[Federal Register Volume 62, Number 239 (Friday, December 12, 1997)]
[Notices]
[Pages 65431-65432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32553]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 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 comments on the collection of information by 
February 10, 1998.
ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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. 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 listed below.
    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; 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, 
314.107(c)(4), (e)(2)(iv), (f)(2), and (f)(3)--(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 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 part 314 (21 CFR part 314). The regulations provide 
instructions for NDA applicants (including section 505(b)(2) 
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) Sec. 314.50(i) requires 
patent certification as part of a section 505(b)(2) 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; and (9) Secs. 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 
for 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 titled ``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

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product receives marketing exclusivity, FDA will not approve (or, in 
limited cases, even receive) an ANDA for the drug product during that 
time period.
    Respondents to this collection of information are new drug and 
abbreviated new drug applicants.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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                                                      No. of                                                    
         21 CFR Section               No. of       Responses per   Total Annual      Hours per      Total Hours 
                                    Respondents     Respondent       Responses       Response                   
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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       
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), (f)(3)                        30               1              30               1              30       
Total                                                                                               1,731       
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\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: December 5, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32553 Filed 12-11-97; 8:45 am]
BILLING CODE 4160-01-F