[Federal Register Volume 77, Number 73 (Monday, April 16, 2012)]
[Notices]
[Page 22615]
[FR Doc No: 2012-9011]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 15g-3, OMB Control No. 3235-0392, SEC File No. 270-346.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
existing collection of information provided for in Rule 15g-3--Broker
or dealer disclosure of quotations and other information relating to
the penny stock market (17 CFR 240.15g-3) under the Securities Exchange
Act of 1934 (15 U.S.C. 78a et seq.).
    Rule 15g-3 requires that brokers and dealers disclose to customers
current quotation prices or similar market information in connection
with transactions in penny stocks. The purpose of the rule is to
increase the level of disclosure to investors concerning penny stocks
generally and specific penny stock transactions.
    The Commission estimates that approximately 209 broker-dealers will
spend an average of 87 hours annually to comply with this rule. Thus,
the total compliance burden is approximately 18,200 burden-hours per
year.
    Rule 15g-3 contains record retention requirements. Compliance with
the rule is mandatory. The required records are available only to the
examination staff of the Commission and the self regulatory
organizations of which the broker-dealer is a member. The Commission
may not conduct or sponsor a collection of information unless it
displays a currently valid OMB control number. No person shall be
subject to any penalty for failing to comply with a collection of
information subject to the PRA that does not display a valid OMB
control number.
    Background documentation for this information collection may be
viewed at the following Web site, www.reginfo.gov. Comments should be
directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503 or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon,
6432 General Green Way, Alexandria, VA 22312 or send an email to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of
this notice.

    Dated: April 10, 2012.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-9011 Filed 4-13-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 18 (Monday, January 30, 2017)]
[Notices]
[Page 8736]
[FR Doc No: 2017-01919]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP17-283-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Transcontinental Gas Pipe Line Company, LLC submits
tariff filing per 154.204: DPEs--WGL to be effective 1/21/2017.
    Filed Date: 12/21/16.
    Accession Number: 20161221-5248.
    Comments Due: 5 p.m. ET 1/3/17.

    Docket Numbers: RP17-284-000.
    Applicants: Dauphin Island Gathering Partners.
    Description: Dauphin Island Gathering Partners submits tariff
filing per 154.204: Negotiated Rate Filing 12-21-2016 to be effective
1/1/2017.
    Filed Date: 12/21/16.
    Accession Number: 20161221-5267.
    Comments Due: 5 p.m. ET 1/3/17.

    Docket Numbers: RP17-285-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Rockies Express Pipeline LLC submits tariff filing per
154.204: 2016-12-21 Electric to PCT to be effective 1/22/2017.
    Filed Date: 12/21/16.
    Accession Number: 20161221-5337.
    Comments Due: 5 p.m. ET 1/3/17.

    Docket Numbers: RP17-286-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Algonquin Gas Transmission, LLC submits tariff filing
per 154.204: AIM Non-Conforming Agreements and Negotiated Rates to be
effective 1/4/2017.
    Filed Date: 12/21/16.
    Accession Number: 20161221-5372.
    Comments Due: 5 p.m. ET 1/3/17.

    Docket Numbers: RP13-316-000.
    Applicants: Tallgrass Interstate Gas Transmission, LLC.
    Description: Tallgrass Interstate Gas Transmission, LLC submits
tariff filing per 154.501: TIGT 2016 Reconcilation Filing to be
effective N/A.
    Filed Date: 12/22/16.
    Accession Number: 20161222-5143.
    Comments Due: 5 p.m. ET 1/3/17.

    Docket Numbers: RP17-287-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America LLC submits
tariff filing per 154.204: Tenaska Marketing Ventures Negotiated Rate
to be effective 1/1/2017.
    Filed Date: 12/22/16.
    Accession Number: 20161222-5074.
    Comments Due: 5 p.m. ET 1/3/17.

    Docket Numbers: RP17-288-000.
    Applicants: USG Pipeline Company, LLC.
    Description: USG Pipeline Company, LLC submits tariff filing per
154.204: Housekeeping Tariff Revisions to be effective 1/22/2017.
    Filed Date: 12/22/16.
    Accession Number: 20161222-5350.
    Comments Due: 5 p.m. ET 1/3/17.

