Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 51479 

1 The comment must be accompanied by an 

explicit request for confidential treatment, 

including the factual and legal basis for the request, 

and must identify the specific portions of the 

comment to be withheld from the public record. 

The request will be granted or denied by the 

Commission’s General Counsel, consistent with 

applicable law and the public interest. See 

Commission Rule 4.9(c), 16 CFR 4.9(c). 

2 Follow-on biologic drugs refer to those drugs 

that are sufficiently similar to an approved or 

Continued 

Open Session 

A. Approval of Minutes 

• June 12, 2008 

B. Business Reports 

• June 30, 2008 Financial Report 

• Report on Insured and Other 

Obligations 

• Quarterly Report on Annual 

Performance Plan 

C. New Business 

• Annual Performance Plan FY 2009– 

2010 

• Proposed 2009 and 2010 Budgets 

• Insurance Fund Progress Review 

and Setting of Premium Range Guidance 

for 2009 

Closed Session 

• Report on System Performance 

Dated: August 27, 2008. 

Roland E. Smith, 

Secretary, Farm Credit System Insurance 

Corporation Board. 

[FR Doc. E8–20380 Filed 9–2–08; 8:45 am] 

BILLING CODE 6710–01–P 

FEDERAL TRADE COMMISSION 

Public Workshops and Roundtables: 

Emerging Health Care Competition and 

Consumer Issues 

AGENCY: Federal Trade Commission 

ACTION: Notice of Public Workshops and 

Roundtables and Opportunity for 

Comment 

SUMMARY: The Federal Trade 

Commission (‘‘FTC’’ or ‘‘Commission’’) 

announces it will hold two workshops 

and roundtables in the fall of 2008 on 

emerging health care competition and 

consumer issues. They will focus on 

two distinct areas in which competition 

and consumer protection policies are 

implicated: (1) competition provided by 

developing an abbreviated regulatory 

approval pathway for follow-on biologic 

drugs; and (2) competition among health 

care providers based on quality 

information. The workshops and 

roundtables will be held at and 

administered by the FTC and their dates 

will be announced in a separate public 

notice. 

This notice poses a series of questions 

for which the FTC seeks public 

comment. The Commission will 

consider these comments as it prepares 

for the public workshops and 

roundtables. In the spring of 2009, the 

FTC will release a report that analyzes 

the potential impacts on the 

marketplace of various policy options in 

these two areas. 

DATES: Specific dates for the workshops 

and roundtables will be announced 

shortly, along with an agenda. 

Comments on the questions contained 

in this Notice must be received on or 

before September 30, 2008. In addition, 

any interested person may submit 

written comments to any of the topics 

addressed during the workshops. 

Comments directed at a particular 

subject considered in a workshop or 

roundtable must be received no later 

than 30 days after the date of that 

workshop or roundtable. 

ADDRESSES: Interested parties are 

invited to submit written comments 

electronically or in paper form. 

Comments should refer to ‘‘Emerging 

Health Care Competition and Consumer 

Issues—Comment, Project No. P083901’’ 

to facilitate the organization of the 

comments. Comments containing 

material for which confidential 

treatment is requested must be filed in 

paper form, must be clearly labeled 

‘‘Confidential,’’ and must comply with 

Commission Rule 4.9(c).1 Comments 

should not include any sensitive 

personal information, such as an 

individual’s Social Security Number; 

date of birth; driver’s license number or 

other state identification number or 

foreign country equivalent; passport 

number; financial account number; or 

credit or debit card number. Comments 

also should not include any sensitive 

health information, such as medical 

records and other individually 

identifiable health information. 

Because paper mail in the Washington 

area, and specifically to the FTC, is 

subject to delay due to heightened 

security screening, please consider 

submitting your comments in electronic 

form. Comments filed in electronic form 

should be submitted by using the 

following weblink: (http:// 

secure.commentworks.com/ftchealthcarecompetition) and following 

the instructions on the web-based form. 

If this Notice appears at http:// 

www.regulations.gov, you may also file 

an electronic comment through that 

website. The Commission will consider 

all comments that regulations.gov 

forwards to it. 

