Department of Health and Human Services September 2014 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 271
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2014-21465
Type: Notice
Date: 2014-09-10
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2014-21464
Type: Notice
Date: 2014-09-10
Agency: Department of Health and Human Services
Georgia Tuberculosis Outbreak Among Homeless
Document Number: 2014-21455
Type: Notice
Date: 2014-09-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) located within the United States Department of Health and Human Services (HHS) announces a notice of award to the Georgia Department of Public Health, Tuberculosis (TB) Program. This award will be in the amount of $419,095.00. The purpose of this award is to halt the further spread of a drug- resistant strain of tuberculosis associated with multiple homeless shelters in Fulton County, Georgia.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-21379
Type: Notice
Date: 2014-09-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-21377
Type: Notice
Date: 2014-09-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee Renewals; Correction
Document Number: 2014-21369
Type: Notice
Date: 2014-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice entitled ``Advisory Committee Renewals'' that appeared in the Federal Register of August 25, 2014 (79 FR 50658). The document announced the renewal of certain FDA advisory committees by the Commissioner of Food and Drugs. The table in the document contained several errors. This document corrects those errors.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-21344
Type: Notice
Date: 2014-09-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-21343
Type: Notice
Date: 2014-09-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2014-21342
Type: Notice
Date: 2014-09-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2014-21341
Type: Notice
Date: 2014-09-09
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Meeting
Document Number: 2014-21340
Type: Notice
Date: 2014-09-09
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2014-21339
Type: Notice
Date: 2014-09-09
Agency: Department of Health and Human Services
Office of the Director; Notice of Charter Renewal
Document Number: 2014-21338
Type: Notice
Date: 2014-09-09
Agency: Department of Health and Human Services, National Institutes of Health
Exploring the Expansion of Conditional Approval to Appropriate Categories of New Animal Drugs
Document Number: 2014-21227
Type: Notice
Date: 2014-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that it is beginning the exploration process described in a stated performance goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter. Consistent with the performance goal, the FDA is inviting comments in regard to the Agency exploring the use of statutory changes to expand the use of conditional approval beyond new animal drugs intended for minor species or for minor uses in major species to additional categories of new animal drugs as appropriate.
Exploring the Feasibility of Pursuing Statutory Revisions and Other Modifications to Existing Procedures and Requirements Related to the Approval of Combination Drug Medicated Feeds
Document Number: 2014-21226
Type: Notice
Date: 2014-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that it is beginning the exploration process described in a stated performance goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter. Consistent with the performance goal, FDA is inviting comments in regard to the Agency exploring the use of statutory changes to modify the current requirement that the use of multiple new animal drugs in a combination drug medicated feed be the subject of an approved new animal drug application (NADA). The Agency also is inviting comment on potential changes to procedures and requirements related to the NADA approval process for such products that can be accomplished under the Agency's existing statutory authority.
HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations
Document Number: 2014-21333
Type: Notice
Date: 2014-09-08
Agency: Department of Health and Human Services
Section 3003(b)(3) of the American Recovery and Reinvestment Act of 2009 mandates that the HIT Standards Committee develop a schedule for the assessment of policy recommendations developed by the HIT Policy Committee and publish it in the Federal Register. This notice fulfills the requirements of Section 3003(b)(3) and updates the schedule posted in the Federal Register on May 8, 2013. In anticipation of receiving recommendations originally developed by the HIT Policy Committee, the HIT Standards Committee has created six (6) workgroups to analyze the following areas: (1) Content standards; (2) semantic standards; (3) transport and security; (4) implementation, certification, and testing; (5) architecture, services and application program interfaces (APIs); (6) a steering committee to provide continuity across all other groups. Other groups are convened to address specific issues as needed. HIT Standards Committee's Schedule for the Assessment of HIT Policy Committee Recommendations is as follows: The National Coordinator will establish priority areas based in part on recommendations received from the HIT Policy Committee regarding health information technology standards, implementation specifications, and/or certification criteria. Once the HIT Standards Committee is informed of those priority areas, it will: (A) Direct the appropriate workgroup or other special group to develop a report for the HIT Standards Committee, to the extent possible, within 90 days, which will include, among other items, the following: (1) An assessment of what standards, implementation specifications, and certification criteria are currently available to meet the priority area; (2) An assessment of where gaps exist (i.e., no standard is available or harmonization is required because more than one standard exists) and identify potential organizations that have the capability to address those gaps; and (3) a timeline, which may also account for NIST testing, where appropriate, and include dates when the HIT Standards Committee is expected to issue recommendation(s) to the National Coordinator. (B) Upon receipt of a report from a workgroup or other special group, the HIT Standards Committee will: (1) Accept the timeline provided by the subcommittee, and, if necessary, revise it; and (2) assign subcommittee(s) to conduct research and solicit testimony, where appropriate, and issue recommendations to the full committee in a timely manner. (C) Advise the National Coordinator, consistent with the accepted timeline in (B)(1) and after NIST testing, where appropriate, on standards, implementation specifications, and/or certification criteria, for the National Coordinator's review and determination whether or not to endorse the recommendations, and possible adoption of the proposed recommendations by the Secretary of the Department of Health and Human Services. The standards and related topics which the HIT Standards Committee is expected to address over the coming year include, but may not be limited to: Quality measurement; the extended portfolio of standards for the nationwide health information network; distributed queries and results; radiology; consumer-mediated information exchange; public health; data portability; and a process for the maintenance of standards. For a listing of upcoming HIT Standards Committee meetings, please visit the ONC Web site at http://www.healthit.gov/facas/calendar. Notice of this schedule is given under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.
Submission for OMB Review; Comment Request
Document Number: 2014-21318
Type: Notice
Date: 2014-09-08
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2014-21283
Type: Notice
Date: 2014-09-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Meeting
Document Number: 2014-21279
Type: Notice
Date: 2014-09-08
Agency: Department of Health and Human Services, Health Resources and Service Administration
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections
Document Number: 2014-21267
Type: Rule
Date: 2014-09-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a document entitled ``Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction'' that appeared in the Federal Register of August 14, 2014 (79 FR 47655). The document published without the required RIN number and in the Notice category. This document corrects those errors.
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction
Document Number: 2014-21266
Type: Rule
Date: 2014-09-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a final rule entitled ``Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements'' that appeared in the Federal Register of June 10, 2014 (79 FR 33072). The document amended FDA's postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. The document was published with an incorrect RIN number. This document corrects the error.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-21257
Type: Notice
Date: 2014-09-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Privacy Act of 1974
Document Number: 2014-21240
Type: Notice
Date: 2014-09-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended; the Improper Payments Elimination and Recovery Improvement Act of 2012, Public Law (Pub. L.) 112-248, 126 Stat. 2390 (31 U.S.C. 3321 (note)); and OMB Memorandum M-13-20 (Protecting Privacy while Reducing Improper Payments with the Do Not Pay Initiative), this notice announces the establishment of a CMP that CMS plans to conduct with the Bureau of the Fiscal Service (Fiscal Service), Department of Treasury.
New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
Document Number: 2014-20325
Type: Rule
Date: 2014-09-08
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 July 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 add a cross reference to a tolerance.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-21180
Type: Notice
Date: 2014-09-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-21179
Type: Notice
Date: 2014-09-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Patient Protection and Affordable Care Act; Annual Eligibility Redeterminations for Exchange Participation and Insurance Affordability Programs; Health Insurance Issuer Standards Under the Affordable Care Act, Including Standards Related to Exchanges
Document Number: 2014-21178
Type: Rule
Date: 2014-09-05
Agency: Department of Health and Human Services
This final rule specifies additional options for annual eligibility redeterminations and renewal and re-enrollment notice requirements for qualified health plans offered through the Exchange, beginning with annual redeterminations for coverage for benefit year 2015. This final rule provides additional flexibility for Exchanges, including the ability to propose unique approaches that meet the specific needs of their state, while streamlining the consumer experience.
Notice of Availability of the Final Environmental Impact Statement
Document Number: 2014-21147
Type: Notice
Date: 2014-09-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the availability of the Final Environmental Impact Statement (FEIS) for the Roybal Campus 2025 Master Plan. The FEIS analyzes the potential impacts associated with the implementation of the 2015-2025 Master Plan (Master Plan) for HHS/CDC's Edward R. Roybal Campus (Roybal Campus) located at 1600 Clifton Road NE., in Atlanta, Georgia. This announcement follows the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR Part 1500-1508); and, the Department of Health and Human Services (HHS) General Administration Manual Part 30 Environmental Procedures, dated February 25, 2000.
Proposed Information Collection Activity; Comment Request
Document Number: 2014-21137
Type: Notice
Date: 2014-09-05
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2014-21135
Type: Notice
Date: 2014-09-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2014-21134
Type: Notice
Date: 2014-09-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2014-21133
Type: Notice
Date: 2014-09-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-21132
Type: Notice
Date: 2014-09-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2014-21131
Type: Notice
Date: 2014-09-05
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-20422
Type: Notice
Date: 2014-09-05
Agency: 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: ``Guide to Nursing Home Antimicrobial Stewardship.'' 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 May 21st 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Submission of a Proposed Draft Guidance for Industry on Developing Drugs for Treatment of Duchenne Muscular Dystrophy; Establishment of a Public Docket
Document Number: 2014-21051
Type: Notice
Date: 2014-09-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a public docket to discuss issues related to developing drugs for Duchenne muscular dystrophy (DMD). During a public-private policy forum for DMD on December 12, 2013, FDA agreed that Parent Project Muscular Dystrophy (PPMD) and other interested parties in the DMD community could submit for FDA consideration a proposal for a draft guidance for industry on developing drugs for DMD. That proposed draft guidance was submitted to FDA on June 25, 2014. FDA values the guidance provided by the DMD community and is posting the document to seek additional guidance and public comment.
