Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices 13803 

decision or dismissal is not supported 

by the preponderance of evidence in the 

record or the ALJ abused his or her 

discretion. Since CMS and its contractor 

do not have explicit authority under the 

existing statutes and regulations to 

participate in or be parties to ALJ 

hearings in Part D cases, we believe it 

is appropriate and consistent with part 

405, subpart I, to allow CMS or the Part 

D IRE to refer Part D cases to the MAC 

to consider review under its own 

motion authority based on the standards 

for referral that apply when CMS or its 

contractor did not participate in the ALJ 

proceedings or appear as a party. 

Similar to how § 405.1110 sets forth 

different referral standards depending 

on whether or not CMS or its contractor 

participate in the ALJ hearing, the 

regulations provide differing standards 

for review. Section 405.1110(c)(1) 

provides that when a referral is made in 

instances where CMS or its contractor 

participated or appeared as a party, the 

MAC exercises its own motion authority 

if there is an error of law material to the 

outcome of the case, an abuse of 

discretion by the ALJ, the decision is 

not consistent with the preponderance 

of the evidence of record, or there is a 

broad policy or procedural issue that 

may affect the public interest. In 

deciding whether to accept review 

under this standard, the MAC will limit 

its consideration of the ALJ’s action to 

those exceptions raised by CMS. 

Section 405.1110(c)(2) provides that 

when referral is made in instances 

where CMS or its contractor did not 

participate or appear as a party, the 

MAC will accept review if the decision 

or dismissal contains an error of law 

material to the outcome of the case, or 

presents a broad policy or procedural 

issue that may affect the public interest. 

In deciding whether to accept review, 

the MAC will limit its consideration of 

the ALJ’s action to those exceptions 

raised by CMS. 

As previously noted, since neither the 

Part D statute nor the current Part D 

regulations explicitly allow a Part D 

plan sponsor, CMS, or a CMS contractor 

to participate in or be parties to appeals 

at the ALJ level, we consider it 

appropriate to implement the standard 

of referral and review in § 405.1110 that 

applies when CMS and its contractor do 

not participate in or are not parties to 

the ALJ hearing. Accordingly, under this 

Ruling, CMS or the Part D IRE may refer 

a Part D case to the MAC and the MAC 

will accept review of a Part D case if the 

ALJ’s decision or dismissal contains an 

error of law material to the outcome of 

the case or presents a broad policy or 

procedural issue that may affect the 

general public interest. In deciding 

whether to accept review, the MAC will 

limit its consideration of the ALJ’s 

action to those exceptions raised by 

CMS or the Part D IRE. 

C. Other Issues Regarding MAC Own 

Motion Review of Part D Cases 

For the most part, the other provisions 

set forth under § 405.1110 apply 

appropriately to Part D cases. The 

requirements related to the 60-day time 

frame for filing the written referral and 

for providing notice to other interested 

parties set forth in § 405.1110(b)(2) are 

processes that are appropriate to apply 

to Part D cases. See also 42 CFR 

405.1110(a). Written referrals must state 

the reasons why CMS or its contractors 

believe the MAC must review the case 

on its own motion. CMS or its 

contractors will send a copy of its 

referral to all parties to the ALJ’s action 

and to the ALJ. Similarly, the 

requirements in § 405.1110(b)(2) 

regarding the filing of exceptions to the 

referral by submitting written comments 

to the MAC within 20 days of the 

referral notice, and sending such 

comments to CMS, appropriately apply 

to Part D cases. 

We also believe it is appropriate to 

apply to Part D cases those requirements 

in § 405.1110(d) regarding the MAC’s 

action. This provision states that if the 

MAC decides to review a decision or 

dismissal on its own motion, it will mail 

the results of its action to all the parties 

to the hearing and to CMS if it is not 

already a party to the hearing. The 

notice of the referral in § 405.1110(b)(2) 

requires that the enrollee will be 

notified that the ALJ’s decision may not 

be the final action in the case. If the 

MAC accepts review, it may adopt, 

modify, or reverse the decision or 

dismissal, may remand the case to an 

ALJ for further proceedings or may 

dismiss a hearing request. The MAC 

must issue its action no later than 90 

days after receipt of the CMS referral, 

unless the 90-day period has been 

extended as provided in 405 CFR 

subpart I. The MAC may not, however, 

issue its action before the 20-day 

comment period has expired, unless it 

determines that the agency’s referral 

does not provide a basis for reviewing 

the case. If the MAC does not act within 

the applicable adjudication deadline, 

the ALJ’s decision or dismissal remains 

the final action in the case. We believe 

it is appropriate to apply these 

procedures to Part D cases that the MAC 

reviews on its own motion. 

