[Federal Register Volume 63, Number 44 (Friday, March 6, 1998)]
[Proposed Rules]
[Pages 11174-11177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5800]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its 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. These proposed amendments reflect current business practices and 
are intended to ensure that notice is provided to patent owners and NDA 
holders in a timely manner. FDA is also proposing to require certain 
applicants to submit to FDA a copy of the notice of certification.

DATES: Submit written comments by June 4, 1998.
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: 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

    Under Secs. 314.52(a) and 314.95(a) (21 CFR 314.52(a) and 
314.95(a)), new drug and abbreviated new drug applicants provide notice 
of certification of invalidity or noninfringement of a patent to patent 
owners and NDA holders by registered or certified mail, return receipt 
requested, or by another method approved in advance by the agency. 
Sections 314.52(c) and 314.95(c) set forth the content requirements of 
the notice of certification. Under Sec. 314.52(e) and Sec. 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 
Sec. 314.52(e) and Sec. 314.95(e), applicants may rely on another form 
of documentation only if FDA has agreed to such documentation in 
advance.
    FDA is proposing to amend these regulations to provide additional 
methods of giving notice of certification without removing the existing 
means. On February 4, 1997, FDA received a citizen petition from 
McKenna & Cuneo, L.L.P., on behalf of the National

[[Page 11175]]

Pharmaceutical Alliance (Docket No. 97P-0044/CP1). The petitioner 
requested that FDA revise Secs. 314.52(a) and 314.95(a) to permit 
notice to patent owners and NDA holders to be given by means in 
addition to ``registered or certified mail, return-receipt requested.'' 
The petition also requested that FDA clarify the meaning of the phrase 
``by mail or in person'' as used throughout FDA's regulations. The 
petitioner stated that most FDA regulations require submissions to be 
made by mail or personal delivery, whereas the patent notification 
provisions require that notice be provided by registered or certified 
mail, return receipt requested. The petitioner argued that ``return 
receipt service can result in inefficient and variable document 
delivery in certain time-sensitive instances,'' (petition at 2), and 
that ``a change in the patent certification regulations to include 
delivery via messenger, delivery and mailing services that provide 
delivery verification would enable the pharmaceutical industry to 
utilize efficient, standard business practices for document delivery'' 
(petition at 4-5).

II. Description of the Proposed Rule

    After careful research, FDA decided to propose this regulation in 
response to the citizen petition. FDA concluded that technological and 
market changes warrant adoption of regulations permitting notification 
to patent owners and NDA holders to be given by means in addition to 
registered or certified mail, return receipt requested. Since 
Secs. 314.52(a) and 314.95(a) were proposed in 1989 (54 FR 28872, July 
10, 1989) and finalized in 1994 (59 FR 50338 at 50366, October 3, 
1994), the use of private and alternative delivery services has 
increased dramatically. Between 1988 and 1994, the U.S. Postal 
Service's market share of mail delivery services dropped from 77 
percent to 62 percent, or 15 percentage points (Ref. 1). This means 
that mail is delivered by means other than the U.S. Postal Service 38 
percent of the time. Nation's Business (Ref. 2) reports that in 1997:
    [t]he Postal Service now handles about 60 percent of the 
nation's business-to-business mail, and some in the industry say the 
figure might drop to 40 percent within five years. Even with its 
recent upsurge in advertising mail and Priority Mail, the Postal 
Service's total mail volume increased only 1 percent last year.
In addition, mail services in general are losing market share to 
facsimiles and e-mail (Refs. 2, 3, and 4).
    Under the current regulation, FDA permits notification by means 
other than registered or certified mail, return receipt requested, but 
applicants must obtain FDA approval in advance of using an alternative 
form of documentation (Secs. 314.52(e) and 314.95(e)). FDA is 
interested in ensuring that patent owners and NDA holders receive 
notification of actions that may affect their patents. Accordingly, all 
delivery methods that provide verification of receipt serve FDA's 
purpose. An acceptable verification of receipt includes a receipt that 
contains the same general type of information as that provided by 
registered or certified mail, return receipt requested: (1) The address 
where the article is delivered, (2) identification of the item 
delivered, (3) the date of receipt, (4) the method of delivery, and (5) 
the signature of the addressee or his or her agent. To permit 
applicants to use delivery methods other than registered or certified 
mail, return receipt requested, FDA is proposing to revise 
Secs. 314.52(a) and 314.95(a) to permit patent certifications to be 
delivered ``by mail or personal delivery'' for which the applicant 
obtains ``verification of receipt.''
    To explain the phrase ``by mail or personal delivery'' in 
Secs. 314.52(a) and 314.95(a), FDA is proposing to amend Sec. 314.3(b) 
(21 CFR 314.3(b)) to include the following definition: ``By mail or 
personal delivery means delivery by registered or certified mail, 
return receipt requested or by an express mail, messenger, delivery, or 
mailing service, including electronic mailing service or facsimile, 
provided that verification of receipt is obtained.''
    To assist recipients in identifying patent notifications received 
by means other than by registered or certified mail, return receipt 
requested, FDA is proposing to amend Secs. 314.52(c)(8) and 
314.95(c)(8), ``Content of a notice,' to add specific instructions 
regarding the envelope, and type size and leading of the caption label 
with the words ``PATENT CERTIFICATION.'' E-mail notices shall state 
``PATENT CERTIFICATION'' as the subject line and as the first line of 
text of the e-mail message.
    To clarify the meaning of the phrase ``verification of receipt'' in 
Secs. 314.52(a) and 314.95(a), FDA is proposing to amend 
Secs. 314.52(e) and 314.95(e), ``Documentation of receipt of notice,'' 
to state that verification of receipt must contain the date notice was 
delivered, the address to which notice was delivered, and the signature 
of the recipient.
    To accommodate delivery by electronic means, FDA is proposing to 
amend Secs. 314.52(e) and 314.95(e) to permit delivery by electronic 
mail or facsimile provided certain additional requirements are met. 
Electronic signatures and electronic records, which includes e-mail and 
electronic facsimiles, would be required to comply with the provisions 
of 21 CFR part 11. Facsimile receipts would include the telephone 
number to which notice was faxed, but would not be required to include 
the recipient's signature. Electronic mail receipts would include the 
e-mail address to which notice was delivered, but would not be required 
to include the recipient's signature.
    FDA is also proposing to amend Sec. 314.52(e) to require under 
section 505(b) of the act (21 U.S.C. 355(b)) applicants to submit a 
copy of the notice to the agency with the delivery receipt. FDA is 
proposing this requirement in order to obtain additional information 
about the relationship between the section 505(b) of the act 
application and the reference drug(s). This information is particularly 
desirable in order to avoid confusion in cases in which the section 
505(b) of the act application refers to multiple reference drugs.
    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 seeks comments on this proposal. In particular, FDA is seeking 
comments addressing the type of receipt which is sufficient to verify 
deliveries made by electronic mail and facsimile. FDA is also seeking 
comments regarding how applicants may obtain the correct electronic or 
facsimile addresses for patent owners and NDA holders in order to 
ensure that notification is received by a responsible person.

III. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Data Analysis Group, ``Market Share of Mail Delivery 
Services,'' Computer Industry Forecasts, April 15, 1996.
    2. Bates, S., ``Postal Service Tackles Competition,'' Nation's 
Business, April 1997, 38.
    3. Blum, A., ``Two-Day Express Market Taking Off,'' Journal of 
Commerce, June 9, 1997, News section, 1A.
    4. Goldstein, M. A., ``Can the U.S. Postal Service Market Itself 
to Success?'' Los Angeles Times Magazine, December 11, 1996, 14.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a class

[[Page 11176]]

of actions that do not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354 and Pub. 
L. 104-121). Executive Order 12866 directs agencies to assess 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 
and so is not subject to further 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 regulation imposes only alternative reporting, 
recordkeeping, or other economic burdens, the agency certifies that the 
proposed rule will not have a significant impact on a substantial 
number of small entities. Therefore, under the Regulatory Flexibility 
Act, no further analysis is required.

VI. Paperwork Reduction Act of 1995

    The proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
title, description, and respondent description of the information 
collection provisions are shown below.
    Title: New Drugs for Human Use; Clarification of Requirements for 
Patent Holder Notification
    Description: The Food and Drug Administration (FDA) is proposing to 
amend its 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 NDA holders, without removing the existing means. These proposed 
amendments reflect current business practices and are intended to 
ensure that notice is provided to patent owners and NDA holders in a 
timely manner. FDA is also proposing to require applicants to submit to 
FDA a copy of the notice of certification.
    Respondent Description: Businesses and other for-profit 
organizations, State or local governments, Federal agencies, and 
nonprofit institutions.
    FDA has determined that the information collection provisions of 
this proposed rule would not impose any additional burdens that have 
not already been estimated and submitted to OMB for approval under OMB 
No. 0910-0305 ``Abbreviated New Drug Application Regulations; Patent 
and Exclusivity Provisions.'' There are additional burdens in this 
proposed rule that are not already required under current regulations 
(and specifically approved under OMB No. 0910-0305): (1) New 
Secs. 314.52(c)(8) and 314.95(c)(8) would require the heading ``Patent 
Certification'' as well as certain print specifications on certain 
notices. (2) A proposed amendment to Sec. 314.52(e) would require 
section 505(b) of the act applicants to submit a copy of the notice of 
certification as an attachment to the verification of receipt. FDA 
believes that the time and cost for respondents to comply with these 
new requirements are negligible. The required heading and print 
specifications would not add any measurable costs to the current 
requirement for preparing and delivering a notice of certification. 
Respondents are already required to submit to FDA a certification of 
receipt, and attaching a copy of the notice of certification would not 
result in any measurable burden.

