[Federal Register Volume 63, Number 111 (Wednesday, June 10, 1998)]
[Notices]
[Pages 31781-31785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement 98058]


National Institute for Occupational Safety and Health: 
Cooperative Agreement To Identify the Incidence of Occupational Asthma; 
Notice of Availability of Funds for Fiscal Year 1998

Introduction

    The Centers for Disease Control and Prevention (CDC), the Nation's 
prevention agency, announces the availability of funds for fiscal year 
(FY) 1998 for a cooperative agreement program to identify incident 
cases of occupational asthma in a defined population, in order to 
calculate the incidence of occupational asthma for the defined 
population and by specific industries and occupations within that 
population.
    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 to the priority area of Occupational Safety and 
Health. (For ordering a copy of Healthy People 2000, see the section 
WHERE TO OBTAIN ADDITIONAL INFORMATION.)

Authority

    This program is authorized under Sections 20(a) and 22(e)(7) of the 
Occupational Safety and Health Act of 1970 [29 U.S.C. 669(a) and 
671(e)(7)].

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products, and 
Pub. L. 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

    Applications may be submitted by public and private, nonprofit and 
for-profit organizations and governments and their agencies. Thus, 
universities, colleges, research institutions, hospitals, other public 
and private organizations, State and local governments or their bona 
fide agents, federally recognized Indian tribal governments, Indian 
tribes or Indian tribal organizations, and small, minority and/or 
woman-owned businesses are eligible to apply.

    Note: Pub. L. 104-65, dated December 19, 1995, prohibits an 
organization described in section 501(c)(4) of the IRS Code of 1986, 
that engages in lobbying activities shall not be eligible for the 
receipt of Federal funds constituting an award, grant, contract, 
loan, or any other form of funding.

Availability of Funds

    Approximately $200,000 is available in FY 1998 to fund one or two 
awards. If one award is made, the award will be funded up to $200,000. 
If two awards are funded, the average award will be $100,000. The 
amount of funding available may vary and is subject to change. This 
award is expected to begin on or about September 30, 1998. The award 
will be made for a 12-month budget period within a project period not 
to exceed 3 years. Continuation awards within the project period will 
be made on the basis of satisfactory progress and availability of 
funds.

Use of Funds

Restrictions on Lobbying

    Applicants should be aware of restrictions on the use of HHS funds 
for lobbying of Federal or State legislative bodies. Under the 
provisions of 31 U.S.C. Section 1352 (which has been in effect since 
December 23, 1989), recipients (and their subtier contractors) are 
prohibited from using appropriated Federal funds (other than profits 
from a Federal contract) for lobbying Congress or any Federal agency in 
connection with the award of a particular contract, grant, cooperative 
agreement, or loan. This includes grants/cooperative agreements that, 
in whole or in part, involve conferences for which federal funds cannot 
be used directly or indirectly to encourage participants to lobby or to 
instruct participants on how to lobby.
    In addition, the current HHS Appropriations Act expressly prohibits 
the use of appropriated funds for indirect or ``grass roots'' lobbying 
efforts that are designed to support or defeat legislation pending 
before state legislatures. Section 503 of the law provides as follows:
    Sec. 503(a) No part of any appropriation contained in this Act 
shall be used, other than for normal and recognized executive-
legislative relationships, for publicity or propaganda purposes, for 
the preparation, distribution, or use of any kit, pamphlet, booklet, 
publication, radio, television, or video presentation designed to 
support or defeat legislation pending before the Congress, or any 
State legislature, except in presentation to the Congress or any 
State legislative body itself.

[[Page 31782]]

    (b) No part of any appropriation contained in this Act shall be 
used to pay the salary or expenses of any grant or contract recipient, 
or agent acting for such recipient, related to any activity designed to 
influence legislation or appropriations pending before the Congress or 
any State legislature.
    Department of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 1997, as enacted by the Omnibus 
Consolidated Appropriations Act, 1997, Division A, Title I, Section 
101(e), Pub. L. No. 104-208 (September 30, 1996).

