968 Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Notices 

receives on the docket (Docket Number 

2006D–0347). Suggestions, 

recommendations, and materials may be 

seen at the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

V. Transcripts 

Following the meeting, transcripts 

will be available for review at http:// 

www.fda.gov/cdrh/oivd/ 

presentations.html#r, and the Division 

of Dockets Management (see ADDRESSES) 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: January 3, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–93 Filed 1–8–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Medical Devices 101: An Educational 

Forum; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA), Office of 

Regulatory Affairs (ORA), Southwest 

Regional Office (SWRO), in 

cosponsorship with the FDA Medical 

Device Industry Coalition (FMDIC) and 

the Risk Management Small Business 

Development Center (RMSBDC), is 

announcing a public workshop entitled 

‘‘Medical Devices 101: An Educational 

Forum.’’ This public workshop is 

intended to provide an overview on 

FDA’s medical device requirements to 

entrepreneurs, startup companies, and 

small businesses. 

Date and Time: The public workshop 

will be held on February 9, 2007, from 

8 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Hoblitzelle Auditorium at 

the Bill Priest Campus of El Centro 

College, 1402 Corinth St. in Dallas, TX. 

Contact Person: David Arvelo, Food 

and Drug Administration, 4040 North 

Central Expressway, suite 900, Dallas, 

TX 75204, 214–253–4952, FAX: 214–

253–4970, e-mail: 

oraswrsbr@fda.hhs.gov. 

Registration: Registration by January 

26, 2007, is strongly encouraged. The 

RMSBDC has a $75 early registration fee 

to cover the cost of facilities, materials, 

and refreshments. Please submit your 

registration as soon as possible. 

Registration at the site may be possible 

on a space available basis on the day of 

the public workshop beginning at 8 a.m. 

The cost of registration after January 26, 

2007, is $99 payable to RMSBDC. If you 

need special accommodations due to a 

disability, please contact David Arvelo 

(see Contact Person) at least 7 days in 

advance. 

Registration Form Instructions: To 

register, please complete the RMSBDC 

registration form and submit along with 

payment to RMSBDC, Attn: Saira 

Roberts, 1402 Corinth St., Dallas, TX 

75215. You may fax the completed 

registration form to RMSBDC at 214–

860–5867. To obtain a copy of the 

registration form, please call RMSBDC 

at 214–860–5887 or 214–860–5849. The 

registration form is also available online 

at http://www.ntsbdc.org/. 

Transcripts: Transcripts of the public 

workshop will not be available due to 

the format of this workshop. Course 

handouts 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, 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page. 

SUPPLEMENTARY INFORMATION: The 

workshop is being held in response to 

the interest in the topics discussed from 

small medical device entrepreneurs and 

startup manufacturers in the Dallas 

District area. FDA presents this 

workshop in cosponsorship with FMDIC 

and RMSBDC to help achieve objectives 

set forth in section 406 of the Food and 

Drug Administration Modernization Act 

of 1997 (21 U.S.C. 393), which include 

working closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. This is also consistent with the 

purposes of FDA’s Regional Small 

Business Program, which are in part to 

respond to industry inquiries, develop 

educational materials, sponsor 

workshops and conferences to provide 

firms, particularly small businesses, 

with firsthand working knowledge of 

FDA’s requirements and compliance 

policies. This workshop is also 

consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Public Law 104–121), as an 

outreach activity by Government 

agencies to small businesses. 

The goal of the workshop is to present 

information that will enable 

manufacturers and regulated industry to 

better comply with the Medical Device 

QSR. The following topics will be 

broadly covered at the workshop: (1) 

Medical device classification, (2) 

establishment registration, (3) device 

listing, (4) premarket notification, (5) 

premarket approval, (6) Quality System 

Regulation, (7) labeling, and (8) 

postmarket surveillance. 

Dated: January 3, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–92 Filed 1–8–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Vaccines and Related Biological 

Products 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). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Vaccines and 

Related Biological Products 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 January 25, 2007, from 8 a.m. 

to 5 p.m. 

Location: Doubletree Hotel, 8120 

Wisconsin Ave., Bethesda, MD 20814. 

Contact Person: Christine Walsh or 

Denise Royster, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–0314, or FDA Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512391. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: In Session I, the committee 

will hear presentations and make 

recommendations on the safety and 

immunogenicity of PENTACEL 

(Diphtheria and Tetanus Toxoids and 

Acellular Pertussis Adsorbed, 

Inactivated Poliovirus and Haemophilus 

b Conjugate (Tetanus Toxoid Conjugate) 

Vaccine Combined (DTaP-IPV/Hib)), 

manufactured by Sanofi Pasteur, Ltd. In 

Session II, the committee will hear an 

overview of the research programs in 

the Office of Vaccines Research and 

Review, Center for Biologics Evaluation 

and Research (CBER). In the closed 

session, the committee will discuss the 


ycherry on PROD1PC63 with NOTICES
Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Notices 969 

report of the Office of Vaccines Research 

and Review Office Site Visit of May 19, 

2006. 

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: On January 25, 2007, from 

8 a.m. to 4:25 p.m., the meeting is open 

to the public. 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 19, 2007. 

Oral presentations from the public will 

be scheduled between approximately 

11:15 a.m. to 11:45 a.m. and 3:55 p.m. 

to 4:25 p.m. 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 11, 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 12, 2007. 

Closed Committee Deliberations: On 

January 25, 2007, from 4:25 p.m. to 5 

p.m., the meeting will be closed to 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The committee will discuss 

the report of the May 19, 2006, review 

of internal research programs in the 

Office of Vaccines Research and Review, 

Division of Viral Products and Division 

of Bacterial, Parasitic, and Allergenic 

Products, CBER. 

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 Christine 

Walsh or Denise Royster 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: January 3, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 07–28 Filed 1–4–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301) 443–1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: The Health Education 

Assistance Loan (HEAL) Program 

Regulations (OMB No. 0915–0108): 

Extension 

The Health Education Assistance 

Loan (HEAL) Program has regulations 

that contain notification, reporting and 

recordkeeping requirements to insure 

that the lenders, holders and schools 

participating in the HEAL program 

follow sound management procedures 

in the administration of federallyinsured student loans. While the 

regulatory requirements are approved 

under the OMB number referenced 

above, much of the burden associated 

with the regulations is cleared under the 

OMB numbers for the HEAL forms and 

electronic submissions used to report 

required information. The table listed at 

the end of this notice contains the 

estimate of burden for the remaining 

regulations. 

The estimates of burden are as 

follows: 

Number of 

respondents 

Number of transactions Total 

transactions 

Hours per 

response 

(minutes) 

Total burden 

hours 

Reporting Requirements 

17 Holders ............................................................................................. 5 78 12 17 

190 Schools ........................................................................................... .4 76 10 13 

Total Reporting ............................................................................... ............................ .......................... .......................... 30 

Notification Requirements 

7,930 Borrowers .................................................................................... 1 7,930 10 1,322 

17 Holders ............................................................................................. 7,910 134,470 10 22,412 

190 Schools ........................................................................................... .89 170 14 40 

Total Notification ............................................................................. ............................ .......................... .......................... 23,774 


ycherry on PROD1PC63 with NOTICES