[Federal Register Volume 66, Number 226 (Friday, November 23, 2001)]
[Rules and Regulations]
[Pages 58667-58672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29173]


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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: Adoption of interim final rule as final rule with amendments.

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SUMMARY: This document adopts the Ricky Ray Hemophilia Relief Fund 
Program interim final rule as a final rule with amendments. This final 
rule facilitates the petitioning process where health care history can 
be certified by physician assistants as well as by physicians or nurse 
practitioners; details the procedures by which the Secretary may 
resolve issues of eligibility or payment raised by a petition; ensures 
that payments made for the benefit of minors and other individuals who 
do not have the legal capacity to receive the payments are used for 
their benefit; and allows additional time for petitioners who are 
having difficulty obtaining needed medical or legal documentation to 
complete their petitions.

DATES: The regulations published on May 31, 2000 (65 FR 34860), were 
effective on July 31, 2000, and the amendments made in this final rule 
are effective November 23, 2001.

FOR FURTHER INFORMATION CONTACT: Paul T. Clark, Program Director, 
Bureau of Health Professions, Health Resources and Services 
Administration, (301) 443-2330.

SUPPLEMENTARY INFORMATION:

Background

    The Ricky Ray Hemophilia Relief Fund Act of 1998 (Public Law 105-
369) established the Ricky Ray Hemophilia Relief Fund Program to 
provide compassionate payments to certain individuals with blood-
clotting disorders, such as hemophilia, who were treated with 
antihemophilic factor between July 1, 1982, and December 31, 1987 and 
contracted HIV. The Act also provides for payments to certain persons 
who contracted HIV from the foregoing individuals. The spouse or former 
spouse of such an individual, who acquired HIV from that individual is 
eligible for payment, as are children who acquired HIV through 
perinatal transmission from an eligible parent. In addition to these 
individuals, certain survivors also are eligible. A lawful spouse is 
eligible for the payment; if there is no surviving spouse, the payment 
is to be made in equal shares to all children of the eligible 
individual. If there are no surviving spouse or children, the parents 
of the eligible individual will receive the payment. 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 to any individual 
beyond those explicitly mentioned in the Act.
    In order to receive a payment, either the eligible individual, or 
someone on behalf of the eligible individual, must file a petition for 
payment with sufficient documentation to prove that he or she meets the 
requirements of the statute.
    Congress appropriated $75 million to support the Ricky Ray 
Hemophilia Relief Fund Program during Fiscal Year (FY) 2000. As a 
result, we began issuing compassionate payments to eligible individuals 
in August 2000, in accordance with the procedures prescribed in the 
interim final rule. Congress has now passed an omnibus appropriations 
bill for FY 2001 that includes $580 million for the Ricky Ray Program. 
The Department anticipates that the combined total of $655 million for 
FY 2000 and 2001 is sufficient to make compassionate payments on all 
eligible petitions.
    An interim final rule was published in the Federal Register on May 
31, 2000 (65 FR 34860), to establish procedures and requirements for 
medical/legal documentation required to prove eligibility for 
individuals, a mechanism for providing compassionate payments to 
eligible individuals under the statute,

[[Page 58668]]

a reconsideration process, and to seek public comment on these 
provisions.

Discussion of Comments

    The public comment period ended on June 30, 2000. The Department 
received a total of 19 public comments. Fourteen were from potential 
petitioners and other individuals; four were from hemophilia and HIV 
advocacy groups; and one was from a professional association. The 
issues raised and the Department's responses appear below.

