[Federal Register Volume 62, Number 46 (Monday, March 10, 1997)]
[Notices]
[Pages 10859-10863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5831]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement 729]


National Institute for Occupational Safety and Health; Research 
and Demonstration Grants Occupational Safety and Health

Introduction

    The National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC) is soliciting 
grant applications for research and demonstration projects related to 
occupational safety and health (see the section Availability of Funds).
    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 the Public Health Service Act, as 
amended, Section 301 (42 U.S.C. 241); the Occupational Safety and 
Health Act of 1970, Sections 20(a) and 22 (29 U.S.C. 669 and 671); and 
the Federal Mine Safety and Health Act of 1977, Section 501 (30 U.S.C. 
951). The applicable program regulations are in 42 CFR
    Part 52.

Eligible Applicants

    Eligible applicants include domestic and foreign non-profit and 
for-profit organizations, universities, colleges, research 
institutions, and other public and private organizations, including 
State and local governments and small, minority and/or woman-owned 
businesses. Exceptions: applicants for the Special Emphasis Research 
Career Award (SERCA) Grant and Small Grant programs must be citizens or 
persons lawfully admitted to the United States for permanent residence 
(resident alien) at the time of application and must be employed by a 
domestic institution.

    Note: An organization described in section 501(c)(4) of the 
Internal Revenue Code of 1986 which engages in lobbying activities 
shall not be eligible to receive Federal funds constituting an 
award, grant, contract, loan, or any other form.

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds and in which education, 
library, day care, health care, and early childhood development 
services are provided to children.

Availability of Funds

    For fiscal year (FY) 1997, the budget is projected to be 
$10,500,000. Of that amount, $7,700,000 is committed to support 41 non-
competing continuing awards. Therefore, $2,800,000 is available for new 
and competing renewal awards. The overall budget includes funds for 
Small Business Innovation Research (SBIR) grants and for health and 
safety research related to the construction industry. Target amounts 
(continuing and new awards) for certain grant mechanisms are as 
follows: 10 R03 grants (about $375,000), 10 K01 grants (about 
$540,000), and 5 R29 grants (about $500,000).
    Grant applications should be focused on the research priorities 
described in the section Funding Priorities that includes new research 
priorities developed in a process which resulted in defining a National 
Occupational Research Agenda.

Background

    In today's society, Americans are working more hours than ever 
before. The workplace environment profoundly affects health. Each of 
us, simply by going to work each day, may face hazards that threaten 
our health and safety. Risking one's life or health should never be 
considered merely part of the job.
    In 1970, Congress passed the Occupational Safety and Health Act to 
ensure Americans the right to ``safe and healthful working 
conditions,'' yet workplace hazards continue to inflict a tremendous 
toll in both human and economic costs.
    Employers reported 6.3 million work injuries in 1994 and 515,000 
cases of occupational illness. An average of 17 American workers die 
each day from injuries on the job. Moreover, even the most conservative 
estimates find that about 137 additional workers die each day from 
workplace diseases.
    Additionally, in 1994 occupational injuries and deaths cost $120.7 
billion in wages and lost productivity, administrative expenses, health 
care and other costs. This does not include the cost of occupational 
disease.
    Occupational injury and disease create needless human suffering, a 
tremendous burden upon health care resources, and an enormous drain on 
U.S. productivity. Yet, to date, this mainstream public health problem 
has escaped mainstream public attention.
    The philosophy of NIOSH is articulated in the Institute's vision 
statement: Delivering on the Nation's Promise: Safety and Health at 
Work for All People * * * Through Research and Prevention. To identify 
and reduce hazardous working conditions, the Institute carries out 
disease, injury, and hazard surveillance and conducts a wide range of 
field and laboratory research. Additionally, NIOSH sponsors extramural 
research in priority areas to complement and expand its efforts. These 
are listed in the section Funding Priorities.

Purpose

    The purpose of this grant program is to develop knowledge that can 
be used in preventing occupational diseases and injuries. Thus, NIOSH 
will support the following types of applied research projects: causal 
research to identify and investigate the relationships between 
hazardous working conditions and associated occupational diseases and 
injuries; methods research to develop more sensitive means of 
evaluating hazards at work sites, as well as methods for measuring 
early markers of adverse health effects and injuries; control research 
to develop new protective equipment, engineering control technology, 
and work practices to reduce the risks of occupational hazards; and 
demonstrations to evaluate the technical feasibility or application of 
a new or improved occupational safety and health procedure, method, 
technique, or system.

