Department of Health and Human Services March 2013 – 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, Center for Scientific Review, the 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 to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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: Monica Basco, ECR Program, Center for Scientific Review, 6701 Rockledge Dr., Room 3220, Bethesda, MD 20892 or call non-toll-free number (301) 300- 3839 or Email your request, including your address to: CSRearlyCareerReviewer@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: Early Career Reviewer Program Online Application SystemCenter for Scientific Review (CSR), 0925- New Information Collection Request), Center for Scientific Review (CSR), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Scientific Review (CSR) is the portal for NIH grant applications and their review for scientific merit. Our mission is to see that NIH grant applications receive fair, independent, expert, and timely reviewsfree from inappropriate influencesso NIH can fund the most promising research. To accomplish this goal, Scientific Review Officers (SRO) form study sections consisting of scientists who have the technical and scientific expertise to evaluate the merit of grant applications. The CSR Early Career Reviewer (ECR) program was developed to identify and train qualified scientists who are early in their scientific careers and who have not had prior CSR review experience. Currently, the application process involves repeated email interactions with potential applicants and manual management of information. To make the application process more efficient for applicants and for CSR staff, we are working with the Information Management Branch at CSR to develop online application software which includes the collection of applicants' names, contact information, and professional CV. This PRA clearance request is to develop online application software for ECR program applicants. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 650.

The purpose of this Request for Information (RFI) is to seek broad public input on the Fiscal Year (FY) 2013-2018 Strategic Plan for the Office of Disease Prevention (ODP), National Institutes of Health (NIH).

The Food and Drug Administration (FDA or ``we'') is reopening the comment period for a document entitled ``Draft Qualitative Risk Assessment of Risk of Activity/ Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the draft RA) that we made available for public comment in the Federal Register of January 16, 2013. We are reopening the comment period to update comments and to receive any new information.

The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for award of a cooperative agreement to the Brookings Institution's Engelberg Center for Health Care Reform (ECHCR) in support of efforts to inform major initiatives for process improvement and regulatory science related to FDA commitments under the 2012 reauthorization of the Prescription Drug User Fee Act (PDUFA V).

This document corrects technical errors in the correcting document that appeared in the October 3, 2012 Federal Register entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals' Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers; Correction.''

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Formal Dispute Resolution: Appeals Above the Division Level.'' This guidance is intended to provide recommendations for industry on the procedures in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for resolving scientific and procedural disputes that cannot be resolved at the division level. This guidance describes procedures for formally appealing such disputes to the office or center level and providing information to assist FDA officials in resolving the issue(s) presented. This guidance revises the guidance of the same name issued in February 2000.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary(OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This interim final rule with comment builds upon standards set forth in the HHS Notice of Benefit and Payment Parameters for 2014, published elsewhere in this issue of the Federal Register. This document will adjust risk corridors calculations that would align the calculations with the single risk pool provision, and set standards permitting issuers of qualified health plans the option of using an alternate methodology for calculating the value of cost-sharing reductions provided for the purpose of reconciliation of advance payments of cost-sharing reductions.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 60 days for public comment on proposed information collection projects, the Bureau of Indian Affairs (BIA) and the Indian Health Service (IHS) are publishing for comment, a summary of a proposed information collection, titled ``Indian Self- Determination and Education Assistance Contracts, 25 CFR part 900,'' to be submitted to the Office of Management and Budget (OMB) for review. The information is collected to process contracts, grants or cooperative agreements (contracts) for award by BIA and IHS, as authorized by the Indian Self-Determination and Education Assistance Act (ISDEAA), as amended (25 U.S.C. 450 et seq.). This previously approved information collection (OMB Control Number 1076-0136) expires May 31, 2013.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft 5-year plan describing the Agency's approach to further developing and implementing a structured framework for benefit-risk assessment in the human drug and biologic review process and the opportunity for public comment on the draft plan. This plan is part of FDA's commitments that were made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). FDA has published the draft plan on its Web site at https:// www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUs erFee/ UCM329758.pdf.