[Federal Register Volume 60, Number 198 (Friday, October 13, 1995)]
[Proposed Rules]
[Pages 53480-53487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25337]




[[Page 53479]]

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Part IV





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Parts 100, 101, et al.



Revocation fo Certain Regulations; Opportunity for Public Comment: 
Proposed Rule

  Federal Register / Vol. 60, No. 198 / Friday, October 13, 1995 / 
Proposed Rules  
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[[Page 53480]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 100, 101, 103, 104, 105, 109, 137, 161, 163, 182, 186, 
197, 200, 250, 310, 500, 505, 507, 508, 510, 570, 601, 620, 630, 
640, 650, 660, 680, 700, and 801

[Docket Nos. 95N-0310, 95N-310B, 95N-310F, 95N-310R, and 95N-310V]


Revocation of Certain Regulations; Opportunity for Public Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to revoke 
certain regulations that are obsolete or no longer necessary to achieve 
public health goals. These regulations have been identified for 
revocation as the result of a page-by-page review of the agency's 
regulations. This regulatory review is in response to the 
Administration's ``Reinventing Government'' initiative which seeks to 
streamline government to ease the burden on regulated industry and 
consumers.

DATES: Submit comments by January 11, 1996. The agency is proposing 
that any final rule that may issue based upon this proposal become 
effective 30 days after its publication in the Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:
    Regarding general information on FDA's ``reinventing initiative'': 
Lisa M. Helmanis, Office of Policy (HF-26), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-3480.
    Regarding food and cosmetic regulations: Corinne Howley, Center for 
Food Safety and Applied Nutrition (HFS-24), Food and Drug 
Administration, 200 C. St., Washington, DC 20004, 202-205-4272.
    Regarding drug regulations: Christine F. Rogers, Center for Drug 
Evaluation and Research (HFD-366), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2041.
    Regarding veterinary medicine regulations: Kristi O. Smedley, 
Center for Veterinary Medicine (HFV-238), Food and Drug Administration, 
7500 Standish Pl., Rockville, MD 20855, 301-594-1737.
    Regarding biologic regulations: Timothy W. Beth, Center for 
Biologics Evaluation and Research (HFM-635), Food and Drug 
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 208529-
1448, 301-594-3074.
    Regarding medical device and radiological health regulations: 
Joseph M. Sheehan, Center for Devices and Radiological Health (HFZ-84), 
Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 
301-594-4765.

SUPPLEMENTARY INFORMATION:

I. Background

    On March 4, 1995, President Clinton announced plans for the reform 
of the Federal regulatory system as part of the Administration's 
``Reinventing Government'' initiative. In his March 4 directive, the 
President ordered all Federal agencies to conduct a page-by-page review 
of all of their regulations and to ``eliminate or revise those that are 
outdated or otherwise in need of reform.'' The first results of FDA's 
efforts in implementing the President's plan are contained in this 
Federal Register document. This document announces the regulations that 
FDA is proposing to eliminate. In a separate, upcoming issue of the 
Federal Register, FDA intends to revise a number of regulations in 
response to the President's initiative.
    The following is a section-by-section analysis of the regulations 
that FDA is proposing to revoke. Each of FDA's Centers has conducted an 
analysis of the regulations in its respective area of responsibility. 
These analyses are set forth in the numerical order in which they 
appear in the Code of Federal Regulations (CFR).
    The sections that FDA is proposing to eliminate from the CFR 
follow.

II. Section-by-Section Analysis

A. Center for Food Safety and Applied Nutrition

    All comments submitted in response to the regulations in this 
section, and pertaining to the Center for Food Safety and Applied 
Nutrition should be identified with docket number 95N-310F.
    1. Section 100.120 Artificially red-dyed yellow varieties of sweet 
potatoes (21 CFR 100.120). This section addresses the adulteration of 
sweet potatoes with artificial coloring. This information can be more 
appropriately given as a statement of policy and need not appear in the 
CFR.
    2. Section 100.130 Combinations of nutritive and nonnutritive 
sweeteners in ``diet beverages'' (21 CFR 100.130). This section 
authorizes the mixture of nutritive sweeteners and saccharin to produce 
a product more acceptable to consumers. This administrative ruling 
became obsolete with the advent of additional nonnutritive sweeteners.
    3. Section 100.135 Disposition of incubator reject eggs (21 CFR 
100.135). This section addresses the introduction of adulterated eggs 
into interstate commerce. This information can be more appropriately 
given as a statement of policy and need not appear in the CFR.
    4. Section 100.140 Label declaration of salt in frozen vegetables 
(21 CFR 100.140). This section addresses the failure to disclose salt 
on the label of frozen vegetables. This section is unnecessary because 
coverage of this information in Sec. 101.4 Designation of ingredients 
(21 CFR 101.4) is sufficient.
    5. Section 100.145 Notice to packers of comminuted tomato products 
(21 CFR 100.145). This section addresses tomato rot. This 
administrative ruling can be more appropriately given as guidance and 
need not appear in the CFR.
    6. Section 100.150 Notice to packers and shippers of shelled 
peanuts (21 CFR 100.150). This section addresses failure to bear 
labeling on the bag as required by the Federal Food, Drug, and Cosmetic 
Act (the act). This section is unnecessary because coverage in 
Secs. 101.3 Identity statement, 101.5 Name and place of business of 
packer or distributor, and 101.105 Statement of net quantity of 
contents is sufficient.
    7. Section 100.160 Tolerances for moldy and insect-infested cocoa 
beans (21 CFR 100.160). This information can be more appropriately 
given as a statement of policy and need not appear in the CFR.
    8. Section 101.33 Label declaration of D-erythroascorbic acid when 
it is an ingredient of a fabricated food (21 CFR 101.33), is 
unnecessary because coverage in Sec. 101.4 Designation of ingredients 
is sufficient.
    9. Section 101.103 Petitions requesting exemptions from or special 
requirements for label declaration of ingredients (21 CFR 101.103) is 
duplicative. The procedures in Sec. 10.30 Citizen petition (21 CFR 
10.30) are sufficient.
    10. Part 103--Quality Standards for Foods With No Identity 
Standards (21 CFR part 103). The definition (103.3) and general 
principles (103.5) 

