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Appendix A: Medical Gas Partnership Agreement
I. PURPOSE AND GOALS
This Partnership Agreement (Agreement) establishes a cooperative program
between two entities (individually a Party -- collectively the Parties):
The Food and Drug Administration (FDA) _____________________________
(District)
AND
The _______________________ (the State Agency) in the State of _________
(the State). 1
The Agreement sets forth working arrangements between the Parties for:
regulatory planning; inspections; compliance and emergency response activities;
information sharing; and training, including an agreement on the number
of medical gas inspections to be conducted by the State Agency.
Through joint planning and coordination of efforts, the Parties seek
to enhance overall consumer protection while reducing duplicative effort
and achieving more efficient use of combined resources.
II. BACKGROUND
The Parties have entered into this Agreement in mutual recognition of
the need to: conserve resources; more effectively and efficiently
use personnel and equipment; exchange information of mutual interest
in a timely manner and according to law; and to the extent practicable,
reduce duplicative inspectional and regulatory efforts in times of restricted
resources. It is understood that each Party will continue to exercise
its own jurisdictional authorities and enforcement discretion, and that
the cooperation the Parties extend to one another does not include transfer
of any jurisdictional authority or responsibilities.
III. PROGRAM COMPONENTS AND ACTIVITIES
- Joint Planning
- The Parties will hold an annual planning meeting to assess coordination
efforts and determine whether any adjustments may be appropriate. In
addition to any other agenda items, these meetings, will include
an update by each Party on its general inspection programs and
on any changes of laws or policies that might affect implementation
of the Agreement, and a determination of which establishments each
Party will inspect over the next twelve month period. Examples
of additional topics of discussion include: the Parties' respective
sampling programs for medical gas products; sampling to be initiated
during the next twelve month period; and training needs.
- Joint Inspections
- FDA and the State Agency will notify each other prior to conducting
any inspection related to a medical gas product in the jurisdiction
of the State Agency. The State Agency will advise FDA if
it wishes to accompany FDA on any such FDA inspections and FDA
will do the same for such inspections by the State Agency. Implementation
of such joint inspections will depend on the availability of personnel
and the lead Party's priorities.
- Compliance Activities
- The State Agency agrees to inspect at least ___ % or ______
(number of facilities) of the medical gas facilities within its
jurisdiction each year. During the annual planning meeting,
the FDA and the State Agency will select facilities to inspect
in accordance with any inspection priorities agreed upon by the
Parties.
- Information Exchange
- In addition to any information the State Agency otherwise provides
to FDA under this Agreement, the State Agency will provide
to FDA the following documents annually or on such other schedule(s)
as the Parties may agree upon in writing:
- Copies of any letters or notices issued by the State Agency
to detain or embargo any medical gas product(s);
- Licensing and registration notices issued by the State
Agency, including notices of proposed or actual revocation
or suspension of licenses or registrations, for medical gas
products and facilities;
- Notification of all litigation concerning medical gases
to which the State Agency is a party;
- Correspondence by or to the State Agency addressing regulatory
matters issued to, received from, or expressly addressing any
medical gas product manufacturers, fillers, transfillers, cascaders,
transferors, wholesalers, or distributors;
- Any letters or other notices from the State Agency to a
medical gas facility concerning violations; and
- Notification of all other regulatory actions, including
announcements or applications of new regulatory interpretations
specifically addressing medical gases. This notification
may be achieved by providing copies of annual summaries and
individual reports by the State Agency discussing the specific
action.
- In addition to any information FDA otherwise provides
to the State Agency under this Agreement, FDA will provide to the
State Agency annually, or on such other schedule(s) as the Parties
may agree in writing, the following documents specifically addressing
medical gas facilities, or the medical gas products of facilities,
in the jurisdiction of the State Agency:
- Copies of Warning or untitled letters issued by FDA;
- Notices issued by FDA of administrative sanctions, such
as citations and Section 305 Meetings;
- Complaints filed by or against FDA; and
- Notification of all litigation to which FDA is a Party
concerning such medical gas facilities..
- Both Parties agree to work toward greater use of electronic
("paperless") means to exchange and share information.
- Disasters
- Each Party will provide, upon request, names, titles, and telephone
numbers of disaster and back-up coordinators. In the event of a
disaster, such as a flood, hurricane, fire, common carrier accident,
or chemical spill, affecting medical gas facilities or products
within the jurisdiction of the State Agency, each Party may request
assistance from the other.
- Recalls
- Each Party will provide to the other information concerning recalls
or product corrections for medical gas products. Such notification
will generally be made through the
Federal-State electronic communication system.
- Training
- Training may be requested by either Party with the understanding
that the ability to fulfill such a request will depend on the availability
of personnel and resources as well as priorities of the responding
Party. Training
courses by FDA or any other training needs will be addressed in
the annual planning report and/or meeting. Partnership funds
provided to the FDA District may be used to support training activities.
- Exchange of Inspectional Information
- The Parties will exchange Official Establishment Inventories
or other appropriate lists of medical gas facilities and cover
sheets or summaries of inspection reports addressing medical gas
facilities, or the medical gas products of facilities, in the jurisdiction
of the State Agency. Each
Party will provide full inspection reports upon request to the
other Party to reduce duplication of effort.
- Complaints
- The Parties will endeavor to notify each other and coordinate
their investigations of consumer and industry complaints consisting
of reports of real and/or potential personal injury or deaths related
to medical gases. For any reports of a death or injury, the
parties should notify each other within 24 hours of receiving the
report; all other reports should be shared annually.
- Confidentiality
- Any information released to either Party
is provided for the sole purpose of furthering the investigatory
functions and cooperative law enforcement and regulatory efforts
of the Parties. The
Parties understand that some of the information each receives from
the other may be information exempt from public disclosure under
Federal laws and regulations -- non-public information such as: confidential
commercial information; trade secret information that the Parties
will share only as permitted by law; personal privacy information;
law enforcement information; or internal, pre-decisional information.
- Before obtaining any non-public information from FDA under
this Agreement, the State Agency must provide FDA with a confidentiality
commitment satisfying the requirements of 21 C.F.R. 20.88(d) ("20.88
Confidentiality Commitment"). If an employee of the State
Agency is commissioned by FDA in accordance with 21 U.S.C. 372(a) receives
Non-public Information from FDA, or under the authority of FDA but not
under the authority of the State Agency, that individual may not share
any such information with the State Agency unless the information falls
within the scope of a 20.88 Confidentiality Commitment. To the
extent that the terms of a 20.88 Confidentiality Commitment conflict
with those of this section of this Agreement, the terms of the 20.88
Confidentiality Commitment will prevail.
- Each Party agrees not to publicly disclose non-public information
provided by the other Party without the prior written authorization of
the sharing Party or a prior written statement from the sharing Party
that the information no longer has non-public status. Public disclosure
includes, but is not limited to, sharing of information with other State
agencies and introduction of information in court without a protective
order.
- The receiving Party will inform the sharing Party immediately
of any effort made to obtain the sharing Party’s non-public information
from the receiving Party by and/or through a court or other government
body of competent jurisdiction. If such a body orders disclosure
of the sharing Party’s non-public information, the receiving Party
will take appropriate measures within its control in an effort to ensure
that the information will be disclosed in a manner that protects the
information from public disclosure.
- Any other provisions of this Agreement notwithstanding,
FDA will not provide the State Agency access to any document or
information to the extent that providing such access would place
the FDA in breach of 18 U.S.C. sec. 1905 (Trade Secrets Act), 5
U.S.C. sec. 552a (Privacy Act), 21 U.S.C. sec. 331(j) (Federal
Food, Drug, and Cosmetic Act), FDA regulations, or any other Federal
law or regulation.
- Funding
- Each Party is responsible for funding its own inspection and
enforcement activities under this Agreement. FDA partnership
funds, if available, may be used to support training, travel to
meetings, or equipment for the State Agency.
IV. NAME AND ADDRESS OF PARTICIPATING PARTIES
V. LIAISON OFFICERS
VI. ASSESSMENT MECHANISMS
This Agreement will be effective for one year from the date of signature
by the later Party to sign it. At the end of that year and, annually
thereafter as long as the Agreement remains in force, the Parties will
evaluate the effectiveness of the Agreement in meeting their goals and
may amend the Agreement, continue it as written, or dissolve the Agreement
by mutual consent. In addition, at any time, the Parties may modify
or terminate the Agreement by mutual written consent, and either Party
may terminate the Agreement by means of a written notice of termination.
VII. SIGNATURES OF RESPONSIBLE PARTIES
APPROVED AND ACCEPTED FOR THE STATE OF ____________________
By: _____________________________________________
Title: ____________________________________________
Date: ____________________________________________
APPROVED AND ACCEPTED FOR THE U.S. FOOD & DRUG ADMINISTRATION
By: ______________________________________________
Title: _____________________________________________
Date: _____________________________________________
1. For purposes
of this Agreement, the term "State" means any of the several
States of the United States, the District of Columbia, the Commonwealth
of Puerto Rico, Tribal agencies or any territory or possession of
the United States.
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