CHPA Submissions

To FDA, Other Government Agencies and Institutions, and USP (1995-present)

Docket Number Ingredient/Topic Date of Submission
FDA-2016-D-3401 Scientific Evaluation of the Evidence of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry, 81 Fed. Reg. 84516 2/13/2017
FDA-2016-N-3389 Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments, 81 Fed. Reg. 84595 2/13/2017
FDA-2011-D-0376 Comments on Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry, 81 Fed. Reg. 53486 12/12/2016
81 Fed. Reg. 74817-74818 Request for Comments on the Office of Management and Budget Information Technology Modernization Initiative 11/22/2016
FDA-2016-N-2523 Comments on the Status of Vinpocetine 11/7/2016
  Comments on Office of Dietary Supplements (ODS) Draft Strategic Plan for 2016-2021 9/30/2016
  Multiple Active Ingredient Product Monographs 9/9/2016
FDA-2016-D-1490 Comments Concerning Quality Attribute Considerations for Chewable Tablets Guidance for Industry 8/16/2016
  Position Statement on Calcium and Cardiovascular Disease 6/21/2016
FDA-2016-N-1092 Over-the-Counter Monograph User Fees: Public Meeting; Request for Comments 6/14/2016
FDA-2016-N-0543 Comments on FDA Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications 5/17/2016
FDA-2014-N-1207 Use of the Term "Natural" in the Labeling of Human Food Products; Request for Information and Comments 5/10/2016
  Nominations to the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information 4/18/2016
FDA-2015-N-1260 Comments on Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients under Consideration for Inclusion in an Over-the-Counter Monograph 3/22/2016
FDA-2015-D-4021 Comments on Over-the-Counter Sunscreens: Safety and Effectiveness Data Draft Guidance for Industry 2/22/2016
FDA-2015-D-3990 CHPA and PCPC Comments on Guidance for Industry: Sunscreen Innovation Act; Section 586C(c) Advisory Committee Process 1/19/2016
FDA-2015-D-4033 CHPA and PCPC Comments on Guidance for Industry: Nonprescription Sunscreen Drug Products - Content and Format of Data Submissions to Support a GRASE Determination under the Sunscreen Innovation Act 1/19/2016
FDA-2015-D-4012 CHPA and PCPC Comments on Guidance for Industry: Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request 1/19/2016
  Public Comment on Dietary Supplement Label Database 12/31/2015
EPA-HQ-RCRA-2007-0932 CHPA Comments in Response to EPA's Proposed Management Standards for Hazardous Waste Pharmaceuticals 12/23/2015
 

41(5) The General Chapters - The Dosage Forms Expert Committee Proposed Revisions to (1), (2), (3), (4). (5), and (771)

11/30/2015
  Proposed Revisions to USP-NF General Chapter <467> on Residual Solvents 11/27/2015
FDA-2015-D-2537

Comments from Crosso-Industry Quality Metrics Collaboration Group on FDA's Draft Guidance on Quality Metrics

11/25/2015
 

Quality Metrics Guidance for Industry

11/24/2015
  National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments (Fluoride and Developmental Neurotoxicity) 11/24/2015
FDA-2015-N-0540 Homeopathic Product Regulation: Evaluating the FDA's Regulatory Framework After a Quarter-Century; Public Hearing 10/9/2015
 

Packaging and Storage Requirements <659>, Correspondence C141017

7/30/2015

FDA-1999-D-1315

Comments on FDA Draft Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products

6/3/2015

FDA–2014–N–1497

Toxicological Principles for the Safety Assessment of Food Ingredients; Public Meeting on Updates and Safety and Risk Assessment Considerations

5/8/2015

FDA-2015-N-0001

Request to participate in the selection process for nonvoting industry representatives to serve on CDER public advisory committees in response to Request for Nomination for Industry Representatives and Participation From Industry Organizations on Public Advisory Committees

4/15/2015

 

Proposals for Developing Compendial Quality Standards for OTC Drugs

4/3/2015

 

Comments on the Office of Dietary Supplements' Strategic Plan 2010-2014 Progress Report

3/6/2015

FDA-2005-N-0453, FDA-2003-N-0196, and FDA-2006-O-0314

Sunscreen Feedback Letters; Notice of Availability Under the Sunscreen Innovation Act

2/23/2015

FDA–2014–D–1862 Comments on the Draft Guidance for Industry - ‘‘Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions’’
1/27/2015
FDA–2014–D–1473 Comments on the Draft Guidance for Industry - "Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen" 12/8/2014
FDA-2014-N-1008 Comments on Exploring the Possibility of Proprietary Name Reservation for Drug Products; Establishment of a Public Docket 10/27/2014
 

General Chapters for Uniformity of Dose from Oral Suspensions in Multi-Unit Containers

9/30/2014
 

OTC Product Monographs

9/18/2014
FDA-2014-D-0622 Comments on FDA Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs 9/15/2014
FDA-2012-N-1210 CHPA Comments in Response to the Proposed Rule - Food Labeling: Revision of the Nutrition and Supplement Facts Labels 8/1/2014
 

General Chapters: Organic Impurities in Drug Substance and Drug Products and Impurities in Drug Substances and Drug Products

7/31/2014

 

Dextromethorphan Proposals for Interim Revision Announcements

7/24/2014

 

