[Federal Register Volume 63, Number 80 (Monday, April 27, 1998)]
[Proposed Rules]
[Pages 20558-20561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11085]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 814
[Docket No. 98N-0168]
Medical Devices; 30-Day Notices and 135-Day PMA Supplement
Review; Companion Document to Direct Final Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations governing the submission and review of premarket
approval application (PMA) supplements to allow for the submission of a
30-day notice for modifications to manufacturing procedures or methods
of manufacture. Amendments are being made to implement revisions to the
Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food
and Drug Administration Modernization Act of 1997 (FDAMA). This
proposed rule is a companion document to the direct final rule
published elsewhere in this issue of the Federal Register.
DATES: Submit written comments on or before July 13, 1998. Submit
written comments on the information collection requirements on or
before June 26, 1998.
ADDRESSES: Submit written comments on the proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Kathy M. Poneleit, Center for Devices
and Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186.
SUPPLEMENTARY INFORMATION:
I. Background
This proposed rule is a companion document to the direct final rule
published elsewhere in this issue of the Federal Register. This
proposed rule is substantively identical to its companion direct final
rule. The proposed rule will provide the procedural framework to
finalize the rule in the event the companion direct final rule receives
any significant adverse comment and is withdrawn. The comment period
for this companion proposed rule runs concurrently with that for the
direct final rule. All comments on this proposed rule will also be
considered as comments on the companion direct final rule. FDA is
publishing the direct final rule because the rule contains
noncontroversial changes, and FDA anticipates that it will receive no
significant adverse comments. If no significant comment is received in
response to the direct final rule, no further action will be taken
related to this proposed rule. Instead, FDA will publish a confirmation
notice within 30 days after the comment period ends confirming that the
direct final rule will go into effect on September 9, 1998. Because
this rule makes noncontroversial changes to an existing regulation in
order to implement changes required by FDAMA, FDA believes that
publication of a direct final rule is appropriate. Additional
information about FDA's direct final rulemaking procedures is set forth
in a guidance published in the Federal Register of November 21, 1997
(62 FR 62466).
If FDA receives a significant adverse comment regarding this rule,
FDA will publish a document withdrawing the direct final rule within 30
days after the comment period ends and will proceed to respond to all
of the comments received under this companion rule using usual notice-
and-comment procedures. The comment period for this companion proposed
rule runs concurrently with the direct final rule's comment period. Any
comments received under this companion proposed rule will also be
considered comments regarding the direct final rule.
A significant adverse comment is defined as a comment that explains
why the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without a change. In determining whether a significant adverse comment
is sufficient to terminate a direct final rulemaking, FDA will consider
whether
[[Page 20559]]
the comment raises an issue serious enough to warrant a substantive
response in a notice-and-comment process. Comments that are frivolous,
insubstantial, or outside the scope of the rule will not be considered
adverse under this procedure. For example, a comment recommending a
rule change in addition to the rule will not be considered a
significant adverse comment, unless the comment states why the rule
would be ineffective without the additional change. In addition, if a
significant adverse comment applies to part of a rule and that part can
be severed from the remainder of the rule, FDA may adopt as final those
parts of the rule that are not the subject of a significant adverse
comment.
This action is part of FDA's continuing effort to achieve the
objectives of the President's ``Reinventing Government'' initiative,
and is intended to reduce the burden of unnecessary regulations on
medical devices, without diminishing the protection of public health.
On November 21, 1997, the President signed FDAMA into law. As one
of its provisions, FDAMA added section 515(d)(6) to the act (21 U.S.C.
360e(d)(6)). This new section provides that PMA supplements are
required for all changes that affect safety and effectiveness, unless
such changes involve modifications to manufacturing procedures or
method of manufacture. Those types of manufacturing changes will
require a 30-day notice or, where FDA finds such notice inadequate, a
135-day PMA supplement. Examples of changes that potentially qualify
for a 30-day notice are those intended by the PMA holder to reduce
manufacturing and/or labor cost, reduce manufacturing time, reduce
waste, or compensate for a change in suppliers of raw material or
components.
