March 9, 2011 – Federal Register Recent Federal Regulation Documents

The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 17, 2010 (75 FR 79009) 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 October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Questionnaire Cognitive Interview and Pretesting. Type of Information Collection Request: Extension. Need and Use of Information Collection: The purpose of the data collection is to conduct cognitive interviews, focus groups, Pilot household interviews, and experimental research in laboratory and field settings, both for applied questionnaire evaluation and more basic research on response errors in surveys. The most common evaluation method is the cognitive interview, in which a questionnaire design specialist interviews a volunteer participant. The interviewer administers the draft survey questions as written, but also probes the participant in depth about interpretations of questions, recall processes used to answer them, and adequacy of response categories to express answers, while noting points of confusion and errors in responding. Interviews are generally conducted in small rounds of 10-15 interviews. When possible, cognitive interviews are conducted in the survey's intended mode of administration. Cognitive interviewing provides useful information on questionnaire performance at minimal cost and respondent burden. Similar methodology has been adopted by other federal agencies, as well as by academic and commercial survey organizations. There are no costs to respondents other than their time. Frequency of Response: Once. Affected Public: Individuals and households, Private Sector (business or other for-profits, not-for-profit institutions) and possibly, State, Local or Tribal Governments. The table below represents the burden over a three-year data collection period, which is a typical request for a generic submission. The estimated total burden hours requested is 3,600 for the three-year clearance period. There are no annualized costs to respondents. The annualized costs to the Federal Government are estimated at $244,000 and include cost of NCI staff to plan, conduct, and analyze outcomes of questionnaire development, contracting for pretesting activities and research, travel costs, and additional materials needed to conduct and recruit participants for the research. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the Department of the Treasury has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). Treasury is requesting clearance for eight separate OMB Control Numbers for eight bureaus and offices within the Department. Each clearance will have the same title and purpose, but will be available for use by each bureau under their control number and burden estimate, as detailed below. Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. Abstract: The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.

The Department of the Treasury, as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). The Consumer Financial Protection Bureau implementation team is soliciting comments regarding forms for questions, complaints, and other information about consumer financial products and services.

The EPA proposes interim approval of the Title V Operating Permits Program submitted by the Southern Ute Indian Tribe (Tribe). The Tribe's Title V Operating Permit Program (Title V Program) was submitted for the purpose of administering a tribal program for issuing operating permits to all major stationary sources, and certain other sources on the Southern Ute Indian Reservation (Reservation).

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, Department of Veterans Affairs will submit a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument. We are republishing this notice because we inadvertently omitted certain information from the Federal Register notice published on January 18, 2011 (76 FR 2953). This document contains the omitted information and agrees with the information in the notice published on November 4, 2010 (75 FR 68036).

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

The Food and Drug Administration (FDA) has determined the regulatory review period for CERVARIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring David E. Berman, MD, for 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Berman was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Berman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Berman failed to respond. Dr. Berman's failure to respond constitutes a waiver of his right to a hearing concerning this action.

As part of the Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the Export-Import Bank of the United States (Ex-Im Bank), has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.)

This notice corrects the March 2011 meeting date published in the Federal Register on March 2, 2011 (76FR41) for the U.S. Department of the Interior, Bureau of Land Management, Northeastern Great Basin Resource Advisory Council.

The Prince of Wales Resource Advisory Committee will meet in Thorne Bay, Alaska, March 28, 2011. The purpose of this meeting is to discuss potential projects under the Secure Rural Schools and Community Self-Determination Act of 2008.