    Docket Numbers: RP17-289-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Texas Eastern Transmission, LP submits tariff filing
per 154.204: Chevron k911109 Releases to ConocoPhillips for 1-1-2017 to
be effective 1/1/2017.
    Filed Date: 12/23/16.
    Accession Number: 20161223-5048.
    Comments Due: 5 p.m. ET 1/4/17.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 23, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-01919 Filed 1-27-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: September 23, 2010 (Volume 75, Number 184)]
[Notices]
[Page 58015]
[DOCID:fr23se10-120]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Mitsubishi MU-
2B Series Airplane Special Training, Experience, and Operating
Procedures

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. This collection of information request is for Mitsubishi
MU-2B Series Airplane Special Training, Experience, and Operating
Requirements Special Federal Aviation Regulation. The pilot training
requires a logbook endorsement and documentation of a training-course
completion record.

DATES: Written comments should be submitted by November 22, 2010.

FOR FURTHER INFORMATION CONTACT: Carla Scott on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0725.
    Title: Mitsubishi MU-2B Series Airplane Special Training,
Experience, and Operating Procedures.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: In response to the increasing number of accidents and
incidents involving the Mitsubishi MU-2B series airplane, the Federal
Aviation Administration (FAA) began a safety evaluation of the MU-2B in
July of 2005. As a result of this safety evaluation, the FAA published
a Special Federal Aviation Regulation (SFAR) on February 6, 2008 (73 FR
7033) that established a standardized pilot training program. The
collection of information is necessary to document participation,
completion, and compliance with the pilot training program.
    Respondents: Approximately 600 MU-2B pilots.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 3 minutes.
    Estimated Total Annual Burden: 100 hours.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Scott, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on September 17, 2010.
Carla Scott,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2010-23734 Filed 9-22-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16182-16183]
[FR Doc No: 2022-06047]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2022-0163; FRL-9408-02-OCSPP]

Pesticide Product Registration; Receipt of Applications for New
Uses--February 2022

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received applications to register new uses for
pesticide products containing currently registered active ingredients.
Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), EPA is hereby providing notice of receipt and opportunity to
comment on these applications.

DATES: Comments must be received on or before April 21, 2022.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number and the File Symbol of the EPA registration
Number of interest as shown in the body of this document, through the
Federal eRulemaking Portal at http://www.regulations.gov. Follow the
online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Additional instructions on commenting or visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets/about-epa-dockets.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. For the latest status information on EPA/DC services
and access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (BPPD) (7511P), main telephone number:
(202) 566-2427, email address: [email protected]; or Marietta
Echeverria, Registration Division (RD) (7505P), main telephone number:
(703) 305-7090, email address: [email protected]. The mailing address
for each contact person: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code. The division to contact is listed at the
end of each application summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark

the part or all of the information that you claim to be CBI. For CBI
information in a disk or CD-ROM that you mail to EPA, mark the outside
of the disk or CD-ROM as CBI and then identify electronically within
the disk or CD-ROM the specific information that is claimed as CBI. In
addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Registration Applications

    EPA has received applications to register new uses for pesticide
products containing currently registered active ingredients. Pursuant
to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA
is hereby providing notice of receipt and opportunity to comment on
these applications. Notice of receipt of these applications does not
imply a decision by the Agency on these applications.

