[Federal Register Volume 65, Number 105 (Wednesday, May 31, 2000)]
[Rules and Regulations]
[Pages 34860-34892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13418]



[[Page 34859]]

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Part III





Department of Health and Human Services





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42 CFR Part 130



Ricky Ray Hemophilia Relief Fund Program; Final Rule

  Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules 
and Regulations  

[[Page 34860]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 130

RIN 0906-AA56


Ricky Ray Hemophilia Relief Fund Program

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Interim final rule.

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SUMMARY: The Ricky Ray Hemophilia Relief Fund Act of 1998, established 
the Ricky Ray Hemophilia Relief Fund Program designed to provide 
compassionate payments to certain individuals with blood-clotting 
disorders, such as hemophilia, who contracted HIV through the use of 
antihemophilic factor administered between July 1, 1982, and December 
31, 1987. The Act also provides for payments to certain persons who 
contracted HIV from the foregoing individuals. Specified survivors of 
these categories of individuals may also receive payments. The 
Department is seeking public comment on this interim final rule to 
establish procedures and requirements for documentation of eligibility 
and to establish a mechanism for providing compassionate payments to 
individuals who are eligible for payment under the statute.

DATES: This regulation is effective on July 31, 2000. Written comments 
must be submitted on or before June 30, 2000. Petitions may be 
postmarked, or accompanied by a receipt from a commercial carrier or 
U.S. Postal Service, on but not before July 31, 2000.

ADDRESSES: All comments concerning this interim final rule should be 
submitted to the Ricky Ray Program Office, Bureau of Health Professions 
(BHPr), Health Resources and Services Administration, Room 8A-54, 
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. 
Comments will be available for public inspection at the above address 
in room 8A-54, BHPr/HRSA, between the hours of 8:30 a.m. and 5 p.m. on 
Federal Government work days.

FOR FURTHER INFORMATION CONTACT: Neil H. Sampson, Deputy Associate 
Administrator for Health Professions, Bureau of Health Professions, 
Health Resources and Services Administration, (301) 443-2330.

SUPPLEMENTARY INFORMATION: The Ricky Ray Hemophilia Relief Fund Act of 
1998 (Pub. L. 105-369) established a Trust Fund with an authorization 
of $750 million to ``provide for compassionate payments with regard to 
individuals with blood-clotting disorders, such as hemophilia, who 
contracted human immunodeficiency virus due to contaminated 
antihemophilic factor * * *'' The statute mandates payments of $100,000 
to any individual with HIV infection who has any blood-clotting 
disorder and was treated with antihemophilic factor at any time between 
July 1, 1982, and December 31, 1987. The spouse or former spouse of 
such an individual who acquired HIV from that individual is eligible 
for payment, and children who acquired HIV through perinatal 
transmission from a parent who is or was one of the persons described 
above may also be eligible for payment. In addition to these 
individuals, certain survivors also may be eligible for payment: a 
lawful spouse of the person with HIV; if there is no surviving spouse, 
the payment is to be made in equal shares to all children of the person 
with HIV; if there is no surviving spouse or children, the parents of 
the person with HIV will receive the payment in equal shares. If none 
of these individuals is living, the money will remain in the Fund. 
There is no provision for payment to be made to an estate or any 
individual other than those explicitly mentioned.
    In order to receive a payment, either the individual who is 
eligible for payment, or his or her personal representative, must file 
a petition for payment with sufficient documentation to prove that he 
or she meets the requirements of the statute. The statute mandates that 
the Secretary of Health and Human Services establish requirements for 
documentation and establish a mechanism for paying the eligible 
individuals.
    The purpose of this interim final rule is to seek public comment on 
the documentation we will require for payment as well as on our payment 
process.

Background

    When the statute was passed in 1998, it included, as noted above, 
an authorization for $750 million, and a directive to pay $100,000 to 
eligible individuals. At that time, however, there were no funds 
appropriated to implement this statute. We were concerned that the 
statute expired 5 years from enactment, and we did not know when, if 
ever, Congress would appropriate funds to implement it. There was also 
the possibility that funds might be appropriated in later years, 
forcing us to begin the actual implementation process near the time 
when the statute would expire. We sought a solution to preserve the 
rights of eligible individuals so that they would not be disadvantaged 
should one of the less desirable funding scenarios develop.
    The solution we devised was to allow individuals who believed that 
they were eligible for payment under this statute to file Notices of 
Intent. We wanted to preserve the rights of these individuals while at 
the same time, keeping the burden on them to a minimum. Since we did 
not know if funds would ever be made available, we did not want people 
to spend great time and effort rushing to file their petitions with the 
documentation required to prove they were eligible. Consequently, we 
published a notice in the Federal Register on March 24, 1999 (64 FR 
14251), asking for Notices of Intent from individuals who believed they 
were eligible for payment. These Notices of Intent were minimal: the 
petitioner's name, address, and phone number, and similar information 
about the petitioner's attorney or other representative. We stated that 
eligible individuals would be able to file a formal petition for 
payment if and when we were provided the funds to implement the 
statute. We received more than 6,000 notices. We made clear in the 
Federal Register that these notices did not qualify individuals for 
payment, but simply preserved their rights under the statute. Payments 
would be based on petitions filed with appropriate documentation at a 
later time. As explained below, now that funds have been appropriated, 
we have begun the payment process which requires a formal petition. 
This process supersedes the Notice of Intent process, and, therefore, a 
Notice of Intent is no longer necessary.
    In November 1999, we received an appropriation of $75 million to 
implement the statute, of which up to $10 million may be used for 
administrative expenses. We continued our work to establish the 
administrative mechanisms to pay individuals. These mechanisms include 
the organizational structure to manage the program, a Ricky Ray Fund in 
the Department of the Treasury, Privacy Act/Confidentiality 
regulations, and accounting procedures. We have also met with a wide 
range of organizations and expert individuals, seeking their input on 
how best to implement the statute. We also intensified our efforts to 
establish the proper regulatory framework for implementation; hence 
this rule.

The Current Appropriation

     The statute requires payments of $100,000 to eligible individuals. 
The appropriation for this statute in FY 2000

[[Page 34861]]

is $75 million, of which up to $10 million may be used for 
administrative expenses. Since the FY 2000 appropriation is less than 
the $750 million that was authorized for the Ricky Ray Hemophilia 
Relief Fund, there are insufficient funds at this time to pay all 
individuals we believe will be eligible (up to 7,500) a $100,000 
payment. We will pay the full $100,000 to individuals who file 
petitions ``in the order received'' until all appropriated funds are 
expended. Further petitions that are reviewed and determined to be 
eligible will remain in queue for payment from subsequent 
appropriations. The FY 2000 Supplemental Appropriations Bill requests 
an additional $100 million for the Fund. The President's budget for FY 
2001 proposes $100 million, of which up to $10 million may be used for 
administrative expenses, for the Ricky Ray Fund. Assuming funds are 
provided in subsequent years, our intention is to continue the payment 
process until all eligible petitions have been paid before the Fund 
expires in FY 2004, as required under current statute.

Summary of Regulation

    This regulation can be conceptualized in three parts: the process 
for payment, the documentation required to prove eligibility, and the 
reconsideration process.

