Department of Health and Human Services September 21, 2010 – 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 the opportunity for public comment on the proposed data collection projects, the National Institutes of Health Clinical Center (CC) 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: Customer and Other Partners Satisfaction Surveys. Type of Information Collection Request: Extension request. Need and Use of Information Collection: The information collected in these surveys will be used by Clinical Center personnel: (1) To evaluate the satisfaction of various Clinical Center customers and other partners with Clinical Center services; (2) to assist with the design of modifications of these services, based on customer input; (3) to develop new services, based on customer need; and (4) to evaluate the satisfaction of various Clinical Center customers and other partners with implemented service modifications. These surveys will almost certainly lead to quality improvement activities that will enhance and/or streamline the Clinical Center's operations. The major mechanisms by which the Clinical Center will request customer input is through surveys and focus groups. The surveys will be tailored specifically to each class of customer and to that class of customer's needs. Surveys will either be collected as written documents, as faxed documents, mailed electronically or collected by telephone from customers. Information gathered from these surveys of Clinical Center customers and other partners will be presented to, and used directly by, Clinical Center management to enhance the services and operations of our organization. Frequency of Response: The participants will respond yearly. Affected public: Individuals and households; businesses and other for profit, small businesses and organizations. Types of respondents: These surveys are designed to assess the satisfaction of the Clinical Center's major internal and external customers with the services provided. These customers include, but are not limited to, the following groups of individuals: Clinical Center patients, family members of Clinical Center patients, visitors to the Clinical Center, NIH intramural collaborators, private physicians or organizations who refer patients to the Clinical Center, volunteers, vendors and collaborating commercial enterprises, small businesses, regulators, and other organizations. The annual reporting burden is as follows:

The Office for Human Research Protections (OHRP), within the Office of the Assistant Secretary for Health, is announcing the availability of a guidance document entitled, ``Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues.'' The guidance document provides OHRP's first formal guidance on this topic. The document, which is available on the OHRP Web site at https:// www.hhs.gov/ohrp/policy/subjectwithdrawal.html or https://www.hhs.gov/ ohrp/policy/subjectwithdrawal.pdf, is intended primarily for institutional review boards (IRBs), investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by the Department of Health and Human Services (HHS). The guidance document announced in this notice finalizes the draft guidance entitled, ``Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued,'' that was made available for public comment through a notice in the Federal Register on December 1, 2008 (73 FR 72804). OHRP received comments on the draft guidance document from 30 individuals and organizations, and those comments were considered as the guidance was finalized.

The Food and Drug Administration (FDA), Office of Critical Path Programs, in cosponsorship with the Clinical Trials Transformation Initiative (CTTI), is announcing a 3-day training course for health care professionals responsible for, or involved in, the conduct and/or design of clinical trials (clinical investigators). This course is intended to assist clinical investigators in understanding what preclinical and clinical information is needed to support the investigational use of medical products, as well as the scientific, regulatory, and ethical considerations involved in the conduct of clinical trials.