Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms; Extension of Comment Period, 56682-56683 [2011-23479]
Download as PDF
<![CDATA[
56682
Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules
is found installed and the S/N of the FDU is
listed in table 1 of this AD: Before further
flight, replace the FDU with a serviceable
FDU, in accordance with the instructions of
Airbus AOT A330–26A3052, dated April 19,
2011 (for Model A330–200 and –300 series
airplanes); Airbus AOT A340–200/300–
26A4044, dated April 19, 2011 (for Model
A340–200 and –300 series airplanes); or
Airbus AOT A340–500/600–26A5024, dated
April 19, 2011 (for Model A340–500 and
–600 series airplanes).
TABLE 1—AFFECTED P/N 3711–00
FIRE DETECTION UNITS
TABLE 1—AFFECTED P/N 3711–00
FIRE DETECTION UNITS—Continued
Serial Nos.
Serial Nos.
ZL0747.
ZL0770.
ZL0772.
ZL0775.
ZL0788.
ZL0804.
ZL0683.
ZL0718.
ZL0721 through ZL0725 inclusive.
ZL0727.
ZL0729 through ZL0731 inclusive.
ZL0736.
ZL0738.
ZL0740.
ZL0742.
ZL0743.
ZL0745.
Note 1: Some of the affected P/N 3711–00
FDUs have been installed in production on
certain airplanes, as indicated in table 2 of
this AD.
TABLE 2—FDU INSTALLED IN PRODUCTION
Model A330–200 and –300 airplanes manufacturer serial numbers
Position
S/N
1177 .................................................................................................
1191 .................................................................................................
1192 .................................................................................................
ENG2 FDU (1WD2) .........................................................................
ENG2 FDU (1WD2) .........................................................................
ENG1 FDU (1WD1) .........................................................................
ENG2 FDU (1WD2) .........................................................................
APU FDU (13WG) ...........................................................................
ENG1 FDU (1WD1) .........................................................................
ENG1 FDU (1WD1) .........................................................................
ENG2 FDU (1WD2) .........................................................................
APU FDU (13WG) ...........................................................................
ENG2 FDU (1WD2) .........................................................................
APU FDU (13WG) ...........................................................................
ENG1 FDU (1WD1) .........................................................................
ENG2 FDU (1WD2) .........................................................................
ZL0683
ZL0723
ZL0721
ZL0722
ZL0718
ZL0740
ZL0742
ZL0736
ZL0743
ZL0738
ZL0731
ZL0747
ZL0770
1193 .................................................................................................
1195 .................................................................................................
1196 .................................................................................................
1198
1199
1200
1206
.................................................................................................
.................................................................................................
.................................................................................................
.................................................................................................
Parts Installation
(i) As of the effective date of this AD, no
person may install on any airplane, any P/N
3711–00 FDU with a serial number listed in
table 1 of this AD, unless the FDU has been
reworked and re-identified by L’Hotellier as
specified in the instructions in Airbus AOT
A330–26A3052, dated April 19, 2011 (for
Model A330–200 and –300 series airplanes);
Airbus AOT A340–200/300–26A4044, dated
April 19, 2011 (for Model A340–200 and
–300 series airplanes); or Airbus AOT A340–
500/600–26A5024, dated April 19, 2011 (for
Model A340–500 and –600 series airplanes).
FAA AD Differences
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Note 2: This AD differs from the MCAI
and/or service information as follows:
No differences.
Other FAA AD Provisions
(j) The following provisions also apply to
this AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, International
Branch, ANM–116, Transport Airplane
Directorate, FAA, has the authority to
approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19.
In accordance with 14 CFR 39.19, send your
request to your principal inspector or local
Flight Standards District Office, as
appropriate. If sending information directly
to the International Branch, send it to Attn:
Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM–116, Transport
Airplane Directorate, FAA, 1601 Lind
Avenue, SW., Renton, Washington 98057–
VerDate Mar<15>2010
17:16 Sep 13, 2011
Jkt 223001
3356; telephone (425) 227–1138; fax (425)
227–1149. Information may be e-mailed to:
9-ANM-116-AMOC-REQUESTS@faa.gov.
Before using any approved AMOC, notify
your appropriate principal inspector, or
lacking a principal inspector, the manager of
the local flight standards district office/
certificate holding district office. The AMOC
approval letter must specifically reference
this AD.
(2) Airworthy Product: For any requirement
in this AD to obtain corrective actions from
a manufacturer or other source, use these
actions if they are FAA-approved. Corrective
actions are considered FAA-approved if they
are approved by the State of Design Authority
(or their delegated agent). You are required
to assure the product is airworthy before it
is returned to service.
Related Information
(k) Refer to MCAI EASA Airworthiness
Directive 2011–0073, dated April 20, 2011;
Airbus AOT A330–26A3052, dated April 19,
2011; Airbus AOT A340–200/300–26A4044,
dated April 19, 2011; and Airbus AOT A340–
500/600–26A5024, dated April 19, 2011; for
related information.
Issued in Renton, Washington, on
September 7, 2011.
Jeffrey E. Duven,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 2011–23470 Filed 9–13–11; 8:45 am]
BILLING CODE 4910–13–P
PO 00000
Frm 00022
Fmt 4702
Sfmt 4702
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 352
[Docket No. FDA–1978–N–0018] (formerly
Docket No. 1978N–0038)
RIN 0910–ZA40
Sunscreen Drug Products for Over-theCounter Human Use; Request for Data
and Information Regarding Dosage
Forms; Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Advance notice of proposed
rulemaking; request for data and
information; extension of comment
period.
ACTION:
The Food and Drug
Administration (FDA) is extending the
comment period for the advance notice
of proposed rulemaking (ANPRM) that
published on June 17, 2011. The
ANPRM is requesting data and
information on certain dosage forms of
over-the-counter (OTC) sunscreen drug
products marketed without approved
applications. The comment period for
that ANPRM will end on September 15,
2011. This document extends the
comment period to October 17, 2011.
SUMMARY:
E:\FR\FM\14SEP1.SGM
14SEP1
Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules
Submit either electronic or
written data and information by October
17, 2011.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–1978–N–
0018 (formerly Docket No. 1978N–0038)
and/or RIN number 0910–ZA40, by any
of the following methods:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
dosage form specifications, for OTC
sunscreen drug products. Among the
data requested is data necessary to
resolve specific questions about the
effectiveness and safety of OTC
sunscreens in spray dosage forms.
II. Extension of the Comment Period
In response to the June 17, 2011,
ANPRM, three submissions (Refs. 1, 2,
and 3) requested an extension of the
comment period, which will end on
September 15, 2011. Two of the
submissions requested that FDA extend
the comment period by 30 days so that
the comment period totals 4 months
(Refs. 1 and 2). The other submission
requested that FDA extend the comment
period by 90 to 180 days so that the
comment period totals 6 to 9 months
(Ref. 3). The submissions cited the need
for additional time to evaluate their
available data and to organize and
submit the data and information that
best addresses FDA’s request while
simultaneously implementing the new
requirements for their sunscreen
products imposed by the Labeling and
Effectiveness Testing final rule that
published in the Federal Register of
June 17, 2011 (76 FR 35620).
FDA is extending the comment period
to end on October 17, 2011. A total
comment period of 4 months is
sufficient for the public to submit
comments to the ANPRM.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments, data, and information by
October 17, 2011. It is only necessary to
submit one set of comments, data, and
information. It is no longer necessary to
two copies of mailed comments, data,
and information. Identify submissions
with the docket number found in
brackets in the heading of this
document, and may be accompanied by
supporting information. Received
submissions may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Information submitted after the closing
date will not be considered except by
petition under 21 CFR 10.30.
I. Background
mstockstill on DSK4VPTVN1PROD with PROPOSALS
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.
Instructions: All submissions received
must include the Agency name, Docket
No. FDA–1978–N–0018, and RIN 0910–
ZA40 for this rulemaking. All comments
received may be posted without change
to https://www.regulations.gov, including
any personal information provided if
not marked as confidential. For
additional information on submitting
comments, see the ‘‘Request for
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, insert the docket
number, 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:
Reynold Tan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5411,
Silver Spring, MD 20993–0002, 301–
796–2090.
SUPPLEMENTARY INFORMATION:
IV. References
In the Federal Register of June 17,
2011 (76 FR 35669) (the June 17, 2011,
ANPRM), FDA published an ANPRM
that requested data and information on
OTC sunscreen products marketed
without approved applications that are
formulated in certain dosage forms. FDA
requested these data to help establish
OTC monograph conditions, including
The following references are on
display in the Division of Dockets
Management (see ADDRESSES) under
Docket No. FDA–1978–N–0018 and may
be seen by interested persons between
9 a.m. and 4 p.m., Monday through
Friday.
1. Comment No. FDA–1978–N–0018–
DRAFT–5225.
VerDate Mar<15>2010
17:16 Sep 13, 2011
Jkt 223001
III. Request for Comments
PO 00000
Frm 00023
Fmt 4702
Sfmt 4702
56683
2. Comment No. FDA–1978–N–0018–
DRAFT–5227.
3. Comment No. FDA–1978–N–0018–
DRAFT–5228.
Dated: September 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23479 Filed 9–13–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE INTERIOR
Bureau of Ocean Energy Management,
Regulation and Enforcement
30 CFR Part 250
[Docket ID BOEM–2011–0003]
RIN 1010–AD73
Oil and Gas and Sulphur Operations in
the Outer Continental Shelf—Revisions
to Safety and Environmental
Management Systems
Bureau of Ocean Energy
Management, Regulation and
Enforcement (BOEMRE), Interior.
