Federal Register / Vol. 69, No. 230 / Wednesday, December 1, 2004 / Notices 69945

Place: The DoubleTree Club Hotel, 720 Las 

Flores Road, Livermore, California 94551, 

telephone 925/443–4950, fax 925/449–9059. 

Status:

Subcommittee Meeting Time and Date:

Open 8:30 a.m.–9:30 a.m., December 13, 

2004. 

Committee Meeting Times and Dates: Open 

9:45 a.m.–1 p.m., December 13, 2004; Closed 

1 p.m.–4:30 p.m., December 13, 2004; Open 

8 a.m.–4:30 p.m., December 14, 2004; Open 

7 p.m.–8:30 p.m., December 14, 2004; Open 

8:30 a.m.–4:30 p.m., December 15, 2004; The 

open portions of the meeting are limited only 

by the space available. The meeting room 

accommodates approximately 65 people.

Background 

The ABRWH was established under 

the Energy Employees Occupational 

Illness Compensation Program Act 

(EEOICPA) of 2000 to advise the 

President, on a variety of policy and 

technical functions required to 

implement and effectively manage the 

new compensation program. Key 

functions of the Board include 

providing advice on the development of 

probability of causation guidelines 

which have been promulgated by HHS 

as a final rule, advice on methods of 

dose reconstruction which have also 

been promulgated by HHS as a final 

rule, advice on the scientific validity 

and quality of dose estimation and 

reconstruction efforts being performed 

for purposes of the compensation 

program, and advice on petitions to add 

classes of workers to the Special 

Exposure Cohort (SEC). In December 

2000 the President delegated 

responsibility for funding, staffing, and 

operating the Board to HHS, which 

subsequently delegated this authority to 

the CDC. NIOSH implements this 

responsibility for CDC. The charter was 

issued on August 3, 2001, and renewed 

on August 3, 2003. 

Purpose 

This board is charged with (a) 

providing advice to the Secretary, HHS, 

on the development of guidelines under 

Executive Order 13179; (b) providing 

advice to the Secretary, HHS, on the 

scientific validity and quality of dose 

reconstruction efforts performed for this 

Program; and (c) upon request by the 

Secretary, HHS, advise the Secretary on 

whether there is a class of employees at 

any Department of Energy facility who 

were exposed to radiation but for whom 

it is not feasible to estimate their 

radiation dose, and on whether there is 

reasonable likelihood that such 

radiation doses may have endangered 

the health of members of this class. 

Matters to Be Discussed 

The agenda for this meeting will focus 

on Program Status Reports from NIOSH 

and the Department of Labor, Contract 

Process and Requirements, Board 

Discussion of Case Reviews, 

Subcommittee Report and 

Recommendations, Site Profile Review, 

NIOSH’s Response to Site Profile 

Review, SEC Petition Process 

Procedures, SEC Petition Evaluation 

Review Plan Workgroup Report, 

Scientific Research Issues Update, and a 

Board working session. There will be an 

evening public comment period 

scheduled for December 14, 2004, and a 

public comment period on December 

15, 2004. 

The Subcommittee will convene on 

December 13, 2004, from 8:30 a.m.–9:30 

a.m. and will focus on review of draft 

minutes and selection of Individual 

Dose Reconstruction Cases for Board 

Review. 

The closed portion of the meeting on 

December 13th will involve discussion 

of individual dose reconstruction case 

reviews, and is required to avoid the 

public disclosure of confidential 

information and claimant’s privacy. 

The agenda is subject to change as 

priorities dictate.

FOR FURTHER INFORMATION CONTACT:

Larry Elliott, Executive Secretary, 

ABRWH, NIOSH, CDC, 4676 Columbia 

Parkway, Cincinnati, Ohio 45226, 

telephone 513/533–6825, fax 513/533–

6826. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register

notices pertaining to announcements of 

meetings and other committee 

management activities for both CDC and 

the Agency for Toxic Substances and 

Disease Registry.

Dated: November 24, 2004. 

B. Kathy Skipper, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention.

[FR Doc. 04–26490 Filed 11–30–04; 8:45 am] 

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0062]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Color Additive Certification Requests 

and Recordkeeping

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Color Additive Certification Requests 

and Recordkeeping’’ has been approved 

by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 19, 2004 (69 FR 

42998), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0216. The 

approval expires on November 30, 2007. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: November 19, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26441 Filed 11–30–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program: Inclusion of Hepatitis A 

Vaccines in the Vaccine in the Injury 

Table

AGENCY: Health Resources and Services 

Administration (HRSA), HHS.

ACTION: Notice.

SUMMARY: Through this notice, the 

Secretary of Health and Human Services 

announces that Hepatitis A 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 Hepatitis A 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 Hepatitis A 

69946 Federal Register / Vol. 69, No. 230 / Wednesday, December 1, 2004 / Notices 

vaccines with the VICP even before such 

vaccines are added as a separate and 

distinct category to the Table through 

rulemaking.

