Comment Info: =================

General Comment:Dear recipient,

I am requesting a extension on the comment period to the proposed, seeing as the proposal becomes law 2 years after its initial publication a 1 year period would be justified for open commentary following each change to the proposal.

I would also like to comment that the proposal is very reminiscent of the former chicken tax fiasco. Regulation of electronic cigarette devices for all intents and purposes should not fall to the FDA as alone they are merely battery and heating elements. A battery powered hairdryer would thus be deemed a tobacco product as some have kanthal based heating elements and thus can be used to vaporize.

Stick to defining tobacco products as products that actually come from tobacco, and there will be little to no backlash from the proposal. A reduction of fees for the application process should also be admissible, as well as use of previous studies for the definition of the general health safety of e-liquids.

Seeing as these products are essentially inhalations I think that timestamped MBI-144 & endotoxin test would be sufficient for determining the relative beyond use and relative purity of e-liquids. This would actually lower the cost and prohibitive nature of providing e-liquids from entering the market.

Thinking more to the nature of USP<797> an ISO class 8 environment with a dedicated work area and proper washing and gowning procedures should be sufficient for the production of e-liquids for inhalation. This combined with the constant improvement manifest in the aforementioned guidelines would be sufficient to relatively guarantee a safe product. (there will always be outliers, i.e. meningitis in compounded IV admixtures)

Thank you for your time, Alex Dybowski

Feel free to reply to<EMAIL_ADDRESS>


[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Proposed Rules]
[Pages 66471-66474]
[FR Doc No: 2021-25464]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-1013; Project Identifier MCAI-2020-01530-T]
RIN 2120-AA64

Airworthiness Directives; BAE Systems (Operations) Limited
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2017-12-08, which applies to all BAE Systems (Operations) Limited Model
BAe 146-100A, -200A, and -300A airplanes; and Model Avro 146-RJ70A,
146-RJ85A, and 146-RJ100A airplanes. AD 2017-12-08 requires revising
the maintenance or inspection program, as applicable, to incorporate
new or revised structural inspection requirements. Since the FAA issued
AD 2017-12-08, the FAA has determined that new or more restrictive
airworthiness limitations are necessary. This proposed AD would require
revising the existing maintenance or inspection program, as applicable,
to incorporate new or more restrictive airworthiness limitations. The
FAA is proposing this AD to address the unsafe condition on these
products.

DATES: The FAA must receive comments on this proposed AD by January 7,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact BAE
Systems (Operations) Limited, Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; telephone +44 1292 675207; fax +44 1292 675704; email
[email protected]; internet http://www.baesystems.com/Businesses/RegionalAircraft/index.htm. You may view this service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 2200 South 216th St., Des Moines, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
1013; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-1013; Project Identifier
MCAI-2020-01530-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated

as private, that you actually treat as private, and that is relevant or
responsive to this NPRM, it is important that you clearly designate the
submitted comments as CBI. Please mark each page of your submission
containing CBI as ``PROPIN.'' The FAA will treat such marked
submissions as confidential under the FOIA, and they will not be placed
in the public docket of this NPRM. Submissions containing CBI should be
sent to Todd Thompson, Aerospace Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des Moines,
WA 98198; telephone and fax<PHONE_NUMBER>; email [email protected].
Any commentary that the FAA receives which is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Background

    The FAA issued AD 2017-12-08, Amendment 39-18923 (82 FR 27414, June
15, 2017) (AD 2017-12-08), for all BAE Systems (Operations) Limited
Model BAe 146-100A, -200A, and -300A airplanes; and Model Avro 146-
RJ70A, 146-RJ85A, and 146-RJ100A airplanes. AD 2017-12-08 requires
revising the maintenance or inspection program, as applicable, to
incorporate new or revised structural inspection requirements. AD 2017-
12-08 resulted from a determination that new or revised structural
inspection requirements are necessary. The FAA issued AD 2017-12-08 to
address fatigue cracking of certain structural elements, which could
adversely affect the structural integrity of the airplane.

Actions Since AD 2017-12-08 Was Issued

    Since the FAA issued AD 2017-12-08, the FAA has determined that new
or more restrictive airworthiness limitations are necessary.
    The Civil Aviation Authority (CAA), which is the aviation authority
for the United Kingdom, has issued CAA AD G-2021-0011, dated October 8,
2021 (CAA AD G-2021-0011) (also referred to after this as the Mandatory
Continuing Airworthiness Information, or the MCAI), to correct an
unsafe condition for all BAe 146 and AVRO 146-RJ airplanes. You may
examine the MCAI in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
1013.
    This proposed AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
proposing this AD to address fatigue cracking of certain structural
elements, which could adversely affect the structural integrity of the
airplane. See the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    BAE Systems has issued Chapter 05 of BAe 146 Series/AVRO 146-RJ
Series Aircraft Maintenance Manual, Revision 132, dated August 18,
2021. This service information describes airworthiness limitations,
including life limits, maintenance tasks, and CDCCLs.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
and service information referenced above. The FAA is proposing this AD
because the FAA evaluated all the relevant information and determined
the unsafe condition described previously is likely to exist or develop
on other products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would retain certain requirements of AD 2017-12-
08. This proposed AD would require revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance according to paragraph
(k)(1) of this proposed AD.

Costs of Compliance

    The FAA estimates that this proposed AD affects 30 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2017-12-08 to be $7,650 (90 work-hours x $85 per work-
hour).
    The FAA has determined that revising the maintenance or inspection
program takes an average of 90 work-hours per operator, although the
agency recognizes that this number may vary from operator to operator.
Since operators incorporate maintenance or inspection program changes
for their affected fleet(s), the FAA has determined that a per-operator
estimate is more accurate than a per-airplane estimate. Therefore, the
agency estimates the average total cost per operator to be $7,650 (90
work-hours x $85 per work-hour).
    The FAA estimates the total cost per operator for the new proposed
actions to be $7,650 (90 work-hours x $85 per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2017-12-08, Amendment 39-18923
(82 FR 27414, June 15, 2017); and
0
b. Adding the following new AD:

BAE Systems (Operations) Limited: Docket No. FAA-2021-1013; Project
Identifier MCAI-2020-01530-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by January 7, 2022.

