[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