ACTION: Proposed rule.
AGENCY:
This rulemaking proposes to
amend BOEMRE regulations to require
operators to develop and implement
additional provisions in their Safety and
Environmental Management Systems
(SEMS) programs for oil, gas, and
sulphur operations in the Outer
Continental Shelf (OCS). These
revisions pertain to developing and
implementing stop work authority and
ultimate work authority, requiring
employee participation in the
development and implementation of
SEMS programs, and establishing
requirements for reporting unsafe
working conditions. In addition, this
proposed rule requires independent
third parties to conduct audits of
operators’ SEMS programs and
establishes further requirements relating
to conducting job safety analysis (JSA)
for activities identified in an operator’s
SEMS program. We believe that these
new requirements will further reduce
the likelihood of accidents, injuries, and
spills in connection with OCS activities
that are regulated under BOEMRE
jurisdiction, by requiring OCS operators
to specifically address issues associated
with human behavior as it applies to
their SEMS program.
DATES: Submit comments by November
14, 2011. BOEMRE may not fully
consider comments received after this
date. Submit comments to the Office of
Management and Budget on the
information collection burden in this
SUMMARY:
E:\FR\FM\14SEP1.SGM
14SEP1
]]>Agencies
[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Proposed Rules]
[Pages 56682-56683]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23479]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 352
[Docket No. FDA-1978-N-0018] (formerly Docket No. 1978N-0038)
RIN 0910-ZA40
Sunscreen Drug Products for Over-the-Counter Human Use; Request
for Data and Information Regarding Dosage Forms; Extension of Comment
Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking; request for data and
information; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending the
comment period for the advance notice of proposed rulemaking (ANPRM)
that published on June 17, 2011. The ANPRM is requesting data and
information on certain dosage forms of over-the-counter (OTC) sunscreen
drug products marketed without approved applications. The comment
period for that ANPRM will end on September 15, 2011. This document
extends the comment period to October 17, 2011.
[[Page 56683]]
DATES: Submit either electronic or written data and information by
October 17, 2011.
ADDRESSES: You may submit comments, identified by Docket No. FDA-1978-
N-0018 (formerly Docket No. 1978N-0038) and/or RIN number 0910-ZA40, 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
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.
Instructions: All submissions received must include the Agency
name, Docket No. FDA-1978-N-0018, and RIN 0910-ZA40 for this
rulemaking. All comments received may be posted without change to
https://www.regulations.gov, including any personal information provided
if not marked as confidential. For additional information on submitting
comments, see the ``Request for 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, insert the docket
number, 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: Reynold Tan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5411, Silver Spring, MD 20993-0002, 301-
796-2090.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 17, 2011 (76 FR 35669) (the June
17, 2011, ANPRM), FDA published an ANPRM that requested data and
information on OTC sunscreen products marketed without approved
applications that are formulated in certain dosage forms. FDA requested
these data to help establish OTC monograph conditions, including dosage
form specifications, for OTC sunscreen drug products. Among the data
requested is data necessary to resolve specific questions about the
effectiveness and safety of OTC sunscreens in spray dosage forms.
II. Extension of the Comment Period
In response to the June 17, 2011, ANPRM, three submissions (Refs.
1, 2, and 3) requested an extension of the comment period, which will
end on September 15, 2011. Two of the submissions requested that FDA
extend the comment period by 30 days so that the comment period totals
4 months (Refs. 1 and 2). The other submission requested that FDA
extend the comment period by 90 to 180 days so that the comment period
totals 6 to 9 months (Ref. 3). The submissions cited the need for
additional time to evaluate their available data and to organize and
submit the data and information that best addresses FDA's request while
simultaneously implementing the new requirements for their sunscreen
products imposed by the Labeling and Effectiveness Testing final rule
that published in the Federal Register of June 17, 2011 (76 FR 35620).
FDA is extending the comment period to end on October 17, 2011. A
total comment period of 4 months is sufficient for the public to submit
comments to the ANPRM.
III. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments, data, and
information by October 17, 2011. It is only necessary to submit one set
of comments, data, and information. It is no longer necessary to two
copies of mailed comments, data, and information. Identify submissions
with the docket number found in brackets in the heading of this
document, and may be accompanied by supporting information. Received
submissions may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday. Information submitted after the
closing date will not be considered except by petition under 21 CFR
10.30.
IV. References
The following references are on display in the Division of Dockets
Management (see ADDRESSES) under Docket No. FDA-1978-N-0018 and may be
seen by interested persons between 9 a.m. and 4 p.m., Monday through
Friday.
1. Comment No. FDA-1978-N-0018-DRAFT-5225.
2. Comment No. FDA-1978-N-0018-DRAFT-5227.
3. Comment No. FDA-1978-N-0018-DRAFT-5228.
Dated: September 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23479 Filed 9-13-11; 8:45 am]
BILLING CODE 4160-01-P
