[Federal Register: September 13, 2010 (Volume 75, Number 176)]
[Notices]
[Page 55632]
[DOCID:fr13se10-105]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Railtown 1897 State Historic Park

[Waiver Petition Docket Number FRA-2010-0092]

    The Railtown 1897 State Historic Park (Railtown), an excursion
train operating in Jamestown, California, seeks a waiver of compliance
from the Safety Glazing Standards of 49 CFR 223.11 Requirements for
existing locomotives. Specifically, Railtown has petitioned FRA for a
waiver for four diesel locomotives: Former U.S. Navy locomotives 613
and 612, built by Alco in 1953; former U.S. Army locomotive 1265, built
by Baldwin/Whitcomb in 1952; and former U.S. Army locomotive 1638,
built by General Electric in 1952.
    Railtown operates weekends only from April through March on three
miles of track in a lightly settled area with a fifteen mph speed
restriction. The locomotives are primarily used in yard switching
service and on rare occasions provide back-up service for Railtown's
historic steam locomotives.
    Additionally, Railtown states the combined annual operation of
their diesel locomotives is less than 200 hours per year, and that in
26 years of operation as a state historic park, they have not sustained
any incidents of breakage on their locomotives. Railtown estimates
glazing costs to be in excess of $20,000.00, and believes it is not
economically justified to replace the glass in light of the ages of the
locomotives, low risk of vandalism and the extremely low hours of
operation.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2010-0092) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the document (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (Volume 65, Number 70;
Page 19477) or at http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on September 7, 2010.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2010-22728 Filed 9-10-10; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 151 (Monday, August 6, 2012)]
[Notices]
[Pages 46753-46754]
[FR Doc No: 2012-19121]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2011-0271; FRL-9521-4]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Integrated Iron and
Steel Manufacturing (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before September 5,
2012.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2011-0271, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
2201T, 1200 Pennsylvania Avenue NW., Washington, DC 20460; and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Avenue
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 9, 2011 (76 FR 26900), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to both EPA and OMB within 30
days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2011-0271, which is available for public viewing
online at http://www.regulations.gov, or in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov, to either submit or view public comments, access
the index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to
www.regulations.gov.
    Title: NESHAP for Integrated Iron and Steel Manufacturing
(Renewal).
    ICR Numbers: EPA ICR Number 2003.05, OMB Control Number 2060-0517.
    ICR Status: This ICR is schedule to expire on August 31, 2012.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
    Abstract: The NESHAP for Integrated Iron and Steel Manufacturing
are subject to the General Provisions of the NESHAP at 40 CFR part 63,
subpart A, and any changes, or additions to the Provisions specified at
40 CFR part 63, subpart FFFFF.
    Owners or operators of the affected facilities must submit initial
notification, performance tests, and periodic reports and results.
Owners or operators are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is

inoperative. Reports, at a minimum, are required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 419
hours per response. ``Burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose and provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Owners or operators of integrated
iron and steel manufacturing facilities.
    Estimated Number of Respondents: 18.
    Frequency of Response: Initially, occasionally, and semiannually.
    Estimated Total Annual Hour Burden: 18,421.
    Estimated Total Annual Cost: $1,832,122, which includes $1,765,120
in labor costs, no capital/startup costs, and $67,002 in operation and
maintenance (O&M) costs.
    Changes in the Estimates: There is no change in the labor hours in
this ICR compared to the previous ICR. This is due to two
considerations: (1) The regulations have not changed over the past
three years and are not anticipated to change over the next three
years; and (2) the growth rate for the industry is very low, negative
or non-existent, so there is no significant change in the overall
burden. However, there is an increase in the total labor and Agency
costs as currently identified in the OMB Inventory of Approved Burdens.
This increase is not due to any program changes. The change in cost
estimates reflects updated labors rates available from the Bureau of
Labor Statistics.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2012-19121 Filed 8-3-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 8, 2010 (Volume 75, Number 25)]
[Notices]
[Page 6195-6197]
[DOCID:fr08fe10-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

January 28, 2010.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER00-3251-023; ER01-1147-011; ER01-1919-017; ER01-
513-029; ER98-1734-020; ER99-2404-016.
    Applicants: Exelon Generation Company, LLC; PECO Energy Company;
Exelon Energy Company; Exelon Framingham, LLC, Exelon New Boston, LLC,
Exelon West Medway, LLC, Exelon Wyman, LLC; Commonwealth Edison
Company; Exelon New England Power Marketing, LP.
    Description: Quarterly Report (Q4 2009) pursuant to Order 697-C of
Exelon MBR Companies.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-5161.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER06-972-004.
    Applicants: Thornwood Management Company, LLC.
    Description: Thornwood Management Co submits revisions to its
market-based rate schedule.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0210.

