Advisory Committees; Tentative Schedule of Meetings for 2011, 80059-80061 [2010-31961]

Download as PDF Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Notices srobinson on DSKHWCL6B1PROD with NOTICES 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 VerDate Mar<15>2010 20:40 Dec 20, 2010 Jkt 223001 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 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 80059 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. 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 SUMMARY: E:\FR\FM\21DEN1.SGM 21DEN1 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 https://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 .................................................................. Risk Communication Advisory Committee ............................................... Science Board to the Food and Drug Administration .............................. March 21, June 21–22, December 5–6. February 10–11, May 5–6, August 15–16, November 17–18. February 25, May 20, August 19, November 10. CENTER FOR BIOLOGICS EVALUATION AND RESEARCH Allergenic Products Advisory Committee ................................................. Blood Products Advisory Committee ........................................................ Cellular, Tissue and Gene Therapies Advisory Committee ..................... Transmissible Spongiform Encephalopathies Advisory Committee ......... Vaccines and Related Biological Products Advisory Committee ............. May 12. April 28–29, August 3–4, December 1–2. February 10, September 22–23. Date(s), if needed, to be determined. 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 ......................... Anti-Infective Drugs Advisory Committee ................................................. Antiviral Drugs Advisory Committee ......................................................... Arthritis Advisory Committee .................................................................... Cardiovascular and Renal Drugs Advisory Committee ............................ Dermatologic and Ophthalmic Drugs Advisory Committee ...................... Drug Safety and Risk Management Advisory Committee ....................... Endocrinologic and Metabolic Drugs Advisory Committee ...................... Gastrointestinal Drugs Advisory Committee ............................................ Nonprescription Drugs Advisory Committee ............................................ Oncologic Drugs Advisory Committee ..................................................... Peripheral and Central Nervous System Drugs Advisory Committee ..... Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. Psychopharmacologic Drugs Advisory Committee .................................. Pulmonary-Allergy Drugs Advisory Committee ........................................ Advisory Committee for Reproductive Health Drugs ............................... March 10. April date(s), if needed, to be determined. April 27–29. March 15–16, May 3. March 31, April 1, July 26–27, October 20–21, December 13–14. April 13. Date(s), if needed, to be determined. March 24. January 12, March 8, May date(s), if needed, to be determined. February 23–24. February 8–9, March 29–30, June 28–29, July 13–14, September 14– 15, December 7–8. January 20–21, March 10. March 2. Date(s), if needed, to be determined. March 8. 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) srobinson on DSKHWCL6B1PROD with NOTICES Anesthesiology and Respiratory Therapy Devices Panel ........................ Circulatory System Devices Panel ........................................................... Clinical Chemistry and Clinical Toxicology Devices Panel ...................... Dental Products Panel .............................................................................. Ear, Nose, and Throat Devices Panel ..................................................... Gastroenterology-Urology Devices Panel ................................................ General and Plastic Surgery Devices Panel ............................................ General Hospital and Personal Use Devices Panel ................................ Hematology and Pathology Devices Panel .............................................. Immunology Devices Panel ...................................................................... Medical Devices Dispute Resolution Panel ............................................. Microbiology Devices Panel ..................................................................... Molecular and Clinical Genetics Panel .................................................... Neurological Devices Panel ..................................................................... Obstetrics and Gynecology Devices Panel .............................................. Ophthalmic Devices Panel ....................................................................... Orthopedic and Rehabilitation Devices Panel .......................................... Radiological Devices Panel ...................................................................... National Mammography Quality Assurance Advisory Committee ........... Technical Electronic Product Radiation Safety Standards Committee .... VerDate Mar<15>2010 20:40 Dec 20, 2010 Jkt 223001 PO 00000 Frm 00027 Fmt 4703 April 15. January 25–26, February 24–25, March 24–25, April 28–29, December 8–9. November 9. April 12–13, September 8–9. September 28–29. January 20–21, April 21–22, July 14–15, October 27–28. February 24–25, May 12–13, August 11–12, November 17–18. July 29. March 24–25, June 9–10, September 15–16, December 15–16. March 31, June 30, September 29, December 1. April 8. October 13. March 3–4. January 27–28, March 17. May 19–20, September 22–23. February 18. April 26–27, July 8. June 17, October 27–28. May 6, August 9. May 25. Sfmt 4703 E:\FR\FM\21DEN1.SGM 21DEN1 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 ........................................................................... 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. 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 srobinson on DSKHWCL6B1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 20:40 Dec 20, 2010 Jkt 223001 November 9–10. 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 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) E:\FR\FM\21DEN1.SGM 21DEN1

Agencies

[Federal Register Volume 75, Number 244 (Tuesday, December 21, 2010)]
[Notices]
[Pages 80059-80061]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31961]


-----------------------------------------------------------------------

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

[[Page 80060]]

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 
https://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       February 25, May 20, August 19,
 Administration.                          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      February 10, September 22-23.
 Advisory Committee.
Transmissible Spongiform                 Date(s), if needed, to be
 Encephalopathies Advisory Committee.     determined.
Vaccines and Related Biological          February 24-25, May 18-19,
 Products Advisory Committee.             September 20-21, November 16-
                                          17.
------------------------------------------------------------------------
                 CENTER FOR DRUG EVALUATION AND RESEARCH
------------------------------------------------------------------------
Anesthetic and Life Support Drugs        March 10.
 Advisory Committee.
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  March 31, April 1, July 26-27,
 Committee.                               October 20-21, December 13-14.
Dermatologic and Ophthalmic Drugs        April 13.
 Advisory Committee.
Drug Safety and Risk Management          Date(s), if needed, to be
 Advisory Committee.                      determined.
Endocrinologic and Metabolic Drugs       March 24.
 Advisory Committee.
Gastrointestinal Drugs Advisory          January 12, March 8, May
 Committee.                               date(s), if needed, to be
                                          determined.
Nonprescription Drugs Advisory           February 23-24.
 Committee.
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    January 20-21, March 10.
 Drugs Advisory Committee.
Advisory Committee for Pharmaceutical    March 2.
 Science and Clinical Pharmacology.
Psychopharmacologic Drugs Advisory       Date(s), if needed, to be
 Committee.                               determined.
Pulmonary-Allergy Drugs Advisory         March 8.
 Committee.
Advisory Committee for Reproductive      March 4, April and May date(s),
 Health Drugs.                            if needed, to be determined.
------------------------------------------------------------------------
               CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
------------------------------------------------------------------------
       Medical Devices Advisory Committee (Comprised of 18 Panels)
------------------------------------------------------------------------
Anesthesiology and Respiratory Therapy   April 15.
 Devices Panel.
Circulatory System Devices Panel.......  January 25-26, February 24-25,
                                          March 24-25, April 28-29,
                                          December 8-9.
Clinical Chemistry and Clinical          November 9.
 Toxicology Devices Panel.
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      February 24-25, May 12-13,
 Panel.                                   August 11-12, November 17-18.
General Hospital and Personal Use        July 29.
 Devices Panel.
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       April 8.
 Panel.
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    April 26-27, July 8.
 Panel.
Radiological Devices Panel.............  June 17, October 27-28.
National Mammography Quality Assurance   May 6, August 9.
 Advisory Committee.
Technical Electronic Product Radiation   May 25.
 Safety Standards Committee.
------------------------------------------------------------------------

[[Page 80061]]

 
              CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
------------------------------------------------------------------------
Food Advisory Committee................  March 30-31.
------------------------------------------------------------------------
                       CENTER FOR TOBACCO PRODUCTS
------------------------------------------------------------------------
Tobacco Products Scientific Advisory     January 10-11, March 17-18,
 Committee.                               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

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