Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Notices 19937 

regulatory/industry project to improve, 

through harmonization, the efficiency of 

the process for developing and 

registering new medicinal products in 

Europe, Japan and the United States 

without compromising the regulatory 

obligations of safety and effectiveness. 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for medical product 

development among regulatory 

agencies. ICH was organized to provide 

an opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. ICH is concerned with 

harmonization among three regions: The 

European Union, Japan, and the United 

States. The six ICH sponsors are the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 

Health, Labor and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and Health Canada, the 

European Free Trade Area and the 

World Health Organization. The ICH 

process has achieved significant 

harmonization of the technical 

requirements for the approval of 

pharmaceuticals for human use in the 

three ICH regions. 

The current ICH process and structure 

can be found at the following Web site: 

http://www.ich.org. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Oral presentations from the 

public will be scheduled between 

approximately 4:30 p.m. and 5 p.m. 

Time allotted for oral presentations may 

be limited to 10 minutes. Those desiring 

to make oral presentations should notify 

the contact person by April 27, 2007, 

and submit a brief statement of the 

general nature of the evidence or 

arguments they which to present, the 

names and addresses, phone number, 

fax, and e-mail of proposed participants, 

and an indication of the approximate 

time requested to make their 

presentation. 

The agenda for the public meeting 

will be made available via the internet 

at http://www.fda.gov/cder/meeting/ 

ICH_20060508.htm. 

Dated: April 12, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–1952 Filed 4–16–07; 3:25 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program: Addition of Meningococcal 

and Human Papillomavirus (HPV) 

Vaccines to the Vaccine Injury Table 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: Through this notice, the 

Secretary announces that 

meningococcal (conjugate and 

polysaccharide) and human 

papillomavirus (HPV) vaccines are 

covered vaccines under the National 

Vaccine Injury Compensation Program 

(VICP), which provides a system of nofault compensation for certain 

individuals who have been injured by 

covered childhood vaccines. This notice 

serves to include meningococcal and 

HPV vaccines as covered vaccines under 

Category XIV (new vaccines) of the 

Vaccine Injury Table (Table), which lists 

the vaccines covered under the VICP. 

This notice ensures that petitioners may 

file petitions relating to meningococcal 

and HPV vaccines with the VICP even 

before such vaccines are added as 

separate and distinct categories to the 

Table through rulemaking. 

DATES: This notice is effective on April 

20, 2007. As described below, 

meningococcal and HPV vaccines are 

covered under the VICP as of February 

1, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Geoffrey Evans, M.D., Division 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 

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 Public Health 

Service (PHS) Act, 42 U.S.C. 300aa–

14(e)(2). Consistent with section 

13632(a)(3) of Pub. L. 103–66, the 

regulations governing the VICP provide 

that such vaccines will be included as 

covered vaccines 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 two prerequisites for adding 

meningococcal (conjugate and 

polysaccharide) and HPV vaccines to 

the VICP as covered vaccines as well as 

to the Table have been satisfied. In its 

May 27, 2005, issue of the Morbidity 

and Mortality Weekly Report (MMWR), 

the CDC published its recommendation 

that meningococcal conjugate vaccines 

be routinely administered to young 

adolescents at the pre-adolescent visit 

(11–12 years olds). Additionally, for 

those individuals who have not 

previously received the meningococcal 

conjugate vaccine, the CDC has 

recommended vaccination before high 

school entry to further reduce the 

incidence of meningococcal disease in 

adolescents and young adults. The CDC 

also recommends routine vaccination 

for college freshmen who live in 

dormitories because they are at higher 

risk for meningococcal disease when 

compared with same aged cohorts. The 

use of meningococcal conjugate vaccine 

is preferred among persons aged 11–55 

years. If meningococcal conjugate 

vaccine is unavailable, meningococcal 

polysaccharide vaccine is an acceptable 

alternative for persons aged 11–55 years. 

Meningococcal polysaccharide vaccine 

is also recommended for children aged 

2–10 years and persons aged 55 years 

and older who are at increased risk for 

meningococcal disease. 

In its March 23, 2007, issue of the 

MMWR, the CDC published its 

recommendation that the HPV vaccine 

be routinely administered to females 

aged 11–12 years. The HPV vaccine can 

be administered to females as young as 

9 years. Vaccination is recommended 

for females aged 13–26 years who have 

not previously received the vaccine or 

who have not completed the full series. 

On December 20, 2006, the excise tax 

legislation for meningococcal and HPV 

vaccines was enacted by Pub. L. 109–

432, the ‘‘Tax Relief and Health Care 

Act of 2006 (the Act).’’ Section 408 of 

this Act adds all meningococcal and 


sroberts on PROD1PC70 with NOTICES
19938 Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Notices 

HPV vaccines to section 4132(a)(1) of 

the Internal Revenue Code of 1986, as 

amended, which defines all taxable 

vaccines. 