[[Page 53481]]
regulations in this part are no longer needed because there are no 
substantive regulations in this part; the agency has proposed to 
establish a standard of identity for bottled water in Sec. 165.110 (21 
CFR 165.110), and recodify the quality standard for bottled water 
(103.35).
    11. Section 104.19 Petitions (21 CFR 104.19). This section 
addresses the submission of petitions for a nutritional quality 
guideline for a class of foods and is duplicative; the procedures in 
Sec. 10.30 are sufficient.
    12. Section 105.67 Label statement relating to food for use in the 
diet of diabetics (21 CFR 105.67), is no longer in accord with current 
dietary advice for persons with diabetes. The regulations that FDA 
adopted in response to the Nutrition Labeling and Education Act of 1990 
(Pub. L. 101-535), and the new ingredient labeling regulations that FDA 
adopted, should ensure that food labels contain sufficient information 
to assist diabetics in making educated food choices.
    13. Section 105.69 Foods used to regulate sodium intake (21 CFR 
105.69) is in conflict with section 403(q) of the act because it allows 
for optional nutrition labeling of sodium, whereas the act requires 
that this information be disclosed.
    14. Section 109.5 Petitions (21 CFR 109.5). This section which 
addresses the submission of petitions for tolerances, regulatory 
limits, and action levels, is duplicative. The procedures in Sec. 10.30 
are sufficient.
    FDA is proposing to revoke the following regulations because they 
are either obsolete, unnecessary, or because they otherwise serve no 
public interest. In a future issue of the Federal Register, the agency 
will seek public comment on the remaining Food Standards not contained 
below.
    15. Section 137.230 Corn Grits (21 CFR 137.230).
    16. Section 137.235 Enriched corn grits (21 CFR 137.235).
    17. Section 137.240 Quick grits (21 CFR 137.240).
    18. Section 137.245 Yellow grits (21 CFR 137.245).
    19. Section 161.131 Extra large oysters (21 CFR 161.131).
    20. Section 161.132 Large oysters (21 CFR 161.132).
    21. Section 161.133 Medium oysters (21 CFR 161.133).
    22. Section 161.134 Small oysters (21 CFR 161.134).
    23. Section 161.135 Very small oysters (21 CFR 161.135).
    24. Section 161.137 Large Pacific oysters (21 CFR 161.137).
    25. Section 161.138 Medium Pacific oysters (21 CFR 161.138).
    26. Section 161.139 Small Pacific oysters (21 CFR 161.139).
    27. Section 161.140 Extra small Pacific oysters (21 CFR 161.140).
    28. Section 163.150 Sweet cocoa and vegetable fat coating (21 CFR 
163.150).
    29. Section 163.153 Sweet chocolate and vegetable fat coating (21 
CFR 163.153).
    30. Section 163.155 Milk chocolate and vegetable fat coating (21 
CFR 163.155).
    31. Subpart F-- Dietary Supplements of part 182 (21 CFR part 182). 
The 56 regulations under this subpart were made obsolete by the Dietary 
Supplement Health and Education Act of 1994 (Pub. L. 103-417), which 
exempted dietary ingredients of dietary supplements from food additive 
and GRAS regulations.
    32. Section 186.1025 Caprylic acid (21 CFR 186.1025) is duplicative 
as the ingredient is already listed as generally recognized as safe 
under Sec. 184.1025 (21 CFR 184.1025).
    33. Part 197--Seafood Inspection Program (21 CFR part 197). The 28 
regulations under this part are obsolete and no longer used by the 
agency or industry.
    34. Section 700.10 Shampoo preparations containing eggs as one of 
the ingredients (21 CFR 700.10). Coverage in section 701.1 is 
sufficient.

