Department of Health and Human Services February 2014 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 344
Training Program for Regulatory Project Managers; Information Available to Industry
The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation GuideData Elements and Message Specification'' (the E2B(R3) implementation guidance) and an appendix to the guidance entitled ``ICSRs: Appendix to the Implementation GuideBackwards and Forwards Compatibility'' (the BFC appendix). The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The E2B(R3) implementation guidance is intended to revise the standards for submission of ICSRs and improve the inherent quality of the data, enabling improved handling and analysis of ICSR reports. The BFC appendix describes the relationship between data elements from the 2001 ICH E2B guidance and the E2B(R3) implementation guidance.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice; Quality System Regulation
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Draft Environmental Impact Statement for the Roybal 2025 Master Plan; Re-Scheduling of Public Meeting and Extension of Public Comment Period
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the re- scheduling of a public meeting to obtain public comment on the Roybal Campus 2025 Master Plan Draft Environmental Impact Statement (DEIS) and the extension of the public comment period. A public meeting had been scheduled for Wednesday, January 29, 2014 but had to be cancelled due to adverse weather conditions. The new date for the public hearing is Thursday, March 20, 2014.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on March 12, 2014 from 1:00 to 4:00 p.m. at the Natcher Conference Center (Building 45) Conference Room E1/E2, on the NIH Campus in Bethesda, MD. The topic for this meeting will be ``Future Needs and Direction of Surveillance of Diabetes in Youth and Young Adults.'' The meeting is open to the public.
Tribal Consultation Meeting
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of four 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, Section 640(l)(4)].
Phenylpropanolamine; Withdrawal of Approval of 13 New Drug Applications and 7 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 13 new drug applications (NDAs) and 7 abbreviated new drug applications (ANDAs) for products containing phenylpropanolamine. The basis for the withdrawals is that the products are no longer considered safe due to the association of phenylpropanolamine use with increased risk of hemorrhagic stroke. The holders of these NDAs and ANDAs have waived their opportunity for a hearing.
Physical Medicine Devices; Reclassification and Renaming of Shortwave Diathermy for All Other Uses
The Food and Drug Administration (FDA) is proposing to reclassify the shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device ``nonthermal shortwave therapy (SWT).'' FDA is proposing this reclassification on its own initiative based on new information. FDA is also proposing a technical correction in the regulation for the carrier frequency for SWD and nonthermal SWT devices. This proposed action would implement certain regulatory requirements.
Physical Medicine Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses
The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of July 6, 2012. In that document, FDA proposed to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendment device, shortwave diathermy (SWD) for all other uses. In response to the requirements issued in the Food and Drug Administration Safety and Innovation Act (FDASIA) and new information received during a panel meeting, FDA is withdrawing the proposed rule and proposing a different action.
Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format; Establishment of a Public Docket
The Food and Drug Administration (FDA) is establishing a public docket to receive information and comments on standards for the interoperable exchange of information associated with transactions involving human prescription drugs in a finished dosage form (prescription drugs) to comply with new requirements in the Drug Supply Chain Security Act (DSCSA). We are seeking information from drug manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies) and other drug supply chain stakeholders and interested parties, including standards organizations, State and Federal Agencies, and solution providers. In particular, stakeholders and other interested parties are requested to comment about the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for each transfer of product in which a change of ownership occurs. This action is related to FDA's implementation of the DSCSA.
Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction
The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of February 10, 2014. The document revised our infant formula regulations to establish requirements for current good manufacturing practices, including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA took the action to improve the protection of infants who consume infant formula products. The document was published with an incorrect docket number. This document corrects that error.
Fibromyalgia Public Meeting on Patient-Focused Drug Development; Rescheduling of Public Meeting; Extension of Comment Period
The Food and Drug Administration (FDA) is rescheduling a December 10, 2013, public meeting on Patient-Focused Drug Development for fibromyalgia, announced in the Federal Register on September 23, 2013. Due to inclement weather, the Federal Government was closed on December 10, 2013. We are rescheduling the public meeting to March 26, 2014, and extending the comment period for the public docket.