    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER06-972-005.
    Applicants: Thornwood Management Company, LLC.
    Description: Thornwood Management Co, LLC submits the Updated
Market Power Analysis.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0211.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-398-001.
    Applicants: Alcoa Power Generating Inc.
    Description: Alcoa Power Generating Inc submits Substitute Revised
Sheet No 31 to FERC Electric Rate Schedule No 19, the Exchange
Agreement with Tennessee Valley Authority.
    Filed Date: 01/27/2010.
    Accession Number: 20100128-0203.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-619-001.
    Applicants: Southwest Power Pool, Inc.
    Description: South Power Pool, Inc submits errata filing to correct
the error, and includes a clean and redlined version of the corrected
Tariff Page as Exhibits I and II.
    Filed Date: 01/27/2010.
    Accession Number: 20100128-0206.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-636-000.
    Applicants: Centre Lane Trading Ltd.
    Description: Centre Lane Trading Ltd submits the Petition for
Acceptance of Initial Rate Schedule, Waivers and Blanket Authority.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0209.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-642-000.
    Applicants: Algonquin Tinker Gen Co.
    Description: Algonquin Tinker Gen Co et al submits a Notice of Name
Change and Succession.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0206.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-643-000.
    Applicants: Algonquin Northern Maine Gen Co.
    Description: Algonquin Tinker Gen Co et al submits a Notice of Name
Change and Succession.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0206.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-644-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits amendments to
Schedule 12 of the Amended and Restated Operating Agreement.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0207.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-645-000.
    Applicants: MidAmerican Energy Company.
    Description: MidAmerican Energy Co submits the jointly executed
Network Customer Owned Transmission Facilities Credit Agreement.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0208.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-646-000.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service Co submits the Morgan-Pinnacle
Peak Participation Agreement.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0205.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-647-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Company submits amendment to a
contract between KU and the City Utilities Commission of City of
Owensboro Kentucky under FERC Rate Schedule 300.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0215.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-648-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Company submits amendment to a
contract between KU and the City of Paris under FERC Rate Schedule 301.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0216.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-649-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Company submits amendment to a
contract between KU and the City of Bradstown Kentucky under FERC Rate
Schedule 302.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0217.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-650-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Company submits amendment to a
contract between KU and the City of Nicholasville, Kentucky under FERC
Rate Schedule 303.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0218.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-651-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Company submits amendment to a
contract between KU and the City of Bardourville, Kentucky under FERC
Rate Schedule.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0219.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-652-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Company submits amendment to a
contract between KU and the City of Providence, Kentucky under FERC
Rate Schedule 305.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0220.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-653-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Company submits amendment to a
contract between KU and the City of Madisonville, Kentucky under FERC
Rate Schedule 306.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0221.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-654-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Company submits amendment to a
contract between KU and the City of Bardwell, Kentucky under FERC Rate
Schedule 302.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0222.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-655-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Company submits amendment to a
contract between KU and the City of Benham, Kentucky under FERC Rate
Schedule 308.
    Filed Date: 01/27/2010.

    Accession Number: 20100127-0223.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-656-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Company submits amendment to a
contract between KU and the City of Corbin, Kentucky under FERC Rate
Schedule 309.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0224.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-657-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Company submits amendment to a
contract between KU and the City of Falmouth, Kentucky under FERC Rate
Schedule 310.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0225.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-658-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Company submits amendment to a
contract between KU and the City of Frankfort City Electric and Water
Plant Bored, Kentucky under FERC Rate Schedule 311.
    Filed Date: 01/27/2010.
    Accession Number: 20100127-0226.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-659-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits revisions to its
Open Access Transmission Tariff, to be effective 1/28/2010.
    Filed Date: 01/27/2010.
    Accession Number: 20100128-0202.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-660-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits letter agreement for Bidding of Regulation Ancillary Service by
Sano Regulation Center with and AES Energy Storage LLC.
    Filed Date: 01/27/2010.
    Accession Number: 20100128-0201.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Docket Numbers: ER10-661-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits executed
interconnection service agreement among PJM, Mehoopany Wind Energy LLC,
et al.
    Filed Date: 01/27/2010.
    Accession Number: 20100128-0204.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 17, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    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 should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-2622 Filed 2-5-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 36 (Monday, February 24, 2014)]
[Notices]
[Pages 10168-10172]
[FR Doc No: 2014-03884]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0202]