B. Center for Drug Evaluation and Research

    All comments submitted in response to the regulations in this 
section, and pertaining to the Center for Drug Evaluation and Research, 
should be identified with docket number 95N-310.
    1. Section 200.100 Use of ox bile from condemned livers from 
slaughtered animals in the manufacture of drugs (21 CFR 200.100). This 
section was issued in response to a question from the Department of 
Agriculture concerning whether it would violate the act to release, for 
use in drug manufacturing, ox bile obtained from the condemned livers 
of slaughtered animals. This section states that ox bile treated with 
sodium hydroxide and properly labeled may be released. This specific 
advice about nonviolation of the act can be more appropriately given in 
the form of a policy statement than a regulation and need not appear in 
the CFR.
    2. Section 200.101 Suprarenal glands from hog carcasses prior to 
final inspection (21 CFR 200.101). This section specifies how 
suprarenal glands from hog carcasses which are intended for use in drug 
manufacturing should be treated in order to eliminate microorganisms or 
toxins. This specific guidance about the processing of a drug component 
can be more appropriately given in the form of a policy statement than 
a regulation and need not appear in the CFR.
    3. Section 250.104 Status of salt substitutes under the Federal 
Food, Drug, and Cosmetic Act (21 CFR 250.104). In 1949, FDA announced 
that it would regard all salt substitutes as new drugs which required 
new drug applications (NDA's). This regulation states that FDA no 
longer regards all salt substitutes as new drugs, and provides that FDA 
will respond to requests as to whether a particular salt substitute 
requires an NDA. The agency opinion about the new drug status of a 
particular category of food additives can be more appropriately given 
in the form of a policy statement than a regulation and need not appear 
in the CFR.
    4. Section 250.203 Status of fluoridated water and foods prepared 
with fluoridated water (21 CFR 250.203). This section was issued in 
response to questions about the use of fluorine. The regulation states 
that the addition of fluorine to public water supplies is not 
actionable under the act as long as the Environmental Protection Agency 
(EPA) limits are observed. Similarly, the use of fluoridated water in 
commercially prepared foods is not actionable unless the process 
involves a significant concentration of fluorine from the water. This 
specific advice about nonviolation of the act can be more appropriately 
given in the form of a policy statement than a regulation and need not 
appear in the CFR.-
    5. Section 310.101 FD&C Red No. 4; procedure for discontinuing use 
in new drugs for ingestion; statement of policy (21 CFR 310.101). This 
section describes the conditions under which products with approved 
NDA's may discontinue using FD&C Red No. 4 and substitute a permitted 
color additive.-This section is unnecessary because there are no longer 
any ingested new drugs that use FD&C Red No. 4.
    6. Section 310.304 Drugs that are subjects of approved new drug 
applications and that require special studies, records, and reports (21 
CFR 310.304). This section relates only to methadone. It states that 
although there is a need for further safety and effectiveness data on 
methadone, methadone may be distributed under certain controlled 
conditions. Section 310.304 has been superseded by Secs. 291.501 and 
291.505 and therefore is obsolete.-

