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
Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices 1417 

Director (CAJS1), Office of the Safety, 

Security and Asset Management (CAJS), 

and renumber the remaining items 

accordingly. 

Delete item (7) of the functional 

statement for the Physical Security 

Laboratory and Technical Branch 

(CAJSEB), Security Services Office 

(CAJSE), Office of the Safety, Security 

and Asset Management (CAJS), and 

renumber remaining items accordingly. 

Delete item (11) of the functional 

statement for the Physical Security 

Operations Branch (CAJSEC), Security 

Services Office (CAJSE), Office of the 

Safety, Security and Asset Management 

(CAJS), and renumber remaining items 

accordingly. 

After the mission statement for the 

Security Services Office (CAJSE), insert 

the following: 

Internal Emergency Management 

Branch (CAJSEE). To lead a 

comprehensive internal emergency 

management program that efficiently 

coordinates CDC resources to, first and 

foremost, protect lives, then to safeguard 

the environment and property through 

mitigation, preparedness training, 

response, continuity and recovery from 

all natural, man-made and technological 

hazards that may impact CDC facilities: 

(1) Implements, maintains, and updates 

CDC’s Occupant Emergency Plan/

Program (OEP); (2) conducts and 

evaluates annual tabletop, functional, 

and full-scale exercises for all CDC 

facilities with Designated Officials and 

Occupant Emergency Organizations 

(OEO); (3) recommends future 

emergency management and emergency 

response-related programs, policies, 

and/or procedures; (4) provides 

leadership and coordination in planning 

and implementation for internal 

emergencies; and (5) provides 

leadership and coordination in planning 

and implementation for internal 

emergency incidents affecting the CDC 

facilities, including incident response 

and support. 

James D. Seligman, 

Acting Chief Operating Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2015–00146 Filed 1–8–15; 8:45 am] 

BILLING CODE 4160–18–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 32739–32740, 

dated June 7, 2014) is amended to 

reflect the reorganization of the Global 

Immunization Division within the 

Center for Global Health. 

Section C–B, Organization and 

Functions, is hereby amended as 

follows: 

Delete in its entirety the title and the 

mission and function statements for the 

Global Immunization Division (CWK) 

and insert the following: 

Global Immunization Division (CWK). 

The Global Immunization Division 

(GID) protects the health of Americans 

and global citizens by preventing 

disease, disability, and death worldwide 

from vaccine-preventable diseases. In 

carrying out its mission, GID: (1) 

Provides national leadership and 

coordination of the Center for Global 

Health (CGH) efforts to eradicate polio; 

eliminate measles and rubella in World 

Health Organization (WHO) regions; 

strengthens global surveillance to 

prevent, detect, and respond to vaccine 

preventable diseases; strengthens 

routine immunization programs; 

introduces new and under-utilized 

vaccines; and promotes safe injection 

practices in collaboration with 

international organizations and CDC 

Centers/Institute/Offices (CIOs); (2) 

provides technical expertise to global 

partners—WHO, United Nations 

International Children’s Emergency 

Fund (UNICEF), Global Alliance for 

Vaccine Immunization (GAVI), and the 

Bill and Melinda Gates Foundation 

(BMGF)—involved in global 

immunization activities and participates 

in international advisory group 

meetings on immunization issues; (3) 

ensures provision of technical expertise 

on evidence-based research, strategies, 

and policy at global and country levels 

in collaboration with multilateral and 

bilateral partners; (4) collaborates with 

other countries and administers grants 

to WHO, Pan American Health 

Organization (PAHO), UNICEF, and 

other international partners and 

advocacy groups as appropriate for the 

provision of technical, programmatic, 

and laboratory support, and vaccine 

procurement for initiatives to support 

global immunization targets; (5) 

improves surveillance for polio, 

measles, rubella, and other vaccine 

preventable diseases by working with 

individual countries and the WHO 

regional offices to improve surveillance 

and to collaborate with groups within 

and outside CDC to expand 

environmental surveillance; (6) achieves 

global immunization targets by 

supporting the strengthening of the 

implementation of national 

immunization policies; (7) strengthens 

appropriate vaccination policy 

development and implementation, 

identifies barriers to vaccine acceptance, 

and develops communication strategies 

to promote vaccine uptake and disease 

reduction; (8) develops strategies to 

improve the technical skills and 

problem-solving abilities of program 

managers and health care workers in 

other countries; (9) prepares 

immunization articles based on findings 

for publication in international 

professional journals and for 

presentation at international 

conferences; and (10) provides technical 

and operational leadership for CDC’s 

activities in support of the initiatives. 

Office of the Director (CWK1). (1) 

Provides leadership, management, and 

oversight for all division activities 

including administrative, budget, 

finance, research, workforce 

development, management and 

operations; (2) assists leadership in the 

formulation and defense of GID budget 

requests, and monitors and seeks 

strategies to mitigate division risks; (3) 

provides coordination and oversight of 

the division’s personnel actions 

including liaison with CGH and CDC’s 

human resource office; (4) provides 

oversight for workforce planning, 

recruitment, deployment, field staff 

support, professional development, and 

monitoring and evaluation; (5) develops 

and promotes partnerships with other 

organizations to support global 

immunization activities and works 

closely with partners in academia; (6) 

liaises and coordinates with other CDC 

offices engaged in global immunization 

activities; (7) provides leadership and 

oversight for scientific and 

programmatic activities related to the 

implementation of GID’s objectives and 

ensures that the research and economic 

portfolios are integrated across the 

branches and with field activities; (8) 

identifies program policy priorities 

through strategic planning and other 

processes as appropriate; (9) clears all 

scientific publications from the division 

working in close collaboration with 

management of GID; (10) provides 

coordination of the division’s 

communications activities including 

liaison with other CDC communications 

offices and those of our partner 

agencies; (11) represents CDC, CGH, and 

the division at global and national 

meetings and other fora for global 

immunization activities; (12) provides 


rljohnson on DSK3VPTVN1PROD with NOTICES