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
14584 Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Notices 

has made education of the research 

community a high priority to ensure the 

quality of clinical data and protect 

research subjects. The workshop helps 

to implement the objectives of section 

406 of the FDA Modernization Act (21 

U.S.C. 393) and the FDA Plan for 

Statutory Compliance, which includes 

working more closely with stakeholders 

and ensuring access to needed scientific 

and technical expertise. The workshop 

also furthers the goals of the Small 

Business Regulatory Enforcement 

Fairness Act (Public Law 104–121) by 

providing outreach activities by 

Government agencies directed to small 

businesses. 

Dated: March 22, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5633 Filed 3–27–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

American Indians into Psychology; 

Notice of Competitive Grant 

Applications for American Indians Into 

Psychology Program 

Announcement Type: New. 

Funding Opportunity Number: HHS–

IHS–2007–INPSY–0001. 

CFDA Number: 92.970. 

Key Dates: 

Application Deadline: May 7, 2007. 

Application Review: May 30, 2007. 

Application Notification: June 22, 

2007. 

Anticipated Award Start Date: August 

1, 2007. 

I. Funding Opportunity Description 

The Indian Health Service (IHS) 

announces that competitive grant 

applications are being accepted for the 

American Indians into Psychology 

Program. This grant is established under 

the authority of ‘‘25 U.S.C. 1621p(a–

d).’’, Indian Health Care Improvement 

Act, Pub. L. 94–437, as amended by 

Pub. L. 102–573. The purpose of the 

Indians into Psychology Program is to 

augment the number of Indian health 

professionals serving Indians by 

encouraging Indians to enter the health 

professions and removing the multiple 

barriers to their entrance into IHS and 

private practice among Indians. This 

program is described at 93.970 in the 

Catalog of Federal Domestic Assistance. 

Costs will be determined in accordance 

with applicable Office of Management 

and Budget Circulars. The Public Health 

Service (PHS) is committed to achieving 

the health promotion and disease 

prevention objectives of Health People 

2010, a PHS-led activity for setting 

priority areas. This program 

announcement is related to the priority 

area of Educational and Communitybased programs. Potential applicants 

may obtain a copy of Healthy People 

2010, summary report in print, Stock 

No. 017–001–00547–9, or via CD–ROM, 

Stock No. 107–0017–00549–5, through 

the Superintendent of Documents, 

Government Printing Office, P.O. Box 

371954, Pittsburgh, PA 15250–7945, 

(202) 512–1800. You may access this 

information via the Internet at the 

following Web site: http:// 

www.health.gov/healthypeople 

The Public Health Service strongly 

encourages all grant and contract 

recipients to provide a smoke-free 

workplace and promote the non-use of 

all tobacco products. In addition, Pub. 

L. 103–227, the Pro-Children Act of 

1994, prohibits smoking in certain 

facilities (or in some cases, any portion 

of the facility) in which regular or 

routine education, library, day care, 

health care, or early childhood 

development services are provided to 

children. This is consistent with the 

PHS mission to protect and advance the 

physical and mental health of the 

American people. 

II. Award Information 

Type of Awards: Grant. 

Estimated Funds Available: the total 

amount identified for Fiscal year 2007 is 

$246,332. The award is for 12 months in 

duration and the average award is 

approximately $246,322. Awards under 

this announcement are subject to the 

availability of funds. 

Anticipated Number of Awards: An 

estimated 1 award will be made under 

the program. If funding becomes 

available, additional awards may be 

made. 

Project Period: 36 months. 

Award Amount: $246,322, per year. 

III. Eligibility Information 

1. Eligible Applicants: 

Public and nonprofit private colleges 

and universities are eligible to apply for 

a grant. However, only one grant will be 

awarded and funded to a college or 

university per funding cycle. 

2. Cost Sharing/Matching: 

This announcement does not require 

matching funds or cost sharing. 

3. Other Requirements: 

Required Affiliations—The grant 

applicant must submit official 

documentation indicating a Tribe’s 

cooperation with and support of the 

program within the schools on its 

reservation and its willingness to have 

a Tribal representative serving on the 

program advisory board. Documentation 

must be in the form prescribed by the 

Tribe’s governing body, i.e., letter of 

support or Tribal resolution. 

Documentation must be submitted from 

every Tribe involved in the grant 

program. If application budgets exceed 

the stated dollar amount that is outlined 

within this announcement it will not be 

considered for funding. 

IV. Applicant and Submission 

Information 

1. Applicant package may be found in 

Grants.gov (www.grants.gov) or at 

http://www.ihs.gov/ 

NonMedicalPrograms/gogp/ 

gogp_funding.asp. Information 

regarding the electronic application 

process may be directed to Michelle G. 

Bulls, at (301) 443 6528 or MichelleBulls@ihs.gov. The entire application 

package is available at: http:// 

www.grants.gov/Apply. Detailed 

application instructions for this 

announcement are downloadable on 

www.Grants.gov 

2. Content and Form of Application 

Submission: 

• Be single spaced. 

• By typewritten. 

• Have consecutively numbered 

pages. 

• Use black type not smaller than 12 

characters per one inch. 

• Contain a narrative that does not 

exceed 7 typed pages that includes the 

other submission requirements below. 

The 7 page narrative does not include 

the work plan, standard forms, Tribal 

resolutions or letters of support (if 

necessary), table of contents, budget, 

budget justifications, narratives, and/or 

other appendix items. 

Public Policy Requirements: All 

Federal-wide public policies apply to 

IHS grants with the exception of 

Lobbying and Discrimination. 

3. Submission Dates and Times: 

Applications must be submitted 

electronically through Grants.gov by 12 

midnight Eastern Standard Time (EST). 

If technical challenges arise and the 

applicant is unable to successfully 

complete the electronic application 

process, the applicant should contact 

Michelle G. Bulls, Grants Policy Staff, 

fifteen days prior to the application 

deadline and advise of the difficulties 

that your organization is experiencing. 

The grantee must obtain prior approval, 

in writing (e-mails are acceptable) 

allowing the paper submission. If 

submission of a paper application is 

requested and approved, the original 

and two copies may be sent to the 

appropriate grants contact that is listed 

in Section IV above. Applications not 


sroberts on PROD1PC70 with NOTICES