Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Notices 80059 

The issues to be considered at the 

hearing are: 

• Whether California has 

demonstrated that the proposed 

payments to providers were sufficient to 

enlist enough providers so that care and 

services were available under the State’s 

Medicaid plan at least to the extent that 

such care and services are available to 

the general population in the geographic 

area as required by section 

1902(a)(30)(A) of the Social Security 

Act. 

• Whether the application of the 

payment rates under the SPAs 

retroactively, based on the proposed 

effective date, would be consistent with 

that requirement under section 

1902(a)(30)(A) of the Act. 

Section 1116 of the Act and Federal 

regulations at 42 CFR part 430, establish 

Department procedures that provide an 

administrative hearing for 

reconsideration of a disapproval of a 

State plan or plan amendment. CMS is 

required to publish a copy of the notice 

to a State Medicaid agency that informs 

the agency of the time and place of the 

hearing, and the issues to be considered. 

If we subsequently notify the agency of 

additional issues that will be considered 

at the hearing, we will also publish that 

notice. 

Any individual or group that wants to 

participate in the hearing as a party 

must petition the presiding officer 

within 15 days after publication of this 

notice, in accordance with the 

requirements contained at 42 CFR 

430.76(b)(2). Any interested person or 

organization that wants to participate as 

amicus curiae must petition the 

presiding officer before the hearing 

begins in accordance with the 

requirements contained at 42 CFR 

430.76(c). If the hearing is later 

rescheduled, the presiding officer will 

notify all participants. 

The notice to California announcing 

an administrative hearing to reconsider 

the disapproval of its SPAs reads as 

follows: 

Mr. Toby Douglas, Chief Deputy 

Director 

Health Care Programs 

Department of Health Care Services 

1501 Capitol Avenue, 6th Floor 

MS 0002 

Sacramento, CA 95814 

Dear Mr. Douglas: 

I am responding to your request for 

reconsideration of the decision to 

disapprove the California State Plan 

Amendments (SPAs) 08–009A; 08– 

009B1; 08–009B2; 08–009D which were 

submitted on September 30, 2008, and 

08–019 which was submitted on 

December 31, 2009, and disapproved on 

November 18, 2010. The SPAs proposed 

to reduce the reimbursement rates for 

certain services furnished under the 

approved State plan. 

The issues to be considered at the 

hearing are: 

• Whether California has 

demonstrated that the SPAs assured that 

the proposed payments to providers 

would be sufficient to enlist enough 

providers so that care and services were 

available under the State’s Medicaid 

plan at least to the extent that such care 

and services are available to the general 

population in the geographic area as 

required by section 1902(a)(30)(A) of the 

Social Security Act. 

• Whether the application of the 

payment rates under the SPAs 

retroactively, based on the proposed 

effective date, would be consistent with 

that requirement under section 

1902(a)(30)(A) of the Act. 

In reviewing this issue, we note that, 

when the SPAs were initially submitted, 

the State did not provide any 

information concerning the impact of 

the proposed reimbursement reductions 

on beneficiary access to services, even 

though available national data indicated 

that this may be an issue for California. 

In Requests for Additional 

Information (RAI) for SPAs TN 08– 

009A, TN 08–009B1, TN 08–009D (sent 

to the State in December 2008) and 08– 

019 (sent to the State in March 2009), 

CMS requested information about 

beneficiary access to services, but 

California never responded. As 

indicated in a January 2, 2001, letter to 

State Medicaid Directors, to the extent 

that responses to such RAIs are not 

received within 90 days, CMS may 

initiate disapproval action. In this 

instance, in addition, CMS was 

concerned that, given the time that had 

elapsed since these SPAs had been 

submitted but were not implemented, 

the cumulative effect of a retroactively 

effective approval of these 

reimbursement reductions exacerbate 

beneficiary access concerns. 

I am scheduling a hearing on your 

request for reconsideration to be held on 

February 10, 2011, at the CMS San 

Francisco Regional Office, 90 7th Street, 

#5–300 (5W), San Francisco, California 

94103–6706, in order to reconsider the 

decision to disapprove SPAs 08–009A; 

08–009B1; 08–009B2; 08–009D; and 08– 

019. If this date is not acceptable, we 

would be glad to set another date that 

is mutually agreeable to the parties. The 

hearing will be governed by the 

procedures prescribed by Federal 

regulations at 42 CFR Part 430. 

I am designating Mr. Benjamin Cohen 

as the presiding officer. If these 

arrangements are not acceptable, please 

contact the presiding officer at (410) 

786–3169. To facilitate any 

communication which may be necessary 

between the parties to the hearing, 

please notify the presiding officer to 

indicate acceptability of the hearing 

date that has been scheduled, and to 

provide names of the individuals who 

will represent the State at the hearing. 

Sincerely, 

Donald M. Berwick, M.D. 

Section 1116 of the Social Security Act 

(42 U.S.C. section 1316; 42 CFR section 

430.18) 

(Catalog of Federal Domestic Assistance 

program No. 13.714, Medicaid Assistance 

Program.) 

