[Federal Register Volume 62, Number 50 (Friday, March 14, 1997)]
[Rules and Regulations]
[Pages 12083-12085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6411]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 200, 250, and 310
[Docket No. 96N-0183]
RIN 0910-AA53
Consolidation of Drug Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is consolidating a list
of drugs, previously determined by rulemaking to be new drugs, into one
section. This document also removes the sections now providing for
these drugs, except for certain information in the regulations that FDA
considers to be necessary. This action, which will make the regulations
more concise and efficient, is being taken in response to the
President's regulatory reinvention initiative (REGO).
EFFECTIVE DATE: April 14, 1997.
FOR FURTHER INFORMATION CONTACT: Mary E. Catchings, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 7500
Standish Pl., Rockville, MD 20855, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background
On March 4, 1995, President Clinton issued a memorandum titled
``Regulatory Reinvention Initiative,'' which directed all Federal
agencies to conduct a page-by-page review of their existing regulations
and to ``eliminate or revise those that are outdated or otherwise in
need of reform.'' As a result of that review and as part of its
response to the President's directive, FDA published a document in the
Federal Register of June 11, 1996 (61 FR 29502), proposing to amend
those parts of its drug regulations codified in parts 200, 250, and 310
(21 CFR parts 200, 250, and 310), regarding certain drugs determined by
rulemaking to be new drugs.
FDA proposed the following: (1) To revise Sec. 310.502 to
consolidate into one section a list of drugs (now codified in parts
200, 250, and 310) that have been determined by rulemaking procedures
to be new drugs requiring approved new drug applications, and (2) to
remove those sections in parts 200, 250, and 310 now providing for
those drugs, except for certain information in Sec. 310.509 that FDA
considers to be necessary. The agency received no comments in response
to the proposal to amend or remove these regulations.
II. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
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 final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
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. The Commissioner of Food and Drugs certifies that
the final 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.
[[Page 12084]]
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) 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.
List of Subjects
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.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR parts 200, 250, and 310 are
amended as follows:
PART 200--GENERAL
1. 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).
Subpart B [Removed]
2. Subpart B, consisting of Secs. 200.30 and 200.31 is removed and
reserved.
PART 250--SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
3. 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. 250.10 [Removed]
4. Section 250.10 Oral prenatal drugs containing fluorides intended
for human use is removed.
Sec. 250.103 [Removed]
5. Section 250.103 Thorium dioxide for drug use is removed.
Sec. 250.106 [Removed]
6. Section 250.106 Cobalt preparations intended for use by man is
removed.
PART 310--NEW DRUGS
7. 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).
8. Section 310.502 is revised to read as follows:
Sec. 310.502 Certain drugs accorded new drug status through rulemaking
procedures.
(a) The drugs listed in this paragraph (a) have been determined by
rulemaking procedures to be new drugs within the meaning of section
201(p) of the act. Except as provided in paragraph (b) of this section,
an approved new drug application under section 505 of the act and part
314 of this chapter is required for marketing the following drugs:
(1) Aerosol drug products for human use containing 1,1,1-
trichloroethane.
(2) Aerosol drug products containing zirconium.
(3) Amphetamines (amphetamine, dextroamphetamine, and their salts,
and levamfetamine and its salts) for human use.
(4) Camphorated oil drug products.
(5) Certain halogenated salicylanilides (tribromsalan (TBS, 3,4',5-
tribromosalicylanilide), dibromsalan (DBS, 4', 5-
dibromosalicylanilide), metabromsalan (MBS, 3, 5-
dibromosalicylanilide), and 3,3', 4,5'-tetrachlorosalicylanilide (TC-
SA)) as an ingredient in drug products.
(6) Chloroform used as an ingredient (active or inactive) in drug
products.
(7) Cobalt preparations intended for use by man.
(8) Intrauterine devices for human use for the purpose of
contraception that incorporate heavy metals, drugs, or other active
substances.
(9) Oral prenatal drugs containing fluorides intended for human
use.
(10) Parenteral drug products in plastic containers.
(11) Sterilization of drugs by irradiation.
(12) Sweet spirits of nitre drug products.
(13) Thorium dioxide for drug use.
(14) Timed release dosage forms.
(15) Vinyl chloride as an ingredient, including propellant, in
aerosol drug products.
(b) Any drug listed in paragraph (a) of this section, when composed
wholly or partly of any antibiotic drug, must be certified under
section 507 of the act or exempted from certification under section 507
of the act for marketing.
Sec. 310.504 [Removed]
9. Section 310.504 Amphetamines (amphetamine, dextroamphetamine,
and their salts and levamfetamine and its salts) for human use is
removed.
Sec. 310.506 [Removed]
10. Section 310.506 Use of vinyl chloride as an ingredient,
including propellant, of aerosol drug products is removed.
Sec. 310.507 [Removed]
11. Section 310.507 Aerosol drug products for human use containing
1,1,1-trichloroethane is removed.
Sec. 310.508 [Removed]
12. Section 310.508 Use of certain halogenated salicylanilides as
an inactive ingredient in drug products is removed.
13. Section 310.509 is revised to read as follows:
Sec. 310.509 Parenteral drug products in plastic containers.
(a) Any parenteral drug product packaged in a plastic immediate
container is not generally recognized as safe and effective, is a new
drug within the meaning of section 201(p) of the act, and requires an
approved new drug application as a condition for marketing. An
``Investigational New Drug Application'' set forth in part 312 of this
chapter is required for clinical investigations designed to obtain
evidence of safety and effectiveness.
(b) As used in this section, the term ``large volume parenteral
drug product'' means a terminally sterilized aqueous drug product
packaged in a single-dose container with a capacity of 100 milliliters
or more and intended to be administered or used intravenously in a
human.
(c) Until the results of compatibility studies are evaluated, a
large volume parenteral drug product for intravenous use in humans that
is packaged in a plastic immediate container on or after April 16,
1979, is misbranded unless its labeling contains a warning that
includes the following information:
(1) A statement that additives may be incompatible.
(2) A statement that, if additive drugs are introduced into the
parenteral system, aseptic techniques should be used and the solution
should be thoroughly mixed.
[[Page 12085]]
(3) A statement that a solution containing an additive drug should
not be stored.
(d) This section does not apply to a biological product licensed
under the Public Health Service Act of July 1, 1944 (42 U.S.C. 201).
Sec. 310.510 [Removed]
14. Section 310.510 Use of aerosol drug products containing
zirconium is removed.
Sec. 310.513 [Removed]
15. Section 310.513 Chloroform, use as an ingredient (active or
inactive) in drug products is removed.
Sec. 310.525 [Removed]
16. Section 310.525 Sweet spirits of nitre drug products is
removed.
Sec. 310.526 [Removed]
17. Section 310.526 Camphorated oil drug products is removed.
Dated: March 7, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-6411 Filed 3-13-97; 8:45 am]
BILLING CODE 4160-01-F