59528 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 

[FR Doc. E8–24009 Filed 10–8–08; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

42 CFR Part 100 

RIN 0906–AA55 

National Vaccine Injury Compensation 

Program: Removal of Separate 

Category for Vaccines Containing Live, 

Oral, Rhesus-Based Rotavirus From 

the Vaccine Injury Table 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Interim final rule. 

SUMMARY: Through this interim final 

rule, the Secretary removes the category 

of vaccines containing live, oral, rhesusbased rotavirus, Category XII, from the 

Vaccine Injury Table (Table). The Table 

includes a list of covered vaccines 

under the National Vaccine Injury 

Compensation Program (VICP). The 

VICP provides a system of no-fault 

compensation for certain individuals 

who have been injured by covered 

childhood vaccines. This interim final 

rule is technical in nature. Even prior to 

the publication of this final rule, 

Category XII, the category that is being 

removed from the Table, only applied to 

vaccines that were administered on or 

before August 26, 2002. Given the 

applicable statute of limitations and the 

fact that Category XII limited its 

application to vaccines administered on 

or before August 26, 2002, the Secretary 

believes that no persons have claims 

that could be pursued under that 

category. Petitioners may still be able to 

file petitions relating to rotavirus 

vaccines under Category XI of the Table, 

the category of ‘‘rotavirus vaccines,’’ 

which does not include any associated 

injuries. Although the Secretary believes 

that the changes made in this interim 

final rule are noncontroversial as they 

do not affect the rights of any potential 

petitioners with the VICP, the 

Department is seeking public comment 

on this interim final rule. Written 

comments must be submitted on or 

before November 10, 2008. The 

Department will consider the comments 

received and will decide whether to 

amend the Table based on such 

comments. 

DATES: This regulation is effective 

November 10, 2008. 

ADDRESSES: You may submit written 

comments, identified by the Regulatory 

Information Number (RIN) 0906–AA55 

by an any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: gevans@hrsa.gov. Include 

RIN 0906–AA55 in the subject line of 

the message. 

• Mail: Geoffrey Evans, M.D., 

Director, Division of Vaccine Injury 

Compensation, Healthcare Systems 

Bureau, Health Resources and Services 

Administration (HRSA), Room 11C–26, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, Maryland 20857. 

• Instructions: All submissions 

received must include the agency name 

and RIN for this rulemaking. All 

comments received will be available for 

public inspection and copying without 

charge, including any personal 

information provided, at Parklawn 

Building, 5600 Fishers Lane Room 11C– 

26, Rockville, Maryland 20857, 

weekdays (Federal holidays excepted) 

between the hours of 8:30 a.m. and 5 

p.m. 

FOR FURTHER INFORMATION CONTACT: 

Geoffrey Evans, M.D., Director, Division 

of Vaccine Injury Compensation, 

Healthcare Systems Bureau, Health 

Resources and Services Administration, 

Parklawn Building, Room 11C–26, 5600 

Fishers Lane, Rockville, Maryland 

20857; telephone number (301) 443– 

6593. 

SUPPLEMENTARY INFORMATION: 

The National Childhood Vaccine 

Injury Act of 1986, title III of Public Law 

99–660 (42 U.S.C. 300aa–10 et seq.) 

established the National Vaccine Injury 

Compensation Program (VICP) for 

persons found to be injured by vaccines. 

Under this Federal program, petitions 

for compensation are filed with the 

United States Court of Federal Claims 

(Court). The Court, acting through 

special masters, makes findings as to 

eligibility for, and amount of, 

compensation. In order to gain 

entitlement to compensation under title 

XXI of the Public Health Service (PHS) 

Act for a covered vaccine, a petitioner 

must establish a vaccine-related injury 

or death, either by proving that the first 

symptom of an injury/condition, as 

defined by the Qualifications and Aids 

to Interpretation, occurred within the 

time period listed on the Vaccine Injury 

Table (Table), and therefore presumed 

to be caused by a vaccine (unless 

another cause is found), or by proof of 

vaccine causation, if the injury/ 

condition is not on the Table or did not 

occur within the time period specified 

on the Table. 

The statute authorizing the VICP 

provides for the inclusion of additional 

vaccines in the VICP when they are 

recommended by the Centers for Disease 

Control and Prevention (CDC) for 

routine administration to children. See 

section 2114(e)(2) of the PHS Act, 42 

U.S.C. 300aa–14(e)(2). Consistent with 

section 13632(a)(3) of Public Law 103– 

66, the regulations governing the VICP 

provide that such vaccines will be 

included in the Table as of the effective 

date of an excise tax to provide funds 

for the payment of compensation with 

respect to such vaccines. (42 CFR 

100.3(c)(5)). The statute authorizing the 

VICP also authorizes the Secretary to 

create and modify a list of injuries, 

disabilities, illnesses, conditions, and 

deaths (and their associated time 

frames) associated with each category of 

vaccines included on the Table. See 

sections 2114(c)(3) and 2114(e)(2) of the 

PHS Act, 42 U.S.C. 300aa–14(c)(3) and 

300aa–14(e)(2). 