A. The Petitioning Process

    One commenter expressed concern that individuals might seek a 
competitive edge in the random selection process by filing multiple 
identical petitions. The commenter urged us to establish specific, 
fixed penalties for those individuals, such as consolidating the 
petitions under the highest randomly-assigned number.
    The Department agrees that multiple filings of identical petitions 
was a possible area of abuse in the petition process. In addition, the 
submission of multiple copies of identical petitions would cause a 
significant increase in administrative costs and hinder our ability to 
make payments on approved petitions in a timely fashion. Accordingly, 
we instituted a policy that if a petitioner submitted multiple 
identical petitions, all such petitions would be consolidated into one 
file prior to being assigned a randomly-selected order number. Because 
we are able to take corrective action prior to the assignment of 
randomly-selected order numbers, we have elected not to impose a 
penalty on individuals who file multiple petitions.
    Another commenter urged us to publish petition forms in Spanish to 
accommodate those individuals who live in Spanish-speaking countries or 
territories (e.g., Puerto Rico).
    The Ricky Ray Program already has in place a Spanish version of the 
Ricky Ray Hemophilia Relief Fund Petition Form. It is available to 
petitioners upon request, and at the Ricky Ray website. In addition, we 
have also provided technical support in Spanish via the Ricky Ray toll-
free Helpline.
    Another commenter suggested that we use other media in addition to 
the Federal Register to publicize availability of the Ricky Ray 
Hemophilia Relief Fund.
    The Ricky Ray Program Office (RRPO) has made a broad effort to 
publicize the Ricky Ray Hemophilia Relief Fund by contacting advocacy 
groups for persons with blood-clotting disorders, hemophilia treatment 
centers, and numerous health care providers to publicize the 
availability of the Program. In addition, the Department has issued 
press releases to the general media, and interviews have been conducted 
by various print and broadcast media groups. The RRPO implemented a 
website (http://www.hrsa.gov/bhpr/rickyray), installed a toll-free 
telephone number (1-888-496-0338), and made mass mailings to inform 
interested individuals of this Program.
    Other commenters suggested that the Department expand the list of 
eligible survivors to include care providers and unmarried partners. In 
addition, one commenter stated that surviving parents of an eligible 
individual should be eligible to petition in conjunction with other 
survivors and receive a portion of the compassionate payment. This 
commenter also suggested that if the surviving spouse of an eligible 
individual remarries, his/her rights to apply as the eligible survivor 
should be forfeited, and the rights should pass to the next eligible 
survivor.
    The interim final rule implements the provision of the Act that 
provides for payments to be made to specified survivors in a specific 
order. Section 103(c) of the Act provides for the payment to be made as 
follows: (1) To a surviving spouse who is living at the time of 
payment; (2) if there is no surviving spouse, the payment is to be made 
in equal shares to all children of the individual who are living at the 
time of payment; and (3) if there are no surviving spouse or surviving 
children, the payment is to be made in equal shares to the surviving 
parents of the eligible individual. If the individual is not survived 
by a person described in 1, 2, or 3 above, the payment will revert back 
to the Ricky Ray Hemophilia Relief Fund. The remarriage of an eligible 
spouse does not alter his/her statutory right to payment. In addition, 
the Act does not allow different classes of survivors to share in the 
payment. Only Congress can change the provisions of the Act.
    One commenter suggested that the time frame for eligibility be 
expanded to include individuals who were treated with antihemophilic 
factor prior to July 1, 1982.
    The time frame for qualifying for a compassionate payment from the 
Fund is established in section 102(a) of the Act. This section directs 
the Secretary to make a compassionate payment from the Fund to any 
individual with an HIV infection who has a blood-clotting disorder, 
such as hemophilia, and was treated with antihemophilic factor at any 
time between July 1, 1982, and December 31, 1987. Only Congress can 
change the provisions of the Act.
    The Department received comments requesting that the Program allow 
individuals to petition on behalf of the estate of deceased individuals 
who had a blood-clotting disorder, received antihemophilic factor and 
contracted HIV. The commenters argued that in the event that a deceased 
individual has no survivors, the executor should be eligible to apply 
on behalf of the deceased individual and apply the payment to the 
estate.
    The Act does not provide for the payment of claims to estates of 
deceased individuals who contracted HIV. That conclusion reflects a 
legislative decision made by Congress, as the statute leaves no room 
for a contrary result. In the case of the deceased individual with HIV, 
section 103(c) of the Act directs the Secretary to make payment first 
to a surviving spouse, then to all surviving children, and lastly to 
the surviving parents of the deceased individual. If there are no 
survivors within those categories, the Act requires that the payment 
revert back to the Fund.
    The Department received a comment urging the Program to eliminate 
Sec. 130.23(a)(2) of the interim final rule, which relates to the 
filing of an amendment by the next eligible survivor in the event that 
a petitioner dies before payment. The commenter suggested that this 
scenario could be addressed through the court system.
    The Department does not concur with this comment. We believe it is 
essential to have mechanisms in place to allow all potentially eligible 
survivors to petition for payment. The effect of Sec. 130.23(a)(2) is 
to allow eligible survivors to retain the assigned order number of an 
individual who filed a petition, but then died prior to receiving 
payment.
    A commenter suggested that the RRPO allow the private sector to 
implement and administer the Ricky Ray Hemophilia Relief Fund Act. 
Further, the commenter urged us to bestow upon the private sector the 
duty of disbursing government funds.
    In accordance with the Act, the Secretary of Health and Human 
Services is required to establish procedures under which individuals 
may submit petitions for payment under the Ricky Ray Hemophilia Relief 
Fund. Section 101(c) of the Act also provides that amounts in the Fund 
shall be available only for disbursement by the Secretary of Health and 
Human Services. We have contracted with private expert consultants, as 
needed, for the purpose of obtaining assistance in reviewing 
petitioners' eligibility for compassionate

[[Page 58669]]

payments, but we retain the functions of determining eligibility and 
making payments. This is a Federal Government Program, and payments 
must be disbursed through the Secretary of the Department.
    The Department received a comment regarding the process by which 
the Secretary will determine whether a petition is complete. 
Specifically, Sec. 130.33(d) of the interim final rule indicates that, 
following the issuance of an incomplete notice, the Secretary will 
continue to process a petition if the petitioner fails to complete the 
petition within the specified deadline or fails to make an adequate 
showing of good cause as to why the required documentation is 
unavailable. The commenter noted that, in the event that the petitioner 
fails to complete the petition, the intended language might have been 
for the Secretary not to finish processing the petition.
    It is the intention of the Secretary to process fully all submitted 
petitions. In the event that a petition does not include all required 
documentation, and the petitioner fails to make an adequate showing of 
good cause as to why the required documentation is unavailable, despite 
the extension of time that may be given under the amendments to 
Sec. 130.33(c) and (d)(2) herein, the petition will be processed and 
may be disapproved.
    One commenter suggested that petitions receive a chance for full 
review, even if the appropriated funds are exhausted for FY 2000 and 
2001. In addition, the commenter asked that a statement be released 
indicating that all petitions will be reviewed regardless of the 
availability of appropriated funds.
    The Secretary will review fully each petition postmarked between 
July 31, 2000, and November 13, 2001, regardless of the status of the 
funding.

