Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 / Notices 41261

3. The Second Longitudinal Study of

Aging (LSOA II)—(0920–0219)—

Revision—National Center for Health

Statistics (NCHS) The Second

Longitudinal Study of Aging is a

second-generation, longitudinal survey

of a nationally representative sample of

civilian, non-institutionalized persons

70 years of age and older. Participation

is voluntary, and individually identified

data are confidential. The LSOA II

replicates portions of the first

Longitudinal Study of Aging (LSOA),

particularly the causes and

consequences of changes in functional

status. In addition, the LSOA II is

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.

In 1994, 9,447 persons aged 70 and

over were interviewed as part of the

National Health Interview Survey’s

Second Supplement on Aging (SOA II)

between October of 1994 and March of

1996. The first LSOA II re-interview

wave was conducted between May 1997

and March 1998. The LSOA II will reinterview the SOA II sample two

additional times: in 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.

The LSOA II contains substantive

topics on scientifically important and

policy-relevant 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 long-term 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

respondents is estimated at $106,275.

Respondents Number of

respondents

Number of

responses/respondent

Avg. burden

per response

(in hrs.)

Total burden

(in hrs.)

Sample adult ..................................................................................................... 9,447 1 .75 7,085

Total ........................................................................................................... ........................ ........................ ........................ 7,085

Dated: July 23, 1998.

Charles W. Gollmar,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–20576 Filed 7–31–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 98100]

Grants for Minority Health Statistics

Dissertation Research; Availability of

Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 98 funds

for a dissertation research grants

program for the Minority Health

Statistics Grants Program of the National

Center for Health Statistics (NCHS),

CDC. This program addresses the

‘‘Healthy People 2000’’ priority area(s),

Surveillance and Data Systems. The

Minority Health Statistics Grants

Program was established to award grants

for (1) the conduct of special surveys or

studies on the health of racial and

ethnic populations or subpopulations;

(2) analysis of data on ethnic and racial

populations and subpopulations; and (3)

research on improving methods for

developing statistics on ethnic and

racial populations and subpopulations.

Grants for Minority Health Statistics

Dissertations advance these purposes by

supporting research and by improving

the quality of minority health statistics

dissertation research projects. These

grants will enable doctoral students to

undertake significant data gathering,

analytic, and methodological research

projects. The students will also gain

invaluable training and research

experience that will be beneficial to

future careers in minority health

research. The use of data from the

National Center for Health Statistics is

encouraged. More information about

NCHS data systems may be obtained via

the Internet at http://www.cdc.gov/

nchswww/.

B. Eligible Applicants

Eligible applicants may be public or

private nonprofit institutions that will

administer the grant on behalf of the

proposed Principal Investigator

(doctoral candidate). Examples of public

and private nonprofit organizations

include universities, colleges, research

institutions, hospitals, and other public

and private nonprofit organizations,

State and local governments or their

bona fide agents, and federally

recognized Indian tribal governments,

Indian tribes, or Indian tribal

organizations.

The proposed Principal Investigator

must be a registered doctoral candidate

in resident or nonresident status. All

requirements for the doctoral degree

other than the dissertation must be

completed by the time of the award.

Students seeking a doctorate in any

relevant research discipline are eligible.

A student enrolled in a doctoral

program in a research discipline which

requires a dissertation based on original

research may apply through their

institution for support to complete the

research and dissertation. The

dissertation must examine and/or

develop some aspect of statistical

research on racial and ethnic

populations or subpopulations. It

should focus on one or more of the

following research program areas:

community-based research, methods

and theory development, health

promotion and data standards

development, and data analysis and

dissemination.

Prior to submission of the application,

the dissertation proposal must be

approved by the dissertation faculty

committee and certified by the faculty

advisor. This information must be

verified in a letter of certification from

the thesis chairperson and submitted

with the grant application.
41262 Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 / Notices

Applications from doctoral students

who are women, members of minority

groups, persons with disability, students

of Historically Black Colleges and

Universities, Hispanic Serving

Institutions, and other predominately

minority and minority serving

institutions are encouraged.

An applicant institution may be either

the degree-granting institution or

another non-profit institution with

which the proposed Principal

Investigator is professionally affiliated.

