Periodic Reporting, 7426 [2010-3225]
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7426
Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules
data in such a way that the data do not
represent what actually occurred.
Examples of falsification of data
include, but are not limited to, the
following:
(A) Creating data that were never
obtained (e.g., making up data or results
and recording or reporting them;
reporting enrollment in a study of a
subject who did not exist; forging the
signature on an informed consent form);
(B) Altering data by replacing original
data with something different that does
not accurately reflect study conduct or
results (e.g., changing a laboratory
measurement to a less extreme deviation
from normal);
(C) Recording or obtaining data from
a specimen, sample, or test whose origin
is not accurately described or in a way
that does not accurately reflect the data
(e.g., changing the date of a specimen,
sample, or test; adding a substance not
called for in the study to a specimen or
sample; identifying a specimen, sample,
or test as coming from a specific subject
when it came from a source other than
the subject);
(D) Omitting data that were obtained
and would be appropriate for recording
based on study design and conduct (e.g.,
not recording exclusionary medical
history or prohibited concomitant
medications or treatments; omitting data
so that a statistical analysis yields a
result that would not have been
obtained had all data been analyzed).
(ii) The term data includes, but is not
limited to, individual facts, tests,
specimens, samples, results, statistics,
items of information, or statements
made by individuals.
(2) Sponsors should not report errors
(e.g., typographical errors, transposed
numbers or characters) to FDA under
paragraph (d) of this section.
Dated: February 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3123 Filed 2–18–10; 8:45 am]
BILLING CODE 4160–01–S
POSTAL REGULATORY COMMISSION
39 CFR Part 3050
srobinson on DSKHWCL6B1PROD with PROPOSALS
[Docket No. RM2010–8; Order No. 406]
Periodic Reporting
Postal Regulatory Commission.
ACTION: Advance notice of proposed
rulemaking; availability of rulemaking
petition.
AGENCY:
The Commission is noticing a
Postal Service petition proposing a
change in transportation cost system
SUMMARY:
VerDate Nov<24>2008
16:02 Feb 18, 2010
Jkt 220001
sampling. The proposal involves
distributing rail costs using inter-BMC
highway distribution factors. This
notice briefly describes the Postal
Service’s rationale for proposing this
change and addresses procedural steps
associated with the petition.
DATES: Comments are due: February 24,
2010.
ADDRESSES: Submit comments
electronically via the Commission’s
Filing Online system at https://
www.prc.gov. Commenters who cannot
submit their views electronically should
contact the person identified in FOR
FURTHER INFORMATION CONTACT by
telephone for advice on alternatives to
electronic filing.
FOR FURTHER INFORMATION CONTACT:
Stephen L. Sharfman, General Counsel,
202–789–6820 or
stephen.sharfman@prc.gov.
SUPPLEMENTARY INFORMATION:
distribution key in FY 2009 would have
had a small impact on the share of
Segment 14 costs borne by each market
dominant product. Id. at 2. The Postal
Service comments that the impact will
be de minimis in FY 2010 when Rail
costs will make up a much smaller share
of Segment 14 costs. The Postal Service
states its desire to make the change
before Quarter 3 of FY 2010 makes more
efficient use of its data collection
resources. Id.
Table of Contents
III. Ordering Paragraphs
I. Background
II. Procedural Matters
III. Ordering Paragraphs
It is ordered:
1. The Petition of the United States
Postal Service Requesting Initiation of a
Proceeding to Consider a Proposed
Change in Analytic Principles (Proposal
One), filed February 9, 2010, is granted.
2. The Commission establishes Docket
No. RM2010–8 to consider the matters
raised by the Postal Service’s Petition.
3. Interested persons may submit
comments on Proposal One no later
than February 24, 2010.
4. Pursuant to 39 U.S.C. 505, Kenneth
Moeller is appointed to serve as the
Public Representative representing the
interests of the general public.
5. The Secretary shall arrange for
publication of this notice in the Federal
Register.
I. Background
On February 9, 2010, the Postal
Service filed a petition to initiate an
informal rulemaking proceeding to
consider a change in the analytical
methods approved for use in periodic
reporting.1 The Postal Service labels its
proposal ‘‘Proposal One’’ because it
intends that it relate to the FY 2010
rather than the FY 2009 compliance
reporting cycle. Proposal One seeks
authorization from the Commission to
immediately eliminate the rail portion
of the Transportation Cost System
(TRACS) sampling, and proposes
instead to distribute rail costs using the
Inter-BC highway distribution factors.
The Postal Service states that as part
of a realignment of its transportation
and distribution systems, it is shifting
much of its transportation needs from
rail to truck. Because rail costs are
rapidly dwindling, it proposes to
eliminate TRACS rail sampling, and to
use the TRACS inter-BMC distribtion in
place of the Rail distribution key in Cost
Segment 14. Table 1 of the supporting
material accompanying the Petition
(Proposal One) shows that Freight Rail
and Rail Plant Load costs are expected
to decline by 75 percent from FY 2009
to FY 2010, when they will amount to
less than $15 million. Id., Proposal One,
at 1. Table 2 shows that substituting the
inter-BMC distribution key for the Rail
1 Petition of the United States Postal Service
Requesting Initiation of a Proceeding to Consider a
Proposed Change in Analytic Principles (Proposal
One), February 9, 2010 (Petition).
