[Federal Register Volume 62, Number 112 (Wednesday, June 11, 1997)]
[Notices]
[Pages 31825-31830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement 738]


National Institute for Occupational Safety and Health; Assessment 
of Respiratory Exposure Hazards in Composting

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1997

[[Page 31826]]

funds for a cooperative agreement to conduct cross-sectional studies at 
composting facilities of respiratory exposures and respiratory health 
effects among compost workers.
    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.)
    CDC, National Institute for Occupational Safety and Health (NIOSH) 
is committed to the program priorities developed by the National 
Occupational Research Agenda (NORA). (For ordering a copy of the NORA, 
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 to 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

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

    Note: Public Law 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 to influence the Federal 
Government, from receiving Federal funds.

Availability of Funds

    Approximately $200,000 will be available in FY 1997 to fund up to 
two awards at approximately $100,000 each. It is expected that the 
awards will begin on or about September 30, 1997, and will be made for 
12-month budget periods within the project period of up to 3 years. The 
funding estimate is subject to change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the 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 FY 1997 HHS Appropriations Act, which became 
effective October 1, 1996, expressly prohibits the use of 1997 
appropriated funds for indirect or ``grass roots'' lobbying efforts 
that are designed to support or defeat legislation pending before State 
legislatures. This new law, Section 503 of Pub. L. No. 104-208, 
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, * * * except 
in presentation to the Congress or any State legislative body itself.
    (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

    Composting is the decomposition of organic materials under aerobic 
conditions which produces a stable, humus-like material which can be 
used as a soil amendment. Materials composted can include yard waste, 
food/household waste, food processing waste, agricultural wastes, 
biosolids, and animal wastes. The recycling of biosolids and the 
organic fractions of municipal solid waste is increasing because of the 
benefits that can arise and because the disposal alternatives such as 
land filling and incineration are more costly, unpopular, or restricted 
by law. The consequence of this is a dramatic increase in the number of 
composting operations and the number of workers exposed to organic 
dusts at these facilities. The proceedings from a national composting 
council workshop indicate that there were approximately 2500 composting 
facilities operating in the United States during 1992 with a large 
expected growth rate (over 45 percent) in the number of composting 
facilities during subsequent years. The rapid growth in this industry, 
combined with the potential for worker exposure to organic dusts 
containing many toxic and immunogenic constituents, indicates the need 
for studies to address potential respiratory health problems among 
workers in this industry. Upper respiratory tract irritation, organic 
dust toxic syndrome (ODTS), asthma, bronchitis, and hypersensitivity 
pneumonitis are among the respiratory health problems described to 
occur from organic dust exposures such as those associated with 
composting.
    Composting is an emerging technology area. Under the NIOSH National 
Occupational Research Agenda (NORA), emerging technologies represent a 
priority area for research efforts to (1) Assess their potential to 
cause harm to workers, (2) evaluate specific worksites, (3) develop 
effective control strategies where occupational hazards exist, (4) 
identify superior new technologies that diminish risk, and (5) share 
information for the benefit of all persons at risk and those 
responsible for managing the risk.
    This project addresses many of these emerging technology criteria 
described in NORA.

Purpose

    The purpose of this project is to conduct research to identify 
potential exposure hazards and respiratory health problems among 
workers in the composting industry. This information

[[Page 31827]]

will be used to promote respiratory health for this workforce and 
direct prevention efforts as appropriate.
    The specific objectives for this cooperative agreement program 
include the following: develop a research protocol(s) for a cross-
sectional study of respiratory exposures and respiratory health effects 
among workers employed at composting facilities; conduct in-depth 
environmental investigations of respiratory exposure hazards at 
selected composting facilities; conduct in-depth clinical 
investigations on the respiratory health status of workers at selected 
composting facilities; and describe the composting processes used at 
each survey site including the control procedures used to reduce worker 
exposures.

    Note: Protocols should exclude sampling sites in Department of 
Health and Human Services (DHHS) Region VII from the sample (DHHS 
Region VII includes the following States: Iowa, Kansas, Missouri, 
and Nebraska). This exclusion is to avoid duplication with ongoing 
composting research efforts completed through the NIOSH funded 
Centers for Agriculture Research, Education and Disease Injury and 
Prevention in DHHS Region VII.

