Federal Register / Vol. 76, No. 65 / Tuesday, April 5, 2011 / Notices 18767 

interim final regulation with comment 

period in the Federal Register (75 FR 

24450), implementing the program as of 

June 1, 2010. Section 1102(e) of the 

Affordable Care Act appropriates 

funding of $5 billion for the temporary 

program, which ends no later than 

January 1, 2014. To participate in the 

program, an employment-based plan 

must submit an application to the 

Secretary. A copy of the application can 

be found at http://www.errp.gov. Section 

1102(f) of the Affordable Care Act grants 

the Secretary the authority to stop 

taking applications for participation in 

the program based on the availability of 

funding under section 1102(e) of the 

Affordable Care Act. The ERRP interim 

final regulation also grants the Secretary 

such authority (75 FR 24456). 

II. Provisions of the Notice 

Based on the amount of the $5 billion 

in appropriated program funding that 

remains available and the rate at which 

it is being disbursed, we are 

announcing, under section 1102(f) of the 

Affordable Care Act, that we will no 

longer accept applications for the 

program after May 5, 2011. We have 

projected the availability of program 

funding based on the rate at which 

appropriated funds are currently being 

used to reimburse plan sponsors, and 

we have concluded that we have 

approved a sufficient number of 

applications to exhaust the program 

funding. Applications were first 

accepted by the ERRP on June 29, 2010, 

and therefore, plan sponsors have so far 

had 9 months to submit applications if 

desired. As a result of this agency 

action, any program applications that 

CMS receives after May 5, 2011 will not 

be accepted for processing. Applications 

must be received in the program’s Intake 

Center on or before May 5, 2011, to be 

accepted for processing. A copy of the 

application, as well as information on 

how to complete and send it, and where 

to send it, can be found on http:// 

www.errp.gov. Merely postmarking an 

application before this date will not be 

sufficient. We will post additional 

information about the mechanics of not 

accepting such applications for 

processing, such as how we will 

respond upon receiving such an 

application, on http://www.errp.gov. 

We note that our decision to no longer 

accept applications after May 5, 2011, is 

based on the actual availability of 

remaining appropriated ERRP funds and 

the rate at which we have been 

disbursing reimbursement, as opposed 

to the projected amounts of ERRP 

reimbursements that applicants listed in 

their ERRP applications. Should 

circumstances related to the availability 

of ERRP funding change, we may decide 

it is appropriate to resume accepting 

ERRP applications. If this occurs, we 

will provide such notice in the Federal 

Register. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. So, it need 

not be reviewed by the Office of 

Management and Budget under the 

authority of the Paperwork Reduction 

Act of 1995. 

Authority: 42 U.S.C. 18002(f). 

Dated: March 29, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–7934 Filed 3–31–11; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Preparation for International 

Cooperation on Cosmetics 

Regulations; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘International 

Cooperation on Cosmetics Regulations 

(ICCR)—Preparation for ICCR–5 Meeting 

in Paris, France’’ to provide information 

and receive comments on the 

International Cooperation on Cosmetics 

Regulations (ICCR) as well as the 

upcoming meetings in Paris, France. 

The topics to be discussed are the topics 

for discussion at the forthcoming ICCR 

Steering Committee meeting. The 

purpose of the meeting is to solicit 

public input prior to the next steering 

committee and expert working group 

meetings in Paris, France scheduled on 

June 28 through July 1, 2011. 

DATES: Date and Time: The public 

meeting will be held on April 26, 2011, 

from 2 p.m. to 4 p.m. 

Location: The public meeting will be 

held at the Washington Theater room at 

the Hilton Washington DC/Rockville 

Hotel & Executive Meeting Center, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: All participants must 

register with Kimberly Franklin, Office 

of the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, email: Kimberly.Franklin@fda.hhs.gov, or 

Fax: 301–595–7937. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), written material, and requests 

to make oral presentations, to the 

contact person by April 22, 2011. 

If you need special accommodations 

due to a disability, please contact 

Kimberly Franklin (see Contact Person) 

at least 7 days in advance. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Time allotted for oral 

presentations may be limited to 10 

minutes. Those desiring to make oral 

presentations should notify the contact 

person by April 22, 2011, and submit a 

brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses, 

telephone number, fax, and e-mail of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information, 12420 

Parklawn Dr., Rockville, MD 20857. 

SUPPLEMENTARY INFORMATION: The 

purpose of the multilateral framework 

on the ICCR is to pave the way for the 

removal of regulatory obstacles to 

international trade while maintaining 

global consumer protection. 

ICCR is a voluntary international 

group of cosmetics regulatory 

authorities from the United States, 

Japan, the European Union, and Canada. 

These regulatory authority members 

will enter into constructive dialogue 

with their relevant cosmetics’ industry 

trade associations. Currently, the ICCR 

members are Health Canada; the 

European Directorate General for 

Enterprise and Industry; the Ministry of 

Health, Labor and Welfare of Japan; and 

the U.S. Food and Drug Administration. 

All decisions made by the consensus 

will be compatible with the laws, 

policies, rules, regulations, and 

directives of the respective 

administrations and governments. 

Members will implement and/or 


srobinson on DSKHWCL6B1PROD with NOTICES
18768 Federal Register / Vol. 76, No. 65 / Tuesday, April 5, 2011 / Notices 

promote actions or documents within 

their own jurisdictions and seek 

convergence of regulatory policies and 

practices. Successful implementation 

will require input from stakeholders. 

The agenda for the public meeting 

will be made available on the Internet 

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

InternationalActivities/Conferences

MeetingsWorkshops/International

CooperationonCosmeticsRegulations

ICCR/default.htm. 

Dated: March 30, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7966 Filed 4–4–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Cellular, Tissue, and Gene Therapies 

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: Cellular, Tissue, 

and Gene Therapies 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 May 31, 2011, from 2:30 p.m. 

to 6:15 p.m. 

Location: National Institutes of Health 

(NIH) Campus, 29 Lincoln Dr., Bldg. 

29B, Conference Rooms A and B, 

Bethesda, MD 20892. 

The public is welcome to attend the 

meeting at NIH, Building 29B, 

Conference Rooms A and B, where a 

speakerphone will be provided. Public 

participation in the meeting is limited to 

the use of the speakerphone in the 

conference room. Important information 

about transportation and directions to 

the NIH campus, parking, and security 

procedures is available on the Internet 

at http://www.nih.gov/about/visitor/ 

index.htm. (FDA has verified the Web 

site address, but FDA is not responsible 

for any subsequent changes to the Web 

site after this document publishes in the 

Federal Register.) Visitors must show 

two forms of identification, one of 

which must be a government-issued 

photo identification such as a Federal 

employee badge, driver’s license, 

passport, green card, etc. Detailed 

information about security procedures is 

located at http://www.nih.gov/about/ 

visitorsecurity.htm. Due to the limited 

available parking, visitors are 

encouraged to use public transportation. 

Contact Person: Gail Dapolito or 

Sheryl Clark (HFM–71), Center for 

Biologics Evaluation and Research, 

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), and follow the 

prompts to the desired center or product 

area. 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 May 31, 2011, the 

committee will meet in open session to 

hear brief overviews of research 

programs in the Laboratory of 

Biochemistry, Division of Therapeutic 

Proteins, Center for Drug Evaluation and 

Research; and the Laboratory of Cell 

Biology, the Laboratory of Molecular 

and Developmental Immunology, the 

Laboratory of Molecular Oncology, 

Division of Monoclonal Antibodies, 

Center for Drug Evaluation and 

Research. 

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: On May 31, 2011, from 

2:30 p.m. to approximately 5:15 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 

May 24, 2011. Oral presentations from 

the public will be scheduled between 

approximately 4:15 p.m. and 5:15 p.m. 

Those individuals interested in making 

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 May 16, 2011. 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 May 17, 2011. 

Closed Committee Deliberations: On 

May 31, 2011, from 5:15 p.m. to 6:15 

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 

a report of intramural research programs 

and make recommendations regarding 

personnel staffing decisions. 

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 Gail Dapolito 

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/ 

AboutAdvisoryCommittees/ 

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: March 30, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7968 Filed 4–4–11; 8:45 am] 

BILLING CODE 4160–01–P 


srobinson on DSKHWCL6B1PROD with NOTICES