Because the prerequisites for adding 

rotavirus vaccines to the VICP occurred, 

the Secretary published a final rule in 

the Federal Register (FR) on July 27, 

1999, adding vaccines against rotavirus 

to the Table (64 FR 40517). Because the 

Secretary had not identified any illness, 

disease, injury or condition caused by 

vaccines against rotavirus, the category 

of vaccines was added to the Table with 

‘‘[n]o condition specified.’’ The 

Secretary made clear that if he learned 

of any such illness, disease, injury or 

condition, he would consider amending 

the Table. 

In a notice of proposed rulemaking 

published on July 13, 2001, the 

Secretary announced his findings that 

the condition of intussusception could 

reasonably be determined in some 

circumstances to be caused by vaccines 

containing live, oral, rhesus-based 

rotavirus (66 FR 36735). Based on those 

findings, the Secretary proposed 

amending the Table by adding to the 

Table vaccines containing live, oral, 

rhesus-based rotavirus (trade name 

Rotashield) as a distinct category, with 

intussusception listed as a covered 

Table injury. This proposal was based 

upon the recommendation by the CDC 

that Rotashield, the only rotavirus 

vaccine licensed in the United States 

(U.S.) at the time, no longer be 

administered to infants in the U.S. 

based on review of data indicating a 

strong association between Rotashield 

and intussusception in the 1 to 2 weeks 

following vaccination. 

In a final rule published July 25, 2002, 

the Secretary made the changes 

proposed in the earlier rule (67 FR 

48558). After these amendments, the 

Table included two categories of 


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Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 59529 

rotavirus vaccines. The first, the general 

category of rotavirus vaccines (current 

Category XI), did not include an 

associated injury. This category of 

vaccines was effective as of October 22, 

1998, the effective date of the excise tax 

enacted for rotavirus vaccines. See 42 

CFR 100.3(a), 100.3(c)(3). The second, 

the more specific category of vaccines 

containing live, oral, rhesus-based 

rotavirus (current Category XII), 

contained an associated injury of 

intussusception with an onset interval 

of 0–30 days. This category of vaccines 

was also effective on October 22, 1998, 

but only applied to vaccines 

administered on or before August 26, 

2002 (the effective date of the final rule 

imposing this category). Because the 

manufacturer of the only U.S.-licensed 

rotavirus vaccine voluntarily ceased 

distribution of the vaccine in July 1999, 

and because the CDC recommended that 

this vaccine no longer be routinely 

administered to children in the United 

States in October 1999, the Secretary 

concluded that it was unlikely that 

potential claims under Category XII 

would arise after the rule’s publication. 

Because that final rule limited the Table 

injury of intussusception to live, oral, 

rhesus-based rotavirus vaccines 

administered on or before the effective 

date of the final rule, individuals who 

sought compensation for injuries related 

to such a vaccine administered after the 

effective date of the final rule were not 

entitled to the presumption of a Table 

injury for intussusception. Such 

individuals were still able to file claims 

under the Table’s general category for 

rotavirus vaccines. No claims had been 

filed under the general category of 

rotavirus vaccines from August 2004 to 

January 2008. Licensure of a new 

rotavirus vaccine in 2006 led to one 

claim filed under this general category 

since January 2008. 

The Secretary views this rule as 

technical in nature because he does not 

believe that any potential petitioners 

would be able to file a claim relying on 

the Table condition set forth in Category 

XII if it were retained on the Table. As 

explained above, petitioners are already 

limited to filing claims relying on this 

Category if the underlying rotavirus 

vaccine was administered on or before 

August 26, 2002. Moreover, petitioners 

are only entitled to the presumption of 

causation conferred by the Table injury 

associated with Category XII if the 

injury of intussusception’s first 

symptom or manifestation of onset 

occurred within 0–30 days after the 

vaccine’s administration. Because the 

applicable statute of limitations requires 

petitioners to file claims within three 

years of the injury’s first symptom or 

manifestation of onset (or four years 

from such onset and two years from the 

date of death, in death cases), the 

Secretary believes that any person with 

a potential Table claim under Category 

XII would be time-barred. The statute of 

limitations available to certain 

petitioners for vaccines or injuries 

newly added to the Table under section 

2116(b) of the PHS Act, 42 U.S.C. 

