[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Proposed Rules]
[Pages 51874-51875]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-25797]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 807

[Docket No. 98N-0520]


Medical Devices; Establishment Registration and Device Listing 
for Manufacturers and Distributors of Devices; Companion 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 
certain regulations governing establishment registration and device 
listing by domestic distributors. This proposed rule is a companion 
document to the direct final rule published elsewhere in this issue of 
the Federal Register. These 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 companion proposed rule is being issued under FDAMA and 
the act as amended.

DATES: Comments must be received on or before December 14, 1998.

ADDRESSES: Submit written comments on the companion proposed rule to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Walter W. Morgenstern, Center for 
Devices and Radiological Health (HFZ-305), Food and Drug 
Administration, 2094 Gaither Rd., Rockville, MD 20852.

SUPPLEMENTARY INFORMATION: 

I. Background

    This proposed rule is a companion to the direct final rule 
published in the final rules section of this issue of the Federal 
Register. The direct final rule and this companion proposed rule are 
substantively identical. FDA is publishing the direct final rule 
because the rule contains noncontroversial changes, and FDA anticipates 
that it will receive no significant adverse comment. A detailed 
discussion of this rule is set forth in the preamble of the direct 
final rule. If no significant adverse 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 document 
within 30 days after the comment period ends confirming that the direct 
final rule will go into effect on February 11, 1999. 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 any significant adverse comment regarding the 
direct final 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 under this companion proposed 
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 as 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 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 (Pub. L. 
105-115). Section 213(b) of FDAMA made the following changes to section 
510(g) of the act (21 U.S.C. 360(g)) regarding establishment 
registration and device listing by domestic distributors:
    1. FDAMA amended section 510(g) of the act to add a new paragraph 
(g)(4) to provide that the registration and listing requirements of 
section 510 of the act do not apply to distributors who act as 
``wholesale distributors,'' and who do not manufacture, repackage, 
process, or relabel a device.
    2. FDAMA also added a definition of ``wholesale distributor'' to 
section 510(g) of the act. A ``wholesale distributor'' is defined as 
``any person (other than the manufacturer or the initial importer) who 
distributes a device from the original place of manufacture to the 
person who makes the final delivery or sale of the device to the 
ultimate consumer or user.''

[[Page 51875]]

    FDA is issuing this companion proposed rule to amend certain 
existing regulations to conform to amendments made by FDAMA to section 
510(g) of the act. For a discussion of the specific provisions of the 
regulation, see the preamble to the direct final rule published 
elsewhere in this issue of the Federal Register.

II. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this proposed 
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 impact of this companion 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 and benefits 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 codifies applicable statutory requirements 
imposed by FDAMA. Because the companion proposed rule exempts certain 
distributors from registration and device listing, it may permit more 
small competitors to enter the marketplace. The agency certifies that 
this proposed rule, if issued, will not have a significant economic 
impact on a substantial number of small entities. In addition, this 
proposed rule does not impose a mandate that results in an expenditure 
of $100 million or more in either the private sector or State, local, 
and tribal governments in the aggregate, and therefore a summary 
statement of analysis under section 202(a) of the Unfunded Mandates 
Reform Act of 1995 is not required.

IV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collections of information. Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520) is not required.

V. Submission of Comments

    Interested persons may, on or before December 14, 1998, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. The comment period runs concurrently with the 
comment period for the direct final rule. Two copies of any comment 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 the 
proposed rule.

List of Subjects in 21 CFR Part 807

    Confidential business information, Imports, Medical devices, 
Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 807 be amended as follows:
    1. The part heading for part 807 is revised to read as follows:

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

    2. The authority citation for 21 CFR part 807 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 360, 360c, 360e, 360i, 360j, 
371, 374.

    3.Section 807.3 is amended by revising paragraphs (d)(2) and (g), 
and by adding paragraph (s) to read as follows:

Sec. 807.3  Definitions.

* * * * *
    (d) * * *
    (2) Initial importation of devices manufactured in foreign 
establishments; or
* * * * *
    (g) Initial importer means any importer who furthers the marketing 
of a device from a foreign manufacturer to the person who makes the 
final delivery or sale of the device to the ultimate consumer or user, 
but does not repackage, or otherwise change the container, wrapper, or 
labeling of the device or device package.
* * * * *
    (s) Wholesale distributor means any person (other than the 
manufacturer or the initial importer) who distributes a device from the 
original place of manufacture to the person who makes the final 
delivery or sale of the device to the ultimate consumer or user.
    4. Section 807.20 is amended by revising paragraph (a)(4), by 
redesignating paragraph (d) as paragraph (c) and paragraph (c) as 
paragraph (d), respectively, and by adding paragraph (c)(3) to read as 
follows:

Sec. 807.20  Who must register and submit a device list.

    (a) * * *
    (4) Acts as an initial importer;
* * * * *
    (c) * * *
    (3) Acts as a wholesale distributor, as defined in Sec. 807.3(s), 
and who does not manufacture, repackage, process, or relabel a device.
* * * * *


Sec. 807.22  [Amended]

    5.Section 807.22 How and where to register establishments and list 
devices is amended in paragraph (c) by removing the words 
``distributor'' and ``distributors'' each time they appear and by 
adding in their place the words ``initial importer'' and ``initial 
importers'', respectively.

    Dated: July 15, 1998.
 William B. Schultz,
 Deputy Commissioner for Policy.
[FR Doc. 98-25797 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F