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

New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin
Document Number: 2013-10152
Type: Rule
Date: 2013-04-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-10130
Type: Notice
Date: 2013-04-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-10122
Type: Notice
Date: 2013-04-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-10098
Type: Notice
Date: 2013-04-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-10097
Type: Notice
Date: 2013-04-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-10096
Type: Notice
Date: 2013-04-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2013-10095
Type: Notice
Date: 2013-04-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications
Document Number: 2013-10088
Type: Notice
Date: 2013-04-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 paperwork associated with abbreviated new animal drug applications submitted to the Center for Veterinary Medicine, FDA.
Findings of Research Misconduct
Document Number: 2013-10085
Type: Notice
Date: 2013-04-30
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Matthew Poore, Advanced Liquid Logic Inc.: Based on the report of an inquiry conducted by Advanced Liquid Logic Inc. (Liquid Logic), the Respondent's admission, and additional analysis conducted by ORI, ORI found that Mr. Matthew Poore, former Technician, Liquid Logic, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), contract HHSN272200900030C. ORI found that the Respondent engaged in research misconduct by falsifying data that were included in one (1) presentation and one (1) report to NIAID and in laboratory records at Liquid Logic. ORI finds that Respondent knowingly and intentionally falsified reverse transcription-polymerase chain reaction (RT-PCR) results by reporting the results from previous experiments as the actual results, when the experiments had not been performed. Specifically: In Liquid Logic laboratory documents, the Respondent falsified the RT-PCR results of human immunodeficiency virus (HIV) viral loads in whole blood patient samples by falsely changing previous results for two (2) samples from negative to positive and one (1) sample from positive to negative. The latter falsified sample result, changed from HIV positive to negative, was included in an April 1-June 30, 2012, quarterly report and a July 12, 2012, presentation to NIAID. In Liquid Logic laboratory documents, the Respondent falsified the RT-PCR whole blood lysis results of testing samples as 100 and 200 HIV viral copies per milliliter, when the experiments were not performed by the Respondent. These falsified results were included in an April 1-June 30, 2012, quarterly report to NIAID. In Liquid Logic laboratory documents, the Respondent falsified the graphs of RT-PCR results of the Escherichia coli bacteriophage MS2, an internal control, viral loads for three (3) clinical samples, when the results were actually from prior experiments of two (2) controls and one (1) unrelated clinical sample. The Respondent falsified the MS2 graphs in an effort to conceal that RT-PCR experiments of the clinical samples had not been performed. Mr. Poore has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of three (3) years, beginning on April 1, 2013: (1) To have his research supervised; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which his participation is proposed and prior to his participation in any capacity on PHS- supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of his research contribution; he agreed that he shall not participate in any PHS- supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; and (2) To exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Meeting of the Advisory Committee on Minority Health
Document Number: 2013-10084
Type: Notice
Date: 2013-04-30
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that a meeting of the Advisory Committee on Minority Health (ACMH) will be held virtually. This virtual meeting will take place via webinar and audio video conferencing technology. This meeting will be open to the public. Preregistration is required for both virtual public participation and comment. Any individual who wishes to participate in the virtual public meeting and/or in the public comment session should preregister at the following email address: acmh@osophs.dhhs.gov.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
Document Number: 2013-10083
Type: Notice
Date: 2013-04-30
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
Centers for Disease Control and Prevention
Document Number: 2013-10064
Type: Notice
Date: 2013-04-30
Agency: Department of Health and Human Services
Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus
Document Number: 2013-10055
Type: Notice
Date: 2013-04-30
Agency: Department of Health and Human Services
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3(b)(4). On April 19, 2013, the Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the avian influenza A (H7N9) virus. On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the avian influenza A (H7N9) virus pursuant to section 564(b)(1) of the FD&C Act, 21 U.S.C. Sec. 360bbb- 3(b)(1), subject to the terms of any authorization issued under that section. The Secretary also specified that this declaration is a declaration of an emergency with respect to in vitro diagnostics as defined under the Public Readiness and Emergency Preparedness (PREP) Act Declaration for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on December 17, 2008.\1\
Announcement of Opportunity and Procedure To Submit Nominations for Nutrients of Interest for Dietary Reference Intake Reviews
Document Number: 2013-10054
Type: Notice
Date: 2013-04-30
Agency: Department of Health and Human Services
The Dietary Reference Intake (DRI) Subcommittee, an entity within the federal Interagency Committee on Human Nutrition Research, has developed procedures jointly with its Canadian counterpart to allow interested parties to nominate nutrients for consideration for DRI review. This notice will serve to announce the opportunity to submit such information to the DRI Subcommittee as it considers updates for nutrients and food components that have previously been considered by Institute of Medicine DRI committees.
