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Proposed Rule

Withdrawal of Certain Proposed Rules and Other Proposed Actions; Notice of Intent

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Food and Drug Administration, HHS.


Notice of intent.


The Food and Drug Administration (FDA) is announcing its intent to withdraw certain advance notice of proposed rulemakings (ANPRMs), proposed rules, and other proposed actions that published in the Federal Register more than 5 years ago. These proposals rules are no longer considered viable candidates for final action at this time. FDA is taking this action to reduce its regulatory backlog and focus its resources on current public health issues. The FDA's actions are part of an overall regulatory reform strategy initiated by HHS Secretary Tommy G. Thompson.


Submit written or electronic comments by July 21, 2003.


Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to​dockets/​ecomments.

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Lisa M. Helmanis, Regulations Policy and Management Staff (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.

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On June 8, 2001, Secretary Thompson announced his regulatory reform initiative designed to reduce regulatory burdens in health care and respond faster to the concerns of health care providers, State, and local governments and individual Americans who are affected by HHS rules. In December of 2001 the Secretary announced the membership of his Regulatory Reform Committee designed to carry out his initiative. In November of 2002 the Committee released its final report with over 255 specific recommendations for simplifying, streamlining and generally reducing the regulatory burden while continuing to require accountability by those doing business with HHS and its agencies. Over 25 of the recommendations have been adopted and the Secretary charged the Office of the Assistant Secretary for Planning and Evaluation to continue the efforts of the Regulatory Reform Committee. FDA's continuing efforts to withdraw regulations that have been proposed but not finalized are part of this overall initiative.

I. Background

In 1990, FDA began a comprehensive review of its regulations process that included a review of the backlog of advance notices of proposed rulemaking, notices of proposed rulemaking, and other notices for which no final action or withdrawal notice had been issued. In the Federal Register of August 28, 1991 (56 FR 42668), FDA announced its intent to withdraw 115 proposed rules published before December 31, 1985, that had never been finalized and invited comment on its intent. In the Federal Register of December 30, 1991 (56 FR 67440), FDA issued its first notice withdrawing 89 of those outstanding proposed rules. Again, in the Federal Register of January 19, 1993 (58 FR 4953), FDA announced its intent to withdraw 10 proposed rules that had never been finalized and invited comment on its intent. In the Federal Register of January 20, 1994 (59 FR 3042), the agency withdrew an additional 9 outstanding proposed rules.

Once again, FDA has reviewed its pending proposed rules and other notices that published in the Federal Register more than 5 years ago, and for which no final rule or notice of withdrawal has been issued. The agency has identified 84 such proposed rules and other actions that should be formally withdrawn. Included in this current list are 19 proposed rules that were included in the original 1991 list, but at that time, the agency decided to defer its decision to withdraw or finalize them until a later date. As with the other proposals it intends to withdraw, FDA believes that it is no longer appropriate to continue these rulemakings. These 19 proposed rules are identified in table 1 of this document.

As with the 1991 review, the agency undertook this most recent review because it believes that the backlog of pending proposals dilutes its ability to concentrate on higher priority regulations that are mandated by statute or necessary to address current public health issues. Because of the agency's limited resources and changing priorities, FDA has been unable to consider, in a timely manner, the issues raised by the comments on these proposals and either complete the action on them or withdraw the proposals. Additionally, because many of the proposals have become outdated in the time that has elapsed since their publication, the agency would need to obtain further comment on them before proceeding to final action. FDA has determined that the proposals identified in this document are lower in priority than those on the Unified Agenda and the Regulatory Plan. It is unlikely that the agency will have sufficient resources in the foreseeable future to further consider or prioritize these proposed rules. Although not required to do so by the Administrative Procedure Act or by regulations of the Office of the Federal Register, the agency believes the public interest is best served by withdrawing these 84 proposals. In some instances, the agency has already completed action on alternatives, e.g., the issuance of guidance or inclusion of provisions in related regulations, that have obviated the need to complete the proposed action.

If the agency does withdraw these proposals, that action would not preclude the agency from reinstituting proceedings to issue rules concerning the issues addressed in the proposals listed in table 1 of this document. Should FDA decide to undertake such a rulemaking sometime in the future, it will re-propose the actions and provide new opportunities for comment. For some proposals, the agency already has plans to institute new proceedings. Further, interested persons may submit a citizen petition requesting that the agency initiate rulemaking on any of the issues covered by the proposed rules that FDA intends to withdraw.

