General Information on Postal Service, 14534-14535 [05-5360]
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14534
Federal Register / Vol. 70, No. 55 / Wednesday, March 23, 2005 / Rules and Regulations
III. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866
and the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Public
Law 104–4). Executive Order 12866
directs agencies to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). The agency
believes that this final rule is not a
significant regulatory action under the
Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because classification of these
devices into class II will relieve
manufacturers of the device of the cost
of complying with the premarket
approval requirements of section 515 of
the act (21 U.S.C. 360e), and may permit
small potential competitors to enter the
marketplace by lowering their costs, the
agency certifies that the final rule will
not have a significant impact on a
substantial number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $115
million, using the most current (2003)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
IV. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, the
agency has concluded that the rule does
not contain policies that have
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15:01 Mar 22, 2005
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federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
V. Paperwork Reduction Act of 1995
Dated: March 10, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–5643 Filed 3–22–05; 8:45 am]
BILLING CODE 4160–01–S
This final rule contains no collections
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
POSTAL SERVICE
VI. Reference
General Information on Postal Service
The following reference has been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
AGENCY:
1. Petition from Vysis, Inc., dated October
13, 2004.
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, Medical
devices.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 866 is
amended as follows:
PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for 21 CFR
part 866 continues to read as follows:
I
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Section 866.4700 is added to subpart
E to read as follows:
I
§ 866.4700 Automated fluorescence in situ
hybridization (FISH) enumeration systems.
(a) Identification. An automated FISH
enumeration system is a device that
consists of an automated scanning
microscope, image analysis system, and
customized software applications for
FISH assays. This device is intended for
in vitro diagnostic use with FISH assays
as an aid in the detection, counting and
classification of cells based on
recognition of cellular color, size, and
shape, and in the detection and
enumeration of FISH signals in
interphase nuclei of formalin-fixed,
paraffin-embedded human tissue
specimens.
(b) Classification. Class II (special
controls). The special control is FDA’s
guidance document entitled ‘‘Class II
Special Controls Guidance Document:
Automated Fluorescence in situ
Hybridization (FISH) Enumeration
Systems.’’ See § 866.1(e) for the
availability of this guidance document.
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39 CFR Part 111
ACTION:
Postal Service.
Final rule.
SUMMARY: The Postal Service will issue
a redesigned Domestic Mail Manual
(DMM). The redesigned manual is
renamed, Mailing Standards of the
United States Postal Service, Domestic
Mail Manual, and replaces the former
Domestic Mail Manual, Issue 58. The
redesigned manual is not intended to
alter existing standards in DMM 58, and
contains the mailing standards effective
through January 6, 2005. The new
manual presents USPS domestic mailing
standards in a manner that increases
usability and provides better access to
USPS products and services.
DATES: Effective Date: This final rule is
effective on March 23, 2005. The
incorporation by reference of Mailing
Standards of the United States Postal
Service, Domestic Mail Manual, is
approved by the Director of the Federal
Register as of March 23, 2005.
FOR FURTHER INFORMATION CONTACT:
Sherry L. Freda, (202) 268–7259.
SUPPLEMENTARY INFORMATION: Effective
March 20, 2005, the Postal Service will
release a redesigned DMM. The
redesigned DMM will be issued under a
new name, Mailing Standards of the
United States Postal Service, Domestic
Mail Manual, and will become the
official DMM that contains the domestic
mailing standards of the Postal Service
effective through January 6, 2005. On
March 20, the new DMM will be
available on line to all Postal employees
and customers.
Focusing on who is mailing led the
Postal Service to create a series of
guides to assist mailers, starting with
the consumer in the retail space. DMM
100, A Customer’s Guide to Mailing,
was launched in September 2002. That
work was followed by DMM 200, A
Guide to Mailing for Businesses and
Organizations, which focuses on the
information needs of small and medium
volume mailers. We believe these first
two provide access to postal services to
customers who may not have
considered using the mail before. These
two guides are now followed by the
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Federal Register / Vol. 70, No. 55 / Wednesday, March 23, 2005 / Rules and Regulations
Mailing Standards of the United States
Postal Service, Domestic Mail Manual,
which replaces the current DMM 58.
The redesigned DMM contains all
USPS domestic mailing standards,
reorganized in a way that is more
intuitive to the user. Essentially, the
new organization will (1) increase user’s
ability to find information, (2) increase
confidence that users have found all the
information they need, and (3) reduce
the need to consult multiple chapters of
the Manual to locate necessary
information.
