[Federal Register Volume 79, Number 83 (Wednesday, April 30, 2014)]
[Notices]
[Pages 24488-24489]
[FR Doc No: 2014-09895]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Noise Exposure Map Notice for Hawthorne Municipal Airport,
Hawthorne, CA

AGENCY: Federal Aviation Administration, (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA announces its determination that the noise exposure
maps submitted by the City of Hawthorne, for Hawthorne Municipal
Airport under the provisions of 49 U.S.C. 47501 et. seq (Aviation
Safety and Noise Abatement Act) and 14 CFR part 150 are in compliance
with applicable requirements.

DATES: This notice is effective April 30, 2014 and applicable April 11,
2014.

FOR FURTHER INFORMATION CONTACT: Victor Globa, Environmental Protection
Specialist, Federal Aviation Administration, Los Angeles Airports
District Office, Mailing Address: P.O. Box 92007, Los Angeles,
California 90009-2007. Street Address: 15000 Aviation Boulevard, Room
3000, Hawthorne, California 90261. Telephone: 310/725-3637. Documents
reflecting this FAA action may be reviewed at this same location.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA finds
that the noise exposure maps submitted for Hawthorne Municipal Airport
are in compliance with applicable requirements of 14 Code of Federal
Regulations (CFR) part 150 (hereinafter referred to as ``Part 150''),
effective April 11, 2014. Under 49 U.S.C. section 47503 of the Aviation
Safety and Noise Abatement Act (hereinafter referred to as ``the
Act''), an airport operator may submit to the FAA noise exposure maps
which meet applicable regulations and which depict non-compatible land
uses as of the date of submission of such maps, a description of
projected aircraft operations, and the ways in which such operations
will affect such maps. The Act requires such maps to be developed in
consultation with interested and affected parties in the local
community, government agencies, and persons using the airport. An
airport operator who has submitted noise exposure maps that are found
by FAA to be in compliance with the requirements of Part 150,
promulgated pursuant to the Act, may submit a noise compatibility
program for FAA approval which sets forth the measures the operator has
taken or proposes to take to reduce existing non-compatible uses and
prevent the introduction of additional non-compatible uses.
    The FAA has completed its review of the noise exposure maps and
accompanying documentation submitted by the City of Hawthorne. The
documentation that constitutes the ``Noise Exposure Maps'' as defined
in section 150.7 of Part 150 includes: ``Exhibit 1, 2012 Noise Contour
(Existing Condition);'' ``Exhibit 2, 2017 Noise Contours (Forecast
Condition).'' The FAA has determined that these Noise Exposure Maps and
accompanying documentation are in compliance with applicable
requirements. This determination is effective on April 11, 2014.
    FAA's determination on an airport operator's noise exposure maps is
limited to a finding that the maps were developed in accordance with
the procedures contained in Appendix A of Part 150. Such determination
does not constitute approval of the applicant's data, information or
plans, or a commitment to approve a noise compatibility program or to
fund the implementation of that program. If questions arise concerning
the precise relationship of specific properties to noise exposure
contours depicted on a noise exposure map submitted under section 47503
of the Act, it should be noted that the FAA is not involved in any way
in determining the relative locations of specific properties with
regard to the depicted noise contours, or in interpreting the noise
exposure maps to resolve questions concerning, for example, which
properties should be covered by the provisions of section 47506 of the
Act. These functions are inseparable from the ultimate land use control
and planning responsibilities of local government. These local
responsibilities are not changed in any way under Part 150 or through
FAA's review of noise exposure maps. Therefore, the responsibility for
the detailed overlaying of noise exposure contours onto the map
depicting properties on the surface rests exclusively with the airport
operator that submitted those maps, or with those public agencies and
planning agencies with which consultation is required under section
47503 of the Act. The FAA has relied on the certification by the
airport operator, under section 150.21 of Part 150, that the
statutorily required consultation has been accomplished.
    Copies of the full noise exposure map documentation and of the
FAA's evaluation of the maps are available for examination at the
following locations:

Federal Aviation Administration, Western-Pacific Region Office,
Airports Division, Room 3012, 15000 Aviation Boulevard, Hawthorne,
California 90261.
Federal Aviation Administration, Los Angeles Airports District Office,
Room 3000, 15000 Aviation Boulevard, Hawthorne, California 90261.
Hawthorne Municipal Airport, 12101 South Crenshaw Boulevard, Suite
3, Hawthorne, California 90250.

