Federal Register / Vol. 73, No. 7 / Thursday, January 10, 2008 / Notices 1891 

Rockville, MD 20852–1448, 301–435–

5681. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs (HFG–

1), Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH steering committee includes 

representatives from each of the ICH 

sponsors and IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In November 2007, the ICH steering 

committee agreed that a draft guidance 

entitled ‘‘Q8(R1) Pharmaceutical 

Development Revision 1’’ should be 

made available for public comment. The 

draft guidance is the product of the 

Quality Expert Working Group of the 

ICH. Comments about this draft will be 

considered by FDA and the Quality 

Expert Working Group. 

The draft guidance is an annex to the 

parent guidance ICH Q8. It provides 

further clarification of key concepts 

outlined in ICH Q8 and describes the 

principles of QbD. The annex is not 

intended to establish new standards or 

increase regulatory expectations. It is 

intended to show how concepts and 

tools (e.g., design space) outlined in ICH 

Q8 could be put into practice by the 

applicant for all dosage forms. Where a 

company chooses to apply QbD and 

quality risk management (see ICH ‘‘Q9 

Quality Risk Management’’), linked to 

an appropriate pharmaceutical quality 

system (see ICH ‘‘Q10 Pharmaceutical 

Quality Systems’’), then opportunities 

arise to enhance science- and risk-based 

regulatory approaches. 

The draft guidance outlines the 

elements that should be included in 

pharmaceutical development and 

additional elements when QbD 

principles are applied. It elaborates, by 

means of description and example, 

possible approaches to gaining a more 

systematic, enhanced understanding of 

the product and process under 

development. The draft guidance also 

provides recommendations on the 

placement of pharmaceutical 

development and other related 

information in module 3 of a regulatory 

submission in the common technical 

document format. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on this topic. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. 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 FDA through the FDMS 

only. When the exact date of the 

transition to FDMS is known, FDA will 

publish a Federal Register notice 

announcing that date. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, http://www.fda.gov/cder/ 

guidance/index.htm, or http:// 

www.fda.gov/cber/publications.htm. 

Dated: January 2, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–213 Filed 1–9–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2007–29070] 

Collection of Information Under 

Review by Office of Management and 

Budget: OMB Control Number 1625–

0108 

AGENCY: Coast Guard, DHS. 

ACTION: Thirty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, this 

request for comments announces that 

the U.S. Coast Guard is forwarding an 

Information Collection Request (ICR), 

abstracted below, to the Office of 

Information and Regulatory Affairs 

(OIRA) of the Office of Management and 

Budget (OMB) requesting an extension 

of their approval for the following 

collection of information: 1625–0108, 

Standard Numbering System for 

Undocumented Vessels. Our ICR 

describes the information we seek to 

collect from the public. Review and 

comments by OIRA ensure we only 

impose paperwork burdens 

commensurate with our performance of 

duties. 

DATES: Please submit comments on or 

before February 11, 2008. 

ADDRESSES: To make sure your 

comments and related material do not 

enter the Coast Guard docket [USCG–

2007–29070] or are received by OIRA 

more than once, please submit them by 

only one of the following means: 

(1) Electronic submission. (a) To Coast 

Guard docket at http:// 

www.regulations.gov. (b) To OIRA by email to: nlesser@omb.eop.gov. 


yshivers on PROD1PC62 with NOTICES
1892 Federal Register / Vol. 73, No. 7 / Thursday, January 10, 2008 / Notices 

(2) Mail or hand delivery. (a) To 

Docket Management Facility (M–30), 

U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590–0001. Hand 

deliver between the hours of 9 a.m. and 

5 p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is 202–366–9329. (b) To OIRA, 725 17th 

Street, NW., Washington, DC 20503, to 

the attention of the Desk Officer for the 

Coast Guard. 

(3) Fax. (a) To Docket Management 

Facility at 202–493–2251. (b) To OIRA 

at 202–395–6566. To ensure your 

comments are received in time, mark 

the fax to the attention of Mr. Nathan 

Lesser, Desk Officer for the Coast Guard. 

The Docket Management Facility 

maintains the public docket for this 

notice. Comments and material received 

from the public, as well as documents 

mentioned in this notice as being 

available in the docket, will become part 

of this docket and will be available for 

inspection or copying at room W12–140 

on the West Building Ground Floor, 

1200 New Jersey Avenue, SE., 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. You may also find this 

docket on the Internet at http:// 

www.regulations.gov. 

A copy of the complete ICR is 

available through this docket on the 

Internet at http://www.regulations.gov. 

Additionally, copies are available from 

Commandant (CG–611), U.S. Coast 

Guard Headquarters, (Attn: Mr. Arthur 

Requina), 2100 2nd Street, SW., 

Washington, DC 20593–0001. The 

telephone number is 202–475–3523. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Arthur Requina, Office of Information 

Management, telephone 202–475–3523 

or fax 202–475–3929, for questions on 

these documents. Contact Ms. Renee V. 

