[Federal Register Volume 68, Number 77 (Tuesday, April 22, 2003)]
[Proposed Rules]
[Pages 19766-19770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9865]


=======================================================================
-----------------------------------------------------------------------

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

[[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
------------------------------------------------------------------------

[[Page 19769]]

 
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
------------------------------------------------------------------------

[[Page 19770]]

 
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.

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