14582 Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response 

Total Burden 

Hours 

25.32(i) 52 3 156 1 156 

25.32(o) 1 1 1 1 1 

25.32(q) 7 2 14 1 14 

Total 171 171 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The above estimates for respondents 

and numbers of responses are based on 

the annualized numbers of petitions and 

notifications qualifying for § 25.32(i) 

and (q) that the agency has received in 

the past 3 years. Please note that, in the 

past 3 years, there have been no 

submissions that requested an action 

that would have been subject to the 

categorical exclusion in § 25.32(o). To 

avoid counting this burden as zero, FDA 

has estimated the burden for this 

categorical exclusion at one respondent 

making one submission a year for a total 

of one annual submission. 

To calculate the estimate for the hours 

per response values, we assumed that 

the information requested in this 

guidance for each of these three 

categorical exclusions is readily 

available to the submitter. For the 

information requested for the exclusion 

in § 25.32(i), we expect that submitter 

will need to gather information from 

appropriate persons in the submitter’s 

company and to prepare this 

information for attachment to the claim 

for categorical exclusion. We believe 

that this effort should take no longer 

than 1 hour per submission. For the 

information requested for the exclusions 

in § 25.32(o) and (q), the submitters will 

almost always merely need to copy 

existing documentation and attach it to 

the claim for categorical exclusion. We 

believe that collecting this information 

should also take no longer than 1 hour 

per submission. 

Dated: March 22, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5634 Filed 3–27–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. 2003E–0243 and 2003E–0244] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; INFUSE BONE GRAFT/LT–

CAGE LUMBAR TAPERED FUSION 

DEVICE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for INFUSE 

BONE GRAFT/LT–CAGE LUMBAR 

TAPERED FUSION DEVICE and is 

publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of two applications to 

the Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of patents which claim that 

medical device. 

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: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–7), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

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 medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. 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 (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 medical device will include 

all of the testing phase and approval 

phase as specified in 35 U.S.C. 

156(g)(3)(B). 

FDA recently approved for marketing 

the medical device INFUSE BONE 

GRAFT/LT–CAGE LUMBAR TAPERED 

FUSION DEVICE. INFUSE BONE 

GRAFT/LT–CAGE LUMBAR TAPERED 

FUSION DEVICE is indicated for spinal 

fusion procedures in skeletally mature 

patients with degenerative disc disease 

(DDD) at one level from L4—S1. 

Subsequent to this approval, the Patent 

and Trademark Office received two 

patent term restoration applications for 

INFUSE BONE GRAFT/LT–CAGE 

LUMBAR TAPERED FUSION DEVICE 

(U.S. Patent Nos. 5,782,919 and 

5,984,967)) from SDGI Holdings, Inc., 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining these patents’ eligibility for 

patent term restoration. In a letter dated 

April 6, 2004, FDA advised the Patent 

and Trademark Office that this medical 

device had undergone a regulatory 

review period and that the approval of 

INFUSE BONE GRAFT/LT–CAGE 

LUMBAR TAPERED FUSION DEVICE 

represented the first permitted 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Notices 14583 

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 

INFUSE BONE GRAFT/LT–CAGE 

LUMBAR TAPERED FUSION DEVICE is 

2,052 days. Of this time, 1,515 days 

occurred during the testing phase of the 

regulatory review period, while 537 

days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date an exemption under 

section 520(g) of the Federal Food, Drug, 

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

360j(g)) involving this device became 

effective: November 20, 1996. FDA has 

verified the applicant’s claim that the 

date the investigational device 

exemption (IDE) required under section 

520(g) of the Federal Food, Drug, and 

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

360j(g)) for human tests to begin became 

effective November 20, 1996. 

2. The date the application was 

initially submitted with respect to the 

device under section 515 of the act (21 

U.S.C. 360e): January 12, 2001. FDA has 

verified the applicant’s claim that the 

premarket approval application (PMA) 

for INFUSE BONE GRAFT/LT–CAGE 

LUMBAR TAPERED FUSION DEVICE 

(PMA P000058) was initially submitted 

January 12, 2001. 

