Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

Components of Participating Organizations

Center for Drug Evaluation and Research (CDER)

Funding Opportunity Title

The Use of Polyethylene Glycol in the Pediatric Population (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • June 5, 2014 - Notice of Termination of RFA-FD-14-002. See Notice NOT-FD-14-012.
  • February 24, 2014 - See Notice NOT-FD-14-004. Notice of Change to Application Due Date and Expiration Date.

Funding Opportunity Announcement (FOA) Number

RFA-FD-14-002

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103

Funding Opportunity Purpose

The purpose of the proposed study is to better understand the extent of pediatric absorption of low molecular weight species that may be found in PEG 3350 products (e.g., ethylene and diethylene glycol). PEG 3350 products are used in the treatment of constipation. These low molecular weight species may be absorbed by children taking PEG 3350 products, potentially leading to adverse events. This is an important first step needed to begin to understand if PEG 3350 use contributes to adverse events in children due to the absorption of these species. 

Key Dates
Posted Date

January 14, 2014

Open Date (Earliest Submission Date)

January 21, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

New Date March 14, 2014 per NOT-FD-14-004), Originally February 28, 2014, by 11:59 PM Eastern Time.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) before 11:59 p.m. Eastern Time on the application due date. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

April 2014

Advisory Council Review

Not Applicable

Earliest Start Date

June 2014

Expiration Date

Now June 6, 2014 per NOT-FD-14-002 (Previously extended to March 15, 2014 per NOT-FD-14-004), Originally March 1, 2014)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Background

Polyethylene glycol laxative is approved for over-the-counter use for occasional constipation in adults and children = 17 years of age, and is recommended for short term use up to seven days. Use in children less than 17 and chronic use is not approved by the FDA, but nevertheless the laxative is used as such in clinical practice.

Polyethylene glycol (PEG) is a long-chain polymer of ethylene oxide commercially available in molecular weights 300 g/mol to 10,000,000 g/mole.  PEG is an osmotic agent which retains water within stool and produces an osmotic diarrhea.  The designation PEG 3550 indicates the average molecular weight of that product and therefore includes a distribution of various molecular weights of PEG potentially including low levels of ethylene glycol, diethylene glycol and possibly other low molecular weight species.   PEG 3550 exists in a stable powder form.  Currently approved products instruct the patients to dissolve the PEG powder in a liquid and use immediately.  The approved products have been tested under these conditions and are stable. Ethylene glycol is a precursor for synthesis and a degradation product of PEG.  Ethylene glycol is known to be neurotoxic in children, and ethylene glycol poisoning causes metabolic acidosis with an increased anion gap.

The Food and Drug Administration has received a number of reports of adverse events in children taking PEG products. The Agency has conducted a review that documented a number of reports of neurological and psychiatric events associated with chronic PEG use in children. A number of these pediatric patients received an adult dose of PEG (17 grams) for a duration ranging from a few days to a couple of years. 

Whether the PEG contributes in some way to these adverse events is not clear at this time. One possible link between PEG use and adverse events in children is the absorption of LMW species leading to these outcomes. In addition, it may be possible that absorption of PEG in children is greater than in adults, especially in constipated patients.  Another possible etiology for these safety concerns is that PEG products may be degraded before ingestion if parents pre-mix the product and store in suspension form for a prolonged period.  Finally, some children may be more susceptible to the adverse effects of PEG, especially when high doses are given or after prolonged use.

To better understand the level of polyethylene glycol impurities in PEG, the FDA Chemistry and Manufacturing group evaluated PEG 3350.  This analysis of eight lots of PEG 3350 confirmed the presence of small amounts of ethylene glycol and diethylene glycol in all lots tested. Based upon the recommended daily adult dose of 17 mg daily dose PEG 3350, the maximum daily exposure of ethylene glycol would be 0.005 mg/kg/day for a 60 kg patient, or 0.015 mg/kg/day for a 20 kg pediatric patient (approx 5 years of age).   Other low molecular weight PEGs were not included in this analysis. However, it is not known if any of these LMW species are absorbed and if so to what extent. Understanding the human absorption profile of LMW species is the first step needed in trying to understand the possible contribution of PEG 3350 use to the development of adverse events in children using this product chronically.

