Technical Amendments To Change a Cross-Reference and To Remove Reference to an Obsolete Form, 14977-14978 [05-5774]
Download as PDF
Federal Register / Vol. 70, No. 56 / Thursday, March 24, 2005 / Rules and Regulations
or on the distribution of power and
responsibilities among the various
levels of government. Therefore, it is
determined that this final rule does not
have federalism implications under
Executive Order 13132.
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.
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 the airspace necessary
to ensure the safety of aircraft and the
efficient use of airspace. This regulation
is within the scope of that authority
since it contains aircraft executing
instrument approach procedures to TriCity Airport.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
Accordingly, the Federal Aviation
Administration amends 14 CFR part 71
as follows:
I
PART 71—DESIGNATION OF CLASS A,
CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS;
AIRWAYS; ROUTES; AND REPORTING
POINTS
1. The authority citation for part 71
continues to read as follows:
I
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in 14
CFR 71.1 of Federal Aviation
Administration Order 7400.9M, dated
August 30, 2004, and effective
September 16, 2004, is amended as
follows:
I
VerDate jul<14>2003
15:02 Mar 23, 2005
Jkt 205001
Paragraph 6005 Class E airspace areas
extending upward from 700 feet or more
above the surface of the earth.
*
*
*
*
*
ACE KS E5 Parsons, KS
Parsons, Tri-City Airport, KS
(Lat. 37°19′48″ N., long. 95°30′22″ W.)
Parsons NDB
(Lat. 37°20′17″ N., long. 95°30′31″ W.)
That airspace extending upward from 700
feet above the surface within a 7.5-mile
radius of Tri-City Airport and within 2.5
miles each side of the 009° bearing from the
Parsons NDB extending from the 7.5-mile
radius of the airport to 7 miles north of the
NDB.
*
*
*
*
*
Issued in Kansas City, MO, on March 14,
2005.
Anthony D. Roetzel,
Acting Area Director, Western Flight Services
Operations.
[FR Doc. 05–5837 Filed 3–23–05; 8:45 am]
BILLING CODE 4910–13–M
[Regulation Nos. 4 and 22]
RIN 0960–AG24
Technical Amendments To Change a
Cross-Reference and To Remove
Reference to an Obsolete Form
Social Security Administration.
Correcting amendments.
AGENCY:
SUMMARY: This document contains two
technical corrections to our regulations.
The first correction changes a crossreference in our regulations regarding
how we credit quarters of coverage for
calendar years before 1978. The second
correction removes reference to a form
that has been obsolete since November
2002.
EFFECTIVE DATE: Effective on March 24,
2005.
FOR FURTHER INFORMATION CONTACT:
Rosemarie Greenwald, Policy Analyst,
Office of Program Development and
Research, Social Security
Administration, 6401 Security
Boulevard, Baltimore, MD 21235–6401.
Call (410) 965–5651 or TTY 1–800–325–
0778 for information about these
correcting amendments. For information
on eligibility or filing for benefits, call
our national toll-free number 1–(800)
772–1213 or TTY 1–(800) 325–0778.
You may also contact Social Security
Online at
https://www.socialsecurity.gov/.
SUPPLEMENTARY INFORMATION: We are
making two corrections to our current
Frm 00009
Fmt 4700
(Catalog of Federal Domestic Assistance
Programs Nos. 96.001, Social Security—
Disability Insurance; 96.002, Social
Security—Retirement Insurance; 96.004,
Social Security—Survivors Insurance)
Sfmt 4700
20 CFR Part 404
Administrative practice and
procedure, Blind, Disability benefits,
Old-Age, Survivors and Disability
Insurance, Reporting and recordkeeping
requirements, Social Security.
20 CFR Parts 404 and 422
PO 00000
regulations. The first correction is being
made to 20 CFR 404.141, How we credit
quarters of coverage for calendar years
before 1978. The cross-reference in
paragraph (d)(1) of this section
incorrectly cross-refers to § 404.1027(a).
