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

Results 201 - 250 of 337
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-08397
Type: Notice
Date: 2013-04-10
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 an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0275, which expires on October 31, 2013. 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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-08348
Type: Notice
Date: 2013-04-10
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. Information Collection Request Title: Corps Community Day Event Form (OMB No. 0915-xxxx)[NEW] Abstract: Corps Community Day was created in 2011 and celebrates the National Health Service Corps (NHSC) every October during National Primary Care Week. The NHSC is a program administered by the Bureau of Clinician Recruitment and Service (BCRS) within HRSA. The goals of Corps Community Day encompass the following: increase awareness of the NHSC to potential applicants and the greater primary health community; create a sense of community and connectedness among NHSC program participants, alumni, partners, and staff; and underscore the NHSC's role in bringing primary health care services to the nation's neediest communities. Current program participants, alumni, NHSC Ambassadors, sites, primary care organizations, and professional associations plan events and report the details of their events to BCRS so that they can be added to the state-by-state map of events. In order to avoid duplication of effort, eliminate confusion regarding allowable event dates, avoid data entry errors, and implement a brief post-event satisfaction survey, BCRS would like to implement a standard form that event planners will use to report to BCRS. The fillable form will be available online and will have less than 20 fields for event planners to populate to submit for inclusion on the map. There will also be approximately 5 fields to populate following the event to measure satisfaction. Both the pre-event and post-event data fields will be held in one form. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. The annual estimate of burden is as follows:
Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2013-08337
Type: Notice
Date: 2013-04-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)
Document Number: 2013-08336
Type: Notice
Date: 2013-04-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission
Document Number: 2013-08315
Type: Notice
Date: 2013-04-10
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 collection of health documents that were created during the period of June 23, 2009, through December 31, 2009.
Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute
Document Number: 2013-08314
Type: Proposed Rule
Date: 2013-04-10
Agency: Department of Health and Human Services, Office of Inspector General
In this proposed rule, the Office of Inspector General (OIG) proposes to amend the safe harbor regulation concerning electronic health records items and services, which defines certain conduct that is protected from liability under the Federal anti-kickback statute in the Social Security Act (the Act). The proposed amendments include an update to the provision under which electronic health records software is deemed interoperable; removal of the electronic prescribing capability requirement; and extension of the sunset provision. In addition, OIG is requesting public comment on other changes it is considering.
Medicare Program; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships: Exception for Certain Electronic Health Records Arrangements
Document Number: 2013-08312
Type: Proposed Rule
Date: 2013-04-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would revise the exception to the physician self-referral prohibition for certain arrangements involving the donation of electronic health records items and services. Specifically, it would extend the sunset date of the exception, remove the electronic prescribing capability requirement, and update the provision under which electronic health records technology is deemed interoperable. In addition, we are requesting public comment on other changes we are considering.
