1416 Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices 

Dated: December 24, 2014. 

Myles Vaughan, 

NEPA Program Manager, Facilities 

Management & Services Programs Division, 

U.S. GSA, Mid-Atlantic Region. 

[FR Doc. 2014–30791 Filed 1–8–15; 8:45 am] 

BILLING CODE 6820–89–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2015–0001] 

Proposed Revised Vaccine Information 

Materials for Multiple Pediatric 

Vaccines (‘‘Your Baby’s First 

Vaccines’’) 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: Under the National 

Childhood Vaccine Injury Act (NCVIA) 

(42 U.S.C. 300aa–26), the Centers for 

Disease Control and Prevention (CDC) 

within the Department of Health and 

Human Services (HHS) develops 

vaccine information materials that all 

health care providers are required to 

give to patients/parents prior to 

administration of specific vaccines. 

HHS/CDC seeks written comment on the 

proposed updated vaccine information 

statement for multiple pediatric 

vaccines. 

DATES: Written comments must be 

received on or before March 10, 2015. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2015– 

0001, by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Written comments should be 

addressed to Suzanne Johnson-DeLeon 

(msj1@cdc.gov), National Center for 

Immunization and Respiratory Diseases, 

Centers for Disease Control and 

Prevention, Mailstop A–19, 1600 Clifton 

Road NE., Atlanta, Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

docket number. All relevant comments 

received will be posted without change 

to http://www.regulations.gov, including 

any personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Skip 

Wolfe (crw4@cdc.gov), National Center 

for Immunization and Respiratory 

Diseases, Centers for Disease Control 

and Prevention, Mailstop A–19, 1600 

Clifton Road NE., Atlanta, Georgia 

30329. 

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 (VICP). 

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 Commission 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. 

Since then, the following vaccines have 

been added to the National Vaccine 

Injury Compensation Program, requiring 

use of vaccine information materials for 

them as well: Hepatitis B, Haemophilus 

influenzae type b (Hib), varicella 

(chickenpox), pneumococcal conjugate, 

rotavirus, hepatitis A, meningococcal, 

human papillomavirus (HPV), and 

seasonal influenza vaccines. 

Instructions for use of the vaccine 

information materials are found on the 

CDC Web site at: http://www.cdc.gov/

vaccines/hcp/vis/index.html. Copies of 

the Vaccine Information Statements are 

found in the docket at 

www.regulations.gov (Docket CDC– 

2015–0001) under ‘‘Supporting and 

Related Materials.’’ 

HHS/CDC is proposing an updated 

version of the multiple pediatric 

vaccines (‘‘Your Baby’s First Vaccines’’) 

vaccine information statement. 

The vaccine information materials 

referenced in this notice are being 

developed in consultation with the 

Advisory Commission on Childhood 

Vaccines, the Food and Drug 

Administration, and parent and health 

care provider groups. 

We invite written comment on the 

proposed vaccine information material 

entitled ‘‘Your Baby’s First Vaccines: 

What You Need to Know.’’ A copy of 

the proposed vaccine information 

statement is available at 

www.regulations.gov (see Docket ID 

CDC–2015–0001). Comments submitted 

will be considered in finalizing these 

materials. When the final materials are 

published in the Federal Register, the 

notice will include an effective date for 

their mandatory use. 

Dated: January 5, 2015. 

Ron A. Otten, 

Acting Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2015–00171 Filed 1–8–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Statement of Organization, Functions, 

and Delegations of Authority 

Part C (Centers for Disease Control 

and Prevention) of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (45 FR 67772–76, dated 

October 14, 1980, and corrected at 45 FR 

69296, October 20, 1980, as amended 

most recently at 79 FR 21760–21763, 

dated April 17, 2014) is amended to 

reflect the reorganization of the Office of 

Safety, Security and Asset Management. 

Section C–B, Organization and 

Functions, is hereby amended as 

follows: 

Delete items (1), (2) and (3) of the 

functional statement for the Office of 

Operations (CAJ13), Office of the 


rljohnson on DSK3VPTVN1PROD with NOTICES