C. Center for Veterinary Medicine

    All comments submitted in response to the regulations in this 
section, and 

[[Page 53482]]
pertaining to the Center for Veterinary Medicine, should be identified 
with docket number 95N-310V.
    1. Section 500.49 Chlorofluorocarbon propellants (21 CFR 500.49). 
This section prohibits the use of chlorofluorocarbons as propellants in 
self-pressurized containers in animal drugs. Chlorofluorocarbons are 
prohibited by the Clean Air Act Amendments of 1990 (42 U.S.C. 7671) and 
can no longer be marketed for this use. This section is unnecessary 
because coverage in Sec. 2.125 (21 CFR 2.125) of this prohibition is 
sufficient.
    2. Section 505.3 Warnings on animal drugs intended for 
administration to diseased animals (21 CFR 505.3). This section states 
that no warning or caution statements recommended for use in the 
labeling of animal drugs intended for administration to diseased 
animals shall be construed to suggest or imply that a product of 
diseased animals is suitable for food use. This provision cautions 
against misuse of language in Sec. 505.20 which is now being withdrawn 
and is, therefore, unnecessary.
    3. Section 505.20 Recommended animal drug warning and caution 
statements (21 CFR 505.20). This section provides recommended animal 
drug warning and caution statements for specific drugs. The statements 
provided are voluntary label statements that do not contain 
requirements and need not appear in the CFR.
    4. Part 507--Thermally Processed Low-Acid Foods Packaged in 
Hermetically Sealed Containers (21 CFR part 507). This part contains 
the criteria that apply in determining whether the facilities, methods, 
practices, and controls used by the commercial processor in the 
manufacture, processing, and packing of low-acid foods for animals in 
hermetically sealed containers are operated or administered in a manner 
adequate to protect the public health. Part 507 is identical to part 
113 (21 CFR part 113), which applies to human foods. Therefore, the 
agency is proposing to remove part 507, and proposing to add a new 
Sec. 500.23 to state that the provisions in part 113 apply to animal 
foods. -
    5. Part 508--Emergency Permit Control (21 CFR part 508) covers the 
requirements and issuance of emergency control permits for the 
manufacturer or packer of thermally processed low-acid foods packaged 
in hermetically sealed containers. Part 508 is identical to part 108 
(21 CFR part 108), which applies to human foods. Therefore, the agency 
is proposing to remove part 508, and proposing to add a new Sec. 500.24 
to state that the provisions in part 108 apply to food intended for 
animals.
    6. Section 510.120 Suspension of approval of new-drug applications 
for certain diethylstilbestrol and diethylstilbestrol-containing drugs 
(21 CFR 510.120). This section provides the suspension of approval of 
the seven listed diethylstilbestrol (DES)-containing animal drug 
products. There are no approved new animal drug applications for DES-
containing products. This regulation is obsolete and should be deleted.
    7. Section 510.200 Export of new animal drug (21 CFR 510.200). This 
section states that to export a new animal drug the product must comply 
with regulations issued under section 512 of the act (21 U.S.C. 360b). 
This provision has been superseded by changes in the act (see 21 U.S.C. 
382).
    8. Section 510.310 Records and reports for new animal drugs 
approved before June 20, 1963 (21 CFR 510.310). This section sets out 
separate requirements for recordkeeping and reporting to the agency for 
drugs approved prior to June 20, 1963. These requirements are outdated 
and inaccurate. The agency believes it is appropriate to have the same 
recordkeeping and reporting requirements for drugs approved before 
1963.
    9. Section 510.413-Chloroform used as an ingredient (active or 
inactive) in animal drug products (21 CFR 510.413). This section 
prohibits the use of chloroform as an ingredient in animal drugs and 
provides certain requirements for products that contain chloroform that 
must be met by October 3, 1977. Chloroform is no longer used as an 
ingredient in any animal drug formulations. Drug formulation is 
reviewed by the manufacturing chemists in FDA's Center for Veterinary 
Medicine (CVM), and this regulation is no longer necessary.
    10. Section 570.22 Safety factors to be considered (21 CFR 570.22). 
This section sets out a proposed safety factor to be used by CVM 
scientists when there is not justification of a different safety 
factor. The safety factors provided in the regulations are 
scientifically obsolete for food additives intended for animals and are 
best handled within the review process.

D. Center For Biologics Evaluation and Research

    All comments submitted in response to the regulations in this 
section, and pertaining to the Center for Biologics Evaluation and 
Research should be identified with docket number 95N-310B.
    Many of the regulations proposed for deletion are regulations that 
duplicate standards that are also specified in product licenses 
required for biological products intended for human use under section 
351 of the Public Health Service Act (42 U.S.C. 262). The additional 
standards regulations and the individual product licenses provide 
standards regarding the required methods of manufacture and testing of 
biological products. In some of these cases, the additional standard 
regulations are therefore duplicative and unnecessary for the following 
reasons: The codification by regulation of many of the additional 
standards for biologicals sometimes does not allow for the flexibility 
necessary to keep abreast of technological advances in science. For 
many years, because of the potential for impeding scientific progress, 
FDA has not codified specific additional standards for licensed 
biological products, but instead has set the required standards in the 
product licenses. The deletion of these regulations will increase 
regulatory flexibility by allowing industry and the agency to more 
readily use and incorporate current scientific technology in the 
manufacture and regulation of licensed biological products.
    FDA is proposing to retain most of the additional standards for 
human blood and blood products because many facilities that manufacture 
these products are intrastate facilities that are registered with FDA 
but do not hold product licenses that specify the methods of 
manufacture and testing to be used. Instead of submitting clinical data 
and license applications to FDA for approval, these intrastate 
manufacturers of blood and blood products must manufacture their 
products in conformance with the additional standards in the 
regulations which have been demonstrated to result in safe, pure, and 
potent products. Also, these additional standards for blood and blood 
components function in lieu of safety and efficacy data in blood 
components and source plasma applications for licensure. Therefore, FDA 
has determined that it is in the best interest of the public health to 
retain most of the additional standards for blood and blood products. 
In this proposed rule FDA is proposing to delete clearly unnecessary 
regulations. FDA is currently reviewing other biologics regulations, 
the potential deletion or revision of which involves issues of greater 
regulatory complexity. As a result of this review, FDA may, in the 
future, propose to delete or significantly revise other biologics 
regulations. 

[[Page 53483]]