The correct cross reference should be to
§§ 404.1047 and 404.1096, which
contain the annual wage limitations
based on wages and self-employment
income.
The second correction we are making
is to remove from § 422.505(b) the
reference to, and description of, form
SSA–1388, Report of Student
Beneficiary at End of School Year. This
form became obsolete on November 1,
2002.
List of Subjects
SOCIAL SECURITY ADMINISTRATION
ACTION:
14977
20 CFR Part 422
Administrative practice and
procedure, Organization and functions
(Government agencies), Reporting and
recordkeeping requirements, Social
Security.
Dated: March 17, 2005.
Martin Sussman,
Regulations Officer.
For the reasons set out in the preamble,
part 404 and part 422 of chapter III of
title 20 of the Code of Federal
Regulations are corrected by making the
following correcting amendments:
I
PART 404–FEDERAL OLD-AGE,
SURVIVORS AND DISABILITY
INSURANCE (1950–)
Subpart B—[Amended]
1. The authority citation for subpart B
continues to read as follows:
I
Authority: Secs. 205(a), 212, 213, 214, 216,
217, 223 and 702(a)(5) of the Social Security
Act (42 U.S.C. 405 (a), 412, 413, 414, 416,
417, 423 and 902(a)(5)).
§ 404.141
[Amended]
2. Paragraph (d)(1) of § 404.141 is
amended by correcting the reference
‘‘§ 404.1027(a)’’ to read ‘‘§§ 404.1047 and
404.1096.’’
I
E:\FR\FM\24MRR1.SGM
24MRR1
14978
Federal Register / Vol. 70, No. 56 / Thursday, March 24, 2005 / Rules and Regulations
have been revised to reflect these
changes.
PART 422—ORGANIZATION AND
PROCEDURES
SUPPLEMENTARY INFORMATION:
Subpart F—[Amended]
A. Transfer of Regulatory Responsibility
from the Center for Biologics Evaluation
and Research to the Center for Drug
Evaluation and Research
In a letter dated June 20, 2003, FDA
notified sponsors that the regulatory
responsibility, review, and continuing
oversight for many biological products
would be transferred from CBER to
CDER. This change in regulatory
responsibility resulted in the transfer of
applications for the affected product
classes (see section I.B of this
document). This consolidation initiative
was undertaken to provide greater
opportunities to further develop and
coordinate scientific and regulatory
activities between CBER and CDER,
leading to a more efficient, effective,
and consistent review program for
human drugs and biologics.
In the Federal Register of June 26,
2003 (68 FR 38067), we published a
notice announcing the transfer of certain
product oversight from CBER to CDER.
On June 30, 2003, the responsibility for
regulating most therapeutic biologics,
with certain exceptions (e.g., cell and
gene therapy products and therapeutic
vaccines) was transferred from the
Office of Therapeutics Research and
Review (OTRR), CBER, to the Office of
New Drugs (OND) and the Office of
Pharmaceutical Science (OPS), CDER.
Initially, this transfer of products was
effected when the divisions of OTRR
formerly within CBER were detailed to
offices within CDER. On October 1,
2003, those CBER offices detailed to
CDER were incorporated into CDER’s
organizational structure. Throughout
these transitions, the staff that was
formerly with OTRR, CBER, maintained
responsibility for the therapeutic
biologic products.
The two new CDER offices established
for review of the therapeutic biologics
include the OND, Office of Drug
Evaluation VI (ODE VI), and the OPS,
Office of Biotechnology Products (OBP).
