63548 Federal Register / Vol. 69, No. 211 / Tuesday, November 2, 2004 / Notices 

extension of a patent that claims that 

human drug product.

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Office of Regulatory 

Policy (HFD–013), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–453–6699.

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive.

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of Patents and Trademarks may 

award (for example, half the testing 

phase must be subtracted, as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a human drug product will 

include all of the testing phase and 

approval phase as specified in 35 U.S.C. 

156(g)(1)(B).

FDA recently approved for marketing 

the human drug product GANIRELIX 

ACETATE INJECTION (ganirelix 

acetate). GANIRELIX ACETATE 

INJECTION is indicated for the 

inhibition of premature LH surges in 

women undergoing controlled ovarian 

hyperstimulation. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for GANIRELIX ACETATE 

INJECTION (U.S. Patent No. 4,801,577) 

from Syntex, and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated December 30, 2002, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of GANIRELIX 

ACETATE INJECTION represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

Patent and Trademark Office requested 

that FDA determine the product’s 

regulatory review period.

FDA has determined that the 

applicable regulatory review period for 

GANIRELIX ACETATE INJECTION is 

3,558 days. Of this time, 3,376 days 

occurred during the testing phase of the 

regulatory review period, while 182 

days occurred during the approval 

phase. These periods of time were 

derived from the following dates:

1. The date an exemption under 

section 505 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355) became effective: November 2, 

1989. The applicant claims October 3, 

1989, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was November 2, 

1989, which was 30 days after FDA 

receipt of the IND.

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the act: January 29, 1999. The 

applicant claims January 28, 1999, as 

the date the new drug application 

(NDA) for GANIRELIX ACETATE 

INJECTION (NDA 21–057) was initially 

submitted. However, FDA records 

indicate that NDA 21–057 was 

submitted on January 29, 1999.

3. The date the application was 

approved: July 29, 1999. FDA has 

verified the applicant’s claim that NDA 

21–057 was approved on July 29, 1999.

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 5 years of patent 

term extension.

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by January 3, 2005. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

May 2, 2005. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30.

Comments and petitions should be 

submitted to the Division of Dockets 

Management (see ADDRESSES). Three 

copies of any mailed information are to 

be submitted, except that individuals 

may submit one copy. Comments are to 

be identified with the docket number 

found in brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday.

Dated: October 15, 2004.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug 

Evaluation and Research.

[FR Doc. 04–24378 Filed 11–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG 2004–19483] 

Review and Approval of Classification 

Societies

AGENCY: Coast Guard, DHS.

ACTION: Notice of policy; request for 

comments. 

SUMMARY: This notice contains 

procedures the Coast Guard will use to 

review classification societies seeking 

Coast Guard approval to perform certain 

functions for vessels. Under the 2004 

Coast Guard and Maritime 

Transportation Authorization Act, after 

January 1, 2005, classification societies 

may not perform those certain functions 

for vessels unless they are either 

approved by the Coast Guard or are full 

members of the International 

Association of Classification Societies. 

Class societies seeking Coast Guard 

approval should submit a package in 

accordance with the procedures in this 

notice. The Coast Guard also seeks 

public comment on the procedures 

described herein for reviewing and 

approving classification societies.

DATES: This notice of policy is effective 

November 2, 2004. Comments and 

related material must reach the Docket 

Management Facility on or before 

January 3, 2005.

ADDRESSES: 

Federal Register / Vol. 69, No. 211 / Tuesday, November 2, 2004 / Notices 63549

Application Process 

Classification societies may request 

review and approval by writing to 

Commandant (G–MSE), 2100 Second 

Street, SW., Washington, DC 20593–

0001. 

Comment Submissions 

You may submit comments identified 

by Coast Guard docket number USCG–

2004–19483 to the Docket Management 

Facility at the U.S. Department of 

Transportation. To avoid duplication, 

please use only one of the following 

methods: 

(1) Web site: http://dms.dot.gov.

(2) Mail: Docket Management Facility, 

U.S. Department of Transportation, 400 

Seventh Street, SW., Washington, DC 

20590–0001. 

(3) Fax: (202) 493–2251. 

(4) Delivery: Room PL–401 on the 

Plaza level of the Nassif Building, 400 

Seventh Street, SW., Washington, DC, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The telephone number is (202) 366–

9329. 

(5) Federal eRulemaking Portal: http:/

/www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For 

questions on this notice of policy, 

contact Mr. William Peters, Office of 

Design and Engineering Standards, (G–

MSE–2), Coast Guard, telephone 202–

267–2988, e-mail: 

wpeters@comdt.uscg.mil.

SUPPLEMENTARY INFORMATION: 

Background and Purpose 

The criteria for classification society 

approval is based, in part, on the 

International Maritime Organization 

(IMO) Resolution A.739(18), 

‘‘Guidelines for the Authorization of 

Organizations Acting on Behalf of the 

Administration.’’ Resolution A.739(18) 

establishes minimum requirements for 

Recognized Organizations (ROs) to act 

on the behalf of Administrations in the 

surveys and certification and 

determination of vessel tonnages as 

required by the applicable international 

conventions. After review and 

consideration, the Coast Guard deems 

Resolution A.739(18) to provide a sound 

and internationally recognized standard 

from which to base the review and 

approval program required by 46 U.S.C. 

3316(c). 

Classification societies often act as 

ROs because of the similarity in the 

technical and survey work these 

organizations perform. To be authorized 

under the resolution, an RO must satisfy 

the Administration that their business 

practices are aligned with the standards 

of Resolution A.739(18). The RO is 

required to publish and systematically 

maintain rules, be professionally staffed 

with strategically placed resources for 

geographic coverage, maintain a high 

level of professional ethics, be 

competent, provide timely and quality 

services, and maintain an internal 

quality system no less effective than ISO 

9000 series certification. 

In addition, the statute outlines 

additional requirements for approval as 

follows: 

(1) Vessels surveyed by the 

classification society must have an 

adequate safety record; 

(2) The classification society must 

have an adequate program to develop 

and implement safety standards for 

vessels it surveys; 

(3) The classification society must 

have an adequate program to make their 

safety records available to the Secretary 

in an electronic format; 

(4) The classification society must 

have a program to make the safety 

records of a vessel available to other 

classification societies (for the purpose 

of a specific vessel survey); and 

(5) The classification society must 

have a program to request records from 

other classification societies that 

previously surveyed the vessel.

As further evidence of the adequacy 

of the safety record of item (2) above, 

the Coast Guard also requires that a 

classification society is an RO for at 

least one sovereign nation that is 

signatory to the International Safety of 

Life at Sea (SOLAS), MARPOL 73/78, 

the International Convention on Load 

Lines (ICLL), 1966, and the Protocol of 

1988 relating to the ICLL, 1966. 

Discussion of Notice of Policy 

This notice of policy describes the 

approval process by which classification 

societies may comply with 46 U.S.C. 

3316(c). This process includes approval 

criteria, review and approval 

procedures, and application procedures 

to assist classification societies to 

comply with this statute. This process 

differs from the requirements of 46 

U.S.C. 3316(b) that establish criteria by 

which certain statutory functions may 

be delegated to the American Bureau of 

Shipping or other recognized 

classification societies. 

Candidate Application Submittals 

For the purposes of 46 U.S.C. 3316(c), 

a classification society desiring an 

approval may apply in writing to 

Commandant (G–MSE), 2100 Second 

Street, SW., Washington, DC 20593–

0001. An application package (written 

in English) must: 

(1) Indicate the type of work the 

classification society wishes to perform 

on vessels in the United States; 

(2) Provide appropriate 

documentation proving that the 

classification society has applied for 

and received approval as an RO from at 

least one Administration that is 

signatory to SOLAS, MARPOL 73/78, 

Load Lines, 1966, and the Protocol of 

1988 relating to Load Lines, 1966, under 

the provisions of IMO Resolution 

A.739(18); 

(3) Demonstrate that the classification 

society operates as an RO on behalf of 

at least one Administration under a 

formal written agreement that includes 

all of the elements set out in Resolution 

A.739(18), Appendix 2; 

(4) Demonstrate that the classification 

society maintains all of the minimum 

standards for ROs as set forth in 

Resolution A.739(18), Appendix 1; 

(5) Demonstrate that the classification 

society is subject to a satisfactory system 

of verification and monitoring by at 

least one Administration, as set forth in 

the Annex to IMO Resolution A.739(18); 

(6) Provide a list of the vessels 

surveyed by the classification society 

including vessel names, flags, and IMO 

numbers; 

(7) Describe a system in which the 

classification society makes its safety 

records and those of persons acting on 

behalf of the classification society 

available to the Coast Guard in 

electronic format;

(8) Describe a system in which the 

classification society provides its safety 

records and those of persons acting on 

behalf of the classification society to 

another classification society that 

requests those records for the purpose of 

conducting surveys of vessels; and 

(9) Describe a system in which the 

classification society or those persons 

acting on its behalf are capable of 

requesting the safety records of a vessel 

to be surveyed from any other 

classification society that previously 

surveyed a vessel. 

On or after January 1, 2005, a 

classification society (including an 

employee or agent of that society) may 

not review, examine, survey, or certify 

the construction, repair, or alteration of 

a vessel in the United States unless it is 

a full member of the International 

Association of Classification Societies 

(IACS) or is approved by the Coast 

Guard. 

Classification societies authorized to 

perform work on behalf of the United 

States under the provisions of 46 U.S.C. 

3316(b) and all full members of IACS 

are approved to perform functions 

otherwise prohibited by 46 U.S.C. 

3316(c). 

63550 Federal Register / Vol. 69, No. 211 / Tuesday, November 2, 2004 / Notices 

Comments and Viewing Documents 

Referenced in This Notice 

If you wish to submit comments 

regarding this notice, please send them 

to the Docket Management Facility at 

the address under ADDRESSES. All 

comments received will be posted, 

without change, to http://dms.dot.gov

and will include any personal 

information you have provided. We 

have an agreement with the Department 

of Transportation (DOT) to use the 

Docket Management Facility. Please see 

DOT’s ‘‘Privacy Act’’ paragraph below. 

Submitting comments: If you submit a 

comment, please include your name and 

address, identify the docket number for 

this rulemaking (USCG–2004–19483), 

indicate the specific section of this 

document to which each comment 

applies, and give the reason for each 

comment. 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 your comments and material 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 will review 

this policy and may amend it in view of 

comments received. 

Viewing Comments and Documents 

To view comments, as well as 

documents mentioned in this preamble 

as being available in the docket, go to 

http://dms.dot.gov at any time and 

conduct a simple search using the 

docket number. You may also visit the 

Docket Management Facility in room 

PL–401 on the Plaza level of the Nassif 

Building, 400 Seventh Street, SW., 

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 into any 

of our 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 

Department of Transportation’s Privacy 

Act Statement in the Federal Register

published on April 11, 2000 (65 FR 

19477), or you may visit http://

dms.dot.gov.

Dated: October 28, 2004. 

Howard L. Hime, 

Acting Director of Standards, Marine Safety, 

Security and Environmental Protection, U.S. 

Coast Guard.

[FR Doc. 04–24453 Filed 10–29–04; 11:40 

am] 

BILLING CODE 4910–15–P

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–4910–N–24] 

Notice of Proposed Information 

Collection for Public Comment; HOPE 

VI Programs: Data Collection

AGENCY: Office of the Assistant 

Secretary for Public and Indian 

Housing, HUD.

ACTION: Notice.

SUMMARY: The proposed information 

collection requirement described below 

will be submitted to the Office of 

Management and Budget (OMB) for 

review, as required by the Paperwork 

Reduction Act. The Department is 

soliciting public comments on the 

subject proposal.

DATES: Comments Due Date: January 3, 

2005.

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name/or OMB Control 

number and should be sent to: Aneita 

Waites, Reports Liaison Officer, Public 

and Indian Housing, Department of 

Housing and Urban Development, 451 

7th Street, SW., Room 4116, 

Washington, DC 20410–5000.

FOR FURTHER INFORMATION CONTACT:

Aneita Waites, (202) 708–0713, 

extension 4114, for copies of the 

proposed forms and other available 

documents. (This is not a toll-free 

number.)

SUPPLEMENTARY INFORMATION: The 

Department will submit the proposed 

information collection to OMB for 

review, as required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

Chapter 35, as amended). This notice is 

soliciting comments from members of 

the public and affected agencies 

concerning the proposed collection of 

information to: (1) Evaluate whether the 

proposed 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 agency’s estimate of the 

burden of the proposed collection of 

information; (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 collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

This notice also lists the following 

information:

Title of Proposal: HOPE VI Programs: 

Data Collection. 

OMB Control Number: 2577–0208. 

Description Of The Need For The 

Information And Proposed Use: Section 

24 of the U.S. Housing Act of 1937, as 

added by section 535 of the Quality 

Housing and Work Responsibility Act of 

1998 (Pub. L. 105–276, 112 Stat. 2461, 

approved October 21, 1998) and the 

HOPE VI Program Reauthorization and 

Small Community Mainstreet 

Rejuvenation and Housing Act of 2003 

(Pub. L. 108–186, 117 Stat. 2685, 

approved December 16, 2003) 

establishes the HOPE VI program for the 

purpose of making assistance available 

on a competitive basis to public housing 

agencies (PHAs) in improving the living 

environment for public housing 

residents of severely distressed public 

housing projects through the 

demolition, rehabilitation, 

reconfiguration, or replacement of 

severely distressed public housing 

projects (or portions thereof); in 

revitalizing areas in which public 

housing sites are located, and 

contributing to the improvement of the 

surrounding community; in providing 

housing that avoids or decreases the 

concentration of very low-income 

families; and in building sustainable 

communities. In addition, the HOPE VI 

Program Reauthorization and Small 

Community Mainstreet Rejuvenation 

and Housing Act of 2003 adds to the 

HOPE VI program the purpose of 

making assistance available on a 

competitive basis to small units of local 

government to develop affordable 

housing as part of Main Street 

rejuvenation projects. 

Agency Form Number: HUD–52774, 

HUD–52780, HUD–52785, HUD–52787, 

HUD–52789, HUD–52790, HUD–52797, 

HUD–52799, HUD–52800, HUD–52825–

A, HUD–52860–A, HUD–52861, HUD–

53001, and HUD–53001–A. 

Members Of Affected Public: Public 

Housing Agencies, Units of local 

government with populations of less 

than 50,000. 

Estimation of the total number of 

hours needed to prepare the information 

collection including number of 

respondents: