Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

# AGENCY:

Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (HHS/ASPE).

# ACTION:

Notice of Meeting. 

# SUMMARY:

This notice announces the date and location of a Town Hall meeting to be held on September 28, 2006 to obtain public comment on patient and physician concerns with access to IVIG. The Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation has contracted with Eastern Research Group, Inc. (ERG) to develop an analysis of supply, distribution, demand, and access issues associate with IVIG. This public meeting provides a forum for interested parties to make oral comments and to submit written comments about IVIG access for use in the analysis. In particular, comments are invited that will aid in the analysis of any physician or patient problems with access to IVIG, including the nature, size, and scope of any problems, as well as estimation of changes in health outcomes that may result from access problems.

# DATES:

The Town Hall meeting will be held on September 28, 2006 from 10 a.m. to 5 p.m.

# ADDRESSES:

Sheraton Crystal City Hotel, 1800 Jefferson Davis Highway, Arlington, VA.

# FOR FURTHER INFORMATION CONTACT:

Amber Jessup. Office of the Assistant Secretary for Planning and Evaluation, 200 Independence Ave., SW., Washington, DC 20201. Telephone: 202-690-6621.

*Web site:*                         Additional details regarding the Town Hall meeting process for public comments, along with information on how to register and guidelines for an effective presentation and/or electronic comment submission, can be found on the project Web site at                         *https://www2.ergweb.com/​projects/​conferences/​hhs.*

# SUPPLEMENTARY INFORMATION:

## I. Background

The Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation has contracted with Eastern Research Group, Inc. (ERG) to develop an analysis of supply, distribution, demand, and access issues associated with IVIG. As part of this analysis, a Town Hall meeting is being scheduled to obtain public comment on access issues to be used in the analysis.

Intravenous Immune Globulin (IVIG) is a plasma product that is used to treat patients with immune system disorders. Immune globulins are antibodies. IVIG has a number of on-label uses including treatment of humoral immunodeficiency, acute and chronic idiopathic thrombocytopenia purpura, B cell chronic lymphocytic leukemia (to prevent recurrent bacterial infections), Kawasaki disease, pediatric HIV, and bone marrow transplantation. It is also used for off-label treatments including autoimmune, neurological, and systemic inflammatory conditions. According to the Department of Health and Human Services Advisory Committee on Blood Safety and Availability, more than half of IVIG use may be for off-label indications. Due at least in part to the increase in off-label uses, demand for IVIG has increased in recent years. The number of infusion days in hospitals  increased to 70,000 days in 2004 from 40,000 days in 2002 and the number of grams infused in physician offices increased by 1.7 million grams, between 2003 and 2004, from 2.3 to 4.0 million grams.

                    IVIG is covered under Medicare Part B. In 2005, Medicare shifted from Average Wholesale Price (AWP) as the basis for reimbursement to Average                           ( print page 53096)                        Sales Price (ASP) as required by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). This shift reduced the reimbursement amount to physicians by 35 percent for the powder form of IVIG and by 15 percent for the liquid form of IVIG. Since January 2005, some patient advocacy groups and physicians have reported difficulty acquiring IVIG. The FDA Center for Biologics Evaluation and Research, however, has not identified a shortage of IVIG. There have also been reports of IVIG being diverted to secondary markets with increases in prices.                

The focus of the Town Hall meeting is on receiving information from stakeholders that will be helpful in the analysis. The Town Hall meeting will accept comments from all stakeholders, but is focused on patient and physician concerns with access to IVIG including:

(1) Patients switching IVIG products due to access problems,

(2) Changes in the administration location,

(3) Patients receiving fewer treatments,

(4) Patients receiving reduced dosages, and

(5) Reimbursement problems with IVIG products,

(6) Patients receiving reduced dosages, and

(7) Health consequences for patients of any access issues.

## II. Registration

                    Registration procedures: Registration can be completed online at                     *https://www2.ergweb.com/​projects/​conferences/​hhs/​.*                     To register by telephone, contact ERG's Conference Registration Line at 781-674-7374. The following information must be provided when registering: Name, organization name and address (if applicable), and consent to publish contact information on a participants list and other reports to document the Town Hall meeting. An ERG staff member will confirm your registration by mail, e-mail, or fax. Attendees may participate in person or by phone. If you wish to participate by phone, please indicate this in your registration and a call-in conference number will be provided in your registration confirmation. Attendees must register by September 21.                

## III. Comment Format

### a. “5-Minute” Public Comment

Meeting attendees can sign up on a first-come, first-served basis to present their comments (maximum of 5 minutes) via the meeting Web site when you register. Comments may be made in person or by phone. Commenters should focus on issues related to access to IVIG and quantify these impacts when possible. Commenters must provide their name, title, and organization (if applicable) on their registration and identify the topic area they will address. Presenters that can not attend in person can participate via phone. If you are unable to attend in person, you should indicate at registration that you wish to participate via phone. A call-in conference number will be provided to you in your registration confirmation.

### b. Written Comments From Meeting Attendees

                    Written comments are welcome from the public regardless of whether you attend the Town Hall Meeting or whether you make an oral presentation at the Town Hall Meeting. Written comments can be submitted either at the meeting, or before or after the meeting via e-mail to                     *meetings@erg.com*                     (subject: IVIG Meeting Comments). Or via regular mail to Attn: IVIG Meeting, ERG, 110 Hartwell Avenue, Lexington, MA 02421. Please note that electronic submissions are preferred due to delays in receiving US Postal Mail. We are able to consider only those comments received in writing and/or via e-mail by 5 p.m. EST on October 15, 2006.                

## IV. Special Accommodations

Individuals attending the meeting who are hearing- or visually-impaired and have special requirements, or a condition that requires special assistance or accommodations, must provide this information when registering for the meeting and accommodations will be made.

Dated: August 31, 2006.

Jerry Regier,

Principal Deputy Assistant Secretary for Planning and Evaluation, Office of the Assistant Secretary for Planning and Evaluation.

[FR Doc. 06-7510 Filed 9-7-06; 8:45 am]

BILLING CODE 4151-06-M