Department of Health and Human Services March 5, 2014 – Federal Register Recent Federal Regulation Documents

Administrative Simplification: Certification of Compliance for Health Plans; Extension of Comment Period
Document Number: 2014-04828
Type: Proposed Rule
Date: 2014-03-05
Agency: Department of Health and Human Services, Office of the Secretary
This document extends the comment period for the Administrative Simplification: Certification of Compliance for Health Plans proposed rule, which was published in the January 2, 2014 Federal Register. The comment period for the proposed rule, which would have ended on March 3, 2014, is extended to April 3, 2014.
Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System; Availability
Document Number: 2014-04813
Type: Notice
Date: 2014-03-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System'' dated March 2014. The guidance document provides recommendations for manufacturers, generally cord blood banks, to apply for licensure of minimally manipulated, unrelated allogeneic placental/ umbilical cord blood, for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. The guidance document is intended to assist manufacturers in obtaining a biologics license. The guidance contains information about the manufacture of minimally manipulated, unrelated allogeneic placental/ umbilical cord blood and how to comply with applicable regulatory requirements. The guidance announced in this document finalizes the draft guidance of the same title dated June 2013 and supersedes the guidance entitled ``Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications'' dated October 2009.
Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System; Availability
Document Number: 2014-04812
Type: Notice
Date: 2014-03-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System'' dated March 2014. The guidance document provides advice to potential sponsors, such as cord blood banks, registries, transplant centers, or individual physicians serving as sponsor-investigators, to assist in the submission of an investigational new drug application (IND) for certain hematopoietic progenitor cells from placental/umbilical cord blood (HPC, Cord Blood), when such HPC, Cord Blood units are not licensed, and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment and there is no satisfactory alternative treatment available. If unlicensed HPC, Cord Blood units are made available for clinical use, they must be distributed under an IND. The guidance announced in this document finalizes the draft guidance of the same title dated June 2013 and supersedes the final guidance entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications'' dated June 2011.
Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes To Be Documented in Annual Reports; Availability
Document Number: 2014-04811
Type: Notice
Date: 2014-03-05
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 ``CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports.'' This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA has determined will likely have a minimal potential to have an adverse effect on product quality and, therefore, should be documented by applicants in an annual report. (The guidance excludes positron emission tomography drug products.)
Announcement of Center for Biologics Evaluation and Research's Move to the Food and Drug Administration's White Oak Campus
Document Number: 2014-04810
Type: Notice
Date: 2014-03-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that the Center for Biologics Evaluation and Research (CBER) will be moving its offices and laboratories from various Rockville and Bethesda, MD, locations to the FDA White Oak campus in Silver Spring, MD. The move will commence on or about May 1, 2014, and will end approximately 8 weeks later, on or about July 1, 2014. During this time persons may continue to send applications and other submissions electronically via the FDA Electronic Submissions Gateway to CBER for review, evaluation, or other handling. However, persons should send submissions on paper or on electronic media (CD, DVD), as well as lot release samples to CBER's new mailing addresses once they take effect. CBER's new mailing addresses, including the dates they take effect, as well as other information concerning CBER's move to the FDA White Oak campus in Silver Spring, MD, will be provided on the FDA Web site at https:// www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsan dTobacco/ CBER/ucm385240.htm, as they become available. During the period required for relocation of files, equipment, and Agency personnel, CBER will make every effort to meet its review time frames and minimize any potential delay. Should delays affecting receipt and review of applications and other submissions occur, we intend to update the FDA Web site as needed.
Draft Guidance for Industry on Ingredients Declared as Evaporated Cane Juice; Reopening of Comment Period; Request for Comments, Data, and Information
Document Number: 2014-04802
Type: Notice
Date: 2014-03-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is reopening the comment period for the draft guidance for industry entitled ``Ingredients Declared as Evaporated Cane Juice.'' A notice announcing the availability of the draft guidance was published in the Federal Register of October 7, 2009, to advise industry of FDA's view that the common or usual name for the solid or dried form of sugar cane syrup is ``dried cane syrup,'' and that sweeteners derived from sugar cane syrup should not be declared on food labels as ``evaporated cane juice'' because that term falsely suggests the sweeteners are juice. We have not reached a final decision on the common or usual name for this ingredient and are reopening the comment period to request further comments, data, and information about the basic nature and characterizing properties of the ingredient sometimes declared as ``evaporated cane juice,'' how this ingredient is produced, and how it compares with other sweeteners.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma Cruzi Infection in Whole Blood and Blood Components for Transfusion
Document Number: 2014-04776
Type: Notice
Date: 2014-03-05
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 Scientific Review; Notice of Closed Meetings
Document Number: 2014-04775
Type: Notice
Date: 2014-03-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2014-04774
Type: Notice
Date: 2014-03-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2014-04773
Type: Notice
Date: 2014-03-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2014-04772
Type: Notice
Date: 2014-03-05
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2014-04771
Type: Notice
Date: 2014-03-05
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2014-04767
Type: Notice
Date: 2014-03-05
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2014-04766
Type: Notice
Date: 2014-03-05
Agency: Department of Health and Human Services, National Institutes of Health
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