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

Results 151 - 200 of 268
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-00737
Type: Notice
Date: 2013-01-16
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. 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.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-00593
Type: Notice
Date: 2013-01-16
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2013-00592
Type: Notice
Date: 2013-01-16
Agency: Department of Health and Human Services, Administration for Children and Families
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
Document Number: 2013-00125
Type: Proposed Rule
Date: 2013-01-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk- based preventive controls for human food. FDA also is proposing to revise certain definitions in FDA's current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for ``farms.'' FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Document Number: 2013-00123
Type: Proposed Rule
Date: 2013-01-16
Agency: Food and Drug Administration, Department of Health and Human Services
To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA) is proposing to establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is proposing these standards as part of our implementation of the FDA Food Safety Modernization Act (FSMA). These standards would not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance would be eligible for exemption from the requirements of this rule. The proposed rule would set forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect that the proposed rule, if finalized as proposed, would reduce foodborne illness associated with the consumption of contaminated produce.
Privacy Act, Exempt Record System; Withdrawal
Document Number: 2013-00726
Type: Rule
Date: 2013-01-15
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) published in the Federal Register of August 28, 2012, a direct final rule to exempt a new system of records from certain provisions of the Privacy Act of 1974 in order to protect the integrity of NIH research misconduct proceedings and to protect the identity of confidential sources in such proceedings. The comment period for this direct final rule closed November 13, 2012. HHS is withdrawing the direct final rule because the agency has received significant adverse comment.
Privacy Act, Exempt Record System; Withdrawal
Document Number: 2013-00723
Type: Rule
Date: 2013-01-15
Agency: Food and Drug Administration, Department of Health and Human Services, Office of the Secretary
The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) are withdrawing the direct final rule that August 28, 2012. HHS/FDA published the direct final rule to exempt scientific research misconduct proceedings records from certain requirements of the Privacy Act of 1974 in order to protect records compiled in the course of misconduct inquiries and investigations, and to safeguard the identity of confidential sources. The comment period closed on November 13, 2012. HHS/FDA is withdrawing the direct final rule because the Agency received significant adverse comment.
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2013-00673
Type: Notice
Date: 2013-01-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (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.
Meeting of the Community Preventive Services Task Force (Task Force)
Document Number: 2013-00666
Type: Notice
Date: 2013-01-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is independent and nonfederal. Its members are nationally known leaders in public health practice, policy, and research, and are appointed by the CDC Director. The Task Force was 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 findings and recommendations 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).
Agency Information Collection Activities; Submission for OMB Review; Comment Request: University Centers for Excellence in Developmental Disabilities Education, Research, and Service-Annual Report
Document Number: 2013-00657
Type: Notice
Date: 2013-01-15
Agency: Department of Health and Human Services
The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL) is announcing an opportunity to comment on the proposed collection of 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 collects comments on the information collection requirements relating to the continuation of an existing collection for University Centers for Excellence in Developmental Disabilities Education, Research, and Service.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-00623
Type: Notice
Date: 2013-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Closed Meetings
Document Number: 2013-00622
Type: Notice
Date: 2013-01-15
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: 2013-00621
Type: Notice
Date: 2013-01-15
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: 2013-00620
Type: Notice
Date: 2013-01-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2013-00619
Type: Notice
Date: 2013-01-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2013-00618
Type: Notice
Date: 2013-01-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-00617
Type: Notice
Date: 2013-01-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-00616
Type: Notice
Date: 2013-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-00615
Type: Notice
Date: 2013-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need; Public Hearing; Request for Comments
Document Number: 2013-00607
Type: Notice
Date: 2013-01-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on a potential new pathway to expedite the development of drugs, including biological products, for serious or life-threatening conditions that would address an unmet medical need. The drug's safety and effectiveness would be studied in a smaller subpopulation of patients with more serious manifestations of a condition. Such a pathway could involve smaller and more rapid clinical trials than would occur if the drug were studied in a broader group of patients with a wide range of clinical manifestations. The labeling of drugs approved using this pathway would make clear that the drug is narrowly indicated for use in limited, well-defined subpopulations in which the drug's benefits have been shown to outweigh its risks. The purpose of the public hearing is to obtain information and comments from the public on the need for and feasibility of this pathway and its potential advantages and disadvantages.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 030
