|
The Food
and Drug Administration (FDA) has regulations that govern human subject
protection aspects of research on products regulated by the Agency. In
addition, other federal agencies and departments and some States have
regulations that govern human subject protection. Each IRB/institution should
be familiar with the laws and regulations that apply to research reviewed by
the IRB. This checklist was developed to help IRBs/institutions evaluate
procedures for the protection of human subjects of research.
Successful
IRBs make use of written procedures that, in one way or another, cover a
common core of topics. This checklist is an effort to present these topics in
a systematic way. Written procedures for some of the items are not
specifically required by FDA regulations (e.g., policy regarding place and
time of meeting) but are appropriate to consider when comprehensive
procedures are being developed.
Once an
IRB/institution establishes its structure and procedures, those procedures
should be followed. FDA inspections assess compliance with both the
regulatory requirements and the IRB/institution's own written procedures.
Since the written procedures should reflect the current processes, the
written procedures should be reviewed on a regular basis and updated as necessary
to remain current. FDA believes that when good procedures are developed,
written, and followed, the rights and welfare of the subjects of research are
more likely to be adequately protected.
Tips
on checklist use:
Three "response" columns are
provided -- "Yes," "No," and N/A." A "Yes"
means that the institution has a
written policy/procedure and that it is current. A "No" may mean that a policy/procedure is lacking or
needs to be updated. The
"N/A" column indicates that a topic is not applicable or a
procedure is not needed by the IRB.
The columns may be completed by checking
the appropriate box. Instead of a
check-mark, some IRBs record the date of issuance or revision date.
Others have found it useful to
record the policy/procedure number on the form. Any "No" responses indicate a need to write/revise
policies and/or procedures.
FOOTNOTED items are referenced in the FDA
regulations. ASTERISKED items are those for which WRITTEN PROCEDURES are
specifically required by the FDA regulations.
DOES
THE INSTITUTION HAVE WRITTEN POLICIES OR PROCEDURES THAT DESCRIBE:
|
YES
NO N/A
|
|
|
___
___ ___
|
I. THE INSTITUTIONAL AUTHORITY UNDER
WHICH THE IRB IS ESTABLISHED AND EMPOWERED. ¾
|
|
___ ___
___
|
II.
THE DEFINITION OF THE PURPOSE OF THE IRB, i.e., THE PROTECTION OF HUMAN
SUBJECTS OF RESEARCH.„
|
|
___ ___
___
|
III.
THE PRINCIPLES WHICH GOVERN THE IRB IN ASSURING THAT THE RIGHTS AND WELFARE
OF SUBJECTS ARE PROTECTED.
|
|
|
IV. THE AUTHORITY OF THE IRB.
|
|
___ ___
___
|
A.
The scope of authority is defined, i.e., what types of studies must be
reviewed.
|
|
___ ___
___
|
B.
Authority to disapprove, modify or approve studies based upon consideration
of human subject protection aspects.4
|
|
___ ___
___
|
*
C. Authority to require progress reports from the investigators and oversee
the conduct of the study.5
|
|
___ ___
___
|
*
D. Authority to suspend or terminate approval of a study.6
|
|
___ ___
___
|
*E.
Authority to place restrictions on a study.7
|
|
|
V. THE IRB'S RELATIONSHIP TO
|
|
___ ___
___
|
A.
The top administration of the institution.
|
|
___ ___
___
|
B.
The other committees and department chairpersons within the institution.
|
|
___ ___
___
|
C.
The research investigators.
|
|
___ ___
___
|
D.
Other institutions.
|
|
___ ___
___
|
E. Regulatory agencies.
|
|
|
|
|
|
VI. THE MEMBERSHIP OF THE IRB.
|
|
___ ___
___
|
A.
Number of members.8
|
|
___ ___
___
|
B.
Qualification of members.9
|
|
___ ___
___
|
C.
Diversity of members10(for example, representation from
the community, and minority groups), including representation by:
|
|
___ ___
___
|
--both
men and women11
|
|
___ ___
___
|
--
multiple professions12
|
|
___ ___
___
|
-- scientific and non-scientific
member(s)13
|
|
___ ___
___
|
-- not otherwise affiliated member(s)14
|
|
___ ___
___
|
D.
Alternate members (if used).
|
|
|
|
|
|
VII. MANAGEMENT OF THE IRB.
|
|
___ ___
___
|
A.