Wright, Program Manager, Docket 

Operations, 202–366–9826, for 

questions on the docket. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard invites comments on whether 

this information collection request 

should be granted based on it being 

necessary for the proper performance of 

Departmental functions. In particular, 

the Coast Guard would appreciate 

comments addressing: (1) The practical 

utility of the collection; (2) the accuracy 

of the estimated burden of the 

collection; (3) ways to enhance the 

quality, utility, and clarity of 

information subject to the collection; 

and (4) ways to minimize the burden of 

collection on respondents, including the 

use of automated collection techniques 

or other forms of information 

technology. 

Comments to the Coast Guard or 

OIRA must contain the OMB Control 

Number of the ICR. Comments to the 

Coast Guard must contain the docket 

number [USCG 2007–29070]. For your 

comments to OIRA to be considered, it 

is best if OIRA receives them on or 

before February 11, 2008. 

Public participation and request for 

comments: We encourage you to 

respond to this request by submitting 

comments and related materials. We 

will post all comments received, 

without change, to http:// 

www.regulations.gov. They will include 

any personal information you provide. 

We have an agreement with DOT to use 

their Docket Management Facility. 

Please see the paragraph on DOT’s 

‘‘Privacy Act Policy’’ below. 

Submitting comments: If you submit a 

comment, please include the docket 

number [USCG–2007–29070], indicate 

the specific section of the document to 

which each comment applies, providing 

a reason for each comment. We 

recommend you include your name, 

mailing address, an e-mail address, or 

other contact information in the body of 

your document so that we can contact 

you if we have questions regarding your 

submission. You may submit your 

comments and material by electronic 

means, mail, fax, or delivery to the 

Docket Management Facility at the 

address under ADDRESSES; but please 

submit them by only one means. If you 

submit them by mail or delivery, submit 

them in an unbound format, no larger 

than 81⁄2 by 11 inches, suitable for 

copying and electronic filing. If you 

submit them by mail and would like to 

know that they reached the Facility, 

please enclose a stamped, self-addressed 

postcard or envelope. We will consider 

all comments and material received 

during the comment period. We may 

change the documents supporting this 

collection of information or even the 

underlying requirements in view of 

them. 

The Coast Guard and OIRA will 

consider all comments and material 

received during the comment period. 

We may change the documents 

supporting this collection of 

information or even the underlying 

requirements in view of them. 

Viewing comments and documents: 

Go to http://www.regulations.gov to 

view documents mentioned in this 

notice as being available in the docket. 

Click on ‘‘Search for Dockets,’’ and enter 

the docket number (USCG–2007–29070) 

in the Docket ID box, and click enter. 

You may also visit the Docket 

Management Facility in room W12–140 

on the West Building Ground Floor, 

1200 New Jersey Avenue, SE., 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

Privacy Act: Anyone can search the 

electronic form of all comments 

received in dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review the 

Privacy Act Statement of DOT in the 

Federal Register published on April 11, 

2000 (65 FR 19477), or you may visit 

http://DocketsInfo.dot.gov. 

Previous Request for Comments 

This request provides a 30-day 

comment period required by OIRA. The 

Coast Guard has published the 60-day 

notice (72 FR 51826, September 11, 

2007) required by 44 U.S.C. 3506(c)(2). 

That notice elicited no comments. 

Information Collection Request 

Title: Standard Numbering System 

(SNS) for Undocumented Vessels. 

OMB Control Number: 1625–0108. 

Type of Request: Extension of a 

currently approved collection. 

Affected Public: Owners of all 

undocumented vessels propelled by 

machinery are required by Federal law 

to apply for a number from the issuing 

authority of the State in which they are 

to be principally operated. In addition, 

States may require other vessels, such as 

sailboats, canoes, and kayaks, to be 

numbered. Owners may include 

individuals or households, non-profit 

organizations, and small businesses 

(e.g., liveries offering recreational 

vessels for rental by the public) or other 

for-profit organizations. 

Abstract: Paragraph (a) of 46 U.S.C. 

12301 requires undocumented vessels 

equipped with propulsion machinery of 

any kind to be numbered in the State 

where they are principally operated. In 

46 U.S.C. 12302(a), Congress authorized 

the Secretary to prescribe, by regulation, 

a SNS, directing approval of a State 

numbering system if it is consistent 

therewith. In DHS Delegation No. 

0170.1 section 2 (92)(h), the Secretary 

has delegated his authority under 46 

U.S.C. 12301 and 12302 to the 

Commandant of the Coast Guard. 

Regulations requiring the numbering of 

undocumented vessels are in 33 CFR 

part 173; those applicable to the States 

for approval of their systems are 

contained in 33 CFR part 174. 