Background

    A useful operational definition of occupational asthma (OA) was 
developed as part of the NIOSH-sponsored Sentinel Event Notification 
System for Occupational Risks (SENSOR). CDC Occupational disease 
surveillance: occupational asthma. MMWR 1990; 39:119-123). For the 
purposes of this announcement, OA is considered to encompass many 
different types of cases in which asthma is associated with 
occupational exposures. OA is intended to include asthma cases whose 
onset is attributed to workplace exposures/conditions, preexisting 
asthma cases whose symptoms have been quiescent but are initiated anew 
by workplace exposures/conditions, and ongoing cases of preexisting 
asthma whose illness is made significantly worse by workplace 
exposures/conditions or for whom an increase in treatment to maintain 
clinical stability is due to workplace exposures/conditions. Also, 
there are a variety of workplace exposures/conditions that can initiate 
or exacerbate asthma: (a) sensitizing agents (e.g., small or large 
molecular weight compounds); (b) brief, high-level irritant exposures 
(e.g., as with reactive airways dysfunction syndrome, or RADS); (c) 
repeated low-level irritant exposures; (d) broncho-constricting 
pharmacologic agents (e.g., as with byssinosis or polymer fume fever); 
(e) physical stimuli (e.g., exercise or exposure to cold).
    Occupational asthma is the most common lung disease seen in 
occupational health clinics in the United States based on data from the 
Association of Occupational and Environmental Clinics for 1991-1996. 
Accurate estimates of incidence are needed to evaluate the medical, 
social, and economic impact of this disease. Unfortunately, incidence 
estimates are few and vary widely, ranging from 5 to 710 cases/
106/year. NIOSH has funded surveillance for OA since 1987 
through the SENSOR program. Estimates of incidence based on SENSOR 
activities range from a low of 5 cases/106/year in 
Massachusetts during 1988-1992 to a high of 44 cases/106/
year in Michigan during 1993. However, SENSOR activities have the 
primary goal of identifying and improving dangerous worksites rather 
than providing a complete count of cases. Consequently, incidence 
figures based on SENSOR data underestimate the actual number of 
diagnosed cases.
    The episodic nature of asthma symptoms makes it difficult to obtain 
objective evidence of work-relatedness. The difficulty of this task and 
limits on patient-contact time discourage the routine investigation of 
work-relatedness by many health care providers. In fact, two recent 
studies report that over 80% of providers fail to explore work-
relatedness of adult asthma. This observation has at least two 
implications for measuring the frequency of OA. First, enhancement of 
existing surveillance activities to identify all diagnosed OA would 
still exclude the cases who have gone unnoticed because their health 
care providers did not explore the work-relatedness of asthma. Second, 
studies that attempt to count incident OA cases must include evaluation 
of work-relatedness of symptoms for all cases of asthma in adults, and 
not rely on health care providers to explore this possible association.
    The fact that OA can be initiated by over 200 agents used in 
hundreds of different processes argues for a population-based rather 
than industry-specific approach to measuring incidence. In the absence 
of nationalized health care in the United States, health maintenance 
organizations (HMOs) provide unique opportunities for population-based 
studies of asthma. The feasibility of using HMO data to measure OA 
incidence was demonstrated in a recent study. The investigators 
estimated the incidence of asthma attributable to occupation was 710 
cases/106/year, a figure over 16 times greater than the 
highest SENSOR estimate.
    An indirect estimate of OA incidence is derived by knowing both the 
incidence of adult-onset asthma and the proportion of cases that are 
work-related. The incidence of new onset asthma among adults during the 
years from 1971-1974 to 1982-1984 was estimated at 2100 cases/
106/year by the NHANES-1 Epidemiologic Follow-up Survey. The 
proportion of incident cases due to occupation can be estimated by 
using the same proportion estimated for prevalent asthma cases, which 
ranges from 0.03 to 0.20 based on studies in the United States. The 
product of this range of proportions and the asthma incidence from the 
NHANES study yields estimates of OA incidence 63 to 420 cases/
106/year. Even the low estimate of 63 cases/106/
year exceeds the highest estimate of 44 cases/106/year 
reported by the SENSOR program. These indirect estimates and the 
estimate of 710 cases/106/year from the HMO study suggest 
that OA is a more common condition in the United States than previously 
thought.
    Additional research is needed to elaborate the incidence of 
occupational asthma and the industries and occupations at highest risk. 
By having accurate estimates of incidence, it will be possible to make 
appropriate allocation of resources to address this problem. Knowledge 
of the industries and occupations at highest risk will assist future 
planning for focused studies or preventive interventions.