300aa–16(b), would no longer be 

available for potential claims 

concerning the rotavirus vaccine 

because that section imposes a 

limitations period of two years from the 

effective date of the Table change. 

Although the CDC in 1999 

recommended that the only thenavailable rotavirus vaccine licensed in 

the U.S. (which was a live, oral, rhesusbased product), no longer be 

administered to infants in the U.S., FDA 

has subsequently licensed two 

additional rotavirus vaccines, and the 

excise tax passed for rotavirus vaccines 

remains in effect. Thus, the general 

category of rotavirus vaccines continues 

to be covered under the VICP under the 

Table’s Category XI for all newly 

licensed rotavirus vaccines. No 

corresponding injury/condition is listed 

in this category since no injuries have 

been associated with these products. 

Because the Table category of 

rotavirus vaccines with the associated 

injury of intussusception is no longer 

available to prospective petitioners, this 

interim final rule is an effort to 

minimize confusion relating to available 

Table categories. 

All petitions filed concerning 

rotavirus vaccines are still subject to the 

applicable statute of limitations. The 

filing limitations applicable to petitions 

filed with the VICP are set out in section 

2116(a) of the PHS Act (42 U.S.C. 

300aa–16(a)). Although section 2116(b) 

of the PHS Act lays out specific 

exceptions to these statutes of 

limitations that apply when the effect of 

a revision to the Table makes a 

previously ineligible person eligible to 

receive compensation or when an 

eligible person’s likelihood of obtaining 

compensation significantly increases, 

this change would not trigger that 

section. 

Justification for Omitting Notice of 

Proposed Rulemaking 

This amendment to 42 CFR 100.3 is 

technical in nature. As explained above, 

the Secretary believes that no persons 

have claims that could be pursued 

under the category that is being 

removed from the Table through this 

interim final rule. For this reason, the 

Secretary has determined under 5 U.S.C. 

553 and Departmental policy that it is 

unnecessary and impractical to follow 

proposed rulemaking procedures. 

Economic and Regulatory Impact 

Regulatory Flexibility Act and Executive 

Order 12866 

Executive Order 12866, as amended 

by Executive Orders 13258 and 13422, 

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, if a rule has a significant 

economic effect on a substantial number 

of small entities the Secretary must 

specifically consider the economic 

effect of a rule on small entities and 

analyze regulatory options that could 

lessen the impact of the rule. Executive 

Order 12866, as amended by Executive 

Orders 13258 and 13422, 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 Secretary has determined that no 

resources are required to implement the 

requirements in this Interim Final Rule. 

Therefore, in accordance with the 

Regulatory Flexibility Act of 1980 

(RFA), and the Small Business 

Regulatory Enforcement 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 Interim Final Rule does not 

meet the criteria for a major rule as 

defined by Executive Order 12866, as 

amended by Executive Orders 13258 

and 13422, and would have no major 

effect on the economy or Federal 

expenditures. The Secretary has 

determined that the Interim 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. 

Unfunded Mandates Reform Act of 1995 

Similarly, it will not have effects on 

State, local, and tribal governments and 

on the private sector such as to require 


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59530 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 

consultation under the Unfunded 

Mandates Reform Act of 1995. 

Federalism Impact Statement 

The Secretary has also reviewed this 

Interim Final Rule in accordance with 

Executive Order 13132 regarding 

federalism, and has determined that it 

does not have ‘‘federalism 

implications.’’ The Interim Final Rule 

would not have ‘‘substantial direct 

effects on the States, or on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ 

Impact on Family Well-Being 

This Interim Final Rule will not 

adversely affect the following family 

elements of family well-being: 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. As stated above, this Interim Final 

Rule will modify the Table included in 

the regulations governing the VICP 

based on legal authority. 

Impact of the New Rule 

This Interim Final Rule is technical in 

nature and will not prevent otherwise 

eligible individuals with claims of 

injuries or deaths allegedly resulting 

from rotavirus vaccines (including 

vaccines containing live, oral, rhesusbased rotavirus) from filing claims with 

the VICP. 

Paperwork Reduction Act 

This rule has no information 

collection requirements. 

List of Subjects in 42 CFR Part 100 

Biologics, Health insurance, and 

Immunization. 

Dated: July 30, 2007. 

Elizabeth M. Duke, 

Administrator, HRSA. 

Approved: June 23, 2008. 

Michael O. Leavitt, 

Secretary, HHS. 

Editorial Note: This document was 

received in the Office of the Federal Register 

on Monday, October 6, 2008. 