Within ODE VI, the following divisions
were established: Division of
Therapeutic Biological Oncology
Products, Division of Therapeutic
Biological Internal Medicine Products,
and Division of Review Management
and Policy. Within OBP, the following
divisions were established: Division of
Monoclonal Antibodies and Division of
Therapeutic Proteins. The delegations of
authority for CBER and CDER, which
give officials in the Centers the legal
authority needed to take substantive
actions and perform certain functions of
the Commissioner of Food and Drugs,
I. Background
3. The authority citation for subpart F
continues to read as follows:
I
Authority: Secs. 205 and 702(a)(5) of the
Social Security Act (42 U.S.C. 405 and
902(a)(5).
§ 422.505
[Amended]
4. In the list of forms in paragraph (b)
of § 422.505, remove the form SSA—
1388 and its description.
I
[FR Doc. 05–5774 Filed 3–23–05; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 25, 26, 99, 201, 203,
206, 310, 312, 314, 600, 601, 606, 607,
610, 640, 660, 680, 807, and 822
Food and Drug Administration
Regulations; Drug and Biological
Product Consolidation; Addresses;
Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending
certain regulations regarding biological
products to include references to the
Center for Drug Evaluation and Research
(CDER) or the Director, CDER, and to
include CDER address information or
updated CDER address information,
where appropriate. FDA is also
amending the regulations to update
mailing address information including
mailing codes for the Center for
Biologics Evaluation and Research
(CBER), and to place the current mailing
addresses for certain biologics
regulations in a single location. These
changes, among others, are being taken
to reflect the reorganization between
CBER and CDER due to the transfer of
responsibility for certain products from
CBER to CDER, and to ensure the
consistency and accuracy of the
regulations.
DATES: This rule is effective March 24,
2005.
FOR FURTHER INFORMATION CONTACT:
Stephen M. Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
VerDate jul<14>2003
15:02 Mar 23, 2005
Jkt 205001
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
B. Products Transferred to CDER and
Products Remaining in CBER
The change in regulatory
responsibility resulted in the transfer of
applications to CDER for products
belonging to the following product
classes:
• Monoclonal antibodies for in-vivo
use;
• Proteins intended for therapeutic
use, including cytokines (e.g.,
interferons), enzymes (e.g.,
thrombolytics), and other novel
proteins, except for those that are
specifically assigned to CBER (e.g.,
vaccines and blood products). This
category includes therapeutic proteins
derived from plants, animals, or
microorganisms, and recombinant
versions of these products;
• Immunomodulators (nonvaccine
and nonallergenic products intended to
treat disease by inhibiting or modifying
a preexisting immune response); and
• Growth factors, cytokines, and
monoclonal antibodies intended to
mobilize, stimulate, decrease or
otherwise alter the production of
hematopoietic cells in vivo.1
The following biological product classes
remain at CBER:
• Cellular products, including
products composed of human, bacterial
or animal cells (such as pancreatic islet
cells for transplantation), or from
physical parts of those cells (such as
whole cells, cell fragments, or other
components intended for use as
preventative or therapeutic vaccines);
• Allergenic extracts used for the
diagnosis and treatment of allergic
diseases and allergen patch tests;
• Antitoxins, antivenins, and venoms;
• Vaccines (products intended to
induce or increase an antigen specific
immune response for prophylactic or
therapeutic immunization, regardless of
the composition or method of
manufacture);
• Blood, blood components, plasma
derived products (e.g., albumin,
immunoglobulins, clotting factors, fibrin
sealants, proteinase inhibitors),
including recombinant and transgenic
versions of plasma derivatives (e.g.,
clotting factors), blood substitutes,
1 Growth factors, cytokines, and monoclonal
antibodies intended to mobilize, stimulate, decrease
or otherwise alter the production of hematopoietic
cells in vivo, for the purpose of being harvested for
use in the production of a therapeutic cellular or
blood product, may be regulated in combination
with the therapeutic cellular or blood product, as
appropriate. Sponsors of products that fit this
description should contact the center jurisdiction
officers for guidance on appropriate center
assignment.