B. Documentation Required To Prove Eligibility

    One commenter requested that the regulations be changed to allow 
physician assistants to submit the Confidential Physician and Nurse 
Practitioner Affidavit. The commenter noted that physician assistants 
are regulated and certified in all States and, in many instances, serve 
as the primary health care providers for potential petitioners.
    The Department agrees with this comment. Therefore, we are amending 
Sec. 130.20(b) of the regulations to allow physician assistants, as 
well as physicians and nurse practitioners, to submit affidavits 
verifying medical eligibility.
    One commenter raised concerns about the use of documents from the 
Factor Concentrate Settlement as delineated in Sec. 130.31(h) of the 
interim final rule. The commenter raised concerns about obtaining such 
documentation and notification regarding whether the documentation was 
sufficient for a petition under the Act.
    As described in Sec. 130.31(h) of the interim final rule, the RRPO 
will accept originals, or duplicate copies, of medical and legal 
documentation used in the Factor Concentrate Settlement (Susan Walker 
v. Bayer Corporation, et al., 96-C-5024 (N.D. Ill)). However, it is the 
responsibility of the petitioner to obtain such documentation or to 
request, in writing, that it be released by the Settlement 
Administrator directly to the Ricky Ray Program. If the Ricky Ray 
petitioner is the same person who originally submitted documents in the 
settlement, the Settlement Administrator may provide copies of those 
documents to the petitioner. However, in cases where the petitioner is 
someone other than the person who submitted the documents in the 
Settlement, the U.S. District Court has approved procedures to expedite 
the Ricky Ray payment process and ensure that confidentiality is 
protected (Settlement Implementation Order No. 16, December 14, 2000).
    This Order authorizes the Settlement Administrator to provide the 
documents needed to complete a Ricky Ray petition, if available, 
directly from the Settlement files to the Ricky Ray Program when a 
petitioner so requests by sending the Settlement Administrator a copy 
of the letter from the Program indicating what required documentation 
is missing from the petition. Requests, which must be in writing and 
include the copy of this letter, should be sent to: Factor Concentrate 
Settlement Litigation, Claims Administrator, 1777 Sentry Parkway West, 
Dublin Hall, Suite 400, Blue Bell, PA 19422.
    It should be noted that whatever eligibility or payment decisions 
were made under the Factor Settlement, those decisions have no bearing 
whatsoever on such determinations under the Ricky Ray Program. Allowing 
petitioners to use their documents from the Factor Settlement files to 
complete their Ricky Ray petitions, when applicable, is merely a 
mechanism to aid petitioners in completing their petitions in the least 
burdensome and most expeditious manner.

C. The Payment Process

    A commenter suggested that the RRPO collect the taxpayer 
identification number (TIN) of attorneys for the purpose of filing tax 
returns. The commenter stated that the Internal Revenue Service 
requires governmental units to collect TINs from attorneys when making 
payments which are income to attorneys, and to report those 
transactions via Form 1099-Misc informational returns.
    In compliance with the statute, payments are made to petitioners 
and not to attorneys. Should the petitioner owe a portion of his or her 
payment to an attorney, within the limit of section 107 of the Act, the 
RRPO is not a party to that transaction and will not have information 
to report to the Internal Revenue Service.
    The Department received a comment concerning the likelihood that 
the FY 2000 appropriation would be insufficient to pay all eligible 
petitioners. The commenter urged us to provide to each petitioner who 
files an approved petition and does not receive payment, a notice 
stating when the funds will be paid.
    As stated earlier, since Congress now has appropriated $580 million 
to the Ricky Ray Hemophilia Relief Fund for FY 2001, we believe that 
there will be sufficient funds to pay all approved petitions.
    The Department received several comments suggesting that we 
prioritize the payment process. The commenters advocated that 
individuals with a blood-clotting disorder and HIV should receive 
compassionate payments before survivors of deceased individuals.
    Section 103(c)(1) of the Act requires us to make payments to 
individuals who file complete and approved petitions ``in the order 
received.'' The process described in the interim final rule was 
designed to comply with this provision of the statute. The Act does not 
provide for prioritizing payments to individuals who are living with a 
blood-clotting disorder and HIV over payments to eligible survivors.
    One commenter expressed concern regarding the amount of payments. 
The interim final rule and section 102(a) of the Act both provide that 
``* * *  if there are sufficient amounts in the Fund to make each 
payment, the Secretary shall make a single payment of $100,000* * *'' 
to an eligible individual with HIV. The commenter questioned whether 
this provision could provide the basis for making partial payments if 
the Secretary determines that there are not sufficient funds available 
to make single payments of $100,000.
    The Secretary has interpreted this provision as requiring full 
payments of $100,000 on behalf of each eligible

[[Page 58670]]

individual with HIV, to the extent that funds are available to make 
each individual payment.

