44374 Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Notices 

Committee. The list of research topics to 

be discussed at the meeting will be 

available on the following Web site 

prior to the meeting: http:// 

www.cms.hhs.gov/mcd/ 

index_list.asp?list_type=mcac. We 

require that you declare at the meeting 

whether you have any financial 

involvement with manufacturers (or 

their competitors) of any items or 

services being discussed. 

The Committee will deliberate openly 

on the topics under consideration. 

Interested persons may observe the 

deliberations, but the Committee will 

not hear further comments during this 

time except at the request of the 

chairperson. The Committee will also 

allow a 15-minute unscheduled open 

public session for any attendee to 

address issues specific to the topics 

under consideration. At the conclusion 

of the day, the members will vote and 

the Committee will make its 

recommendation(s) to CMS. 

III. Registration Instructions 

CMS’ Coverage and Analysis Group is 

coordinating meeting registration. While 

there is no registration fee, individuals 

must register to attend. You may register 

by contacting the person listed in the 

FOR FURTHER INFORMATION CONTACT

section of this notice by the deadline 

listed in the DATES section of this notice. 

Please provide your full name (as it 

appears on your State-issued driver’s 

license), address, organization, 

telephone, fax number(s), and e-mail 

address. You will receive a registration 

confirmation with instructions for your 

arrival at the CMS complex or you will 

be notified the seating capacity has been 

reached. 

IV. Security, Building, and Parking 

Guidelines 

This meeting will be held in a Federal 

government building; therefore, Federal 

security measures are applicable. We 

recommend that confirmed registrants 

arrive reasonably early, but no earlier 

than 45 minutes prior to the start of the 

meeting, to allow additional time to 

clear security. Security measures 

include the following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. 

• Inspection of vehicle’s interior and 

exterior (this includes engine and trunk 

inspection) at the entrance to the 

grounds. Parking permits and 

instructions will be issued after the 

vehicle inspection. 

• Inspection, via metal detector or 

other applicable means of all persons 

entering the building. We note that all 

items brought into CMS, whether 

personal or for the purpose of 

presentation 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 

presentation or to support a 

presentation. 

Note: Individuals who are not registered in 

advance will not be permitted to enter the 

building and will be unable to attend the 

meeting. The public may not enter the 

building earlier than 45 minutes prior to the 

convening of the meeting. 

All visitors must be escorted in areas 

other than the lower and first floor 

levels in the Central Building. 

Authority: 5 U.S.C. App. 2, section 10(a). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: August 24, 2009. 

Barry M. Straube, 

Chief Medical Officer and Director, Office 

of Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services. 

[FR Doc. E9–20844 Filed 8–27–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Blood Establishment Computer 

Software: Understanding What to 

Include in a 510(k) Submission; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘Blood Establishment 

Computer Software: Understanding 

What to Include in a 510(k) 

Submission.’’ The purpose of the public 

workshop is to educate industry on the 

laws and regulations for medical 

devices that are applicable to Blood 

Establishment Computer Software 

(BECS), including requirements for the 

content of a 510(k) submission. The 

public workshop will feature 

presentations and panel discussions led 

by FDA and other experts in software 

quality engineering. 

Date and Time: The public workshop 

will be held on November 4, 2009, from 

8:30 a.m. to 5 p.m. and November 5, 

2009, from 8:30 a.m. to 12 noon. 

Location: The public workshop will 

be held at The Universities at Shady 

Grove Conference Center, Bldg. II, 

multipurpose room, 9630 Gudelsky Dr., 

Rockville, MD 20850. 

Contact Person: Rhonda Dawson, 

Center for Biologics Evaluation and 

Research (HFM–302), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 550N, Rockville, MD 20852–1448, 

301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov. 

Registration: Mail, fax, or e-mail your 

registration information (including 

name, title, firm name, address, 

telephone, and fax numbers) to the 

contact person by October 16, 2009. 

There is no registration fee for the 

public workshop. Early registration is 

recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space available basis beginning at 7:30 

a.m. 

If you need special accommodations 

due to a disability, please contact 

Rhonda Dawson (see Contact Person) at 

least 7 days in advance. 

SUPPLEMENTARY INFORMATION: BECS is a 

device used in the prevention of disease 

in humans, by identifying unsuitable 

donors and preventing the release of 

infectious or otherwise harmful blood 

and blood components for transfusion 

or for further manufacturing use. 

Facilities that manufacture and 

distribute BECS are subject to device 

provisions of the Federal Food, Drug, 

and Cosmetic Act (the act), including 

premarket notification under section 

510(k) of the act (21 U.S.C. 360(k)) and 

applicable regulations at 21 CFR 807, 

subpart E. The public workshop will 

consist of a series of presentations, 

question-and-answer sessions, and a 

panel discussion on the following 

topics: 

• The history and legal framework of 

BECS regulation in the United States; 

• Content of 510(k) submissions, 

applicable regulations, and guidance; 

• Common challenges in obtaining 

510(k) clearance; 

• FDA-recognized software standards; 

• General software quality 

engineering; 

• Transfusion safety management 

systems (blood administration software); 

• Virtualization; and 

• Wireless technology. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Notices 44375 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page. A transcript of the public 

workshop will be available on the 

Internet at http://www.fda.gov/ 

BiologicsBloodVaccines/NewsEvents/ 

WorkshopsMeetingsConferences/ 

TranscriptsMinutes/default.htm. 

Dated: August 21, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20781 Filed 8–27–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; 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 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: National Heart, Lung, 

and Blood Institute Special Emphasis Panel. 

Cardiopulmonary and Hematology Grant 

Opportunities (ARRA). 

Date: September 2, 2009. 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call) 

Contact Person: Robert Blaine Moore, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7213, 

Bethesda, MD 20892. 301–594–8394. 

mooreb@nhlbi.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research; 93.701, ARRA 

Related Biomedical Research and Research 

Support Awards., National Institutes of 

Health, HHS) 

Dated: August 21, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–20775 Filed 8–27–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; 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 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: National Cancer 

Institute Initial Review Group; Subcommittee 

J—Population and Patient-Oriented Training. 

Date: October 28, 2009. 

Time: 7:45 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Monaco Alexandria, 480 King 

Street, Alexandria, VA. 

Contact Person: Ilda M. Mckenna, PhD, 

Scientific Review Officer, Research Training 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Boulevard, Room 8111, Bethesda, 

MD 20892, 301–496–7481, 

mckennai@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: August 21, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–20782 Filed 8–27–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form I–485 and 

Supplements A and E, Revision of a 

Currently Approved Information 

Collection; Comment Request 

ACTION: 30-Day Notice of Information 

Collection Under Review: Form I–485 

and Supplements A and E, Application 

to Register Permanent Residence or 

Adjust Status; OMB Control No. 1615– 

0023. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) has 

submitted the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection was 

previously published in the Federal 

Register on June 11, 2009, at 74 FR 

27811, allowing for a 60-day public 

comment period. USCIS did not receive 

any comments for this information 

collection. 

The purpose of this notice is to allow 

an additional 30 days for public 

comments. Comments are encouraged 

and will be accepted until September 

28, 2009. This process is conducted in 

accordance with 5 CFR 1320.10. 

Written comments and/or suggestions 

regarding the item(s) contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time, should be directed to the 

Department of Homeland Security 

(DHS), and to the Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB), USCIS 

Desk Officer. Comments may be 

submitted to: USCIS, Chief, Regulatory 

Products Division, Clearance Office, 111 

Massachusetts Avenue, Washington, DC 

20529–2210. Comments may also be 

submitted to DHS via facsimile to 202– 

272–8352 or via e-mail at 

rfs.regs@dhs.gov, and to OMB USCIS 

Desk Officer via facsimile at 202–395– 

5806 or via e-mail at 

oira_submission@omb.eop.gov. 

When submitting comments by e-mail 

please make sure to add OMB Control 

Number 1615–0023. Written comments 

and suggestions from the public and 

affected agencies should address one or 

more of the following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 


hsrobinson on DSK69SOYB1PROD with NOTICES