[Federal Register: March 25, 2008 (Volume 73, Number 58)]
[Proposed Rules]
[Page 15678-15681]
[DOCID:fr25mr08-12]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0353; Directorate Identifier 2007-CE-101-AD]
RIN 2120-AA64

Airworthiness Directives; Hawker Beechcraft Corporation Model 390
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Hawker Beechcraft Corporation Model 390 airplanes. This
proposed AD would require you to repetitively do a post-flight check
(owner/operator holding at least a private pilot certificate checking
for residual heat in the angle-of-attack (AOA) probes or an
appropriately-rated mechanic doing a maintenance manual operational
test of the heat of the AOA probes) after every flight and replace or
modify (upload software) the stall warning AOA transmitters. This
proposed AD results from reports of the potential for unannunciated
loss of the heating function in the left-hand (LH) and right-hand (RH)
stall warning AOA transmitters of Model 390 airplanes. We are proposing
this AD to correct potentially inadequate stall warning with loss of
stick pusher function.

DATES: We must receive comments on this proposed AD by May 27, 2008.

ADDRESSES: Use one of the following addresses to comment on this
proposed AD:
     Federal eRulemaking Portal: Go to http://
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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Hawker Beechcraft Corporation, 9709 East Central, Wichita, Kansas
67291; telephone:<PHONE_NUMBER> or<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Philip Petty, Aerospace Engineer,
Wichita Aircraft Certification Office, 1801 Airport Road, Room 100,
Wichita, Kansas 67209; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments regarding this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include the docket number, ``FAA-
2008-0353; Directorate Identifier 2007-CE-101-AD'' at the beginning of
your comments. We specifically invite comments on the overall
regulatory, economic, environmental, and energy aspects of the proposed
AD. We will consider all comments received by the closing date and may
amend the proposed AD in light of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive concerning this proposed AD.

Discussion

    We have received reports of the potential for unannunciated loss of
the heating function in the LH/RH stall warning AOA transmitters of
Model 390 airplanes. The current AOA transmitter software may not
always annunciate certain failure modes of the probe or case heating
circuits.
    This condition, if not corrected, could result in potentially
inadequate stall warning with loss of stick pusher function.

Relevant Service Information

    We have reviewed Hawker Beechcraft Mandatory Service Bulletin No.
SB 27-3787, issued: May 2007; and Raytheon Aircraft Company Temporary
Change to the FAA Approved Airplane Flight Manual P/N 390-590001-
0003CTC7, issued: March 15, 2007. The service information describes
procedures for the replacement/modification of the stall warning AOA
transmitters. The airplane flight manual (AFM) describes procedures for
doing a post-flight check. This post-flight check can be either the
pilot checking for residual heat in the AOA probes as part of the
shutdown procedure or, alternatively, having the AOA probe heat
operational test maintenance manual procedure done by an appropriately-
rated mechanic.

FAA's Determination and Requirements of the Proposed AD

    We are proposing this AD because we evaluated all information and
determined the unsafe condition described previously is likely to exist
or develop on other products of the same type design. This proposed AD
would require a repetitive post-flight check for residual heat in the
AOA probes or a maintenance manual operational test of the heat of the
AOA probes after every flight and replace or modify (upload software)
the stall warning AOA transmitters. Replacement or modification (upload
software) of the stall warning AOA transmitters terminates the
repetitive requirement to do the post-flight action.

Costs of Compliance

    We estimate that this proposed AD would affect 152 airplanes in the
U.S. registry.
    We estimate the following costs to incorporate and remove the
temporary change to the AFM.

------------------------------------------------------------------------
                                                          Total cost per
            Labor cost                  Parts cost           airplane
------------------------------------------------------------------------
0.5 work-hour x $80 per hour =     Not Applicable......             $40
 $40.
------------------------------------------------------------------------

    We estimate that the proposed post-flight residual heat check
requires about 3 minutes to do. We estimate the following costs to do
10 of the proposed post-flight residual heat checks. We have no way of
determining the number of airplanes that would have this post-flight
residual heat check, or how many times this will need to be performed
before the terminating action is done:

------------------------------------------------------------------------
 Labor cost to do 10 post-flight                          Total cost per
       residual heat checks             Parts cost           airplane
------------------------------------------------------------------------
0.5 work-hour x $80 per hour =     Not Applicable......             $40
 $40.
------------------------------------------------------------------------

    We estimate the following costs to do the proposed maintenance
manual operational test of the heat of the AOA probes. We have no way
of determining the number of airplanes that would have this operational
test, or how many times this will need to be performed before the
terminating action is done:

------------------------------------------------------------------------
                                                          Total cost per
            Labor cost                  Parts cost           airplane
------------------------------------------------------------------------
0.5 work-hour x $80 per hour =     Not Applicable......             $40
 $40.
------------------------------------------------------------------------

    We estimate the following costs to do any proposed upload of
software to the AOA transmitters. We have no way of determining the
number of airplanes that would have this modification:

------------------------------------------------------------------------
                                                          Total cost per
            Labor cost                  Parts cost           airplane
------------------------------------------------------------------------
4 work-hours x $80 per hour =      Not Applicable......            $320
 $320.
------------------------------------------------------------------------

    We estimate the following costs to do any proposed replacement of 2
stall warning AOA transmitters. We have no way of determining the
number of airplanes that would have this replacement:

------------------------------------------------------------------------
                                                          Total cost per
              Labor cost                   Parts cost        airplane
------------------------------------------------------------------------
2 work-hours x $80 per hour = $160....         $18,600          $18,760
------------------------------------------------------------------------

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.
    We are 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

    We have 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 that the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket that contains the proposed AD, the
regulatory evaluation, any comments received, and other information on
the Internet at http://www.regulations.gov; or in person at the Docket
Management Facility between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Docket Office (telephone<PHONE_NUMBER>)
is located at the street address stated in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Hawker Beechcraft Corporation: Docket No. FAA-2008-0353; Directorate
Identifier 2007-CE-101-AD.

Comments Due Date

    (a) We must receive comments on this airworthiness directive
(AD) action by May 27, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Model 390 airplanes, serial numbers RB-4
through RB-204, that are certificated in any category.

Unsafe Condition

    (d) This AD results from reports of the potential for
unannunciated loss of the heating function in the left-hand (LH) and
right-hand (RH) stall warning angle-of-attack (AOA) transmitters of
Model 390 airplanes. We are issuing this AD to correct potentially
inadequate stall warning with loss of stick pusher function.

