34860 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

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.

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

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

34862 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

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

Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations 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 Rraylprogram@hrsa.gov.

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 §§ 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

34864 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

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 bloodclotting 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:

Form Number of

respondents *

Responses

per respondent

Hourly

response

Total burden

hours Wage rate Total hour 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

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

§ 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.

§ 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 § 130.10(c).

(e) Former lawful spouse means a

person to whom an individual described

in § 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

§ 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 § 130.10(a).

(k) Lawful spouse means a person to

whom an individual described in

§ 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 § 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 § 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.

§ 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

§ 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 § 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 bloodclotting 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.

§ 130.11 Who is eligible for payment under

the Act—survivors of persons with HIV.

(a) Survivors of persons with HIV, as

described in § 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 § 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 § 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’’).

34866 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

(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

§ 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.

§ 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

§ 130.10(a) has (or had) a blood-clotting

disorder, such as hemophilia;

(2) That the individual with a bloodclotting 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 bloodclotting disorder and HIV has (or had)

an HIV infection under any of the

criteria set out in the definition of HIV

infection at § 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 bloodclotting 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 bloodclotting 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.

§ 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 § 130.10, dies

before filing a petition under the Act, a

survivor of that person, as described in

§ 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

§ 130.21(b).

(2) The lawful spouse. Petitions filed

by a survivor of the lawful spouse with

HIV must include the documentation

described in § 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

§ 130.21(d).

(4) The child. Petitions filed by a

survivor of the child with HIV must

include the documentation described in

§ 130.21(e).

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

§ 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 § 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

§ 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.

§ 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 § 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 § 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 § 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

§ 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 § 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 § 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

§ 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

§ 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

§ 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.

§ 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

34868 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

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 bloodclotting 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 § 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 § 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.

§ 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 § 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.

§ 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 § 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 § 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.

§ 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:

Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations 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 § 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 § 130.3.

(b) Petitions will be reviewed based

upon the assigned number indicating

the order of receipt, as described in

§ 130.32.

§ 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 § 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

§ 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 § 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

§ 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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34870 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

Appendix A to Part 130—Definition of HIV Infection or HIV

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34872 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

Appendix B to Part 130—Confidential Physician or Nurse Practitioner Affidavit

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34874 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

Appendix C to Part 130—Petition Form, Petition Instructions, and Documentation Checklist

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34876 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations 34877

34878 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations 34879

34880 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations 34881

34882 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations 34883

34884 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations 34885

34886 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations 34887

34888 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations 34889

34890 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations 34891

34892 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Rules and Regulations

[FR Doc. 00–13418 Filed 5–26–00; 8:45 am]

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