    1. Section 601.30 Licenses required; products for controlled 
investigation only (21 CFR 601.30). The requirements of this section 
are contained in section 351 of the Public Health Service Act and in 
section 505 of the act and in 21 CFR parts 50, 56, 58, and 312. 
Therefore, Sec. 601.30 is duplicative and unnecessary.
    2. Section 601.31 Procedure (21 CFR 601.31). The licensing 
procedures for foreign establishments and products are the same as 
those that the agency follows for domestic establishments and products, 
which are codified in 21 CFR part 601, subparts A through C. Therefore, 
this regulation is duplicative and unnecessary.
    3. Section 601.32 Form of License (21 CFR 601.32). The form of 
licenses for foreign establishments and products, including the 
availability for inspection requirement is the same as the form for 
domestic establishments and products. Therefore, this regulation is 
duplicative and unnecessary.
    4. Part 620--Additional Standards for Bacterial Products (21 CFR 
part 620). The 31 regulations in this part are more appropriately 
specified in the product license. As currently written, these 
regulations can be too restrictive for certain products because they 
specify particular methodologies or standards when alternatives may be 
available that provide the same level of assurance of safety, purity 
and potency. Allowing the product standards to be specified in the 
product license will give manufacturers the flexibility to improve 
their products and make appropriate changes to their methods of 
manufacture. Therefore, these regulations may be unduly restrictive and 
are duplicative and unnecessary.
    5. Part 630--Additional Standards for Viral Vaccines (21 CFR part 
630). The 42 regulations in this part are more appropriately specified 
in the product license. As currently written, these regulations can be 
too restrictive for certain products because they specify particular 
methodologies or standards when alternatives may be available that 
provide the same level of assurance of safety, purity and potency. 
Allowing the additional standards to be specified in the product 
license will allow manufacturers the flexibility to improve their 
products and make appropriate changes to their methods of manufacture. 
Therefore, these regulations may be unduly restrictive and are 
duplicative and unnecessary.-
    6. Part 640, Subpart K--Measles Immune Globulin (Human) (21 CFR 
part 640, subpart). There has been no manufacturer licensed for measles 
immune globulin in the United States since 1982. These five regulations 
would be more appropriately specified in a product license if 
manufacture should resume. Therefore, these regulations may be unduly 
restrictive and are obsolete and unnecessary.
    7. Part 650--Additional Standards for Diagnostic Substances for 
Dermal Tests (21 CFR part 650). These 12 regulations may be unduly 
restrictive and are duplicative and unnecessary.
    8. Part 660, Subpart K--Limulus Amebocyte Lysate (21 CFR part 660, 
Subpart K). These six regulations for limulus amebocyte lysate products 
are specified in the product license. Therefore, these regulations may 
be unduly restrictive and are duplicative and unnecessary.
    9. Part 680, Subpart B--Trivalent Organic Arsenicals (21 CFR part 
680, Subpart B). There has been no manufacturer licensed for trivalent 
organic arsenical products in the United States since 1956. These seven 
regulations would be more appropriately specified in a product license 
if manufacture should resume. Therefore, these regulations may be 
unduly restrictive and are obsolete and unnecessary.
    10. Part 680, Subpart C--Blood Group Substances (21 CFR part 680, 
Subpart C). The seven regulations for these products are specified in 
the product license. Therefore, these regulations may be unduly 
restrictive and are duplicative and unnecessary.

E. Center for Devices and Radiological Health

    All comments submitted in response to the regulations in this 
section, and pertaining to the Center for Devices and Radiological 
Health should be identified with docket number 95N-310R.
    1. Section 801.403 Specific medical devices; recommended warning 
and caution statements (21 CFR 801.403). This regulation recommends 
certain warning and caution statements for: denture reliners, pads, and 
cushions; denture repair kits; infrared generators (including hearing 
pads); insulin syringes; mechanical massagers and vibrators; steam or 
turkish baths; and ultraviolet generators. This section does not 
contain requirements and, therefore, need not appear in the CFR.
    2. Section 801.408 Pessaries for intracervical and intrauterine use 
(21 CFR 801.408). This section contains information that can be more 
appropriately given as statements of policy and need not appear in the 
CFR.
    3. Section 801.427 Professional and patient labeling for 
intrauterine contraceptive devices (21 CFR 801.427). This regulation is 
no longer necessary because these devices are no longer being marketed. 
If any intrauterine contraceptive devices are approved for marketing in 
the future, the labeling will be approved during the premarket approval 
process.

III. Economic Impact

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the proposed deletions have no compliance 
costs and do not result in any new requirements, the agency certifies 
that the proposed rule will not have a significant economic impact on a 
substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(9) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

V. Request for Comments

    Interested persons may, on or before January 11, 1996, submit to 
the Dockets Management Branch (address above) written 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 assigned to the particular 
center(s) involved. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 53484]]


List of Subjects

21 CFR Part 100

    Administrative practice and procedure, Food labeling, Food 
packaging, Foods, Intergovernmental relations.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 103

    Beverages, Bottled water, Food grades and standards.

21 CFR Part 104

    Food grades and standards, Frozen foods, Nutrition.

21 CFR Part 105

    Dietary Foods, food grades and standards, Food labeling, Infants 
and children.

21 CFR Part 109

    Food packaging, Foods, Polychlorinated biphenyls (PCB's).

21 CFR Part 137

    Cereal(s) (food).

21 CFR Part 161

    Food grades and standards, Frozen foods, Seafood.

21 CFR Part 163

    Cacao products, Food grades and standards.

21 CFR Part 182

    Food ingredients, Food packaging, Spices and flavorings.

21 CFR Part 186

    Food ingredients, Food packaging.

21 CFR Part 197

    Food grades and standards, Reporting and recordkeeping 
requirements, Seafood.

