[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Proposed Rules]
[Pages 51874-51875]
From the Federal Register Online via the Government Publishing 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