[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Draft Guidance for Industry and Food and Drug Administration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availability of a draft guidance for industry and FDA staff entitled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 This draft guidance intends to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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 22, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Combination Products, Food and Drug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 The draft guidance may also be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Submit electronic comments on the draft guidance to http://www.regulations.gov.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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