Medical Device Reporting: Electronic Submission Requirements, 42810 [Z9-19683]
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42810
Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules
Paperwork Reduction Act (44 U.S.C. 3501 et
seq.), the Office of Management and Budget
(OMB) has approved the information
collection requirements contained in this AD
and has assigned OMB Control Number
2120–0056.
(1) If the inspection was done on or before
the effective date of this AD: Send the report
within 30 days after the effective date of this
AD.
(2) If the inspection was done after the
effective date of this AD: Send the report
within 30 days after the inspection is done.
Alternative Methods of Compliance
(AMOCs)
(m)(1) The Manager, Seattle Aircraft
Certification Office (ACO), FAA, has the
authority to approve AMOCs for this AD, if
requested using the procedures found in 14
CFR 39.19. Send information to ATTN: Ivan
Li, Aerospace Engineer, Airframe Branch,
ANM–120S, FAA, Seattle ACO, 1601 Lind
Avenue, SW., Renton, Washington 98057–
3356; telephone (425) 917–6437; fax (425)
917–6590; Or, e-mail information to 9–ANM–
Seattle–ACO–AMOC–Requests@faa.gov.
(2) To request a different method of
compliance or a different compliance time
for this AD, follow the procedures in 14 CFR
39.19. Before using any approved AMOC on
any airplane to which the AMOC applies,
notify your principal maintenance inspector
(PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal
inspector, your local Flight Standards District
Office. The AMOC approval letter must
specifically reference this AD.
(3) An AMOC that provides an acceptable
level of safety may be used for any repair
required by this AD, if it is approved by an
Authorized Representative for the Boeing
Commercial Airplanes Delegation Option
Authorization Organization who has been
authorized by the Manager, Seattle ACO, to
make those findings. For a repair method to
be approved, the repair must meet the
certification basis of the airplane, and the
approval must specifically refer to this AD.
Issued in Renton, Washington, on August
7, 2009.
Stephen P. Boyd,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. E9–20382 Filed 8–24–09; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 803
jlentini on DSKJ8SOYB1PROD with PROPOSALS
[Docket No. FDA–2008–N–0393]
RIN 0910–AF86
Medical Device Reporting: Electronic
Submission Requirements
Correction
In proposed rule document E9–19683
beginning on page 42203 in the issue of
VerDate Nov<24>2008
23:52 Aug 24, 2009
Jkt 217001
Friday, August 21, 2009 make the
following correction:
On page 42204, in the first column,
under the DATES section, in the first line,
‘‘November 19, 2009’’ should read
‘‘Submit written or electronic comments
on the proposed rule by November 19,
2009’’.
[FR Doc. Z9–19683 Filed 8–24–09; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2009–N–0344]
Microbiology Devices; Reclassification
of Herpes Simplex Virus Types 1 and
2 Serological Assays
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
SUMMARY: The Food and Drug
Administration (FDA) is proposing to
amend its device classification
regulations by correcting the regulation
classifying herpes simplex virus (HSV)
serological assays by removing the
reference to HSV serological assays
other than type 1 and type 2. When
reclassifying this device, FDA
mistakenly distinguished between HSV
serological assays type 1 and type 2 and
all other HSV serological assays. At that
time, and today, the only
preamendments HSV serological assays
FDA was aware of were type 1 and type
2, and therefore, the classification of
HSV assays other than type 1 and type
2 was incorrect. FDA is correcting the
classification of this device to eliminate
possible confusion resulting from this
error. Elsewhere in this issue of the
Federal Register, we are publishing a
companion direct final rule. This
proposed rule will provide a procedural
framework to finalize the rule in the
event we receive significant adverse
comment and withdraw the direct final
rule.
DATES: Submit written or electronic
comments by November 9, 2009.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2009–N–
0344, by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD-ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal, as
described previously, in the ADDRESSES
portion of this document under
Electronic Submissions.
Instructions: All submissions received
must include the agency name and
Docket No(s). and Regulatory
Information Number (RIN) (if a RIN
number has been assigned) for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number(s), found in brackets in
the heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Scott McFarland, Center for Devices and
Radiological Health WO/66, rm. 5543,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993, 301–796–6217.
SUPPLEMENTARY INFORMATION:
I. Why Is This Companion Proposed
Rule Being Issued?
This proposed rule is a companion to
the direct final rule correcting
§ 866.3305 (21 CFR 866.3305) by
removing HSV serological assays other
than type 1 and type 2 from the
regulation. The direct final rule and this
companion proposed rule are
substantively identical. This companion
proposed rule provides the procedural
framework to finalize the rule in the
event that the direct final rule receives
any significant adverse comment and is
withdrawn. We are publishing the direct
final rule because we believe the rule is
noncontroversial, and we do not
anticipate receiving any significant
adverse comments. If no significant
E:\FR\FM\25AUP1.SGM
25AUP1
]]>Agencies
[Federal Register Volume 74, Number 163 (Tuesday, August 25, 2009)]
[Proposed Rules]
[Page 42810]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: Z9-19683]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 803
[Docket No. FDA-2008-N-0393]
RIN 0910-AF86
Medical Device Reporting: Electronic Submission Requirements
Correction
In proposed rule document E9-19683 beginning on page 42203 in the
issue of Friday, August 21, 2009 make the following correction:
On page 42204, in the first column, under the DATES section, in the
first line, ``November 19, 2009'' should read ``Submit written or
electronic comments on the proposed rule by November 19, 2009''.
[FR Doc. Z9-19683 Filed 8-24-09; 8:45 am]
BILLING CODE 1505-01-D
