Federal Register / Vol. 74, No. 196 / Tuesday, October 13, 2009 / Notices 52493 

for Chronic Disease Prevention and 

Health Promotion (NCCDPHP), Centers 

for Disease Control and Prevention 

(CDC). 

Background and Brief Description 

Cardiovascular disease (CVD), which 

includes heart disease, myocardial 

infarction, and stroke, is the leading 

cause of death for women in the United 

States, and is largely preventable. The 

WISEWOMAN program (Well-Integrated 

Screening and Evaluation for Women 

Across the Nation), administered by the 

Centers for Disease Control and 

Prevention (CDC), was established to 

examine ways to improve the delivery 

of services for women who have limited 

access to health care and elevated risk 

factors for CVD. The program focuses on 

reducing CVD risk factors and provides 

screening services for select risk factors 

such as elevated blood cholesterol, 

hypertension and abnormal blood 

glucose levels. The program also 

provides lifestyle interventions and 

medical referrals. On an annual basis, 

15 grantees funded through the 

WISEWOMAN program have provided 

services to approximately 30,000 

women who are already participating in 

the National Breast and Cervical Cancer 

Early Detection Program (NBCCEDP), 

also administered by CDC. CDC plans to 

increase the reach of the WISEWOMAN 

program by increasing the number of 

grantees from 15 to 21. 

CDC currently collects information 

from WISEWOMAN grantees to support 

continuous program monitoring and 

improvement activities. CDC seeks to 

extend OMB approval for three 

additional years. The total estimated 

annualized burden will increase due to 

the increase in the number of funded 

grantees. However, the burden to each 

respondent will decrease due to a 

reduction in the frequency of data 

collection for items that were previously 

collected on a quarterly basis. During 

the next OMB approval period, all 

information will be collected twice per 

year. 

Information reported to CDC includes 

baseline and follow-up data (12 months 

post enrollment) for all women served 

through the WISEWOMAN program. 

These data, called the minimum data 

elements (MDE), include data elements 

that describe risk factors for the women 

served in each program and data 

elements that describe the number and 

type of intervention sessions attended. 

Funded grantees compile the data from 

their existing databases and report the 

MDE to CDC in April and October of 

each year. The MDE data provide an 

assessment of how effective the 

WISEWOMAN program is at reducing 

the burden of cardiovascular disease 

risk factors among women who utilize 

program services. The information 

collected from grantees is also used to 

assess the cost-effectiveness and impact 

of the program. The overall program 

evaluation is designed to demonstrate 

how WISEWOMAN can obtain more 

complete health data on vulnerable 

populations, promote public education 

about disease incidence and risk-factors, 

improve the availability of screening 

and diagnostic services for under-served 

women, ensure the quality of services 

provided to under-served women, and 

develop strategies for improved 

interventions. The information reported 

to CDC also includes programmatic 

information related to grantee 

management, public education and 

outreach, professional education, 

service delivery, cost, and progress 

toward meeting stated programmatic 

objectives. 

All MDE information will be 

submitted to CDC electronically. 

Progress reports will be submitted in 

hardcopy format. Because certain 

demographic information has already 

been collected as part of NBCCEDP, the 

additional burden on grantees will be 

modest. There is no cost to the 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondent Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response (in 

hours) 

Total burden 

(in hours) 

WISEWOMAN Grantees ................... WISEWOMAN MDEs ....................... 21 2 40 1,680 

Progress Report ............................... 21 2 16 672 

Total ........................................... ........................................................... ........................ ........................ ........................ 2,352 

Dated: October 5, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–24522 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–0484] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance on 

Reagents for Detection of Specific 

Novel Influenza A Viruses 

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 

guidance on reagents for detection of 

specific novel influenza A viruses. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 14, 2009. 

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: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 


erowe on DSK5CLS3C1PROD with NOTICES
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