[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]
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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.
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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.
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FR publication
Title Docket No. date and cite
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Radioactive Drugs, Including 75N-0069 July 25, 1975, 40
Biological Products FR 31314
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Conditions for Use of Methadone 75N-0125 April 29, 1976, 41
FR 17922
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Pasteurized Milk Ordinance and 75N-0243 May 5, 1975, 40 FR
Interstate Milk Shippers 19513
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Oral Contraceptive Drug Products; 75N-0304 December 7, 1976,
Physician and Patient Labeling 41 FR 53633
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Penicillin Streptomycin Powder; 75N-0374 July 9, 1976, 41
Penicillin--Dihydrostreptomycin FR 28313
Powder; Proposed Revocation of
Certification Provision
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Conditions for Use of Methadone; 76N-0098 April 29, 1976, 41
Physiologic Dependence, Staffing, FR 17926
and Urine Testing Requirements
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Sorbic Acid and Its Salts; Proposed 77G-0379\1\ March 10, 1978, 43
Affirmation and Deletion of GRAS FR 9823
Status
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Butylated Hydroxytoluene; Use 77N-0003\1\ May 31, 1977, 42
Restrictions FR 27603
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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
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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
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Acrylonitrile Copolymers Intended for 77N-0078 March 11, 1977, 42
Use in Contact With Food; Proposed FR 13562
Rulemaking
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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)
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New Animal Drugs for Use in Animal 77N-0318 January 20, 1978,
Feeds; Animal Feeds Containing 43 FR 3032
Penicillin and Tetracycline
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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
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Label Designation of Ingredients in 77P-0146 July 19, 1984, 49
Cheese and Cheese Products FR 29242
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Food Chemicals Codex Monographs; 78N-0072 April 18, 1978, 43
Opportunity for Public Comment on FR 16413
Revisions
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Cellulose Derivatives; Affirmation of 78N-0144\1\ February 23, 1979,
GRAS Status 44 FR 10751
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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
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Chlortetracycline-Sulfamethazine 78N-0247 September 22,
Tablets 1978, 43 FR 43036
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Phosphates; Proposed Affirmation of 78N-0272 December 18, 1979,
and Deletion From GRAS Status as 44 FR 74845
Direct and Human Food Ingredients
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Biotin; Proposed Affirmation of GRAS 78N-0308\1\ January 14, 1983,
Status 48 FR 1739
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Lard and Lard Oil; Proposed 78N-0336\1\ May 18, 1979, 44
Affirmation of GRAS Status as FR 29102
Indirect Human Food Ingredients
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Glycerin; Affirmation of GRAS Status 78N-0348\1\ February 8, 1983,
as a Direct Human Food Ingredient 48 FR 5758
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Medical Devices; Sponges for Internal 78N-1074 November 28, 1976,
Use 43 FR 55697
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Medical Devices; Classification of 78N-1183 August 28, 1979,
Powered Myoelectric Biofeedback 44 FR 50464
Equipment
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Porcine burn dressing 78N-2670 January 19, 1982,
47 FR 2828
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Food Ingredient Labeling, 78P-0052 April 17, 1985, 50
Emulsifiers, and Stabilizers (Carob FR 15177
Bean Gum); Exemptions
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[[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)
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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
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Hydrochloric Acid; Proposed 80N-0148\1\ April 26, 1984, 49
Affirmation of GRAS Status as a FR 17966
Direct Human Food Ingredient
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Cheeses and Related Cheese Products; 80N-0373 April 23, 1984, 49
General Standard of Identity for FR 17018
``Certain Other Cheeses''
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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
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Policy for Regulating Carcinogenic 81N-0281 April 2, 1982, 47
Chemicals in Food and Color FR 14464
Additives; Advance Notice of
Proposed Rulemaking
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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
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Protein Hydrolysates and 82N-0006\1\ December 8, 1983,
Enzymatically Hydrolyzed Animal 48 FR 54990
(Milk Casein) Protein; Proposed GRAS
Status
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Zinc Salts; Proposed Affirmation of 82N-0167\1\ October 26, 1982,
GRAS Status 47 FR 47441
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Regenerated Collagen; Proposed GRAS 82N-0219\1\ April 26, 1983, 48
Status as a Direct Human Food FR 18833
Ingredient
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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
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Caffeine in Nonalcoholic Carbonated 82N-0318 May 20, 1987, 52
Beverages FR 18923
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Common or Usual Names for 82N-0389 June 1, 1984, 49
Nonstandardized Foods; Diluted Fruit FR 22831
or Vegetable Juice Beverages
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Reclassification of Electroconvulsive 82P-0316 September 5, 1990,
Therapy 55 FR 36578
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New Drug and Antibiotic Application 84N-0101 August 6, 1985, 50
Review; Proposed User Charge FR 31726
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Proposed Uses of Vinyl Chloride 84N-0334 February 3, 1986,
Polymers 51 FR 4177
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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
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Use of Acrylonitrile Copolymers 85N-0145 March 8, 1990, 55
FR 8476
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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
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New Drugs for Human Use: Proposed 86N-0077 June 4, 1986, 51
Clarification of Requirements for FR 20310
Application Supplements
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Quality Standard for Foods With No 86N-0445 September 16,
Identity Standards; Bottled Water 1988, 53 FR 36063
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Pineapple Juice; Proposal to Amend 86P-0338 May 21, 1987, 52
U.S. Standards of Identity and FR 19169
Quality
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New Animal Drug Regulations 88N-0058 December 17, 1991,
56 FR 65544
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Current Good Manufacturing Practices 88N-0413 June 6, 1989, 54
for Blood and Blood Components; FR 24296
Proficiency Testing Requirements
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Canned Pineapple; Proposal to Amend 88P-0224 March 24, 1989, 54
Standards of Identity and Quality FR 12237
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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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[[Page 19769]]
Erythromycin Capsules; Proposed 89N-0378\1\ October 26, 1989,
Amendment of Dissolution Standard of 54 FR 43592
Erythromycin Capsules
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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
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Exemption From Preemption of State 89P-0314 October 30, 1990,
and Local Hearing Aid Requirements; 55 FR 45615
Vermont
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Amend Animal Care Regulations 89P-0320 July 3, 1990, 55
FR 27476
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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
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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
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Cosmetic Products Containing Certain 91N-0245 September 9, 1993,
Hormone Ingredients; Notice of 58 FR 47611
Proposed Rulemaking
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Substances in Food-Contact Articles 91N-0313 April 12, 1974, 39
in the Household, Food Service FR 13285
Establishments, and Food Dispensing
Equipment
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Drug Listing Compliance Verification 92N-0291 September 2, 1993,
Reports 58 FR 46587
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Food Labeling; Metric Labeling 92N-0406 May 21, 1993, 58
Requirements FR 29716
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Food Labeling; Net Quantity of 92P-0441 March 4, 1997, 62
Contents; Compliance FR 9826
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Cardiovascular Devices; Effective 93M-0150 July 6, 1993, 58
Date of Requirement for PMA of FR 36290
Nonroller-Type Cardiopulmonary
Bypass Blood Pump
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Amendment of Performance Standards; 93N-0044 March 24, 1999, 64
Laser Products FR 14180
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Quality Standards for Foods With No 93N-0200 October 6, 1993,
Identity Standards; Bottled Water 58 FR 52042
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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
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Lead in Food and Color Additives and 93N-0348 February 4, 1994,
GRAS Ingredients; Request for Data 59 FR 5363
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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
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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
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Food Labeling; Nutrient Content 95N-0103 February 2, 1996,
Claims and Health Claims; Special 61 FR 3885
Requirements
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Maltodextrin; Food Chemicals Codex 95N-0189 September 21,
Specifications 1995, 60 FR 48939
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Beverages: Bottled Water 95N-0203 November 13, 1995,
60 FR 57132
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Dental Devices; Effective Date of 95N-0298 November 29, 1995,
Requirement for Premarket Approval 60 FR 61232
of Partially Fabricated Denture Kits
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Yogurt; Low Fat And Non-Fat, 95P-0250 November 9, 1995,
Revocation 60 FR 56541
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Food Standards; Reinvention of 96N-0149 June 12, 1996, 61
Regulations Needing Revisions; FR 29701
Request for Comments on Certain
Existing Regulations
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Reinvention of Certain Food Additive 96N-0177 June 12, 1996, 61
Regulations FR 29711
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Food Labeling; Declaration of Free 96N-0244 September 12,
Glutamate in Food 1996, 61 FR 48102
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Regulation of Medical Foods 96N-0364 November 29, 1996,
61 FR 60661
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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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[[Page 19770]]
Food Labeling; Serving Sizes; 96P-0023 and January 8, 1998,
Reference Amounts for Candies 96P-0179 63 FR 1078
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\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