[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20232-20233]
[FR Doc No: 2015-08618]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0471]

Agency Information Collection Activities: Proposed Collection;
Comment Request; User Fee Cover Sheet; Form FDA 3397

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 information collection
requirements relating to Form FDA 3397, User Fee Cover Sheet, that must
be submitted along with certain drug and biologic product applications
and supplements.

DATES: Submit either electronic or written comments on the collection
of information by June 15, 2015.

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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<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 comment 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.

User Fee Cover Sheet; Form FDA 3397 (OMB Control Number 0910-0297)--
Extension

    Under the prescription drug user fee provisions of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736 (21
U.S.C. 379g and 379h)), as amended, FDA has the authority to assess and
collect user fees for certain drug and biologics license applications
(BLAs) and supplements to those applications. Under this authority,
pharmaceutical companies pay a fee for certain new human drug
applications (NDAs), BLAs, or supplements submitted to the Agency for
review. Because the submission of user fees concurrently with
applications and supplements is required, review of an application by
FDA cannot begin until the fee is submitted. The Prescription Drug User
Fee Cover Sheet, Form FDA 3397, is designed to provide the minimum
necessary information to determine whether a fee is required for review
of an application, to determine the amount of the fee required, and to
account for and track user fees. The form provides a cross-reference of
the fee submitted for an application by using a unique number tracking
system. The information collected is used by FDA's Center for Drug
Evaluation and Research (CDER) and Center for Biologics Evaluation and
Research (CBER) to initiate the administrative screening of NDAs, BLAs,
and/or, supplemental applications to those applications.
    Respondents to this collection of information are new drug and
biologics manufacturers. Based on FDA's database system for fiscal year
(FY) 2014, there are an estimated 290 manufacturers of products subject
to the Prescription Drug User Fee Act (Pub. L. 105-115). The total
number of annual responses is based on the number of submissions
received by FDA in FY 2014. CDER received 3,005 annual responses that
include the following submissions: 128 NDAs; 7 BLAs; 1,586
manufacturing supplements; 1,081 labeling supplements; and 203 efficacy
supplements. CBER received 705 annual responses that include the
following submissions: 11 BLAs; 611 manufacturing supplements; 64
labeling supplements; and 19 efficacy supplements. The estimated hours
per response are based on past FDA experience with the various
submissions.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
            FDA form                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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FDA 3397........................             290           12.79           3,710   0.5 (30 min.)           1,855
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: March 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08618 Filed 4-14-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 11, 2008 (Volume 73, Number 113)]
[Notices]
[Page 33143-33144]
[DOCID:fr11jn08-119]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2008-0160]

Medical Review Board Public Meeting

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of Medical Review Board (MRB) Public Meeting.

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SUMMARY: FMCSA announces a public meeting of the Agency's MRB. The MRB
public meeting will provide the public an opportunity to observe and
participate in MRB deliberations about the revision and development of
Federal Motor Carrier Safety Regulation (FMCSR) medical standards, in
accordance with the Federal Advisory Committee Act (FACA).

DATES: The MRB meeting will be held from 9:00 a.m.-11:30 a.m. on July
18, 2008. Please refer to the preliminary agenda for this meeting in
the SUPPLEMENTARY INFORMATION section of this notice for specific
information.

ADDRESSES: The meeting will take place at the Embassy Suites Old Town
Alexandria, 1900 Diagonal Road, Virginia Ballroom--Salon A, Alexandria,
VA 22314. You may submit comments bearing the Federal Docket Management
System (FDMS) Docket ID FMCSA-2008-0160 using any of the following
methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket ID for
this Notice. Note that DOT posts all comments received without change
to http://www.regulations.gov, including any personal information
included in a

comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://Docketinfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.
    Information on Services for Individuals with Disabilities: For
information on facilities or services for individuals with disabilities
or to request special assistance at the meeting, contact Jennifer
Musick at<PHONE_NUMBER> ext. 237.