Manufacturers who believe that the change they intend to make
qualifies for this review will be required to submit a 30-day notice to
FDA that describes in detail the change the manufacturer intends to
make, summarizes the data or information supporting the change, and
states that the change has been made in accordance with the
requirements of part 820 (21 CFR part 820). The manufacturer may
distribute the device 30 days after FDA receives the notice, unless FDA
notifies the applicant within that 30-day period that the notice is not
adequate. If the notice is not adequate, FDA will inform the applicant
in writing that a 135-day supplement is needed and will describe what
further action or information is required for FDA to approve the
change. The time FDA uses to review the 30-day notice will be deducted
from the 135-day supplement review period if the notice contains the
appropriate information that is required for review of PMA supplements.
This rule incorporates the provisions for a 30-day notice and 135-
day PMA supplements into FDA's regulations at Sec. 814.39 (21 CFR
814.39).
The agency has developed guidance on this issue, entitled ``CDRH
Guidance for 30-Day Notices and 135-Day PMA Supplements for
Manufacturing Method or Process Changes for Use by OC, ODE, and
Industry,'' and it has announced the availability of the guidance in
the Federal Register of February 25, 1998 (63 FR 9570).
II. Environmental Impact
The agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
III. Analysis of Impacts
FDA has examined the impacts of this proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all
costs of available regulatory alternatives and, when regulatory action
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity).
The agency believes that this proposed rule is consistent with the
regulatory philosophy and principles identified in the Executive Order.
In addition, this proposed rule is not a significant regulatory action
as defined by the Executive Order and so is not subject to review under
the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The rule merely codifies applicable statutory
requirements imposed by the FDAMA. The Commissioner of Food and Drugs
certifies that this final rule will not have a significant economic
impact on a substantial number of small entities. This proposed rule
also does not trigger the requirement for a written statement under
section 202(a) of the Unfunded Mandates Reform Act because it does not
impose a mandate that results in an expenditure of $100 million or more
by State, local, or tribal governments in the aggregate, or by the
private sector, in any 1 year.
IV. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions which
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The title, description, and respondent description of the
information collection provisions are shown below along with an
estimate of the annual reporting burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and, (4) ways to minimize the burden of
the collection of information on respondents, including through the use
of automated collection techniques, when appropriate, and other forms
of information technology.
Title: Supplements to Premarket Approval Applications for Medical
Devices
Description: FDAMA (Pub. L. 105-115) added section 515(d)(6) to the
act, modifying FDA's statutory authority regarding premarket approval
of medical devices. This new section provides for an alternate form of
notice to the agency for certain types of changes to a device for which
the manufacturer has an approved PMA. Under section 515(d)(6) of the
act, PMA supplements are required for all changes that affect safety
and effectiveness unless such changes involve modifications to
manufacturing procedures or the method of manufacture. For those types
of manufacturing changes, the manufacturer may submit to the agency an
alternate form of notice in the form of a 30-day notice or, where FDA
finds such notice inadequate, a 135-day PMA supplement. The 30-day
notice must describe the change the manufacturer
[[Page 20560]]
intends to make, summarize the data or information supporting the
change, and state that the change has been made in accordance with the
requirements of part 820.
The manufacturer may distribute the device 30 days after FDA
receives the notice, unless FDA notifies the applicant, within that 30-
day period, that the notice is inadequate. If the notice is not
adequate, FDA will inform the manufacturer that a 135-day supplement is
required and will describe what additional information or action is
necessary for FDA to approve the change.
This rule would incorporate the provisions for a 30-day notice and
135-day supplements into FDA's regulations at Sec. 814.39 to reflect
the changes made by FDAMA.
Description of Respondents: Businesses or other for profit
organizations.