Compliance

    (e) To address this problem, you must do the following, unless
already done:

----------------------------------------------------------------------------------------------------------------
                   Actions                                Compliance                        Procedures
----------------------------------------------------------------------------------------------------------------
(1) Incorporate Raytheon Aircraft Company      Within 15 hours time-in-service   Not Applicable.
 Temporary Change to the FAA Approved           (TIS) after the effective date
 Airplane Flight Manual P/N 390-590001-         of the AD or within 30 days
 0003CTC7, issued: March 15, 2007, into the     after the effective date of the
 airplane flight manual (AFM).                  AD, whichever occurs first.
(2) After every flight do the following:       Within 15 hours TIS after the     (A) For the post-flight check
(i) Do a post-flight check for residual heat    effective date of the AD or       for residual heat in the AOA
 in the AOA probes. CAUTION: TO PREVENT         within 30 days after the          probes: Follow AFM Temporary
 POSSIBLE BURNS, USE EXTREME CAUTION TOUCHING   effective date of the AD,         Change P/N 390-590001-
 HEATED AREAS. TO CHECK HEATING AND AVOID       whichever occurs first.           0003CTC7, issued: March 15,
 BURNS, HOLD HAND NEAR HEATED AREA OR MOVE      Completion of paragraph           2007. The owner/operator
 HAND GRADUALLY FROM AMBIENT AREA TOWARD        (e)(3)(i) or (e)(3)(ii) of this   holding at least a private
 HEATED AREA UNTIL WARMTH CAN BE FELT. If you   AD terminates the required        pilot certificate as
 do not feel heat in the AOA probes, then do    repetitive post-flight check of   authorized by section 43.7 of
 paragraph (e)(2)(ii) of this AD; or            this AD.                          the Federal Aviation
(ii) Do a post-flight maintenance manual                                          Regulations (14 CFR 43.7) may
 operational test of the heat of the AOA                                          do this post-flight check
 probes. If the AOA probe fails the                                               required by paragraph
 operational test, replace the AOA probe.                                         (e)(2)(i) of this AD. Make an
                                                                                entry into the aircraft
                                                                                records showing compliance
                                                                                with this AD following section
                                                                                43.9 of the Federal Aviation
                                                                                Regulations (14 CFR 43.9).
                                                                                (B) For the post-flight
                                                                                maintenance manual operational
                                                                                test of the heat of the AOA
                                                                                probes: Follow the procedures
                                                                                of the maintenance manual to
                                                                                do the operational test of the
                                                                                heat of the AOA probes
                                                                                required by paragraph
                                                                                (e)(2)(ii) of this AD. The
                                                                                maintenance manual operational
                                                                                test must be done by an
                                                                                appropriately-rated mechanic.
                                                                                (C) For AOA probe replacement:
                                                                                Follow Hawker Beechcraft
                                                                                Mandatory Service Bulletin No.
                                                                                SB 27-3787, issued: May 2007.
(3) Replace or modify (upload software) the    Within 250 hours TIS after the    Follow Hawker Beechcraft
 stall warning AOA transmitters by doing one    effective date of this AD or      Mandatory Service Bulletin No.
 of the following:                              within 12 months after the        SB 27-3787, issued: May 2007.
(i) Upload new software Kit No. 123-3436        effective date of this AD,
 (Field Software Upload SLZ8060-3,-4) to the    whichever occurs first.
 AOA transmitters; or                           Completion of either paragraph
(ii) Replace any part number (P/N) SLZ8060-3    (e)(3)(i) or (e)(3)(ii) of this
 and/or P/N SLZ8060-4 AOA transmitters with     AD terminates the required
 new P/N SLZ8060-5 AOA transmitters.            repetitive post-flight check of
                                                this AD.
(4) Remove Raytheon Aircraft Company           Before further flight after       Follow Hawker Beechcraft
 Temporary Change to the FAA Approved           doing the actions required by     Mandatory Service Bulletin No.
 Airplane Flight Manual P/N 390-590001-         paragraph (e)(3)(i) or            SB 27-3787, issued: May 2007.
 0003CTC7, issued: March 15, 2007, from the     paragraph (e)(3)(ii) of this AD.
 AFM.
(5) Do not install any P/N SLZ8060-3 or P/N    As of the effective date of this  Not Applicable.
 SLZ8060-4 AOA transmitter that does not have   AD.
 the new upgraded software required by
 paragraph (e)(3)(i) of this AD.
----------------------------------------------------------------------------------------------------------------

Alternative Methods of Compliance (AMOCs)

    (f) The Manager, Wichita Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. Send information to
ATTN: Philip Petty, Aerospace Engineer, Wichita ACO, 1801 Airport
Road, Room 100, Wichita, Kansas 67209; telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>. Before using any approved AMOC on any airplane
to which the AMOC applies, notify your appropriate principal
inspector (PI) in the FAA Flight Standards District Office (FSDO),
or lacking a PI, your local FSDO.

Related Information

    (g) To get copies of the service information referenced in this
AD, contact Hawker Beechcraft Corporation, 9709 East Central,
Wichita, Kansas 67291; telephone:<PHONE_NUMBER> or<PHONE_NUMBER>.
To view the AD docket, go to U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, or on the
Internet at http://www.regulations.gov.

    Issued in Kansas City, Missouri, on March 19, 2008.
John Colomy,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.

[FR Doc. E8-5959 Filed 3-24-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Rules and Regulations]
[Page 58871-58872]
[DOCID:fr08oc08-3]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2008-N-0039]

Implantation or Injectable Dosage Form New Animal Drugs;
Ceftiofur Crystalline Free Acid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA provides for veterinarian
prescription use of ceftiofur crystalline free acid injectable
suspension for the treatment

of bovine foot rot (interdigital necrobacillosis).

DATES:  This rule is effective October 8, 2008.

FOR FURTHER INFORMATION CONTACT:  Donald A. Prater, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement
to NADA 141-209 for EXCEDE (ceftiofur crystalline free acid) Sterile
Suspension. The supplemental NADA provides for veterinarian
prescription use of ceftiofur crystalline free acid injectable
suspension for the treatment of bovine foot rot (interdigital
necrobacillosis) in beef, non-lactating dairy, and lactating dairy
cattle. The application is approved as of August 15, 2008, and the
regulations are amended in 21 CFR 522.313a to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of the safety and
effectiveness data and information submitted to support approval of
these applications may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval. The 3 years of marketing exclusivity apply only to the bovine
foot rot indication for which this supplement is approved.
    The agency has determined under 21 CFR 25.33(d)(5) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

0
2. In Sec.  522.313a, amend paragraph (e)(2)(ii) by adding a third
sentence to read as follows:

Sec.  522.313a   Ceftiofur crystalline free acid.

* * * * *
    (e) * * *
    (2) * * *
    (ii) * * * For the treatment of bovine foot rot (interdigital
necrobacillosis) associated with Fusobacterium necrophorum and
Porphyromonas levii in beef, non-lactating dairy, and lactating dairy
cattle.
* * * * *

    Dated: September 29, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-23830 Filed 10-7-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Rules and Regulations]
[Pages 48495-48496]
[FR Doc No: 2021-18717]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0171; Airspace Docket No. 21-ASO-4]
RIN 2120-AA66

Amendment of Class E Airspace; Tuscaloosa, AL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace extending upward from 700
feet above the surface at Tuscaloosa National Airport, Tuscaloosa, AL.
The FAA is taking this action as a result of an airspace review caused
by the decommissioning of the CRIMSON Very High Frequency
Omnidirectional Range collocated with TACAN (VORTAC). This action also
updates the name of Tuscaloosa National Airport, (formerly Tuscaloosa
Municipal Airport) AL. Controlled airspace is necessary for the safety
and management of instrument flight rules (IFR) in the area.