The Process for Payment

    Given the fact that the statute requires payments to be made to 
individuals who file petitions ``in the order received,'' we need to 
establish a process to ensure this provision is met. First, we need to 
establish a date on which we will begin to accept petitions. It is 
important to set this specific date to allow all eligible individuals 
an equal opportunity to file. We are establishing July 31, 2000, as the 
first day we will accept petitions. No petition sent (i.e., postmarked) 
earlier will be accepted, and we will return any petition postmarked 
before that date. The fact that someone filed a Notice of Intent in 
response to the Federal Register notice of March 24, 1999, does not 
establish a place in queue. In addition, there is no need to file a 
Notice of Intent before a full petition is filed. As noted above, the 
Notice of Intent was our method for preserving the right to file in 
case funds were not appropriated in sufficient time to allow for a 
reasonable process for filing petitions within the statutory deadline. 
To the extent feasible, we hope to forward a copy of the petition form 
to all individuals who filed a Notice of Intent.
    Since we have only enough money under this year's appropriation to 
pay a relatively small number of eligible individuals, we need to 
establish an equitable process to determine the ``order received.'' We 
are establishing July 31, 2000, as the date on which we will begin to 
accept petitions. Any petition postmarked on that date, or stamped by a 
commercial carrier or the U.S. Postal Service on that date, will be 
considered as ``first to arrive.'' Petitions postmarked later will be 
sorted after those postmarked on the initial date. Petitions with 
earlier postmarks will be returned. Furthermore, no private meter 
postmarks will be allowed and, to assure fairness to all petitioners, 
we will not accept hand-delivered petitions.
    We expect that there will be many petitions postmarked on the 
initial date. Therefore, these petitions will be the ``first 
received.'' To ensure fairness in the payment process, we will begin a 
random selection procedure to determine the order in which petitions 
will be processed among the ``first received.'' This process will be 
equitable to allow sufficient time for distant mailings.
    It is our intention to begin to select envelopes containing the 
petitions ``first received'' in a random manner and begin numbering 
them from one until all are numbered. We will continue this procedure 
for petitions postmarked on later days. We will then begin with number 
one and continue to process petitions and make payments as long as 
funds are available.

Important Notice

    The process described above, in light of limited appropriations, 
means that those who file complete petitions earlier will be paid 
before those who file later or who file without complete documentation. 
We encourage all potential petitioners to complete their petitions and 
to compile all required documents, so that they can have their 
petitions postmarked on or as close to the initial date as possible.
    We are required under the statute to determine whether a petition 
is eligible for payment ``not later than 120 days after the date the 
petition is filed.'' We anticipate receiving thousands of petitions 
within a short time. We cannot process them all simultaneously and have 
insufficient funds to pay all petitions that are processed. Therefore, 
we intend to implement this provision based on the date we determine 
that a petition is complete.
    As a part of this process, if we open a petition and determine it 
is incomplete, we will notify the petitioner of this and give the 
petitioner 60 calendar days from the date of notification to submit the 
missing information. In the event that the petitioner is unable to 
secure the required documentation to complete the petition, the 
petitioner may submit a statement to the Secretary within 60 calendar 
days which shows good cause why the required legal and/or medical 
documentation is not available. If the petition is completed within 
that timeframe or if we determine that the petitioner has provided an 
adequate showing of good cause for not submitting the required 
documentation, and the petitioner is eligible for payment, we will pay 
that petitioner based on the number assigned in the random numbering 
process. If the required documentation is not included even after the 
opportunity to complete this documentation within 60 days, or if an 
adequate showing of good cause why the documentation is unavailable is 
not provided, the petition will be denied, subject to a right of 
reconsideration. Any subsequent filing of a petition will result in 
that petition being assigned a new number based on the date it is 
postmarked.

Filing Deadlines

    First, we note that the Ricky Ray Hemophilia Relief Fund Act states 
that the Secretary may not pay a petition unless it is filed within 3 
years after the date of the enactment of the Act. This statute was 
enacted on November 12, 1998; thus, the statutory filing deadline is 
November 11, 2001. However, since November 11, 2001, is a Sunday and is 
the Veteran's Day holiday, and since November 12, 2001, is the day on 
which Veteran's Day holiday is observed by the Federal Government, we 
have extended the deadline for filing a petition to Tuesday, November 
13, 2001.
    Second, we are calling special attention to the deadline for filing 
full petitions as it relates to our Notice of Intent procedures 
described in the Federal Register of March 24, 1999. The Notice of 
Intent was described in that March 24 document as satisfying the 
statutory filing deadline of November 11, 2001. However, as noted 
above, that procedure was an interim one that we developed before we 
knew whether Congress would provide funds to operate the program. Now 
that we have funds for paying petitions and for operating the program, 
we are able to establish a procedure which requires compliance with the 
statutory deadline. Therefore, even if a timely Notice of Intent was 
filed, a petitioner must file a full petition by the November 13, 2001, 
deadline. Furthermore, any individual who has not filed a Notice of 
Intent

[[Page 34862]]

need not file such a notice; it is only the filing of a full petition 
that will establish eligibility under the statute. Finally, those who 
filed a Notice of Intent should understand that their place in queue 
for processing and payment will be determined by the date of submission 
of their full petitions and will not be related to the date they filed 
their Notices of Intent or to the case numbers assigned to those 
notices.
    We would also like to note other deadlines that apply under the 
regulation. First, where a petitioner submits a petition which is 
denied payment, the petitioner may file a new petition, which includes 
documentation that was not included in the original petition. The 
deadline for filing this new petition is November 13, 2001. Second, 
where a petitioner submits a petition and the Secretary has not yet 
made the determination whether the petition meets the requirements of 
the Act, the petitioner may supplement the original petition with 
additional documentation. The petitioner may file this supplemental 
documentation at any time until the date of the Secretary's 
determination. Third, where a survivor files an amendment to a 
petition, which is required when a petition has already been submitted 
but the petitioner has died before payment is made, the deadline for 
filing this amendment is the date of the Secretary's determination of 
eligibility or the date of payment, whichever is later. Survivors must 
file amendments to petitions in order to retain the original assigned 
order number and to receive payment under the Act.

Documentation Required

    It is extremely important to establish the medical and legal 
documentation required so that we can begin to make payments to 
individuals who are eligible for payment. We are attempting to balance 
our fiduciary and accountability responsibilities with our desire to 
impose a minimal burden on those who file a petition. We are therefore, 
providing two options to meet the medical documentation requirement. 
The first is medical records, test results, prescription information, 
or other documentation deemed credible by the Secretary (which may 
include, but is not limited to, infusion logs and packing slips). The 
second is a sworn affidavit by a doctor or nurse practitioner verifying 
that the relevant medical requirements have been satisfied. We are also 
requiring a variety of legal documents from most petitioners. We 
encourage all petitioners to consult the Petition Documentation 
Checklist to determine the specific documentation required for each 
petition.
A. Persons with HIV
    The terms used below refer to the relationship to the individual 
with a blood-clotting disorder and HIV.
    1. To prove an individual with a blood-clotting disorder is 
eligible for payment, the petition must include medical documentation 
that the individual had a blood-clotting disorder, such as hemophilia, 
and was treated with antihemophilic factor at any time between July 1, 
1982, and December 31, 1987, and contracted an HIV infection.
    2. For lawful spouses with HIV who are filing, in addition to the 
medical documentation for the individual with a blood-clotting 
disorder, the petition must include evidence of marriage consisting of 
a marriage certificate or other proof of a lawful marriage and proof 
that the spouse has HIV.
    3. For former lawful spouses with HIV, we are requiring the medical 
documentation for the individual with a blood-clotting disorder, proof 
that he or she was married to the individual with a blood-clotting 
disorder at any time after the individual's treatment with 
antihemophilic factor (the date of treatment must have been between 
July 1, 1982, and December 31, 1987), proof of the termination of the 
marriage (such as a divorce certificate), and medical documentation 
which shows with reasonable certainty that the former spouse contracted 
HIV from the individual with a blood-clotting disorder.
    4. For the child with HIV who is filing (or for whom a personal 
representative is filing) because the parent is or was one of the 
persons described above, in addition to medical documentation for the 
individual with a blood-clotting disorder, we are requiring a birth 
certificate or other proof that the person filing is, in fact, the 
child of an individual with a blood-clotting disorder or his or her 
spouse or former spouse, a marriage certificate or other proof of a 
lawful marriage between the individual with a blood-clotting disorder 
and his spouse or former spouse, and medical documentation that the 
child acquired HIV infection through perinatal transmission from the 
individual with a blood-clotting disorder or his or her former spouse.
B. Survivors of Persons with HIV
    1. For the surviving spouse of a person with HIV, in addition to 
the medical and legal documentation for the person with HIV, we are 
requiring evidence of the death of the person with HIV, evidence of a 
lawful marriage, and a sworn statement that they were married at the 
time of the death of the person with HIV.
    2. For the surviving child/children of a person with HIV, in 
addition to the medical and legal documentation for the person with 
HIV, we are requiring evidence of the death of the person with HIV, 
evidence that the petitioner is, in fact, the child or stepchild of the 
person with HIV, and a sworn statement that either states that there 
are no other survivors eligible for payment or provides information 
about others who are eligible.
    3. For the surviving parent of a person with HIV, in addition to 
the medical and legal documentation for the person with HIV, we are 
requiring proof of the death of the person with HIV, evidence to prove 
that the petitioner is, in fact, the parent, and a sworn statement that 
either states that there are no other survivors eligible for payment or 
provides information about others who are eligible.
    In cases in which more than one (i.e., multiple) surviving children 
or surviving parents are filing, they may file one petition form 
jointly, which will contain the required documentation for all 
survivors, or they can file separate petition forms, which together 
will contain all of the required documentation for all survivors. In 
either case, survivors who have submitted all required documentation 
and are otherwise eligible for payment under the Act, will be paid 
their share(s) of the payment. Payment share(s) for multiple surviving 
children or surviving parents who do not submit the required 
documentation will remain in the Fund until such time as they complete 
their petitions by submitting such documentation or, if they have not 
submitted the documentation until the time that the Fund terminates, 
will revert back to the Treasury.

Petitioners Who Filed Claims Under the Factor Concentrate Settlement

    We expect that many petitioners have previously filed claims under 
the ``Factor Concentrate Settlement'' (that is, under the class 
settlement in the case of Susan Walker v. Bayer Corporation, et al.). 
In order for these petitioners to satisfy the documentation 
requirements, they may submit original or duplicate copies of the 
documents submitted in the class action. However, while the settlement 
documents may be submitted, they do not necessarily meet all of the 
documentation requirements under the Ricky Ray Hemophilia Relief Fund 
Act. Thus, if the documents submitted in the class action do not

[[Page 34863]]

consist of all documentation required under the Act, these petitioners 
must submit additional documentation in order to establish eligibility 
under the Act.

The Reconsideration Process

    Every individual who filed a petition and is denied payment may ask 
for a reconsideration. The request must be sent to the Deputy Associate 
Administrator for Health Professions, Health Resources and Services 
Administration, at the address designated in the regulation. The 
request must be received by the Department within 60 calendar days of 
the date the Department denied payment. The request should state the 
reasons for the reconsideration, but may not include any additional 
documentation not previously provided. The Deputy Associate 
Administrator will convene a panel to review all requests. The panel 
will consist of three individuals who are independent of the Ricky Ray 
Program Office and who are qualified to evaluate the petitions. The 
panel will review the case and make a recommendation to the Deputy 
Associate Administrator, who will review the recommendation and make a 
final determination as to whether or not the petitioner is eligible for 
payment. If the petition is deemed eligible for payment, it will be 
processed as soon as practicable in accordance with available funds.

Assistance Available to the Public

    The Ricky Ray Program office will respond to inquiries from 
petitioners and other individuals regarding program policies and Trust 
Fund status, as well as questions relating to the content, format and 
procedure for filing a full petition. This information may be obtained 
by telephoning the Ricky Ray Program Office at 1-888-496-0338 between 
the hours of 8:30 a.m. and 5 p.m. (Eastern Standard Time). This is a 
toll-free number. Interested parties may also contact the Program 
office by regular or electronic mail. The e-mail address is 
[email protected]. Additional program information, including 
downloadable versions of all forms needed to file a petition, may be 
obtained at the Ricky Ray Program Office website located at http://www.hrsa.gov/bhpr/rickyray. The website will be regularly updated.

Justification for Omitting Notice of Proposed Rulemaking

    The Department has decided to issue this document as an interim 
final regulation with a comment period of 30 days after publication in 
the Federal Register. Under 5 U.S.C. 553(b), the Secretary has 
determined that it is contrary to the public interest to follow 
proposed rulemaking procedures before issuance of these regulations. We 
make this finding for the following reasons:
    The purpose of the statute is to provide compassionate payments to 
individuals with blood-clotting disorders and HIV, to certain other 
individuals, and to their survivors. These are individuals with 
significant medical and other financial needs, and a delay in their 
ability to obtain the compassionate payments to which they are entitled 
would be inconsistent with the statutory purpose, with their needs, and 
thus, with the public interest. In addition, should any such individual 
die without one of the survivors described in the statute, no payment 
is permitted to be made to that individual's estate. The sooner the 
rule becomes effective, the more eligible individuals will be able to 
recover the statutory payment.
    In addition, we believe that the streamlined filing procedures 
provided for by this rule will impose a minimal burden on petitioners 
and thus should not result in any controversy. Nevertheless, we are 
providing for a 30-day comment period which will expire 30 days before 
the effective date of the rule specified above. Thus, should we receive 
any significant comments that would cause us to revise this rule in any 
way that would affect the filing of the petitions, we will be able to 
do so, or to advise potential petitioners of our intent to do so, 
before they take any final action to file.

Economic and Regulatory Impact

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when rulemaking is 
necessary, to select regulatory approaches that provide the greatest 
net benefits (including potential economic, environmental, public 
health, safety distributive and equity effects). In addition, under the 
Regulatory Flexibility Act (RFA) of 1980, if a rule has a significant 
economic effect on a substantial number of small entities, the 
Secretary must specifically consider the economic effect of the rule on 
small entities and analyze regulatory options that could lessen the 
impact of the rule.
    Executive Order 12866 requires that all regulations reflect 
consideration of alternatives, of costs, of benefits, of incentives, of 
equity, and of available information. Regulations must meet certain 
standards, such as avoiding an unnecessary burden. Regulations which 
are ``significant'' because of cost, adverse effects on the economy, 
inconsistency with other agency actions, effects on the budget, or 
novel legal or policy issues, require special analysis.
    The Department has determined that resources to implement this rule 
are required only of petitioners in submitting their petitions and of 
the Department in reviewing them. Therefore, in accordance with the RFA 
of 1980, and the Small Business Regulatory Enforcement Fairness Act of 
1996, which amended the RFA, the Secretary certifies that this rule 
will not have a significant impact on a substantial number of small 
entities. The Secretary has also determined that this rule does not 
meet the criteria for a major rule as defined by Executive Order 12866 
and would have no major effect on the economy or Federal expenditures.
    We have determined that the rule is not a ``major rule'' within the 
meaning of the statute providing for Congressional Review of Agency 
Rulemaking, 5 U.S.C. 801. We have made this decision because Congress, 
not the Department, determined the amount of compensation to be 
disbursed to eligible petitioners under the Act. In promulgating this 
rule, the Department is not exercising any discretion as to the amount 
of money given to petitioners deemed eligible under the Act.
    Nor on the basis of family well-being will the provisions of this 
rule for the payment of awards to petitioners affect the following 
family elements: family safety, family stability; marital commitment; 
parental rights in the education, nurture and supervision of their 
children; family functioning, disposable income or poverty; or the 
behavior and personal responsibility of youth, as determined under 
section 654(c) of the Treasury and General Government Appropriations 
Act of 1999. This rule does not have an effect on disposable income 
because it provides compassionate payments to eligible petitioners 
without imposing a corresponding burden on petitioners.

Paperwork Reduction Act of 1995

    In accordance with section 3506(c)(2)(A) of the Paperwork Reduction 
Act (PRA) of 1995, the Department is required to solicit public 
comments, and receive final Office of Management and Budget (OMB) 
approval, on any information collection requirements set forth in 
rulemaking. As indicated, in order to implement the Ricky Ray 
Hemophilia Relief Fund Act of 1998, certain information is required as 
set forth in Secs. 130.20, 130.21, 130.22, 130.23, 130.30, and 130.31 
in this rule.
    In accordance with the PRA, we are submitting to OMB at this time 
the

[[Page 34864]]

following requirements for seeking emergency review of these 
provisions. We are requesting an emergency review because the data 
collection and reporting of this information is needed before the 
expiration of the normal time limits under OMB's regulations at 5 CFR 
part 1320, to ensure the timely availability of data as necessary to 
ensure payment to eligible petitioners. Delaying the data collection 
would delay implementation of the statutory purpose of providing 
compassionate payments to individuals with blood-clotting disorders and 
HIV, to certain other persons, and to their survivors. It is clear that 
eligible petitioners have significant medical and financial needs, and 
the emergency review will minimize any delay in their ability to obtain 
the compassionate payments to which they are entitled in accordance 
with the statutory purpose. Further, by statute, if an individual dies 
before receiving payment and there is no eligible survivor, as 
described in the statute, the $100,000 will revert to the Trust Fund. 
Implementing this regulation and making payments as soon as possible 
will ensure that Congress' intent in making compassionate payments to 
eligible individuals will be implemented, to the extent possible. We 
are requesting OMB's review and approval of this collection within 15 
days from the date of publication of this rule, with a 180-day approval 
period. Written comments and recommendations will be accepted from the 
public if received by the individual designated below within 13 days 
from the date of publication of this rule. During this 180-day approval 
period, we will publish a separate Federal Register notice announcing 
the initiation of an extensive 60-day agency review and public comment 
period on the requirements set forth.
    Collection of Information: The Ricky Ray Hemophilia Relief Fund 
Program.
    Description of Respondents: Individuals who have an HIV infection 
and have any form of blood-clotting disorder, such as hemophilia, and 
were treated with antihemophilic factor at any time between July 1, 
1982, and December 31, 1987. The spouse and former spouse of such 
individuals who acquired HIV from that individual qualify for payment, 
and children who acquired HIV through perinatal transmission from an 
eligible parent also qualify. In addition to these individuals, certain 
survivors also qualify.
    Estimated Annual Reporting: The estimated annual reporting for this 
data collection is three hours for completing the petition and 
providing supporting documentation and one hour for the physician 
documentation. The estimated annual response burden is as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Number of     Responses per      Hourly       Total burden                     Total hour
                          Form                             respondents *    respondent       response          hours         Wage rate         cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Petition Form and Supporting Documentation..............           5,000               1               3          15,000             $15        $225,000
Physician Documentation.................................           1,000               1               1           1,000              40          40,000
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................           6,000  ..............  ..............          16,000  ..............        265,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
* It is estimated that no more than 7,500 individuals would be eligible for payment under the statute, and all petitions must be submitted by November
  13, 2001. The burden estimate in this table is calculated by annualizing the predicted number of respondents over an 18-month period in which a
  petition may be filed. Approximately 6,000 of these eligible individuals may have existing documentation resulting from the class settlement Susan
  Walker v. Bayer Corporation et al.

    The annual burden estimate includes the time required to review and 
complete the petition as well as the time to obtain and provide further 
medical and legal documentation of eligibility. Comments on this 
information collection activity should be sent to Wendy A. Taylor, OMB 
Desk Officer, Office of Management and Budget, Room 10235, New 
Executive Office Building, 725 17th Street, NW., Washington, DC 20053; 
FAX: (202) 395-6974.

List of Subjects in 42 CFR Part 130

    Blood diseases, Federal aid programs, HIV/AIDS, Indemnity payments, 
Reporting and recordkeeping requirements.

    Dated: April 26, 2000.
Claude Earl Fox,
Administrator, Health Resources and Services Administration.

    Approved: May 12, 2000.
Donna E. Shalala,
Secretary.

    For the reasons stated above, the Department of Health and Human 
Services adds to Chapter I of Title 42 CFR, a new Subchapter L, and 
within Subchapter L a new Part 130 to read as follows:

SUBCHAPTER L--COMPASSIONATE PAYMENTS

PART 130--RICKY RAY HEMOPHILIA RELIEF FUND PROGRAM

Subpart A--General Provisions
Sec.
130.1   Purpose.
130.2   Definitions.
130.3   Amount of payments.
Subpart B--Criteria for Eligibility
130.10   Who is eligible for payment under the Act--living persons 
with HIV.
130.11   Who is eligible for payment under the Act--survivors of 
persons with HIV.
Subpart C--Documentation Required for Complete Petitions
130.20   Form of medical documentation.
130.21   What documentation is required for petitions filed by 
living persons with HIV?
130.22   What documentation is required for petitions filed by 
survivors of persons with HIV, which are filed in cases where the 
person with HIV dies before filing a petition?
130.23   What documentation is required for amendments to petitions, 
which are filed by survivors of persons with HIV?
Subpart D--Procedures for Filing and Paying Complete Petitions
130.30   Who may file a petition for payment or an amendment to a 
petition?
130.31   How and when is a petition for payment filed?
130.32   How and when will the Secretary determine the order of 
receipt of petitions?
130.33   How will the Secretary determine whether a petition is 
complete?
130.34   How will the Secretary determine whether to pay a petition?
130.35   How and when will the Secretary pay a petition?
Subpart E--Reconsideration Procedures
130.40   Reconsideration of denial of petitions.
Subpart F--Attorney Fees
130.50   Limitation on agent and attorney fees.
APPENDIX A TO PART 130--DEFINITION OF HIV INFECTION OR HIV

[[Page 34865]]

APPENDIX B TO PART 130-- CONFIDENTIAL PHYSICIAN OR NURSE 
PRACTITIONER AFFIDAVIT
APPENDIX C TO PART 130-- PETITION FORM, PETITION INSTRUCTIONS, AND 
DOCUMENTATION CHECKLIST

    Authority: Secs. 101-108 of Pub. L. 105-369, 112 Stat. 3368 (42 
U.S.C. 300c-22 note); sec. 215 of the Public Health Service Act (42 
U.S.C. 216).

