[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)]
[Notices]
[Pages 58259-58260]
[FR Doc No: 2015-24524]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3326]

Biosimilar User Fee Act; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public meeting on the reauthorization of the Biosimilar User Fee Act
(BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA
to collect user fees for the process for the review of biosimilar
biological products. The current legislative authority for BsUFA
expires in September 2017. At that time, new legislation will be
required for FDA to continue collecting user fees in future fiscal
years. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires
that FDA begin the BsUFA reauthorization process by publishing a notice
in the Federal Register requesting public input and holding a public
meeting where the public may present its views on the reauthorization.
FDA invites public comment on the BsUFA performance goals as the Agency
begins the process to reauthorize the program in FYs 2018-2022.

DATES: The public meeting will be held on December 18, 2015, from 9
a.m. to 2 p.m. Registration to attend the meeting must be received by
November 18, 2015. See section III of this document for information on
how to register for the meeting. Submit written or electronic comments
by January 19, 2016.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, in section B and C of
the Great Room (Rm. 1503), Silver Spring, MD 20993. Participants must

enter through Building 1 and undergo security screening. For more
information on parking and security procedures, please visit http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061.
Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket
number found in brackets in the heading of this document.
    Transcripts of the meeting will be available on the FDA Web site
approximately 30 days after the meeting.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993, 301-796-
1042, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Introduction

    On July 9, 2012, the Food and Drug Administration Safety and
Innovation Act, which included BsUFA (Pub. L. 112-144, title IV), was
signed into law by the President. BsUFA authorizes FDA to collect fees
for certain activities relating to biosimilar biological product
development, for certain types of applications and supplements for
approval of biosimilar biological products, on establishments where
approved biosimilar biological products are made, and on biosimilar
biological products after approval.
    BsUFA's intent is to provide additional revenues so that FDA can
hire more staff, improve systems, and establish a better managed
biosimilar biological product review process to make biosimilar
biological product therapies available to patients sooner without
compromising review quality. As part of FDA's agreement with industry
during the first BsUFA authorization, the Agency agreed to certain
performance goals. These goals, which are captured in a Commitment
Letter, apply to the process for the review of biosimilar biological
product applications, including biosimilar biological product
development meetings, review of applications and supplements, and other
review activities.
    Although BsUFA is similar to the Prescription Drug User Fee Act
(PDUFA) program in that it includes fees for marketing applications,
manufacturing establishments, and products, there are some differences
because of the relatively nascent state of the biosimilar industry in
the United States. For example, at the time BsUFA was signed into law,
there were no currently marketed biosimilar biological products.
Accordingly, BsUFA includes fees for products in the development phase
in order to generate fee revenue to support FDA's review work during
this phase and enable sponsors to have meetings with FDA early in the
development of biosimilar biological product candidates. Additional
information concerning BsUFA, including the text of the law, the
``Biosimilar Biological Product Authorization Performance Goals And
Procedures--Fiscal Years 2013 Through 2017'' (the Commitment Letter),
key Federal Register documents, BsUFA-related guidances, performance
reports, and financial reports may be found on the FDA Web site at
http://www.fda.gov/forindustry/userfees/biosimilaruserfeeactbsufa/default.htm.

II. Purpose of Public Meeting

    FDA is announcing a public meeting on BsUFA. The authority for
BsUFA expires at the end of September 2017. Without new legislation,
FDA will no longer be able to collect user fees to fund the biosimilar
biological product review process. Before FDA begins negotiations with
the regulated industry on BsUFA reauthorization, the Agency is holding
the public meeting announced in this notice, at which members of the
public may present their views on reauthorization, including any
suggestions for changes to the performance goals referred to in the
Commitment Letter. In addition, FDA will provide a period of 30 days
after the public meeting to obtain written comments from the public.
The purpose of this public meeting is to hear stakeholder views as we
consider whether to retain, change, or discontinue the current BsUFA
performance goals in the next BsUFA. In addition to any other relevant
information the public would like to share, the FDA is interested in
responses to the following two general questions:
     What is your assessment of the overall performance of the
BsUFA program to date?
     What aspects of BsUFA performance goals should be
retained, changed, or discontinued to further strengthen and improve
the program?
    The meeting will likely include presentations by FDA and a series
of panels representing different stakeholder groups. We will also
provide an opportunity for other stakeholders to provide public comment
at the meeting. FDA policy issues are beyond the scope of these
reauthorization discussions. Accordingly, the comments should focus on
process enhancements and funding issues, and not on policy issues.

