[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 42002-42003]
[FR Doc No: 2020-15010]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1253 (formerly FDA-1987-N-0054)]

Pentaerythritol Tetranitrate; Final Decision on Proposal To
Withdraw Approval From New Drug Applications and Abbreviated New Drug
Applications; Availability of Final Decision

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
initial decision of the Administrative Law Judge (ALJ), to withdraw
approval of new drug applications (NDAs) and abbreviated new drug
applications (ANDAs) for pentaerythritol tetranitrate (PETN), is the
final decision of the Commissioner of Food and Drugs (the Commissioner)
by operation of law. In the initial decision, the ALJ found that PETN
had not been shown to be supported by substantial evidence consisting
of adequate and well-controlled studies to be effective for
prophylactic treatment of angina pectoris and ordered the withdrawal of
approval for all NDAs and ANDAs. Several parties to the hearing filed
exceptions to the ALJ's initial decision; however, all parties who
submitted exceptions have since voluntarily withdrawn them, or FDA has
deemed them withdrawn after their associated NDA or ANDA was withdrawn.
Consequently, the proceeding is in the same procedural position as if
no exceptions to the ALJ's initial decision had been filed. Therefore,
the ALJ's initial decision has become the final decision of the
Commissioner by operation of law.
    Applicable Date: This notice is applicable July 13, 2020.

ADDRESSES: For access to the docket, 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday

through Friday. Publicly available submissions may be seen in the
docket.

FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of the
Chief Scientist, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In 1962, the Federal Food, Drug, and Cosmetic Act (FD&C Act) was
amended by the Drug Amendments of 1962 (Pub. L. 87-781), and these
amendments provided that new drugs could no longer be approved unless
both safety and efficacy had been established for them. As amended, the
FD&C Act also required FDA to evaluate drugs approved as safe between
1938 and 1962 to determine whether such drugs were effective and to
withdraw approval for any applications where there was not substantial
evidence of the drug's effectiveness. The person contesting the
withdrawal of the approval had the burden of coming forward with
evidence of effectiveness for the drug. FDA's review of these pre-1962
drugs is known as the Drug Efficacy Study Implementation program.
    In a notice published in the Federal Register of February 25, 1972
(37 FR 4001) available at https://www.govinfo.gov/content/pkg/FR-1972-02-25/pdf/FR-1972-02-25.pdf), after evaluating reports received from
the National Academy of Sciences/National Research Council, Drug
Efficacy Study Group, and other available evidence, FDA classified
certain coronary vasodilators containing PETN as ``possibly effective''
for the management, prophylaxis, or treatment of angina attacks. Parke-
Davis, a Division of Warner Lambert Co. (Parke-Davis) submitted data
intended to support the effectiveness of single-entity coronary
vasodilator drugs containing PETN in the treatment of angina pectoris.
    In a notice published in the Federal Register of October 15, 1984
(49 FR 40213, available at https://www.govinfo.gov/content/pkg/FR-1984-10-15/pdf/FR-1984-10-15.pdf), the Center for Drugs and Biologics (the
Center) concluded that, after reviewing all the data previously
submitted to support the effectiveness of single-entity coronary
vasodilator drugs containing PETN in the treatment of angina pectoris,
the data did not constitute substantial evidence of effectiveness for
the listed drug products in the treatment of angina pectoris. Further,
the Center issued a notice of opportunity for hearing on a proposal to
withdraw approval of 15 total NDAs and ANDAs for certain coronary
vasodilators containing PETN.
    Multiple manufacturers responded to the notice for opportunity of
hearing and submitted requests for hearings. By a notice published in
the Federal Register of August 26, 1987 (52 FR 32170), available at
https://www.govinfo.gov/content/pkg/FR-1987-08-26/pdf/FR-1987-08-26.pdf), the Office of the Commissioner granted requests for hearing
with respect to seven NDAs and two ANDAs. Following the submission of
written testimony and documentary evidence, an ALJ, Daniel J. Davidson,
conducted a hearing from October 5-26, 1988. He issued his initial
decision on May 10, 1989. The ALJ found that the effectiveness of PETN
had not been shown to be supported by substantial evidence and, as a
result, ordered that the approval of all affected NDAs and ANDAs be
withdrawn.
    On July 10, 1989, three parties, Parke-Davis, Jones Medical
Industries, Inc. (Jones Medical) (formerly Marion Laboratories, Inc.),
and Bolar Pharmaceutical Co., Inc., appealed the ALJ's initial decision
by filing exceptions with the Commissioner under 21 CFR 12.125.
However, since the three parties submitted their exceptions, FDA has
withdrawn approval of all applications held by the three parties,
either through withdrawal requests or, after notice and opportunity for
hearing, for failure to file annual reports.
    The Commissioner now finds that all exceptions have either been
withdrawn upon the party's request or are deemed withdrawn. For these
reasons, the Commissioner concludes that there are no pending appeals
of the ALJ's initial decision. Parke-Davis, by a letter dated June 11,
1996, requested withdrawal of its exceptions. Watson Laboratories
(successor to Bolar Pharmaceutical Co.) also submitted a letter dated
November 9, 1999, requesting the withdrawal of its exceptions as to its
NDA. The letter did not reference its ANDA, but the ANDA was withdrawn
under a plea agreement with the United States pursuant to which Bolar
Pharmaceutical Co. pled guilty to fraud and admitted to falsifying drug
testing records (see July 6, 2016, 56 FR 43928), available at https://www.govinfo.gov/content/pkg/FR-1991-09-05/pdf/FR-1991-09-05.pdf). In
light of those circumstances, the Commissioner interprets Watson
Laboratories' request to withdraw exceptions to apply to both the NDA
and the ANDA. When the Center for Drug Evaluation and Research (CDER)
withdrew approval of Jones Medical's NDAs, CDER notified Jones Medical
that its appeal in this proceeding was also regarded as withdrawn (see
62 FR 61338, available at https://www.govinfo.gov/content/pkg/FR-1997-11-17/pdf/97-30148.pdf#page=1). Given that Jones Medical has never
filed an objection to CDER's determination that its appeal and
exceptions are regarded as withdrawn, the Commissioner affirms that
Jones Medical's appeal and exceptions are deemed withdrawn.

