[Federal Register Volume 62, Number 124 (Friday, June 27, 1997)]
[Proposed Rules]
[Pages 34680-34681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16792]



[[Page 34680]]

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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to revise 
the premarket approval application (PMA) announcement procedure. FDA is 
proposing to discontinue the publication of PMA approvals and denials 
in the Federal Register. Instead, the agency is proposing to announce 
approvals and denials of PMA's on the Internet. Finally, FDA is 
proposing to make 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.

DATES: Written comments by September 25, 1997. FDA intends that any 
final rule based on this proposal become effective 30 days after its 
date of publication in the Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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 preamble to the proposed rule prescribing the contents of a 
PMA and the criteria for approving, disapproving, or withdrawing 
approval of a PMA (45 FR 81769 at 81772, December 12, 1980), 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 notice of opportunity to petition for 
administrative review in the announcement 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 notice of opportunity 
for administrative review in the announcement 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).)

II. Contents of the Proposed Regulation

    FDA is proposing to discontinue publication of individual PMA 
approvals and denials in the Federal Register. Instead, FDA is 
proposing to 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 
Docket's 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 the proposed procedure would 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 would 
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 10.33(b) (21 CFR 10.33(b)) for 
notices announcing approval of a PMA would 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 only be sought by the applicant; in 
these cases, the 30-day period would 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 proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
Executive Order 12866 directs agencies to asses all costs and benefits 
of available regulatory alternatives and, when regulation 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, the 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. Because this proposed rule involves a minor 
procedural change that primarily affects FDA and has no direct effect 
on small companies, the agency certifies that this proposed 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. Comments

    Interested persons may, on or before September 25, 1997, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. 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 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.

List of Subjects in 21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

[[Page 34681]]

    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 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: Secs. 501, 502, 503, 510, 513-520, 701, 702, 703, 
704, 705, 708, 721, 801 of the Federal Food, Drug, and Cosmetic Act 
(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 an 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: June 17, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-16792 Filed 6-26-97; 8:45 am]
BILLING CODE 4160-01-F