Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review; Companion Document to Direct Final Rule

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any significant adverse comment and is withdrawn.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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