A comment filed in paper form 

should include the ‘‘Emerging Health 

Care Competition and Consumer 

Issues—Comment, Project No. P083901’’ 

reference both in the text and on the 

envelope, and should be mailed or 

delivered to the following address: 

Federal Trade Commission, Office of the 

Secretary, Room H-135 (Annex F), 600 

Pennsylvania Avenue, NW, Washington, 

DC 20580. 

The Federal Trade Commission Act 

(‘‘FTC Act’’) and other laws the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives, 

whether filed in paper or electronic 

form. Comments received will be 

available to the public on the FTC 

website, to the extent practicable, at 

(http://www.ftc.gov/os/ 

publiccomments.htm.) As a matter of 

discretion, the Commission makes every 

effort to remove home contact 

information for individuals from the 

public comments it receives before 

placing those comments on the FTC 

website. More information, including 

routine uses permitted by the Privacy 

Act, may be found in the FTC’s privacy 

policy, at www.ftc.gov/ftc/ 

privacy.shtmwww.ftc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Michael Wroblewski, Bureau of 

Competition, 600 Pennsylvania Avenue, 

N.W., Washington, D.C. 20580; 

telephone (202) 326-2435; e-mail: 

mwroblewski@ftc.gov. Detailed agendas 

for the workshop will be available on 

the FTC Home Page (http:// 

www.ftc.gov). 

SUPPLEMENTARY INFORMATION: Issues 

arising from the application of 

competition and consumer protection 

law to health care have tremendous 

significance for the U.S. economy and 

consumer/patient welfare. The 2004 

Federal Trade Commission and 

Department of Justice Report, 

‘‘Improving Health Care: A Dose of 

Competition’’ described the economic 

significance of health care to U.S. 

productivity. It has become even more 

so in the intervening four years. The 

Commission has an important role to 

play in health care markets through its 

missions of maintaining competition 

and protecting consumers. 

The Commission intends to focus on 

two emerging areas that implicate both 

its competition and consumer 

protection mission: (1) competition 

provided by developing an abbreviated 

regulatory approval pathway for followon biologic drugs;2 and (2) competition 


sroberts on PROD1PC70 with NOTICES
51480 Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 

referenced biologic product to permit the follow-on 

applicant to rely on existing scientific knowledge 

about the safety and effectiveness of the referenced 

biologic product to obtain approval of the followon product. A follow-on biologic drug is not 

necessarily interchangeable or substitutable at the 

pharmacy level with the referenced drug product. 

3 On May 2, 2008, the FTC responded to 

questions from the Subcommittee on Health of the 

Committee on Energy and Commerce relating to the 

creation of a pathway for FDA approval of followon biologic products. See (http:// 

energycommerce.house.gov/Press_110/110- 

ltr.050208.respto040308.FTC.pdf.) 

4 See FTC, Overview of FTC Antitrust Action in 

Pharmaceutical Services and Products (March 

2008), available at http://www.ftc.gov/bc/ 

0608rxupdate.pdf. 

among health care providers based on 

quality information. Through these 

workshops and roundtables the 

Commission intends to analyze the 

potential impacts on the marketplace of 

various policy options in these two 

areas.3

I. Competition Issues Involving Followon Biologic Drugs 

A. Regulatory Exclusivities and Followon Biologic Drug Competition 

One of the central questions in 

establishing an abbreviated regulatory 

approval pathway for follow-on biologic 

products involves how to strike the right 

balance between regulatory exclusivity 

periods and competition to spur the 

development of new, improved, and 

follow-on biologic drug products. The 

present regulatory scheme governing 

approval of non-biologic (or small 

molecule) generic pharmaceutical drug 

products offers innovator companies 

incentives through regulatory 

exclusivities that provide some degree 

of protection from new competition in 

the marketplace, separate and apart 

from whatever patent protection may 

exist. In addition, first generic drug 

applicants are eligible for a 180-day 

exclusivity period during which other 

generic drug applicants are precluded 

from receiving FDA approval to enter 

the market. The question arises whether, 

or to what the extent, these regulatory 

incentives should be adopted in creating 

a pathway for the approval of follow-on 

biologic drug products. The FTC invites 

comments on the following questions. 

1. What is the likely competitive 

effect of the market entry of a follow-on 

biologic competitor? Are there empirical 

models that predict the nature of this 

competition based on existing biologic 

drug product competition? How has 

competition developed between 

referenced and follow-on products in 

European markets? Would referenced 

product manufacturers lower their 

prices, offer discounts, and/or engage in 

enhanced marketing activities? 

2. What is the likely impact of a 

follow-on biologic product being 

designated ‘‘interchangeable’’ (i.e., 

receiving an approval that would permit 

pharmacists, without physician 

authorization, to fill a prescription for 

the referenced product with the followon product)? What are the prospects for 

the use of ‘‘authorized follow-on 

biologics’’ in these circumstances? Do 

the answers to these questions differ 

based on the type of biologic product 

involved? 

3. What competitive concerns are 

raised by joint research and 

development, supply, licensing, 

marketing, and distribution agreements 

between referenced biologic 

manufacturers and their follow-on 

biologic competitors? What would be 

the likely impact of a requirement that 

agreements between referenced drug 

product manufacturers and follow-on 

biologic applicants be filed with the 

FTC and the Department of Justice 

Antitrust Division? 

4. How would the prospect of 

competition from follow-on biologic 

drugs influence research and 

development for new biologic drugs, 

improvements to existing biologic 

drugs, and the timing and rollout of new 

and/or improved biologic drugs? Does 

the market experience with non-biologic 

generic pharmaceutical drug products 

provide insights into these issues? 

5. How does the method used by 

Medicare for reimbursement of biologic 

drug products affect pricing and 

competition of referenced biologic 

products? What factors are important for 

this effect and why? How would the 

Medicare reimbursement system likely 

affect prices for both the referenced and 

follow-on biologic products? For 

example, does Medicare reimburse Part 

B drugs, including biological drugs, 

based on the Average Sales Price of all 

the biological drugs whose National 

Drug Codes (NDCs) reference the same 

Biologic License Application (BLA)? If 

so, how would a follow-on biologic drug 

that does not reference the BLA of the 

referenced drug affect the Medicare 

reimbursed price for referenced drug 

product? How will these and other 

Medicare reimbursement methodologies 

likely affect models of price competition 

after follow-on biologic drug entry? 

6. How are the patent portfolios 

claiming biologic drugs similar or 

dissimilar to the patent portfolios that 

claim small molecule (nonbiologic) 

drugs approved under the federal Food, 

Drug, and Cosmetic Act (FDCA)? 

7. Are the regulatory exclusivities 

currently provided to pharmaceutical 

drug products in the FDCA appropriate 

for new biologic drugs and/or 

significant improvements to existing 

biologic products? Are they appropriate 

for specific types of biologics? Why or 

why not? 

8. What are the appropriate factors to 

consider when determining the optimal 

length of regulatory exclusivity periods 

for biologic drug products? Do these 

factors change based on the type of 

referenced product involved, the extent 

of competition facing the referenced 

product, or patent portfolios claiming 

the referenced product, and if so, how? 

9. How does the European Medicines 

Agency’s approach to regulatory 

exclusivities in its abbreviated 

regulatory approval pathway for followon biologics inform the U.S. approach? 

10. Is a marketing exclusivity period 

necessary to encourage companies to 

develop follow-on biologics and to seek 

their approval by the FDA? If so, why, 

and how should such an exclusivity 

period be structured? 

B. Patent Dispute Resolution Issues 

One of the features of the HatchWaxman Amendments to the FDCA is a 

regulatory structure that encourages the 

initiation of patent litigation early in the 

FDA approval process for a generic drug 

application that challenges a patent 

claiming the innovator’s drug product (a 

Paragraph IV application). Since 1998, 

the FDA has faced many fact situations 

that have required the agency to 

interpret this aspect of the HatchWaxman regulatory scheme. Many of 

these interpretations have been 

challenged by industry participants, 

resulting in substantial court review of 

the FDA’s decisions. Moreover, the FTC 

has taken numerous enforcement 

actions against brand and generic drug 

manufacturers that have allegedly 

abused this regulatory structure.4 In 

light of these experiences, the FTC 

invites comments on the following 

questions and topics. 

