[Federal Register Volume 61, Number 113 (Tuesday, June 11, 1996)]
[Proposed Rules]
[Pages 29502-29504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14706]
=======================================================================
-----------------------------------------------------------------------
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: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to
consolidate a list of drugs, previously determined by rulemaking to be
new drugs, into one section. This document would also remove 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).
DATES: Written comments by August 26, 1996. FDA proposes that any final
rule based on this proposal become effective 2 weeks after its date of
publication in the Federal Register.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
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. Introduction
On March 4, 1995, President Clinton issued a memorandum titled
``Regulatory Reinvention Initiative.'' This memorandum, part of the
reform of the Federal regulatory system, directed heads of departments
and agencies to undertake a page-by-page review of their existing
regulations and to eliminate or modify those that are outdated or
otherwise in need of reform. FDA has conducted a comprehensive review
of
[[Page 29503]]
its existing regulations and has identified regulations to eliminate or
modify. As a result of that review and as part of its response to the
President's directive, FDA is proposing to amend or remove 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 is preparing other revisions resulting
from the page-by-page review for future publication.
FDA is proposing to revise Sec. 310.502 to consolidate into one
section a list of drugs that have been determined by previous
rulemaking procedures to be new drugs within the meaning of section
201(p) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
321(p)) for which approved new drug applications under section 505 of
the act (21 U.S.C. 355) and 21 CFR part 314 are required for marketing.
The list would include those new drugs now codified in parts 200, 250,
and 310. As the agency identifies other new drugs as being new drugs
through its rulemaking procedures, FDA would add such other new drugs
to the list.
Revised Sec. 310.502 would list the names of the drugs and would
not include the existing background information describing the agency's
basis for determination of new drug status and, for some drugs,
requirements for marketing. FDA has determined that with the exception
of certain information in Sec. 310.509 that FDA considers to be
necessary, the background information no longer needs to be set out in
the regulations. For some drugs, the information is outdated. For other
drugs, removal of the existing explanatory text should not present a
hardship or burden because the information is available from other
sources. This proposal would make the regulations more concise and
efficient.
II. 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.
III. Analysis of Impacts
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 this document merely proposes to consolidate
existing regulations, the agency certifies that the proposed rule will
not have a significant impact on a substantial number of small
entities. Therefore, under the Regulatory Flexibility Act no further
analysis is required.
IV. Request for Comments
Interested persons may, on or before August 26, 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 found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
V. Effective Date
FDA proposes that any final rule based on this proposal be
effective 2 weeks after its date of publication in the Federal
Register.
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, it is proposed that 21 CFR parts 200,
250, and 310 be 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.
[[Page 29504]]
(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.
(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: June 5, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-14706 Filed 6-6-96; 11:50 am]
BILLING CODE 4160-01-F
