[Federal Register Volume 63, Number 55 (Monday, March 23, 1998)]
[Notices]
[Pages 13864-13865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7474]



[[Page 13864]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0487]


Agency Information Collection Activities; Patent and Exclusivity 
Provisions; Submission for OMB Review; Comment Request

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 (the PRA).

DATES: Submit written comments on the collection of information by 
April 22, 1998.
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: 
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 section 3507 of the PRA 
(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; 21 CFR 314.50(i), 314.50(j), 314.52, 
314.53, 314.54(a)(1)(vii), 314.70(f), 314.94(a)(12), 314.95, and 
314.107(c)(4), (e)(2)(iv), (f)(2), and (f)(3)--(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 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 application (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: (1) Section 314.50(i) requires 
patent certification as part of a section 505(b)(2) of the act 
application; (2) Sec. 314.50(j) requires an NDA applicant to submit 
information if seeking marketing exclusivity; (3) Sec. 314.52 requires 
section 505(b)(2) applicants to provide notice of certification of 
noninfringement of patent or invalidity to patent holders and NDA 
holders; (4) Sec. 314.53 requires submission of patent information as 
part of an NDA or supplement; (5) Sec. 314.54(a)(1)(vii) requires 
applicants to submit a statement if a section 505(b)(2) applicant is 
seeking marketing exclusivity for changes to a listed drug; (6) 
Sec. 314.70(f) requires a statement if an applicant is seeking 
marketing exclusivity for a supplement; (7) Sec. 314.94(a)(12) requires 
an applicant to submit patent information as part of an ANDA; (8) 
Sec. 314.95 requires ANDA applicants to provide notice of certification 
of noninfringement of patent or invalidity to patent holders and NDA 
holders; (9) Sec. 314.107(c)(4), (e)(2)(iv), (f)(2), and (f)(3) require 
notice to FDA by ANDA or section 505(b)(2) application holders of any 
legal action concerning patent infringement.
    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.
    In the Federal Register of December 12, 1997 (62 FR 65431), the 
agency requested comments on the proposed collection of information. No 
comments were received.
    Respondents to this collection of information are new drug and 
abbreviated new drug applicants.

                                  Table 1.--Estimated Annual Reporting Burden1                                  
----------------------------------------------------------------------------------------------------------------
                                                      No. of                                                    
         21 CFR Section               No. of       Responses per   Total Annual      Hours per      Total Hours 
                                    Respondents     Respondent       Responses       Response                   
----------------------------------------------------------------------------------------------------------------
314.50(i)                               8               1               8               2              16       
314.50(j)                              50               1              50               2             100       
314.52                                  8               1               8               8              64       
314.53                                200               1             200               1             200       
314.54(a)(1)(vii)                       8               1               8               1               8       

[[Page 13865]]

                                                                                                                
314.70(f)                              43               1              43               1              43       
314.94(a)(12)                         395               1             395               2             790       
314.95                                 30               1              30              16             480       
314.107(c)(4), (e)(2)(iv),                                                                                      
 (f)(2), and (f)(3)                    30               1              30               1              30       
Total                                                                                               1,731       
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  

    This estimate is based on FDA's experience over the last 3 years in 
receiving this information, and the familiarity by FDA reviewers with 
the amount of time it takes to prepare and submit the information to 
FDA.

    Dated: March 16, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-7474 Filed 3-20-98; 8:45 am]
BILLING CODE 4160-01-F