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2013-08288
Type: Notice
Date: 2013-04-10
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-08287
Type: Notice
Date: 2013-04-10
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Alternative Medicine; Notice of Closed Meeting
Document Number: 2013-08286
Type: Notice
Date: 2013-04-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-08285
Type: Notice
Date: 2013-04-10
Agency: Department of Health and Human Services, National Institutes of Health
Funding Opportunity Announcement for Family Violence Prevention and Services/Grants for Domestic Violence Shelters/Grants to Native American Tribes (including Alaska Native Villages) and Tribal Organizations
Document Number: 2013-08275
Type: Notice
Date: 2013-04-10
Agency: Department of Health and Human Services, Administration for Children and Families
This announcement governs the proposed award of formula grants under the Family Violence Prevention and Services Act (FVPSA) to Native American Tribes (including Alaska Native Villages) and Tribal organizations. The purpose of these grants is to assist Tribes in efforts to increase public awareness about, and primary and secondary prevention of family violence, domestic violence, and dating violence and to provide immediate shelter and supportive services for victims of family violence, domestic violence, or dating violence, and their dependents. This announcement sets forth the application requirements, the application process, and other administrative and fiscal requirements for grants in Fiscal Year 2013. Grantees are to be mindful that although the expenditure period for grants is a two-year period, an application is required each year to provide continuity in the provision of services.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-08258
Type: Notice
Date: 2013-04-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-08257
Type: Notice
Date: 2013-04-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission for OMB Review; 30-day Comment Request: The Clinical Trials Reporting Program (CTRP) Database (NCI)
Document Number: 2013-08270
Type: Notice
Date: 2013-04-09
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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 1, 2013 (Volume 78, Page 7437) 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 Cancer Institute (NCI), 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.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2013-08218
Type: Notice
Date: 2013-04-09
Agency: Food and Drug Administration, Department of Health and Human Services
Findings of Research Misconduct
Document Number: 2013-08207
Type: Notice
Date: 2013-04-09
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: Andrew Aprikyan, Ph.D., University of Washington: Based on the report of an investigation conducted by the University of Washington (UW), the UW School of Medicine Dean's Decision, the Decision of the Hearing Panel at UW, and additional analysis conducted by ORI, ORI found by a preponderance of the evidence that Dr. Andrew Aprikyan, former Research Assistant Professor, Division of Hematology, UW, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant CA89135 and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grant DK18951, and applies to the following publications and grant applications: Blood pre-published online on January 16, 2003 (``NEM'') Experimental Hematology 31:372-381, 2003 (``CMA'') Blood 97:147-153, 2001 (``ISB'') R01 CA89135-01A1 R01 HL73063-01 R01 HL79615-01 Blood pre-published online on January 16, 2003, has been retracted and Experimental Hematology 31:372-381, 2003, has been corrected. Specifically, ORI finds that by a preponderance of the evidence, Respondent falsified and/or fabricated results relating to the above publications and grants. Specifically, Respondent: 1. Falsely reported sequencing data in the NEM manuscript to strengthen the hypothesis that NE mutations contributed to the phenotype observed in severe congenital neutropenia (SCN) patients. Specifically: a. Respondent falsely reported in Figures 2A and 3 that patient 3 had the R191Q neutrophil elastase (NE) mutation, when the majority of the sequencing experiments showed that the mutation was not present. b. Respondent fabricated text (p. 12) reporting that sequencing of RT-PCR products confirmed the expression of the NE mutants in the SCN patients and that no mutations were present in the granulocyte colony stimulating factor receptor (G-CSFR) gene and the Wiskott-Aldrich Syndrome (WAS) gene in SCN patients, when based on the lack of original records the experiments were not performed. The false claim for G-CSFR sequencing was also reported in CA89135-03. 2. Falsely reported a two-fold increase in apoptosis of human promyelocytic (HL-60) cells transfected with NE mutants compared to wild type NE in Figure 4A, NEM, Figure 6A, CMA, Figure 8, HL73063-01, and Figure 7, HL79615-01. Respondent used arbitrary flow cytometry data files to generate histograms with the desired result. The false results supported the hypothesis that the NE mutations were sufficient for impaired survival of human myeloid cells. 