SUPPLEMENTARY INFORMATION: The preliminary agenda \*\ for the meeting
includes:
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    \*\ Breaks will be announced on meeting day and may be adjusted
according to schedule changes and other meeting requirements.
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0900-0920 Call to Order, Introduction and Agenda Review
0920-0945 Medical Review Board Administrative Discussion
0945-1015 Public Comment on Renal Disease
1015-1045 MRB Deliberations on Renal Disease
1045-1130 FMCSA Agency Update and Answers to Frequently Asked Questions
1130 Call to Adjourn

Background

    The U.S. Secretary of Transportation announced on March 7, 2006,
the five medical experts who serve on FMCSA's Medical Review Board
(MRB). Section 4116 of the Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users (SAFETEA-LU, Pub. L. 109-
59) requires the Secretary of Transportation with the advice of the MRB
to ``establish, review, and revise medical standards for operators of
Commercial Motor Vehicles (CMVs) that will ensure that the physical
condition of operators is adequate to enable them operate the vehicles
safely.'' FMCSA is planning updates to the physical qualification
regulations of CMV drivers, and the MRB will provide the necessary
science-based guidance to establish realistic and responsible medical
standards.
    The MRB operates in accordance with the Federal Advisory Committee
Act (FACA) as announced in the Federal Register (70 FR 57642, October
3, 2005). The MRB is charged initially with the review of all current
FMCSA medical standards (49 CFR 391.41), as well as proposing new
science-based standards and guidelines to ensure that drivers operating
CMVs in interstate commerce, as defined in CFR 390.5, are physically
capable of doing so.

Meeting Participation

    Attendance is open to the interested public, including medical
examiners, motor carriers, drivers, and representatives of medical and
scientific associations. Written comments for this MRB meeting will
also be accepted beginning on June 11, 2008. and continuing until
August 1, 2008, and should include the docket ID that is listed in the
ADDRESSES section.
    During the MRB meeting (0945-1015), oral comments may be limited
depending on how many persons wish to comment; and will be accepted on
a first come, first serve basis as requestors register at the meeting.
The comments must directly address relevant medical and scientific
issues on the MRB meeting agenda. For more information, please view the
following Web site: http://www.fmcsa.dot.gov/mrb.

    Issued on: June 4, 2008.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E8-13103 Filed 6-10-08; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31454-31455]
[FR Doc No: 2015-13345]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2012-0087]

Advisory Committee for Aviation Consumer Protection

AGENCY: Office of the Secretary (OST), Department of Transportation
(DOT).

ACTION: Notice of eighth meeting of advisory committee.

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SUMMARY: This notice announces the eighth meeting of the Advisory
Committee for Aviation Consumer Protection.

DATES: The eighth meeting of the advisory committee is scheduled for
June 23, 2015, from 9:00 a.m. to 4:00 p.m., Eastern Time.

ADDRESSES: The meeting will be held in the Media Center (located on the
lobby level of the West Building) at the U.S. Department of
Transportation (DOT) headquarters, 1200 New Jersey Avenue SE.,
Washington, DC. Attendance is open to the public up to the room's
capacity of 100 attendees. Since space is limited and access to the DOT
headquarters building is controlled for security purposes, any member
of the general public who plans to attend this meeting must notify the
registration contact identified below no later than June 16, 2015.

FOR FURTHER INFORMATION CONTACT: To register to attend the meeting,
please contact Amy Przybyla, Research Analyst, CENTRA Technology, Inc.,
<EMAIL_ADDRESS>703-894-6962. For other information
please contact Kathleen Blank Riether, Senior Attorney, Office of
Aviation Enforcement and Proceedings<EMAIL_ADDRESS>
U.S. Department of Transportation, 1200 New Jersey Ave. SE.,
Washington, DC, 20590;<PHONE_NUMBER> (phone),<PHONE_NUMBER> (fax).

