Department of Health and Human Services January 27, 2015 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting to discuss essential health benefits and provider networks, the integration of the Affordable Care Act (ACA) qualified health plan and the Ryan White Program; an update on the National HIV/AIDS Strategy; and a discussion on surveillance data. The meeting will be open to the public.

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 Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects 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: Pothur Srinivas, Ph.D., Project Officer/ICD Contact, Two Rockledge Center, 6701 Rockledge Drive, Room 10188, MSC 10193, Bethesda, MD 20892, or call non-toll-free number (301) 435-0550, or Email your request to: srinivap@nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments 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: Evaluation of the NHLBI Proteomics Centers Program: Qualitative Interviews 0925-New, National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH). Need and Use of Information Collection: The Proteomics Centers Program was established in 2010 with the goal of applying proteomic approaches to gain a better mechanistic understanding of the physiologic pathways underlying defined clinical conditions related to heart, lung, and blood diseases. The primary goal of the program is to help facilitate a better understanding of the underlying mechanisms in heart, lung, and blood diseases which could contribute to more effective diagnoses, risk stratification, intervention, and prevention. Given the rapid developments in proteomic technologies and approaches in the last five years, it is important to determine the extent to which the efforts of the centers have matured, leading to discovery of new targets for intervention and clinically actionable tool sets. An eighteen-month outcome evaluation will coincide with the completion of funding for the program. This information collection request is being made for one component of this evaluation: Semi-structured interviews with key informants across four targeted groups, internal and external to the program. The results of the evaluation will help determine the extent to which these desired outcomes were achieved as well as to inform future of proteomics research funding and commitments by the NHLBI. The key informant interviews are necessary to understand the perspectives of internal and external program stakeholders as it relates to the success, limitations, and opportunities that can shape future research funding. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 48.

The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.'' The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA and includes presentations from key FDA officials, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom to create synergies focused on finding solutions which make a difference. The experience level of the audience has fostered engaged dialog that has led to innovative initiatives. Dates and Times: The public conference will be held on March 25, 2015, from 8:30 a.m. to 5 p.m.; March 26, 2015, from 8:30 a.m. to 5 p.m.; and March 27, 2015, from 8:30 a.m. to 12:45 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3020. Contact Persons: For information regarding this notice: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East 7th Street, Cincinnati, OH 45202, 513-246-4134, email: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207- 5471, 513-745-3073, email: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and dinners for the 2\1/2\ days of the conference. There will be onsite registration. The cost of registration is as follows:

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.'' This guidance is intended to provide recommendations when finalized regarding clinical trial design for medical devices intended either to provide improvement in the appearance of nails affected by onychomycosis or to treat onychomycosis (fungal nail infection). This draft guidance is not final nor is it in effect at this time.

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 the information collection in Form FDA 3792, ``Biosimilars User Fee Cover Sheet''.