29014 Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 / Notices

Dated: May 22, 1998.

Marcia B. Buchanan,

Assistant Director.

[FR Doc. 98–14133 Filed 5–22–98; 12:49 pm]

BILLING CODE 1610–02–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration on Aging

Public Information Collection

Requirement Submitted to the Office of

Management and Budget for Clearance

AGENCY: Administration on Aging.

SUMMARY: The Administration on Aging

(AoA), Department of Health and

Human Services, in compliance with

the Paperwork Reduction Act (Pubic

Law 95–511), is submitting to the Office

of Management and Budget for

clearance and approval an information

collection instrument, namely

Performance (Progress) Reports for Title

IV Grantees.

Type of Request: Extension of

currently approved collection.

Use: Consistent with 45 CFR Part 74,

Subpart J, the AoA requires grantees

funded under Title IV of the Older

Americans Act to report on the

performance of their projects. The report

is used by the AoA to review and

monitor the grantee’s progress in

achieving project objectives, provide

advice and assistance, and to take

corrective action as necessary.

Frequency: Semiannually.

Respondent: Title IV grantees.

Estimated number of respondents: 60

Estimated burden hours: 20 hours for

each semiannual report.

Additional Information: Each progress

report, typically 5 pages in length, is

expected to cover the following subjects:

recent major activities and

accomplishments; problems

encountered; significant findings and

events; dissemination activities; and;

activities planned for the next 6 months.

OMB Comment: OMB is required to

make a decision concerning this

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

as soon as possible after its publication.

Written comments and

recommendations for the proposed

information collection should be sent to

the following address within 30 days of

the publication of this notice: Office of

Information and Regulatory Affairs,

Attention: Allison Eydt, OMB Desk

Officer, Office of Management and

Budget, Washington, DC 20503.

Diane Justice,

Deputy Assistant Secretary for Aging.

[FR Doc. 98–14005 Filed 5–26–98; 8:45 am]

BILLING CODE 4150–40–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[INFO–98–19]

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 projects or to obtain a copy of

the data collection plans and

instruments, call the CDC Reports

Clearance Officer on (404) 639–7090.

Comments are invited on: (a) Whether

the proposed collection of information

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 through the

use of automated collection techniques

for other forms of information

technology. Send comments to Seleda

Perryman, CDC Assistant Reports

Clearance Officer, 1600 Clifton Road,

MS–D24, Atlanta, GA 30333. Written

comments should be received within 60

days of this notice.

Proposed Projects

1. Surveillance for Bloodstream and

Vascular Access Infections in

Outpatient Hemodialysis Centers—

New—National Center for Infectious

Diseases (NCID). The Hospital Infections

Program, NCID is proposing a study of

bloodstream infections, vascular access

infections, hospitalizations, and

antimicrobial starts at U.S. outpatient

hemodialysis centers. Although

bloodstream and vascular access

infections are common in hemodialysis

patients, there is no existing system to

record and track these complications.

Participation in the proposed project is

voluntary; it is estimated that 100 of the

approximately 3,000 U.S. outpatient

hemodialysis centers will participate.

Participating centers may collect data

continuously, or may discontinue

participation at any time; we estimate

that the average center will participate

for six months. Each month,

participating centers will record the

number of hemodialysis patients they

treat and maintain a log of all

hospitalizations and intravenous (IV)

antimicrobial starts. For each

hospitalization or IV antimicrobial start,

further information (e.g., type of

vascular access, clinical symptoms,

presence of a vascular access infection,

and blood culture results) will be

collected. A computer program will be

developed to allow dialysis center

personnel to enter and analyze their

own data; they will also transmit the

data to CDC with all patient identifiers

removed. CDC will aggregate this data

and generate reports which will be sent

to participating dialysis centers. Rates of

bloodstream infection, vascular access

infection, and antimicrobial use per

1000 patient-days will be calculated.

Also, the percentage of antimicrobial

starts for which a blood culture is

performed will be calculated. Through

use of these data, dialysis centers will

be able to track rates of key infectious

complications of hemodialysis. This

will facilitate quality control

improvements to reduce the incidence

of infections, and clinical practice

guidelines to improve use of

antimicrobials. The total cost to the

respondents is $78,000.

Form Number of respondents

Number of responses/respondentAverage burden/response

(in hours)

Total burden

(in hours)

Agreement to Participate ................................................................................ 100 1 1 100

Census Form .................................................................................................. 100 1 1 100

Log .................................................................................................................. 100 1 10 1 1,000

Incident Form .................................................................................................. 100 1 200 0.2 4,000
Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 / Notices 29015

Form Number of respondents

Number of responses/respondentAverage burden/response

(in hours)

Total burden

(in hours)

Total ..................................................................................................... ........................ ........................ .......................... 5,200

1Estimated mean.