Subpart A--General Provisions


Sec. 130.1  Purpose.

    This part establishes criteria and procedures for implementation of 
the Ricky Ray Hemophilia Relief Fund Act of 1998 (the Act). This 
statute provides for compassionate payments to certain individuals with 
blood-clotting disorders, such as hemophilia, who contracted human 
immunodeficiency virus (HIV) due to contaminated antihemophilic factor 
within a specified time period, as well as to certain persons who 
contracted HIV from these individuals. In the event the individual 
eligible for payment is deceased, the Act also provides for payments to 
certain survivors of this individual.


Sec. 130.2  Definitions.

    As used in this part:
    (a) Act means the Ricky Ray Hemophilia Relief Fund Act of 1998, 42 
U.S.C. 300c-22 note, as amended.
    (b) Antihemophilic factor means any blood product (including, but 
not limited to, fresh frozen plasma, cryoprecipitate, factor VIII 
concentrate, and factor IX concentrate) used to treat a blood-clotting 
disorder.
    (c) Blood-clotting disorder means a disorder (including, but not 
limited to, hemophilia and von Willebrand's disease) in which the blood 
does not clot normally, usually resulting in prolonged bleeding.
    (d) Child with HIV means the individual described in 
Sec. 130.10(c).
    (e) Former lawful spouse means a person to whom an individual 
described in Sec. 130.10(a):
    (1) Was married according to the laws of the place where the person 
resided at any time after the date of the individual's treatment with 
antihemophilic factor (this date of treatment must have been between 
July 1, 1982, and December 31, 1987); and
    (2) Is no longer married.
    (f) Former lawful spouse with HIV means the individual described in 
Sec. 130.10(b)(2).
    (g) Fund means the ``Ricky Ray Hemophilia Relief Fund,'' which is a 
Trust Fund established in the Treasury of the United States and 
administered by the Secretary of the Treasury.
    (h) Hemophilia means a bleeding disorder in which a clotting factor 
(including, but not limited to, factors VIII or IX) is missing or does 
not function normally.
    (i) HIV infection or HIV means any of the following:
    (1) For individuals diagnosed with the HIV infection at any age, 
including infants: the presence of an opportunistic disease 
characteristic of AIDS, sufficient to satisfy the definition of HIV 
infection as set forth in Appendix A to this part; or
    (2) For individuals diagnosed with the HIV infection at over 15 
months of age: the presence of laboratory evidence of HIV based on 
identification of:
    (i) HIV antibodies;
    (ii) HIV viral antigens;
    (iii) HIV viral cultures; or
    (iv) Plasma HIV RNA; or
    (3) For infants diagnosed with the HIV infection due to perinatal 
transmission at or before 15 months of age: identification of the 
presence of HIV by a positive virologic test (i.e., detection of HIV by 
culture, HIV antigen, or HIV DNA or RNA polymerase chain reaction 
[PCR]).
    (j) Individual with a blood-clotting disorder and HIV means the 
individual described in Sec. 130.10(a).
    (k) Lawful spouse means a person to whom an individual described in 
Sec. 130.10(a) is married according to the laws of the place where the 
person resides on the date the petition is filed. If the laws of the 
place where the person resides consider an individual who is legally 
separated or in a common law marriage to be married, then such a person 
is a lawful spouse.
    (l) Lawful spouse with HIV means the individual described in 
Sec. 130.10(b)(1).
    (m) Perinatal transmission means transmission of HIV infection from 
mother to child that occurs during pregnancy, delivery, or 
breastfeeding.
    (n) Person(s) with HIV means all of the individuals described in 
Sec. 130.10(a), (b) or (c).
    (o) Place means any State of the United States of America, the 
District of Columbia, and United States territories, commonwealths, and 
possessions.
    (p) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department to whom the authority 
involved has been delegated.


Sec. 130.3  Amount of payments.

    If there are sufficient amounts in the Fund to make payments, the 
Secretary will make a single payment of $100,000 to eligible 
individuals, as defined in accordance with subpart B of this part. .

Subpart B--Criteria for Eligibility


Sec. 130.10  Who is eligible for payment under the Act--living persons 
with HIV.

    The following individuals are eligible for payment under the Act if 
they are living at the time that payment is to be made on a petition 
and have an HIV infection:
    (a) An individual who has any form of blood-clotting disorder, such 
as hemophilia, who was treated with antihemophilic factor at any place 
defined in Sec. 130.2(o), or at any diplomatic area or military 
installation of the United States, at any time during the time period 
from July 1, 1982, to December 31, 1987.
    (b) An individual who is:
    (1) The lawful spouse of the individual with a blood-clotting 
disorder and HIV; or
    (2) The former lawful spouse of the individual with a blood-
clotting disorder and HIV, if the former lawful spouse can assert with 
reasonable certainty, through medical documentation, transmission of 
HIV from the individual with a blood-clotting disorder and HIV.
    (c) An individual who acquired the HIV infection through perinatal 
transmission from a parent who is the individual with a blood-clotting 
disorder and HIV, the lawful spouse with HIV or the former lawful 
spouse with HIV.


Sec. 130.11  Who is eligible for payment under the Act--survivors of 
persons with HIV.

    (a) Survivors of persons with HIV, as described in Sec. 130.10, are 
eligible for payment under the Act if:
    (1) The person with HIV dies before filing a petition under the 
Act. In this case, an eligible survivor may file a petition as a 
survivor of the person with HIV, as set forth in Sec. 130.22; or
    (2) The person with HIV has filed a petition under the Act, but 
dies before payment is made. In this case, an eligible survivor must 
file an amendment to the petition in order to retain the assigned order 
number and to receive payment under the Act, as set forth in 
Sec. 130.23.
    (b) Payments to survivors shall be made in the following order:
    (1) If the person with HIV is survived by a spouse who is living at 
the time of payment, the payment shall be made to the surviving spouse 
(hereinafter referred to as ``the surviving spouse'').
    (2) If the person with HIV is not survived by a living spouse, the 
payment shall be made in equal shares to all children of the individual 
who are living at the time of payment (hereinafter referred to as ``the 
surviving child/children'').

[[Page 34866]]

    (3) If the person with HIV is not survived by a spouse or children 
who are living at the time of payment, the payment shall be made in 
equal shares to the parents of the individual who are living at the 
time of payment (hereinafter referred to as ``the surviving 
parent(s))'.
    (c) If the person with HIV is not survived at the time payment is 
to be made by any of the survivors listed in paragraph (b) of this 
section, no payments will be made for the person with HIV and the 
payment will revert back to the Fund.
    (d) For purposes of this section, the following definitions apply:
    (1) The term spouse means a person who was lawfully married to the 
person with HIV according to the laws of the place where the person 
resided at the time of death.
    (2) The term child includes a recognized natural child, a stepchild 
who lived with the person with HIV in a regular parent-child 
relationship, and an adopted child.
    (3) The term parent includes fathers and mothers through adoption.