Sodium Salicylate Proposed Monograph

7/24/2014

FDA-2013-N-1425 Focused Mitigation Strategies to Protech Food Against Intentional Adulteration 6/30/2014
FDA-2013-1001/CP1 Comments on Citizen's Petition Re: Adding a Warning to Labeling to Products Containing an Ingredient with Anticholinergic or Histamine H1 Inverse Agonist Effects (attachment referenced in letter: Review of Evidence by Howard Druce, MD) 6/4/2014
FDA-2014-0202 CHPA Comments in Response to the Notice of Hearing on OTC Drug Monograph System 5/8/2014
FDA-2010-D-0503 Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Reopening of the Comment Period 4/7/2014
FDA-2013-N-0500 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 3/11/2014
FDA-2013-N-1317 Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information 3/7/2014
  Comments on quality metrics to assist FDA in identifying objective measures of product quality and plant operations performance for the purpose of supporting risk-based inspection approaches 12/19/2013
FDA–2012–N–0781 Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives on Public Advisory Committees and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Committees 11/14/2013
FDA-2013-N-0878 Agency Information Collection Activities, Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient 10/24/2013
FDA-2013-P-0999/CP1 CHPA Citizen Petition Requesting FDA Statement of Enforcement Policy that Expressly Permits Manufacturers of Acetaminophen OTC Drugs to Label Products with Dosage Information for Children Aged Six Months to Two Years 8/15/2013
FDA-2013-D-0558 Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements 8/12/2013
  CHPA Submission to USP re: 4-Aminophenol in Acetaminophen-Containing Drug Products (Attachment) 7/31/2013
FDA-2011-D-0376 Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues 7/12/2013
FDA-2013-N-0430 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device 7/12/2013
FDA-2011-D-0376 Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues 5/10/2013
 

Stimuli to the Revision Process, USP's Monographs in Support of FDA's OTC Monograph System: Modernization Opportunities

3/29/2013

 

General Notices Section 5.60.30 Elemental Impurities in USP and NF Articles

3/29/2013

FDA-2013-N-0032 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Notification Procedures for Statements on Dietary Supplements 3/19/2013
FDA-2011-N-0900 Unique Device Identification System; FDA, Proposed Rule 11/7/2012
77 Fed. Reg. 59702 U.S.-EU Regulatory Compatibility, Request for Comments from the Public 9/28/2012
FDA–2012–N–0781 Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives on the Pediatric Advisory Committee and Request for Nominations for Nonvoting Industry Representatives on Pediatric Advisory Committee 9/5/2012
FDA-2012-D-0529 Guidance for Industry; Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for OTC Human Use - Labeling for Products That Contain Acetaminophen 9/4/2012
Docket No. FDA-2012-N-0171 Using Innovative Technologies and other Conditions of Safe Use to Expand Which Drug Products Can Be Considered Nonprescription (these comments supplement the association’s March 22, 2012, presentation at FDA’s public meeting on the subject) 5/7/2012
CPSC-2012-0005 Products Containing Imidazolines Equivalent to 0.08 Milligrams or More 4/9/2012
FDA-2011-N-0842 Gluten in Drug Products: Request for Information and Comments 3/20/2012
78N-0301 External Analgesic Drug Products for OTC Human Use 2/27/2012    
CMS-5060-P Proposed Rule for Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests 2/16/2012
FDA-2011-D-0376 Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues 12/2/2011
FDA-2011-D-0620-0001 Guidance for Industry; Self-Selection for Nonprescription Drug Products 11/15/2011
RIN 3209-AA04 Standards of Ethical Conduct for Employees of the Executive Branch; Proposed Amendments Limiting Gifts from Registered Lobbyists and Lobbying Organizations 11/8/2011
FDA-2010-N-0128 Prescription Drug User Fee Act 10/31/2011
FDA-1978-N-0018 (formerly Docket No. 1978N-0038) Advance Notice of Proposed Rulemaking: Sunscreen Drug Products for OTC Human Use; Request for Data and Information Regarding Dosage Forms 10/17/2011
FDA-1978-N-0018 (formerly 1978N-0038) Proposed Rule: Revised Effectiveness Determination; Sunscreen Drug Products for OTC Human Use 09/15/2011
  Hazard Identification Materials for Fluoride and Its Salts 9/6/2011
FDA-2010-D-0509 Draft Guidance for Industry on Enforcement Policy for OTC Sunscreen Products Marketed Without an Approved Application 8/16/2011
FDA 2011-N-0449 SPF Labeling and Testing Requirements and Drug Facts Labeling for OTC Sunscreen Drug Products 8/16/2011
FDA-2010-D-0530 Drug Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology 8/15/2011
 

