[Federal Register: August 19, 2004 (Volume 69, Number 160)]
[Page 51468-51469]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0204]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Patent Term 
Restoration, Due Diligence Petitions, Filing, Format, and Content of 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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

DATES: Fax written comments on the collection of information by 
September 20, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management 
Programs (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.

Patent Term Restoration, Due Diligence Petitions, Filing, Format, and 
Content of Petitions--21 CFR Part 60 (OMB Control Number 0910-0233)--

    FDA's patent extension activities are conducted under the authority 
of the Drug Price Competition and Patent Term Restoration Act of 1984 
and the Animal Drug and Patent Term Restoration Act of 1988 (35 U.S.C. 
156). New human drugs, animal drugs, human, biological, medical device, 
food additive, or color additive products regulated by FDA must undergo 
FDA safety, or safety and effectiveness, review before marketing is 
permitted. Where the product is covered by a patent, part of the 
patent's term may be consumed during this review, which diminishes the 
value of the patent. In enacting 35 U.S.C. 156, Congress sought to 
encourage development of new, safer, and more effective medical and 
food additive products. It did so by authorizing the U.S. Patent and 
Trademark Office (PTO) to extend the patent term by a portion of the 
time during which FDA's safety and effectiveness review prevented 
marketing of the product. The length of the patent term extension is 
generally limited to a maximum of 5 years, and is calculated by PTO 
based on a statutory formula. When a patent holder submits an 
application for patent term extension to PTO, PTO requests information 
from FDA, including the length of the regulatory review period for the 
patented product. If PTO concludes that the product is eligible for 
patent term extension, FDA publishes a document in the Federal 
Register, which describes the length of the regulatory review period, 
and the dates used to calculate that period. Interested parties may 
request, under Sec.  60.24 (21 CFR 60.24), revision of the length of 
the regulatory review period, or may petition under Sec.  60.30 (21 CFR 
60.30) to reduce the regulatory review period by any time where 
marketing approval was not pursued with ``due diligence.'' The statute 
defines due diligence as ``that degree of attention, continuous 
directed effort, and timeliness as may reasonably be expected from, and 
are ordinarily exercised by, a person during a regulatory review 
period.'' As provided in Sec.  60.30(c), a due diligence petition 
``shall set forth sufficient facts, including dates if possible, to 
merit an investigation by FDA of whether the applicant acted with due 
diligence.'' Upon receipt of a due diligence petition, FDA reviews the 
petition and evaluates whether any change in the regulatory review 
period is necessary. If so, the corrected regulatory review period is 
published in the Federal Register. A due diligence petitioner not 
satisfied with FDA's decision regarding the petition may, under Sec.  
60.40 (21 CFR 60.40), request an informal hearing for reconsideration 
of the due diligence determination. Petitioners are likely to include 
persons or organizations having knowledge that FDA's marketing 
permission for that product was not actively pursued throughout the 
regulatory review period. The information collection for which an 
extension of approval is being sought is the use of the statutorily 
created due diligence petition.
    Since 1992, seven requests for revision of the regulatory review 

[[Page 51469]]

have been submitted under Sec.  60.24. Three regulatory review periods 
have been altered. Two due diligence petitions have been submitted to 
FDA under Sec.  60.30. There have been no requests for hearings under 
Sec.  60.40 regarding the decisions on such petitions.
    In the Federal Register of May 19, 2004 (69 FR 28929), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 

                                                          Estimated Annual Reporting Burden\1\
                                                                  Annual Frequency per      Total Annual
              21 CFR Section                 No. of Respondents         Response              Responses        Hours per Response        Total Hours
60.24(a)                                                 7                     1                     7                   100                   700
60.30                                                    2                     0                     2                    50                   100
60.40                                                    0                     0                     0                     0                     0
Total                                       ....................  ....................  ....................  ....................             800
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: August 12, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18976 Filed 8-18-04; 8:45 am]