Objectives

The purpose of the proposed study is to understand the potential exposure (extent of absorption) of the pediatric population to low molecular weight species, such as ethylene glycol and diethylene glycol, that may be found in PEG 3350 and that, may be absorbed by children taking this product chronically.

Detailed Description

All funded studies will be required to recruit children who are treated chronically with PEG 3350 and obtain serum samples for future analysis, to help understand the pharmacokinetics of these low molecular weight species in children.  The RFA seeks to obtain information to begin to adequately characterize whether and to what extent these LMW species are absorbed by children taking this product.

As part of the objectives of this RFA, a high-quality study would entail a recruitment of a minimum of 50 children and adolescents aged of 0-17 years, with chronic constipation who are already taking PEG 3350 on a chronic basis as prescribed by their physician.  Patients should be stratified by age from 0-6, 6-12 and 12-17 years, with an emphasis on the younger age children.  These children may or may not have other underlying disorders or be on other medications. Consent/assent will need to be obtained from the children and their parents.  Clinical information including the indication for PEG 3350 use, dosage and duration of use, a description of underlying disease(s) and other medication(s) as well as age and weight of the child should also be obtained.  A description of any adverse events especially those related to neuropsychiatric events should also be collected, if present.  Serum samples (and the timing of the last dose prior to the blood draw) for subsequent analysis for the presence of these LMW species such as ethylene and diethylene glycol will also need to be obtained.  This information is critical for understanding if these species may be contributing in any way to adverse events seen in some children taking PEG 3350 chronically.  These samples will need to be stored appropriately until they can be provided to the FDA laboratory for further analysis.  This information specifically related to the potential for absorption of LMW species has heretofore not been collected and is the first step needed to begin to understand if PEG 3350 use contributes to adverse events in children due to the absorption of these species.  At the end of the study, data analysis and a clinical study report should be provided to the Agency.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

FDA/CDER intends to fund up to $225,000 to this grant program for fiscal year 2014.  

It is anticipated that up to one award will be made, not to exceed $225,000 in total costs (direct plus indirect) per award.

Award Budget

Awards are contingent upon the availability of funds.  Budgets should not exceed $225,000 in total costs.

Award Project Period

Maximum project period is one (1) year.

FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

 
Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are  eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

FDA will not accept any application that is essentially the same as one already reviewed within the past twelve months, except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission.  This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA’s electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

No awardee or performance site institution may spend funds on human subject research or enroll subjects until documentation of IRB approval for the IRB of record is on file with the FDA grants management office.

Additional funding restrictions may be part of the Notice of Award.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA.  Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? 

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel concepts, approaches or methodologies, instrumentation, or interventions?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? 

If the project involves human subjects and/or FDA-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

Not applicable

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications determined to be complete and responsive will undergo an objective review process.  An objective review panel will evaluate complete and responsive applications, using the stated review criteria.

As part of the objective review process, all applications:

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the HHS Grants Policy Statement.

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

Additional terms and conditions regarding FDA/CDER regulatory and Programmatic requirements may be part the Notice of Award.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the HHS Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the HHS Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

Scientific/Research Contact(s)

Lucie Yang
Food and Drug Administration/Center for Drug Evaluation and Research
Telephone: 301-796-5112
Email: Lucie.Yang@fda.hhs.gov

Objective Review Contact(s)

Lisa Ko
Food and Drug Administration
Office of Acquisition & Grants Services (OAGS)
Telephone: 301-827-5095
Email:  Lisa.Ko@fda.hhs.gov

Financial/Grants Management Contact(s)

Lisa Ko
Food and Drug Administration
Office of Acquisition & Grants Services (OAGS)
Telephone: 301-827-5095
Email: Lisa.Ko@fda.hhs.gov

Section VIII. Other Information

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

Consistent with the property management requirements of 45 CFR Sections 74.36 and 92.34, FDA/CDER reserves a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use work that was developed for Federal purposes, and to authorize others to do so.


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