[Federal Register Volume 78, Number 227 (Monday, November 25, 2013)]
[Rules and Regulations]
[Pages 70211-70214]
[FR Doc No: 2013-27843]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0334; Directorate Identifier 2013-NM-027-AD;
Amendment 39-17671; AD 2013-23-16]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model 757 airplanes. This AD was prompted by a report of
a broken forward support fitting at the inboard track of the inboard
flap. This AD requires repetitive inspections of the forward support
fitting assemblies of the inboard track of the left and right inboard
flaps for cracking, and corrective actions if necessary. We are issuing
this AD to detect and correct cracking of the forward support fitting
assembly, which could result in loss of inboard flap control and
subsequent loss of airplane control.

DATES: This AD is effective December 30, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of December 30,
2013.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at 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 AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building

Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC
20590.

FOR FURTHER INFORMATION CONTACT: Nancy Marsh, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to the specified products. The
NPRM published in the Federal Register on April 22, 2013 (78 FR 23694).
The NPRM proposed to require repetitive inspections of the forward
support fitting assemblies of the inboard track of the left and right
inboard flaps for cracking, and corrective actions if necessary.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(78 FR 23964, April 22, 2013) and the FAA's response to each comment.

Supportive Comment

    Boeing stated that it concurs with the NPRM (78 FR 23964, April 22,
2013).

Request To Provide Justification for AD Action

    FedEx requested further data and justification for this AD action.
FedEx stated that it expected a single data point (i.e., the one
failure of a forward support fitting assembly) would represent an
anomaly. FedEx asked if a root cause analysis was done to determine
whether the single failure was an anomaly induced during manufacture or
operator maintenance before proceeding with service information and
NPRM development.
    We find that clarification is necessary. Boeing Special Attention
Service Bulletin 757-57-0071, dated September 12, 2012, states that the
cracking occurred at a compound radius in the part. This design detail,
which occurs on each part having the part number identified in that
service bulletin, has been identified as an area of high stress
concentration and a likely location for fatigue cracking to initiate at
a relatively low number of flight cycles. The airplane event, as
detailed in that service bulletin, occurred at 22,328 flight cycles and
both components of the forward support fitting assembly were found to
be completely cracked through. Therefore, the occurrence of cracking in
this part at this location is likely to occur on other airplanes, and
cannot be considered an anomaly. Since these cracked fittings result in
an unsafe condition and we determined that this unsafe condition is
likely to exist or develop in other products of the same type design,
we determined that this AD rulemaking is necessary. We have not changed
this final rule in this regard.

Request for Procedures To Apply a Chemical Conversion Coating

    American Airlines (AAL) recommended that a step be added between
steps 10 and 11 in sheet 3 of 6 of the Forward Support Fitting Assembly
Replacement figures of Boeing Special Attention Service Bulletin 757-
57-0071, dated September 12, 2012. The additional step would specify
applying a chemical conversion coating after match drilling holes as
part of the fitting assembly replacement process. AAL noted that in the
Material Information of Boeing Special Attention Service Bulletin 757-
57-0071, dated September 12, 2012, chemical conversion coating is
identified in the parts lists, but the Accomplishment Instructions
section of that service bulletin omits the coating.
    We agree that Boeing Special Attention Service Bulletin 757-57-
0071, dated September 12, 2012, does not specify applying a chemical
conversion coating after match drilling holes. Boeing specified that
the installation of the fasteners with sealant, as specified in the
instructions in the service information, provides corrosion protection
at the fastener locations and that application of the chemical
conversion coating is not required. Once we issue this AD, any person
may request approval of an alternative method of compliance (AMOC) to
apply alternative corrosion protection coatings under the provisions of
paragraph (i) of this final rule. We have not changed this final rule
in this regard.