Submission for OMB Review; 30-Day Comment Request: Request for Human Embryonic Stem Cell Line To Be Approved for Use in NIH-Funded Research
Document Number: 2013-10042
Type: Notice
Date: 2013-04-29
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 has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection instrument listed below. This proposed information collection was previously published in the Federal Register on February 28, 2013, pages 13688-13689, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The 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.
Proposed Collection, 60-day Comment Request: Certificate of Confidentiality Electronic Application System
Document Number: 2013-10041
Type: Notice
Date: 2013-04-29
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, to provide the opportunity for public comment on proposed data collection projects, the Office of Extramural Research (OER) of the National Institutes of Health (NIH) is developing an electronic application form for the submission of requests to NIH for Certificates of Confidentiality (CoCs). 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: Dr. Ann M. Hardy, NIH Extramural Human Research Protections Officer and Coordinator, Certificates of Confidentiality, Office of Extramural Programs, OER, NIH, 3701 Rockledge Drive, Room 3002, Bethesda, MD 20892; or call the non-toll-free number (301) 435-2690; or email your request, including your address, to hardyan@od.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: Certificate of Confidentiality Electronic Application System 0925-New, Office of Extramural Research (OER), National Institutes of Health (NIH). Need and Use of Information Collection: This application system will provide one electronic form to be used by all research organizations that wish to request a Certificate of Confidentiality (CoC) from NIH. As described in the authorizing legislation (Section 301(d) of the Public Health Service Act, 42 U.S.C. 241(d)), CoCs are issued by the agencies of the Department of Health and Human Services (HHS), including NIH, to authorize researchers conducting sensitive research to protect the privacy of human research subjects by enabling them to refuse to release names and identifying characteristics of subjects to anyone not connected with the research. At the NIH, the issuance of CoCs has been delegated to the individual NIH Institutes and Centers (ICs). The NIH ICs collectively issue approximately 1,000 new CoCs each year for eligible research projects. However, the process for submitting a CoC request is not consistent across the ICs, which creates confusion for applicants. To make the application process consistent across the entire agency, the OER is proposing to use an electronic application system that will be accessed by research organizations that wish to request a CoC from any NIH IC. Having one system for all CoC applications to NIH will be efficient for both applicants and NIH staff who process these requests. As is currently done, the NIH will use the information in the application to determine eligibility for a CoC and to issue the CoC to the requesting organization. Office of Management and Budget approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours is 1,500.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-09992
Type: Notice
Date: 2013-04-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Requirements for the Medicare Incentive Reward Program and Provider Enrollment
Document Number: 2013-09991
Type: Proposed Rule
Date: 2013-04-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would revise the Incentive Reward Program provisions in Sec. 420.405 and certain provider enrollment requirements in part 424, subpart P. The most significant of these revisions include: changing the Incentive Reward Program potential reward amount for information on individuals and entities who are or have engaged in acts or omissions which resulted in the imposition of a sanction from 10 percent of the overpayments recovered in the case or $1,000, whichever is less, to 15 percent of the final amount collected applied to the first $66,000,000 for the sanctionable conduct; expanding the instances in which a felony conviction can serve as a basis for denial or revocation of a provider or supplier's enrollment; if certain criteria are met, enabling us to deny enrollment if the enrolling provider, supplier, or owner thereof had an ownership relationship with a previously enrolled provider or supplier that had a Medicare debt; enabling us to revoke Medicare billing privileges if we determine that the provider or supplier has a pattern or practice of submitting claims for services that fail to meet Medicare requirements; and limiting the ability of ambulance suppliers to ``backbill'' for services performed prior to enrollment. We believe this proposed rule wouldincrease the incentive for individuals to report information on individuals and entities that have or are engaged in sanctionable conduct; improve our ability to detect new fraud schemes; and help us ensure that fraudulent entities and individuals do not enroll in or maintain their enrollment in the Medicare program.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-09948
Type: Notice
Date: 2013-04-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-09742
Type: Notice
Date: 2013-04-29
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: ``Improving Sickle Cell Transitions of Care through Health Information Technology Phase 1.'' 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 February 7th, 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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-09946
Type: Notice
Date: 2013-04-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984.