Under the regulations governing the 

VICP, Category XIV of the Table 

specifies that ‘‘[a]ny new vaccine 

recommended by the [CDC] for routine 

administration to children, after 

publication by the Secretary of a notice 

of coverage’’ is a covered vaccine under 

the Table (42 CFR 100.3(a), Item XIV). 

As explained above, the CDC issued its 

recommendation. This notice serves to 

satisfy the regulation’s publication 

requirement. Through this notice, 

meningococcal and HPV vaccines are 

included as covered vaccines under 

Category XIV of the Table. 

Under section 2114(e) of the PHS Act, 

as amended by section 13632(a) of the 

Omnibus Budget Reconciliation Act of 

1993, coverage for a vaccine 

recommended by the CDC for routine 

administration to children shall take 

effect upon the effective date of the tax 

enacted to provide funds for 

compensation with respect to the 

vaccine included as a covered vaccine 

in the Table. Under section 408 of the 

Tax Relief and Health Care Act of 2006, 

the effective date for the excise taxes 

enacted for meningococcal vaccines 

against meningococcal disease and the 

HPV vaccine against HPV disease and 

infection applies to sale and uses on or 

after ‘‘the first day of the first month 

which begins more than 4 weeks after 

the date of the enactment of this Act.’’

It further provides that if the vaccines 

were sold on or before the effective date 

of the excise tax, but delivered after this 

date, the delivery date of such vaccines 

shall be considered the sale date. 

Under this authorizing statutory 

language, the effective date for coverage 

of the meningococcal and HPV vaccines 

under the VICP is February 1, 2007. 

Thus, meningococcal and HPV vaccines 

are included as covered vaccines under 

Category XIV of the Table as of February 

1, 2007. Petitioners may file petitions 

related to meningococcal and HPV 

vaccines as of February 1, 2007. 

Petitions filed concerning vaccinerelated injuries or deaths associated 

with meningococcal and HPV vaccines 

must be filed within 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)). Persons who may be 

eligible must file petitions within: three 

(3) years from the first symptom or 

manifestation of onset of an injury or of 

the significant aggravation of the injury; 

or two (2) years from the date of a 

vaccine-related death and four (4) years 

after the start of the first symptom of the 

vaccine-related injury from which the 

death occurred. 

In addition, 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. Under this provision, persons 

who may be eligible to file petitions 

based on the addition of a new vaccine 

under Category XIV of the Table may 

file a petition for compensation not later 

than 2 years after the effective date of 

the revision if the injury or death 

occurred not more than 8 years before 

the effective date of the revision of the 

Table (42 U.S.C. 300aa–16(b)). Thus, 

persons whose petitions may not be 

timely under the limitations periods 

described in section 2116(a) of the PHS 

Act, may still file petitions concerning 

vaccine-related injuries or deaths 

associated with meningococcal and HPV 

vaccines until February 2, 2009, as long 

as the vaccine-related injury or death 

occurred on or after February 1, 1999 (8 

years prior to the effective date of the 

addition that included meningococcal 

vaccines and HPV as covered vaccines). 

Although two years from the date of 

February 1, 2007, would be February 1, 

2009, under the current Rules of the 

United States Court of Federal Claims, 

the deadline under section 2116(b) of 

the PHS Act would be February 2, 2009, 

because February 1, 2009, falls on a 

Sunday. 

The Secretary plans to amend the 

Table through the rulemaking process 

by including meningococcal and HPV 

vaccines as separate categories of 

vaccines in the Table. February 1, 2007, 

will remain the applicable effective date 

when the Secretary makes a 

corresponding amendment to add 

meningococcal and HPV vaccines as 

separate categories on the Table through 

rulemaking. 

Dated: April 16, 2007. 

Elizabeth M. Duke, 

Administrator. 

[FR Doc. E7–7591 Filed 4–19–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

National Heart, Lung, and Blood 

Advisory Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Advisory Council. 

Date: June 5, 2007. 

Open: 8:30 a.m. to 12 p.m. 

Agenda: To discuss program policies and 

issues. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 10, Bethesda, MD 20892. 

Closed: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 10, Bethesda, MD 20892. 

Contact Person: Stephen Mockrin, PhD., 

Director, Division of Extramural Research 

Activities, National Institutes of Health, 6701 

Rockledge Drive, Room 7100, Bethesda, MD 

20892, (301) 435–0260, 

mockrins@nhlbi.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: 

www.nhlbi.nih.gov/meetings/index.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 


sroberts on PROD1PC70 with NOTICES