[Federal Register Volume 66, Number 2 (Wednesday, January 3, 2001)]
[Notices]
[Pages 372-374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-45]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1666]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Abbreviated New Drug Application Regulations; Patent 
and Exclusivity Provisions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the patent and exclusivity 
notification requirements under the new drug application (NDA) and 
abbreviated new drug application (ANDA) regulations.

DATES: Submit written or electronic comments on the collection of 
information by March 5, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party.

[[Page 373]]

Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Abbreviated New Drug Application Regulations; Patent and 
Exclusivity Provisions (OMB Control Number 0910-0305)--Extension

    Section 505 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 355) requires patent owners to submit to FDA information 
about patents that cover approved drugs. Generic copies of these drugs 
may be approved when the patents expire or if a generic company 
certifies that the patent is invalid or will not be infringed. In such 
cases, the generic company must notify the patent owner about the 
certification, and approval of the drug may not be made effective until 
after the court decides the patent infringement suit or a period of 36 
months, whichever occurs first. In addition, section 505 of the act 
provides several periods of marketing exclusivity ranging from 3 to 10 
years (depending primarily on the nature of the innovation). If a drug 
product receives marketing exclusivity, FDA will not approve (or, in 
limited cases not receive) an ANDA for the drug product.
    Under the authority found in sections 505 and 701 of the act (21 
U.S.C. 371), FDA issued regulations governing patent and exclusivity 
provisions in 21 CFR part 314. The regulations provide instructions for 
NDA applicants (including section 505(b)(2) of the act applicants) and 
ANDA applicants on how to file patent information and request marketing 
exclusivity; require patent certification information for section 
505(b)(2) applications and ANDA's; require information for requests for 
marketing exclusivity for NDA's (including section 505(b)(2) 
applications and certain NDA supplements); and require patent 
information for NDA's.
    The specific reporting requirements that are the subject of this 
information collection are as follows:
    21 CFR 314.50(i)--Requires the submission of patent certification 
information.
    21 CFR 314.50(j)--Requires the submission of marketing exclusivity 
information.
    21 CFR 314.52--Requires notice of certification of invalidity or 
noninfringement of a patent.
    21 CFR 314.53--Requires the submission of patent information.
    21 CFR 314.54(a)(1)(vii)--Requires the submission of marketing 
exclusivity information.
    21 CFR 314.70(e)--Requires the submission of patent information.
    21 CFR 314.70(f)--Requires the submission of marketing exclusivity 
information.
    21 CFR 314.94(a)(12)--Requires the submission of patent 
certification information.
    21 CFR 314.95--Requires notice of certification of invalidity or 
noninfringement of a patent.
    21 CFR 314.107(c)(4), (e)(2)(iv), and (f)--Requires notice of the 
date of commercial marketing; a copy of the entry of the order or 
judgement; notice of the filing of legal action after notice of 
certification.
    Applicants must provide information on patents to FDA to enable the 
agency to determine whether a product is covered by a patent or whether 
approval of a proposed drug product would result in patent 
infringement. The agency lists the patent information as a reference of 
potential applicants. If an applicant believes a patent is invalid or 
would not be infringed, Federal law also requires it to notify the 
patent holder. FDA approval, in such cases, is affected should there be 
any patent litigation. Failure to provide this information would result 
in an incomplete application and constitute grounds for refusing to 
approve the application.
    Applicants submitting NDA's are required under the act to provide 
information on certain patents that cover their drug products. The 
agency lists this patent information in its publication entitled List 
of Approved Drug Products With Therapeutic Equivalence Evaluations.
    To promote product innovation, the act also gives NDA applicants 
several periods of ``market exclusivity'' ranging from 3 to 10 years 
(depending primarily on the nature of the innovation). If a drug 
product receives marketing exclusivity, FDA will not approve (or, in 
limited cases, even receive) an ANDA for the drug product during that 
time period.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                     Number fo
         21 CFR Section              Number of     Responses per   Total Annual      Hours per      Total Hours
                                    Respondents     Respondent       Responses       Response
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Patent Information                     85               3.8           325               2             650
314.50(h)
314.53
314.70(e)
Patent Certification Information       97               3.4           331               2             662
314.50(i)
314.94(a)(12)
Notice of Certification of             37               2              75              16           1,200
 Invalidity or Non-infringement
 of a Patent
 314.52
 314.95

[[Page 374]]

 
Marketing Exclusivity                  92               2.7           250               2             500
 Information
314.50(j)
314.54(a)(1)(vii)
314.70(f)
Notification of Date of                34               2              71               1              71
 Commercial Marketing; Entry of
 the Order or Judgement; Filing
 of Legal Action
314.107(c)(4),(e)(2)(iv),(f)(2),
 and (f)(3)
Total                                                                                              3,083
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\1\There are no capital costs or operating and maintenance costs associated with this collection.


    Dated: December 26, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-45 Filed 1-2-01; 8:45 am]
BILLING CODE 4160-01-F