III. Meeting Attendance and Participation

    If you wish to attend this meeting, visit https://fdapublicmeeting-bsufa.eventbrite.com. Please register by November 18, 2015. If you are
unable to attend the meeting in person, you can register to view a live
Webcast of the meeting. You will be asked to indicate in your
registration if you plan to attend in person or via the Webcast. Your
registration must also contain your complete contact information,
including name, title, affiliation, address, email address, and phone
number. Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once their registrations have been accepted. Onsite
registration on the day of the meeting will be based on space
availability. If you need special accommodations because of a
disability, please contact Sandra Benton (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the meeting.
    In addition, any person may submit written or electronic comments
to the Division of Dockets Management (see ADDRESSES). Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov. To
ensure consideration, all comments must be received by January 19,
2016.
    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM461774.htm.

    Dated: September 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24524 Filed 9-25-15; 8:45 am]
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[Federal Register: October 22, 2010 (Volume 75, Number 204)]
[Rules and Regulations]
[Page 65224-65225]
[DOCID:fr22oc10-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0407; Airspace Docket No. 10-AGL-7]

Amendment of Class E Airspace; Williston, ND

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace for Williston, ND, to
accommodate Area Navigation (RNAV) Standard Instrument Approach
Procedures (SIAPs) at Sloulin Field

International Airport, Williston, ND. The FAA is taking this action to
enhance the safety and management of Instrument Flight Rule (IFR)
operations at the airport.

DATES: Effective date: 0901 UTC, January 13, 2011. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On June 17, 2010, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace for Williston,
ND, creating additional controlled airspace at Sloulin Field
International Airport (75 FR 34391) Docket No. FAA-2010-0407.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received. Class E airspace designations are published in
paragraph 6005 of FAA Order 7400.9U signed August 18, 2010, and
effective September 15, 2010, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by adding additional Class E airspace extending upward from 700
feet above the surface to accommodate SIAPs at Sloulin Field
International Airport, Williston, ND. Geographic coordinates will be
updated in accordance with the FAA's National Aeronautical Navigation
Services. This action is necessary for the safety and management of IFR
operations at the airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Sloulin Field International
Airport, Williston, ND.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, signed August 18, 2010, and effective September 15,
2010, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

AGL ND E5 Williston, ND [Amended]

Sloulin Field International Airport, ND
    (Lat. 48[deg]10'41'' N., long. 103[deg]38'32'' W.)
Williston VORTAC
    (Lat. 48[deg]15'12'' N., long. 103[deg]45'02'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Sloulin Field International Airport, and
within 4 miles each side of the Williston VORTAC 317[deg] radial
extending from the 6.6-mile radius to 12.7 miles northwest of the
airport, and within 4 miles each side of the 304[deg] bearing from
the airport extending from the 6.6-mile radius to 12.1 miles
northwest of the airport, and within 4 miles each side of the
124[deg] bearing from the airport extending from the 6.6-mile radius
to 13.4 miles southeast of the airport, and within 3.8 miles each
side of the Williston VORTAC 135[deg] radial extending from the 6.6-
mile radius to 12.3 miles southeast of the airport; and that
airspace extending upward from 1,200 feet above the surface within a
21.8-mile radius of the Williston VORTAC extending from the
Williston VORTAC 172[deg] radial clockwise to V-430, and within 39.2
miles of the Williston VORTAC extending from V-430 clockwise to V-
71, and within a 60-mile radius of the Williston VORTAC extending
from V-71 clockwise to the Williston VORTAC 172[deg] radial,
excluding those portions within Federal airways.

    Issued in Fort Worth, Texas, on October 7, 2010.
Anthony D. Roetzel,
Manager Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-26525 Filed 10-21-10; 8:45 am]
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