The information collection for Sec. 814.39 has been approved by OMB
until September 30, 1998, under Premarket Approval of Medical Devices,
OMB Control Number 0910-0231, for a total of 36,063 hours. FDA believes
that the submission of 30-day notices in lieu of PMA supplements will
result in approximately a 10 percent reduction in total number of hours
needed to comply with Sec. 814.39. As a result, FDA estimates that the
new total number of hours needed to comply with the information
collection requirements in Sec. 814.39 is 32,612 for a reduction of
3,451 hours.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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814.39 493 1 493 66.15 32,612
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA believes that the proposed amendments to Sec. 814.39 permitting
the submission of 30-day notices in lieu of PMA supplements would
result in approximately a 10-percent reduction in the total number of
hours needed to comply as compared to Sec. 814.39 prior to these
proposed amendments. As a result, FDA estimates that the new total
number of hours that would be needed to comply with the information
collection requirements in Sec. 814.39 is 32,612, for a reduction of
3,451 hours.
For consistency with the direct final rule to which this proposed
rule is a companion, FDA is following the PRA comment procedures for
direct final rules in this proposed rule. As provided in 5 CFR
1320.5(c)(1), collections of information in a direct final rule is
subject to the procedures set forth in 5 CFR 1320.10. Interested
persons and organizations may submit comments on the information
collection requirements of this proposed rule by June 26, 1998 to the
Dockets Management Branch (address above).
At the close of the 60-day comment period, FDA will review the
comments received, revise the information collection provisions as
necessary, and submit these provisions to OMB for review. FDA will
publish a notice in the Federal Register when the information
collection provisions are submitted to OMB, and an opportunity for
public comment to OMB will be provided at that time. Prior to the
effective date of the direct final rule, FDA will publish a notice in
the Federal Register of OMB's decision to approve, modify, or
disapprove the information collection provisions. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.
V. Comments
Interested persons may, by July 13, 1998, submit to the Dockets
Management Branch (address above) written comments regarding this
proposal. This comment period runs concurrently with the comment period
for the direct final rule. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in the brackets in the
heading of this document. Received comments may be seen in the office
above between 9 a.m. and 4 p.m., Monday through Friday. All comments
received will be considered as comments regarding the direct final rule
and this proposed rule. In the event the direct final rule is
withdrawn, all comments received will be considered comments on this
proposed rule.
List of Subjects in 21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under the authority delegated to the Commissioner of the Food and
Drugs, 21 CFR part 814 is amended as follows:
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
1. The authority citation for 21 CFR part 814 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.
2. Section 814.39 is amended by revising paragraph (a) introductory
text and paragraph (a)(4) and by adding paragraph (f) to read as
follows:
Sec. 814.39 PMA supplements.
(a) After FDA's approval of a PMA, an applicant shall submit a PMA
supplement for review and approval by FDA before making a change
affecting the safety or effectiveness of the device for which the
applicant has an approved PMA, unless the change is of a type for which
FDA, under paragraph (e) of this section, has advised that an alternate
submission is permitted or is of a type which, under section
515(d)(6)(A) of the act and paragraph (f) of this section, does not
require a PMA supplement under this paragraph. While the burden for
determining whether a supplement is required is primarily on the PMA
holder, changes for which an applicant shall submit a PMA supplement
include, but are not limited to, the following types of changes if they
affect the safety or effectiveness of the device:
* * * * *
(4) Changes in manufacturing facilities, methods, or quality
control procedures that do not meet the requirements for a submission
under paragraph (e) or (f) of this section.
* * * * *
(f) Under section 515(d) of the act, modifications to manufacturing
procedures or methods of manufacture that affect the safety and
effectiveness of a device subject to an approved PMA do not require
submission of a PMA supplement under paragraph (a) of this
[[Page 20561]]
section and are eligible to be the subject of a a 30-day notice. A 30-
day notice shall describe in detail the change, summarize the data or
information supporting the change, and state that the change has been
made in accordance with the requirements of 21 CFR part 820. The
manufacturer may distribute the device 30 days after the date on which
FDA receives the 30-day notice, unless FDA notifies the applicant
within 30 days from receipt of the notice that the notice is not
adequate. If the notice is not adequate, FDA shall inform the applicant
that a 135-day PMA supplement is needed and shall describe what further
information or action is required for acceptance of such change. The
number of days under review as a 30-day notice shall be deducted from
the 135-day PMA supplement review period if the notice meets
appropriate content requirements for a PMA supplement.
Dated: March 24, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-11085 Filed 4-24-98; 8:45 am]
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