In order to have an approved state 

numbering system, a State must collect 

and report annually to the Coast Guard 

information on its numbered vessels 

(number, size, construction, etc.). We 


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Federal Register / Vol. 73, No. 7 / Thursday, January 10, 2008 / Notices 1893 

need this information for the following 

reasons: (1) To provide Federal, State, 

and local law enforcement personnel 

information for enforcement of boating 

laws and for theft/fraud investigations; 

(2) To increase officers’ safety by 

assisting boarding officers in 

determining how best to approach a 

vessel suspected of illegal activity; (3) 

To publish annual Boating Statistics 

reports required by 46 U.S.C. 6102(b); 

and (4) To determine proper allocation 

of Federal funds to assist States in 

carrying out the National Recreational 

Boating Safety Program established by 

46 U.S.C. chapter 131. 

Burden Estimate: The estimated 

burden has increased from 15,507 hours 

to 286,458 hours a year. 

Dated: December 21, 2007. 

D.T. Glenn, 

Rear Admiral, U.S. Coast Guard, Assistant 

Commandant for Command, Control, 

Communications, Computers and 

Information Technology. 

[FR Doc. E8–212 Filed 1–9–08; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form I–601, Revision of a 

Currently Approved Information 

Collection; Comment Request 

ACTION: 30-Day Notice of Information 

Collection Under Review: I–601, 

Application for Waiver of Grounds of 

Inadmissibility; OMB Control Number 

1615–0029. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) has 

submitted the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection was 

previously published in the Federal 

Register on July 31, 2007, at 72 FR 

41771. The notice allowed for a 60-day 

public comment period. USCIS received 

two comments from the public on this 

information collection. 

The purpose of this notice is to allow 

an additional 30 days for public 

comments. Comments are encouraged 

and will be accepted until February 11, 

2008. This process is conducted in 

accordance with 5 CFR 1320.10. 

Written comments and/or suggestions 

regarding the item(s) contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time, should be directed to the 

Department of Homeland Security 

(DHS), USCIS, Chief, Regulatory 

Management Division, Clearance Office, 

111 Massachusetts Avenue, 3rd floor, 

Washington, DC 20529. Comments may 

also be submitted to DHS via facsimile 

to 202–272–8352 or via e-mail at 

rfs.regs@dhs.gov, and to the OMB USCIS 

Desk Officer via facsimile at 202–395–

6974 or via e-mail at 

kastrich@omb.eop.gov. 

When submitting comments by e-mail 

please make sure to add OMB Control 

Number 1615–0029 in the subject box. 

Written comments and suggestions from 

the public and affected agencies should 

address one or more of the following 

four points: 

(1) Evaluate whether the collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of the 

agencies estimate of the burden of the 

collection of information, including the 

validity of the methodology and 

assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

Revision of a currently approved 

information collection. 

(2) Title of the Form/Collection: 

Application for Waiver of Grounds of 

Inadmissibility. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: Form I–601. 

U.S. Citizenship and Immigration 

Services. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individuals or 

Households. The information collected 

on this form is used by U.S Citizenship 

and Immigration Services (USCIS) to 

determine whether the applicant is 

eligible for a waiver of excludability 

under section 212 of the Immigration 

and Nationality Act. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 15,500 responses at 1 1/2 

hours per response. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 23,250 annual burden hours. 

If you have additional comments, 

suggestions, or need a copy of the 

information collection instrument, 

please visit the USCIS Web site at: 

http://www.regulations.gov/fdmspublic/ 

component/main. We may also be 

contacted at: USCIS, Regulatory 

Management Division, 111 

Massachusetts Avenue, NW., 3rd floor, 

Suite 3008, Washington, DC 20529, 

telephone number 202–272–8377. 

Dated: January 7, 2008. 

Richard Sloan, 

Chief, Regulatory Management Division, U.S. 

Citizenship and Immigration Services, 

Department of Homeland Security. 

[FR Doc. E8–282 Filed 1–9–08; 8:45 am] 

BILLING CODE 4410–10–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[FWS–R1–ES–2007–N0005] 

Proposed Safe Harbor Agreement for 

the Guam Rail on Cocos Island, Guam 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Receipt of application; notice of 

availability. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), have received 

applications for enhancement of 

survival permits pursuant to section 

10(a)(1)(A) of the Endangered Species 

Act of 1973, as amended (ESA), from 

Cocos Island Resort and the Guam 

Department of Agriculture (Applicants). 

The permit applications include a 

proposed Safe Harbor Agreement (SHA) 

among the Applicants and the Service. 

Implementation of the proposed SHA 

provides for voluntary habitat 

restoration, maintenance, enhancement, 

or the creation of activities to enhance 

the habitat and recovery of the Guam 

rail (Gallirallus owstonii) (‘‘Covered 

Species’’) on 83.1 acres of non-Federal 

lands on Cocos Island, Guam. The 

proposed duration of both the SHA and 

permits is 10 years. 

The Service has made a preliminary 

determination that the proposed SHA 

and permit application are eligible for 

categorical exclusion under the National 

Environmental Policy Act of 1969 

(NEPA). The basis for this determination 


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