CHPA's Proposal of Limit for the Process Degradant 4-aminophenol

7/12/2011

FDA-2011-N-0002 Analgesic and Antipyretic Claims for Labeling for Children 6 Months to 2 Years 6/27/2011
FDA–2010–N–0002    Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatrics Advisory Committee to Discuss Use of Over-the-Counter Acetaminophen in Children 5/17/2011
  FDA Food Advisory Committee Public Meeting March 30-31, 2011: Whether available relevant data demonstrate a link between children’s consumption of synthetic color additives in food and adverse effects on behavior    4/6/2011
FDA-2000-P-0102, FDA-2000-P-0133, and FDA-2006-P-0033 Food Labeling; Health Claims; Phytosterols and Risk of Coronary Heart Disease (Proposed Rule) 1/31/2011
FDA-2010-D-0503 Draft Guidance for Industry on Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application 1/11/2011
  Alternative Safety Information Database Rule Proposal from Commissioners Anne Northup and Nancy Nord 11/16/2010
FDA-2010-N-0001 Drug Safety and Risk Management Advisory Committee meeting to discuss the abuse potential of dextromethorphan and the public health benefits and risks of this ingredient as a cough suppressant (appendices 1, 2, and 3) 09/14/2010
  CHPA and CRN Amici Brief with the U.S. Supreme Court in AER Reporting Standard Case 8/27/2010
CPSC-2010-0038 Testing and Labeling Pertaining to Product Certification 8/3/2010
FDA-2009-N-0247 FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration 7/20/2010
CPSC-2010-0041 Consumer Product Safety Information Database 7/20/2010
78N-0301 External Analgesic Drug Producs for OTC Human Use 2/16/2010
FDA-2009-D-0322 Dosage Delivery Devices for OTC Liquid Drug Products Guidance 2/2/2010
FDA-2009-N-0664 Nomination for a Nonvoting Member Representing Industry Interests on the CFSAN Food Advisory Committee 11/18/2009
FDA-2008-N-0334; RIN 0910-AF96 Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements 11/10/2009
FDA -2009-N-0247 FDA Transparency Task Force; Public Meeting; Request for Comments 11/6/2009
FDA-1977-N-0013 Organ-Specific Warnings; Internal Analgesics, Antipyretic, and Antirheumatic Drug Products for OTC Human Use—Clarification of Provisions in the Final Rule 8/26/2009
FDA-1977-N-0013 Organ-Specific Warnings; Internal Analgesics, Antipyretic, and Antirheumatic Drug Products for OTC Human Use—Request for Agency Exercise of Enforcement Discretion on a Phrase 8/26/2009
FDA-2009-D-0181 Organ-Specific Warnings; Internal Analgesics, Antipyretic, and Antirheumatic Drug Products for OTC Human Use—Request for Agency Exercise of Enforcement Discretion on a PhraseGuidance for Industry; Label Comprehension Studies for Nonprescription Drug Products 7/30/2009
FDA-2009-N-0138-0001 Organ-Specific Warnings; Internal Analgesics, Antipyretic, and Antirheumatic Drug Products for OTC Human Use—Clarification of Provisions in the Final RuleJoint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee (June 29 and 30, 2009) 6/8/2009
  Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108 3/24/2009
  Proposition 65 Beneficial Nutrients Regulatory Concept 1/12/2009
FDA-2008-N-0466 OTC Cough and Cold Medications for Pediatric Use; Notice of Public Hearing 12/2/2008
FDA-2008-N-0389 Food and Drug Administration Amendments Act of 2007 Prohibition Against Food to Which Drugs or Biological Products Have Been Added 11/25/2008
FDA-2005-N-0464 Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing 11/24/2008
  CHPA Comments on Consumer Product Safety Commission Section 102 Certificate Requirements 10/29/2008
  Industry Coalition Comments on Consumer Product Safety Commission Section 102 Certificate Requirements 10/29/2008
  Industry Coalition Comments on Consumer Product Safety Commission Section 102 Certificate RequirementsCHPA Response to Request for Relevant Information on the Developmental and Reproductive Toxicity of Caffeine  10/27/2008
FDA-2008-N-0416 CHPA Position Statement on Engineered Nanomaterials (Nanotechnology) 10/24/2008
FDA-2008-N-0448 International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; . . . Dextromethorphan 10/20/2008
FDA-2008-D-0413 FDA Draft Guidance for Industry, Residual Solvents in Drug Products Marketed in the United States, August 2008 10/6/2008
FDA-2005-N-0464 Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing 9/9/2008
1981N-0033P Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/ Antiplaque Drug Products; Establishment of a Monograph; Proposed Rules 9/5/2008
  Labeling Issues Regarding OTC Oral Pediatric Cough and Cold Medicines 7/10/2008
  Response to Request for Public Participation, Notice of Public Workshop, Proposition 65 Regulatory Update Project—Labor Code Mechanism Regulatory Concepts; Attachment A 7/17/08
FDA-2008-N-2081 Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting; Request for Comments 7/7/2008
  Proposition 65 Regulatory Update Project, Beneficial Nutrients Regulatory Concept 4/30/2008
FDA-2008-N-0040 Advanced Notice of Proposed Rulemaking for Food Labeling: Revision of Reference Values and Mandatory Nutrients 4/30/2008
2007D-0496 and 2007D-0491 Draft Guidance for Industry on Questions and Answers Re: the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act and Questions and Answers Re: the Labeling of Dietary Supplements as Required by the Dietary Supplemlent and Nonprescription Drug Consumer Protection Act (attachment) 3/3/2008
1978N-0038 Sunscreen Products for OTC Human Use; Proposed Amendment of Final Monograph 12/26/2007
2007N-0356 Behind the Counter Availability of Certain Drugs; Public Meeting 12/17/2007
2006N-0168 Request for Extension of Comment Period: Advanced Notice of Proposed Rulemaking for Food Labeling: Revision of Reference Values and Mandatory Nutrients 12/17/2007
2007D-0388 and 2007D-0386 Notice of Draft Guidance for Industry: Questions and Answers Re: Adverse Event Reporting and Recordkeeping for Dietary Supplements and Notice of Drug Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application 12/13/2007
  Voluntary Plans on Safety and Efficacy of OTC Oral Pediatric Cough and Cold Medicines 11/28/2007
2007D-0125 Notice on Draft Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims (request for extension) 9/9/2007
2007N-0186; RIN 0910-AB88 Interim Final Rule on Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (request for extension) 9/9/2007
 

