[Federal Register Volume 65, Number 46 (Wednesday, March 8, 2000)]
[Proposed Rules]
[Pages 12154-12155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. 97P-0044]


New Drugs for Human Use; Clarification of Requirements for Patent 
Holder Notification; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of its proposed rule published in the Federal Register on 
March 6, 1998 (63 FR 11174). The document proposed to amend FDA's 
regulations on notice of certification of invalidity or noninfringement 
of a patent to provide additional methods for new drug and abbreviated 
new drug applicants to provide notice to patent owners and new drug 
application (NDA) holders, without removing the existing means. FDA is 
withdrawing this proposal based on comments regarding the inability of 
large corporations to track receipt of deliveries by means other than 
certified mail, return receipt requested.

DATES: The proposed rule is withdrawn March 8, 2000.

FOR FURTHER INFORMATION CONTACT:  Leanne Cusumano, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 6, 1998 (63 FR 11174), FDA 
proposed to permit new drug and abbreviated new drug applicants to 
provide notice of certification of invalidity or noninfringement of a 
patent to patent owners and NDA holders by overnight delivery service, 
facsimile, and electronic mail, in addition to U.S. Postal Service 
(USPS) registered or certified mail, return receipt requested, or 
another method approved in advance by the agency. Sections 314.52(c) 
and 314.95(c) (21 CFR 314.52(c) and 314.95(c)) set forth the content 
requirements of the notice of certification. Under Secs. 314.52(e) and 
314.95(e), applicants must amend their applications to document receipt 
of the notice of certification by each person provided the notice. 
Applicants must include a copy of the return receipt or other similar 
evidence of the date the notification was received. FDA accepts as 
adequate documentation of the date of receipt a return receipt or a 
letter acknowledging receipt by the person provided the notice. Under 
Secs. 314.52(e) and 314.95(e), applicants may rely on another form of 
documentation only if FDA has agreed to such documentation in advance. 
FDA reminds those providing notice of certification to application 
holders that if an application holder does not reside or maintain a 
place of business within the United States, notice must be sent to the 
application holder's U.S. attorney, agent, or other authorized official 
(Secs. 314.52(a)(2) and 314.95(a)(2)). FDA also notes that the term 
``registered or certified mail'' as used in Secs. 314.52(a) and 
314.95(a) means USPS registered or certified mail, and not equivalent 
delivery via foreign mail. Since the actual form of international 
registered or certified mail and receipt may vary from country to 
country, use of international mail could put a substantial burden on 
innovator companies to be alert to multiple forms of notice. Therefore, 
applicants must use USPS mail. Delivery by USPS mail should not be 
burdensome since applicants are required to have a U.S. agent.

II. Comments on the Proposed Rule

    FDA received three comments on the proposed rule. The comments were 
from two large pharmaceutical companies and from the Pharmaceutical 
Research and Manufacturers Association. All of the comments stated that 
electronic methods of delivery, including facsimile and electronic 
mail, are too unreliable at this stage to be used to deliver 
notification.
    One of the comments supported use of overnight and messenger 
delivery services. One comment stated that overnight delivery service 
would be acceptable only if the person receiving the notice signed a 
form verifying receipt of the notice. The other comment stated that 
overnight delivery services are not acceptable because deliveries are 
made in bulk, accompanied by a manifest that does not guarantee that 
each item listed is in fact in the bulk package and that individual 
items are not signed for.
    All of the comments stated that the present system is workable.

III. Withdrawal of the Proposed Rule

    After careful consideration of these comments, FDA has concluded 
that the current system, which requires only that an applicant send 
notice by USPS registered or certified mail, return receipt requested, 
is not overly

[[Page 12155]]

burdensome. This requirement is intended to provide maximum assurance 
that the notice will be received by the patent holder and the NDA 
holder, and that such receipt will be documented adequately. In 
addition, FDA has concluded that adding new methods of notification 
presents complications in ensuring that notification is received by 
sponsors. Accordingly, FDA is withdrawing its proposed rule to permit 
new drug and abbreviated new drug applicants to provide notice of 
certification of invalidity or noninfringement of a patent to patent 
owners and NDA holders by overnight delivery service, facsimile, and 
electronic mail, in addition to USPS registered or certified mail, 
return receipt requested, or another method approved in advance by the 
agency.

    Dated: February 29, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-5527 Filed 3-7-00; 8:45 am]
BILLING CODE 4160-01-F