Health Center Program
Document Number: 2013-09942
Type: Notice
Date: 2013-04-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) will be transferring Health Center Program (section 330 of the Public Health Service Act) funds originally awarded to the County of Genesee to ensure the provision of critical primary health care services to underserved populations in Genesee County, Michigan.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-09913
Type: Notice
Date: 2013-04-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
Document Number: 2013-09910
Type: Notice
Date: 2013-04-26
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The NTP BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public and preregistration is requested for both public attendance and comment. Information about the meeting and registration is available at http://ntp.niehs.nih.gov/go/165.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2013-09908
Type: Notice
Date: 2013-04-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-09907
Type: Notice
Date: 2013-04-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2013-09906
Type: Notice
Date: 2013-04-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2013-09905
Type: Notice
Date: 2013-04-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 2013-09904
Type: Notice
Date: 2013-04-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2013-09903
Type: Notice
Date: 2013-04-26
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-09902
Type: Notice
Date: 2013-04-26
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. 207 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.
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-09901
Type: Notice
Date: 2013-04-26
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. 207 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.
National Institutes of Health
Document Number: 2013-09900
Type: Notice
Date: 2013-04-26
Agency: Department of Health and Human Services
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a start-up exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/026,816, entitled ``O\2\-Aryl Substituted Diazeniumdiolates'', filed September 27, 1996, now abandoned (HHS Ref. No. E-093-1996/0-US-01); U.S. Provisional Patent Application No. 60/045,917, entitled ``O\2\-Aryl Substituted Diazeniumdiolates and Use Thereof'', filed May 7, 1997, now abandoned (HHS Ref. No. E-093-1996/1-US-01); U.S. Provisional Patent Application No. 60/051,696, entitled ``O\2\-Glycosylated 1-Substituted Diazen-l- IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1- YL] Diazen-1-IUM-l,2-Diolates'', filed July 3, 1997, now abandoned (HHS Ref. No. E-093-1996/2-US-01); PCT Patent Application No. PCT/US1997/ 017267, entitled ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates'', filed September 26, 1997, now abandoned (HHS Ref. No. E-093-1996/3-PCT-01); European Patent No. 0929538, entitled ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates'', issued on November 24, 2004 [HHS Ref. No. E-093-1996/3-EP-02], which is validated in Great Britain [E-093-1996/3-GB-09], Germany [E-093-1996/3-DE-10], France [E- 093-1996/3-FR-11], Ireland [E-093-1996/3-IE-12], Italy [E-093-1996/3- IT-13], Switzerland [E-093-1996/3-CH-14] and Belgium [E-093-1996/3-BE- 15]; Australian Patent No. 733590, entitled ``O\2\-Arylated or O\2\- Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\- Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2- Diolates'', issued on August 30, 2001 [HHS Ref. No. E-093-1996/3-AU- 03]; Canadian Patent No. 2266908, ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2- Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates,'' issued on July 20, 2010 [HHS Ref. No. E-093-1996/3-CA-04]; Japanese Patent No. 4285775, ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l- IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1- YL] Diazen-1-IUM-l,2-Diolates,'' issued on April 3, 1999 [HHS Ref. No. E-093-1996/3-JP-05]; U.S. Patent No. 6,610,660, entitled ``O\2\- Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM- l,2-Diolates,'' issued on August 26, 2003 [HHS Ref. No. E-093-1996/3- US-06]; U.S. Patent No. 6,911,433, entitled ``O\2\-Glycosylated 1- Substituted Diazen-l-IUM-1,2-Diolates,'' issued on June 28, 2005 [HHS Ref. No. E-093-1996/3-US-07]; European Patent Application No. 04009529.1, entitled ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates,'' filed on April 22, 2004 [E-093-1996/3-EP-08]; U.S. Patent No. 7,081,524, entitled ``O\2\- Substituted 1-[(2-Carboxylato)Pyrrolidin-1-YL] Diazen-1-IUM-l,2- Diolates,'' issued on July 25, 2006 [HHS Ref. No. E-093-1996/3-US-16]; Japanese Patent No. 5015903, entitled ``O\2\-Substituted 1-[(2- Carboxylato)Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates and Compositions Thereof,'' issued on June 15, 2012 [HHS Ref. No. E-093-1996/3-JP-17]; Canadian Patent Application No. 2,705,474, entitled ``O\2\-Glycosylated 1-Substituted Diazen-1-IUM-l,2-Diolates,'' filed on May 28, 2010 [E- 093-1996/3-CA-18]; and European Patent Application No. 10010885.1, entitled ``O\2\-Substituted 1-[(2-Carboxylato)Pyrrolidin-1-YL] Diazen- 1-IUM-l,2-Diolates,'' filed on September 24, 2012 [E-093-1996/3-EP-19], developed by Dr. Larry K. Keefer, Dr. Joseph E. Saavedra, et al. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to: ``use of O\2\-Arylated, O\2\- Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates, and O\2\- Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2- Diolates for cancer treatment and prevention in humans.'' to JSK Therapeutics, Inc. (``JSKT''), a company incorporated under the laws of the State of Delaware having an office in at least Salt Lake City, Utah, U.S.A. The patent rights in these inventions have been assigned to the United States of America.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2013-09899
