Department of Health and Human Services April 22, 2014 – Federal Register Recent Federal Regulation Documents

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 Clinical Center (CC), 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. 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: Daniel Hobbs, National Institutes of Health, Clinical Research Center, 6100 Executive Blvd. Suite 3C01 MSC 7515, Bethesda, MD 20892-7515 or call non-toll-free number 301-496-3817 or Email your request, including your address to: daniel.hobbs@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: The SSA-NIH Collaboration to Improve the Disability Determination Process: Calibration II & Predictive Validity Testing of IRT-CAT Tools, 0925-New, Clinical Center (CC), National Institutes of Health (NIH). Need and Use of Information Collection: The Social Security Administration (SSA) entered into an interagency agreement (IAA) with the National Institutes of Health (NIH), Clinical Center (CC), Rehabilitation Medicine Department (RMD), to explore innovative methods of functional assessment to improve SSA's disability determination process. As part of its study, NIH recommended item response theory (IRT) coupled with computer adaptive testing (CAT) as a promising approach to efficiently and consistently capture claimant functional information to assist SSA adjudicators. IRT is a framework for the design, analysis, and scoring of tests, questionnaires, and similar instruments measuring abilities, aptitudes, and other variables. It is often the preferred method for the development of tests such as the Graduate Record Examination (GRE) and the Graduate Management Admission Test (GMAT). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 11,361.

In accordance with the Awarding Agency Grants Management Manual (AAGAM) Chapter 1.03.103, the Bureau of Primary Health Care (BPHC) requests a class deviation to award low-cost extensions of up to 6 months or, when necessary, administrative supplements to minimize disruption of services for specific health center program service areas. Per the requirements for low-cost extensions outlined in the AAGAM Chapter 2.04.104B-4A.1.a.(5)(b), these extensions may not exceed 25 percent of the approved federal direct cost budget authorized for the budget period (exclusive of the additional funding requested) or $100,000. Likewise, per the requirements for administrative supplements outlined in the AAGAM Chapter 2.04.104B-4A.4.b, these supplements may not exceed 25 percent of the approved federal direct cost budget authorized for the budget period (exclusive of the additional funding) or $250,000, whichever is less. In each case, the Health Resources and Services Administration (HRSA) is required to publish a notice in the Federal Register in advance of, or concurrent with, the awarding of the funds. BPHC is requesting a class deviation to the requirements for low- cost extensions to allow HRSA to award extensions that exceed 25 percent of the approved federal direct cost budget authorized for the budget period (exclusive of the additional funding requested) and/or $100,000 in cases where the grantee would not receive future continued support under the Health Center Program. Likewise, BPHC is requesting a class deviation to the requirements for administrative supplements to allow HRSA to award supplements that exceed 25 percent of the approved federal direct cost budget authorized for the budget period (exclusive of the additional funding) and/or $250,000 in cases where the award is to a currently funded grantee located in or adjacent to the service area of a grantee that will not receive continued support under the Health Center Program. BPHC is also requesting that the deviation allow for the publication of a consolidated notice in the Federal Register annually that summarizes the actions taken in the prior fiscal year. The sole purpose of these low-cost extensions or administrative supplements is to avoid a gap in the provision of critical health care services for a funded service area by providing a ``bridge'' until HRSA is able to make an award to an eligible applicant under a Service Area Competition (SAC) and/or to assure an orderly phase-out of Health Center Program activities by the current grantee. BPHC is not requesting that this class deviation cover single source replacement awards and will continue to request single case deviations for such non-competitive actions if necessary.

The Food and Drug Administration (FDA) is withdrawing approval of 3 new drug applications and 41 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.