Department of Health and Human Services June 28, 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 https://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
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