80 FR 37269 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Export Certificates for Food and Drug Administration Regulated Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 125 (June 30, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 125 (June 30, 2015)
| Page Range | 37269-37269 | |
| FR Document | 2015-16023 |
[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)] [Notices] [Page 37269] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16023] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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, [email protected]. 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 http://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
![Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices 37269
to a state Medicaid agency that informs exclusion would permit the state to make Products’’ has been approved by the
the agency of the time and place of the Medicaid DSH payments that are above and Office of Management and Budget
hearing, and the issues to be considered. beyond hospitals’ reported uncompensated (OMB) under the Paperwork Reduction
costs of providing services to Medicaid and
If we subsequently notify the agency of Act of 1995.
uninsured individuals.
additional issues that will be considered The issue to be considered at the hearing FOR FURTHER INFORMATION CONTACT: FDA
at the hearing, we will also publish that is: PRA Staff, Office of Operations, Food
notice. • Whether Texas SPA 14–25 is and Drug Administration, 8455
Any individual or group that wants to inconsistent with Medicaid DSH Colesville Rd., COLE–14526, Silver
participate in the hearing as a party requirements at sections 1902(a)(13)(A)(iv) Spring, MD 20993–0002, PRAStaff@
must petition the presiding officer and 1923 of the Social Security Act (Act) fda.hhs.gov.
within 15 days after publication of this because it would provide for payment to
notice, in accordance with the disproportionate share hospitals of amounts SUPPLEMENTARY INFORMATION: On
requirements contained at 42 CFR that exceed the hospital’s uncompensated February 10, 2015, the Agency
430.76(b)(2). Any interested person or costs which cannot be considered consistent submitted a proposed collection of
with DSH requirements pursuant to the information entitled, ‘‘Export
organization that wants to participate as hospital-specific limit under section
amicus curiae must petition the Certificates for FDA Regulated
1923(g)(1) of the Act. Products’’ to OMB for review and
presiding officer before the hearing In the event that CMS and the State come
begins in accordance with the to agreement on resolution of the issues
clearance under 44 U.S.C. 3507. An
requirements contained at 42 CFR which formed the basis for disapproval, this Agency may not conduct or sponsor,
430.76(c). If the hearing is later SPA may be moved to approval prior to the and a person is not required to respond
rescheduled, the presiding officer will scheduled hearing. I am responding to your to, a collection of information unless it
notify all participants. request for reconsideration of the decision to displays a currently valid OMB control
The notice to Texas announcing an disapprove Texas’ Medicaid state plan number. OMB has now approved the
amendment (SPA) 14–025, which was information collection and has assigned
administrative hearing to reconsider the
submitted to the Centers for Medicare and OMB control number 0910–0498. The
disapproval of its SPA reads as follows: Medicaid Services (CMS) on August 26, approval expires on March 31, 2018. A
Ms. Kay Ghahremani 2014, and disapproved on April 7, 2015. I am
scheduling a hearing on your request for
copy of the supporting statement for this
State Medicaid/CHIP Director
Health and Human Services Commission reconsideration to be held on August 6, 2015, information collection is available on
Post Office Box 13247 at the Department of Health and Human the Internet at http://www.reginfo.gov/
Mail Code H100 Services, Centers for Medicare and Medicaid public/do/PRAMain.
Austin, TX 78711 Services, Division of Medicaid & Children’s Dated: June 25, 2015.
Dear Ms. Ghahremani: Health, Dallas Regional Office, 1301 Young
Leslie Kux,
Street, Room 714, Dallas, TX 75202.
I am responding to your request for Associate Commissioner for Policy.
reconsideration of the decision to disapprove Sincerely,
[FR Doc. 2015–16023 Filed 6–29–15; 8:45 am]
Texas’ State Plan amendment (SPA) 14–25, Andrew M. Slavitt BILLING CODE 4164–01–P
which was submitted to the Centers for
cc: Benjamin R. Cohen
Medicare & Medicaid Services (CMS) on
August 26, 2014, and disapproved on April Section 1116 of the Social Security Act (42
7, 2015. I am scheduling a hearing on your U.S.C. 1316; 42 CFR 430.18) (Catalog of
DEPARTMENT OF HEALTH AND
request for reconsideration to be held on Federal Domestic Assistance program No. HUMAN SERVICES
August 6, 2015, at the Department of Health 13.714. Medicaid Assistance Program.)
and Human Services, Centers for Medicare & Food and Drug Administration
Dated: June 24, 2015.
Medicaid Services, Division of Medicaid & [Docket No. FDA–2009–N–0025]
Children’s Health, Dallas Regional Office, Andrew M. Slavitt,
1301 Young Street, Room 714, Dallas, TX Acting Administrator, Centers for Medicare Agency Information Collection
75202. & Medicaid Services.
Activities; Submission for Office of
I am designating Mr. Benjamin R. Cohen as [FR Doc. 2015–16098 Filed 6–29–15; 8:45 am] Management and Budget Review;
the presiding officer. If these arrangements BILLING CODE 4120–01–P
present any problems, please contact Mr. Comment Request; Animal Food
Cohen at (410) 786–3169. In order to Labeling; Declaration of Certifiable
facilitate any communication that may be Color Additives
DEPARTMENT OF HEALTH AND
necessary between the parties prior to the
hearing, please notify the presiding officer to HUMAN SERVICES AGENCY: Food and Drug Administration,
indicate acceptability of the hearing date that HHS.
has been scheduled and provide names of the Food and Drug Administration ACTION: Notice.
individuals who will represent the State at [Docket No. FDA–2010–N–0161]
the hearing. If the hearing date is not SUMMARY: The Food and Drug
acceptable, Mr. Cohen can set another date Agency Information Collection Administration (FDA) is announcing
mutually agreeable to the parties. The Activities; Announcement of Office of that a proposed collection of
hearing will be governed by the procedures Management and Budget Approval; information has been submitted to the
prescribed by federal regulations at 42 CFR Office of Management and Budget
part 430.
Export Certificates for Food and Drug
Administration Regulated Products (OMB) for review and clearance under
In part, this SPA requested CMS approval
asabaliauskas on DSK5VPTVN1PROD with NOTICES
to revise the methodology for calculating the the Paperwork Reduction Act of 1995.
AGENCY: Food and Drug Administration,
hospital-specific limit for the DATES: Fax written comments on the
HHS.
Disproportionate Share Hospital (DSH) collection of information by July 30,
program. Specifically, SPA 14–25 proposed ACTION: Notice. 2015.
to exclude from the calculation, the portion
of a Medicare payment for an individual who SUMMARY: The Food and Drug ADDRESSES: To ensure that comments on
is dually-eligible for Medicare and Medicaid Administration (FDA) is announcing the information collection are received,
that exceeds the Medicaid allowable cost for that a collection of information entitled, OMB recommends that written
the service provided to the recipient. This ‘‘Export Certificates for FDA Regulated comments be faxed to the Office of
VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1](https://thefederalregister.org/doc/80_FR_37394/page/1.svg)
Document Created: 2018-02-22 11:17:23
Document Modified: 2018-02-22 11:17:23
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 37269 |
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