Request for Nominations for Nonvoting Industry Representatives on the Food Safety Public Advisory Committee

 
7/11/2007
 

CHPA's Nomination for Industry Representative to the Nonprescription Drugs Advisory Committee

 
7/3/2007 
  Request for Notification from Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives on Food Safety Public Advisory Committee 6/26/2007
1977N-0094L, RIN 0901-AF36 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for OTC Human Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling 5/25/07
1998 N-0337C; RIN No. 0910-AD47 Proposed Rule on Labeling Requirements for OTC Human Drugs 5/7/2007
1998 N-0337C; RIN No. 0910-AD-47 Proposed Rule on Labeling Requirements for OTC Human Drugs (request for extension) 3/23/2007
2004P-0464 Proposed Rule on Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis 3/14/2007
76N-052N

OTC Monograph for Nasal Decongestant Drug Products

NOTE TO PRESS: CHPA is offering a "media kit" with background information and presentations for the December 14, 2007 NDAC meeting

2/1/2007
2005N-0403 / RIN 0910-AA49 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that Are Regulated Under a Biologics License Application, and Animal Drugs 1/26/2007
2005N-0403 / RIN 0910-AA49 Request for Extension of Comment Period on the Proposed Rule "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs" 10/12/2007
  CHPA request to FDA for time on September 25 to address NDAC; CHPA's letter to NDAC; and "Outcomes from the CHPA-FDA Consumer Behavior Roundtable"  9/11/2006
1998N-0359 Request for Comments on the Program Priorities in the Center for Food Safety and Applied Nutrition 8/25/2006
2005N-0097 Experimental Study of Qualified Health Claims: Consumer Inferences About Omega-3 Fatty Acids, Monounsaturated Fatty Acids from Olive Oil, and Green Tea 6/21/2006
1981N-0033; Comment Number C76

Designing a Protocol to Address the Safety and Effectiveness of Benzocaine for the Relief of Toothache Pain

Revised Final Protocol - Benzocaine Gel Toothache Dose-Resonse Study 

6/5/2006
DEA-266P Controlled Substances and List I Chemical Registration and Reregistration Application Fees 1/17/06
  CHPA's Nomination for Industry Liaison Representative to the Nonprescription Drugs Advisory Committee; Resume 11/28/2005
2005N-0345 FDA Request for Comments on Advance Notice of Proposed Rulemaking, "Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product" 10/31/2005
205D-0240 Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention; Availability 10/27/2005
05-006N U.S. Government draft positions for the Codex Committee on Nutrition and Foods for Special Dietary Uses 10/21/2005
  Statement of Record Re: Comprehensively Combating Methamphetamines: Impacts on Health and the Environment 10/20/2005
2005D-0062 Draft Guidance for Industry on the Food and Drug Administration's "Drug Watch" for Emerging Drug Safety Information 8/8/2005
1998N-0359 Request for Comments on the Program Priorities in the Center for Food Safety and Applied Nutrition 7/18/2005
2005D-0240 Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention; Availability 7/15/2005
  CHPA Comments and Slide Presentation Before the Institute of Medicine of the National Academies Committee on Identifying and Preventing Medication Errors 7/6/2005
  Nomination for a Nonvoting Member Representing Industry Interests on the Food Advisory Committee 4/21/2005
05-0001N    U.S. Government Positions in Preparation for the 33rd Session of the Codex Committee on Food Labelling of the Codex Alimentarius Commission 4/13/2005
2004N-0454 Solicitation of Written Comments on the Premarket Notification for New Dietary Ingredient Notifications 2/1/2005
  Joint Submission to European Commission on 6% Hydrogen Peroxide Tooth Whitening Products 1/27/2005
 

Stimuli Article in PF Vol. 30(5) Entitled "Development of a New Official Compendium, Separate from USP-NF, for Articles Not Legally Marketed in the U.S."

