[Federal Register: April 16, 2010 (Volume 75, Number 73)]
[Notices]
[Page 19967-19968]
[DOCID:fr16ap10-63]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0778; FRL-8822-2]

Maneb; Cancellation Order for a Certain Pesticide Registration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces EPA's order for the cancellation,
voluntarily requested by the registrant and accepted by the Agency, of
a product containing maneb, pursuant to section 6(f)(1) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This
cancellation order follows a March 4, 2010, Federal Register Notice of
Receipt of Request from the registrant listed in Table 2 in Unit II. of
this document, to voluntarily cancel this product registration. This is
the last product containing this pesticide registered for use in the
United States. In the March 4, 2010 Notice, EPA indicated that it would
issue an order implementing the cancellation, unless the Agency
received substantive comments within the 30 day comment period that
would merit its further review of these requests, or unless the
registrant withdrew their request. The Agency did not receive any
comments on the notice. Further, the registrant did not withdraw their
request. Accordingly, EPA hereby issues in this notice a cancellation
order granting the requested cancellation. Any distribution, sale, or
use of the product subject to this cancellation order is permitted only
in accordance with the terms of this order, including any existing
stocks provisions.

DATES: The cancellation is effective April 16, 2010.

FOR FURTHER INFORMATION CONTACT: Barbara Briscoe, Pesticide Re-
evaluation Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0778. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. What Action is the Agency Taking?

    This notice announces the cancellation, as requested by registrant,

of a product registered under section 3 of FIFRA. This registration is
listed in Table 1 of this unit.

                  Table 1.--Maneb Product Cancellations
------------------------------------------------------------------------
          EPA Registration Number                   Product Name
------------------------------------------------------------------------
000352-00655                                DuPont (TM) Manex
------------------------------------------------------------------------

    Table 2 of this unit includes the name and address of record for
the registrant of the product in Table 1.

                Table 2.--Registrant of Cancelled Product
------------------------------------------------------------------------
            EPA Company Number                Company Name and Address
------------------------------------------------------------------------
000352                                      Dupont Crop Protection
                                            Stine-Haskell Research
                                             Center
                                            P.O. Box 30
                                            Newark, DE 19714-0030
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    During the public comment period provided, EPA received no comments
in response to the March 4, 2010, Federal Register notice (75 FR 9896;
FRL-8813-5) announcing the Agency's receipt of request for voluntary
cancellation of the product listed in Table 1.

 IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
cancellation of the maneb registration identified in Table 1.
Accordingly, the Agency hereby orders that the product registration
identified in Table 1 is canceled. The effective date of the
cancellation that is the subject of this notice is April 16, 2010. Any
distribution, sale, or use of existing stocks of the product identified
in Table 1 in a manner inconsistent with any of the Provisions for
Disposition of Existing Stocks set forth in Unit VI. will be a
violation of FIFRA.

V. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the Administrator may approve such
a request. The notice of receipt for this action was published for
comment on March 4, 2010. The comment period closed on April 5, 2010.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
action. The existing stocks provision for the product subject to this
order is as follows:
    1. The registrant may continue to sell or distribute existing
stocks of the maneb end-use product identified in Table 1 until such
stocks are exhausted.
    2. Persons other than the registrant may continue to sell or
distribute existing stocks of maneb products identified in Table 1 with
previously approved labeling until such stocks are exhausted.
    3. Persons other than the registrant may use the maneb end use
products identified in Table 1 until exhausted. Any use of existing
stocks must be in a manner consistent with the previously approved
labeling for that product.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: April 9, 2010.
 Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.

[FR Doc. 2010-8631 Filed 4-15-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Proposed Rules]
[Pages 11198-11204]
[FR Doc No: 2021-02671]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0014]
RIN 1625-AA00

Safety Zones; Coast Guard Sector Ohio Valley Annual and Recurring
Safety Zones

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to amend and update its list of
recurring safety zone regulations that take place in the Coast Guard
Sector Ohio Valley area of responsibility (AOR). Through this rule the
current list of recurring safety zones is proposed to be updated with
revisions, additional events, and removal of events that no longer take
place. This proposed rule would reduce administrative costs involved in
producing separate proposed rules for each individual recurring safety
zone and serve to provide notice of the known recurring safety zones
throughout the year. We invite your comments on this proposed
rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before March 26, 2021.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0014 using the Federal

eRulemaking Portal at https://www.regulations.gov. See the ``Public
Participation and Request for Comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Petty Officer Christopher Roble,
Sector Ohio Valley, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Ohio Valley
DHS Department of Homeland Security
E.O. Executive Order
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
AOR Area of Responsibility

II. Background, Purpose, and Legal Basis

    The Captain of the Port Sector Ohio Valley (COTP) proposes to amend
section 165.801 of Title 33 of the Code of Federal Regulations (CFR) to
update our regulations for annual fireworks displays and other events
in the Eighth Coast Guard District requiring safety zones with respect
to those in Sector Ohio Valley.
    The current list of annual and recurring safety zones occurring in
Sector Ohio Valley's area of responsibility (AOR) is published under 33
CFR 165.801 in Table No. 1 for annual safety zones in the AOR. The most
recent list was created June 2, 2020 through the rulemaking 85 FR
33561.
    The Coast Guard proposes to amend and update the safety zone
regulations under 33 CFR part 165 to include the most up to date list
of recurring safety zones for events held on or around navigable waters
within Sector Ohio Valley's AOR. These events include air shows,
fireworks displays, and other marine related events requiring a limited
access area restricting vessel traffic for safety purposes. The current
list in 33 CFR 165.801 needs to be amended to provide new information
on existing safety zones, and to include new safety zones expected to
recur annually or biannually, and to remove safety zones that are no
longer required. Issuing individual regulations for each new safety
zone, amendment, or removal of an existing safety zone would create
unnecessary administrative costs and burdens. This single proposed
rulemaking would considerably reduce administrative overhead and
provide the public with notice through publication in the Federal
Register of the upcoming recurring safety zone regulations.
    The Coast Guard encourages the public to participate in this
proposed rulemaking through the comment process so that any necessary
changes can be identified and implemented in a timely and efficient
manner. The Coast Guard will address all public comments accordingly,
whether through response, additional revision to the regulation, or
otherwise.