3. The date the application was 

approved: July 2, 2002. FDA has verified 

the applicant’s claim that PMA P000058 

was approved on July 2, 2002. 

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 applications for patent extension, 

this applicant seeks 463 days of patent 

term extension for U.S. Patent No. 

5,984,967 or 347 days of patent term 

extension for U.S. Patent No. 5,782,919. 

Anyone with knowledge that any of 

the dates as published is incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by May 29, 2007. 

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 

September 24, 2007. 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: March 12, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–5635 Filed 3–27–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Industry Exchange Workshop on Food 

and Drug Administration Clinical Trial 

Requirements; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Chicago District, 

in cooperation with the Society of 

Clinical Research Associates (SoCRA), is 

announcing a workshop on FDA clinical 

trial statutory and regulatory 

requirements. This 2-day workshop for 

the clinical research community targets 

sponsors, monitors, clinical 

investigators, institutional review 

boards, and those who interact with 

them for the purpose of conducting 

FDA-regulated clinical research. The 

workshop will include both industry 

and FDA perspectives on proper 

conduct of clinical trials regulated by 

FDA. 

Date and Time: The public workshop 

is scheduled for May 16, 2007, from 

8:30 a.m. to 5 p.m. and May 17, 2007, 

from 8:30 a.m. to 4:30 p.m. 

Location: The public workshop will 

be held at the Oak Brook Hills Marriott 

Resort, 3500 Midwest Rd., Oak Brook, IL 

60523, 630–850–5555, FAX: 630–850–

5569. 

Contact: Marie Falcone, Food and 

Drug Administration, U.S. 

Customhouse, 200 Chestnut St., rm. 900, 

Philadelphia, PA 19106, 215–717–3703, 

FAX: 215–597–5798, e-mail: 

marie.falcone@fda.hhs.gov. 

Registration: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number) and the registration fee of $575 

(member), $650 (nonmember), or $525 

(Federal Government employee 

nonmember). (Registration fee for 

nonmembers includes a 1-year 

membership.) The registration fee for 

FDA employees is waived. Make the 

registration fee payable to SoCRA, 530 

West Butler Ave., suite 109, Chalfont, 

PA, 18914. To register via the Internet 

go to www.socra.org (FDA has verified 

the Web site address, but is not 

responsible for subsequent changes to 

the Web site after this document 

publishes in the Federal Register). 

The registrar will also accept payment 

by major credit cards. For more 

information on the meeting, or for 

questions on registration, contact 800–

SoCRA92 (800–762–7292), or 215–822–

8644, or via e-mail: socramail@aol.com. 

Attendees are responsible for their own 

accommodations. To make reservations 

at the Oak Brook Hills Marriott Resort, 

at the reduced conference rate, contact 

the Oak Brook Hills Marriott Resort (see 

Location) before April 24, 2007, citing 

meeting code SCRSCRA. The 

registration fee will be used to offset the 

expenses of hosting the conference, 

including meals, refreshments, meeting 

rooms, and materials. 

Space is limited, therefore interested 

parties are encouraged to register early. 

Limited onsite registration may be 

available. Please arrive early to ensure 

prompt registration. If you need special 

accommodations due to a disability, 

please contact Marie Falcone (see 

Contact) at least 7 days in advance of 

the workshop. 

SUPPLEMENTARY INFORMATION: The 

workshop on FDA clinical trials 

statutory and regulatory requirements 

helps fulfill the Department of Health 

and Human Services’ and FDA’s 

important mission to protect the public 

health by educating researchers on 

proper conduct of clinical trials. Topics 

for discussion include the following: (1) 

FDA regulation of the conduct of 

clinical research; (2) medical device, 

drug, biological and food product 

aspects of clinical research; (3) 

investigator initiated research; (4) preinvestigational new drug application 

meetings and FDA meeting process; (5) 

informed consent requirements; (6) 

ethics in subject enrollment; (7) FDA 

regulation of institutional review 

boards; (8) electronic records 

requirements; (9) adverse event 

reporting; (10) how FDA conducts 

bioresearch inspections; and (11) what 

happens after the FDA inspection. FDA 


sroberts on PROD1PC70 with NOTICES