Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Notices 16217 

1OCRA Student Rate applies to those individuals 

enrolled in a Regulatory or Quality related 

academic program at an accredited institution. 

Proof of enrollment required. 

only upon valid scientific evidence to 

determine whether there is reasonable 

assurance of the safety and effectiveness 

of the device, if regulated by general 

controls alone (class I) or by general 

controls and special controls (class II). 

Valid scientific evidence consists of 

evidence from well-controlled 

investigations, partially controlled 

studies, studies and objective trials 

without matched controls, welldocumented case histories conducted by 

qualified experts, and reports of 

significant human experience with a 

marketed device, from which it can 

fairly and responsibly be concluded by 

qualified experts that there is reasonable 

assurance of the safety and effectiveness 

of a device under its conditions of use. 

The evidence required may vary 

according to the characteristics of the 

device, its conditions of use, the 

existence and adequacy of warnings and 

other restrictions, and the extent of 

experience with its use. Isolated case 

reports, random experience, reports 

lacking sufficient details to permit 

scientific evaluation, and 

unsubstantiated opinions are not 

regarded as valid scientific evidence to 

show safety or effectiveness (see 

§ 860.7(c)(2)). 

According to § 860.7(d)(1), there is 

reasonable assurance that a device is 

safe when it can be determined, based 

upon valid scientific evidence, that the 

probable benefits to health from use of 

the device for its intended uses and 

conditions of use, when accompanied 

by adequate directions and warnings 

against unsafe use, outweigh any 

probable risks. The valid scientific 

evidence used to determine the safety of 

a device shall adequately demonstrate 

the absence of unreasonable risk of 

illness or injury associated with the use 

of the device for its intended uses and 

conditions for use. Moreover, under 

§ 860.7(e)(1), there is reasonable 

assurance that a device is effective when 

it can be determined, based upon valid 

scientific evidence, that in a significant 

portion of the target population, the use 

of the device for its intended uses and 

conditions of use, when accompanied 

by adequate directions for use and 

warnings against unsafe use, will 

provide clinically significant results. 

IV. Submission of Required Information 

The summary of, and citation to, any 

information required by the act must be 

submitted by the dates listed in the 

DATES section of this document to the 

Division of Dockets Management (see 

ADDRESSES). 

V. Paperwork Reduction Act of 1995 

This order refers to collections of 

information necessary to comply with 

the requirements found in sections 

510(k) of the act (21 U.S.C. 360(k)) and 

21 CFR part 807, subpart E or the 

requirements of 515(b) of the act (21 

U.S.C. 360e(b)), 21 CFR part 860, and 21 

CFR part 814. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

860.123 have been approved under 

OMB control number 0910–0138; the 

collections of information in 21 CFR 

part 814, have been approved under 

OMB control number 0910–0231; and 

the collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120. 

Dated: April 2, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–8022 Filed 4–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

The 12th Annual Food and Drug 

Administration-Orange County 

Regulatory Affairs Educational 

Conference; ‘‘Regulatory Affairs: The 

Challenges of Ensuring Product 

Safety’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

The Food and Drug Administration 

(FDA) is announcing the following 

conference: 12th Annual Educational 

Conference co-sponsored with the 

Orange County Regulatory Affairs 

Discussion Group (OCRA). The 

conference is intended to provide the 

Drug, Device, and Biologics industries 

with an opportunity to interact with 

FDA reviewers and compliance officers 

from the Centers and District Offices, as 

well as other industry experts. The main 

focus of this interactive conference will 

be product approval, compliance, and 

risk management in the three medical 

product areas. Industry speakers, 

interactive questions and answers, and 

workshop sessions will also be included 

to assure open exchange and dialogue 

on the relevant regulatory issues. 

Date and Time: The conference will 

be held on June 9 and 10, 2009, from 

7:30 a.m. to 5 p.m. 

Location: The conference will be held 

at the Irvine Marriott Hotel, 18000 Von 

Karman Ave., Irvine, CA 92612. 

Contact: Linda Hartley, Food and 

Drug Administration, 19701 Fairchild, 

Irvine, CA 92612, 949–608–4413, FAX: 

949–608–4417, or OCRA, Attention to 

Detail, 5319 University Dr., suite 641, 

Irvine, CA 92612, 949–387–9046, FAX: 

949–387–9047, Web site: http:// 

www.ocra-dg.org. 

Registration and Meeting Information: 

See OCRA Web site, http://www.ocradg.org. Contact Attention to Detail at 

949–387–9046. 

Before May 8, 2009, registration fees 

are as follows: $675.00 for members, 

$725.00 for nonmembers and $475.00 

for FDA/Govt/Students.1 After May 8, 

2009, $725.00 for members, $775.00 for 

nonmembers, and $475.00 for FDA/ 

Govt/Students.1

The registration fee will cover actual 

expenses including refreshments, lunch, 

materials, parking, and speaker 

expenses. 

If you need special accommodations 

due to a disability, please contact Linda 

Hartley at least 10 days in advance. 

Dated: April 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–8135 Filed 4–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 


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