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

ADDRESSES: FAA Order 7400.11E, 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 7400.11E at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Ave., College Park, GA 30337; 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 airspace extending upward from 700 feet above
the surface in Tuscaloosa, AL, to support IFR operations in the area.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (86 FR 33588, June 25, 2021) for Docket No. FAA-2021-0171 to
amend Class E airspace extending upward from 700 feet above the surface
at Tuscaloosa National Airport, Tuscaloosa, AL, due to the
decommissioning of the CRIMSON VORTAC.
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class E airspace designations are published in Paragraph 6005, of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, 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 7400.11E, Airspace Designations and
Reporting Points, dated July 21, 2020, and effective September 15,
2020. FAA Order 7400.11E is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11E lists Class A,
B, C, D, and E airspace areas, air traffic routes, and reporting
points.

The Rule

    The FAA is amending 14 CFR part 71 by amending the Class E airspace
extending upward from 700 feet above the surface at Tuscaloosa National
Airport, Tuscaloosa, AL, as the CRIMSON VORTAC is being decommissioned.
The Class E airspace extending upward from 700 feet above the surface
is amended by increasing the radius from 7.0 miles to 9.4 miles, adding
an extension 4.0 miles each side of the 117[deg] bearing from the
airport extending from the 9.4-mile radius to 11.8 miles southeast of
the airport and within 2.0 miles each side of the of the 041[deg]
bearing extending from the 9.4-mile radius to 11.5 miles northeast of
the airport and within 4.0 miles each side of the 296[deg] bearing
extending from the 9.4-mile radius to 10.8 miles northwest of the
airport and within 2.0 miles each side of the 221[deg] bearing
extending from the 9.4-mile radius to 11.8 miles southwest of the
airport. This action also updates the name of Tuscaloosa National
Airport, (formerly Tuscaloosa Municipal Airport) AL.
    FAA Order 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.
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 minimal. Since this is a routine matter that only
affects air traffic procedures an 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 5-6.5a. 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 Part 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 Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

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

* * * * *

ASO AL E5 Tuscaloosa, AL [Amended]

Tuscaloosa National Airport, AL
    (Lat. 33[deg]13'14'' N, long. 87[deg]36'41'' W)

    That airspace extending upward from 700 feet above the surface
within a 9.4-mile radius of Tuscaloosa National Airport and within
4.0 miles each side of the 117[deg] bearing from the airport
extending from the 9.4-mile radius to 11.8 miles southeast of the
airport and within 2.0 miles each side of the of the 041[deg]
bearing extending from the 9.4-mile radius to 11.5 miles northeast
of the airport and within 4.0 miles each side of the 296[deg]
bearing extending from the 9.4-mile radius to 10.8 miles northwest
of the airport and within 2.0 miles each side of the 221[deg]
bearing extending from the 9.4-mile radius to 11.8 miles southwest
of the airport.

    Issued in College Park, Georgia, on August 26, 2021.
Matthew N. Cathcart,
Manager, Airspace & Procedures Team North, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2021-18717 Filed 8-30-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Page 25717]
[FR Doc No: 2023-08879]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-281, OMB Control No. 3235-0316]

Submission for OMB Review; Comment Request; Extension: Form N-3

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') has submitted to the Office of
Management and Budget a request for extension of the previously
approved collection of information discussed below.
    The title for the collection of information is ``Form N-3 (17 CFR
239.17a and 274.11b) under the Securities Act of 1933 (15 U.S.C. 77)
and under the Investment Company Act of 1940 (15 U.S.C. 80a),
Registration Statement of Separate Accounts Organized as Management
Investment Companies.'' Form N-3 is the form used by separate accounts
offering variable annuity contracts which are organized as management
investment companies to register under the Investment Company Act of
1940 (``Investment Company Act'') and/or to register their securities
under the Securities Act of 1933 (``Securities Act''). Form N-3 is also
the form used to file a registration statement under the Securities Act
(and any amendments thereto) for variable annuity contracts funded by
separate accounts which would be required to be registered under the
Investment Company Act as management investment companies except for
the exclusion provided by Section 3(c)(11) of the Investment Company
Act (15 U.S.C. 80a-3(c)(11)). Section 5 of the Securities Act (15
U.S.C. 77e) requires the filing of a registration statement prior to
the offer of securities to the public and that the statement be
effective before any securities are sold, and Section 8 of the
Investment Company Act (15 U.S.C. 80a-8) requires a separate account to
register as an investment company.
    Form N-3 also permits separate accounts offering variable annuity
contracts which are organized as investment companies to provide
investors with a prospectus and a statement of additional information
covering essential information about the separate account when it makes
an initial or additional offering of its securities. Section 5(b) of
the Securities Act requires that investors be provided with a
prospectus containing the information required in a registration
statement prior to the sale or at the time of confirmation or delivery
of the securities. The form also may be used by the Commission in its
regulatory review, inspection, and policy-making roles.
    Commission staff estimates that there will be 1 initial
registration statement over the next three years and 6 insurer separate
accounts that file post-effective amendments on Form N-3 per year, with
an average of 3 investment options per post-effective amendment. The
Commission further estimates that the hour burden for preparing and
filing a post-effective amendment on Form N-3 is 157.55 hours per
portfolio. The total annual hour burden for preparing and filing post-
effective amendments is 2,836 hours (6 post-effective amendments x 3
investment options per post-effective amendment x 157.55 hours per
portfolio). The estimated annual hour burden for preparing and filing
initial registration statements is 309 hours. The total annual hour
burden for Form N-3, therefore, is estimated to be 3,145 hours (2,836
hours + 309 hours). Respondents may rely on outside counsel or auditors
in connection with the preparation and filing of Form N-3. Commission
staff estimates that the annual cost burden associated with preparing
and filing Form N-3 is $139,696.
    The information collection requirements imposed by Form N-3 are
mandatory. Responses to the collection of information will not be kept
confidential. An agency may not conduct or sponsor, and a person is not
required to respond to a collection of information unless it displays a
currently valid control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
by May 30, 2023 to (i) [email protected] and
(ii) David Bottom, Director/Chief Information Officer, Securities and
Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC
20549, or by sending an email to: [email protected].

