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

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