Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

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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.
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.
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.
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.
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.
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.
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.
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:
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.
Document Number: 2014-25873
Type: Notice
Date: 2014-10-31
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25839
Type: Notice
Date: 2014-10-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This document corrects two notices that were published in the Federal Register on March 19, 2014, Volume 79, Number 53, pages 15349 and 15350. The times and dates should read as follows:
Document Number: 2014-25838
Type: Notice
Date: 2014-10-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-25837
Type: Notice
Date: 2014-10-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-25822
Type: Notice
Date: 2014-10-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public listening session on Wednesday, November 12, 2014, to solicit information concerning the Criteria for Certified Community Behavioral Health Clinics (CCBHC) to participate in Demonstration Programs. The scheduled listening session provides an opportunity for SAMHSA to seek public input on the criteria development process. The scope of this session will be on the development of the Criteria only. The session will be held in Rockville, MD, to obtain direct input from stakeholders on the development of criteria for state certification of Community Behavioral Health Clinics.
Document Number: 2014-25800
Type: Notice
Date: 2014-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing a public meeting to solicit comments on certain topics related to our guidance titled ``Toxicological Principles for the Safety Assessment of Food Ingredients,'' known less formally as the ``Redbook.'' The purpose of our public meeting is to invite public input into possibly expanding the scope of the Redbook to include chemical safety assessments for all products over which FDA's Center for Food Safety and Applied Nutrition (CFSAN) has statutory authority including regulatory contexts such as food additives, food contact substances, dietary supplement ingredients, food contaminants, and cosmetics. The Redbook would describe toxicological principles which apply across regulatory categories while still providing specific guidance for applying these principles within each particular context. The safety of foods containing microbial contaminants will continue to remain outside of the scope of the Redbook.
Document Number: 2014-25795
Type: Notice
Date: 2014-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any small business tobacco manufacturing industry organizations interested in participating in the selection of nonvoting industry representatives to represent the interests of the small business tobacco manufacturing industry, to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to be included in a pool of individuals to represent the interests of the small business tobacco manufacturing industry on the Tobacco Products Scientific Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. This position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee. Nominations will be accepted for current vacancies effective with this notice.
Document Number: 2014-25792
Type: Notice
Date: 2014-10-30
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Document Number: 2014-25790
Type: Notice
Date: 2014-10-30
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Evaluation of the AHRQ Healthcare Horizon Scanning System.'' 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. This proposed information collection was previously published in the Federal Register on August 12th, 2014 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Document Number: 2014-25777
Type: Notice
Date: 2014-10-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-25766
Type: Notice
Date: 2014-10-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25765
Type: Notice
Date: 2014-10-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25764
Type: Notice
Date: 2014-10-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25763
Type: Notice
Date: 2014-10-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25762
Type: Notice
Date: 2014-10-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25761
Type: Notice
Date: 2014-10-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25689
Type: Notice
Date: 2014-10-29
Agency: Department of Health and Human Services
Document Number: 2014-25684
Type: Notice
Date: 2014-10-29
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-25681
Type: Notice
Date: 2014-10-29
Agency: Department of Health and Human Services, Office of Inspector General
This document announces an extension of the public comment period for the OIG Federal Register notice published on July 11, 2014 (79 FR 40114). The notice solicited input from the public on revising the criteria used by OIG in implementing its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act. Due to a technical problem, the public may have been unable to submit comments at http://www.regulations.gov during the comment period. Accordingly, we are extending the comment period to ensure that the public has an opportunity to provide input.
Document Number: 2014-25649
Type: Notice
Date: 2014-10-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25648
Type: Notice
Date: 2014-10-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25647
Type: Notice
Date: 2014-10-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25644
Type: Notice
Date: 2014-10-29
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-25641
Type: Notice
Date: 2014-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties, including academic institutions, regulated industry, and other interested organizations on best practices for communication between FDA and investigational new drug application (IND) sponsors during drug development. These comments will help FDA identify and ultimately establish best practices to be included in a draft guidance for industry and review staff.
Document Number: 2014-25638
Type: Notice
Date: 2014-10-29
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.
Document Number: 2014-25637
Type: Notice
Date: 2014-10-29
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.
Document Number: 2014-25601
Type: Notice
Date: 2014-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(l)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 21, 2014, page 49523 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The Center for Scientific Review (CSR), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 31, 2014, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Document Number: 2014-25591
Type: Notice
Date: 2014-10-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (samhsa)
Document Number: 2014-25588
Type: Rule
Date: 2014-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during August 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of two NADAs and one ANADA, and to reflect a revised food safety warning.
Document Number: 2014-25582
Type: Notice
Date: 2014-10-28
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email OMH-ACMH@hhs.gov by November 19, 2014. Instructions regarding participating in the call and how to provide verbal public comments will be given at the time of preregistration. Information about the meeting is available from the designated contact and will be posted on the Web site for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH Web site under the heading About OMH.
Document Number: 2014-25567
Type: Notice
Date: 2014-10-28
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below. The OS also welcomes comments on any other aspect of the ICR.
Document Number: 2014-25565
Type: Notice
Date: 2014-10-28
Agency: Department of Health and Human Services, Office of the Secretary
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, Department of Health and Human Services has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).
Document Number: 2014-25563
Type: Notice
Date: 2014-10-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-25562
Type: Notice
Date: 2014-10-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-25561
Type: Notice
Date: 2014-10-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-25560
Type: Notice
Date: 2014-10-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-25534
Type: Notice
Date: 2014-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that DIAMOX (acetazolamide) intravenous, 500 milligrams (mg) base/vial, and DIAMOX (acetazolamide) tablets, 125 mg and 250 mg, 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 these products, if all other legal and regulatory requirements are met.
Document Number: 2014-25511
Type: Notice
Date: 2014-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25510
Type: Notice
Date: 2014-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25509
Type: Notice
Date: 2014-10-28
Agency: Department of Health and Human Services, National Institutes of Health