5442 Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices

11See also § 493.513(d), which requires exempted

States to provide HCFA with certain information,

including license approvals, revocations, sanctions

and withdrawals.

agency’s regulations and has been cited

by the Commonwealth as the key

penalty provision for cases involving

immediate jeopardy. However, this must

be compared with 42 CFR

493.1834(d)(2) which allows HCFA to

impose a penalty amount from $3,050 to

$10,000 per day of noncompliance or

per violation for condition level

deficiencies that represent immediate

jeopardy.

Lastly, with the exception of

information provided concerning cases

of immediate jeopardy, the

Commonwealth cannot be said to have

submitted comprehensible

documentation of what actions are taken

when less severe deficiencies are not

corrected.

In summary, while I disagree with

HCFA’s initial determination that the

Commonwealth did not demonstrate an

ability to take enforcement action in

cases of immediate and serious

jeopardy, I concur with their assessment

that the Commonwealth did not

adequately explain certain key aspects

of their enforcement proceedings. I find

that the Commonwealth has not

demonstrated the existence of

regulations to ensure the timely

investigation of and correction of

deficiencies. I also find that the amount

of civil monetary penalties that the

Commonwealth may assess in cases of

immediate and serious jeopardy is

insufficient when compared to the CLIA

regulations. For these reasons, I find

that the Commonwealth has failed to

document the existence of regulations

equal to or more stringent than

§ 493.1820 of the CLIA regulations.

3. Laboratory Registry. Section

493.1850 of the regulations requires

HCFA to make available once a year

specific information that is useful in

evaluating the performance of

laboratories. The regulation explicitly

mandates that this information include

a list of laboratories convicted under

laws relating to fraud and abuse, false

billing, or kickbacks. In its initial

determination, HCFA found that the

Commonwealth did not evidence the

existence of a regulation or law that

would require it to make available to

physicians and the public, via HCFA, a

list of laboratories convicted of fraud

and abuse, false billing, or kickbacks,

under Puerto Rican law.11

The Commonwealth in its Position

Paper indicates that it does not have any

information about any laboratory

convicted under Puerto Rican laws

sanctioning fraud and abuse, false

billing or kickbacks. (Position Paper, p.

34). As concerns its future duty to report

pursuant to § 493.1850, the

Commonwealth ‘‘guarantees’’

submission of such information and the

future amendment of its regulations, if

necessary. (Position Paper, p. 34).

We are unsure of how one should

interpret the Commonwealth’s lack of

information in this regard. One

interpretation is that there have been no

laboratories in the Commonwealth of

Puerto Rico have been convicted of

fraud and abuse, false billing or

kickbacks. Another interpretation is that

the Secretary does not obtain

information or maintain a record of the

disposition of fraud and abuse, false

billing or kickback cases involving

laboratories.

In any event, to the extent that the

CLIA regulations specifically require

disclosure of this information to the

public, any State seeking exemption

from CLIA must show the existence of

a corresponding reporting mechanism.

As conceded by the Commonwealth, it

does not currently have regulations that

require it to collect and submit this data

to HCFA. Without such current

regulations, I have no alternative but to

concur with the initial determination

reached by HCFA. For the above-noted

reasons, I find that the Commonwealth

has failed to demonstrate the existence

of a regulation equal to or more

stringent than the CLIA regulation

requiring laboratory registry.

IV. Findings

After undertaking an exhaustive and

complete review of the documentation

submitted by the Commonwealth in

connection with its application for

exemption, HCFA determined that

Puerto Rico did not satisfy the

requirements of § 493.513(a)(1) and

could not be granted exemption from

CLIA. I have considered the record,

supplementary information provided by

the Commonwealth, the Position Paper

and testimony in preparing this

decision. I hereby make the following

findings:

1. Section 493.513 of the regulations

sets forth the general requirements for

States seeking exemption from CLIA

program requirements.

2. Subsection 493.513(a)(1) provides

that HCFA may grant a State exemption

from CLIA if the State has in effect laws

that provide for requirements equal to or

more stringent than CLIA conditionlevel requirements.

3. The application for exemption and

supporting documentation submitted by

the Commonwealth of Puerto Rico was

evaluated by HCFA using this standard.

4. In fourteen instances involving

condition-level requirements, HCFA

properly determined that the

Commonwealth was unable to

demonstrate the existence of laws

providing for requirements equal to or

more stringent than the CLIA

regulations. These deficiencies have

been thoroughly discussed in this

decision.