    Questions may be directed to the individual named above under the
heading FOR FURTHER INFORMATION CONTACT.

    Issued in Hawthorne, California, April 11, 2014.
Mark A. McClardy,
Manager, Airports Division, Western-Pacific Region.
[FR Doc. 2014-09895 Filed 4-29-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 100 (Wednesday, May 23, 2018)]
[Notices]
[Pages 23911-23912]
[FR Doc No: 2018-11047]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD18-13-000]

Notice of Availability of the New Engineering Guidelines for the
Evaluation of Hydropower Projects: Chapter 12--Water Conveyance and
Request for Comments

    The staff of the Office of Energy Projects (OEP) have drafted its
initial version of ``Chapter 12--Water Conveyance'' of its Engineering
Guidelines for the Evaluation of Hydropower Projects. Comments are now
requested on the draft document from federal and state agencies,
licensees whose infrastructure portfolio includes penstocks, canals,
flumes and tunnel to convey water, independent consultants and
inspectors, and other interested parties with special expertise with
respect dam safety. A 60-day public comment period is allotted to
collect comments. Please note that this comment period will close on
July 16, 2018.
    Interested parties can help us determine the appropriate updates
and improvements by providing: Meaningful comments or suggestions that
focus on the specific sections requiring clarification; updates to
reflect current laws and regulations; or improved

measures for evaluating the safety of water conveyances. The more
specific your comments, the more useful they will be. A detailed
explanation of your submissions and/or any references of scientific
studies associated with your comments will greatly help us with this
process. We will consider all timely comments on the revised Guidelines
before issuing the final version.
    For your convenience, there are three methods which you can use to
submit your comments to the Commission. In all instances please
reference the docket number (AD18-13-000) on the first page of your
submission. The Commission strongly encourages electronic filing.
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for interested persons to
submit brief, text-only comments up to 6,000 characters. You must
include your name and contact information at the end of your comments;
    (2) You can file your comments electronically using the eFiling
feature on the Commission's website (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' When selecting the filing type, select ``General'', then
chose ``Comment (on Filing, Environ. Report or Tech Conf)''; or
    (3) In lieu of electronic filing, you can mail a paper copy of your
comments to: Kimberly D. Bose, Secretary Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
    The OEP staff provided copies of ``Chapter 12--Water Conveyance''
to federal and state agencies, licensees whose portfolio includes
penstocks, canals, flumes and tunnel to convey water, independent
consultants and inspectors, and other interested parties. In addition,
all information related to ``Chapter 12--Water Conveyance'' and
submitted comments can be found on the FERC website (www.ferc.gov)
using the eLibrary link. Click on the eLibrary link, click on ``General
Search'' and enter the docket number, excluding the last three digits
in the Docket Number field (i.e., AD18-13). Be sure you have selected
an appropriate date range. The Commission also offers a free service
called eSubscription which allows you to keep track of all formal
issuances and submittals in specific dockets. This can reduce the
amount of time you spend researching proceedings by automatically
providing you with electronic notification of these filings and direct
links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp. Users must be registered in order to use
eSubscription.
    For assistance with filing or any of the Commission's online
systems, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

    Dated: May 17, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-11047 Filed 5-22-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: May 27, 2009 (Volume 74, Number 100)]
[Notices]
[Page 25236-25237]
[DOCID:fr27my09-31]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-RCRA-2009-0319, FRL-8909-8]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Part B Permit Application, Permit Modifications, and
Special Permits, EPA ICR Number 1573.12, OMB Control Number 2050-0009

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on November 30, 2009. Before submitting the ICR to
OMB for review and approval, EPA is soliciting comments on specific
aspects of the proposed information collection as described below.

DATES: Comments must be submitted on or before July 27, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2009-0319, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: RCRA Docket (2822T), U.S. Environmental Protection
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
     Hand Delivery: 1301 Constitution Ave., NW., Room 3334,
Washington, DC 20460. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-RCRA-
2009-0319. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Toshia King, Office of Resource
Conservation and Recovery, mailcode 5303P, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-RCRA-2009-0319, which is available for online viewing at
www.regulations.gov, or in person viewing at the RCRA Docket in the EPA
Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave.,
NW., Washington, DC. The EPA/DC Public Reading Room is open from 8 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 RCRA Docket is<PHONE_NUMBER>.
    Use www.regulations.gov to obtain a copy of the draft collection of
information, submit or view public comments, access the index listing
of the contents of the docket, and access those documents in the public
docket that are available electronically. Once in the system, select
``search,'' then key in the docket ID number identified in this
document.

What Information Is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What Information Collection Activity or ICR Does This Apply to?

    Affected entities: Entities potentially affected by this action are
business or other for-profit; as well as State, Local, or Tribal
governments.

    Title: Part B Permit Application, Permit Modifications, and Special
Permits.
    ICR numbers: EPA ICR No. 1573.12, OMB Control No. 2050-0009.
    ICR status: This ICR is currently scheduled to expire on November
30, 2009. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: Section 3005 of Subtitle C of RCRA requires treatment,
storage or disposal facilities (TSDFs) to obtain a permit. To obtain
the permit, the TSDFs must submit an application describing the
facility's operation. There are two parts to the RCRA permit
application--Part A and Part B. Part A defines the processes to be used
for treatment, storage, and disposal of hazardous wastes; the design
capacity of such processes; and the specific hazardous wastes to be
handled at the facility. Part B requires detailed site specific
information such as geologic, hydrologic, and engineering data. In the
event that permit modifications are proposed by the applicant or EPA,
modifications must conform to the requirements under Sections 3004 and
3005.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 262
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or 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.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 109.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent:
1.3.
    Estimated total annual burden hours: 32,477 hours.
    Estimated total annual costs: $7,517,000. This includes an
estimated burden cost of $1,814,000 for labor and an estimated cost of
$5,703,000 for capital investment or maintenance and operational costs.

What Is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: May 15, 2009.
Matt Hale,
Director, Office of Resource Conservation and Recovery.
[FR Doc. E9-12285 Filed 5-26-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 107 (Thursday, June 4, 2015)]
[Notices]
[Page 31965]
[FR Doc No: 2015-13639]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2004-19950]