Subpart C--Documentation Required for Complete Petitions


Sec. 130.20  Form of medical documentation.

    In all instances in which medical documentation is referred to, 
medical documentation may be submitted in the following forms:
    (a) Copies of relevant portions of medical records, records 
maintained by a physician, nurse, or other licensed health care 
provider, test results, prescription information, or other 
documentation deemed credible by the Secretary; or
    (b) An affidavit, signed under penalty of perjury, by a physician 
or nurse practitioner, verifying that the medical criteria necessary 
for a petitioner to be eligible for payment under the Act are 
satisfied. Such an affidavit must include the physician or nurse 
practitioner's State and license number. A sample affidavit is set 
forth at Appendix B to this part.


Sec. 130.21  What documentation is required for petitions filed by 
living persons with HIV?

    The following rules apply to all petitions filed by persons with 
HIV:
    (a) All petitions filed under the Act must include written medical 
documentation showing the following:
    (1) That the individual described in Sec. 130.10(a) has (or had) a 
blood-clotting disorder, such as hemophilia;
    (2) That the individual with a blood-clotting disorder and HIV was 
treated with antihemophilic factor at any time between July 1, 1982, to 
December 31, 1987; and
    (3) That the individual with a blood-clotting disorder and HIV has 
(or had) an HIV infection under any of the criteria set out in the 
definition of HIV infection at Sec. 130.2(i).
    (b) The individual. Petitions filed by the individual with a blood-
clotting disorder and HIV need only include the documentation described 
in paragraph (a) of this section.
    (c) The lawful spouse. Petitions filed by the lawful spouse with 
HIV must include the following written documentation:
    (1) The documentation described in paragraph (a) of this section;
    (2) Medical documentation showing that the lawful spouse with HIV 
has an HIV infection; and
    (3) A marriage certificate or other proof of a lawful marriage, 
which shows that the lawful spouse with HIV and the individual with a 
blood-clotting disorder and HIV are married.
    (d) The former lawful spouse. Petitions filed by the former lawful 
spouse with HIV must include the following written documentation:
    (1) The documentation described in paragraph (a) of this section;
    (2) Medical documentation showing that the former lawful spouse 
with HIV has an HIV infection;
    (3) A marriage certificate or other proof of a lawful marriage, 
which shows that the former lawful spouse with HIV and the individual 
with a blood-clotting disorder and HIV were married at any time after 
the date of the individual's treatment with antihemophilic factor (this 
date of treatment must have been between July 1, 1982, to December 31, 
1987);
    (4) A divorce certificate or other proof of termination of the 
marriage between the former lawful spouse with HIV and the individual 
with a blood-clotting disorder and HIV; and
    (5) Medical documentation which shows with reasonable certainty 
that the former lawful spouse with HIV contracted HIV from the person 
with a blood-clotting disorder and HIV.
    (e) The child. Petitions filed by the child with HIV must include 
the following written documentation:
    (1) The documentation described in paragraph (a) of this section;
    (2) Medical documentation showing that the child with HIV has an 
HIV infection;
    (3) A birth certificate or other proof, which shows that the child 
with HIV is the child of:
    (i) The individual with a blood-clotting disorder and HIV;
    (ii) The lawful spouse with HIV; or
    (iii) The former lawful spouse with HIV;
    (4) A marriage certificate or other proof of a lawful marriage, 
which shows that the lawful spouse with HIV or the former lawful spouse 
with HIV and the individual with a blood-clotting disorder and HIV are/
were married, except where the individual with a blood-clotting 
disorder and HIV is the mother of the child with HIV;
    (5) Medical documentation showing that the child with HIV acquired 
an HIV infection through perinatal transmission from a parent who is:
    (i) The individual with a blood-clotting disorder and HIV;
    (ii) The lawful spouse with HIV; or
    (iii) The former lawful spouse with HIV; and
    (6) Where the child with HIV acquired an HIV infection through 
perinatal transmission from the former lawful spouse with HIV, medical 
documentation which shows with reasonable certainty that the former 
lawful spouse with HIV contracted HIV from the person with the blood-
clotting disorder and HIV.


Sec. 130.22  What documentation is required for petitions filed by 
survivors of persons with HIV, which are filed in cases where the 
person with HIV dies before filing a petition?

    (a) In those cases in which the person with HIV, as described in 
Sec. 130.10, dies before filing a petition under the Act, a survivor of 
that person, as described in Sec. 130.11, may file a petition.
    (b) Petitions filed by survivors must include two types of 
information:
    (1) Documentation regarding the person with HIV; and
    (2) Documentation regarding the eligibility of the survivor to 
receive payments as a survivor of the person with HIV.
    (c) Petitions filed by survivors must include the following 
information regarding the person with HIV:
    (1) The individual. Petitions filed by a survivor of the individual 
with a blood-clotting disorder and HIV must include the documentation 
described in Sec. 130.21(b).
    (2) The lawful spouse. Petitions filed by a survivor of the lawful 
spouse with HIV must include the documentation described in 
Sec. 130.21(c).
    (3) The former lawful spouse. Petitions filed by a survivor of the 
former lawful spouse with HIV must include the documentation described 
in Sec. 130.21(d).
    (4) The child. Petitions filed by a survivor of the child with HIV 
must include the documentation described in Sec. 130.21(e).

[[Page 34867]]

    (d) Petitions filed by survivors must include the following 
information regarding the relationship between the survivor and the 
person with HIV:
    (1) The surviving spouse. Petitions filed by the surviving spouse 
must include the following written documentation:
    (i) A death certificate for the person with HIV, or other evidence 
of that individual's death;
    (ii) A marriage certificate or other proof of a lawful marriage, 
which shows that the survivor was the spouse, as defined in 
Sec. 130.11(d)(1), of the person with HIV; and
    (iii) A sworn statement signed by the surviving spouse which states 
that the surviving spouse and the person with HIV were married at the 
time of that individual's death.
    (2) The surviving child/children. Petitions filed by the surviving 
child/children must include the following written documentation:
    (i) A death certificate for the person with HIV, or other evidence 
of that individual's death;
    (ii) A birth certificate, adoption certificate, documentation that 
shows that the survivor is the stepchild of the person with HIV (for 
example, a certificate of marriage between the survivor's parent and 
the person with HIV), or other documentation which shows that the 
survivor is the child, as defined in Sec. 130.11(d)(2), of the person 
with HIV; and
    (iii) A sworn statement signed by the surviving child/children 
which either:
    (A) States that, to the best of the petitioner's knowledge, there 
are no other survivors who are eligible for payment under the Act, as 
described in Sec. 130.11 (i.e., no eligible surviving spouses or other 
surviving children); or
    (B) Provides information regarding other survivors who are eligible 
for payment under the Act.
    (3) The surviving parent(s). Petitions filed by the surviving 
parent(s) must include the following written documentation:
    (i) A death certificate for the person with HIV, or other evidence 
of that individual's death;
    (ii) A birth certificate, adoption certificate or other 
documentation which shows that the survivor is the parent, as defined 
in Sec. 130.11(d)(3), of the person with HIV; and
    (iii) A sworn statement signed by the surviving parent(s) which 
either:
    (A) States that, to the best of the petitioner's knowledge, there 
are no other survivors who are eligible for payment under the Act, as 
described in Sec. 130.11 (i.e., no eligible surviving spouse, surviving 
children or other surviving parents); or
    (B) Provides information regarding other survivors who are eligible 
for payment under the Act.


