Department of Health and Human Services February 19, 2014 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
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Draft Guidance for Industry on Analytical Procedures and Methods Validation for Drugs and Biologics; Availability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.
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