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

Results 101 - 150 of 337
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-09267
Type: Notice
Date: 2013-04-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-09256
Type: Notice
Date: 2013-04-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting
Document Number: 2013-09222
Type: Notice
Date: 2013-04-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-09221
Type: Notice
Date: 2013-04-19
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 Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Submission of Medical Device Registration and Listing
Document Number: 2013-09182
Type: Notice
Date: 2013-04-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Electronic Submission of Medical Device Registration and Listing'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification
Document Number: 2013-09181
Type: Notice
Date: 2013-04-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Clinical Laboratory Improvement Amendments Waiver Applications
Document Number: 2013-09180
Type: Notice
Date: 2013-04-19
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Health Care Professional Survey of Prescription Drug Promotion
Document Number: 2013-09176
Type: Notice
Date: 2013-04-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Health Care Professional Survey of Prescription Drug Promotion'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Use of Certain Symbols in Labeling
Document Number: 2013-09175
Type: Proposed Rule
Date: 2013-04-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to revise medical device and biological product labeling regulations to explicitly allow for the inclusion of stand-alone graphical representations of information, or symbols, if the symbol has been established as part of a standard developed by a nationally or internationally recognized standards development organization (SDO) (referred to in this document as a ``standardized symbol'') and such standardized symbol is part of a standard recognized by FDA for use on the labeling of medical devices (or on a subset of medical devices), provided that such symbol is explained in a symbols glossary that contemporaneously accompanies the medical device. FDA is also proposing to revise prescription device labeling regulations to authorize the use of the symbol statement ``Rx only'' on the labeling of prescription devices.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-09174
Type: Notice
Date: 2013-04-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-09173
Type: Notice
Date: 2013-04-19
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: 2013-09172
Type: Notice
Date: 2013-04-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-09171
Type: Notice
Date: 2013-04-19
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Meeting
Document Number: 2013-09135
Type: Notice
Date: 2013-04-18
Agency: Department of Health and Human Services, Health Resources and Service Administration
Findings of Misconduct in Science/Research Misconduct
Document Number: 2013-09134
Type: Notice
Date: 2013-04-18
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that effective on March 14, 2013, a Settlement Agreement was made and entered into by and between Dr. Philippe Bois and the United States Department of Health and Human Services (HHS), Kathleen Sebelius, Howard K. Koh, Nancy Gunderson, and Donald Wright (collectively HHS) by and through the United States Attorney for the District of Columbia in Bois v. HHS, et al., Civil Action no. 11-cv-1563, which was pending before the U.S. District Court for the District of Columbia. In the Settlement Agreement, HHS and Dr. Bois agreed to settle the proceedings before the District Court of the District of Columbia as well as to resolve all administrative matters pending at HHS. ORI found that Philippe Bois, Ph.D., former postdoctoral fellow, Department of Biochemistry, St. Jude Children's Research Hospital, engaged in research misconduct in research funded by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM071596, and National Cancer Institute (NCI), NIH, grants P30 CA021765, P01 CA071907, R01 CA072996, and R01 CA100603. In the Settlement Agreement, the parties agreed that ORI found by a preponderance of the evidence that the Respondent committed misconduct in science and research misconduct by: 1. Knowingly and intentionally falsely reporting that FOXO1a was not expressed in cell lysates from alveolar rhabdomyosarcoma (ARMS) tumor biopsies, by selecting a specific FOX01a immunoblot to show the desired result, in Figure 1A of the following paper: Bois, P.R., Izeradjene, K., Houghton, P.J., Cleveland, J.L., Houghton, J.A., & Grosveld, C.G. ``FOXO1a acts as a selective tumor suppressor in alveolar rhabdomyosarcoma.'' J. Cell. Biol. 170:903-912, September 2005 (``JCB 2005'') 2. Falsifying data showing SDS-PAGE for papain digestion of VBS3 and [alpha]VBS, by falsely labeling lane 1 to represent papain only digestion, by falsely labeling lane 5 to represent papain digestion of the [alpha]VBS peptide, and by falsely inserting a band in lane 3 to represent the [alpha]VBS peptide, in Figure 4B of the following paper: Bois, P.R., Borgon, R.A., Vornhein, C., & Izard, T. ``Structural dynamics of [alpha]-actinin-vinculin interactions.'' Mol. Cell. Biol. 25:6112-6122, July 2005 (``MCB 2005''). The parties further agreed that Dr. Bois denied committing research misconduct and, pursuant to 42 CFR part 93, filed a timely request for a hearing at which to contest ORI's findings. An HHS Administrative Law Judge (ALJ) denied Dr. Bois' request for a hearing. HHS subsequently entered a debarment order against Dr. Bois. Dr. Bois filed the above referenced lawsuit in the United States District Court for the District of Columbia asking the Court to vacate the debarment order and remand the matter for further proceedings before HHS, including but not limited to granting Dr. Bois' request for a hearing. On March 2, 2012, Judge Berman Jackson of the United States District Court for the District of Columbia issued an order vacating HHS' debarment order, affirming Finding 1, and remanding the matter to HHS for further proceedings regarding Finding 2. On March 30, 2012, HHS filed a Motion for Reconsideration before Judge Berman Jackson. On March 14, 2013, Dr. Bois and HHS entered into a Settlement Agreement (Agreement) to settle and dismiss the pending civil action. The terms of the Settlement Agreement include that Dr. Bois denied that he committed research misconduct but he agreed not to further appeal ORI's findings of research misconduct set-forth above. Dr. Bois and HHS further agreed to the following administrative actions beginning on March 14, 2013: (1) To have his research supervised for a period of three (3) years beginning on the effective date of the Agreement; he 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, he 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, with such review and approval to be conducted promptly by ORI and not unreasonably withheld; he agreed to maintain responsibility for compliance with the agreed upon supervision plan; (2) that for three (3) years beginning with the effective date of the Agreement, 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 Dr. Bois is involved, a certification to ORI that the data provided by him 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) 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 for a period of three years (3) beginning with the effective date of the Agreement. Dr. Bois further agreed to dismiss his lawsuit with prejudice and to withdraw further proceedings before HHS. Dr. Bois and HHS both agreed to waive or abandon all other claims. This notice supercedes the notice regarding this matter that was previously published in: Federal Register 76:111, June 9, 2011.
Submission for OMB Review; Comment Request
Document Number: 2013-09097
Type: Notice
Date: 2013-04-18
Agency: Department of Health and Human Services, Administration for Children and Families
Administration for Children and Families
Document Number: 2013-09095
Type: Notice
Date: 2013-04-18
Agency: Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
Document Number: 2013-09093
Type: Notice
Date: 2013-04-18
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 information collection associated with the guidance ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims,'' which is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension.
Determination That the OXYCONTIN (Oxycodone Hydrochloride) Drug Products Covered by New Drug Application 20-553 Were Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2013-09092
Type: Notice
Date: 2013-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that OXYCONTIN (oxycodone hydrochloride) extended-release tablets (10 milligrams (mg), 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg) approved under new drug application (NDA) 20-553 were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for products that reference NDA 20-553.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-09074
Type: Notice
Date: 2013-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-09046
Type: Notice
Date: 2013-04-18
Agency: Department of Health and Human Services
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), 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 reinstatement of a previously-approved information collection assigned OMB control number 4040-0001, which expired on March 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. 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.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-08946
Type: Notice
Date: 2013-04-18
Agency: Agency for Healthcare Research and Quality, 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: ``Pilot Test of the Proposed Value and Efficiency Surveys and Communicating with Patients Checklist.'' 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 January 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.
Request for Measures and Domains To Use in Development of a Standardized Instrument for Use in Public Reporting of the Quality of Transition From Child-focused to Adult-focused Care in Young Adults With Chronic Conditions
Document Number: 2013-08937
Type: Notice
Date: 2013-04-18
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b- 9a). Section 1139A(b) charged the Department of Health and Human Services with improving pediatric health care quality measures. The Agency for Healthcare Research and Quality (AHRQ) is requesting the submission of instruments or domains (for example, key concepts) measuring aspects of the transition from child-focused to adult-focused care in young adults with chronic health conditions from all researchers, vendors, hospitals, stakeholders, and other interested parties. AHRQ is interested in instruments and items through which young adults or parent proxies may assess experiences they have with the health care system, including the transition from pediatric to adult health care. The goal is to develop a standardized instrument for use in assessing the quality of transition from child-focused to adult- focused care in young adults with chronic health conditions.
Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF)
Document Number: 2013-08935
Type: Notice
Date: 2013-04-18
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).
Standing Funding Opportunity Announcement for Family Violence Prevention and Services Grants to States for Domestic Violence Shelters and Support Services
Document Number: 2013-08711
Type: Notice
Date: 2013-04-18
Agency: Department of Health and Human Services, Administration for Children and Families
This announcement governs the proposed award of mandatory grants under the Family Violence Prevention and Services Act (FVPSA) to States (including territories and insular areas). The purpose of these grants is to: (1) assist States in efforts to increase public awareness about, and primary and secondary prevention of, family violence, domestic violence, and dating violence; and (2) assist States in efforts to provide immediate shelter and supportive services for victims of family violence, domestic violence, or dating violence (42 U.S.C. 10401 et seq.). This announcement sets forth the application requirements, the application process, and other administrative and fiscal requirements for grants in Fiscal Year (FY) 2013, 2014 and 2015.
Reimbursement Rates for Calendar Year 2013
Document Number: 2013-09030
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, Indian Health Service
Notice is given that the Director of the Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42 U.S.C. 2001(a)), and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2013 for Medicare and Medicaid beneficiaries, and beneficiaries of other Federal programs, and for recoveries under the Federal Medical Care Recovery Act (42 U.S.C. 2651-2653). The Medicare Part A inpatient rates are excluded from the table below as they are paid based on the prospective payment system. Since the inpatient rates set forth below do not include all physician services and practitioner services, additional payment shall be available to the extent that those services are provided.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-09029
Type: Notice
Date: 2013-04-17
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 Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-09026
Type: Notice
Date: 2013-04-17
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 Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
National Advisory Council on Migrant Health; Notice of Meeting
Document Number: 2013-09025
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Advisory Council on Nurse Education and Practice; Notice of Meeting
Document Number: 2013-09023
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
World Trade Center Health Program; Certification of Breast Cancer in WTC Responders and Survivors Exposed to PCBs
Document Number: 2013-09003
Type: Rule
Date: 2013-04-17
Agency: Department of Health and Human Services
On September 12, 2012, HHS published a final rule in the Federal Register adding certain types of cancer to the List of World Trade Center (WTC)-Related Health Conditions (List) established in the WTC Health Program regulation. Breast cancer was included on the List, although only individuals experiencing nighttime sleep disruption as a result of response and cleanup activities involving shiftwork are currently considered to have experienced exposure relevant for certification. A recent publication in The Lancet Oncology by the International Agency for Research on Cancer (IARC) concludes that there is limited evidence that polychlorinated biphenyls (PCBs) cause breast cancer in humans. As described below, the WTC Program Administrator (Administrator) has found that PCBs were present in WTC dust in the New York City disaster area and, accordingly, the Program will now certify breast cancer in eligible WTC responders and survivors who were exposed to either shiftwork/nighttime sleep disruption or PCBs as a result of the 9/11 attacks.
Proposed Collection; 60-day Comment Request: Topic-based Studies for the Population Assessment of Tobacco and Health (PATH) Study
Document Number: 2013-08954
Type: Notice
Date: 2013-04-17
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 on Drug Abuse (NIDA), 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. 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 Kevin P. Conway, Ph.D., Deputy Director, Division of Epidemiology, Services, and Prevention Research, National Institute on Drug Abuse, 6001 Executive Blvd., Room 5185; Rockville, MD 20852, or call non-toll free number (301) 443-8755 or Email your request, including your address to: PATHprojectofficer@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
National Institute of Nursing Research; Notice of Meeting
Document Number: 2013-08945
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-08944
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2013-08943
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 2013-08942
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Fogarty International Center; Notice of Closed Meeting
Document Number: 2013-08941
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-08940
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-08939
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-08938
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices Framework for Preventing Cross-Contamination; Availability
Document Number: 2013-08913
Type: Notice
Date: 2013-04-17
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 ``Non-Penicillin Beta- Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.'' This guidance describes the importance of implementing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactams. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of sensitizing beta-lactams (including both penicillins and non-penicillin beta-lactams), beta-lactamase inhibitors, and beta-lactam intermediates and derivatives. Finally, this guidance clarifies that manufacturers should generally utilize separate facilities for manufacture of non- penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-08912
Type: Notice
Date: 2013-04-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-08911
Type: Notice
Date: 2013-04-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents
Document Number: 2013-08906
Type: Notice
Date: 2013-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
AHRQ Standing Workgroup for Quality Indicator Measure Specification
Document Number: 2013-08834
Type: Notice
Date: 2013-04-17
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking nominations for both a time-limited workgroup and a standing workgroup to be convened by an AHRQ contractor. The workgroups shall be comprised of individuals with knowledge of the AHRQ Quality Indicators (QIs), their technical specifications, and associated methodological issues. The overarching goals of each group are to provide feedback to AHRQ regarding refinements to the QIs. The time-limited workgroup is more restricted to specific clinical or methodological issues, while the standing workgroup addresses broader issues related to the measurement cycle. Because AHRQ did not get a set of candidates with anticipated breadth of diversity of experience as required in response to our notice (https://www.federalregister.gov/articles/2013/01/28/2013-013 48/ ahrq-standing-workgroup-for-quality-indicator-measure-specifi cation) published on January 28, 2013, Volume 78, No. 18, page numbers: 5810 & 5811, AHRQ resubmits the same notice to give opportunity to those interested in this objective.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-08833
Type: Notice
Date: 2013-04-17
Agency: Agency for Healthcare Research and Quality, 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: ``Applying Novel Methods to Better Understand the Relationship between Health IT and Ambulatory Care Workflow Redesign.'' 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 January 28th, 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.
Document to Support Submission of an Electronic Common Technical Document-Specifications for File Format Types Using Electronic Common Technical Document Specifications; Availability
Document Number: 2013-08867
Type: Notice
Date: 2013-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the following document that supports making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: ``Specifications for File Format Types Using eCTD Specification.''
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-08862
Type: Notice
Date: 2013-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-08861
Type: Notice
Date: 2013-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pretesting of Tobacco Communications
Document Number: 2013-08860
Type: Notice
Date: 2013-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Pretesting of Tobacco Communications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.