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

Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2013-23774
Type: Notice
Date: 2013-09-30
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 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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-23772
Type: Notice
Date: 2013-09-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Submission for OMB Review; 30-Day Comment Request; Interactive Informed Consent for Pediatric Clinical Trials
Document Number: 2013-23755
Type: Notice
Date: 2013-09-30
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 Institute Heart, Lung, and Blood Institute (NHBLI), 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. The 60-day FRN was published 05/9/2013 (Vol. 78, No. 90, page 27243). No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health, 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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. 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.
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2013-23746
Type: Notice
Date: 2013-09-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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 http:// www.workplace.samhsa.gov.
Announcement of Requirements and Registration for Respirator Trusted-Source Mobile Application Challenge
Document Number: 2013-23731
Type: Notice
Date: 2013-09-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH) located within the Department of Health and Human Services (HHS) is challenging teams of developers to design a mobile application (app) that will be used by the public to query the NIOSH trusted source site http:// knowits.niosh.gov for specific criteria and display all relevant information on the Web page in an easy to view format on a mobile device. The NIOSH Trusted-Source Web page is the one-stop resource to get reliable respirator information. The goal is to create a mobile app that can run on multiple platforms, such as Apple iOS, Windows and Android, and that makes the Respirator Trusted-Source content selectable and easy-to-use, reaching users with portable technology.
Meeting of the Community Preventive Services Task Force (Task Force)
Document Number: 2013-23730
Type: Notice
Date: 2013-09-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-23641
Type: Notice
Date: 2013-09-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2013-23640
Type: Notice
Date: 2013-09-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2013-23639
Type: Notice
Date: 2013-09-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2013-23638
Type: Notice
Date: 2013-09-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2013-23637
Type: Notice
Date: 2013-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Office of Minority Health: Statement of Organization, Functions and Delegations of Authority
Document Number: 2013-23680
Type: Notice
Date: 2013-09-27
Agency: Department of Health and Human Services, Office of the Secretary
Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee
Document Number: 2013-23678
Type: Notice
Date: 2013-09-27
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health (OASH), within the Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of HHS, through the Assistant Secretary for Health (ASH), on a broad range of issues and topics related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The appointments of several Committee members are scheduled to end during the 2014 calendar year. Nominations of qualified candidates are being sought to fill the positions that are scheduled to be vacated.
Proposed Collection; 30-Day Comment Request; Evaluation of a Kidney Disease Education and Awareness Program in the Hispanic Community
Document Number: 2013-23673
Type: Notice
Date: 2013-09-27
Agency: Department of Health and Human Services, National Institutes of Health
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).
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections
Document Number: 2013-23672
Type: Notice
Date: 2013-09-27
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill three positions on the Committee membership that will be vacated during the 2014 calendar year.
Medicare Program; Approval of Accrediting Organization for Suppliers of Advanced Diagnostic Imaging Supplier Accreditation Program
Document Number: 2013-23664
Type: Notice
Date: 2013-09-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington
Document Number: 2013-23659
Type: Notice
Date: 2013-09-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that laboratories located in and licensed by the State of Washington that possess a valid license under the Medical Test Site law, Chapter 70.42 of the Revised Code of Washington, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 6 years.
Medicare Program; Medicare Appeals: Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2014
Document Number: 2013-23655
Type: Notice
Date: 2013-09-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-23588
Type: Notice
Date: 2013-09-27
Agency: Department of Health and Human Services, Office of the Secretary
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, Office of the Secretary, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Secure Supply Chain Pilot Program; Correction
Document Number: 2013-23563
Type: Notice
Date: 2013-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
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.''
Guidance for Industry #223: Small Entity Compliance Guide-Declaring Color Additives in Animal Foods; Availability
Document Number: 2013-23560
Type: Rule
Date: 2013-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 223 entitled ``Small Entity Compliance GuideDeclaring Color Additives in Animal Foods.'' This small entity compliance guide (SECG) aids industry in complying with the requirements of the final rule that published in the Federal Register of November 17, 2011. FDA issued the regulation in response to the Nutrition Labeling and Education Act of 1990 (the 1990 amendments), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, FDA amended its regulations regarding the declaration of certified color additives on the labels of animal food including animal feeds and pet foods.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-23534
Type: Notice
Date: 2013-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Prospective Grant of Exclusive Commercialization License: The Use of Cysteamine for the Treatment of Pancreatic Cancer, Breast Cancer and Hepatocellular Cancer
Document Number: 2013-23528
Type: Notice
Date: 2013-09-27
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, indicates that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive commercialization license to practice the inventions embodied in technology family E-219-2013/0, including U.S. patent application 61/ 814,010 entitled ``A Novel Role of Cysteamine in Suppression of Cancer Invasion and Metastasis and Prolonging Survival of Host Through Inhibition of Matrix Metalloproteinases in Human Cancer'' [HHS Ref. E- 219-2013/0-US-01], Canadian patent application 2,813,514 entitled ``Use of Cysteamine and Derivatives Thereof to Suppress Tumor Metastases'' [HHS Ref. E-219-2013/0-CA-02], South Korean patent application 10-2013- 43713 entitled ``Use of Cysteamine and Derivatives Thereof to Suppress Tumor Metastases''[HHS Ref. E-219-2013/0-KR-03], Australian patent application 2013205350 entitled ``Use of Cysteamine and Derivatives Thereof to Suppress Tumor Metastases'' [HHS Ref. E-219-2013/0-AU-04], and Mexican patent application MX/a/2013/004423 entitled ``Use of Cysteamine and Derivatives Thereof to Suppress Tumor Metastases'' [HHS Ref. E-219-2013/0-MX-05]; and all related continuing and foreign patents/patent applications for these technology families, to Raptor Pharmaceuticals, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive commercialization license territory may be worldwide, and the field of use may be limited to: The treatment of pancreatic cancer, breast cancer and hepatocellular carcinoma (HCC) by using compositions containing cysteamine.
