[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]


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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.

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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