[Federal Register: November 30, 2007 (Volume 72, Number 230)]
[Rules and Regulations]
[Page 67639-67640]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30no07-4]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 310 and 369
[Docket No. 1976N-0052T (formerly Docket No. 76N-052T)]
RIN 0910-AF33
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug
Products for Over-the-Counter Human Use; Final Rule for Over-the-
Counter Antitussive Drug Products; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule, technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations (exemption for certain drugs limited by new-drug
applications to prescription sale, and warning and caution statements
required by regulations for drugs) by removing the entries for
carbetapentane citrate. This action is associated with FDA's
determination that carbetapentane citrate has not been shown to be
effective at the over-the-counter (OTC) doses stated in the exempting
regulation. FDA made this determination in 1987 as part of its ongoing
review of OTC drug products.
DATES: This rule is effective November 30, 2007.
FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5496, Silver Spring, MD 20993, 301-796-
2090.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 13, 1957 (22 FR 7315), FDA
proposed to exempt carbetapentane citrate preparations from the
prescription-dispensing requirements of section 503(b)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (the act) (formerly 21 U.S.C.
353(b)(1)(C); currently 21 U.S.C. 353(b)(1)(B)). FDA stated:
Evidence now available through investigation and marketing
experience shows that drug products containing this ingredient can be
safely used by the laity in self-medication if they are used in
accordance with the proposed labeling and
The restriction to prescription sale is no longer
necessary for the protection of the public health.
FDA did not receive any comments on this proposal and published a
final order (final rule) in the Federal Register of November 1, 1957
(22 FR 8812). FDA amended Sec. 130.102 (21 CFR 130.102) by adding new
paragraph (a)(20) with marketing conditions for OTC drug products
containing carbetapentane citrate labeled for the temporary relief of
cough. FDA subsequently recodified Sec. 130.102(a)(20) as Sec.
310.201(a)(20) (21 CFR 310.201(a)(20)).
As part of FDA's OTC drug review, the Advisory Review Panel on OTC
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products
(the Panel) evaluated carbetapentane citrate and found it safe but
lacking adequate effectiveness data for OTC antitussive use (41 FR
38312 at 38345, September 9, 1976). In the tentative final monograph
for OTC antitussive drug products (48 FR 48576 at 48580, October 19,
1983), one comment objected to the Panel's effectiveness determination.
FDA responded that it agreed with the Panel's conclusions that the data
were insufficient to establish effectiveness. FDA did not receive any
additional effectiveness data on carbetapentane citrate. In the final
rule for OTC antitussive drug products (52 FR 30042, August 12, 1987),
FDA classified carbetapentane citrate as nonmonograph (not generally
recognized as safe and effective) for OTC antitussive use.
II. The Technical Amendment
Because carbetapentane citrate had not been shown to be effective
at the OTC dosages stated in Sec. 310.201(a)(20), FDA should have
removed that paragraph from Sec. 310.201 in 1987. The current final
rule corrects that oversight by removing paragraph (a)(20) from Sec.
310.201 and reserving paragraph (a)(20) for future use. In addition,
the entry for ``CARBETAPENTANE CITRATE PREPARATIONS'' in Sec. 369.21
(21 CFR 369.21) states: ``(See Cough-Due-to-Cold Preparations.)'' The
entry for ```COUGH-DUE-TO-COLD' PREPARATIONS'' entry states:
``(CARBETAPENTANE CITRATE). (See Sec. 310.201(a)(20) of this chapter.)
`Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away.''' Both of those entries
also should have been removed in 1987, and the current final rule
removes them.
III. Analysis of Impacts
FDA has examined the impacts of this final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et
[[Page 67640]]
seq.). 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).
Under the Regulatory Flexibility Act, if a rule has a significant
economic impact on a substantial number of small entities, an agency
must analyze regulatory options that would minimize any significant
impact of the rule on small entities. Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires that agencies prepare a written
statement of anticipated costs and benefits before proposing any rule
that may result in an expenditure in any 1 year by state, local, and
tribal governments, in the aggregate, or by the private sector, of $100
million or more (adjusted annually for inflation).
FDA has determined that this final rule is consistent with the
principles set out in Executive Order 12866 and in these two statutes.
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. As explained later in this document, the final rule will not
have a significant economic impact on a substantial number of small
entities. The Unfunded Mandates Reform Act does not require FDA to
prepare a statement of costs and benefits for this final rule, because
the rule is not expected to result in any 1-year expenditure that would
exceed $100 million adjusted for inflation. The current inflation
adjusted statutory threshold is about $127 million using the most
current (2006) Implicit Price Deflator for the Gross Domestic Product.
The purpose of this final rule is to remove the exemption in Sec.
310.201(a)(20) for carbetapentane citrate from the prescription-
dispensing requirements of section 503(b)(1)(B) of the act and to
remove two entries for carbetapentane citrate in Sec. 369.21. FDA has
reviewed its Drug Listing System and determined that there currently
are no marketed OTC drug products that contain carbetapentane citrate.
Therefore, FDA certifies that this final rule will not have a
significant economic impact on a substantial number of small entities.
No further analysis is required under the Regulatory Flexibility Act (5
U.S.C. 605(b)).
IV. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
V. Environmental Impact
FDA has determined under 21 CFR 25.31(a) 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.
VI. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that this rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Any effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government occurred in 1987 when FDA classified carbetapentane citrate
as not generally recognized as safe and effective for OTC antitussive
use. States had the opportunity to comment at the time that final rule
was published (52 FR 30042, August 12, 1987). Accordingly, FDA has
concluded that this rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
List of Subjects
21 CFR Part 310
Administrative practice and procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.
21 CFR Part 369
Labeling, Medical devices, Over-the-counter drugs.
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Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
310 and 369 are amended as follows:
PART 310--NEW DRUGS
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1. The authority citation for 21 CFR part 310 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f,
360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
263b-263n.
Sec. 310.201 [Amended]
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2. In Sec. 310.201 remove and reserve paragraph (a)(20).
PART 369--INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND
DEVICES FOR OVER-THE-COUNTER SALE
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3. The authority citation for 21 CFR part 369 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371.
Sec. 369.21 [Amended]
0
4. In Sec. 369.21 remove the following entries:
``CARBETAPENTANE CITRATE PREPARATIONS. (See Cough-Due-to-Cold
Preparations.)''
```COUGH-DUE-TO-COLD'PREPARATIONS (CARBETAPENTANE CITRATE). (See Sec.
310.201(a)(20) of this chapter.)
`Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away.'''
Dated: November 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23207 Filed 11-29-07; 8:45 am]
BILLING CODE 4160-01-S