Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices 56767 

Dated: September 8, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–23430 Filed 9–13–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10334] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Application for 

Coverage in the Pre-Existing Condition 

Insurance Plan; Use: The Department of 

Health and Human Services (HHS) 

Centers for Medicare & Medicaid 

Services, Center for Consumer 

Information and Insurance Oversight is 

requesting clearance by the Office of 

Management and Budget for 

modifications to this previously 

approved collection package. These 

changes are being requested to (1) 

provide a mechanism for a PCIP 

enrollee who has moved from a stateadministered PCIP to quickly and 

efficiently enroll into the federallyadministered PCIP (2) provide a 

mechanism for a PCIP applicant to 

identify a third party entity will pay 

their premium to ensure appropriate 

premium billing (3) provide a 

mechanism whereby a licensed 

insurance agent or broker may identify 

their referral of an applicant (4) request 

employer information to expand ways to 

identify and prevent instances of insurer 

dumping and (5) make clarifications to 

existing application language. Form 

Number: CMS–10334 (OCN: 0938–1095) 

Frequency: Once; Affected Public: 

Individuals or households; Number of 

Respondents: 83,333; Number of 

Responses: 83,333; Total Annual Hours: 

179,499. (For policy questions regarding 

this collection, contact Laura Dash at 

410–786–8623. For all other issues call 

(410) 786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on October 14, 2011 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov. 

Dated: September 8, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–23429 Filed 9–13–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9980–NC] 

Request for Information Regarding 

State Flexibility To Establish a Basic 

Health Program Under the Affordable 

Care Act 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Request for information. 

SUMMARY: This notice is a request for 

information regarding section 1331 of 

the Affordable Care Act, which provides 

States with the option to establish a 

Basic Health Program. This option 

permits States to enter into contracts to 

offer one or more ‘‘standard health 

plans’’ providing at least the essential 

health benefits described in section 

1302(b) of the Affordable Care Act to 

eligible individuals in lieu of offering 

such individuals coverage through the 

Affordable Insurance Exchange 

(Exchange). 

DATES: Comment Date: To be assured 

consideration, responses must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

October 31, 2011. 

ADDRESSES: In responding, please refer 

to file code CMS–9980–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit responses in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–9980–NC, P.O. Box 8016, 

Baltimore, MD 21244–8016. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–9980–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

mstockstill on DSK4VPTVN1PROD with NOTICES

56768 Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244– 

1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Shaina Rood, (301) 492–4422. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Section 1331(a) of the Patient 

Protection and Affordable Care Act 

(Pub. L. 111–148), as amended by the 

Health Care and Education 

Reconciliation Act of 2010 (Pub. L. 111– 

152), referred to collectively as the 

Affordable Care Act, directs the 

Secretary of Health and Human Services 

(the Secretary) to establish a Basic 

Health Program under which States may 

enter into contracts with one or more 

standard health plans that provide 

health coverage to eligible individuals 

in lieu of offering such individuals 

coverage through the Exchange. For 

States choosing this option, section 

1331(a)(2) of the Affordable Care Act 

provides that the Secretary certify that 

the amount of the monthly premium 

charged to eligible individuals enrolled 

in a plan under contract under this 

program, called a standard health plan, 

does not exceed the amount of the 

monthly premium that an eligible 

individual would have paid if he or she 

were to receive coverage from the 

applicable benchmark plans (as defined 

in section 36B(b)(3)(B) of the Internal 

Revenue Code of 1986) through the 

Exchange. This section also directs the 

Secretary to certify that cost-sharing 

does not exceed the standards specified 

in section 1331(a)(2)(A)(ii) of the 

Affordable Care Act. 

Section 1331(b) of the Affordable Care 

Act defines a standard health plan as 

one selected by the State that: (1) Only 

enrolls applicants who are determined 

eligible using the eligibility standards 

specified in section 1331(e) of the 

Affordable Care Act; (2) covers at least 

the essential health benefits described 

in section 1302(b) of the Affordable Care 

Act; and (3) in the case of a plan that 

provides health insurance coverage 

offered by a health insurance issuer, has 

a medical loss ratio of at least 85 

percent. 

