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

The Administration for Community Living (ACL), Administration on Aging (AoA) 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 the information collection requirements relating to the Evidence-Based Falls Prevention Program.

This proposed notice acknowledges the receipt of an application from Det Norske Veritas Healthcare (DNVHC) for continued recognition as a national accrediting organization for critical access hospitals (CAHs) that wish to participate in the Medicare or Medicaid programs.

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 (the 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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award up to $1,448,432 (total costs) for one year to Link2Health Solutions, Inc., as a program supplement to the National Suicide Prevention Lifeline. The purpose of this program is to provide national telephonic access at any time of the day or night to suicide prevention and crisis intervention services through toll-free suicide prevention hotline numbers, including 1-800-273-TALK (8255). Supplemental funding is being provided for the National Suicide Prevention Lifeline to expand and enhance the currently funded chat and text-based SMS services from 12 hours a day to 24/7 coverage. The Lifeline will continue awareness raising activities such as, but not limited to, social media engagement and promotion of services that will continue to be directed towards the suicide prevention needs of high-risk populations identified by the National Action Alliance for Suicide Prevention; lesbian, gay, bisexual, or transgender (LGBT) youth, American Indian/Alaska Native (AI/AN), military family members and veterans, and suicide attempt survivors. These services directly support the objectives of the National Strategy for Suicide Prevention. Funding Opportunity Title: SM-14-021. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Labeling Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled ``Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.'' This guidance explains FDA's current thinking on determining whether FDA-regulated products involve the application of nanotechnology. The guidance identifies two Points to Consider, which address both particle dimensions and dimension-dependent properties or phenomena. If either point applies to a given product, industry and FDA should consider whether evaluations of safety, effectiveness, public health impact, or regulatory status of that product have identified and adequately addressed any unique properties or behaviors of the product. These two Points to Consider are intended to provide an initial screening tool that can be broadly applied to all FDA-regulated products, with the understanding that these points are subject to change in the future as new information becomes available.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled ``Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives.'' The guidance explains FDA's current thinking on the factors to be considered when determining whether changes in manufacturing process, including the intentional reduction in particle size to the nanoscale, for a food substance already in the market affect the identity of the food substance, impact the safety of the use of the food substance, change the regulatory status of the use of the food substance, or warrant a new regulatory submission to FDA.

In accordance with the requirements of the Privacy Act of 1974 (the Privacy Act) and the Food and Drug Administration's (FDA) regulations for the protection of privacy, FDA is deleting four system of records notices (SORNs) from its existing inventory of SORNs and adding routine uses to the remaining SORNs. The systems related to the SORNs that are being deleted are no longer in use by FDA. The additional routine uses are for standard disclosures common to systems across the government. They allow disclosure to other Federal Agencies and contractors as needed to respond to a breach of system security or confidentiality, to contractors or other external individuals performing work for FDA that requires access to Agency records subject to the Privacy Act, to Federal record keeping authorities for the purpose of records management oversight, to appropriate public authorities when a record indicates a potential violation of law, and to the U.S. Department of Justice (DOJ) for guidance on Freedom of Information Act issues. FDA will require that all of these recipients comply with the requirements of the Privacy Act. The added routine uses will be inserted in each existing system notice and will be included in future FDA SORNs.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff.'' This guidance finalizes, as a single document, all sections of, ``Global Unique Device Identification (GUDID): Draft Guidance for Industry.'' The guidance includes, with minor modifications, the previously finalized sections on how device labelers will interface with the GUDID, establish GUDID accounts and begin initial submissions. The guidance also finalizes the sections on the Device Identifier (DI) record, Health Level 7 Structured Product Labeling (HL7 SPL) submission, search/retrieval of devices information, and GUDID submissions and maintaining and submitting electronic records. The guidance also finalizes Appendix AGUDID Package Information Examples.

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 document corrects a notice that was published in the Federal Register on June 6, 2014 (79 FR 32737-32738). The time and date should read as follows: Time and Date: 9:30 a.m.-3:30 p.m., June 19, 2014 (Closed). For Further Information Contact: Gwendolyn H. Cattledge, Ph.D., M.S.E.H., F.A.C.E., Deputy Associate Director for Science, National Center for Injury Prevention and Control, CDC, 4770 Buford Highway NE., Mailstop F63, Atlanta, Georgia 30341, Telephone: (770) 488-4655, GXC8@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Gluten-Free Labeling of FoodsSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is being issued for a final rule published in the Federal Register of August 5, 2013, and is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Importer's Entry Notice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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.