    Dated: April 24, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-08879 Filed 4-26-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: June 16, 2008 (Volume 73, Number 116)]
[Notices]
[Page 34005-34006]
[DOCID:fr16jn08-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP08-415-000]

International Paper Company and RSFC Land Management, LLC; Notice
of Application

June 9, 2008.
    Take notice that on June 2, 2008, International Paper Company (IP),
6400 Poplar Avenue, Memphis, TN 38197 and RSFC Land Management, LLC
RSFC, 10877 Wilshire Boulevard, Suite 710, Los Angeles, CA 90024, filed
with the Federal Energy Regulatory Commission an abbreviated joint
application, pursuant to sections 7(b) and 7(c) of the Natural Gas Act
(NGA), as amended, and Part 157 of the Commission's regulations. In
this joint application, IP requests Commission authorization to abandon
by sale to RSFC approximately 17.83 miles of 6 \5/8\-inch-diameter
pipeline running from Tensas parish, Louisiana to Natchez, Mississippi,
1,000 feet of 6-inch-diameter pipeline, a 200 horsepower compressor
station and appurtenant facilities. Accordingly, RSFC requests
Commission authorization to acquire these facilities from IP. RSFC also
requests a blanket certificate under Part 157 of the Commission's
regulations as well as various waivers under Parts 154, 201, 260, and
284 all as more fully set forth in the application which is on file
with the Commission and open to public inspection. The filing may also
be viewed on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Carolyn F. Corwin, Covington & Burling LLP, 1201 Pennsylvania Avenue,
NW., Washington, DC 20004, phone<PHONE_NUMBER><EMAIL_ADDRESS>or
Barbara S. Jost, Davis Wright Tremaine LLP, 1919 Pennsylvania Avenue,
NW., Washington, DC 20006, phone<PHONE_NUMBER>, fax<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify Federal and State agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all Federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date, file with the Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426, a motion to
intervene in accordance with the requirements of the Commission's Rules
of Practice and Procedure (18 CFR 385.214 or 385.211) and the
Regulations under the NGA (18 CFR 157.10). A person obtaining party
status will be placed on the service list maintained by the Secretary
of the Commission and will receive copies of all documents filed by the
applicant and by all other parties. A party must submit 14 copies of
filings made with the Commission and must mail a copy to the applicant
and to every other party in the proceeding. Only parties to the

proceeding can ask for court review of Commission orders in the
proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.
    Comment Date: June 30, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-13416 Filed 6-13-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Page 45006]
[FR Doc No: 2018-19104]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2016-0028]

Petition for Waiver of Compliance

    Under part 211 of Title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on August 3, 2018, the
Regional Transportation District (RTD) and the City of Denver,
Colorado, petitioned the Federal Railroad Administration (FRA) for a
waiver of compliance from certain provisions of the Federal railroad
safety regulations contained at 49 CFR part 222. FRA assigned the
petition Docket Number FRA-2016-0028.
    Specifically, petitioners seek a waiver from the provisions of 49
CFR 222.35(b)(1) to establish a new quiet zone consisting of twelve
public highway-rail grade crossings with active grade crossing warning
devices comprising both flashing lights and gates that are not equipped
with constant warning time devices. The crossing warning devices on the
proposed ``Denver East Corridor Quiet Zone'' on the RTD A-Line are
primarily activated by a wireless crossing activation system (WCAS)
using ``GPS-determined train speed and location to predict how many
seconds a train is from the crossing.'' Petitioners assert that this
information is communicated wirelessly to the crossing warning devices
and seeks to provide constant warning times. Additionally, this system
is supplemented by a conventional track warning system in case the WCAS
is unavailable.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE, W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by October 19, 2018 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2018-19104 Filed 8-31-18; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26537-26538]
[FR Doc No: 2018-12298]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Dealer's
Aircraft Registration Certificate Application

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The collection involves submittal of pertinent information
by a

business or an individual to support issuance by the FAA of a Dealer's
Aircraft Registration Certificate, which allows operation of an
aircraft on a temporary basis under the auspices of a dealer business
rather than having to obtain permanent registration.

DATES: Written comments should be submitted by August 6, 2018.

ADDRESSES: Send comments to the FAA at the following address: Barbara
Hall, Federal Aviation Administration, ASP-110, 10101 Hillwood Parkway,
Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Barbara Hall by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Public Comments Invited: You are asked to
comment on any aspect of this information collection, including (a)
Whether the proposed collection of information is necessary for FAA's
performance; (b) the accuracy of the estimated burden; (c) ways for FAA
to enhance the quality, utility and clarity of the information
collection; and (d) ways that the burden could be minimized without
reducing the quality of the collected information. The agency will
summarize and/or include your comments in the request for OMB's
clearance of this information collection.
    OMB Control Number: 2120-0024.
    Title: Dealer's Aircraft Registration Certificate Application.
    Form Numbers: AC Form 8050-5.
    Type of Review: Renewal of an information collection.
    Background: This information collection supports the Department of
Transportation's strategic goals on safety and security. Maintaining
proper registration of aircraft is fundamental to ensure compliance
with operations/airworthiness safety requirements in order to promote
the public health and safety by working toward the elimination of
transportation-related deaths, injuries, and property damage. Proper
registration of aircraft is necessary to advance the nations vital
security interest in support of national strategies by ensuring that
the national transportation system is secure.
    Public Law 103-272 states that all aircraft must be registered
before they may be flown. It sets forth registration eligibility
requirements and provides for application for registration as well as
suspension and/or revocation of registration.
    a. Federal Aviation Regulation (FAR) Part 47 prescribes procedures
that implement Public Law 103-272 which provides for the issuance of
dealer's aircraft registration certificates and for their use in
connection with aircraft eligible for registration under this Act by
persons engaged in manufacturing, distributing or selling aircraft.
Dealer's certificates enable such persons to fly aircraft for sale
immediately without having to go through the paperwork and expense of
applying for and securing a permanent Certificate of Aircraft
Registration. It also provides a system of identification of aircraft
dealers.
    b. Federal Aviation Regulations (FAR) Part 47 establishes
procedures for implementing Section 505 of the Act. Specifically,
Subpart C, Parts 47.61 through 47.71, describes procedures for
obtaining and using dealer's certificates in FAR Part 47.63, elicit the
information needed from the applicant in order to comply with Section
505 of the Act and FAR Part 47, Subpart C.
    Respondents: Application for dealer's certificate may be made by
any individual or company engaged in manufacturing, distributing, or
selling aircraft who wants to be able operate those aircraft with a
dealer's certificate instead of registering them permanently in the
name of the entity.
    Frequency: To maintain the certificate, the holder must renew/re-
submit annually as the certificate expires one year after issuance.
    Estimated Average Burden per Response: 45 minutes.
    Estimated Total Annual Burden: During FY-2017, the FAA received
3,579 applications for dealer certificate.

    Issued in Fort Worth, TX on June 1, 2018.
Barbara L. Hall,
FAA Information Collection Clearance Officer, Performance, Policy, and
Records Management Branch, ASP-110.
[FR Doc. 2018-12298 Filed 6-6-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11790-11793]
[FR Doc No: 2011-4702]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-1981-N-0077 (formerly 81N-0393), FDA-1981-N-0248
(formerly 81N-0396), FDA-1982-N-0046 (formerly 82N-0095), FDA-1982-N-
0264 (formerly 82N-0096), and FDA-1983-N-0137 (formerly 83N-0095); DESI
6514, 11935, and 12152]

Drugs for Human Use; Drug Efficacy Study Implementation; Oral
Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or
Allergy; Withdrawal of Hearing Requests; Final Resolution of Dockets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that all
outstanding hearing requests pertaining to oral prescription drugs
offered for relief of symptoms of cough, cold, or allergy, Docket Nos.
FDA-1981-N-0077 (formerly 81N-0393), FDA-1981-N-0248 (formerly 81N-
0396), FDA-1982-N-0046 (formerly 82N-0095), FDA-1982-N-0264 (formerly
82N-0096), and FDA-1983-N-0137 (formerly 83N-0095), have been
withdrawn. Therefore, shipment in interstate commerce of the products
identified in those dockets, or any identical, related, or similar
(IRS) product that is not the subject of an approved new drug
application (NDA) or abbreviated new drug application (ANDA) (other
than an over-the-counter (OTC) product that complies with an

applicable OTC monograph), is unlawful as of the effective date of this
notice.

