[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20688-20689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8886]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1998-D-0281]
Guidance for Industry and Food and Drug Administration Staff; 30-
Day Notices, 135-Day Premarket Approval Supplements and 75-Day
Humanitarian Device Exemption Supplements for Manufacturing Method or
Process Changes; 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 the guidance entitled ``30-Day Notices, 135-Day
Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device
Exemption (HDE) Supplements for Manufacturing Method or Process
Changes.'' This document provides guidance on the type of changes to an
approved application that FDA believes may qualify for submission as
30-day notices, the type of information to submit in a 30-day notice,
and the user fees associated with these submissions. The guidance
document is immediately in effect, but it remains subject to comment in
accordance with the Agency's good guidance practices (GGP).
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health (CDRH), Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993-0002; or to the Office of Communication,
Outreach and Development (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.
Submit electronic comments on the 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:
For devices regulated by CDRH: Anastacia Bilek, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3656, Silver Spring, MD 20993-0002, 301-
796-5588.
For devices regulated by CBER: Stephen Ripley, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``30-Day Notices, 135-Day Premarket Approval (PMA) Supplements
and 75-Day Humanitarian Device Exemption (HDE) Supplements for
Manufacturing Method or Process Changes.'' This guidance is being
issued consistent with FDA's GGP regulation (Sec. 10.115 (21 CFR
10.115). This guidance is being implemented without prior public
comment because the Agency has determined that prior public
participation is not feasible or appropriate (Sec. 10.115(g)(2)). The
Agency made this determination because statutory provisions regarding
medical device user fees under the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Pub. L. 110-85) are in effect and being
implemented, and guidance is needed to help effect such implementation.
Although this guidance is immediately in effect, it remains subject to
comment in accordance with the Agency's GGP regulation.
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Pub. L. 107-250) amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. et seq.) to authorize FDA to collect user fees for
the review of certain premarket submissions (See section 708 of the
FD&C Act (21 U.S.C. 379j).) FDAAA further amended the FD&C Act to
extend FDA's authority to collect medical device user fees through
September 30, 2012, and added 30-day notices to the types of premarket
submissions subject to user fees (21 U.S.C. 379j(a)(2)(A)(vi)). For
additional information on the MDUFMA, please see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm.
This guidance supersedes the previous guidance document entitled
``30-Day Notices and 135-Day PMA Supplements for Manufacturing Method
or Process Changes, Guidance for Industry and CDRH,'' that published in
the Federal Register of February 25, 1998 (63 FR 9570). This guidance
describes the user fees authorized, updates the previous guidance to
clarify the process for submitting a 30-day notice, and provides
additional information on the types of changes that may be submitted.
The previous guidance did not include information on HDEs even though
certain modifications to a manufacturing procedure or method of
manufacture for HDEs are subject to the 30-day notice provisions. The
current guidance includes this information.
The guidance represents the Agency's current thinking on 30-day
notices, 135-day PMA supplements and 75-Day HDE supplements for
manufacturing method or process changes. 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 statute and regulations.
II. Paperwork Reduction Act of 1995
This 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-
[[Page 20689]]
3520). The collections of information 21 CFR part 814, subparts B and
E, have been approved under OMB control number 0910-0231; the
collections of information 21 CFR part 814, subpart H, have been
approved under OMB control number 0910-0332; the collections of
information 21 CFR part 820 have been approved under OMB control number
0910-0073; the collections of information in FDA form 3601 have been
approved under OMB control number 0910-0511; and the collections of
information in FDA form 3602a have been approved under OMB control
number 0910-0508.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or http://www.regulations.gov. Always access an FDA guidance document
by using FDA's Web site listed previously to find the most current
version of the guidance.
Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8886 Filed 4-12-11; 8:45 am]
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