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

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.

The Department of Health and Human Services (HHS) notifies federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified laboratories and IITF is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov.

The Centers for Disease Control and Prevention (CDC) published a document in the Federal Register of September 17, 2013, announcing the next meeting of the Community Preventive Services Task Force (Task Force). The document did not contain the registration information.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on July 19, 2013, Volume 78, pages 43214-43215, and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Kidney Disease Education Program, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institutes of Health (NIH), may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Office of Management and Budget, Office of Regulatory Affairs, OIRAsubmission @omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Eileen Newman, Associate Director, National Kidney Disease Education Program, OCPL, NIDDK, NIH, Building 31, Room 9A06, 9000 Rockville Pike, Bethesda, MD 20892, or call non-toll-free number (301) 435-8116 or Email your request, including your address to: Eileen.newman@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 30 days of the date of this publication. Proposed Collection: Evaluation of a Kidney Disease Education Program with Promotores in the Hispanic Community, 0925NEW, National Kidney Disease Education Program, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH). Need and Use of Information Collection: NKDEP is developing a kidney disease education program to raise awareness among the Hispanic community at risk for kidney disease. Since diabetes is the most common cause of kidney disease, the program is being developed for inclusion in existing diabetes programs being conducted by ``promotores de salud'' (Spanish/English-speaking community health workers). A pilot evaluation will assess: (a) Overall quality of the program from the client and promotor/a perspective, including strengths and weaknesses of the program and the training, and areas for program improvement; (b) effectiveness of the program on the clients (the community members being educated); and (c) effectiveness of materials and training, including promotores' ability to deliver education to the client and administer the client pre-test/post-test surveys. The pilot study will deliver strategic and actionable guidance for refining the educational and training materials for national dissemination. Based on outcomes from the pilot study, a national evaluation is planned that will use the client pre-test/post-test surveys to assess: (a) Knowledge gains about kidney disease, (b) awareness of NKDEP resources and importance of kidney health, (c) reported behavior change outcomes and (d) reported health status. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 101 (see table below).

This notice announces our approval of RadSiteTM, a national accreditation organization to accredit suppliers seeking to furnish the technical component (TC) of advanced diagnostic imaging services under the Medicare program.

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2014. The calendar year 2014 AIC threshold amounts are $140 for ALJ hearings and $1,430 for judicial review.

The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of August 20, 2013 (78 FR 51192). The document announced the start of the Secure Supply Chain Pilot Program (SSCPP). The document was published with an incorrect email address for the SSCPP mailbox. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Katharine Neckers, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Building 51, Rm. 4259, 301-796-3339, email: Katharine.Neckers@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In FR Doc. 2013-20215, appearing on page 51192 in the Federal Register of August 20, 2013, the following correction is made: On page 51194, in the second column, under ``IV. Process for Applying to Participate in the Pilot,'' in the third full paragraph, the sentence that reads ``For communications other than the submission of the SSCPP application (Form FDA 3676), please contact the CDER SSCPP mailbox at SSCPPMailbox@fda.hhs.gov'' is corrected to read ``For communications other than the submission of the SSCPP application (Form FDA 3676), please contact the CDER SSCPP mailbox at CDERSSCPP@fda.hhs.gov.''

The Food and Drug Administration (FDA) is seeking comment on a proposal regarding the content and format of data tables for the Agency's annual summary report of sales and distribution data collected from sponsors of antimicrobial new animal drugs in accordance with the new animal drug records and reporting provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Animal Drug User Fee Amendments of 2008 (ADUFA).

The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from Cogent Patient Safety Organization, Inc. of its status as a PSO, and has delisted the PSO accordingly.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Mobile Medical Applications.'' The FDA is issuing this guidance to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or ``mobile apps''). At this time, the FDA intends to apply regulatory requirements to only a small subset of mobile apps referred to in this guidance as mobile medical applications (mobile medical apps).

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. 209 and 37 CFR Part 404 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.

To facilitate the design of toxicological studies for vinpocetine (CAS RN: 42971-09-5), the National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences (NIEHS) requests the submission of available information regarding (1) exposure, pharmacokinetics, toxicity, safety, or efficacy in humans; (2) production, use, and consumption patterns in the United States; (3) genotoxicity, repeated dose toxicity, prenatal developmental toxicity, reproductive toxicity, chronic toxicity, and carcinogenicity studies in experimental animals; and (4) any other information relative to the safety or toxicity of vinpocetine not listed above.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.