Dated: December 15, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–32007 Filed 12–20–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Advisory Committees; Tentative 

Schedule of Meetings for 2011 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

tentative schedule of forthcoming 

meetings of its public advisory 

committees for 2011. During 1991, at the 

request of the Commissioner of Food 

and Drugs (the Commissioner), the 

Institute of Medicine (the IOM) 

conducted a study of the use of FDA’s 

advisory committees. In its final report, 

one of the IOM’s recommendations was 

for the Agency to publish an annual 

tentative schedule of its meetings in the 

Federal Register. This publication 

implements the IOM’s recommendation. 

FOR FURTHER INFORMATION CONTACT: 

Teresa L. Hays, Advisory Committee 

Oversight and Management Staff (HF– 

4), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

Rm. 5290, Silver Spring, MD 20993– 

0002, 301–796–8220. 

SUPPLEMENTARY INFORMATION: The IOM, 

at the request of the Commissioner, 

undertook a study of the use of FDA’s 

advisory committees. In its final report 

in 1992, one of the IOM’s 

recommendations was for FDA to adopt 

a policy of publishing an advance yearly 

schedule of its upcoming public 


srobinson on DSKHWCL6B1PROD with NOTICES
80060 Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Notices 

advisory committee meetings in the 

Federal Register; FDA has implemented 

this recommendation. The annual 

publication of tentatively scheduled 

advisory committee meetings will 

provide both advisory committee 

members and the public with the 

opportunity, in advance, to schedule 

attendance at FDA’s upcoming advisory 

committee meetings. Because the 

schedule is tentative, amendments to 

this notice will not be published in the 

Federal Register. However, changes to 

the schedule will be posted on the FDA 

advisory committees’ Internet site 

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

AdvisoryCommittees/default.htm. FDA 

will continue to publish a Federal 

Register notice 15 days in advance of 

each upcoming advisory committee 

meeting, to announce the meeting (21 

CFR 14.20). 

The following list announces FDA’s 

tentatively scheduled advisory 

committee meetings for 2011. 

TABLE 1 

Committee name Tentative date(s) of meeting(s) 

OFFICE OF THE COMMISSIONER 

Pediatric Advisory Committee .................................................................. March 21, June 21–22, December 5–6. 

Risk Communication Advisory Committee ............................................... February 10–11, May 5–6, August 15–16, November 17–18. 

Science Board to the Food and Drug Administration .............................. February 25, May 20, August 19, November 10. 

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH 

Allergenic Products Advisory Committee ................................................. May 12. 

Blood Products Advisory Committee ........................................................ April 28–29, August 3–4, December 1–2.

Cellular, Tissue and Gene Therapies Advisory Committee ..................... February 10, September 22–23. 

Transmissible Spongiform Encephalopathies Advisory Committee ......... Date(s), if needed, to be determined. 

Vaccines and Related Biological Products Advisory Committee ............. February 24–25, May 18–19, September 20–21, November 16–17. 

CENTER FOR DRUG EVALUATION AND RESEARCH 

Anesthetic and Life Support Drugs Advisory Committee ......................... March 10. 

Anti-Infective Drugs Advisory Committee ................................................. April date(s), if needed, to be determined. 

Antiviral Drugs Advisory Committee ......................................................... April 27–29. 

Arthritis Advisory Committee .................................................................... March 15–16, May 3. 

Cardiovascular and Renal Drugs Advisory Committee ............................ March 31, April 1, July 26–27, October 20–21, December 13–14. 

Dermatologic and Ophthalmic Drugs Advisory Committee ...................... April 13. 

Drug Safety and Risk Management Advisory Committee ....................... Date(s), if needed, to be determined. 

Endocrinologic and Metabolic Drugs Advisory Committee ...................... March 24. 

Gastrointestinal Drugs Advisory Committee ............................................ January 12, March 8, May date(s), if needed, to be determined. 

Nonprescription Drugs Advisory Committee ............................................ February 23–24. 

Oncologic Drugs Advisory Committee ..................................................... February 8–9, March 29–30, June 28–29, July 13–14, September 14– 

15, December 7–8. 

Peripheral and Central Nervous System Drugs Advisory Committee ..... January 20–21, March 10. 

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology.March 2. 

Psychopharmacologic Drugs Advisory Committee .................................. Date(s), if needed, to be determined. 

Pulmonary-Allergy Drugs Advisory Committee ........................................ March 8. 

Advisory Committee for Reproductive Health Drugs ............................... March 4, April and May date(s), if needed, to be determined. 

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH 

Medical Devices Advisory Committee (Comprised of 18 Panels) 

Anesthesiology and Respiratory Therapy Devices Panel ........................ April 15. 

Circulatory System Devices Panel ........................................................... January 25–26, February 24–25, March 24–25, April 28–29, December 

8–9. 

Clinical Chemistry and Clinical Toxicology Devices Panel ...................... November 9. 

Dental Products Panel .............................................................................. April 12–13, September 8–9. 

Ear, Nose, and Throat Devices Panel ..................................................... September 28–29. 

Gastroenterology-Urology Devices Panel ................................................ January 20–21, April 21–22, July 14–15, October 27–28. 

General and Plastic Surgery Devices Panel ............................................ February 24–25, May 12–13, August 11–12, November 17–18. 

General Hospital and Personal Use Devices Panel ................................ July 29. 

Hematology and Pathology Devices Panel .............................................. March 24–25, June 9–10, September 15–16, December 15–16. 

Immunology Devices Panel ...................................................................... March 31, June 30, September 29, December 1. 

Medical Devices Dispute Resolution Panel ............................................. April 8. 

Microbiology Devices Panel ..................................................................... October 13. 

Molecular and Clinical Genetics Panel .................................................... March 3–4. 

Neurological Devices Panel ..................................................................... January 27–28, March 17. 

Obstetrics and Gynecology Devices Panel .............................................. May 19–20, September 22–23. 

Ophthalmic Devices Panel ....................................................................... February 18. 

Orthopedic and Rehabilitation Devices Panel .......................................... April 26–27, July 8. 

Radiological Devices Panel ...................................................................... June 17, October 27–28. 

National Mammography Quality Assurance Advisory Committee ........... May 6, August 9. 

Technical Electronic Product Radiation Safety Standards Committee .... May 25. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Notices 80061 

TABLE 1—Continued 

Committee name Tentative date(s) of meeting(s) 

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION 

Food Advisory Committee ........................................................................ March 30–31. 

CENTER FOR TOBACCO PRODUCTS 

Tobacco Products Scientific Advisory Committee ................................... January 10–11, March 17–18, May, July, September, and November 

date(s), if needed, to be determined. 

CENTER FOR VETERINARY MEDICINE 

Veterinary Medicine Advisory Committee ................................................ April 11, September 12. 

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH 

Science Advisory Board ........................................................................... November 9–10. 

Dated: December 16, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–31961 Filed 12–20–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0626] 

Abbott Laboratories, Inc.; Withdrawal 

of Approval of a New Drug Application 

for MERIDIA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of a new drug application 

(NDA) for MERIDIA (sibutramine 

hydrochloride (HCl)) oral capsules held 

by Abbott Laboratories, Inc. (Abbott), 

100 Abbott Park Rd., Abbott Park, IL 

60064. Abbott has voluntarily requested 

that approval of this application be 

withdrawn, thereby waiving its 

opportunity for a hearing. 

DATES: Effective December 21, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Mueller, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6312, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: On 

October 7, 2010, FDA requested that 

Abbott voluntarily withdraw MERIDIA 

(sibutramine HCl) oral capsules from the 

market, based on FDA’s recent analysis 

of clinical trial data from the 

Sibutramine Cardiovascular Outcomes 

Trial (SCOUT) that indicated that 

MERIDIA poses an increased risk of 

heart attack and stroke. In a letter dated 

October 12, 2010, Abbott requested that 

FDA withdraw approval of NDA 20–632 

for MERIDIA (sibutramine HCl) oral 

capsules under § 314.150(d) (21 CFR 

314.150(d)). In that letter, Abbott also 

waived its opportunity for a hearing, 

provided under § 314.150(a). In FDA’s 

acknowledgment letter of November 1, 

2010, the agency stated that based on 

the review of the SCOUT data and the 

assessment of the September 15, 2010, 

meeting of FDA’s Endocrinologic and 

Metabolic Drugs Advisory Committee at 

which the SCOUT data were reviewed, 

we find the benefits of MERIDIA 

(sibutramine HCl) oral capsules, 

indicated for the management of 

obesity, including weight loss and 

maintenance of weight loss, no longer 

outweigh the risks in any identifiable 

patient population. FDA also 

acknowledged that Abbott waived its 

opportunity for a hearing. 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 355(e)), 

§ 314.150(d), and under authority 

delegated by the Commissioner of Food 

and Drugs to the Director, Center for 

Drug Evaluation and Research, approval 

of NDA 20–632, and all amendments 

and supplements thereto, is withdrawn 

(see DATES). Distribution of this product 

in interstate commerce without an 

approved application is illegal and 

subject to regulatory action (see sections 

505(a) and 301(d) of the FD&C Act (21 

U.S.C. 355(a) and 331(d)). 

Dated: December 6, 2010. 

Janet Woodcock, 

Director, Center for Drug Evaluation and 

Research. 

[FR Doc. 2010–31986 Filed 12–20–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, Unsolicited Multi-Project 

(P01) Grant Applications. 

Date: January 12, 2011. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817. 

(Telephone Conference Call.) 

Contact Person: Roberta Binder, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

NIAID/NIH/DHHS, 6700B Rockledge Drive, 

Room 3130, Bethesda, MD 20892–7616. 301– 

496–7966. rbinder@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 


srobinson on DSKHWCL6B1PROD with NOTICES