21 CFR 16, Subpart C - Commissioner and Presiding Officer
Title 21 published on 2012-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10292 RIN 0910-AG49 Docket No. FDA-2011-N-0079 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 16, 312, 511, and 812 The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 1451 - Congressional declaration of policy
§ 1452 - Unfair and deceptive packaging and labeling; scope of prohibition
§ 1453 - Requirements of labeling; placement, form, and contents of statement of quantity; supplemental statement of quantity
§ 1454 - Rules and regulations
§ 1455 - Procedure for promulgation of regulations
§ 1456 - Enforcement
§ 1457 - Omitted
§ 1458 - Cooperation with State authorities; transmittal of regulations to States; noninterference with existing programs
§ 1459 - Definitions
§ 1460 - Savings provisions
§ 1461 - Effect upon State law
§ 141 - Prohibition of importation without permit
§ 142 - Milk or cream when unfit for importation
§ 143 - Inspection; certified statement in lieu thereof; waiver of requirements of
§ 144 - Unlawful receiving of imported milk or cream
§ 145 - Penalties
§ 146 - Authorization of appropriations
§ 147 - Repeal of inconsistent laws
§ 148 - Powers of State with respect to milk or cream lawfully imported
§ 149 - Definitions
§ 321 - Definitions; generally
§ 321a - “Butter” defined
§ 321b - “Package” defined
§ 321c - Nonfat dry milk; “milk” defined
§ 321d - Market names for catfish and ginseng
§ 331 - Prohibited acts
§ 332 - Injunction proceedings
§ 333 - Penalties
§ 333a - Repealed.
§ 334 - Seizure
§ 335 - Hearing before report of criminal violation
§ 335a - Debarment, temporary denial of approval, and suspension
§ 335b - Civil penalties
§ 335c - Authority to withdraw approval of abbreviated drug applications
§ 336 - Report of minor violations
§ 337 - Proceedings in name of United States; provision as to subpoenas
§ 341 - Definitions and standards for food
§ 342 - Adulterated food
§ 343 - Misbranded food
21 USC § 343–1 - National uniform nutrition labeling
21 USC § 343–2 - Dietary supplement labeling exemptions
21 USC § 343–3 - Disclosure
§ 343a - Repealed.
§ 344 - Emergency permit control
§ 345 - Regulations making exemptions
§ 346 - Tolerances for poisonous or deleterious substances in food; regulations
§ 346a - Tolerances and exemptions for pesticide chemical residues
§ 346b - Authorization of appropriations
§ 347 - Intrastate sales of colored oleomargarine
§ 347a - Congressional declaration of policy regarding oleomargarine sales
§ 347b - Contravention of State laws
§ 348 - Food additives
§ 349 - Bottled drinking water standards; publication in Federal Register
§ 350 - Vitamins and minerals
§ 350a - Infant formulas
§ 350b - New dietary ingredients
§ 350c - Maintenance and inspection of records
§ 350d - Registration of food facilities
§ 350e - Sanitary transportation practices
§ 350f - Reportable food registry
§ 350g - Hazard analysis and risk-based preventive controls
§ 350h - Standards for produce safety
§ 350i - Protection against intentional adulteration
§ 350j - Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
§ 350k - Laboratory accreditation for analyses of foods
21 USC § -
21 USC § -
§ 351 - Adulterated drugs and devices
§ 352 - Misbranded drugs and devices
§ 353 - Exemptions and consideration for certain drugs, devices, and biological products
§ 353a - Pharmacy compounding
§ 353b - Prereview of television advertisements
§ 354 - Veterinary feed directive drugs
§ 355 - New drugs
21 USC § 355–1 - Risk evaluation and mitigation strategies
§ 355a - Pediatric studies of drugs
§ 355b - Adverse-event reporting
§ 355c - Research into pediatric uses for drugs and biological products
§ 355d - Internal committee for review of pediatric plans, assessments, deferrals, and waivers
§ 355e - Pharmaceutical security
§ 356 - Fast track products
21 USC § 356–1 - Accelerated approval of priority countermeasures
§ 356a - Manufacturing changes
§ 356b - Reports of postmarketing studies
§ 356c - Discontinuance of life saving product
§ 357 - Repealed.
§ 358 - Authority to designate official names
§ 359 - Nonapplicability of subchapter to cosmetics
§ 360 - Registration of producers of drugs or devices
§ 360a - Clinical trial guidance for antibiotic drugs
§ 360b - New animal drugs
§ 360c - Classification of devices intended for human use
§ 360d - Performance standards
§ 360e - Premarket approval
21 USC § 360e–1 - Pediatric uses of devices
§ 360f - Banned devices
§ 360g - Judicial review
§ 360h - Notification and other remedies
§ 360i - Records and reports on devices
§ 360j - General provisions respecting control of devices intended for human use
§ 360k - State and local requirements respecting devices
21 USC § -
§ 360m - Accredited persons
§ 360n - Priority review to encourage treatments for tropical diseases
§ 360aa - Recommendations for investigations of drugs for rare diseases or conditions
§ 360bb - Designation of drugs for rare diseases or conditions
§ 360cc - Protection for drugs for rare diseases or conditions
§ 360dd - Open protocols for investigations of drugs for rare diseases or conditions
§ 360ee - Grants and contracts for development of drugs for rare diseases and conditions
§ 360hh - Definitions
§ 360ii - Program of control
§ 360jj - Studies by Secretary
§ 360kk - Performance standards for electronic products
21 USC § -
§ 360mm - Imports
§ 360nn - Inspection, records, and reports
21 USC § -
§ 360pp - Enforcement
§ 360qq - Repealed.
§ 360rr - Federal-State cooperation
§ 360ss - State standards
§ 360aaa to 360aaa–6 - Omitted
§ 360bbb - Expanded access to unapproved therapies and diagnostics
21 USC § 360bbb–1 - Dispute resolution
21 USC § 360bbb–2 - Classification of products
21 USC § 360bbb–3 - Authorization for medical products for use in emergencies
21 USC § 360bbb–4 - Technical assistance
21 USC § 360bbb–5 - Critical Path Public-Private Partnerships
21 USC § 360bbb–6 - Risk communication
§ 360ccc - Conditional approval of new animal drugs for minor use and minor species
21 USC § 360ccc–1 - Index of legally marketed unapproved new animal drugs for minor species
21 USC § 360ccc–2 - Designated new animal drugs for minor use or minor species
§ 361 - Adulterated cosmetics
§ 362 - Misbranded cosmetics
§ 363 - Regulations making exemptions
§ 364 - Repealed.
§ 371 - Regulations and hearings
§ 372 - Examinations and investigations
§ 372a - Transferred
§ 373 - Records
§ 374 - Inspection
§ 374a - Inspections relating to food allergens
§ 375 - Publicity
§ 376 - Examination of sea food on request of packer; marking food with results; fees; penalties
§ 377 - Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
§ 378 - Advertising of foods
§ 379 - Confidential information
§ 379a - Presumption of existence of jurisdiction
§ 379b - Consolidated administrative and laboratory facility
§ 379c - Transferred
§ 379d - Automation of Food and Drug Administration
21 USC § 379d–1 - Conflicts of interest
21 USC § 379d–2 - Policy on the review and clearance of scientific articles published by FDA employees
§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics
§ 379f - Recovery and retention of fees for freedom of information requests
§ 379g - Definitions
§ 379h - Authority to assess and use drug fees
21 USC § 379h–1 - Fees relating to advisory review of prescription-drug television advertising
21 USC § 379h–2 - Reauthorization; reporting requirements
§ 379i - Definitions
§ 379j - Authority to assess and use device fees
21 USC § 379j–1 - Reauthorization; reporting requirements
21 USC § 379j–11 - Definitions
21 USC § 379j–12 - Authority to assess and use animal drug fees
21 USC § 379j–13 - Reauthorization; reporting requirements
21 USC § 379j–21 - Authority to assess and use generic new animal drug fees
21 USC § 379j–22 - Reauthorization; reporting requirements
21 USC § 379j–31 - Authority to collect and use fees
§ 379k - Information system
21 USC § -
21 USC § -
§ 379r - National uniformity for nonprescription drugs
§ 379s - Preemption for labeling or packaging of cosmetics
§ 379v - Safety report disclaimers
§ 379aa - Serious adverse event reporting for nonprescription drugs
21 USC § 379aa–1 - Serious adverse event reporting for dietary supplements
§ 379dd - Establishment and functions of the Foundation
21 USC § 379dd–1 - Location of Foundation
21 USC § 379dd–2 - Activities of the Food and Drug Administration
§ 381 - Imports and exports
§ 382 - Exports of certain unapproved products
§ 383 - Office of International Relations
§ 384 - Importation of prescription drugs
§ 384a - Foreign supplier verification program
§ 384b - Voluntary qualified importer program
§ 384c - Inspection of foreign food facilities
§ 384d - Accreditation of third-party auditors
§ 387 - Definitions
§ 387a - FDA authority over tobacco products
21 USC § 387a–1 - Final rule
§ 387b - Adulterated tobacco products
§ 387c - Misbranded tobacco products
§ 387d - Submission of health information to the Secretary
§ 387e - Annual registration
§ 387f - General provisions respecting control of tobacco products
21 USC § 387f–1 - Enforcement action plan for advertising and promotion restrictions
§ 387g - Tobacco product standards
§ 387h - Notification and other remedies
