50820 Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices 

Company/Jayhawk Works near 

Pittsburg, Kansas, as an addition to the 

Special Exposure Cohort (SEC) under 

the Energy Employees Occupational 

Illness Compensation Program Act of 

2000. On August 15, 2008, the Secretary 

of HHS designated the following class of 

employees as an addition to the SEC: 

All Atomic Weapons Employer (AWE) 

employees who worked at Spencer Chemical 

Company/Jayhawk Works near Pittsburg, 

Kansas, from January 1, 1956 through 

December 31, 1961 for a number of work 

days aggregating at least 250 work days 

occurring either solely under this 

employment or in combination with work 

days within the parameters established for 

one or more other classes of employees in the 

Special Exposure Cohort. 

This designation will become 

effective on September 14, 2008, unless 

Congress provides otherwise prior to the 

effective date. After this effective date, 

HHS will publish a notice in the 

Federal Register reporting the addition 

of this class to the SEC or the result of 

any provision by Congress regarding the 

decision by HHS to add the class to the 

SEC. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health (NIOSH), 4676 

Columbia Parkway, MS C–46, 

Cincinnati, OH 45226, Telephone 513–

533–6800 (this is not a toll-free 

number). Information requests can also 

be submitted by e-mail to 

OCAS@CDC.GOV. 

Dated: August 22, 2008. 

Christine M. Branche, 

Acting Director, National Institute for 

Occupational Safety and Health. 

[FR Doc. E8–19967 Filed 8–27–08; 8:45 am] 

BILLING CODE 4160–17–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–08–08AL] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

The Natural History of Spina Bifida in 

Children Pilot Project-New-National 

Center on Birth Defects and 

Developmental Disabilities (NCBDDD), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

Spina Bifida (SB) is one of the most 

common birth defects, affecting 

approximately 2 per 10,000 live births 

in the United States annually. To date, 

there are no U.S. population-based 

cohort studies or programs on the 

natural history of SB. This is of 

importance because persons with SB 

often experience condition-specific 

difficulties and secondary conditions 

that detrimentally affect several aspects 

of their lives. The long-term purpose of 

this project is to increase the knowledge 

about the natural history of Spina Bifida 

by prospectively studying children who 

were born with this potentially 

disabling condition. We estimate to 

enroll approximately 40 parents with a 

child with Spina Bifida ages 3-, 4-, or 5- 

years of age, and 20 of the children of 

these forty parents. The data to be 

collected will relate to medical concerns 

prevalent among individuals with Spina 

Bifida in the areas of neurology/ 

neurosurgery, urology, and orthopedics; 

development and learning; nutrition 

and physical growth; mobility and 

functioning; general health; and family 

demographics. Families interested in 

participating can choose between 

participating in a phone survey (no 

more than 45 minutes) or an in-person 

assessment (no more than 3 hrs). For 

families who participate in the inperson assessment (estimated to be 

twenty of the forty families), the child 

will also be invited to participate in a 

child-appropriate assessment. 

Data will also be collected on the 

actual recruitment process. Results from 

the project will be evaluated and 

disseminated to provide guidance for 

states that are interested in following 

children with Spina Bifida 

prospectively. The proposed project is 

the initial step to document the 

development, the health status, and the 

onset of complications among children 

with SB in order that effective 

interventions may be identified that will 

ameliorate the course of this complex, 

multi-system condition. Long-term 

results will help determine if it would 

be beneficial to systematically screen 

children with Spina Bifida for certain 

health-related educational and 

developmental problems that these 

children are at an increased risk of 

experiencing and at what age such a 

screening should be performed. 

There will be no cost to the 

respondents other than their time. The 

total estimated annualized burden hours 

are 97. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average burden per 

response 

(in hours) 

Parents (phone survey) ............................................................................................................... 20 1 45/60 

Parents (in-person assessment) .................................................................................................. 20 1 2.5 

Child (in-person assessment) ...................................................................................................... 20 1 1.5 

SB Clinic Coordinator (recruitment effort) ................................................................................... 1 1 2 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices 50821 

Dated: August 22, 2008. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E8–19968 Filed 8–27–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Consolidated Vaccine Information 

Materials for Multiple Infant Vaccines; 

Revised Instructions for Use of 

Vaccine Information Statements 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: Under the National 

Childhood Vaccine Injury Act (NCVIA) 

(42 U.S.C. § 300aa–26), the CDC must 

develop vaccine information materials 

that all health care providers are 

required to give to patients/parents prior 

to administration of specific vaccines. 

CDC seeks written comment on a 

proposed new vaccine information 

statement that consolidates the six 

vaccine information statements for the 

following childhood vaccines: DTaP, 

Haemophilus influenzae type b, 

inactivated polio vaccine, 

pneumococcal conjugate vaccine, 

hepatitis B, and rotavirus. This 

consolidated Vaccine Information 

Statement would be available to be used 

by vaccination providers as an 

alternative to providing the six 

individual Vaccine Information 

Statements for the same vaccines. On 

October 4, 2007, CDC published a notice 

in the Federal Register (72 FR 56765) 

seeking public comments on the 

proposed consolidated vaccine 

information materials. The 60 day 

comment period ended on December 3, 

2007. Following review of the 

comments submitted and consultation 

as required under the law, CDC has 

finalized these vaccine information 

materials. The final materials, and 

revised instructions for their use and for 

use of materials for other covered 

vaccines, are contained in this notice. 

