Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices 34841

cases, it is possible to conceive

situations in which senior or key

personnel might not meet the definition

of ‘‘investigator.’’ Institutions are also

responsible for obtaining financial

disclosures from persons other than

senior or key personnel who meet the

definition of ‘‘investigator.’’

Q16: How should institutions with

fewer than 50 employees complete the

certification page for NSF proposals?

A16: Such institutions should

annotate NSF Form 1207 or the

addendum page (See Q&A1 above) to

indicate that they have fewer than 50

employees and are therefore exempt

from the Investigator Financial

Disclosure Policy. These institutions are

not exempt from the PHS regulations.

Q17: Salary, royalties and other

payments that ‘‘are not expected to

exceed $10,000 over the next twelve

month period’’ are excluded from the

definition of ‘‘significant financial

interest.’’ How should an investigator

estimate expected income over the next

twelve months?

A17: The agencies have no preferred

estimation method. Investigators must

make their best reasonable estimates of

expected income in determining

whether salary, royalties or other

payments constitute ‘‘significant

financial interests.’’ This issue is

separate from an investigator’s ongoing

duty to update financial disclosures

either annually or as new significant

financial interests are obtained

throughout the period of the award.

Q18: How can an institution

determine that all required disclosures

have been made before submitting a

proposal to NSF or PHS?

A18: As part of the institution’s

routine proposal preparation procedures

institutions should require investigators

to ensure that they have made all

required financial disclosures in accord

with the regulations prior to the time

the organizational representative makes

the certification in an NSF or PHS

proposal. NSF and PHS staff, auditors

and others concerned with the proper

implementation of these regulations

would expect such an arrangement at

any institution that certifies to the

maintenance of an appropriate written,

enforced policy on conflict of interest.

Q19: Must an investigator report to

the institution a single share of stock?

A19: A single share of stock would

have to be reported only if (i) it is

valued at more than $10,000 or

represents more than a five percent

ownership interest in the corporation;

and (ii) it would reasonably appear that

the value of the stock could be affected

by the research for which funding is

sought or that the financial interest of

the corporation would be so affected.

The rules define a significant

financial interest as anything of

monetary value including equity

interests (e.g., stocks, stock options, or

other ownership interests) but the

definition excludes an equity interest

that does not exceed $10,000 in value

and represents no more than a 5%

ownership interest in any single entity.

This means that, under the rules, an

investigator would never have to report

an equity interest of $10,000 or less

which represents 5% or less ownership

interest in any single entity because that

combination of value and ownership is

excluded by definition from the term

‘‘significant financial interest.’’ On the

other hand, under the rules, an

investigator would always have to

report an equity interest exceeding

$10,000 or an ownership interest

exceeding 5% in any single entity,

regardless of value, if that equity

interest or ownership interest was held

in an entity whose financial interests

would reasonably appear to be affected

by the specified activities for which

funding is sought.

Q20: When and how will the NSF and

PHS rules be reviewed and revised?

A20: The agencies anticipate that after

two or three years of experience with

the rules, they will solicit public

comments regarding whether changes

are necessary or appropriate.

Dated: June 13, 1996.

Dr. Harold Varmus, M.D.,

Director, National Institutes of Health.

Lawrence Rudolph,

General Counsel, National Science

Foundation.

[FR Doc. 96–16974 Filed 7–2–96; 8:45 am]

BILLING CODE 7555–01–P, 4140–01–P

Centers for Disease Control and

Prevention

[INFO–96–18]

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 at (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 Wilma

Johnson, CDC 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. Survey of State-Based Diabetes

Control Cooperative Agreement

Programs—New—Diabetes mellitus and

related complications are the seventh

leading cause of death in the United

States, and accounts for $105 billion in

direct medical costs and lost

productivity each year. Approximately

14 million Americans have been

diagnosed with diabetes, a leading cause

of new blindness and end-stage renal

failure in the United States and a major

co-morbid factor in lower extremity

amputation, cardiovascular disease and

related death, and neonatal morbidity

and mortality.

Through the support of the Centers for

Disease Control and Prevention’s (CDC)

‘‘State-Based Program to Reduce the

Burden of Diabetes: A Health Systems

Approach,’’ public health departments

in 42 states and four U.S. territorial

affiliated jurisdictions have been

charged with providing leadership in

reducing the gap between what should

be and what is the current standard of

diabetes care.

CDC will collect information from

diabetes State Program Coordinators

regarding the four key areas of program

implementation. They are (1) capacity

building and infrastructure

development, (2) surveillance and data

collection, (3) health systems change,

and (4) working with local programs.

The survey has three main objectives:

1. Document the progress made by

Diabetes Control Programs in the four

main areas of program implementation.

2. Assess the relationship between the

level of infrastructure development, and

a program’s efforts to carry out

surveillance activities, health systems

change activities, and work with local

programs. Information will help

improve technical assistance (TA) and

guidance offered to states by CDC.
34842 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices

3. Lay the groundwork for an

evaluation instrument that can be used

to collect data from Diabetes Control

Programs at the end of the funding cycle

in order to assess whether progress in

program implementation and

development is linked to reduced

diabetes morbidity and mortality.

The data will result from selfadministered mailed surveys sent to the

Program Coordinator in each state. Most

questions will be in the form of

checklists although each of the four

sections contain a number of openended questions for explanation of

unique features of programs. It is

expected that the burden in time to each

respondent will be about two (2) hours

per Program Coordinator or Designee,

resulting in a total burden of 92 hours.

Results will also be made available to

participants upon request. The total cost

to respondents is estimated at $1,840.

Respondents No. of Respondents

No. of responses/respondentAvg. burden

response (in

hrs.)

Total burden (in hrs.)

Diabetes program coordinators ........................................................................................ 46 1 2 92

Total ........................................................................................................................... 92

2. List of Ingredients Added to

Tobacco in the Manufacture of Cigarette

Products—(0920–0210)—Extension

without change - Cigarette smoking is

the leading preventable cause of

premature death and disability in our

nation. Each year more than 400,000

premature deaths occur as the result of

cigarette smoking related diseases. The

Centers for Disease Control and

Prevention (CDC), Office on Smoking

and Health has primary responsibility

for the Department of Health and

Human Services’ (HHS) smoking and

health program. HHS’s overall goal is to

reduce death and disability resulting

from cigarette smoking and other forms

of tobacco use through programs of

information, education and research.

The Comprehensive Smoking

Education Act of 1984 (15 USC 1336

Pub.L. 98–474) requires each person

who manufactures, packages, or imports

cigarettes to provide the Secretary of

HHS with a list of ingredients added to

tobacco in the manufacture of cigarettes.

This legislation also authorizes HHS to

undertake research, and to report to the

Congress (as deemed appropriate), on

the health effects of the ingredients.

In 1993, OMB reinstated approval for

collection of ingredients information

(0920–0210) after the expiration of the

previous approval; this current approval

expires on December 31, 1996. The total

cost to the respondent is estimated at

$189,000.

Respondents No. of respondents

No. of responses/respondent

Average

burden/response (in

hrs.)

Total burden (in hrs.)

Tobacco manufacturers .................................................................................................... 14 1 190 2,660

3. The Fourth National Health and

Nutrition Examination Survey

(NHANES IV) Pretests—New—The

National Health and Nutrition

Examination Survey (NHANES) has

been conducted periodically since 1970

by the National Center for Health

Statistics, CDC. NHANES IV is planned

for 1998–2004 and two pretests are

proposed to include 400 sample persons

in each. They will receive an interview

and a physical examination. The first

pretest is needed to test the sampling

process, data collection procedures,

computer-assisted personal interviews

(including translations into Spanish),

examination protocols, and automated

computer systems. The second pretest

will test the revised survey

questionnaires and examination

procedures, quality control procedures

and response rates. Participation in the

pretests and the full survey will be

completely voluntary and confidential.

NHANES programs produce

descriptive statistics which measure the

health and nutrition status of the

general population. Through the use of

questionnaires, physical examinations,

and laboratory tests, NHANES studies

the relationship between diet, nutrition

and health in a representative sample of

the United States. NHANES monitors

the prevalence of chronic conditions

and risk factors related to health such as

coronary heart disease, arthritis,

osteoporosis, pulmonary and infectious

diseases, diabetes, high blood pressure,

high cholesterol, obesity, smoking, drug

and alcohol use, environmental

exposures, and diet. NHANES data are

used to establish the norms for the

general population against which health

care providers can compare such patient

characteristics as height, weight, and

nutrient levels in the blood. Data from

future NHANES can be compared to

those from previous NHANES to

monitor changes in the health of the

U.S. population. NHANES IV will also

establish a national probability sample

of genetic material for future genetic

testing for susceptibility to disease.

Users of NHANES data include

Congress; the World Health

Organization; Federal agencies such as

NIH, EPA, and USDA; private groups

such as the American Heart Association;

schools of public health; private

businesses; individual practitioners; and

administrators. NHANES data are used

to establish, monitor, and evaluate

recommended dietary allowances, food

fortification policies, programs to limit

environmental exposures, immunization

guidelines and health education and

disease prevention programs. The total

cost to respondents for the two pretests

is estimated at $54,600.

Respondents Number of

respondents

Number of

responses/

respondent

Avg. burden/response

(in hrs.)

Total burden (in hrs.)

Children ............................................................................................................................ 80 1 2.75 220
Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices 34843

Respondents Number of

respondents

Number of

responses/

respondent

Avg. burden/response

(in hrs.)

Total burden (in hrs.)

Adolescents and Adults .................................................................................................... 720 1 4.75 3420

Total ........................................................................................................................... 3640

4. The Second Longitudinal Study of

Aging (LSOA II)—(0920–0219)—

Revision—The Second Longitudinal

Study of Aging is a second generation,

longitudinal survey of a nationally

representative sample of civilian, noninstitutionalized persons 70 years of age

and older. Participation is voluntary,

and individually identified data are

confidential. It will replicate portions of

the first Longitudinal Study of Aging

(LSOA), particularly the causes and

consequences of changes in functional

status. LSOA II is also designed to

monitor the impact of changes in

Medicare, Medicaid, and managed care

on the health status of the elderly and

their patterns of health care utilization.

Both LSOAs are joint projects of the

National Center for Health Statistics

(NCHS) and the National Institute on

Aging (NIA).

The Supplement on Aging (SOA), part

of the 1984 National Health Interview

Survey (NHIS), established a baseline on

7,527 persons who were then aged 70

and older. The first LSOA reinterviewed

them in 1986, 1988 and 1990. Data from

the SOA and LSOA have been widely

used for research and policy analysis

relevant to the older population.

Approximately 10,000 persons aged

70 and over were interviewed for the

1994 National Health Interview Survey’s

second Supplement on Aging (SOA II)

between October of 1994 and March of

1996. LSOA II will reinterview the SOA

II sample three times: in 1997, 1999, and

2001. As in the first LSOA, these

reinterviews will be conducted using

computer assisted telephone

interviewing (CATI). Beyond that, LSOA

II will use methodological and

conceptual developments of the past

decade.

LSOA II will contain modules on

scientifically important and policyrelevant domains, including: (1)

assistance with activities of daily living,

(2) chronic conditions and impairments,

(3) family structure, relationships, and

living arrangements, (4) health opinions

and behaviors, (5) use of health,

personal care and social services, (6) use

of assistive devices and technologies, (7)

health insurance, (8) housing and longterm care, (9) social activity, (10)

employment history, (11) transportation,

and (12) cognition. This new data will

result in publication of new national

health statistics on the elderly and the

release of public use micro data files.

The total cost to the respondents is

estimated at $112,500.

Respondents Number of

respondents

Number of

responses/

respondent

Avg. burden/response

(in hrs.)

Total burden (in hrs.)

Sample adult ..................................................................................................................... 10,000 1 .75 7,500

Total ........................................................................................................................... 7,500

Dated: June 27, 1996.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–16947 Filed 7–2–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 658]

State Grants to Support the Evaluation

of 5 A Day Nutrition Programs and

Physical Activity Programs

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for grants to support the

evaluation of State and community

nutrition and physical activity

intervention programs.

This announcement addresses one

required component and one optional

component:

I. ‘‘5 A Day Evaluation’’ for supporting the

evaluation of 5 A Day for Better Health

nutrition intervention programs.

Applicants must apply for the 5 A Day

Evaluation component.

II. ‘‘Physical Activity Evaluation’’ for

supporting the evaluation of a physical

activity intervention. Application for the

Physical Activity Evaluation component

is optional.

The CDC is committed to achieving

the health promotion and disease

prevention objectives of ‘‘Healthy

People 2000’’ a national activity to

reduce morbidity and mortality and

improve the quality of life. This

announcement is related specifically to

the priority area of Nutrition with a

secondary emphasis on Physical

Activity and Fitness. (For ordering a

copy of ‘‘Healthy People 2000’’ see the

Section, ‘‘Where to Obtain Additional

Information.’’)

Authority

This program is authorized under

section 317(k)(2) [42 U.S.C. 247b(k)(2)]

of the Public Health Service Act, as

amended.

Smoke-Free Workplace

CDC encourages all grant recipients to

provide a smoke-free workplace and

promote the nonuse of all tobacco

products, and Public Law 103–227, the

Pro-Children Act of 1994, prohibits

smoking in certain facilities that receive

Federal funds in which education,

library, day care, health care, and early

childhood development services are

provided to children.

Eligible Applicants

Eligible applicants are the official

public health agencies of States or their

bona fide agents. This includes the

District of Columbia, American Samoa,

the Commonwealth of Puerto Rico, the

Virgin Islands, the Federated States of

Micronesia, Guam, the Northern

Mariana Islands, the Republic of the

Marshall Islands, the Republic of Palau,

and federally recognized Indian tribal

governments, that have established,