Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 7279 

Medical Devices; Exception From 

General Requirements for Informed 

Consent—21 CFR 50.23 (OMB Control 

Number 0910–0586)—Extension 

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. 

FDA estimates the burden of the 

collection of information as follows: 

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 

50.23(e)(1)(2) 150 3 450 2 900 

50.23(e)(4) 150 3 450 1 450 

Total 1350 

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

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 Centers 

for Disease Controls’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. 

This interim final rule refers to 

previously approved collections of 

information found in FDA regulations. 

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 50.25 have 

been approved under 0910–0130. 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3025 Filed 2–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0496] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Tobacco Product 

Standard on Flavored Cigarettes 

AGENCY: Food and Drug Administration, 

HHS. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

7280 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 

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 March 22, 

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 0910–0647. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, 

Jonnalynn.capezzuto@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. 

Tobacco Product Standard on Flavored 

Cigarettes—(OMB Control Number 

0910–0647)—Extension 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (Tobacco 

Control Act) (Public Law 111–31) into 

law. The Tobacco Control Act amended 

the Federal Food, Drug, and Cosmetic 

Act (the act) by adding a new chapter 

granting FDA important new authority 

to regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

FDA is requesting an extension of an 

existing collection of information 

pertaining to section 907(a)(1)(A) of the 

act (21 U.S.C. 397(a)(1)(A), as amended 

by the Tobacco Control Act, which 

provides a general tobacco standard 

special rule for cigarettes that became 

effective on September 22, 2009. This 

special rule for cigarettes states in part 

that ‘‘* * * a cigarette or any of its 

component parts (including the tobacco, 

filter, or paper) shall not contain, as a 

constituent (including a smoke 

constituent) or additive, an artificial or 

natural flavor (other than tobacco or 

menthol) or an herb or spice, including 

strawberry, grape, orange, clove, 

cinnamon, pineapple, vanilla, coconut, 

licorice, cocoa, chocolate, cherry, or 

coffee, that is a characterizing flavor of 

the tobacco product or tobacco smoke.’’ 

As part of our enforcement strategy, 

FDA created a Tobacco Call Center 

(with a toll-free number) to accept 

information from the public about 

violations of this provision, known as 

the cigarette flavor ban. Callers are able 

to report violations of the cigarette 

flavor ban and FDA will determine 

whether to conduct targeted followup 

investigations based on information the 

agency receives. Members of the public 

who wish to report a violation will be 

asked for certain information: Name and 

contact information, which are optional, 

date that the caller observed or 

purchased the alleged violative product, 

description of the tobacco product, and 

address of the retail outlet or Internet 

address where the violative product was 

available. FDA developed a form (FDA 

Form 3734) that Tobacco Call Center 

representatives use to record this 

information. Additionally, this form is 

posted on FDA’s Internet at http:// 

www.accessdata.fda.gov/scripts/email/ 

TobaccoProducts/ 

flavoredCigarettes.cfm) which allows 

the public to report violations of the 

cigarette flavor ban by filling out the 

form online. Others may simply choose 

to send a letter to FDA. (Information 

about how to contact FDA’s Center for 

Tobacco Products is posted at http:// 

www.fda.gov/TobaccoProducts/ 

default.htm). 

FDA described how to report 

information about possible violations in 

a Federal Register notice reminding 

regulated industry of the effective date 

of the ban on certain flavored cigarettes 

(74 FR 48974, September 25, 2009). FDA 

also included this information in the 

following outreach materials: 

• Letter to our tobacco control 

partners announcing the cigarette flavor 

ban and soliciting information on 

possible violations, 

• Press release announcing the 

effective date of the cigarette flavor ban, 

• Flavored tobacco products fact 

sheet, and 

• Flavored tobacco products parental 

advisory. 

