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Federal Register/Vol. 80, No. 232/Thursday, December 3, 2015/Notices

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Federal Register/Vol. 80, No. 232/Thursday, December 3, 2015/Notices Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices 75681 control number 0938–0685; the CMS– 2. CY 2016 Estimates significant impact on the operations of 855S is approved under OMB control a. Medicare a substantial number of small rural number 0938–1056. hospitals. This analysis must conform to Based on CMS data, we estimate that the provisions of section 604 of the IV. Regulatory Impact Statement in CY 2016 approximately— RFA. For purposes of section 1102(b) of • A. Background 10,000 newly enrolling institutional the Act, we define a small rural hospital providers will be subject to and pay an We have examined the impact of this as a hospital that is located outside of application fee; and a Metropolitan Statistical Area for notice as required by Executive Order • 45,000 revalidating institutional 12866 on Regulatory Planning and Medicare payment regulations and has providers will be subject to and pay an fewer than 100 beds. We are not Review (September 30, 1993), Executive application fee. Order 13563 on Improving Regulation preparing an analysis for section 1102(b) Using a figure of 55,000 (10,000 newly of the Act because we have determined, and Regulatory Review (January 18, enrolling + 45,000 revalidating) 2011), the Regulatory Flexibility Act and the Secretary certifies, that this institutional providers, we estimate an notice would not have a significant (RFA) (September 19, 1980, Pub. L. 96– increase in the cost of the Medicare 354), section 1102(b) of the Social impact on the operations of a substantial application fee requirement in CY 2016 number of small rural hospitals. Security Act, section 202 of the of $5,585,000 (or (10,000 additional Unfunded Mandates Reform Act of 1995 Section 202 of the Unfunded newly enrolling or revalidating Mandates Reform Act of 1995 (UMRA) (March 22, 1995; Pub. L. 104–4), institutional providers × $554) + (45,000 Executive Order 13132 on Federalism × also requires that agencies assess $1.00) from our CY 2015 projections anticipated costs and benefits before (August 4, 1999), and the Congressional and as previously described. Review Act (5 U.S.C. 804(2)). issuing any rule whose mandates Executive Orders 12866 and 13563 b. Medicaid and CHIP require spending in any 1 year of $100 million in 1995 dollars, updated direct agencies to assess all costs and Based on CMS and state statistics, we annually for inflation. In 2015, that benefits of available regulatory estimate that approximately 30,000 threshold is approximately $144 alternatives and, if regulation is (9,000 newly enrolling + 21,000 million. The Agency has determined necessary, to select regulatory revalidating) Medicaid and CHIP that there will be minimal impact from approaches that maximize net benefits, institutional providers will be subject to the costs of this notice, as the threshold including potential economic, an application fee in CY 2016. Using is not met under the UMRA. environmental, public health and safety this figure, we project an increase in the Executive Order 13132 establishes effects, distributive impacts, and equity. cost of the Medicaid and CHIP certain requirements that an agency A regulatory impact analysis (RIA) must application fee requirement in CY 2016 must meet when it promulgates a be prepared for major rules with of $1,213,973 (or ((562 additional newly proposed rule (and subsequent final economically significant effects ($100 enrolling institutional providers + 1,579 rule) that imposes substantial direct million or more in any 1 year). As additional revalidating institutional requirement costs on state and local explained in this section of the notice, providers, or 2,141 total additional governments, preempts state law, or we estimate that the total cost of the institutional providers) × $554) + 27,859 otherwise has federalism implications. increase in the application fee will not × $1.00) from our CY 2015 projections Since this notice does not impose exceed $100 million. Therefore, this and as previously described. notice does not reach the $100 million substantial direct costs on state or local c. Total economic threshold and is not governments, the requirements of considered a major notice. Based on the foregoing, we estimate Executive Order 13132 are not the total increase in the cost of the applicable. B. Costs application fee requirement for In accordance with the provisions of The costs associated with this notice Medicare, Medicaid, and CHIP Executive Order 12866, this notice was involve the increase in the application providers and suppliers in CY 2016 to reviewed by the Office of Management fee amount that certain providers and be $6,798,973 ($5,585,000 + $1,213,973) and Budget. suppliers must pay in CY 2016. from our CY 2015 projections. Dated: November 14, 2015. The RFA requires agencies to analyze 1. Estimates of Number of Affected Andrew M. Slavitt, options for regulatory relief of small Acting Administrator, Centers for Medicare Institutional Providers