[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73296-73298]
[FR Doc No: 2021-27946]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1252]

Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.;
Proposal To Withdraw Approval of Three New Drug Applications;
Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is proposing to withdraw approval
of three new drug applications (NDAs) and is announcing an opportunity
for the NDA holders to

request a hearing on this proposal. The basis for the proposal is that
the NDA holders have repeatedly failed to file required annual reports
for those NDAs.

DATES: The NDA holders may submit a request for a hearing by January
26, 2022. Submit all data, information, and analyses upon which the
request for a hearing relies February 25, 2022. Submit electronic or
written comments by February 25, 2022.

ADDRESSES: The request for a hearing may be submitted by the NDA
holders by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments to submit your request
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a
hearing, will be posted to the docket unchanged.

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     Because your request for a hearing will be made public,
you are solely responsible for ensuring that your request 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. The request for a hearing must include the
Docket No. FDA-2021-N-1252 for ``Panray Corp. Sub Ormont Drug and
Chemical Co., Inc., et al.; Proposal To Withdraw Approval of Three New
Drug Applications; Opportunity for a Hearing.'' The request for a
hearing will be placed in the docket and publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
    The NDA holders may submit all data and analyses upon which the
request for a hearing relies in the same manner as the request for a
hearing except as follows:
     Confidential Submissions--To submit any data analyses with
confidential information that you do not wish to be made publicly
available, submit your data and analyses only as a written/paper
submission. You should submit two copies total of all data and
analyses. 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
any decisions on this matter. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov
or available at the Dockets Management Staff between 9 a.m. and 4 p.m.,
Monday through Friday,<PHONE_NUMBER>. Submit both copies to the Dockets
Management Staff. Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law.
    Comments Submitted by Other Interested Parties: For all comments
submitted by other interested parties, 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2021-N-1252 for ``Panray Corp. Sub Ormont Drug and Chemical Co.,
Inc., et al.; Proposal To Withdraw Approval of Three New Drug
Applications; Opportunity for a Hearing.'' Received comments, those
filed in a timely manner (see DATES, will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

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 holder of an approved NDA to market a
new drug for human use is required to submit annual reports to FDA
concerning its approved NDA under Sec. Sec.  314.81 and 314.98 (21 CFR
314.81 and 314.98). The holders of the approved NDAs listed in Table 1
have repeatedly failed to submit the required annual reports and have
not responded to the Agency's request for submission of the reports.

     Table 1--Approved NDAs for Which Required Reports Have Not Been
                                Submitted
------------------------------------------------------------------------
     Application No.               Drug                 NDA holder
------------------------------------------------------------------------
NDA 008284..............  Cortisone Acetate       Panray Corp. Sub
                           Tablets, 5 milligrams   Ormont Drug and
                           (mg) and 25 mg.         Chemical Co., Inc.,
                                                   520 South Dean St.,
                                                   Englewood, NJ 07631.
NDA 009659..............  Hydrocortisone          Do.
                           Tablets, 10 mg and 20
                           mg.
NDA 019503..............  Triamcinolone           Parnell
                           Acetonide Suspension,   Pharmaceuticals Inc.,
                           3 mg/milliliters (mL).  111 Francisco Blvd.,
                                                   San Rafael, CA 94901.
------------------------------------------------------------------------