SUPPLEMENTARY INFORMATION:
    On May 24, 2012, the Secretary, as mandated by section 411 of the
FAA Modernization and Reform Act of 2012 (Pub. L. 112-95, 126 Stat. 11
(2012)), established the Advisory Committee for Aviation Consumer
Protection. The committee's charter, drafted in accordance with the
Federal Advisory Committee Act, as amended, 5 U.S.C. App. 2, sets forth
policies for the operation of the advisory committee and is available
on the Department's Web site at http://www.facadatabase.gov/committee/charters.aspx?cid=2448&aid=47.
    The eighth meeting of the committee is scheduled for Tuesday, June
23, 2015, from 9:00 a.m. to 4:00 p.m. Eastern Time in the Media Center
at the DOT headquarters, 1200 New Jersey Avenue SE., Washington, DC
20590. The issues that will be discussed at the meeting are airline
policies on change and cancellation fees, the disclosure of hotel
resort fees, and airline policies and procedures for the transport of
baggage.
    This meeting will be open to the public and comments by members of
the public are invited. Attendance will necessarily be limited by the
size of the meeting room (maximum 100 attendees). We ask that any
member of the general public who plans to attend the eighth meeting
notify the registration contact noted above no later than June 16,
2015. Additionally, DOT will stream the event live on the Internet and
provide a link to the recorded Web cast for future viewing at
www.dot.gov/airconsumer/ACACP.
    To the extent time is available, we plan to provide an opportunity
for oral comments by interested individuals and/or representatives of
organizations representing airlines, travel agents, airport operators,
state and local governments, and consumer and other public interest
groups. Any oral comments presented must be limited to the objectives
of the committee and not exceed five (5) minutes per person. Not later
than June 16, 2015, commenters should notify the registration contact
person indicated above via email that they wish to present and provide
that person a written summary of their presentation to help the
committee members prepare for the meeting. Efforts will be made to
accommodate each individual/organization that wishes to comment.
However, given time constraints, there is no guarantee that all the
individuals/organizations that make such a request will be able to
address the committee at the June 23rd meeting. In order to provide for
a balanced presentation of views and to facilitate the orderly conduct
of the meeting, including time for questions from committee members,
the Chairperson may impose rules or procedures, including the order of
individuals/organizations that will be making presentations, as she
deems necessary.
    Members of the public may present written comments at any time. The
docket number referenced above (DOT-OST-2012-0087, available at https://www.regulations.gov) has been established for committee documents
including any written comments that may be filed.
    Persons with a disability who plan to attend the meeting and
require special accommodations, such as an interpreter for the hearing
impaired, should notify the registration contact noted above no later
than June 16, 2015.
    Notice of this meeting is being provided in accordance with the
Federal Advisory Committee Act and the General Services Administration
regulations covering management of

Federal advisory committees. (41 CFR part 102-3.)

    Issued in Washington, DC, on May 27, 2015.
Blane A. Workie,
Assistant General Counsel for Aviation Enforcement & Proceedings, U.S.
Department of Transportation.
[FR Doc. 2015-13345 Filed 6-1-15; 8:45 am]
 BILLING CODE 4910-9X-P


[Federal Register: January 30, 2008 (Volume 73, Number 20)]
[Notices]
[Page 5555]
[DOCID:fr30ja08-74]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP08-51-000]

Transwestern Pipeline Company, LLC; Notice of Request Under
Blanket Authorization

January 22, 2008.
    Take notice that on January 14, 2008, Transwestern Pipeline
Company, LLC (Transwestern), 711 Louisiana Street, Suite 900, Houston,
Texas 77002-2716, filed in Docket No. CP08-51-000, a prior notice
request pursuant to sections 157.205, 157.210, and 157.216 of the
Federal Energy Regulatory Commission's regulations under the Natural
Gas Act for authorization to construct, own, operate, and abandon
compression equipment, located in Apache County, Arizona, all as more
fully set forth in the application, which is on file with the
Commission and open to public inspection. The filing may also be viewed
on the Web 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. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,

(202) 502-8659.
    Transwestern proposes to: (i) Construct, own, and operate
compression equipment consisting of three 5,000 electric horsepower
(HP) motors, compressor units, station piping, and ancillary
facilities; and (ii) to abandon, in place, the existing three 4,000 HP
reciprocating gas engines, compressors, and ancillary facilities, at
Transwestern's Compressor Station 4, located in Apache County, Arizona
(Station 4 Electrification Project). Transwestern estimates the cost of
the project to be $14,000,000. Transwestern states that the purpose of
the project is to improve system reliability and to reduce operating
and maintenance costs by replacing older gas engines with new, more
efficient electric engines.
    Any questions regarding the application should be directed to Kelly
Allen, Manager of Certificates and Reporting, Transwestern Pipeline
Company, LLC, 711 Louisiana Street, 9th Floor South Tower, Houston,
Texas 77002-2716, call<PHONE_NUMBER>, fax<PHONE_NUMBER>, or by e-mail
<EMAIL_ADDRESS>
    Any person or the Commission's Staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the Natural Gas Act (NGA) (18 CFR
157.205) a protest to the request. If no protest is filed within the
time allowed therefore, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request shall be treated as
an application for authorization pursuant to section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

 Kimberly D. Bose,
Secretary.
 [FR Doc. E8-1592 Filed 1-29-08; 8:45 am]

BILLING CODE 6717-01-P