[[Page 10860]]

Mechanisms of Support

    Applications responding to this announcement will be reviewed by 
staff for their responsiveness to the following program requirements. 
Grants are funded for 12-month budget periods in project periods up to 
five years for research project grants and demonstration project 
grants; three years for SERCA grants; and two years for small grants. 
Continuation awards within the project period are made on the basis of 
satisfactory progress and on the availability of funds. The types of 
grants NIOSH supports are as follow:
1. Research Project Grants (R01)
    A research project grant application should be designed to 
establish, discover, develop, elucidate, or confirm information 
relating to occupational safety and health, including innovative 
methods, techniques, and approaches for dealing with problems. These 
studies may generate information that is readily available to solve 
problems or contribute to a better understanding of the causes of work-
related diseases and injuries.
2. Demonstration Project Grants (R18)
    A demonstration project grant application should address, either on 
a pilot or full-scale basis, the technical or economic feasibility of 
implementing a new/improved innovative procedure, method, technique, or 
system for preventing occupational safety or health problems. The 
project should be conducted in an actual workplace where a baseline 
measure of the problem will be defined, the new/improved approach will 
be implemented, a follow-up measure of the problem will be documented, 
and an evaluation of the benefits will be conducted.
3. First Independent Research Support and Transition (FIRST) Grants 
(R29)
    The FIRST grant is to provide a sufficient period of research 
support for newly independent investigators to initiate their own 
research and demonstrate the merit of their own research ideas. These 
grants are intended to underwrite the first independent investigative 
efforts of an individual; to provide a reasonable opportunity to 
demonstrate creativity, productivity, and further promise; and to help 
in the transition to traditional types of research project grants. The 
award is not intended for individuals in mid-career who may be in 
transition to another undertaking. It is for a distinct research 
endeavor and may not be used merely to supplement or broaden an ongoing 
project.
    Candidates must (1) be genuinely independent of a mentor, yet at 
the same time be at the beginning stages of their research careers, (2) 
have no more than 5 years of research experience since completing post-
doctoral research training or its equivalent, (3) not be in training 
status at the time of the award, (4) have never been the principal 
investigator (PI) on any Public Health Service grant except a Small 
Grant (R03) or a Special Emphasis Research Career Award Grants (K01), 
and (5) not necessarily be U.S. citizens, although the applicant 
organizations must be domestic.
    The PI must request 5 years of support; otherwise, the application 
will be reviewed as a traditional research project (R01). There must be 
a commitment of no less than 50 percent effort to the proposed project. 
The total direct cost for the 5-year period may not exceed $350,000. 
The direct cost award in any budget period may not exceed $100,000. 
FIRST awards are not renewable; however, a PI may submit an R01 
application to continue and extend the research supported by a FIRST 
award. Replacement of the PI on a FIRST award will not be approved.
    The application must include the following documentation: (1) A 
letter or memorandum is needed from a suitable department head or dean 
which addresses the eligibility of the proposed PI to lead a research 
project independently at the applicant organization (i.e., Is the 
proposed PI otherwise qualified to be the PI on a traditional project 
grant?). When the application is from the institution where the 
proposed PI received post-doctoral research training, it must be made 
absolutely clear that the FIRST award would be to support a research 
endeavor independent of that conducted in the former training 
environment. Details of the intended commitment of the institution to 
the project for the 5-year period should be provided. (2) At least 
three letters of reference must be submitted. FIRST applicants are to 
request the letters well in advance of the application submission, 
advising the referees to return the reference letters to the applicant 
in sealed envelopes as soon as possible. To protect the utility and 
confidentiality of reference letters, applicants are not to open the 
envelopes. The sealed envelopes must be attached to the front of the 
original application. Reference letters should reflect the 
investigator's research originality and potential for independent 
investigation. A list of individuals providing letters must be included 
as Section 10 of the Research Plan. Names, titles, and institutional 
affiliation is needed for each person.
4. Special Emphasis Research Career Award (SERCA) Grants (K01)
    The SERCA grant is intended to provide opportunities for 
individuals to acquire experience and skills while under the direction 
of at least one mentor, and in so doing, create a pool of highly 
qualified investigators who can make future contributions to research 
in the area of occupational safety and health. SERCA grants are not 
intended for individuals without research experience, or for 
productive, independent investigators with a significant number of 
publications and of senior academic rank. Moreover, the award is not 
intended to substitute one source of salary support for another for an 
individual who is already conducting full-time research; nor is it 
intended to be a mechanism for providing institutional support.
    Candidates must: (1) Hold a doctoral degree; (2) have research 
experience at or above the doctoral level; (3) not be above the rank of 
associate professor; (4) be employed at a domestic institution; and (5) 
be citizens or persons lawfully admitted to the United States for 
permanent residence (resident alien) at the time of application.
    This non-renewable award provides support for a three-year period 
for individuals engaged in full-time research and related activities. 
Awards will not exceed $50,000 per year in direct costs for salary 
support (plus fringe benefits), technical assistance, equipment, 
supplies, consultant costs, domestic travel, publications, and other 
costs. The indirect cost rate applied is limited to 8 percent of the 
direct costs, excluding tuition and related fees and equipment 
expenses, or to the actual indirect cost rate, whichever results in the 
lesser amount.
    A minimum of 60 percent time must be committed to the proposed 
research project, although full-time is desirable. Other work in the 
area of occupational safety and health will enhance the candidate's 
qualifications but is not a substitute for this requirement. Related 
activities may include research career development activities as well 
as involvement in patient care to the extent that it will strengthen 
research skills. Fundamental/basic research will not be supported 
unless the project will make an original contribution for applied 
technical knowledge in the identification, evaluation, or control of 
occupational safety and health hazards (e.g., development of a 
diagnostic technique for early detection of an occupational disease). 
Research project