In determining which institution is

more appropriate, the Principal

Investigator must consider the extent to

which the resources of the designated

institution are capable of supporting the

proposed research effort.

The proposed investigator who

receives support for dissertation

research under a grant may not at the

same time receive support under a

predoctoral training grant or fellowship

awarded by any other agency, or

component, of the U.S. Department of

Health and Human Services.

Note: Pub. L. 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan or any other form.

C. Availability of Funds

Approximately $250,000 is available

in FY 98 to fund approximately 10

awards. It is expected that the average

award will be $20,000 ranging from

$15,000 to $30,000. It is expected that

the awards will begin on or about

September 30, 1998. The awards will be

made for a 12-month budget period

within a project period of up to 2 years.

Funding estimates are subject to change.

Funding support may only be

requested for the amount of time

necessary to complete the dissertation

within the authorized project period.

Use of Funds

Responsibility for the planning,

direction, and execution of the proposed

project will be solely that of the

proposed Principal Investigator (the

doctoral candidate).

The total direct costs must not exceed

$30,000 for the entire project period. An

application that exceeds this amount

will be returned to the applicant. No

supplemental funds will be awarded.

Allowable costs include: the

investigator’s salary and direct project

expenses such as travel, data processing,

and supplies. Fees for maintaining

matriculation or other fees imposed on

those preparing dissertations are

allowable costs, provided the fees are

required of all students of similar

standing, regardless of the source of

funding. Applicants are expected to

work full time on the project. Any level

of effort that is less than full time must

be fully justified.

Indirect costs under this grant

program are limited to eight percent of

direct costs, excluding tuition and

related fees and expenditures for

equipment. Indirect costs will be

awarded at the actual indirect cost rate

for the institution, if the rate is less than

eight percent.

D. Program Requirements

The dissertation constitutes the final

report of the grant. The dissertation

must be officially accepted by the

faculty committee or university official

responsible for the candidate’s

dissertation and must be signed by the

responsible officials. Three copies of the

dissertation shall be submitted to the

CDC.

E. Application Content

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan. The narrative should be no more

than 25 pages, double-spaced, printed

on one side, with one inch margins, and

unreduced font. Applications will be

eligible for support only during the

review cycle for which they are

submitted. No application can be

submitted more than once even in

revised form.

Applicants must follow the

instructions in the research grant

application PHS Form 398 in preparing

the application with the following

information/changes:

1. The graduate student should be

identified as the Principal Investigator.

2. A questionnaire may be included as

an appendix if it is essential to evaluate

the proposal. A list of literature cited is

required and may be included in the

appendix. No other material should be

provided in an appendix.

3. A letter from the faculty committee

or the university official directly

responsible for supervising the

dissertation research must be submitted

with the grant application. The letter

must certify that (a) the committee has

approved the formal proposal for the

dissertation, (b) the grant application

represents the dissertation proposal, and

(c) the applicant will complete all

requirements for the doctoral degree

except the dissertation by the

anticipated date of the grant award.

4. The application must identify all

members of the faculty committee by

listing the names on Form BB. A brief

biographical sketch for each should be

provided as explained in Form 398,

page FF.

5. Applicants should give special

attention to the sections of the

application dealing with human

subjects, protection and gender and

minority representation by addressing

the applicability and method of

compliance.

6. The project description in the

application must describe the scientific

significance of the work, including its

relationship to other current research,

and the design of the project in

sufficient detail to permit evaluation. It

should also present and interpret

progress to date if the research is

already underway.

7. A detailed budget must be provided

identifying the items for which funds

are requested and their estimated costs.

A budget justification explaining the

necessity of these expenses for the

research should also be included.

8. Statements of ‘‘Current and

Pending Support’’ for both the student

and the dissertation advisor must be

identified on Form GG.

F. Submission and Deadline

Letter of Intent (LOI)

The LOI should identify program

announcement number 98100, and the

name of the principal investigator. The

letter of intent does not influence

review or funding decisions, but it will

enable CDC to plan the review more

efficiently. The LOI should be submitted

on or before August 17, 1998, to: David

Elswick, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office,

Announcement 98100, Centers for

Disease Control and Prevention (CDC),

Room 321, 255 East Paces Ferry Road,

NE., M/S E13, Atlanta, Georgia 30305–

2209.