Purpose

    The purpose of this program is to: 1. evaluate the work-relatedness 
of incident asthma cases in a defined population (e.g., an HMO) during 
a minimum 12-month period (in order to account for seasonal variation 
of incidence), and calculate (a) the incidence of occupational asthma 
for the defined population; (b) the incidence of occupational asthma 
for specific industries and/or occupations in the defined population; 
and (c) the proportion of all incident asthma cases that are associated 
with workplace exposures; and 2. encourage the use of population-based 
data to investigate the impact of occupational diseases.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for activities under A. (Recipient 
Activities), and CDC/NIOSH will be responsible for the activities 
listed under B. (CDC/NIOSH Activities).

A. Recipient Activities

    1. Develop and implement a research protocol.
    2. Develop, field test, and revise data collection instruments.
    3. Analyze data and interpret findings.
    4. Disseminate research results to the scientific community.
    5. Collaborate with CDC/NIOSH on these activities, and the 
activities listed below.
    6. Meet annually at CDC/NIOSH to coordinate planned efforts and 
review progress.

[[Page 31783]]

B. CDC/NIOSH Activities

    1. Provide scientific, epidemiologic, engineering, environmental, 
industrial hygiene, and clinical technical assistance.
    2. Collaborate on the development of the research protocol(s).
    3. Provide technical assistance on the development and evaluation 
of the data collection instruments.
    4. Collaborate with awardee(s) on data analysis, and interpretation 
of findings.
    5. Provide technical assistance to awardees (if more than one award 
is made) to ensure that the methods used are similar enough so that 
data can be meaningfully combined.
    6. Provide assistance for the dissemination of information 
resulting from this project.
    7. Facilitate an annual meeting between awardee(s) and CDC/NIOSH to 
coordinate planned efforts and review progress.

Technical Reporting Requirements

    An original and two copies of a progress report are required semi-
annually. Timelines for the semi-annual reports will be established at 
the time of award. Final financial status and performance reports are 
required no later than 90 days after the end of the project period. All 
reports are submitted to the Grants Management Branch, Procurement and 
Grants Office, CDC.
    The semi-annual progress report should include:
    A. A brief program description.
    B. A listing of program goals and objectives accompanied by a 
comparison of the actual accomplishments related to the goals and 
objectives established for the period.
    C. If established goals and objectives to be accomplished were 
delayed, describe both the reason for the deviation and anticipated 
corrective action or deletion of the activity from the project.
    D. Other pertinent information, including the status of 
completeness, timeliness and quality of data.

Application Content

    The entire application, including appendices, should not exceed 40 
pages and the Proposal Narrative section contained therein should not 
exceed 25 pages. Pages should be clearly numbered and a complete index 
to the application and any appendices included. The original and each 
copy of the application must be submitted unstapled and unbound. All 
materials must be typewritten, double-spaced, with unreduced type (font 
size 12 point) on 8\1/2\'' by 11'' paper, with at least 1'' margins, 
headers, and footers, and printed on one side only. Do not include any 
spiral or bound materials or pamphlets.

A. Title Page

    The heading should include the title of grant program, project 
title, organization, name and address, project director's name address 
and telephone number.

B. Abstract

    A one page, singled-spaced, typed abstract must be submitted with 
the application. The heading should include the title of grant program, 
project title, organization, name and address, project director and 
telephone number. This abstract should include a work plan identifying 
activities to be developed, activities to be completed, and a time-line 
for completion of these activities.

C. Proposal Narrative

    The narrative of each application must:
    1. Briefly state the applicant's understanding of the need or 
problem to be addressed, the purpose, and goals over the 3 year period 
of the cooperative agreement.
    2. Describe in detail the objectives and the methods to be used to 
achieve the objectives of the project. The objectives should be 
specific, time-phased, measurable, and achievable during each budget 
period. The objectives should directly relate to the program goals. 
Identify the steps to be taken in planning and implementing the 
objectives and the responsibilities of the applicant for carrying out 
the steps.
    3. Provide the name, qualifications, and proposed time allocation 
of the Project Director who will be responsible for administering the 
project. Describe staff, experience, facilities, equipment available 
for performance of this project, and other resources that define the 
applicant's capacity or potential to accomplish the requirements stated 
above. List the names (if known), qualifications, and time allocations 
of the existing professional staff to be assigned to (or recruited for) 
this project, the support staff available for performance of this 
project, and the available facilities including space.
    4. Document the applicant's expertise, and extent of experience in 
the areas of asthma, occupational lung diseases, and population-based 
studies.
    5. Provide letters of support or other documentation demonstrating 
collaboration where collaboration is necessary for the conduct of the 
investigation.
    6. Human Subjects: State whether or not Humans are subjects in this 
proposal. (See Human Subjects in the Evaluation Criteria and Other 
Requirements sections.)
    7. Inclusion of women, ethnic, and racial groups:
    Describe how the CDC policy requirements will be met regarding the 
inclusion of women, ethnic, and racial groups in the proposed research. 
(See Women, Racial and Ethnic Minorities in the Evaluation Criteria and 
Other Requirements sections.)

D. Budget

    Provide a detailed budget which indicates anticipated costs for 
personnel, equipment, travel, communications, supplies, postage, and 
the sources of funds to meet these needs. The applicant should be 
precise about the program purpose of each budget item. For contracts 
described within the application budget, applicants should name the 
contractor, if known; describe the services to be performed; and 
provide an itemized breakdown and justification for the estimated costs 
of the contract; the kinds of organizations or parties to be selected; 
the period of performance; and the method of selection. Place the 
budget narrative pages showing, in detail, how funds in each object 
class will be spent, directly behind form 424A. Do not put these pages 
in the body of the application. CDC may not approve or fund all 
proposed activities.

Evaluation Criteria

    The application will be reviewed and evaluated according to the 
following criteria:

A. Understanding of the Problem (10%)

    Responsiveness to the objectives of the cooperative agreement 
including (1) the applicant's understanding of the general objectives 
of the proposed cooperative agreement, and (2) relevance of the 
proposal to the objectives.

B. Program Personnel (20%)

    1. Applicant's technical experience and understanding (e.g., in the 
areas of asthma, occupational lung diseases, and population-based 
studies).
    2. Qualifications and time allocation of the professional staff to 
be assigned to this project.
    3. Extent to which the management staff and their working partners 
are clearly described.

[[Page 31784]]

C. Goals, Objectives, and Study Design (Total 60%)

    1. The extent to which the proposed goals and objectives are 
clearly stated and measurable. Adequacy of the study design and 
methodology for accomplishing the stated goals and objectives. A 
description of the study methodology, data to be collected, and the 
respective responsibilities of the applicant for carrying out these 
steps. The degree to which efficient and innovative approaches are 
proposed to address the problems. Issues of specific concern to this 
project include the adequacy of the applicant's (a) evidence of access 
to an appropriate study population; (b) description of the study 
population, including the occupation/industry mix; (c) operational 
definitions for asthma and occupational asthma; (d) methods for 
identifying incident asthma cases and assessing work-relatedness of 
asthma. The extent to which the applicant's plans and schedule proposed 
for accomplishing the activities to be carried out in this project are 
clearly stated, are realistic given the length of the funding period, 
and can be achieved within the proposed budget.
    2. The degree to which the applicant has met the CDC policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in the proposed project. This includes: (a) The proposed plan 
for the inclusion of both sexes and racial and ethnic minority 
populations for appropriate representation; (b) The proposed 
justification when representation is limited or absent; (c) A statement 
as to whether the design of the study is adequate to measure 
differences when warranted; and (d) A statement as to whether the plan 
for recruitment and outreach for study participants includes the 
process of establishing partnerships with community(ies) and 
recognition of mutual benefits.

D. Facilities and Resources (10%)

    The adequacy of the applicant's facilities, equipment, and other 
resources available for performance of this project.

E. Human Subjects (Not scored)

    Whether or not exempt from the Department of Health and Human 
Services (DHHS) regulations, are procedures adequate for the protection 
of human subjects? Recommendations on the adequacy of protections 
include: (1) protections appear adequate, and there are no comments to 
make or concerns to raise, (2) protections appear adequate, but there 
are comments regarding the protocol, (3) protections appear inadequate 
and the Objective Review Group has concerns related to human subjects 
or (4) disapproval of the application is recommended because the 
research risks are sufficiently serious and protection against the 
risks are inadequate as to make the entire application unacceptable.

F. Budget Justification (Not Scored)

    The budget will be evaluated to the extent that it is reasonable, 
clearly justified, and consistent with the intended use of funds.

Executive Order 12372 Review

    The applicant is not subject to review under Executive Order 12372 
Review.

Public Health System Reporting Requirements

    The applicant is not subject to review under the Public Health 
System Reporting Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.957.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from ten or 
more individuals and funded by this cooperative agreement will be 
subject to review and approval by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act.

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the DHHS Regulations, 45 CFR Part 46, 
regarding the protection of human subjects. Assurance must be provided 
to demonstrate the project will be subject to initial and continuing 
review by an appropriate institutional review committee. The applicant 
will be responsible for providing assurance in accordance with the 
appropriate guidelines and form provided in the application kit.
    In addition to other applicable committees, Indian Health Service 
(IHS) institutional review committees also must review the project if 
any component of IHS will be involved or will support the research. If 
any American Indian community is involved, its tribal government must 
also approve that portion of the project applicable to it.

Confidentiality

    All personal identifying information obtained in connection with 
the delivery of services provided to any person in any program carried 
out under this cooperative agreement cannot be disclosed unless 
required by a law of a State or political subdivision or unless such a 
person provides written, voluntary informed consent.
    A. Nonpersonal identifying, unlinked information, which preserves 
the individual's anonymity, derived from any such program may be 
disclosed without consent:
    1. In summary, statistical, or other similar form, or
    2. For clinical or research purposes.
    B. Personal identifying information: Recipients of CDC funds who 
must obtain and retain personally identifying information as part of 
their CDC-approved work plan must:
    1. Maintain the physical security of such records and information 
at all times;
    2. Have procedures in place and staff trained to prevent 
unauthorized disclosure of client-identifying information;
    3. Obtain informed client consent by explaining the risks of 
disclosure and the recipient's policies and procedures for preventing 
unauthorized disclosure;
    4. Provide written assurance to this effect including copies of 
relevant policies; and
    5. Obtain assurances of confidentiality by agencies to which 
referrals are made.
    Assurance of compliance with these and other processes to protect 
the confidentiality of information will be required of all recipients. 
A DHHS certificate of confidentiality may be required for some 
projects.