Document Number: 2013-00605
Type: Notice
Date: 2013-01-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 030'' (Recognition List Number: 030), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-00585
Type: Notice
Date: 2013-01-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Collection; Comment Request (60-Day FRN): The National Cancer Institute (NCI) SmokefreeTXT (Text Message) Program Evaluation (NCI)
Document Number: 2013-00572
Type: Notice
Date: 2013-01-14
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 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 to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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 in writing, request more information on the proposed project, or to obtain a copy of the data collection plans and instruments, contact: Erik Augustson, Ph.D., MPH, Behavioral Scientist/ Health Science Administrator, Division of Cancer Control and Population Sciences, 6130 Executive Blvd., EPN-4034, Bethesda, MD 20892-7337 or call non-toll-free number 301-435-7610 or Email your request, including your address to: augustse@mail.nih.gov. 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: The National Cancer Institute (NCI) SmokefreeTXT Program Evaluation (NCI), 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This is a request for OMB to approve the new submission titled, ``The National Cancer Institute (NCI) SmokefreeTXT Program Evaluation'' for 3 years. The supporting statements and various attachments accompany this memorandum. This study seeks to assess the efficacy of the SmokefreeTXT program, a text message smoking cessation intervention designed for young adult smokers ages 18-29. The SmokefreeTXT program is a component of a larger series of eHealth/mHealth tobacco cessation intervention programs. SmokefreeTXT has been developed (and is managed) by the National Cancer Institute (NCI) Tobacco Control Research Branch (TCRB) at the request of the Office of the Assistant Secretary for Health (OASH) at the Department of Health and Human Services (DHHS). The study seeks to recruit a large sample of young adult smokers ages 18-29 to examine how exposure to the SmokefreeTXT intervention affects participants' success at quitting smoking. There will be 3-arms to the study; participants will be enrolled for a maximum of 8 weeks of treatment in the SmokefreeTXT program, with frequency and duration of the treatment varying by study arm. The SmokefreeTXT Study will collect self-reported cessation data using the bidirectional aspect of text- messaging service and a series of web-based surveys. All web-based survey data will be collected and stored by a third-party, Research Triangle Institute International (RTI). Respondents will complete the following 5 web-based surveys for a total of 7,136 burden hours: (1) Pre-treatment baseline survey; (2) one week post quit date questionnaire; (3) end of active cessation treatment questionnaire; (4) 12-week post-treatment questionnaire; (5) 24-weeks post-treatment questionnaire. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 8,353.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-00523
Type: Notice
Date: 2013-01-14
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-00500
Type: Notice
Date: 2013-01-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-00499
Type: Notice
Date: 2013-01-14
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-00498
Type: Notice
Date: 2013-01-14
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2013-00497
Type: Notice
Date: 2013-01-14
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-00496
Type: Notice
Date: 2013-01-14
Agency: Department of Health and Human Services, National Institutes of Health
Blood Products Advisory Committee; Notice of Meeting
Document Number: 2013-00491
Type: Notice
Date: 2013-01-14
Agency: Food and Drug Administration, Department of Health and Human Services
Mandatory Guidelines for Federal Workplace Drug Testing Programs
Document Number: 2013-00476
Type: Notice
Date: 2013-01-14
Agency: Department of Health and Human Services
The current version of the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs. Subpart M-Medical Review Officer (MRO), Section 13.1(b), ``Who may serve as an MRO?'' states as follows: ``Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal employee drug testing results that seek approval by the Secretary must submit their qualifications and a sample examination. Based on an annual objective review of the qualifications and content of the examination, the Secretary shall publish a list in the Federal Register of those entities and boards that have been approved.'' HHS has completed its review of entities that train and certify MROs, in accordance with requests submitted by such entities to HHS. (1) The HHS Secretary approves the following MRO certifying entities that offer both MRO training and certification through examination:
Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling; Availability
Document Number: 2013-00474
Type: Notice
Date: 2013-01-14
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 ``Abuse- Deterrent OpioidsEvaluation and Labeling.'' The draft guidance describes how abuse-deterrent properties of opioid analgesic products should be studied and evaluated, and what claims regarding such properties may be suitable for inclusion in labeling. In addition to general input on this draft guidance, FDA is seeking input on the research topics outlined in the final section of the draft guidance. FDA also intends to hold a public meeting to solicit additional input from affected stakeholders on the draft guidance.
Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant
Document Number: 2013-00388
Type: Proposed Rule
Date: 2013-01-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to reclassify the blade- form endosseous dental implant, a preamendments class III device, into class II (special controls). On its own initiative, based on new information, FDA is proposing to revise the classification of blade-form endosseous dental implants.
