82400 Federal Register / Vol. 75, No. 250 / Thursday, December 30, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Stakeholders Meeting To Provide 

Updates on NIOSH-Funded Research, 

Certification and Standards, Educate 

Participants on Resources To 

Reinforce the Proper Use of NIOSHCertified Respirators, and Explore 

Personal Protective Technology Use in 

Industry Sectors 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention (CDC), Department of 

Health and Human Services (HHS). 

ACTION: Notice of a public meeting. 

SUMMARY: The National Institute for 

Occupational Safety and Health 

(NIOSH), Personal Protective 

Technology (PPT) Program and National 

Personal Protective Technology 

Laboratory (NPPTL) will conduct a 

stakeholders meeting to provide updates 

on NIOSH-funded research, certification 

and standards, educate participants on 

resources to reinforce the proper use of 

NIOSH-certified respirators, and explore 

personal protective technology use in 

industry sectors. In addition, conformity 

assessment (certification and standards) 

needs and gaps relative to the personal 

protective technology will be discussed 

at this meeting. 

DATES: The public meeting will be held 

8 a.m. to 5 p.m., March 29, 2011. 

ADDRESSES: The public meeting will be 

held at Hyatt Regency Pittsburgh 

International Airport, 1111 Airport 

Boulevard, Pittsburgh, PA 15231, 

telephone 724–899–1234. 

FOR FURTHER INFORMATION CONTACT: Ed 

Fries, NPPTL, Office of the Director, 

P.O. Box 18070, Pittsburgh, PA 15236, 

telephone 412–386–6111, fax 412–386– 

4951, E-mail npptlevents@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Status: The meeting will be open to 

the public, limited only by the space 

available. The meeting room 

accommodates approximately 200 

people. Preregistration is recommended. 

This meeting will also be available 

through remote access capabilities 

(Microsoft Live Meeting), whereby 

participants simultaneously listen and 

view presentations over the internet. 

This option will be available to 

participants on a first-come, first-serve 

basis and is limited to the first 100 

participants. Preregistration for this 

option is required. 

Instructions: Registration and 

additional Information is available on 

the NIOSH NPPTL Web site, http:// 

www.cdc.gov/niosh/npptl or by 

contacting NIOSH NPPTL Office of the 

Director, P.O. Box 18070, Pittsburgh, PA 

15236, telephone 412–386–6111, fax 

412–386–6617, E-mail 

npptlevents@cdc.gov. 

Background: While this meeting will 

highlight the personal protective 

technology related to the four 

industries, the information and 

technology is relevant and can be 

transferred to other industries. 

Discussions will highlight the 

following four occupational sectors: 

1. Agriculture—Discussions will focus 

on identifying solutions to major 

barriers for appropriate PPE use 

practices that occur in pesticide 

handling in agricultural crop 

production. Discussions will use a 

process flow approach for focusing on 

each of the critical stages for PPE use in 

pesticide handling. Potential barriers 

and regulations, such as those identified 

from brainstorming meetings of the 

NIOSH PPE Surveillance and 

Intervention Program for Agricultural 

Pesticide Handlers, that may influence 

safe performance will be highlighted. 

Stakeholders will provide their input, 

clarify barriers and help identify 

solutions for future development. The 

goal of these discussions is to bring 

diverse stakeholders together to discuss 

barriers to appropriate PPE use and to 

jointly formulate and develop creative 

solutions. 

2. Mining—One session will focus on 

technologies to improve current selfcontained self-rescuer (SCSR) designs 

and mine rescue ensembles. 

Presentations from researchers, 

manufacturers, and users will focus on 

SCSR design improvements and 

technologies to address user needs. The 

second session will focus on best 

practices learned from ensemble users, 

performance requirements for mine 

rescue ensembles and identification of 

existing limitations and current best 

practices. 

3. Healthcare—PPE use and usability 

issues in acute care and community 

healthcare settings and the alignment of 

current and recommended PPT research 

to narrow knowledge gaps, reduce 

exposures, and improve healthcare 

worker proper use and compliance will 

be emphasized. These sessions will 

explore respiratory protective 

equipment use and application issues as 

well as use and application issues with 

other types of PPE commonly used in 

healthcare, including integrated 

ensembles. 

4. Public Safety—These sessions will 

focus on personal protective technology 

applications, performance/certification 

standards and use related to the fire 

service and law enforcement 

communities. Two breakout sessions 

will be conducted, one for fire service 

and one for law enforcement. The fire 

service-related breakout session will 

include issues and requirements related 

to the design, certification, inspection of 

firefighting personal protection 

ensembles, and NIOSH research 

supporting use of protective ensembles 

and respiratory protective equipment by 

the fire service. The law enforcement 

breakout session will address 

performance requirements and 

standards for law enforcement 

protective ensembles with a focus on 

CBRN hazards. The CBRN Protective 

Ensemble Standard for Law 

Enforcement released by the National 

Institute for Justice in late 2010 will be 

discussed. 

Dated: December 21, 2010. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–32964 Filed 12–29–10; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Development of Health Risk 

Assessment Guidance; Public Forum 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of Public Meeting. 

SUMMARY: On November 16, 2010, the 

Centers for Disease Control and 

Prevention (CDC), located within the 

Department of Health and Human 

Services (HHS), published a notice in 

the Federal Register (75 FR 70009) 

requesting public comment to assist 

development of guidance for Health 

Risk Assessments (HRAs). Section 4103 

of the Affordable Care Act (ACA) (Pub. 

L. 111–148) requires that a Health Risk 

Assessment be included in the annual 

wellness visit benefit authorized for 

Medicare beneficiaries under the ACA. 

CDC is collaborating with the Centers 

for Medicare and Medicaid Services 

(CMS), also located within HHS, in the 

development of guidance for this type of 

assessment. This guidance is also 

intended to be useful for HRAs 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 250 / Thursday, December 30, 2010 / Notices 82401 

conducted in other patient populations, 

including those persons covered by 

employer healthcare plans. In the 

November 16, 2010 notice, CDC also 

announced that it would hold a public 

forum in early February 2011 to obtain 

additional public comment. Today’s 

notice announces the public forum. 

DATES: The public forum will be held 

on: 

Tuesday, February 1, 2011, from 

9 a.m. to 5 p.m. EST and Wednesday, 

February 2, 2011, from 9 a.m. to 5 p.m. 

EST. 

ADDRESSES: The Public Forum will be 

held at the Centers for Disease Control 

and Prevention, Roybal Campus, Tom 

Harkin Global Communications Center, 

Building 19, Auditorium A, 1600 Clifton 

Road, NE., Atlanta, Georgia 30333. 

Upon entering the campus visitors 

must stop at the CDC Visitor’s Center 

parking guard station. Visitors will be 

asked for identification and the purpose 

of the visit. Please be aware that your 

vehicle is subject to search before being 

allowed to enter the facility. A 

government-issued photo ID is required 

for entry for all adults over the age of 

16. Acceptable forms of identification 

include a valid driver’s license, a 

passport or a state-issued photo 

identification card. Parking spaces for 

visitors are available in the parking lot 

adjacent to the CDC Visitor’s Center 

(Building 19). Once inside the CDC 

Visitor’s Center, visitors will be asked to 

show their picture ID again and a 

visitor’s badge will be issued. Those 

who have registered in advance will 

have a visitor’s badge waiting and entry 

will be expedited. Non-U.S. citizens 

(including permanent residents) must 

register in advance. Please note, this is 

a working Federal Facility. Please 

follow the guards’ directions. 

Backpacks, suitcases or large containers 

are prohibited and photography is 

restricted. 

Please visit our Web site for 

additional information on security and 

for directions to the facility (http:// 

www.cdc.gov/museum/security.htm). 

CDC will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Paula Staley 

at (404) 639–0210 at least 7 days in 

advance of the meeting. 

Registration: Participants are 

encouraged to pre-register for the Public 

Forum. On-line registration and a draft 

agenda is available at: http:// 

www.cdc.gov/policy. As space is 

limited, registration by January 7, 2011 

is strongly encouraged. 

FOR FURTHER INFORMATION CONTACT: 

Paula Staley, Office of Prevention 

through Healthcare, Office of the 

Associate Director for Policy, Centers for 

Disease Control and Prevention, 1600 

Clifton Road, NE., Atlanta, Georgia 

30333; phone: (404) 639–0210. 

SUPPLEMENTARY INFORMATION: Section 

4103 of the Affordable Care Act (ACA) 

requires that a Health Risk Assessment 

(HRA) be included in the annual 

wellness visit benefit authorized for 

Medicare beneficiaries under the ACA. 

CDC is collaborating with the Centers 

for Medicare and Medicaid Services 

(CMS) in the development of guidance 

for this type of assessment. This 

guidance is also intended to be useful 

for HRAs conducted in other patient 

populations such as privately insured 

populations, including those persons 

covered by employer healthcare plans. 

Currently there is considerable variation 

in available HRAs, with the majority 

created to support employer-based 

health and wellness programs. Several 

instruments have been created for use in 

research and are not available in the 

marketplace; and the scientific rigor of 

HRA tools is not always evident. 

Therefore, the development of HRA 

guidance is essential for effective 

implementation of this part of the 

Medicare wellness visit and to support 

broader HRA use within primary care. 

Agenda: The meeting will open with 

presentations related to background 

information on the elderly population, 

HRAs and the HRA guidance 

development. The meeting will consist 

of panel presentations for each of the 

areas of emphasis which are listed in 

this notice as well as in the November 

16, 2010 Federal Register notice. 

Participants attending the public forum 

will be invited to provide comment at 

the end of each half day of the meeting. 

The final agenda and panelists’ 

presentations will be made available to 

the public no later than two business 

days before the meeting. If CDC is 

unable to post the presentations on its 

Web site prior to the meeting, the 

material will be made publicly available 

at the location of the meeting. The final 

agenda and panelists’ presentations will 

be available at http://www.cdc.gov/ 

policy. The agenda is subject to change 

without notice. 

