Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Notices 77033 

scheduled to speak in the order in 

which they register and grouped by new 

technology applicant. Therefore, 

individuals who want to be presenters 

must register and submit their agenda 

item(s) by the date specified in the 

‘‘DATES’’ section. Once the agenda is 

completed, it will be posted on the IPPS 

Web site at http://www.cms.hhs.gov/ 

AcuteInpatientPPS/ 

08_newtech.asp#TopOfPage. Comments 

from participants will be heard (time 

permitting) after the completion of the 

presentations. 

For presenters or participants who 

cannot come to CMS for the meeting, an 

open toll-free phone line, (888) 577–

8990, has been made available. If you 

are calling in, the operator will ask you 

for the conference code. The conference 

code is ‘‘New Tech.’’ In addition, 

written comments will also be accepted 

and presented at the meeting if they are 

received by the date specified in the 

‘‘DATES’’ section. Written comments may 

also be submitted after the meeting. If 

the comments are to be considered 

before the publication of the proposed 

rule, the comments must be received by 

the date specified in the ‘‘DATES’’

section. 

III. Registration Instructions 

The Division of Acute Care in CMS is 

coordinating the meeting registration for 

both the Informational Workshop and 

Town Hall Meeting. While there is no 

registration fee, individuals must 

register to attend the Town Hall Meeting 

on substantial clinical improvement and 

for the Informational Workshop (two 

separate registrations). 

Individuals may present their 

comments for the Town Hall Meeting 

either in person or by phone. These 

individuals must register and submit 

their agenda item(s) by the date 

specified in the ‘‘DATES’’ section. All 

other participants for the Town Hall 

Meeting must register by the date 

specified in the ‘‘DATES’’ section. 

All registrants will receive 

confirmation with instructions for 

arrival at the CMS complex (persons 

who register on-line will receive this 

confirmation upon completion of 

registration process and should print the 

confirmation and bring it with them to 

the meeting). Because of limited 

meeting space and our desire to 

maintain an accurate count of 

registrants who plan to come to CMS, 

we prefer that these persons register online. In addition, we would prefer that 

registrants who plan to participate by 

phone register by phone or fax. 

A. On-line Registration 

Registration may be completed online at the following Web address: 

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

AcuteInpatientPPS/

08_newtech.asp#TopOfPage. Select the 

link ‘‘Register to Attend the New 

Technology Town Hall Meeting’’ and/or 

‘‘Register to attend the New Technology 

Informational Workshop.’’ After 

completing the registration, on-line 

registrants should print the 

confirmation page and bring it with 

them to the meeting(s). 

B. Registration by Phone, Fax or Mail 

Registration for both meetings may 

also be completed by contacting Tiffany 

Swygert at (410) 786–4642 or Michael 

Treitel at (410) 786–4552. Registration 

may also be completed by fax to the 

attention of the New Technology Team 

at (410) 786–0169. If registration is 

completed by phone fax or mail, please 

provide your name, address, and 

telephone number, meetings, which you 

are registering for Town Hall Meeting 

and/or Informational Workshop and, if 

available, e-mail address and fax 

number. Please send mail in registration 

to address specified in the ‘‘ADDRESSES’’

section. 

IV. Security Information 

Because this meeting will be located 

on Federal property, for security 

reasons, any persons wishing to attend 

this Informational Workshop and Town 

Meeting must register by close of 

business on February 15, 2007. 

Individuals who have not registered in 

advance will not be allowed to enter the 

building to attend the meeting. Seating 

capacity is limited to the first 250 

registrants. 

The on-site check-in for visitors will 

begin at 8:30 a.m. Please allow sufficient 

time to go through the security 

checkpoints. It is suggested that you 

arrive at central building by 8:30 a.m. so 

that you will have enough time to 

check-in before the session begins. 

Individuals that will only attend the 

Town Hall Meeting must check-in at 1 

p.m. Security measures will include 

inspection of vehicles, inside and out, at 

the entrance to the grounds. In addition, 

all persons entering the building must 

check in by name, provide a 

government-issued identification, and 

pass through a metal detector. All items 

brought to CMS, whether personal or for 

the purpose of demonstration or to 

support a presentation, including items 

such as laptops, cell phones, and palm 

pilots, are subject to physical 

inspection. Participants attending the 

Informational Workshop will be able to 

attend the Town Hall meeting without 

an additional check-in unless they exit 

the building. In this case, a participant 

will need to repeat the security checkin and procedures. 

Authority: Section 503 of Public Law 108–

173. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 30, 2006. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 06–9838 Filed 12–20–06; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

AGENCY: Administration for Native 

Americans (ANA), HHS. 

ACTION: Notice of Public Comment on 

the Proposed Adoption of ANA Program 

Policies and Procedures; Correction 

SUMMARY: Pursuant to section 814 of the 

Native American Programs Act of 1974 

(the Act) 42 U.S.C. 2992b–1, ANA 

herein describes its proposed 

interpretive rules, statements of general 

policy and rules of agency procedure or 

practice in relation to the Social and 

Economic Development Strategies 

(hereinafter referred to as SEDS), Native 

Language Preservation and Maintenance 

(hereinafter referred to as Native 

Language), Environmental Regulatory 

Enhancement (hereinafter referred to as 

Environmental), Environmental 

Mitigation (hereinafter referred to as 

Mitigation), Improving the Well-Being 

of Children—Native American Health 

Marriage Initiative (hereinafter referred 

to as Healthy Marriage) programs and 

any Special Initiatives. Under the 

statute, ANA is required to provide 

members of the public an opportunity to 

comment on proposed changes in 

interpretive rules, statements of general 

policy and rules of agency procedure or 

practice and to give notice of the final 

adoption of such changes at least thirty 

(30) days before the changes become 

effective. This Notice also provides 

additional information about ANA’s 

plan for administering the programs. 

FOR FURTHER INFORMATION CONTACT: 

Sheila K. Cooper, Director of Program 

Operations, toll-free at (877) 922–9262. 

In the Federal Register Notice 

published on November 21, 2006 (Vol. 


jlentini on PROD1PC65 with NOTICES
77034 Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Notices 

71, No. 224), make the following 

addition under Additional Information: 

VI. ANA Administrative Policy 

ANA is issuing a policy clarification 

statement. Currently, ANA has an 

administrative policy that states ‘‘An 

applicant can have only one active 

Social and Economic Development 

Strategies (SEDS) grant operating at any 

given time.’’ In addition to the regular 

SEDS competition, ANA currently 

conducts two special initiative awards 

programs under Section 803(a) of the 

Native American Programs Act, 42 

U.S.C. 2991b(a). The two additional 

programs funded under the SEDS 

Catalog of Federal Domestic Assistance 

number 93.612 are the SEDS-Alaska and 

the Improving the Well-Being of 

Children: Native American Health 

Marriage Initiative (NAHMI). By issuing 

this statement, ANA is reinforcing the 

policy that applicants may submit only 

one application for SEDS or one 

application for NAHMI, but not for both. 

ANA will only accept for funding 

competition the first application 

submitted. If two applications are 

received from the same applicant at the 

same time, the applicant will be 

notified, prior to an eligibility 

determination, that only one application 

will be accepted. ANA will continue to 

enforce its policy that grantees cannot 

receive two or more grant awards under 

the SEDS category. 

Dated: December 9, 2006. 

Quanah Crossland Stamps, 

Commissioner, Administration for Native 

Americans. 

[FR Doc. 06–9834 Filed 12–21–06; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Advisory Committee for Reproductive 

Health Drugs; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Advisory 

Committee for Reproductive Health 

Drugs. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on January 23, 2007, from 8:30 a.m. 

to 6 p.m. and on January 24, 2007, from 

8:30 a.m. to 5:00 p.m. 

Location: Food and Drug 

Administration, Center for Drug 

Evaluation and Research Advisory 

Committee Conference Room, rm. 1066, 

5630 Fishers Lane, Rockville, MD. 

Contact Person: Teresa Watkins, 

Center for Drug Evaluation and Research 

(HFD–21), Food and Drug 

Administration, 5600 Fishers Lane (for 

express delivery, 5630 Fishers Lane, rm. 

1093), Rockville, MD 20857, 301–827–

7001, FAX: 301–827–6776, e-mail: 

Teresa.Watkins@fda.hhs.govor FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512537. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: On January 23 and 24, 2007, 

presentations and committee 

discussions will address current issues 

which influence the consideration for 

approval of oral and non-oral (i.e., 

transdermal and intravaginal) hormonal 

contraceptive drug products. 

Implantable and injectable hormone 

products will not be discussed. Issues 

for discussion will include clinical trial 

design, expectations for efficacy and 

safety outcomes, and measures of 

acceptability of the product to the user, 

including cycle control. FDA intends to 

make background material available to 

the public no later than 1 business day 

before the meeting. If FDA is unable to 

post the background material on its Web 

site prior to the meeting, the background 

material will be made publicly available 

at the location of the advisory 

committee meeting, and the background 

material will be posted on FDA’s Web 

site after the meeting. Background 

material is available at http:// 

www.fda.gov/ohrms/dockets/ac/ 

acmenu.htm, click on the year 2007 and 

scroll down to the appropriate advisory 

committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before January 12, 2007. 

Oral presentations from the public will 

be scheduled between approximately 10 

a.m. and 12 noon on January 24, 2007. 

Those desiring to make formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before January 

5, 2007. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by January 8, 2007. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Teresa 

Watkins at least 7 days in advance of the 

meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: December 15, 2006. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E6–21949 Filed 12–21–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0172] 

Guidance for Clinical Investigators, 

Institutional Review Boards, and 

Sponsors; Process for Handling 

Referrals to Food and Drug 

Administration Under 21 CFR 50.54: 

Additional Safeguards for Children in 

Clinical Investigations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Guidance for Clinical Investigators, 

Institutional Review Boards, and 

Sponsors; Process for Handling Referrals 

to FDA Under 21 CFR 50.54: Additional 

Safeguards for Children in Clinical 

Investigations.’’ This guidance is 

intended to assist clinical investigators, 

Institutional Review Boards (IRBs), 

sponsors, and other interested parties in 

understanding FDA’s process for 

handling clinical investigations that 

include children as subjects and that 


jlentini on PROD1PC65 with NOTICES