3. Falsified NE and [szlig]-actin Western blots in Figure 4B Blood, pre-published online January 16, 2003, Figure 5B of the manuscript initially submitted to Blood April 2002, and Figure 6B Experimental Hematology 31:372-381, 2003, by falsely labeling lanes to support the hypothesis that accelerated apoptosis in mutant NE transfect HL-60 cells was due to the mutation and not the level of protein present. Specifically: a. Respondent used portions of a single NE Wester blot to represent: Figure 4B as HL-60 cells transfected with L92H, R191Q, and wtNE, when the cells were transfected with R191Q, P110L, and D145-152; Figure 5B as HL-60 transfected with wtNE, mutNE, and EGFP when they were cells transfected with NE mutants, P110L, D145-152, and 194 b. Respondent used portions of a single [szlig]-actin Western blot to represent: Figure 4B as HL-60 cells transfected with L92H, R191Q, and wtNE, when they were cells transfected with I31T, P110L, and G185R mutants; Figure 5B as HL-60 cells transfected with wtNE, mutNE, and EGFP, when they were cells transfected with P110L, I31T, and INE; Figure 6B as HL-60 cells transfected with G185R, mock, D145-152, and P110L NE mutants, when they were cells transfected with I31T, P110L, G185R, and 32. The false [szlig]-actin Western blot in Figure 6B was also included in HL73063-01, Figure 8 (where the I31Tlane was labeled correctly), and HL79615-01, Figure 7. 4. Falsified the reported methodology for flow cytometry experiments in Figure 4A, NEM, Figures 1 and 2, and Tables 2 and 3, CMA, and Figures 4, 5, and 6, ISB, to validate the key hypothesis showing accelerated apoptosis in SCN and CN patients. The methodology claimed that flow cytometry experiments were gated for GFP+ populations, or that cell purity was greater than 96%, when based on the available original records, the experiments were not performed as stated. 5. Falsified Figure 2, CMA, Figure 2, HL73063-01, Figure 3, HL79615-01, and Figure 5, CA89135-01A1, demonstrating that the overnight cultures of CD34+ and CD33+ bone marrow cells from SCN/AML patients showed normal cell survival, and only the CD15+ overnight cultures showed accelerated apoptosis, when the actual record available contradicted this result. Respondent used flow cytometry data files to generate histograms with the desired result to support the hypothesis that the progression from SCN to leukemia (AML) involves acquired G- CSFR mutations that override the pro-apoptotic effect of the NE mutations in primitive progenitor cells. Dr. Aprikyan has entered into a Settlement Agreement in which he denied ORI's findings of research misconduct based on the UW Faculty Adjudication Hearing Panel decision. The settlement is not an admission of liability on the part of the Respondent. Respondent entered into the Agreement solely because contesting the findings would cause him undue financial hardship and stress, lead to lengthy and costly appellate proceedings, and he wished to seek finality. Respondent agreed not to appeal the ORI findings of research misconduct set forth above. He has agreed, beginning on March 12, 2013: (1) If within two (2) years from the effective date of the Agreement, Respondent receives or applies for U.S. Public Health Service (PHS) support, Respondent agreed to have his research supervised for a period of two (2) years; Respondent agreed that prior to the submission of an application for 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; Respondent 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; (2) If within two (2) years from the effective date of the Agreement, Respondent receives PHS support, Respondent agreed that for two (2) years, any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and (3) Respondent agreed not to serve 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 for a period of two (2) years beginning with the effective date of the Agreement.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-08189
Type: Notice
Date: 2013-04-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-08187
Type: Notice
Date: 2013-04-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-08167
Type: Notice
Date: 2013-04-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Molecular Diagnostic Instruments with Combined Functions.'' This draft guidance document provides industry and Agency staff with FDA's current thinking on regulation of molecular diagnostic instruments that have both device functions and non-device functions, and on the type of information that FDA recommends that applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions. This draft guidance is not final nor is it in effect at this time.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-08150
Type: Notice
Date: 2013-04-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2013-08149
Type: Notice
Date: 2013-04-09
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of An Exclusive Evaluation Option License: Pre-clinical Evaluation of Anti-tyrosine Kinase-like Orphan Receptor 1 Immunotoxins for the Treatment of Human Cancers
Document Number: 2013-08148
Type: Notice
Date: 2013-04-09
Agency: Department of Health and Human Services, National Institutes of Health