Over-The-Counter Drug Monograph System--Past, Present, and
Future; Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public hearing to obtain input on the Over-The-Counter
(OTC) Drug Review (sometimes referred to as the OTC Monograph Process,
OTC Monograph, or OTC Drug Review). The Agency would like input on how
to improve or alter the current OTC Monograph Process for reviewing
nonprescription drugs (sometimes referred to as OTC drugs) marketed
under the OTC Drug Review. This public hearing is being held to obtain
information and comments from the public on the strengths and
weaknesses of the current OTC Monograph Process, and to obtain and
discuss ideas about modifications or alternatives to this process.

DATES: Public Hearing: The public hearing will be held on March 25 and
26, 2014, from 9 a.m. to 4 p.m. The meeting may be extended or may end
early depending on the level of public participation. Register to
attend or provide oral testimony at the meeting by March 12, 2014. See
Registration and Request To Provide Oral Testimony for information on
how to register or make an oral presentation at the meeting. Written or
electronic comments will be accepted until May 12, 2014.

ADDRESSES: The public hearing will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, rm. 1503A, Silver Spring, MD 20993-
0002. Entrance for the public meeting participants (non-FDA employees)
is through Building 1 where routine security check procedures will be
performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Mary Gross, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20903-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Georgiann Ienzi, Center for Drug Evaluation
and Research, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002,
301-796-3515, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>    Registration and Request To Provide Oral Testimony: The public
hearing is free and seating will be on a first-come, first-served
basis. If you wish to attend the public hearing or make an oral
presentation, see section IV of this notice (Attendance and/or
Participation in the Public Hearing) for information on how to register
and the deadline for registration. For those who cannot attend in
person, information about how to access a live Webcast of the meeting
will be located at: http://www.fda.gov/Drugs/NewsEvents/ucm380446.htm.
    Comments and Transcripts: Interested persons may submit either
electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. You should annotate and organize your
comments to identify the specific questions identified by the topic to
which they refer. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.
    Transcripts of the hearing will be available for review at the
Division of Dockets Management and at http://www.regulations.gov
approximately 45 days after the hearing. A transcript also will be
available in either hard copy or on CD-ROM after submission of a
Freedom of Information request. Send requests to the Division of
Freedom of Information (ELEM-1029), Office of Management Programs, Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857.

SUPPLEMENTARY INFORMATION:  FDA is announcing a public hearing to
obtain input on the OTC Drug Review. We believe that the OTC Drug
Review needs a critical examination at this juncture to examine whether
and how to modernize its processes and regulatory framework. The Agency
is interested in exploring ways to re-engineer the process of
regulating OTC drugs that are currently regulated under the OTC
Monograph Process to, among other things, create a process that is more
efficient and more responsive to newly emerging information and
evolving science, and to allow for more rapid product innovation where
appropriate.

I. Background

    FDA has been assessing the OTC Monograph Process and, in
particular, has been considering how effectively the monograph system
is functioning in today's world, 40 years after its inception, from the
scientific, policy, and process perspectives. We are now soliciting
opinions about whether and how to modernize the process for the future.

