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. 

Federal Register / Vol. 74, No. 101 / Thursday, May 28, 2009 / Notices 25555 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

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. 

Importer’s Entry Notice (OMB Control 

Number 0910–0046)—Extension 

In order to make an admissibility 

decision for each entry, FDA needs four 

additional pieces of information that are 

not available in the U.S. Customs and 

Border Protection’s (CBP’s) dataset. 

These data elements are the FDA 

Product Code, FDA country of 

production, FDA manufacturer/shipper, 

and ultimate consignee. It is the 

‘‘automated’’ collection of these four 

data elements for which OMB approval 

is requested. FDA construes this request 

as an extension of the prior approval of 

collection of this data via a different 

media, i.e., paper. There are additional 

data elements which filers can provide 

to FDA along with other entry-related 

information which, by doing so, may 

result in their receiving an FDA 

admissibility decision more 

expeditiously, e.g., the quantity, value, 

and Affirmation(s) of Compliance with 

Qualifier(s). 

At each U.S. port of entry (seaport, 

landport, and airport) where foreignorigin FDA-regulated products are 

offered for import, FDA is notified, 

through CBP’s Automated Commercial 

System (ACS) by the importer (or his 

agent) of the arrival of each entry. 

Following such notification, FDA 

reviews relevant data to ensure the 

imported product meets the standards 

as are required for domestic products, 

makes an admissibility decision, and 

informs the importer and CBP of its 

decision. A single entry frequently 

contains multiple lines of different 

products. FDA may authorize specific 

lines to enter the United States 

unimpeded, while others in the same 

entry are to be held pending further 

FDA review/action. 

An important feature developed and 

programmed into FDA’s automated 

system is that all entry data passes 

through a screening criteria program. 

FDA’s electronic screening criteria 

module makes the initial screening 

decision on every entry of foreign-origin 

FDA-regulated product. Virtually 

instantaneously after the entry is filed, 

the filer receives FDA’s admissibility 

decision covering each entry, i.e., ‘‘MAY 

PROCEED’’ or ‘‘FDA REVIEW.’’ 

Examples of FDA’s need to further 

review an entry include: Products 

originating from a specific country or 

manufacturer known to have a history of 

problems, FDA has no previous 

knowledge of the foreign manufacturer 

and/or product, or an import alert 

covering the product has been issued, 

etc. The system assists FDA entry 

reviewers by notifying them of 

information, such as the issuance of 

import alerts, thus averting the chance 

that such information will be missed. 

With the inception of the interface 

with CBP’s ACS, FDA’s electronic 

screening criteria program is applied 

nationwide. This virtually eliminates 

problems such as ‘‘port shopping,’’ e.g., 

attempts to intentionally slip products 

through one FDA port when refused by 

another, or to file entries at a port 

known to receive a high volume of 

entries. Every electronically submitted 

entry line of foreign-origin FDAregulated product undergoes automated 

screening described previously. The 

screening criteria can be set to be as 

specific or as broad as applicable; 

changes are virtually immediately 

effective. This capability is of 

tremendous value in protecting the 

public in the event there is a need to 

immediately halt a specific product 

from entering the United States. 

In the Federal Register of February 

25, 2009 (74 FR 8549), FDA published 

a 60-day notice requesting comments on 

the information collection requirements 

for FDA regulated products. Two 

comments were received. 

One comment was submitted by the 

American Association of Exporters and 

Importers. General comments expressed 

support for the automation of the data 

elements sought by FDA. A second 

comment encouraged FDA to pursue 

risk management methodologies which 

will reduce FDA’s dependence on 

transaction data for admissibility 

decisions. The comments encouraged 

FDA to develop risk management 

methodologies using account 

management techniques assessing the 

internal controls of foreign 

manufacturers and U.S. importers will 

provide FDA with better insight into 

admissibility decisions before entry of 

the merchandise. 

FDA agrees that risk management 

methodologies are key to effective and 

efficient oversight of FDA regulated 

commodities. However, different 

commodities may have different risk 

factors and being able to identify the 

commodity, where it was manufactured, 

and who shipped the commodity are 

essential for FDA to determine the risk 

factors that should be applied when the 

product is offered for entry. These data 

elements are key for FDA in order to 

apply the appropriate risk strategy. 

A second comment was submitted by 

Organon Schering-Plough. No specific 

comments were provided about the 

collection of the additional FDA data 

elements. The submission suggested 

that FDA develop a process similar to 

the ‘‘binding ruling’’ process that is 

maintained by CBP because of the 

impact on the filers compliance-score 

rating. However, the development of a 

‘‘binding ruling’’ process is outside the 

scope of this announcement. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Number of Respondents Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

3,727 1,070 3,988,371 .263 1,048,447 

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

25556 Federal Register / Vol. 74, No. 101 / Thursday, May 28, 2009 / Notices 

Dated: May 20, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–12317 Filed 5–27–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–09–08AW] 

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 

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 email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Quarantine Station Illness Response 

Forms: Airline, Maritime, and Land/ 

Border Crossing—Existing Collection in 

Use without an OMB Number—National 

Center for Preparedness, Detection, and 

Control of Infectious Diseases 

(NCPDCID), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

CDC proposes to collect patient-level 

clinical, epidemiologic, and 

demographic data from ill travelers and 

their possible contacts in order to fulfill 

its regulatory responsibility to prevent 

the importation of communicable 

diseases from foreign countries (42 CFR 

Part 71) and interstate control of 

communicable diseases in humans (42 

CFR Part 70). 