1/25/2005

81N-0033 Benzocaine-Containing Products for the Temporary Relief of Toothache Pain 12/17/2004
2004N-0454 Request for Extension of Comment Period: Premarket Notifications for New Dietary Ingredients 11/3/2004
  Solicitation of Written Comments on Proposed Definition of Bioactive Food Components 11/1/2004
DEA-211P    Proposed Rule: Security Requirements for Manufacturers, Distributors, Importers, and Exports of Pseudoephedrine, Ephedrine, and PhenylpropanolamineOctober 28, 2004, DEA PSE  10/28/2004
DEA-211P Proposed Rule: Security Requirements for Handlers of Pseudoephedrine, Ephedrine, and Phenylpropanolamine 10/22/2004
2004N-0267 Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications, Proposed Rule 10/18/2004
  Comments on Proposed Revisions to the Proposition 65 Prioritization Procedure 10/4/2004
DEA-211P Security Requirements for Manufacturers, Distributors, Importers, and Exporters of Pseudoephedrine, Ephedrine, and Phenylpropanolamine 9/20/2004
  Industry Coalition on 21 CFR Part 11 Citizen Petition 9/17/2004
  U.S. Government Position Re: Codex Committee on Nutrition and Foods for Special Dietary Uses 8/9/2004
1998N-0359 Program Priorities in the Center for Food Safety and Applied Nutrition: Request for Comment 8/9/2004
2003N-0342; RIN 0910-AC35 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products, Proposed Rule 7/21/2004
1994P-0390 and 1995P-2041 Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims; Reopening of Comment Period 7/6/2004
2003N-0539 Over-the-Counter Drug Products; Safety and Efficacy Review 6/28/2004
FHWA-2004-17321 Specific Service and General Service Signing for 24-Hour Pharmacies 6/23/2004
  Industry Coalition on Part 11 (presentation at FDA Part 11 Public Meeting) 6/11/2004
2004D-0027 Draft Guidance for Industry on Time and Extent Applications 3/31/2004
DEA-239T Clarification of the Exemption of Sales by Retail Distributors of Pseudoephedrine and Phenylpropanolamine Products 2/27/2004
2003N-0496 Food Labeling: Health Claims; Dietary Guidance 2/25/2004
96N-0417 Good Manufacturing Practices for Dietary Supplements 2/24/2004
1978-036L, RIN 0910-AA01 Laxative Drug Products for OTC Human Use; Reopening of the Administrative Record (attachment) 1/20/2004
2003N-0496 Food Labeling: Health Claims; Dietary Guidance 1/13/2004
  Comments with Respect to the Annual National Trade Estimate Report on Foreign Trade Barriers 12/12/2003
81N-033P Proposed Monograph on OTC Antigingivitis / Antiplaque Drug Products (Appendix I; Appendix II, Appendix III) 11/25/2003
78N-0301 External Analgesic Drug Products for Over-the-Counter Human Use; Reopening of the Administrative Record and Amendment of Tentative Final Monograph 10/15/2003
  Safety Reporting Requirements for Human Drug and Biological Products 10/14/2003
2003N-0233 Notice of Eligibility; Request for Data and Information (Sunscreen Ingredients) 10/9/2003
03-024N Codex Committee on Nutrition and Foods for Special Dietary Uses 9/10/2003
78N-0038 Petition Seeking Permission To Use Truthful Labeling For High SPF Sunscreen Products 8/22/2003
78N-0038 Petition for Inclusion of Anti-Aging Claims in the Sunscreen Drug Products for Over-the-Counter Use Final Monograph 8/22/2003
96N-0417 Current Good Manufacturing Practice in Manufacturing, Packaging, or Holding Dietary Ingredients and Dietary Supplements 8/8/2003
  Amicus Brief Re: FDA’s Requirement for Specific Warning Language on OTC Nicotine Replacement Therapy Drugs Take Precedence Over a California Court of Appeal's Decision that a Proposition 65 Warning Must Appear on Such Products 7/21/2003
81N-033P July 9, 2003, Similar Drug NamesOral Health Care Drug Products for Over-the-Counter Human Use: Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph 7/15/2003
2003N-0201 Evaluating Drug Names for Similarities 7/9/2003
2003N-0201 Evaluating Drug Names for Similarities; Methods and Approaches (meeting formerly called Minimizing Medication Errors-Methods for Evaluating Proprietary Names for Their Confusion Potential); Public Meeting; Request for Comments 7/9/2003
02N-0277 Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 7/7/2003
02N-0204 FDA Proposed Rule on Bar Code Label Requirements for Human Drug Products and Blood 6/11/2003
03N-0069 FDA Task Force on Consumer Health Information for Better Nutrition 5/27/2003
98N-0044 Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body 5/27/2003
03D-0060, 99D-1458, 00D-1538, 00D-1543, 00D-1542, 00D-1539 Draft Guidance for Industry on "Part 11, Electronic Records, Electronic Signatures-Scope and Application"; Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Document and a Compliance Policy Guide 4/28/2003
02N-0276 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 4/4/2003