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 an exclusive license to practice the inventions embodied in U.S. Patent Application 61/172,099 entitled ``Anti-human ROR1 Antibodies'' [HHS Ref. E-097-2009/0-US-01], U.S. Patent Application 60/703,798 entitled ``Mutated Pseudomonas Exotoxins with Reduced Antigenicity'' [HHS Ref. E-262-2005/0-US-01], U.S. Patent Application 60/969,929 entitled ``Deletions in Domain II of Pseudomonas Exotoxin A that Remove Immunogenic Epitopes with Affecting Cytotoxic Activity'' [HHS Ref. E- 292-2007/0-US-01], U.S. Patent Application 61/241,620 entitled ``Improved Pseudomonas Exotoxin A with Reduced Immunogenicity'' [HHS Ref. E-269-2009/0-US-01], U.S. Patent Application 61/483,531 entitled ``Recombinant Immunotoxin Targeting Mesothelin'' [HHS Ref. E-117-2011/ 0-US-01], U.S. Patent Application 61/495,085 entitled ``Pseudomonas Exotoxin A with Less Immunogenic T-Cell/or B-Cell Epitopes'' [HHS Ref. E-174-2011/0-US-01], U.S. Patent Application 61/535,668 entitled ``Pseudomonas Exotoxin A with Less Immunogenic B-Cell Epitopes'' [HHS Ref. E-263-2011/0-US-01], and all related continuing and foreign patents/patent applications for the technology family, to SPEED BioSystems, LLC. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive evaluation option license territory may be worldwide and the field of use may be limited to pre-clinical evaluation of lead therapeutic candidates for the development and use of anti-tyrosine kinase-like orphan receptor 1 (ROR1) targeted immunotoxins for the treatment of human ROR1 expressing cancers, wherein the immunotoxin comprises an anti-ROR1 antibody designated as 2A2 and Pseudomonas exotoxin A (PE). Upon expiration or termination of the exclusive evaluation option license, SPEED will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no broader territory than granted in the exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion.
Establishment of a Public Docket for Administrative Detention Under the Food and Drug Administration Safety and Innovation Act
Document Number: 2013-08120
Type: Proposed Rule
Date: 2013-04-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the establishment of a public docket for comments pertaining to the implementation of its administrative detention authority with respect to drugs under the Food and Drug Administration Safety and Innovation Act (FDASIA). This document is intended to solicit input from all relevant stakeholders before FDA issues regulations to implement its administrative detention authority with respect to drugs and to announce that such information submitted to FDA is available to all interested persons in a timely fashion.
New Animal Drugs; Change of Sponsor
Document Number: 2013-07542
Type: Rule
Date: 2013-04-09
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 a change of sponsor for 43 approved new animal drug applications (NADAs) and 3 approved abbreviated new animal drug applications (ANADAs) from Boehringer Ingelheim Vetmedica, Inc. to Strategic Veterinary Pharmaceuticals, Inc.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-08071
Type: Notice
Date: 2013-04-08
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.
Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2013-08069
Type: Notice
Date: 2013-04-08
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-08067
Type: Notice
Date: 2013-04-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-08051
Type: Notice
Date: 2013-04-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
Document Number: 2013-08034
Type: Notice
Date: 2013-04-08
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Center for Devices and Radiological Health: Health of Women Program; Public Workshop; Request for Comments
Document Number: 2013-08015
Type: Notice
Date: 2013-04-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop: ``The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist and ExploreHoW to Improve the Health of Women.'' CDRH is developing the HoW Program to explore unique issues in the regulation of medical devices related to the health of women and seeks public input on the priority activities. The CDRH HoW program seeks to bring together industry, clinicians, researchers, academia, government agencies, and patient/advocacy groups in an effort to: (1) Highlight device-specific clinical Study recruitment and retention strategies; (2) improve analysis and communication of sex-specific findings to providers and patients; (3) develop a priority research road map for the HoW device ecosystem. The workshop focus will be device- and disease-specific, patient centered, and action oriented. Dates and Times: The public workshop will be held on June 24, 2013, from 8 a.m. to 5 p.m. and June 25, 2013, from 8 a.m. to 5 p.m. Location: The public workshop will be held on FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993. Contact: Nada Hanafi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5422, Silver Spring, MD 20993-0002, 301-796-5427, Nada.Hanafi@fda.hhs.gov; or Kathryn O'Callaghan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5568, Silver Spring, MD 20993-0002, 301-796-6349, Kathryn.OCallaghan@fda.hhs.gov. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 5 p.m. on June 14, 2013. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration will be provided beginning at 7:30 a.m. on the day of the public workshop. If you need special accommodations due to a disability, please contact Joyce Raines (Joyce.Raines@fda.hhs.gov or 301-796-5709) by 5 p.m. on June 14, 2013. To register for the public workshop, please visit FDA's Medical Devices News & EventsWorkshops & Conferences calendar at http:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm and select this public workshop from the posted events list. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, telephone number and primary HoW Program area of expertise or interest. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the public workshop: The plenary portions of this workshop will be Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on June 14, 2013. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and connection access information after June 19, 2013. An archived file of the Webcast will be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). Workshop format: This workshop will begin with plenary sessions to outline the three primary areas of focus for the CDRH HoW Program. In each area, panels will examine major themes using data-driven case studies with a focus on practical strategies relevant to particular challenges in the medical device arena. Participants will then rotate through breakout sessions, collectively building an action plan for each activity area. The meeting will conclude with specific commitments by stakeholder groups to partner with CDRH and each other in a collaborative effort to educate, enable, enlist and explore, with a common goal of improving the health of women. Comments: In order to permit the widest possible opportunity to obtain public information from interested persons on the workshop topics, FDA is opening the docket to gather electronic or written comments on the three areas of focus for the HoW workshop identified in section II. Comments received will be reviewed by FDA as part of this effort. The deadline for submitting comments related to this public workshop topic is July 31, 2013. Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Please identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific topics as outlined in section II, please identify the topic you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov.
Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report); Availability
Document Number: 2013-08014
Type: Notice
Date: 2013-04-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International Conference on Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. periodic adverse drug experience report (PADER), or U.S. periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The guidance describes the steps applicants can take to submit the PBRER, and discusses the format, content, submission deadline, and frequency of reporting for the PBRER.
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
Document Number: 2013-08013
Type: Notice
Date: 2013-04-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Investigational New Drug Applications
Document Number: 2013-08012
Type: Notice
Date: 2013-04-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation to sponsors of investigational new drug (IND) applications to participate in a pilot evaluation program for CBER's eSubmitter Program (eSubmitter). CBER's eSubmitter is a computer-assisted automated program that has been customized to facilitate the creation of IND applications in electronic format, including a template specifically for IND applications related to antivenom drugs/antivenins. Participation in the pilot program is open to sponsors that submit IND applications to the Office of Blood Research and Review, the Office of Cellular, Tissue and Gene Therapy, or the Office of Vaccines Research and Review in CBER. CBER will only accept participation from up to nine sponsors. The pilot program is intended to provide industry and CBER regulatory review staff with an opportunity to evaluate the eSubmitter system and determine if it facilitates the IND submission process. The purpose of this notice is to invite sponsors of IND applications to contact CBER for more information if they are interested in participating in this pilot program.
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2013-08008
Type: Notice
Date: 2013-04-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2013-08007
Type: Notice
Date: 2013-04-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-08006
Type: Notice
Date: 2013-04-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2013-08005
Type: Notice
Date: 2013-04-08
Agency: Department of Health and Human Services
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2013-08004
Type: Notice
Date: 2013-04-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-08003
Type: Notice
Date: 2013-04-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-08002
Type: Notice
Date: 2013-04-08
Agency: Department of Health and Human Services, National Institutes of Health
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
Document Number: 2013-08032
Type: Notice
Date: 2013-04-05
Agency: Department of Health and Human Services
The Presidential Commission for the Study of Bioethical Issues will conduct its thirteenth meeting on April 30, 2013. At this meeting, the Commission will discuss the ethical implications of incidental findings.
Tribal Consultation Meeting
Document Number: 2013-08029
Type: Notice
Date: 2013-04-05
Agency: Department of Health and Human Services, Administration for Children and Families
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of two 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, 640(l)(4)].