(b) Affected ADs

    This AD replaces AD 2017-12-08, Amendment 39-18923 (82 FR 27414,
June 15, 2017) (AD 2017-12-08).

(c) Applicability

    This AD applies to all BAE Systems (Operations) Limited
airplanes, certificated in any category, identified in paragraphs
(c)(1) and (2) of this AD.
    (1) Model BAe 146-100A, -200A, and -300A airplanes.
    (2) Model Avro 146-RJ70A, 146-RJ85A, and 146-RJ100A airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address fatigue cracking of certain structural
elements, which could adversely affect the structural integrity of
the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Revision to the Maintenance or Inspection Program, With No
Changes

    This paragraph restates the requirements of paragraph (i) of AD
2017-12-08, with no changes. Within 90 days after July 20, 2017 (the
effective date of AD 2017-12-08): Revise the maintenance or
inspection program, as applicable, to incorporate new and revised
limitations, tasks, thresholds, and intervals using a method
approved by the Manager, Large Aircraft Section, International
Validation Branch, FAA.

    Note 1 to paragraph (g): An additional source of guidance for
the actions specified in paragraph (g) of this AD can be found in
BAe 146/AVRO 146-RJ Airplane Maintenance Manual, Revision 112, dated
October 15, 2013.
    Note 2 to paragraph (g): An additional source of guidance for
the actions specified in paragraph (g) of this AD can be found in
Corrosion Prevention Control Program (CPCP) Document No. CPCP-146-
01, Revision 4, dated September 15, 2010.
    Note 3 to paragraph (g): An additional source of guidance for
the actions specified in paragraph (g) of this AD can be found in
Supplemental Structural Inspections Document (SSID) Document No.
SSID-146-01, Revision 2, dated August 15, 2012.
    Note 4 to paragraph (g): An additional source of guidance for
the actions specified in paragraph (g) of this AD can be found in
Maintenance Review Board Report Document No. MRB 146-01, Issue 2,
Revision 19, dated August 2012.
    Note 5 to paragraph (g): An additional source of guidance for
the actions specified in paragraph (g) of this AD can be found in
BAE Systems (Operations) Limited Inspection Service Bulletin ISB.53-
237, Revision 1, dated April 2, 2013.

(h) Retained No Alternative Actions, Intervals, and/or Critical Design
Configuration Control Limitations (CDCCLs), With No Changes

    This paragraph restates the requirements of paragraph (j) of AD
2017-12-08, with no changes. Except as specified in paragraph (i) of
this AD: After accomplishing the revision required by paragraph (g)
of this AD, no alternative actions (e.g., inspections), intervals,
and/or CDCCLs may be used, unless the actions, intervals, and/or
CDCCLs are approved as an alternative method of compliance (AMOC) in
accordance with the procedures specified in paragraph (k)(1) of this
AD.

(i) New Maintenance or Inspection Program Revision

    Within 90 days after the effective date of this AD, revise the
existing maintenance or inspection program, as applicable, to
incorporate the information specified in Chapter 05 of BAe 146
Series/AVRO 146-RJ Series Aircraft Maintenance Manual, Revision 132,
dated August 18, 2021. The initial compliance time for doing the
tasks is at the time specified in Chapter 05 of BAe 146 Series/AVRO
146-RJ Series Aircraft Maintenance Manual, Revision 132, dated
August 18, 2021, or within 90 days after the effective date of this
AD, whichever occurs later. Accomplishing the revision required by
this paragraph terminates the actions required by paragraph (g) of
this AD.

(j) New No Alternative Actions, Intervals, or CDCCLs

    After the existing maintenance or inspection program has been
revised as required by paragraph (i) of this AD, no alternative
actions (e.g., inspections), intervals, or CDCCLs may be used unless
the actions, intervals, and/or CDCCLs are approved as an AMOC in
accordance with the procedures specified in paragraph (k)(1) of this
AD.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (l)(2) of
this AD. Information may be emailed to: [email protected].
    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (ii) AMOCs approved for AD 2017-12-08 are approved as AMOCs for
the corresponding provisions of this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or the Civil Aviation
Authority (CAA); or BAE Systems (Operations) Limited's CAA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) CAA AD G-2021-0011, dated October 8, 2021, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2021-1013.
    (2) For more information about this AD, contact Todd Thompson,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email [email protected].
    (3) For service information identified in this AD, contact BAE
Systems (Operations) Limited, Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; telephone +44 1292 675207; fax +44 1292 675704; email
[email protected]; internet http://www.baesystems.com/Businesses/RegionalAircraft/index.htm. You may view this service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 2200 South 216th St., Des Moines, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued on November 17, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-25464 Filed 11-22-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 105 (Friday, May 31, 2013)]
[Rules and Regulations]
[Pages 32556-32558]
[FR Doc No: 2013-12888]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0378]
RIN 1625-AA00

Safety Zone; 2013 Ocean City Air Show, Atlantic Ocean; Ocean
City, MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of the Atlantic Ocean in the vicinity of Ocean City,
MD to support the Ocean City Air Show. This action is intended to
restrict vessel traffic movement in the restricted area in order to
protect mariners from the hazards associated with air show events.

DATES: This rule is effective from June 6, 2013, at 10 a.m. until June
9, 2013, at 4 p.m. This rule will be enforced from 10 a.m. until 4 p.m.
daily between June 6, 2013, and June 9, 2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0378]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LCDR Hector Cintron, Waterways Management Division Chief,
Sector Hampton Roads, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this final rule without prior notice and
opportunity to comment pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the final details of the event were
not made known until recently. Therefore, publishing an NPRM would be
impracticable since immediate action is needed to provide for the
safety of life and property on navigable waters.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date would
be impracticable and contrary to the public interest since immediate
action is needed to ensure the safety of the event participants,
spectator craft, and other vessels transiting the event area.

B. Basis and Purpose

    From June 6, 2013, until June 9, 2013, Ocean City, MD will host an
air show event between Talbot Street and 33rd Street over the Atlantic
Ocean in Ocean City, MD. In recent years, there have been unfortunate
instances of jets and planes crashing during performances at air shows.
In addition, there is typically a wide area of scattered debris that
also damages property and could cause significant injury or death to
mariners observing the air shows. In order to protect mariners and the
public transiting the Atlantic Ocean immediately below the air show
from hazards associated with the air show, the Coast Guard is
establishing a safety zone.