Areas of Emphasis: 

Content and Design 

• Risk assessment domains—What 

are generic elements of any HRA and 

what elements must be tailored to 

specific populations, particularly those 

stratified by age? 

• How should literacy and other 

cultural appropriateness factors be 

factored into the design? 

• Should the HRA instrument 

support shared decision-making by 

provider and patient? If so, how? 

Mode of Administration 

• How will individuals access the 

HRA (e.g., via kiosk or some other 

means in the physician’s office, internet, 

mail-in paper form, other nontraditional healthcare locations, such as, 

kiosk in a pharmacy)? 

• What are the cultural 

appropriateness factors in patient HRA 

access? 

Primary Care Office Capacity 

• What primary care office capacity 

(personnel, Information Technology 

(IT), etc.) is required to utilize HRA data 

effectively in support of personalized 

prevention planning? 

• Is training and technical assistance 

necessary for effective practice 

utilization of an HRA? What entity 

should provide this technical 

assistance? 

• What are potential or demonstrated 

community care transition linkages— 

follow-up outside the office by other 

providers—that help patients and 

providers manage priority risks 

identified by the HRA? 

• What is the current practice of HRA 

in medical practices of various sizes, 

particularly those with five or fewer 

physicians? 

Consumer/Patient Perspective 

• How could HRA data be shared 

with the patients for their feedback and 

follow up in the primary care practice? 

• What role, if any, do incentives play 

in motivating patients to take the HRA 

and/or participate in follow-up 

interventions? 

Data 

• With respect to IT, how could HRA 

data entered in any form populate 

electronic health records, and what 

special challenges and solutions occur if 

the data are entered in a non-electronic 

form? 

• Are there standardized and certified 

tools available to support this data 

migration from multiple data entry 

sources? 

Certification 

• What certification tools and 

processes should complement the HRA 

standards and how should they be made 

available to support primary care office 

selection of an HRA instrument? 


jlentini on DSKJ8SOYB1PROD with NOTICES
82402 Federal Register / Vol. 75, No. 250 / Thursday, December 30, 2010 / Notices 

Evaluation and Quality Assurance 

• How should the HRA standards be 

evaluated and updated with respect to 

individual and population-level 

(practice-based panel management) 

health outcomes? 

Procedure: Interested persons may 

present data, information, or views 

orally or in writing, on topics listed in 

this Federal Register notice. Written 

submissions for the public comment 

period may be made to the contact 

person on or before January 18, 2011. 

Oral presentations from the public will 

be scheduled during 30-minute public 

comment periods at the end of each half 

day of proceedings, i.e., from 11:30 a.m. 

to 12 noon and 4:30 p.m. to 5 p.m. on 

Tuesday, February 1, 2011 and 

Wednesday, February 2, 2011. Those 

individuals interested in making formal 

oral comments should notify the contact 

person and submit a brief statement of 

the general nature of the comments they 

wish to present and the names and 

addresses of proposed participants on or 

before January 11, 2011. Each 

commenter will be limited to 3–5 

minutes. The CDC is not responsible for 

providing access to electrical outlets. 

Individuals who have not submitted 

comments ahead of time will have the 

opportunity to sign up to comment 

during registration on the day of the 

forum. However, if time does not allow 

for all interested parties to comment, 

individuals who have submitted their 

comments ahead of time will be given 

preference. If the number of participants 

requesting to comment is greater than 

can be reasonably accommodated, the 

CDC may conduct a lottery to determine 

the speakers for the scheduled open 

public comment sessions. The contact 

person will notify interested persons 

regarding their request to comment by 

January 18, 2011. 

Public forum participants not 

receiving an opportunity to comment 

during the open public comment period 

may submit their comments to OPTH 

mailbox at: http://www.cdc.gov/policy. 

CDC will make all comments it receives 

available to the public without change, 

including personal information you may 

provide, which includes the name of the 

person submitting the comment or 

signing the comment on behalf of an 

organization, business, or any such 

entity. If anyone does not wish to have 

this information published, then that 

information should not be included 

when submitting the comment. 

Dated: December 21, 2010. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–32963 Filed 12–29–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Proposed Consolidated Vaccine 

Information Materials for Multiple 

Infant 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 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 is available to be used by 

vaccination providers as an alternative 

to providing the six individual Vaccine 

Information Statements for the same 

vaccines. 

DATES: Written comments are invited 

and must be received on or before 

February 28, 2011. 

ADDRESSES: Written comments should 

be addressed to Jennifer Hamborsky, 

National Center for Immunization and 

Respiratory Diseases, Centers for 

Disease Control and Prevention, 

Mailstop E–52, 1600 Clifton Road, NE., 

Atlanta, Georgia 30333. 

FOR FURTHER INFORMATION CONTACT: Skip 

Wolfe, National Center for 

Immunization and Respiratory Diseases, 

Mailstop E–52, 1600 Clifton Road, NE., 

Atlanta, Georgia 30333, telephone (404) 

639–8809. 

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 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. 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES