Department of Health and Human Services May 12, 2014 – Federal Register Recent Federal Regulation Documents
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Confidentiality of Alcohol and Drug Abuse Patient Records
The Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public listening session on Wednesday, June 11, 2014, to solicit information concerning the Confidentiality of Alcohol and Drug Abuse Patient Records Regulations, 42 CFR Part 2. This session will be held in Rockville, MD, to obtain direct input from stakeholders on updating the regulations. The scheduled listening session provides an opportunity for SAMHSA to seek public input on potential changes to the regulations.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Medicare Program; Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition
Under section 1877(i) of the Social Security Act (the Act), a physician-owned hospital is effectively prohibited from expanding facility capacity, unless the Secretary grants the hospital's request for an exception to that prohibition after considering input on the hospital's request from individuals and entities in the community where the hospital is located. The Centers for Medicare & Medicaid Services (CMS) has received a request from a physician-owned hospital for an exception to the prohibition against expansion of facility capacity. This notice solicits comments on the request from individuals and entities in the community in which the physician-owned hospital is located. Community input may inform our determination regarding whether the requesting hospital qualifies for an exception to the prohibition against expansion of facility capacity.
Fiscal Year (FY) 2014 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $520,000 (total costs) per year for the remaining two years of the APAIT Health Center grant. The original grant was awarded to APAIT Health Center in FY 2013 in response to the Request for Applications (RFA) TI-13-011: Substance Abuse Treatment for Racial/Ethnic Minority Women at High Risk for HIV/AIDS (TCE:HIV Minority Women). Additional information on this program can be found in the original funding announcement, TI-13-011, https://www.samhsa.gov/grants/2013/ti-13- 011.aspx. APAIT Health Center relinquished their grant in November 2013 and Special Service for Groups, Inc. took over APAIT's operations and activities in the same geographic area as APAIT Health Center. SSG submitted an application in response to SAMHSA's Request for Applications (RFA) TI-14-011, in which SSG provided documentation of their capabilities to maintain a comprehensive, integrated, trauma-informed, women-centered outpatient substance abuse treatment system of care. SSG and their partnering provider organizations meet the needs of the population of focus, as stated in the original application. Special Service for Groups, Inc. must continue to use awarded funds to provide a comprehensive, integrated, trauma-informed, women-centered outpatient substance abuse treatment service system of care as described in the 2013 RFA. SSG will use awarded funds to conduct the required activities as stated in the original application. Funding Opportunity Title: TI-14-011. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its seventeenth meeting on June 9-10, 2014. At this meeting, the Commission will discuss the BRAIN Initiative and ongoing work in neuroscience.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Updating and Expanding the AHRQ QI Toolkit for Hospitals.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104- 13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting. These meetings will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C. 552b(c)(4), and 5 U.S.C. 552b(c)(6).
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review, Technical Amendment
In a final rule that was published in the Federal Register on October 5, 2012, we amended and republished the list of select agents and toxins that have the potential to pose a severe threat to public health and safety; reorganized the list of select agents and toxins based on the relative potential of each select agent or toxin to be misused to adversely affect human health (designation of Tier 1); and amended the regulations in order to add definitions and clarify language concerning security, training, biosafety, biocontainment, and incident response. In that final rule, all of our regulatory language was not precisely aligned with that used by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture (USDA) in their parallel select agent regulations published on the same day in the Federal Register. This document corrects inconsistencies in language between the HHS/CDC and USDA/APHIS regulations. We are also correcting an improper term used in those sections of the regulations associated with identification of a viral strain or subspecies that is excluded from the requirements of the regulations, modifying the terms used when a select toxin is excluded from the regulations, clarifying those parts of the regulations that deal with temporary exemptions granted during periods of public health or agricultural emergencies, and adding language to specify that individuals not approved for unescorted access to registered space for activities not related to select agents or toxins (e.g., routine cleaning, maintenance, and repairs) would not have to be continuously escorted by an approved individual so long as those non-approved persons would not be able to gain access to select agents or toxins.
Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II
This final rule reforms Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This final rule also increases the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert resources away from providing high quality patient care. We are issuing this rule to achieve regulatory reforms under Executive Order 13563 on improving regulation and regulatory review and the Department's plan for retrospective review of existing rules. This is the latest in a series of rules developed by CMS over the last 5 years to reform existing rules to reduce unnecessary costs and increase flexibility for health care providers.
Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Civil Monetary Penalty Rules
This proposed rule would amend the civil monetary penalty (CMP or penalty) rules of the Office of Inspector General (OIG) to incorporate new CMP authorities, clarify existing authorities, and reorganize regulations on civil money penalties, assessments and exclusions to improve readability and clarity.
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