C. Discussion of the Final Rule

    The Coast Guard is establishing a safety zone on specified waters
of the Atlantic Ocean bounded by the following coordinates:
38[deg],21',38'' N/075[deg],04',04'' W, 38[deg],21',27'' N/
075[deg],03',29'' W, 38[deg],19',35'' N/075[deg],04',19'' W,
38[deg],19',45'' N/075[deg],04',54'' W (NAD 1983) in the vicinity of
Ocean City, MD. This safety zone is effective from 10 a.m. on June 6,
2013, until 4 p.m. on June 9, 2013, and will be enforced daily between
the hours of 10 a.m. and 4 p.m. Access to the safety zone will be
restricted during the specified date and times. No person or vessel may
enter or remain in the safety zone except for vessels authorized by the
Captain of the Port or his Representative.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary. Although this
proposed regulation restricts access to the safety zone, the effect of
this rule will not be significant because: (i) The safety zone will be
in effect for a limited duration; (ii) the zone is of limited size; and
(iii) the Coast Guard will make notifications via maritime advisories
so mariners can adjust their plans accordingly.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 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 rule
will not have a significant economic impact on a substantial number of
small entities because the zone will only be in place for a limited
duration and maritime advisories will be issued allowing the mariners
to adjust their plans accordingly.
    This rule would affect the following entities, some of which might
be small entities: The owners and operators of vessels intending to
transit or anchor in that portion of the Atlantic Ocean from June 6,
2013, until June 9, 2013, between the hours of 10 a.m. and 4 p.m. each
day.

3. Assistance for Small Entities

    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 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
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

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

5. Federalism

    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 rule under that Order and

determined that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact 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.

7. 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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does 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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the establishment of a safety zone on
the navigable waters of the Atlantic Ocean in Ocean City, MD in order
to restrict vessel traffic movement to protect mariners from the
hazards associated with air show events. This rule is categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of the
Commandant Instruction. An environmental analysis checklist supporting
this determination and a Categorical Exclusion Determination will be
available in the docket where indicated under ADDRESSES.

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 amends
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:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6 and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.
0
2. Add Sec.  165.T05-0378 to read as follows:

Sec.  165.T05-0378  Safety Zone; Ocean City Air Show, Atlantic Ocean,
Ocean City, MD.

    (a) Regulated area. The following area is a safety zone: Specified
waters of the Captain of the Port Sector Hampton Roads zone, as defined
in 33 CFR 3.25-10, in the vicinity of the Atlantic Ocean in Ocean City,
MD bound by the following coordinates: 38[deg],21',38'' N/
075[deg],04',04'' W, 38[deg],21',27'' N/075[deg],03',29'' W,
38[deg],19',35'' N/075[deg],04',19'' W, 38[deg],19',45'' N/
075[deg],04',54'' W (NAD 1983).
    (b) Definition. For the purposes of this part, Captain of the Port
Representative means any U.S. Coast Guard commissioned, warrant or
petty officer who has been authorized by the Captain of the Port,
Hampton Roads, Virginia to act on his behalf.
    (c) Regulations. (1) In accordance with the general regulations in
165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port, Hampton Roads or his designated
representatives.
    (2) The operator of any vessel in the immediate vicinity of this
safety zone shall:
    (i) Stop the vessel immediately upon being directed to do so by any
commissioned, warrant or petty officer on shore or on board a vessel
that is displaying a U.S. Coast Guard Ensign.
    (ii) Proceed as directed by any commissioned, warrant or petty
officer on shore or on board a vessel that is displaying a U.S. Coast
Guard Ensign.
    (3) The Captain of the Port, Hampton Roads can be reached through
the Sector Duty Officer at Sector Hampton Roads in Portsmouth, Virginia
at telephone Number<PHONE_NUMBER>.
    (4) The Coast Guard Representatives enforcing the safety zone can
be contacted on VHF-FM marine band radio channel 13 (165.65 Mhz) and
channel 16 (156.8 Mhz).
    (d) Enforcement period. This regulation will be enforced from June
6, 2013 until June 9, 2013 between the hours of 10 a.m. and 4 p.m. each
day.

    Dated: May 13, 2013.
John K. Little,
Captain, U.S. Coast Guard, Captain of the Port Hampton Roads.
[FR Doc. 2013-12888 Filed 5-30-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: March 28, 2008 (Volume 73, Number 61)]
[Notices]
[Page 16676-16677]
[DOCID:fr28mr08-75]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0162; FRL-8355-5

Pesticide Products; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces receipt of an application to register a
pesticide product containing a new active ingredient not included in
any currently registered products pursuant to the provisions of section
3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended.

DATES: Comments must be received on or before May 27, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0162, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0162. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. 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 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 telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Jeannine Kausch, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.

    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA received the application as follows to register a pesticide
product containing an active ingredient not included in any previously
registered products pursuant to the provision of section 3(c)(4) of
FIFRA. Notice of receipt of this application does not imply a decision
by the Agency on the application.

Product Containing a New Active Ingredient not Included in any
Previously Registered Product

    File Symbol: 84863-R. Applicant: BioNext sprl, Passage des
deportes, 2, B-5030 Gembloux, Belgium, submitted by SynTech Global,
LLC, P.O. Box 640, Hockessin, DE 19707. Product name: NEXY.
Biofungicide. Active ingredient: Candida oleophila strain O at 57%.
Proposal classification/Use: Post-harvest control of grey and blue mold
on apples and pears.

List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: March 19, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. E8-6266 Filed 3-27-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: December 18, 2007 (Volume 72, Number 242)]
[Proposed Rules]
[Page 71606-71607]
[DOCID:fr18de07-7]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-29372; Airspace Docket No. 7-ASW-09]

Proposed Establishment of Class D Airspace; New Braunfels, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: This action proposes to establish Class D airspace at New
Braunfels, TX. The establishment of an air traffic control tower at New
Braunfels Municipal Airport, TX has made this action necessary for the
safe control of aircraft within this airspace.

