80_FR_64626 80 FR 64421 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Labeling Regulations

80 FR 64421 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Labeling Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 205 (October 23, 2015)

Page Range64421-64421
FR Document2015-26986

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device Labeling Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 80 Issue 205 (Friday, October 23, 2015) 
[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Page 64421]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26986]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1048]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Medical Device Labeling Regulations

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 ``Medical Device Labeling 
Regulations'' 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 January 30, 2015, the Agency submitted a 
proposed collection of information entitled ``Medical Device Labeling 
Regulations'' 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 0910-0485. The approval 
expires on September 30, 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: October 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26986 Filed 10-22-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices 64421 a beneficiary that is subject to the prior need not be reviewed by the Office of OMB control number 0910–0291. The authorization process, and the claim is Management and Budget under the approval expires on September 30, submitted to the MAC for payment authority of the Paperwork Reduction 2018. A copy of the supporting without requesting a prior Act of 1995. statement for this information collection authorization, the claim will be stopped is available on the Internet at http:// IV. Regulatory Impact Statement for prepayment review and www.reginfo.gov/public/do/PRAMain. documentation will be requested. This document announces an Dated: October 15, 2015. ++ If the claim is determined not to expansion of the 3-year Medicare Prior be medically necessary or to be Authorization Model for Repetitive Leslie Kux, insufficiently documented, the claim Scheduled Non-Emergent Ambulance Associate Commissioner for Policy. will be denied, and all current policies Transport. Therefore, there are no [FR Doc. 2015–26923 Filed 10–22–15; 8:45 am] and procedures regarding liability for regulatory impact implications BILLING CODE 4164–01–P payment will apply. The ambulance associated with this notice. provider/supplier or the beneficiary or Authority: Section 1115A of the Social both can appeal the claim denial if they Security Act. DEPARTMENT OF HEALTH AND believe the denial was inappropriate. HUMAN SERVICES ++ If the claim is determined to be Dated: October 2, 2015. payable, it will be paid. Andrew M. Slavitt, Food and Drug Administration Under the model, we will work to Acting Administrator, Centers for Medicare limit any adverse impact on & Medicaid Services. [Docket No. FDA–2014–N–1048] beneficiaries and to educate [FR Doc. 2015–27030 Filed 10–22–15; 8:45 am] beneficiaries about the process. If a prior BILLING CODE P Agency Information Collection authorization request is not affirmed, Activities; Announcement of Office of and the claim is still submitted by the Management and Budget Approval; provider/supplier, the claim will be DEPARTMENT OF HEALTH AND Medical Device Labeling Regulations denied in full, but beneficiaries will HUMAN SERVICES continue to have all applicable AGENCY: Food and Drug Administration, administrative appeal rights. Food and Drug Administration HHS. Only one prior authorization request [Docket No. FDA–2014–N–1960] per beneficiary per designated time ACTION: Notice. period can be provisionally affirmed. If Agency Information Collection the initial provider/supplier cannot Activities; Announcement of Office of SUMMARY: The Food and Drug complete the total number of prior Management and Budget Approval; Administration (FDA) is announcing authorized transports (for example, the MedWatch: The Food and Drug that a collection of information entitled initial ambulance company closes or no Administration Medical Products ‘‘Medical Device Labeling Regulations’’ longer services that area), the initial Reporting Program has been approved by the Office of request is cancelled. In this situation, a Management and Budget (OMB) under AGENCY: Food and Drug Administration, the Paperwork Reduction Act of 1995. subsequent prior authorization request HHS. may be submitted for the same FOR FURTHER INFORMATION CONTACT: FDA beneficiary and must include the ACTION: Notice. PRA Staff, Office of Operations, Food required documentation in the SUMMARY: The Food and Drug and Drug Administration, 8455 submission. If multiple ambulance Administration (FDA) is announcing Colesville Rd., COLE–14526, Silver providers/suppliers are providing that a collection of information entitled Spring, MD 20993–0002, PRAStaff@ transports to the beneficiary during the ‘‘MedWatch: The Food and Drug fda.hhs.gov. same or overlapping time period, the Administration Medical Products prior authorization decision will only Reporting Program’’ has been approved SUPPLEMENTARY INFORMATION: On cover the provider/supplier indicated in by the Office of Management and January 30, 2015, the Agency submitted the provisionally affirmed prior Budget (OMB) under the Paperwork a proposed collection of information authorization request. Any provider/ Reduction Act of 1995. entitled ‘‘Medical Device Labeling supplier submitting claims for repetitive Regulations’’ to OMB for review and FOR FURTHER INFORMATION CONTACT: FDA scheduled non-emergent ambulance clearance under 44 U.S.C. 3507. An PRA Staff, Office of Operations, Food transports for which no prior Agency may not conduct or sponsor, and Drug Administration, 8455 authorization request is recorded will be and a person is not required to respond Colesville Rd., COLE–14526, Silver subject to 100 percent pre-payment to, a collection of information unless it Spring, MD 20993–0002, PRAStaff@ medical review of those claims. displays a currently valid OMB control fda.hhs.gov. Additional information is available on number. OMB has now approved the the CMS Web site at http://go.cms.gov/ SUPPLEMENTARY INFORMATION: On June information collection and has assigned PAAmbulance. 11, 2015, the Agency submitted a OMB control number 0910–0485. The proposed collection of information approval expires on September 30, III. Collection of Information entitled ‘‘MedWatch: The Food and 2018. A copy of the supporting Requirements Drug Administration Medical Products statement for this information collection mstockstill on DSK4VPTVN1PROD with NOTICES Section 1115A(d)(3) of the Act, as Reporting Program’’ to OMB for review is available on the Internet at http:// added by section 3021 of the Affordable and clearance under 44 U.S.C. 3507. An www.reginfo.gov/public/do/PRAMain. Care Act, states that chapter 35 of title Agency may not conduct or sponsor, Dated: October 16, 2015. 44, United States Code (the Paperwork and a person is not required to respond Reduction Act of 1995), shall not apply to, a collection of information unless it Leslie Kux, to the testing and evaluation of models displays a currently valid OMB control Associate Commissioner for Policy. or expansion of such models under this number. OMB has now approved the [FR Doc. 2015–26986 Filed 10–22–15; 8:45 am] section. Consequently, this document information collection and has assigned BILLING CODE 4164–01–P VerDate Sep<11>2014 18:05 Oct 22, 2015 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 9990 E:\FR\FM\23OCN1.SGM 23OCN1


Document Created: 2015-12-14 15:31:43
Document Modified: 2015-12-14 15:31:43
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 64421 
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