Request To Delay AD To Address Parts Availability

    AAL requested that the FAA ensure ample parts availability before
releasing the AD. AAL stated that there is a lead time of 160 days for
the fitting assembly and suggested that the NPRM (78 FR 23964, April
22, 2013) be revised to allow for manufacture of parts and provide
material specifications and part dimensions. FedEx stated that about
seven fitting assemblies are due to be in stock in July 2013.
    We disagree to revise or delay this final rule. In developing this
final rule, we coordinated with the manufacturer an appropriate
compliance time to address the unsafe condition in a timely manner and
take parts availability into consideration. We have not changed this
final rule in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (78 FR 23964, April 22, 2013) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 23964, April 22, 2013).

Costs of Compliance

    We estimate that this AD affects 690 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                   Labor cost          Parts cost       Cost per product        operators
----------------------------------------------------------------------------------------------------------------
High-frequency eddy current       11 work-hours x     None..............  $935, per           $645,150, per
 inspection.                       $85 per hour =                          inspection cycle.   inspection cycle.
                                   $935, per
                                   inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the inspection. We have
no way of determining the number of aircraft that might need this
replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                 Action                          Labor cost             Parts cost         Cost per product
----------------------------------------------------------------------------------------------------------------
Replacement............................  7 work-hours x $85 per             $10,000   $10,595, per assembly.
                                          hour = $595, per assembly.
----------------------------------------------------------------------------------------------------------------

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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 this AD:
    (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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2013-23-16 The Boeing Company: Amendment 39-17671; Docket No. FAA-
2013-0334; Directorate Identifier 2013-NM-027-AD.

(a) Effective Date

    This AD is effective December 30, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 757-200, -200PF,
-200CB, and -300 series airplanes, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 5753, Trailing edge flaps.

(e) Unsafe Condition

    This AD was prompted by a report of a broken forward support
fitting at the inboard track of the inboard flap. We are issuing
this AD to detect and correct cracking of the forward support
fitting assembly, which could result in loss of inboard flap control
and subsequent loss of airplane control.

(f) Compliance

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

(g) Inspection and Corrective Action

    Except as provided by paragraph (h) of this AD, at the
applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Special Attention Service Bulletin 757-57-0071, dated
September 12, 2012: Do a high frequency eddy current (HFEC)
inspection for cracking in the forward support fitting assemblies of
the inboard track of the left and right inboard flaps, and do all
applicable corrective actions, in accordance with paragraph 3.B.2.
of the Accomplishment Instructions of Boeing Special Attention
Service Bulletin 757-57-0071, dated September 12, 2012. Do all
applicable corrective actions before further flight. Thereafter,
repeat the inspections at intervals not to exceed 6,000 flight
cycles, except as required by paragraphs (g)(1) and (g)(2) of this
AD.
    (1) For Group 1 airplanes, as identified in Boeing Special
Attention Service Bulletin 757-57-0071, dated September 12, 2012, on
which any forward support fitting assembly is replaced: Do the next
inspection before 15,000 flight cycles have accumulated on that
assembly.
    (2) For Group 2 airplanes, as identified in Boeing Special
Attention Service Bulletin 757-57-0071, dated September 12, 2012, on
which any forward support fitting assembly is replaced: Do the next
inspection before 18,000 flight cycles have accumulated on that
assembly.

(h) Exceptions to the Service Information

    (1) Where Boeing Special Attention Service Bulletin 757-57-0071,
dated September 12, 2012, specifies compliance times ``after the
original issue date of this service bulletin,'' this AD requires
compliance within the specified compliance times ``after the
effective date of this AD.''
    (2) Paragraphs 3.B.1. and 3.B.3. of the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 757-57-
0071, dated September 12, 2012, are not required by this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle 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. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (j) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(j) Related Information

    For more information about this AD, contact Nancy Marsh,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Special Attention Service Bulletin 757-57-0071, dated
September 12, 2012.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Ave SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on November 6, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-27843 Filed 11-22-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Notices]
[Pages 60690-60691]
[FR Doc No: 2023-19013]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3549]

Merck Sharp & Dohme LLC, et al.; Withdrawal of Approval of 35 New
Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 35 new drug applications (NDAs) from multiple
applicants. The applicants notified the Agency in writing that the drug
products were no longer marketed and requested that the approval of the
applications be withdrawn.