[[Page 10861]]

proposals must be of the applicants' own design and of such scope that 
independent investigative capability will be evident within three 
years. At the completion of this three-year award, it is intended that 
awardees should be better able to compete for individual research 
project grants awarded by NIOSH.
    SERCA grant applications should be identified as such on the 
application form. Section 2 of the application (the Research Plan) 
should include a statement regarding the applicant's career plans and 
how the proposed research will contribute to a career in occupational 
safety and health research. This section should also include a letter 
of recommendation from the proposed advisor(s).
5. Small Grants (R03)
    The small grant program is intended to stimulate proposals from 
individuals who are considering a research career in occupational 
safety and health; as such, the minimum time commitment is 10%. It is 
expected that a recipient would subsequently compete for other grant 
mechanisms which are described above in items 1 to 4. The award is not 
intended to supplement ongoing or other proposed research; nor is it 
intended to be a mechanism for providing institutional support. Please 
note that fundamental/basic research is generally not supported.
    The small grant investigators must be United States citizens or 
persons lawfully admitted to the United States for permanent residence 
(resident alien) at the time of application who are predoctoral 
students, post-doctoral researchers (within 3 years following 
completion of doctoral degree or completion of residency or public 
health training), or junior faculty members (no higher than assistant 
professor). If university policy requires that a more senior person be 
listed as principal investigator, it should be clear in the application 
which person is the small grant investigator. Except for applicants who 
are assistant professors, there must be one or more named mentors to 
assist with the project. A biographical sketch is required for the 
small grant investigator, as well as for the supervisor and other key 
consultants, as appropriate.
    This non-renewable award provides support for project periods of up 
to two years to carry out exploratory or pilot studies, to develop or 
test new techniques or methods, or to analyze data previously 
collected. Awards will not exceed $25,000 per year in direct costs for 
salary support (plus fringe benefits), technical assistance, equipment, 
supplies, consultant costs, domestic travel, publications, and other 
costs. The indirect costs will be based upon the negotiated indirect 
cost rate of the applicant organization. An individual may not receive 
more than two small grant awards, and then, only if the awards are at 
different stages of development (e.g., doctoral student, post-doctoral 
researcher, or junior faculty member).

Funding Priorities

    The NIOSH program priorities, listed below, are applicable to all 
of the above types of grants listed under the section Mechanisms of 
Support. These priority areas were developed by NIOSH and its partners 
in the public and private sectors to provide a framework to guide 
occupational safety and health research in the next decade--not only 
for NIOSH but also for the entire occupational safety and health 
community. Approximately 500 organizations and individuals outside 
NIOSH provided input into the development of the National Occupational 
Research Agenda (NORA). This attempt to guide and coordinate research 
nationally is responsive to a broadly perceived need to address 
systematically those topics that are most pressing and most likely to 
yield gains to the worker and the nation. Fiscal constraints on 
occupational safety and health research are increasing, making even 
more compelling the need for a coordinated and focused research agenda. 
NIOSH intends to support projects that facilitate progress in 
understanding and preventing adverse effects among workers. The 
conditions or examples listed under each category are selected 
examples, not comprehensive definitions of the category. Investigators 
may also apply in other areas related to occupational safety and 
health, but the rationale for the significance of the research to the 
field of occupational safety and health must be presented in the grant 
application.
    Potential applicants with questions concerning the acceptability of 
their proposed work are strongly encouraged to contact the ``Technical 
Information Contact,'' Dr. Roy M. Fleming, listed in this announcement 
under the section Where To Obtain Additional Information.
    The Agenda identifies 21 research priorities. These priorities 
reflect a remarkable degree of concurrence among a large number of 
stakeholders. The NORA priority research areas are grouped into three 
categories: Disease and Injury, Work Environment and Workforce, and 
Research Tools and Approaches. The NORA document is available through 
the NIOSH Home Page; http://www.cdc.gov/niosh/nora.html.

NORA Priority Research Areas

Disease and Injury
    Allergic and Irritant Dermatitis
    Asthma and Chronic Obstructive Pulmonary Disease
    Fertility and Pregnancy Abnormalities
    Hearing Loss
    Infectious Diseases
    Low Back Disorders
    Musculoskeletal Disorders of the Upper Extremities
    Traumatic Injuries
Work Environment and Workforce
    Emerging Technologies
    Indoor Environment
    Mixed Exposures
    Organization of Work
    Special Populations at Risk
Research Tools and Approaches
    Cancer Research Methods
    Control Technology and Personal Protective Equipment
    Exposure Assessment Methods
    Health Services Research
    Intervention Effectiveness Research
    Risk Assessment Methods
    Social and Economic Consequences of Workplace Illness and Injury
    Surveillance Research Methods

Applications Submission and Deadlines and Review Dates

    The research grant application Form PHS-398 (OMB Number 0925-0001) 
is to be used in applying for these grants. These forms are available 
at most institutional offices of sponsored research; from the 
Extramural Outreach and Information Resources Office, Office of 
Extramural Research, 6701 Rockledge Drive, MS-C7910, Bethesda, MD 
20892-7910, telephone (301) 435-0714; fax (301) 480-8443; Internet 
[email protected]; and from the contacts listed under the section 
Where To Obtain Additional Information.
    The original and five copies of the PHS-398 must be submitted to 
Division of Research Grants, National Institutes of Health, Suite 1040, 
6701 Rockledge Drive, MS-C7710, Bethesda, MD 20892-7710, on or before 
the specified receipt dates provided below. A mailing label is provided 
in the Form PHS-398 application package.
    The timetable for receiving applications and awarding grants is 
given below. This is a continuous announcement, consequently, these 
receipt dates will be on-going until further notice.

[[Page 10862]]



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                                                                                            Earliest  possible  
            Receipt date *                  Initial  review         Secondary  review           start date      
----------------------------------------------------------------------------------------------------------------
Research and Demonstration Project                                                                              
 Grants:                                                                                                        
    Feb. 1............................  June/July..............  Sept...................  Dec. 1.               
    June 1............................  Oct./Nov...............  Jan....................  Apr. 1.               
    Oct. 1............................  Feb./Mar...............  May....................  Aug. 1.               
SERCA and Small Grants:                                                                                         
    Mar. 1............................  June/July..............  Aug....................  Nov. 1.               
    July 1............................  Oct./Nov...............  Dec....................  Mar. 1.               
    Nov. 1............................  Feb./Mar...............  Apr....................  July 1.               
----------------------------------------------------------------------------------------------------------------
* Deadlines for competing continuation applications or revised applications are 1 month later.                  

    Applications must be received by the above receipt dates. To 
prevent problems caused by carrier delays, retain a legible proof-of-
mailing receipt from the carrier, dated no later than one week prior to 
the receipt date. If the receipt 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 work day. The receipt date will be waived only in 
extenuating circumstances. To request such a waiver, include an 
explanatory letter with the signed, completed application. No request 
for a waiver will be considered prior to receipt of the application.

