Department of Health and Human Services October 31, 2014 – Federal Register Recent Federal Regulation Documents

Medicare Program; Approval of 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
Document Number: 2014-25940
Type: Notice
Date: 2014-10-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the request from Lake Pointe Medical Center for an exception to the prohibition against expansion of facility capacity.
Privacy Act of 1974; Report of Modified System of Records
Document Number: 2014-25937
Type: Notice
Date: 2014-10-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify an existing SOR titled, ``Chronic Condition Data Repository (CCDR), System No. 09-70-0573'' last published at 71 FR 54495, September 15, 2006. The current name of the SOR, Chronic Condition Data Repository, was developed during the planning and development stages of the system. Upon the implementation and throughout the operations and maintenance stages of the system, the system has been referred to as the Chronic Condition Warehouse (CCW) in common usage and written references. In keeping with this current usage, we will modify the name of this SOR to read, and from this point forward will refer to the system as: ``Chronic Condition Warehouse (CCW).'' We propose to broaden the scope of the system to include data that can be easily linked, at the individual patient level, to all Medicare and Medicaid claims, enrollment and/or eligibility data, nursing home and home health assessments, and CMS beneficiary survey data. Accordingly, we are updating the Authority Section to include Title XVIII of the Social Security Act as amended (the Act); Section 1902(a)(6) of the Act; Section 1142(c)(6) of the Act; and Title IV of the Balanced Budget Act (Pub. L. 105-33). The Record Source Categories section will be modified to include data from two new systems of records: the CMS Encounter Data System, System No. 09-70-0506, and the National Death Index, System No. 09-20-0166. These modifications will make the CCW a more useful tool by which to support research, policy analysis, quality improvement activities, and demonstrations that attempt to foster a better understanding of how to improve the quality of life and contain the health care costs of the chronically ill. We propose to modify existing Routine Use Number 1, to limit disclosures only to contractors of CMS. We also propose to add two new routine uses. Specifically, we propose adding a routine use to permit disclosures to healthcare providers who seek patient information for use in care coordination and quality improvement activities as described at 45 CFR 164.506(c)(4). This routine use will be added as Routine Use Number 4. We also propose adding a routine use to support public or private Qualified Entities (QEs) that use Medicare claims data to evaluate the performance of providers of services and suppliers on measures of quality, efficiency, effectiveness, and resource use. This routine use will be added as routine use number 6. Finally, we are modifying the language in Routine Use Number 3 to include grantees of CMS administered grant programs and have made minor grammatical changes to Routine Use Number 10. These modifications will provide a better explanation as to the need for the routine use, and to clearly state CMS's intention when making disclosures of individually identifiable information contained in this system. We have provided background information about the modified system in the Supplementary Information section below. Although the Privacy Act requires only that the ``Routine Use'' section of the system of records notice be published for comment, CMS invites comments on all portions of this notice. See the Effective Dates section for information on the comment period.
Native American Programs
Document Number: 2014-25921
Type: Proposed Rule
Date: 2014-10-31
Agency: Department of Health and Human Services, Administration for Children and Families
The Department of Health and Human Services, Administration for Children and Families, Administration for Native Americans (ANA) is seeking comments, data, and information from the public related to planned revisions and amendments to regulations implementing the Native American Programs Act of 1974 (the NAPA). ANA anticipates making revisions and amendments to update and revise procedures and policies involved in executing the requirements of 42 U.S.C. 2991b, 2991b-1, 2991b-2, 2991b-3, 2991d, 2991g, 2991h, 2992, and 2992b-1 (Section 803, 803A, 803B, 803C, 805, 809, 810, 811, and 814 of the NAPA) currently found in our regulations. ANA is interested in receiving feedback to this advance notice of proposed rulemaking (ANPRM) about potential means of streamlining applicable regulations, removing undue burdens, and clarifying procedures and policies related to accessing programs. We are also interested in receiving recommendations related to the activities of the Commissioner of the Administration for Native Americans as an advocate on behalf of Native Americans.
Notice of Intent To Award Ebola Response Outbreak Funding to Eligible Ministries of Health and Their Bona Fide Agents
Document Number: 2014-25920
Type: Notice
Date: 2014-10-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This notice provides public announcement of CDC's intent to award Ebola appropriations to select Ministries of Health and their bona fide agents for response to the Ebola outbreak funding. This award was proposed in Fiscal Year (FY) 2015 under funding opportunity announcement GH14-1418, ``Protecting and Strengthening Public Health Impact, Systems, Capacity, and Security.'' This notice replaces the Notice of Intent to award Ebola Response outbreak funding to eligible Ministries of Health and their bona fide agents which was published on October 22, 2014 (79 FR 63126, October 22, 2014). CDC is correcting the application date, award dates, amount of funding available, and one of the points of contact. Catalogue of Federal Domestic Assistance Number (CFDA): 93.318.
Determination That TOPICORT (Desoximetasone) Cream and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2014-25911
Type: Notice
Date: 2014-10-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements; Correction
Document Number: 2014-25910
Type: Notice
Date: 2014-10-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 14, 2014. The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. In this document, we correct some errors that appeared in the notice.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Food and Drug Administration Commissioner's Fellowship Program
Document Number: 2014-25893
Type: Notice
Date: 2014-10-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Findings of Research Misconduct
Document Number: 2014-25887
Type: Notice
Date: 2014-10-31
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Bijan Ahvazi, Ph.D., National Institutes of Health: Based on the report of an investigation conducted by the National Institutes of Health (NIH) and additional analysis by ORI in its oversight review, ORI found that Dr. Bijan Ahvazi, former Director of the Laboratory of X-ray Crystallography, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH, engaged in research misconduct in research supported by the Intramural Program at NIAMS, NIH. ORI found that Respondent engaged in research misconduct by falsifying data related to or in the following published papers: 1. Ahvazi, B., Boeshans, K.M., Idler, W., Baxa, U., & Steinert, P.M. ``Structural basis for the coordinated regulation of transglutaminase 3 by guanine nucleotides and calcium/magnesium.'' J. Biol. Chem. 279(8):7180-92, 2004 Feb 20 (withdrawn) (hereinafter ``JBC 2004a'') 2. Ahvazi, B., Boeshans, K.M., & Steinert, P.M. ``Crystal structure of transglutaminase 3 in complex with BMP: Structural basis for nucleotide specificity.'' J. Biol. Chem. 279:26716-25, 2004 (withdrawn) (hereinafter ``JBC 2004b'') 3. Ahvazi, B., Boeshans, K.M., Idler, W.,& Cooper, A.J.L. ``Crystal structure of transglutaminase 3-cystamine complex: Binding of two cystamines to the nucleotide-binding pocket. M6:06060, Submitted to J. Biol. Chem., 2006 (rejected) (hereinafter ``JBC 2006''). Specifically, ORI finds that Respondent: 1. Falsely labeled Figure 3A in JBC 2004b representing an isothermal calorimetric titration (ITC) experiment using guanine monophosphate (GMP) and transglutaminase 3 (TGase 3) when the figure was actually a relabeled version of an unrelated experiment that Respondent previously published as Figure 1A in JBC 2004a. 2. falsified Figure 4B, Figure 4C, and Figure 6D in JBC 2004b and Figure 5E in JBC 2006, by altering the original data in the following ways to represent the desired experiment:
Government-Owned Inventions; Availability for Licensing
Document Number: 2014-25874
Type: Notice
Date: 2014-10-31
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2014-25873
Type: Notice
Date: 2014-10-31
Agency: Department of Health and Human Services, National Institutes of Health