24960 Federal Register / Vol. 75, No. 87 / Thursday, May 6, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0062] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Exception From 

General Requirements for Informed 

Consent 

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 June 7, 

2010. 

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: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0586. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

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. 

Medical Devices; Exception From 

General Requirements for Informed 

Consent—21 CFR 50.23 (OMB Control 

Number 0910–0586)—Extension 

Background Information 

In the Federal Register of June 7, 2006 

(71 FR 32827), FDA issued an interim 

final rule (hereinafter referred to as the 

June 7, 2006, interim final rule) to 

amend its regulations to establish a new 

exception from the general requirements 

for informed consent, to permit the use 

of investigational in vitro diagnostic 

devices to identify chemical, biological, 

radiological, or nuclear agents without 

informed consent in certain 

circumstances. The agency took this 

action because it was concerned that, 

during a potential terrorism event or 

other potential public health emergency, 

delaying the testing of specimens to 

obtain informed consent may threaten 

the life of the subject. In many 

instances, there may also be others who 

have been exposed to, or who may be 

at risk of exposure to, a dangerous 

chemical, biological, radiological, or 

nuclear agent, thus necessitating 

identification of the agent as soon as 

possible. FDA created this exception to 

help ensure that individuals who may 

have been exposed to a chemical, 

biological, radiological, or nuclear agent 

are able to benefit from the timely use 

of the most appropriate diagnostic 

devices, including those that are 

investigational. 

Section 50.23(e)(1) (21 CFR 

50.23(e)(1)) provides an exception to the 

general rule that informed consent is 

required for the use of an investigational 

in vitro diagnostic device. This 

exception will apply to those situations 

in which the in vitro investigational 

diagnostic device is used to prepare for 

and respond to a chemical, biological, 

radiological, or nuclear terrorism event 

or other public health emergency, if the 

investigator and an independent 

licensed physician make the 

determination and later certify in 

writing that: (1) There is a lifethreatening situation necessitating the 

use of the investigational device; (2) 

obtaining informed consent from the 

subject is not feasible because there was 

no way to predict the need to use the 

investigational device when the 

specimen was collected and there is not 

sufficient time to obtain consent from 

the subject or the subject’s legally 

authorized representative; and (3) no 

satisfactory alternative device is 

available. Under the June 7, 2006, 

interim final rule, these determinations 

are made before the device is used, and 

the written certifications are made 

within 5 working days after the use of 

the device. If use of the device is 

necessary to preserve the life of the 

subject and there is not sufficient time 

to obtain the determination of the 

independent licensed physician in 

advance of using the investigational 

device, § 50.23(e)(2) provides that the 

certifications must be made within 5 

working days of use of the device. In 

either case, the certifications are 

submitted to the Institutional Review 

Board (IRB) within 5 working days of 

the use of the device. 

Section 50.23(e)(4) provides that an 

investigator must disclose the 

investigational status of the device and 

what is known about the performance 

characteristics of the device at the time 

test results are reported to the subject’s 

health care provider and public health 

authorities, as applicable. Under the 

June 7, 2006, interim final rule, the 

investigator provides the IRB with the 

information required by § 50.25 (21 CFR 

50.25) (except for the information 

described in § 50.25(a)(8)) and the 

procedures that will be used to provide 

this information to each subject or the 

subject’s legally authorized 

representative. 

From its knowledge of the industry, 

FDA estimates that there are 

approximately 150 laboratories that 

could perform testing that uses 

investigational in vitro diagnostic 

devices to identify chemical, biological, 

radiological, or nuclear agents. FDA 

estimates that in the United States each 

year there are approximately 450 

naturally occurring cases of diseases or 

conditions that are identified in the 

Centers for Disease Control’s list of 

category ‘A’ biological threat agents. The 

number of cases that would result from 

a terrorist event or other public health 

emergency is uncertain. Based on its 

knowledge of similar types of 

submissions, FDA estimates that it will 

take about 2 hours to prepare each 

certification. 

Based on its knowledge of similar 

types of submissions, FDA estimates 

that it will take about 1 hour to prepare 

a report disclosing the investigational 

status of the in vitro diagnostic device 

and what is known about the 

performance characteristics of the 

device and submit it to the health care 

provider and, where appropriate, to 

public health authorities. 

The June 7, 2006, interim final rule 

refers to previously approved 

collections of information found in FDA 

regulations. These collections of 

information are subject to review by 

OMB under the Paperwork Reduction 

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

collections of information in § 50.25 

have been approved under 0910–0130. 

In the Federal Register of February 

18, 2010 (75 FR 7278), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates this burden of the 

collection of information as follows: 

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Federal Register / Vol. 75, No. 87 / Thursday, May 6, 2010 / Notices 24961 

TABLE 1.—ESTIMATED AVERAGE ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

of Responses 

Total Annual 

Responses 

Hours per 

Response Total Hours Total Operating & Maintenance Costs 

50.23(e)(1) 

and (e)(2) 150 3 450 2 900 $0 .00 

50.23(e)(4) 150 3 450 1 450 $100 .00 

Total 1,350 $100 .00 

Dated: April 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10656 Filed 5–5–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0480] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Investigational Device Exemptions 

Reports and Records 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘ Investigational Device Exemptions 

Reports and Records—21 CFR Part 812’’ 

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 19, 2010 (75 

FR 2869), the agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0078. The 

approval expires on February 28, 2013. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: April 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10657 Filed 5–6–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis Panel; NADIA Consortium Review 

(IN). 

Date: May 19, 2010. 

Time: 8 a.m. to 7 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Ranga Srinivas, PhD, 

Chief, Extramural Project Review Branch, 

Office of Extramural Activities, National 

Institutes of Health, National Institute on 

Alcohol Abuse & Alcoholism, 5635 Fishers 

Lane, Room 2085, Rockville, MD 20852. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis Panel; NADIA Consortium Review 

(NC). 

Date: May 20, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Ranga Srinivas, PhD, 

Chief, Extramural Project Review Branch, 

Office of Extramural Activities, National 

Institutes of Health, National Institute on 

Alcohol Abuse & Alcoholism, 5635 Fishers 

Lane, Room 2085, Rockville, MD 20852. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards, National 

Institutes of Health, HHS) 

Dated: April 28, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10432 Filed 5–5–10; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2009–1086] 

Pittsburgh Area Maritime Security 

Committee; Vacancies 

AGENCY: Coast Guard, DHS. 

ACTION: Solicitation for membership. 

SUMMARY: This notice requests 

individuals interested in serving on the 

Pittsburgh Area Maritime Security 

Committee (AMSC) to submit their 

application for membership, to the 

Captain of the Port, Pittsburgh, 

Pennsylvania. 

DATES: Requests for membership should 

reach the Pittsburgh Captain of the Port 

on or before June 7, 2010. 

ADDRESSES: Requests for membership 

should be submitted to the Captain of 

the Port at the following address: 

Commander, USCG Marine Safety Unit 

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