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 


ebenthall on PRODPC61 with PROPOSALS
Federal Register / Vol. 72, No. 228 / Wednesday, November 28, 2007 / Proposed Rules 67265 

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 90- 

day 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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