[Federal Register Volume 78, Number 14 (Tuesday, January 22, 2013)]
[Notices]
[Pages 4417-4418]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1240]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Submissions for Postapproval Modifications to a Combination 
Product Approved Under Certain Marketing Applications; 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availability of a draft guidance for industry and FDA staff entitled 
``Submissions for Postapproval Modifications to a Combination Product 
Approved Under a BLA, NDA, or PMA.'' This draft guidance intends to 
provide the underlying principles to determine the type of marketing 
submission that may be required for postapproval changes to a 
combination product that is approved under one marketing application, 
i.e., a biologics license application (BLA), a new drug application 
(NDA), or a device premarket approval application (PMA).

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 22, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Combination Products, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver 
Spring, MD 20993. Send one self-addressed adhesive label to assist the 
office in processing your request. The draft guidance may also be 
obtained by mail by calling the Office of Combination Products at 301-
796-8930. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Patricia Y. Love, Office of 
Combination Products, Food and Drug Administration, Bldg. 32, rm. 5129, 
10903 New Hampshire Ave., Silver Spring, MD 20993.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Submissions for Postapproval Modifications to 
a Combination Product Approved Under a BLA, NDA, or PMA.'' This 
document provides guidance to industry and FDA staff on the underlying 
principles to determine the type of marketing submission that may be 
required for postapproval changes to a combination product, as defined 
in 21 CFR 3.2(e), that is approved under one marketing application, 
i.e., a BLA, an NDA, or a device PMA.
    The regulatory standards for when to provide a postmarket 
submission for a change to an approved, stand-alone drug, device, or 
biological product or its manufacturing process are described in the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (sections 505, 506A, 
and 515 of the FD&C Act), the Public Health Service Act (PHS Act) 
(section 351 of the PHS Act), and FDA's associated regulations (21 CFR 
314.70, 601.12, and 814.39). As a general matter, these provisions set 
forth similar criteria for when a submission for a changed article is 
required, but do not expressly address submissions for changes to an 
approved combination product.
    This draft guidance intends to provide clarity in the postapproval 
change requirements and consistency in the type of postmarket 
submission to provide for a change to a combination product approved 
under one marketing application (BLA, NDA, or PMA). In particular, the 
draft guidance document provides tables that may be helpful in 
determining what type of submission to provide for a postmarket change 
to a constituent part of a combination product where the regulatory 
identity of the modified constituent part differs from the application 
type under which the combination product is approved.
    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 
``Submissions for Postapproval Modifications to a Combination Product 
Approved Under a BLA, NDA, or PMA.'' 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 to http://www.regulations.gov or written comments regarding this document 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. 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.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
collections of information in 21 CFR part 314 for NDAs have been 
approved under OMB control number 0910-0001. The collections of 
information in 21 CFR part 601 for BLAs have been approved

[[Page 4418]]

under OMB control number 0910-0338. The collections of information in 
21 CFR part 814, subpart B for PMAs have been approved under OMB 
control number 0910-0231.

    Dated: January 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01069 Filed 1-18-13; 8:45 am]
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