    Therefore, notice is given to the holders of the approved NDAs
listed in table 1 and to all other interested persons that the Director
of CDER proposes to issue an order, under section 505(e) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)), withdrawing
approval of the NDAs and all amendments and supplements thereto on the
grounds that the NDA holders have failed to submit reports required
under Sec.  314.81.
    In accordance with section 505 of the FD&C Act and 21 CFR part 314,
the NDA holders are hereby provided an opportunity for a hearing to
show why the approval of the NDAs listed previously should not be
withdrawn and an opportunity to raise, for administrative
determination, all issues relating to the legal status of the drug
products covered by these NDAs.
    An NDA holder who decides to seek a hearing must file the
following: (1) A written notice of participation and request for a
hearing (see DATES and ADDRESSES) and (2) the data, information, and
analyses relied on to demonstrate that there is a genuine and
substantial issue of fact that requires a hearing (see DATES and
ADDRESSES). Any other interested person may also submit comments on
this notice. The procedures and requirements governing this notice of
opportunity for a hearing, notice of participation and request for a
hearing, the information and analyses to justify a hearing, other
comments, and a grant or denial of a hearing are contained in Sec.
314.200 (21 CFR 314.200) and in 21 CFR part 12.
    The failure of an NDA holder to file a timely written notice of
participation and request for a hearing, as required by Sec.  314.200,
constitutes an election by that NDA holder not to avail itself of the
opportunity for a hearing concerning CDER's proposal to withdraw
approval of the NDAs and constitutes a waiver of any contentions
concerning the legal status of the drug products. FDA will then
withdraw approval of the NDAs, and the drug products may not thereafter
be lawfully introduced or delivered for introduction into interstate
commerce. Any new drug product introduced or delivered for introduction
into interstate commerce without an approved NDA is subject to
regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or
denials but must present specific facts showing that there is a genuine
and substantial issue of fact that requires a hearing. If a request for
a hearing is not complete or is not supported, the Commissioner of Food
and Drugs will enter summary judgment against the person who requests
the hearing, making findings and conclusions, and denying a hearing.
    All paper submissions under this notice of opportunity for a
hearing must be filed in two copies. Except for data and information
prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C.
1905, the submissions may be seen at the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, and will
be posted to the docket at https://www.regulations.gov.
    This notice is issued under section 505(e) of the FD&C Act and
under authority delegated to the Director of CDER by the Commissioner
of Food and Drugs.

    Dated: December 20, 2021.
Jacqueline Corrigan-Curay,
Principal Deputy Center Director, Center for Drug Evaluation and
Research.
[FR Doc. 2021-27946 Filed 12-23-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: January 28, 2010 (Volume 75, Number 18)]
[Notices]
[Page 4578]
[DOCID:fr28ja10-77]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

Notice of Adjustment of Statewide Per Capita Threshold for
Recommending a Cost Share Adjustment

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: FEMA gives notice that the statewide per capita threshold for
recommending cost share adjustments for major disasters declared on or
after January 1, 2010, through December 31, 2010, is $125.

DATES: This notice applies to major disasters declared on or after
January 1, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Pursuant to 44 CFR 206.47, the statewide per
capita threshold that is used to recommend an increase of the Federal
cost share from seventy-five percent (75%) to not more than ninety
percent (90%) of the eligible cost of permanent work under section 406
and emergency work under section 403 and section 407 of the Robert T.
Stafford Disaster Relief and Emergency Assistance Act is adjusted
annually. The adjustment to the threshold is based on the Consumer
Price Index for All Urban Consumers published annually by the U.S.
Department of Labor. For disasters declared on January 1, 2010, through
December 31, 2010, the qualifying threshold is $125 per capita of State
population.
    This adjustment in based on an increase of 2.7 percent in the
Consumer Price Index for All Urban Consumers for the 12-month period
that ended December 2009. The Bureau of Labor Statistics of the U.S.
Department of Labor released the information on January 15, 2010.

    (The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-1757 Filed 1-27-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: January 11, 2007 (Volume 72, Number 7)]
[Rules and Regulations]
[Page 1282-1283]
[DOCID:fr11ja07-11]

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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 200

[Release No. 34-40761A; File No. S7-13-98]
RIN 3235-AH39

Amendment to Rule Filing Requirements for Self-Regulatory
Organizations Regarding New Derivative Securities Products; Correction

AGENCY: Securities and Exchange Commission.

ACTION: Correcting amendment.

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SUMMARY: In connection with rules adopted in Release No. 34-40761
(December 8, 1998), 63 FR 70952 (December 22, 1998) (``Original
Release''), the Commission is making a technical correction to the
delegation of authority to the Director of the Division of Market
Regulation appearing in the Commission's Rules of Practice and
Investigations. Specifically, the Commission is correcting a cross-
reference appearing in the delegation.

EFFECTIVE DATE: February 20, 1999.

FOR FURTHER INFORMATION CONTACT: Frances Sienkiewicz, Securities and
Exchange Commission, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Commission is making a technical
correction to Rule 30-3(a)(59) of its

Rules of Practice and Investigations. Currently, Rule 30-3(a)(59)
contains a cross-reference to paragraph (e)(6)(iii) of Rule 19b-4 under
the Securities Exchange Act of 1934. In connection with the adoption in
the Original Release of a new paragraph (e) to Rule 19b-4, the cross-
reference to paragraph (e)(6)(iii) of Rule 19b-4 appearing in Rule 30-
3(a)(59) should have been redesignated as paragraph (f)(6)(iii) of Rule
19b-4, to reflect the redesignation of former paragraph (e) of Rule
19b-4 as paragraph (f) of Rule 19b-4. This document corrects that
cross-reference.

List of Subjects in 17 CFR Part 200

    Administrative practice and procedure, Authority delegations
(Government agencies), Organization and functions (Government
agencies).

0
Accordingly, 17 CFR part 200 is corrected by making the following
correcting amendment:

PART 200--ORGANIZATION; CONDUCT AND ETHICS; AND INFORMATION AND
REQUESTS

0
1. The authority citation for Part 200 continues to read in part as
follows:

    Authority: 15 U.S.C. 77o, 77s, 77sss, 78d, 78d-1, 78d-2, 78w,
78ll(d), 78mm, 80a-37, 80b-11, and 7202, unless otherwise noted.
* * * * *

Sec.  200.30-3  [Amended]

0
2. Section 200.30-3(a)(59) is amended by revising the cite
``(e)(6)(iii)'' to read ``(f)(6)(iii)''.

    Dated: January 5, 2007.
Nancy M. Morris,
Secretary.
 [FR Doc. E7-238 Filed 1-10-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: February 25, 2010 (Volume 75, Number 37)]
[Rules and Regulations]
[Page 8481-8482]
[DOCID:fr25fe10-8]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0876; Airspace Docket No. 09-ASW-24]

Amendment of Class E Airspace; Stamford, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace for Stamford, TX, adding
additional controlled airspace to accommodate Area Navigation (RNAV)
Standard Instrument Approach Procedures (SIAPs) at Arledge Field
Airport, Stamford, TX. The FAA is taking this action to enhance the
safety and management of Instrument Flight Rule (IFR) operations at the
airport.

DATES: Effective date: 0901 UTC, June 3, 2010. 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 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On November 24, 2009, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace for Stamford,
TX, reconfiguring controlled airspace at Arledge Field Airport (74 FR
61289) Docket No. FAA-2009-0876. 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 7400.9T
signed August 27, 2009, and effective September 15, 2009, which is
incorporated by reference in 14 CFR Part 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace for the Stamford, TX area, adding
additional controlled airspace extending upward from 700 feet above the
surface to accommodate SIAPs at Arledge Field Airport. This action is
necessary for the safety and management of IFR operations at the
airport.
    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.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, 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 controlled airspace at Arledge Field Airport, Stamford,
TX.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
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 14 CFR Part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR Part 71.1 of the Federal
Aviation Administration Order 7400.9T, Airspace Designations and
Reporting Points, signed August 27, 2009, and effective September 15,
2009, is amended as follows:
* * * * *
Paragraph 6005 Class E airspace areas extending upward from 700 feet
or more above the surface.
* * * * *

ASW TX E5 Stamford, TX [Amended]

Arledge Field Airport, TX
    (Lat. 32[deg]54'33'' N., long. 99[deg]44'10'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Arledge Field Airport, and within 2
miles each side of the 180[deg] bearing from the airport extending
from the 6.4-mile radius to 11.5 miles south of the airport.

    Issued in Fort Worth, Texas, on February 4, 2010.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-3716 Filed 2-24-10; 8:45 am]
BILLING CODE 4910-13-P