[Federal Register Volume 63, Number 20 (Friday, January 30, 1998)]
[Rules and Regulations]
[Pages 4571-4572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2263]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 814
[Docket No. 97N-0133]
Revising the Announcement Procedures for Approvals and Denials of
Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to revise the premarket approval application (PMA) announcement
procedure. FDA is discontinuing the publication of individual PMA
approvals and denials in the Federal Register. Instead, the agency will
announce approvals and denials of PMA's on the Internet. FDA will make
the summaries of safety and effectiveness available through the
Internet and by placing them in FDA's Dockets Management Branch. FDA
will publish in the Federal Register for each quarter a list of the
approvals and denials announced in that quarter. FDA is taking this
action in order to expedite the availability of this information.
EFFECTIVE DATE: March 2, 1998.
FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-827-2974.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 12, 1980 (45 FR 81769 at
81772), FDA prescribed the contents of a PMA and the criteria for
approving, disapproving, or withdrawing approval of a PMA. FDA
acknowledged that, although the statute does not require it to publish
the approval of a PMA in the Federal Register, section 515(d)(3) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(3))
permits an interested person to obtain review of an approved PMA.
Consequently, FDA proposed to announce approval of any PMA in the
Federal Register and to include in the announcement notice of
opportunity to petition for administrative review under section 515(g)
of the act. (See 45 FR 81769 at 81772 and 81776). FDA also proposed to
publish notice of any denial of approval or proposed withdrawal of
approval of any PMA in the Federal Register and to include in the
announcement notice of opportunity for administrative review under
section 515(g) of the act. (See 45 FR 81769 at 81773 and 81777.)
Subsequently, in the Federal Register of July 22, 1986 (51 FR 26342),
FDA issued a final rule providing, among other things, that notice of
approval of a PMA, notice of an order denying approval of a PMA, and
notice of an order withdrawing approval of a PMA will be published in
the Federal Register. (See 21 CFR 814.44(d), 814.45(d), and 814.46(e).)
In the Federal Register of June 27, 1997 (62 FR 34680), FDA issued a
proposed rule to revise the PMA announcement procedure by discontinuing
publication of PMA approvals and denials in the Federal Register and,
instead, announcing them on the Internet. Interested persons were given
until September 25, 1997, to comment on the proposed regulation. FDA
received two comments supporting the proposal, one from an in vitro
diagnostic manufacturer and the other from a dental association.
II. Summary of the Final Rule
FDA is discontinuing publication of individual PMA approvals and
denials in the Federal Register. Instead, FDA will notify the public of
PMA approvals and denials by posting them on FDA's home page on the
Internet (http://www.fda.gov), by placing the summaries of safety and
effectiveness on the Internet and in FDA's Dockets Management Branch,
and by publishing in the Federal Register after each quarter a list of
the PMA approvals and denials announced in that quarter.
FDA believes that this procedure will expedite public notification
of these actions because announcements can be placed on the Internet
more quickly than they can be published in the Federal Register, and
FDA believes that the Internet is accessible to more people than is the
Federal Register.
In accordance with section 515(d)(3) of the act, notification of an
order approving, denying, or withdrawing approval of a PMA will
continue to include a notice of opportunity to request review of the
order under section 515 (g) of the act. The 30-day period for
requesting reconsideration of an FDA action under Sec. 10.33(b) (21 CFR
10.33(b)) for notices announcing approval of a PMA will begin on the
day the notice is placed on the Internet. Section 10.33(b) provides
that FDA may, for good cause, extend this 30-day period.
Reconsideration of a denial or withdrawal of approval of a PMA may be
sought only by the applicant, in these cases, the 30-day period will
begin when the applicant is notified by FDA in writing of its decision.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) 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.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to selects regulatory
[[Page 4572]]
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). The agency believes that the final
rule is consistent with regulatory philosophy and principles identified
in the Executive Order. In addition, the final 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. Because the final rule involves a minor procedural
change that primarily affects FDA and has no direct effect on small
companies, the agency certifies that the final rule will not have a
significant economic impact on a substantial number of small entities.
Therefore, under the Regulatory Flexibility Act, no further analysis is
required.
V. Paperwork Reduction Act of 1995
This final rule contains no additional information collection
requirements which are subject to review by the Office of Management
and Budget under the Paperwork Reduction Act of 1995 (Pub. L. 104-13).
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
authority delegated to the Commissioner of 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 814.44 is amended by revising paragraph (d) to read as
follows:
Sec. 814.44 Procedures for review of a PMA.
* * * * *
(d)(1) FDA will issue to the applicant an order approving a PMA if
none of the reasons in Sec. 814.45 for denying approval of the
application applies. FDA will approve an application on the basis of
draft final labeling if the only deficiencies in the application
concern editorial or similar minor deficiencies in the draft final
labeling. Such approval will be conditioned upon the applicant
incorporating the specified labeling changes exactly as directed and
upon the applicant submitting to FDA a copy of the final printed
labeling before marketing. FDA will also give the public notice of the
order, including notice of and opportunity for any interested persons
to request review under section 515(d)(3) of the act. The notice of
approval will be placed on FDA's home page on the Internet (http://
www.fda.gov), and it will state that a detailed summary of information
respecting the safety and effectiveness of the device, which was the
basis for the order approving the PMA, including information about any
adverse effects of the device on health, is available on the Internet
and has been placed on public display, and that copies are available
upon request. FDA will publish in the Federal Register after each
quarter a list of the approvals announced in that quarter. When a
notice of approval is published, data and information in the PMA file
will be available for public disclosure in accordance with Sec. 814.9.
(2) A request for copies of the current PMA approvals and denials
document and for copies of summaries of safety and effectiveness shall
be sent in writing to the Dockets Management Branch (HFA-305), Food and
Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
* * * * *
3. Section 814.45 is amended by revising paragraph (d) to read as
follows:
Sec. 814.45 Denial of approval of a PMA.
* * * * *
(d)(1) FDA will give the public notice of an order denying approval
of the PMA. The notice will be placed on the FDA's home page on the
Internet (http://www.fda.gov), and it will state that a detailed
summary of information respecting the safety and effectiveness of the
device, including information about any adverse effects of the device
on health, is available on the Internet and has been placed on public
display and that copies are available upon request. FDA will publish in
the Federal Register after each quarter a list of the denials announced
in that quarter. When a notice of denial of approval is made publicly
available, data and information in the PMA file will be available for
public disclosure in accordance with Sec. 814.9.
(2) A request for copies of the current PMA approvals and denials
document and copies of summaries of safety and effectiveness shall be
sent in writing to the Freedom of Information Staff (HFI-35), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
* * * * *
Dated: January 22, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-2263 Filed 1-29-98; 8:45 am]
BILLING CODE 4160-01-F