Notice of Receipt--New Uses

    1. EPA Registration Number: 8033-102 and 8033-103. Docket ID
number: EPA-HQ-OPP-2021-0788. Applicant: Nippon Soda Co., Ltd., Shin-
Ohtemachi Bldg., 2-1, 2-Chome Ohtemachi, Chiyoda-ku, Tokyo, 100-8165,
Japan. Active ingredient: Cyflufenamid. Product type: Fungicide.
Proposed use: Sugar beet. Contact: RD.
    2. EPA Registration Numbers: 10163-354, 10163-355, and 10163-356.
Docket ID number: EPA-HQ-OPP-2021-0555. Applicant: Gowan Company, LLC
370 S Main St., Yuma, AZ 85366. Active ingredient: Ethalfluralin.
Product type: Herbicide. Proposed use: 3-07A. onion, bulb subgroup.
Contact: RD.
    3. EPA Registration Numbers: 61842-21, 61842-22, and 61842-24.
Docket ID number: EPA-HQ-OPP-2022-0134. Applicant: Tessenderlo Kerley,
Inc./NovaSource 2910 N 44th Street, Suite 100, Phoenix, AZ 85018.
Active ingredient: Linuron. Product type: Herbicide. Proposed use:
Alfalfa forage and hay. Contact: RD.
    4. EPA Registration Numbers: 67690-6, 67690-78. Docket ID number:
EPA-HQ-OPP-2021-0787. Applicant: SePRO Corporation, 11550 North
Meridian Street, Suite 600, Carmel, IN 46032. Active ingredient:
Fluridone. Product type: Herbicide. Proposed uses: Citrus fruit (crop
group 10-10); pome fruit (crop group 11-10); berry and small fruit
(crop group 13-07); tree nut (crop group 14-12); grass forage, fodder
and hay (crop group 17); non-grass animal feeds (crop group 18);
tropical and subtropical, small fruit, edible peel (crop subgroup 23A);
tropical and subtropical fruit, inedible peel (crop subgroup 24B);
rice, and hops. Contact: RD.
    5. EPA Registration Numbers: 71512-21 & 71512-22. Docket ID number:
EPA-HQ-OPP-2021-0385. Applicant: Interregional Research Project Number
4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road
East, Suite 201 W, Princeton, NJ 08540. Active ingredient: Isofetamid.
Product type: Fungicide. Proposed use: Ginseng, and crop group
expansion to all of the bean and pea commodities in proposed subgroups
6-19A edible podded bean legume vegetable subgroup; 6-19B edible podded
pea legume vegetable subgroup, 6-19C succulent shelled bean subgroup;
6-19D succulent shelled pea subgroup; 6-19E dried shelled bean, except
soybean, subgroup; and 6-19F dried shelled pea subgroup. Contact: RD.
    6. EPA Registration Number: 71512-25, 71512-24 & 71512-43. Docket
ID number: EPA-HQ-OPP-2021-0386. Applicant: The State University of New
Jersey Rutgers, 500 College Road East, Suite 201 W, Princeton, NJ
08540. Active ingredient: Pyriofenone. Product type: Fungicide.
Proposed use: New greenhouse uses of pyriofenone on tomato subgroup 8-
10A; pepper/eggplant subgroup 8-10B and cucumber. Contact: RD.
    7. File Symbol: 89600-T. Docket ID number: EPA-HQ-OPP-2022-0224.
Applicant: Anatis Bioprotection Inc., 278 Rang Saint-Andr[eacute], St-
Jacques-le-Mineur, Quebec J0J 1Z0, Canada (c/o SciReg, Inc., 12733
Director's Loop, Woodbridge, VA 22192). Active ingredient: Beauveria
bassiana strain ANT-03. Product type: Insecticide. Proposed use: For
use on poultry litter and livestock bedding. Contact: BPPD.
    8. EPA Registration Number: 91746-5. Docket ID number: EPA-HQ-OPP-
2022-0257. Applicant: Belchim Crop Protection US Corporation, 2751
Centreville Road, Suite 100, Wilmington, Delaware 19808. Active
ingredient: Pyridate. Product type: herbicide. Proposed use: Dry peas
and soybeans. Contact: RD.
    Authority: 7 U.S.C. 136 et seq.

    Dated: March 16, 2022.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Program Support.
[FR Doc. 2022-06047 Filed 3-21-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34679-34681]
[FR Doc No: 2015-14885]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0389]

Medical Device User Fee Amendments; Public Meeting; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

