Department of Health and Human Services April 23, 2013 – Federal Register Recent Federal Regulation Documents

HIPAA Privacy Rule and the National Instant Criminal Background Check System (NICS)
Document Number: 2013-09602
Type: Proposed Rule
Date: 2013-04-23
Agency: Department of Health and Human Services, Office of the Secretary
On January 16, 2013, President Barack Obama announced a series of Executive Actions to reduce gun violence in the United States, including efforts to improve the Federal government's background check system for the sale or transfer of firearms by licensed dealers, called the National Instant Criminal Background Check System (NICS). Among those persons disqualified from possessing or receiving firearms under Federal law are individuals who have been involuntarily committed to a mental institution; found incompetent to stand trial or not guilty by reason of insanity; or otherwise have been determined, through a formal adjudication process, to have a severe mental condition that results in the individuals presenting a danger to themselves or others or being incapable of managing their own affairs (referred to below as the ``mental health prohibitor''). Concerns have been raised that, in certain states, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule may be a barrier to States' reporting the identities of individuals subject to the mental health prohibitor to the NICS. The Department of Health and Human Services (HHS or ``the Department''), which administers the HIPAA regulations, is issuing this Advance Notice of Proposed Rulemaking (ANPRM) to solicit public comments on such barriers to reporting and ways in which these barriers can be addressed. In particular, we are considering creating an express permission in the HIPAA rules for reporting the relevant information to the NICS by those HIPAA covered entities responsible for involuntary commitments or the formal adjudications that would subject individuals to the mental health prohibitor, or that are otherwise designated by the States to report to the NICS. In addition, we are soliciting comments on the best methods to disseminate information on relevant HIPAA policies to State level entities that originate or maintain information that may be reported to NICS. Finally, we are soliciting public input on whether there are ways to mitigate any unintended adverse consequences for individuals seeking needed mental health services that may be caused by creating express regulatory permission to report relevant information to NICS. The Department will use the information it receives to determine how best to address these issues.
Notice of Interest Rate on Overdue Debts
Document Number: 2013-09578
Type: Notice
Date: 2013-04-23
Agency: Department of Health and Human Services, Office of the Secretary
Early Retiree Reinsurance Program
Document Number: 2013-09541
Type: Notice
Date: 2013-04-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice sets forth termination dates for several processes under the Early Retiree Reinsurance Program (ERRP) in preparation for the January 1, 2014 program sunset date. These operational processes, which involve plan sponsors and other parties, include: the submission of changes to information in a plan sponsor's ERRP application; the reporting of plan sponsor change of ownership; the submission of reimbursement requests; the reporting and correction of data inaccuracies; and the request for reopenings of reimbursement determinations.
Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the Duration of the Program
Document Number: 2013-09528
Type: Notice
Date: 2013-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the extension of the Early Feasibility Study Investigational Device Exemption (IDE) Applications pilot program to May 8, 2014, for sponsors who have already been accepted for the program.
Proposed Collection; 60-Day Comment Request: The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NCI)
Document Number: 2013-09527
Type: Notice
Date: 2013-04-23
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: Jane Hoppin, Sc.D., Epidemiology Branch, National Institute of Environmental Health Sciences, NIH, 111 T.W. Alexander Drive, PO Box 12233, MD A3-05, Research Triangle Park, NC 27709, or call non-toll-free number 919-541- 7622, or email your request, including your address to: hoppin1@niehs.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: The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture, 0925-0406, Expiration Date 5/31/2013, REVISION, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this information collection is to request initiation of a new dust specimen component as part of the ongoing Study of Biomarkers of Exposures and Effects in Agriculture (BEEA) as well as continue and complete phase IV (2013-2015) of the Agricultural Health Study (AHS) and continue buccal cell collection. Phase IV will continue to update the occupational and environmental exposure information as well as medical history information for licensed pesticide applicators and their spouses enrolled in the AHS. The new BEEA dust component will include a brief paper-and-pen questionnaire mailed to the participant in advance of the home visit; at the home visit, the study phlebotomist will to collect and review the questionnaire, and collect the participant's disposable vacuum bag (or empty the dust from vacuums without disposable bags). The dust component will use similar procedures to ones that have been employed on other NCI studies to obtain information about the dust specimen and to collect and ship the dust specimen. The primary objectives of the study are to determine the health effects resulting from occupational and environmental exposures in the agricultural environment. Secondary objectives include evaluating biological markers that may be associated with agricultural exposures and risk of certain types of cancer. Phase IV questionnaire data are collected by using self-administered computer assisted web survey (CAWI); self- administered paper-and-pen (Paper/pen); or an interviewer administered computer assisted telephone interview (CATI) and in-person interview (CAPI) systems for telephone screeners and home visit interviews, respectively. Some respondents are also asked to participate in the collection of biospecimens and environmental samples, including blood, urine, buccal cells (loose cells from the respondent's mouth), and vacuum dust. The findings will provide valuable information concerning the potential link between agricultural exposures and cancer and other chronic diseases among Agricultural Health Study cohort members, and this information may be generalized to the entire agricultural community. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 10,679.
