39792 Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before August 25, 2017. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by August 28, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Marieann Brill 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: August 17, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17726 Filed 8–21–17; 8:45 am] 

BILLING CODE 4164–01–P 

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; Medical Devices; 

Exception From General Requirements 

for Informed Consent 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) 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 September 

21, 2017. 

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 emailed 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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North 10A63, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

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 OMB Control Number 0910– 

0586—Extension 

In the Federal Register of June 7, 2006 

(71 FR 32827), FDA issued an 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 applies 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 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) and, 

under § 50.23(e)(3) (76 FR 36989, June 

24, 2011), to FDA 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 

§ 50.23(e)(4), 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 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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39793 

naturally occurring cases of diseases or 

conditions that are identified in the 

Centers for Disease Control and 

Prevention’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. We 

estimate the operating and maintenance 

cost of $200 for copying and mailing the 

information to FDA. 

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. 

In the Federal Register of April 18, 

2017 (82 FR 18294), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Total 

operating and 

maintenance 

costs 

Written certification (sent to 

FDA)—50.23(e)(3).

150 3 450 0.25 (15 minutes) ............... 113 $200 

1There are no capital costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR Part Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Written certification (sent to IRB)—50.23(e)(1) and (2) ...... 150 3 450 2 900 

Informed consent information—50.23(e)(4) ......................... 150 3 450 1 450 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,350 

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

Dated: August 17, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17702 Filed 8–21–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0258] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Submission of 

Petitions: Food Additive, Color 

Additive (Including Labeling), 

Submission of Information to a Master 

File in Support of Petitions; and 

Electronic Submission Using Food and 

Drug Administration Form 3503 

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 September 

21, 2017. 

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 emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0016 and 

title ‘‘Submission of Petitions: Food 

Additive, Color Additive (Including 

Labeling), Submission of Information to 

a Master File in Support of Petitions; 

and Electronic Submission Using Food 

and Drug Administration Form 3503.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

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. 

Submission of Petitions: Food 

Additive, Color Additive (Including 

Labeling), Submission of Information to 

a Master File in Support of Petitions; 

and Electronic Submission Using Food 

and Drug Administration Form 3503— 

21 CFR 70.25, 71.1, and 171.1, and 21 

CFR parts 172, 173, 179, and 180; OMB 

Control Number 0910–0016—Extension. 

Section 409(a) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 348(a)) provides that a food 

additive shall be deemed to be unsafe, 

unless: (1) The additive and its use, or 

intended use, are in conformity with a 

regulation issued under section 409 of 

the FD&C Act that describes the 

condition(s) under which the additive 

may be safely used; (2) the additive and 

its use, or intended use, conform to the 

terms of an exemption for 

investigational use; or (3) a food contact 

notification submitted under section 

409(h) is effective. Food additive 

petitions (FAPs) are submitted by 

individuals or companies to obtain 

approval of a new food additive or to 

amend the conditions of use permitted 


sradovich on DSK3GMQ082PROD with NOTICES