    The Food and Drug Administration (FDA) is announcing a public
meeting on the reauthorization of the Medical Device User Fee
Amendments (MDUFA) for fiscal years 2018 through 2022. The current
legislative authority for the medical device user fee program expires
on October 1, 2017, and new legislation will be required for FDA to
continue collecting user fees for the medical device program in future
fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act)
requires that before FDA begins negotiations with the regulated
industry on MDUFA reauthorization, we publish a notice in the Federal
Register requesting public input on the reauthorization, hold a public
meeting at which the public may present its views on the
reauthorization, provide a period of 30 days after the public meeting
to obtain written comments from the public suggesting changes to MDUFA,
and publish the comments on FDA's Web site. FDA invites public comment
on the medical device user fee program and suggestions regarding the
commitments FDA should propose for the next reauthorized program.
    Date and Time: The public meeting will be held on July 13, 2015,
from 9 a.m. to 5 p.m.
    Location: The public meeting will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for public
meeting participants (non-FDA employees) is through Building 1 where
routine security screening procedures will be performed. For parking
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Aaron Josephson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5449, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration: Registration is required to attend this meeting in
person or to view the Webcast. Registration is free and available on a
first-come, first-served basis. Persons interested in participating in
the meeting must register online by July 2, 2015, at 4 p.m. Early
registration is recommended because space is limited and, therefore,
FDA may limit the number of participants from each organization. If
time and space permit, onsite registration on the day of the meeting
will be provided beginning at 8 a.m.
    If you have registered and need special accommodations, please
contact Susan Monahan,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
no later than July 1, 2015.
    To register for the public meeting, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public meeting from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, email, and telephone number. Those without Internet
access should contact Susan Monahan to register. All registrants will
receive confirmation after they have been successfully registered.
Registrants not confirmed to participate, but added to a waiting list,
will be notified of that as well.
    Streaming Webcast of the Public Meeting: This public meeting will
be Webcast. Persons interested in viewing the Webcast must register
online (see Web link above) by July 2, 2015, at 4 p.m. Early
registration is recommended because Webcast connections are limited.
FDA requests that organizations with multiple registrants in the same
location register all participants individually but view the Webcast
using one connection per location. Webcast participants will be sent
technical system requirements upon confirmation and will be sent
connection access information after July 6, 2015. If you have not
previously attended an event hosted by Connect Pro, it is recommended
that you test your connection in advance at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. A short
overview of the Connect Pro program is available at http://www.adobe.com/go/connectpro_overview.
    Requests for Oral Presentations: This public meeting includes
public comment and topic-focused sessions. During registration you may
indicate if you wish to present during a public comment session or
participate in a topic-focused session, and specify the topic(s) you
wish to address. FDA has included general topics in this document. FDA
will do its best to accommodate all persons who wish to speak. FDA
encourages individuals and organizations with common interests to
consolidate or coordinate their presentations, and request time for a
joint presentation, or submit requests for designated representatives
to participate in the topic-focused sessions. After

registration closes, FDA will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to
begin, and will notify selected speakers by July 7, 2015. All requests
to make oral presentations must be received by the close of
registration on July 2, 2015, at 4 p.m. Presenters should submit all
presentation materials via email to Aaron Josephson (see Contact
Person) no later than July 10, 2015. No commercial or promotional
material should be presented or distributed at the public meeting.
    Comments: FDA is holding this public meeting to hear stakeholder
views on the medical device user fee program. In order to obtain a
broad range of public comment, FDA is soliciting either electronic or
written comments on all aspects of the public meeting topics. The
deadline for submitting comments related to this public meeting is
August 12, 2015.
    Regardless of attendance at the public meeting, interested persons
may submit either electronic comments regarding reauthorization of
MDUFA 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. 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. In addition, when
responding to specific questions as outlined in section I, please
identify the question you are addressing. Received comments may be
viewed 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: As soon as a transcript is available, it will be
accessible at http://www.regulations.gov. It may also be viewed in
person at the Division of Dockets Management (see Comments). A link to
the transcript will also be available approximately 45 days after the
public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public
meeting from the posted events list.)

