Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Notices 65431

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.

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) § 314.50(i)

requires patent certification as part of a

section 505(b)(2) application; (2)

§ 314.50(j) requires an NDA applicant to

submit information if seeking marketing

exclusivity; (3) § 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) § 314.53 requires

submission of patent information as part

of an NDA or supplement; (5)

§ 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) § 314.70(f) requires a statement if an

applicant is seeking marketing

exclusivity for a supplement; (7)

§ 314.94(a)(12) requires an applicant to

submit patent information as part of an

ANDA; (8) § 314.95 requires ANDA

applicants to provide notice of

certification of noninfringement of

patent or invalidity to patent holders

and NDA holders; and (9)

§§ 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
65432 Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Notices

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

21 CFR Section No. of

Respondents

No. of

Responses per

Respondent

Total Annual

Responses

Hours per

Response Total Hours

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

1There 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0320]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Filing Objections and Requests for a

Hearing on a Regulation or Order’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(the PRA).

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 6, 1997 (62

FR 42257 to 42258), the agency

announced that the proposed

information collection had been

submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0184. The

approval expires on September 30,

2000.

Dated: December 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32583 Filed 12–11–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0443]

Iron-Containing Supplements and

Drugs: Label Warning Statements and

Unit-Dose Packaging Requirements;

Small Entity Compliance Guide;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a small entity compliance

guide entitled ‘‘Iron-Containing

Supplements and Drugs: Label Warning

Statements and Unit-Dose Packaging

Requirements; Small Entity Compliance

Guide’’ (compliance guide). This

compliance guide is intended to help

small entities comply with the final rule

requiring label warnings and unit-dose

packaging for iron-containing

supplements and drug products. This

action is being taken under the Small

Business Regulatory Enforcement

Fairness Act of 1996 (the SBREFA).

DATES: Written comments on the

compliance guide may be submitted at

any time.

ADDRESSES: An electronic version of the

compliance guide entitled ‘‘IronContaining Supplements and Drugs:

Label Warning Statements and UnitDose Packaging Requirements; Small

Entity Compliance Guide’’ is available

on the Internet at ‘‘http://

vm.cfsan.fda.gov/∼dms/secqiron.html’’.

Printed copies may be obtained from the

Iron Labeling and Packaging, Industry

Activities Staff (HFS–565), Center for

Food Safety and Applied Nutrition,

Food and Drug Administration, 200 C

St. SW., Washington, DC 20204. Submit

written comments on the compliance

guide to the contact person below.

FOR FURTHER INFORMATION CONTACT:

Linda S. Kahl, Center for Food Safety

and Applied Nutrition (HFS–206), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3101.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 15, 1997 (62

FR 2218), FDA issued a final rule

requiring: (1) Label warning statements

on products taken in solid oral dosage

form to supplement the dietary intake of

iron or to provide iron for therapeutic

purposes and (2) unit-dose packaging

for iron-containing products that

contain 30 milligrams or more of iron

per dosage unit. This final rule became

effective July 15, 1997.