■ Accordingly, 42 CFR part 100 is 

amended as set forth below. 

PART 100—VACCINE INJURY 

COMPENSATION 

■ 1. The authority citation for 42 CFR 

part 100 continues to read as follows: 

Authority: Sec. 215 of the PHS Act (42 

U.S.C. 216); secs. 312 and 313 of Public Law 

99–660, 100 Stat. 3779–3782 (42 U.S.C. 

300aa–1 note); sec. 2114(c) and (e) of the PHS 

Act, 100 Stat. 3766 and 107 Stat. 645–646 (42 

U.S.C. 300aa–14(c) and (e)); sec. 904(b) of 

Public Law 105–34, 111 Stat. 873; sec. 1503 

of Public Law 105–277, 112 Stat. 2681–741; 

and sec. 523(a) of Public Law 106–170, 113 

Stat. 1927–1928. 

§ 100.3 [Amended] 

■ 2. Section 100.3 is amended as 

follows: 

■ A. In paragraph (a) in the Vaccine 

Injury Table remove Item XII and 

redesignate Items XIII and XIV as XII 

and XIII respectively. 

■ B. In paragraph (c)(3) remove the 

second sentence; in paragraph (c)(4) 

remove the words ‘‘(Item XIII of the 

Table)’’ and add in their place ‘‘(Item 

XII of the Table)’’; in paragraph (c)(5) 

remove the words ‘‘(Item XIV of the 

Table)’’ and add in their place ‘‘(Item 

XIII of the Table)’’. 

[FR Doc. E8–24017 Filed 10–8–08; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF TRANSPORTATION 

Maritime Administration 

46 CFR Part 393 

[Docket No. MARAD–2008 0096] 

RIN 2133–AB70 

America’s Marine Highway Program 

AGENCY: Maritime Administration, DOT. 

ACTION: Interim final rule with request 

for comments. 

SUMMARY: The purpose of this interim 

final rule is to solicit recommendations 

for short sea transportation routes to be 

designated as Marine Highway 

Corridors and to solicit applications 

from interested parties to participate in 

a short sea transportation Project, as 

required by section 55605(c) of Public 

Law 110–140, the Energy Independence 

and Security Act of 2007. Section 

55601(d) specifically states, that ‘‘[t]he 

Secretary may designate a project to be 

a short sea transportation project if the 

Secretary determines that the project 

may—offer a waterborne alternative to 

available landside transportation 

services using documented vessels; and 

provide transportation services for 

passengers or freight (or both) that may 

reduce congestion on landside 

infrastructure using documented 

vessels.’’ Further, section 55605 defines 

short sea transportation as meaning ‘‘the 

carriage by vessel of cargo that is 

contained in intermodal cargo 

containers and loaded by crane on the 

vessel or loaded on the vessel by means 

of wheeled technology; and that is 

loaded at a port in the United States and 

unloaded either at another port in the 

United States or at a port in Canada 

located in the Great Lakes Saint 

Lawrence Seaway System; or loaded at 

a port in Canada located in the Great 

Lakes Saint Lawrence Seaway System 

and unloaded at a port in the United 

States.’’ Section 55605(c) directs the 

Secretary of Transportation to 

promulgate interim regulations not later 

than 90 days after the date of enactment 

of this Act. The Secretary of 

Transportation will delegate authority to 

the Maritime Administrator to 

administer this program. Final 

regulations are to be issued no later than 

October 1, 2008. The program 

established in Section 55605 will be 

titled ‘‘America’s Marine Highway 

Program.’’ A final regulation will be 

published following this public 

comment period. Solicitations from 

applicants desiring Marine Highway 

Project designation will be initiated 

through notification in the Federal 

Register at a future date. 

DATES: 

The effective date of this interim 

regulation is November 10, 2008. Any 

further comments are due by February 

6, 2009. 

ADDRESSES: You may submit comments 

[identified by DOT Docket Number 

MARAD–2008–0096] by any of the 

following methods: 

• Web Site: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments 

on the electronic docket site. 

• Mail: Docket Management Facility; 

U.S. Department of Transportation, 1200 

New Jersey Avenue, SE., Room PL–401, 

Washington, DC 20590–0001. 

• Hand Delivery: Room PL–401 of the 

Department of Transportation, 1200 

New Jersey Avenue, SE., Washington, 

DC, between 9 am and 5 pm, Monday 

through Friday, except Federal holidays. 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

online instructions for submitting 

comments. 

Instructions: All submissions must 

include the agency name and docket 

number for this rulemaking. Note that 

all comments received will be posted 

without change to http:// 

www.regulations.gov including any 

personal information provided. Please 


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