Type: Notice
Date: 2013-04-26
Agency: Department of Health and Human Services, National Institutes of Health
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-09874
Type: Notice
Date: 2013-04-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or Institute)
Document Number: 2013-09873
Type: Notice
Date: 2013-04-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability
Document Number: 2013-09872
Type: Notice
Date: 2013-04-26
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 entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data the applicant should submit to support the appropriate classification of a co-crystal, as well as the regulatory implications of the classification. The recommendations in this guidance apply to materials that the Agency has not previously evaluated and determined to be pharmaceutical co-crystals. The recommendations do not apply to materials that the Agency has previously designated as salts, complexes, or other non-co- crystalline forms.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods
Document Number: 2013-09763
Type: Proposed Rule
Date: 2013-04-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' that appeared in the Federal Register of January 16, 2013. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability; Extension of the Comment Period
Document Number: 2013-09762
Type: Proposed Rule
Date: 2013-04-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for a document that we made available for public comment by notification in the Federal Register of January 16, 2013. We are taking this action to make the comment period for the draft RA conform to the comment period for proposed rules entitled ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' (the proposed preventive controls rule) and ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' (the proposed produce safety rule). Elsewhere in this issue of the Federal Register, we are announcing a 120-day extension of the comment period for the proposed preventive controls rule and the proposed produce safety rule.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Periods
Document Number: 2013-09761
Type: Proposed Rule
Date: 2013-04-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' that appeared in the Federal Register of January 16, 2013. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
Scientific Information Request Therapies for Clinically Localized Prostate Cancer
Document Number: 2013-09739
Type: Notice
Date: 2013-04-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from medical device manufacturers with products falling within the following UMDNS product codes: Brachytherapy Systems [20-352]; Cyclotrons [15-818]; Radiotherapy Systems, Linear Accelerator [12-364]; Radiotherapy Systems, and Proton Beam [20-546]. Scientific information is being solicited to inform the update of our Comparative Effectiveness Review of Therapies for Clinically Localized Prostate Cancer which is currently being conducted by one of the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
National Institutes of Health
Document Number: 2013-09824
Type: Notice
Date: 2013-04-25
Agency: Department of Health and Human Services
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 Human Genome Research Institute (NHGRI), 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 any 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 Contact: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Laura M. Koehly, Ph.D., Senior Investigator, Social and Behavioral Research Branch, NHGRI, NIH, 31 Center Drive MSC 2073, Building 31, Room B1B54, Bethesda, MD 20892, or call non-toll-free number (301) 451- 3999, or Email your request, including your address to: koehlyl@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
Meeting of the President's Council on Fitness, Sports, and Nutrition; Correction
Document Number: 2013-09815
Type: Notice
Date: 2013-04-25
Agency: Department of Health and Human Services
The Department of Health and Human Services published a notice in the Federal Register of April 11, 2013 to announce a meeting of the President's Council on Fitness, Sports, and Nutrition that will be held on May 7, 2013, from 10:00 a.m. to 4:30 p.m., at the Department of Health and Human Services, 200 Independence Ave. SW., Room 800; Washington, DC 20201. The meeting location has changed.
Submission for OMB Review; Comment Request
Document Number: 2013-09797
Type: Notice
Date: 2013-04-25
Agency: Department of Health and Human Services, Administration for Children and Families
Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-09759
Type: Notice
Date: 2013-04-25
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 ``Assay Migration Studies for In Vitro Diagnostic Devices.'' This guidance presents a least burdensome regulatory approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved assay is migrating (i.e., transitioning) to a new system for which the assay has not been previously approved, licensed, or cleared.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-09756
Type: Notice
Date: 2013-04-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-09753
Type: Notice
Date: 2013-04-25
Agency: Department of Health and Human Services, National Institutes of Health
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2013-09744
Type: Notice
Date: 2013-04-25
Agency: Food and Drug Administration, Department of Health and Human Services