As described in this section, the 

provisions in § 405.1110 are procedural 

rules that apply appropriately to Part D 

appeals. Further, applying these 

regulatory processes to Part D appeals 

does not conflict with existing Part D 

requirements. 

Authority: Sections 1852, 1860D–4(g)–(h), 

and 1869 of the Social Security Act (42 

U.S.C. 1395w–22, 1395w–104 and 1395ff). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 15, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–5304 Filed 3–22–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1481–N3] 

Medicare Program; Emergency Medical 

Treatment and Labor Act (EMTALA) 

Technical Advisory Group (TAG) 

Meeting—May 3–4, 2007 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces the 

sixth meeting of the Emergency Medical 

Treatment and Labor Act (EMTALA) 

Technical Advisory Group (TAG). The 

purpose of the EMTALA TAG is to 

review regulations affecting hospital 

and physician responsibilities under 

EMTALA to individuals who come to a 

hospital seeking examination or 

treatment for medical conditions. The 

primary purpose of the sixth meeting is 

to enable the EMTALA TAG to hear 

additional testimony and further 

consider written responses from 

medical societies and other 

organizations on specific issues 

considered by the EMTALA TAG at 

previous meetings. The public is 

permitted to attend this meeting and, to 

the extent that time permits and at the 

discretion of the Chairperson, the 

EMTALA TAG may hear comments 

from the floor. 

DATES: Meeting Date: The meetings of 

the EMTALA TAG announced in this 

notice are as follows: 

Thursday, May 3, 2007, 9 a.m. to 5 p.m. 

Friday, May 4, 2007, 9 a.m. to 5 p.m. 

Registration Deadline: All individuals 

must register in order to attend this 

meeting. Individuals who wish to attend 

the meeting but do not wish to present 

testimony must register by April 26, 


sroberts on PROD1PC70 with NOTICES
13804 Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices 

2007. Individuals who wish to attend 

the meeting and to present their 

testimony must register by April 12, 

2007 and must submit copies of their 

testimony in writing by April 19, 2007. 

See section III for more detailed 

registration instructions. 

Comment Deadline: Written 

comments/statements to be presented to 

the EMTALA TAG must be received by 

April 19, 2007. 

Special Accommodations: Individuals 

requiring sign-language interpretation or 

other special accommodations should 

send a request for these services to Eric 

Ruiz by 5 p.m. by April 19, 2007 at the 

address listed below. 

ADDRESSES: Meeting Address: The 

EMTALA TAG meeting will be held in 

Room 705a of the Hubert Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20001. 

Mailing and E-mail Addresses for 

Inquiries or Comments: Inquiries or 

comments regarding this meeting may 

be sent to—Eric Ruiz, Division of Acute 

Care, Centers for Medicare & Medicaid 

Services, Mail Stop C4–08–06, 7500 

Security Boulevard, Baltimore, MD 

21244–1850. Inquiries or comments may 

also be e-mailed to 

Eric.Ruiz@cms.hhs.gov or 

EMTALATAG@cms.hhs.gov. 

Web Site Address for Additional 

Information: For additional information 

on the EMTALA TAG meeting agenda 

topics, updated activities, and to obtain 

Charter copies, please search our 

Internet Web site at (http:// 

www.cms.hhs.gov/faca/ 

07_emtalatag.asp). 

FOR FURTHER INFORMATION CONTACT: Eric 

Ruiz, (410) 786–0247. George Morey, 

(410) 786–4653. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 1866(a)(1)(I), 1866(a)(1)(N), 

and 1867 of the Social Security Act (the 

Act) impose specific obligations on 

Medicare-participating hospitals that 

offer emergency services. These 

obligations concern individuals who 

come to a hospital emergency 

department and request or have a 

request made on their behalf for 

examination or treatment for a medical 

condition. The Emergency Medical 

Treatment and Labor Act (EMTALA) 

applies to all these individuals, 

regardless of whether or not they are 

beneficiaries of any program under the 

Act. Section 1867 of the Act sets forth 

requirements for medical screening 

examinations for medical conditions, as 

well as necessary stabilizing treatment 

or appropriate transfer. 

Regulations implementing the 

EMTALA legislation are set forth at 42 

CFR 489.20(l), (m), (q), and (r) and 

§ 489.24. Section 945 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) (Pub. 

