Revocation of Certain Regulations; Opportunity for Public Comment

[[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