[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Rules and Regulations]
[Pages 67639-67640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23207]


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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.

0
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]

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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