Sec. 130.23  What documentation is required for amendments to 
petitions, which are filed by survivors of persons with HIV?

    (a) The following survivors must file amendments to petitions in 
order to retain the assigned order number described in Sec. 130.32 and 
to receive payment under the Act:
    (1) A survivor of the person with HIV, when the person with HIV has 
filed a petition under the Act, but then died before receiving payment;
    (2) The next-ranked survivor eligible to receive payment under the 
Act, as described in Sec. 130.11(b), when a previously-ranked survivor 
has filed a petition or an amendment to a petition as a survivor of the 
person with HIV, but then died before receiving payment; and
    (3) In the case of petitions filed by multiple survivors (i.e., 
multiple surviving children or multiple surviving parents), where one 
of the survivors dies before receiving payment, the other survivors 
must file an amendment in order to notify the Secretary that the 
payment should be made to, and divided among, only the remaining 
survivors.
    (b) Survivors described in paragraph (a) of this section shall 
amend the original petition by filing the petition form set forth at 
Appendix C to this part, including the section pertaining to amendments 
to petitions.
    (c) Amendments to petitions filed by survivors must include the 
following documentation:
    (1) Survivors described in paragraph (a)(1) of this section must 
include the documentation described in Sec. 130.22(d), which shows that 
the survivor is eligible to file a petition as a survivor of the person 
with HIV.
    (2) Survivors described in paragraph (a)(2) of this section must 
include:
    (i) The documentation described in Sec. 130.22(d), which shows that 
the survivor is eligible to file a petition as a survivor of the person 
with HIV; and
    (ii) A death certificate for the survivor whose petition is being 
amended, or other evidence of that survivor's death.
    (3) Survivors described in paragraph (a)(3) of this section must 
include a death certificate for the survivor who has died, or other 
evidence of that survivor's death.
    (d) Amendments to petitions filed by survivors described in 
paragraph (a) of this section will retain the same order number 
assigned to the original petition.
    (e) In those cases in which the Secretary has reviewed the original 
petition prior to receiving an amendment to the petition, the Secretary 
will determine whether to pay the survivors described in paragraph (a) 
as follows:
    (1) If the Secretary has determined that the original petition does 
not include all of the documentation described in this Subpart C (i.e., 
it is incomplete), the survivor will be given the opportunity to 
complete the petition prior to a final determination in accordance with 
the procedures set forth at Sec. 130.33.
    (2) If the Secretary has determined that the original petition does 
not meet the requirements of the Act, the survivor will be so notified 
and payment will not be made. The survivor may seek reconsideration 
under Sec. 130.40.
    (3) If the Secretary has determined that the original petition 
meets the requirements of the Act, and the survivor meets the survivor 
requirements of the Act, the survivor will receive payment as described 
in Sec. 130.3.
    (f) In those cases in which the Secretary has not yet made the 
determination whether the original petition meets the requirements of 
the Act, the Secretary will review the amended petition according to 
the order number assigned to the original petition, and then determine 
whether the petition is complete and whether to pay the petition as 
described in paragraph (e) of this section.

Subpart D--Procedures for Filing and Paying Complete Petitions


Sec. 130.30  Who may file a petition for payment or an amendment to a 
petition?

    The following individuals may file a petition for payment under the 
Act:
    (a) All eligible individuals, as described in subpart B of this 
part, including living persons with HIV and survivors of persons with 
HIV; and
    (b) Personal representatives of eligible individuals:
    (1) Where the eligible individual does not have the legal capacity 
to receive payment under the Act, as described in Sec. 130.35(e); or
    (2) Where the eligible individual does have the legal capacity to 
receive payment under the Act and signs the sworn statement included at 
the end of the petition.


Sec. 130.31  How and when is a petition for payment filed?

    (a) In order to receive payment under the Act, all eligible 
individuals, as described in subpart B of this part, must file a 
complete petition with the Secretary. A complete petition is one

[[Page 34868]]

that contains all of the required documentation described in Subpart C 
of this part.
    (b) A copy of the petition form, which must be filed by all 
eligible individuals, including individuals with a blood-clotting 
disorder and HIV, the lawful spouse with HIV, the former lawful spouse 
with HIV, the child with HIV, and the survivors of persons with HIV, is 
set forth at Appendix C to this part. Appendix C includes the petition 
form, the instructions for filing the petition form, and a 
documentation checklist.
    (c) Where there are multiple surviving children or surviving 
parents, payments on the petition will be made to each survivor 
separately. The survivors shall:
    (1) File one petition form jointly, which will contain the required 
documentation for all survivors, and which will be signed by at least 
one survivor; or
    (2) File separate petition forms, which together will contain all 
of the required documentation for all survivors, and which will be 
signed by each survivor.
    (d) Petitions may be obtained from the Ricky Ray Program Office, 
Bureau of Health Professions, HRSA, Room 8A-54, 5600 Fishers Lane, 
Rockville, Maryland 20857.
    (e) All petitions must be submitted to the Ricky Ray Program 
Office, Bureau of Health Professions, HRSA, Room 8A-54, 5600 Fishers 
Lane, Rockville, Maryland 20857.
    (f) The date on which the Secretary will begin accepting petitions 
is July 31, 2000.
    (1) In order to be eligible for review, petitions may be postmarked 
on or after this date. A legibly dated receipt from a commercial 
carrier or U.S. Postal Service will be accepted in lieu of a postmark. 
Petitions that are postmarked by a private meter will not be accepted.
    (2) Petitions that are postmarked, or accompanied by a receipt from 
a commercial carrier or U.S. Postal Service, prior to this date will be 
returned to the petitioner. Petitions that are delivered by hand at any 
time will be returned to the petitioner.
    (g) Deadlines. The deadline for filing a petition is November 13, 
2001. To meet this deadline, the petition must be postmarked, or 
accompanied by a receipt from a commercial carrier or U.S. Postal 
Service, by such date. Any new petition filed after such date will be 
returned to the petitioner as ineligible for payment, even if the 
petitioner filed a timely Notice of Intent as provided in the procedure 
described in the Federal Register of March 24, 1999 (64 FR 14251).
    (1) If a petitioner submits a petition to the Secretary by November 
13, 2001, and the Secretary has determined, in accordance with 
Sec. 130.34, that the petition does not meet the requirements of the 
Act, the petitioner may submit a new petition for payment, which 
includes additional documentation that was not included in the original 
petition. The deadline for filing this new petition is November 13, 
2001.
    (2) If a petitioner submits a petition to the Secretary by November 
13, 2001, and the Secretary has not yet made the determination whether 
the petition meets the requirements of the Act, the petitioner may 
supplement the original petition with additional documentation at any 
time until the date of the Secretary's determination.
    (3) If a petitioner files an amendment to a petition, as described 
in Sec. 130.23, the deadline for filing this amendment is the date of 
the Secretary's determination of eligibility or the date of payment, 
whichever is later.
    (h) Petitioners who filed claims under the Factor Concentrate 
Settlement. Petitioners who filed claims under the class settlement in 
the case of Susan Walker v. Bayer Corporation, et al., 96-C-5024 (N.D. 
Ill.) (i.e., the Factor Concentrate Settlement) must file a complete 
petition with the Secretary, together with all required documentation, 
as described in subpart C of this part.
    (1) If the petitioner submitted a claim in the Factor Concentrate 
Settlement which included all of the documents required to establish 
eligibility under the Act, he or she may submit original or duplicate 
copies of those documents to the Secretary.
    (2) If the petitioner submitted a claim in the Factor Concentrate 
Settlement which included some, but not all, of the documents required 
to establish eligibility under the Act, he or she may submit original 
or duplicate documents as described in paragraph (h)(1) of this 
section, together with the additional documents required under the Act.
    (3) If the petition is filed by someone other than an individual 
who filed a claim in the Factor Concentrate Settlement (e.g., survivors 
of the person with HIV, personal representatives), he or she may submit 
original or duplicate documents as described in paragraph (h)(1) or 
(h)(2) of this section in order to satisfy that portion of the petition 
relating to the person with HIV.