Section 1331(c) of the Affordable Care 

Act specifies that a Basic Health 

Program will establish a competitive 

process for entering into contracts with 

standard health plans, including 

negotiation of premiums, cost-sharing, 

and benefits in addition to the essential 

health benefits. The statute provides 

that the State include in its competitive 

process the inclusion of innovative 

features such as care coordination and 

care management for enrollees, 

incentives for the use of preventive 

services, and the establishment of 

relationships between providers and 

patients that maximize patient 

involvement in health care decisionmaking. The contracting process shall 

also take into consideration, and make 

suitable allowances for, the differences 

in the health care needs of enrollees and 

the differences in local availability of, 

and access to, health care providers. 

Section 1331(c)(2) of the Affordable 

Care Act provides that the competitive 

process shall also include contracting 

with managed care systems, or with 

systems that offer as many of the 

attributes of managed care as are 

feasible in the local health care market. 

The competitive contracting process 

shall also include the establishment of 

specific performance measures and 

standards for issuers that focus on 

quality of care and improved health 

outcomes. Section 1331(c)(3) provides 

that a State shall, to the maximum 

extent feasible, seek to make multiple 

standard health plans available to 

ensure individuals have a choice of 

such plans. It also provides that a State 

may negotiate a regional compact with 

other States to include coverage of 

eligible individuals in all such States in 

agreements with issuers of standard 

health plans. 

Section 1331(c)(4) of the Affordable 

Care Act directs a State choosing to 

establish a Basic Health Program to 

coordinate the administration of a Basic 

Health Program with Medicaid, the 

Children’s Health Insurance Program 

(CHIP), and other State-administered 

health programs. 

Section 1331(d)(1) of the Affordable 

Care Act allows the Secretary to transfer 

Federal funds to a State that establishes 

a Basic Health Program in accordance 

with the standards of the program under 

section 1331(a). Section 1331(d)(2) of 

the Affordable Care Act directs that a 

State establish a trust fund for the 

deposit of the Federal funds it receives 

for its Basic Health Program, and 

specifies that the amounts in the trust 

may only be used to reduce the 

premiums and cost-sharing of, or to 

provide additional benefits for, eligible 

individuals enrolled in standard health 

plans within a Basic Health Program. 

Section 1331(d)(3) of the Affordable 

Care Act specifies that a State that 

operates a Basic Health Program will 

receive 95 percent of the amount of 

premium tax credits, and the costsharing reductions, that would have 

been provided to (or on behalf of) 

eligible individuals enrolled in standard 

health plans through a Basic Health 

Program, if the eligible individuals were 

instead enrolled in qualified health 

plans (QHP) through the Exchange and 

receiving premium tax credits and costsharing reductions. To determine the 

amount of payment, the Secretary shall 

take into account all relevant factors 

necessary to determine the amount that 

would have been provided to eligible 

individuals as specified in 1331(d)(3), 

including, but not limited to, whether 

any reconciliation of the credit or costsharing reductions would have occurred 

if the enrollee had been so enrolled. 

Section 1331(d)(3) also provides that 

the determination shall also take into 

consideration the experience of other 

States with respect to participation in an 

Exchange and such credits and 

reductions provided to residents of the 

other States, with a special focus on 

enrollees with income below 200 

percent of poverty. Additionally, the 

Secretary shall adjust the amount of 

payment for any fiscal year to reflect 

any error in the determinations for any 

preceding fiscal year. 

Section 1331(e) of the Affordable Care 

Act specifies eligibility standards for a 

Basic Health Program. To be determined 

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Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices 56769 

eligible for a Basic Health Program, an 

individual must: 

(1) Be a resident of a State 

participating in a Basic Health Program; 

(2) Be eligible for enrollment in a QHP 

through the Exchange but for the 

existence of a Basic Health Program; 

(3) Not be eligible to enroll in the 

State’s Medicaid program under title 

XIX of the Social Security Act (the Act), 

for benefits that at a minimum consist 

of the essential health benefits described 

in section 1302(b) of the Act; 

(4) Have a household income that 

exceeds 133 percent but does not exceed 

200 percent of the Federal poverty level 

(FPL), or, for a non-citizen lawfully 

present who is not eligible for Medicaid 

based on immigration status, a 

household income that is not greater 

than 133 percent of the FPL; 

(5) Not be eligible for minimum 

essential coverage or is eligible for an 

employer-sponsored plan that is not 

affordable coverage; and 

(6) Not have attained age 65 as of the 

beginning of the plan year. 

Section 1331(f) of the Affordable Care 

Act directs the Secretary to conduct an 

annual review of each State Basic 

Health Program to ensure that it 

complies with the standards of section 

1331. Through this annual review, the 

State will provide information to 

demonstrate that its Basic Health 

Program meets: (1) Eligibility 

verification standards for participation 

in the program; (2) standards for the use 

of Federal funds received by the 

program; and (3) quality and 

performance standards. 

As specified in section 1331(g) of the 

Affordable Care Act, a standard health 

plan offeror may be a licensed health 

maintenance organization, a licensed 

health insurance insurer, or a network 

of health care providers established to 

offer services under the program; the 

statute provides authority for the State 

to determine eligibility to offer a 

standard health plan. 

II. Request for Information 

Section 1321(a)(2) of the Affordable 

Care Act directs the Secretary to consult 

with stakeholders to ensure balanced 

representation among interested parties 

in issuing regulations to implement 

programs pursuant to title I. The 

Department of Health and Human 

Services has consulted with 

stakeholders through regular meetings 

with the National Association of 

Insurance Commissioners, regular 

contact with States through the 

Exchange grant process, and meetings 

with tribal representatives, health 

insurance issuers, trade groups, 

consumer advocates, employers, and 

other interested parties. This 

consultation will continue throughout 

the development of guidance and 

regulations related to the Basic Health 

Program. 

As such, we are requesting 

information to aid in the development 

of standards for the establishment and 

operation of a Basic Health Program. To 

assist in responding, this request for 

information describes the specific areas 

where input is particularly requested. 

Specifically, we ask for responses to 

the questions below to provide the 

Secretary with relevant information for 

the development of guidance and 

regulations regarding the Basic Health 

Program. However, it is not necessary 

for respondents to address every 

question below and respondents may 

also address additional issues about the 

Basic Health Program that are not listed 

here. Individuals, groups, and 

organizations interested in providing 

responses may do so at their discretion 

by following the above mentioned 

instructions. 

A. General Provisions 

1. What are some of the major factors 

that States are likely to consider in 

determining whether to establish a Basic 

Health Program? Are there additional 

flexibilities, advantages, costs, savings 

or challenges for the State and/or 

consumer that would make this option 

more or less attractive to States? If so, 

what are they? 

2. What are key considerations for 

States in placing responsibility for a 

Basic Health Program within the State 

organizational structure? 

3. What are the challenges and costs 

associated with managing a Basic Health 

Program? 

4. Are States that are exploring the 

Basic Health Program considering 

implementation for 2014, or for later 

years? What are the key tasks that need 

to be accomplished, and within what 

timeframes, to implement the Basic 

Health Program in a timely fashion? 

What kinds of business functions will 

need to be operational before 

implementation, and how soon will 

they need to be operational? Are there 

opportunities to leverage existing 

systems and increase efficiency within 

the State structure? To what extent have 

States begun developing business plans 

or budgets relating to Basic Health 

Program implementation? 

5. To what extent have States already 

begun to assess whether to establish a 

Basic Health Program? What internal 

and/or external entities are involved, or 

will likely be involved in this planning 

process? 