List of Subjects in 21 CFR Part 314

    Administrative practice and procedure, Confidential business 
information, Drugs, Reporting and recordkeeping requirements.
    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 314 be amended as follows:

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG OR AN 
ANTIBIOTIC DRUG

    1. The authority citation for 21 CFR part 314 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 
371, 374, 379e.

    2. Section 314.3 is amended in paragraph (b) by alphabetically 
adding a definition for ``By mail or personal delivery,'' to read as 
follows:


Sec. 314.3  Definitions.

* * * * *
    (b) * * *
* * * * *
    By mail or personal delivery means delivery by registered or 
certified mail, return receipt requested or by an express mail, 
messenger, delivery, or mailing service, including electronic mailing 
service or facsimile, provided that verification of receipt is 
obtained.
* * * * *
    3. Section 314.52 is amended by revising the introductory text of 
paragraph (a) and paragraph (e) and adding paragraph (c)(8) to read as 
follows:


Sec. 314.52  Notice of certification of invalidity or noninfringement 
of a patent.

    (a) Notice of certification. For each patent that claims the drug 
or drugs on which investigations that are relied upon by the applicant 
for approval of its application were conducted or that claims a use for 
such drug or drugs and that the applicant certifies under 
Sec. 314.50(i)(1)(i)(A)(4) that a patent is invalid, unenforceable, or 
will not be infringed, the applicant shall give notice of such 
certification by mail or personal delivery to and shall obtain 
verification of receipt from each of the following persons: * * *
* * * * *
    (c) * * *
    (8) The envelope, where applicable, and cover sheet of the notice 
shall be clearly labeled in 14 point or larger, bold, all capitals type 
with the words ``PATENT CERTIFICATION.'' E-mail notices shall state 
``PATENT CERTIFICATION'' as the subject line and as the first line of 
text of the e-mail message.
* * * * *
    (e) Documentation of receipt of notice. The applicant shall amend 
its application to document receipt of the notice required under 
paragraph (a) of this section by each person provided the notice. The 
applicant shall include a copy of the return receipt or other similar 
evidence of the date the notification was received. A copy of the 
notice shall be attached to the receipt submitted to the agency if the 
applicant has made a submission under 21 U.S.C. 355(b). FDA will accept 
as adequate documentation of the date of receipt a return receipt from 
registered or certified mail, a letter acknowledging receipt by the 
person provided the notice, or a verification of receipt that contains 
the date notice was delivered, the address to which notice was 
delivered, and the signature of the recipient. Electronic signatures 
and electronic records shall comply with the provisions of 21 CFR part 
11. Facsimile receipts shall also include the telephone number to which 
notice was faxed, but

[[Page 11177]]

need not include the recipient's signature. Electronic mail receipts 
shall also include the e-mail address to which notice was delivered, 
but need not include the recipient's signature. An applicant may rely 
on another form of documentation only if FDA has agreed to such 
documentation in advance.
* * * * *
    4. Section 314.95 is amended by revising the introductory text of 
paragraph (a) and paragraph (e) and adding paragraph (c)(8) to read as 
follows:


Sec. 314.95  Notice of certification of invalidity or noninfringement 
of a patent.

    (a) Notice of certification. For each patent that claims the listed 
drug or that claims a use for such listed drug for which the applicant 
is seeking approval and that the applicant certifies under 
Sec. 314.94(a)(12) is invalid, unenforceable, or will not be infringed, 
the applicant shall give notice of such certification by mail or 
personal delivery to and shall obtain verification of receipt from each 
of the following persons:* * *
* * * * *
    (c) * * *
    (8) The envelope, where applicable, and cover sheet of the notice 
shall be clearly labeled in 14 point or larger, bold, all capitals type 
with the words ``PATENT CERTIFICATION.'' E-mail notices shall state 
``PATENT CERTIFICATION'' as the subject line and as the first line of 
text of the e-mail message.
* * * * *
    (e) Documentation of receipt of notice. The applicant shall amend 
its abbreviated application to document receipt of the notice required 
under paragraph (a) of this section by each person provided the notice. 
The applicant shall include a copy of the return receipt or other 
similar evidence of the date the notification was received. FDA will 
accept as adequate documentation of the date of receipt a return 
receipt from registered or certified mail, a letter acknowledging 
receipt by the person provided the notice, or a verification of receipt 
that contains the date notice was delivered, the address to which 
notice was delivered, and the signature of the recipient. Electronic 
signatures and electronic records shall comply with the provisions of 
21 CFR part 11. Facsimile receipts shall also include the telephone 
number to which notice was faxed, but need not include the recipient's 
signature. Electronic mail receipts shall also include the e-mail 
address to which notice was delivered, but need not include the 
recipient's signature. An applicant may rely on another form of 
documentation only if FDA has agreed to such documentation in advance.
* * * * *

    Dated: February 26, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-5800 Filed 3-5-98; 8:45 am]
BILLING CODE 4160-01-F