Department of Health and Human Services June 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry.'' The guidance document is to assist sponsors and investigators in designing early-phase clinical trials for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products). The guidance document provides recommendations regarding clinical trials in which the primary objectives are the initial assessments of safety, tolerability, or feasibility of administration of investigational products. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2013.

In accordance with the Awarding Agency Grants Administration Manual (AAGAM) Chapter 2.04.103, the Bureau of Primary Health Care (BPHC) has been granted a class deviation from the exceptions to maximum competition requirements contained in the AAGAM Chapter 2.04.104A-5 to provide additional funding without competition to the 37 Health Center Controlled Networks (HCCNs) awarded under announcement HRSA-13-237, extending their December 1, 2014, to November 31, 2015, budget period through July 31, 2016. This action will align the project period end dates of all active HCCN grants and ensure maximum competition for a single HCCN funding opportunity in fiscal year (FY) 2016.

In accordance with the Privacy Act of 1974 (5 U.S.C. 522a), as amended, OCSE is publishing notice of a computer matching program between OCSE and state agencies administering the Unemployment Compensation program.

The Administration for Children and Families (ACF), Office of Community Services (OCS), Division of Energy Assistance (DEA) announces the estimated median income of four-person households in each state, the District of Columbia, and Puerto Rico for FFY 2016 (October 1, 2015, to September 30, 2016).

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. This summary describes the existing information collection at ClinicalTrials.gov, for which an extension is requested; it does not include any changes to the information collection that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 (79 FR 225, Nov. 21, 2014). Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: David Sharlip, Office of Administrative and Management Analysis Services, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number (301) 402-9680, or Email your request, including your address to: sharlipd@mail.nih.gov Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM), 0925-0586, Expiration Date: 08/31/2015, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Health operates ClinicalTrials.gov, which was established as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include a results data bank by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects registration and results information for clinical trials and other types of clinical studies (e.g., observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical studies, to the benefit of public health. It is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research. While many clinical studies are registered and submit results information voluntarily, FDAAA requires the registration of certain applicable clinical trials of drugs and devices and the submission of results information for completed applicable clinical trials of drugs and devices that are approved, licensed, or cleared by the Food and Drug Administration. Beginning in 2009, results information was required to include information about serious and frequent adverse events. This extension request does not include any changes to the information submission requirements for ClinicalTrials.gov that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 and for which the public comment period closed on March 23, 2015 (79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted public comments as it prepares the final rule. The NIH will make any corresponding changes to the ClinicalTrials.gov information collection via separate procedure. OMB approval is requested for 3 years. The total estimated annualized cost to respondents is $49,399,851. The total estimated annualized burden hours are 682,535.

The Food and Drug Administration (FDA) has determined that Ondansetron (ondansetron hydrochloride (HCl)) Injection, USP in PL 2408 Plastic Container, 32 milligrams (mg) in 50 milliliters (mL), single intravenous (IV) dose, was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for Ondansetron (ondansetron HCl) Injection, USP in PL 2408 Plastic Container, 32 mg/50 mL, single IV dose.

The Food and Drug Administration (FDA) is extending the comment period for the notice of public hearing that appeared in the Federal Register of March 27, 2015. In the notice of public hearing, FDA requested comments on a number of specific questions identified in the document. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of X-linked Duchenne muscular dystrophy (DMD) and related dystrophinopathies.

Pursuant to the NIH Reform Act of 2006 (42 U.S.C. Sec.281 (d)(4)), notice is hereby given that the National Institute on Drug Abuse (NIDA) will provide two opportunities to enable public discussion on the Institute's proposal to reorganize its extramural program.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal statute and regulation require each Protection and Advocacy (P&A) System to prepare and submit to HHS a Statement of Goals and Priorities (SGP) for the P&A for Developmental Disabilities (PADD) program for each coming fiscal year. While the P&A is mandated to protect and advocate under a range of different Federally authorized disabilities programs, only the PADD program requires an SGP. Following the required public input for the coming fiscal year, the P&As submit the final version of this SGP to the Administration on Intellectual and Developmental Disabilities (AIDD). AIDD will analyze each SGP for compliance and aggregate the information in the SGPs into a national profile of programmatic emphasis for P&A Systems in the coming year. This aggregation will provide AIDD with a tool for monitoring of the P&As, including the public input requirement. Furthermore, it will provide an overview of program priorities, and permit AIDD to track accomplishments against goals, permitting the formulation of technical assistance and compliance with the Developmental Disabilities Assistance and Bill of Rights Act of 2000.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Risk and Benefit Perception Scale Development'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.