[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]]
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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.
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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
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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
[[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
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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: 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