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing its intention to hold a public meeting on the
reauthorization of the Medical Device User Fee Amendments of 2012
(MDUFA III), which currently authorizes FDA to collect user fees and
use them for the process for the review of device applications until
October 1, 2017. Without new legislation, referred to as
reauthorization, FDA will not be able to collect user fees after fiscal
year (FY) 2017 to fund the medical device review process.
    Prior to reauthorization, FDA must consult with the regulated
industry and make recommendations to Congress regarding the goals for
the process for the review of device applications (see 21 U.S.C. 379j-
1(b)(1)(F)). Before beginning negotiations with the regulated industry
on user fee reauthorization, section 738A(b)(2) of the FD&C Act (21
U.S.C. 379j-1(b)(2)) requires that FDA do the following: (1) Publish a
notice in the Federal Register requesting public input on the
reauthorization; (2) hold a public meeting at which the public may
present its views on the reauthorization, including specific
suggestions for changes to the goals set under MDUFA III; (3) provide a
period of 30 days after the public meeting to obtain written comments
from the public suggesting changes to MDUFA; and (4) publish the
comments on FDA's Web site. This notice, the public meeting, the 30-day
comment period after the meeting, and the posting of the comments on
FDA's Web site will satisfy these requirements.
    The purpose of the meeting is to hear stakeholder views on medical
device user fee reauthorization as we consider FDA's recommendation to
Congress for the next medical device user fee program. FDA is
interested in responses to the following two general questions and
welcomes any other pertinent information stakeholders would like to
share:
    1. What is your assessment of the overall performance of the
medical device user fee program under MDUFA III?
    2. What aspects of the medical device user fee program should be
retained, changed, or discontinued to further strengthen and improve
the program?
    The following information is provided to help potential meeting
participants better understand the history and evolution of the medical
device user fee program and its current status.

II. What is the Medical Device User Fee Program? What does it do?

    In the years preceding enactment of the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), FDA's medical
device program suffered a long-term, significant loss of resources that
undermined the program's capacity and performance. MDUFMA was enacted
``in order to provide FDA with the resources necessary to better review
medical devices, to enact needed regulatory reforms so that medical
device manufacturers can bring their safe and effective devices to the
American people at an earlier point in time, and to ensure that
reprocessed medical devices are as safe and effective as original
devices'' (H. Rept. 107-728 at 21 (2002)). MDUFMA had a 5-year life and
contained two particularly important features which relate to
reauthorization:
     User fees for the review of medical device premarket
applications, reports, supplements, and premarket notification
submissions provided additional resources to make FDA reviews more
timely, predictable, and transparent to applicants. MDUFMA fees and
appropriations for the medical device program helped FDA expand
available expertise, modernized its information management systems,
provided new review options, and provided more guidance to prospective
submitters. The ultimate goal was for FDA to approve and clear safe and
effective medical devices more rapidly, benefiting applicants, the
health care community, and most importantly, patients.
     Negotiated performance goals for many types of premarket
reviews provided FDA with benchmarks for measuring review improvements.
These quantifiable goals became more demanding each year and included
FDA decision goals and cycle goals (cycle goals refer to FDA actions
prior to a final action on a submission). Under MDUFMA, FDA also agreed
to several other commitments that did not have specific timeframes or
direct measures of performance, such as expanding the use of meetings
with industry, maintenance of current performance in review areas where
specific performance goals had not been identified, and publication of
additional guidance documents.
    Medical device user fees and increased appropriations are essential
to support high-quality, timely medical device reviews, and other
activities critical to the device review program.
    MDUFMA provided for fee discounts and waivers for qualifying small
businesses. Small businesses make up a large proportion of the medical
device industry, and these discounts and waivers helped reduce the
financial impact of user fees on this sector of the medical device
industry, which plays an important role in fostering innovation.
    Since MDUFMA was first passed in 2002, it has been reauthorized
twice: The 2007 Medical Device User Fee Amendments (MDUFA II) and the
2012 Medical Device User Fee Amendments (MDUFA III). Under MDUFA III,
which

has been in effect since 2012 and will expire in 2017, FDA has met or
exceeded nearly all submission performance goals while implementing
program enhancements designed to ensure more timely access to safe and
effective medical devices.
     Premarket Notifications (510(k)s): Comparison of outcomes
for receipt cohorts at the same levels of completion (or ``closure'')
show a 16 percent decrease in total review time between FY 2010 and FY
2013 when the cohort is 99.8 percent closed, and 10 percent decrease in
total review time between FY 2010 and FY 2014 when the cohort is 75.8
percent closed.
     Premarket Approvals (PMAs): Comparison of outcomes for
receipt cohorts at the same closure levels show a 32 percent decrease
in total review times between FY 2009 and FY 2012 when the cohort is 98
percent closed, and a 26 percent decrease in total review times between
FY 2009 and FY 2014 when the cohort is 41 percent closed.
    FDA has met or exceeded all MDUFA III performance goals for FDA
time to decisions in FY 2013 and FY 2014. More information about FDA's
performance is available in the yearly MDUFA performance reports, which
are available online at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/UCM2007450.htm.
    User fees and related performance goals have played an important
role in providing resources and supporting the process for the review
of device applications.