Evaluation Criteria

    Applications will be reviewed for scientific and technical merit by 
the CDC/NIOSH Occupational Safety and Health Chartered Study Section 
(SOH), in accordance with the standard peer review procedures. 
Following scientific technical review, the applications will receive a 
second-level programmatic review. Notification of the review 
recommendations will be sent to the applicants after the initial 
review. Awards will be made based on results of the initial and 
secondary reviews, as well as availability of funds.
    Applications that are complete and responsive to the program 
announcement will be evaluated for scientific merit by the SOH peer 
review group. As part of the initial merit review, all applications 
will receive a written critique and undergo a process in which only 
those applications deemed to have the highest scientific merit, 
generally the top half of applications under review, will be discussed, 
assigned a priority score, and receive a second level review by the 
Institute programmatic review committee.
    1. The initial (peer) review is based on scientific merit and 
significance of the project, competence of the proposed staff in 
relation to the type of research involved, feasibility of the project, 
likelihood of its producing meaningful results, appropriateness of the 
proposed project period, adequacy of the applicant's resources 
available for the project, and appropriateness of the budget request.
    Demonstration grant applications will be reviewed additionally on 
the basis of the following criteria:
     Degree to which project objectives are clearly 
established, obtainable, and for which progress toward attainment can 
and will be measured.
     Availability, adequacy, and competence of personnel, 
facilities, and other resources needed to carry out the project.
     Degree to which the project can be expected to yield or 
demonstrate results that will be useful and desirable on a national or 
regional basis.
     Documentation of cooperation from industry, unions, or 
other participants in the project, where applicable.
    SERCA grant applications will be reviewed additionally on the basis 
of the following criteria:
     The review process will consider the applicant's 
scientific achievements, the applicant's research career plan in 
occupational safety and health, and the degree to which the applicant's 
institution offers a superior research environment (supportive nature, 
including letter(s) of reference from advisor(s) which should accompany 
the application).
    Consideration will be given to the fact that the applicants for 
small grants do not have extensive experience with the grants process.
    2. In the secondary review, the following factors will be 
considered:
     The results of the initial review.
     The significance of the proposed study to the mission of 
NIOSH.
    (1) Relevance to occupational safety and health by contributing to 
achievement of research objectives specified in Sections 20(a) and 22 
of the Occupational Safety and Health Act of 1970 and Section 501 of 
the Federal Mine Safety and Health Act of 1977,
    (2) Magnitude of the problem in terms of numbers of workers 
affected,
    (3) Severity of the disease or injury in the worker population,
    (4) Potential contribution to applied technical knowledge in the 
identification, evaluation, or control of occupational safety and 
health hazards,
    (5) Program balance, and
    (6) Policy and budgetary considerations.
    Questions regarding the above criteria should be addressed to the 
Programmatic Technical Information Contact listed under Where To Obtain 
Additional Information.

Technical Reporting Requirements

    Progress reports are required annually as part of the continuation 
application (75 days prior to the start of the next budget period). The 
annual progress reports must contain information on accomplishments 
during the previous budget period and plans for each remaining year of 
the project. Financial status reports (FSR) are required no later than 
90 days after the end of the budget period. The final performance and 
financial status reports are required 90 days after the end of the 
project period. The final performance report should include, at a 
minimum, a statement of original objectives, a summary of research 
methodology, a summary of positive and negative findings, and a list of 
publications resulting from the project. Research papers, project 
reports, or theses are acceptable items to include in the final report. 
The final report should stand alone rather than citing the original 
application. Three copies of reprints of publications prepared under 
the grant should accompany the report.

Executive Order 12372 Review

    Applications are not subject to review as governed by Executive 
Order 12372.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.262.

Public Health System Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirements.

[[Page 10863]]

Other Requirements

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations (45 CFR Part 46) regarding the protection of human 
subjects. Assurance must be provided to demonstrate that 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 
forms provided in the application kit.

Women and Racial and Ethnic Minorities

    It is the policy of the Centers for Disease Control and Prevention 
(CDC) to ensure that women and 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, Pacific Islander, Black and Hispanic. Applicants 
shall ensure that women and racial and ethnic minority populations are 
appropriately represented in applications for research involving human 
subjects. Where clear and compelling rationale exist that inclusion is 
inappropriate or not feasible, this situation must be explained as part 
of the application. In conducting review for scientific merit, review 
groups will evaluate proposed plans for inclusion of minorities and 
both sexes as part of the scientific assessment and scoring. This 
policy does not apply to research 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.

Where To Obtain Additional Information

    To receive additional written information call (404) 332-4561. You 
will be asked to leave your name, address, and telephone number and 
will need to refer to announcement 729. You will receive a complete 
program description, information on application procedures, and 
application. Business management information may be obtained from 
Georgia Jang, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., MS-E13, Atlanta, GA 
30305, telephone (404) 842-6814; fax: (404) 842-6513; Internet: 
[email protected].
    Programmatic technical assistance may be obtained from Roy M. 
Fleming, Sc.D., Associate Director for Grants, National Institute for 
Occupational Safety and Health, Centers for Disease Control and 
Prevention (CDC), 1600 Clifton Road, NE., Building 1, Room 3053, MS-
D30, Atlanta, GA 30333, telephone: (404) 639-3343; fax: (404) 639-4616; 
Internet: [email protected].
    Please Refer to Announcement Number 729 When Requesting Information 
and Submitting an Application.
    This and other CDC Announcements can be found on the CDC home page 
at http://www.cdc.gov.
    CDC will not send application kits by facsimile or express mail.
    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.

    Dated: March 4, 1997.
Diane D. Porter,
Acting Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention (CDC).
[FR Doc. 97-5831 Filed 3-7-97; 8:45 am]
BILLING CODE 4163-19-P