DATES: This Notice is effective on 

December 1, 2004. As described below, 

Hepatitis A vaccines will be covered 

under the VICP on December 1, 2004.

FOR FURTHER INFORMATION CONTACT:

Geoffrey Evans, M.D., Medical 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) 443–4198.

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) to the 

Secretary 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 Public Law 103–

66, the regulations governing the VICP 

provide that such vaccines will be 

included in the Table as covered 

vaccines 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 

Hepatitis A vaccines to the VICP as 

covered vaccines as well as to the Table 

have been satisfied. First, the CDC 

published its recommendation that 

Hepatitis A vaccines be routinely 

administered to certain children in the 

October 1, 1999, issue of the Morbidity 

and Mortality Weekly Report (MMWR). 

Specifically, the CDC recommended that 

all children in States, counties, and 

communities with rates of Hepatitis A 

that are twice the 1987–1997 national 

average or greater (i.e., greater than or 

equal to 20 cases per 100,000 

population) receive the Hepatitis A 

vaccine. 

Second, on October 22, 2004, the 

excise tax for Hepatitis A vaccines was 

enacted by Public Law 108–357, the 

‘‘American Jobs Creation Act of 2004.’’

Section 889 of this Act adds all vaccines 

against Hepatitis A to section 4132(a)(1) 

of the Internal Revenue Code of 1986, 

which defines all taxable vaccines. 

Unlike the CDC’s recommendation, the 

American Jobs Creation Act of 2004 

does not distinguish between Hepatitis 

A vaccines administered in areas in 

which rates of Hepatitis A are at least 

twice the national average and Hepatitis 

A vaccines administered in other areas 

of the country. For this reason, all 

Hepatitis A vaccines manufactured or 

produced in the United States, or 

entered into the United States for 

consumption, use, or warehousing, will 

be subject to this excise tax (26 U.S.C. 

4132(a)(1)). 

Under the regulations governing the 

VICP, Item XIV of the Table specifies 

that ‘‘[a]ny new vaccine recommended 

by the Centers for Disease Control and 

Prevention 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’s recommendation was 

accepted. This notice serves to satisfy 

the regulation’s publication 

requirement. Through this notice, 

Hepatitis A vaccines are included as 

covered vaccines under Category XIV of 

the Table. As explained above, because 

the American Jobs Creation Act of 2004 

enacted an excise tax for Hepatitis A 

vaccines administered throughout the 

United States, all Hepatitis A vaccines 

will be covered under the VICP and 

under 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. The American Jobs 

Creation Act of 2004 provides that the 

addition of Hepatitis A vaccines to the 

list of taxable vaccines applies to sales 

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 

the Act. It further provides that if the 

vaccines were sold before or on the 

effective date of the excise tax, but 

delivered after this date, the delivery 

date of such vaccines shall be 

considered the sale date. Because the 

American Jobs Creation Act of 2004 was 

enacted on October 22, 2004, the 

effective date of the excise tax adding 

Hepatitis A vaccines as taxable vaccines 

is December 1, 2004. Thus, Hepatitis A 

vaccines are included as covered 

vaccines under Category XIV of the 

Table as of December 1, 2004. 

Petitioners may file petitions related to 

Hepatitis A vaccines as of December 1, 

2004. 

Petitions filed concerning vaccinerelated injuries or deaths associated 

with Hepatitis A vaccines must, of 

course, be filed within the applicable 

statute of limitations. The statutes of 

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)). 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, a person who may 

be eligible to file a petition 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 satisfy 

the limitations periods described in 

section 2116(a) of the PHS Act may still 

file petitions concerning vaccine-related 

injuries or deaths associated with 

Hepatitis A vaccines until December 1, 

2006, as long as the vaccine-related 

injury or death occurred on or after 

December 1, 1996 (8 years prior to the 

effective date of the addition that 

included Hepatitis A as a covered 

vaccine). 

The Secretary plans to amend the 

Table through the rulemaking process 

by including Hepatitis A vaccines as a 

separate category of vaccines in the 

Table. December 1, 2004, will remain 

the applicable effective date when the 

Secretary makes a corresponding 

amendment to add Hepatitis A vaccines 

as a separate category on the Table 

through rulemaking.

Dated: November 22, 2004. 

Elizabeth M. Duke, 

Administrator, HRSA.

[FR Doc. 04–26273 Filed 11–30–04; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of Laboratories Which 

Meet Minimum Standards To Engage in 

Urine Drug Testing for Federal 

Agencies

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS.

ACTION: Notice.

SUMMARY: The Department of Health and 

Human Services (HHS) notifies Federal 

agencies of the laboratories currently 

certified to meet the standards of 

subpart C of the Mandatory Guidelines