Revising the Announcement Procedures for Approvals and Denials of Premarket Approval Applications

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