A. The Past: OTC Drug Review Implementation and Accomplishments

1. OTC Drug Review Regulatory Framework
    FDA's regulations in 21 CFR part 330 describe the conditions for a
drug to be considered generally recognized as safe and generally
recognized as effective (GRAS/GRAE) and not misbranded. If a drug meets
each of the conditions contained in part 330, as well as each of the
conditions contained in any applicable OTC drug monograph, and other
applicable regulations, it is considered GRAS/GRAE and not misbranded,
and is not required by FDA to obtain approval of a new drug application
(NDA) under section 505 of the FD&C Act (21 U.S.C. 355).
    The lengthy notice and comment rulemaking procedures for evaluating
each therapeutic category are set forth at Sec.  330.10. These
regulations require a three part regulatory rulemaking process
including the publication of an Advanced Notice of Proposed Rulemaking,
a Tentative Final Monograph (TFM) or Proposed Rule, and a Final
Monograph or Final Rule to establish the conditions under which drugs
under the OTC Drug Review are considered GRAS/GRAE and are not
misbranded. FDA does not require OTC products conforming to the
conditions of a final monograph and other applicable regulations to
have approved NDAs prior to marketing. As a corollary, it has also
generally been FDA's enforcement approach since the early days of the
OTC Drug Review to not pursue regulatory action against OTC products
marketed in conformance with the conditions proposed in a TFM. (See
Compliance Policy Guide Section 450.200 Drugs--General Provisions and
Administrative Procedures for Recognition as Safe and Effective at:
http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074388.htm).
2. Accomplishments of FDA's OTC Drug Review
    The OTC Drug Review has been successful in a variety of ways. Under
the OTC Drug Review, FDA was able to evaluate the safety and efficacy
of thousands of OTC drug products by therapeutic category, instead of
reviewing NDAs for each drug product. FDA has issued final monographs
for the majority of the original drug categories (see 21 CFR parts 331
to 361) and over 150 TFMs. The final rules cover large segments of the
OTC marketplace. Examples include fluoride toothpastes, acne products,
and topical antifungals. As a result of the OTC Drug Review, thousands
of OTC drugs that FDA determined are GRAS/GRAE and not misbranded are
regulated under final monographs and continue to be available to
consumers, and numerous other OTC drugs that were considered unsafe,
ineffective, or both, have been removed from the market.

B. The Present: Challenges and Changed Landscapes

    Our examination, however, has revealed significant challenges
associated with the OTC Drug Review as it functions today. When we look
at how rapidly science now evolves and the impact this has had on the
emergence of drug safety issues and on drug development, it is clear to
us that

