Federal Register / Vol. 62, No. 53 / Wednesday, March 19, 1997 / Notices 13157

Dated: March 14, 1997.

Wendy M. Comes,

Executive Director.

[FR Doc. 97–6913 Filed 3–18–97; 8:45 am]

BILLING CODE 1610–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30 DAY–197]

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

Office on (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.

The following requests have been

submitted for review since the last

publication date on March 12, 1997.

Proposed Project

1. Examination of Barriers to

Participant Compliance in a Flexible

Sigmoidoscopy Screening Program.

Kaiser Foundation, Oakland—New—

With colorectal cancer comprising the

second highest mortality rate among all

U.S. cancers and ranked as the fourth

most common form of cancer, the active

promotion of population-based

screening and early detection is

becoming increasingly important.

Recognizing the importance of

screening, American Cancer Society

guidelines and the new US Preventive

Services Task Force guidelines

recommend colorectal cancer screening

for individuals over the age of 50. Still,

although early detection of colorectal

neoplasms has been effectively

demonstrated to significantly reduce

morbidity and mortality and associated

economic costs, compliance is very low.

This three-year study involving

investigators at one of the nation’s

largest Health Maintenance

Organizations’’ research foundation

(Kaiser Foundation of Northern

California) seeks to identify barriers

associated with low compliance in a

colorectal cancer screening program

utilizing flexible sigmoidoscopy.

Phase I will target and recruit

participants from an existing pool of

Health Maintenance Organization

enrollees who are at a relatively high

age-related risk (ages 50–64) for

developing colorectal cancers via short

survey and invitation to screening. In

Phase II, investigators will conduct a

telephone survey to identify the relative

impact of economic, psychological, and

related factors on participation and nonparticipation in the mass screening

programs. In phase III, investigators will

analyze and widely disseminate results

of the study via publication in the

professional literature. Results will also

be made available to participants upon

request. Interventions designed to

mitigate the barriers identified through

this study will be incorporated into

future screening efforts and general

health education/health promotion

efforts.

Participation in this study is

voluntary and subsequent follow-up and

treatment, if indicated, will be provided

at no cost to participants. Informed

consent will be obtained where

appropriate and oversight will be

provided by federal and institutional

review. The total annual burden hours

are 2,141.

Respondents Number of

respondents

Number of

responses/

respondent

Average

burden/response

(in hrs.)

HMO Enrollees ......................................................................................................................................... 6165 1 .3473

2. Reliability and Validity Assessment

of the Use of Scales of Stressful Life

Events in Black Women of Reproductive

Age (0920–0356)—Extension—A CDC

review of studies of psychosocial factors

and adverse pregnancy outcome

supports the hypothesis that high levels

of exposure to stressful life experiences

put black women at increased risk for

adverse reproductive outcome,

particularly Preterm Delivery (PTD) and

Very Low Birth Weight (VLBW). The

purpose of this study is to evaluate the

reliability and validity of existing

instruments that measure stressful life

events in black women of reproductive

age. Respondents will consist of

reproductive age residents who live in

the Atlanta area and may attend a health

care facility that has a behavioral

prenatal unit. Approximately one half

the women will be pregnant at the time

of data collection.

Women enrolled in the study respond

to a series of demographic and

psychosocial questionnaires. They also

ask that women provide a 24 hour urine

sample and saliva sample. Both samples

are used to correlate reported levels of

stress with laboratory measures of

stress.

Participation in this study is

voluntary and participants will receive

a reimbursement for their time. A

written informed consent will be

obtained and local institutional review

will provide oversight.

The study is ongoing and by

December 31, 1996, approximately twothirds of data collected was completed.

Approximately 130 women need to be

interviewed. This leaves 130 women in

the validity study, of which 30 women

will repeat the process for the reliability

study. The total annual burden hours

are 1,134.

Respondents Number of

respondents

Number of

responses/

respondent

Average burden/response

(in hrs.)

Total burden

(in hrs.)

Screening ........................................................................................................................ 300 1 .083 25

Validity study group—African-American Women for the ages of 18 to 45 .................... 100 1 7.07 707

Reliability study group—African-American Women for the ages of 18 to 45 ................ 30 1 13.4 402
13158 Federal Register / Vol. 62, No. 53 / Wednesday, March 19, 1997 / Notices

3. Survey Component of the CDC’s

Prevention Marketing Initiative Local

Demonstration Site Project Evaluation

—NEW— The Centers for Disease

Control and Prevention, National Center

for HIV, STD, and TB Prevention,

Division of HIV/AIDS Prevention,

Behavioral Intervention Research

Branch is planning to conduct a crosssectional tracking study as part of the

evaluation of a five-city HIV prevention

demonstration program. The program

involves the integration of social

marketing strategies and community

participation in an effort to develop and

implement HIV prevention activities.

