[Federal Register Volume 73, Number 213 (Monday, November 3, 2008)]
[Rules and Regulations]
[Pages 65258-65260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26172]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 1

RIN 2900-AM65


Disclosure of Information to Organ, Tissue and Eye Procurement 
Organizations

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This document adopts, with changes, a Department of Veterans 
Affairs (VA) interim final rule that implemented provisions of the 
Veterans Benefits, Health Care, and Information Technology Act of 2006 
concerning disclosure of information to organ, tissue and eye 
procurement organizations. The regulation will provide authority for VA 
to provide individually-identifiable VA medical records of veterans or 
dependents of veterans who are deceased or whose death is imminent to 
representatives of organ procurement organizations, eye banks, and 
tissue banks to determine whether the patients are suitable potential 
donors. This document modifies the interim final rule to clarify the 
definition of ``near death'' and to correct a grammatical error in the 
definition of ``procurement organization.'' This document also 
clarifies that eye bank and tissue bank registration with FDA must have 
an active status.

DATES: Effective Date: November 3, 2008.

FOR FURTHER INFORMATION CONTACT: Stephania Putt, Veterans Health 
Administration (VHA) Privacy Officer, Office of Information (19F2), 
Veterans Health Administration, Department of Veterans Affairs, 810 
Vermont Ave., NW., Washington, DC 20420, (704) 245-2492.

SUPPLEMENTARY INFORMATION: On August 23, 2007, the Department of 
Veterans Affairs (VA) published an interim final rule in the Federal 
Register (72 FR 48239) to implement section 204 of Public Law 109-461. 
We provided a 60-day comment period which ended on October 22, 2007. We 
received comments from three organizations, the American Association of 
Tissue Banks (AATB), the Association of Organ Procurement Organizations 
(AOPO), and the Eye Bank Association of America (EBAA).
    AATB and EBAA commented on their support of the provisions in the 
Interim Final Rule in general. The support of the AATB and EBAA is 
welcomed.
    EBAA commented on the title of the Interim Final Rule and suggested 
a title of ``Disclosure of Information to Organ, Tissue and Eye 
Procurement Organizations'' to provide clarification. The title of the 
Interim Final Rule is just a title of the regulatory packet for 
tracking and publication purposes; it is not the title of the actual 
regulations. We are amending the title of the Final Rule to provide a 
clear understanding of the organizations discussed in this regulation.
    AOPO commented that the definition of ``near death'' used in the 
regulations was vague and recommended the use of clinical triggers in 
clearly defining near or imminent death. We are amending the definition 
of ``near death'' to include the use of defined clinical triggers by 
the health care provider when

[[Page 65259]]

determining that death of a patient is imminent.
    In its comments, AATB notated that the definition of ``Procurement 
Organization'' contained a grammatical error by using ``tissue banks'' 
instead of the singular form. We are amending the definition to reflect 
``tissue bank'' and remove the plural form of the word.
    AATB and EBAA both recommended that the definition of ``Eye bank 
and tissue bank'' include language regarding the accreditation of eye 
bank and/or tissue bank by the EBAA for eyes and AATB for tissues along 
with the addition of this accreditation requirement to Sections 
1.485a(d) and 1.514b(d). The rationale proposed by AATB and EBAA of the 
additional requirement is the belief that it will provide additional 
protection of VHA facilities and their respective patient populations. 
However, no evidence or documentation was provided to support this 
belief. And though there should be no administrative burden for VHA 
facilities to verify whether an eye bank or tissue bank is accredited 
by EBAA or AATB, there is a potential impact on VA's overall donor 
program. The Food and Drug Administration (FDA) is responsible for 
reviewing the services provided by registered eye banks and tissue 
banks across the country. VA has several facilities in rural and remote 
areas where the number of FDA registered and accredited organ, tissue 
and eye procurement organizations may be limited. To impose another 
non-Federal accreditation requirement on these procurement 
organizations prior to VA's ability to work with the procurement 
organization may limit VA's capacity to honor a veteran's wish to be an 
organ donor. For the reasons stated above, VA does not accept the 
recommendation to require the accreditation of eye bank and/or tissue 
bank by the EBAA for eyes and AATB for tissue.
    EBAA and AOPO made several comments suggesting changes to the 
preamble language for the published Interim Final Rule. The parameters 
and contents of rulemakings are dictated by 1 CFR 18.12, Preamble 
requirements. Specifically, paragraph (a) clarifies that a preamble, 
``* * * will inform the reader, who is not an expert in the subject 
area, of the basis and purpose for the rule * * *'' The preamble does 
not get codified in the Code of Federal Regulations. Thus, when 
comments deal only with the language of Interim Final preamble sections 
that do not impact the basis and purpose explained therein, nor the 
substance of the regulation, it is beyond the scope of the final rule 
preamble to comment on those comments.
    Finally, AATB and EBAA recommended VHA verify the organ, eye or 
tissue bank status with FDA as being active and not subject to any 
order to cease, suspend or limit operations. VA has accepted this 
recommendation and amended the regulatory language at Sec.  1.485a(d) 
and Sec.  1.514b(d) by adding the requirement for VA medical centers to 
verify annually with the FDA that an eye bank and tissue bank 
registration status is active before permitting an eye bank or tissue 
bank to receive protected health information.

Administrative Procedure Act

    Pursuant to 5 U.S.C. 553(b)(3)(B), we find that there is good cause 
to dispense with advance public notice and opportunity to comment on 
this rule because any delay in promulgating the rule would be contrary 
to the public interest. In enacting section 204 of Public Law 109-461, 
Congress recognized the public's immediate need for VA's disclosure of 
organ donor information and specified that VA shall prescribe rules 
implementing the new law within 180 days. Also, as documented by 
information and data on http://www.organdonor.gov, the number of 
patients awaiting organ transplants far exceeds the number of available 
organs. Every day, 17 patients die waiting for an organ. VA's immediate 
collaboration with OPOs, eye banks, and tissue banks to facilitate 
organ, eye and tissue donation will result in individuals receiving 
lifesaving or life-enhancing transplants that otherwise would be 
unavailable. Accordingly, it would be contrary to the intent of 
Congress to delay an initiative that seeks to address a compelling 
public need, while VA engages in advance notice and opportunity to 
comment. Pursuant to 5 U.S.C. 553(d), and for the reasons stated above, 
we also find that there is good cause to dispense with the requirement 
that a substantive rule be published no less than 30 days before its 
effective date.

Paperwork Reduction Act of 1995

    This rule contains no provisions constituting a collection of 
information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. This final rule governs VA's disclosure of individuals' medical 
records to certain Organ Procurement Organizations, eye banks, and 
tissue banks, some of which may be small entities. However, it will not 
affect a substantial number of small entities and will not have a 
significant economic impact on any such entity. Therefore, under 5 
U.S.C. 605(b), this final rule is exempt from the initial and final 
regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604.

Executive Order 12866

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). The Executive 
Order classifies a ``significant regulatory action,'' requiring review 
by the Office of Management and Budget (OMB) unless OMB waives such 
review, as any regulatory action that is likely to result in a rule 
that may: (1) Have an annual effect on the economy of $100 million or 
more or adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities; (2) create a serious inconsistency or otherwise interfere 
with an action taken or planned by another agency; (3) materially alter 
the budgetary impact of entitlements, grants, user fees, or loan 
programs or the rights and obligations of recipients thereof; or (4) 
raise novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in the Executive 
Order.
    The economic, interagency, budgetary, legal, and policy 
implications of this final rule have been examined and it has been 
determined to be a significant regulatory action under Executive Order 
12866 because it is likely to result in a rule that may raise novel 
legal or policy issues arising out of legal mandates, the President's 
priorities, or principles set forth in the Executive Order.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any 1 year. This rule will have no such

[[Page 65260]]

effect on State, local, and tribal governments, or on the private 
sector.

Catalog of Federal Domestic Assistance Numbers and Titles

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.009, Veterans Medical 
Care Benefits; 64.010, Veterans Nursing Home Care; and 64.011, Veterans 
Dental Care.

List of Subjects in 38 CFR Part 1

    Administrative practice and procedure, Archives and records, 
Cemeteries, Claims, Courts, Crime, Flags, Freedom of information, 
Government contracts, Government employees, Government property, 
Infants and children, Inventions and patents, Parking, Penalties, 
Privacy, Reporting and recordkeeping requirements, Seals and insignia, 
Security measures, Wages.

    Approved: September 30, 2008.
Gordon H. Mansfield,
Deputy Secretary of Veterans Affairs.

0
For the reasons set out in the preamble, the interim final rule 
amending 38 CFR part 1, which was published at 72 FR 48239 on August 
23, 2007, is adopted as a final rule with the following changes:

PART 1--GENERAL PROVISIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority: 38 U.S.C. 501(a), and as noted in specific sections.


0
2. In Sec.  1.460, revise the definitions for ``Near death'' and 
``Procurement organization'' in alphabetical order to read as follows:


Sec.  1.460  Definitions.

* * * * *
    Near death. The term ``near death'' means that in the clinical 
judgment of the patient's health care provider based on defined 
clinical triggers, the patient's death is imminent.
* * * * *
    Procurement organization. The term ``procurement organization'' 
means an organ procurement organization, eye bank, and/or tissue bank 
as defined in this section.
* * * * *

0
3. Revise Sec.  1.485a(d), to read as follows:


Sec.  1.485a  Eye, organ and tissue donation.

* * * * *
    (d) The VHA health care facility has confirmed with HHS that it has 
certified or recertified the organ procurement organization as provided 
in the applicable HHS regulations. VA medical centers must verify 
annually in January of each calendar year with the Food and Drug 
Administration (FDA) that an eye bank or tissue bank has complied with 
the FDA registration requirements of 21 CFR part 1271 and that the 
registration status is active before permitting an eye bank or tissue 
bank to receive protected health information.

(Authority: 38 U.S.C. 5701(k), 7332(b)(2)(E))


0
4. Revise Sec.  1.514b(d), to read as follows:


Sec.  1.514b  Disclosures to procurement organizations.

* * * * *
    (d) The VHA health care facility has confirmed with HHS that it has 
certified or recertified the organ procurement organization as provided 
in the applicable HHS regulations. VA medical centers must verify 
annually in January of each calendar year with FDA that an eye bank or 
tissue bank has complied with the FDA registration requirements of 21 
CFR Part 1271 and that the registration status is active before 
permitting an eye bank or tissue bank to receive protected health 
information.

(Authority: 38 U.S.C. 5701(k), 7332(b)(2)(E))

 [FR Doc. E8-26172 Filed 10-31-08; 8:45 am]
BILLING CODE 8320-01-P