L. 108–173), mandates that the Secretary 

establish a Technical Advisory Group 

(TAG) for advice concerning issues 

related to EMTALA regulations and 

implementation. 

Section 945 of the MMA specifies that 

the EMTALA TAG—

• Shall review the EMTALA 

regulations; 

• May provide advice and 

recommendations to the Secretary 

concerning these regulations and their 

application to hospitals and physicians; 

• Shall solicit comments and 

recommendations from hospitals, 

physicians, and the public regarding 

implementation of such regulations; and 

• May disseminate information 

concerning the application of these 

regulations to hospitals, physicians, and 

the public. 

The EMTALA TAG, as chartered 

under section 945 of the MMA, is also 

governed by the provisions of the 

Federal Advisory Committee Act 

(FACA) (5 U.S.C. Appendix 2) for the 

selection of members and the conduct of 

all meetings. 

In the May 28, 2004 Federal Register 

(69 FR 30654), we specified the 

statutory requirements regarding the 

charter, general responsibilities, and 

structure of the EMTALA TAG. That 

notice also solicited nominations for 

members based on the statutory 

requirements for the EMTALA TAG. In 

the August 27, 2004 Federal Register 

(69 FR 52699), we solicited nominations 

again for members in two categories 

(patient representatives and a State 

survey agency representative) for which 

no nominations were received in 

response to the May 28, 2004 Federal 

Register notice. In the March 15, 2005 

Federal Register (70 FR 12691), we 

announced the inaugural meeting of the 

EMTALA TAG and the membership 

selection. In the May 18, 2005 Federal 

Register (70 FR 28541), the September 

23, 2005 Federal Register (70 FR 

55903), the April 7, 2006 Federal 

Register (71 FR 17888), and the 

September 29, 2006 Federal Register (71 

FR 57543), we announced the second, 

third, fourth, and fifth meetings of the 

EMTALA TAG, respectively, with a 

purpose to hear public testimony and 

consider written responses from 

medical societies and other 

organizations on specific issues 

considered by the EMTALA TAG at its 

previous meetings. The EMTALA TAG 

has established the following three 

subcommittees: 

• On-Call Subcommittee 

(Chairperson, John Kusske, M.D.) 

charged with reviewing the testimony 

and other materials provided to the TAG 

to identify some specific issues related 

to on-call requirements. 

• Action Subcommittee (Chairperson, 

Julie Nelson, J.D.) charged with 

identifying issues other than on-call 

issues. 

• Framework Subcommittee 

(Chairperson, Charlotte Yeh, M.D.) 

charged with clarifying the historical 

context and conceptual basis for the 

TAGs recommendations and developing 

a document for review and approval by 

the TAG. 

II. Meeting Format, Agenda, and 

Presentation Topics 

A. Meeting Format 

The initial portion of the meeting, 

which will convene at 9 a.m. on May 3, 

will involve opening remarks and a 

limited period of public testimony on 

issues related to EMTALA and its 

implementation. TAG members will 

have the opportunity to ask questions, 

prioritize the topics presented, and to 

conduct other necessary business. At 

the conclusion of each day’s meeting, to 

the extent that time is available and at 

the discretion of the Chairperson, the 

public will be permitted a reasonable 

time to comment on issues being 

considered by the TAG. 

B. Tentative Meeting Agenda 

The tentative agenda for the EMTALA 

TAG meetings is as follows: 

Day 1 

Convenes at 9 a.m. 

• Welcome, Call to Order, and 

Opening Remarks. 

• Administrative and Housekeeping 

Issues. 

• Public Testimony on Issues Related 

to EMTALA and its 

Implementation. 

• Subcommittee Reports. 

• Public Comment. 

Day 2 

Convenes at 9 a.m. 

• Subcommittee Reports. 

• Public Comment. 

C. Public Presentations 

Only individuals who register and 

submit written testimony as specified in 

the Registration section of this notice 

will be considered registered presenters. 

The time allotted for each presentation 

will be approximately 5 minutes and 

will be based on the number of 

registered presenters. Presenters will 


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Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices 13805 

speak in their assigned order. If 

registered presenters are not given an 

opportunity to speak because of time 

restrictions, we will accept and present 

their written testimony to the TAG 

members. Time permitting, comments 

from other participants (individuals 

who are not registered presenters) may 

be heard after the scheduled 

testimonies. 

If there are individuals who cannot 

attend the meeting but wish to submit 

comments/statements regarding issues 

related to the EMTALA TAG, we will 

accept and present their written 

comments/statements at the meeting if 

their comments/statements are received 

by postal mail or e-mail at the address 

listed in the ADDRESSES section of this 

notice by April 19, 2007. 

III. Registration Instructions 

The Center for Medicare Management 

of CMS is coordinating meeting 

registration. While there is no 

registration fee, all individuals must 

register to attend due to limited seating. 

As specified in the DATES section of this 

notice, individuals who wish to attend 

the meeting but do not plan to present 

testimony must register by April 26, 

2007. Individuals who would like both 

to attend and to present testimony on 

issues relating to the EMTALA TAG 

must register by April 12, 2007 and 

must state specifically in their 

registration request that they wish to 

present testimony for EMTALA TAG 

consideration. A copy of the presenter’s 

written testimony must be received by 

CMS at the address specified in the 

ADDRESSES section of this notice by 

April 19, 2007. 

You may register by e-mail to 

Marianne Myers at 

Marianne.Myers@cms.hhs.gov, by fax to 

the attention of Marianne Myers at (410) 

786–0681, or by telephone at (410) 786–

5962. All registration requests must 

include your name, name of the 

organization (if applicable), address, 

telephone and fax numbers, e-mail 

address (if available). Individuals will 

receive a registration confirmation with 

instructions for your arrival at the 

Hubert Humphrey Building. If seating 

capacity has been reached, registrants 

will be notified that the meeting has 

reached capacity. All registrants are 

asked to arrive at the Hubert Humphrey 

Building no later than 20 minutes before 

the scheduled starting time of each 

meeting session they wish to attend. 

IV. Security Information 

Since this meeting will be held in a 

Federal government building, Federal 

security measures are applicable. As 

noted above, in planning your arrival 

time, we recommend allowing 

additional time to clear security. In 

order to gain access to the building, 

participants must bring a governmentissued photo identification such as a 

driver’s license or a passport and a copy 

of your registration information for the 

meeting. Access may be denied to 

persons without proper identification. 

All persons entering the building 

must pass through a metal detector. In 

addition, all items brought to CMS, 

whether personal or for the purpose of 

demonstration or to support a 

presentation, are subject to inspection. 

We cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for 

demonstration or to support a 

presentation. 

Authority: Section 945 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 16, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–5329 Filed 3–22–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0101] 

Draft Guidance for the Public, FDA 

Advisory Committee Members, and 

FDA Staff on Procedures for 

Determining Conflict of Interest and 

Eligibility for Participation in FDA 

Advisory Committees; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document for the 

public, FDA advisory committee 

members, and FDA staff entitled 

‘‘Guidance for the Public, FDA Advisory 

Committee Members, and FDA Staff: 

Procedures for Determining Conflict of 

Interest and Eligibility for Participation 

in FDA Advisory Committees’’ dated 

March 2007. This draft guidance 

describes the factors and analyses that 

should be used in considering whether 

an advisory committee member has a 

potential conflict of interest and 

whether participation in a meeting is 

appropriate. This guidance is intended 

to help the public, FDA advisory 

committee members, and FDA staff to 

understand and implement FDA policy 

in applying the applicable statutory and 

regulatory requirements. This draft 

guidance, when finalized, will replace 

the guidance document entitled ‘‘FDA 

Waiver Criteria 2000.’’

DATES: Submit written or electronic 

comments on the draft guidance by May 

21, 2007. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Policy (HF–11), Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit phone requests to 800–835–4709 

or 301–827–1800. Submit written 

comments on the draft guidance to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.fda.gov/dockets/ 

ecomments. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: Jill 

Hartzler Warner, Office of Policy and 

Planning (HF–11), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–3370. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document, entitled ‘‘Guidance 

for the Public, FDA Advisory Committee 

Members, and FDA Staff; Procedures for 

Determining Conflict of Interest and 

Eligibility for Participation in FDA 

Advisory Committees,’’ dated March 

2007. FDA’s advisory committees 

provide independent and expert advice 

on scientific, technical, and policy 

matters related to the development and 

evaluation of products regulated by 

FDA. 

FDA is committed to strictly adhering 

to the laws and regulations governing 

the process for selecting advisory 

committee members. FDA for many 

years has screened, prior to each 

meeting, all advisory committee 

members who are special government 

employees or regular government 

employees, to determine whether the 

potential for a financial conflict of 

interest exists. The agency may grant a 

waiver to allow an individual to 


sroberts on PROD1PC70 with NOTICES