02N-0278 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 4/4/2003
  FDA Adoption of a Forced Switch Policy 03/26/03
02N-0209 Request for Comment on First Amendment Issues 10/28/2002
02N-0209    Request for Comment on First Amendment Issues    9/13/2002
02N-0276, 02N-0277, 02N-0278, 02N-0275 2002 Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL107-188) 9/4/2002
98N-0359 2003 Program Priorities for Dietary Supplements in the Center for Food Safety and Applied Nutrition 8/20/2002
02-022N Codex Committee on Nutrition and Foods for Special Dietary Uses 8/19/2002
02N-0058 Pediculicide Drug Products for OTC Human Use 8/8/2002
RIN 1515-AD05 Conditional Release Period and Customs Bond Obligations for Food, Drugs, Devices, and Cosmetics 8/2/2002
02N-0204 Comments at FDA's Public Meeting on Call on Bar Code Requirements for Human Drug Products 7/26/2002
78N-0038 Petition for Stay of Action and Reconsideration of Effective Date of a Technical Amendment to the Final Monograph for Sunscreen Drug Products for Over-the-Counter Human Use 7/26/2002
80N-0042 OTC Anticaries Drug Products: Use of Intraoral Appliance Models for Compliance with Biological Testing Requirements; Request for Information and Comments 7/12/2002
02N-0204 CHPA Comments on FDA's July 26 Public Meeting on Bar Code Label Requirements for Human Drug Products 7/12/2002
98N-0337; 96N-0420; 95N-0259; 90P-0201 Over the Counter Drugs: Labeling Requirements: Partial Delay of Compliance 7/5/2002
8IN-003 Comment No. PR5 Benzocaine 4/16/2002
98N-0583 Petition for Stay of Action on "Exports: Notification and Recordkeeping Requirements" 3/8/2002
  CHPA Comments to HHS' Advisory Committee on Regulatory Reform 3/5/2002
01N-0397 Second Follow-Up Submission by CHPA to the FDA/NTSB Joint Public Meeting on Transportation Safety and Potentially Sedating or Impairing Medications: Comments on the Safety of OTC Antihistamines and OTC Labeling 2/1/2002
81N-0114 Comments on Benzoyl Peroxide 12/27/2001
  Comments with Respect to the National Trade Estimate Report on Foreign Trade Barriers, 66 Fed.Reg. 60237 (12/3/01) 12/17/2001
01N-0397 FDA/NTSB Joint Public Meeting on Transportation Safety and Potentially Sedating or Impairing Medications: Comments on the Safety of OTC Antihistamines and OTC Labeling 12/17/2001
  CHPA Comments to the Institute of Medicine on the Scientific Framework for Safety Evaluation of Dietary Supplements 10/11/2001
98N-0359 2002 Program Priorities for Dietary Supplements in the Center for Food Safety and Applied Nutrition 9/17/2001
  Comments to the Institute of Medicine's Food and Nutrition Board on Their Proposed Definition for Dietary Fiber 6/1/2001
01D-0058 Comments on Guidance on Applying the Structure/Function Rule; Request for Comments 5/22/2001
98P-0610 Comments on FDA's Background Materials Relating to May 11, 2001, Joint Meeting of the Nonprescription Drugs Advisory Committee and Pulmonary Allergy Drugs Advisory Committee 5/4/2001
  CHPA Comments to White House Commission on CAMP on Information Development and Dissemination 3/26/2001
  CHPA Oral Testimony to the White House Commission on CAMP: Minnesota Town Hall Meeting 3/16/2001
00D-1584 Guidance for Industry: Labeling of OTC Human Drug Products - Submitting Requests for Exemptions and Deferrals; Availability Published in Federal Register December 19, 2000 2/20/2001
98N-0044 Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body: Availability of Citizen Petitions for Comment 12/22/2000
76N-052H Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC Use; Reopening of the Administrative Record for Antihistamine Drug Products 11/22/2000
  Child-Resistant Packaging for Certain OTC Drug Products; Notice of Proposed Rulemaking 11/10/2000
78N-036L CHPA’s Laxative Task Group’s Comments on Psyllium 10/23/2000
00D-1392 Guidance for Industry: Botanical Drug Products: Drug Guidance 10/10/2000
00N-1200 Dietary Supplements Containing Ephedrine Alkaloids 9/29/2000
81N-0022 and 76N-052N Background Information on Phenylpropanolamine 9/21/2000
98N-0337, 96N-0420, 95N-2059 and 90P-0201 OTC Drugs: Labeling Requirements: Partial Extension of Compliance Dates 9/18/2000
78N-0038 Sunscreen Drug Products for OTC Human Use; Monograph; Extension of Effective Date; Reopening of Administrative Record 9/6/2000
98N-0359 2001 Program Priorities for Dietary Supplements in the Center for Food Safety and Applied Nutrition 8/25/2000
00N-1256 OTC Drug Products: Request for Comments 8/25/2000
  CHPA Comments on the Safety Evaluation of Ephedra 8/8-9/2000
  CHPA Presentations at FDA OTC Hearing: Over-the-Counter Medications: A Success Story; Legal Perspective; Scientific/Regulatory Perspective on Rx-to-OTC Switch 6/28-29/2000
  Citizen Petition Asking FDA to Establish a Regulation to Define Labeling Requirements for Dietary Supplements Containing St. John’s Wort 6/20/2000
00N-1256 Over-the-Counter Drug Products Public Hearing 5/25/2000
81N-0022 and 76N-052N CHPA Phenylpropanolamine Working Group Comments on Yale Hemorrhagic Stroke Project Report 5/24/2000
98N-0044 Citizen Petition to Amend Final Regulation on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body 5/11/2000
00N-0598 Comments on “Food Labeling; Dietary Supplement Health Claims; Public Meeting Regarding Pearson Health Claims”   4/19/2000
00N-0598 Comments on FDA’s Request for Input on Changes to the Agency’s General Health Claim Regulations for Dietary Supplements that May Be Warranted in Light of the Court Decision in Pearson v. Shalala 4/4/2000
  FDA Proposal to Revise the Citizen Petition Regulation 2/28/2000
99D-5424 Comments on “Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements; Availability” 2/22/2000
  Draft Guidance for Industry Labeling OTC Human Drug Products Using a Column Format 1/31/2000
80N-0042 Anticaries Drug Products for Over-the-Counter Human Use 12/14/1999
98N-0337, 96N-0420, 95N-0259, 90P-0201 OTC Label Rule 11/22/1999
99N-4235 Survey of Manufacturing Practices in the Dietary Supplement Industry 11/5/1999
99N-1819 CHPA Comments to FDA on the Labeling of Topical Antifungal Drug Products for OTC Human Use 10/20/1999
98N-0359 CHPA Comments to FDA on CFSAN’s Program Priorities for the Year 2000 9/30/1999
98N-0359 CHPA Request to FDA for Extension for Submitting Comments on CFSAN’s Program Priorities 9/20/1999
99N-1174 Stakeholder Input on CFSAN’s Overall Strategic Plan for Dietary Supplements 8/20/1999
98N-0044 Regulations on Statements for Dietary Supplements Concerning Structure/Function of the Body 8/4/1999
99N-0391 CHPA Comments on Codex Vitamin/Mineral Background Paper 6/8/1999
99N-1174 Stakeholder input on FDA strategy for dietary supplements 6/8/1999
99N-0554 How to Use Health Claims and Nutrient Content Claims in Food Labeling 5/11/1999
99N-0386 Talking with Stakeholders about FDA Modernization 4/26/1999
80N-0228 CHPA Comments on Oral Discomfort Over-the-Counter Drug Products 4/22/1999
98N-0826 Use of Dietary Supplements of Health Claims Based on Authoritative Statements 4/6/1999
98P-0043 Food Labeling: Nutrition Labeling of Dietary Supplements on a “Per Day” Basis 3/29/1999
81N-0114 Update on Safety Studies with Benzoyl Peroxide 2/26/1999
98N-0148 International Drug Scheduling: Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization Scheduling Recommendations for Ephedrine, Dihydroetorphine, Remifentanil and Certain Isomers 2/18/1999
98N-0750 Electronic Reporting of Postmarketing Adverse Drug Reactions 2/3/1999
Healthy People 2010 CHPA comments on HHS Healthy People 2010 Objectives 12/17/1998
98D-0362 Draft guidance for industry on stability testing of drug substances and drug products 12/7/1998
98N-004 Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body 9/24/1998
78N-036L Reclassification of Bisacodyl as a Category I (generally recognized as safe and effective) active ingredient to Category III (further testing is required) 9/17/1998
78N-036L Stimulant laxative ingredient bisacodyl -- study reports and protocol 9/16/1998
98N-0339 FDA Modernization Act -- questions posed by the agency to best meet objectives in the modernization plan 9/4/1998
78N-036L Proposed amendment to the tentative final monograph for laxative drug products 8/19/1998
78N-036L Regarding July 15 feedback meeting on sodium phosphate enemas 8/5/1998
78N-036L Petition for reconsideration of portions of Final Rule on package size limitations for sodium phosphates oral solution; warning and directions statements for oral and rectal sodium phosphates for OTC laxative use; petition for stay of action of effective date of those portions 7/22/1998
96N-0420, 92N-454A, 90P-0201, 95N-0259 OTC proposed rule on labeling requirements; package size exemption 7/13/1998
  Comments to Office of U.S. Trade Representative regarding the U.S. and European Union Transatlantic Economic Partnership 7/6/1998
88N-004 Request for feedback meeting on Nonprescription Drugs Advisory Committee 9/11/98 meeting on pediatric labeling, dosages and dosage forms for cough/cold products 5/27/1998
98N-0056 Pediatric exclusivity eligibility under FDA Modernization Act 5/27/1998
98N-0002 Proposed Amendment to Ophthalmic Final Monograph 5/26/1998
81N-0033 Documents relating to Dental Plaque Subcommittee Meeting of 5/27-29/98 5/19/1998
81N-0033 Testing standards for OTC drugs treating oral discomfort 4/29/1998
98N-0148 International drug scheduling; convention on psychotropic substances 4/17/1998
98N-0056 Draft list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population 4/15/1998
96N-0420, 92N-454A, 90P-0201, 95N-0259 Proposed OTC labeling requirements: listing of active and inactive ingredients 3/31/1998
