Department of Health and Human Services April 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Blood Establishment Registration and Product Listing, Form FDA 2830'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Modified Risk Tobacco Product Applications.'' The draft guidance provides information about submitting applications for modified risk tobacco products under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance describes the information that the FD&C Act requires you to submit in your modified risk tobacco product application and the scientific evidence FDA recommends you submit to support your application. The draft guidance also permits the filing of a single application for any modified risk tobacco product that is also a new tobacco product under the FD&C Act.

The Food and Drug Administration (FDA) is establishing a list of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke (the established HPHC list) as required by the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), 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. Proposed Collection: Title: Generic Clearance to Conduct Voluntary Customer/Partner Surveys; Type of Information Collection Request: Extension of currently approved collection [OMB No. 0925-0476, expiration date 06/30/2012], Form Number: NA; Need and Use of Information Collection:: Executive Order 12962 directed agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. Additionally, since 1994, the NLM has been a ``Federal Reinvention Laboratory'' with a goal of improving its methods of delivering information to the public. An essential strategy in accomplishing reinvention goals is the ability to periodically receive input and feedback from customers about the design and quality of the services they receive. The NLM provides significant services directly to the public including health providers, researchers, universities, other federal agencies, state and local governments, and to others through a range of mechanisms, including publications, technical assistance, and Web sites. These services are primarily focused on health and medical information dissemination activities. The purpose of this submission is to obtain OMB's generic approval to continue to conduct satisfaction surveys of NLM's customers. The NLM will use the information provided by individuals and institutions to identify strengths and weaknesses in current services and to make improvements where feasible. The ability to periodically survey NLM's customers is essential to continually update and upgrade methods of providing high quality service. Frequency of Response: Annually or biennially. Affected Public: Individuals or households; businesses or other for profit; state or local governments; Federal agencies; non-profit institutions; small businesses or organizations. Type of Respondents: Organizations, medical researchers, physicians and other health care providers, librarians, students, and the general public. The annual reporting burden is as follows:

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 information collection project: ``Development of a Health Information Rating System (HIRS).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

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 collection of information associated with the Food Contact Substance Notification Program, including revisions to Form FDA 3480, new Form FDA 3480A, and electronic submission via the Electronic Submission Gateway (ESG).

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 2, 2012 (77 FR 12853). The document announced a public hearing entitled ``Draft Guidances Related to the Development of Biosimilar Products; Public Hearing; Request for Comments'' to obtain input on recently issued draft guidances relating to the development of biosimilar products. The document published with an incorrect date for submission of electronic and written comments. This document corrects that error.