Federal Register / Vol. 71, No. 172 / Wednesday, September 6, 2006 / Notices 52547 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator; 

American Health Information 

Community Chronic Care Workgroup 

Meeting 

ACTION: Announcement of meeting. 

SUMMARY: This notice announces the 

ninth meeting of the American Health 

Information Community Chronic Care 

Workgroup in accordance with the 

Federal Advisory Committee Act (Pub. 

L. No. 92–463, 5 U.S.C., App.). 

DATES: September 20, 2006 from 1 p.m. 

to 4 p.m. 

ADDRESSES: Mary C. Switzer Building 

(330 C Street, SW., Washington, DC 

20201), Conference Room 4090. [Please 

bring photo ID for entry to a Federal 

building.] 

FOR FURTHER INFORMATION CONTACT: 

http://www.hhs.gov/healthit/ahic/ 

cc_main.html. 

SUPPLEMENTARY INFORMATION: The 

meeting will be available via Web cast 

at http://www.eventcenterlive.com/ 

cfmx/ec/login/login1.cfm?BID=67. 

Dated: August 29, 2006. 

Judith Sparrow, 

Director, American Health Information 

Community, Office of Programs and 

Coordination, Office of the National 

Coordinator. 

[FR Doc. 06–7455 Filed 9–5–06; 8:45 am] 

BILLING CODE 4150–24–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0185] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance on 

Informed Consent for In Vitro 

Diagnostic Device Studies Using 

Leftover Human Specimens That Are 

Not Identifiable 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 6, 

2006. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1472. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance: 

Guidance on Informed Consent for In 

Vitro Diagnostic Device Studies Using 

Leftover Human Specimens that Are 

Not Individually Identifiable—(OMB 

Control Number 0910–0582)—Extension 

FDA’s investigational device 

regulations are intended to encourage 

the development of new, useful devices 

in a manner that is consistent with 

public health, safety and with ethical 

standards. Investigators should have 

freedom to pursue the least burdensome 

means of accomplishing this goal. 

However, to ensure that the balance is 

maintained between product 

development and the protection of 

public health, safety and ethical 

standards, FDA has established human 

subject protection regulations 

addressing requirements for informed 

consent and Institutional Review 

Committee (IRB) review that apply to all 

FDA-regulated clinical investigations 

involving human subjects. In particular, 

informed consent requirements further 

both safety and ethical considerations 

by allowing potential subjects to 

consider both the physical and privacy 

risks they face if they agree to 

participate in a trial. 

Under FDA regulations, clinical 

investigations using human specimens 

conducted in support of premarket 

submissions to FDA are considered 

human subject investigations (see 21 

CFR 812.3(p)). Many investigational 

device studies are exempt from most 

provisions of part 812 (21 CFR part 812), 

Investigational Device Exemptions, 

under § 812.2(c)(3), but FDA’s 

regulations for the protection of human 

subjects (parts 50 and 56 (21 CFR parts 

50 and 56)) apply to all clinical 

investigations that are regulated by FDA 

(see §§ 50.1 and 56.101, 21 U.S.C. 

360j(g)(3)(A) and (g)(3)(D)). 

FDA regulations do not contain 

exceptions from the requirements of 

informed consent on the grounds that 

the specimens are not identifiable or 

that they are remnants of human 

specimens collected for routine clinical 

care or analysis that would otherwise 

have been discarded. Nor do FDA 

regulations allow IRBs to decide 

whether or not to waive informed 

consent for research involving leftover 

or unidentifiable specimens. 

In a level 1 guidance document issued 

under the good guidance practices 

(GGP) regulations (21 CFR 10.115), FDA 

outlines the circumstances in which it 

intends to exercise enforcement 

discretion as to the informed consent 

regulations for clinical investigators, 

sponsors, and IRBs. 

In the Federal Register of May 19, 

2006 (71 FR 29158), FDA published a 

60-day notice requesting comments on 

the information collection provisions. In 

response to this notice, no comments 

were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

No. of Recordkepers Annual Frequency 

per Recordkeeper 

Total annual 

Records 

Hours per 

Record Total Hours Total Capital Cost 

Total Operating 

and 

Maintenance Cost 

700 1 700 4 2,800 $210,000 $210,000 


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