Department of Health and Human Services June 25, 2014 – Federal Register Recent Federal Regulation Documents

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 23, 2014, available on the Health Resources and Services Administration (HRSA) Web site at https:// 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 HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 332 of the Public Health Service (PHS) Act and 42 CFR part 5.

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.

These final regulations clarify the maximum allowed length of any reasonable and bona fide employment-based orientation period, consistent with the 90-day waiting period limitation set forth in section 2708 of the Public Health Service Act, as added by the Patient Protection and Affordable Care Act (Affordable Care Act), as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices.'' FDA is issuing this document to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to Medical Device Data Systems (MDDS), medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health. In this document, FDA is also proposing changes to its guidance entitled ``Mobile Medical Applications,'' issued on September 25, 2013, to conform to the proposed policy discussed in this draft guidance document. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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 review and discuss its recommendations on informal caregiving, hear presentations on statistics about caregivers and existing programs to provide them with help, and hear presentations from the four subcommittees (Research, Clinical Care, Long-Term Services and Supports, and Ethics). The Advisory Council will also discuss the G7 Dementia Summit that was held on June 19th, 2014 in the UK.