Sec. 130.32  How and when will the Secretary determine the order of 
receipt of petitions?

    (a) The order that the petition was received by the Secretary will 
be determined by the postmark date or the date indicated by a 
commercial carrier or the U.S. Postal Service, in accordance with 
Sec. 130.31(f).
    (b) If the Secretary receives more than one petition which is 
either postmarked or dated by a commercial carrier or the U.S. Postal 
Service on the same date, the Department will conduct a random 
selection of each day's submissions to determine the order within each 
group of petitions.
    (c) A number will be assigned to each petition indicating the order 
in which it is selected.


Sec. 130.33  How will the Secretary determine whether a petition is 
complete?

    (a) If the Secretary determines that a petition does not include 
all of the documentation described in subpart C of this part (i.e., it 
is incomplete), the petitioner will be given the opportunity to 
complete the petition prior to a final determination.
    (b) The petitioner will be notified that the Secretary has 
determined that the petition is incomplete and, for purposes of 
retaining the assigned order number described in Sec. 130.32, will be 
given 60 calendar days from the date of the notice to submit the 
missing information. If the petitioner submits the missing information 
within 60 calendar days, and the Secretary determines that the petition 
meets the requirements of the Act, the petitioner will be paid 
according to the assigned order number.
    (c) If the petitioner is unable to complete the petition, the 
petitioner may submit written documentation to the Secretary, within 60 
calendar days, which shows good cause why the required medical or legal 
documentation is unavailable. If the Secretary determines that the 
petitioner has provided an adequate showing of good cause and is 
otherwise eligible for payment under the Act, the petitioner will be 
paid according to the assigned order number.
    (d) The Secretary will process the petition according to 
Sec. 130.34 if:
    (1) The petition does not include the required documentation, as 
described in subpart C, even after the opportunity is given to complete 
it;
    (2) The 60-day deadline to complete the petition is not met; or
     (3) An adequate showing of good cause why the required medical or 
legal documentation is unavailable is not provided.


Sec. 130.34  How will the Secretary determine whether to pay a 
petition?

    (a) Subject to available resources, the Secretary will review each 
petition filed under the Act and make one of the following 
determinations:

[[Page 34869]]

    (1) If the Secretary concludes that the petition does not meet the 
requirements of the Act, the petitioner will be so notified and payment 
will not be made. These petitioners may seek reconsideration under 
Sec. 130.40.
    (2) If the Secretary concludes that the petition does meet the 
requirements of the Act, the petitioner will receive payment as 
described in Sec. 130.3.
    (b) Petitions will be reviewed based upon the assigned number 
indicating the order of receipt, as described in Sec. 130.32.


Sec. 130.35  How and when will the Secretary pay a petition?

    (a) To the extent practicable, determinations on complete petitions 
will be made not later than 120 calendar days after the date that the 
Secretary determines that the petition is complete.
    (b) Payments on petitions will be made as soon as practicable after 
a determination that a complete petition meets the requirements of the 
Act.
    (c) For each eligible individual, as described in subpart B of this 
part, the Secretary will make only one payment on a petition.
    (d) Where there are multiple surviving children or surviving 
parents, survivors who have submitted all required documentation and 
are otherwise eligible for payment under the Act, will be paid their 
share(s) of the payment, as described in Sec. 130.11(b)(2) and (3). If 
any surviving children or surviving parents who are otherwise eligible 
for payment have not submitted the required documentation, their 
share(s) of the payment will remain in the Fund until such time as they 
complete their petitions by submitting such documentation. If they have 
not submitted the required documentation by the time that the Fund 
terminates, their share(s) will revert back to the Treasury.
    (e) Payments on petitions will be made to eligible individuals, as 
described in subpart B, unless the eligible individual is legally 
incompetent to receive payment. A personal representative may receive 
payment for a legally incompetent individual by submitting the 
following written documentation to the Secretary:
    (1) Proof showing that the eligible individual does not have the 
legal capacity to receive payment under the Act, such as a birth 
certificate showing that the eligible individual is a minor, or other 
evidence showing that the eligible individual is legally incompetent; 
and
    (2) Proof showing that the personal representative has the 
authority to receive payment for the eligible individual, such as proof 
of legal guardianship.

Subpart E--Reconsideration Procedures


Sec. 130.40  Reconsideration of denial of petitions.

    (a) Right of reconsideration. Every individual who has filed a 
petition and has been denied payment may seek reconsideration. To seek 
such reconsideration, the petitioner must put a request for 
reconsideration in writing and send it to the Deputy Associate 
Administrator for Health Professions, Health Resources and Services 
Administration, Room 8A-54, 5600 Fishers Lane, Rockville, Maryland 
20857. The request for reconsideration must be received by the Deputy 
Associate Administrator for Health Professions within 60 calendar days 
of the date the Department denied the petition for payment.
    (b) Request for reconsideration. The request for reconsideration 
must state the reasons why the petitioner is seeking reconsideration. 
However, the request for reconsideration may not include any additional 
documentation that was not included in the completed petition.
    (c) Review process. When the Deputy Associate Administrator for 
Health Professions receives a request for reconsideration, he will 
convene a panel of three individuals, who are independent of the Ricky 
Ray Program Office, to review the initial determination and make a 
recommendation regarding payment. The Deputy Associate Administrator 
for Health Professions will review the panel's recommendation and then 
determine whether the petitioner is eligible for payment under the Act. 
The Deputy Associate Administrator for Health Professions' 
determination will constitute the Department's final action on the 
request for reconsideration. If the determination is that the 
petitioner is eligible for payment, the petitioner will receive payment 
as described in Sec. 130.3. If the determination is that the petitioner 
is not eligible for payment, the Deputy Associate Administrator for 
Health Professions will inform the petitioner in writing of the reasons 
for this determination.

Subpart F--Attorney Fees


Sec. 130.50  Limitation on agent and attorney fees.

    As provided by section 107 of the Act:
    (a) Notwithstanding any contract, the representative of an 
individual may not receive, for services rendered in connection with 
the petition of an individual under this Act, more than 5 percent of a 
payment made under this Act (i.e., $5,000) on the petition.
    (b) Any such representative who violates this section is subject to 
a fine of not more than $50,000.
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Appendix A to Part 130--Definition of HIV Infection or HIV
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Appendix B to Part 130--Confidential Physician or Nurse 
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Documentation Checklist
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[FR Doc. 00-13418 Filed 5-26-00; 8:45 am]
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