Federal Register/Vol. 72, No. 228/Wednesday, November 28 ... - FDA

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67264 Federal Register / Vol. 72, No. 228 / Wednesday, November 28, 2007 / Proposed Rules
on these figures, the estimated cost of
the proposed AD for U.S. operators is
between $160 and $640, or between $80
and $320 per airplane.
Authority for This Rulemaking
Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
Section 106, describes the authority of
the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in Subtitle VII,
Part A, Subpart III, Section 44701,
‘‘General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
Regulatory Findings
We have determined that this
proposed AD would not have federalism
implications under Executive Order
13132. This proposed AD would not
have a substantial direct effect 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.
For the reasons discussed above, I
certify that the proposed regulation:
1. Is not a ‘‘significant regulatory
action’’ under Executive Order 12866;
2. Is not a ‘‘significant rule’’ under the
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979); and
3. Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
We prepared a regulatory evaluation
of the estimated costs to comply with
this proposed AD and placed it in the
AD docket. See the ADDRESSES section
for a location to examine the regulatory
evaluation.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Safety.
The Proposed Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13 [Amended]
2. The Federal Aviation
Administration (FAA) amends § 39.13
by adding the following new
airworthiness directive (AD):
Boeing: Docket No. FAA–2007–0254;
Directorate Identifier 2007–NM–209–AD.
Comments Due Date
(a) The FAA must receive comments on
this AD action by January 14, 2008.
Affected ADs
(b) None.
Applicability
(c) This AD applies to Boeing Model 777–
200, –200LR, –300, –300ER series airplanes,
certificated in any category; as identified in
Boeing Alert Service Bulletin 777–31A0119,
Revision 1, dated March 27, 2007; and
Boeing Alert Service Bulletin 777–31A0120,
Revision 1, dated March 23, 2007.
Unsafe Condition
(d) This AD results from an investigation
that revealed that detrimental effects could
occur on certain airplane information
management system (AIMS) software during
flight. We are issuing this AD to prevent an
unannunciated loss of cabin pressure. If an
undetected loss of pressure event were to
cause an unsafe pressure in the cabin, the
flight crew could become incapacitated.
Compliance
(e) You are responsible for having the
actions required by this AD performed within
the compliance times specified, unless the
actions have already been done.
Software Installation
(f) Within 15 months after the effective
date of this AD, do the actions specified in
paragraphs (f)(1) and (f)(2) of this AD, as
applicable.
(1) Install the AIMS Blockpoint 2006
(BP06) operational software by doing all the
actions in accordance with the
Accomplishment Instructions of Boeing Alert
Service Bulletin 777–31A0119, Revision 1,
dated March 27, 2007; or Boeing Alert
Service Bulletin 777–31A0120, Revision 1,
dated March 23, 2007; as applicable.
(2) Prior to or concurrently with
accomplishing the software installation,
install the AIMS Blockpoint 2005A (BP05A)
software in accordance with the
Accomplishment Instructions of Boeing
Special Attention Service Bulletin 777–31–
0098, Revision 1, dated May 3, 2007; or
Boeing Special Attention Service Bulletin
777–31–0097, Revision 3, dated February 22,
2007; as applicable.
Credit for Actions Done Using Previous
Service Information
(g) Actions accomplished before the
effective date of this AD in accordance with
Boeing Alert Service Bulletin 777–31A0119,
or Boeing Alert Service Bulletin 777–
31A0120, both dated October 16, 2006, are
considered acceptable for compliance with
the corresponding actions specified in this
AD.
Alternative Methods of Compliance
(AMOCs)
(h)(1) The Manager, Seattle Aircraft
Certification Office (ACO), FAA, has the
authority to approve AMOCs for this AD, if
requested in accordance with the procedures
found in 14 CFR 39.19.
(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 appropriate principal inspector
(PI) in the FAA Flight Standards District
Office (FSDO), or lacking a PI, your local
FSDO.
Issued in Renton, Washington, on
November 20, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. E7–23117 Filed 11–27–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 347 and 352
[Docket No. 1978N–0038] (formerly 78N–
0038)
RIN 0910–AF43
Sunscreen Drug Products for OverThe-Counter Human Use; Proposed
Amendment of Final Monograph;
Extension of Comment Period
AGENCY: Food and Drug Administration,
HHS.
ACTION: Proposed rule; extension of
comment period.
SUMMARY: The Food and Drug
Administration (FDA) is extending to
December 26, 2007, the comment period
for the August 27, 2007, proposed rule
to amend the final monograph for overthe-counter (OTC) sunscreen drug
products (72 FR 49070). The comment
period for the proposed rule was to end
on November 26, 2007. The agency is
taking this action in response to
requests for an extension to allow
interested persons additional time to
submit comments.
DATES: Submit written or electronic
comments by December 26, 2007.
ADDRESSES: You may submit comments,
identified by Docket No. 1978N–0038
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67265 Federal Register / Vol. 72, No. 228 / Wednesday, November 28, 2007 / Proposed Rules
and RIN number 0910–AF43, by any of
the following methods:
Electronic Submissions
Submit electronic comments in the
following ways:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: http://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
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.
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 or the
agency Web site, as described in the
Electronic Submissions portion of this
paragraph.
Instructions: All submissions received
must include the agency name, docket
number and regulatory information
number (RIN) for this rulemaking. All
comments received may be posted
without change to http://www.fda.gov/
ohrms/dockets/default.htm, including
any personal information provided. 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 http://
www.fda.gov/ohrms/dockets/
default.htm and 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:
Matthew R. Holman, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5414,
Silver Spring, MD 20993, 301–796–
2090.
SUPPLEMENTARY INFORMATION:
I. Discussion
In the Federal Register of May 21,
1999 (64 FR 27666), FDA published the
final monograph for OTC sunscreen
drug products in part 352 (21 CFR part
352) with an effective date of May 21,
2001. Issues concerning active
ingredients, labeling, and test methods
for products intended to provide
ultraviolet A (UVA) protection were
deferred for future regulatory action
because more time was required to
review comments from interested
parties. In the Federal Register of June
8, 2000 (65 FR 36319), FDA reopened
the administrative record of the
rulemaking for OTC sunscreen drug
products to allow for specific comment
on high sun protection factor (SPF) and
UVA radiation testing and labeling
issues. FDA also extended the effective
date for the final monograph to
December 31, 2002.
In the Federal Register of December
31, 2001 (66 FR 67485), FDA stayed the
December 31, 2002, effective date of the
final monograph for OTC sunscreen
drug products in part 352 pending
further notice from FDA in a future
issue of the Federal Register. FDA took
this action because we planned to
amend part 352 to address formulation,
labeling, and testing requirements for
both ultraviolet B (UVB) and UVA
radiation protection. The existing stay of
the effective date for part 352 remains
in effect at this time.
In the Federal Register of August 27,
2007 (72 FR 49070), FDA issued a
proposed rule that would amend the
final monograph for OTC sunscreen
drug products to address both UVB and
UVA testing and labeling requirements
for sunscreen and sunscreen-skin
protectant combination drug products.
FDA requested comments on the
proposed amendments. FDA also
requested comments on issues related to
OTC sunscreen drug products
containing alpha hydroxy acids or
titanium dioxide and zinc oxide
formulated in particle sizes as small as
a few nanometers. The comment period
on the proposed rule was scheduled to
end on November 26, 2007.
II. Extension of the Comment Period
The agency has received requests for
an extension of the comment period for
the proposed rule. Each request
conveyed concern that the current 90day comment period does not allow
sufficient time to develop a meaningful
or thoughtful response to the proposed
rule.
FDA has considered the requests and
is extending the comment period for the
proposed rule for 30 days, until
December 26, 2007. The agency believes
that a 30-day extension allows adequate
time for interested persons to submit
comments without significantly
delaying rulemaking on these important
issues.
In response to several requests to
extend the comment period, we are
extending the comment period for 30
days, until December 26, 2007.
III. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on this document. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that in January 2008, the
FDA Web site is expected to transition
to the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. After the transition
date, electronic submissions will be
accepted by us through the FDMS only.
When the exact date of the transition to
FDMS is known, we will publish a
Federal Register notice announcing that
date.
IV. References
The following references are on
display in the Division of Dockets
Management (see ADDRESSES) under
Docket No. 1978N–0038 and may be
seen by interested persons between 9
a.m. and 4 p.m., Monday through
Friday.
1. Comment No. EXT10.
2. Comment No. EXT11.
3. Comment No. EXT12.
4. Comment No. EXT13.
5. Comment No. EXT14.
6. Comment No. EXT15.
7. Comment No. EXT16.
8. Comment No. EXT17.
9. Comment No. EXT18.
Dated: November 21, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 07–5853 Filed 11–26–07; 9:25 am]
BILLING CODE 4160–01–S
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