[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]]
_______________________________________________________________________
Part IV
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
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