DATES: Approval is withdrawn as of October 5, 2023.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].

SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process in Sec.  314.150(c) (21 CFR 314.150(c)). The applicants have
also, by their requests, waived their opportunity for a hearing.
Withdrawal of approval of an application or abbreviated application
under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 001546.............  Guanidine (guanidine     Merck Sharp & Dohme
                          hydrochloride (HCl))     LLC, 126 East Lincoln
                          Tablets, 125             Ave., P.O. Box 2000,
                          milligrams (mg).         Rahway, NJ 07065.
NDA 010841.............  Peganone (ethotoin)      Recordati Rare
                          Tablets, 250 mg and      Diseases Inc., 100
                          500 mg.                  Corporate Dr.,
                                                   Lebanon, NJ 08833.
NDA 016801.............  Xylocaine Preservative   Fresenius Kabi USA,
                          Free (lidocaine HCl)     LLC, 3 Corporate Dr.,
                          Injection, 1%, 2%, 4%,   Lake Zurich, IL
                          10%, and 20%.            60047.
NDA 016822.............  FreAmine 8.5% (amino     B. Braun Medical Inc.,
                          acids) Injection, 8.5    901 Marcon Blvd.,
                          grams (g)/100            Allentown, PA 18109.
                          milliliters (mL).
                         FreAmine HBC 6.9%
                          (amino acids)
                          Injection, 6.9 g/100
                          mL.
                         FreAmine II 8.5% (amino
                          acids) Injection, 8.5
                          g/100 mL.
                         FreAmine III 10% (amino
                          acids) Injection, 10 g/
                          100 mL.
                         FreAmine III 8.5%
                          (amino acids)
                          Injection, 8.5 g/100
                          mL.
                         FreAmine III 8.5% with
                          electrolytes (amino
                          acids, magnesium
                          acetate, phosphoric
                          acid, potassium
                          acetate, potassium
                          chloride, sodium
                          acetate) Injection,
                          8.5%; 110mg/100mL;
                          230mg/100mL; 10mg/
                          100mL; 440mg/100mL;
                          690mg/100mL.
                         FreAmine III 3% with
                          electrolytes (amino
                          acids, magnesium
                          acetate, phosphoric
                          acid, potassium
                          chloride, sodium
                          acetate, sodium
                          chloride) Injection,
                          3%; 54mg/100mL; 40mg/
                          100mL; 150mg/100mL;
                          200mg/100mL; 120mg/
                          100mL.
NDA 017407.............  Catapres (clonidine      Boehringer Ingelheim
                          HCl) Tablets, 0.1 mg,    Pharmaceuticals,
                          0.2 mg, and 0.3 mg.      Inc., 900 Ridgebury
                                                   Rd., P.O. Box 368,
                                                   Ridgefield, CT 06877.
NDA 017425.............  Proglycem (diazoxide)    Teva Branded
                          Capsules, 50 mg and      Pharmaceutical
                          100 mg.                  Products R&D, Inc.,
                                                   145 Brandywine Pkwy.,
                                                   West Chester, PA
                                                   19380.
NDA 017534.............  Fiorinal (aspirin,       AbbVie Inc., 1 North
                          butalbital, caffeine)    Waukegan Rd., North
                          Capsules, 325 mg/50 mg/  Chicago, IL 60064.
                          40 mg.
                         Fiorinal (aspirin,
                          butalbital, caffeine)
                          Tablets, 325 mg/50 mg/
                          40 mg.
NDA 018582.............  Procalamine (amino       B. Braun Medical Inc.
                          acids, calcium
                          acetate, glycerin,
                          magnesium acetate,
                          phosphoric acid,
                          potassium chloride,
                          sodium acetate, sodium
                          chloride) Injection,
                          3%; 26mg/100mL; 3g/
                          100mL; 54mg/100mL;
                          41mg/100mL; 150mg/
                          100mL; 200mg/100mL;
                          120mg/100mL.
NDA 018676.............  HepatAmine 8% (amino     Do.
                          acids) Injection, 8g/
                          100mL.
NDA 018878.............  Indocin (indomethacin    Recordati Rare
                          sodium) Injection,       Diseases Inc.
                          equivalent to (EQ) 1
                          mg base/vial.

NDA 019099.............  Dopamine HCl and         B. Braun Medical Inc.
                          Dextrose 5% Injection,
                          80 mg/100 mL and 320
                          mg/100 mL.
                         Dopamine HCl and
                          Dextrose 5% in plastic
                          container Injection,
                          40 mg/100 mL and 160
                          mg/100 mL.
NDA 019111.............  Tussionex Pennkinetic    UCB Inc., 1950 Lake
                          (chlorpheniramine        Park Dr., Building
                          polistirex,              2100, Smyrna, GA
                          hydrocodone              30080.
                          polistirex) Extended-
                          Release Suspension, EQ
                          8 mg maleate/5 mL; EQ
                          10 mg bitartrate/5 mL.
NDA 019429.............  Fiorinal with Codeine    AbbVie Inc.
                          (aspirin, butalbital,
                          caffeine, codeine
                          phosphate) Capsules,
                          325 mg/50 mg/40 mg/30
                          mg.
NDA 019898.............  Pravachol (pravastatin   Bristol-Myers Squibb
                          sodium) Tablets, 10      Co., P.O. Box 4000,
                          mg, 20 mg, 40 mg, and    Princeton, NJ 08543.
                          80 mg.
NDA 020281.............  Ultram (tramadol HCl)    Janssen
                          Tablets, 50 mg and 100   Pharmaceuticals,
                          mg.                      Inc., 1125 Trenton-
                                                   Harbourton Rd.,
                                                   Titusville, NJ 08560.
NDA 020381.............  Niaspan (niacin)         AbbVie Inc.
                          Extended-Release
                          Tablets, 375 mg, 500
                          mg, 750 mg, and 1 g.
                         Niaspan Titration
                          Starter Pack (niacin)
                          Extended-Release
                          Tablets, 375 mg, 500
                          mg, and 750 mg.
NDA 020544.............  Jadelle                  Population Council,
                          (levonorgestrel)         1230 York Ave., New
                          Implants for Subdermal   York, NY 10065.
                          Use, 75 mg/implant.
NDA 020616.............  Kadian (morphine         AbbVie Inc.
                          sulfate) Extended-
                          Release Capsules, 10
                          mg, 20 mg, 30 mg, 40
                          mg, 50 mg, 60 mg, 70
                          mg, 80 mg, 100 mg, 130
                          mg, 150 mg, and 200 mg.
NDA 020636.............  Viramune (nevirapine)    Boehringer Ingelheim
                          Tablets, 200 mg.         Pharmaceuticals, Inc.
NDA 021065.............  Femhrt (ethinyl          Allergan
                          estradiol,               Pharmaceuticals
                          norethindrone acetate)   International Limited
                          Tablets, 0.0025 mg/0.5   c/o AbbVie Inc., 1
                          mg and 0.005 mg/1 mg.    North Waukegan Rd.,
                                                   North Chicago, IL
                                                   60064.
NDA 021066.............  Zaditor (ketotifen       Alcon Laboratories,
                          fumarate) Ophthalmic     Inc., 6201 South
                          Solution, EQ 0.025%      Freeway, Fort Worth,
                          base.                    TX 76134.
NDA 021123.............  Ultracet                 Janssen
                          (acetaminophen,          Pharmaceuticals, Inc.
                          tramadol HCl) Tablets,
                          325 mg/37.5 mg.
NDA 021513.............  Enablex (darifenacin     AbbVie Inc.
                          hydrobromide) Extended-
                          Release Tablets, EQ
                          7.5 mg base and EQ 15
                          mg base.
NDA 021615.............  Razadyne ER              Janssen Research and
                          (galantamine             Development, LLC,
                          hydrobromide) Extended-  1125 Trenton-
                          Release Capsules, EQ 8   Harbourton Rd.,
                          mg base, EQ 16 mg        Titusville, NJ 08560.
                          base, and EQ 24 mg
                          base.
NDA 021790.............  Dacogen (decitabine)     Otsuka Pharmaceutical
                          Injection, 50 mg/vial.   Co., Ltd., c/o Otsuka
                                                   Pharmaceutical
                                                   Development and
                                                   Commercialization,
                                                   Inc., 2440 Research
                                                   Blvd., Rockville, MD
                                                   20850.
NDA 021830.............  Asacol HD (mesalamine)   AbbVie Inc.
                          Delayed-Release
                          Tablets, 800 mg.
NDA 021844.............  Desonate (desonide)      LEO Pharma A/S, c/o
                          Gel, 0.05%.              LEO Pharma Inc., 7
                                                   Giralda Farms,
                                                   Madison, NJ 07940.
NDA 022292.............  Aptivus (tipranavir)     Boehringer Ingelheim
                          Oral Solution, 100 mg/   Pharmaceuticals, Inc.
                          mL.
NDA 022439.............  Zutripro                 Persion
                          (chlorpheniramine        Pharmaceuticals LLC,
                          maleate, hydrocodone     10 North Park Place,
                          bitartrate,              Suite 201,
                          pseudoephedrine HCl)     Morristown, NJ 07960.
                          Oral Solution, 4 mg/5
                          mL; 5 mg/5 mL; 60 mg/5
                          mL.
NDA 022442.............  Rezira (hydrocodone      Do.
                          bitartrate,
                          pseudoephedrine HCl)
                          Oral Solution, 5 mg/5
                          mL; 60 mg/5 mL.
NDA 204307.............  Vituz (chlorpheniramine  Do.
                          maleate, hydrocodone
                          bitartrate) Oral
                          Solution, 4 mg/5 mL; 5
                          mg/5 mL.
NDA 204768.............  Tivorbex (indomethacin)  Genus Lifesciences
                          Capsules, 20 mg and 40   Inc., 514 North 12th
                          mg.                      St., Allentown, PA
                                                   18102.
NDA 206619.............  Viekira Pak (dasabuvir   AbbVie Inc.
                          sodium; ombitasvir,
                          paritaprevir,
                          ritonavir) Tablets, EQ
                          250 mg base; 12.5 mg/
                          75 mg/50 mg.
NDA 208374.............  Bivalirudin in 0.9%      Baxter Healthcare
                          Sodium Chloride          Corp., 1 Baxter
                          Intravenous Solution,    Pkwy., Deerfield, IL
                          250 mg/50 mL and 500     60015.
                          mg/100 mL.
NDA 210583.............  Anjeso (meloxicam)       Baudax Bio, Inc., 490
                          Intravenous Solution,    Lapp Rd., Malvern, PA
                          30 mg/mL.                19355.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
October 5, 2023. Approval of each entire application is withdrawn,
including any strengths and dosage forms included in the application
but inadvertently missing from the table. Introduction or delivery for
introduction into interstate commerce of products listed in the table
without approved new drug applications violates sections 505(a) and
301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a)
and 331(d)). Drug products that are listed in the table that are in
inventory on October 5, 2023 may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.