E:\FR\FM\24MRR1.SGM
24MRR1
Agencies
[Federal Register Volume 70, Number 56 (Thursday, March 24, 2005)]
[Rules and Regulations]
[Pages 14977-14978]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5774]
=======================================================================
-----------------------------------------------------------------------
SOCIAL SECURITY ADMINISTRATION
20 CFR Parts 404 and 422
[Regulation Nos. 4 and 22]
RIN 0960-AG24
Technical Amendments To Change a Cross-Reference and To Remove
Reference to an Obsolete Form
AGENCY: Social Security Administration.
ACTION: Correcting amendments.
-----------------------------------------------------------------------
SUMMARY: This document contains two technical corrections to our
regulations. The first correction changes a cross-reference in our
regulations regarding how we credit quarters of coverage for calendar
years before 1978. The second correction removes reference to a form
that has been obsolete since November 2002.
EFFECTIVE DATE: Effective on March 24, 2005.
FOR FURTHER INFORMATION CONTACT: Rosemarie Greenwald, Policy Analyst,
Office of Program Development and Research, Social Security
Administration, 6401 Security Boulevard, Baltimore, MD 21235-6401. Call
(410) 965-5651 or TTY 1-800-325-0778 for information about these
correcting amendments. For information on eligibility or filing for
benefits, call our national toll-free number 1-(800) 772-1213 or TTY 1-
(800) 325-0778. You may also contact Social Security Online at https://
www.socialsecurity.gov/.
SUPPLEMENTARY INFORMATION: We are making two corrections to our current
regulations. The first correction is being made to 20 CFR 404.141, How
we credit quarters of coverage for calendar years before 1978. The
cross-reference in paragraph (d)(1) of this section incorrectly cross-
refers to Sec. 404.1027(a). The correct cross reference should be to
Sec. Sec. 404.1047 and 404.1096, which contain the annual wage
limitations based on wages and self-employment income.
The second correction we are making is to remove from Sec.
422.505(b) the reference to, and description of, form SSA-1388, Report
of Student Beneficiary at End of School Year. This form became obsolete
on November 1, 2002.
(Catalog of Federal Domestic Assistance Programs Nos. 96.001, Social
Security--Disability Insurance; 96.002, Social Security--Retirement
Insurance; 96.004, Social Security--Survivors Insurance)
List of Subjects
20 CFR Part 404
Administrative practice and procedure, Blind, Disability benefits,
Old-Age, Survivors and Disability Insurance, Reporting and
recordkeeping requirements, Social Security.
20 CFR Part 422
Administrative practice and procedure, Organization and functions
(Government agencies), Reporting and recordkeeping requirements, Social
Security.
Dated: March 17, 2005.
Martin Sussman,
Regulations Officer.
0
For the reasons set out in the preamble, part 404 and part 422 of
chapter III of title 20 of the Code of Federal Regulations are
corrected by making the following correcting amendments:
PART 404-FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950-
)
Subpart B--[Amended]
0
1. The authority citation for subpart B continues to read as follows:
Authority: Secs. 205(a), 212, 213, 214, 216, 217, 223 and
702(a)(5) of the Social Security Act (42 U.S.C. 405 (a), 412, 413,
414, 416, 417, 423 and 902(a)(5)).
Sec. 404.141 [Amended]
0
2. Paragraph (d)(1) of Sec. 404.141 is amended by correcting the
reference ``Sec. 404.1027(a)'' to read ``Sec. Sec. 404.1047 and
404.1096.''
[[Page 14978]]
PART 422--ORGANIZATION AND PROCEDURES
Subpart F--[Amended]
0
3. The authority citation for subpart F continues to read as follows:
Authority: Secs. 205 and 702(a)(5) of the Social Security Act
(42 U.S.C. 405 and 902(a)(5).
Sec. 422.505 [Amended]
0
4. In the list of forms in paragraph (b) of Sec. 422.505, remove the
form SSA--1388 and its description.
[FR Doc. 05-5774 Filed 3-23-05; 8:45 am]
BILLING CODE 4191-02-P