Department of Health and Human Services January 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2010.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Pre- Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion'' dated January 2011. The draft guidance document provides blood establishments with recommendations for pre- storage leukocyte reduction of Whole Blood and blood components intended for transfusion, including recommendations for validation and quality control monitoring of the leukocyte reduction process. This second draft guidance document incorporates revisions after reviewing comments on the January 2001 draft. This draft guidance replaces the draft guidance of the same title dated January 2001. This draft guidance, when finalized, will supersede the FDA memorandum issued on May 29, 1996, entitled ``Recommendations and Licensure Requirements for Leukocyte- Reduced Blood Products.''

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of Intramural Training & Education, 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 July 20, 2010 (Vol. 75, No. 138 on pages 42097-42098) 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: NIH Office of Intramural Training & Education Application. Type of Information Collection Request: REVISION. Need and Use of Information Collection: The Office of Intramural Training & Education (OITE) administers a variety of programs and initiatives to recruit pre-college through post-doctoral educational level individuals into the National Institutes of Health Intramural Research Program (NIH-IRP) to facilitate develop into future biomedical scientists. The proposed information collection is necessary in order to determine the eligibility and quality of potential awardees for traineeships in these programs. The applications for admission consideration include key areas such as: Personal information, eligibility criteria, contact information, student identification number, training program selection, scientific discipline interests, educational history, standardized examination scores, reference information, resume components, employment history, employment interests, dissertation research details, letters of recommendation, financial aid history, sensitive data, future networking contact, travel information, as well as feedback questions about interviews and application submission experiences. Sensitive data collected on the applicants, race, gender, ethnicity and recruitment method, are made available only to OITE staff members or in aggregate form to select NIH offices and are not used by the admission committee for admission consideration; optional to submit. Over the last several years the OITE has used three OMB Clearance Numbers for the collection of applications for the training programs. To improve announcement of all training programs and lessen the burden of applicants, the OITE proposes to merge the following:

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables'' 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 that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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 requirements under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Premarket Approval of Medical Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this document is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.