Department of Health and Human Services June 2013 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-15558
Type: Notice
Date: 2013-06-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Proposed Collection; 60-Day Comment Request; Family Life, Activity, Sun, Health, and Eating (FLASHE) Study (NCI)
Document Number: 2013-15541
Type: Notice
Date: 2013-06-28
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. 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. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Linda Nebeling, Ph.D., Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Drive, Room 3E102, Bethesda, MD 20892-9671 or call non-toll-free number 240-276-6855 or Email your request, including your address to: nebelinl@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Family Life, Activity, Sun, Health, and Eating (FLASHE) Study 0925NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The FLASHE study seeks to examine psychosocial, generational (parent-adolescent), and environmental correlates of cancer preventive behaviors. FLASHE will examine the science of cancer and obesity prevention by examining correlates of cancer preventive behaviors, mainly diet, activity, and sedentary behaviors (but also examining other behaviors such as sleep, sun-safety, and tobacco) in new ways not previously addressed comprehensively on other surveys. The survey's goal is to advance understanding of the dynamic relationship between the environment, psychosocial factors, and behavior from a dyadic perspective. Data collected will ultimately be a public use dataset and resource to the research community. FLASHE will be collecting data from parents and their adolescent children through a web survey with a final sample size of 2,500 dyads with motion sensing data collected in a subsample of 900 adolescents. OMB approval is requested for two years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,931.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-15539
Type: Notice
Date: 2013-06-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
National Vaccine Injury Compensation Program, List of Petitions Received
Document Number: 2013-15535
Type: Notice
Date: 2013-06-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Availability of Draft Toxicological Profiles
Document Number: 2013-15523
Type: Notice
Date: 2013-06-28
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This notice announces the availability of Set 25 Toxicological Profiles for review and comment. Comments can include additional information or reports on studies about the health effects of Set 25 substances. Although ATSDR considered key studies for each of these substances during the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion in the profile. ATSDR remains committed to providing a public comment period for this document as a means to best serve public health and our clients. The Set 25 Toxicological Profile is available online at http://www.atsdr.cdc.gov/ toxprofiles/index.asp and www.regulations.gov, docket ATSDR-2013-0001. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Sec. 104(i)(3), [42 U.S.C. 9604(i)(3)], directs the ATSDR administrator to prepare toxicological profiles of priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile.
Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-15505
Type: Notice
Date: 2013-06-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Implanted Blood Access Devices for Hemodialysis.'' This guidance was developed to support the reclassification of the Implanted Blood Access Devices for Hemodialysis into class II (special controls). This draft guidance is not final nor is it in effect at this time.
Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
Document Number: 2013-15504
Type: Proposed Rule
Date: 2013-06-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the implanted blood access device preamendments class III device into class II (special controls) and subject to premarket notification, and to further clarify the identification. FDA is proposing this reclassification under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) based on new information pertaining to the device. This action implements certain statutory requirements.
Agency Information Collection Activities: Proposed Collection; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration
Document Number: 2013-15469
Type: Notice
Date: 2013-06-28
Agency: Food and Drug Administration, Department of Health and Human Services
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 information collection resulting from focus groups about drug products as used by FDA.
Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals of Medical Devices and Radiation Emitting Products
Document Number: 2013-15468
Type: Notice
Date: 2013-06-28
Agency: Food and Drug Administration, Department of Health and Human Services
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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an electronic process for submitting reports of corrections and removals (806 reports) that are associated with medical and radiation emitting products regulated by FDA's Center for Devices and Radiological Health (CDRH). The electronic process is expected to both enhance consistency of submission data and speed submission processing.
New Policies and Procedural Requirements for Electronic Submission of State Plans, and Program and Financial Reporting Forms, for Mandatory Grant Programs
Document Number: 2013-15465
Type: Notice
Date: 2013-06-28
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), an Operating Division of the Department of Health and Human Services (HHS), announces the opportunity for public comment on our plan to implement required electronic submission of State plans, which includes applications as applicable; and programmatic and financial reporting forms, for mandatory grant programs. In accordance with the e- Government initiatives mandated by the Federal Financial Assistance Management Improvement Act of 1999, ACF officially acknowledges that electronically generated and/or stored documents are recognized equivalents of an official paper grant file. Recognizing the equivalency of such documents eliminates duplicative effort and administrative burden for Federal grant applicants, recipients, and the awarding agency, by facilitating the submission and storage of official grant files. ACF has previously afforded recipients of mandatory State grant programs the option of submitting State plans, and programmatic and financial reporting forms, in both electronic and paper formats. This notice announces that recipients of mandatory State grant programs will now be required to submit State plans, and programmatic and financial reporting forms, electronically. The electronic portal used to support this effort is the ACF On-Line Data Collection (OLDC) system, which is available to State applicants and grantees at https:// extranet.acf.hhs.gov/oldcdocs/materials.html.
World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP-STAC)
Document Number: 2013-15455
Type: Notice
Date: 2013-06-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-15454
Type: Notice
Date: 2013-06-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-15453
Type: Notice
Date: 2013-06-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-15452
Type: Notice
Date: 2013-06-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-15451
Type: Notice
Date: 2013-06-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-15450
Type: Notice
Date: 2013-06-28
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Meeting
Document Number: 2013-15291
Type: Notice
Date: 2013-06-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``LIMITED COMPETITION: ENHANCING INVESTMENTS COMPARATIVE EFFECTIVENESS RESEARCH RESOURCES GRANTS (R01)''.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-15290
Type: Notice
Date: 2013-06-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Medical Expenditure Panel Survey Insurance Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Statement of Organization Functions, and Delegations of Authority
Document Number: 2013-15289
Type: Notice
Date: 2013-06-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Statement of Organization, Functions and Delegations of Authority
Document Number: 2013-15420
Type: Notice
Date: 2013-06-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas
Document Number: 2013-15380
Type: Notice
Date: 2013-06-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice advises the public of the published lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of May 11, 2013, available on the Health Resources and Services Administration (HRSA) Web site at http:// www.hrsa.gov/shortage/. HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 332 of the Public Health Service (PHS) Act and 42 CFR part 5.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-15332
Type: Notice
Date: 2013-06-27
Agency: Food and Drug Administration, Department of Health and Human Services
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation; Corrections
Document Number: 2013-15321
Type: Proposed Rule
Date: 2013-06-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the proposed rule that appeared in the May 10, 2013 Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation.''
Medicare and Medicaid Programs; Requirements for Long Term Care Facilities; Hospice Services
Document Number: 2013-15313
Type: Rule
Date: 2013-06-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will revise the requirements that an institution will have to meet in order to qualify to participate as a skilled nursing facility (SNF) in the Medicare program, or as a nursing facility (NF) in the Medicaid program. These requirements will ensure that long-term care (LTC) facilities (that is, SNFs and NFs) that choose to arrange for the provision of hospice care through an agreement with one or more Medicare-certified hospice providers will have in place a written agreement with the hospice that specifies the roles and responsibilities of each entity. This final rule reflects the Centers for Medicare and Medicaid Services' (CMS') commitment to the principles of the President's Executive Order 13563, released on January 18, 2011, titled ``Improving Regulation and Regulatory Review.'' It will improve quality and consistency of care between hospices and LTC facilities in the provision of hospice care to LTC residents.
Scientific Information Request on Imaging Tests for the Staging of Colorectal Cancer
Document Number: 2013-15288
Type: Notice
Date: 2013-06-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions on imaging tests for the staging of colorectal cancer (e.g., Chest x-ray, computed tomography, multidetector computed tomography (MD-CT), CT colonography, magnetic resonance imaging (MRI), transabdominal ultrasound (TUS), endoscopic ultrasound (EUS), transrectal ultrasound (TRUS), positron emission tomography (PET), positron emission tomography combined with computed tomography (PET/CT fusion), or positron emission tomography combined with magnetic resonance imaging (PET/MRI fusion)) from medical device manufacturers. Scientific information is being solicited to inform our Comparative Effectiveness Review of Imaging Tests for the Staging of Colorectal Cancer, which is currently being conducted by one of the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on these devices will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a)
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
Document Number: 2013-15326
Type: Notice
Date: 2013-06-26
Agency: Department of Health and Human Services
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the July meeting, the Advisory Council will discuss the National Plan to Address Alzheimer's Disease: 2013 Update, and the 2013 recommendations. The Advisory Council will discuss international activities related to Alzheimer's disease since the April meeting. The Advisory Council will discuss issues related to long-term care financing.
Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
Document Number: 2013-15324
Type: Notice
Date: 2013-06-26
Agency: Department of Health and Human Services
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled to be held for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: http:// www.surgeongeneral.gov/initiatives/prevention/advisorygrp/ind ex.html.
Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics; Availability
Document Number: 2013-15250
Type: Notice
Date: 2013-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Expedited Programs for Serious ConditionsDrugs and Biologics.'' The purpose of this draft guidance is to provide a single resource for information on FDA's policies and procedures related to expedited drug development and review programs. The following programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of serious or life-threatening conditions (expedited programs): Fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation.
Blood Products Advisory Committee; Notice of Meeting
Document Number: 2013-15239
Type: Notice
Date: 2013-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
Document Number: 2013-15233
Type: Notice
Date: 2013-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information. 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 requests for exemption from the Threshold of Regulation for Substances Used in Food-Contact Articles.
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2013-15230
Type: Notice
Date: 2013-06-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-15204
Type: Notice
Date: 2013-06-26
Agency: Department of Health and Human Services, National Institutes of Health
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. 209 and 37 CFR part 404 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.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-15203
Type: Notice
Date: 2013-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2013-15202
Type: Notice
Date: 2013-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-15201
Type: Notice
Date: 2013-06-26
Agency: Department of Health and Human Services
National Cancer Institute Amended; Notice of Meeting
Document Number: 2013-15200
Type: Notice
Date: 2013-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-15199
Type: Notice
Date: 2013-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-15198
Type: Notice
Date: 2013-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Subcommittee on Procedures Review, Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2013-15194
Type: Notice
Date: 2013-06-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2013-15193
Type: Notice
Date: 2013-06-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of a Department of Health and Human Services Public Meeting and Request for Comments on Matters Related to the Protection of Human Subjects and Research Studying Standard of Care Interventions
Document Number: 2013-15160
Type: Notice
Date: 2013-06-26
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) is announcing a public meeting to seek public input and comment on how certain provisions of the HHS requirements related to the protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non- research context. HHS specifically is requesting input regarding how an institutional review board (IRB) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects in the informed consent process. HHS is seeking participation in the meeting and written comments from all interested parties, including, but not limited to, IRB members, IRB staff, institutional officials, research institutions, investigators, research subject advocacy groups, ethicists, and the regulated community at large. This meeting and the written comments are intended to assist HHS, through the Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), in developing guidance regarding what constitutes reasonably foreseeable risk in research involving standard of care interventions such that the risk is required to be disclosed to research subjects. HHS is seeking input on a number of specific questions but is interested in any other pertinent information participants in the public meeting would like to share.
Medicare and Medicaid Programs; Application From the American Osteopathic Association/Health Facilities Accreditation Program for Continued CMS-Approval of Its Critical Access Hospital Accreditation Program
Document Number: 2013-15175
Type: Notice
Date: 2013-06-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the American Osteopathic Association/Health Facilities Accreditation Program (AOA/HFAP) for continued recognition as a national accrediting organization for critical access hospitals (CAHs) that wish to participate in the Medicare or Medicaid programs.
Submission for OMB review; 30-day comment request: NLM PEOPLE LOCATOR® System
Document Number: 2013-15173
Type: Notice
Date: 2013-06-25
Agency: Department of Health and Human Services, National Institutes of Health
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 April 15, 2013, page 22271 and allowed 60-days for public comment. A single comment submission was received which is currently under review for further consideration. The purpose of this notice is to allow an additional 30 days for public comment. The National Library of Medicine (NLM), 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-15114
Type: Notice
Date: 2013-06-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-15113
Type: Notice
Date: 2013-06-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Recruitment of Sites for Assignment of Corps Personnel Obligated Under the National Health Service Corps Scholarship Program
Document Number: 2013-15112
Type: Notice
Date: 2013-06-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) announces that the listing of entities, and associated Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) scholarship recipients serving as Corps members, as well as those serving under the Private Practice Option (``NHSC scholars'' collectively), during the period July 1, 2013, through June 30, 2014, is posted on the NHSC Web site at http://nhscjobs.hrsa.gov. The NHSC Jobs Center includes all sites that are approved for performance of service by NHSC scholars; however, note that entities on this list may or may not have current job vacancies. Eligible HPSAs and Entities
Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective Date
Document Number: 2013-15111
Type: Rule
Date: 2013-06-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is confirming the effective date of May 2, 2013, for the final rule that published in the Federal Register of April 1, 2013 (78 FR 19413), and that amended the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2- hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses.
Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2013-15102
Type: Notice
Date: 2013-06-25
Agency: Food and Drug Administration, Department of Health and Human Services
Regulatory Systems Strengthening
Document Number: 2013-15101
Type: Notice
Date: 2013-06-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of International Programs. The goal of the Cooperative Agreement is to strengthen global regulatory capacity through activities that may include: Development of global norms and standards for product regulation; generation and analysis of evidence of regulatory systems performance; and provision of technical support to national regulatory systems strengthening efforts.
Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality; Availability
Document Number: 2013-15100
Type: Notice
Date: 2013-06-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.'' This guidance was initially published as a draft guidance on February 13, 2012. The draft was revised to clarify FDA's expectations and recommendations and to include references to a recently-developed assay for detecting ruminant contamination of crude heparin.