Petition for Waiver of Compliance

    In accordance with part 211 of title 49 of the Code of Federal
Regulations (CFR), this provides the public notice that by a document
dated December 9, 2014, the New York & Lake Erie Railroad (NYLE) has
petitioned the Federal Railroad Administration (FRA) for a waiver of
compliance from certain provisions of the Federal railroad safety
regulations contained at 49 CFR 223.11 Requirements for existing
locomotives. FRA assigned the petition Docket Number FRA-2004-19950.
    The New York & Lake Erie Railroad of Gowanda, New York, has
petitioned for a permanent waiver of compliance for two locomotives,
numbered NYLE 1013 and NYLE 308, from the requirements of the Railroad
Safety Glazing Standards, title 49 CFR part 223, which requires
certified glazing in all windows. The types of glazing currently used
in the two locomotives are as follows: Locomotive NYLE 1013--Laminated
Safety Glass AS-1, DOT 14M-220-ASI-030, and locomotive NYLE 308--Clear
Laminated Safety Glass AS-2 101. The NYLE is a short line carrier that
operates over 29.5 miles through rural countryside and small
communities. They traverse two line segments which are connected and
extend from Cattaraugus, NY, to Dayton, NY, (10.1 miles) and from
Conewango Valley, NY, to Gowanda, NY, (19.4 miles).
    The original waiver, approved on June 18, 2010, granted relief to
the NYLE for limited freight service over 29.5-mile-long line,
consisting of Class 1 track, at speeds not to exceed 10 mph. However,
the current petition, dated December 9, 2014, states that the NYLE has
now improved the track to Class 2. In addition to the limited freight
service, the NYLE now occasionally operates tourist passenger
excursions. In the new petition, NYLE is asking to include in the
waiver passenger excursions, and to increase the maximum operating
speed to 25 mph, both for the freight service and the passenger
excursions.
    The NYLE states that there has been no problem with window breakage
due to vandalism, and that they have not had to replace glass due to
breakage from flying objects. Because of low risk of exposure to injury
due to vandalism, prohibitive cost of the glazing material and
decreased operating revenue due to declining freight shippers, the NYLE
is requesting the waiver of this regulation for the two locomotives
listed above.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey Ave.
SE., W12-140, Washington, DC 20590. The Docket Operations Facility is
open from 9 a.m. to 5 p.m., Monday through Friday, except Federal
Holidays.
    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 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. DOT, 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 by July 20, 2015 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    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 comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its processes. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.
See also http://www.regulations.gov/#!privacyNotice/ for the privacy
notice of regulations.gov or interested parties may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477).

    Issued in Washington, DC, on May 28, 2015.
Ron Hynes,
Director, Office of Technical Oversight.
[FR Doc. 2015-13639 Filed 6-3-15; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 133 (Wednesday, July 11, 2018)]
[Notices]
[Pages 32130-32132]
[FR Doc No: 2018-14800]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2434]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Formal Meetings With Sponsors
and Applicants for Prescription Drug User Fee Act Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 contained in the
guidance for industry on formal meetings with sponsors and applicants
for Prescription Drug User Fee Act (PDUFA) products.

DATES: Submit either electronic or written comments on the collection
of information by September 10, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 10, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-2434 for ``Guidance for Industry on Formal Meetings with
Sponsors and Applicants for PDUFA Products.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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 on Formal Meetings With Sponsors and Applicants
for Prescription Drug User Fee Act Products

OMB Control Number 0910-0429--Extension

    This information collection supports the above captioned Agency
guidance document. The guidance document was issued to help individuals
with procedures on formal meetings between FDA and sponsors or
applicants regarding the development and review of PDUFA products. The
guidance describes procedures for requesting, scheduling, conducting,
and documenting such formal meetings. The guidance provides information
on how FDA interprets and applies section 119(a) of the Food and Drug
Administration Modernization Act of 2007 (FDAMA) (Pub. L. 105-115),
specific PDUFA goals for the management of meetings associated with the
review of human drug applications for PDUFA products, and provisions of
existing regulations describing certain meetings (Sec. Sec.
[thinsp]312.47 and 312.82 (21 CFR 312.47 and 312.82)). The collection
of information described in the guidance reflects the current and past
practice of sponsors and applicants to submit meeting requests and
background information prior to a scheduled meeting. Agency regulations
currently permit such requests and recommend the submission of an
information package before an ``end-of-phase 2 meeting'' (Sec. Sec.
[thinsp]312.47(b)(1)(ii) and (iv)) and a ``pre-NDA meeting'' (Sec.
[thinsp]312.47(b)(2)). While the information collection provisions of
Sec.  [thinsp]312.47 are currently approved under OMB control number
0910-0014, the guidance provides additional recommendations for
submitting information to FDA in support of a meeting request. The
guidance document is available on our website at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf.
    Request for a Meeting--Consistent with recommendations found in the
guidance, a sponsor or applicant interested in meeting with the Center
for Drug Evaluation and Research (CDER) or the Center for Biologics
Evaluation and Research (CBER) should submit a meeting request to the
appropriate FDA component as an amendment to the application for the
underlying product in accordance with our regulations (Sec. Sec.
[thinsp]312.23, 314.50, and 601.2 (21 CFR 312.23, 314.50, and 601.2)).
Information provided to the Agency as part of an investigational new
drug application (IND), NDA, or biological license application (BLA)
must be submitted with an appropriate cover form. Form FDA 1571 must
accompany IND submissions, and Form FDA 356h must accompany NDA and BLA
submissions. These Agency forms are approved under OMB control numbers
0910-0014 and 0910-0338, respectively.
    We recommend that a request be submitted in this manner to ensure
that each request is kept in the administrative file with the complete
application, and to ensure that pertinent information about the request
is entered into appropriate tracking databases. Using information from
our tracking databases enables us to monitor progress on activities
attendant to scheduling and holding a formal meeting and to ensure that
appropriate steps will be taken in a timely manner.
    The guidance recommends that meeting requests include the following
information:

