52494 Federal Register / Vol. 74, No. 196 / Tuesday, October 13, 2009 / Notices 

(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. 

Guidance on Reagents For Detection of 

Specific Novel Influenza A Viruses–21 

CFR 866.3332–(OMB Control Number 

0910–0584)–Extension 

In accordance with section 513 of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360c), FDA 

evaluated an application for an in vitro 

diagnostic device for detection of 

influenza subtype H5 (Asian lineage), 

commonly known as avian flu. FDA 

concluded that this device is properly 

classified into class II in accordance 

with 21 U.S.C. 360c(a)(1)(B), because it 

is a device for which the general 

controls by themselves are insufficient 

to provide reasonable assurance of the 

safety and effectiveness of the device, 

but there is sufficient information to 

establish special controls to provide 

such assurance. 

The statute permits FDA to establish 

as special controls many different 

things, including postmarket 

surveillance, development and 

dissemination of guidance 

recommendations, and ‘‘other 

appropriate actions as the Secretary 

deems necessary’’ (21 U.S.C. 

360c(a)(1)(B)). This information 

collection is a measure that FDA 

determined to be necessary to provide 

reasonable assurance of safety and 

effectiveness of reagents for detection of 

specific novel influenza A viruses. 

FDA issued an order classifying the 

H5 (Asian lineage) diagnostic device 

into class II on February 3, 2006, 

establishing the special controls 

necessary to provide reasonable 

assurance of the safety and effectiveness 

of that device and similar future 

devices. The new classification will be 

codified in 21 CFR 866.3332, a 

regulation that will describe the new 

classification for reagents for detection 

of specific novel influenza A viruses 

and set forth the special controls that 

help to provide a reasonable assurance 

of the safety and effectiveness of devices 

classified under that regulation. The 

regulation will refer to the special 

controls guidance document entitled 

‘‘Class II Special Controls Guidance 

Document: Reagents for Detection of 

Specific Novel Influenza A Viruses,’’ 

which provides recommendations for 

measures to help provide a reasonable 

assurance of safety and effectiveness for 

these reagents. 

The guidance document recommends 

that sponsors obtain and analyze 

postmarket data to ensure the continued 

reliability of their device in detecting 

the specific novel influenza A virus that 

it is intended to detect, particularly 

given the propensity for influenza 

viruses to mutate and the potential for 

changes in disease prevalence over time. 

As updated sequences for novel 

influenza A viruses become available 

from the World Health Organization, 

National Institutes of Health, and other 

public health entities, sponsors of 

reagents for detection of specific novel 

influenza A viruses will collect this 

information, compare them with the 

primer/probe sequences in their 

devices, and incorporate the result of 

these analyses into their quality 

management system, as required by 21 

CFR 820.100(a)(1). These analyses will 

be evaluated against the device design 

validation and risk analysis required by 

21 CFR 820.30(g), to determine if any 

design changes may be necessary. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the 

Federal Food, 

Drug, and Cosmetic Act 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Total Operating & 

Maintenance 

Costs 

513 10 2 20 10 200 $5,000 

FDA estimates that 10 respondents 

will be affected annually. Each 

respondent will collect this information 

twice per year, estimated to take 10 

hours. This results in a total data 

collection burden of 200 hours (10 x 20= 

200). FDA estimates that cost of 

developing standard operating 

procedures for each data collection is 

$500 (10 hours of work at $50/hour). 

This results in a total cost to industry of 

$5,000 ($500 x 10 respondents). 

The guidance also refers to previously 

approved information collections found 

in FDA regulations. The information 

collections in 21 CFR part 820 have 

been approved under OMB control 

number 0910–0073. 

Dated: October 5, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24544 Filed 10–9–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–09–0469] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 196 / Tuesday, October 13, 2009 / Notices 52495 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an 

e-mail to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

National Program of Cancer Registries 

Cancer Surveillance System (OMB no. 

0920–0469 exp. Date 1/31/2010)— 

Revision—National Center for Chronic 

Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

In 1992, Congress passed the Cancer 

Registries Amendment Act, which 

established the National Program of 

Cancer Registries (NPCR). The NPCR 

provides support for central cancer 

registries (CCR) that collect, manage and 

analyze data about cancer cases. The 

NPCR-funded CCR, which are located in 

states, the District of Columbia, and U.S. 

territories, report information to CDC 

annually through the National Program 

of Cancer Registries Cancer Surveillance 

System (NPCR CSS) (OMB No. 0920– 

0469, exp. 1/31/2010). CDC plans to 

request OMB approval to continue 

collecting this information for three 

years. 

The NPCR CSS allows CDC to collect, 

aggregate, evaluate and disseminate 

cancer incidence data at the national 

level, and is the primary source of 

information for United States Cancer 

Statistics (USCS), which CDC has 

published annually since 2002. The 

NPCR CSS also allows CDC to monitor 

cancer trends over time, describe 

geographic variation in cancer incidence 

throughout the country, and provide 

incidence data on minority populations 

and rare cancers. These activities and 

analyses further support CDC’s planning 

and evaluation efforts for State and 

national cancer control and prevention. 

In addition, datasets can be made 

available for secondary analysis. 

Each responding CCR is asked to 

report a cumulative file containing 

incidence data from the first diagnosis 

year for which the cancer registry 

collected data with the assistance of 

NPCR funds (e.g., 1995) through 12 

months past the close of the most recent 

diagnosis year (e.g., 2007). Because 

cancer incidence data are already 

collected and aggregated at the State 

level the additional burden of reporting 

the information to CDC is small. 

Information is transmitted to CDC 

electronically once per year. 

The Revision request will include 

changes. First, data definitions will be 

updated to reflect changes in national 

standards for cancer diagnosis and 

coding. In addition, the number of 

respondents will decrease. Respondents 

will be 45 State-based CCR, the CCR of 

the District of Columbia, the CCR of 

Puerto Rico, and the CCR that aggregates 

information from 10 flag territories and 

freely associated States in the Pacific 

Islands. States that receive sole funding 

from the National Cancer Institute are 

not included as respondents. The 

adjusted number of respondents will 

result in a reduction in the total 

estimated burden hours for the NPCR 

CSS. The estimated burden per response 

will not change. 

There are no costs to respondents 

except their time. The total estimated 

annualized burden hours are 96. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Central Cancer Registries in States, Territories, and the District of Columbia .......................... 48 1 2 

Dated: October 5, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–24520 Filed 10–9–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0406] 

Agency Emergency Processing Under 

Office of Management and Budget 

Review; Tobacco Product 

Establishment Registration and 

Submission of Certain Health 

Information; Reopening of the 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

October 26, 2009, the comment period 

for the notice published in the Federal 

Register of September 1, 2009 (74 FR 

45219). The document announced the 

proposed collection of information 

concerning the submission of tobacco 

product establishment registration and 

submission of certain health 

information, including ingredient listing 

and health related documents, as 

required by The Family Smoking 

Prevention and Tobacco Control Act 

(FSPTCA). The agency is reopening the 

comment period because FDA has 

reevaluated the expected launch date of 

the electronic portal and to allow 

interested persons additional time to 

review the proposed collection of 

information and submit comments. 

DATES: Fax written comments on the 

collection of information by October 26, 

2009. FDA is requesting approval of this 

emergency processing by November 2, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

the Office of Management and Budget 

(OMB) recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–5806, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–710), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–796– 

3794, e-mail: 

Jonnalynn.Capezzuto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of September 1, 2009 

(74 FR 45219), FDA requested 

emergency processing of this proposed 

collection of information under section 


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