6. What guidance or information 

would be helpful to States, plans, and 

other stakeholders as they begin the 

planning process? What other terms or 

provisions need additional clarification 

to facilitate implementation and 

compliance? What specific clarifications 

would be helpful? 

7. How can the Administration 

provide technical assistance? What 

form(s) of technical assistance would be 

most helpful to States? 

B. Standard Health Plan Standards and 

Standard Health Plan Offerors 

1. What additional standards, if any, 

should standard health plans 

participating in a State’s Basic Health 

Program meet? What consumer 

protections should be included? How 

should quality and performance be 

measured? 

2. What plan design issues should be 

considered? How likely is it for a State 

to consider an expanded benefit package 

beyond the essential health benefits for 

standard health plans participating in a 

State’s Basic Health Program? What are 

the advantages and disadvantages of an 

expanded benefit package for standard 

health plans compared to qualified 

health plans? 

3. What is the expected impact of 

standard health plans on provider 

payments and consumer access? 

C. Contracting Process 

1. What innovative features should 

States consider when negotiating 

through the contracting process with 

standard health plans to participate in a 

Basic Health Program? 

2. What considerations exist in 

determining whether to utilize the 

regional compact authority in Section 

1331(c)(3)(B) of the Affordable Care Act? 

Are States interested in pursuing this 

approach? 

D. Coordination With Other State 

Programs 

1. What is the expected impact of a 

Basic Health Program on the Exchange’s 

purchasing power and viability? How 

might States organize a Basic Health 

Program with respect to purchasing 

structure? 

2. What is the expected impact of a 

Basic Health Program on plans 

participating in the Exchange in terms 

of risk profile, enrollment, and premium 

stability? What is the expected impact 

on overall coverage? 

3. What are some of the major factors 

that States are likely to consider in 

determining how to structure their Basic 

Health Program? Are States likely to 

structure the Basic Health Program as 

one component of its other public 

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56770 Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices 

programs? Are States likely to consider 

a CHIP-like approach or other options? 

What are the pros and cons of these 

various options? 

4. How can eligibility and enrollment 

be effectively coordinated between the 

Basic Health Program and other State 

programs to reduce churning between 

programs and promote continuity of 

care? 

5. How could establishing a Basic 

Health Program affect the ability of an 

entire family to be covered by the same 

plan? 

6. Are standard health plans likely to 

also participate in other coverage 

programs, such as the Exchanges, 

Medicaid, or CHIP? Should this be 

encouraged, and if so, how could CMS 

and States encourage it? 

E. Amount of Payment 

1. The statute specifies that amounts 

in the trust fund may only be used to 

reduce the premiums and cost-sharing 

of, or to provide additional benefits for, 

eligible individuals enrolled in standard 

health plans within a Basic Health 

Program. What options are States 

considering for reducing premiums and 

cost-sharing, or providing additional 

benefits? What, if any, guidance is 

needed on this provision? 

2. What are the likely administrative 

costs for a Basic Health Program? What 

factors, especially in terms of resources, 

are likely to affect a State’s ability to 

establish a Basic Health Program? How 

are States likely to fund the costs 

associated with establishing and 

administering a Basic Health Program? 

3. The statute specifies that in 

developing the financial methodology 

for the Basic Health Program, the 

determination of the value of the 

premium tax credits and cost-sharing 

reductions should take into 

consideration the experience of other 

States. What information would be most 

helpful to inform this methodology? 

Should implementation of the Basic 

Health Program be postponed until 

other States’ experiences are available? 

4. Other than those listed in the 

statute, what factors should be 

considered when establishing the 

methodology for determining the 

amount of Basic Health Program 

funding to States? How should the 

Federal government implement this 

calculation? 

5. The statute specifies that the 

funding calculation is on a per-enrollee 

basis. How should the Federal 

government acquire the detailed 

information necessary to perform this 

calculation? 

6. What are the best State-specific 

data sources to use in estimating the 

availability of affordable employersponsored insurance? 

7. What methods should be 

considered to measure and monitor 

compliance with the 95 percent cap on 

funding? How should CMS implement 

the provisions in Section 1331(d)(3)(B) 

of the Affordable Care Act regarding 

corrections to overpayments made in 

any year? 

F. Eligibility 

1. What education and outreach will 

be necessary to facilitate a helpful 

consumer experience? 

G. Secretarial Oversight 

1. What process should the Secretary 

use to certify or recertify Basic Health 

Programs? How should this process be 

similar to or different from Exchange 

certification? 

2. What should be considered when 

developing an oversight process for the 

Basic Health Program? 

Authority: Catalog of Federal Domestic 

Assistance Program No. 93.773, Medicare— 

Hospital Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program. 

Dated: July 27, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–23388 Filed 9–9–11; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Food and Drug Administration/Xavier 

University Global Outsourcing 

Conference 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

SUMMARY: The Food and Drug 

Administration (FDA) Cincinnati 

District, in cosponsorship with Xavier 

University, is announcing a public 

conference entitled ‘‘FDA/Xavier 

University Global Outsourcing 

Conference.’’ This 2.5-day public 

conference for the pharmaceutical 

industry is in direct alignment with the 

‘‘FDA Strategic Priorities 2011–2015,’’ 

and includes presentations from key 

FDA officials, global regulators, and 

industry experts. This conference drives 

collaboration on the topic of global 

outsourcing compliance by bringing 

pharmaceutical/biotechnology 

companies and contract partners to the 

same event to address the issues that 

reside on both sides of the contract. 

Expert presentations address the ‘‘how 

to’’ aspects of improving outsourced 

product quality through topics such as 

Strategic Procurement, End-to-End 

lifecycle product management, 

Managing Global Complex Supply 

Chains, and other topics. The 

experience level of our audience has 

fostered engaged dialog that has lead to 

innovative initiatives. 

Dates and Times: The public 

conference will be held on October 3, 

2011, from 8:30 a.m. to 5 p.m., October 

4, 2011, from 8:30 a.m. to 5 p.m., and 

October 5, 2011, from 8:30 a.m. to 1 

p.m. 

Location: The public conference will 

be held on the campus of Xavier 

University, 3800 Victory Pkwy., 

Cincinnati, OH 45207, 513–745–3073 or 

513–745–3396. 

Contact Persons: 

For information regarding this 

document: Steven Eastham, Food and 

Drug Administration, Cincinnati South 

Office, 36 East Seventh Street, 

Cincinnati, OH 45202, 513–246–4134, email: steven.eastham@fda.hhs.gov. 

For information regarding the 

conference and registration: Marla 

Phillips, Xavier University, 3800 

Victory Pkwy., Cincinnati, OH 45207, 

513–745–3073, e-mail: 

phillipsm4@xavier.edu. 

Registration: There is a registration 

fee. The conference registration fees 

cover the cost of the presentations, 

training materials, receptions, 

breakfasts, lunches, dinners, and dinner 

speakers for the 2.5 days of the 

conference. Prior online registration or 

registration by mail must be done by 

October 3, 2011. There will also be 

onsite registration. The cost of 

registration is as follows: 

TABLE 1—REGISTRATION FEES 1

Attendee Fee 

Industry ......................................... $1,495 

Small Business (<100 employees) 1,000 

Consultants ................................... 700 

Startup Manufacturer .................... 300 

Academic/Government ................. 300 

Media ............................................ Free 

1The fourth registration from the same company is free. 

The following forms of payment will 

be accepted: American Express, Visa, 

Mastercard, and company checks. 

To register online for the public 

conference, please visit the ‘‘Register 

Now’’ link on the conference Web site 

at http://www.XavierGOC.com. FDA has 

verified the Web site address, but is not 

responsible for subsequent changes to 

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