[Federal Register Volume 66, Number 66 (Thursday, April 5, 2001)]
[Notices]
[Pages 18094-18096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8307]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1666]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Abbreviated New Drug Application Regulations; 
Patent and Exclusivity Provisions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (PRA).

DATES: Submit written comments on the collection of information by May 
7, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Abbreviated New Drug Application Regulations; Patent and 
Exclusivity Provisions (OMB Control No. 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

[[Page 18095]]

these drugs may be approved when the patents expire is 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 abbreviated new drug application 
(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 part 314 (21 CFR part 314). The regulations provide 
instructions for new drug applications (NDA) applications (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:
 Sec. 314.50(i)--Requires the submission of patent 
certification information
 Sec. 314.50(j)--Requires the submission of marketing 
exclusivity information
 Sec. 314.5--Requires notice of certification of invalidity or 
noninfringement of a patent
 Sec. 314.53--Requires the submission of patent information.
 Sec. 314.54(a)--Requires the submission of marketing 
exclusivity information.
 Sec. 314.70(e)--Requires the submission of patent information
 Sec. 314.70(f)--Requires the submission of marketing 
exclusivity information
 Sec. 314.94(a)(12)--Requires the submission of patent 
certification information
 Sec. 314.95--Requires notice of certification of invalidity or 
noninfringement of a patent.
 Sec. 314.107(c)(4), (e)(2)(iv), and (f)--Requires notice of 
the date of commercial marketing; a copy of the entry (c)(4), 
(e)(2)(iv), of the order or judgment; 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, 
which is available on the Internet at www.fda.gov/Cder/OB.
    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.
    In the Federal Register of January 3, 2001 (66 FR 372), the agency 
requested comments on the proposed collections of information. No 
significant comments were received.

[[Page 18096]]



                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                               No. of          Annual
              21 CFR Section                 respondent     frequency per   Total annual      Hours per    Total
                                            per response      response        rsponses        response     hours
----------------------------------------------------------------------------------------------------------------
Patent Information.......................
  314.50(h)..............................
  314.53.................................
  314.70(e)..............................       85               3.8           325               2         650
Patent Certification Information.........
  314.50(i)..............................
  314.94(a)(12)..........................       97               3.4           331               2         662
Notice of Certification of Invalidity or
 Noninfringement of a Patent.............
  314.52.................................
  314.95.................................       37               2              75              16         1,200
Marketing Exclusivity Information
 314.50(j)...............................
  314.54(a)(1)(vii)......................
  314.70(f)..............................       92               2.7           250               2         500
Notification of Date of Commercial
 Marketing; Entry of the Order or
 Judgement; Filing of Legal Action.......
  314.107(c)(4), (e)(2)(iv), (f)(2), and        34               2              71               1          71
 (f)(3)..................................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: March 29, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-8307 Filed 4-4-01; 8:45 am]
BILLING CODE 4160-01-S