DATES: Comments must be received on or before February 1, 2008.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. You
must identify the docket number FAA-2007-29372/Airspace Docket No. 7-
ASW-09, at the beginning of your comments. You may also submit comments
on the Internet at http://www.regulations.gov. You may review the

public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527) is on the ground floor of the building at
the above address.

FOR FURTHER INFORMATION CONTACT: Rich Hall, Central Service Center,
System Support Group, Federal Aviation

Administration, Southwest Region, Fort Worth, TX 76193-0530; at
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No: FAA-2007-29372/
Airspace Docket No. 7-ASW-09.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov Recently published rulemaking documents can also be accessed through the FAA's Web page at http://.

www.faa.gov or the Superintendent of Document's Web page at http://www.access.gpo.gov/nara
.

    Additionally, any person may obtain a copy of this notice by
submitting a request to the Federal Aviation Administration (FAA),
Office of Air Traffic Airspace Management, ATA-400, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.
Communications must identify both docket numbers for this notice.
Persons interested in being placed on a mailing list for future NPRM's
should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR) part 71 by establishing a Class D airspace area extending
upward from the surface to and including 2,700 feet MSL within a 4.1-
mile radius of New Braunfels Municipal Airport, TX. The establishment
of an air traffic control tower has made this action necessary. The
intended effect of this proposal is to provide controlled airspace for
flight operations at New Braunfels Municipal Airport, TX. The area
would be depicted on appropriate aeronautical charts.
    Class D airspace areas are published in Paragraph 5000 of FAA Order
7400.9R, dated August 15, 2007, and effective September 15, 2007, which
is incorporated by reference in 14 CFR 71.1. The Class D airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
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
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    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 the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
since it improves the safety of aircraft executing IFR procedures at
New Braunfels Municipal Airport, TX.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9R, Airspace Designations and
Reporting Points, dated August 15, 2007, and effective September 15,
2007, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASW TX D New Braunfels, TX [New]

New Braunfels Municipal Airport, TX
    (Lat. 29[deg]42'16'' N., long. 98[deg]02'32'' W.)

    That airspace extending upward from the surface to and including
2,700 feet MSL within a 4.1-mile radius of New Braunfels Municipal
Airport. This Class D airspace area is effective during the specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.
* * * * *

    Issued in Fort Worth, TX, on December 5, 2007.
Rick Farrell,
Acting Manager, System Support Group, ATO Central Service Center.
[FR Doc. 07-6066 Filed 12-17-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34672-34677]
[FR Doc No: 2015-14880]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1794]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Impact of Ad Exposure
Frequency on Perception and Mental Processing of Risk and Benefit
Information in Direct-to-Consumer Prescription Drug Ads

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 July
17, 2015.

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_ADDRESS>All
comments should be identified with the OMB control number 0910-New and
title ``Impact of Ad Exposure Frequency on Perception and Mental
Processing of Risk and Benefit Information in Direct-To-Consumer
Prescription Drug Ads.'' Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Impact of Ad Exposure Frequency on Perception and Mental Processing of
Risk and Benefit Information in Direct-to-Consumer Prescription Drug
Ads; OMB Control Number 0910-NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the FD&C Act.
    In a typical promotional campaign, consumers may be exposed to a
direct-to-consumer (DTC) prescription drug ad any number of times.
Perceptual and cognitive effects of increased ad exposure frequency
have been studied extensively using non-drug ads. For instance, one
study demonstrated that a commercial message repeated twice generates
better recall than a message broadcast only once (Ref. 1). Another
study demonstrated that increased ad exposures improve product
attitudes and recall for product attributes, particularly when the
substance of the repeat messages is varied (Ref. 2). Generally, it has
been argued that first exposure to an ad results in attention, second
exposure affects learning of the advertised message, and third and

subsequent exposures reinforce the learning effects of the second
exposure (Ref. 3). To our knowledge, the literature concerning ad
exposure frequency has not been extended to include specific attention
to prescription drug ads. Prescription drug ads are unique in that they
are required to provide both benefit and risk information whereas other
ad types tend to include only benefit information. The Office of
Prescription Drug Promotion (OPDP) plans to examine the effects of
variation in ad exposure frequency on perception and mental processing
of risk and benefit information in DTC prescription drug ads through
empirical research.
    The main study will be preceded by up to two pretests designed to
delineate the procedures and measures used in the main study. Across
pretests and the main study, participants will be individuals who have
been diagnosed with seasonal allergies. All participants will be 18
years of age or older. We will exclude individuals who work in
healthcare or marketing settings because their knowledge and
experiences may not reflect those of the average consumer. Participants
will be recruited in one of two geographic locations (Washington, DC
and Raleigh, North Carolina) for in-person administration of protocols.
    The experimental design is summarized below. Participants will be
randomly assigned to view a prescription drug ad one, two, or four
times as part of clutter reels embedded in 42 minutes of TV
programming. They will then answer preprogrammed survey questions on
laptops. Measures are designed to assess perception, memory, judgments
about the ad, intentions to use the medication advertised, and possible
moderators of effects, such as need for cognition and demographics. The
questionnaire is available upon request.

