68 FR 77 pgs. 19766-19770 - Withdrawal of Certain Proposed Rules and Other Proposed Actions; Notice of Intent
Type: PRORULEVolume: 68Number: 77Pages: 19766 - 19770
Docket number: [Docket No. 02N-0434]
FR document: [FR Doc. 03-9865 Filed 4-21-03; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. 02N-0434]
Withdrawal of Certain Proposed Rules and Other Proposed Actions; Notice of Intent
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of intent.
SUMMARY:
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.
DATES:
Submit written or electronic comments by July 21, 2003.
ADDRESSES:
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 http://www.fda.gov/dockets/ecomments .
FOR FURTHER INFORMATION CONTACT:
Lisa M. Helmanis, Regulations Policy and Management Staff (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.
SUPPLEMENTARY INFORMATION:
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 announces its intent to withdraw the following documents, published in the Federal Register on the dates indicated in table 1:
| Title | Docket No. | FR publication date and cite |
|---|---|---|
| Radioactive Drugs, Including Biological Products | 75N-0069 | July 25, 1975, 40 FR 31314 |
| Conditions for Use of Methadone | 75N-0125 | April 29, 1976, 41 FR 17922 |
| Pasteurized Milk Ordinance and Interstate Milk Shippers | 75N-0243 | May 5, 1975, 40 FR 19513 |
| Oral Contraceptive Drug Products; Physician and Patient Labeling | 75N-0304 | December 7, 1976, 41 FR 53633 |
| Penicillin Streptomycin Powder; Penicillin-Dihydrostreptomycin Powder; Proposed Revocation of Certification Provision | 75N-0374 | July 9, 1976, 41 FR 28313 |
| Conditions for Use of Methadone; Physiologic Dependence, Staffing, and Urine Testing Requirements | 76N-0098 | April 29, 1976, 41 FR 17926 |
| Sorbic Acid and Its Salts; Proposed Affirmation and Deletion of GRAS Status | 77G-03791 | March 10, 1978, 43 FR 9823 |
| Butylated Hydroxytoluene; Use Restrictions | 77N-00031 | May 31, 1977, 42 FR 27603 |
| Color Additives; Proposed Use of Abbreviations for Labeling Foods, Drugs, Cosmetics, and Medical Devices | 77N-0009 and 78P-0164 | June 6, 1985, 50 FR 23815 |
| Brown and Yellow Mustard and Their Derivatives; Proposed Affirmation of GRAS Status as Direct Human Food Ingredients | 77N-00331 | August 26, 1977, 42 FR 43092 |
| Acrylonitrile Copolymers Intended for Use in Contact With Food; Proposed Rulemaking | 77N-0078 | March 11, 1977, 42 FR 13562 |
| Gelatin; Affirmation of GRAS Status as a Direct and Indirect Human Food Ingredient | 77N-02321 | November 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 Tetracycline | 77N-0318 | January 20, 1978, 43 FR 3032 |
| Ethylene Oxide, Ethylene Chlorohydrin, and Ethylene Glycol; Proposed Maximum Residue Limits and Maximun Daily Levels of Exposure | 77N-04241 | June 23, 1978, 43 FR 27474 |
| Label Designation of Ingredients in Cheese and Cheese Products | 77P-0146 | July 19, 1984, 49 FR 29242 |
| Food Chemicals Codex Monographs; Opportunity for Public Comment on Revisions | 78N-0072 | April 18, 1978, 43 FR 16413 |
| Cellulose Derivatives; Affirmation of GRAS Status | 78N-01441 | February 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 Ingredients | 78N-02131 | October 27, 1978, 43 FR 50193 |
| Chlortetracycline-Sulfamethazine Tablets | 78N-0247 | September 22, 1978, 43 FR 43036 |
| Phosphates; Proposed Affirmation of and Deletion From GRAS Status as Direct and Human Food Ingredients | 78N-0272 | December 18, 1979, 44 FR 74845 |
| Biotin; Proposed Affirmation of GRAS Status | 78N-03081 | January 14, 1983, 48 FR 1739 |
| Lard and Lard Oil; Proposed Affirmation of GRAS Status as Indirect Human Food Ingredients | 78N-03361 | May 18, 1979, 44 FR 29102 |
| Glycerin; Affirmation of GRAS Status as a Direct Human Food Ingredient | 78N-03481 | February 8, 1983, 48 FR 5758 |
| Medical Devices; Sponges for Internal Use | 78N-1074 | November 28, 1976, 43 FR 55697 |
| Medical Devices; Classification of Powered Myoelectric Biofeedback Equipment | 78N-1183 | August 28, 1979, 44 FR 50464 |
| Porcine burn dressing | 78N-2670 | January 19, 1982, 47 FR 2828 |
| Food Ingredient Labeling, Emulsifiers, and Stabilizers (Carob Bean Gum); Exemptions | 78P-0052 | April 17, 1985, 50 FR 15177 |
| Sodium Dithionite and Zinc Dithionite; Proposed Affirmation of GRAS Status | 79N-00951 | January 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 Products | 79P-0265 | April 1, 1983, 48 FR 14003 |
| Hydrochloric Acid; Proposed Affirmation of GRAS Status as a Direct Human Food Ingredient | 80N-01481 | April 26, 1984, 49 FR 17966 |
| Cheeses and Related Cheese Products; General Standard of Identity for "Certain Other Cheeses" | 80N-0373 | April 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 Study | 80N-04181 | October 21, 1980, 45 FR 69817 |
| Policy for Regulating Carcinogenic Chemicals in Food and Color Additives; Advance Notice of Proposed Rulemaking | 81N-0281 | April 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 Ingredients | 81N-0382 | October 29, 1982, 47 FR 49028 |
| Protein Hydrolysates and Enzymatically Hydrolyzed Animal (Milk Casein) Protein; Proposed GRAS Status | 82N-00061 | December 8, 1983, 48 FR 54990 |
| Zinc Salts; Proposed Affirmation of GRAS Status | 82N-01671 | October 26, 1982, 47 FR 47441 |
| Regenerated Collagen; Proposed GRAS Status as a Direct Human Food Ingredient | 82N-02191 | April 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 Ingredients | 82N-02461 | January 14, 1983, 48 FR 1735 |
| Caffeine in Nonalcoholic Carbonated Beverages | 82N-0318 | May 20, 1987, 52 FR 18923 |
| Common or Usual Names for Nonstandardized Foods; Diluted Fruit or Vegetable Juice Beverages | 82N-0389 | June 1, 1984, 49 FR 22831 |
| Reclassification of Electroconvulsive Therapy | 82P-0316 | September 5, 1990, 55 FR 36578 |
| New Drug and Antibiotic Application Review; Proposed User Charge | 84N-0101 | August 6, 1985, 50 FR 31726 |
| Proposed Uses of Vinyl Chloride Polymers | 84N-0334 | February 3, 1986, 51 FR 4177 |
| Unmodified Food Starches and Acid-Modified Starches; Proposed Affirmation of GRAS Status as Direct and Indirect Food Ingredients | 84N-03411 | April 1, 1985, 50 FR 12821 |
| Use of Acrylonitrile Copolymers | 85N-0145 | March 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 Components | 85N-0241 | February 19, 1988, 53 FR 5108 |
| New Drugs for Human Use: Proposed Clarification of Requirements for Application Supplements | 86N-0077 | June 4, 1986, 51 FR 20310 |
| Quality Standard for Foods With No Identity Standards; Bottled Water | 86N-0445 | September 16, 1988, 53 FR 36063 |
| Pineapple Juice; Proposal to Amend U.S. Standards of Identity and Quality | 86P-0338 | May 21, 1987, 52 FR 19169 |
| New Animal Drug Regulations | 88N-0058 | December 17, 1991, 56 FR 65544 |
| Current Good Manufacturing Practices for Blood and Blood Components; Proficiency Testing Requirements | 88N-0413 | June 6, 1989, 54 FR 24296 |
| Canned Pineapple; Proposal to Amend Standards of Identity and Quality | 88P-0224 | March 24, 1989, 54 FR 12237 |
| Shellac and Shellac Wax; Proposed Affirmation of GRAS Status With Specific Limitations as Direct Human Food Ingredients | 89N-0106 | July 26, 1989, 54 FR 31055 |
| Erythromycin Capsules; Proposed Amendment of Dissolution Standard of Erythromycin Capsules | 89N-03781 | October 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 Standards | 89P-0208 and 89P-0444 | May 31, 1991, 56 FR 24760 |
| Exemption From Preemption of State and Local Hearing Aid Requirements; Vermont | 89P-0314 | October 30, 1990, 55 FR 45615 |
| Amend Animal Care Regulations | 89P-0320 | July 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 Drinks | 90N-361M | January 6, 1993, 58 FR 2950 |
| Use of Aseptic Processing and Terminal Sterilization in the Preparation of Sterile Pharmaceuticals for Human and Veterinary Use | 91N-0074 | October 11, 1991, 56 FR 51354 |
| Cosmetic Products Containing Certain Hormone Ingredients; Notice of Proposed Rulemaking | 91N-0245 | September 9, 1993, 58 FR 47611 |
| Substances in Food-Contact Articles in the Household, Food Service Establishments, and Food Dispensing Equipment | 91N-0313 | April 12, 1974, 39 FR 13285 |
| Drug Listing Compliance Verification Reports | 92N-0291 | September 2, 1993, 58 FR 46587 |
| Food Labeling; Metric Labeling Requirements | 92N-0406 | May 21, 1993, 58 FR 29716 |
| Food Labeling; Net Quantity of Contents; Compliance | 92P-0441 | March 4, 1997, 62 FR 9826 |
| Cardiovascular Devices; Effective Date of Requirement for PMA of Nonroller-Type Cardiopulmonary Bypass Blood Pump | 93M-0150 | July 6, 1993, 58 FR 36290 |
| Amendment of Performance Standards; Laser Products | 93N-0044 | March 24, 1999, 64 FR 14180 |
| Quality Standards for Foods With No Identity Standards; Bottled Water | 93N-0200 | October 6, 1993, 58 FR 52042 |
| Metric Labeling; Quantity of Contents Labeling Requirement for Foods, Human and Animal Drugs, Animal Foods, Cosmetics, and Medical Devices | 92N-0406 and 93N-0226 | December 21, 1993, 58 FR 67444 |
| Lead in Food and Color Additives and GRAS Ingredients; Request for Data | 93N-0348 | February 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; Scrapie | 93N-0467 | August 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 Kits | 95N-0034 | July 11, 1995, 60 FR 35713 |
| Food Labeling; Nutrient Content Claims and Health Claims; Special Requirements | 95N-0103 | February 2, 1996, 61 FR 3885 |
| Maltodextrin; Food Chemicals Codex Specifications | 95N-0189 | September 21, 1995, 60 FR 48939 |
| Beverages: Bottled Water | 95N-0203 | November 13, 1995, 60 FR 57132 |
| Dental Devices; Effective Date of Requirement for Premarket Approval of Partially Fabricated Denture Kits | 95N-0298 | November 29, 1995, 60 FR 61232 |
| Yogurt; Low Fat And Non-Fat, Revocation | 95P-0250 | November 9, 1995, 60 FR 56541 |
| Food Standards; Reinvention of Regulations Needing Revisions; Request for Comments on Certain Existing Regulations | 96N-0149 | June 12, 1996, 61 FR 29701 |
| Reinvention of Certain Food Additive Regulations | 96N-0177 | June 12, 1996, 61 FR 29711 |
| Food Labeling; Declaration of Free Glutamate in Food | 96N-0244 | September 12, 1996, 61 FR 48102 |
| Regulation of Medical Foods | 96N-0364 | November 29, 1996, 61 FR 60661 |
| Food Labeling: Nutrient Content Claims Pertaining to the Available Fat Content of Food | 96N-0421 and 94P-0453/CP1 | December 20, 1996, 61 FR 67243 |
| Food Labeling; Serving Sizes; Reference Amounts for Candies | 96P-0023 and 96P-0179 | January 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.
Dated: April 10, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-9865 Filed 4-21-03; 8:45 am]
BILLING CODE 4160-01-S