion'').)
---------------------------------------------------------------------------

    The Agency, however, does not intend to exercise its enforcement
discretion as outlined previously if the following apply: (1) A
manufacturer or distributor of drug products covered by this notice is
violating other provisions of the FD&C Act, including, but not limited
to, violations related to FDA's current good manufacturing practices,
adverse drug event reporting, labeling or misbranding requirements
other than those identified in this notice or (2) it appears that a
firm, in response to this notice, increases its manufacture or
interstate shipment of drug products covered by this notice above its
usual volume during these periods.
    Nothing in this notice, including FDA's intent to exercise its
enforcement discretion, alters any person's liability or obligations in
any other enforcement action, or precludes the Agency from initiating
or proceeding with enforcement action in connection with any other
alleged violation of the FD&C Act, whether or not related to a drug
product covered by this notice. Similarly, a person who is or becomes
enjoined from marketing unapproved or misbranded drugs may not resume
marketing of such products based on FDA's exercise of enforcement
discretion that is set forth in this notice.
    Drug manufacturers and distributors should be aware that the Agency
is exercising its enforcement discretion as described previously only
in regard to

drug products covered by this notice that are marketed under an NDC
number listed with the Agency in full compliance with section 510 of
the FD&C Act before March 2, 2011. As previously stated, drug products
covered by this notice that are currently marketed but not listed with
the Agency on the date of this notice must, as of the effective date of
this notice, have approved applications prior to their shipment in
interstate commerce. Moreover, any person or firm that has submitted or
submits an application but has yet to receive approval for such
products is still responsible for full compliance with this notice.

V. Discontinued Products

    Some firms may have previously discontinued the manufacturing or
distribution of products covered by this notice without removing them
from the listing of their products under section 510(j) of the FD&C
Act. Other firms may discontinue manufacturing or marketing listed
products in response to this notice. Firms that wish to notify the
Agency of product discontinuation should send a letter, signed by the
firm's chief executive officer, fully identifying the discontinued
product(s), including NDC number(s), and stating that the product(s)
has (have) been discontinued. The letter should be sent to Sakineh
Walther (see ADDRESSES). Firms should also update the listing of their
products under section 510(j) of the FD&C Act to reflect
discontinuation of products covered by this notice. FDA plans to rely
on its existing records, including its drug listing records, or other
available information when it targets violations for enforcement
action.
    This notice is issued under the Federal Food, Drug, and Cosmetic
Act (sections 502 and 505 (21 U.S.C. 352 and 355)) and under authority
delegated to the Assistant Commissioner for Policy under section
1410.21 of the FDA Staff Manual Guide.

    Dated: February 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4703 Filed 3-2-11; 8:45 am]
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