                                                                  Table 1--Study Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Episode #1                                                  Episode #2
     Experimental arm number     -----------------------------------------------------------------------------------------------------------------------
                                    Clutter Reel 1      Clutter Reel 2      Clutter Reel 3      Clutter Reel 4      Clutter Reel 5      Clutter Reel 6
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 (views ad 1 time).............  ..................  ..................  ..................  ..................  ..................  Mock DTC ad
2 (views ad 2 times)............  ..................  ..................  Mock DTC ad.......  ..................  ..................  Mock DTC ad
3 (views ad 4 times)............  Mock DTC ad.......  ..................  Mock DTC ad.......  Mock DTC ad.......  ..................  Mock DTC ad
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In the Federal Register of November 12, 2014 (79 FR 67172), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received five public submissions. In the
following section, we outline the observations and suggestions raised
in the comments and provide our responses. Comments that are not PRA-
relevant (e.g., ``Ban DTC'') or do not relate to the proposed study are
not included below or addressed in our responses.
    (Comment from Valeant Pharmaceuticals) Develop and publish a
strategic plan for how FDA will collate and make use of data from all
FDA-sponsored studies concerning consumer and physician perception and
comprehension of prescription drug advertising and promotion.
    (Response) The OPDP research Web page (Ref. 4) has recently been
updated to reflect the current status of completed and ongoing
research. As stated on our Web page, OPDP maintains an active research
program designed to investigate applied and theoretical issues in the
communication of risk and benefit information in DTC and professional
promotional prescription drug materials. OPDP's research supports FDA's
goal of science-based policy while maintaining its commitment to
protect the public health. The research provides FDA management with
evidence that can be considered along with other relevant research in
future policy decisions.
    (Comment from Valeant Pharmaceuticals) Provide data to confirm
limiting the study recruitment to Washington, DC and Raleigh Durham, NC
area is representative of the entire United States.
    (Response) The research questions examined in this study (e.g.,
risk and benefit recall as a function of the number of target ad
exposures) are believed to apply to human judgment and decision making
and not to be contingent upon geographic residence. We acknowledge that
collecting data across a greater number of geographic locations may
provide value, but choose to allocate our limited funding in ways we
believe more appropriately ensure the integrity of the research. For
example, the requirement that participants view 60 minutes of
programming led us to collect data in person, which allows for us to
supervise participant engagement with the survey and therefore ensure
that stimuli are, in fact, viewed. Although the current research
includes limited geographic diversity, note that other forms of
diversity (e.g., gender, age, and race) will be sought during
recruitment and accounted for in our analyses.
    (Comment from Valeant Pharmaceuticals) Six exposures during the
same 42-minute television program are not reflective of how advertising
is delivered and could inadvertently bias the results.
    (Response) The study design has been revised such that the
experimental groups will view the ad one, two, or four times over the
course of the 60-minute viewing period. Additional details about this
change are provided in later responses.
    (Comment from Valeant Pharmaceuticals) Consumer comprehension of
benefit and risk is not solely based on the viewing of the DTC TV ad in
isolation. Consumer comprehension should take into account the role of
the healthcare professional and other materials.
    (Response) We appreciate that consumer judgment and decision making
often results from multiple information sources. In many cases, DTC TV
ads serve as the first source of information received, and therefore
may influence whether or not additional information is sought, and
ultimately whether or not a product is requested from a healthcare
professional. Through broad research on DTC advertising, we seek to
ensure that consumers are appropriately informed about the risks and
benefits of prescription drugs across all information sources, when
viewed in isolation or in combination with other sources.
    (Comment from Valeant Pharmaceuticals) Because the study is limited
to one DTC TV ad and one therapeutic area, the results should not be
broadly applied to other forms of advertising or other therapeutic
areas.
    (Response) We agree that results should not be broadly applied to
other forms of advertising. We do not agree that results necessarily
need be restricted to the selected therapeutic

area. Our primary research question for the study is whether increasing
ad exposure frequency will result in different risk or benefit
perceptions than less exposure to the ad. This question pertains to
human perception and judgment and is not thought to be unique to any
particular therapeutic area. Nonetheless, we agree that replication of
this research using other forms of advertising and different
therapeutic areas would be valuable.
    (Comment from Abbvie) It is not clear how the proposed collection
is necessary for the proper performance of FDA's functions. It is
difficult to ascertain how the Agency will utilize the results of this
study within its statutory authority. For example, should the results
of this study demonstrate that the frequency of ad exposure matters,
how would the Agency modify the airing frequency of DTC TV ads or the
frequency at which consumers are exposed to the advertisements in a
real world setting? Rather than conduct this study, we suggest that FDA
resources and taxpayer dollars would be better directed to research
that enhances the quality of how we communicate benefit and risk
information to consumers regardless of the medium and the frequency of
the exposure. Guidance is needed on the best practices for
communicating benefit and risk information to consumers who are
prescribed prescription drugs. This is particularly important as the
quality of the communication has the power to result in a better
informed consumer.
    (Response) This research reflects the need to understand not only
the message that consumers receive, but also the delivery of those
messages, and how that delivery influences perception, judgment, and
decision making. It may be that full comprehension of benefit
information is achieved upon a single exposure, whereas full
comprehension of risk information requires multiple exposures. Insight
on this topic may allow FDA to make more informed judgments regarding
consumer information processing of DTC television ads.
    (Comment from Abbvie) Should the Agency proceed with this study,
FDA could enhance the quality, utility, and clarity of the information
to be collected by avoiding introducing bias into the way the survey is
conducted. For example, in the draft survey (version 10.22.14), FDA
creates an artificial setting in which participants are instructed to
watch the commercials that air during a 90-minute TV program during
which the same ad airs three to six times. This is very different from
the airing and viewing frequency of DTC ads that occur today. Hence, we
question the applicability of the results of this study to a real world
setting.
    (Response) Please note that stimuli play for 60 minutes (not 90),
and that the original design involved airing of the ad one, three, or
six times (not three to six). We appreciate that six viewings would be
unusual and so the study design has been revised such that the
experimental groups will view the ad one, two, or four times over the
course of the 60-minute viewing period. Additional details about this
change are provided in later responses.
    (Comment from Eli Lilly) The FDA sample does not currently include
a ``General Population'' control group, as all participants will be
screened to qualify when identified as suffering from seasonal
allergies, a condition that could be relieved by the drug described in
advertisement. It may be helpful to the FDA's analysis plan to include
a control group.
    (Response) Researching each medical condition, or general
population sample, requires significant resources. We are committed to
conducting this research using our available resources while ensuring
the integrity of the research by collecting data on a high prevalence
condition for which participants might be thought of as sufficiently
representative of the average consumer, thus allowing us to draw
conclusions about broad perceptual and cognitive processing outcomes.
    (Comment from Eli Lilly) In the proposed study design, respondents
will watch a 42-minute television program with an embedded clutter reel
of ads. Within this time period, respondents will be exposed to a drug
ad 1, 3, or 6 times and then administered a survey instrument. While we
acknowledge that a consumer can be exposed to an ad 6 times or more, we
do not believe 6 exposures in such a compressed time period represents
a reasonable real-world experience and is likely to overstate consumer
reaction, particularly given that such reactions will be tested
immediately after viewing. We believe the current design imposes a risk
of creating artificial differences between the study arms by skewing
perception, judgment, retention of information, intent, etc.,
ultimately leading to erroneous conclusions and unactionable
expectations.
    Specifically, research data on multiple ad exposures and
``effective frequency'' is long established. Based upon multiple
studies, experience, and client preference across industries, a leading
global media-buying firm with whom we work generally adheres to two (2)
``units'' per hour as its standard (i.e. a broadcast advertisement is
delivered to the intended audience in a single program no more than
twice each hour). While there may be occasions where some advertisers
allow for increased frequency (such as holiday weeks or the like), the
norm tends to gravitate to no more than two per hour. This implies that
in the consumer packaged goods space, 6 exposures in a 42-minute
television program exceeds standard practice. In the drug advertising
category, that level of exposure would be well beyond reasonable
expectations.
    We recommend that FDA limit study arms to more realistic scenarios
(e.g. 1, 2, and 3 exposures) or, alternatively, to spread out the
higher frequency arm (e.g. 6) over a longer study period, preferably
with a longitudinal design, to more closely represent how consumers
receive and process information in a real-world environment.
    (Response) We appreciate this insight. The study design has been
revised such that the experimental groups will view the ad one, two, or
four times over the course of the 60-minute viewing period. We consider
the one and two exposure conditions to be realistic. The four-exposure
condition, while limited in its ecological validity, allows for
experimental examination of ``excessive'' exposures, which may be
associated with outcomes such as consumer wearout; that is,
deterioration or diminishment of effects of ad repetition on mental
processing after a certain amount of exposure. Also, it is important to
note that in studying advertising effects, it is necessary to create
enough difference in the manipulations between experimental groups to
allow for variation in outcomes to be detected. Given the laboratory
setting, it is not possible to extend the viewing period longer than 1
hour without significantly increasing the burden on respondents.
    (Comment from Eli Lilly) We were unable to determine if the study
arms that will see multiple exposures will be exposed to the same
version of the ad or variations of the ad. We recommend utilizing the
same version of the ad for consistency between the study arms.
    (Response) These participants will view the same ad across all
exposures.
    (Comment from Eli Lilly) In the pre-stimulus instructions/
disclosure section, we recommend removing ``on behalf of a public
health agency.'' This language may trigger the respondent, who would
see it before being exposed to the clutter reel, to be on the alert for
health-related content and create bias that is not accurate in a real-
world setting.

    (Response) We agree with this concern. This language has been
revised to ``on behalf of a government agency.''
    (Comment from Eli Lilly) In the post-stimulus/survey instrument
instructions section, we recommend removing references to (a) ``a drug
ad'' and, (b) specific product name. Introducing this language provides
the name of the product they are asked to identify in the first survey
instrument question. It may also create unnecessary bias by identifying
for the respondent the subject of the survey instrument.
    (Response) These references have been removed.
    (Comment from Eli Lilly) We recommend combining Questions 6 and 7
(risks and benefits) and randomizing the order. We believe this will
more accurately represent recall rather than grouping risks together
and benefits together.
    (Response) In natural settings, consumers may think about drug
benefits and risks simultaneously or separately. We argue that there
are empirical advantages to collecting data on these measures
separately. There is literature to suggest personally relevant
threatening information may be defensively processed (Refs. 5, 6, and
7) and thus processed differently than benefit information. We prefer
to compare responses to benefit and risk items to one another, and
combining them into one question would hinder this analysis. Moreover,
note that in related literature, these constructs are typically
measured with independent scales, or at least independent scales within
a single scale. This assessment is based on an ongoing literature
review concerning item and scale measure development.
    Additionally, splitting these measures reduces psychological burden
on participants. It is believed to be easier for participants to
respond to seven items concerning benefits in one matrix, followed by
seven items concerning risks in another matrix, than for participants
to respond to 14 items about both benefits and risks in a single
matrix. Omitting items would reduce our ability to adequately measure
either benefits or risks. Relatedly, collecting data on benefits and
risks separately may increase the likelihood that participants take
time to process each item and respond accurately.
    (Comment from Eli Lilly) We recommend adding a ``Don't Know''
answer choice for Questions 9, 10, and 13 as respondents may be unable
to assess the likelihood or seriousness of side effects, or
effectiveness of the product. The current range of answers may force
inaccurate or speculative responses; a ``Don't Know'' answer would be a
legitimate choice and informative for the study. Our standard practice
is to provide a ``Don't Know'' option whenever it could be a valid
answer.
    (Response) We understand the value of providing such responses for
items of a factual nature. The drawback to providing such response
options to these questions, however, is that we may lose information by
allowing respondents to choose an easy response instead of giving the
item some thought. Research by Krosnick et al. (Ref. 8) demonstrated
that providing ``no opinion'' options likely results in the loss of
data without any corresponding increase in the quality of the data.
Thus, we prefer not to add these options to the survey.
    (Comment from Eli Lilly) We recommend randomizing the answers to
Question 15 to avoid order bias. We note that the answer choices are in
sequence of probable behavior after being informed by advertising.
    (Response) Indeed, ordering of items was chosen to reflect sequence
of probable behavior after being informed by advertising. We believe
maintaining this continuum most appropriately reflects decision making
on the part of the consumer. Moreover, we have conducted surveys both
with and without randomizing these items, and no differences in
responses were observed.
    (Comment from Eli Lilly) For Question 16, we suggest explicitly
stating ``after being prescribed by a doctor'' to the end of the
question. The question currently does not provide this context, leaving
respondents to interpret whether or not they are to consider how they
feel about ``taking'' Drug X without guidance from a learned
intermediary. We believe this may render the data on this question
ambiguous.
    (Response) We have incorporated this suggestion into the revised
questionnaire.
    (Comment from Eli Lilly) For Questions 20 a and b, we suggest
spelling out ``FDA.''
    (Response) We have incorporated this suggestion into the revised
questionnaire.
    (Comment from Eli Lilly) For Questions 20 a and c, we recommend
eliminating the adverb ``extremely'' as it may create ambiguity. It
would be reasonable for some people to answer ``false'' to ``extremely
effective'' while also believing simply ``effective'' was true, while
other respondents may not see a distinction. This may skew the data
artificially toward ``false.''
    (Response) Indeed, participants may respond differently depending
on whether or not the adverb ``extremely'' is included. The item is
designed to assess perceptions of whether only extremely effective
products are approved by the FDA (likewise, only ``serious'' risks are
assessed in Q20b and Q20d.) We prefer to retain this item because it
captures the intended outcome we wish to measure, whereas an item that
excludes the adverb ``extremely'' would not. Also note that these items
have been previously published elsewhere and we prefer to match the
original language (Ref. 9).
    (Comment from Eli Lilly) We recommend eliminating Question 20 g,
which seems redundant with 20 f. If respondents were to answer False
for 20 f but True for 20 g, it would provide no insight but could skew
perceptions of the data. If the question is retained, we recommend
eliminating the word ``in'' (i.e. ``believe in''), which in this
context may connote a broader judgment about the drug industry, for
which there is ample existing data, than of the regulatory oversight of
drug advertisements. The language creates bias by implying that
misleading information is embedded in drug ads, skewing the data toward
``false.''
    (Response) We have deleted Q20g, and modified Q20f as follows:
``All of the information in prescription drug commercials is approved
by the U.S. Food and Drug Administration.'' In addition, we have added
the following items: ``All of the benefit information in prescription
drug commercials is approved by the U.S. Food and Drug
Administration,'' and ``All of the risk information in prescription
drug commercials is approved by the U.S. Food and Drug
Administration.''
    (Comment from Eli Lilly) For Question 20 h, we recommend changing
the word ``safest'' to ``safe,'' which may force respondents to make a
subjective judgment about what constitutes ``safest'' (i.e. is there a
set of safest, or simply the single-most safest drug?) even though they
may believe that all advertised drugs have been deemed to be safe. This
may strongly skew data toward ``false.''
    (Response) We appreciate that asking about ``safest'' versus
``safe'' drugs will likely result in different responses. We prefer to
retain the current language because it captures the intended outcome we
wish to measure. Nonetheless, we will be careful to restrict our
interpretation of findings pertaining to this question based on these
potential differences in responding.

    (Comment from Eli Lilly) Questions 21 a and b seem to be leading
questions that may strongly bias respondents to presuppose that the ad
is misleading and that the survey instrument is simply trying to
understand the extent to which it is misleading. We acknowledge that
the answer choices allow respondents to select ``not at all
misleading,'' but four-fifths of the answer options represent degrees
of ``misleading,'' which may create strong response bias. Although 21 c
provides the alternative question, by the time the respondents reach
this question they will have been biased by the previous two questions
that the ad is misleading, skewing the data toward ``not truthful.'' We
recommend this section be revised.
    (Response) These three items were included in the survey for the
purposes of cognitive testing. Results from cognitive testing suggest
that participants have difficulty answering the question about
``truthful'' because they feel they do not know the truth. They
generally provide the same answer to both questions that ask about how
misleading the ad is. We therefore will omit questions 21a and 21c.
    (Comment from Eli Lilly) For Questions 24 and 25, we recommend
adding ``or difficult'' to the question to minimize biasing respondents
that the product is ``easy'' to use and to make the question and answer
choices consistent.
    (Response) We have incorporated this suggestion into the revised
questionnaire.
    (Comment from Eli Lilly) We are concerned that Question 27 has
potential to create bias and to confuse respondents. It contains
language that may trigger respondents to believe they should be
``concerned'' to some extent. The question language combined with the
inference of doctor's involvement is potentially confusing. We suggest
revising this question, perhaps to something more simple like: ``If you
were considering taking [Drug X], how would you feel about the side
effects mentioned in the ad?''
    (Response) The suggested revised version of Q27 points out to
participants that the ad notes side effects and so also ``biases''
participants but in a slightly different way. The core assumption that
there are always side effects to be considered in some form seems
sufficiently reflective of contemporary DTC prescription drugs and thus
we prefer not to change the language.
    (Comment from Eli Lilly) For Question 28, we recommend using
``Neither Agree nor Disagree'' as the midpoint of the scale, consistent
with previous scale language in the survey instrument.
    (Response) This measure of need for cognition has been published
and validated in the literature (Ref. 10). Thus, we prefer not to
change the wording.
    (Comment from Eli Lilly) Question 28 b is potentially unclear. We
recommend revising the question.
    (Response) This measure of need for cognition has been published
and validated in the literature. Thus, we prefer not to change the
wording.
    (Comment from Eli Lilly) Question 29 seems to have an omitted word.
We recommend revising to: ``How confident are you about filling out
medical forms by yourself?''
    (Response) This is an item that has been used in the literature,
and thus we prefer not to change the wording (Ref. 11).
    (Comment from Eli Lilly) We recommend revising Question 31 by
deleting or amending the language ``Below are statements other people
have made about their medications.'' This language appears unnecessary
and may bias respondents by implying that, because the statements are
included in the survey instrument, they are truthful and may warrant
the respondents to feel that way to some extent.
    (Response) This item has been validated in the literature (Ref. 12)
and thus we prefer not to change the language.
    (Comment from Eli Lilly) Also for Question 31, we recommend using
``Neither Agree nor Disagree'' as the language midpoint of the scale,
consistent with previous scale language in the survey instrument.
    (Response) This item is from the Beliefs in Medicines
Questionnaire. This item has been validated in the literature and thus
we prefer not to change the language.
    (Comment from Eli Lilly) In Questions 35 and 36, we believe there
could be variability in consumers' definition of what constitutes
``serious'' side effect without additional definition. We recommend the
survey design consider providing additional context for the consumer in
the question wording.
    (Response) We agree there is likely to be variability in how
consumers define serious side effects. We examined these items in
cognitive testing. Based on results from that cognitive testing,
respondents generally define ``serious'' side effects as those that
require medical attention or that are life threatening. It does not
seem that respondents have trouble answering this question.
    To examine differences between experimental conditions, we will
conduct inferential statistical tests such as analysis of variance.
With the sample size described below, we will have sufficient power to
detect small-to-medium sized effects in the main study.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Pretest 1 screener completes               1,050               1           1,050    .08 (5 min.)              84
 (assumes 10% eligible).........
Pretest 2 screener completes               1,050               1           1,050    .08 (5 min.)              84
 (assumes 10% eligible).........
Number of main study screener               6000               1            6000    .08 (5 min.)             480
 completes (assumes 10%
 eligible)......................
Pretest 1 completes \2\.........             125               1             125             1.5             188
Pretest 2 completes \2\.........             125               1             125             1.5             188
Number of completes, main study              620               1             620             1.5             930
 \2\............................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,954
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Note: While target sample sizes for pretests are 105 and for main study is 600, we have accounted for some
  potential overage in the burden table. As data is being collected in two locations simultaneously, it may be
  possible that the target will be exceeded if alternates are included in order to try to achieve the target.