It is important to note that the
redesign of the DMM does not alter and
should not be construed as altering
existing mailing standards in DMM 58.
The Postal Service has not revised any
standards based on the DMM redesign.
Changes to mailing standards will
continue to be published through
Federal Register notices and the Postal
Bulletin, and will appear in the next
printed version of Mailing Standards of
the United States Postal Service,
Domestic Mail Manual, and in the
online version available via Postal
Explorer (http//:pe.usps.gov).
List of Subjects in 39 CFR Part 111
Administrative practice and
procedure, Incorporation by reference.
In view of the considerations
discussed above, the Postal Service
hereby amends 39 CFR Part 111 as
follows:
I
14535
Authority: 5 U.S.C. 552(a); 39 U.S.C. 101,
401, 403, 414, 416, 3001–3011, 3201–3219,
3403–3406, 3621, 3626, 5001.
§§ 111.1, 111.2, 111.3, and 111.4
[Amended]
2. Amend §§ 111.1, 111.2, 111.3, and
111.4 by removing the words ‘‘Domestic
Mail Manual’’ each time they appear,
and adding the words ‘‘Mailing
Standards of the United States Postal
Service, Domestic Mail Manual’’ in their
place.
I
3. Amend § 111.3(f) by adding the
following new entry to the end of the
table:
I
PART 111—GENERAL INFORMATION
ON POSTAL SERVICE
§ 111.3 Amendment to the Mailing
Standards of the United States Postal
Service, Domestic Mail Manual.
1. The authority citation for part 111
continues to read as follows:
*
I
*
*
(f) * * *
*
*
Transmittal letter for issue
Dated
*
*
Premier Edition .................................................
*
*
*
January 6, 2005 ................................................
*
*
[insert FR citation for this Final Rule].
§ 111.4
dinotefuran, [N-methyl-N′-nitro-N′′((tetrahydro-3furanyl)methyl)guanidine] alone in or
on cattle meat, fat, and meat byproducts
(mbyp); goat meat, fat, and mbyp; hog
meat, fat, and mbyp; horse meat, fat, and
mbyp; sheep meat, fat, and mbyp; and
milk. Mitsui Chemicals, Inc. requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA).
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This docket facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT: Rita
Kumar, Registration Division (7505C),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8291; e-mail address:
kumar.rita@epa.gov.
[Amended]
4. Amend § 111.4 by removing ‘‘March
29, 1979’’ and adding ‘‘March 23, 2005’’
in its place.
I
Stanley F. Mires,
Chief Counsel, Legislative.
[FR Doc. 05–5360 Filed 3–22–05; 8:45 am]
BILLING CODE 7710–12–P
ENVIRONMENTAL PROTECTION
AGENCY
This regulation is effective
March 23, 2005. Objections and requests
for hearings must be received on or
before May 23, 2005.
DATES:
40 CFR Part 180
[OPP–2005–0003; FRL–7695–5]
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of
dinotefuran, [N-methyl-N′-nitro-N′′((tetrahydro-3furanyl)methyl)guanidine] and its
metabolites DN [1-methyl-3-(tetrahydro3-furylmethyl)guanidine] and UF [1methyl-3-(tetrahydro-3furylmethyl)urea], expressed as
dinotefuran in or on vegetable, fruiting,
group 8; vegetable, cucurbit, group 9;
brassica, head and stem, subgroup 5A;
grape; grape, raisin; potato; potato,
chips; potato, granules/flakes; tomato,
paste; cotton, undelinted seed; cotton,
gin byproducts; and for residues of
15:02 Mar 22, 2005
Jkt 205001
To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under docket
identification (ID) number OPP–2005–
0003. All documents in the docket are
listed in the EDOCKET index at
https://www.epa.gov/edocket. Although
listed in the index, some information is
not publicly available, i.e., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically in EDOCKET or in hard
copy at the Public Information and
Records Integrity Branch (PIRIB), Rm.
ADDRESSES:
Dinotefuran; Pesticide Tolerance
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SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
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]]>Agencies
[Federal Register Volume 70, Number 55 (Wednesday, March 23, 2005)]
[Rules and Regulations]
[Pages 14534-14535]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5360]
=======================================================================
-----------------------------------------------------------------------
POSTAL SERVICE
39 CFR Part 111
General Information on Postal Service
AGENCY: Postal Service.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Postal Service will issue a redesigned Domestic Mail
Manual (DMM). The redesigned manual is renamed, Mailing Standards of
the United States Postal Service, Domestic Mail Manual, and replaces
the former Domestic Mail Manual, Issue 58. The redesigned manual is not
intended to alter existing standards in DMM 58, and contains the
mailing standards effective through January 6, 2005. The new manual
presents USPS domestic mailing standards in a manner that increases
usability and provides better access to USPS products and services.
DATES: Effective Date: This final rule is effective on March 23, 2005.
The incorporation by reference of Mailing Standards of the United
States Postal Service, Domestic Mail Manual, is approved by the
Director of the Federal Register as of March 23, 2005.
FOR FURTHER INFORMATION CONTACT: Sherry L. Freda, (202) 268-7259.
SUPPLEMENTARY INFORMATION: Effective March 20, 2005, the Postal Service
will release a redesigned DMM. The redesigned DMM will be issued under
a new name, Mailing Standards of the United States Postal Service,
Domestic Mail Manual, and will become the official DMM that contains
the domestic mailing standards of the Postal Service effective through
January 6, 2005. On March 20, the new DMM will be available on line to
all Postal employees and customers.
Focusing on who is mailing led the Postal Service to create a
series of guides to assist mailers, starting with the consumer in the
retail space. DMM 100, A Customer's Guide to Mailing, was launched in
September 2002. That work was followed by DMM 200, A Guide to Mailing
for Businesses and Organizations, which focuses on the information
needs of small and medium volume mailers. We believe these first two
provide access to postal services to customers who may not have
considered using the mail before. These two guides are now followed by
the
[[Page 14535]]
Mailing Standards of the United States Postal Service, Domestic Mail
Manual, which replaces the current DMM 58.
The redesigned DMM contains all USPS domestic mailing standards,
reorganized in a way that is more intuitive to the user. Essentially,
the new organization will (1) increase user's ability to find
information, (2) increase confidence that users have found all the
information they need, and (3) reduce the need to consult multiple
chapters of the Manual to locate necessary information.
It is important to note that the redesign of the DMM does not alter
and should not be construed as altering existing mailing standards in
DMM 58. The Postal Service has not revised any standards based on the
DMM redesign. Changes to mailing standards will continue to be
published through Federal Register notices and the Postal Bulletin, and
will appear in the next printed version of Mailing Standards of the
United States Postal Service, Domestic Mail Manual, and in the online
version available via Postal Explorer (http//:pe.usps.gov).
List of Subjects in 39 CFR Part 111
Administrative practice and procedure, Incorporation by reference.
0
In view of the considerations discussed above, the Postal Service
hereby amends 39 CFR Part 111 as follows:
PART 111--GENERAL INFORMATION ON POSTAL SERVICE
0
1. The authority citation for part 111 continues to read as follows:
Authority: 5 U.S.C. 552(a); 39 U.S.C. 101, 401, 403, 414, 416,
3001-3011, 3201-3219, 3403-3406, 3621, 3626, 5001.
Sec. Sec. 111.1, 111.2, 111.3, and 111.4 [Amended]
0
2. Amend Sec. Sec. 111.1, 111.2, 111.3, and 111.4 by removing the
words ``Domestic Mail Manual'' each time they appear, and adding the
words ``Mailing Standards of the United States Postal Service, Domestic
Mail Manual'' in their place.
0
3. Amend Sec. 111.3(f) by adding the following new entry to the end of
the table:
Sec. 111.3 Amendment to the Mailing Standards of the United States
Postal Service, Domestic Mail Manual.
* * * * *
(f) * * *
------------------------------------------------------------------------
Federal Register
Transmittal letter for issue Dated publication
------------------------------------------------------------------------
* * * * * * *
Premier Edition................. January 6, 2005... [insert FR
citation for this
Final Rule].
------------------------------------------------------------------------
Sec. 111.4 [Amended]
0
4. Amend Sec. 111.4 by removing ``March 29, 1979'' and adding ``March
23, 2005'' in its place.
Stanley F. Mires,
Chief Counsel, Legislative.
[FR Doc. 05-5360 Filed 3-22-05; 8:45 am]
BILLING CODE 7710-12-P
