Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 / Notices 38409

Services’ Office of International Affairs,

other government and nongovernment

organizations, and academic

institutions, as appropriate.

Office of the Director (CAB1). (1)

Manages, directs, and coordinates the

activities of the OGH; (2) provides

leadership in developing OGH policy,

program planning, implementation, and

evaluation; (3) coordinates the

management of legislated international

ceiling exempt positions; (4) coordinates

the CDC cable clearance function; (5)

provides for the orientation and

scheduling of foreign visitors to CDC; (6)

provides CDC support services related

to international travel, such as the

acquisition of passports, visas, and

international clearances; (7) maintains

international travel database and

develops related reports; (8) serves as

the CDC focal point for information

regarding CDC’s overseas assignees.

Dated: July 7, 1998.

Claire V. Broome, M.D.,

Acting Director.

[FR Doc. 98–18935 Filed 7–15–98; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0494]

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, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the requirements for domestic

manufacturers and initial importers of

devices to register their establishments

and list their devices.

DATES: Submit written comments on the

collection of information by September

14, 1998.

ADDRESSES: Submit written comments

on the collection of information to the

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:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301827–1223

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,

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.

Medical Device Registration and

Listing—21 CFR 807

Section 510 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360) requires that manufacturers and

initial importers engaged in the

manufacture, preparation, propagation,

compounding, assembly, or processing

of medical devices intended for human

use and in commercial distribution

register their establishments and list the

devices they manufacture with FDA.

This is accomplished by completing

FDA Form 2891, ‘‘Initial Registration of

Device Establishment’’ and FDA Form

2892, ‘‘Medical Device Listing.’’ In

addition, each year active, registered

establishments must notify FDA of

changes to the current registration and

device listing for the establishment.

Annual changes to current registration

information are pre-printed on FDA

Form 2891a and sent to registered

establishments. The form must be sent

back to FDA’s Center for Devices and

Radiological Health (CDRH), even if no

changes have occurred. Changes to

listing information are submitted on

Form 2892. Refurbishers/reconditioners

are not required to register or list;

however, FDA will accept voluntary

registration and listings from firms that

wish to be registered with FDA.

In addition, under § 807.31 (21 CFR

807.31), each owner or operator is

required to maintain a historical file

containing the labeling and

advertisements in use on the date of

initial listing, and in use after October

10, 1978, but before the date of initial

listing. The owner or operator must

maintain in the historical file any

labeling or advertisements in which a

material change has been made anytime

after initial listing, but may discard

labeling and advertisements from the

file 3 years after the date of the last

shipment of a discontinued device by an

owner or operator. Along with the

recordkeeping requirements above, the

owner or operator must be prepared to

submit to FDA upon specific request all

labeling and advertising mentioned

above (§ 807.31(e)).

The information collected through

these provisions is used by FDA to

identify firms subject to FDA’s

regulations and is used to identify

geographic distribution in order to

effectively allocate FDA’s field

resources for these inspections and to

identify the class of the device which

determines the inspection frequency.

When complications occur with a

particular device or component,

manufacturers of similar or related

devices can easily be identified.

The likely respondents to this

information collection will be domestic

establishments engaged in the

manufacture, preparation, propagation,

compounding, assembly, or processing

of medical devices intended for human

use and commercial distribution.

FDA estimates the burden of this

collection of information as follows:
38410 Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section FDA Form No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

807.22(a) Form 2891–Initial Establishment. Registration1,462 1 1,462 .25 366

807.22(b) Form 2892–Device Listing (initial and update)5,640 1 5,640 .50 2,820

807.22(a) Form 2891a–Registration

Update

22,000 1 22,000 .25 5,500

807.31(e) 200 1 200 .50 100

TOTALS 8,786

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

807.31 7,900 10 79,000 0.5 39,500

TOTALS 39,500

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

The annual reporting burden hours to

respondents for registering

establishments and listing devices is

estimated to be 8,786 hours, and

recordkeeping burden hours for

respondents is estimated to be 39,500

hours. The estimates cited in the tables

above are based primarily upon the

annual FDA Accomplishment Report,

which includes actual FDA registration

and listing figures from fiscal year (FY)

1997. These estimates are also based on

conversations with industry and trade

association representatives, and internal

review of the FDA forms and documents

referred to in the previous tables.

According to 21 CFR part 807, all

owners/operators are required to list,

and establishments are required to

register. Each owner/operator has an

average of two establishments,

according to statistics gathered from

FDA’s Registration and Listing Data

Base. The data base has 22,000

establishments listed in it. Based on

past experience, the agency anticipates

that approximately 1,462 registrations

will be processed annually, and that

5,640 initial and update device listings

will be submitted. Although FDA only

processed 12,237 annual registrations

during FY 1997 due to a delay in

sending out the annual registration

forms, the normal amount of processing

of annual registrations in the past has

been 22,000. FDA anticipates reviewing

200 historical files annually. Finally,

because initial importers (currently

estimated at 6,200) do not have to

maintain historical files, FDA estimates

that the number of recordkeepers

required to maintain the initial

historical information will be 7,900

(which is the number of establishments,

22,000 minus the number of initial

importers, 6,200, divided by 2, the

average number of establishments per

owner/operator).

Dated: July 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18877 Filed 7–15–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0271]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; PANDEL Cream

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

PANDEL Cream and is publishing this

notice of that determination as required

by law. FDA has made the

determination because of the

submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6620.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may