Department of Health and Human Services May 10, 2011 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 25, 2010, page 52351 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after July 31, 2005, unless it displays a currently valid OMB control number. Proposed Collection: Title: Special Volunteer and Guest Researcher Assignment for use in NIH facilities. Type of Information Collection Request: Reinstatement, 0MB 0925-0177, Expiration Date July 31, 2005. Need and Use of Information Collection Request: Form Number: NIH-590. A single Form NIH-590 is completed by an NIH official for each Guest Researcher or Special Volunteer prior to his/her arrival at NIH. The information on the form is necessary for the approving official to reach a decision on whether to allow a Guest Researcher to use NIH facilities, or whether to accept volunteer services offered by a Special Volunteer. If the original assignment is extended, another form notating the extension is completed to update the file. Frequency of Response: once. Affected Public: Individuals. Type of Respondents: Non- federal scientific professionals and/or individuals. The annual Reporting burden is as follows: Estimated Number of Respondents: 1660; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: 0.1; and Estimated Total Annual Burden Hours Requested: 166. The estimated annualized cost to respondents is $2,275. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: 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.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Information From United States Firms and Processors That Export to the European Community'' 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 the Agency) is issuing this document to request comments relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications submitted under the Public Health Service Act (PHS Act). FDA is requesting input on the identified principles for development of a 351(k) user fee program, FDA's proposed structure for a 351(k) user fee program that would adhere to these principles, and performance goals for this program. FDA plans to review the comments submitted to the docket, hold meetings with public stakeholders, and hold industry stakeholder meetings to develop proposed recommendations for a user fee program for 351(k) applications for fiscal years (FYs) 2013 through 2017.