2. Pulmonary Function Testing Course

Approval Program, 29 CFR 1910.1043

(0920–0138)—Extension—The National

Institute for Occupational Safety and

Health (NIOSH) has responsibility

under the Cotton Dust Standard, 29 CFR

1910.1043, for approving courses to

train technicians to perform pulmonary

function testing. Successful completion

of a NIOSH approved course is

mandatory under the Standard. To carry

out its responsibility, NIOSH maintains

a Pulmonary Function Testing Course

Approval Program. The program

consists of an application submitted by

potential sponsors who seek NIOSH

approval to conduct courses, and if

approved, notification to NIOSH of any

course or faculty changes during the

period of approval. The application

form and addended materials including

agenda, vitae and course materials are

reviewed by NIOSH to determine if the

applicant has developed a program

which adheres to the criteria required in

the Standard. The letter seeking

approval for subsequent changes is

reviewed to assure that changes in

faculty or course content continue to

meet course requirements. Applications

to be a course sponsor and carry out

training are submitted voluntarily by

institutions and organizations from

throughout the country. If an

application is not submitted for review,

NIOSH is unable to evaluate a course to

determine whether it meets the criteria

in the Cotton Dust Standard and

whether technicians will be adequately

trained as mandated under the

Standard. The total cost to respondents

for the three year period is $1,851.00.

Respondents Number of respondents

Number of responses/respondentAverage burden/response

(in hours)

Total burden

(in hours)

Sponsoring organizations ................................................................................. 66 1 .614 40.5

Total ....................................................................................................... ........................ ........................ ........................ 40.5

3. Measurement of Stress and

Stressful Life Events in Black Women of

Reproductive Age (0920–0356)—

Reinstatement—National Center for

Chronic Disease Prevention and Health

Promotion. A review of studies of

psycho-social 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 stress and stressful life events

in black women of reproductive age.

Eligible subjects will be black women

who live in the Atlanta metropolitan

area. Subjects will be recruited from

flyers, newspaper announcements,

hospitals and clinics in the metropolitan

Atlanta area. Subjects will be screened

and selected based on age (18–30 or 31–

45 years), years of education (12, 13–15,

16 or more), and pregnancy status

(pregnant, not pregnant). A maximum of

thirty women will be selected for each

combination of age, education and

pregnancy status. The minimum age for

participation will be 18 to avoid the

complications due to requirement of

parental consent. Women will be

excluded if they use illicit drugs, such

as heroin, cocaine and marijuana

because these substances may alter the

metabolism of cortisol. The contact,

timing and spacing of the interviews

and laboratory collection are based on

the methodology developed and used

for conducting reliability and validity

tests. Approximately one half of the

women will be pregnant at the time of

data collection.

Women enrolled in the study respond

to a series of face-to-face and selfadministered demographic and psychosocial questionnaires. Women are also

asked to provide a saliva sample so that

we can correlate reported levels of stress

with biological measures of stress.

Participation in this study is

voluntary and participants will receive

compensation for their time. A written

informed consent will be obtained and

oversight will be provided by local

institutional review board.

This project should take two years.

One hundred fifteen (115) women will

participate only in the validity study

and thirty-nine (39) women will

participate in the validity and reliability

study. The validity study requires one

interview and one salivary sample. The

reliability study requires a second

interview and a second salivary

specimen, approximately two weeks

after the first interview.

During the first three months of the

study, the Project Director will set up

the office, hire staff and student

assistants and provide interviewer and

data entry training. The Project Director

will also make contacts and explore

potential sites for recruiting women for

the study. During the next nine months,

all of the interviews (approximately 115

validity subjects and 39 reliability

subjects remaining) will be conducted

and data entry of the quantitative

instruments (i.e Demographic Lifestyle

Questionnaire, Cohen Perceived Stress

Scale, Life Experience Survey (LES),

ARIC/BAECKE Questionnaire of

Habitual Physical Activity, Center for

Epidemiologic Studies Depression Scale

(CES–D), Profile of Mood States,

Multiple Affect Adjustive Checklist,

Speilberger Trait Anxiety Inventory—

Self Evaluation Questionnaire) will be

completed. Scoring for the qualitative

instruments (i.e. Structured Event Probe

and Narrative Rating Method

(SEPRATE) and Life Events and

Difficulties Schedule (LEDS) will be

initiated during year 1, but the bulk of

the qualitative scoring will be

completed during Year 2. The data entry

of the qualitative date will be completed

during Year 2. Preliminary analyzes will

be conducted during Year 2, with the

technical assistance of CDC. The total

estimated cost to respondents is $6,755.
29016 Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 / Notices

Respondents Number of respondents

Number of responses/respondentAverage burden/response

(in hours)

Total burden

(in hours)

Reliability Study Group ..................................................................................... 39 2 3 234

Validity Study Group ......................................................................................... 115 1 3 345

Total ....................................................................................................... ........................ ........................ ........................ 579

4. The National Death Index (NDI) (0920–0215)—Extension—A service of the National Center for Health Statistics

(NCHS), that assists health and medical researchers to determine the vital status of their study subjects. The NDI

is a national data base containing identifying death record information submitted annually to NCHS by all the state

vital statistics offices, beginning with deaths in 1979. Searches against the NDI file provide the states and dates of

death and the death certificate numbers of deceased study subjects. With the recent implementation of the NDI Plus

service, researchers now have the option of also receiving cause of death information for deceased subjects, thus reducing

the need to request copies of death certificates from the states. The NDI Plus option currently provides the ICD–

9 codes for the underlying and multiple causes of death for the years 1979–1996. The five administrative forms are

completed by health researchers in government, universities, and private industry in order to apply for NDI services

and to submit records of study subjects for computer matching against the NDI file. The total cost to respondents

is estimated at $5,685.

Respondents Number of respondents

Number of responses/respondentsAverage burden/response

(in hours)

Total burden

(in hours)

Government researchers .................................................................................. 48 1 1.89 90.8

University researchers ...................................................................................... 60 1 1.89 113.5

Private industry researchers ............................................................................. 12 1 1.89 22.7

Total ....................................................................................................... ........................ ........................ ........................ 227.0

Charles W. Gollmar,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–13952 Filed 5–26–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Food Safety Research: Availability of

Cooperative Agreements; Request for

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA), Center for Food

Safety and Applied Nutrition (CFSAN)

is announcing the availability of

research funds for fiscal year (FY) 1998

to conduct research to support the

reduction of the incidence of foodborne

illness, specifically to support: The

development of sampling methods to

enhance the detection, and more

specifically the enumeration, of low

levels of pathogens in foods; the

development of intervention strategies

for consumers to improve food safety in

the home; and total genome sequence

analyses of the pathogen Escherichia

coli O157:H7, towards a molecular

definition of microbial virulence and

pathogenicity. Approximately $700,000

will be available in FY 1998. FDA

anticipates making three to five awards

at $100,000 to $200,000 (direct and

indirect costs) per award per year.

Support of these agreements may be up

to 3 years. The number of agreements

funded will depend on the quality of the

applications received and the

availability of Federal funds to support

the project. After the first year,

additional years of noncompetitive

support are predicated upon

performance and the availability of

Federal FY funds. FDA is mandated by

the President’s Food Safety Initiatiative

(FSI) to reduce the incidence of

foodborne illness to the greatest extent

feasible.

DATES: Submit applications by July 13,

1998. If the closing date falls on a

weekend, it will be extended to

Monday; if the date falls on a holiday,

it will be extended to the following

workday.

ADDRESSES: Application forms are

available from, and completed

applications should be submitted to:

Robert L. Robins, Division of Contracts

and Procurement Management (HFA–

520), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–6170. (Applications

hand-carried or commercially delivered

should be addressed to 5630 Fishers

Lane, rm. 2129, Rockville, MD 20852.)

FOR FURTHER INFORMATION CONTACT:

Regarding the administrative and

financial management aspects of

this notice: Robert L. Robins

(address above).

Regarding the programmatic aspects

of this notice: Robert L. Buchanan,

Center for Food Safety and Applied

Nutrition, Food and Drug

Administration (HFS–500), 200 C

St. SW., Washington DC 20204,

202–205–5053.

SUPPLEMENTARY INFORMATION: FDA will

support the research studies covered by

this notice under section 301 of the

Public Health Service Act (the PHS Act)

(42 U.S.C. 241). FDA’s research program

is described in the Catalog of Federal

Domestic Assistance, No. 93.103.

The Public Health Service (PHS)

strongly encourages all award recipients

to provide a smoke-free workplace and

to discourage the use of all tobacco

products. This is consistent with the

PHS mission to protect and advance the

physical and mental health of the

American people.

PHS urges applicants to submit work

plans that address specific objectives of

‘‘Healthy People 2000.’’ Potential

applicants may obtain a copy of

‘‘Healthy People 2000 (Full Report,

stock No. 017–00100474–0) through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, 202–512–

1800.