questions need to be asked about whether this impact necessitates a
more agile and responsive process than the OTC Drug Review allows. When
the OTC Monograph Process was initially established and implemented in
the early 1970s, the multistep rulemaking strategy was thought to be an
effective and efficient approach to reviewing large categories of
active ingredients in drug products at the same time given what was the
current thinking about the known science related to these ingredients.
Indeed, the questions we are raising in this notice about the OTC Drug
Review become all the more important to the public health when we
compare the statutory changes that have been made to update the
regulation of prescription NDA drugs to address the scientific advances
in evaluating drug safety. These changes give FDA the ability to
quickly obtain new information and take administrative action as needed
efficiently and effectively.
    We have identified what we believe are the biggest challenges to
efficiently and effectively regulating under the OTC Drug Review. We
are also interested in feedback that identifies any other scientific or
regulatory challenges associated with the OTC Drug Review that are not
described here.
    We believe that the biggest challenges of the current system are:
     The large number of products marketed under the OTC Drug
Review for which there are not yet final monographs,
     limitations on FDA's ability to require, for example, new
warnings or other labeling changes to address emerging safety or
effectiveness issues for products marketed under the OTC Drug Review in
a timely and effective manner, and
     the inability of the OTC Drug Review to easily accommodate
innovative changes to products regulated under the OTC Drug Review.
1. Monographs That Have Not Been Finalized
    The OTC Drug Review is one of the largest and most complex
regulatory undertakings ever at FDA. It now consists of approximately
88 simultaneous rulemakings in 26 broad categories that encompass
hundreds of thousands of OTC drug products marketed in the United
States and some 800 active ingredients for over 1,400 different
ingredient uses. However, several significant segments of the OTC
marketplace are still not covered by final monographs, and these
products may lack sufficient data for FDA to determine whether they are
safe, effective, or both. Under the enforcement approach we have been
using since the early days of the OTC Drug Review, most of these
products have remained on the market pending finalization of their
monograph. Over the years, it has become clear that one unintended
consequence of this enforcement approach is that it creates negative
incentives for those who manufacture or market these OTC drugs to
conduct studies or otherwise respond to safety concerns as to do so may
hasten a determination that their product is not GRAS/GRAE.
2. Emerging Safety Concerns, Evolving Science, and Product Formulation
    The OTC Monograph Process also presents challenges to FDA's ability
to respond to emerging safety issues, keep pace with evolving science,
and ensure the consistent safety and effectiveness of varying
formulations.
    a. New safety concerns can arise before or after a monograph is
finalized. The OTC Drug Monograph Process is not agile enough to
quickly change a monograph to address new safety concerns that may be
identified during the rulemaking process or after a monograph is
finalized (e.g., the addition of a warning into the monograph
regulation, narrowing of an indication in the monograph regulation, or
removal of an active ingredient from the monograph). Although the
Agency may be able to take some actions to deal with safety issues that
emerge, in order to change the monograph under the current process FDA
engages in a lengthy rulemaking process. This process for changing a
monograph is not well-adapted to address new safety issues with the
speed and agility that are necessary to serve the public health.
    b. Keeping Pace with Evolving Science. As we have already
described, the OTC Drug Review is not able to easily keep pace with
evolving science. When the OTC Drug Review was established, it was
generally thought that safety and effectiveness evaluations for the
various active ingredients would be fairly straightforward and would
not necessarily need continuous reexamination over time. Forty years
later we know that information and data regarding medicine and science
are changing at increasingly rapid rates. For example, scientific
advancements have changed what is known about how drugs act in the body
and in turn, how drugs are evaluated by FDA. These changes cannot be
reflected under the OTC Drug Review in an efficient or timely manner.
For example, many drug products regulated under the OTC Drug Review are
indicated for use by children and are labeled with dosing instructions
for this population. For most OTC monograph products, the information
and data available at the time the initial advisory review panels
established by FDA evaluated the various active ingredients, in the
1970s, lacked specific data on use in children and infants. FDA did
what was scientifically customary at the time, and extrapolated known
data to use in children by simply reducing adult doses by a percentage.
For most monographs that include specific labeling for use in the
pediatric population, the pediatric dosing instructions were developed
in this manner. The science of pharmacokinetics has advanced over the
years and, as a result, the preferred approach to pediatric dosing has
changed. Ideally, data from actual use in the pediatric population
would be needed for an indication for use in children.
    In addition, with some categories of OTC drugs, changes in patterns
of use take place which, in turn, impact consumer exposure to the
drugs. Exposure patterns are a key component of any safety and
effectiveness assessment. The current process of changing a monograph
does not contain an efficient mechanism to assess or address these
kinds of changes to exposure patterns.
    c. Product Formulation. Under the OTC Drug Review, the monographs
set forth the conditions under which a specific active ingredient used
in a drug product is GRAS/GRAE and not misbranded. The monographs,
however, generally do not dictate what other non-active ingredients can
be added, or other aspects of the formulation (other than the general
requirement that they be safe and suitable and not interfere with the
effectiveness of the preparation, see Sec.  330.1(e)). Thus, under the
OTC Drug Review, products in their final formulation are not
specifically evaluated by the Agency to ensure product safety,
effectiveness, and consistency. Although FDA regulations require that
inactive ingredients not interfere with the safety or efficacy of the
drug product, for drug products marketed under the OTC Drug Review, FDA
generally does not receive information about specific varying
formulations that it can use to ensure that the final finished drug
products meet the standards for safety and effectiveness.
3. Limited Opportunity for Innovation
    Eligibility for the OTC Drug Review is limited to active
ingredients that were on the market in their specific dosage forms at
the inception of the OTC Drug

Review, and products that have become eligible under the Time and
Extent Application process set forth at Sec.  330.14. Thus, when
manufacturers develop new combinations of ingredients or new dosage
forms (e.g. dissolving films or tablets), the OTC Drug Review is not
facile in accommodating these types of changes. Due to these changes,
products that are not eligible for consideration under the OTC Drug
Review would otherwise require an NDA prior to marketing.

II. The Future: Modernizing the OTC Drug Review

    In light of the challenges posed by the OTC Drug Review, FDA
believes it is time for considering ideas for modernizing the
regulation of drugs under the OTC Drug Review. We are interested in
hearing ideas for changes to the existing OTC Monograph Process or
ideas for its replacement with an entirely new regulatory or statutory
framework.
    In developing suggestions for change, FDA notes that many of the
OTC Drug Review's present day challenges are systemic, and thus cannot
be addressed solely by increasing resources. In this section, we
identify some preliminary ideas for potential changes to the OTC
Monograph Process. Although none of these ideas appear likely to lead
to a comprehensive solution, we are sharing them as a starting point
for a discussion on modernizing the OTC Drug Review. Our summary of
these initial ideas here is not intended to define the limits of the
kind of changes that might be proposed. We are interested in hearing a
full range of ideas, including novel ideas for new regulatory
frameworks.
    Suggestions and other comments from the public need not be
comprehensive to be useful. FDA is interested in ideas that may not
solve every problem, but do address one or more of them. Ideally, a
comprehensive solution (made up of a single proposal or a group of
proposed solutions) would address all the challenges of the current
system. We believe that an ideal, comprehensive solution would:
     Use modern standards for safety and efficacy,
     provide an efficient mechanism for finalizing the status
of drug products that are currently marketed under pending TFMs,
     allow for innovative changes to drug products,
     provide FDA with the ability to respond promptly to
emerging safety or effectiveness concerns,
     allow FDA to easily and quickly require additional
information or data necessary to develop pediatric labeling where
appropriate, and
     allow FDA to obtain final formulation information about
individual products or readily establish final formulation testing
standards.
    We recognize that the preliminary concepts we discuss in this
document touch upon some, but not all, of the challenges we have
identified. In addition, these ideas are not necessarily limited to
approaches for which FDA has existing statutory authority. These
preliminary ideas are:
     Identifying a streamlined process that would allow prompt
resolution of existing TFMs,
     issuing monographs by administrative order,
     issuing regulations to require product specific
information and expanding the use of guidances, and
     expanding the NDA deviation process.
    We invite the public to comment on these potential options, but we
also encourage comments that propose other ideas.

A. Promptly Resolve Existing Tentative Final Monographs Pursuant to a
Streamlined Process

    FDA is considering ways to more efficiently bring TFMs to closure.
We are interested in ideas for developing streamlined processes under
which the Agency could promptly finalize the existing TFMs.

B. Issue Monographs by Administrative Order

    This idea would involve establishing a process similar to that
enacted by the Food and Drug Administration Safety and Innovation Act
(FDASIA) (Pub. L. 112-144) for device reclassifications. FDASIA changed
the process by which devices are reclassified under section 513(e) of
the FD&C Act from notice and comment rulemaking to an administrative
order process (see 21 U.S.C. 360c(e)(1)(A)(i)). Under this model,
monographs could be established by administrative order, after issuance
of a proposed order for comment.

C. Issuing Regulations To Require Product Specific Information and
Expanding the Use of Guidances

    FDA could issue new regulations that would require that
manufacturers submit, prior to marketing, limited information about
individual products that will be using active ingredients that have
been determined to be GRAS/GRAE. The individual product information
requested might be similar to, but less detailed than, what is required
under an NDA and could include, for example, labeling, and quality and
pharmacokinetic information. FDA could then issue guidances
recommending the types of information FDA would be seeking. FDA's use
of guidances under this framework could increase the Agency's
flexibility to address specific product issues as they arise.

D. Expand the NDA Deviation Process

    The OTC Drug Review regulations provide a process for approving a
drug product that complies with the conditions of a final monograph
except for a deviation (Sec.  330.11). In this instance, a sponsor can
apply for an NDA deviation by submitting an NDA showing that the
product complies with the conditions of the monograph except for the
deviation and providing the necessary data to demonstrate the safety
and effectiveness of the product with the deviation. For example, an
OTC monograph may not cover certain dosage forms of a monograph
ingredient. The manufacturer of a proposed different dosage form could
submit an NDA that relies on the final monograph to demonstrate the
safety and efficacy for the drug except for the differences related to
the change in dosage form. The NDA would also need to include the
appropriate data to demonstrate the safety and effectiveness of the new
dosage form. The approved NDA would be specific only to the NDA sponsor
and would not amend the monograph.
    Industry has not utilized the NDA deviation process as a pathway to
marketing very often. The Agency is interested in learning why this is
and whether there are changes that could be made to the existing NDA
deviation process that would make it a more attractive alternative for
industry and that could allow marketing of additional drug products
without having to submit a full NDA.

III. Scope of the Public Hearing

    FDA is holding this public hearing to seek input on possible ways
to modernize the OTC Monograph Process in order to make the process
more responsive to emerging safety information and scientific advances.
We would like feedback from a variety of interested members of the
public, including consumers; industry; and pharmacists, physicians, and
other members of the medical community. FDA is interested in obtaining
information and public comment in the following areas:

A. Strengths and Weaknesses of the Existing OTC Drug Review

     What aspects of the OTC Drug Review continue to function
effectively?
     Which aspects of the OTC Drug Review are most in need of
change?
     Are there additional mechanisms to eligibility for the OTC
Drug Review that could be explored? If so, what should be the
parameters of eligibility?
     Why is the NDA deviation process rarely used by industry?
Are there changes to that process that would make it a more appealing
and appropriate alternative pathway?