1. Would it be important to have the 

litigation of any patent disputes proceed 

concurrently with the abbreviated FDA 

approval process for follow-on 

biologics? Why or why not? What has 

been learned from the experience under 

Hatch-Waxman about the incentives 

necessary to encourage early resolution 

of patent issues? 

2. How long might the approval 

process for a follow-on biologic 

application take? What factors might 

influence this timing? 

3. How might differences between 

patent portfolios for small molecule 

drugs and biologics affect patent 

litigation involving follow-on biologics? 

How long might patent litigation 

involving a follow-on biologic product 

take? 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 51481 

4. When is it in the interest of a 

referenced biologic drug manufacturer 

to resolve patent issues prior to 

marketing by a follow-on applicant? 

When is it in the interest of a follow-on 

biologic applicant to resolve patent 

issues prior to marketing its follow-on 

biologic? When is it in the interest of 

either party to resolve patent issues 

following commercial marketing of the 

follow-on product? 

5. What are the legal impediments 

facing a follow-on biologic applicant 

that has not been sued for infringement 

to obtaining a declaratory judgment on 

patent infringement or invalidity issues 

prior to commercial marketing of its 

follow-on product? 

6. Are regulatory exclusivities needed 

to encourage follow-on biologic 

applicants to challenge patents? Why or 

why not? 

7. What opportunities will biologic 

drug manufacturers and follow-on 

applicants have to manipulate proposed 

new regulatory obligations (e.g., 

application notification obligations, 

declarations of patents claiming biologic 

drugs, etc.) and exclusivity periods 

surrounding a concurrent patent 

resolution process? What are the 

prospects for the improper use of citizen 

petitions to delay approval of follow-on 

biologic applications? 

8. How might referenced biologic 

product manufacturers and follow-on 

biologic applicants structure patent 

settlement agreements given the 

competitive dynamics arising from the 

marketing of follow-on biologic drugs? 

What incentives might exist for these 

companies to enter anticompetitive 

settlements? Should patent settlement 

agreements be filed with the antitrust 

agencies? What would be the likely 

effect of the filing requirement on 

settlements? 

II. Competitive Significance of Health 

Care Quality Information 

Competition in health care markets is 

enhanced when purchasers have 

information to help evaluate the cost 

and quality of the services purchased. 

The 2004 Health Care Report found, 

however, that information regarding 

health care prices and quality is often 

difficult to measure and obtain and is 

not necessarily reliable. A 2008 FTC 

Workshop on Innovations in Health 

Care Delivery considered ongoing issues 

about health care price and quality 

transparency. Panelists at the 2008 

Workshop discussed the potential 

importance to consumers of relevant 

price information, including out-ofpocket price information. Also 

discussed were forms of transparency 

that may be anticompetitive. For 

instance, public disclosure of 

confidential contract rates between 

providers and payers could be 

anticompetitive because it could foster 

coordinated pricing. The FTC seeks to 

build on its 2008 Workshop to explore 

further the competitive significance of 

qualitative health care information from 

the purchasers’ viewpoint (i.e., the 

demand side). The FTC will explore 

whether or how quality information can 

be used to help purchaser decision 

making. The FTC will examine the 

extent to which there is demand is for 

high quality health care, the attributes of 

quality information that motivate 

purchasers to select high quality 

providers, and the ramifications of 

quality-based competition on the 

availability of health care. Along these 

lines, the FTC will explore whether 

providers delivering high quality 

services are rewarded with more 

business (and/or greater revenue) and 

whether those failing to do so either 

improve or are penalized with less 

business (and/or lower revenue). In this 

context, purchasers include consumers, 

employers, insurers, hospitals, doctors, 

and others who can use quality 

information in their decision making. 

The FTC also will examine the costs and 

benefits of different federal policies that 

could be used to facilitate the 

measurement, collection, and reporting 

of health care provider quality 

information to these various purchasers. 

The FTC invites comments on the 

following issues and topics set out 

below. The FTC encourages comments 

that analyze the results of recent 

experiments, demonstration projects, 

and initiatives designed to report health 

care quality measures to various types of 

purchasers. 

