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
13806 Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices 

participate in a meeting when statutory 

criteria are met; for example, when the 

need for the individual’s services 

outweighs the potential for a conflict of 

interest created by the financial interest 

involved. FDA administers several laws 

and regulations that govern conflict of 

interest determinations; these laws are 

not entirely consistent and set out 

different standards. FDA’s Waiver 

Criteria 2000 guidance, which this draft 

guidance would replace, attempted to 

comprehensively address the complex 

set of variables that can be applied in 

reaching a determination about an 

individual advisory committee 

participant. However, because of its 

complexity and discretionary elements, 

FDA staff found it difficult to achieve 

consistent results that the public could 

readily understand. As part of FDA’s 

recent internal assessment of its 

advisory committee process, the agency 

has targeted its assessment of potential 

conflicts of interest and granting of 

waivers as an area that needs 

improvement. This draft guidance will 

implement a more stringent approach 

for considering eligibility for 

participation in FDA advisory 

committee meetings. The purpose of 

this draft guidance is to simplify and 

streamline the process by which FDA 

considers meeting participation, 

increase the transparency, clarity, and 

consistency of the process, and enhance 

public trust in this important function. 

We welcome comments on the draft 

guidance and specifically seek comment 

on (1) whether the draft approach, due 

to its stringency, could unduly restrict 

eligibility of needed experts for advisory 

committee meetings, (2) whether the 

$50,000 figure generally employed as 

the maximum amount for disqualifying 

financial interests, after applying certain 

exemptions, is appropriate or, 

alternatively, whether a different figure 

(higher or lower) should be used, and 

(3) whether and what additional 

examples should be provided for the 

steps described in this draft guidance 

for determining conflicts of interest and 

eligibility for participating in an 

advisory committee meeting. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance represents the 

agency’s current thinking on procedures 

for considering conflict of interest and 

eligibility for participation in FDA 

advisory committees. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at: http:// 

www.fda.gov/opacom/morechoices/ 

industry/guidedc.htm 

Dated: March 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–1459 Filed 3–21–07; 1:43 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, call the 

HRSA Reports Clearance Officer on 

(301) 443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: The National Health 

Service Corps (NHSC) Scholarship 

Program In-School Worksheets (OMB 

No. 0915–0250): Extension 

The National Health Service Corps 

(NHSC) Scholarship program provides 

scholarships to students in health 

professions in return for service in a 

federally-designated Health Professional 

Shortage Area (HPSA). If awarded an 

NHSC scholarship, the program requires 

the schools and the awardees to review 

and complete data collection 

worksheets for each year that the 

student is an NHSC Scholar. The forms 

provide information on the following: 

Verification of enrollment status; 

current curriculum; current contact 

information; and verification of 

accuracy of student data. The 

worksheets require minimal burden and 

provide the program with information 

that is required to determine if scholars 

are maintaining their status of eligibility 

as required by Federal statute. 

The annual estimate of burden is as 

follows: 

Instrument Number of 

respondents 

Responses 

per respondent 

Total responses 

Hours per 

response 

(minutes) 

Total burden 

hours 

Scholar Worksheet ............................................................... 800 1 800 10 134 

School Verification Worksheet ............................................. 300 1 300 10 50 

School Contact Information ................................................. 550 1 550 10 92 

Total .............................................................................. 1,650 ........................ 1,650 ........................ 276 


sroberts on PROD1PC70 with NOTICES