Microbiology Devices; Reclassification of Hepatitis A Virus Serological Assays; Correction, 10433 [06-1871]
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Federal Register / Vol. 71, No. 40 / Wednesday, March 1, 2006 / Rules and Regulations
the Associate Commissioner for
Disability Determinations or his or her
delegate to be deficient, the Associate
Commissioner or his or her delegate will
take appropriate action to assure that
the deficiency is corrected before a
reconsidered determination is issued.
The action taken by the Associate
Commissioner or his or her delegate will
take one of two forms:
(1) The Associate Commissioner or
his or her delegate may return the case
file either to the component responsible
for preparing the case for hearing or to
the disability hearing officer, for
appropriate further action; or
(2) The Associate Commissioner or
his or her delegate may issue a written
reconsidered determination which
corrects the deficiency.
(c) Further action on your case if it is
sent back by the Associate
Commissioner for Disability
Determinations or his or her delegate
either to the component that prepared
your case for hearing or to the disability
hearing officer. If the Associate
Commissioner for Disability
Determinations or his or her delegate
sends your case back either to the
component responsible for preparing
the case for hearing or to the disability
hearing officer for appropriate further
action, as provided in paragraph (b)(1)
of this section, any additional
proceedings in your case will be
governed by the disability hearing
procedures described in § 416.1416(f) or
if your case is returned to the disability
hearing officer and an unfavorable
determination is indicated, a
supplementary hearing may be
scheduled for you before a reconsidered
determination is reached in your case.
(d) Opportunity to comment before
the Associate Commissioner for
Disability Determinations or his or her
delegate issues a reconsidered
determination that is unfavorable to
you. If the Associate Commissioner for
Disability Determinations or his or her
delegate proposes to issue a
reconsidered determination as described
in paragraph (b)(2) of this section, and
that reconsidered determination is
unfavorable to you, he or she will send
you a copy of the proposed reconsidered
determination with an explanation of
the reasons for it, and will give you an
opportunity to submit written
comments before it is issued. At your
request, you will also be given an
opportunity to inspect the pertinent
materials in your case file, including the
reconsidered determination prepared by
the disability hearing officer, before
submitting your comments. You will be
given 10 days from the date you receive
the Associate Commissioner’s notice of
VerDate Aug<31>2005
14:36 Feb 28, 2006
Jkt 208001
10433
proposed action to submit your written
comments, unless additional time is
necessary to provide access to the
pertinent file materials or there is good
cause for providing more time, as
illustrated by the examples in
§ 416.1411(b). The Associate
Commissioner or his or her delegate will
consider your comments before taking
any further action on your case.
have a significant economic impact on a
substantial number of small entities.
[FR Doc. 06–1872 Filed 2–28–06; 8:45 am]
DEPARTMENT OF HOMELAND
SECURITY
BILLING CODE 4191–02–P
Dated: February 21, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 06–1871 Filed 2–28–06; 8:45 am]
BILLING CODE 4160–01–S
Coast Guard
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
33 CFR Part 117
[CGD05–05–079]
RIN 1625–AA09
21 CFR Part 866
[Docket No. 2003P–0564]
Microbiology Devices; Reclassification
of Hepatitis A Virus Serological
Assays; Correction
Drawbridge Operation Regulations;
New Jersey Intracoastal Waterway,
Manasquan River
AGENCY:
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
final rule that appeared in the Federal
Register of February 9, 2006 (71 FR
6677). That document reclassified
hepatitis A virus (HAV) serological
assays from class III (premarket
approval) into class II (special controls).
That document inadvertently published
with an error. This document corrects
the error.
DATES: This rule is effective March 13,
2006.
FOR FURTHER INFORMATION CONTACT:
Sally Hojvat, Center for Devices and
Radiological Health (HFZ–440), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–0496.
SUPPLEMENTARY INFORMATION: In FR Doc.
06–1206, appearing on page 6677 in the
Federal Register of Thursday, February
9, 2006, the following correction is
made:
1. On page 6679, beginning in the first
column, under section ‘‘VI. Analysis of
Impacts,’’ the second paragraph is
corrected to read:
The Regulatory Flexibility Act requires
agencies to analyze regulatory options that
would minimize any significant impact of a
rule on small entities. Reclassification of
HAV serological assays from class III into
class II will relieve manufacturers of the cost
of complying with the premarket approval
requirements in section 515 of the act.
Because reclassification will reduce
regulatory costs with respect to these devices,
the agency certifies that the final rule will not
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
ACTION:
Coast Guard, DHS.
Temporary final rule.
SUMMARY: The Coast Guard is
temporarily changing the operating
regulations that govern the operation of
the Route 35 Bridge, at New Jersey
Intracoastal Waterway (NJICW) mile 1.1,
across Manasquan River, at Brielle, New
Jersey. The bridge will be closed to
navigation on three four-month closure
periods from 8 a.m. November 1, 2006
until 5 p.m. March 1, 2007; from 8 a.m.
on November 1, 2007 until 5 p.m. March
1, 2008; and from 8 a.m. on November
1, 2008 until 5 p.m. March 1, 2009.
Extensive structural, mechanical, and
electrical repairs and improvements
necessitate these closures.
DATES: This temporary final rule is
effective from April 17, 2006.
ADDRESSES: The 5th Coast Guard
District maintains the public docket for
this rulemaking. Comments and
material received from the public, as
well as documents indicated in this
preamble as being available in the
docket are part of docket CGD05–05–
079 and are available for inspection or
copying at Commander (obr), Fifth Coast
Guard District, Federal Building, 4th
Floor, 431 Crawford Street, Portsmouth,
Virginia 23703–5004, between 8 a.m.
and 4 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: Gary
Heyer, Bridge Management Specialist,
Fifth Coast Guard District, at (757) 398–
6629.
SUPPLEMENTARY INFORMATION:
Regulatory Information
On July 20, 2005, we published a
notice of proposed rule making (NPRM)
E:\FR\FM\01MRR1.SGM
01MRR1
]]>Agencies
[Federal Register Volume 71, Number 40 (Wednesday, March 1, 2006)]
[Rules and Regulations]
[Page 10433]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-1871]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. 2003P-0564]
Microbiology Devices; Reclassification of Hepatitis A Virus
Serological Assays; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule that appeared in the Federal Register of February 9, 2006 (71 FR
6677). That document reclassified hepatitis A virus (HAV) serological
assays from class III (premarket approval) into class II (special
controls). That document inadvertently published with an error. This
document corrects the error.
DATES: This rule is effective March 13, 2006.
FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-0496.
SUPPLEMENTARY INFORMATION: In FR Doc. 06-1206, appearing on page 6677
in the Federal Register of Thursday, February 9, 2006, the following
correction is made:
1. On page 6679, beginning in the first column, under section ``VI.
Analysis of Impacts,'' the second paragraph is corrected to read:
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a
rule on small entities. Reclassification of HAV serological assays
from class III into class II will relieve manufacturers of the cost
of complying with the premarket approval requirements in section 515
of the act. Because reclassification will reduce regulatory costs
with respect to these devices, the agency certifies that the final
rule will not have a significant economic impact on a substantial
number of small entities.
Dated: February 21, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 06-1871 Filed 2-28-06; 8:45 am]
BILLING CODE 4160-01-S