III. Discussion of Proposed Rule

    Part 165 of 33 CFR contains regulations establishing limited access
areas to restrict vessel traffic for the safety of persons and
property. Section 165.801 establishes recurring safety zones to
restrict vessel transit into and through specified areas to protect
spectators, mariners, and other persons and property from potential
hazards presented during certain events taking place in the AOR. This
section requires amendment from time to time to properly reflect the
recurring safety zone regulations in the AOR. This proposed rule would
amend and update Sec.  165.801 by revising the current Table 1.
    This proposed rule would add the following 2 safety zones to the
existing Table 1 Sec.  165.801 as follows:

----------------------------------------------------------------------------------------------------------------
                Date                        Event/sponsor          Ohio Valley location       Regulated area
----------------------------------------------------------------------------------------------------------------
1 night in July....................  Steubenville fireworks.....  Steubenville, OH......  Ohio River Mile 67.5-
                                                                                68.5.
A weekend in June..................  Alzheimer's Water Lantern    Wheeling, WV..........  Ohio River Mile 90.3-
                                      Festival/IC Care.                                    91.8.
----------------------------------------------------------------------------------------------------------------

    The effect of this proposed rule would be to restrict general
navigation in the safety zones during the events. Vessels intending to
transit the designated waterway through the safety zones would only be
allowed to transit the area when the COTP, or a designated
representative, has deemed it safe to do so or at the completion of the
event. The proposed annually recurring safety zones are necessary to
provide for the safety of life on navigable waters during the events.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    The Coast Guard expects the economic impact of this proposed rule
to be minimal, therefore a full regulatory evaluation is unnecessary.
This proposed rule would establish safety zones limiting access to
certain areas under 33 CFR part 165 within Sector Ohio Valley's AOR.
The effect of this proposed rulemaking would not be significant because
these safety zones would be limited in scope and duration.
Additionally, the public would be given advance notification through
the Federal Register, and/or Notices of Enforcement and, thus, will be
able to plan operations around the safety zones. Broadcast Notices to
Mariners, Local Notices to Mariners, and Safety Marine Information
Broadcasts would inform the community of these safety zones. Vessel
traffic would be allowed to request permission from the COTP or a
designated representative to enter the restricted areas. Broadcast
Notices to Mariners, Local Notices to Mariners, and Safety Marine
Information Broadcasts would inform the community of these safety
zones. Vessel traffic would be allowed to request permission from the
COTP or a designated representative to enter the restricted areas.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please call or email the person listed in the FOR FURTHER INFORMATION
CONTACT section. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has a substantial direct effect on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule would not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that would not individually or cumulatively have a significant
effect on the human environment. Normally such actions are
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
preliminary Record of Environmental Consideration supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, call or email the person
in the FOR FURTHER INFORMATION CONTACT section of this document for
alternate instructions.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's eRulemaking System
of Records notice (85 FR 14226, March 11, 2020).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5;

Department of Homeland Security Delegation No. 0170.1.

0
2. In Sec.  165.801, revise Table 1 to read as follows:

Sec.  165.801  Annual fireworks displays and other events in the Eighth
Coast Guard District recurring safety zones.

* * * * *

                 Table 1 of Sec.   165.801--Sector Ohio Valley Annual and Recurring Safety Zones
----------------------------------------------------------------------------------------------------------------
              Date                   Sponsor/name        Sector Ohio Valley location           Safety zone
----------------------------------------------------------------------------------------------------------------
1. 3 days--Third or Fourth        Henderson           Henderson, KY....................  Ohio River, Miles 802.5-
 weekend in April.                 Breakfast Lions                                        805.5 (Kentucky).
                                   Club Tri-Fest.
2. Multiple days--April through   Pittsburgh Pirates  Pittsburgh, PA...................  Allegheny River, Miles
 November.                         Season Fireworks.                                      0.2-0.9
                                                                                (Pennsylvania).
3. Multiple days--April through   Cincinnati Reds     Cincinnati, OH...................  Ohio River, Miles 470.1-
 November.                         Season Fireworks.                                      470.4; extending 500
                                                                                ft. from the State of
                                                                                Ohio shoreline (Ohio).
4. Multiple days--April through   Pittsburgh          Pittsburgh, PA...................  Monongahela River,
 November.                         Riverhounds                                            Miles 0.22-0.77
                                   Season Fireworks.                                      (Pennsylvania).
5. 1 day--First week in May.....  Belterra Park       Cincinnati, OH...................  Ohio River, Miles 460.0-
                                   Gaming Fireworks.                                      462.0 (Ohio).
6. 3 days in May................  US Rowing           Oak Ridge, TN....................  Clinch River, Miles
                                   Southeast Youth                                        48.5-52 (Tennessee).
                                   Championship
                                   Regatta.
7. 1 day--One Friday in May       Live on the Levee   Charleston, WV...................  Kanawha River, Mile
 prior to Memorial Day.            Memorial Day                                           58.1-59.1 (West
                                   Fireworks/City of                                      Virginia).
                                   Charleston.
8. 1 day--Saturday before         Venture Outdoors    Pittsburgh, PA...................  Allegheny River, Miles
 Memorial Day.                     Festival.                                              0.0-0.25; Monongahela
                                                                                River, Miles 0.0-0.25
                                                                                (Pennsylvania).
9. 3 days in June...............  CMA Festival......  Nashville, TN....................  Cumberland River, Miles
                                                                                190.7-191.1 extending
                                                                                100 feet from the left
                                                                                descending bank
                                                                                (Tennessee).
10. 1 day in June...............  Cumberland River    Nashville, TN....................  Cumberland River, Miles
                                   Compact/Nashville                                      189.7-192.1
                                   Splash Bash.                                           (Tennessee).
11. 2 days--A weekend in June...  Rice's Landing      Rice's Landing, PA...............  Monongahela River,
                                   Riverfest.                                             Miles 68.0-68.8
                                                                                (Pennsylvania).
12. 2 days--Second Friday and     City of Newport,    Newport, KY......................  Ohio River, Miles 468.6-
 Saturday in June.                 KY/Italianfest.                                        471.0 (Kentucky and
                                                                                Ohio).
13. 1 day in June...............  Friends of the      Chattanooga, TN..................  Tennessee River, Miles
                                   Festival, Inc./                                        462.7-465.2
                                   Riverbend                                              (Tennessee).
                                   Festival
                                   Fireworks.
14. 1 day--Second or Third week   TriState Pottery    East Liverpool, OH...............  Ohio River, Miles 42.5-
 of June.                          Festival                                               45.0 (Ohio).
                                   Fireworks.
15. 3 days--One of the last       Hadi Shrine/        Evansville, IN...................  Ohio River, Miles 790.0-
 three weekends in June.           Evansville                                             796.0 (Indiana).
                                   Freedom Festival
                                   Air Show.
16. 1 day--One weekend in June..  West Virginia       Charleston, WV...................  Kanawha River, Miles
                                   Symphony                                               59.5-60.5 (West
                                   Orchestra/                                             Virginia).
                                   Symphony Sunday.
17. One weekend in June.........  Alzheimer's Water   Wheeling, WV.....................  Ohio River Mile 90.3-
                                   Lantern Festival/                                      91.8.
                                   IC Care.
18. 1 day--Last weekend in June   Riverview Park      Louisville, KY...................  Ohio River, Miles 617.5-
 or first weekend in July.         Independence                                           620.5 (Kentucky).
                                   Festival.
19. 1 day--Last weekend in June   City of Point       Point Pleasant, WV...............  Ohio River, Miles 265.2-
 or First weekend in July.         Pleasant/Point                                         266.2, Kanawha River
                                   Pleasant                                               Miles 0.0-0.5 (West
                                   Sternwheel                                             Virginia).
                                   Fireworks.
20. 1 day--Last weekend in June   City of Aurora/     Aurora, IN.......................  Ohio River, Mile 496.7;
 or first weekend in July.         Aurora                                                 1400 ft. radius from
                                   Firecracker                                            the Consolidated Grain
                                   Festival.                                              Dock located along the
                                                                                State of Indiana
                                                                                shoreline at (Indiana
                                                                                and Kentucky).
21. 1 day--Last week of June or   PUSH Beaver County/ Beaver, PA.......................  Ohio River, Miles 25.2-
 first week of July.               Beaver County                                          25.6 (Pennsylvania).
                                   Boom.
22. 1 day--Last weekend in June   Evansville Freedom  Evansville, IN...................  Ohio River, Miles 790.0-
 or first week in July.            Celebration/4th                                        796.0 (Indiana).
                                   of July Fireworks.
23. 1 day--Last week in June or   Newburgh Fireworks  Newburgh, IN.....................  Ohio River, Miles 777.3-
 first week of July.               Display.                                               778.3 (Indiana).
24. 1 day--Last week in June or   Rising Sun          Rising Sun, IN...................  Ohio River, Miles 506.0-
 First week in July.               Fireworks.                                             507.0 (Indiana).
25. 1 day--Weekend before the     Kentucky Dam        Gilbertsville, KY................  350 foot radius, from
 4th of July.                      Marine/Kentucky                                        the fireworks launch
                                   Dam Marina                                             site, on the entrance
                                   Fireworks.                                             jetties at Kentucky
                                                                                Dam Marina, on the
                                                                                Tennessee River at
                                                                                Mile Marker 23
                                                                                (Kentucky).
26. 1 day in July...............  Town of Cumberland  Cumberland City, TN..............  Cumberland River, Miles
                                   City/Lighting up                                       103.0-105.5
                                   the Cumberlands.                                       (Tennessee).
27. 1 day in July...............  Chattanooga         Chattanooga, TN..................  Tennessee River, Miles
                                   Presents/Pops on                                       462.7-465.2
                                   the River.                                             (Tennessee).

