[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Draft Guidance for Industry on New Chemical Entity Exclusivity 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availability of a draft guidance for industry entitled ``New Chemical 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 This draft guidance sets forth a change in the Agency's 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 25, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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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