[Federal Register Volume 79, Number 36 (Monday, February 24, 2014)]
[Notices]
[Pages 10167-10168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03885]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1675]
Draft Guidance for Industry on New Chemical Entity Exclusivity
Determinations for Certain Fixed-Combination Drug Products;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``New Chemical
Entity Exclusivity Determinations for Certain Fixed-Combination Drug
Products.'' This draft guidance sets forth a change in the Agency's
interpretation of the 5-year new chemical entity (NCE)
[[Page 10168]]
exclusivity statutory and regulatory provisions as they apply to
certain fixed-combination drug products (fixed combinations). If the
guidance is finalized, a drug product will be eligible for 5-year NCE
exclusivity if it contains a drug substance that meets the definition
of ``new chemical entity,'' regardless of whether that drug substance
is approved alone or in certain fixed-combinations.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 25, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455; or Jay
Sitlani, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6272, Silver
Spring, MD 20993-0002, 301-796-5202.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``New Chemical Entity Exclusivity Determinations for Certain
Fixed-Combination Drug Products.'' This guidance sets forth a change in
the Agency's interpretation of the 5-year NCE exclusivity provisions as
they apply to certain fixed-combinations. Sections 505(c)(3)(E)(ii) and
(j)(5)(F)(ii) of the Food, Drug, and Cosmetic Act and 21 CFR 314.108,
among other provisions, establish the scheme under which a drug product
is eligible for 5-year NCE exclusivity. The Agency currently interprets
the term ``drug'' as it appears in the first subclause of the statutory
provisions and in the definition of ``new chemical entity'' in its
regulation to mean ``drug product.'' This results in a fixed-
combination not being eligible for 5-year NCE exclusivity if it
contains any drug substance that contains an active moiety that had
been previously approved by the Agency, even if the fixed-combination
also contains another drug substance that contains a previously
unapproved active moiety.
The Agency recognizes, however, that fixed-combinations have become
increasingly prevalent in certain therapeutic areas and that these
products play an important role in optimizing adherence to dosing
regimens and improving patient outcomes. Therefore, to further
incentivize the development of fixed-combinations containing previously
unapproved active moieties, the Agency is revising its existing
interpretation regarding the eligibility for 5-year NCE exclusivity of
certain fixed-combinations. Under the revised interpretation, the term
``drug'' in the relevant provisions would be interpreted to mean ``drug
substance'' or ``active ingredient,'' and not ``drug product.''
Accordingly, a drug product would be eligible for 5-year NCE
exclusivity provided that it contains any drug substance that contains
no active moiety that has been previously approved. This will permit a
drug substance that meets the definition of new chemical entity (i.e.,
it contains no previously approved active moiety) to be eligible for 5-
year NCE exclusivity, even when it is approved in a fixed-combination
with another drug substance that contains a previously approved active
moiety.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on 5-year NCE
exclusivity for certain fixed-combinations. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
III. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: February 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03885 Filed 2-21-14; 8:45 am]
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