 Information identifying and describing the product
 the type of meeting being requested
 a brief statement of the purpose of the meeting
 a list of objectives and expected outcomes from the meeting
 a preliminary proposed agenda
 a draft list of questions to be raised at the meeting
 a list of individuals who will represent the sponsor or
applicant at the meeting
 a list of Agency staff requested to be in attendance
 the approximate date that the information package will be sent
to the Agency
 suggested dates and times for the meeting

    We use the information to determine the purpose of the meeting, the
necessary participants, the proposed agenda, and to schedule the
meeting.
    Information Package--The guidance also recommends that a sponsor or
applicant submitting an information package provide summary information
relevant to the product and supplementary information pertaining to any
issue raised by the sponsor, applicant, or FDA. Information packages
should generally include:

 Identifying information about the underlying product
 a brief statement of the purpose of the meeting
 a list of objectives and expected outcomes of the meeting
 a proposed agenda for the meeting
 a list of specific questions to be addressed at the meeting
 a summary of clinical data that will be discussed (as
appropriate)
 a summary of preclinical data that will be discussed (as
appropriate)
 chemistry, manufacturing, and controls information that may be
discussed (as appropriate)

    The information package enables Agency staff to prepare for the
meeting and allows appropriate time for reviewing relevant product
data. Although FDA reviews similar information in the meeting request,
the information package should provide updated data reflecting the most
current and accurate information available to the sponsor or applicant.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    Guidance recommendations         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Meeting Requests:
    CDER........................           1,319            2.31           3,058              10          30,580
    CBER........................             301            1.21             363              10           3,630
                                 -------------------------------------------------------------------------------
        Subtotal................  ..............  ..............  ..............  ..............          34,210
Information Packages:
    CDER........................           1,149            2.19           2,522              18          45,396
    CBER........................             187            1.12             210              18           3,780
                                 -------------------------------------------------------------------------------
        Subtotal................  ..............  ..............  ..............  ..............          49,176
                                 -------------------------------------------------------------------------------
            Total...............  ..............  ..............  ..............  ..............          83,386
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an
overall increase since the previous OMB approval. We attribute this
adjustment to an increase in the number of meeting requests and
information packages received over the last few years.
    Based on Agency data, we estimate 1,319 sponsors and applicants
(respondents) request 3,058 formal meetings with CDER annually, and 301
respondents request 363 formal meetings with CBER annually regarding
the development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent spends
preparing the information to be submitted with a meeting request in
accordance with the guidance, is estimated to be 10 hours. We expect it
takes this amount of time to gather and copy brief statements about the
product as well as a description of the purpose and details of the
meeting.
    Also consistent with Agency data, we estimate 1,149 respondents
submitted 2,522 information packages to CDER annually, and 187
respondents submitted 210 information packages to CBER annually, prior
to a formal meeting regarding the development and review of a PDUFA
product. We estimate 18 hours is needed to prepare the information
package in accordance with the guidance.

    Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14800 Filed 7-10-18; 8:45 am]
 BILLING CODE 4164-01-P