New Drugs Exempted From Prescription-Dispensing Requirements; Technical Amendment, 15043 [E7-5895]
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Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations
and standard temperature, and the type
of surface for which it is valid;
(4) The effect on landing distances of
operation on other than smooth hard
surfaces, when dry, determined under
SC 23.45(g); and
(5) The effect on landing distances of
runway slope and 50 percent of the
headwind component and 150 percent
of the tailwind component.
(b) Not applicable.
(c) Not applicable.
(d) In addition to paragraph (a) of this
section the following information must
be furnished—
(1) The accelerate-stop distance
determined under SC 23.55;
(2) The takeoff distance determined
under SC 23.59(a);
(3) At the option of the applicant, the
takeoff run determined under SC
23.59(b);
(4) The effect on accelerate-stop
distance, takeoff distance and, if
determined, takeoff run, of operation on
other than smooth hard surfaces, when
dry, determined under SC 23.45(g);
(5) The effect on accelerate-stop
distance, takeoff distance, and if
determined, takeoff run, of runway
slope and 50 percent of the headwind
component and 150 percent of the
tailwind component;
(6) The net takeoff flight path
determined under SC 23.61(b);
(7) The enroute gradient of climb/
descent with one engine inoperative,
determined under § 23.69(b);
(8) The effect, on the net takeoff flight
path and on the enroute gradient of
climb/descent with one engine
inoperative, of 50 percent of the
headwind component and 150 percent
of the tailwind component;
(9) Overweight landing performance
information (determined by
extrapolation and computed for the
range of weights between the maximum
landing and maximum takeoff weights)
as follows—
(i) The maximum weight for each
airport altitude and ambient
temperature at which the airplane
complies with the climb requirements of
SC 23.63(d)(2); and
(ii) The landing distance determined
under § 23.75 for each airport altitude
and standard temperature.
(10) The relationship between IAS
and CAS determined in accordance with
§ 23.1323 (b) and (c).
(11) The altimeter system calibration
required by § 23.1325(e).
VerDate Aug<31>2005
15:49 Mar 29, 2007
Jkt 211001
Issued in Kansas City, Missouri on March
23, 2007.
Kim Smith,
Manager, Small Airplane Directorate, Aircraft
Certification Service.
[FR Doc. E7–5951 Filed 3–29–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 310
[Docket No. 2007N–0099]
New Drugs Exempted From
Prescription-Dispensing
Requirements; Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
Amendments to the Federal
Food, Drug, and Cosmetic Act (the act)
necessitate several changes to the
citations used in Food and Drug
Administration (FDA) regulations
regarding the prescription-exemption
procedure and the list of new drugs that
are exempted from the prescriptiondispensing requirements. These changes
are editorial, pertaining only to
citations, and do not constitute a change
in FDA regulation.
DATES: This rule is effective March 30,
2007.
FOR FURTHER INFORMATION CONTACT:
Gerald M. Rachanow, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5496,
Silver Spring, MD 20993, 301–796–
2090.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Section
126 of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Public Law 105–115)
amended section 503(b)(1) of the act (21
U.S.C. 353(b)(1)). Specifically, the
previous paragraph (b)(1)(A) of the act
was stricken from the act and
paragraphs (b)(1)(B) and (b)(1)(C) were
redesignated as paragraphs (b)(1)(A) and
(b)(1)(B), respectively. This amendment
to the act necessitates that FDA revise
the corresponding citations in its
regulations. FDA is making this change
in 21 CFR part 310 (§§ 310.200 and
310.201). These changes are editorial,
pertaining only to citations, and do not
constitute a change in FDA regulation.
Publication of this document
constitutes final action on this change
under the Administrative Procedure Act
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
15043
(5 U.S.C. 553). Notice and public
procedures are unnecessary because
FDA is merely implementing a change
in citation to a section of the act as a
result of amendment of the act.
List of Subjects in 21 CFR Part 310
Administrative practice and
procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping
requirements.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 310 is
amended as follows:
PART 310—NEW DRUGS
1. The authority citation for 21 CFR
part 310 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360b–360f, 360j, 361(a), 371, 374,
375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
263b–263n.
§ 310.200
[Amended]
2. In § 310.200(a), (b), and (e) remove
‘‘503(b)(1)(C)’’ wherever it appears and
add in its place ‘‘503(b)(1)(B)’’.
I
§ 310.201
[Amended]
3. In § 310.201(a) remove
‘‘503(b)(1)(C)’’ and add in its place
‘‘503(b)(1)(B)’’.
I
Dated: March 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–5895 Filed 3–29–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9320]
RIN 1545-BF67
United States Dollar Approximate
Separate Transactions Method
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulation.
AGENCY:
SUMMARY: This document contains final
regulations which provide the
translation rates that must be used when
translating into dollars certain items and
amounts transferred by a qualified
business unit (QBU) to its home office
or parent corporation for purposes of
computing dollar approximate separate
transactions method (DASTM) gain or
loss. This regulation is necessary to
provide guidance under section 985
E:\FR\FM\30MRR1.SGM
30MRR1
]]>Agencies
[Federal Register Volume 72, Number 61 (Friday, March 30, 2007)]
[Rules and Regulations]
[Page 15043]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5895]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 310
[Docket No. 2007N-0099]
New Drugs Exempted From Prescription-Dispensing Requirements;
Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: Amendments to the Federal Food, Drug, and Cosmetic Act (the
act) necessitate several changes to the citations used in Food and Drug
Administration (FDA) regulations regarding the prescription-exemption
procedure and the list of new drugs that are exempted from the
prescription-dispensing requirements. These changes are editorial,
pertaining only to citations, and do not constitute a change in FDA
regulation.
DATES: This rule is effective March 30, 2007.
FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5496, Silver Spring, MD 20993, 301-796-
2090.
SUPPLEMENTARY INFORMATION: Section 126 of the Food and Drug
Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115)
amended section 503(b)(1) of the act (21 U.S.C. 353(b)(1)).
Specifically, the previous paragraph (b)(1)(A) of the act was stricken
from the act and paragraphs (b)(1)(B) and (b)(1)(C) were redesignated
as paragraphs (b)(1)(A) and (b)(1)(B), respectively. This amendment to
the act necessitates that FDA revise the corresponding citations in its
regulations. FDA is making this change in 21 CFR part 310 (Sec. Sec.
310.200 and 310.201). These changes are editorial, pertaining only to
citations, and do not constitute a change in FDA regulation.
Publication of this document constitutes final action on this
change under the Administrative Procedure Act (5 U.S.C. 553). Notice
and public procedures are unnecessary because FDA is merely
implementing a change in citation to a section of the act as a result
of amendment of the act.
List of Subjects in 21 CFR Part 310
Administrative practice and procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
310 is amended as follows:
PART 310--NEW DRUGS
0
1. The authority citation for 21 CFR part 310 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f,
360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
263b-263n.
Sec. 310.200 [Amended]
0
2. In Sec. 310.200(a), (b), and (e) remove ``503(b)(1)(C)'' wherever
it appears and add in its place ``503(b)(1)(B)''.
Sec. 310.201 [Amended]
0
3. In Sec. 310.201(a) remove ``503(b)(1)(C)'' and add in its place
``503(b)(1)(B)''.
Dated: March 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5895 Filed 3-29-07; 8:45 am]
BILLING CODE 4160-01-S
