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 The draft guidance document provides blood establishments with recommendations for pre- storage leukocyte reduction of Whole Blood and blood components intended for transfusion,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 This second draft guidance document incorporates revisions after reviewing comments on the January 2001 draft. This draft guidance replaces the draft guidance of the same title dated January 2001. This draft guidance, when finalized, will supersede the FDA memorandum issued on May 29, 1996, entitled ``Recommendations and Licensure Requirements for Leukocyte- Reduced Blood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.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

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 the Guide to Patient and Family Engagement in Health Care Quality and Safety in the Hospital Setting.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on November 15th, 2010 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Process Validation: General Principles and Practices.'' This guidance provides information for the pharmaceutical industry on the elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs). The guidance is intended to provide clear and consistent communication of regulatory expectations and to promote voluntary compliance with current FDA requirements. This guidance revises and replaces the guidance for industry entitled ``Guideline on General Principles of Process Validation,'' dated May 1987.

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: ``Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.

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: ``Synthesis Reports for Grants and Cooperative Agreements for Transforming Healthcare Quality through Information Technology (THQIT).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on November 2, 2010 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Department of Health and Human Services proposes to alter System of Records, 09-20-0170, National Select Agent Registry (NSAR)/ Select Agent Transfer and Entity Registration Information System (SATERIS), HHS/CDC/COTPER''. HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER), Division of Select Agents and Toxins (DSAT).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0161, ``Records of Health Professionals in Disease Prevention and Control Training Programs, HHS/CDC/NCHSTP.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Center for HIV, STD and TB Prevention (NCHSTP).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0159, ``Records of Subject in Certification, Testing, Studies of Personal Protective Devices, and Accident Investigations, HHS/CDC/NIOSH.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory (NPPTL).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0153, ``Mortality Studies in Coal Mining, Metal and Non-metal Mining and General Industry, HHS/CDC/NIOSH.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Institute for Occupational Safety and Health (NIOSH).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0147, ``Occupational Health Epidemiological Studies and EEOICPA Program Records, HHS/CDC/NIOSH.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Institute for Occupational Safety and Health (NIOSH).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0137, ``Passport File, HHS/CDC/COGH.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07- 16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Coordinating Office for Global Health (COGH), Office of Global Program Support Services.

The Department of Health and Human Services proposes to alter System of Records, 09-20-0118, ``Study at Work Sites Where Agents Suspected of Being Occupational Hazards Exist, HHS/CDC/NIOSH.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07- 16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Institute for Occupational Safety and Health (NIOSH).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0113, ``Epidemic Investigation Case Records, HHS/CDC/NCID.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Center for Infectious Diseases (NCID).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0106, ``Specimen Handling for Testing and Related Data, HHS/CDC/NCID.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Center for Infectious Diseases (NCID), Scientific Resources Program, Material, Data and Specimen Handling Section.

The Department of Health and Human Services proposes to alter System of Records, 09-20-0102, ``Alien Mental Waiver Program, HHS/CDC/ NCID. HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Center for Infectious Diseases (NCID), Division of Quarantine, Medical Screening and Health Assessment Branch, Medical Screening Section.

The Department of Health and Human Services proposes to alter System of Records, 09-20-0090, ``Studies of Testing for Tuberculosis and other Mycobacterioses, HHS/CDC/NCHSTP.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Division of Tuberculosis Elimination, National Center for HIV, STD and TB Prevention (NCHSTP).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0055, ``Administrative Files for Research/ Demonstration and Training Grants, and Cooperative Agreements Applications, HHS/CDC/PGO.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Procurement and Grants Office (PGO). Data is also occasionally located at contractor sites as studies are developed, data collected, and reports written. A list of contractor sites where individually identified data are currently located is available upon request to the system manager. Data is occasionally located at grantee sites as studies are developed, data collected, and reports written. A list of grantee sites where individually identified data is currently located is available upon request to the system manager.

The Department of Health and Human Services proposes to alter System of Records, 09-19-0001, ``Records of Persons Exposed or Potentially Exposed to Toxic or Hazardous Substances, HHS/ATSDR.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Agency for Toxic Substances and Disease Registry (ATSDR), Coordinating Center for Environmental Health and Injury Prevention (CCEHIP), Division of Health Studies.

The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Task Force on Community Preventive Services (Task Force). The Task Forcean independent, nonfederal body of nationally known leaders in public health practice, policy, and research who are appointed by the CDC Directorwas convened in 1996 by the Department of Health and Human Services (HHS) to assess the effectiveness of community, environmental, population, and healthcare system interventions in public health and health promotion. During this meeting the Task Force will consider the findings of systematic reviews and issue recommendations and findings to help inform decision making about policy, practice, and research in a wide range of U.S. settings. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).

The Food and Drug Administration (FDA) is announcing the availability for public comment of a document for The National Antimicrobial Resistance Monitoring System (NARMS) entitled ``NARMS Strategic Plan 2011-2015.'' The document outlines the strategic goals and objectives for 2011 through 2015 of the NARMS program developed by the participating Agencies (FDA, the Centers for Disease Control and Prevention (CDC), and the United States Department of Agriculture (USDA)) based on recommendations of an External Subcommittee of the Science Board to FDA. The Agency is soliciting public comment on the goals and objectives in the Strategic Plan and whether the goals and objectives meet the recommendations of the subcommittee.

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 the procedures by which sponsors of orphan drugs may request eligibility for the incentives by implementing a program as outlined in the Orphan Drug Act and the joint adoption by FDA and the European Medicines Agency (EMA) of the Common EMA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671).

HHS gives notice of a decision to designate a class of employees from BWX Technologies, Inc., Lynchburg, Virginia, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On January 6, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:

This notice provides an update of the Department of Health and Human Services (HHS) poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Norbrook Laboratories, Ltd. The NADA provides for veterinary prescription use of a combination drug injectable solution containing oxytetracycline and flunixin meglumine in cattle.

The NIH Guidelines currently require that recombinant DNA experiments designed to create new transgenic rodents be registered with the Institutional Biosafety Committee (IBC). Specifically, Section III-E-3 of the NIH Guidelines addresses the generation of transgenic rodents that may be housed under biosafety level (BL) 1 conditions and allows the work to proceed simultaneously with registration of the experiment with the IBC. The IBC must then review and approve the experiment. The NIH Guidelines address two pathways for generation of a transgenic rodent: altering the animal's genome using recombinant DNA technology, or breeding one or more transgenic rodents to create a new transgenic rodent (i.e., breeding of two different transgenic rodents or the breeding of a transgenic rodent and a non-transgenic rodent). On July 20, 2010 the NIH Office of Biotechnology Activities (OBA) published a proposed action (75 FR 42114) to amend Section III-E-3 and to add a new Section to Appendix C (Appendix C-VII) of the NIH Guidelines so as to exempt breeding of almost all transgenic rodents that can be housed at BL1, with the exception of rodents that contain a transgene encoding more than fifty percent of an exogenous eukaryotic virus and transgenic rodents in which the transgene is under the control of a gammaretroviral promoter. After receiving public comment on the proposed changes, OBA is implementing these changes.

The Food and Drug Administration (FDA) has determined that ALBAMYCIN (novobiocin sodium) capsule, 250 milligrams (mg) was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for ALBAMYCIN (novobiocin sodium) capsule, 250 mg.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for hemoglobin glutamer-200 from Biopure Corp. to OPK Biotech, LLC.

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: ``Barriers to Meaningful Use in Medicaid.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) is taking steps to reduce the maximum dosage unit strength of acetaminophen in prescription drug products. This change will provide an increased margin of safety to help prevent liver damage due to acetaminophen overdosing, a serious public health problem. This notice explains the reasons for the reduction in dosage unit strength and describes how FDA is implementing it for approved prescription drug products that exceed the new maximum tablet or capsule strength. FDA is also requiring safety labeling changes, including a new boxed warning, for acetaminophen-containing prescription drug products to address new safety information about the risk of liver damage.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting. The meeting is open to the public.