Source: https://www.federalregister.gov/documents/2001/04/05/01-8307/agency-information-collection-activities-submission-for-omb-review-comment-request-abbreviated-new
Timestamp: 2018-02-24 00:37:39
Document Index: 374098723

Matched Legal Cases: ['art 314', 'art 314', '§\u2009314', '§\u2009314', '§\u2009314', '§\u2009314', '§\u2009314', '§\u2009314', '§\u2009314', '§\u2009314', '§\u2009314', '§\u2009314']

Federal Register :: Agency Information Collection Activities; Submission for OMB Review; Comment Request; Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions
A Notice by the Food and Drug Administration on 04/05/2001
Submit written comments on the collection of information by May 7, 2001.
18094-18096 (3 pages)
Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions (OMB Control No. 0910-0305—Extension
https://www.federalregister.gov/d/01-8307 https://www.federalregister.gov/d/01-8307
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 Start Printed Page 18095these 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.
§ 314.50(i)—Requires the submission of patent certification information
§ 314.50(j)—Requires the submission of marketing exclusivity information
§ 314.5—Requires notice of certification of invalidity or noninfringement of a patent
§ 314.53—Requires the submission of patent information.
§ 314.54(a)—Requires the submission of marketing exclusivity information.
§ 314.70(e)—Requires the submission of patent information
§ 314.70(f)—Requires the submission of marketing exclusivity information
§ 314.94(a)(12)—Requires the submission of patent certification information
§ 314.95—Requires notice of certification of invalidity or noninfringement of a patent.
§ 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 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.
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.
No. of respondent per response
Total annual rsponses
Patent Information 314.50(h) 314.53 314.70(e) 85
Patent Certification Information 314.50(i) 314.94(a)(12) 97 3.4
Notice of Certification of Invalidity or ­Noninfringement of a Patent 314.52 314.95 37 2
Marketing Exclusivity Information 314.50(j) 314.54(a)(1)(vii) 314.70(f) 92 2.7
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 (f)(3) 34 2 71
[FR Doc. 01-8307 Filed 4-4-01; 8:45 am]