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 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.

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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. ), 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. and 4 p.m., Monday document provides blood guidance before it begins work on the through Friday. establishments that collect blood and • final version of the guidance, submit Confidential Submissions—To blood components for transfusion or either electronic or written comments submit a comment with confidential further manufacture, including Source on the draft guidance by March 2, 2016. information that you do not wish to be Plasma, with FDA recommendations for assessing blood donor suitability, donor ADDRESSES: You may submit comments made publicly available, submit your deferral, and blood product as follows: comments only as a written/paper submission. You should submit two management in the event that an Electronic Submissions copies total. One copy will include the outbreak of EVD with widespread Submit electronic comments in the information you claim to be confidential transmission is declared in at least one following way: with a heading or cover note that states country. • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS Ebola virus is a member of the family www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The that can cause severe instructions for submitting comments. Agency will review this copy, including hemorrhagic fever in humans and non- Comments submitted electronically, the claimed confidential information, in human primates with historically high including attachments, to http:// its consideration of comments. The morbidity and mortality rates of up to www.regulations.gov will be posted to second copy, which will have the 90 percent. However, in the 2014 the docket unchanged. Because your claimed confidential information outbreak in West , the mortality comment will be made public, you are redacted/blacked out, will be available rate has been markedly lower. In solely responsible for ensuring that your for public viewing and posted on humans, EVD is typically characterized comment does not include any http://www.regulations.gov. Submit at onset by fever, severe headache, confidential information that you or a both copies to the Division of Dockets muscle pain and weakness, followed by third party may not wish to be posted, Management. If you do not wish your diarrhea, vomiting, abdominal pain, and such as medical information, your or name and contact information to be sometimes diffuse hemorrhage (bleeding anyone else’s Social Security number, or made publicly available, you can or bruising). In previous outbreaks of confidential business information, such provide this information on the cover EVD, symptoms generally appeared as a manufacturing process. Please note sheet and not in the body of your within 21 days and most often within 4– that if you include your name, contact comments and you must identify this 10 days following infection; however, information, or other information that information as ‘‘confidential.’’ Any based on mathematical models, identifies you in the body of your information marked as ‘‘confidential’’ symptom onset later than 21 days is comments, that information will be will not be disclosed except in estimated as possible in 0.1 to 12 posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other percent of cases. In addition, there have • If you want to submit a comment applicable disclosure law. For more been isolated reports of apparently with confidential information that you information about FDA’s posting of asymptomatic Ebola virus infection in do not wish to be made available to the comments to public dockets, see 80 FR

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individuals who had contact with Ebola a person known to have recovered from Dated: November 27, 2015. patients. Ebola virus disease. In addition, FDA Leslie Kux, Transmission of Ebola virus from recommends that establishments defer Associate Commissioner for Policy. human to human occurs by direct for a period of 8 weeks after exposure [FR Doc. 2015–30589 Filed 12–2–15; 8:45 am] contact with body fluids (such as blood, a donor who has been notified by a BILLING CODE 4164–01–P urine, stool, saliva, semen, vaginal Federal, State, or local public health fluids, or vomit) of symptomatic authority that he or she may have been infected individuals. Therefore, blood exposed to a person with Ebola virus DEPARTMENT OF HOMELAND and blood products from symptomatic disease. individuals, if they were to donate, SECURITY The draft guidance includes FDA would have the potential of transmitting U.S. Customs and Border Protection Ebola virus to recipients. recommendations on retrieval and Current regulations 21 CFR 640.3(b) quarantine of blood and blood [1651–0017] and 21 CFR 640.63(b)(3) require that a components from a donor later donor be in good health with a normal determined to have Ebola virus Agency Information Collection temperature at the time of donation. infection or disease or risk factors for Activities: Protest Standard procedures that are in place to Ebola virus infection or disease, for AGENCY: assure that the donor feels healthy at the notification of consignees, and for U.S. Customs and Border time of donation serve as an effective reporting a biological product deviation Protection, Department of Homeland safeguard against collecting blood or to FDA. The draft guidance also Security. blood components from a donor who addresses convalescent plasma intended ACTION: 60-Day Notice and request for seeks to donate after the onset of clinical for transfusion. comments; extension of an existing collection of information. symptoms. FDA is providing guidance The draft guidance is being issued to reduce the risks of collecting blood consistent with FDA’s good guidance SUMMARY: U.S. Customs and Border and blood components from potentially practices regulation (21 CFR 10.115). Ebola virus-infected persons during the Protection (CBP) of the Department of The draft guidance, when finalized, will asymptomatic incubation period before Homeland Security will be submitting represent the current thinking of FDA the onset of clinical symptoms, as well the following information collection on ‘‘Recommendations for Assessment as from individuals with a history of request to the Office of Management and Ebola virus infection or disease. of Blood Donor Suitability, Donor Budget (OMB) for review and approval The draft guidance permits blood Deferral and Blood Product in accordance with the Paperwork establishments to update their donor Management in Response to Ebola Reduction Act: Protest. CBP is educational materials to instruct donors Virus; Draft Guidance for Industry.’’ It proposing that this information with a history of Ebola virus infection does not establish any rights for any collection be extended with no change or disease to not donate blood or blood person and is not binding on FDA or the to the burden hours or to the components. In the event that one or public. You can use an alternative information collected. This document is more countries is designated as having approach if it satisfies the requirements published to obtain comments from the widespread transmission of Ebola virus, of the applicable statutes and public and affected agencies. the draft guidance includes regulations. DATES: Written comments should be recommendations to blood received on or before February 1, 2016 II. Paperwork Reduction Act of 1995 establishments to update their donor to be assured of consideration. history questionnaire (DHQ), including The draft guidance refers to ADDRESSES: Written comments may be the full-length and abbreviated DHQ previously approved collections of mailed to U.S. Customs and Border and accompanying materials, to assess information found in FDA regulations. Protection, Attn: Tracey Denning, prospective donors for risk of Ebola These collections of information are Regulations and Rulings, Office of virus infection or disease. The draft subject to review by the Office of International Trade, 90 K Street NE., guidance also includes Management and Budget (OMB) under 10th Floor, Washington, DC 20229– recommendations to blood the Paperwork Reduction Act of 1995 1177. establishments to defer indefinitely a (44 U.S.C. 3501–3520). The collections FOR FURTHER INFORMATION CONTACT: blood donor with a history of Ebola of information in 21 CFR 601.12 have virus infection or disease, until more Requests for additional information been approved under OMB control data regarding the persistence of Ebola should be directed to Tracey Denning, number 0910–0338; the collections of virus in survivors becomes available. U.S. Customs and Border Protection, information in 21 CFR 606.160(b)(1)(i), For a donor who in the past 8 weeks has Regulations and Rulings, Office of 640.3(a) and 640.63(b)(3) have been been a resident of or has travelled to a International Trade, 90 K Street NE., approved under OMB control number country with widespread transmission 10th Floor, Washington, DC 20229– of Ebola virus disease, FDA 0910–0116; the collection of 1177, at 202–325–0265. recommends that establishments defer information in 21 CFR 606.171 has been SUPPLEMENTARY INFORMATION: CBP the donor for 8 weeks from the time of approved under OMB control number invites the general public and other the donor’s departure from that country. 0910–0458. Federal agencies to comment on For a donor who has had close contact III. Electronic Access proposed and/or continuing information with a person confirmed or under collections pursuant to the Paperwork investigation for Ebola virus infection or Persons with access to the Internet Reduction Act of 1995 (Pub. L. 104–13). disease in whom diagnosis is pending, may obtain the draft guidance at either The comments should address: (a) FDA recommends that establishments http://www.fda.gov/ Whether the collection of information is defer a donor for 8 weeks after the last BiologicsBloodVaccines/Guidance necessary for the proper performance of close contact that could have resulted in ComplianceRegulatoryInformation/ the functions of the agency, including direct contact with body fluids, or 8 Guidances/default.htm or http:// whether the information shall have weeks after the last sexual contact with www.regulations.gov. practical utility; (b) the accuracy of the

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