21 CFR Part 200

    Drugs, Prescription drugs.

21 CFR Part 250

    Drugs.

21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical 
devices, Reporting and recordkeeping requirements.

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Polychlorinated 
biphenyls (PCB's).

21 CFR Part 505

    Animal drugs, Labeling, Over-the-counter drugs.

21 CFR Part 507

    Animal foods, Packaging and containers, Reporting and recordkeeping 
requirements.

21 CFR Part 508

    Animal foods.

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 570

    Animal feeds, Animal foods, Food additives.

21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential 
business information.

21 CFR Part 620

    Biologics, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 630

    Biologics, Labeling.

21 CFR Part 640

    Blood, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 650

    Biologics.

21 CFR Part 660

    Biologics, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 680

    Biologics, Blood, Reporting and recordkeeping requirements.

21 CFR Part 700

    Cosmetics, Packaging and containers.

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) and under authority delegated to the Commissioner 
of Food and Drugs, it is proposed that 21 CFR parts 100, 101, 103, 104, 
105, 109, 137, 161, 163, 182, 186, 197, 200, 250, 310, 500, 505, 507, 
508, 510, 570, 601, 620, 630, 640, 650, 660, 680, 700, and 801 be 
amended as follows:

PART 100--GENERAL

    1. The authority citation for 21 CFR part 100 continues to read as 
follows:

    Authority: Secs. 201, 301, 307, 402, 403, 409, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 337, 342, 
343, 348, 371).


Sec. 100.120   [Removed]

    2. Section 100.120 Artificially red-dyed yellow varieties of sweet 
potatoes is removed from subpart G.


Sec. 100.130   [Removed]

    3. Section 100.130 Combinations of nutritive and nonnutritive 
sweeteners in ``diet beverages'' is removed from subpart G.


Sec. 100.135   [Removed]

    4. Section 100.135 Disposition of incubator reject eggs is removed 
from subpart G.


Sec. 100.140   [Removed]

    5. Section 100.140 Label declaration of salt in frozen vegetables 
is removed from subpart G.


Sec. 100.145   [Removed]

    6. Section 100.145 Notice to packers of comminuted tomato products 
is removed from subpart G.


Sec. 100.150   [Removed]

    7. Section 100.150 Notice to packers and shippers of shelled 
peanuts is removed from subpart G.


Sec. 100.160   [Removed]

    8. Section 100.160 Tolerances for moldy and insect-infested cocoa-
beans is removed from subpart G.

PART 101--FOOD LABELING

    9. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).


Sec. 101.33   [Removed]

    10. Section 101.33 Label declaration of D-erythroascorbic acid when 
it is an ingredient of a fabricated food is removed from subpart B.


Sec. 101.103   [Removed]

    11. Section 101.103 Petitions requesting exemptions from or special 
requirements for label declaration of ingredients is removed from 
subpart G.

PART 103--QUALITY STANDARDS FOR FOODS WITH NO IDENTITY STANDARDS


Part 103  [Removed]

    12-13. Part 103 is removed.

[[Page 53485]]


PART 104--NUTRITIONAL QUALITY GUIDELINES FOR FOODS

    14. The authority citation for 21 CFR part 104 continues to read as 
follows:

    Authority: Secs. 201, 403, 701(a) of the Federal Food, Drug and 
Cosmetic Act (21 U.S.C. 321, 343, 371(a)).


Sec. 104.19   [Removed]

    15. Section 104.19 Petitions is removed from subpart A.

PART 105--FOODS FOR SPECIAL DIETARY USE

    16. The authority citation for 21 CFR part 105 continues to read as 
follows:

    Authority: Secs. 201, 401, 403, 409, 411, 701, 721 of the 
Federal Food, Drug and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 
350, 371, 379e).


Sec. 105.67   [Removed]

    17. Section 105.67 Certain label statements relating to food for 
use in the diet of diabetics is removed from subpart B.


Sec. 105.69   [Removed]

    18. Section 105.69 Foods used to regulate sodium intake is removed 
from subpart B.

PART 109--UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION 
AND FOOD-PACKAGING MATERIAL

    19. The authority citation for 21 CFR part 109 continues to read as 
follows:

    Authority: Secs. 201, 306, 402, 406, 408, 409, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 336, 342, 346, 
346a, 348, 371).


Sec. 109.5   [Removed]

    20. Section 109.5 Petitions is removed.

PART 137--CEREAL FLOURS AND RELATED PRODUCTS

    21. The authority citation for 21 CFR part 137 continues to read as 
follows:

    Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 
379e).


Sec. 137.230  [Removed]-

    22. Section 137.230 Corn grits is removed.


Sec. 137.235  [Removed]

    23. Section 137.235 Enriched corn grits is removed.


Sec. 137.240  [Removed]

    24. Section 137.240 Quick grits is removed.


Sec. 137.245  [Removed]

    25. Section 137.245 Yellow grits is removed.

PART 161--FISH AND SHELLFISH

    26. The authority citation for 21 CFR part 161 continues to read as 
follows:

    Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 
379e).


Sec. 161.131  [Removed]

    27. Section 161.131 Extra large oysters is removed from subpart B.


Sec. 161.132  [Removed]

    28. Section 161.132 Large oysters is removed from subpart B.


Sec. 161.133  [Removed]

    29. Section 161.133 Medium oysters is removed from subpart B.


Sec. 161.134  [Removed]

    30. Section 161.134 Small oysters is removed from subpart B.


Sec. 161.135  [Removed]

    31. Section 161.135 Very small oysters is removed from subpart B.


Sec. 161.137  [Removed]

    32. Section 161.137 Large Pacific oysters is removed from subpart 
B.


Sec. 161.138  [Removed]

    33. Section 161.138 Medium Pacific oysters is removed from subpart 
B.


Sec. 161.139  [Removed]

    34. Section 161.139 Small Pacific oysters is removed from subpart 
B.


Sec. 161.140  [Removed]

    35. Section 161.140 Extra small Pacific oysters is removed from 
subpart B.

PART 163--COCAO PRODUCTS

    36. The authority citation for 21 CFR part 163 continues to read as 
follows:

    Authority: Secs. 201, 301, 401, 403, 409, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 341, 343, 
348, 371, 379e).


Sec. 163.150  [Removed]

    37. Section 163.150 Sweet cocoa and vegetable fat coating is 
removed.


Sec. 163.153  [Removed]

    38. Section 163.153 Sweet chocolate and vegetable fat coating is 
removed.


Sec. 163.155  [Removed]

    39. Section 163.155 Milk chocolate and vegetable fat coating is 
removed.

PART 182--SUBSTANCES GENERALLY RECOGNIZED AS SAFE

    40. The authority citation for 21 CFR part 182 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).


Subpart F  [Removed]

    41. Subpart F, consisting of Secs. 182.5013 through 182.5997, is 
removed.

PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

    42. The authority citation for 21 CFR part 186 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).


Sec. 186.1025  [Removed]-

    43. Section 186.1025 Caprylic acid is removed from subpart B.

PART 197--SEAFOOD INSPECTION PROGRAM


Part 197  [Removed]

    44-45. Part 197 is removed.

PART 200--GENERAL-

    46. The authority citation for 21 CFR Part 200 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 508, 
515, 701, 704, 705 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 358, 360e, 371, 374, 
375).


Sec. 200.100  [Removed]

    47. Section 200.100 Use of ox bile from condemned livers from 
slaughtered animals in the manufacture of drugs is removed.


Sec. 200.101  [Removed]

    48. Section 200.101 Suprarenal glands from hog carcasses prior to 
final inspection is removed.

PART 250--SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS

    49. The authority citation for 21 CFR part 250 continues to read as 
follows:

    Authority: Secs. 201, 306, 402, 502, 503, 505, 601(a), 602(a) 
and (c), 701, 705(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321, 336, 342, 352, 353, 355, 361(a), 362(a) and (c), 371, 
375(b)).


Sec. 250.104  [Removed]

    50. Section 250.104 Status of salt substitutes under the Federal 
Food, Drug, and Cosmetic Act is removed.

[[Page 53486]]



Sec. 250.203  [Removed]

    51. Section 250.203 Status of fluoridated water and foods prepared 
with fluoridated water is removed.

PART 310--NEW DRUGS

    52. The authority citation for 21 CFR part 310 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 512-
516, 520, 601(a), 701, 704, 705, 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 
360b-360f, 360j, 361(a), 371, 374, 375, 379e); secs. 215, 301, 
302(a), 351, 354-360F of the Public Health Service Act (42 U.S.C. 
216, 241, 242(a), 262, 263b-263n).


Sec. 310.101  [Removed]

    53. Section 310.101 FD&C Red No. 4; procedure for discontinuing use 
in new drugs for ingestion; statement of policy is removed.


Sec. 310.304  [Removed]-

    54. Section 310.304 Drugs that are subjects of approved new drug 
applications and that require special studies, records, and reports is 
removed.

PART 500--GENERAL

    55. The authority citation for 21 CFR part 500 continues to read as 
follows:

    Authority: Secs. 201, 301, 402, 403, 409, 501, 502, 503, 512, 
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 
342, 343, 348, 351, 352, 353, 360b, 371).
    56. Section 500.23 is added to subpart B to read as follows:


Sec. 500.23  Thermally processed low-acid foods packaged in 
hermetically sealed containers.

    The provisions of part 113 of this chapter shall apply to the 
manufacture, processing or packing of low-acid foods in hermetically 
sealed containers, and intended for use as food for animals.
    57. Section 500.24 is added to subpart B to read as follows:


Sec. 500.24  Emergency permit control.

    The provisions of part 108 of this chapter shall apply to the 
issuance of emergency control permits for the manufacturer or packer of 
thermally processed low-acid foods packaged in hermetically sealed 
containers, and intended for use as food for animals.--


Sec. 500.49  [Removed]

    58. Section 500.49 Chlorofluorocarbon propellants is removed from 
subpart B.

Part 505--INTERPRETIVE STATEMENTS RE: WARNINGS ON ANIMAL DRUGS FOR 
OVER-THE-COUNTER SALE


Part 505  [Removed]

    59-61. Part 505 is removed.