DATES: Beginning August 28, 2008, each 

health care provider who administers 

vaccine that contains diphtheria, 

tetanus, pertussis, hepatitis B, 

pneumococcal conjugate, inactivated 

polio, Haemophilus influenzae type b, 

or rotavirus vaccines may, prior to 

administration of each dose of these 

vaccines, provide a copy of the vaccine 

information materials contained in this 

notice, dated January 30, 2008, to the 

parent or legal representative of any 

child to whom such provider intends to 

administer the vaccines, in lieu of 

providing vaccine information materials 

for each individual vaccine. 

FOR FURTHER INFORMATION CONTACT: 

Anne Schuchat, M.D., Director, National 

Center for Immunization and 

Respiratory Diseases, Centers for 

Disease Control and Prevention, 

Mailstop E–05, 1600 Clifton Road, NE., 

Atlanta, Georgia 30333, telephone (404) 

639–8200. 

SUPPLEMENTARY INFORMATION: The 

National Childhood Vaccine Injury Act 

of 1986 (Pub. L. 99–660), as amended by 

section 708 of Public Law 103–183, 

added section 2126 to the Public Health 

Service Act. Section 2126, codified at 42 

U.S.C. 300aa–26, requires the Secretary 

of Health and Human Services to 

develop and disseminate vaccine 

information materials for distribution by 

all health care providers in the United 

States to any patient (or to the parent or 

legal representative in the case of a 

child) receiving vaccines covered under 

the National Vaccine Injury 

Compensation Program. 

Development and revision of the 

vaccine information materials, also 

known as Vaccine Information 

Statements (VIS), have been delegated 

by the Secretary to the Centers for 

Disease Control and Prevention (CDC). 

Section 2126 requires that the materials 

be developed, or revised, after notice to 

the public, with a 60-day comment 

period, and in consultation with the 

Advisory Committee on Childhood 

Vaccines, appropriate health care 

provider and parent organizations, and 

the Food and Drug Administration. The 

law also requires that the information 

contained in the materials be based on 

available data and information, be 

presented in understandable terms, and 

include: 

(1) A concise description of the 

benefits of the vaccine, 

(2) a concise description of the risks 

associated with the vaccine, 

(3) a statement of the availability of 

the National Vaccine Injury 

Compensation Program, and 

(4) such other relevant information as 

may be determined by the Secretary. 

The vaccines initially covered under 

the National Vaccine Injury 

Compensation Program were diphtheria, 

tetanus, pertussis, measles, mumps, 

rubella and poliomyelitis vaccines. 

Since April 15, 1992, any health care 

provider in the United States who 

intends to administer one of these 

covered vaccines is required to provide 

copies of the relevant vaccine 

information materials prior to 

administration of any of these vaccines. 

Hepatitis B, Haemophilus influenzae 

type b (Hib), varicella (chickenpox), 

pneumococcal conjugate, hepatitis A, 

meningococcal conjugate and 

polysaccharide, rotavirus, human 

papillomavirus (HPV), and trivalent 

influenza vaccines have subsequently 

been added to the National Vaccine 

Injury Compensation Program. Use of 

the Vaccine Information Statements 

applicable to all of these vaccines, 

[except meningococcal, rotavirus and 

HPV,] is also required. [(Interim 

versions of Vaccine Information 

Statements for meningococcal, rotavirus 

and HPV vaccines are available for 

discretionary use pending completion of 

the statutory process for finalizing VISs 

applicable to those vaccines.)] 

Instructions for use of the vaccine 

information materials and copies of the 

materials can be found on the CDC Web 

site at: http://www.cdc.gov/vaccines/ 

pubs/vis. In addition, single cameraready copies are available from State 

health departments. A list of State 

health department contacts for obtaining 

copies of these materials is included in 

a December 17, 1999 Federal Register 

notice (64 FR 70914). 

Consolidated Vaccine Information 

Materials 

With six vaccines recommended for 

infants from birth through 6 months of 

age—all covered by the National 

Vaccine Injury Compensation 

Program—CDC, as required under 42 

U.S.C. 300aa–26, developed Vaccine 

Information Statements for each of those 

vaccines. CDC proposed an alternative 

consolidated Vaccine Information 

Statement covering those six vaccines in 

one document, which providers could 

choose to use instead of the existing 

individual Vaccine Information 

Statements for the same vaccines. 

Following consultation as required 

under the law and review of comments 

submitted, these vaccine information 

materials have been finalized and are 

contained in this notice. They are 

entitled Your Baby’s First Vaccines: 

What You Need to Know, and are dated 

January 30, 2008. CDC has also revised 

the Instructions for the Use of Vaccine 

Information Statements. The revised 

instructions, dated May 12, 2008, are 

included in this notice. These 

instructions and copies of the materials 

for all covered vaccines can also be 

found on the CDC Web site at: http:// 

www.cdc.gov/vaccines/pubs/VIS. 

* * * * * 


jlentini on PROD1PC65 with NOTICES