DATES: Effective Date: This notice is effective March 3, 2011.

ADDRESSES: All communications in response to this notice should be
identified with the appropriate docket number, and directed to Sakineh
Walther, Division of New Drugs and Labeling Compliance, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 51, rm. 5242, Silver Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Sakineh Walther, Division of New Drugs
and Labeling Compliance, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5242,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of January 7, 2011
(76 FR 1174) (the January 7, 2011, notice), FDA announced that all
outstanding hearing requests pertaining to certain dockets established
under the Agency's Drug Efficacy Study Implementation (DESI) program
had been withdrawn.1 2 Also in that notice, FDA announced
the withdrawal of certain hearing requests pertaining to Docket Nos.
FDA-1981-N-0077 (formerly 81N-0393), FDA-1981-N-0248 (formerly 81N-
0396), FDA-1982-N-0046 (formerly 82N-0095), FDA-1982-N-0264 (formerly
82N-0096), and FDA-1983-N-0137 (formerly 83N-0095), and offered an
opportunity for companies with outstanding hearing requests under those
dockets to withdraw or affirm their outstanding hearing requests.
---------------------------------------------------------------------------

    \1\ For background on the DESI review in general and the DESI
review as it relates to the dockets addressed in this notice, please
see the January 7, 2011, notice.
    \2\ In the January 7, 2011, notice, FDA stated that with respect
to Docket No. FDA-1982-N-0225 (formerly 82N-0078), Chlor-Trimeton
Repetabs Tablets, containing 12 milligrams (mg) chlorpheniramine
maleate and marketed under NDA 7-638, had been discontinued. FDA
notes that NDA 7-638 is currently active; however, products under it
are not marketed for indications found ineffective under DESI.
---------------------------------------------------------------------------

A. Docket No. FDA-1981-N-0077 (formerly 81N-0393) (DESI 6514)

    The products reviewed under Docket No. FDA-1981-N-0077 (formerly
81N-0393) (DESI 6514) were Phenergan Expectorant with Codeine
(containing promethazine hydrochloride, ipecac fluidextract, potassium
guaiacolsulfonate, citric acid, sodium citrate, and codeine phosphate,
marketed under NDA 8-306); Phenergan VC Expectorant Plain (containing
promethazine hydrochloride, ipecac fluidextract, potassium
guaiacolsulfonate, citric acid, sodium citrate, and phenylephrine
hydrochloride, marketed under NDA 8-306); Phenergan VC Expectorant With
Codeine (containing promethazine hydrochloride, ipecac fluidextract,
potassium guaiacolsulfonate, citric acid, sodium citrate, phenylephrine
hydrochloride, and codeine phosphate, marketed under NDA 8-306);
Phenergan Expectorant Plain (containing promethazine hydrochloride,
ipecac fluidextract, potassium guaiacolsulfonate, citric acid, and
sodium citrate, marketed under NDA 8-604); and Pediatric Phenergan
Expectorant with Dextromethorphan (containing promethazine
hydrochloride, ipecac fluidextract, potassium guaiacolsulfonate, citric
acid, sodium citrate, and dextromethorphan hydrobromide, marketed under
NDA 11-265). In a notice published in the Federal Register of May 25,
1982 (47 FR 22610), FDA revoked the temporary exemption that permitted
these drug products, and those products IRS to these products, to
remain on the market beyond the time limit established for DESI. The
notice also reclassified the products to lacking substantial evidence
of effectiveness, and offered an opportunity for a hearing on a
proposal to withdraw approval of the NDAs for the products.
    After Wyeth Laboratories, the holder of the NDAs for the Phenergan
products, withdrew its hearing request after approval of reformulated
versions of four of its five products, FDA announced in the Federal
Register of August 15, 1984 (49 FR 32681) that the Agency was
withdrawing approval of NDAs 8-306, 8-604, and 11-265 pertaining to the
old formulations of the Phenergan products, effective September 14,
1984.
    At the time of the January 7, 2011, notice (76 FR 1174), there were
two outstanding hearing requests under this docket filed by Bay
Laboratories, 3654 West Jarvis, Skokie, IL 60076, for its IRS products
Promethazine Expectorant with Codeine, Promethazine VC Expectorant
Plain, Promethazine VC Expectorant with Codeine, Promethazine
Expectorant Plain, and Promethazine Pediatric Expectorant, and by
National Pharmaceuticals, Inc., 7205 Windsor Blvd., Baltimore, MD
21207, for its products IRS to all five Phenergan products considered
under this docket. FDA was unable to find current contact information
for Bay Laboratories and National Pharmaceuticals. In the January 7,
2011, notice, FDA gave these companies an opportunity to affirm or
withdraw their hearing requests. Requests that were not affirmed within
30 days of that notice were to be deemed withdrawn by FDA.

B. Docket FDA-1981-N-0248 (formerly 81N-0396) (DESI 6514)

    The products reviewed under Docket No. FDA-1981-N-0248 (formerly
81N-0396) (DESI 6514) were Dimetane Expectorant (containing
brompheniramine maleate, phenylephrine hydrochloride,
phenylpropanolamine hydrochloride, and guaifenesin, marketed under NDA
11-694); Dimetane Expectorant-DC (containing codeine phosphate,
brompheniramine maleate, phenylephrine hydrochloride,
phenylpropanolamine hydrochloride, and guaifenesin, marketed under NDA
11-694); and Actifed-C Expectorant (containing codeine phosphate,
triprolidine hydrochloride, pseudoephedrine hydrochloride, and
guaifenesin, marketed under NDA 12-575). In a notice published in the
Federal Register of May 25, 1982, FDA revoked the temporary exemption
that permitted these drug products, and those products IRS to these
products, to remain on the market beyond the time limit established for
DESI. The notice also reclassified the products to lacking substantial
evidence of effectiveness, and offered an opportunity for a hearing on
a proposal to withdraw approval of the NDAs for the products.
    On April 3, 1984, A.H. Robins, the holder of the NDA for Dimetane
Expectorant and Dimetane Expectorant-DC, withdrew its hearing request
after approval of reformulated versions of its products. Accordingly,
in the Federal Register of August 24, 1984 (49 FR 33726), FDA announced
that it was withdrawing approval of those portions of NDA 11-694
pertaining to the old formulations of the Dimetane Expectorant
products, effective September 24, 1984.
    In the Federal Register of September 14, 1984 (49 FR 36169), FDA
announced that it was withdrawing approval of those portions of NDA 12-
575 pertaining to the old formulation of Actifed-C Expectorant,
effective October 15, 1984, after the NDA holder, Burroughs Wellcome,
obtained approval for a reformulated version of the product and
withdrew its hearing request.
    At the time of the January 7, 2011, notice, there were two
outstanding

hearing requests under this docket filed by Bay Laboratories, 3654 West
Jarvis, Skokie, IL 60076, for its IRS products Triphen Expectorant,
Triphen Expectorant DC, and Pseudodine ``C'' Expectorant, and by
National Pharmaceuticals, Inc., 7205 Windsor Blvd., Baltimore, MD
21207, for its products IRS to Dimetane Expectorant, Dimetane
Expectorant DC, and Actifed-C. FDA was unable to find current contact
information for Bay Laboratories and National Pharmaceuticals. In the
January 7, 2011, notice, FDA gave these companies an opportunity to
affirm or withdraw their hearing requests. Requests that were not
affirmed within 30 days of that notice were to be deemed withdrawn by
FDA.

C. Docket FDA-1982-N-0046 (formerly 82N-0095) (DESI 6514, 11935)

    The products reviewed under Docket No. FDA-1982-N-0046 (formerly
82N-0095) (DESI 6514 and 11935) were Ambenyl Expectorant (containing
codeine sulfate, bromodiphenhydramine hydrochloride, diphenhydramine
hydrochloride, ammonium chloride, potassium guaiacolsulfonate, and
menthol, marketed under NDA 9-319); and Pyribenzamine and Ephedrine
Tablets (containing tripelennamine hydrochloride and 12 mg ephedrine
sulfate, marketed under NDA 5-914). In a notice published in the
Federal Register of May 25, 1982 (47 FR 22604), FDA revoked the
temporary exemption that permitted these drug products, and those
products IRS to these products, to remain on the market beyond the time
limit established for DESI. The notice also reclassified the products
to lacking substantial evidence of effectiveness, and offered an
opportunity for a hearing on a proposal to withdraw approval of the
NDAs for the products.
    In the Federal Register of May 24, 1983 (48 FR 23311), FDA
announced that it was withdrawing approval of NDA 5-914 as it pertains
to Pyribenzamine and Ephedrine Tablets, effective June 23, 1983,
because no hearing was requested for the product by the NDA holder. On
February 27, 1984, Marion Laboratories, the NDA holder for Ambenyl
Expectorant, withdrew its hearing request after a reformulated version
of its product was approved. Accordingly, in the Federal Register of
August 24, 1984, FDA announced it was withdrawing approval of those
portions of NDA 9-319 pertaining to the old formulation of Ambenyl
Expectorant, effective September 24, 1984.
    At the time of the January 7, 2011, notice, there was one
outstanding hearing request under this docket filed by National
Pharmaceuticals, Inc., 7205 Windsor Blvd., Baltimore, MD 21207, for its
products IRS to Ambenyl Expectorant. FDA was unable to find current
contact information for National Pharmaceuticals. In the January 7,
2011, notice, FDA gave this company an opportunity to affirm or
withdraw its hearing request. Its hearing request was to be deemed
withdrawn if the company did not affirm the request within 30 days of
that notice.

D. Docket FDA-1982-N-0264 (formerly 82N-0096) (DESI 12152)

    The product reviewed under Docket No. FDA-1982-N-0264 (formerly
82N-0096) (DESI 12152) was Ornade Spansules. Ornade Spansules, as
formulated early in the DESI review process, was a three-ingredient
product containing 8 mg of chlorpheniramine maleate, 50 mg of
phenylpropanolamine hydrochloride, and 2.5 mg of isopropamide, and was
marketed under NDA 12-152. Subsequently, Ornade Spansules was
reformulated as a controlled-release product containing 12 mg
chlorpheniramine maleate and 75 mg phenylpropanolamine. In a notice
published in the Federal Register of August 17, 1982 (47 FR 35870), FDA
revoked the temporary exemption that permitted Ornade Spansules, as
originally formulated, and those products IRS to it, to remain on the
market beyond the time limit established for DESI. In the notice, FDA
also announced the conditions for marketing Ornade Spansules, as
reformulated, and the products IRS to it, for the indication for which
they were regarded as effective, and offered an opportunity for a
hearing concerning a proposal to withdraw approval of the NDA with
respect to the old formulation and the indications reclassified to
lacking substantial evidence of effectiveness.
    In the Federal Register of December 12, 1984 (49 FR 48387), FDA
announced that it was withdrawing approval of those portions of NDA 12-
152 covering the old, three-ingredient formulation for Ornade
Spansules, effective January 11, 1985, noting that no party submitted a
hearing request regarding the three-ingredient formulation.
    At the time of the January 7, 2011, notice, there were two
outstanding hearing requests under this docket filed by Pioneer
Pharmaceuticals, Inc., 209 40th Street, Irvington, NJ 07111, for its
IRS product characterized by the company as a generic version of Ornade
Spansules, and by Zenith Laboratories, Inc., 140 LeGrand Ave.,
Northvale, NJ 07647, for its IRS product, a sustained release product
containing chlorpheniramine and phenylpropanolamine. FDA did not
receive any response to its attempt to contact Zenith Laboratories and
was unable to find current contact information for Pioneer
Pharmaceuticals, Inc. In the January 7, 2011, notice, FDA gave these
companies an opportunity to affirm or withdraw their hearing requests.
Requests that were not affirmed within 30 days of that notice were to
be deemed withdrawn by FDA.

E. Docket FDA-1983-N-0137 (formerly 83N-0095) (DESI 11935)

    The products reviewed under Docket No. FDA-1983-N-0137 (formerly
83N-0095) (DESI 11935) were Dimetapp Extentabs and Dimetapp Elixir. As
originally formulated during the period of the DESI review, Dimetapp
Extentabs contained 12 mg brompheniramine maleate, 15 mg phenylephrine
hydrochloride, and 15 mg phenylpropanolamine hydrochloride in
controlled-release form, and was marketed under NDA 12-436; and
Dimetapp Elixir contained 4 mg brompheniramine maleate, 5 mg
phenylephrine hydrochloride, and 5 mg phenylpropanolamine hydrochloride
per 5 milliliters (mL), and was marketed under NDA 13-087. In a notice
published in the Federal Register of December 23, 1983 (48 FR 56854)
(the December 23, 1983, notice), FDA revoked the temporary exemption
that permitted these drug products, and those products IRS to these
products, to remain on the market beyond the time limit established for
DESI, and offered an opportunity for a hearing concerning a proposal to
withdraw approval of the NDAs for the original formulations of these
products and for the indications reclassified to lacking substantial
evidence of effectiveness.
    At the time of the publication of the December 23, 1983, notice,
the manufacturer had submitted supplemental applications proposing to
reformulate Dimetapp Extentabs to contain 12 mg brompheniramine maleate
and 75 mg phenylpropanolamine hydrochloride in a controlled-release
form, and Dimetapp Elixir to contain 4 mg brompheniramine maleate and
25 mg phenylpropanolamine hydrochloride per 5 mL. The supplements to
NDA 12-436 and NDA 13-087 were approved by FDA on April 20, 1984, and
March 29, 1984, respectively. In the December 23, 1983, notice, FDA
also announced the conditions for marketing the reformulated versions
of these products

for the indication for which they were regarded as effective.
    At the time of the January 7, 2011, notice (76 FR 1174), there were
14 outstanding hearing requests under this docket filed by American
Therapeutics Inc., 75 Carlough Rd., Bohemia, NY 11716, for its product
IRS to Dimetapp Extentab Tablets; Amide Pharmaceutical, Inc., 101 East
Main St., Little Falls, NJ 07424, for its IRS product Ami-Tapp; Bay
Laboratories, Inc., 3654 West Jarvis, Skokie, IL 60076, for Triphen
Elixir, its product IRS to Dimetapp Elixir; Carnrick Laboratories,
Inc., 65 Horse Hill Rd., Cedar Knolls, NJ 07927, for Nolamine Timed
Release Tablets, its product IRS to Dimetapp Extentabs; Copley
Pharmaceutical, Inc., 398 West Second St., P.O. Box 107, Boston, MA
02127, for its products IRS to Dimetapp Extentabs; LuChem
Pharmaceuticals, Inc., P.O. Box 6038, 8910 Linwood Ave., Shreveport, LA
71136, for its IRS products Ban-Tuss HC, Ban-Tuss C Expectorant, Tuss-
Delay Tablets, Ban-Tuss Plain, Klerist-D Tablets, Respergen, Am-Tuss
Liquid, Novadyne DH, Novadyne Expectorant, Dexophed Tablets, Chem-Tuss-
SR, Chem-Tuss Elixir, Chem-Tuss DM, Chem-Tuss DME, and Chem-Tuss N;
Mayrand Inc., 4 Dundas Circle, P.O. Box 8860, Greensboro, NC 27419, for
its products IRS to Dimetapp Extentabs and Dimetapp Elixir; National
Pharmaceutical Manufacturing Co., 7205 Windsor Blvd., Baltimore, MD
21207, for its product IRS to Dimetapp Elixir; Pharmaceutical Basics,
Inc., 301 S. Cherokee, Denver, CO 80223, for its IRS product Basamine
S.R. Tablets; Pioneer Pharmaceuticals, Inc., 209 40th St., Irvington,
NJ 07111, for Pioten Tablets, its product IRS to Dimetapp Extentabs;
Quantum Pharmics, Ltd., 26 Edison St., Amityville, NY 11701, for its
IRS product, Brom-Tapp; Superpharm Corp., 155 Oval Dr., Central Islip,
NY 11722, for its product IRS to Dimetapp Extentab Tablets; United
States Trading Corp., 10718 McCune Ave., Los Angeles, CA 90034, for its
products IRS to Dimetapp Extentabs; and Upsher-Smith Laboratories,
Inc., 14905 23d Ave. North, Minneapolis, MN 55441, for unspecified
products.
    FDA was unable to find current contact information for American
Therapeutics, Amide Pharmaceutical, Inc., Bay Laboratories, Inc.,
National Pharmaceutical Manufacturing Co., Pharmaceutical Basics, Inc.,
Superpharm Corp., and United States Trading Corp. FDA did not receive
any response to its attempt to contact Carnrick Laboratories, a
subsidiary of Elan Corp., PLC, 800 Gateway Blvd., South San Francisco,
CA 94080; Copley Pharmaceutical, Inc.; LuChem Pharmaceuticals, Inc.;
Merz Pharmaceuticals, LLC, P.O. Box 18806, Greensboro, NC 27419,
successor to Mayrand Inc. Pharmaceuticals; Pioneer Pharmaceuticals,
Inc.; Quantum Pharmics, Ltd.; or Upsher-Smith Laboratories, Inc. In the
January 7, 2011, notice, FDA gave these companies an opportunity to
affirm or withdraw their hearing requests. Requests that were not
affirmed within 30 days of that notice were to be deemed withdrawn by
FDA.

II. Final Resolution of Docket Nos. FDA-1981-N-0077 (formerly 81N-
0393), FDA-1981-N-0248 (formerly 81N-0396), FDA-1982-N-0046 (formerly
82N-0095), FDA-1982-N-264 (formerly 82N-0096), and FDA-1983-N-0137
(formerly 83N-0095)

    The time period for responding to the January 7, 2011, notice has
elapsed, and no companies with outstanding hearing requests responded
to the notice. Because no outstanding hearing requests were affirmed in
response to the January 7, 2011, notice (or in response to FDA's
previous attempts to contact companies with outstanding hearing
requests), all of the outstanding hearing requests pertaining to Docket
Nos. FDA-1981-N-0077 (formerly 81N-0393), FDA-1981-N-0248 (formerly
81N-0396), FDA-1982-N-0046 (formerly 82N-0095), FDA-1982-N-0264
(formerly 82N-0096), and FDA-1983-N-0137 (formerly 83N-0095) are deemed
to be withdrawn. Therefore, shipment in interstate commerce of the
products identified in those dockets, or any IRS product that is not
the subject of an approved NDA or ANDA, is unlawful as of the effective
date of this notice. This notice is not applicable to OTC products that
comply with an OTC monograph (21 CFR 310.6(f)). Any person who wishes
to determine whether a specific product is covered by this notice
should write to the Center for Drug Evaluation and Research (see
ADDRESSES).

III. Discontinued Products

    Some firms may have previously discontinued the manufacturing or
distribution of products covered by this notice without removing them
from the listing of their products under section 510(j) of the Federal
Food, Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(j)). Other
firms may discontinue manufacturing or marketing listed products in
response to this notice. Firms that wish to notify the Agency of
product discontinuation should send a letter, signed by the firm's
chief executive officer, fully identifying the discontinued product(s),
including NDC number(s), and stating that the product(s) has (have)
been discontinued. The letter should be sent to Sakineh Walther (see
ADDRESSES).
    Firms should also update the listing of their products under
section 510(j) of the FD&C Act to reflect discontinuation of unapproved
products. FDA plans to rely on its existing records, including drug
listing records or other available information, when it targets
violations for enforcement action. Firms should be aware that, after
the effective date of this notice, FDA intends to take enforcement
action without further notice against any firm that manufactures or
ships in interstate commerce any unapproved product covered by this
notice that is not the subject of an ongoing DESI proceeding.

IV. Reformulated Products

    Some of the active ingredients found in drug products covered by
this notice are included in the OTC monograph in 21 CFR part 341,
``Cold, Cough, Allergy, Bronchodilator, and Antihistamine Drug Products
for Over-the-Counter Human Use.'' OTC products that comply with the
monograph may be marketed without approval.
    However, FDA cautions firms against reformulating products into OTC
products or different unapproved new drugs that are marketed under the
same name or substantially the same name (including a new name that
contains the old name). Reformulated products marketed under a name
previously identified with a different active ingredient or combination
of active ingredients have the potential to confuse health care
practitioners and harm patients.
    This notice is issued under sections 502 and 505 of the FD&C Act
(21 U.S.C. 352 and 355), and under authority delegated to the Assistant
Commissioner for Policy under section 1410.21 of the FDA Staff Manual
Guide.

    Dated: February 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4702 Filed 3-2-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Notices]
[Page 5612]
[FR Doc No: 2015-01947]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Meeting of the National Parks Overflights Advisory
Group Aviation Rulemaking Committee

ACTION: Notice of meeting.