Charged with developing programs for

those 25 years of age and younger,

community groups in the local

demonstration sites chose to segment

the target audience even further, and to

mount a variety of types of

interventions. Decisions about

segmentation and the nature of local

interventions were based on formative

research conducted in each community.

It is hoped that this demonstration

project will result in reductions in HIV

risk behavior among members of the

target audiences, as well as in enhanced

collaboration among individuals and

organizations in the participating

communities.

As part of the evaluation of the

effectiveness of the interventions,

questionnaire data will be collected in

three of the demonstration

communities. These data will be

collected at four time points over a two

year period after prevention activities

and message campaigns are launched.

Baseline survey data have been

collected recently under OMB No.0920–

0343 (Evaluation of the National AIDS

information and Education Program

Activities). The total annual burden

hours are 4,260.

Respondents Number of

respondents

Number of

responses/

respondent

Average burden/response

(in hrs.)

Total burden

(in hrs.)

Eligibility Screening ........................................................................................................ 157,680 1 0.01667 2,628

Consent .......................................................................................................................... 5,768 1 0.05 289

Young People under 25 years of age in targeted prevention program communities .... 3,504 1 0.3833 1,343

Dated: March 13, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

And Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–6887 Filed 3–18–97; 8:45 am]

BILLING CODE 4163–18–P

Meeting Announcement

The National Center for

Environmental Health (NCEH) of the

Centers for Disease Control and

Prevention (CDC) announces the

following meeting:

Name: Preventing Birth Defects Due to

Thalidomide Exposure.

Time and date: 8 a.m.-5 p.m., March 26,

1997.

Place: Sheraton Colony Square Hotel, 188

14th Street, NE, Atlanta, Georgia 30361.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 75 people.

Registration is not required.

Purpose: The meeting will enable academic

and public health professionals to discuss

strategies to prevent birth defects due to

exposure to thalidomide and other human

teratogens. Thalidomide, a potent human

teratogen, is now available as an

investigational drug in the USA. Although

the drug is currently being considered for

approval only for the treatment of leprosy, its

potential applications appear to be

numerous. This meeting will bring together

leaders from the fields of birth defects

research, clinical practice, bioethics, and

public health to review existing strategies for

limiting intrauterine exposure to human

teratogens, and to discuss and provide

individual input on new approaches for

preventing birth defects due to future

teratogens such as thalidomide.

Matters to be discussed: Agenda items will

include presentations on the following

topics: (1) Assessment of the Accutane

Pregnancy Prevention Program, (2) use and

limitations of drug registries, (3)

contraception efficacy, (4) ethical issues on

teratogen exposure, and (5) measures to

assure appropriate use of pharmaceuticals.

Group discussions on strategies for health

care provider education, patient education,

and appropriate use of pharmaceuticals will

follow the presentations. Written materials

may be submitted to CDC until March 21,

1997, for distribution to meeting participants.

Agenda items are subject to change as

priorities dictate.

FOR FURTHER INFORMATION

CONTACT: Dwight Jones, Division of Birth

Defects and Developmental Disabilities,

NCEH, CDC, 4770 Buford Highway, NE, M/

S F–45, Atlanta, Georgia 30341–3724,

telephone 770/488–7160, Fax 770/488–7197.

Dated: March 13, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–7017 Filed 3–18–97; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

Request for Nominations for a

Nonvoting Representative of Industry

Interests on a Public Advisory

Committee

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

nominations for a nonvoting industry

representative to serve on the

Nonprescription Drugs Advisory

Committee in the Center for Drug

Evaluation and Research. This vacancy

will occur on June 1, 1997.

FDA has a special interest in ensuring

that women, minority groups, and

individuals with disabilities are

adequately represented on advisory

committees and, therefore, the agency

encourages nominations of

appropriately qualified candidates from

these groups.

DATES: Nominations should be received

by April 18, 1997.

ADDRESSES: All nominations and

curricula vitae for the industry

representative should be sent to Andrea

G. Neal (address below).

FOR FURTHER INFORMATION CONTACT:

Andrea G. Neal, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FAX 301–443–0699.

SUPPLEMENTARY INFORMATION: FDA is

requesting that any industry

organization interested in participating

in the selection of an appropriate

nonvoting member to represent industry

interests should send a letter to the

contact person (address above). After 30

days, a letter will be sent to each

organization that has made a

nomination, and to those organizations

indicating an interest in participating in

the selection process, together with a

complete list of all such organizations

and the nominees. This letter will state

that it is the responsibility of each

organization indicating an interest in

participating in the selection process to

consult with the others in selecting a