PART 507--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN 
HERMETICALLY SEALED CONTAINERS


Part 507  [Removed]

    62-63. Part 507 is removed.

PART 508--EMERGENCY PERMIT CONTROL


Part 508  [Removed]

    64-65. Part 508 is removed.

PART 510--NEW ANIMAL DRUGS

    66. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).


Sec. 510.120  [Removed]

    67. Section 510.120 Suspension of approval of new-drug applications 
for certain diethylstilbestrol and diethylstilbestrol-containing drugs 
is removed from subpart B.


Sec. 510.200  [Removed]

    68. Subpart C, consisting of Sec. 510.200, is removed and reserved.


Sec. 510.310  [Removed]

    69. Section 510.310 Records and reports for new animal drugs 
approved before June 20, 1963 is removed from subpart D.


Sec. 510.413

    70. Section 510.413 Chloroform used as an ingredient (active or 
inactive) in animal drug products is removed from subpart E.

PART 570--FOOD ADDITIVES

    71. The authority citation for 21 CFR part 570 continues to read as 
follows:

    Authority: Secs. 201, 401, 402, 408, 409, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 346a, 348, 
371).


Sec. 570.22

    72. Section 570.22 Safety factors to be considered is removed from 
subpart B.

PART 601--LICENSING

    73. The authority citation for 21 CFR part 601 continues to read as 
follows:

    Authority: Secs. 201, 501, 502, 503, 505, 510, 513-516, 518-520, 
701, 704, 721, 801, of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 374, 
379e, 381); secs. 215, 301, 351, 352 of the Public Health Service 
Act (42 U.S.C. 216, 241, 262, 263); secs. 2-12 of the Fair Packaging 
and Labeling Act (15 U.S.C. 1451-1461).


Sec. 601.30  [Removed]

    74. Section 601.30 Licenses required; products for controlled 
investigation only is removed.


Sec. 601.31  [Removed]

    75. Section 601.31 Procedure is removed.


Sec. 601.32  [Removed]

    76. Section 601.32 Form of license is removed.

PART 620--ADDITIONAL STANDARDS FOR BACTERIAL PRODUCTS-


Part 620  [Removed]

    77-78. Part 620 is removed.

PART 630--ADDITIONAL STANDARDS FOR VIRAL VACCINES


Part 630  [Removed]

    79-80. Part 630 is removed.

PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS

    81. The authority citation for 21 CFR part 640 continues to read as 
follows:

    Authority: Secs. 201, 501, 502, 503, 505, 510, 701, of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 
355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health 
Service Act (42 U.S.C. 216, 262, 263, 263a, 264).


Subpart K  [Removed and Reserved]

    82. Subpart K, consisting of Secs. 640.110 through 640.114, is 
removed and reserved.

PART 650--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR DERMAL 
TESTS


Part 650  [Removed]

    83-84. Part 650 is removed.

PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR 
LABORATORY TESTS

    85. The authority citation for 21 CFR part 660 continues to read as 
follows:

    Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 
355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health 
Service Act (42 U.S.C. 216, 262, 263, 263a, 264).


Subpart K  [Removed]

    86. Subpart K, consisting of Secs. 660.100 through 660.105, is 
removed.

[[Page 53487]]


PART 680--ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS

    87. The authority citation for 21 CFR part 680 continues to read as 
follows:

    Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 
355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health 
Service Act (42 U.S.C. 216, 262, 263, 263a, 264).
    88. The heading for Subpart A--Allergenic Products is removed.


Subpart B  [Removed]

    89. Subpart B, consisting of Secs. 680.10 through 680.16, is 
removed.


Subpart C  [Removed]

    90. Subpart C, consisting of Secs. 680.20 through 680.26, is 
removed.

PART 700--GENERAL

    91. The authority citation for 21 CFR part 700 continues to read as 
follows:

    Authority: Secs. 201, 301, 502, 505, 601, 602, 701, 704 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 352, 355, 
361, 362, 371, 374).


Sec. 700.10  [Removed]

    92. Section 700.10 Shampoo preparations containing eggs as one of 
the ingredients is removed.

PART 801--LABELING

    93. The authority citation for 21 CFR part 801 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 507, 519, 520, 701, 704 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 
352, 357, 360i, 360j, 371, 374).


Sec. 801.403  [Removed]

    94. Section 801.403 Specific medical devices; recommended warning 
and caution statements is removed from subpart H.


Sec. 801.408  [Removed]

    95. Section 801.408 Pessaries for intracervical and intrauterine 
use is removed from subpart H.


Sec. 801.427  [Removed]

    96. Section 801.427 Professional and patient labeling for 
intrauterine contraceptive devices is removed from subpart H.

    Dated: October 6, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-25337 Filed 10-11-95; 9:23 am]
BILLING CODE 4160-01-F