III. What information should you know about the meeting?

    Through this notice, we are announcing a public meeting to hear
stakeholder views on the reauthorization of MDUFA for fiscal years 2018
through 2022, including specific suggestions for any changes to the
program that we should consider. We will conduct the meeting on July
13, 2015. In general, the meeting format will include presentations by
FDA and a series of panels representing different stakeholder interest
groups (such as patient advocates, consumer protection groups,
industry, health care professionals, and academic researchers). FDA
will also provide an opportunity for individuals to make presentations
during the meeting and for organizations and individuals to submit
written comments to the docket after the meeting. The presentations
should focus on program improvements and funding issues, including
specific suggestions for changes to performance goals, and not focus on
other general policy issues.

    Dated: June 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14885 Filed 6-16-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: November 27, 2007 (Volume 72, Number 227)]
[Notices]
[Page 66205-66206]
[DOCID:fr27no07-122]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56818; File No. SR-CBOE-2007-65]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of a Proposed Rule Change as Modified by
Amendment No. 1 Thereto Regarding Nullification and Modification of
Transactions Executed on CBOE Stock Exchange

November 19, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 12, 2007, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by the Exchange. On November 8, 2007, the CBOE submitted
Amendment No. 1 to the proposed rule change.\3\ The Commission is
publishing this notice to solicit comments on the proposed rule change,
as amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 supersedes and replaces the original filing
in its entirety. The substance of Amendment No. 1 is incorporated
into this notice.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes various revisions to CBOE Stock Exchange
(``CBSX'') Rule 52.4, which governs the nullification and modification
of transactions executed on CBSX. The text of the proposed rule change
is available at the Exchange, the Commission's Public Reference Room,
and http://www.cboe.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange states that the purpose of this proposed rule change
is to revise CBSX Rule 52.4, which governs the nullification and
modification of transactions executed on CBSX. Specifically, the
Exchange proposes to: (1) Require a request for review of a transaction
to be made by only one of the following methods: Telephone; facsimile;
or e-mail (in order to simplify the process for those making requests);
(2) require such a request to be made within thirty minutes of the
trade in question, or within forty-five minutes of the trade if that
trade occurred within the first thirty minutes of trading in the
product involved in the trade (in order to give more time for requests
which, based on the Exchange's experience so far, is necessary); (3)
give the individual(s) who reviews transactions under the Rule the
label of ``designated official,'' so that they need not be officers of
the Exchange; and (4) eliminate the requirement that the notification
to the parties to the trade of the official's determination be given in
writing and by the official. The aforementioned changes labeled (1) and
(4) are based on, and conform CBSX Rule 52.4 to NYSE Arca Equities
Rules 7.10(b) and 7.10(c)(1), respectively.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
section 6(b) of the Act,\4\ in general, and furthers the objectives of
section 6(b)(5) of the Act,\5\ in particular, in that it is designed to
promote just and equitable principles of trade, serve to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and to protect investors and the public
interest.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received from Members, Participants or Others

    No written comments were solicited or received by the Exchange with
respect to the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding, or (ii) as to
which the Exchange consents, the Commission will:
    A. By order approve the proposed rule change or
    B. Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2007-65 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2007-65. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2007-65 and should be
submitted on or before December 18, 2007.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
Florence E. Harmon,
Deputy Secretary.
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    \6\ 17 CFR 200.30-3(a)(12).
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 [FR Doc. E7-22985 Filed 11-26-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Notices]
[Pages 62527-62528]
[FR Doc No: 2019-24769]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10684-095]

