Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Notices 38289

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

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 set forth in this document.

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.

Export of Medical Devices—Foreign

Letters of Approval—Federal Food,

Drug, and Cosmetic Act—21 U.S.C.

381(e)(2) (OMB Control No. 0910–

0264)—Extension

Section 801(e)(2) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 381(e)(2)) provides for the

exportation of an unapproved device

under certain circumstances if the

exportation is not contrary to the public

health and safety and it has the approval

of the foreign country to which it is

intended for export.

Requesters communicate (either

directly or through a business associate

in the foreign country) with a

representative of the foreign government

to which they seek exportation, and

written authorization must be obtained

from the appropriate office within the

foreign government approving the

importation of the medical device.

FDA uses the written authorization

from the foreign country to determine

whether the foreign country has any

objection to the importation of the

device into their country.

The respondents to this collection of

information are companies that seek to

export medical devices.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Statute No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Section 801(e)(2) of the Federal Food, Drug, and

Cosmetic Act

20 1 20 2.5 50

Total 50

1There are no capital costs or operating and maintenance costs associated with this collection of information.

These estimates are based on the

experience of FDA’s medical device

program personnel, who estimate that

completion of the requirements of this

collection of information should take

approximately 2.5 hours to complete.

Prior to the enactment of the Food and

Drug Export Reform and Enhancement

Act of 1996, FDA received

approximately 800 requests from U.S.

firms to export medical devices under

section 801(e)(2) of the act. The

enactment of the Food and Drug Export

Reform and Enhancement Act of 1996

has greatly reduced the number of

export permit requests made to the

present estimated 20 per year.

Dated: June 14, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–15433 Filed 6–19–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–4166]

Agency Information Collection

Activities; Announcement of OMB

Approval; Electronic Records;

Electronic Signatures

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Electronic Records; Electronic

Signatures’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezutto, 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 October 1, 1999 (64

FR 53392), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 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 0910–0303. The

approval expires on May 31, 2003. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

38290 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Notices

Dated: June 14, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–15432 Filed 6–19–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0726]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; General

Licensing Provisions: Changes to an

Approved Application, Labeling, and

Revocation and Suspension

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

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.

DATES: Submit written comments on the

collection of information by July 20,

2000.

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: Wendy

Taylor, Desk Officer for FDA.

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

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

General Licensing Provisions: Changes

to an Approved Application, Labeling,

and Revocation and Suspension (OMB

Control Number 0910–0315)—Extension

Under Section 351 of the Public

Health Services Act (PHS Act) (42

U.S.C. 262), manufacturers of biological

products must submit a license

application for FDA review and

approval prior to marketing a biological

product in interstate commerce.

Licenses may be issued only upon

showing that the establishment and the

products for which a license is desired

meet standards prescribed in regulations

designed to ensure the continued safety,

purity, and potency of such products.

All such licenses are issued, suspended,

and revoked as prescribed by

regulations.

In part 601 (21 CFR part 601),

§ 601.2(a) requires a manufacturer of a

biological product to submit an

application with accompanying

information, including labeling

information, to FDA for approval to

market a product in interstate

commerce. Section 601.12(b), (c), and

(d) requires applicants to follow specific

procedures in informing FDA of each

change, established in an approved

license application, in the product,

production process, quality controls,

equipment, facilities, or responsible

personnel depending on the potential

for the change to have a substantial,

moderate, minimal or no adverse effect

on the safety or effectiveness of the

product. Section 601.12(e) requires

applicants to submit a protocol, or

change to a protocol, as a supplement

requiring FDA approval prior to

distributing the product. Section

601.12(f)(1), (f)(2), and (f)(3) requires

applicants to follow specific procedures

in reporting labeling changes to FDA.

Section 601.12(f)(4) requires advertising

and promotional labeling and any

changes to be reported to FDA. Section

601.45 requires applicants to submit to

the agency for consideration, during the

preapproval review period, copies of all

promotional materials, including

promotional labeling as well as

advertisements. In addition to §§ 601.2

and 601.12, there are other regulations

that relate to certain information

submitted in a license application or

supplement as follows: Part 640 (21 CFR

part 640), specifically §§ 640.6, 640.17,

640.21(c), 640.22(c), 640.25(c),

640.56(c), 640.64(c), 640.74(a), and

(b)(2); 21 CFR 660.51(a)(4) and

680.1(b)(2)(iii) and (c). The burden

associated with the information

collection requirements in these

regulations is included in the burden

estimate for § 601.2, reported under

OMB Control No. 0910–0427, and

§ 601.12 in table 1 of this document.

Sections 600.15(b) and 610.53(d) require

the submission of a request for an

exemption or modification regarding the

temperature requirements during

shipment and from dating periods,

respectively, for certain biological

products. Section 601.25(b) requests

interested persons to submit, for review

and evaluation by an advisory review

panel, published and unpublished data

and information pertinent to a

designated category of biological

products that have been licensed prior

to July 1, 1972. Section 601.26(f)

requests that licensees submit to FDA a

written statement intended to show that

studies adequate and appropriate to

resolve questions raised about a

biological product have been

undertaken for a product if designated

as requiring further study under the

reclassification procedures. Section

601.5(a) requires a licensee to give

notice of its intention to discontinue

manufacture of a product or all

products. Section 601.6(a) requires the

licensee to notify selling agents and

distributors upon suspension of its

license, and provide FDA with records

of such notification.

Form FDA 2567 is used by

manufacturers of licensed biological

products to submit labeling (e.g.,

circulars, package labels, container

labels, etc.) and labeling changes for

FDA review and approval. The labeling

information is submitted with the form

for license applications, supplements, or

as part of an annual report. Form FDA

2567 is also used for the transmission of

advertisements and promotional

labeling. Form FDA 2567 serves as an

easy guide to assure that the

manufacturer has provided the

information required for expeditious

handling of their labeling by the Center

for Biologics Evaluation and Research

(CBER). For advertisements and

promotional labeling, manufacturers of

licensed biological products may submit

to CBER either Form FDA 2567 or 2253.

Form FDA 2253 was previously used

only by drug manufacturers regulated by

the Center for Drug Evaluation and

Research. In August of 1998, FDA

revised and harmonized Form FDA

2253 to enable the form to be used to

transmit specimens of promotional

labeling and advertisements for

biological products as well as for

prescription drugs and antibiotics. The

revised, harmonized form updates the

information about the types of

promotional materials and the codes

that are used to clarify the type of

advertisement or labeling submitted;

clarifies the intended audience for the

advertisements or promotional labeling

(e.g., consumers, professionals, news

services); and helps ensure that the

submission is complete.

The number of respondents is based

on the estimated annual number of

manufacturers that submitted the

required information to FDA. There are

an estimated 350 licensed biologics

manufacturers. However, not all

manufacturers will have any

submissions in a given year and some

may have multiple submissions. The