§ 387i - Records and reports on tobacco products
§ 387j - Application for review of certain tobacco products
§ 387k - Modified risk tobacco products
21 USC § -
§ 387m - Equal treatment of retail outlets
§ 387n - Jurisdiction of and coordination with the Federal Trade Commission
21 USC § -
§ 387p - Preservation of State and local authority
§ 387q - Tobacco Products Scientific Advisory Committee
§ 387r - Drug products used to treat tobacco dependence
§ 387s - User fees
§ 387t - Labeling, recordkeeping, records inspection
§ 387u - Studies of progress and effectiveness
§ 391 - Separability clause
§ 392 - Exemption of meats and meat food products
§ 393 - Food and Drug Administration
§ 393a - Office of Pediatric Therapeutics
§ 394 - Scientific review groups
§ 467f - Federal Food, Drug, and Cosmetic Act applications
§ 679 - Application of Federal Food, Drug, and Cosmetic Act
§ 821 - Rules and regulations
§ 1034 - Inspection of egg products
§ 2112 - Record on review and enforcement of agency orders
§ 201 - Definitions
§ 262 - Regulation of biological products
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 16 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-09763 RIN 0910-AG36 Docket No. FDA-2011-N-0920 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; extension of comment periods. The comment period for the proposed rule published January 16, 2013, at 78 FR 3646, is extended. In addition, the comment period for the information collection issues in the proposed rule, extended February 19, 2013, at 78 FR 11611, is further extended. Submit either electronic or written comments on the proposed rule by September 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 16, 2013 (see the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” that appeared in the Federal Register of January 16, 2013. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-09761 RIN 0910-AG35 Docket No. FDA-2011-N-0921 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; extension of comment periods. The comment period for the proposed rule published January 16, 2013, at 78 FR 3504, is extended. In addition, the comment period for the information collection issues in the proposed rule, extended February 19, 2013, at 78 FR 11611, is further extended. Submit either electronic or written comments on the proposed rule by September 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 16, 2013 (see the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 16 and 112 The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” that appeared in the Federal Register of January 16, 2013. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-06356 RIN 0910-AG36 Docket No. FDA-2011-N-0920 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; correction. 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 The Food and Drug Administration (FDA or we) is correcting a proposed rule that published in the Federal Register of January 16, 2013. That proposed rule would amend our regulation for current good manufacturing practice in manufacturing, packing, or holding human food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That proposed rule also would revise certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” We proposed these actions as part of our announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The document published with several typographical errors, stylistic errors (such as incorrect indentation of bulleted paragraphs and a gap in the sequential numbering of tables), and a mistake in the date of a reference. The document also published with an Appendix in which all references are numbered incorrectly. This document corrects those errors.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-06357 RIN 0910-AG35 Docket No. FDA-2011-N-0921 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; correction. 21 CFR Parts 16 and 112 The Food and Drug Administration (FDA or we) is correcting the preamble to a proposed rule that published in the Federal Register of January 16, 2013. That proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA proposed these standards as part of our implementation of the FDA Food Safety Modernization Act. The document published with several technical errors, including some errors in cross references, as well as several errors in reference numbers cited throughout the document. This document corrects those errors. We are also placing a corrected copy of the proposed rule in the docket.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-03732 RIN 0910-AG36 Docket No. FDA-2011-N-0920 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; extension of comment period for information collection provisions. The comment period for the proposed rule published January 16, 2013 (78 FR 3646), is extended. Submit either electronic or written comments by May 16, 2013. 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 The Food and Drug Administration (FDA or “we”) is extending the comment period for the information collection related to the proposed rule on “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” that appeared in the Federal Register of January 16, 2013. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the information collection provisions associated with the rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-03778 RIN 0910-AG35 Docket No. FDA-2011-N-0921 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; extension of comment period for information collection provisions. The comment period for the proposed rule published January 16, 2013 (78 FR 3504), is extended. Submit either electronic or written comments by May 16, 2013. 21 CFR Parts 16 and 112 The Food and Drug Administration (FDA or “we”) is extending the comment period for the information collection provisions of the proposed rule on “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” that appeared in the Federal Register of January 16, 2013. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the information collection provisions associated with the rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-03316 RIN Docket No. s. FDA-2011-N-0920 and FDA-2011-N-0921 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of public meeting. See section II “How to Participate in the Public Meeting” in the SUPPLEMENTARY INFORMATION section of this document for dates and times of the Chicago, IL and Portland, OR public meetings, closing dates for advance registration, and information on deadlines for submitting either electronic or written comments to FDA's Division of Dockets Management. 21 CFR Parts 1, 16, 106, 110, 112, 114, 117, 120, 123, 129, 179, and 211 The Food and Drug Administration (FDA) is providing public meeting registration information for two FSMA related public meetings announced in the January 31, 2013, Federal Register . These public meetings will be held along with the February 28 to March 1, 2013, Washington, DC public meeting to discuss the proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls proposed rule). These proposed rules are the first of several proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The purpose of the public meetings is to solicit oral stakeholder and public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-02089 RIN Docket No. s. FDA-2011-N-0920 and FDA-2011-N-0921 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of public meeting. See section II “How to Participate in the Public Meeting” in the SUPPLEMENTARY INFORMATION section of this document for date and time of the public meeting, closing dates for advance registration, and information on deadlines for submitting either electronic or written comments to FDA's Division of Dockets Management. 21 CFR Parts 1, 16, 106, 110, 112, 114, 117, 120, 123, 129, 179, and 211 The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls proposed rule), which are the first of several proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The purpose of the public meeting is to solicit oral stakeholder and public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-00123 RIN 0910-AG35 Docket No. FDA-2011-N-0921 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by May 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 15, 2013 (see the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 16 and 112 To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA) is proposing to establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is proposing these standards as part of our implementation of the FDA Food Safety Modernization Act (FSMA). These standards would not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance would be eligible for exemption from the requirements of this rule. The proposed rule would set forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect that the proposed rule, if finalized as proposed, would reduce foodborne illness associated with the consumption of contaminated produce.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-00125 RIN 0910-AG36 Docket No. FDA-2011-N-0920 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by May 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 15, 2013, (see the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. FDA also is proposing to revise certain definitions in FDA's current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22821 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment period. Submit either electronic or written comments on the proposed collection of information by October 25, 2012. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20383 RIN Docket No. FDA-2011-D-0398 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of availability. Submit either electronic or written comments on Agency guidances at any time. 21 CFR Parts 16 and 118 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” The guidance contains questions we have received on the final rule since its publication and responses to those questions, and is intended to assist egg producers and other persons who are covered by the final rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16621 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10292 RIN 0910-AG49 Docket No. FDA-2011-N-0079 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 16, 312, 511, and 812 The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.