Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Notices 58445

Technology, and Finance, Office of 

Information and Resource Management, 

Attention: Naomi Cook (0937–0191), 

Room 531–H, 200 Independence 

Avenue, SW., Washington, DC 20201.

Dated: September 21, 2004. 

Robert E. Polson, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer.

[FR Doc. 04–21888 Filed 9–29–04; 8:45 am] 

BILLING CODE 4168–17–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

[Document Identifier: OS–0990–0115] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request

AGENCY: Office of the Secretary.

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of 

proposed collections for public 

comment. Interested persons are invited 

to send comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

#1 Type of Information Collection 

Request: Extension of a Currently 

Approved Collection; 

Title of Information Collection: HHS 

Acquisition Regulation—Solicitation 

and Contracts; 

Form/OMB No.: OS–0990–0115; 

Use: Information is needed to evaluate 

feasibility of contractor(s) scientific or 

technical approach, management plan, 

and cost to accomplish the program or 

services required by the government. 

Frequency: Recordkeeping, reporting; 

Affected Public: State, local, or tribal 

governments and not-for-profit 

institutions; 

Annual Number of Respondents:

5,357; 

Total Annual Responses: 5,357; 

Average Burden Per Response: 1 hour; 

Total Annual Hours: 883,905; 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access the HHS Web 

site address at http://www.hhs.gov/

oirm/infocollect/pending/ or e-mail your 

request, including your address, phone 

number, OMB number, and OS 

document identifier, to 

naomi.cook@hhs.gov, or call the Reports 

Clearance Office on (202) 690–6162. 

Written comments and 

recommendations for the proposed 

information collections must be mailed 

within 30 days of this notice directly to 

the OMB Desk Officer at the following 

address: OMB Desk Officer: John 

Kraemer, OMB Human Resources and 

Housing Branch, Attention: (OMB 

#0990–0115), New Executive Office 

Building, Room 10235, Washington, DC 

20503.

Dated: September 21, 2004. 

Robert E. Polson, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer.

[FR Doc. 04–21889 Filed 9–29–04; 8:45 am] 

BILLING CODE 4168–17–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Scientific Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

SUMMARY: Notice is hereby given that 

the Office of Research Integrity (ORI) 

and the Acting Assistant Secretary for 

Health have taken final action in the 

following case: 

Charles N. Rudick, Northwestern 

University: Based on the report of an 

investigation conducted by 

Northwestern University (NU Report) 

and additional analysis conducted by 

ORI in its oversight review, PHS found 

that Charles N. Rudick, Graduate 

Student, Department of Neurobiology 

and Physiology at NU (Respondent), 

engaged in scientific misconduct in 

research supported by National Institute 

of Neurological Disorders and Stroke 

(NINDS), National Institutes of Health 

(NIH), grant R29 NS37324, ‘‘Estrogeninduced hippocampal seizure 

susceptibility,’’ and National Institute of 

General Medical Sciences (NIGMS), 

NIH, grant T32 GM08061, ‘‘Cellular and 

Molecular Basis of Disease Training 

Program.’’

Specifically, PHS found that Mr. 

Rudick falsified illustrations in 

Photoshop pertaining to unpublished 

traces of electrophysiological recordings 

of inhibitory postsynaptic currents. 

Mr. Rudick has entered into a 

Voluntary Exclusion Agreement 

(Agreement ) in which he has 

voluntarily agreed for a period of three 

(3) years, beginning on September 14, 

2004: 

(1) To exclude himself from serving in 

any advisory capacity to PHS including 

but not limited to service on any PHS 

advisory committee, board, and/or peer 

review committee, or as a consultant; 

and 

(2) That any institution which 

submits an application for PHS support 

for a research project on which the 

Respondent’s participation is proposed 

or which uses the Respondent in any 

capacity on PHS supported research, or 

that submits a report of PHS-funded 

research in which the Respondent is 

involved, must concurrently submit a 

plan for supervision of the Respondent’s 

duties to the funding agency for 

approval. The supervisory plan must be 

designed to ensure the scientific 

integrity of the Respondent’s research 

contribution. Respondent agrees to 

ensure that a copy of the supervisory 

plan is also submitted to ORI by the 

institution. Respondent agrees that he 

will not participate in any PHSsupported research until such a 

supervision plan is submitted to and 

accepted by ORI.

FOR FURTHER INFORMATION CONTACT:

Director, Division of Investigative 

Oversight, Office of Research Integrity, 

1101 Wootton Parkway, Suite 750, 

Rockville, MD 20852, (301) 443–5330.

Chris B. Pascal, 

Director, Office of Research Integrity.

[FR Doc. 04–21920 Filed 9–29–04; 8:45 am] 

BILLING CODE 4150–31–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003E–0260]

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; AMEVIVE

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

AMEVIVE and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

58446 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Notices 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human biological 

product.

ADDRESSES: Submit written or electronic 

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 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human biological product and 

continues until FDA grants permission 

to market the biological 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 biological 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 biologic product AMEVIVE 

(alefacept). AMEVIVE is indicated for 

the treatment of adult patients with 

moderate to severe chronic plaque 

psoriasis who are candidates for 

systemic therapy or phototherapy. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

AMEVIVE (U.S. Patent No. 5,547,853) 

from Biogen, Inc., and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated November 18, 2003, FDA 

advised the Patent and Trademark 

Office that this human biologic product 

had undergone a regulatory review 

period and that the approval of 

AMEVIVE represented the first 

permitted commercial marketing or use 

of the product. Shortly 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 

AMEVIVE is 2,104 days. Of this time, 

1,618 days occurred during the testing 

phase of the regulatory review period, 

while 486 days occurred during the 

approval phase. These periods of time 

were derived from the following dates:

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(i)) 

became effective (21 U.S.C. 355(i)): 

April 29, 1997. FDA has verified the 

applicant’s claim that the date the 

investigational new drug application 

became effective was on April 29, 1997.

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): October 2, 2001. FDA has 

verified the applicant’s claim that the 

biological license application (BLA) for 

Amevive (BLA 12536) was initially 

submitted on October 2, 2001.

3. The date the application was 

approved: January 30, 2003. FDA has 

verified the applicant’s claim that BLA 

12536 was approved on January 30, 

2003.

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 1,259 days 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 

comments and ask for a redetermination 

by November 29, 2004. 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 March 29, 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. 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: August 30, 2004.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug 

Evaluation and Research.

[FR Doc. 04–21874 Filed 9–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2004M–0147, 2004M–0145, 

2004M–0207, 2004M–0253, 2004M–0165, 

2004M–0200, 2004M–0199, 2004M–0256, 

2004M–0248, 2004M–0249, 2004M–0250, 

2004M–0260, and 2004M–0259]

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

agency’s Division of Dockets 

Management.

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Please cite 

the appropriate docket number as listed 

in table 1 of this document when 

submitting a written request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the summaries of 

safety and effectiveness.

FOR FURTHER INFORMATION CONTACT:

Thinh Nguyen, Center for Devices and