The Chairperson
|
|
___ ___
___
|
--
selection and appointment
|
|
___ ___
___
|
--
length of term/service
|
|
___ ___
___
|
--
duties
|
|
___ ___
___
|
--
removal
|
|
|
B.
The IRB Members.
|
|
___ ___
___
|
--
selection and appointment
|
|
___ ___
___
|
--
length of term/service and description of staggered rotation or overlapping
of terms, if used
|
|
___ ___
___
|
--
duties
|
|
___ ___
___
|
--
attendance requirements
|
|
___ ___
___
|
--removal
|
|
___ ___
___
|
C.
Training of IRB Chair and members
|
|
___ ___
___
|
--
orientation
|
|
___ ___
___
|
--
continuing education
|
|
___ ___
___
|
--
reference materials (IRB library)
|
|
___ ___
___
|
D.
Compensation of IRB members.
|
|
___ ___
___
|
E.
Liability coverage for IRB members.
|
|
___ ___
___
|
F.
Use of consultants.15
|
|
___ ___
___
|
G.
Secretarial/administrative support staff (duties).
|
|
___ ___
___
|
H.
Resources (for example, meeting area, filing space, reproduction equipment,
computers).
|
|
___ ___
___
|
I.
Conflict of interest policy
|
|
___ ___
___
|
--
no selection of IRB members by investigators
|
|
___ ___
___
|
--
prohibition of participation in IRB deliberations and voting by
investigators.16
|
|
|
VIII. FUNCTIONS OF THE IRB.
|
|
___ ___
___
|
*
A. Conducting initial and continuing review.17
|
|
___ ___
___
|
*
B. Reporting, in writing, findings and actions of the IRB to the
investigator and the institution.18
|
|
___ ___
___
|
*
C. Determining which studies require review more often than annually.19
|
|
___ ___
___
|
*
D. Determining which studies need verification from sources other than the
investigators that no material changes have occurred since previous IRB
review.20
|
|
___ ___
___
|
E.
Ensuring prompt reporting to the IRB of changes in research activities. 21
|
|
___ ___
___
|
*
F. Ensuring that changes in approved research are not initiated without IRB
review and approval except where necessary to eliminate apparent immediate
hazards. 22
|
|
___ ___
___
|
G.
Ensuring prompt reporting to the IRB, appropriate institutional officials,
and the FDA of:
|
|
___ ___
___
|
*
-- unanticipated problems involving risks to subjects or others23
|
|
___ ___
___
|
*
-- serious or continuing noncompliance with 21 CFR parts 50 and 56 or the
requirements of the IRB24
|
|
___ ___
___
|
*
-- suspension or termination of IRB approval.25
|
|
|
|
|
___ ___
___
|
H.
Determining which device studies pose significant or non-significant risk.
|
|
|
|
|
|
IX. OPERATIONS OF THE IRB.
|
|
___ ___
___
|
*
A. Scheduling of meetings. 26
|
|
___ ___
___
|
B.
Pre-meeting distribution to members, of, for example, place and time of
meeting, agenda, and study material to be reviewed.
|
|
___ ___
___
|
C.
The review process
|
|
___ ___
___
|
*
-- description of the process ensuring that 27
|
|
___ ___
___
|
1) all members receive complete study documentation for review
(see XI.B);
|
|
|
or
|
|
___ ___
___
|
2) one or more "primary reviewers"/"secondary
reviewers" receives the complete study documentation for review,
reports to IRB and leads discussion; if other members review summary
information only, these members must have access to complete study documentation
|
|
___ ___
___
|
--
role of any subcommittees of the IRB
|
|
___ ___
___
|
*
-- emergency use notification and reporting procedures 28
|
|
___ ___
___
|
*
-- expedited review procedure 29
|
|
___ ___ ___
|
--
for approval of studies that are both minimal risk and on the FDA approved list (see Appendix
A)
|
|
___ ___
___
|
--
for approval of modifications to ongoing studies involving no more than minimal
risk
|
|
___ ___
___
|
D.
Criteria for IRB approval contain all requirements of 21 CFR
56.111.
|
|
___ ___
___
|
E.
Voting requirements 30
|
|
___ ___
___
|
--
quorum required to transact business
|
|
___ ___
___
|
--
diversity requirements of quorum (for example requiring at least one
physician member when reviewing studies of FDA regulated articles)
|
|
___ ___
___
|
--
percent needed to approve or disapprove a study
|
|
___ ___
___
|
--
full voting rights of all reviewing members
|
|
___ ___
___
|
--
no proxy votes (written or telephone)
|
|
___ ___
___
|
--
prohibition against conflict-of-interest voting
|
|
___ ___
___
|
F.
Further review/approval of IRB actions by others within the institution.
(Override of disapprovals is prohibited.)31
|
|
___ ___
___
|
G.
Communication from the IRB.
|
|
___ ___
___
|
*
- to the investigator for additional information 32
|
|
___ ___
___
|
*
- to the investigator conveying IRB decision 33
|
|
___ ___
___
|
*
- to institution administration conveying IRB decision 34
|
|
___ ___
___
|
_-
to sponsor of research conveying IRB decision
|
|
___ ___
___
|
H.
Appeal of IRB decisions.
|
|
___ ___
___
|
-
criteria for appeal
|
|
___ ___
___
|
-
to whom appeal is addressed
|
|
___ ___
___
|
-
how appeal is resolved (Override of IRB disapprovals by external
body/official is prohibited.) 35
|
|
|
|
|
|
X. IRB RECORD REQUIREMENTS.
|
|
___ ___
___
|
A.
IRB membership roster showing qualifications 36
|
|
___ ___
___
|
*
B. Written procedures and guidelines. 37
|
|
___ ___
___
|
C.
Minutes of meetings. 38
|
|
___ ___
___
|
-
members present (any consultants/ guests/others shown separately)
|
|
___ ___
___
|
-
summary of discussion on debated issues - record of IRB decisions
|
|
___ ___
___
|
-
record of voting (showing votes for, against and abstentions)
|
|
___ ___
___
|
D.
Retention of protocols reviewed and approved consent documents 39
|
|
___ ___
___
|
E.
Communications to and from the IRB.40
|
|
___ ___
___
|
*
F. 1) Adverse reactions reports, and 41
|
|
___ ___
___
|
2)
documentation that the IRB reviews such reports.
|
|
___ ___
___
|
_H.
Records of continuing review.42
|
|
___ ___
___
|
I.
Record retention requirements. (at least 3 years after completion for FDA
studies)
43
|
|
___ ___
___
|
J.
Budget and accounting records.
|
|
___ ___
___
|
K.
Emergency use reports. 44
|
|
___ ___
___
|
_L.
Statements of significant new findings provided to subjects.45
|
|
|
|
|
|
XI. INFORMATION THE INVESTIGATOR PROVIDES TO
THE IRB.
|
|
___ ___
___
|
A.
Professional qualifications to do the research (including a description of
necessary support services and facilities).
|
|
___ ___
___
|
B.
Study protocol which includes/addresses 46
|
|
___ ___
___
|
-
title of the study.
|
|
___ ___
___
|
-
purpose of the study (including the expected benefits obtained by doing the
study).
|
|
___ ___
___
|
-
sponsor of the study.
|
|
___ ___
___
|
-
results of previous related research.
|
|
___ ___
___
|
-
subject inclusion/exclusion criteria.
|
|
___ ___
___
|
-
justification for use of any special/vulnerable subject populations (for
example, the decisionally impaired, children)
|
|
___ ___
___
|
-
study design (including as needed, a discussion of the appropriateness of
research methods).
|
|
___ ___
___
|
-
description of procedures to be performed.
|
|
___ ___
___
|
-
provisions for managing adverse reactions
|
|
___ ___
___
|
-
the circumstances surrounding consent procedure, including setting, subject
autonomy concerns, language difficulties, vulnerable populations
|
|
___ ___
___
|
-
the procedures for documentation of informed consent, including any procedures
for obtaining assent from minors, using witnesses, translators and document
storage.
|
|
___ ___
___
|
-
compensation to subjects for their participation.
|
|
___ ___
___
|
-
any compensation for injured research subjects.
|
|
___ ___
___
|
-
provisions for protection of subject's privacy.
|
|
___ ___
___
|
-
extra costs to subjects for their participation in the study.
|
|
___ ___
___
|
-
extra costs to third party payers because of subject's participation.
|
|
___ ___
___
|
C.
Investigator's Brochure (when one exists) 47
|
|
___ ___
___
|
D.