    Dated: August 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19013 Filed 9-1-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 205 (Wednesday, October 25, 2023)]
[Notices]
[Page 73387]
[FR Doc No: 2023-23557]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-564, OMB Control No. 3235-0628]

Submission for OMB Review; Comment Request; Extension: Rule 17g-2

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 (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in Rule 17g-
2 (17 CFR 240.17g-2) under the Securities Exchange Act of 1934 (15
U.S.C. 78a et seq.) (``Exchange Act'').
    Rule 17g-2, ``Records to be made and retained by nationally
recognized statistical rating organizations,'' implements the
Commission's recordkeeping rulemaking authority under section 17(a) of
the Exchange Act.\1\ The rule requires a Nationally Recognized
Statistical Rating Organization (``NRSRO'') to make and retain certain
records relating to its business and to retain certain other business
records, if such records are made. The rule also prescribes the time
periods and manner in which all these records must be retained. There
are 10 credit rating agencies registered with the Commission as NRSROs
under section 15E of the Exchange Act, which have already established
the recordkeeping policies and procedures required by Rule 17g-2. Based
on staff experience, NRSROs are estimated to spend a total industry-
wide burden of 2,600 annual hours to make and retain the appropriate
records.\2\
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    \1\ 15 U.S.C. 78q.
    \2\ 10 currently registered NRSROs x 260 hours = 2,600 hours.
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    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information on
respondents; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
    The Commission may not conduct or sponsor a collection of
information unless it displays a currently valid control number. No
person shall be subject to any penalty for failing to comply with a
collection of information subject to the PRA that does not display a
valid OMB 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 November 24, 2023 to (i) [email protected]
and (ii) Please direct your written comments to: Dave Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Cynthia Roscoe, 100 F St. NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: October 20, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-23557 Filed 10-24-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Notices]
[Page 43465]
[FR Doc No: 2014-17602]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9016-1]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/
Weekly receipt of Environmental Impact Statements
Filed 07/14/2014 Through 07/18/2014
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html

EIS No. 20140196, Second Draft Supplement, FSA, 00, PROGRAMMATIC--
Conservation Reserve Program (CRP), Implement Certain Changes to the
CRP as Enacted by Congress in the 2008 Farm Bill Comment Period Ends:
09/08/2014, Contact: Nell Fuller<PHONE_NUMBER>.
EIS No. 20140197, Final EIS, USACE, CA, Placer Vineyards Specific Plan,
Review Period Ends: 08/25/2014, Contact: William Ness<PHONE_NUMBER>.
EIS No. 20140198, Draft EIS, NMFS, WA, Two Joint State and Tribal
Resource Management Plans for Puget Sound Salmon and Steelhead Hatchery
Programs, Comment Period Ends: 10/23/2014, Contact: Steve Leider 360-
753-4650.
EIS No. 20140199, Draft EIS, USN, CA, Naval Base Coronado Coastal
Campus, Comment Period Ends: 09/22/2014, Contact: Teresa Bresler 619-
556-7315.
EIS No. 20140200, Final EIS, USFS, ID, Upper North Fork HFRA Ecosystem
Restoration Project, Review Period Ends: 08/25/2014, Contact: Maggie
Seaberg<PHONE_NUMBER>.
EIS No. 20140201, Draft EIS, USFWS, NM, Proposed Revision to the
Nonessential Experimental Population of the Mexican Wolf (Canis lupus
baileyi), Comment Period Ends: 09/23/2014, Contact: Tracy Melbihess
208-258-0253.

Amended Notices

EIS No. 20140153, Draft EIS, NPS, NC, Cape Lookout National Seashore
Off-Road Vehicle Management Plan, Comment Period Ends: 09/04/2014,
Contact: Michael B. Edwards<PHONE_NUMBER> Revision to FR Notice
Published on 05/23/2014; Extending Comment Period from 07/21/2014 to
09/04/2014.
EIS No. 20140165, Draft EIS, USACE, WA, Skagit River Flood Risk
Management General Investigation, Comment Period Ends: 08/05/2014,
Contact: Hannah Hadley<PHONE_NUMBER>.

    Revision to FR Notice Published on 06/06/2014; Extending Comment
Period from 7/21/2014 to 08/05/2014.

    Dated: July 22, 2014.
Cliff Rader,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2014-17602 Filed 7-24-14; 8:45 am]
BILLING CODE 6560-50-P