28. 1 day in July...............  Randy Boyd/         Knoxville, TN....................  Tennessee River, Miles
                                   Independence                                           625.0-628.0
                                   Celebration                                            (Tennessee).
                                   Fireworks Display.
29. 1 day--July 3rd.............  Moors Resort and    Gilbertsville, KY................  600 foot radius, from
                                   Marina/Kentucky                                        the fireworks launch
                                   Lake Big Bang.                                         site, on the entrance
                                                                                jetty to Moors Resort
                                                                                and Marina, on the
                                                                                Tennessee River at
                                                                                mile marker 30.5
                                                                                (Kentucky).
30. 1 day--3rd or 4th of July...  City of Paducah,    Paducah, KY......................  Ohio River, Miles 934.0-
                                   KY.                                                    936.0; Tennessee
                                                                                River, Miles 0.0-1.0
                                                                                (Kentucky).
31. 1 day--3rd or 4th of July...  City of Hickman,    Hickman, KY......................  700 foot radius from
                                   KY/Town Of                                             GPS coordinate
                                   Hickman Fireworks.                                     36[deg]34.5035 N,
                                                                                089[deg]11.919 W, in
                                                                                Hickman Harbor located
                                                                                at mile marker 921.5
                                                                                on the Lower
                                                                                Mississippi River
                                                                                (Kentucky).
32. 1 day--July 4th.............  City of Knoxville/  Knoxville, TN....................  Tennessee River, Miles
                                   Knoxville                                              646.3-648.7
                                   Festival on the                                        (Tennessee).
                                   4th.
33. 1 day in July...............  Nashville NCVC/     Nashville, TN....................  Cumberland River, Miles
                                   Independence                                           189.7-192.3
                                   Celebration.                                           (Tennessee).
34. 1 day in July...............  Shoals Radio Group/ Florence, AL.....................  Tennessee River, Miles
                                   Spirit of Freedom                                      254.5-257.4 (Alabama).
                                   Fireworks.
35. 1 day--4th of July (Rain      Monongahela Area    Monongahela, PA..................  Monongahela River,
 date--July 5th).                  Chamber of                                             Milse 032.0-033.0
                                   Commerce/                                              (Pennsylvania).
                                   Monongahela 4th
                                   of July
                                   Celebration.
36. 1 day--July 4th.............  Cities of           Newport, KY......................  Ohio River, Miles 469.6-
                                   Cincinnati, OH                                         470.2 (Kentucky and
                                   and Newport, KY/                                       Ohio).
                                   July 4th
                                   Fireworks.
37. 1 day--July 4th.............  Wellsburg 4th of    Wellsburg, WV....................  Ohio River, Miles 73.5-
                                   July Committee/                                        74.5 (West Virginia).
                                   Wellsburg 4th of
                                   July Freedom
                                   Celebration.
38. 1 day--Week of July 4th.....  Wheeling Symphony   Wheeling, WV.....................  Ohio River, Miles 90-92
                                   fireworks.                                             (West Virginia).
39. 1 day--First week or weekend  Summer Motions      Ashland, KY......................  Ohio River, Miles 322.1-
 in July.                          Inc./Summer                                            323.1 (Kentucky).
                                   Motion.
40. 1 day--Week of July 4th.....  Chester Fireworks.  Chester, WV......................  Ohio River mile 42.0-
                                                                                44.0 (West Virginia).
41. 1 day--First week of July...  Toronto 4th of      Toronto, OH......................  Ohio River, Mile 58.2-
                                   July Fireworks.                                        58.8 (Ohio).
42. 1 day--First week of July...  Cincinnati          Cincinnati, OH...................  Ohio River, Miles 460.0-
                                   Symphony                                               462.0 (Ohio).
                                   Orchestra.
43. 1 day--First weekend or week  Queen's Landing     Greenup, KY......................  Ohio River, Miles 339.3-
 in July.                          Fireworks.                                             340.3 (West Virginia).
44. 1 day--First week or weekend  Gallia County       Gallipolis, OH...................  Ohio River, Miles 269.5-
 in July.                          Chamber of                                             270.5 (Ohio).
                                   Commerce/
                                   Gallipolis River
                                   Recreation
                                   Festival.
45. 1 day--First week or weekend  Kindred             Huntington, WV...................  Ohio River, Miles 307.8-
 in July.                          Communications/                                        308.8 (West Virginia).
                                   Dawg Dazzle.
46. 1 day--First week or weekend  Greenup City......  Greenup, KY......................  Ohio River, Miles 335.2-
 in July.                                                                                336.2 (Kentucky).
47. 1 day--First week or weekend  Middleport          Middleport, OH...................  Ohio River, Miles 251.5-
 in July.                          Community                                              252.5 (Ohio).
                                   Association.
48. 1 day--First week or weekend  People for the      South Point, OH..................  Ohio River, Miles 317-
 in July.                          Point Party in                                         318 (Ohio).
                                   the Park.
49. 1 day--One of the first two   City of Bellevue,   Bellevue, KY.....................  Ohio River, Miles 468.2-
 weekends in July.                 KY/Bellevue Beach                                      469.2 (Kentucky &
                                   Park Concert                                           Ohio).
                                   Fireworks.
50. 1 day--First Week of July...  Pittsburgh 4th of   Pittsburgh, PA...................  Ohio River, Miles 0.0-
                                   July Celebration.                                      0.5, Allegheny River,
                                                                                Miles 0.0-0.5, and
                                                                                Monongahela River,
                                                                                Miles 0.0-0.5
                                                                                (Pennsylvania).
51. 1 day--First week or weekend  City of Charleston/ Charleston, WV...................  Kanawha River, Miles
 in July.                          City of                                                58.1-59.1 (West
                                   Charleston                                             Virginia).
                                   Independence Day
                                   Celebration.
52. 1 day--First week or weekend  Portsmouth River    Portsmouth, OH...................  Ohio River, Miles 355.5-
 in July.                          Days.                                                  357.0 (Ohio).
53. 1 day--During the first week  Louisville Bats     Louisville, KY...................  Ohio River, Miles 602.0-
 of July.                          Baseball Club/                                         605.0 (Kentucky).
                                   Louisville Bats
                                   Firework Show.
54. 1 day--During the first week  Waterfront          Louisville, KY...................  Ohio River, Miles 602.0-
 of July.                          Independence                                           605.0 (Kentucky).
                                   Festival/
                                   Louisville
                                   Orchestra
                                   Waterfront 4th.
55. 1 day--During the first week  Celebration of the  Owensboro, KY....................  Ohio River, Miles 754.0-
 of July.                          American Spirit                                        760.0 (Kentucky).
                                   Fireworks/All
                                   American 4th of
                                   July.

56. 1 day--During the first week  Riverfront          New Albany, IN...................  Ohio River, Miles 606.5-
 of July.                          Independence                                           609.6 (Indiana).
                                   Festival
                                   Fireworks.
57. 1 day in July...............  Grand Harbor        Counce, TN.......................  Tennessee-Tombigbee
                                   Marina/Grand                                           Waterway, Miles 448.5-
                                   Harbor Marina                                          451.0 (Tennessee).
                                   July 4th
                                   Celebration.
58. 1 night in July.............  Steubenville        Steubenville, OH.................  Ohio River Mile 67.5-
                                   fireworks.                                             68.5.
59. 1 day--During the first two   City of Maysville   Maysville, KY....................  Ohio River, Miles 408-
 weeks of July.                    Fireworks.                                             409 (Kentucky).
60. 1 day--One of the first two   Madison Regatta,    Madison, IN......................  Ohio River, Miles 554.0-
 weekends in July.                 Inc./Madison                                           561.0 (Indiana).
                                   Regatta.
61. 1 day--Third Saturday in      Pittsburgh Irish    Pittsburgh, PA...................  Ohio River, Miles 7.0-
 July.                             Rowing Club/St.                                        9.0 (Pennsylvania).
                                   Brendan's Cup
                                   Currach Regatta.
62. 1 day--Third or fourth week   Upper Ohio Valley   Wheeling, WV.....................  Ohio River, Miles 90.0-
 in July.                          Italian Heritage                                       90.5 (West Virginia).
                                   Festival/Upper
                                   Ohio Valley
                                   Italian Heritage
                                   Festival
                                   Fireworks.
63. 1 day--Saturday Third or      Oakmont Yacht Club/ Oakmont, PA......................  Allegheny River, Miles
 Fourth full week of July (Rain    Oakmont Yacht                                          12.0-12.5
 date--following Sunday).          Club Fireworks.                                        (Pennsylvania).
64. 2 days--One weekend in July.  Marietta            Marietta, OH.....................  Ohio River, Miles 171.6-
                                   Riverfront Roar                                        172.6 (Ohio).
                                   Fireworks.
65. 1 Day in July...............  Three Rivers        Knoxville, TN....................  Tennessee River, Miles
                                   Regatta.                                               642-653 (Tennessee).
66. 1 day--Last weekend in July   Fort Armstrong      Kittanning, PA...................  Allegheny River, Mile
 or first weekend in August.       Folk Music                                             45.1-45.5
                                   Festival.                                              (Pennsylvania).
67. 1 day--First week of August.  Kittaning Folk      Kittanning, PA...................  Allegheny River, Miles
                                   Festival.                                              44.0-46.0
                                                                                (Pennsylvania).
68. 1 day--First week in August.  Gliers Goetta Fest  Newport, KY......................  Ohio River, Miles 469.0-
                                   LLC.                                                   471.0.
69. 1 day--First or second week   Bellaire All-       Bellaire, OH.....................  Ohio River, Miles 93.5-
 of August.                        American Days.                                         94.5 (Ohio).
70. 1 day--Second full week of    PA FOB Fireworks    Pittsburgh, PA...................  Allegheny River, Miles
 August.                           Display.                                               0.8-1.0
                                                                                (Pennsylvania).
71. 1 day--Second Saturday in     Guyasuta Days       Pittsburgh, PA...................  Allegheny River, Miles
 August.                           Festival/Borough                                       005.5-006.0
                                   of Sharpsburg.                                         (Pennsylvania).
72. 1 day--In the Month of        Pittsburgh          Pittsburgh, PA...................  Ohio River, Mile 0.0-
 August.                           Foundation/Bob                                         0.5 (Pennsylvania).
                                   O'Connor Cookie
                                   Cruise.
73. 1 day--Third week of August.  Beaver River        Beaver, PA.......................  Ohio River, Miles 25.2-
                                   Regatta Fireworks.                                     25.8 (Pennsylvania).
74. 1 day--One weekend in August  Parkersburg         Parkersburg, WV..................  Ohio River, Miles 183.5-
                                   Homecoming                                             185.5 (West Virginia).
                                   Festival-
                                   Fireworks.
75. 1 day--One weekend in August  Ravenswood River    Ravenswood, WV...................  Ohio River, Miles 220-
                                   Festival.                                              221 (West Virginia).
76. 1 day--The second or third    Green Turtle Bay    Grand Rivers, KY.................  420 foot radius, from
 weekend of August.                Resort/Grand                                           the fireworks launch
                                   Rivers Marina Day.                                     site, at the entrance
                                                                                to Green Turtle Bay
                                                                                Resort, on the
                                                                                Cumberland River at
                                                                                mile marker 31.5
                                                                                (Kentucky).
77. 1 day--Last 2 weekends in     Wheeling Dragon     Wheeling, WV.....................  Ohio River, Miles 90.4-
 August/first week of September.   Boat Race.                                             91.5 (West Virginia).
78. Sunday, Monday, or Thursday   Pittsburgh          Pittsburgh, PA...................  Allegheny River, Miles
 from August through February.     Steelers                                               0.0-0.25, Ohio River,
                                   Fireworks.                                             Miles 0.0-0.1,
                                                                                Monongahela River,
                                                                                Miles 0.0-0.1
                                                                                (Pennsylvania).
79. 1 day--Labor day............  Portsmouth Labor    Portsmouth, OH...................  Ohio River, Mile 355.8-
                                   Day Fireworks/                                         356.8 (Ohio).
                                   Hamburg Fireworks.
80. 1 day--One weekend before     Riverfest/          Nitro, WV........................  Kanawha River, Miles
 Labor Day.                        Riverfest Inc.                                         43.1-44.2 (West
                                                                                Virginia).
81. 2 days--Sunday before Labor   Cincinnati Bell,    Cincinnati, OH...................  Ohio River, Miles 469.2-
 Day and Labor Day.                WEBN, and Proctor                                      470.5 (Kentucky and
                                   and Gamble/                                            Ohio) and Licking
                                   Riverfest.                                             River, Miles 0.0-3.0
                                                                                (Kentucky).
82. 1 day--Labor Day or first     Labor Day           Marmet, WV.......................  Kanawha River, Miles
 week of September.                Fireworks Show.                                        67.5-68 (West
                                                                                Virginia).
83. 1 day in September..........  Nashville Symphony/ Nashville, TN....................  Cumberland River, Miles
                                   Concert Fireworks.                                     190.1-192.3
                                                                                (Tennessee).
84. 1 day--Second weekend in      City of             Clarksville, TN..................  Cumberland River, Miles
 September.                        Clarksville/                                           124.5-127.0
                                   Clarksville                                            (Tennessee).
                                   Riverfest.

85. 3 days--Second or third week  Wheeling Heritage   Wheeling, WV.....................  Ohio River, Miles 90.2-
 in September.                     Port Sternwheel                                        90.7 (West Virginia).
                                   Festival
                                   Foundation/
                                   Wheeling Heritage
                                   Port Sternwheel
                                   Festival.
86. 1 day--One weekend in         Boomtown Days--     Nitro, WV........................  Kanawha River, Miles
 September.                        Fireworks.                                             43.1-44.2 (West
                                                                                Virginia).
87. 1 day--One weekend in         Ohio River          Marietta, OH.....................  Ohio River, Miles 171.5-
 September.                        Sternwheel                                             172.5 (Ohio).
                                   Festival
                                   Committee
                                   fireworks.
88. 1 day--One weekend in         Tribute to the      Point Pleasant, WV...............  Ohio River, Miles 264.6-
 September.                        River.                                                 265.6 (West Virginia).
89. 1 day--One weekend in         Aurora Fireworks..  Aurora, IN.......................  Ohio River, Mile 496.3-
 September.                                                                               497.3 (Ohio).
90. 1 day--Last two weekends in   Cabana on the       Cincinnati, OH...................  Ohio River, Mile 483.2-
 September.                        River.                                                 484.2 (Ohio).
91. Multiple days--September      University of       Pittsburgh, PA...................  Ohio River, Miles 0.0-
 through January.                  Pittsburgh                                             0.1, Monongahela
                                   Athletic                                               River, Miles 0.0-0.1,
                                   Department/                                            Allegheny River, Miles
                                   University of                                          0.0-0.25
                                   Pittsburgh                                             (Pennsylvania).
                                   Fireworks.
92. 1 day--First three weeks of   Leukemia &          Pittsburgh, PA...................  Ohio River, Mile 0.0-
 October.                          Lymphoma Society/                                      0.5, Allegheny River,
                                   Light the Night.                                       Mile 0.0-0.5, and
                                                                                Monongahela River,
                                                                                Mile 0.0-0.5
                                                                                (Pennsylvania).
93. 1 day in October............  Leukemia and        Nashville, TN....................  Cumberland River, Miles
                                   Lymphoma Society/                                      189.7-192.1
                                   Light the Night                                        (Tennessee).
                                   Walk Fireworks.
94. 1 day--First two weeks in     Yeatman's           Cincinnati, OH...................  Ohio River, Miles 469.0-
 October.                          Fireworks.                                             470.5 (Ohio).
95. 1 day in October............  Outdoor             Chattanooga, TN..................  Tennessee River, Miles
                                   Chattanooga/Swim                                       452.0-454.5
                                   the Suck.                                              (Tennessee).
96. 1 day in October............  Chattajack........  Chattanooga, TN..................  Tennessee River, Miles
                                                                                462.7-465.5
                                                                                (Tennessee).
97. 1 day--One weekend in         West Virginia       Charleston, WV...................  Kanawha River, Miles 58-
 October.                          Motor Car                                              59 (West Virginia).
                                   Festival.
98. 2 days--One of the last       Monster Pumpkin     Pittsburgh, PA...................  Allegheny River, Mile
 three weekends in October.        Festival.                                              0.0-0.25
                                                                                (Pennsylvania).
99. 1 day--Friday before          Pittsburgh          Pittsburgh, PA...................  Allegheny River, Miles
 Thanksgiving.                     Downtown                                               0.0-1.0
                                   Partnership/Light                                      (Pennsylvania).
                                   Up Night.
100. 1 day--Friday before         Kittanning Light    Kittanning, PA...................  Allegheny River, Miles
 Thanksgiving.                     Up Night Firework                                      44.5-45.5
                                   Display.                                               (Pennsylvania).
101. 1 day--Friday before         Santa Spectacular/  Pittsburgh, PA...................  Ohio River, Mile 0.0-
 Thanksgiving.                     Light up Night.                                        0.5, Allegheny River,
                                                                                Mile 0.0-0.5, and
                                                                                Monongahela River,
                                                                                Mile 0.0-0.5
                                                                                (Pennsylvania).
102. 1 day--Friday before         Monongahela         Monongahela, PA..................  Ohio River, Miles 31.5-
 Thanksgiving.                     Holiday Show.                                          32.5 (Pennsylvania).
103. 1 day in November..........  Friends of the      Chattanooga, TN..................  Tennessee River, Miles
                                   Festival/Cheer at                                      462.7-465.2
                                   the Pier.                                              (Tennessee).
104. 1 day--Third week of         Gallipolis in       Gallipolis, OH...................  Ohio River, Miles 269.2-
 November.                         Lights.                                                270 (Ohio).
105. 1 day--December 31.........  Pittsburgh          Pittsburgh, PA...................  Allegheny River, Miles
                                   Cultural Trust/                                        0.5-1.0
                                   Highmark First                                         (Pennsylvania).
                                   Night Pittsburgh.
106. 7 days--Scheduled home       University of       Knoxville, TN....................  Tennessee River, Miles
 games.                            Tennessee/UT                                           645.6-648.3
                                   Football                                               (Tennessee).
                                   Fireworks.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: Febuary 2, 2021.
A.M. Beach,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2021-02671 Filed 2-23-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Notices]
[Pages 67356-67358]
[FR Doc No: 2016-23623]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0007]

Fee for Using a Tropical Disease Priority Review Voucher in
Fiscal Year 2017

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rates for using a tropical disease priority review
voucher for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the Food and Drug Administration
Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect
priority review user fees for certain applications for approval of drug
or biological products when those applications use a tropical disease
priority review voucher awarded by the Secretary of Health and Human
Services. These vouchers are awarded to the sponsors of certain
tropical disease product applications, submitted after September 27,
2007, upon FDA approval of such applications. The amount of the fee
submitted to FDA with applications using a tropical disease priority
review voucher is determined each fiscal year based on the difference
between the average cost incurred by FDA in the review of a human drug
application subject to priority review in the previous fiscal year, and
the average cost incurred in the review of an application that is not
subject to priority review in the previous fiscal year. This notice
establishes the tropical disease priority review fee rate for FY 2017.

FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of
Financial Management, Food and Drug Administration, 8455 Colesville
Rd., COLE-14202F, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1102 of FDAAA (Pub. L. 110-85) added section 524 to the
FD&C Act (21 U.S.C. 360n). In section 524, Congress encouraged
development of new drug and biological products for prevention and
treatment of certain tropical diseases by offering additional
incentives for obtaining FDA approval

of such products. Under section 524, the sponsor of an eligible human
drug application submitted after September 27, 2007, for a tropical
disease (as defined in section 524(a)(3) of the FD&C Act), shall
receive a priority review voucher upon approval of the tropical disease
product application. The recipient of a tropical disease priority
review voucher may either use the voucher with a future submission to
FDA under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or
section 351 of the Public Health Service Act (42 U.S.C. 262), or
transfer (including by sale) the voucher to another party. The voucher
may be transferred (including by sale) repeatedly until it ultimately
is used for a human drug application submitted to FDA under section
505(b)(1) of the FD&C Act or section 351(a) of the Public Health
Service Act. A priority review is a review conducted with a
Prescription Drug User Fee Act (PDUFA) goal date of 6 months after the
receipt or filing date, depending upon the type of application.
Information regarding the PDUFA goals is available at: http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    The applicant that uses a priority review voucher is entitled to a
priority review but must pay FDA a priority review user fee in addition
to any other fee required by PDUFA. FDA published draft guidance on its
Web site about how this tropical disease priority review voucher
program operates (available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080599.pdf).
    This notice establishes the tropical disease priority review fee
rate for FY 2017 as $2,706,000 and outlines FDA's process for
implementing the collection of the priority review user fees. This rate
is effective on October 1, 2016, and will remain in effect through
September 30, 2017, for applications submitted with a tropical disease
priority review voucher. The payment of this priority review user fee
is required in addition to the payment of any other fee that would
normally apply to such an application under PDUFA before FDA will
consider the application complete and acceptable for filing.

II. Tropical Disease Priority Review User Fee for FY 2017

    FDA interprets section 524(c)(2) of the FD&C Act as requiring that
FDA determine the amount of the tropical disease priority review user
fee each fiscal year based on the difference between the average cost
incurred by FDA in the review of a human drug application subject to
priority review in the previous fiscal year, and the average cost
incurred by FDA in the review of a human drug application that is not
subject to priority review in the previous fiscal year.
    A priority review is a review conducted with a PDUFA goal date of 6
months after the receipt or filing date, depending on the type of
application. Under the PDUFA goals letter, FDA has committed to
reviewing and acting on 90 percent of the applications granted priority
review status within this expedited timeframe. Normally, an application
for a human drug or biological product will qualify for priority review
if the product is intended to treat a serious condition and, if
approved, would provide a significant improvement in safety or
effectiveness. An application that does not receive a priority
designation will receive a standard review. Under the PDUFA goals
letter, FDA committed to reviewing and acting on 90 percent of standard
applications within 10 months of the receipt or filing date, depending
on the type of application. A priority review involves a more intensive
level of effort and a higher level of resources than a standard review.
    As interpreted by FDA, section 524(c)(2) of the FD&C Act requires
that the fee amount should be based on the difference between the
average cost incurred by the Agency in the review of a human drug
application subject to a priority review in the previous fiscal year,
and the average cost incurred by FDA in the review of a human drug
application that is not subject to priority review in the previous
fiscal year. FDA is setting fees for FY 2017, and the previous fiscal
year is FY 2016. However, the FY 2016 submission cohort has not been
closed out yet, and the cost data for FY 2016 are not complete. The
latest year for which FDA has complete cost data is FY 2015.
Furthermore, because FDA has never tracked the cost of reviewing
applications that get priority review as a separate cost subset, FDA
estimated this cost based on other data that the Agency has tracked.
FDA uses data that the Agency estimates and publishes on its Web site
each year--standard costs for review. FDA does not publish a standard
cost for ``the review of a human drug application subject to priority
review in the previous fiscal year.'' However, we expect all such
applications would contain clinical data. The standard cost application
categories with clinical data that FDA does publish each year are: (1)
New drug applications (NDAs) for a new molecular entity (NME) with
clinical data and (2) biologics license applications (BLAs).
    The worksheets for standard costs for FY 2015, show a standard cost
(rounded to the nearest thousand dollars) of $5,251,000 for a NME NDA
and $5,055,000 for a BLA. Based on these standard costs, the total cost
to review the 56 applications in these two categories in FY 2015 (32
NME NDAs with clinical data and 24 BLAs) was $289,352,000. (Note: These
numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no
investigational new drug review costs are included in this amount.) 25
of these applications (18 NDAs and 7 BLAs) received priority review,
which would mean that the remaining 31 received standard reviews.
Because a priority review compresses a review that ordinarily takes 10
months into 6 months, FDA estimates that a multiplier of 1.67 (10
months divided by 6 months) should be applied to non-priority review
costs in estimating the effort and cost of a priority review as
compared to a standard review. This multiplier is consistent with
published research on this subject which supports a priority review
multiplier in the range of 1.48 to 2.35 (Ref. 1). Using FY 2015
figures, the costs of a priority and standard review are estimated
using the following formula:

(25 [alpha] x 1.67) + (31 [alpha]) = $289,352,000

where ``[alpha]'' is the cost of a standard review and ``[alpha] times
1.67'' is the cost of a priority review. Using this formula, the cost
of a standard review for NME NDAs and BLAs is calculated to be
$3,977,000 (rounded to the nearest thousand dollars) and the cost of a
priority review for NME NDAs and BLAs is 1.67 times that amount, or
$6,642,000 (rounded to the nearest thousand dollars). The difference
between these two cost estimates, or $2,665,000, represents the
incremental cost of conducting a priority review rather than a standard
review.
    For the FY 2017 fee, FDA will need to adjust the FY 2015
incremental cost by the average amount by which FDA's average costs
increased in the three years prior to FY 2016, to adjust the FY 2015
amount for cost increases in FY 2016. That adjustment, published in the
Federal Register on July 28, 2016 (see 81 FR 49674 at 49676), setting
FY 2017 PDUFA fees, is 1.5468 percent for the most recent year, not
compounded. Increasing the FY 2015 incremental priority review cost of
$2,665,000 by 1.5468 percent results in an estimated cost of $2,706,000
(rounded to the nearest thousand dollars). This is the

tropical disease priority review user fee amount for FY 2017 that must
be submitted with a priority review voucher for a human drug
application in FY 2017, in addition to any PDUFA fee that is required
for such an application.

III. Fee Schedule for FY 2017

    The fee rate for FY 2017 is set out in Table 1:

     Table 1--Tropical Disease Priority Review Schedule for FY 2017
------------------------------------------------------------------------
                                                         Fee rate for FY
                      Fee category                             2017
------------------------------------------------------------------------
Application submitted with a tropical disease priority       $2,706,000
 review voucher in addition to the normal PDUFA fee....
------------------------------------------------------------------------

IV. Implementation of Tropical Disease Priority Review User Fee

    Under section 524(c)(4)(A) of the FD&C Act, the priority review
user fee is due upon submission of a human drug application for which
the priority review voucher is used. Section 524(c)(4)(B) of the FD&C
Act specifies that the application will be considered incomplete if the
priority review user fee and all other applicable user fees are not
paid in accordance with FDA payment procedures. In addition, FDA may
not grant a waiver, exemption, reduction, or refund of any fees due and
payable under this section of the FD&C Act and FDA may not collect
priority review voucher fees ``except to the extent provided in advance
in appropriation Acts.'' Section 524(c)(4)(C) and 524(c)(5)(B).
Beginning with FDA's appropriation for FY 2009, the annual
appropriation language states specifically that ``priority review user
fees authorized by 21 U.S.C. 360n (section 524 of the FD&C Act) may be
credited to this account, to remain available until expended.'' (Pub.
L. 111-8, Section 5, Division A, Title VI).
    The tropical disease priority review fee established in the new fee
schedule must be paid for any application that is received on or after
October 1, 2016, and submitted with a priority review voucher. This fee
must be paid in addition to any other fee due under PDUFA. Payment must
be made in U.S. currency by electronic check, check, bank draft, wire
transfer, credit card, or U.S. postal money order payable to the order
of the Food and Drug Administration. The preferred payment method is
online using electronic check (Automated Clearing House (ACH) also
known as eCheck). Secure electronic payments can be submitted using the
User Fees Payment Portal at https://userfees.fda.gov/pay. Once you
search for your invoice, click ``Pay Now'' to be redirected to Pay.gov.
Note that electronic payment options are based on the balance due.
Payments must be drawn on U.S bank accounts.
    FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a Web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA Web site after the
user fee ID number is generated.
    The user fee identification (ID) number should be included on the
check, followed by the words ``Tropical Disease Priority Review.''
Payments can be mailed to: Food and Drug Administration, P.O. Box
979107, St. Louis, MO 63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery contact the U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier
delivery.) The FDA post office box number (P.O. Box 979107) must be
written on the check. The tax identification number of FDA is 53-
0196965.
    If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. The originating financial
institution may charge a wire transfer fee. Please ask your financial
institution about the fee and include it with your payment to ensure
that your fee is fully paid. The account information is as follows:
U.S. Dept. of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045,
Account Number: 75060099, Routing Number: 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 8455 Colesville Rd., 14th Floor, Silver Spring, MD
20993-0002.
    Paying by credit card (Discover, VISA, MasterCard, American
Express) is available for balances less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
drawn on U.S. credit cards.

V. Reference

    The following reference is on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and is available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006.

    Dated: September 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23623 Filed 9-29-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)]
[Notices]
[Pages 56035-56036]
[FR Doc No: 2017-25453]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0076]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Signatures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
December 27, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0303.
Also include the FDA docket number found in brackets in the heading of
this document.

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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Electronic Records; Electronic Signatures

OMB Control Number 0910-0303--Extension

    This information collection supports FDA regulations; specifically,
in part 11 (21 CFR part 11), which sets forth criteria for acceptance
of electronic records, electronic signatures, and handwritten
signatures executed to electronic records as equivalent to paper
records. Under these regulations, records and reports may be submitted
to FDA electronically provided the Agency has stated its ability to
accept the records electronically in an Agency-established public
docket and that the other requirements of part 11 are met.
    The recordkeeping provisions in part 11 (Sec. Sec.  11.10, 11.30,
11.50, and 11.300) require the following standard operating procedures
to assure appropriate use of, and precautions for, systems using
electronic records and signatures: (1) Sec.  11.10 specifies procedures
and controls for persons who use closed systems to create, modify,
maintain, or transmit electronic records; (2) Sec.  11.30 specifies
procedures and controls for persons who use open systems to create,
modify, maintain, or transmit electronic records; (3) Sec.  11.50
specifies procedures and controls for persons who use electronic
signatures; and (4) Sec.  11.300 specifies controls to ensure the
security and integrity of electronic signatures based upon use of
identification codes in combination with passwords. The reporting
provision (Sec.  11.100) requires persons to certify in writing to FDA
that they will regard electronic signatures used in their systems as
the legally binding equivalent of traditional handwritten signatures.
    The burden created by the information collection provision of this
regulation is a one-time burden associated with the creation of
standard operating procedures, validation, and certification. The
Agency anticipates the use of electronic media will substantially
reduce the paperwork burden associated with maintaining FDA required
records. The respondents are businesses and other for-profit
organizations, State or local governments, Federal Agencies, and
nonprofit institutions.
    In the Federal Register of June 19, 2017 (82 FR 27838), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received
in response to the information collection topics solicited in the
notice. However, one comment was received regarding a related Agency
draft guidance entitled, ``Use of Electronic Records and Electronic
Signatures in Clinical Investigations Under 21 CFR part 11--Questions
and Answers,'' and the comment has been directed to the appropriate
Agency components for consideration.
    We therefore estimate the burden of this collection of information
as follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Average  burden
                           21 CFR section                               Number of      responses per     Total annual    per  response     Total hours
                                                                       respondents       respondent       responses        (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.100.............................................................           4,500                1            4,500                1            4,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                Table 2--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
         21 CFR section             respondents    responses per     responses     response (in     Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
11.10...........................           2,500               1           2,500              20          50,000
11.30...........................           2,500               1           2,500              20          50,000
11.50...........................           4,500               1           4,500              20          90,000
11.300..........................           4,500               1           4,500              20          90,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         280,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25453 Filed 11-24-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 187 (Thursday, September 30, 2021)]
[Rules and Regulations]
[Pages 54042-54043]
[FR Doc No: 2021-21245]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0517; Airspace Docket No. 21-ACE-15]
RIN 2120-AA66

Amendment of Class E Airspace; Newton, KS

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends the Class E airspace at Newton-City-County
Airport, Newton, KS. This action is the result of an airspace review
caused by the decommissioning of the Newton non-directional beacon
(NDB). The geographic coordinates of the airport are also being updated
to coincide with the FAA's aeronautical database.

DATES: Effective 0901 UTC, December 2, 2021. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR 51, subject to the annual revision of FAA Order JO 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order JO 7400.11F at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, 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 the Class E surface airspace and Class E airspace
extending upward from 700 feet above the surface at Newton-City-County
Airport, Newton, KS, to support instrument flight rule operations at
this airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (86 FR 38245; July 20, 2021) for Docket No. FAA-2021-0517 to
amend the Class E airspace at Newton-City-County Airport, Newton, KS.
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 6002 and
6005, respectively, of FAA Order JO 7400.11F, dated August 10, 2021,
and effective September 15, 2021, 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.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021, and effective September
15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to 14 CFR part 71:
    Amends the Class E surface airspace at Newton-City-County Airport,
Newton, KS by removing the Newton NDB and associated extensions from
the airspace legal description;
    And amends the Class E airspace extending upward from 700 feet
above the surface to within a 6.7-mile (reduced from a 6.8-mile) radius
of Newton-City-County Airport; removes the Newton NDB and associated
extension from the airspace legal description; and updates the
geographic coordinates of the airport to coincide with the FAA's
aeronautical database.
    This action is due to an airspace review caused by the
decommissioning of the Newton NDB which provided navigation information
for the instrument procedures this airport.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    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, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (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 only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    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 part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 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 FAA JO Order
7400.11F,

Airspace Designations and Reporting Points, dated August 10, 2021, and
effective September 15, 2021, is amended as follows:

Paragraph 6002 Class E Airspace Areas Designates as Surface Areas.