Self-Contained Breathing Apparatus Remaining Service-Life Indicator Performance Requirements
Document Number: 2013-00371
Type: Rule
Date: 2013-01-14
Agency: Department of Health and Human Services
On June 25, 2012, the Department of Health and Human Services (HHS) published a notice of proposed rulemaking proposing to update respirator approval standards in response to a petition to amend our regulations, current requirements for self-contained breathing apparatus (SCBA) remaining service-life indicators or warning devices. These indicators are built into a respirator to alert the user that the breathing air provided by the respirator is close to depletion. In this final rule, HHS responds to public comment on the proposed rule and revises the current standard, employed by the National Institute for Occupational Safety and Health (NIOSH) located within the Centers for Disease Control and Prevention (CDC), to allow greater flexibility in the setting of the indicator alarm to ensure that the alarm more effectively meets the different worker protection needs of different work operations. This final rule sets a minimum alarm point at 25 percent of the rated service time and allows the manufacturer to offer remaining service life set point at a higher value or values appropriate to the purchaser's use scenario.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-00473
Type: Notice
Date: 2013-01-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Office of Urban Indian Health Programs; Announcement Type: Meeting Notice
Document Number: 2013-00472
Type: Notice
Date: 2013-01-11
Agency: Department of Health and Human Services, Indian Health Service
The purpose of this Notice is to announce an Indian Health Service (IHS) Listening Session on the draft Policy on Conferring with Urban Indian Organizations (UIOs). IHS will provide an opportunity for interested parties to provide oral comments on the draft Policy on Conferring with UIOs that was published in the Federal Register on July 26, 2012. Name of Listening Session: IHS Urban Listening Session. Type of Meeting: Open Listening Session.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-00468
Type: Notice
Date: 2013-01-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-00467
Type: Notice
Date: 2013-01-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2013-00416
Type: Notice
Date: 2013-01-11
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Mental Health; Notice of Meeting
Document Number: 2013-00385
Type: Notice
Date: 2013-01-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2013-00384
Type: Notice
Date: 2013-01-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2013-00383
Type: Notice
Date: 2013-01-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2013-00382
Type: Notice
Date: 2013-01-11
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2013-00364
Type: Notice
Date: 2013-01-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (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. Information Collection Request Title: Patient Survey-Health Centers (OMB No. 0915-xxxx) NEW. The Health Center program supports Health Centers (HCs), Migrant Health Centers (MHCs), Health Care for the Homeless (HCH) programs, and Public Housing Primary Care (PHPC) programs. Health Centers (HCs) receive grants from HRSA to provide primary and preventive health care services to medically underserved populations. The proposed Patient Survey will collect nationally in-depth information about HC patients, their health status, the reasons they seek care at the HCs, their diagnoses, the services they utilize at HCs and elsewhere, the quality of those services, and their satisfaction with the care they receive, through personal interviews of a stratified random sample of HC patients. Prior to the national study, a cognitive pre-test will be conducted to refine and test the survey instrument in different languages, and to test the survey sampling methodologies and procedures. The pre-test will include cognitive interviews to ensure that the questions are being understood as was intended. Interviews conducted in the pre-test and the national study are estimated to take approximately 1 hour and 15 minutes each. The Patient Survey builds on previous periodic Patient User-Visit Surveys, which were conducted to learn about the process and outcomes of care in HCs and MHCs, HCHs, and PHPCs. The original questionnaires were derived from the National Health Interview Survey (NHIS) and the National Ambulatory Medical Care Survey (NAMCS) conducted by the National Center for Health Statistics (NCHS). Conformance with the NHIS and NAMCS allowed comparisons between these NCHS surveys and the previous HC and HCH User-Visit Surveys. The new Patient Survey was developed using a questionnaire methodology similar to that used in the past and will also potentially allow some longitudinal comparisons for HCs and HCHs with the previous User-Visit survey data, including monitoring of processes and outcomes over time. In addition, this survey will be conducted in languages not used during previous surveys (which were conducted in English and Spanish) to include patients from different racial and ethnic backgrounds, including Chinese (Mandarin and Cantonese), Korean, and Vietnamese. With the exception of Spanish speakers, other racial and ethnic subgroups were not able to participate in the previous surveys. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows:
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Forms To Implement the Privacy Rule
Document Number: 2013-00363
Type: Notice
Date: 2013-01-11
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (0MB) for review. This proposed information collection project was previously published in the Federal Register (77 FR 60219) on October 2, 2012, and allowed 60 days for public comment, as required by 3506(c)(2)(A). No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-0030, ``IHS Forms to Implement the Privacy Rule (45 CFR parts 160 & 164).'' Type of Information Collection Request: Extension, without revisions, of currently approved information collection, 0917-0030, ``IHS Forms to Implement the Privacy Rule (45 CFR parts 160 & 164).'' Form Number(s): IHS-810, IHS-912-1, IHS-912-2, IHS-913 and IHS-917. Need and Use of Information Collection: This collection of information is made necessary by the Department of Health and Human Services Rule entitled ``Standards for Privacy of Individually Identifiable Health Information'' (Privacy Rule) (45 CFR parts 160 and 164). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996, creates national standards to protect individuals' personal health information, and gives patients increased access to their medical records. 45 CFR 164.508, 164.522, 164.526 and 164.528 of the Rule require the collection of information to implement these protection standards and access requirements. The IHS will continue to use the following data collection instruments to meet the information collection requirements contained in the Rule. 45 CFR 164.508: This provision requires covered entities to obtain or receive a valid authorization for its use or disclosure of protected health information for other than for treatment, payment and healthcare operations. Under the provision individuals may initiate a written authorization permitting covered entities to release their protected health information to entities of their choosing. The form IHS-810, ``Authorization for Use or Disclosure of Protected Health Information,'' is used to document an individual's authorization to use or disclose their protected health information. 45 CFR 164.522: Section 164.522(a)(1) requires a covered entity to permit individuals to request that the covered entity restrict the use and disclosure of their protected health information. The covered entity may or may not agree to the restriction. The form IHS-912-1, ``Request for Restrictions(s),'' is used to document an individual's request for restriction of their protected health information, and whether IHS agreed or disagreed with the restriction. Section 164.522(a)(2) permits a covered entity to terminate its agreement to a restriction if the individual agrees to or requests the termination in writing. The form IHS-912-2, ``Request for Revocation of Restriction(s),'' is used to document the agency or individual request to terminate a formerly agreed to restriction regarding the use and disclosure of protected health information. 45 CFR 164.528 and 45 CFR 5b.9(c): This provision requires covered entities to permit individuals to request that the covered entity provide an accounting of disclosures of protected health information made by the covered entity. The form IHS-913, ``Request for an Accounting of Disclosures,'' is used to document an individual's request for an accounting of disclosures of their protected health information and the agency's handling of the request. 45 CFR 164.526: This provision requires covered entities to permit an individual to request that the covered entity amend protected health information. If the covered entity accepts the requested amendment, in whole or in part, the covered entity must inform the individual that the amendment is accepted. If the covered entity denies the requested amendment, in whole or in part, the covered entity must provide the individual with a written denial. The form IHS-917, ``Request for Correction/Amendment of Protected Health Information,'' will be used to document an individual's request to amend their protected health information and the agency's decision to accept or deny the request. Completed forms used in this collection of information are filed in the IHS medical, health and billing record, a Privacy Act System of Records Notice. Affected Public: Individuals and households. Type of Respondents: Individuals. Burden Hours: The table below provides the estimated burden hours for this information collection:
National Advisory Council on Nurse Education and Practice; Notice of Meeting
Document Number: 2013-00356
Type: Notice
Date: 2013-01-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
Canned Tuna Deviating From Identity Standard; Temporary Permit for Market Testing
Document Number: 2013-00293
Type: Notice
Date: 2013-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) received an application for a temporary permit from Chicken of the Sea International (the applicant). We are announcing that we have issued a temporary permit to the applicant to market test products (designated as ``no drain canned tuna'' products) that deviate from the U.S. standard of identity for canned tuna. The purpose of the temporary permit is to market test the product throughout the United States. The permit will allow the applicant to measure consumer acceptance of the new product and assess the new product's commercial feasibility.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-00292
Type: Notice
Date: 2013-01-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984. Information Collection Request Title: Telehealth Resource Center Performance Measurement Tool (OMB No. 0915-xxxx)NEW. Abstract: In order to ensure the best use of public funds and to meet GPRA requirements, the Office for the Advancement of Telehealth (OAT) in collaboration with Telehealth Resource Centers (TRCs) has developed a set of performance metrics to evaluate the technical assistance services provided by the TRCs. The TRC Performance Indicator Data Collection Tool contains the data elements that would need to be collected by TRCs in order to report on the performance metrics. This tool can be easily translated into a web-based data collection system (PIMS). Also, it will allow the TRCs to report to OAT around their projects' performance progress and will allow OAT to demonstrate to Congress the value added from the TRC Grant Program. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. The annual estimate of burden is as follows: