Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Export Certificates for Food and Drug Administration Regulated Products, 37269 [2015-16023]

Download as PDF Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices 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 Texas announcing an administrative hearing to reconsider the disapproval of its SPA reads as follows: Ms. Kay Ghahremani State Medicaid/CHIP Director Health and Human Services Commission Post Office Box 13247 Mail Code H100 Austin, TX 78711 asabaliauskas on DSK5VPTVN1PROD with NOTICES Dear Ms. Ghahremani: I am responding to your request for reconsideration of the decision to disapprove Texas’ State Plan amendment (SPA) 14–25, which was submitted to the Centers for Medicare & Medicaid Services (CMS) on August 26, 2014, and disapproved on April 7, 2015. I am scheduling a hearing on your request for reconsideration to be held on August 6, 2015, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid & Children’s Health, Dallas Regional Office, 1301 Young Street, Room 714, Dallas, TX 75202. I am designating Mr. Benjamin R. Cohen as the presiding officer. If these arrangements present any problems, please contact Mr. Cohen at (410) 786–3169. In order to facilitate any communication that may be necessary between the parties prior to the hearing, please notify the presiding officer to indicate acceptability of the hearing date that has been scheduled and provide names of the individuals who will represent the State at the hearing. If the hearing date is not acceptable, Mr. Cohen can set another date mutually agreeable to the parties. The hearing will be governed by the procedures prescribed by federal regulations at 42 CFR part 430. In part, this SPA requested CMS approval to revise the methodology for calculating the hospital-specific limit for the Disproportionate Share Hospital (DSH) program. Specifically, SPA 14–25 proposed to exclude from the calculation, the portion of a Medicare payment for an individual who is dually-eligible for Medicare and Medicaid that exceeds the Medicaid allowable cost for the service provided to the recipient. This VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 exclusion would permit the state to make Medicaid DSH payments that are above and beyond hospitals’ reported uncompensated costs of providing services to Medicaid and uninsured individuals. The issue to be considered at the hearing is: • Whether Texas SPA 14–25 is inconsistent with Medicaid DSH requirements at sections 1902(a)(13)(A)(iv) and 1923 of the Social Security Act (Act) because it would provide for payment to disproportionate share hospitals of amounts that exceed the hospital’s uncompensated costs which cannot be considered consistent with DSH requirements pursuant to the hospital-specific limit under section 1923(g)(1) of the Act. In the event that CMS and the State come to agreement on resolution of the issues which formed the basis for disapproval, this SPA may be moved to approval prior to the scheduled hearing. I am responding to your request for reconsideration of the decision to disapprove Texas’ Medicaid state plan amendment (SPA) 14–025, which was submitted to the Centers for Medicare and Medicaid Services (CMS) on August 26, 2014, and disapproved on April 7, 2015. I am scheduling a hearing on your request for reconsideration to be held on August 6, 2015, at the Department of Health and Human Services, Centers for Medicare and Medicaid Services, Division of Medicaid & Children’s Health, Dallas Regional Office, 1301 Young Street, Room 714, Dallas, TX 75202. Sincerely, 37269 Products’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. On February 10, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Export Certificates for FDA Regulated Products’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0498. The approval expires on March 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: June 25, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–16023 Filed 6–29–15; 8:45 am] Andrew M. Slavitt BILLING CODE 4164–01–P cc: Benjamin R. Cohen Section 1116 of the Social Security Act (42 U.S.C. 1316; 42 CFR 430.18) (Catalog of Federal Domestic Assistance program No. 13.714. Medicaid Assistance Program.) Dated: June 24, 2015. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2015–16098 Filed 6–29–15; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0161] Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Export Certificates for FDA Regulated SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Food and Drug Administration [Docket No. FDA–2009–N–0025] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certifiable Color Additives AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 30, 2015. SUMMARY: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Export Certificates for Food and Drug Administration Regulated Products AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of ADDRESSES: E:\FR\FM\30JNN1.SGM 30JNN1

Agencies

[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Page 37269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0161]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Export Certificates for Food and 
Drug Administration Regulated Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled, ``Export Certificates for FDA 
Regulated Products'' has been approved by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On February 10, 2015, the Agency submitted a 
proposed collection of information entitled, ``Export Certificates for 
FDA Regulated Products'' to OMB for review and clearance under 44 
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0498. 
The approval expires on March 31, 2018. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16023 Filed 6-29-15; 8:45 am]
 BILLING CODE 4164-01-P

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