In the Federal Register of October 26, 

2009 (74 FR 55050), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment in response to the 60-day 

notice soliciting public comment on the 

extension of OMB approval for this 

information collection generally 

supporting ‘‘the extension of this 

collection of information regarding the 

enforcement of the cigarette flavor ban 

and submits that the extension of data 

collection is critical to the ‘proper 

performance of FDA’s functions’ and 

that it will have great ‘practical utility’.’’ 

Although FDA did not receive comment 

on the estimated number of 

respondents, FDA is adjusting this 

estimate based on current reporting 

experience to 170 respondents. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity and Form FDA 3734 No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Minutes Per 

Response Total Hours 

Reporting violations of section 

907(a)(1)(A) of the act 170 1 170 10 (0.167 hours) 28 

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

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 7281 

Dated: February 12, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3036 Filed 2–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Translating 

Research Into Action for Diabetes 

(TRIAD) Legacy Study, Funding 

Opportunity Announcement (FOA) DP 

10–005, Initial Review 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

Time and Date: 11 a.m.–5 p.m., March 31, 

2010 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c) (4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘TRIAD Legacy Study, FOA DP 

10–005.’’ 

Contact Person for More Information: Don 

Blackman, PhD, Scientific Review Officer, 

National Center for Chronic Disease and 

Health Promotion, Office of the Director, 

Extramural Research Program Office, 4770 

Buford Highway, NE., Mailstop K–92, 

Atlanta, GA 30341, telephone: (770) 488– 

3023, e-mail: DBlackman@cdc.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: February 10, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–3064 Filed 2–17–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Center for Injury Prevention 

and Control/Initial Review Group, 

(NCIPC/IRG) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), 

announces the following meeting of the 

aforementioned review group: 

Time and Date: 12:30 p.m.–4 p.m., 

March 3, 2010 (closed). 

Place: Teleconference. 

Status: The meetings will be closed to 

the public in accordance with 

provisions set forth in Section 

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

the Determination of the Director, 

Management Analysis and Services 

Office, CDC, pursuant to Section 10(d) 

of Public Law 92–463. 

Purpose: This group is charged with 

providing advice and guidance to the 

Secretary, Department of Health and 

Human Services, and the Director, CDC, 

concerning the scientific and technical 

merit of grant and cooperative 

agreement applications received from 

academic institutions and other public 

and private profit and nonprofit 

organizations, including State and local 

government agencies, to conduct 

research that will build the scientific 

base for the prevention of unintentional 

poisonings from drug overdoses in the 

adult population. 

Matters to be Discussed: The meeting 

will include the review, discussion, and 

evaluation of applications intended to 

encourage exploratory/developmental 

research in unintentional childhood 

injury. Requests for Applications are 

related to the following individual 

research announcement: CE10–002 

Unintentional Poisoning from 

Prescription Drug Overdoses in Adults 

(R21). 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: 

J. Felix Rogers, PhD, M.P.H., Telephone 

(770) 488–4334, NCIPC, CDC, 4770 

Buford Highway, NE., Mail Stop F63, 

Atlanta, Georgia 30341–3724. The 

Director, Management Analysis and 

Services Office has been delegated the 

authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both CDC and 

the Agency for Toxic Substances and 

Disease Registry. 

Dated: February 4, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–3047 Filed 2–17–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Pediatric 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on Monday, March 22, 2010, from 

8 a.m. to 6 p.m. 

Location: Bethesda Marriott Hotel, 

5151 Pooks Hill Rd., Bethesda, MD., 

20814. 

Contact Person: Doreen Kezer, Office 

of the Commissioner, Food and Drug 

Administration, 5600 Fishers Lane (HF– 

33), rm. 14–65, Rockville, MD 20857, 

301–827–1249, e-mail: 

Doreen.Kezer@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

8732310001. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: The Pediatric Advisory 

Committee will meet to discuss 

pediatric-focused safety reviews, as 

mandated by the Best Pharmaceuticals 

for Children Act and the Pediatric 

Research Equity Act, for: Anthelios 40, 

Cardiolite (technetium Tc-99), Nasacort 

AQ (triamcinolone), Viramune 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES