25732 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

system does not exist for the source

plasma industry for either HIV or

hepatitis C (HCV).

The source plasma industry collects

approximately 14 million of plasma

each year. The majority of source

plasma is used to produce immune

globulins, albumin and other blood

products utilized in the United States

and in other countries. Donors may

donate up to two times per week and are

remunerated for each donation.

Although the source collection industry

plays an important role in the

production of blood products, little

information regarding HIV or HCV rates

within the industry has been published

to date.

The objectives of this study of HIV

and HCV in plasma donors are to:

1. Analyze the risk behavior

characteristics of infected donors to

assess distribution and trends of HIV

and HCV;

2. Study the motivations and risk

factors of HIV and HCV infected

deferred donors in order to improve the

donor screening and deferral processes;

3. Monitor additional human

immunodeficiency and hepatitis

viruses, HIV and HCV genetic variation,

and other infections relevant to the

epidemiology of HIV and HCV among

U.S. plasma donors;

4. Evaluate the laboratory

characteristics of plasma from infected

donors to determine the effectiveness of

current and anticipated test modalities;

and

5. Evaluate risk factors for

transmission of HCV among recently

infected individuals.

The above objectives will be attained

though a questionnaire designed to

evaluate demographic information,

knowledge of HIV and HCV, risks for

HIV and HCV and motivations for

donating plasma. In order to elucidate

risks for transmission among this

population, a group of HIV and HCV

negative persons will also be given the

questionnaire. Respondents will be

interviewed with the aid of a computer

assisted telephone interview (CATI) and

respondents will receive a stipend for

their time and travel expenses.

Participation is voluntary, and all

information will be gathered only after

written informed consent has been

obtained.

The CDC anticipates 430 individuals

will be enrolled annually in this study

(based upon combined estimates

obtained from the plasma companies

regarding the number of HIV and HCV

positive donors identified per year, plus

the number of HIV and HCV negative

individuals enrolled as comparisons). It

has been estimated that the interview

will take approximately 20 minutes to

complete; therefore, the response

burden will be 143 hours. The

approximate hourly wage earned per

respondent is $10.00/hour. The total

cost to the respondents would be

$1430.00. The Annual Burden hours are

218.

Respondents No. of

respondents

No. of

responses/

respondent

Avg. burden

per response

(in hrs.)

Questionnaire ............................................................................................................................... 430 1 20/60

Form ............................................................................................................................................. 90 5 10/60

Dated: April 26, 2000.

Charles W. Gollmar,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 00–10978 Filed 5–2–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30 DAY–27–00]

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) 639–7090. Send written

comments to CDC, Desk Officer; Human

Resources and Housing Branch, New

Executive Office Building, Room 10235;

Washington, DC 20503. Written

comments should be received within 30

days of this notice.

Proposed Projects

1. Importation of Etiologic Agents and

Packaging and Handling Infectious

Substances and Select Agents—(0920–

0199)—Extension—Interstate shipment

of etiologic agents are regulated by 42

CFR Part 7. This rule establishes

minimal packaging requirements for all

viable microorganisms, illustrates the

appropriate shipping label, and

provides reporting instructions

regarding damages packages and failure

to receive a shipment. In recent years

the threat of illegitimate use of

infectious agents has attracted

increasing interest from the perspective

of public health. The Centers for Disease

Control and Prevention (CDC) is

concerned about the possibility that the

interstate transportation of certain

infectious agents could have adverse

consequences for human health and

safety. CDC has already requested that

all those entities that ship dangerous

human infectious agents exercise

increased vigilance prior to shipment to

minimize the risk of illicit access to

infectious agents. Of special concern are

pathogens and toxins causing anthrax,

botulism, brucellosis, plague, Q fever,

tularemia, and all agents classified for

work at Biosafety Level 4. This

information collection ensures that

selected infectious agents are not

shipped to parties ill-equipped to

handle them appropriately, or who do

not have legitimate reasons to use them

and to implement a system whereby

scientists and researchers involved in

legitimate research may continue

transferring and receiving these agents

without undue burdens. Respondents

include laboratory facilities such as

those operated by government agencies,

universities, research institutions, and

commercial entities. This request is for

the information collection requirements

contained in 42 CFR 71.54, 72.3(e) and

72.4 relating to the importation and

shipment of etiologic agents. Total

annual hours burden are 1,925.

CFR Section No. of respondents

No. of

responses/ respondent

Avg. burden/

response (in

hrs.)

Application for Permit .................................................................................................................. 2,000 1 20/60

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices 25733

CFR Section No. of respondents

No. of

responses/ respondent

Avg. burden/

response (in

hrs.)

72.3(e) .......................................................................................................................................... 50 1 6/60

72.3(f) ........................................................................................................................................... 200 10 12/60

72.4 .............................................................................................................................................. 20 1 12/60

72.6(a) .......................................................................................................................................... 100 1 210/60

72.6(d) .......................................................................................................................................... 300 2 30/60

72.6(e) .......................................................................................................................................... 300 2 10/60

72.6(f) ........................................................................................................................................... 300 2 10/60

Dated: April 26, 2000.

Charles W. Gollmar,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 00–10979 Filed 5–2–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30 DAY–28–00]

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) 639–7090. Send written

comments to CDC, Desk Officer; Human

Resources and Housing Branch, New

Executive Office Building, Room 10235;

Washington, DC 20503. Written

comments should be received within 30

days of this notice.

Proposed Projects

1. Chronic Fatigue Syndrome (CFS)

Surveillance and Related Studies,

Prevalence and Incidence of Fatiguing

Illnesses in Sedgwick County, Kansas

(0920–0401)—Extension—The Centers

for Disease Control and Prevention

(CDC) A Population-Based CFS Study

was done previously in Kansas in 1997.

Data from this cross-sectional, randomdigit-dial survey of prolonged fatiguing

illness in Wichita, Kansas will be added

to the data previously obtained during

the past 24 months from this

population.

The proposed study continues the

Sedgwick County study using identical

methodology and data collection

instruments. Beginning with a randomdigit-dial telephone survey to identify

previously identified fatigued and nonfatigued individuals, followed by a

detailed telephone interview to obtain

additional data on participants’ health

status during the last 12-month period.

Study objectives remain to refine

estimates of CFS in Wichita, identify

similarities and differences among

fatigued and non-fatigued subjects and

to describe the clinical course of

fatiguing illness in the population. Total

annual hours burden are 2,066.

Form name No. of respondents

No. of responses/respondentAvg. burden/

response

(in hrs.)

Telephone Questionnaire ............................................................................................................ 4,500 1 20/60

Self-Administered Questionnaire—Initially Fatigued Adult .......................................................... 75 1 20/60

Self-Administered Questionnaire—Follow-up Fatigued Adult ..................................................... 147 1 20/60

Self-Administered Questionnaire—Non Fatigued Adult .............................................................. 93 1 30/60

Self-Administered Questionnaire—Initially Fatigued Adolescent ................................................ 2 1 30/60

Self-Administered Questionnaire—Parent of Initially Fatigued Adolescent ................................ 2 1 30/60

Self-Administered Questionnaire—Follow-up Fatigued Adolescent ............................................ 2 1 30/60

Self-Administered Questionnaire—Parent of Follow-up Fatigued Adolescent ............................ 2 1 30/60

Self-Administered Questionnaire—Non-Fatigued Adolescent ..................................................... 1 1 30/60

Self-Administered Questionnaire—Parent of Non-Fatigued Adolescent ..................................... 1 1 30/60

Symptom Questionnaire—Initially Fatigued Adult ....................................................................... 75 1 10/60

Symptom Questionnaire—Follow-up Fatigued Adult .................................................................. 147 1 10/60

Symptom Questionnaire—Initially Fatigued Adolescent and Parent of Fatigued Adolescent .... 4 1 10/60

Symptom Questionnaire—Follow-up Fatigued Adolescent and Parent of Fatigued Adolescent 4 1 10/60

Course of Fatiguing Illness Questionnaire .................................................................................. 208 1 4/60

Diagnostic Interview Schedule—Adults Questionnaire ............................................................... 315 1 45/60

Diagnostic Interview Schedule—Parent Version ......................................................................... 5 1 45/60

Diagnostic Interview Schedule—Child Version ........................................................................... 5 1 45/60

Sleep Disorders Questionnaire—Fatigued Adults ....................................................................... 222 1 7/60

Fatigue Questionnaire—Adults and Adolescents ........................................................................ 226 1 15/60

Fatigue Questionnaire—Parent of Adolescent ............................................................................ 4 1 15/60

SF–36 Questionnaire ................................................................................................................... 320 1 11/60