Privacy Act of 1974; Report of a New Routine Use for Selected CMS Systems of Records
Document Number: 2013-09511
Type: Notice
Date: 2013-04-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), CMS is adding a new routine use for emergency preparedness and response to eight CMS systems of records. The new routine use will authorize CMS to disclose beneficiary-identifiable records to public health authorities and entities acting under a delegation of authority of a public health authority requesting such information for the purpose of identifying vulnerable individuals who may need health assistance in the event of an incident, emergency or disaster, and for purposes of planning and providing such assistance. Disclosures made pursuant to the new routine use will be limited to the minimum data necessary to carry out statutorily-authorized public health-related emergency preparedness and response activities, as provided in Section 1106 of the Social Security Act (42 U.S.C. 1306) and the HIPAA Privacy Rule at 45 CFR Sec. Sec. 154.502, 164.512(b), 164.502(b) and 164.514(d)(3)(iii)(A). Requests and disclosures made pursuant to the routine use will be coordinated through HHS' Office of the Assistant Secretary for Preparedness and Response (ASPR). The eight systems of records that will include the new routine use are: the National Claims History (NCH), System No. 09-70-0558; Medicare Integrated Data Repository (IDR), System No. 09-70-0571; Common Working Files (CWF), System No. 09-70-0526; Enrollment Database (EDB), System No. 09-70-0502; Medicare Beneficiary Database (MBD), System No. 09-70- 0536; Medicare Drug Data Processing System (DDPS), System No. 09-70- 0553; Long Term Care-Minimum Data Set (MDS), System No. 09-70-0528; and Home Health Agency (HHA) Outcome and Assessment Information Set (OASIS), System No. 09-70-0522.
Advisory Committee on Infant Mortality; Notice of Meeting
Document Number: 2013-09507
Type: Notice
Date: 2013-04-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising
Document Number: 2013-09482
Type: Notice
Date: 2013-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational Device Exemptions Reports and Records
Document Number: 2013-09481
Type: Notice
Date: 2013-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Investigational Device Exemptions Reports and Records'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
Document Number: 2013-09480
Type: Notice
Date: 2013-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing”; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-09479
Type: Notice
Date: 2013-04-23
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 ``Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.' '' FDA has developed this guidance document to assist industry in preparing premarket applications (PMAs), humanitarian device exemptions (HDEs), investigational device applications (IDEs), premarket notifications (510(k)s), and de novo requests for medical devices that come into direct or indirect contact with the human body in order to determine the potential toxicity resulting from contact of the component materials of the device with the body. The purpose of this guidance is to provide further clarification and updated information on the use of the Office of Device Evaluation (ODE) General Program Memorandum G95-1 entitled ``Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,' '' dated May 1, 1995. When final, this guidance will therefore replace G95-1. This draft guidance is not final nor is it in effect at this time.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2013-09453
Type: Notice
Date: 2013-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2013-09451
Type: Notice
Date: 2013-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-09426
Type: Notice
Date: 2013-04-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-09425
Type: Notice
Date: 2013-04-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration