Proposed rules and actions (84) published in Federal Register over 5 years ago; notice of intent to withdraw,
[Federal Register: April 22, 2003 (Volume 68, Number 77)]
[Proposed Rules]
[Page 19766-19770]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ap03-21]
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.
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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
[[Page 19767]]
announces its intent to withdraw the following documents, published in the Federal Register on the dates indicated in table 1:
Table 1.
FR publication Title
Docket No. date and cite
Radioactive Drugs, Including
75N-0069 July 25, 1975, 40 Biological Products
FR 31314
Conditions for Use of Methadone
75N-0125 April 29, 1976, 41 FR 17922
Pasteurized Milk Ordinance and
75N-0243 May 5, 1975, 40 FR Interstate Milk Shippers
19513
Oral Contraceptive Drug Products; 75N-0304 December 7, 1976, Physician and Patient Labeling
41 FR 53633
Penicillin Streptomycin Powder;
75N-0374 July 9, 1976, 41 Penicillin--Dihydrostreptomycin
FR 28313 Powder; Proposed Revocation of Certification Provision
Conditions for Use of Methadone; 76N-0098 April 29, 1976, 41 Physiologic Dependence, Staffing,
FR 17926 and Urine Testing Requirements
Sorbic Acid and Its Salts; Proposed 77G-0379\1\ March 10, 1978, 43 Affirmation and Deletion of GRAS
FR 9823 Status
Butylated Hydroxytoluene; Use
77N-0003\1\ May 31, 1977, 42 Restrictions
FR 27603
Color Additives; Proposed Use of 77N-0009 and June 6, 1985, 50 Abbreviations for Labeling Foods, 78P-0164 FR 23815 Drugs, Cosmetics, and Medical Devices
Brown and Yellow Mustard and Their 77N-0033\1\ August 26, 1977, Derivatives; Proposed Affirmation of
42 FR 43092 GRAS Status as Direct Human Food Ingredients
Acrylonitrile Copolymers Intended for 77N-0078 March 11, 1977, 42 Use in Contact With Food; Proposed
FR 13562 Rulemaking
Gelatin; Affirmation of GRAS Status 77N-0232\1\ November 11, 1977, as a Direct and Indirect Human Food
42 FR 58763 and Ingredient
May 12, 1993, 58 FR 27959 (Tentative final rule)
New Animal Drugs for Use in Animal 77N-0318 January 20, 1978, Feeds; Animal Feeds Containing
43 FR 3032 Penicillin and Tetracycline
Ethylene Oxide, Ethylene
77N-0424\1\ June 23, 1978, 43 Chlorohydrin, and Ethylene Glycol;
FR 27474 Proposed Maximum Residue Limits and Maximun Daily Levels of Exposure
Label Designation of Ingredients in 77P-0146 July 19, 1984, 49 Cheese and Cheese Products
FR 29242
Food Chemicals Codex Monographs; 78N-0072 April 18, 1978, 43 Opportunity for Public Comment on
FR 16413 Revisions
Cellulose Derivatives; Affirmation of 78N-0144\1\ February 23, 1979, GRAS Status
44 FR 10751
Tocopherols and Derivatives; Proposed 78N-0213\1\ October 27, 1978, Affirmation of GRAS Status for
43 FR 50193 Certain Tocopherols and Removal of Certain Others From GRAS Status as Direct Human Food Ingredients
Chlortetracycline-Sulfamethazine 78N-0247 September 22, Tablets
1978, 43 FR 43036
Phosphates; Proposed Affirmation of 78N-0272 December 18, 1979, and Deletion From GRAS Status as
44 FR 74845 Direct and Human Food Ingredients
Biotin; Proposed Affirmation of GRAS 78N-0308\1\ January 14, 1983, Status
48 FR 1739
Lard and Lard Oil; Proposed
78N-0336\1\ May 18, 1979, 44 Affirmation of GRAS Status as
FR 29102 Indirect Human Food Ingredients
Glycerin; Affirmation of GRAS Status 78N-0348\1\ February 8, 1983, as a Direct Human Food Ingredient
48 FR 5758
Medical Devices; Sponges for Internal 78N-1074 November 28, 1976, Use
43 FR 55697
Medical Devices; Classification of 78N-1183 August 28, 1979, Powered Myoelectric Biofeedback
44 FR 50464 Equipment
Porcine burn dressing
78N-2670 January 19, 1982, 47 FR 2828
Food Ingredient Labeling,
78P-0052 April 17, 1985, 50 Emulsifiers, and Stabilizers (Carob
FR 15177 Bean Gum); Exemptions
[[Page 19768]]
Sodium Dithionite and Zinc
79N-0095\1\ January 25, 1980, Dithionite; Proposed Affirmation of
45 FR 6117 and GRAS Status
September 17, 1982, 47 FR 41137 (Tentative final rule)
Current Good Manufacturing Practice 79P-0265 April 1, 1983, 48 in Manufacture Processing, Packing,
FR 14003 or Holding; Proposed Exemption From Active Ingredient Identity and Strength Testing for Homoeopathic Drug Products
Hydrochloric Acid; Proposed
80N-0148\1\ April 26, 1984, 49 Affirmation of GRAS Status as a
FR 17966 Direct Human Food Ingredient
Cheeses and Related Cheese Products; 80N-0373 April 23, 1984, 49 General Standard of Identity for
FR 17018 ``Certain Other Cheeses''
Caffeine; Deletion of GRAS Status, 80N-0418\1\ October 21, 1980, Proposed Declaration That No Prior
45 FR 69817 Sanction Exists, and Use on an Interim Basis Pending Additional Study
Policy for Regulating Carcinogenic 81N-0281 April 2, 1982, 47 Chemicals in Food and Color
FR 14464 Additives; Advance Notice of Proposed Rulemaking
Magnesium Gluconate, Potassium
81N-0382 October 29, 1982, Gluconate, Sodium Gluconate, Zinc
47 FR 49028 Gluconate, and Gluconic Acid; Proposed GRAS Status as Direct and Indirect Human Food Ingredients
Protein Hydrolysates and
82N-0006\1\ December 8, 1983, Enzymatically Hydrolyzed Animal
48 FR 54990 (Milk Casein) Protein; Proposed GRAS Status
Zinc Salts; Proposed Affirmation of 82N-0167\1\ October 26, 1982, GRAS Status
47 FR 47441
Regenerated Collagen; Proposed GRAS 82N-0219\1\ April 26, 1983, 48 Status as a Direct Human Food
FR 18833 Ingredient
Ascorbic Acid and Its Sodium and 82N-0246\1\ January 14, 1983, Calcium Salts, Erythorbic Acid and
48 FR 1735 Its Sodium Salt, and Ascorbyl Palmitate; Proposed Affirmation of GRAS Status and Removal of Calcium Ascorbate From the List of GRAS Ingredients
Caffeine in Nonalcoholic Carbonated 82N-0318 May 20, 1987, 52 Beverages
FR 18923
Common or Usual Names for
82N-0389 June 1, 1984, 49 Nonstandardized Foods; Diluted Fruit
FR 22831 or Vegetable Juice Beverages
Reclassification of Electroconvulsive 82P-0316 September 5, 1990, Therapy
55 FR 36578
New Drug and Antibiotic Application 84N-0101 August 6, 1985, 50 Review; Proposed User Charge
FR 31726
Proposed Uses of Vinyl Chloride
84N-0334 February 3, 1986, Polymers
51 FR 4177
Unmodified Food Starches and Acid- 84N-0341\1\ April 1, 1985, 50 Modified Starches; Proposed
FR 12821 Affirmation of GRAS Status as Direct and Indirect Food Ingredients
Use of Acrylonitrile Copolymers
85N-0145 March 8, 1990, 55 FR 8476
Hematology and Pathology Devices; 85N-0241 February 19, 1988, Premarket Approval of the Automated
53 FR 5108 Blood Cell Separator Intended for Routine Collection of Blood and Blood Components
New Drugs for Human Use: Proposed 86N-0077 June 4, 1986, 51 Clarification of Requirements for
FR 20310 Application Supplements
Quality Standard for Foods With No 86N-0445 September 16, Identity Standards; Bottled Water
1988, 53 FR 36063
Pineapple Juice; Proposal to Amend 86P-0338 May 21, 1987, 52 U.S. Standards of Identity and
FR 19169 Quality
New Animal Drug Regulations
88N-0058 December 17, 1991, 56 FR 65544
Current Good Manufacturing Practices 88N-0413 June 6, 1989, 54 for Blood and Blood Components;
FR 24296 Proficiency Testing Requirements
Canned Pineapple; Proposal to Amend 88P-0224 March 24, 1989, 54 Standards of Identity and Quality
FR 12237
Shellac and Shellac Wax; Proposed 89N-0106 July 26, 1989, 54 Affirmation of GRAS Status With
FR 31055 Specific Limitations as Direct Human Food Ingredients
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Erythromycin Capsules; Proposed
89N-0378\1\ October 26, 1989, Amendment of Dissolution Standard of
54 FR 43592 Erythromycin Capsules
Yogurt Products; Frozen Yogurt,
89P-0208 and May 31, 1991, 56 Frozen Lowfat Yogurt, and Frozen 89P-0444 FR 24760 Nonfat Yogurt; Petitions to Establish Standards of Indentity and to Amend the Existing Standards
Exemption From Preemption of State 89P-0314 October 30, 1990, and Local Hearing Aid Requirements;
55 FR 45615 Vermont
Amend Animal Care Regulations
89P-0320 July 3, 1990, 55 FR 27476
Food Labeling; Declaration of
90N-361M January 6, 1993, Ingredients; Common or Usual Name
58 FR 2950 Declaration for Protein Hydrolysates and Vegetable Broth in Canned Tuna; ``and/or'' Labeling for Soft Drinks
Use of Aseptic Processing and
91N-0074 October 11, 1991, Terminal Sterilization in the
56 FR 51354 Preparation of Sterile Pharmaceuticals for Human and Veterinary Use
Cosmetic Products Containing Certain 91N-0245 September 9, 1993, Hormone Ingredients; Notice of
58 FR 47611 Proposed Rulemaking
Substances in Food-Contact Articles 91N-0313 April 12, 1974, 39 in the Household, Food Service
FR 13285 Establishments, and Food Dispensing Equipment
Drug Listing Compliance Verification 92N-0291 September 2, 1993, Reports
58 FR 46587
Food Labeling; Metric Labeling
92N-0406 May 21, 1993, 58 Requirements
FR 29716
Food Labeling; Net Quantity of
92P-0441 March 4, 1997, 62 Contents; Compliance
FR 9826
Cardiovascular Devices; Effective 93M-0150 July 6, 1993, 58 Date of Requirement for PMA of
FR 36290 Nonroller-Type Cardiopulmonary Bypass Blood Pump
Amendment of Performance Standards; 93N-0044 March 24, 1999, 64 Laser Products
FR 14180
Quality Standards for Foods With No 93N-0200 October 6, 1993, Identity Standards; Bottled Water
58 FR 52042
Metric Labeling; Quantity of Contents 92N-0406 and December 21, 1993, Labeling Requirement for Foods,
93N-0226 58 FR 67444 Human and Animal Drugs, Animal Foods, Cosmetics, and Medical Devices
Lead in Food and Color Additives and 93N-0348 February 4, 1994, GRAS Ingredients; Request for Data
59 FR 5363
Substances Prohibited From Use in 93N-0467 August 29, 1994, Animal Food or Feed; Specified Offal
59 FR 44584 From Adult Sheep and Goats Prohibited in Ruminant Feed; Scrapie
Dental Devices; Effective Date of 95N-0034 July 11, 1995, 60 Requirement for Premarket Approval
FR 35713 of Over-the-Counter (OTC) Denture Cushions or Pads and OTC Denture Repair Kits
Food Labeling; Nutrient Content
95N-0103 February 2, 1996, Claims and Health Claims; Special
61 FR 3885 Requirements
Maltodextrin; Food Chemicals Codex 95N-0189 September 21, Specifications
1995, 60 FR 48939
Beverages: Bottled Water
95N-0203 November 13, 1995, 60 FR 57132
Dental Devices; Effective Date of 95N-0298 November 29, 1995, Requirement for Premarket Approval
60 FR 61232 of Partially Fabricated Denture Kits
Yogurt; Low Fat And Non-Fat,
95P-0250 November 9, 1995, Revocation
60 FR 56541
Food Standards; Reinvention of
96N-0149 June 12, 1996, 61 Regulations Needing Revisions;
FR 29701 Request for Comments on Certain Existing Regulations
Reinvention of Certain Food Additive 96N-0177 June 12, 1996, 61 Regulations
FR 29711
Food Labeling; Declaration of Free 96N-0244 September 12, Glutamate in Food
1996, 61 FR 48102
Regulation of Medical Foods
96N-0364 November 29, 1996, 61 FR 60661
Food Labeling: Nutrient Content
96N-0421 and December 20, 1996, Claims Pertaining to the Available 94P-0453/CP1 61 FR 67243 Fat Content of Food
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Food Labeling; Serving Sizes;
96P-0023 and January 8, 1998, Reference Amounts for Candies
96P-0179 63 FR 1078
\1\Denotes documents that were included in the December 1991 withdrawal notice, but were not withdrawn at that time.
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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