in December 5, businesses. For purposes of the RFA, 2014 Fee Notice & Medicaid Services. small entities include small businesses, [FR Doc. 2015–30686 Filed 12–2–15; 8:45 am] In the December 5, 2014 application nonprofit organizations, and small BILLING CODE 4120–01–P fee notice, we estimated that based on governmental jurisdictions. Most CMS statistics— hospitals and most other providers and • 10,000 newly enrolling Medicare suppliers are small entities, either by DEPARTMENT OF HEALTH AND institutional providers would be subject nonprofit status or by having revenues HUMAN SERVICES to and pay an application fee in CY of less than $7.5 million to $38.5 2015. million in any 1 year. Individuals and Food and Drug Administration • 35,000 revalidating Medicare states are not included in the definition [Docket No. FDA–2014–D–2175] institutional providers would be subject of a small entity. As we stated in the to and pay an application fee in CY RIA for the February 2, 2011 final rule Recommendations for Assessment of 2015. with comment period (76 FR 5952), we • Blood Donor Suitability, Donor Deferral 8,438 newly enrolling Medicaid and do not believe that the application fee and Blood Product Management in CHIP providers would be subject to and will have a significant impact on small Response to Ebola Virus; Draft pay an application fee in CY 2015. entities. Guidance for Industry; Availability • 19,421 revalidating Medicaid and In addition, section 1102(b) of the Act CHIP providers would be subject to and requires us to prepare a regulatory AGENCY: Food and Drug Administration, pay an application fee in CY 2015. impact analysis if a rule may have a HHS. VerDate Sep<11>2014 15:11 Dec 02, 2015 Jkt 238001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\03DEN1.SGM 03DEN1 Lhorne on DSK5TPTVN1PROD with NOTICES 75682 Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices ACTION: Notice. public, submit the comment as a 56469, September 18, 2015, or access written/paper submission and in the the information at: http://www.fda.gov/ SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ Administration (FDA or Agency) is Submissions’’ and ‘‘Instructions’’). default.htm. announcing the availability of a draft document entitled ‘‘Recommendations Written/Paper Submissions Docket: For access to the docket to read background documents or the for Assessment of Blood Donor Submit written/paper submissions as Suitability, Donor Deferral and Blood electronic and written/paper comments follows: received, go to http:// Product Management in Response to • Mail/Hand delivery/Courier (for www.regulations.gov and insert the Ebola Virus; Draft Guidance for written/paper submissions): Division of docket number, found in brackets in the Industry.’’ The draft guidance document Dockets Management (HFA–305), Food heading of this document, into the provides blood establishments that and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts collect blood and blood components for Lane, Rm. 1061, Rockville, MD 20852. transfusion or further manufacture, • For written/paper comments and/or go to the Division of Dockets including Source Plasma, with FDA submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm. recommendations for assessing blood Management, FDA will post your 1061, Rockville, MD 20852. donor suitability, donor deferral, and comment, as well as any attachments, FOR FURTHER INFORMATION CONTACT: Paul blood product management in the event except for information submitted, E. Levine, Jr., Center for Biologics that an outbreak of Ebola virus disease marked and identified, as confidential, Evaluation and Research, Food and (EVD) with widespread transmission is if submitted as detailed in Drug Administration, 10903 New declared in at least one country. The ‘‘Instructions.’’ Hampshire Ave., Bldg. 71, Rm. 7301, draft guidance document applies Instructions: All submissions received Silver Spring, MD 20993–0002, 240– primarily to Ebola virus (species Zaire must include the Docket No. FDA 2014– 402–7911. ebolavirus), but recommendations are D–2175 for ‘‘Recommendations for SUPPLEMENTARY INFORMATION: expected to apply to other viruses of the Assessment of Blood Donor Suitability, Ebolavirus genus such as Sudan virus, Donor Deferral and Blood Product I. Background Bundibugyo virus, and Taı¨ Forest virus. Management in Response to Ebola The recommendations would apply to Virus; Draft Guidance for Industry.’’ FDA is announcing the availability of routine collection of blood and blood Received comments will be placed in a draft document entitled components for transfusion or further the docket and, except for those ‘‘Recommendations for Assessment of manufacture, including Source Plasma. submitted as ‘‘Confidential Blood Donor Suitability, Donor Deferral and Blood Product Management in DATES: Although you can comment on Submissions,’’ publicly viewable at any guidance at any time (see 21 CFR http://www.regulations.gov or at the Response to Ebola Virus; Draft Guidance 10.115(g)(5)), to ensure that the Agency Division of Dockets Management for Industry.’’ The draft guidance considers your comment on this draft between 9 a.m.
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