Investigational New Drug Applications; Technical Amendment, 55770-55771 [E9-26095]
Download as PDF
<![CDATA[
55770
Federal Register / Vol. 74, No. 208 / Thursday, October 29, 2009 / Rules and Regulations
Material Incorporated by Reference
(i) You must use Bombardier Service
Bulletin 670BA–27–051, dated May 14, 2009,
to do the actions required by this AD, unless
the AD specifies otherwise.
(1) The Director of the Federal Register
approved the incorporation by reference of
this service information under 5 U.S.C.
552(a) and 1 CFR part 51.
(2) For service information identified in
ˆ
this AD, contact Bombardier, Inc., 400 Cote
´
Vertu Road West, Dorval, Quebec H4S 1Y9,
Canada; telephone 514–855–5000; fax 514–
855–7401; e-mail
thd.crj@aero.bombardier.com; Internet https://
www.bombardier.com.
(3) You may review copies of the service
information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the
availability of this material at the FAA, call
425–227–1221 or 425–227–1152.
(4) You may also review copies of the
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 202–741–6030, or go
to: https://www.archives.gov/federal_register/
code_of_federal_regulations/
ibr_locations.html.
3. In § 35.17, the heading and
paragraphs (c) and (d) are revised to
read as follows:
Background
■
The final regulations that are the
subject of these corrections concern the
filing of rate schedules, tariffs, and
service agreements under the Federal
Power Act.
§ 35.17 Withdrawals and amendments of
rate schedule, tariff or service agreement
filings.
Need for Correction
*
BILLING CODE 4910–13–P
■
*
*
*
*
(c) Withdrawal of suspended rate
schedules, tariffs, or service agreements,
or parts thereof. Where a rate schedule,
tariff, or service agreement, or part
thereof has been suspended by the
Commission, it may be withdrawn
during the period of suspension only by
special permission of the Commission
granted upon application therefor and
for good cause shown. If permitted to be
withdrawn, any such rate schedule,
tariff, or service agreement may be
refiled with the Commission within a
one-year period thereafter only with
special permission of the Commission
for good cause shown.
(d) Changes in suspended rate
schedules, tariffs, or service agreements,
or parts thereof. A public utility may
not, within the period of suspension,
file any change in a rate schedule, tariff,
or service agreement, or part thereof,
which has been suspended by order of
the Commission except by special
permission of the Commission granted
upon application therefor and for good
cause shown.
*
*
*
*
*
DEPARTMENT OF ENERGY
§ 35.1 Application; obligation to file rate
schedules, tariffs and certain service
agreements.
Kimberly D. Bose,
Secretary.
[FR Doc. E9–25972 Filed 10–28–09; 8:45 am]
Issued in Renton, Washington, on October
16, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. E9–25917 Filed 10–28–09; 8:45 am]
[Docket No. RM01–5–000; Order No. 714]
Electronic Tariff Filings; Correction
October 23, 2009.
Federal Energy Regulatory
Commission, DOE.
ACTION: Correcting amendments.
AGENCY:
This document contains
corrections to the final regulations,
which were published in the Federal
Register of Wednesday, October 3, 2008
(73 FR 57515). The regulations relate to
the obligation to file rate schedules,
tariffs and certain service agreements
and to the withdrawals and
amendments of rate schedules, and tariff
or service agreement filings.
DATES: Effective on October 29, 2009.
FOR FURTHER INFORMATION CONTACT:
Andre Goodson, 888 First St., NE.,
Washington, DC 20426, (202) 502–8560,
Andre.Goodson@ferc.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
dcolon on DSK2BSOYB1PROD with RULES
Electric power rates, Electric utilities,
Reporting and recordkeeping
requirements, Electricity, Incorporation
by reference.
■ Accordingly, 18 CFR part 35 is
corrected by making the following
correcting amendments:
PART 35—FILING OF RATE
SCHEDULES AND TARIFFS
1. The authority citation for part 35
continues to read as follows:
■
Authority: 16 U.S.C. 791A–825R, 2601–
2645; 31 U.S.C. 9701; 42 U.S.C. 7101–7352.
*
18 CFR Part 35
14:45 Oct 28, 2009
List of Subjects in 18 CFR Part 35
2. In § 35.1, paragraphs (b) and (c) are
revised to read as follows:
Federal Energy Regulatory
Commission
VerDate Nov<24>2008
In Order No. 714, the instructions for
the amendatory language contained
errors that resulted in the publication of
incorrect language in the Federal
Register for sections 35.1 and 35.17. In
particular, the published regulations do
not reflect that they are applicable to
rate schedules, tariffs, and service
agreements.
Jkt 220001
*
*
*
*
(b) A rate schedule, tariff, or service
agreement applicable to a transmission
or sale of electric energy, other than that
which proposes to supersede, cancel or
otherwise change the provisions of a
rate schedule, tariff, or service
agreement required to be on file with
this Commission, shall be filed as an
initial rate in accordance with § 35.12.
(c) A rate schedule, tariff, or service
agreement applicable to a transmission
or sale of electric energy which
proposes to supersede, cancel or
otherwise change any of the provisions
of a rate schedule, tariff, or service
agreement required to be on file with
this Commission (such as providing for
other or additional rates, charges,
classifications or services, or rules,
regulations, practices or contracts for a
particular customer or customers) shall
be filed as a change in rate in
accordance with § 35.13, except
cancellation or termination which shall
be filed as a change in accordance with
§ 35.15.
*
*
*
*
*
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 312
[Docket No. FDA–2009–N–0464]
Investigational New Drug Applications;
Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Final rule; technical
amendment.
SUMMARY: The Food and Drug
Administration (FDA) is amending its
investigational new drug application
(IND) regulations to add an address for
applicants to submit INDs for in vivo
bioavailability and bioequivalence
studies in humans. INDs for these
studies that are intended to support
abbreviated new drug applications
(ANDAs) should be sent directly to the
E:\FR\FM\29OCR1.SGM
29OCR1
Federal Register / Vol. 74, No. 208 / Thursday, October 29, 2009 / Rules and Regulations
Office of Generic Drugs. This action is
being taken to ensure accuracy and
clarity in the agency’s regulations.
DATES: This rule is effective October 29,
2009.
FOR FURTHER INFORMATION CONTACT:
Peter Chen, Center for Drug Evaluation
and Research (HFD–615), Food and
Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8436.
SUPPLEMENTARY INFORMATION: FDA is
amending its regulations in part 312 (21
CFR part 312) to clarify where ANDA
applicants should submit INDs for in
vivo bioavailability and bioequivalence
studies in humans. This document adds
the address for the Office of Generic
Drugs in § 312.140(a)(1).
Publication of this document
constitutes final action on these changes
under the Administrative Procedure Act
(5 U.S.C. 553). FDA has determined that
notice and public comment are
unnecessary because this amendment to
the regulations provides only technical
changes to add an address for the
submission of INDs related to ANDAs.
List of Subjects in 21 CFR Part 312
Drugs, Exports, Imports,
Investigations, Labeling, Medical
research, Reporting and recordkeeping
requirements, Safety.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 312 is
amended as follows:
PART 312—INVESTIGATIONAL NEW
DRUG APPLICATION
1. The authority citation for 21 CFR
part 312 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360bbb, 371; 42 U.S.C. 262.
2. Section 312.140 is amended by
revising paragraph (a)(1) to read as
follows:
■
dcolon on DSK2BSOYB1PROD with RULES
§ 312.140
Address for correspondence.
(a) * * *
(1) For drug products regulated by
CDER. Send the IND submission to the
Central Document Room, Center for
Drug Evaluation and Research, Food
and Drug Administration, 5901–B
Ammendale Rd., Beltsville, MD 20705–
1266; except send an IND submission
for an in vivo bioavailability or
bioequivalence study in humans to
support an abbreviated new drug
application to the Office of Generic
Drugs (HFD–600), Center for Drug
Evaluation and Research, Food and
Drug Administration, Metro Park North
II, 7500 Standish Pl., Rockville, MD
20855.
*
*
*
*
*
VerDate Nov<24>2008
14:45 Oct 28, 2009
Jkt 220001
Dated: October 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26095 Filed 10–28–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF DEFENSE
Office of the Secretary
[DOD–2006–HA–0149; RIN 0720–AB01]
32 CFR Part 199
Civilian Health and Medical Program of
the Uniformed Services (CHAMPUS);
TRICARE; Implementation of Changes
to the Pharmacy Benefits Program;
Double Coverage With Medicare Part D
Department of Defense.
Final rule.
AGENCY:
ACTION:
TRICARE eligible
beneficiaries, who are entitled to
Medicare Part A on the basis of age,
disability, or end-stage renal disease,
maintain their TRICARE eligibility
when they are enrolled in the
supplementary medical insurance
program under Part B of Medicare. In
general, in the case of medical or dental
care provided to these individuals for
which payment may be made under
both Medicare and TRICARE, Medicare
is the primary payer and TRICARE will
normally pay the actual out-of-pocket
costs incurred by the person. This final
rule prescribes double coverage
payment procedures and makes
revisions to TRICARE rules to
accommodate beneficiaries who are
eligible under both Medicare and
TRICARE, and who participate in
Medicare’s outpatient prescription drug
program under Medicare Part D. These
revisions are necessary because of the
requirements contained in the Centers
for Medicare and Medicaid Services
(CMS) final rule for the Medicare
Prescription Drug Benefit, Part D plans
with other prescription drug coverage.
This final rule also establishes
requirements and procedures for
implementation of the improvements to
the TRICARE Pharmacy Benefits
Program directed by section 714 of the
Ronald W. Reagan National Defense
Authorization Act (NDAA) for Fiscal
Year (FY) 2005 (NDAA FY 05) (Pub.
L.108–365). The rule clarifies that the
cost-sharing requirements for Medicareeligible beneficiaries may not be in
excess of the cost-sharing requirements
applicable to other retirees, their
dependents, former spouses and
survivors. Additionally, the rule
authorizes the Department of Defense
(DoD) Pharmacy and Therapeutics
SUMMARY:
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
55771
Committee (P&T) to make a separate and
additional determination of the relative
clinical and cost effectiveness of
pharmaceutical agents that provide
greater value than other uniform
formulary agents in that therapeutic
class. This rule also describes the
transition process that will occur as the
uniform formulary is developed and
uniform service facilities move to a
uniform formulary, consistent with their
scope of practice.
DATES: Effective Date: This final rule is
effective November 30, 2009.
FOR FURTHER INFORMATION CONTACT:
RADM Thomas McGinnis, TRICARE
Management Activity, Pharmaceutical
Operations Directorate, telephone (703)
681–2890.
SUPPLEMENTARY INFORMATION:
I. Double Coverage With Medicare
Part D
Section 101 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA),
(Pub. L. 108–173), amended Title XVIII
of the Social Security Act by
establishing a new Part D: the Voluntary
Prescription Drug Benefit Program
(henceforth, Medicare Part D). The
Department of Health and Human
Services, CMS, published their Final
Rule on January 28, 2005 (70 FR 4193–
4585). The addition of a prescription
drug benefit to Medicare represents a
landmark change to the Medicare
program, and became available to
beneficiaries beginning on January 1,
2006.
The Floyd D. Spence NDAA for FY
2001 (Pub. L. 106–398), established the
TRICARE Senior Pharmacy Program
under section 711 (which was effective
April 1, 2001). The Act, also under
section 712 (which was effective
October 1, 2001), continued TRICARE
eligibility for beneficiaries entitled to
Medicare Part A on the basis of age,
provided they also are enrolled in
Medicare Part B. This program has come
to be known as TRICARE for Life (TFL).
Under section 701 of the National
Defense Authorization Act for Fiscal
Year 2000 (Pub. L. 106–65), codified at
Title 10, U.S.C., Section 1074g, the
Department established its new
pharmacy benefits program for all
TRICARE beneficiaries (as implemented
by 32 CFR 199.21). The full
implementation of the pharmacy benefit
program was not effective until May 3,
2004; however, changes in pharmacy
cost shares were effective with the
implementation of TRICARE Senior
Pharmacy on April 1, 2001.
In implementing TRICARE Senior
Pharmacy, DoD stated that the double
E:\FR\FM\29OCR1.SGM
29OCR1
]]>Agencies
[Federal Register Volume 74, Number 208 (Thursday, October 29, 2009)]
[Rules and Regulations]
[Pages 55770-55771]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26095]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 312
[Docket No. FDA-2009-N-0464]
Investigational New Drug Applications; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
investigational new drug application (IND) regulations to add an
address for applicants to submit INDs for in vivo bioavailability and
bioequivalence studies in humans. INDs for these studies that are
intended to support abbreviated new drug applications (ANDAs) should be
sent directly to the
[[Page 55771]]
Office of Generic Drugs. This action is being taken to ensure accuracy
and clarity in the agency's regulations.
DATES: This rule is effective October 29, 2009.
FOR FURTHER INFORMATION CONTACT: Peter Chen, Center for Drug Evaluation
and Research (HFD-615), Food and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240-276-8436.
SUPPLEMENTARY INFORMATION: FDA is amending its regulations in part 312
(21 CFR part 312) to clarify where ANDA applicants should submit INDs
for in vivo bioavailability and bioequivalence studies in humans. This
document adds the address for the Office of Generic Drugs in Sec.
312.140(a)(1).
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has
determined that notice and public comment are unnecessary because this
amendment to the regulations provides only technical changes to add an
address for the submission of INDs related to ANDAs.
List of Subjects in 21 CFR Part 312
Drugs, Exports, Imports, Investigations, Labeling, Medical
research, Reporting and recordkeeping requirements, Safety.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
312 is amended as follows:
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION
0
1. The authority citation for 21 CFR part 312 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371;
42 U.S.C. 262.
0
2. Section 312.140 is amended by revising paragraph (a)(1) to read as
follows:
Sec. 312.140 Address for correspondence.
(a) * * *
(1) For drug products regulated by CDER. Send the IND submission to
the Central Document Room, Center for Drug Evaluation and Research,
Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD
20705-1266; except send an IND submission for an in vivo
bioavailability or bioequivalence study in humans to support an
abbreviated new drug application to the Office of Generic Drugs (HFD-
600), Center for Drug Evaluation and Research, Food and Drug
Administration, Metro Park North II, 7500 Standish Pl., Rockville, MD
20855.
* * * * *
Dated: October 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26095 Filed 10-28-09; 8:45 am]
BILLING CODE 4160-01-S
