[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