Administrative Detention; Corrections
The Food and Drug Administration (FDA) published a document in the Federal Register on Friday, March 9, 1979 (44 FR 13239). The document established administrative detention procedures for devices intended for human use believed to be adulterated or misbranded. The document was published with a citation in the first column on page 13240 that subsequently was changed by the Nutrition Labeling and Education Act Amendments of 1993. In addition, the document was published with one typographical error in the first column on page 13241. This document corrects these errors.
Medical Devices; Reports of Corrections and Removals; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulation regarding reports of corrections to and removals of medical devices to address a minor change as a result of the enactment of the Food and Drug Administration Amendments Act of 2007 (FDAAA). This action is technical in nature and is intended to provide accuracy to the Agency's regulation.
Draft Guidance for Industry on Analytical Procedures and Methods Validation for Drugs and Biologics; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Analytical Procedures and Methods Validation for Drugs and Biologics.'' This revised draft guidance supersedes the 2000 draft guidance for industry on ``Analytical Procedures and Methods Validation'' and, when finalized, will also replace the 1987 FDA guidance for industry on ``Submitting Samples and Analytical Data for Methods Validation.'' This draft guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.
Proposed Collection; 30-day Comment Request; Incident HIV/Hepatitis B Virus Infections in South African Blood Donors: Behavioral Risk Factors, Genotypes and Biological Characterization of Early Infection
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register in Volume 78 on Friday, November 8, 2013, and page 67175, and allowed 60 days for public comment. One public comment was received that was a personal opinion regarding protecting the safety of the American blood donation system. 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. Comments 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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Human Tissue Intended for Transplantation
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Human Tissue Intended for Transplantation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Common Formats for Patient Safety Data Collection and Event Reporting
As authorized by the Secretary of HHS, AHRQ coordinates the development of common definitions and reporting formats (Common Formats) for reporting patient safety events to Patient Safety Organizations (PSOs) and other entities. The purpose of this notice is to announce the availability of a new type of Common Formats for public review and commentCommon Formats for SurveillanceHospital.
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``AHRQ Grants Reporting System (GRS).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on December 6th, 2013 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``Pharmacy Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on December 6th, 2013 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``Assessing the Impact of the National Implementation of TeamSTEPPS Master Training Program.'' 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 August 27th, 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; Announcement of Office of Management and Budget Approval; Animal Feed Regulatory Program Standards
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Animal Feed Regulatory Program Standards'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination That GANITE (Gallium Nitrate) Injectable and Five Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Determination That STAVZOR (Valproic Acid) Delayed-Release Capsules, 125 Milligrams, 250 Milligrams, and 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or the Agency) has determined that STAVZOR (valproic acid) delayed-release capsules, 125 milligrams (mg), 250 mg, and 500 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for valproic acid, delayed-release capsules, 125 mg, 250 mg, and 500 mg, if all other legal and regulatory requirements are met.
Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings With Food and Drug Administration Staff; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with FDA Staff.'' The purpose of this guidance is to provide an overview of the mechanisms available to application sponsors through which to obtain FDA feedback regarding potential or planned medical device submissions reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), including the Pre-Submission program (formerly the pre-Investigational Device Exemption (pre-IDE) program). In addition, the guidance provides recommendations regarding information that should be included in a Pre- Submission Package. This guidance also describes the procedures that CDRH and CBER intend to follow when manufacturers, their representatives, or application sponsors request a meeting with review staff.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of Exclusive License: Pre-Clinical Evaluation and Commercial Development of Human Therapeutics for Liver Cancer and Ovarian Cancer Within the Scope of the Licensed Patent Rights
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive evaluation option license to practice the inventions covered under the scope of the following patents and patent applications: United States Patent No. 8,207,142 issued Jun 26, 2012 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2- US-06); EP Patent No. 1418949 issued June 19, 2013, entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-EP-02) and validated in Great Britain, Germany and France; Australia Patent No. 2002322805 issued February 21, 2008 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2- AU-03); Australia Patent No. 2008200601 issued November 25, 2010 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2- AU-07); Canada Patent No. 2,454,147 issued May 21, 2013 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-CA-04); Japan Patent Application No. 2003-517229 filed July 30, 2002 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081- 2001/2-JP-05); and Japan Patent No. 5416660 issued November 22, 2013 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-JP-08)
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