* * * * *

ACE KS E2 Newton, KS [Amended]

Newton-City-County Airport, KS
    (Lat. 38[deg]03'26'' N, long. 97[deg]16'31'' W)

    Within a 4.2-mile radius of Newton-City-County Airport.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ACE KS E5 Newton, KS [Amended]

Newton-City-County Airport, KS
    (Lat. 38[deg]03'26'' N, long. 97[deg]16'31'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.7-mile radius of Newton-City-County Airport.

    Issued in Fort Worth, Texas, on September 27, 2021.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2021-21245 Filed 9-29-21; 8:45 am]
BILLING CODE 4910-13-P


C-E
  C-E-BL2
  4362
  4362
  2114

  C-E
  C-E-BL4
  2084
  1940
  1222

  C-E
  C-E-X1
  2392
  2195
  1548

  N
  3
  3
  3

  Average
  2946.3
  2832.7
  1627.9

  Std. Dev
  1236.1
  1330.9
  451.5

  RSD
  42.0%
  47.0%
  27.7%

  C-N
  C-N-BL2
  2516
  2410
  1404

  C-N
  C-N-BL4
  3592
  3633
  2327

  C-N
  C-N-X1
  2857
  2857
  1766

  N
  3
  3
  3

  Average
  2988.3
  2966.6
  1832.1

  Std. Dev
  549.8
  618.7
  465.0

  RSD
  18.4%
  20.9%
  25.4%

  C-S
  C-S-BL2
  3915
  3781
  2046

  C-S
  C-S-BL5
  3986
  3941
  2373

  C-S
  C-S-X1
  2180
  2600
  1797

  C-S
  C-S-X2
  4624
  4624
  2477

  N
  4
  4
  4

  Average
  3675.9
  3736.5
  2173.5

  Std. Dev
  1047.1
  840.9
  310.8

  RSD
  28.5%
  22.5%
  14.3%

  ALL C Boards

  N
  107
  107
  107

  Average
  2074.2
  2095.8
  1465.0

  Std. Dev
  990.1
  997.4
  2016.1

  RSD
  48.9%
  48.8%
  138.6%

  Min
  65
  96
  57

  Max
  4624
  4624
  21179

 <![if supportMisalignedColumns]>

 <![endif]>


[Federal Register Volume 79, Number 144 (Monday, July 28, 2014)]
[Notices]
[Pages 43814-43815]
[FR Doc No: 2014-17634]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms and Record Keeping Requirements; Agency
Information Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation (DOT).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collections and their expected
burden. The Federal Register Notices with a 60-day and a 30-day comment
period were published on February 27, 2012 (77 FR 11626) and on
December 23, 2013 (78 FR 77554), respectively. No comments were
received on this matter.
    This document describes the collection of information for which
NHTSA intends to seek OMB approval. The collection of information
described is the ``Consolidated Child Restraint System Registration,
Labeling and Defect Notification.'' (OMB Control Number: 2127-0576)

DATES: Comments must be submitted on or before August 27, 2014.

FOR FURTHER INFORMATION CONTACT: Ms. Cristina Echemendia at U.S.
Department of Transportation, NHTSA, 1200 New Jersey Avenue SE., West
Building Room W43-447, NVS-113, Washington, DC 20590. Mrs. Cristina
Echemendia's telephone number is<PHONE_NUMBER> and fax number is (202)
366-7002.

SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: Consolidated Child Restraint System Registration, Labeling
and Defect Notifications.
    OMB Control Number: 2127-0576.
    Type of Request: Label revision of a currently approved collection.
    Abstract: A final rule published on February 27, 2012 (77 FR 11626)
amended the Federal motor vehicle safety standard for child restraint
systems (CRSs) to expand its applicability to child restraints sold for
children weighing up to 80 pounds (lb). The final rule also added a
sentence to the printed instructions and labeling of certain CRSs
(those that have internal harnesses, and that are recommended for older
children). Currently, child restraint manufacturers are required to
provide printed instructions with step by-step information on how the
restraint is to be used. Without proper use, the effectiveness of these
systems is greatly diminished. Each CRS must also have a permanent
label.\1\ A permanently attached label gives ``quicklook'' information
on whether the restraint meets the safety requirements, recommended
installation and use, and warnings against misuse. The requested
revision is to add a sentence to the existing instructions brochure and
labeling that will inform the consumer that the lower anchors of a
Lower Anchors and Tethers for Children (LATCH) system may only be used
for children weighing ``x'' lb or less, where the ``x'' value depends
on the weight of the CRS. The purpose of this label is to reduce
consumer confusion about using LATCH, and to assure that the lower
anchors will be able to withstand the forces generated by the child and
CRS in virtually all crashes.
---------------------------------------------------------------------------

    \1\ FMVSS No. 213 also requires child restraint manufacturers to
provide owner-registration cards and to keep records relating to
owner registration information, so that owners can be notified about
noncompliance or defect recall campaigns. These owner registration
requirements are not affected by the final rule (77 FR 11626).
---------------------------------------------------------------------------

    Under the final rule, CRSs equipped with internal harnesses to
restrain the child and with components to attach to a child restraint
anchorage system, will be required to be labeled with a child weight
limit for using the lower anchors to attach the child restraint to the
vehicle. The child weight limit depends on the weight of the CRS.
    On February 25, 2014 the agency published a final rule responding
to petitions for reconsideration (79 FR 10396) of the February 2012
final rule. The petitions stated, among other things, that the label
that was required by the 2012 rule was unclear and could be
misunderstood. In response, NHTSA made minor adjustments to the
labeling requirement to make it clearer and more reader friendly.
    NHTSA anticipates a change to the hour burden or costs associated
with the revised child restraint labels and written instructions. Child
restraint manufacturers produce, on average, a total of approximately
4,500,000 child restraints per year. The label would apply to
approximately 50 percent of the total annual production (2,250,000
units). The hour burden associated with the revised label consists of
the child restraint manufacturer: (1) Determining the maximum allowable
child weight when using the lower anchor attachments as a means of
installation and (2) adding this information on an existing label and
instruction manual. We estimate 2 seconds of additional burden per
child restraint for the determination of the maximum allowable weight
and the addition of the information on the existing label and
instruction manual (2 seconds x 2,250,000 units = 4,500,000 seconds =
1,250 hours).

    Affected Public: Businesses, Individuals and Households.
    Estimated Additional Annual Burden: 1,250 hours.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725 17th
Street NW., Washington, DC 20503, Attention NHTSA Desk Officer.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology. A comment to OMB is most effective if OMB
receives it within 30 days of publication.

David M. Hines,
Acting Associate Administrator for Rulemaking.
[FR Doc. 2014-17634 Filed 7-25-14; 8:45 am]
BILLING CODE 4910-59-P