Legal Conclusion

For the reasons discussed herein, and

based upon the above-referenced

findings of fact, I conclude that the

initial determination reached by HCFA

to deny the Commonwealth of Puerto

Rico’s application for exemption from

CLIA was consistent with the applicable

laws and regulations. It is recommended

that the initial determination denying

the Commonwealth’s application for

CLIA exemption be affirmed.

Dated: September 27, 1996.

Richard W. Besdine,

Hearing Officer, Health Care Financing

Administration.

[FR Doc. 97–2761 Filed 2–4–97; 8:45 am]

BILLING CODE 4120–03–P

Health Resources and Services

Administration

National Vaccine Injury Compensation

Program; List of Petitions Received

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice.

SUMMARY: The Health Resources and

Services Administration (HRSA) is

publishing this notice of petitions

received under the National Vaccine

Injury Compensation Program (‘‘the

Program’’), as required by section

2112(b)(2) of the Public Health Service

(PHS) Act, as amended. While the

Secretary of Health and Human Services

is named as the respondent in all

proceedings brought by the filing of

petitions for compensation under the

Program, the United States Court of

Federal Claims is charged by statute

with responsibility for considering and

acting upon the petitions.

FOR FURTHER INFORMATION CONTACT: For

information about requirements for

filing petitions, and the Program

generally, contact the Clerk, United

States Court of Federal Claims, 717

Madison Place, N.W., Washington, D.C.

20005, (202) 219–9657. For information

on HRSA’s role in the Program, contact

the Director, National Vaccine Injury

Compensation Program, 5600 Fishers

Lane, Room 8A35, Rockville, MD 20857,

(301) 443–6593.
Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices 5443

SUPPLEMENTARY INFORMATION: The

Program provides a system of no-fault

compensation for certain individuals

who have been injured by specified

childhood vaccines. Subtitle 2 of title

XXI of the PHS Act, 42 U.S.C. 300aa–

10 et seq., provides that those seeking

compensation are to file a petition with

the U.S. Court of Federal Claims and to

serve a copy of the petition on the

Secretary of Health and Human

Services, who is named as the

respondent in each proceeding. The

Secretary has delegated her

responsibility under the Program to

HRSA. The Court is directed by statute

to appoint special masters who take

evidence, conduct hearings as

appropriate, and make initial decisions

as to eligibility for, and amount of,

compensation.

A petition may be filed with respect

to injuries, disabilities, illnesses,

conditions, and deaths resulting from

vaccines described in the Vaccine Injury

Table (the Table) set forth at section

2114 of the PHS Act or as set forth at

42 CFR 100.3, as applicable. This Table

lists for each covered childhood vaccine

the conditions which will lead to

compensation and, for each condition,

the time period for occurrence of the

first symptom or manifestation of onset

or of significant aggravation after

vaccine administration. Compensation

may also be awarded for conditions not

listed in the Table and for conditions

that are manifested after the time

periods specified in the Table, but only

if the petitioner shows that the

condition was caused by one of the

listed vaccines.

Section 2112(b)(2) of the PHS Act, 42

U.S.C. 300aa–12(b)(2), requires that the

Secretary publish in the Federal

Register a notice of each petition filed.

Set forth below is a partial list of

petitions received by HRSA on October

10, 1996 through December 30, 1996.

Section 2112(b)(2) also provides that

the special master ‘‘shall afford all

interested persons an opportunity to

submit relevant, written information’’

relating to the following:

1. The existence of evidence ‘‘that

there is not a preponderance of the

evidence that the illness, disability,

injury, condition, or death described in

the petition is due to factors unrelated

to the administration of the vaccine

described in the petition,’’ and

2. Any allegation in a petition that the

petitioner either:

(a) ‘‘Sustained, or had significantly

aggravated, any illness, disability,

injury, or condition not set forth in the

Table but which was caused by’’ one of

the vaccines referred to in the Table, or

(b) ‘‘Sustained, or had significantly

aggravated, any illness, disability,

injury, or condition set forth in the

Table the first symptom or

manifestation of the onset or significant

aggravation of which did not occur

within the time period set forth in the

Table but which was caused by a

vaccine’’ referred to in the Table.

This notice will also serve as the

special master’s invitation to all

interested persons to submit written

information relevant to the issues

described above in the case of the

petitions listed below. Any person

choosing to do so should file an original

and three (3) copies of the information

with the Clerk of the U.S. Court of

Federal Claims at the address listed

above (under the heading ‘‘For Further

Information Contact’’), with a copy to

HRSA addressed to Director, Bureau of

Health Professions, 5600 Fishers Lane,

Room 8–05, Rockville, MD 20857. The

Court’s caption (Petitioner’s Name v.

Secretary of Health and Human

Services) and the docket number

assigned to the petition should be used

as the caption for the written

submission.

Chapter 35 of title 44, United States

Code, related to paperwork reduction,

does not apply to information required

for purposes of carrying out the

Program.

List of Petitions

1. Sarah Jean Busby on behalf of Payton

Elizabeth Helms, Kennett, Missouri,

Court of Federal Claims Number 96–

0628 V

2. Kimberly Berg on behalf of Ryan Berg,

Deceased, Salt Lake City, Utah, Court

of Federal Claims Number 96–0630 V

3. Alberta Wagner and Derrick Shaw on

behalf of Eric N. Shaw, Kingstree,

South Carolina, Court of Federal

Claims Number 96–0638 V

4. Elizabeth Watson, Waldorf, Maryland,

Court of Federal Claims Number 96–

0639 V

5. Tina and Gene Albert Simpson on

behalf of Gene Albert Simpson, Jr.,

English, Indiana, Court of Federal

Claims Number 96–0643 V

6. Nicholas Francis DeLouis on behalf of

Amanda Rachel Ingebretson, San

Antonio, Texas, Court of Federal

Claims Number 96–0655 V

7. Catherine Colluro, Woodmere, New

York, Court of Federal Claims Number

96–0662 V

8. Kathleen Kurtzhall, Glens Falls, New

York, Court of Federal Claims Number

96–0669 V

9. Teary Evaline Gardner, North Fort

Myers, Florida, Court of Federal

Claims Number 96–0679 V

10. Kristen Matheny on behalf of

Kaitlyn Rose Matheny, Woodford,

Illinois, Court of Federal Claims

Number 96–0722 V

11. Jane and Stephen Miller on behalf of

Sarah Miller, Boulder, Colorado,

Court of Federal Claims Number 96–

0727 V

12. Joanne DeRobertis on behalf of Dean

Wesley DeRobertis, Deceased, West

Chester, Pennsylvania, Court of

Federal Claims Number 96–0746 V

13. Michelle Kelleher on behalf of

Jennifer Dawn Bieliauskaus, Jersey

City, New Jersey, Court of Federal

Claims Number 96–0747 V

14. Michelle Emmer-Gilbank on behalf

of Dakota Emmer, Deceased Baraboo,

Wisconsin, Court of Federal Claims

Number 96–0761 V

15. Susan and Gaylen Weil on behalf of

Anthony Duane Weil, Shenandoah,

Iowa, Court of Federal Claims Number

96–0762 V

16. Breggett and Terrence Rideau on

behalf of Terrence Carl Rideau,

Bedford, Texas, Court of Federal

Claims Number 96–0765 V

17. Angela and Aaron Hill on behalf of

Arielle Hill, Jacksonville, Florida,

Court of Federal Claims Number 96–

0783 V

18. Mary Zwinn on behalf of Kaitlyn

Zwinn, LaGrange, Illinois, Court of

Federal Claims Number 96–0785 V

19. Angela Ward and Duane Booden on

behalf of Alysa Booden, Deceased,

Andrews Air Force Base, Maryland,

Court of Federal Claims Number 96–

0789 V

20. Patricia and Michael Sawinski on

behalf of Kaitlyn Sawinski, Melrose

Park, Illinois, Court of Federal Claims

Number 96–0796 V

21. Carmen Heller on behalf of Isaiah

Jones, Deceased, Cuyahoga Falls,

Ohio, Court of Federal Claims

Number 96–0797 V

22. Tawny and Robert Buck on behalf of

Quincy Mason Buck, Wrangell,

Alaska, Court of Federal Claims

Number 96–0802 V

23. Chatie Bantug Cruz, San Diego,

California, Court of Federal Claims

Number 96–0820 V.

Dated: January 30, 1997.

Ciro V. Sumaya,

Administrator.

[FR Doc. 97–2867 Filed 2–4–97; 8:45 am]

BILLING CODE 4160–15–P

Health Professions Preparatory,

Pregraduate and Indian Health

Professions Scholarship Programs

AGENCY: Indian Health Service, HHS.

ACTION: Standing Notice of Availability

of Funds for Health Professions