II. Conclusion and Order

    Given that the exceptions have all been withdrawn or deemed
withdrawn, this proceeding is now in the same procedural posture as if
no exceptions had ever been filed. When parties do not file exceptions
to the ALJ's initial decision, and the Commissioner does not file a
notice of review, the ALJ's initial decision becomes the final decision
of the Commissioner (see 21 CFR 12.120(e)). FDA will publish a notice
in the Federal Register when an initial decision becomes the final
decision of the Commissioner without appeal to or review by the
Commissioner (see 21 CFR 12.120(f)).
    Therefore, the ALJ's initial decision is the final decision of the
Commissioner. Pursuant to the findings in the ALJ's initial decision,
under section 505(e) of the FD&C Act (21 U.S.C. 355(e)) and under the
authority delegated by the Secretary of Health and Human Services,
there is a lack of substantial evidence that PETN will have the effect
it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in its labeling for prophylactic
treatment of angina pectoris. Distribution of products subject to the
initial decision in interstate commerce without an approved application
is prohibited and subject to regulatory action (see, e.g., sections
505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).
    The full text of the ALJ's initial decision may be seen in the
Dockets Management Staff and in this docket (see ADDRESSES).

    Dated: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15010 Filed 7-10-20; 8:45 am]
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[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Rules and Regulations]
[Pages 26385-26386]
[FR Doc No: 2021-10205]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31368; Amdt. No. 3955]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums
and Obstacle Departure procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or because of changes occurring in the
National Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective May 14, 2021. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of May 14, 2021.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Information Services, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104,
Oklahoma City, OK 73169. Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends 14 CFR part 97 by
establishing, amending, suspending, or removes SIAPS, Takeoff Minimums
and/or ODPS. The complete regulatory description of each SIAP and its
associated Takeoff Minimums or ODP for an identified airport is listed
on FAA form documents which are incorporated by reference in this
amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20.
The applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B,
when required by an entry on 8260-15A, and 8260-15C.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
refer to their graphic depiction on charts printed by publishers or
aeronautical materials. Thus, the advantages of incorporation by
reference are realized and publication of the complete description of
each SIAP, Takeoff Minimums and ODP listed on FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the typed of SIAPS, Takeoff Minimums and ODPs with their
applicable effective dates. This amendment also identifies the airport
and its location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPS, Takeoff
Minimums and/or ODPs as identified in the amendatory language for part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flights safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedure under 5 U.S.C. 553(b) are impracticable and contrary
to the public interest and, where applicable, under 5 U.S.C. 553(d),
good cause exists for making some SIAPs effective in less than 30 days.
    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 so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial

number of small entities under the criteria of the Regulatory
Flexibility Act.

Lists of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC on April 30, 2021.
Wade Terrell,
Aviation Safety, Manager, Flight Procedures & Airspace Group, Flight
Technologies and Procedures Division.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CRF part 97) is amended by
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40106, 40113,
40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 17 June 2021

Big Lake, AK, PAGQ, RNAV (GPS) RWY 7, Amdt 2
Big Lake, AK, PAGQ, RNAV (GPS RWY 25, Amdt 2
Big Lake, AK, PAGQ, VOR RWY 7, Amdt 7B
Venetie, AK, Venetie, Takeoff Minimums and Obstacle DP, Amdt 1
Venetie, AK, Venetie, Venetie Three Graphic DP
Bay Minette, AL, 1R8, RNAV (GPS) RWY 8, Amdt 2A
Bay Minette, AL, 1R8, RNAV (GPS) RWY 26, Orig-E
Daytona Beach, FL, KDAB, RNAV (GPS) RWY 25L, Amdt 1D
Cynthiana, KY, 0I8, RNAV (GPS) RWY 11, Orig-B
Cynthiana, KY, 0I8, RNAV (GPS) RWY 29, Orig-B
Beverly, MA, KBVY, LOC RWY 16, Amdt 8
Beverly, MA, Beverly Rgnl, VOR RWY 16, Amdt 5E, CANCELLED
Sanford, ME, KSFM, RNAV (GPS) RWY 32, Amdt 1
Ennis, MT, Ennis-Big Sky, Ennis Two Graphic DP
Ennis, MT, Ennis-Big Sky, Takeoff Minimums and Obstacle DP, Amdt 1
Rochester, NH, KDAW, RNAV (GPS) RWY 33, Amdt 1
Rochester, NH, KDAW, VOR/DME-A, Amdt 2A, CANCELLED
Schenectady, NY, KSCH, RNAV (GPS) RWY 4, Orig-D
Spartanburg, SC, KSPA, ILS OR LOC RWY 5, Amdt 2
Spartanburg, SC, KSPA, RNAV (GPS) RWY 5, Amdt 1
Dickson, TN, Dickson Muni, Takeoff Minimums and Obstacle DP, Amdt 3
Houston, TX, KIAH, GLS RWY 27, Amdt 1C
Medford, WI, KMDZ, RNAV (GPS) RWY 9, Amdt 1
Medford, WI, KMDZ, RNAV (GPS) RWY 27, Amdt 1

    RESCINDED: On April 26, 2021 (86 FR 21932), the FAA published an
Amendment in Docket No. 31366 Amdt No. 3953, to Part 97 of the
Federal Aviation Regulations under section 97.29 and 97.33. The
following entries for Gary, IN, effective June 17, 2021, are hereby
rescinded in their entirety:

Gary, IN, KGYY, ILS OR LOC RWY 30, Amdt 7
Gary, IN, KGYY, RNAV (GPS) Y RWY 12, Amdt 3
Gary, IN, KGYY, RNAV (GPS) Y RWY 30, Amdt 2
Gary, IN, KGYY, RNAV (RNP) Z RWY 12, Amdt 2
Gary, IN, KGYY, RNAV (RNP) Z RWY 30, Amdt 2

[FR Doc. 2021-10205 Filed 5-13-21; 8:45 am]
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