A. Purchaser Decision Making and 

Quality Information 

1. What decisions do quality 

information help different types of 

purchasers make? 

2. What are the relevant times at 

which purchasers make health care 

decisions? What quality information 

about health care services and providers 

should be presented at these critical 

junctures? 

3. What quality information is the 

most competitively significant for 

different types of purchasers? Are 

different types of data (e.g., licensing 

information, compliance with process 

measures, customer satisfaction, 

outcomes, outcomes per dollar spent) 

appropriate for different purchasers and 

purchaser decisions? How should any 

differences in measurement of the same 

provider or service (over the same time 

frame) be reconciled? 

4. Does health care quality vary based 

by medical condition, provider, and 

patient? Does it vary over time? If so, 

how should quality measures be 

adjusted to take these differences into 

account? 

5. What information is needed to 

measure the efficiency of a provider? 

What is the proper weighting of quality 

and resource use in an efficiency 

measure? 

6. How broad a range of differences 

among health care providers and 

services is needed to motivate 

purchasers to switch service providers? 

7. How should regional variations be 

accounted for in showing the results of 

quality measures? Should local, state, 

regional, or national benchmarks be 

used to show differences among service 

providers? Why or why not? 

8. How does the framing of quality 

information affect the purchasers’ 

decisions? Do symbols and summaries 

affect purchaser understanding of health 

care quality information? 

9. What has been learned from public 

and private quality reporting initiatives 

that can aid the competitive process? 

10. What are the tradeoffs between 

quality-based competition and the 

availability of health care? 

B. Barriers To Developing and 

Implementing Quality Measures 

1. What barriers—clinical, 

marketplace, regulatory, or other— 

restrict the measurement, collection, 

and reporting of health care quality 

information? Can health care quality be 

measured such that it is of value to 

purchasers in their decision making? 

2. Do providers and insurers have 

business reasons to develop and 

implement public reporting of quality 

measures? 

3. How should quality measurements 

deal with organizational variation on 

the supply side (e.g., solo physician 

practitioners, small physician groups, 

integrated physician groups, etc.). If so, 

how should the measures be adjusted to 

consider this variation? 

4. How does the development of 

reimbursement and payment reform 

affect the development of quality 

measurements? 

5. Several private and public entities 

have developed standards to measure 

health care quality. Are concerns about 

provider capture of these organizations 

relevant in this context? 

C. Federal Policies To Facilitate Quality 

Information Collection and Reporting 

1. What federal policies can help 

overcome any marketplace barriers to 

the measurement, collection, and 

reporting of quality information? 


sroberts on PROD1PC70 with NOTICES
51482 Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 

2. How can government use its role as 

a payer (e.g., Medicare, Medicaid) to 

facilitate the development and use of 

quality information more broadly? 

3. What are the costs and benefits of 

a single entity developing the quality 

measures, collecting and analyzing the 

data, and reporting the results? What are 

the costs and benefits of governmental 

involvement in these activities? 

4. How should federal, state, and 

private sector efforts to measure and 

report on health care quality be 

harmonized so that purchasers obtain 

the benefits of cost and quality 

information? 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. E8–20399 Filed 9–2–08: 8:45 am] 

BILLING CODE 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; 

American Health Information 

Community Electronic Health Records 

Workgroup Meeting 

ACTION: Announcement of meeting. 

SUMMARY: This notice announces the 

25th meeting of the American Health 

Information Community Electronic 

Health Records Workgroup in 

accordance with the Federal Advisory 

Committee Act (Pub. L. 92–463, 5 

U.S.C., App.) 

DATES: September 10, 2008, from 1 p.m. 

to 4 p.m. [Eastern] 

ADDRESSES: Mary C. Switzer Building 

(330 C Street, SW., Washington, DC 

20201), Conference Room 1114. Please 

use the C Street entrance closest to 3rd 

Street and bring photo ID for entry to a 

Federal building. 

FOR FURTHER INFORMATION CONTACT: 

http://www.hhs.gov/healthit/ahic/ 

healthrecords/. 

SUPPLEMENTARY INFORMATION: The 

Workgroup will continue its discussion 

on ways to achieve widespread 

adoption of certified EHRs, minimizing 

gaps in adoption among providers. 

The meeting will be available via Web 

cast. For additional information, go to: 

http://www.hhs.gov/healthit/ahic/ 

healthrecords/ehr_instruct.html. 

Dated: August 13, 2008. 

Judith Sparrow, 

Director, American Health Information 

Community, Office of Programs and 

Coordination, Office of the National 

Coordinator for Health Information 

Technology. 

[FR Doc. E8–20328 Filed 9–2–08; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; 

American Health Information 

Community Quality Workgroup 

Meeting 

ACTION: Announcement of meeting. 

SUMMARY: This notice announces the 

20th meeting of the American Health 

Information Community Quality 

Workgroup in accordance with the 

Federal Advisory Committee Act (Pub. 

L. 92–463, 5 U.S.C., App.) 

DATES: September 5, 2008, from 2 p.m. 

to 4 p.m. [Eastern] 

ADDRESSES: Mary C. Switzer Building 

(330 C Street, SW., Washington, DC 

20201), Conference Room 1114. Please 

use the C Street entrance closest to 3rd 

Street and bring photo ID for entry to a 

Federal building. 

FOR FURTHER INFORMATION CONTACT: 

http://www.hhs.gov/healthit/ahic/ 

quality/. 

SUPPLEMENTARY INFORMATION: The 

Workgroup will continue its discussion 

on how health information technology 

can provide the data needed for the 

development of quality measures that 

are useful to patients and others in the 

health care industry, automate the 

measurement and reporting of a 

comprehensive current and future set of 

quality measures, and accelerate the use 

of clinical decision support that can 

improve performance on those quality 

measures. 

The meeting will be available via Web 

cast. For additional information, go to: 

http://www.hhs.gov/healthit/ahic/ 

quality/quality_instruct.html. 

Dated: August 16, 2008. 

Judith Sparrow, 

Director, American Health Information 

Community, Office of Programs and 

Coordination, Office of the National 

Coordinator for Health Information 

Technology. 

[FR Doc. E8–20330 Filed 9–2–08; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; 

American Health Information 

Community Chronic Care Workgroup 

Meeting 

ACTION: Announcement of meeting. 

SUMMARY: This notice announces the 

26th meeting of the American Health 

Information Community Chronic Care 

Workgroup in accordance with the 

Federal Advisory Committee Act (Pub. 

L. 92–463, 5 U.S.C., App.) 

DATES: September 8, 2008, from 1 p.m. 

to 4 p.m., Eastern Time. 

ADDRESSES: Mary C. Switzer Building 

(330 C Street, SW., Washington, DC 

20201), Conference Room 1114. Please 

use the C Street entrance closest to 3rd 

Street and bring photo ID for entry to a 

Federal building. 

FOR FURTHER INFORMATION CONTACT: 

http://www.hhs.gov/healthit/ahic/ 

chroniccare/. 

SUPPLEMENTARY INFORMATION: The 

Workgroup will discuss progress made 

to date and future steps regarding secure 

messaging and remote care as it relates 

to the transition to the new AHIC. 

The meeting will be available via Web 

cast. For additional information, go to: 

http://www.hhs.gov/healthit/ahic/ 

chroniccare/cc_instruct.html. 

Dated: August 11, 2008. 

Judith Sparrow, 

Director, American Health Information 

Community, Office of Programs and 

Coordination, Office of the National 

Coordinator for Health Information 

Technology. 

[FR Doc. E8–20331 Filed 9–2–08; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; 

American Health Information 

Community Confidentiality, Privacy, & 

Security Workgroup Meeting 

ACTION: Announcement of meeting. 

SUMMARY: This notice announces the 

22nd meeting of the American Health 

Information Community Confidentiality, 

Privacy, & Security Workgroup in 

accordance with the Federal Advisory 

Committee Act (Pub. L. 92–463, 5 

U.S.C., App.) 

DATES: September 11, 2008, from 1 p.m. 

to 5 p.m. [Eastern Time]. 


sroberts on PROD1PC70 with NOTICES