[Federal Register Volume 68, Number 106 (Tuesday, June 3, 2003)]
[Rules and Regulations]
[Pages 32981-32983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13827]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 349

[Docket No. 03N-0193]
RIN 0910-AA01


Ophthalmic Drug Products for Over-the-Counter Human Use; Final 
Monograph; 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 the 
regulation that established conditions under which over-the-counter 
(OTC) ophthalmic drug products are generally recognized as safe and 
effective and not misbranded. This amendment updates the monograph to 
incorporate a United States Pharmacopeia (USP) name change for one 
active ingredient included in the monograph. This final rule is part of 
FDA's ongoing review of OTC drug products.

DATES: This final rule is effective July 3, 2003. Submit written or 
electronic comments by August 4, 2003.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Michael T. Benson, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 4, 1988 (53 FR 7076), FDA issued a 
final monograph for OTC ophthalmic drug products in part 349 (21 CFR 
part 349). Section 349.12 of that monograph included the active 
ingredient hydroxypropyl methylcellulose. In 2000, the USP proposed 
(for inclusion in the Third Supplement to USP 24) a name change for 
this ingredient based on a name adopted by the United States Adopted 
Names Council (Ref. 1). The new name for hydroxypropyl methylcellulose 
is hypromellose. This name change became official on March 1, 2001, and 
was subsequently included in the USP with an effective date of 
September 1, 2002 (Ref. 2).

II. Naming Process

    The Federal Food, Drug, and Cosmetic Act (the act) in section 
502(e)(1)(A)(i) (21 U.S.C. 352(e)(1)(A)(i)) requires the label of a 
drug to bear the established name of the drug to the exclusion of any 
other nonproprietary name (except the applicable systematic chemical 
name or the chemical formula). The established name of the drug is 
defined as:
    * * * (A) the applicable official name designated pursuant to 
section 508 [of the act], or (B) if there is no such name and such 
drug, or such ingredient, is an article recognized in an official 
compendium, then the official title thereof in such compendium, or 
(C) if neither clause (A) nor clause (B) of this subparagraph 
applies, then the common or usual name, if any, of such drug or of 
such ingredient * * *.
21 U.S.C. 352(e)(3).
    Section 508 of the act (21 U.S.C. 358) authorizes FDA to designate 
an official name for any drug if FDA determines ``that such action is 
necessary or desirable in the interest of usefulness and simplicity.'' 
FDA does not, however, routinely designate official names for drug 
products under section 508 of the act (Sec.  299.4(e) (21 CFR 
299.4(e))). In the absence of designation by FDA of an official name, 
interested persons may rely on the current compendial name as the 
established name (Sec.  299.4(e)).

III. The Technical Amendment

    FDA has not designated an official name for the active ingredient 
hydroxypropyl methylcellulose. Thus, its established name is the 
current compendial name. The USP has now changed the compendial name 
for hydroxypropyl methylcellulose to hypromellose. To be consistent 
with the change in this official compendial name, the agency is 
changing this name in Sec.  349.12 in the ingredient listing. As noted 
previously, this USP name change became official on March 1, 2001, with 
a USP effective date of September 1, 2002.
    Because section 502(e)(1) and (e)(3) of the act requires the 
established name of a drug to be used, any ophthalmic drug product 
initially introduced or initially delivered for introduction into 
interstate commerce after September 1, 2002, would need to bear the new 
established name ``hypromellose.'' However, the agency is aware that 
many manufacturers of OTC ophthalmic drug products have not yet 
implemented this name change in their product labeling. Therefore, 
elsewhere in this issue of the Federal Register, as a matter of its 
enforcement discretion, the agency is issuing guidance stating its 
intent to provide manufacturers of affected OTC ophthalmic drug 
products until September 1, 2003 (1 extra year from the USP effective 
date), to implement this labeling change. Accordingly, on or after 
September 1, 2003, any OTC ophthalmic drug product initially introduced 
or initially delivered for introduction into interstate commerce that 
contains the ingredient hypromellose (formerly known as hydroxypropyl 
methylcellulose) must bear labeling that contains the new name for this 
ingredient.
    To the extent that 5 U.S.C. 553 applies to this action, it is 
exempt from notice and comment because it constitutes a rule of agency 
procedure under 5 U.S.C. 553(b)(3)(A). Alternatively, the agency's 
implementation of this action without opportunity for public comment 
comes within the good cause exceptions in 5 U.S.C. 553(b)(3)(B) in that 
obtaining public comment is impracticable, unnecessary, and contrary to 
public interest. This labeling revision

[[Page 32982]]

represents a minor clarifying change that does not change the substance 
of the labeling requirements contained in the final regulations. As 
discussed previously in this document, manufacturers must relabel their 
products as a result of the USP name change to remain in compliance 
with the act. This amendment updates the name of one active ingredient 
in the final monograph for OTC ophthalmic drug products to reflect this 
official name change that has already been implemented by the USP. In 
accordance with 21 CFR 10.40(e)(1), FDA is providing an opportunity for 
comment on whether the regulation should be modified or revoked.

IV. 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), and 
the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 
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 UMRA requires that agencies prepare a 
written statement of anticipated costs and benefits before proposing 
any rule that may result in an expenditure in any one year by State, 
local, and tribal governments, in the aggregate, or by the private 
sector, of $100 million (adjusted annually for inflation).
    The agency concludes that this final rule is consistent with the 
principles set out in Executive Order 12866 and in these two statutes. 
FDA has determined that 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 UMRA does not require FDA to prepare a statement of costs and 
benefits for this final rule, because the final 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 $110 million.
    The purpose of this final rule is to update the final monograph for 
OTC ophthalmic drug products to incorporate a USP name change for one 
active ingredient included in the monograph. As discussed in section II 
of this document, section 502(e)(1) and (e)(3) of the act requires that 
the established name of a drug be used. Under Sec.  299.4(e), because 
FDA does not routinely designate official names under section 508 of 
the act, the established name under section 502(e) of the act 
ordinarily is the compendial name of the drug. Therefore, because FDA 
has not designated an official name under section 508 of the act, 
manufacturers must relabel their products as a result of the USP name 
change to remain in compliance with the act. Updating the name of the 
active ingredient in the ophthalmic monograph to reflect its current 
established name will eliminate possible confusion by the public. 
Because manufacturers must relabel their products as a result of the 
USP name change to remain in compliance with the act, this rule does 
not impose any additional costs on industry. Consequently, the agency 
certifies that this final rule will not have a significant economic 
impact on a substantial number of small entities. Therefore, no further 
analysis is required.

V. Paperwork Reduction Act of 1995

    The agency concludes that the labeling requirements in this 
document are not subject to review by the Office of Management and 
Budget because they do not constitute a ``collection of information'' 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 
Rather, the labeling statements are a ``public disclosure of 
information originally supplied by the Federal government to the 
recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)).

VI. Environmental Impact

    The agency 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.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the 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. Accordingly, the agency has concluded 
that the 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.

VIII. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or three paper copies of 
any mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document and may be accompanied by a supporting 
memorandum or brief. Received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

IX. References

    The following references have been placed on display in the Dockets 
Management Branch (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. ``Pharmacopeial Forum,'' The United States Pharmacopeial 
Convention, Inc., Rockville, MD, pp. 702-705, May and June 2000.
    2. ``Third Supplement,'' United States Pharmacopeia 24, National 
Formulary 19, The United States Pharmacopeial Convention, Inc., 
Rockville, MD, pp. 3041-3042, January 2, 2001.

List of Subjects in 21 CFR Part 349

    Labeling, Ophthalmic goods and services, 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 part 
349 is amended as follows:

PART 349--OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

0
1. The authority citation for 21 CFR part 349 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

0
2. Section 349.12 is amended by revising paragraph (a)(3) to read as 
follows:


Sec.  349.12  Ophthalmic demulcents.

* * * * *
    (a) * * *
    (3) Hypromellose, 0.2 to 2.5 percent.
* * * * *


[[Page 32983]]


    Dated: May 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13827 Filed 6-2-03; 8:45 am]
BILLING CODE 4160-01-S