Standing Funding Opportunity Announcement for Family Violence Prevention and Services/Grants to State Domestic Violence Coalitions
Document Number: 2013-08027
Type: Notice
Date: 2013-04-05
Agency: Department of Health and Human Services, Administration for Children and Families
This notice for family violence prevention and services grants to Coalitions serves four purposes: To confirm a Federal commitment to reducing family violence, domestic violence, and dating violence; to provide for Coalitions to collaborate and coordinate with States, tribes, localities, cities, and the private sector to be involved in State and local planning towards an integrated service delivery approach that meets the needs of all victims, including those in underserved communities and racial and ethnic minorities; to provide training and technical assistance to domestic violence programs and providers of direct services; and to increase public awareness about and prevention of family violence, domestic violence, and dating violence, and increase the quality and availability of immediate shelter and supportive services for victims of family violence, domestic violence, and dating violence, and their dependents. Statutory Authority: This announcement governs the proposed award of formula grants under the Family Violence Prevention and Services Act (FVPSA) to private, non-profit State Domestic Violence Coalitions (Coalitions). The purpose of these grants is to further the intervention and prevention of family violence, domestic violence, and dating violence (42 U.S.C. 10401, et seq.).
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 2013-07961
Type: Notice
Date: 2013-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
Patient Protection and Affordable Care Act; Exchange Functions: Standards for Navigators and Non-Navigator Assistance Personnel
Document Number: 2013-07951
Type: Proposed Rule
Date: 2013-04-05
Agency: Department of Health and Human Services
The proposed regulations would create conflict-of-interest, training and certification, and meaningful access standards applicable to Navigators and non-Navigator assistance personnel in Federally- facilitated Exchanges, including State Partnership Exchanges, and to non-Navigator assistance personnel in State-based Exchanges that are funded through federal Exchange Establishment grants. These proposed standards would help ensure that Navigators and non-Navigator assistance personnel will be fair and impartial and will be appropriately trained, and that they will provide services and information in a manner that is accessible. The proposed regulations would also make two amendments to the existing regulation for Navigators that would apply to all Navigators in all Affordable Insurance Exchanges (Exchanges), including State- based Exchanges, clarifying that any Navigator licensing, certification, or other standards prescribed by the state or Exchange must not prevent the application of the provisions of title I of the Affordable Care Act; and adding to the list of entities ineligible to become Navigators, those entities with relationships to issuers of stop loss insurance, including those who are compensated directly or indirectly by issuers of stop loss insurance in connection with enrollment in Qualified Health Plans or non-Qualified Health Plans. The proposed regulations would also clarify that the same ineligibility criteria that apply to Navigators would also apply to non-Navigator assistance personnel providing services in any Federally-facilitated Exchanges, including in State Consumer Partnership Exchanges, and to federally funded non-Navigator assistance personnel in State-based Exchanges.
Medicare and Medicaid Programs; Survey, Certification and Enforcement Procedures
Document Number: 2013-07950
Type: Proposed Rule
Date: 2013-04-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would revise the survey, certification, and enforcement procedures related to CMS oversight of national accreditation organizations (AOs). These revisions would implement certain provisions under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The proposed revisions would also clarify and strengthen our oversight of AOs that apply for, and are granted, recognition and approval of an accreditation program in accordance with the Social Security Act.
Preparation for International Cooperation on Cosmetics Regulation; Public Meeting
Document Number: 2013-07949
Type: Notice
Date: 2013-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
Pediatric Device Consortia Grant Program
Document Number: 2013-07948
Type: Notice
Date: 2013-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia (PDC) Grant Program. The goal of the PDC Grant Program is to facilitate the development, production, and distribution of pediatric medical devices. The PDC will provide grants to nonprofit consortia which provide expert advising and support services to innovators of pediatric devices. These services should include business and regulatory consulting as well as device testing capabilities. This program is intended to further the development of multiple pediatric devices; thus, grants are not awarded to support the development of a single device project. Although administered by the OOPD, this grant program is intended to encompass devices that could be used in all pediatric conditions and diseases, not just rare diseases. The pediatric population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or younger at the time of diagnosis or treatment.