Women, Racial and Ethnic Minorities

    It is the policy of the Centers for Disease Control and Prevention 
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) 
to ensure that individuals of both sexes and the various racial and 
ethnic groups will be included in CDC/ATSDR-supported research projects 
involving human subjects, whenever feasible and appropriate. Racial and 
ethnic groups are those defined in OMB Directive No. 15 and include 
American Indian, Alaska Native, Asian, Black or African American, 
Hispanic or Latino, and Native Hawaiian or other Pacific Islander. 
Applicants shall ensure that women, racial and ethnic minority 
populations are appropriately represented in applications for research 
involving human subjects. Where clear and compelling rationales exist 
that inclusion is inappropriate or not feasible, this situation must be 
explained as part of the application. This policy does not apply to 
research

[[Page 31785]]

studies when the investigator cannot control the race, ethnicity and/or 
sex of subjects. Further guidance to this policy is contained in the 
Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated 
Friday, September 15, 1995.

Application Submission and Deadlines

A. Preapplication Letter of Intent

    Although not a prerequisite of application, a non-binding letter of 
intent-to-apply is requested from potential applicants. The letter 
should be submitted to Victoria F. Sepe, Grants Management Specialist, 
Grants Management Branch, Procurement and Grants Office, CDC at the 
address listed in this section. It should be postmarked no later than 
July 2, 1998. The letter should identify program announcement number 
98058, and 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 and will ensure that each applicant 
receives timely and relevant information prior to application 
submission.

B. Application

    The original and two copies of the application PHS Form 5161-1 
(Revised 7/92, OMB Number 0937-0189) must be submitted to Victoria 
Sepe, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE, Room 321, Atlanta, GA 
30305, on or before July 31, 1998.
    1. Deadline: Applications will be considered as meeting the 
deadline if they are either:
    (a) Received on or before the deadline date, or
    (b) Sent on or before the deadline date and received in time for 
submission to the objective review group. (The applicants must request 
a legibly dated U.S. Postal Service postmark or obtain a receipt from a 
commercial carrier or the U.S. Postal Service. Private metered 
postmarks will not be acceptable as proof of timely mailing.)
    2. Late Applicants: Applications that do not meet the criteria in 
1.(a) or 1.(b) above are considered late applications. Late 
applications will not be considered in the current competition and will 
be returned to the applicants.

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 NIOSH Announcement 98058. 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 NIOSH ANNOUNCEMENT NUMBER 98058 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 
from Victoria Sepe, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), Mailstop E-13, Room 321, 255 East Paces Ferry Road, 
NE., Atlanta, GA 30305, telephone (404) 842-6804, Internet: 
[email protected].
    Programmatic technical assistance may be obtained from Paul K. 
Henneberger, MPH, ScD, Research Epidemiologist, Division of Respiratory 
Disease Studies, National Institute for Occupational Safety and Health, 
Center for Disease Control and Prevention (CDC), Mailstop 234, 1095 
Willowdale Road, Morgantown, WV 26505, telephone 304-285-6161, or 
Internet: [email protected].
    This and other CDC announcements are available through the CDC 
homepage on the Internet. The address for the CDC homepage is: http://
www.cdc.gov.
    Potential applicants may obtain a copy of Healthy People 2000 (Full 
Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary 
Report, Stock No. 017-001-00473-1) through the Superintendent of 
Documents, Government Printing Office, Washington, DC 20402-9325, 
telephone (202) 512-1800.

The National Occupational Research Agenda

    Copies of this publication may be obtained from The National 
Institute of Occupational Safety and Health, Publications Office, 4676 
Columbia Parkway, Cincinnati, OH 45226-1998 or phone 1-800-356-4674, 
and is available through the NIOSH Home Page; ``http:/www.cdc.gov/
niosh/nora.html''.

    Dated: June 2, 1998.
Diane D. Porter,
Acting Director, National Institute For Occupational Safety and Health 
Centers For Disease Control and Prevention (CDC).
[FR Doc. 98-15359 Filed 6-9-98; 8:45 am]
BILLING CODE 4163-19-P