Section 361 of the Public Health 

Service (PHS) Act (42 U.S.C. 264) 

authorizes the Secretary of Health and 

Human Services to make and enforce 

regulations necessary to prevent the 

introduction, transmission or spread of 

communicable diseases from foreign 

countries into the United States. The 

regulations that implement this law, 42 

CFR Parts 70 and 71, authorize 

quarantine officers and other personnel 

to inspect and undertake necessary 

control measures with respect to 

conveyances (e.g., airplanes, cruise 

ships, trucks, etc.), persons, and 

shipments of animals and etiologic 

agents in order to protect the public 

health. The regulations also require 

conveyances to immediately report an 

‘‘ill person’’ or any death on board to 

the Quarantine Station prior to arrival in 

the United States. An ‘‘ill person’’ is 

defined in statute by: 

— Fever (≥100° F or 38° C) persisting 

≥48 hours. 

— Fever (≥100° F or 38° C) and rash, 

glandular swelling, or jaundice. 

— Diarrhea (≥3 stools in 24 hours or 

greater than normal amount). 

The Severe Acute Respiratory 

Syndrome (SARS) situation and concern 

about pandemic influenza and other 

communicable diseases have prompted 

CDC Quarantine Stations to recommend 

that all illnesses be reported prior to 

arrival. 

CDC Quarantine Stations are currently 

located at 20 international U.S. Ports of 

Entry. When a suspected illness is 

reported to the Quarantine Station, 

officers promptly respond to this report 

by meeting the incoming conveyance 

(when possible), collecting information 

and evaluating the patient(s), and 

determining whether an ill person can 

safely be admitted into the U.S. If 

Quarantine Station staff is unable to 

meet the conveyance, the crew or 

medical staff of the conveyance is 

trained to complete the required 

documentation and forward it (using a 

secure system) to the Quarantine Station 

for review and follow-up. 

To perform these tasks in a 

streamlined manner and ensure that all 

relevant information is collected in the 

most efficient and timely manner 

possible, Quarantine Stations use a 

number of forms—the Airline Screening 

and Illness Response Form, the Ship 

Illness/Death Reporting Form, and the 

Land/Border Crossing Form—to collect 

data on passengers with suspected 

illness and other travelers/crew who 

may have been exposed to an illness. 

These forms are also used to respond to 

a report of a death aboard a conveyance. 

The purpose of all of the forms is the 

same: to collect information that helps 

quarantine officials detect and respond 

to potential public health 

communicable disease threats. All forms 

collect the following categories of 

information: demographics and mode of 

transportation, clinical and medical 

history, and any other relevant facts 

(e.g., travel history, traveling 

companions, etc.). As part of this 

documentation, quarantine public 

health officers look for specific signs 

and symptoms common to the nine 

quarantinable diseases (Pandemic 

influenza; SARS; Cholera; Plague; 

Diphtheria; Infectious Tuberculosis; 

Smallpox; Yellow fever; and Viral 

Hemorrhagic Fevers), as well as most 

communicable diseases in general. 

These signs and symptoms include 

fever, difficulty breathing, shortness of 

breath, cough, diarrhea, jaundice, or 

signs of a neurological infection. The 

forms also collect data specific to the 

traveler’s conveyance. 

These data are used by Quarantine 

Stations to make decisions about a 

passenger’s suspected illness as well as 

its communicability. This in turn 

enables Quarantine Station staff to assist 

conveyances in the public health 

management of passengers and crew. 

The estimated total burden on the 

public, included in the chart below, can 

vary a great deal depending on the 

severity of the illness being reported, 

the number of contacts, the number of 

follow-up inquiries required, and who is 

recording the information (e.g., 

Quarantine Station staff versus the 

conveyance medical authority). In all 

cases, Quarantine Stations have 

implemented practices and procedures 

that balance the health and safety of the 

American public against the public’s 

desire for minimal interference with 

their travel and trade. Whenever 

possible, Quarantine Station staff obtain 

information from other documentation 

(e.g., manifest order, other airline 

documents) to reduce the amount of the 

public burden. 

There is no cost to respondents other 

than their time to complete the survey. 

The estimated annual burden for this 

data collection is 172 hours. 

ESTIMATE OF ANNUALIZED BURDEN

Respondents Form Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Quarantine Staff / Crew or Medical Staff ....... Airline Illness or Death Investigation Form .... 1320 1 6/60