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SUMMARY: The Federal Aviation Administration (FAA) and the National
Park Service (NPS), in accordance with the National Parks Air Tour
Management Act of 2000, announce the next meeting of the National Parks
Overflights Advisory Group (NPOAG) Aviation Rulemaking Committee (ARC).
This notification provides the date, location, and agenda for the
meeting.
    Date and Location: The NPOAG ARC will meet on March 5, 2015. The
meeting will take place in Room S230DE in the South Concourse of the
Orange County Convention Center at 9899 International Drive Orlando, FL
32819. The meeting will be held from 8:30 a.m. to 4:30 p.m. on March 5,
2015. This NPOAG meeting will be open to the public.

FOR FURTHER INFORMATION CONTACT: Keith Lusk, AWP-1SP, Special Programs
Staff, Federal Aviation Administration, Western-Pacific Region
Headquarters, P.O. Box 92007, Los Angeles, CA 90009-2007, telephone:
(310) 725-3808, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The National Parks Air Tour Management Act of 2000 (NPATMA),
enacted on April 5, 2000, as Public Law 106-181, required the
establishment of the NPOAG within one year after its enactment. The Act
requires that the NPOAG be a balanced group of representatives of
general aviation, commercial air tour operations, environmental
concerns, and Native American tribes. The Administrator of the FAA and
the Director of NPS (or their designees) serve as ex officio members of
the group. Representatives of the Administrator and Director serve
alternating 1-year terms as chairperson of the advisory group.
    The duties of the NPOAG include providing advice, information, and
recommendations to the FAA Administrator and the NPS Director on;
implementation of Public Law 106-181; quiet aircraft technology; other
measures that might accommodate interests to visitors of national
parks; and at the request of the Administrator and the Director, on
safety, environmental, and other issues related to commercial air tour
operations over national parks or tribal lands.

Agenda for the March 5, 2015 NPOAG Meeting

    The agenda for the meeting will include, but is not limited to, an
update on ongoing park specific air tour planning projects, commercial
air tour reporting, and agency research on effects of aircraft noise on
park visitors.

Attendance at the Meeting and Submission of Written Comments

    Although this is not a public meeting, interested persons may
attend. Because seating is limited, if you plan to attend please
contact the person listed under FOR FURTHER INFORMATION CONTACT so that
meeting space may be made to accommodate all attendees. Written
comments regarding the meeting will be accepted directly from attendees
or may be sent to the person listed under FOR FURTHER INFORMATION
CONTACT.

Record of the Meeting

    If you cannot attend the NPOAG meeting, a summary record of the
meeting will be made available under the NPOAG section of the FAA ATMP
Web site at: http://www.faa.gov/about/office_org/headquarters_offices/arc/programs/air_tour_management_plan/parks_overflights_group/minutes.cfm or through the Special Programs Staff, Western-Pacific
Region, P.O. Box 92007, Los Angeles, CA 90009-2007, telephone: (310)
725-3808.

    Issued in Hawthorne, CA on January 27, 2015.
Keith Lusk,
Program Manager, Special Programs Staff, Western-Pacific Region.
[FR Doc. 2015-01947 Filed 1-30-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Notices]
[Page 60014]
[FR Doc No: 2011-24883]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP11-2573-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Iroquois Gas Transmission System, L.P. submits tariff
filing per 154.204: 09/21/11 Negotiated Rates--Citigroup Energy Inc. to
be effective 11/1/2011.
    Filed Date: 09/21/2011.
    Accession Number: 20110921-5067.
    Comment Date: 5 p.m. Eastern Time on Monday, October 03, 2011.

    Docket Numbers: RP11-2574-000.
    Applicants: Sabine Pipe Line LLC.
    Description: Sabine Pipe Line LLC submits tariff filing per
154.204: Revised Imbalance Language to be effective 10/1/2011.
    Filed Date: 09/21/2011.
    Accession Number: 20110921-5090.
    Comment Date: 5 p.m. Eastern Time on Monday, October 03, 2011.

    Docket Numbers: RP11-2575-000.
    Applicants: Monroe Gas Storage Company, LLC.
    Description: Monroe Gas Storage Company, LLC submits tariff filing
per 154.204: Monroe Gas Storage Tariff Revised 9.2.11 to be effective
9/21/2011.
    Filed Date: 09/21/2011.
    Accession Number: 20110921-5095.
    Comment Date: 5 p.m. Eastern Time on Monday, October 03, 2011.

    Docket Numbers: RP11-2576-000.
    Applicants: Transwestern Pipeline Company, LLC.
    Description: Petition of Transwestern Pipeline Company, LLC for
Approval of Stipulation and Agreement of Settlement and Request for
Expedited Action.
    Filed Date: 09/21/2011.
    Accession Number: 20110921-5124.
    Comment Date: 5 p.m. Eastern Time on Monday, October 03, 2011.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: September 22, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-24883 Filed 9-27-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Notices]
[Page 31916]
[FR Doc No: 2013-12508]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL13-67-000]

City of Boulder, Colorado; Notice of Petition for Declaratory
Order

    Take notice that on May 17, 2013, the City of Boulder, Colorado
(Boulder), pursuant to section 207 of the Federal Energy Regulatory
Commission's (Commission) Rules of Practice and Procedure, 18 CFR
385.207, filed a petition for declaratory order requesting the
Commission to confirm that upon becoming a retail-turned-wholesale
customer Boulder will have no stranded cost obligation for the portion
of its wholesale power requirements that Boulder purchases from its
former retail supplier, Public Service Company of Colorado.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on June 17, 2013.

    Dated: May 20, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-12508 Filed 5-24-13; 8:45 am]
BILLING CODE 6717-01-P


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

General Comment:Good Morning,

   I am writing as an individual consumer requesting an extension for the comment period. 75 day is not enough time to do detailed research and to compile data.

   Please consider and implement an extension of time for the comment period.

                                                 Thank you, Sincerely,,,   Chip Banks


[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Pages 83845-83847]
[FR Doc No: 2016-28049]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-4875]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ANAVIP

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ANAVIP and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by January
23, 2017. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by May 22, 2017. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-E-4875 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ANAVIP.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
biological product will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product ANAVIP
(crotalidae Immune F(ab')2 (equine)). ANAVIP is indicated for
management of adult and pediatric patients with North American
rattlesnake envenomation. Subsequent to this approval, the USPTO
received a patent term restoration application for ANAVIP (U.S. Patent
No. 6,709,655) from Instituto Bioclon, SA de CV, and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated March 10, 2016, FDA advised
the USPTO that this human biological product had undergone a regulatory
review period and that the approval of ANAVIP represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ANAVIP is 4,223 days. Of this time, 3,443 days occurred during the
testing

phase of the regulatory review period, while 780 days occurred during
the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: October 15,
2003. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on October
15, 2003.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): March 18, 2013. FDA has verified the
applicant's claim that the biologics license application (BLA) for
ANAVIP (BLA 125488/0) was initially submitted on March 18, 2013.
    3. The date the application was approved: May 6, 2015. FDA has
verified the applicant's claim that BLA 125488/0 was approved on May 6,
2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28049 Filed 11-21-16; 8:45 am]
 BILLING CODE 4164-01-P