City of Lansing, MI; Notice of Application for Surrender of
License, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Application for surrender of minor license.
    b. Project No: 10684-095.
    c. Date Filed: September 30, 2019.
    d. Applicant: City of Lansing, Michigan.
    e. Name of Project: Moores Park Hydroelectric Project.
    f. Location: The 600-kilowatt project is located on the Grand
River, in the City of Lansing, Ingham County, Michigan. The project
does not occupy any federal lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Lori Myott, Manager, Environmental Services
Department, Lansing Board of Water and Light, 1201 South Washington
Avenue, Lansing, MI 48910-1650,<PHONE_NUMBER>, or<EMAIL_ADDRESS>    i. FERC Contact: Diana Shannon,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: December 9, 2019.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426. The first page of any filing
should include docket number P-10684-095. Comments emailed to
Commission staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The applicant proposes to surrender its
license for the project. The project has not operated since 2013 due to
mechanical equipment problems. No ground disturbance is proposed and

project features will remain in place. The applicant would retain
ownership of the dam and maintain the current reservoir elevation of
833.4  0.2 NGVD29. In order to decommission the project
facilities, the applicant proposes to close the intake for the units
with steel bulkheads and to disconnect the project generators from the
grid. The applicant proposes to keep the generating equipment in place.
The powerhouse would remain secured with the existing fencing and
security system. The current license expires on December 31, 2023.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE, Room 2A, Washington, DC
20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above. Agencies may obtain copies of the application directly from
the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title COMMENTS, PROTEST, or MOTION TO INTERVENE as
applicable; (2) set forth in the heading the name of the applicant and
the project number of the application to which the filing responds; (3)
furnish the name, address, and telephone number of the person
commenting, protesting or intervening; and (4) otherwise comply with
the requirements of 18 CFR 385.2001 through 385.2005. All comments,
motions to intervene, or protests must set forth their evidentiary
basis. Any filing made by an intervenor must be accompanied by proof of
service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 385.2010.

    Dated: November 7, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-24769 Filed 11-14-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Notices]
[Pages 14405-14407]
[FR Doc No: 2011-6055]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No.FDA-2011-N-0085]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry: Cooperative Manufacturing
Arrangements for Licensed Biologics

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the proposed extension of the
collection of information concerning the guidance for industry on
cooperative manufacturing arrangements for licensed biologics.

DATES: Submit either electronic or written comments on the collection
of information by May 16, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to: http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide

information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance For Industry: Cooperative Manufacturing Arrangements for
Licensed Biologics--(OMB Control Number 0910-0629--Extension)

    The guidance document provides information concerning cooperative
manufacturing arrangements applicable to biological products subject to
licensure under section 351 of the Public Health Service Act (42 U.S.C.
262). The guidance addresses several types of manufacturing
arrangements (i.e., short supply arrangements, divided manufacturing
arrangements, shared manufacturing arrangements, and contract
manufacturing arrangements) and describes certain reporting and
recordkeeping responsibilities, associated with these arrangements,
including the following: (1) Notification of all important proposed
changes to production and facilities, (2) notification of results of
tests and investigations regarding or possibly impacting the product,
(3) notification of products manufactured in a contract facility, and
(4) standard operating procedures as follows:

1. Notification of All Important Proposed Changes to Production and
Facilities

    Each licensed manufacturer in a divided manufacturing arrangement
or shared manufacturing arrangement must notify the appropriate FDA
Center regarding proposed changes in the manufacture, testing, or
specifications of its product, in accordance with Sec.  601.12 (21 CFR
601.12). In the guidance, we recommend that each licensed manufacturer
that proposes such a change should also inform other participating
licensed manufacturer(s) of the proposed change.
    For contract manufacturing arrangements, we recommend that the
contract manufacturer should share with the license manufacturer all
important proposed changes to production and facilities (including
introduction of new products or at inspection). The license holder is
responsible for reporting these changes to FDA Sec.  601.12).

2. Notification of Results of Tests and Investigations Regarding or
Possibly Impacting the Product

    In the guidance, we recommend the following for contract
manufacturing arrangements:
     The contract manufacturer should fully inform the license
manufacturer of the results of all tests and investigations regarding
or possibly having an impact on the product; and
     The license manufacturer should obtain assurance from the
contractor that any FDA list of inspectional observations will be
shared with the license manufacturer to allow evaluation of its impact
on the purity, potency, and safety of the license manufacturer's
product.

3. Notification of Products Manufactured in a Contract Facility

    In the guidance, we recommend for contract manufacturing
arrangements that a license manufacturer cross reference a contract
manufacturing facility's Master Files only in circumstances involving
certain proprietary information of the contract manufacturer, such as a
list of all products manufactured in a contract facility. In this
situation, the license manufacturer should be kept informed of the
types or categories of all products manufactured in the contract
facility.

4. Standard Operating Procedures

    In the guidance, we (FDA) remind the license manufacture that the
license manufacturer assumes responsibility for compliance with the
applicable product and establishment standards (21 CFR 600.3(t)).
Therefore, if the license manufacturer enters into an agreement with a
contract manufacturing facility, the license manufacturer must ensure
that the facility complies with the applicable standards. An agreement
between a license manufacturer and a contract manufacturing facility
normally includes procedures to regularly assess the contract
manufacturing facility's compliance. These procedures may include, but
are not limited to, review of records and manufacturing deviations and
defects, and periodic audits.
    For shared manufacturing arrangements, each manufacturer must
submit a separate biologics license application (BLA) describing the
manufacturing facilities and operations applicable to the preparation
of that manufacturer's biological substance or product (21 CFR
601.2(a)). In the guidance, we state that we expect the manufacturer
that prepares (or is responsible for the preparation of) the product in
final form for commercial distribution to assume primary responsibility
for providing data demonstrating the safety, purity, and potency of the
final product. We also state that we expect the licensed finished
product manufacturer to be primarily responsible for any post-approval
obligations, such as postmarketing clinical trials, additional product
stability studies, complaint handling, recalls, postmarket reporting of
the dissemination of advertising and promotional labeling materials as
required under Sec.  601.12(f)(4) and adverse experience reporting. We
recommend that the final product manufacturer establish a procedure
with the other participating manufacturer(s) to obtain information in
these areas.
    Description of Respondents: The recordkeeping and reporting
recommendations described in this document affect the participating
licensed manufacturer(s), final product manufacturer(s), and contract
manufacturer(s) associated with cooperative manufacturing arrangements.
Burden Estimate
    We believe that the information collection provisions in the
guidance do not create a new burden for respondents. We believe the
reporting and recordkeeping provisions are part of usual and customary
business practices. Licensed manufacturers would have contractual
agreements with participating licensed manufacturers, final product
manufacturers, and contract manufacturers, as applicable for the type
of cooperative manufacturing arrangement, to address all these
information collection provisions.
    The guidance also refers to previously approved collections of
information found in FDA regulations at parts 201, 207, 211, 600, 601,
606, 607, 610, 660,

801, 803, and 807, 809, and 820 (21 CFR parts 201, 207, 211, 600, 601,
606, 607, 610, 660, 801, 803, 807, 809, and 820). The collections of
information in Sec. Sec.  606.121, 606.122, and 610.40 have been
approved under OMB Control No. 0910-0116; Sec.  610.2 has been approved
under OMB Control No. 0910-0206; Sec. Sec.  600.12(e) and 600.80 have
been approved under OMB Control No. 0910-0308; Sec. Sec.  601.2(a),
601.12, 610.60 through 610.65, 610.67, 660.2(c), 660.28(a) and (b),
660.35(a), 660.35(c) through (g), 660.35(i) through (m), 660.45, and
660.55(a) and (b) have been approved under OMB Control No. 0910-0338;
Sec. Sec.  803.20, 803.50, and 803.53 have been approved under OMB
Control No. 0910-0437; and Sec. Sec.  600.14 and 606.171 have been
approved under OMB Control No. 0910-0458. The current good
manufacturing practice regulations for finished pharmaceuticals (part
211) have been approved under OMB Control No. 0910-0139; Sec. Sec.
820.181 and 820.184 have been approved under OMB Control No. 0910-0073;
the establishment registration regulations (parts 207, 607, and 807)
have been approved under OMB Control Nos. 0910-0045, 0910-0052, and
0910-0387; and the labeling regulations (parts 201, 801, and 809) have
been approved under OMB Control Nos. 0910-0537, 0910-0572, and 0910-
0485.

    Dated: February 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6055 Filed 3-15-11; 8:45 am]
BILLING CODE 4160-01-P