Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Notices 54583 

pay the premiums for dually-eligible 

beneficiaries. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This notice will not have a substantial 

effect on State or local governments. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

reviewed by the Office of Management 

and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance) 

Dated: September 1, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Dated: September 17, 2009. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. E9–25371 Filed 10–16–09; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Radiological Devices Panel of the 

Medical Devices Advisory Committee; 

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: Radiological Devices 

Panel of the Medical Devices Advisory 

Committee. 

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 November 17 and 18, 2009, from 8 a.m. 

to 5:30 p.m. 

Location: Holiday Inn, Ballroom, Two 

Montgomery Village Ave., Gaithersburg, MD. 

Contact Person: Toby Lowe, Center for 

Devices and Radiological Health, Food and 

Drug Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301–796– 

6512, or FDA Advisory Committee 

Information Line, 1–800–741–8138 (301– 

443–0572 in the Washington, DC area), code 

3014512526. Please call the Information Line 

for up-to-date information on this meeting. A 

notice in the Federal Register about last 

minute modifications that impact a 

previously announced advisory committee 

meeting cannot always be published quickly 

enough to provide timely notice. Therefore, 

you should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn about 

possible modifications before coming to the 

meeting. 

Agenda: On November 17, 2009, the 

committee will discuss and make 

recommendations regarding the agency’s 

regulatory strategy for Full Field Digital 

Mammography (FFDM) Devices. The 

committee will discuss the public comments 

received in response to the publication of the 

draft guidance document entitled ‘‘Class II 

Special Controls Guidance Document: Full 

Field Digital Mammography System.’’ This 

guidance document can be found on the FDA 

Web site at http://www.fda.gov/ 

MedicalDevices/DeviceRegulation

andGuidance/GuidanceDocuments/ 

ucm107552.htm. 

On November 18, 2009, the committee will 

discuss and make recommendations 

regarding the agency’s regulatory strategy for 

computer-assisted detection (CADe) devices 

for radiological devices. CADe devices are 

devices intended to identify, mark, highlight 

or in any other manner direct attention to 

potential abnormalities revealed in 

radiological data of the human body or 

imaging device data during interpretation of 

patient images or patient imaging data by a 

physician or other health care professional. 

The committee will discuss two draft 

guidance documents entitled ‘‘ComputerAssisted Detection Devices Applied to 

Radiology Images and Radiology Device 

Data—Premarket Notification [510(k)] 

Submissions’’ and ‘‘Clinical Performance 

Assessment: Considerations for ComputerAssisted Detection Devices Applied to 

Radiology Images and Radiology Device 

Data—Premarket Approval (PMA) and 

Premarket Notification [510(k)] 

Submissions.’’ These guidance documents 

can be found on the FDA Web site at http:// 

www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/Guidance

Documents. Type in the title of the guidance 

document included in this notice. The 

guidance documents will also be available as 

background materials. 

FDA intends to make background material 

available to the public no later than 2 

business days 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/AdvisoryCommittees/Calendar/ 

default.htm. 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 

November 12, 2009. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 p.m. on both 

days. 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 

November 6, 2009. 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 November 9, 2009. 

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 AnnMarie 

Williams, Conference Management Staff, 

301–796–5966, at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly conduct 

of its advisory committee meetings. Please 

visit our Web site at http://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for procedures 

on public conduct during advisory 

committee meetings. 

Notice of this meeting is given under the 

Federal Advisory Committee Act (5 U.S.C. 

app. 2). 

Dated: October 16, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25406 Filed 10–21–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

Scientific Management Review Board. 

The NIH Reform Act of 2006 (Pub. 

L.109–482) provides organizational 

authorities to HHS and NIH officials to: 

(1) Establish or abolish national research 

institutes; (2) reorganize the offices 

within the Office of the Director, NIH 

including adding, removing, or 

transferring the functions of such offices 

or establishing or terminating such 

offices; and (3) reorganize, divisions, 

centers, or other administrative units 

within an NIH national research 


dcolon on DSK2BSOYB1PROD with NOTICES
54584 Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Notices 

institute or national center including 

adding, removing, or transferring the 

functions of such units, or establishing 

or terminating such units. The purpose 

of the Scientific Management Review 

Board (also referred to as SMRB or 

Board) is to advise appropriate HHS and 

NIH officials on the use of these 

organizational authorities and identify 

the reasons underlying the 

recommendations. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: Scientific 

Management Review Board. 

Date: November 12–13, 2009. 

Time: November 12, 2009, 1 p.m. to 5 p.m. 

Agenda: Presentation and discussion will 

include updates from SMRB Working 

Groups: Deliberating Organizational Change 

and Effectiveness; NIH Intramural Research 

Program; and Substance Use, Abuse, and 

Addiction. There will also be time allotted on 

the agenda for public comment. Sign up for 

public comment will begin at approximately 

12 p.m. In the event that time does not allow 

for all those interested to present oral 

comments, anyone may file written 

comments using the address below. 

Place: National Institutes of Health, 

Building 31, 6th Floor, Conference Room 6, 

31 Center Drive, Bethesda, MD 20892. 

Time: November 13, 2009, 8:30 a.m. to 12 

p.m. 

Agenda: Continuation of November 12th 

meeting. 

Place: National Institutes of Health, 

Building 31, 6th Floor, Conference Room 6, 

31 Center Drive, Bethesda, MD 20892. 

Contact Person: Dr. Lyric Jorgenson, PhD, 

NIH–AAAS Science and Technology Policy 

Fellow, Office of Science Policy, Office of the 

Director, NIH, National Institutes of Health, 

Building 1 Room 218 MSC 0166, 9000 

Rockville Pike, Bethesda, MD 20892, 

smrb@mail.nih.gov, (301) 496–6837. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

The meeting will also be webcast. The draft 

meeting agenda and other information about 

the SMRB, including information about 

access to the webcast, will be available at 

http://smrb.od.nih.gov. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxis, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 

Enhancement Award; 93.936, NIH Acquired 

Immunodeficiency Syndrome Research Loan 

Repayment Program; 93.187, Undergraduate 

Scholarship Program for Individuals from 

Disadvantaged Backgrounds, National 

Institutes of Health, HHS) 

Dated: October 15, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–25403 Filed 10–21–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: AIDS and Related 

Research Integrated Review Group; AIDS 

Discovery and Development of Therapeutics 

Study Section. 

Date: November 13, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Ritz Carlton Hotel, 1150 22nd 

Street, NW., Washington, DC 20037. 

Contact Person: Shiv A. Prasad, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5220, 

MSC 7852, Bethesda, MD 20892, 301–443– 

5779, prasads@csr.nih.gov. 

Name of Committee: AIDS and Related 

Research Integrated Review Group; 

NeuroAIDS and other End-Organ Diseases 

Study Section. 

Date: November 13, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: InterContinental Mark Hopkins San 

Francisco, One Nob Hill, San Francisco, CA 

94108. 

Contact Person: Mary Clare Walker, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5208, 

MSC 7852, Bethesda, MD 20892, (301) 435– 

1165, walkermc@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business Grant Applications: Immunology. 

Date: November 16–17, 2009. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The River Inn, 924 25th Street, NW., 

Washington, DC 20037. 

Contact Person: Stephen M. Nigida, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4212, 

MSC 7812, Bethesda, MD 20892, 301–435– 

1222, nigidas@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business Innovation Research Grants. 

Date: November 17, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Rass M. Shayiq, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2182, 

MSC 7818, Bethesda, MD 20892, (301) 435– 

2359, shayiqr@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: October 14, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–25402 Filed 10–21–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 


dcolon on DSK2BSOYB1PROD with NOTICES