References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site address in this reference section, but we are
not responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)

    1. Singh, S. N., D. Linville, and A. Sukhdial, ``Enhancing the
Efficacy of Split Thirty-Second Television Commercials: An Encoding
Variability Application,'' Journal of Advertising, 24, pp. 13-23
(1995).
    2. Haugtvedt, C. P., et al., ``Advertising Repetition and
Variation Strategies: Implications for Understanding Attitude
Strength,'' Journal of Consumer Research, 21, pp. 176-189 (1994).
    3. Naples, M. J., ``Effective Frequency: Then and Now,'' Journal
of Advertising Research, 37, pp. 7-12 (1997).
    4. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090276.htm.
    5. Janis, I. L. and S. Feshbach, ``Effects of Fear-Arousing
Communications,'' Journal of Abnormal and Social Psychology, 48, pp.
78-92 (1953).
    6. Liberman, A. and S. Chaiken, ``Defensive Processing of
Personally Relevant Health Messages,'' Personality and Social
Psychology Bulletin, 18, pp. 669-679 (1992).
    7. Smith, S. M. and R. E. Petty, ``Message Framing and
Persuasion: A Message Processing Analysis,'' Personality and Social
Psychology Bulletin, 22, pp. 257-268 (1996).
    8. Krosnick, J. A., A. L. Holbrook, M. K. Berent, et al., ``The
Impact of `No Opinion' Response Options on Data Quality: Non-
Attitude Reduction or an Invitation to Satisfice?'' Public Opinion
Quarterly, 66, pp. 371-403 (2002).
    9. Woloshin, S. and L. M. Schwartz, ``Communicating Data About
the Benefits and Harms of Treatment: A Randomized Trial,'' Annals of
Internal Medicine, 155, pp. 87-96 (2011).
    10. Cacioppo, J. T. and R. E. Petty, ``The Efficient Assessment
of Need for Cognition,'' Journal of Personality Assessment, 48, pp.
306-307 (1984).
    11. Chew, L. D., J. M. Griffin, M. R. Partin, et al.,
``Validation of Screening Questions for Limited Health Literacy in a
Large VA Outpatient Population,'' Journal of General Internal
Medicine, 23, pp. 561-566 (2008).
    12. Horne, R., J. Weinman, and M. Hankins, ``The Beliefs About
Medicines Questionnaire: The Development and Evaluation of a New
Method for Assessing the Cognitive Representation of Medication,''
Psychology & Health, 14, pp. 1-24 (1999).

    Dated: June 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14880 Filed 6-16-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 12 (Thursday, January 18, 2018)]
[Notices]
[Pages 2627-2628]
[FR Doc No: 2018-00751]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 2593-000; 2823-000]

Algonquin Power (Beaver Falls), LLC; Notice of Authorization for
Continued Project Operation

    On December 30, 2015, Algonquin Power (Beaver Falls), LLC, licensee
for the Upper Beaver Falls Hydroelectric Project No. 2593 and the Lower
Beaver Falls Hydroelectric Project No. 2823, filed a joint application
for subsequent license \1\ pursuant to the Federal Power Act (FPA) and
the Commission's regulations thereunder. Both projects are located on
the Beaver River in the towns of Croghan and New Bremen in Lewis
County, New York.
---------------------------------------------------------------------------

    \1\ The Commission issued a minor license for the Upper Beaver
Falls Project on April 19, 1985 (expiring December 31, 2017), and
for the Lower Beaver Falls Project on October 18, 1979 (expiring
September 30, 2019). On June 8, 2012, the licensee requested to
accelerate expiration of the Lower Beaver Falls Project license term
to December 31, 2017, in order to coordinate relicensing proceedings
for both projects, which the Commission granted on October 10, 2012.
In its December 30, 2015, license application, Algonquin Power
(Beaver Falls), LLC proposes to combine both minor projects into a
single, major project under 5 megawatts. However, the current
licenses for both projects are minor licenses where the
applicability of section 15 of the FPA was waived.
---------------------------------------------------------------------------

    The license terms for Project Nos. 2593 and 2823 ended on December
31, 2017. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires
the Commission, at the expiration of a license term, to issue from
year-to-year an annual license to the then licensee under the terms and
conditions of the prior license until a new license is issued, or the
project is otherwise disposed of as provided in section 15 or any other
applicable section of the FPA. If the project's prior license waived
the applicability of section 15 of the FPA, then, based on section 9(b)
of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth
at 18 CFR 16.21(a), if the licensee of such project has filed an
application for a subsequent license, the licensee may continue to
operate the project in accordance with the terms and conditions of the
license after the minor or minor part license expires, until the
Commission acts on its application. If the licensee of such a project
has not filed an application for a subsequent license, then it may be
required, pursuant to 18 CFR 16.21(b), to continue project operations
until the Commission issues someone else a license for the project or
otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 2593 is issued to
the licensee for a period effective January 1, 2018 through December
31, 2018 or until the issuance of a new license for the project or
other disposition under the FPA, whichever comes first. If issuance of
a new license (or other disposition) does not take place on or before
December 31, 2018, notice is hereby given that, pursuant to 18 CFR
16.18(c), an annual license

under section 15(a)(1) of the FPA is renewed automatically without
further order or notice by the Commission, unless the Commission orders
otherwise.
    If the projects are not subject to section 15 of the FPA, notice is
hereby given that the licensee, Algonquin Power (Beaver Falls), LLC, is
authorized to continue operation of the Upper Beaver Falls and Lower
Beaver Falls Hydroelectric Projects, until such time as the Commission
acts on its license application.

    Dated: January 11, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-00751 Filed 1-17-18; 8:45 am]
 BILLING CODE 6717-01-P