B. Preliminary Concepts for Modernization Described in This Document

    We welcome views on the following preliminary concepts identified
by FDA for modernizing the OTC Drug Review:
     Ideas for a streamlined process that would allow us to
promptly resolve all TFMs.
     Issue monographs by administrative order.
     Issue regulations to require product specific information
and expand the use of guidances.
     Expand the NDA deviation process.

C. Your Suggestions for Modifications or Alternatives to the OTC Drug
Review

     What alternatives or changes to the OTC Drug Review would
modernize or improve FDA's regulation of monograph drugs?
     What changes can facilitate speedier finalization of the
remaining monographs?
     How can the Agency most expeditiously address emerging
safety issues for drugs regulated under the OTC Drug Review?
     Are there specific changes to the OTC Drug Review that the
Agency could employ to address the lack of pediatric data for some
final monographs?
     Should the only alternative to marketing an OTC drug under
an OTC monograph be an NDA or abbreviated NDA approval? If not, what
could another alternative be?
     Are there other regulatory mechanisms (not necessarily
used for the regulation of drug products) that are used by other
agencies in the United States or in other countries that FDA could
consider using to regulate OTC drugs products?

IV. Attendance and/or Participation in the Public Hearing

    The public hearing is free and seating will be on a first-come,
first-served basis. If you wish to make an oral presentation during the
hearing, you must register by submitting either an electronic or a
written request by 5 p.m. on March 12, 2014, to Mary Gross or Georgiann
Ienzi (see FOR FURTHER INFORMATION CONTACT). Submit electronic requests
to<EMAIL_ADDRESS>We recommend that you register early
because seating is limited. You must provide your name, title, business
affiliation (if applicable), address, telephone and fax numbers, email
address, and type of organization you represent (e.g., industry,
consumer organization, etc.). You also should submit a brief summary of
the presentation, including the discussion topic(s) that will be
addressed and the approximate time requested for your presentation. FDA
encourages individuals and organizations with common interests to
coordinate and give a joint, consolidated presentation. Registrants
will receive confirmation once they have been accepted to attend the
meeting. FDA may limit both the number of participants from individual
organizations and the total number of attendees based on space
limitations. Registered presenters should check in before the hearing.
    Participants should submit a copy of each presentation to Mary
Gross or Georgiann Ienzi (see FOR FURTHER INFORMATION CONTACT) no later
than 5 p.m. on March 12, 2014. We will file the hearing schedule,
indicating the order of presentation and the time allotted to each
person, with the Division of Dockets Management (see Comments and
Transcripts). FDA will post an agenda of the public hearing and other
background material at least 3 days before the public hearing and
additional information will be available at: http://www.fda.gov/Drugs/NewsEvents/ucm380446.htm (select this hearing from the events list).
    We will mail, email, or telephone the schedule to each participant
before the hearing. In anticipation of the hearing presentations moving
ahead of schedule, participants are encouraged to arrive early to
ensure their designated order of presentation. Participants who are not
present when called risk forfeiting their scheduled time.
    If you need special accommodations due to a disability, contact
Mary Gross or Georgiann Ienzi (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the hearing.

V. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner and the relevant centers.
    Under Sec.  15.30(f), the hearing is informal and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation
(Sec.  15.30(e)). Public hearings under part 15 are subject to FDA's
policy and procedures for electronic media coverage of FDA's public
administrative proceedings (21 CFR part 10, subpart C) (Sec.
10.203(a)). Under Sec.  10.205, representatives of the electronic media
may be permitted, subject to certain limitations, to videotape, film,
or otherwise record FDA's public administrative proceedings, including
presentations by participants. The hearing will be transcribed as
stipulated in Sec.  15.30(b). (See section VII for more details.) To
the extent that the conditions for the hearing as described in this
document conflict with any provisions set out in part 15, this notice
acts as a waiver of those provisions as specified in Sec.  15.30(h).

    Dated: February 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03884 Filed 2-21-14; 8:45 am]
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