96N-0420, 92N-454A, 90P-0201, 95N-0259 Comments on FDA’s Study A (OTC labeling) 3/31/1998
96N-0420, 92N-454A, 90P-0201, 95N-0259  OTC label content and format: Package size exemption 3/19/1998
80N-0476, 78N-0301, 78N-0021, 78N-0183 OTC vaginal douche products 2/17/1998
96N-0420, 92N-454A, 90P-0201, 95N-0259 OTC drug labeling survey 2/13/1998
77N-094W Proposed Alcohol Warning for Analgesic/Antipyretic drugs 1/28/1998
97N-0128 Labeling of diphenhydramine-containing OTCs    11/25/1997
81N-0112 Benzoyl peroxide study 11/12/1997
  OTC antiplaque/antigingivitis combination products 10/29/1997 
96N-0420, 92N-454A, 90P-0201, 95N-0259 Proposed OTC labeling requirements 10/6/1997
97N-0201 OTC label consumer surveys 9/30/1997
78N-036L Bisacodyl 9/29/1997
  Vitamin/Mineral  8/4/1997
  Proposed OTC labeling requirements (NDAC) 7/14/1997
97P-0233/CP1 Lead/Calcium    6/26/1997
97P-0034/CP1 Lead/Calcium 6/26/1997
81N-0022 Phenylpropanolamine 6/25/1997
97N-0201 Proposed OTC labeling content and format 6/13/1997
97P-0233/CP1    Lead/Calcium 6/10/1997
78N-036L Phenolphthalein 6/10/1997
96N-0417 Vitamin/mineral supplements    6/6/1997
  International harmonization of chemical safety and health information 6/2/1997
  OTC drug labeling and MaPPs and procedures 5/21/1997
81N-0114 Benzoyl Peroxide 4/23/1997
96N-0420, 92N-454A, 90P-0201, 95N-0259 Proposed OTC label requirements -- 90-day extension request 4/14/1997
  Pseudoephedrine, methamphetamine, ephedrine, phenylpropanolamine 4/11/1997
80N-0280 Nonoxynol-9 3/10/1997
80N-0280 Nonoxynol-9  3/3/1997
  Vitamin/Mineral 2/27/1997
90N-0309, 95N-0254 Calcium, magnesium, potassium 2/25/1997
78N-036L Bisacodyl Phenolphthalein 1/17/1997
96N-0277 ANPR - OTC Monographs and foreign marketing data 12/30/1996
80N-0280 Nonoxynol-9 Octoxynol-9 12/19/1996
  Hydrogen Peroxide 12/17/1996
80N-0280 Nonoxynol-9 Octoxynol-9 11/22/1996
80N-0280 OTC vaginal contraceptives: spermicides 11/4/1996
95N-0362 CGMP -- finished pharmaceuticals 9/27/1996
95N-0254 Calcium, magnesium, potassium 9/20/1996
90N-0309 Sodium 9/20/1996
80N-0042 Fluoride 9/5/1996
  Vitamin/Mineral 9/5/1996
  Manual of Policies and Procedures 8/16/1996
80N-0042 Fluoride 7/11/1996
90N-0309 Sodium 6/18/1996
90N-0309, 95N-0254 Sodium, calcium, magnesium, potassium 6/18/1996
  Hydrogen Peroxide 5/30/1996
81N-0114 Benzoyl Peroxide 5/23/1996
81N-033P Alcohol 5/15/1996
95N-0062 Bacitracin, bacitracin zinc, neomycin, neomycin sulfate, polymyxin B, polymyxin B sulfate 5/14/1996
95N-0060 Phenylpropanolamine 5/14/1996
95N-0060 Phenylpropanolamine 5/14/1996
92N-454A OTC labeling -- interchangeable terms 4/18/1996
80N-0042 Fluoride 4/17/1996
80N-0042 Fluoride 4/17/1996
80N-0042 Fluoride 4/17/1996
80N-0042 Fluoride 4/17/1996
80N-0042 Fluoride 4/17/1996
78N-036D Attapulgite 4/11/1996
90N-0134 Vitamin/Mineral 4/11/1996
95N-0282 Vitamin/Mineral 4/11/1996
95N-0347 Vitamin/Mineral 4/11/1996
95N-0245 Vitamin/Mineral 4/11/1996 
80N-0042 Fluoride 4/10/1996
80N-0042 Fluoride 4/3/1996
80N-0042    Fluoride 3/27/1996
78N-036L Phenolphthalein 1/30/1996
78N-0065 Hydroquinone 1/26/1996
78N-036L Phenolphthalein 12/15/1995
  Hydrogen Peroxide 12/4/1995
95N-0205 Pseudoephedrine/ephedrine 11/27/1995
76N-052H Antihistamines 11/16/1995
95N-0259 OTC labeling -- improving communications of information 11/14/1995
  Vitamin/Mineral 10/18/1995
78N-036D Attapulgite 10/11/1995
  OTC labeling -- even easier to use labels 9/29/1995
82N-0165 Pyrilamine 9/21/1995
75N-0357 Aluminum 8/10/1995
81N-0033 Plaque 7/31/1995
91P-0186 and 93P-0306 Iron 7/24/1995
92N-0311 Benzoyl Peroxide 7/17/1995
81N-0114 Benzoyl Peroxide 6/30/1995
81N-0114 Benzoyl Peroxide 6/15/1995
  OTC labeling -- Principal Display Panel 6/7/1995
80N-0280 Nonoxynol-9 6/5/1995
81N-0033 Alcohol 5/30/1995
91P-0186 and 93P-0306 Iron 5/22/1995
  Letter to Rubel Re: CPSC/Coalition for Responsible Packaging Meeting 5/10/1995
  Letter to Semple Re: CPSC/Coalition for Responsible Packaging Meeting  5/10/1995
91P-0186 and 93P-0306 Iron 4/26/1995
91P-0186 and 93P-0306 Iron 4/13/1995
81N-0033 Plaque 4/10-13/95
  Child-Resistant Packaging 4/5/1995
93D-0403 Supplements to new drug applications 3/31/1995
88N-0004 Pediatric dosing schedules 3/29/1995
  Rx-to-OTC switch of muscle relaxants 3/28/1995
  Child-resistant packaging 3/22/1995
75N-0244 Acetaminophen/diphenhydramine 3/17/1995
  Child-resistant packaging 3/7/1995 
78N-036D Attapulgite 2/28/1995
93N-0182 Aspirin & Non-aspirin salicylates 2/28/1995
78N-36D Attapulgite 2/27/1995
78N-036D Attapulgite 2/9/1995
93N-0181 Adverse experience reporting requirements 1/25/1995
88N-0004 OTC Antipyretic/analgesic dosing schedules 1/13/1995
  Child-resistant packaging 1/3/1995
  Child-resistant packaging 1/3/1995