Department of Health and Human Services August 29, 2014 – Federal Register Recent Federal Regulation Documents

Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports; Availability
Document Number: 2014-20635
Type: Notice
Date: 2014-08-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Electronic Submission of Lot Distribution Reports'' dated August 2014. The draft guidance document provides information and recommendations pertaining to the electronic submission of lot distribution reports for applicants with approved biologics license applications (BLAs). FDA recently published in the Federal Register a final rule requiring that, among other things, lot distribution reports be submitted to FDA in an electronic format that the Agency can process, review, and archive. The draft guidance, when finalized, is intended to help licensed manufacturers of products distributed under approved BLAs (henceforth referred to as applicants) comply with the final rule.
Determination That JADELLE (Levonorgestrel) Implant, 75 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2014-20634
Type: Notice
Date: 2014-08-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) has determined that JADELLE (levonorgestrel) implant, 75 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for JADELLE (levonorgestrel) implant, 75 mg, if all other legal and regulatory requirements are met.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
Document Number: 2014-20620
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on September 29, 2014. The topic for this meeting will be ``Implementing the Department of Health and Human Services National Action Plan for Hypoglycemic Safety.'' The meeting is open to the public.
Evaluation Policy; Cooperative Research or Demonstration Projects
Document Number: 2014-20616
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, Administration for Children and Families
Administration for Children and Families (ACF) is announcing its evaluation policy for research or demonstration projects as authorized by 42 U.S.C. 1310.
Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice of Meeting
Document Number: 2014-20599
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, Health Resources and Service Administration
Council on Graduate Medical Education; Notice of Meeting
Document Number: 2014-20598
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, Health Resources and Service Administration
Submission for OMB Review; Comment Request
Document Number: 2014-20594
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-20590
Type: Notice
Date: 2014-08-29
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: 2014-20589
Type: Notice
Date: 2014-08-29
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.
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 2014-20577
Type: Notice
Date: 2014-08-29
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. 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. We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. We are, however, requesting an emergency review of the information collection reference below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. This is necessary to ensure compliance with an initiative of the Administration. We are requesting an emergency review under 5 CFR part 1320(a)(2)(i) because public harm is reasonably likely to result if the normal clearance procedures are followed. We are seeking emergency approval for modifications to the ICR currently approved under Office of Management and Budget (OMB) control number 0938-0760, entitled Medicare and Medicaid Programs OASIS Collection Requirements as Part of the CoPs for HHAs and Supporting Regulations. The revisions contained in this request pertain only to the Outcome Assessment and Information Set, C-1/ICD-9 Version (OASIS-C1/ICD-9 Version); therefore all other requirements in the currently approved PRA package are not being revised. The approval of this data collection instrument is essential because OASIS data is used in the calculation of provider payment as well as for measurement of the quality of care provided by Home Health Agencies (HHAs).
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-20553
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-20552
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2014-20551
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive Start-up Option License: Use of Oligodeoxynucleotide as Neuroprotectants in Cerebral and Other Ischemic Injury
Document Number: 2014-20548
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive start-up option license to practice the inventions embodied in: (E-147- 1999/0 &1) US provisional patent application No. 60/128/898 filed 4/12/ 1999, and PCT application No. PCT/US00/09839 filed 4/12/2000, and U.S. patent No. 6,977,245 filed 02/06/2002 issued 12/20/2005, and U.S. patent No. 7,960,356 filed 05/17/2005 and issued 06/14/2011, and EP1176966 granted 4/3/2013, each entitled ``Oligodeoxynucleotide and Its Use to Induce an Immune Response''; and (E-036-2005/0) US provisional patent application No. 60/713,547 filed August 31, 2005, and PCT application No. PCT/US2006/033774 filed August 28, 2006, and US patent 7,892,569 filed 8/31/2005 issued 2/22/2011, and Canada application number 2620582 filed 2/28/08, and Australia patent 2006284889 filed 8/28/2006 issued 12/1/11, and Japan patent 5481068 filed 8/28/2006 issued 2/21/2014, each entitled ``Method of Altering an Immune Response Induced by CpG Oligodeoxynucleotides''; and (E-214- 2001/0) US provisional patent application No. 60/312,190 filed August 14, 2001, and PCT application No. PCT/US202/025732, and US patent 7,354,909 filed February 2, 2004 issued April 8, 2008, and US patent 7,959,934 filed March 28, 2008 issued June 14, 2011, each entitled ``Method for Rapid Generation of Mature Dendritic Cells'' by Klinman et al. (FDA), to Neuralexo, LLC, having a place of business at 17367 Canal Circle, Lake Oswego, Oregon 97035. The United States of America is an assignee to the patent rights of these inventions. The prospective exclusive start-up option licensed territory may be worldwide, and the field of use may be limited to: preventative treatment for ischemic injury in organs.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2014-20547
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2014-20546
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-20545
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-20544
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Scientific Information Request on Health Information Exchange
Document Number: 2014-20425
Type: Notice
Date: 2014-08-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Health Information Exchange, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
Patient Safety Organizations: Voluntary Relinquishment From Patient Safety Services, LLC
Document Number: 2014-20424
Type: Notice
Date: 2014-08-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR Part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732-70814, provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of NHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from Patient Safety Services, LLC of its status as a PSO, and has delisted the PSO accordingly.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-20423
Type: Notice
Date: 2014-08-29
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 changes to the currently approved information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.