19936 Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Notices 

Estimated Total Annual Burden 

Hours: 880. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for ACF. 

Dated: March 15, 2007. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 07–1976 Filed 4–19–07; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Help America Vote Act (HAVA) 

Voting Access Annual Report. 

OMB No.: New Collection. 

Description: An annual report is 

required by Federal statute (the Help 

America Vote Act (HAVA) of 2002, 

Public Law 107–252, Section 291, 

Payments for Protection and Advocacy 

Systems, 42 U.S.C. 15461). Each State or 

Unit of Local Government must prepare 

and submit an annual report at the end 

of every fiscal year. The report 

addresses the activities conducted with 

the funds provided during the year. The 

information collected from the annual 

report will be aggregated into an annual 

profile of how States have utilized the 

funds and establish best practices for 

election officials. It will also provide an 

overview of the State election goals and 

accomplishment and permit the 

Administration on Developmental 

Disabilities to track voting progress to 

monitor grant activities. 

Respondents: Secretaries of State, 

Directors, State Election Boards, State 

Chief Election officials. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Help America Vote Act (HAVA) Voting Access Annual Report ...................... 55 1 24 1,320 

Estimated Total Annual Burden 

Hours: 1,320. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. E-mail 

address: infocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after the publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collected should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: March 15, 2007. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 07–1977 Filed 4–19–07; 8:45am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Preparation for International 

Conference on Harmonization 

Meetings in Brussels, Belgium; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

ICH meetings in Brussels, Belgium’’ to 

provide information and receive 

comments on the International 

Conference on Harmonization (ICH) as 

well as the upcoming meetings in 

Brussels, Belgium. The topics to be 

discussed are the topics for discussion 

at the forthcoming ICH Steering 

Committee Meeting. The purpose of the 

meeting is to solicit public input prior 

to the next Steering Committee and 

Expert Working Groups meetings in 

Brussels, Belgium, May 5 through 10, 

2007, at which discussion of the topics 

underway and the future of ICH will 

continue. 

Date and Time: The meeting will be 

held on Thursday, May 3, 2007, from 

11:30 a.m. to 1 p.m. 

Location: The meeting will be held at 

5600 Fishers Lane, 3rd floor, Conference 

Room D, Rockville, MD 20857. For 

security reasons, all attendees are asked 

to arrive no later than 11:20 a.m., as you 

will be escorted from the front entrance 

of 5600 Fishers Lane to Conference 

Room D. 

Contact Person: All participants must 

register with Tammie Bell, Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, e-mail: 

Tammie.Bell2@fda.hhs.gov or fax: 301–

827–0003. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), written material and requests 

to make oral presentations, to the 

contact person by April 20, 2007. 

If you need special accommodations 

due to a disability, please contact 

Tammie Bell at least 7 days in advance. 

Transcripts: Transcripts of the 

meeting may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

12A–16, Rockville, MD 20857, 

approximately 15 working days after the 

meeting at a cost of 10 cents per page. 

SUPPLEMENTARY INFORMATION: The ICH 

was established in 1990 as a joint 


sroberts on PROD1PC70 with NOTICES
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