PO 00000
Frm 00022
Fmt 4702
Sfmt 4702
II. Procedural Matters
The Commission sets February 24,
2010 as the due date for public
comments. The Commission will
determine the need for reply comments
after reviewing the initial comments
received.
Kenneth Moeller is designated as the
Public Representative to represent the
interests of the general public in this
proceeding.
By the Commission.
Shoshana M. Grove,
Secretary.
[FR Doc. 2010–3225 Filed 2–18–E8; 8:45 am]
BILLING CODE 7710–FW–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 80, 85, and 86
[EPA–HQ–OAR–2010–0052; FRL–9113–8]
RIN 2060–AI23; 2060–AQ12
Tier 2 Light-Duty Vehicle and LightDuty Truck Emission Standards and
Gasoline Sulfur Control Requirements
(Section 610 Review)
AGENCY: Environmental Protection
Agency (EPA).
E:\FR\FM\19FEP1.SGM
19FEP1
Agencies
[Federal Register Volume 75, Number 33 (Friday, February 19, 2010)]
[Proposed Rules]
[Page 7426]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3225]
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POSTAL REGULATORY COMMISSION
39 CFR Part 3050
[Docket No. RM2010-8; Order No. 406]
Periodic Reporting
AGENCY: Postal Regulatory Commission.
ACTION: Advance notice of proposed rulemaking; availability of
rulemaking petition.
-----------------------------------------------------------------------
SUMMARY: The Commission is noticing a Postal Service petition proposing
a change in transportation cost system sampling. The proposal involves
distributing rail costs using inter-BMC highway distribution factors.
This notice briefly describes the Postal Service's rationale for
proposing this change and addresses procedural steps associated with
the petition.
DATES: Comments are due: February 24, 2010.
ADDRESSES: Submit comments electronically via the Commission's Filing
Online system at https://www.prc.gov. Commenters who cannot submit their
views electronically should contact the person identified in FOR
FURTHER INFORMATION CONTACT by telephone for advice on alternatives to
electronic filing.
FOR FURTHER INFORMATION CONTACT: Stephen L. Sharfman, General Counsel,
202-789-6820 or stephen.sharfman@prc.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Procedural Matters
III. Ordering Paragraphs
I. Background
On February 9, 2010, the Postal Service filed a petition to
initiate an informal rulemaking proceeding to consider a change in the
analytical methods approved for use in periodic reporting.\1\ The
Postal Service labels its proposal ``Proposal One'' because it intends
that it relate to the FY 2010 rather than the FY 2009 compliance
reporting cycle. Proposal One seeks authorization from the Commission
to immediately eliminate the rail portion of the Transportation Cost
System (TRACS) sampling, and proposes instead to distribute rail costs
using the Inter-BC highway distribution factors.
---------------------------------------------------------------------------
\1\ Petition of the United States Postal Service Requesting
Initiation of a Proceeding to Consider a Proposed Change in Analytic
Principles (Proposal One), February 9, 2010 (Petition).
---------------------------------------------------------------------------
The Postal Service states that as part of a realignment of its
transportation and distribution systems, it is shifting much of its
transportation needs from rail to truck. Because rail costs are rapidly
dwindling, it proposes to eliminate TRACS rail sampling, and to use the
TRACS inter-BMC distribtion in place of the Rail distribution key in
Cost Segment 14. Table 1 of the supporting material accompanying the
Petition (Proposal One) shows that Freight Rail and Rail Plant Load
costs are expected to decline by 75 percent from FY 2009 to FY 2010,
when they will amount to less than $15 million. Id., Proposal One, at
1. Table 2 shows that substituting the inter-BMC distribution key for
the Rail distribution key in FY 2009 would have had a small impact on
the share of Segment 14 costs borne by each market dominant product.
Id. at 2. The Postal Service comments that the impact will be de
minimis in FY 2010 when Rail costs will make up a much smaller share of
Segment 14 costs. The Postal Service states its desire to make the
change before Quarter 3 of FY 2010 makes more efficient use of its data
collection resources. Id.
II. Procedural Matters
The Commission sets February 24, 2010 as the due date for public
comments. The Commission will determine the need for reply comments
after reviewing the initial comments received.
Kenneth Moeller is designated as the Public Representative to
represent the interests of the general public in this proceeding.
III. Ordering Paragraphs
It is ordered:
1. The Petition of the United States Postal Service Requesting
Initiation of a Proceeding to Consider a Proposed Change in Analytic
Principles (Proposal One), filed February 9, 2010, is granted.
2. The Commission establishes Docket No. RM2010-8 to consider the
matters raised by the Postal Service's Petition.
3. Interested persons may submit comments on Proposal One no later
than February 24, 2010.
4. Pursuant to 39 U.S.C. 505, Kenneth Moeller is appointed to serve
as the Public Representative representing the interests of the general
public.
5. The Secretary shall arrange for publication of this notice in
the Federal Register.
By the Commission.
Shoshana M. Grove,
Secretary.
[FR Doc. 2010-3225 Filed 2-18-E8; 8:45 am]
BILLING CODE 7710-FW-S