Medicare and Medicaid Programs; Modifications to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program for 2014 and Other Changes to the EHR Incentive Program; and Health Information Technology: Revisions to the Certified EHR Technology Definition and EHR Certification Changes Related to Standards
Document Number: 2014-21021
Type: Rule
Date: 2014-09-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary
This final rule changes the meaningful use stage timeline and the definition of certified electronic health record technology (CEHRT) to allow options in the use of CEHRT for the EHR reporting period in 2014. It also sets the requirements for reporting on meaningful use objectives and measures as well as clinical quality measure (CQM) reporting in 2014 for providers who use one of the CEHRT options finalized in this rule for their EHR reporting period in 2014. In addition, it finalizes revisions to the Medicare and Medicaid EHR Incentive Programs to adopt an alternate measure for the Stage 2 meaningful use objective for hospitals to provide structured electronic laboratory results to ambulatory providers; to correct the regulation text for the measures associated with the objective for hospitals to provide patients the ability to view online, download, and transmit information about a hospital admission; and to set a case number threshold exemption for CQM reporting applicable for eligible hospitals and critical access hospitals (CAHs) beginning with FY 2013. Finally, this rule finalizes the provisionally adopted replacement of the Data Element Catalog (DEC) and the Quality Reporting Document Architecture (QRDA) Category III standards with updated versions of these standards.
Ryan White HIV/AIDS Program, AIDS Education and Training Centers, The University of Washington, Northwest AIDS Education and Training Center
Document Number: 2014-21012
Type: Notice
Date: 2014-09-04
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA will be issuing a non-competitive award under the AETC Program, to current grantee, the University of Washington NWAETC, for approximately $250,239 during the budget period July 1, 2014, to June 30, 2015. This will allow the University of Washington NWAETC to develop a unique and flexible HIV distance learning curriculum that can be used in a variety of health care settings by a variety of health care providers. This on-line curriculum will enhance our ability to reach and so increase the numbers of health care providers skilled in delivering HIV/AIDS care and treatment at a time when there is a greater demand for these professionalsespecially primary care physicians.
Ryan White HIV/AIDS Program, Special Projects of National Significance (SPNS), the Albert Einstein College of Medicine, Enhancing Access to and Retention in Quality HIV Care for Women of Color Initiative
Document Number: 2014-21011
Type: Notice
Date: 2014-09-04
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA will be issuing a non-competitive award under the SPNS Program to current grantee, the Albert Einstein College of Medicine (Grant 5 H97HA15152-05-00), for approximately $55,000 during the budget period September 1, 2014, to August 31, 2015. This will allow the Albert Einstein College of Medicine to cover the costs associated with the publication of a special supplemental issue of the journal AIDS Patient Care and STD's, which will feature eight articles on findings from the Special Projects of National Significance (SPNS) Program Enhancing Access to and Retention in Quality HIV Care for Women of Color Initiative. A program expansion supplement will allow SPNS wider dissemination of the most current best practices and lessons learned for the care of women of color living with HIV. The journal AIDS Patient Care and STD's has a combined 18,200 print and online subscribers, and the publisher will also extend online distribution to readers of the Journal of Women's Health (approximately 32,000 additional subscribers) and to attendees of the Congress on Women's Health (approximately 800 physicians and nurses).
Statement of Organization, Functions and Delegations of Authority
Document Number: 2014-21010
Type: Notice
Date: 2014-09-04
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Institute of Mental Health; Notice of Workshop
Document Number: 2014-20934
Type: Notice
Date: 2014-09-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2014-20933
Type: Notice
Date: 2014-09-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-20932
Type: Notice
Date: 2014-09-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2014-20931
Type: Notice
Date: 2014-09-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2014-20930
Type: Notice
Date: 2014-09-04
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-20918
Type: Notice
Date: 2014-09-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medical Devices; Hematology and Pathology Devices; Classification of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization
Document Number: 2014-20882
Type: Rule
Date: 2014-09-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the early growth response 1 (EGR1) gene fluorescence in-site hybridization (FISH) test system for specimen characterization classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-20880
Type: Notice
Date: 2014-09-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-20876
Type: Notice
Date: 2014-09-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Prospective Transfer of Ownership and Exclusive Use of 510(K) Number K113336 for the CDC DENV-1-4 Real-Time RT-PCR ASSAY
Document Number: 2014-20859
Type: Notice
Date: 2014-09-03
Agency: Department of Health and Human Services, National Institutes of Health
This is notice that the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the transfer of ownership and exclusive use of 510(k) Number K113336 to American Type Culture Collection (ATCC), a District of Columbia non- profit corporation. 510(k) Number K113336 allows marketing of the CDC DENV-1-4 Real-Time RT-PCR Assay, an in vitro molecular diagnostic test that consists of a panel of oligonucleotide primers and dual-labeled hydrolysis (TaqMan[supreg]) probes for the qualitative detection of dengue virus target sequences in serum and plasma using nucleic acid isolation, amplification, and detection on the ABI 7500 Fast Dx Real- Time PCR instrument. The contemplated transfer would occur in conjunction with the grant of a non-exclusive patent license to ATCC to practice the inventions embodied in patent applications under HHS Ref. No E-148-2013/0, including U.S. Provisional Patent Application No. 61/ 554,126, entitled ``Broad Detection of Dengue Virus Serotypes'', filed November 1, 2011.