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 This draft guidance will 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this draft guidance is to simplify and 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steps described in this draft guidance 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This draft guidance is being issued 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The draft guidance represents the 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
Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices 13807 

Send comments to Susan G. Queen, 

Ph.D., HRSA Reports Clearance Officer, 

Room 10–33, Parklawn Building, 5600 

Fishers Lane, Rockville, MD 20857. 

Written comments should be received 

within 60 days of this notice. 

Dated: March 15, 2007. 

Alexandra Huttinger, 

Acting Director, Division of Policy Review 

and Coordination. 

[FR Doc. E7–5293 Filed 3–22–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Heritable 

Disorders and Genetic Diseases in 

Newborns and Children; Notice of 

Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Committee on Heritable 

Disorders and Genetic Diseases in Newborns 

and Children (ACHDGDNC). 

Dates and Times: May 17, 2007, 9 a.m. to 

5 p.m. May 18, 2007, 8:30 a.m. to 3 p.m. 

Place: Ronald Reagan Building and 

International Trade Center, Rotunda Room, 

1300 Pennsylvania Avenue, NW., 

Washington, DC 20004. 

Status: The meeting will be open to the 

public with attendance limited to space 

availability. 

Purpose: The Advisory Committee was 

established to advise and guide the Secretary 

regarding the most appropriate application of 

universal newborn screening tests, 

technologies, policies, guidelines and 

programs for effectively reducing morbidity 

and mortality in newborns and children 

having or at risk for heritable disorders. The 

Committee also provides advice and 

recommendations concerning the grants and 

projects authorized under the Heritable 

Disorders Program. 

Agenda: The first day will be devoted to 

discussion of the Committee’s 

decisionmaking process, including a 

discussion of the evidence review group’s 

nomination/evaluation process for candidate 

conditions on the uniform newborn 

screening panel, and an evaluation of the 

system infrastructure for long-term follow-up 

and proposals for strategies for such followup. The Committee’s subcommittees on 

Laboratory Standards and Procedures, 

Follow-up and Treatment, and Education and 

Training will meet in the afternoon. The 

second day will include a report from the 

Department of Defense on its newborn 

screening program and activities and reports 

to the Committee by its subcommittees on 

Laboratory Standards and Procedures, 

Follow-up and Treatment, and Education and 

Training. 

Proposed agenda items are subject to 

change. 

Time will be provided each day for public 

comment. Individuals who wish to provide 

public comment or who plan to attend the 

meeting and need special assistance, such as 

sign language interpretation or other 

reasonable accommodations, should notify 

the ACHDGDNC Staff, Jill F. Shuger, M.S. 

(contact information provided below). 

Contact Person: Anyone interested in 

obtaining a roster of members or other 

relevant information should write or contact 

Jill F. Shuger, M.S., Maternal and Child 

Health Bureau, Health Resources and 

Services Administration, Room 18A–19, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, Maryland 20857, Telephone (301) 

443–1080. Information on the Advisory 

Committee is available at http:// 

mchb.hrsa.gov/programs/genetics/committee. 

Dated: March 15, 2007. 

Alexandra Huttinger, 

Acting Director, Division of Policy Review 

and Coordination. 

[FR Doc. E7–5300 Filed 3–22–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on Nurse 

Education and Practice; Notice of 

Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: National Advisory Council on 

Nurse Education and Practice (NACNEP). 

Dates and Times: April 19, 2007, 9 a.m.—

5 p.m. April 20, 2007, 8 a.m.–5 p.m. 

Place: Hotel Washington, 515 15th Street, 

NW., Washington, DC 20004. 

Status: The meeting will be open to the 

public. 

Agenda: Agency and Bureau 

administrative updates will be provided. The 

purpose of the meeting will be to discuss the 

integration of health information technology 

into nursing education and practice. Experts 

will promote the awareness of the latest 

simulated learning, informatics, distance 

learning, and telehealth trends, advances, 

and issues. Data will be presented on use of 

healthcare information systems to enhance 

nursing education and practice, optimize 

patient safety, and drive improvements in 

health care quality. Representatives from the 

Department of Health and Human Services, 

the National Center for Cultural Competence, 

and the National Nursing Centers Consortium 

will be presenting. During this meeting, 

Council workgroups will deliberate on the 

content presented and formulate 

recommendations to the Secretary of Health 

and Human Services and the Congress on the 

integration of technology into nursing 

education and practice. This meeting will 

form the basis for NACNEP’s mandated 

Eighth Annual Report. 

For Further Information Contact: Anyone 

interested in obtaining a roster of members, 

minutes of the meeting, or other relevant 

information should write or contact Dr. Joan 

Weiss, Executive Secretary, National 

Advisory Council on Nurse Education and 

Practice, Parklawn Building, Room 9–35, 

5600 Fishers Lane, Rockville, Maryland 

20857, telephone (301) 443–5688. 

Dated: March 15. 2007. 

Alexandra Huttinger, 

Acting Director, Division of Policy Review 

and Coordination. 

[FR Doc. E7–5295 Filed 3–22–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Availability of Final Policy 

Guidance 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Final Agency Guidance and 

Response to Public Comments. 

SUMMARY: HRSA is publishing a final 

Agency Guidance (‘‘Policy Information 

Notice’’ (PIN) 2007–09) to describe and 

clarify HRSA’s current policy and 

process for resolving issues and 

conflicts related to health center service 

area overlap. The PIN, ‘‘Service Area 

Overlap: Policy and Process,’’ and the 

Agency’s ‘‘Response to Public 

Comments’’ are available on the Internet 

at http://bphc.hrsa.gov/chc/sao.htm. 

DATES: The effective date of this final 

Agency guidance is March 12, 2007. 

Background: HRSA manages the 

Health Center Program, which supports 

more than 3,800 health care delivery 

sites, including community health 

centers, migrant health centers, health 

care for the homeless centers, and 

public housing primary care centers. 

Health centers serve clients that are 

primarily low-income and minorities, 

and deliver preventive and primary care 

services to patients regardless of their 

ability to pay. Charges for health care 

services are set according to income. 

On June 22, 2006, HRSA made the 

draft PIN, ‘‘Service Area Overlap: Policy 

and Process,’’ available for public 

comment on HRSA’s Web site. The 

purpose of the PIN is to describe and 

clarify HRSA’s current policy and 

process for resolving issues and 

conflicts related to health center service 

area overlap. Comments were due to 

HRSA by August 18, 2006. 


sroberts on PROD1PC70 with NOTICES