[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any significant adverse comment and is withdrawn.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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