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2013-23527
Type: Notice
Date: 2013-09-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-23526
Type: Notice
Date: 2013-09-27
Agency: Department of Health and Human Services, National Institutes of Health
Antimicrobial Animal Drug Sales and Distribution Annual Summary Report Data Tables
Document Number: 2013-23488
Type: Proposed Rule
Date: 2013-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
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).
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-23409
Type: Notice
Date: 2013-09-26
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0360, scheduled to expire on September 30, 2013. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-23408
Type: Notice
Date: 2013-09-26
Agency: Department of Health and Human Services
National Cancer Institute; Amended Notice of Meeting
Document Number: 2013-23407
Type: Notice
Date: 2013-09-26
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-23406
Type: Notice
Date: 2013-09-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-23405
Type: Notice
Date: 2013-09-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Amended; Notice of Meeting
Document Number: 2013-23404
Type: Notice
Date: 2013-09-26
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-23302
Type: Notice
Date: 2013-09-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Patient Safety Organizations: Voluntary Relinquishment From Cogent Patient Safety Organization, Inc.
Document Number: 2013-23300
Type: Notice
Date: 2013-09-25
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-23299
Type: Notice
Date: 2013-09-25
Agency: Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Pretest of the Ambulatory Surgery/Procedure Survey on Patient Safety Culture Questionnaire (Ambulatory Surgery SOPS).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 8th, 2013 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-23293
Type: Notice
Date: 2013-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
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).
Basic Health Program: State Administration of Basic Health Programs; Eligibility and Enrollment in Standard Health Plans; Essential Health Benefits in Standard Health Plans; Performance Standards for Basic Health Programs; Premium and Cost Sharing for Basic Health Programs; Federal Funding Process; Trust Fund and Financial Integrity
Document Number: 2013-23292
Type: Proposed Rule
Date: 2013-09-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary
This proposed rule would establish the Basic Health Program, as required by section 1331 of the Affordable Care Act. The Basic Health Program provides states the flexibility to establish a health benefits coverage program for low-income individuals who would otherwise be eligible to purchase coverage through the state's Affordable Insurance Exchange (Exchange, also called a Health Insurance Marketplace). The Basic Health Program would complement and coordinate with enrollment in a QHP through the Exchange, as well as with enrollment in Medicaid and the Children's Health Insurance Program (CHIP). This proposed rule sets forth a framework for Basic Health Program eligibility and enrollment, benefits, delivery of health care services, transfer of funds to participating states, and federal oversight. Additionally, this rule would amend other rules issued by the Secretary of the Department of Health and Human Services (Secretary) in order to clarify the applicability of those rules to the Basic Health Program.
Submission for OMB Review; Comment Request
Document Number: 2013-23265
Type: Notice
Date: 2013-09-25
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2013-23234
Type: Notice
Date: 2013-09-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2013-23233
Type: Notice
Date: 2013-09-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2013-23232
Type: Notice
Date: 2013-09-25
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-23231
Type: Notice
Date: 2013-09-25
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. 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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-23211
Type: Notice
Date: 2013-09-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2013-23210
Type: Notice
Date: 2013-09-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2013-23209
Type: Notice
Date: 2013-09-25
Agency: Department of Health and Human Services, National Institutes of Health
Request for Information: The National Toxicology Program Requests Information on Use, Human Exposure, and Toxicity of Vinpocetine
Document Number: 2013-23212
Type: Notice
Date: 2013-09-24
Agency: Department of Health and Human Services, National Institutes of Health
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.
Agency Recordkeeping/Reporting Requirements Under Emergency
Document Number: 2013-23188
Type: Notice
Date: 2013-09-24
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-23176
Type: Notice
Date: 2013-09-24
Agency: Department of Health and Human Services, Office of the Secretary
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.
National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health and Health Care
Document Number: 2013-23164
Type: Notice
Date: 2013-09-24
Agency: Department of Health and Human Services
The Department of Health and Human Service (HHS), Office of the Secretary, Office of Minority Health (OMH) announces the publication of the final enhanced National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health and Health Care, known as the enhanced National CLAS Standards. In developing the enhanced National CLAS Standards, OMH undertook the National CLAS Standards Enhancement Initiative. From 2010-2012, this initiative included input from a National Project Advisory Committee composed of subject matter experts representing public, private and government sectors, regional public meetings, public comment period, and a systematic literature review. The enhanced National CLAS Standards, including a brief background summary of the development process and public comment period, are printed below.
Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2013-23135
Type: Notice
Date: 2013-09-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services