The case report form (when one exists)
|
|
___ ___
___
|
E.
The proposed informed consent document 48.
|
|
___ ___
___
|
-
containing all requirements of 21 CFR 50.25(a)
|
|
___ ___
___
|
-
containing requirements of 21 CFR 50.25(b) that are appropriate to
the study.
|
|
___ ___
___
|
-
meeting all requirements of 21 CFR 50.20
|
|
___ ___
___
|
-
translated consent documents, as necessary, considering likely subject
population(s)
|
|
___ ___
___
|
*
F. Requests for changes in study after initiation.49
|
|
___ ___
___
|
*
G. Reports of unexpected adverse events.50
|
|
___ ___
___
|
*
H. Progress reports.51
|
|
___ ___
___
|
I.
Final report.
|
|
___ ___
___
|
J.
Institutional forms/reports
|
|
|
|
|
___ ___
___
|
XII. EXEMPTION FROM PROSPECTIVE IRB REVIEW52
|
|
___ ___
___
|
*
A. Notify IRB within 5 working days 53
|
|
___ ___
___
|
B.
Emergency use 54
|
|
___ ___
___
|
C.
Review protocol and consent when subsequent use is anticipated. 55
|
|
|
XIII. EMERGENCY RESEARCH CONSENT EXCEPTION56
|
|
___ ___
___
|
A.
The IRB may find that the 50.24 requirements are met 57
|
|
___ ___
___
|
B.
The IRB shall promptly notify in writing the investigator and the sponsor
when it determines it cannot approve a 50.24 study 58
|
|
___ ___
___
|
C.
The IRB shall provide in writing to the sponsor a copy of the information
that has been publically disclosed under 50.24(a)(7)(ii) and (a)(7)(iii) 59
|
|
___ ___
___
|
D.
In order to approve an emergency research consent waiver study, the IRB
must find and document:
|
|
___ ___
___
|
(1)
subjects are in a life-threatening situation, available treatments unproven
or unsatisfactory and collection of scientific evidence is necessary 60
|
|
___ ___
___
|
(2)
Obtaining informed consent is not feasible because:61
-
medical condition precludes consent 62
|
|
___ ___
___
|
-
no time to get consent from legally authorized
representative 63
|
|
___ ___
___
|
-
prospective identity of likely subjects not reasonable 64
|
|
|
(3)
Prospect of direct benefits to study subjects because:65
|
|
___ ___
___
|
-
life-threatening situation that necessitates treatment
|
|
___ ___
___
|
-
data support potential for direct benefit to individual subjects
|
|
___ ___
___
|
-
risk/benefit of both standard and proposed treatments reasonable
|
|
___ ___
___
|
(4)
waiver needed to carry out study
|
|
___ ___
___
|
(5)
plan defines therapeutic window, during which investigator will seek consent
rather than starting without consent. Summary of efforts will be given to
IRB at time of continuing review.
|
|
___ ___
___
|
(6)
IRB reviews and approves consent procedures and document. IRB reviews and
approves family member objection procedures
|
|
|
(7)
Additional protections, including at least:
|
|
___ ___
___
|
-
consultation with community representatives
|
|
___ ___
___
|
-
public disclosure of plans, risks and expected benefits
|
|
___ ___
___
|
-
public disclosure of study results
|
|
___ ___
___
|
-
assure an independent Data Monitoring Committee established
|
|
___ ___
___
|
-
objection of family member summarized for continuing review
|
|
___ ___
___
|
(8)
Ensure procedures in place to inform at earliest feasible opportunity of
subject's inclusion in the study, participation may be discontinued.
Procedures to inform family the subject was in the study if subject dies.
|
|
___ ___
___
|
(9)
Separate IND or IDE required, even for marketed products.
|
|
___ ___
___
|
(10)
IRB disapproval must be documented in writing and sent to the clinical
investigator and the sponsor of the clinical investigation. Sponsor must
promptly disclose to FDA, other investigators and other IRBs.
|
_____
¾ 21 CFR56.109(a)
,,21 CFR 56.101(a)
4 21 CFR 56.109(a)
5 21 CFR 56.108(a)(1) and 56.109(f)
621 CFR 56.108(b)(3) and 56.113
721 CFR 56.108(a)(1), 56.109(a) and 56.113
821 CFR 56.107(a)
921 CFR 56.107(a)
1021 CFR 56.107(a)
1121
CFR 56.107(b) Only requires every
nondiscriminatory effort
1221
CFR56.107(a)
1321
CFR 56.107(c)
1421 CFR 56.107(d)
1521 CFR 56.107(f) Consultant use not required
by FDA regulation.
1621 CFR 56.107(e)
1721 CFR 56.108(a)(1) and 56.109(a - f)
1821 CFR 56.108(a)(1) and 56.109(e)
1921 CFR 56.108(a)(2) and 56.109(f)
2021 CFR 56.108(a)(2)
2121 CFR 56.108(a)(3)
2221 CFR 56.108(a)(4) and 56.115(a)(1)
2321 CFR 56.108(b)(1) and 56.115(a)(1)
2421 CFR 56.108(b)(2)
2521 CFR 56.108(b)(3) and 56.113
2621 CFR 56.108(a)(1)
2721CFR56.108(a)(1)
2821 CFR 56.104(c), 56.108(a)(1) and 108(b)(1)
2921 CFR 56.108(a)(1) and 56.110(a - c) not required if IRB does
not use expedited procedures
3021 CFR 56.108(c) and 56.107(e - f)
3121 CFR 56.112
3221 CFR 56.108(a)(1), 56.109(a) and 56.115(a)(4)
3321 CFR 56.108(a)(1) and 56.109(e)
3421 CFR 56.108(a)(1) and 56.109(e)
3521 CFR 56.112
3621 CFR 56.115(a)(5)
3721 CFR 56.108(a - b) and 56.115(a)(6)
3821 CFR 56.115(a)(2)
3921 CFR 56.115(a)(1)
4021 CFR 56.115(a)(4)
4121 CFR 56.108(a) and 56.115(a)(1 and 4)
4221 CFR 56.115(a)(3)
4321 CFR 56.115(b)
4421 CFR 56.115(a)(4) and 56.104(c)
4521 CFR 56.115(a)(7)
4621 CFR 56.103(a) and 56.115(a)(1)
4721 CFR 56.111 (a)(2), 56.115(a)(1) and 21 CFR 312.55
4821 CFR 56.111(a)(4 - 5) and 56.111(a)(1)
4921
CFR 56.108(a)(4) and 56.115(a)(3 - 4)
5021 CFR 56.108(b)(1), 56.115(a)(3 - 4), 56.115(a)(1) and 56.113
5121 CFR 56.108(a)(1) and 56.115(a)(1, 3 and 4)
52Not
required when the scope of studies reviewed by the IRB does not include serious
and life-threatening diseases or conditions.
5321 CFR 56.104(c) and 56.108(a)(3)
5421 CFR 56.102(d) and 56.108(a)(3)
5521 CFR 56.104(c) and 56.108(a)(3) The IRB may determine that
a rapid means of approval is preferable to a preapproved protocol and
consent. Also see information sheet: "Emergency
Use of a Drug or Biologic."
5621 CFR 50.24 The
IRB/institituion may determine that research in emergent settings will not be
conducted or supported. When that is the case, written procedures for this
section need not be prepared.
5721 CFR 56.109(c)(2)
5821 CFR 56.109(e) The written statement shall
include a statement of the reasons for the IRB's determination.
5921 CFR 56.109(g)
6021 CFR 50.24(a)(1)
6121 CFR 50.24(a)(2)
6221
CFR 50.24(a)(2)(i)
6321 CFR 50.24(a)(2)(ii)
6421 CFR 50.24(a)(2)(iii)
6521 CFR 50.24(a)(3)
6621 CFR 50.24(a)(3)(i)
6721 CFR 50.24(a)(3)(ii)
6821 CFR 50.24(a)(3)(iii)
6921 CFR 50.24(a)(4)
7021 CFR 50.24(a)(5)
7121 CFR 50.24(a)(6) Family
member objection procedures at 50.24 (a)(7)(v)
7221 CFR 50.24(a)(7)
7321 CFR 50.24(a)(7)(i)
7421 CFR 50.24(a)(7)(ii)
7521 CFR 50.24(a)(7)(iii)
7621 CFR 50.24(a)(7)(iv)
7721 CFR 50.24(a)(7)(v)
7821 CFR 50.24(b)
7921 CFR 50.24(d) The study may
not begin until FDA approves the separate IND/IDE.
8021 CFR 50.24(e)
INFORMATION SHEETS
Guidance for Institutional Review Boards and Clinical Investigators
1998 Update
APPENDIX
I
FDA
District Offices
Food and
Drug Administration (FDA) District Offices are located throughout the
country. IRB and other inspections are conducted by FDA District Office
personnel. Problems or questions related to FDA regulated products or IRB
inspections may be directed to the Director of the Investigations Branch
(unless otherwise indicted), or the Bioresearch Monitoring Program
Coordinator, in the
appropriate
District Office.
District States
Served
ATLANTA
District
60 Eighth
Street, N.E.
Atlanta,
Georgia 30309
(404) 347-
3218 Georgia,
North Carolina, South Carolina
BALTIMORE
District
900
Madison Avenue
Baltimore,
Maryland 21201-2199
(410) 962-
3590 District
of Columbia, Maryland, Virginia, West Virginia
NEW
ENGLAND District
One
Montvale Avenue
Stoneham,
Massachusetts 02180
(617)
279-1675, EXT 128 Connecticut,
Maine, Massachusetts, New Hampshire,
Rhode Island, Vermont
BUFFALO
District
599
Delaware Avenue
Buffalo,
New York 14202
(716)
551-4461 New
York (except New York City, Long Island)
CHICAGO
District
300 S.
Riverside Plaza 5th Floor, Suite 550
South
Chicago, Illinois 60606
(312)
353-5863 EXT 132 Illinois
CINCINNATI
District
1141
Central Parkway
Cincinnati,
Ohio 45202-1097
(513)
684-3501 EXT 130 Ohio,
Kentucky
DALLAS
District
3310 Live
Oak St.
Dallas,
Texas 75204
(214)
655-5310 EXT 504 Arkansas,
Oklahoma, Texas
DENVER
District
P.O. Box
25087
6th and
Kipling Sts.
Denver
Federal Center
Denver,
Colorado 80225-0087
(303)
236-3051 Colorado,
New Mexico, Utah
DETROIT
District
1560 East
Jefferson
Detroit
Michigan 48207-3179
(313) 226-
6260 Indiana,
Michigan
FLORIDA
District
555
Winderley Place
Maitland,
Florida 32751
(407)
475-4700 Florida
KANSAS
CITY District
11630 West
80th St.
Lenexa,
Kansas 66285-5905
(913)
752-2423 Iowa,
Kansas, Missouri, Nebraska
LOS
ANGELES District
19900
MacArthur Blvd., Suite 300
Irvine,
California 92612-2445
(714)
798-7769 Arizona,
California (southern)
MINNEAPOLIS
District
240
Hennepin Avenue
Minneapolis,
Minnesota 55401-1912
(612)
334-4100 EXT 162 Minnesota,
Wisconsin, North Dakota, South Dakota,
NASHVILLE
District
297 Plus
Park Boulevard
Nashville,
Tennessee 37217
(615) 781-
5378 Alabama,
Tennessee
NEW JERSEY
District
Waterview
Corp. Center
10
Waterway Bend, 3rd Floor
Parsippany,
New Jersey 07054
(201)
526-6000 New
Jersey
NEW
ORLEANS District
4298
Elysian Fields Avenue
New
Orleans, Louisiana 70122
(504)
589-6344 Louisiana,
Mississippi
NEW YORK District
850 Third
Avenue
Brooklyn,
New York 11232-1593
(718)340-7000 New York
City, Long Island
PHILADELPHIA
District
2nd and
Chestnut Streets
Room 900
Philadelphia,
Pennsylvania 19106
(215)
597-4390 Delaware,
Pennsylvania
SEATTLE
District
22201 23rd
Drive S.E.
P.O. Box
3012
Bothell,
Washington 98041-3012
(206)
483-4941 Alaska,
Idaho, Oregon, Montana, Washington
SAN
FRANCISCO District
1431
Harbor Bay Parkway
Alameda,
California 94502-7070
(510)
337-6733 California
(northern), Hawaii, Nevada, American Samoa,
Guam, Pacific Trust Territory
SAN JUAN
District
#466
Fernandez Juncos Avenue
Stop 8 1/2
San Juan,
Puerto Rico 00901-3223
(809) 729-
6608 Puerto
Rico
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