The agency advises that in some cases the preambles of these proposals may still reflect the current position of FDA on the matter addressed. In addition, withdrawal of a proposal is not intended to affect whatever utility the preamble statements may currently have as indications of FDA's position on a matter at the time the proposal was published.

Therefore, for the reasons set forth previously, and under the Federal Food, Drug, and Cosmetic Act, the agency Start Printed Page 19767announces its intent to withdraw the following documents, published in the Federal Register on the dates indicated in table 1:

Table 1.

TitleDocket No.FR publication date and cite
Radioactive Drugs, Including Biological Products75N-0069July 25, 1975, 40 FR 31314
Conditions for Use of Methadone75N-0125April 29, 1976, 41 FR 17922
Pasteurized Milk Ordinance and Interstate Milk Shippers75N-0243May 5, 1975, 40 FR 19513
Oral Contraceptive Drug Products; Physician and Patient Labeling75N-0304December 7, 1976, 41 FR 53633
Penicillin Streptomycin Powder; Penicillin—Dihydrostreptomycin Powder; Proposed Revocation of Certification Provision75N-0374July 9, 1976, 41 FR 28313
Conditions for Use of Methadone; Physiologic Dependence, Staffing, and Urine Testing Requirements76N-0098April 29, 1976, 41 FR 17926
Sorbic Acid and Its Salts; Proposed Affirmation and Deletion of GRAS Status77G-03791March 10, 1978, 43 FR 9823
Butylated Hydroxytoluene; Use Restrictions77N-00031May 31, 1977, 42 FR 27603
Color Additives; Proposed Use of Abbreviations for Labeling Foods, Drugs, Cosmetics, and Medical Devices77N-0009 and 78P-0164June 6, 1985, 50 FR 23815
Brown and Yellow Mustard and Their Derivatives; Proposed Affirmation of GRAS Status as Direct Human Food Ingredients77N-00331August 26, 1977, 42 FR 43092
Acrylonitrile Copolymers Intended for Use in Contact With Food; Proposed Rulemaking77N-0078March 11, 1977, 42 FR 13562
Gelatin; Affirmation of GRAS Status as a Direct and Indirect Human Food Ingredient77N-02321November 11, 1977, 42 FR 58763 and May 12, 1993, 58 FR 27959 (Tentative final rule)
New Animal Drugs for Use in Animal Feeds; Animal Feeds Containing Penicillin and Tetracycline77N-0318January 20, 1978, 43 FR 3032
Ethylene Oxide, Ethylene Chlorohydrin, and Ethylene Glycol; Proposed Maximum Residue Limits and Maximun Daily Levels of Exposure77N-04241June 23, 1978, 43 FR 27474
Label Designation of Ingredients in Cheese and Cheese Products77P-0146July 19, 1984, 49 FR 29242
Food Chemicals Codex Monographs; Opportunity for Public Comment on Revisions78N-0072April 18, 1978, 43 FR 16413
Cellulose Derivatives; Affirmation of GRAS Status78N-01441February 23, 1979, 44 FR 10751
Tocopherols and Derivatives; Proposed Affirmation of GRAS Status for Certain Tocopherols and Removal of Certain Others From GRAS Status as Direct Human Food Ingredients78N-02131October 27, 1978, 43 FR 50193
Chlortetracycline-Sulfamethazine Tablets78N-0247September 22, 1978, 43 FR 43036
Phosphates; Proposed Affirmation of and Deletion From GRAS Status as Direct and Human Food Ingredients78N-0272December 18, 1979, 44 FR 74845
Biotin; Proposed Affirmation of GRAS Status78N-03081January 14, 1983, 48 FR 1739
Lard and Lard Oil; Proposed Affirmation of GRAS Status as Indirect Human Food Ingredients78N-03361May 18, 1979, 44 FR 29102
Glycerin; Affirmation of GRAS Status as a Direct Human Food Ingredient78N-03481February 8, 1983, 48 FR 5758
Medical Devices; Sponges for Internal Use78N-1074November 28, 1976, 43 FR 55697
Medical Devices; Classification of Powered Myoelectric Biofeedback Equipment78N-1183August 28, 1979, 44 FR 50464
Porcine burn dressing78N-2670January 19, 1982, 47 FR 2828
Food Ingredient Labeling, Emulsifiers, and Stabilizers (Carob Bean Gum); Exemptions78P-0052April 17, 1985, 50 FR 15177
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Sodium Dithionite and Zinc Dithionite; Proposed Affirmation of GRAS Status79N-00951January 25, 1980, 45 FR 6117 and September 17, 1982, 47 FR 41137 (Tentative final rule)
Current Good Manufacturing Practice in Manufacture Processing, Packing, or Holding; Proposed Exemption From Active Ingredient Identity and Strength Testing for Homoeopathic Drug Products79P-0265April 1, 1983, 48 FR 14003
Hydrochloric Acid; Proposed Affirmation of GRAS Status as a Direct Human Food Ingredient80N-01481April 26, 1984, 49 FR 17966
Cheeses and Related Cheese Products; General Standard of Identity for “Certain Other Cheeses”80N-0373April 23, 1984, 49 FR 17018
Caffeine; Deletion of GRAS Status, Proposed Declaration That No Prior Sanction Exists, and Use on an Interim Basis Pending Additional Study80N-04181October 21, 1980, 45 FR 69817
Policy for Regulating Carcinogenic Chemicals in Food and Color Additives; Advance Notice of Proposed Rulemaking81N-0281April 2, 1982, 47 FR 14464
Magnesium Gluconate, Potassium Gluconate, Sodium Gluconate, Zinc Gluconate, and Gluconic Acid; Proposed GRAS Status as Direct and Indirect Human Food Ingredients81N-0382October 29, 1982, 47 FR 49028
Protein Hydrolysates and Enzymatically Hydrolyzed Animal (Milk Casein) Protein; Proposed GRAS Status82N-00061December 8, 1983, 48 FR 54990
Zinc Salts; Proposed Affirmation of GRAS Status82N-01671October 26, 1982, 47 FR 47441
Regenerated Collagen; Proposed GRAS Status as a Direct Human Food Ingredient82N-02191April 26, 1983, 48 FR 18833
Ascorbic Acid and Its Sodium and Calcium Salts, Erythorbic Acid and Its Sodium Salt, and Ascorbyl Palmitate; Proposed Affirmation of GRAS Status and Removal of Calcium Ascorbate From the List of GRAS Ingredients82N-02461January 14, 1983, 48 FR 1735
Caffeine in Nonalcoholic Carbonated Beverages82N-0318May 20, 1987, 52 FR 18923
Common or Usual Names for Nonstandardized Foods; Diluted Fruit or Vegetable Juice Beverages82N-0389June 1, 1984, 49 FR 22831
Reclassification of Electroconvulsive Therapy82P-0316September 5, 1990, 55 FR 36578
New Drug and Antibiotic Application Review; Proposed User Charge84N-0101August 6, 1985, 50 FR 31726
Proposed Uses of Vinyl Chloride Polymers84N-0334February 3, 1986, 51 FR 4177
Unmodified Food Starches and Acid-Modified Starches; Proposed Affirmation of GRAS Status as Direct and Indirect Food Ingredients84N-03411April 1, 1985, 50 FR 12821
Use of Acrylonitrile Copolymers85N-0145March 8, 1990, 55 FR 8476
Hematology and Pathology Devices; Premarket Approval of the Automated Blood Cell Separator Intended for Routine Collection of Blood and Blood Components85N-0241February 19, 1988, 53 FR 5108
New Drugs for Human Use: Proposed Clarification of Requirements for Application Supplements86N-0077June 4, 1986, 51 FR 20310
Quality Standard for Foods With No Identity Standards; Bottled Water86N-0445September 16, 1988, 53 FR 36063
Pineapple Juice; Proposal to Amend U.S. Standards of Identity and Quality86P-0338May 21, 1987, 52 FR 19169
New Animal Drug Regulations88N-0058December 17, 1991, 56 FR 65544
Current Good Manufacturing Practices for Blood and Blood Components; Proficiency Testing Requirements88N-0413June 6, 1989, 54 FR 24296
Canned Pineapple; Proposal to Amend Standards of Identity and Quality88P-0224March 24, 1989, 54 FR 12237
Shellac and Shellac Wax; Proposed Affirmation of GRAS Status With Specific Limitations as Direct Human Food Ingredients89N-0106July 26, 1989, 54 FR 31055
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Erythromycin Capsules; Proposed Amendment of Dissolution Standard of Erythromycin Capsules89N-03781October 26, 1989, 54 FR 43592
Yogurt Products; Frozen Yogurt, Frozen Lowfat Yogurt, and Frozen Nonfat Yogurt; Petitions to Establish Standards of Indentity and to Amend the Existing Standards89P-0208 and 89P-0444May 31, 1991, 56 FR 24760
Exemption From Preemption of State and Local Hearing Aid Requirements; Vermont89P-0314October 30, 1990, 55 FR 45615
Amend Animal Care Regulations89P-0320July 3, 1990, 55 FR 27476
Food Labeling; Declaration of Ingredients; Common or Usual Name Declaration for Protein Hydrolysates and Vegetable Broth in Canned Tuna; “and/or” Labeling for Soft Drinks90N-361MJanuary 6, 1993, 58 FR 2950
Use of Aseptic Processing and Terminal Sterilization in the Preparation of Sterile Pharmaceuticals for Human and Veterinary Use91N-0074October 11, 1991, 56 FR 51354
Cosmetic Products Containing Certain Hormone Ingredients; Notice of Proposed Rulemaking91N-0245September 9, 1993, 58 FR 47611
Substances in Food-Contact Articles in the Household, Food Service Establishments, and Food Dispensing Equipment91N-0313April 12, 1974, 39 FR 13285
Drug Listing Compliance Verification Reports92N-0291September 2, 1993, 58 FR 46587
Food Labeling; Metric Labeling Requirements92N-0406May 21, 1993, 58 FR 29716
Food Labeling; Net Quantity of Contents; Compliance92P-0441March 4, 1997, 62 FR 9826
Cardiovascular Devices; Effective Date of Requirement for PMA of Nonroller-Type Cardiopulmonary Bypass Blood Pump93M-0150July 6, 1993, 58 FR 36290
Amendment of Performance Standards; Laser Products93N-0044March 24, 1999, 64 FR 14180
Quality Standards for Foods With No Identity Standards; Bottled Water93N-0200October 6, 1993, 58 FR 52042
Metric Labeling; Quantity of Contents Labeling Requirement for Foods, Human and Animal Drugs, Animal Foods, Cosmetics, and Medical Devices92N-0406 and 93N-0226December 21, 1993, 58 FR 67444
Lead in Food and Color Additives and GRAS Ingredients; Request for Data93N-0348February 4, 1994, 59 FR 5363
Substances Prohibited From Use in Animal Food or Feed; Specified Offal From Adult Sheep and Goats Prohibited in Ruminant Feed; Scrapie93N-0467August 29, 1994, 59 FR 44584
Dental Devices; Effective Date of Requirement for Premarket Approval of Over-the-Counter (OTC) Denture Cushions or Pads and OTC Denture Repair Kits95N-0034July 11, 1995, 60 FR 35713
Food Labeling; Nutrient Content Claims and Health Claims; Special Requirements95N-0103February 2, 1996, 61 FR 3885
Maltodextrin; Food Chemicals Codex Specifications95N-0189September 21, 1995, 60 FR 48939
Beverages: Bottled Water95N-0203November 13, 1995, 60 FR 57132
Dental Devices; Effective Date of Requirement for Premarket Approval of Partially Fabricated Denture Kits95N-0298November 29, 1995, 60 FR 61232
Yogurt; Low Fat And Non-Fat, Revocation95P-0250November 9, 1995, 60 FR 56541
Food Standards; Reinvention of Regulations Needing Revisions; Request for Comments on Certain Existing Regulations96N-0149June 12, 1996, 61 FR 29701
Reinvention of Certain Food Additive Regulations96N-0177June 12, 1996, 61 FR 29711
Food Labeling; Declaration of Free Glutamate in Food96N-0244September 12, 1996, 61 FR 48102
Regulation of Medical Foods96N-0364November 29, 1996, 61 FR 60661
Food Labeling: Nutrient Content Claims Pertaining to the Available Fat Content of Food96N-0421 and 94P-0453/CP1December 20, 1996, 61 FR 67243
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Food Labeling; Serving Sizes; Reference Amounts for Candies96P-0023 and 96P-0179January 8, 1998, 63 FR 1078
1 Denotes documents that were included in the December 1991 withdrawal notice, but were not withdrawn at that time.

II. Submission of Comments

Interested persons may submit to the Dockets Management Branch (see ADDRESSES) written or electronic comments regarding this proposal. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

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Dated: April 10, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 03-9865 Filed 4-21-03; 8:45 am]