Department of Health and Human Services April 18, 2012 – Federal Register Recent Federal Regulation Documents

Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2012-9356
Type: Notice
Date: 2012-04-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2012-9337
Type: Notice
Date: 2012-04-18
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 2; Corrections
Document Number: 2012-9331
Type: Proposed Rule
Date: 2012-04-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors and typographical errors in the proposed rule entitled ``Medicare and Medicaid Programs; Electronic Health Record Incentive ProgramStage 2'' which appeared in the March 7, 2012, Federal Register.
Determination of Regulatory Review Period for Purposes of Patent Extension; KEPIVANCE; Correction
Document Number: 2012-9325
Type: Notice
Date: 2012-04-18
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 April 2, 2007 (72 FR 15699). The document concerned FDA's determination of the regulatory review period for KEPIVANCE. The document cited an incorrect statute under which the KEPIVANCE biologics license application was submitted. This document corrects the citation.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2012-9323
Type: Notice
Date: 2012-04-18
Agency: Department of Health and Human Services
Determination That FUNDUSCEIN-25 (fluorescein sodium injection), 25%, and AK-FLUOR (fluorescein sodium injection), 25%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2012-9292
Type: Notice
Date: 2012-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that FUNDUSCEIN-25 (fluorescein sodium injection), 25%, and AK-FLUOR (fluorescein sodium injection), 25%, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for fluorescein sodium injection, 25%, if all other legal and regulatory requirements are met.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2012-9259
Type: Notice
Date: 2012-04-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-9258
Type: Notice
Date: 2012-04-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations
Document Number: 2012-9251
Type: Notice
Date: 2012-04-18
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 4, 2011. In anticipation of receiving recommendations originally developed by the HIT Policy Committee, the HIT Standards Committee has created four (4) workgroups to analyze the areas of clinical quality, clinical operations, implementation, and privacy and security. Other groups are convened to address specific issues as needed, such as the Nationwide Health Information Network Power Team, the Consumer/Patient Engagement Power Team, and the Vocabulary Task Force. 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 https://healthit.hhs.gov. Notice of this schedule is given under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification
Document Number: 2012-9241
Type: Notice
Date: 2012-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Form FDA 3602 and Form FDA 3602A, which will allow domestic and foreign applicants to certify that they qualify as a ``small business'' and pay certain medical device user fees at reduced rates.
Statement of Organization, Functions, and Delegations of Authority; Administration for Community Living
Document Number: 2012-9238
Type: Notice
Date: 2012-04-18
Agency: Department of Health and Human Services
The Department of Health and Human Services establishes the Administration for Community Living in order to achieve several important objectives: reduce the fragmentation that currently exists in Federal programs addressing the community living service and support needs of both the aging and disability populations; enhance access to quality health care and long-term services and supports for all individuals; promote consistency in community living policy across other areas of the Federal government; and complement the community infrastructure, as supported by both Medicaid and other Federal programs, in order to better respond to the full spectrum of needs of seniors and persons with disabilities.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-9105
Type: Notice
Date: 2012-04-18
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: ``CHIPRA Pediatric Quality Measures Program Candidate Measure Submission Form.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
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