7278 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 

Guidance for Industry on ‘‘How to 

Submit a Protocol Without Data in 

Electronic Format to the Center for 

Veterinary Medicine’’—21 CFR 58.120 

and 514.117(b) (OMB Control Number 

0910–0524—Extension) 

Protocols for nonclinical laboratory 

studies (safety studies), are required 

under 21 CFR 58.120 for approval of 

new animal drugs. Protocols for 

adequate and well-controlled 

effectiveness studies are required under 

21 CFR 514.117(b). Upon request by the 

animal drug sponsors, the Center for 

Veterinary Medicine (CVM) reviews 

protocols for safety and effectiveness 

studies. CVM and the sponsor consider 

this to be an essential part of the basis 

for making the decision to approve or 

not approve an animal drug application 

or supplemental animal drug 

application. The establishment of a 

process for acceptance of the electronic 

submission of protocols for studies 

conducted by sponsors in support of 

new animal drug applications is part of 

CVM’s ongoing initiative to provide a 

method for paperless submissions. 

Sponsors may submit protocols to CVM 

in paper format. CVM’s guidance on 

how to submit a study protocol permits 

sponsors to submit a protocol without 

data as an e-mail attachment via the 

Internet. Further, this guidance also 

electronically implements provisions of 

the Government Paperwork Elimination 

Act (GPEA). The GPEA required Federal 

agencies, by October 21, 2003, to 

provide the following: (1) The option of 

electronic maintenance, submission, or 

disclosure of information, if practicable, 

as a substitution for paper and (2) the 

use and acceptance of electronic 

signatures, where applicable. FDA Form 

3536 is used to facilitate the use of 

electronic submission of protocols. This 

collection of information is for the 

benefit of animal drug sponsors, giving 

them the flexibility to submit data for 

review via the Internet. 

The likely respondents are sponsors 

of new animal drug applications. 

FDA estimates the burden for this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/FDA Form 3536 No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses2

Hours per 

Response Total Hours 

514.117(b) and 58.120 40 1.8 72 .20 14.4 

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

2Electronic submissions received between January 1, 2008, and December 31, 2008. 

The number of respondents in table 1 

of this document is the number of 

sponsors registered to make electronic 

submissions (40). The number of total 

annual responses is based on a review 

of the actual number of such 

submissions made between July 1, 2005, 

and June 30, 2006, (72 x .20 hours per 

response = 14.4 total hours). 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3026 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–2010–N–0062] 

Agency Information Collection 

Activities; Proposed Collection; 

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 an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

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. 

DATES: Submit written or electronic 

comments on the collection of 

information by April 19, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

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