Application

Submit the original and five copies of

PHS–398 (OMB Number 0925–0001)

(adhere to the instructions on the Errata

Instruction Sheet for PHS 398). Forms

are in the application kit. On or before

August 31, 1998, submit the application

to: David Elswick, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office,

Announcement 98100, Centers for

Disease Control and Prevention (CDC),

Room 300, 255 East Paces Ferry Road,

NE., M/S E13, Atlanta, Georgia 30305–

2209.

If your application does not arrive in

time for submission to the independent
Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 / Notices 41263

review group, it will not be considered

unless you can provide proof that you

mailed it on or before the deadline (i.e.,

receipt from U.S. Postal Service or a

commercial carrier; private metered

postmarks are not acceptable).

G. Evaluation Criteria

Proposals are judged on the basis of

their scientific merit, the theoretical

importance of the research question and

the appropriateness of the proposed

data and methodology to be used in

addressing the question.

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Significance and originality of the

research.

2. Knowledge of research relevant to

the topic.

3. Appropriateness of methods and

data, including a description and

justification of the analytic techniques

that will be employed and a discussion

of the methodological problems that

might be encountered.

4. Availability and adequacy of data.

5. Organization of the project.

6. Adequacy of facilities and

resources. Human subjects involvement

and protection (when appropriate).

7. Representation of women and

minorities (when appropriate).

8. Appropriateness of the budget.

In evaluating applications and making

recommendations reviewers assess the

applicant’s potential for making

significant contributions to the field of

minority health statistics research.

Three factors influence the final

funding decisions on applications for

support of dissertations: (1) Reviewers’

evaluation of the application; (2) the

potential of the applicant to contribute

to the field; and (3) the general needs of

the field.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Annual progress reports;

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial status and

performance reports, no more than 90

days after the end of the project period.

Send all reports to David Elswick,

Grants Management Specialist, using

the address information listed under

Section J of this program announcement

entitled ‘‘Where to Obtain Additional

Information.’’

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I. included in the

application kit.

AR98–1 Human Subjects

Requirements

AR98–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR98–4 HIV/AIDS Confidentiality

Provisions

AR98–9 Paperwork Reduction Act

Requirements

AR98–10 Smoke-Free Workplace

Requirements

AR98–11 Healthy People 2000

AR98–12 Lobbying Restrictions

AR98–13 Prohibition on Use of CDC

Funds for Certain Gun Control

Activities

AR98–14 Accounting System

Requirements

AR98–15 Proof of Non-Profit Status

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 306(m) of the Public Health

Service Act (42 U.S.C. 242k(m)), as

amended. The Catalog of Federal

Domestic Assistance number is 93.283.

J. Where To Obtain Additional

Information

To receive additional written

information call 1–888-GRANTS4. You

will be asked to leave your name,

address, and phone number and will

need to refer to Announcement 98100.

You will receive a complete program

description, information on application

procedures, and application forms. CDC

will not send application kits by

facsimile or express mail.

Please refer to announcement number

98100 when requesting information and

submitting an application.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained by

contacting: David Elswick, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Announcement 98100,

Centers for Disease Control and

Prevention (CDC), Room 300, 255 East

Paces Ferry Road, NE., M/S E–13,

Atlanta, GA 30305–2209, telephone

(404)842–6521.

See also the CDC home page on the

Internet: http://www.cdc.gov

For program technical assistance,

contact: Audrey L. Burwell, M.S.,

Minority Health Statistics Grants

Program Director, National Center for

Health Statistics, CDC, 6525 Belcrest

Road, Room 1100, Hyattsville, MD

20782, Telephone: (301) 436–7062,

extension 127, Email: AZB2@CDC.GOV.

Website: www.cdc.gov/nchswww/

about/grants/grants1.htm.

Dated: July 28, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–20575 Filed 7–31–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E–0314]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; GEMZAR

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

GEMZAR and is publishing this notice

of that determination as required by

law. FDA has made the determination

because of the submission of an

application to the Commissioner of

Patents and Trademarks, Department of

Commerce, for the extension of a patent

which claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6620.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical