52110 Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Notices 

FDA expects that, although all sizes of 

business are eligible, small businesses 

and very small businesses are the firms 

most likely to be able to demonstrate a 

need to request an extension to the trans 

fat labeling deadline. The agency has 

already received three requests from 

businesses regarding the trans fat 

labeling compliance date of January 1, 

2006. Because small businesses are 

more likely to submit requests for 

extensions, and most of the affected 

businesses are small, we use the number 

of small businesses as the base to 

calculate the reporting burden. The 

regulatory flexibility analysis of the 

trans fat final rule estimated that 11,180 

small businesses will have to revise the 

label on their products as a result of the 

trans fat final rule. Given that only three 

businesses have submitted requests to 

FDA so far, FDA estimates that, in the 

first year following the issuance of the 

guidance, the total number of businesses 

that will request a labeling compliance 

extension from FDA can be estimated as 

approximately 0.5 percent of the 

number of small businesses, which 

equals 56. 

FDA estimates that it will take one 

employee approximately 4 hours to put 

together a request to FDA and 

approximately 1 hour for a supervisor to 

look over the request before submitting 

it to the agency. Thus, each firm 

submitting a compliance extension 

request will need 5 hours of employee 

time to complete the request. Given that 

56 businesses are expected to submit 

written requests in year one, the total 

burden hours for year one are 280. 

In year two, FDA expects about onehalf as many firms to request a labeling 

compliance extension. So for year two, 

28 firms are expected to file a request 

for an extension to the labeling 

compliance date. Again, assuming that 

it will take 5 hours to complete each 

request, the total burden hours for year 

two will be 140. 

Dated: August 26, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17413 Filed 8–29–05; 2:49 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

General Hospital and Personal Use 

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: General Hospital 

and Personal Use 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 September 27, 2005, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, Ballroom, 620 Perry 

Pkwy., Gaithersburg, MD. 

Contact Person: Scott Colburn, Center 

for Devices and Radiological Health 

(HFZ–480), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 301–594–1287, 

ext. 177, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512520. Please call the 

Information Line for up-to-date 

information on this meeting. 

Agenda: The committee will hear a 

presentation on FDA’s Critical Path 

Initiative. Subsequently, the committee 

will discuss and make 

recommendations regarding general 

issues related to the model used for 

validation testing to support a claim of 

decontamination of potentially 

transmissible spongiform 

encephalopathy (TSE)-contaminated 

surgical instruments. Background 

information for the topics, including the 

agenda and questions for the committee, 

will be available to the public 1 

business day before the meeting, on the 

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

panelmtg.html. 

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 by September 13, 2005. Oral 

presentations from the public will be 

scheduled for approximately 60 minutes 

at the beginning of deliberations and for 

approximately 30 minutes near the end 

of deliberations. Time allotted for each 

presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before September 13, 2005, 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. 

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 

Willliams at 240–276–0450, ext. 113, 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: August 23, 2005. 

Scott Gottlieb, 

Deputy Commissioner for Policy. 

[FR Doc. 05–17412 Filed 8–31–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Commission on Childhood 

Vaccines; Notice of Meeting 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice; amendment. 

SUMMARY: The Health Resources and 

Services Administration is amending a 

notice that appeared in the Federal 

Register of August 22, 2005 (70 FR 

48962–48963) announcing an Advisory 

Commission on Childhood Vaccines 

meeting on September 14, 2005. The 

document announced that the public 

can join the meeting by attending in 

person or by audio conference call. The 

meeting will now be held by audio 

conference call only. This document 

amends the notice by changing the place 

of the meeting. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Cheryl Lee at 301–443–2124 or e-mail 

clee@hrsa.gov. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

05–16502, beginning on page 48962 in 

the Federal Register of Monday, August 

22, 2005, make the following 

amendment on page 48963 in the third 

paragraph: Change place of meeting to 

Audio Conference Call. 

Dated: August 25, 2005. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. 05–17379 Filed 8–31–05; 8:45 am] 

BILLING CODE 4165–15–P