Program Requirements

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

A. Recipient Activities

    1. Develop a research protocol(s) for a cross-sectional study of 
respiratory exposures and respiratory effects among workers employed at 
composting facilities. Obtain scientific peer review of the 
protocol(s), revise, and finalize the protocol(s).
    2. Conduct a comprehensive environmental investigation of 
respiratory exposure hazards at selected composting facilities. 
Personal and area environmental sampling data collected from each of 
these facilities should include, at a minimum, particulate not 
otherwise regulated (formerly known as ``total dust''), metals, 
endotoxins, viable microorganisms, and ammonia.
    3. Conduct in-depth clinical investigations on the respiratory 
health status of workers at selected composting facilities. Study 
design should take into account sources of bias in particular the 
problems encountered when limiting the study to current employees. 
Clinical investigations should include, at a minimum:
    a. The development and administration of a questionnaire designed 
to gather information on work and exposure history and respiratory 
health effects. The questionnaire should be administered to all members 
of this study population.
    b. The development and implementation of a pulmonary function 
testing program appropriate to the investigation of respiratory health 
effects among compost workers at selected facilities.
    4. Clarify the composting processes used at each survey site 
including the control procedures used to reduce worker exposures.
    5. Collaborate with CDC/NIOSH scientists on study research efforts.
    6. Report and disseminate, if desired, research results and 
relevant health and safety education and training information to 
appropriate health care providers, the scientific community, 
agricultural workers and their families, management and union or other 
worker representatives, and Federal, State, and local agencies. 
Emphasis should be placed on the rapid dissemination of significant 
public health findings and the translation of research findings into 
prevention efforts.

B. CDC/NIOSH Activities

    1. Provide technical assistance in the areas of program development 
and study research efforts, implementation, maintenance.
    2. Provide technical assistance, if needed, related to the 
development and implementation of the pulmonary function testing 
program.
    3. Provide technical assistance, if needed, related to the 
collection, review and/or analysis of data.
    4. Collaborate in the reporting and dissemination of research 
results and relevant health and safety education and training 
information.

Technical Reporting Requirements

    An original and two copies of semi-annual progress reports are 
required. 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.
    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.

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.
    The applicant should provide a detailed budget, with accompanying 
justification of all operating expenses, that is consistent with the 
stated objectives and planned activities of the project. CDC may not 
approve or fund all proposed activities. Applicants 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; described the services to be performed and provide an 
itemized breakdown and justification for the estimated cost of the 
contract; the kinds of organizations or parties to be selected; the 
period of performance; and the method of selection. Place 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.
    The applicant should provide a detailed description of first-year 
activities and briefly describe future-years objectives and activities.

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, specific activities to be

[[Page 31828]]

completed, and a time-line for completion 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 and the purpose of this cooperative agreement. 
This should include a draft protocol for the study. The protocol(s) 
should include:
    (a) A sampling strategy to insure that a representative sample of 
composting operations and technologies are included in the study, and
    (b) The sampling strategy should maximize the number of study sites 
and include a representative sample based on geographic considerations.
    2. (a) Describe clearly the objectives of this project, the steps 
to be taken in planning and implementing this project, and the 
respective responsibilities of the applicant for carrying out those 
steps.
    (b) Provide a proposed schedule for accomplishing each of the 
activities to be carried out in this project and a method of evaluating 
the accomplishments.
    3. Provide documentation of access to potential study sites with 
the sample characteristics specified, and provide documentation of 
management and labor representatives to participate in the intervention 
study.
    4. Document the applicant's expertise in the area of exposure and 
health assessment as they pertain to occupational safety and health.
    5. 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.
    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.)
    8. Provide a detailed budget which indicates: (a) anticipated costs 
for personnel, travel, communications, postage, equipment, supplies, 
etc., and (b) all sources of funds to meet those needs.

Evaluation Criteria

    Applications will be reviewed and evaluated according to the 
following criteria:

A. Background and Need (20%)

    Responsiveness to the purpose of this project, including the 
applicant's understanding of the objectives of the proposed cooperative 
agreement and the relevance of the proposal to the objectives.

B. Goals, Objectives and Methods (25%)

    1. The extent to which the proposed goals and objectives are 
clearly stated, time-phased, and measurable. The extent to which the 
methods are sufficiently detailed to allow assessment of whether the 
objectives can be achieved for the budget period. The extent to which a 
qualified plan is proposed that will help achieve the goals stated in 
the proposal.
    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 include the process 
of establishing partnerships with community(ies) and recognition of 
mutual benefits.

C. Strength of Programs (20%)

    Strength of the applicant's environmental and clinical research 
programs including a demonstrated ability in the conduct of 
occupational health studies involving organic dusts, gases, and 
respiratory health assessment.

D. Project Management and Staffing Plan (20%)

    Training and experience, qualifications, and time commitment of the 
project director, staff, and organization. This includes a Project 
director who is a distinguished scientist and technical expert and 
staff with the necessary training and experience sufficient to 
accomplish proposed project.

E. Experience/Expertise (10%)

    Applicant's knowledge/understanding and experience in the 
composting industry.

F. Facilities and Resources (5%)

    Efficiency of resources and novelty of program. This includes the 
efficient use of existing and proposed personnel with assurances of a 
major time commitment of the Project Director to the program and the 
novelty of program approach.

G. Human Subjects (Not Scored)

    Whether or not exempt from the DHHS regulations, are procedures 
adequate for 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.

H. 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

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets 
up a system for State and local government review of proposed Federal 
assistance applications. Applicants (other than federally recognized 
Indian tribal governments) should contact their State Single Point of 
Contact (SPOC) as early as possible to alert them to the prospective 
applications and receive any necessary instructions on the State 
process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC for each affected State. A 
current list of SPOCs is included in the application kit.
    If SPOCs have any State process recommendations on applications 
submitted to CDC, they should be sent to Victoria Sepe, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Centers

[[Page 31829]]

for Disease Control and Prevention (CDC), 255 East Paces Ferry Road, 
NE., Room 321, Atlanta, GA 30305, no later than September 1, 1997. The 
Program Announcement Number 738 and Program Title should be referenced 
on the document. The granting agency does not guarantee to 
``accommodate or explain'' State process recommendations it receives 
after that date.
    Indian tribes are strongly encouraged to request tribal government 
review of the proposed application. If tribal governments have any 
tribal process recommendations on applications submitted to CDC, they 
should forward them to: Victoria Sepe, Grants Management Specialist, 
Grants Management Branch, Centers for Disease Control and Prevention, 
255 East Paces Ferry Road, NE., Room 321, Mailstop E-13, Atlanta, GA 
30305. This should be done no later than September 1, 1997. The 
granting agency does not guarantee to ``accommodate or explain'' for 
tribal process recommendations it receives after that date.

Public Health System Reporting Requirements

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

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance Number for this program 
is 93.262.

Other Requirements

Paperwork Reduction Act

    Projects funded through the cooperative agreement mechanism of this 
program involving the collection of information from 10 or more 
individuals 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.

Women and Minority Inclusion Policy

    It is the policy of the Centers of Disease Control and Prevention 
(CDC) to ensure that women and racial and ethnic groups will be 
included in CDC 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, Alaskan 
Native, Asian, Pacific Islander, Black and Hispanic. Applicants shall 
ensure that women, racial and ethnic minority population are 
appropriately represented 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 the review of applications for scientific 
merit, review groups will evaluate proposed plans for inclusion of 
minorities and both sexes as part of the scientific assessment and 
assigned score. This policy does not apply to research studies when the 
investigator cannot control the race, ethnicity and/or sex of subjects. 
Further guidance on this policy is contained in the Federal Register, 
Vol. 60, No. 179, Friday, September 15, 1995, pages 47947-47951.

Application Submission and Deadline

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 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 1, 1997. The letter should identify Program Announcement 738 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 18, 1997.
    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 and will be returned to the 
applicants.

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 NIOSH Announcement 738. 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 738 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 Patrick 
Hintz, M.S., Division of Respiratory Disease Studies, National 
Institute for Occupational Safety and Health, Centers for Disease 
Control and Prevention (CDC), Mailstop P04/111, 1095 Willowdale Road, 
Morgantown, WV 26505-2888, telephone (304) 285-5744, Internet: 
[email protected].
    This and other CDC announcements are available through the CDC 
homepage

[[Page 31830]]

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) referenced in the Introduction 
section 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 for 
Occupational Safety and Health, Publications Office, 4676 Columbia 
Parkway, Cincinnati, OH 45226-1998 or telephone 1-800-356-4674, and 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

    Dated: June 4, 1997.
Diane D. Porter,
Acting Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention (CDC).
[FR Doc. 97-15180 Filed 6-10-97; 8:45 am]
BILLING CODE 4163-19-P