D. The Reconsideration Process

    The Department received comments regarding the reconsideration 
process for petitions denied payment. One commenter expressed concern 
that the reconsideration review panel be independent of, and not 
subject to influence from, the RRPO. In addition, another commenter 
asked where the request for reconsideration would have to be sent if 
different from the RRPO. The commenters also requested that the review 
process be clearly defined.
    Every petitioner who files a petition and is denied payment may ask 
for reconsideration. As stated in Sec. 130.40(a) of the interim final 
rule, the request must be sent to the Deputy Associate Administrator 
for Health Professions, Health Resources and Services Administration, 
Room 8A-54, 5600 Fishers Lane, Rockville, MD 20857. The request must be 
received within 60 calendar days of the date the petition was denied. 
The request should state the reasons that the petitioner is seeking 
reconsideration, but may not include any additional documentation not 
previously provided. The Deputy Associate Administrator will convene a 
panel to review all requests for reconsideration. The panel will 
consist of three individuals qualified to evaluate the petitions who 
are independent of the RRPO. The panel will review each case and make 
recommendations to the Deputy Associate Administrator. The 
recommendations of the review panel will be made independently of the 
RRPO. The Deputy Associate Administrator will review the 
recommendations and make the final determination.

Explanation of Provisions

    Section 130.20(b) of the interim final rule currently provides that 
the medical documentation required to prove that an individual is 
eligible for payment may be submitted in the form of relevant medical 
records or of an affidavit, signed under penalty of perjury, by a 
physician or nurse practitioner, verifying that the individual had a 
blood-clotting disorder, such as hemophilia, received antihemophilic 
factor between July 1, 1982, and December 31, 1987, and was diagnosed 
as having HIV.
    As previously noted, we are herein amending Sec. 130.20(b) of the 
interim final rule to allow physician assistants, as well as physicians 
or nurse practitioners, to submit such sworn affidavits to verify 
medical eligibility. Although we are not amending the sample affidavit 
in Appendix B to the final rule to reflect this addition, we will 
accept the affidavit when completed and signed by a physician 
assistant. This will apply to affidavits from physician assistants for 
petitions that have not yet been reviewed. According to the comment 
received on this issue, licensure terminology per se is not used by all 
States for physician assistants. Therefore, in the space currently 
provided in Section C of the affidavit for ``License Number and State 
Where Licensed'' physician assistants must include their State 
certification or registration number (and name of State) if a license 
number is not applicable.
    A new Sec. 130.24 is added to Subpart C stating that, where a 
petition raises an eligibility or payment question, the Secretary may 
require additional documentation to resolve the issue. For example, 
where the medical records submitted are inconclusive in establishing 
HIV infection, a sworn affidavit verifying satisfaction of the medical 
criteria necessary for eligibility, or evidence of one or more of the 
opportunistic diseases listed in Appendix A may be required.
    Under the Act and regulations, if the person with HIV is no longer 
living and is not survived by a spouse or children who are living at 
the time of payment, the compassionate payment is made in equal shares 
to the surviving parents (Sec. 130.11(b)(3)). If one parent is 
deceased, the sole surviving parent is eligible to receive the full 
payment of $100,000. In order for the Secretary to determine the 
appropriate amount of the payment to be made, a petitioner filing a 
petition designating him/herself to be the sole surviving parent must 
provide proof of death, or termination of parental rights, of the other 
parent. Where a parent is seeking the full $100,000 payment but cannot 
document that the other parent is deceased, proof of termination of 
parental rights or other evidence establishing eligibility for the full 
payment would be required to determine the proper payment amount.
    The RRPO may make compassionate payments for the benefit of a 
legally incompetent individual (i.e., a minor or other individual who 
does not have the legal capacity to receive payment directly). However, 
in order to ensure that these payments are, in fact, used for their 
benefit, we are requiring that evidence of a guardianship (sometimes 
called a conservatorship) established in accordance with applicable 
State and local laws, as well as proof of a guardianship account, be 
provided before a compassionate payment can be made for the benefit of 
these individuals. Payments will be made electronically to the 
guardianship account. If these requirements have not been met at the 
time the petition is submitted, the RRPO will not delay review of the 
petition.
    Although there may be a time and cost burden associated with the 
establishment of a guardianship and guardianship account (all fees 
associated with these requirements are to be borne by the petitioner), 
persons without legal capacity to receive payments who participated in 
the Factor Concentrate Settlement (i.e., the Walker v. Bayer case) may 
already have established such an account. If so, this would reduce any 
burden associated with the requirements of this policy, since it is 
unnecessary to establish a separate guardianship account specifically 
for payments made under the Ricky Ray Program.
    We recognize that the personal representative (such as a parent, 
guardian, or attorney) who files the petition on behalf of a minor or 
other legally incompetent individual may not be the guardian of that 
person's property and, therefore, would not have the authority to 
receive the payment on his/her behalf. It is the responsibility of the 
personal representative filing the petition to submit the documentation 
showing that the guardianship and guardianship account have been set up 
as required, before payment can be made.
    Further information regarding the RRPO policy on payments for the 
benefit of minors and legally incompetent adults is available on the 
Ricky Ray website at http://www.hrsa.gov/bhpr/rickyray.
    Currently, Sec. 130.33 provides that, as a part of the petition 
review process, if we determine that a petition is incomplete, we so 
notify the petitioner and give the petitioner 60 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 written documentation to the 
Secretary within the 60 days showing good cause as to why the required 
legal and/or medical evidence is not available.
    In the interest of minimizing the burden on those who may be 
eligible for payment but who are having difficulty obtaining the 
required medical or legal documentation, the Department has determined 
that it may be helpful for some petitioners to have additional time 
beyond the 60-day deadline, at the discretion of the Secretary, in 
which to provide missing documentation and,

[[Page 58671]]

thereby, complete their petitions. Thus, we are amending Sec. 130.33(c) 
to allow for this additional time, as the Secretary may deem 
appropriate, for petitioners to obtain and submit their missing 
documentation before the Secretary makes a final determination of 
eligibility. We are amending Sec. 130.33(d)(2) as well and believe that 
we are thereby giving petitioners every opportunity to submit evidence 
of their eligibility where additional time would enable them to do so.

Technical Amendments

    Technical amendments are being made to part 130 to add at the end 
of Secs. 130.20, 130.21, 130.22, 130.23, 130.24, 130.30, and 130.31 a 
parenthetical statement indicating that these sections contain 
information collection requirements that have been reviewed and given 
an approval number by the Office of Management and Budget.

Justification of Waiver of Delay of Effective Date

    The Secretary has found that a delay in the effective date of these 
amendments is unnecessary and contrary to the public interest. The 
amendments enable the RRPO to facilitate making compassionate payments 
to eligible petitioners with no additional burdens. They have no effect 
on any individual's rights or responsibilities.

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 
final 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 final rule will not have a significant impact on a 
substantial number of small entities. The Secretary has also determined 
that this final 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 final 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 the 
compassionate payment to be disbursed to eligible petitioners under the 
Act. In promulgating this final rule, the Department is not exercising 
any discretion as to the amount of money given to petitioners deemed 
eligible under the Act.

Impact on Federalism

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed or final rule that 
imposes substantial direct requirement costs on State and local 
governments, preempts State law, or otherwise has Federalism 
implications. This final rule will impose no direct requirement costs 
on State and local governments, does not preempt State law, or have any 
Federalism implications.

Impact on Family Well-Being

    The Secretary has determined that, by implementing the provision of 
compassionate payments to eligible petitioners, this final rule has a 
positive effect on family well-being. Therefore, in accordance with 
Section 654(c) of the Treasury and General Government Appropriations 
Act of 1999, the Department has assessed the impact of the rule on the 
seven elements of family well-being specified in the law, namely: 
family safety, family stability; marital commitment; parental rights in 
the education, nurture and supervision of their children; family 
functioning, disposable income or poverty; and the behavior and 
personal responsibility of youth. The only element on which this rule 
has an impact is disposable income or poverty. The rule has a positive 
impact on disposable income or poverty because it implements the 
provision of compassionate payments of $100,000 to eligible petitioners 
without imposing a corresponding burden on them.

Paperwork Reduction Act

    The information collection requirements set forth in the final rule 
under Secs. 130.20, 130.21, 130.22, 130.23, 130.24, 130.30, and 130.31 
for the Ricky Ray Hemophilia Relief Fund (45 CFR part 130) have been 
approved under OMB No. 0915-0244. This approval included an extensive 
60-day agency review and public comment period on the information 
collections requirements set forth in rulemaking.

List of Subjects in 42 CFR Part 130

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

    Dated: June 29, 2001.
Elizabeth M. Duke,
Acting Administrator, Health Resources and Services Administration.
    Approved: August 30, 2001.
Tommy G. Thompson,
Secretary.

    For the reasons stated above, the Department of Health and Human 
Services is adopting the interim final rule adding 42 CFR chapter I, 
subchapter L and part 130, published at 65 FR 34860 on Wednesday, May 
31, 2000, as a final rule with the following changes:

SUBCHAPTER L--COMPASSIONATE PAYMENTS

PART 130--RICKY RAY HEMOPHILIA RELIEF FUND PROGRAM

    1. The authority citation for part 130 continues to read as 
follows:

    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 C--Documentation Required for Complete Petitions

    2. Section 130.20 is amended by revising the first and second 
sentence in paragraph (b); and by adding a parenthetical phrase at the 
end of the section to read as follows:


Sec. 130.20  Form of medical documentation.

* * * * *
    (b) An affidavit, signed under penalty of perjury, by a physician, 
nurse practitioner or physician assistant, 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's, 
nurse practitioner's or

[[Page 58672]]

physician assistant's State of practice, and license, certification or 
registration number, as applicable. * * *

(Approved by the Office of Management and Budget under control 
number 0915-0244.)

    3. Section 130.21 is amended by adding a parenthetical phrase at 
the end of the section to read as follows:


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

* * * * *

(Approved by the Office of Management and Budget under control 
number 0915-0244.)


    4. Section 130.22 is amended by adding a parenthetical phrase at 
the end of the section to read as follows:


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?

* * * * *

(Approved by the Office of Management and Budget under control 
number 0915-0244.)


    5. Section 130.23 is amended by adding a parenthetical phrase at 
the end of the section to read as follows:


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

* * * * *

(Approved by the Office of Management and Budget under control 
number 0915-0244.)


    6. A new Sec. 130.24 is added to subpart C to read as follows:


Sec. 130.24  What additional documentation may the Secretary require to 
resolve eligibility or payment issues?

    (a) In addition to the applicable documentation required under this 
subpart, the Secretary may require the petitioner to provide other 
documentation, as the Secretary deems appropriate, to resolve issues of 
eligibility, or of the procedure for payment, raised by a petition.
    (b) Where a petition filed on behalf of a minor or other individual 
who is legally incompetent to receive payment has been approved for 
payment, the personal representative filing the petition on the 
individual's behalf must submit the following before payment can be 
made for the legally incompetent individual:
    (1) Documentation of a guardianship or conservatorship, established 
in accordance with State and local law; and
    (2) Information identifying a guardianship or conservatorship 
account.

(Approved by the Office of Management and Budget under control 
number 0915-0244.)

Subpart D--Procedures for Filing and Paying Complete Petitions

    8. Section 130.30 is amended by adding a parenthetical phrase at 
the end of the section to read as follows:


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

* * * * *

(Approved by the Office of Management and Budget under control 
number 0915-0244.)


    9. Section Sec. 130.31 is amended by adding a parenthetical phrase 
at the end of the section to read as follows:


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

* * * * *

(Approved by the Office of Management and Budget under control 
number 0915-0244.)


    10. Section 130.33 is amended by adding a sentence at the end of 
paragraph (c), and by revising paragraph (d)(2) to read as follows:


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

* * * * *
    (c) * * * The Secretary may allow additional time beyond the 60-day 
deadline, as the Secretary deems appropriate, for the petitioner to 
provide the documentation required to complete the petition.
    (d) * * *
    (2) The 60-day deadline, or the extended deadline under 
Sec. 130.33(c), as applicable, to complete the petition is not met; or
* * * * *
[FR Doc. 01-29173 Filed 11-21-01; 8:45 am]
BILLING CODE 4165-15-P