Federal Register / Vol. 74, No. 101 / Thursday, May 28, 2009 / Notices 25553 

Center for Environmental Health and 

Injury Prevention (CCEHIP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

On October 10, 2008, President Bush 

signed S. 1382: ALS Registry Act which 

amended the Public Health Service Act 

to provide for the establishment of an 

Amyotrophic Lateral Sclerosis (ALS) 

Registry. The activities described are 

part of the effort to create the National 

ALS Registry. The purpose of the 

registry is to: (1) Better describe the 

incidence and prevalence of ALS in the 

United States; (2) examine appropriate 

factors, such as environmental and 

occupational, that might be associated 

with the disease; (3) better outline key 

demographic factors (such as age, race 

or ethnicity, gender, and family history) 

associated with the disease; and (4) 

better examine the connection between 

ALS and other motor neuron disorders 

that can be confused with ALS, 

misdiagnosed as ALS, and in some cases 

progress to ALS. The registry will 

collect personal health information that 

may provide a basis for further scientific 

studies of potential risks for developing 

ALS. 

During a workshop held by The 

Agency for Toxic Substances and 

Disease Registry (ATSDR) in March 

2006 to discuss surveillance of selected 

autoimmune and neurological diseases, 

it was decided to develop a proposal to 

build on work that had already been 

done and coordinate existing datasets to 

create a larger database, rather than to 

start from scratch with medical records 

review and physician reporting. Four 

pilot projects were funded to evaluate 

the accuracy and reliability of existing 

data from the Center for Medicare and 

Medicaid Services (CMS) and various 

datasets from the Veterans 

Administration. Preliminary results 

indicate that additional ways to identify 

cases of ALS will be necessary to 

increase completeness of the registry. 

Therefore, ATSDR developed a Web site 

where individuals will register and will 

also have the opportunity to provide 

additional information on such things as 

occupation, military service, and family 

history of ALS, which is not available in 

existing records. 

The registration portion of the data 

collection will be limited to information 

that can be used to identify an 

individual to assure that there are not 

duplicate records for an individual. 

Avoiding duplication of registrants due 

to obtaining records from multiple 

sources is imperative to get accurate 

estimates of incidence and prevalence, 

as well as accurate information on 

demographic characteristics of the cases 

of ALS. 

In addition to questions required for 

registration, there will be a series of 

short surveys to collect information on 

such things as military history, 

occupations, and family history that 

would not likely be available from other 

sources. 

This project proposes to collect 

information on individuals with ALS 

which can be combined with 

information obtained from existing 

sources of information. This combined 

data will become the National ALS 

Registry and will be used to provide 

more accurate estimates of the incidence 

and prevalence of disease as well as the 

demographic characteristics of the 

cases. Information obtained from the 

surveys will be used to better 

characterize potential risk factors for 

ALS which will lead to further in-depth 

studies. 

The existence of the Web site will be 

advertised by ATSDR and advocacy 

groups such as the Amyotrophic Lateral 

Sclerosis Association (ALSA) and the 

Muscular Dystrophy Association 

(MDA). 

There will be approximately 30,000 

individuals living with ALS when the 

National ALS Registry is initiated, and 

it is estimated that approximately 25% 

of those individuals will also 

participate. In addition, approximately 

6,000 people are diagnosed with ALS 

each year and we expect about one-third 

of them will participate in the registry. 

Because an advantage to registration is 

participating in the surveys, we expect 

the one time surveys, and the twice 

yearly survey participation rate will be 

50%. 

There are no costs to the respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Data collection instruments/respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Validation questions (Screener) for suspected ALS cases ............................. 6,000 1 2/60 200 

Registration Form of ALS cases ...................................................................... 4,667 1 7/60 544 

Cases of ALS completing 1-time surveys ....................................................... 2,334 6 5/60 1167 

Cases of ALS completing twice yearly surveys .............................................. 2,334 2 5/60 389 

Total ................................................................................................................. ........................ ........................ ........................ 2300 

Dated: May 20, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–12397 Filed 5–27–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–09–0214] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed project or to obtain a copy of 

data collection plans and instruments, 

call the CDC Reports Clearance Officer 

on 404–639–5960 or send comments to 

CDC Assistant Reports Clearance 

Officer, 1600 Clifton Road, MS D–74, 

Atlanta, GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

25554 Federal Register / Vol. 74, No. 101 / Thursday, May 28, 2009 / Notices 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Written comments should be received 

within 60 days of this notice. 

Proposed Project 

National Health Interview Survey 

(NHIS), (OMB No. 0920–0214)— 

Revision—National Center for Health 

Statistics (NCHS), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

Section 306 of the Public Health 

Service (PHS) Act (42 U.S.C. 242k), as 

amended, authorizes that the Secretary 

of Health and Human Services (DHHS), 

acting through NCHS, shall collect 

statistics on the extent and nature of 

illness and disability of the population 

of the United States. 

The annual National Health Interview 

Survey is a major source of general 

statistics on the health of the U.S. 

population and has been in the field 

continuously since 1957. Clearance is 

sought for three years, to collect data for 

2010, 2011, and 2012. This voluntary 

household-based survey collects 

demographic and health-related 

information on a nationally 

representative sample of persons and 

households throughout the country. 

Information is collected using computer 

assisted personal interviews (CAPI). A 

core set of data is collected each year 

while sponsored supplements vary from 

year to year. For 2010, supplement 

information will be collected on cancer, 

occupational injury, epilepsy, and child 

mental health. The child mental health 

component includes a follow-up study 

to assess the validity of a short series of 

questions for measuring mental distress 

in children. 

In accordance with the 1995 initiative 

to increase the integration of surveys 

within the Department of Health and 

Human Services, respondents to the 

NHIS serve as the sampling frame for 

the Medical Expenditure Panel Survey 

conducted by the Agency for Healthcare 

Research and Quality. The NHIS has 

long been used by government, 

university, and private researchers to 

evaluate both general health and 

specific issues, such as cancer, diabetes, 

and access to health care. It is a leading 

source of data for the Congressionallymandated ‘‘Health US’’ and related 

publications, as well as the single most 

important source of statistics to track 

progress toward the National Health 

Promotion and Disease Prevention 

Objectives, ‘‘Healthy People 2010.’’ 

There is no cost to the respondents 

other than their time. 

ANNUALIZED BURDEN TABLE

Questionnaire 

(respondent) 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

in hours 

Total burden 

in hours 

Screener Questionnaire (adult family member) ............................................... 10,000 1 5/60 833 

Family Core (adult family member) ................................................................. 33,000 1 23/60 12,650 

Adult Core (sample adult) ................................................................................ 25,000 1 17/60 7,083 

Child Core (adult family member) .................................................................... 10,000 1 9/60 1,500 

Adult Cancer (sample adult) ............................................................................ 25,000 1 19/60 7,917 

Child Cancer (adult family member) ................................................................ 10,000 1 1/60 167 

Adult Occupational Injury (sample adult) ......................................................... 25,000 1 2/60 833 

Adult Epilepsy (sample adult) .......................................................................... 25,000 1 1/60 417 

Child Mental Health (adult family member) ..................................................... 10,000 1 2/60 333 

Child Mental Health Follow-Up (parent) .......................................................... 430 1 40/60 287 

Child Mental Health Follow-Up (child) ............................................................. 319 1 28/60 149 

Re-interview Survey) ....................................................................................... ........................ 1 5/60 250 

Total Burden Hours .................................................................................. ........................ ........................ ........................ 32,419 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Office of 

the Chief Science Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–12393 Filed 5–27–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0050] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Importer’s Entry 

Notice 

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 June 29, 

2009. 

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: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0046. Also 

include the FDA docket number found 

in brackets in the heading of this 

document.